Cancer and Oxalic Acid : Hart Dietary Procedure Plan : the Cure in Food : Oxalic Acid, God's Natural Chemotherapy 0972645705, 9780972645706

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Cancer and Oxalic Acid : Hart Dietary Procedure Plan : the Cure in Food : Oxalic Acid, God's Natural Chemotherapy
by Colonel Joe, Colonel Joe Francis Joseph Hart, Colonel Joe, Col Joe, Francis J Hart, Francis Hart

"Colonel Joe" Hart
February 19, 1921 - May 23, 2014

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U.S. VeteranFrancis Joseph Hart, aka Colonel Joe, 93, of Pea Ridge passed away peacefully at home on May 23rd. He was well known around the area for his strong opinions and his frequent contributions on local radio, particularly about topics related to government activities and his patented "Harts Dietary Procedure". A decorated war hero, Colonel Joe, enlisted in the military during WWII as a minor; beginning his career as a mechanic and working his way up through the ranks and becoming a B17 Bomber pilot. He flew 29 missions over Germany and was shot down on his final mission. He spent a year in a Nazi Prisoner of War camp. In January of 1945, he left the camp on foot as part of the infamous Death March in the midst of one of the worst blizzards in history. During the course of the expedition, he aided fellow American soldiers as well as the Nazi guards as many succumbed to the affects of the weather and the dysentery that plagued so many.

Colonel Joe received many awards and commendations during his illustrious career including the Purple Heart, the Distinguished Flying Cross, the Air Force Commendation Medal, the Air Medal with Leaf Clusters, and several others. After the war he became a test pilot for Boeing in Tulsa, Oklahoma, certifying new planes for delivery to the Air Force, including the B47 Strategic Jet Bomber. He then went on to work on quality control for the Titan ICBM launch sites. After retiring from the military; he worked for Martin Marietta in Denver, Colorado where he was a Quality Control coordinator for the Lunar Lander.

Upon retirement, he moved to Pea Ridge where he began a quest to determine the cause of the untimely death of his beloved poodle. After a significant amount of research, he learned that the dog's death was likely due to a dietary phenomenon. His research also led led him to the discovery of a chemical in plants that he believed to have natural chemotherapeutic properties. He applied and received three patents for the chemical as a cancer fighting agent, about which he wrote the book, "Harts Dietary Procedure".

Throughout his retirement, he was always going out of his way to help others with no expectation for recognition or anything in return. He was preceded in death by his parents, Lewis D Hart and Minnie B. Bauch; two brothers and three sisters.

Colonel Joe is survived by his two sons, Mike Hart of Cypress, Texas, Pat (Sheri) Hart of El Centro, California; a daughter, Toni (Ron) Isliefson of Lakeview, Minnesota and a granddaughter Krystal Marie.

A memorial service will be held at a later date. Arrangements are by Sisco Funeral Home in Pea Ridge.

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Sisco Funeral Home, Inc. "Colonel Joe" Hart ( February 19, 1921 - May 23, 2014 )

Francis Joseph Hart, aka Colonel Joe, 93, of Pea Ridge passed away peacefully at home on May 23rd. He was well known around the area for his strong opinions and his frequent contributions on local radio, particularly about topics related to government activities and his patented "Harts Dietary Procedure". A decorated war hero, Colonel Joe, enlisted in the military during WWII as a minor; beginning his career as a mechanic and working his way up through the ranks and becoming a B17 Bomber pilot. He flew 29 missions over Germany and was shot down on his final mission. He spent a year in a Nazi Prisoner of War camp. In January of 1945, he left the camp on foot as part of the infamous Death March in the midst of one of the worst blizzards in history. During the course of the expedition, he aided fellow American soldiers as well as the Nazi guards as many succumbed to the affects of the weather and the dysentery that plagued so many. Colonel Joe received many awards and commendations during his illustrious career including the Purple Heart, the Distinguished Flying Cross, the Air Force Commendation Medal, the Air Medal with Leaf Clusters, and several others. After the war he became a test pilot for Boeing in Tulsa, Oklahoma, certifying new planes for delivery to the Air Force, including the B47 Strategic Jet Bomber. He then went on to work on quality control for the Titan ICBM launch sites. After retiring from the military; he worked for Martin Marietta in Denver, Colorado where he was a Quality Control coordinator for the Lunar Lander. Upon retirement, he moved to Pea Ridge where he began a quest to determine the cause of the untimely death of his beloved poodle. After a significant amount of research, he learned that the dog's death was likely due to a dietary

phenomenon. His research also led led him to the discovery of a chemical in plants that he believed to have natural chemotherapeutic properties. He applied and received three patents for the chemical as a cancer fighting agent, about which he wrote the book, "Harts Dietary Procedure". Throughout his retirement, he was always going out of his way to help others with no expectation for recognition or anything in return. He was preceded in death by his parents, Lewis D Hart and Minnie B. Bauch; two brothers and three sisters. Colonel Joe is survived by his two sons, Mike Hart of Cypress, Texas, Pat (Sheri) Hart of El Centro, California; a daughter, Toni (Ron) Isliefson of Lakeview, Minnesota and a granddaughter Krystal Marie. A memorial service will be held at a later date. Arrangements are by Sisco Funeral Home in Pea Ridge.

USOO6133317A

United States Patent (19)

11 Patent Number: (45) Date of Patent:

Hart 54) OXALIC ACID OR OXALATE

COMPOSITION AND METHOD OF TREATMENT

76 Inventor: Francis J. Hart, 390 Ryan Rd., Pea Ridge, Ark. 72751 *

Notice:

This patent is Subject to a terminal dis claimer.

21 Appl. No.: 08/629,538 22 Filed: Apr. 9, 1996 60 51) 52 58

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Cowdry, E. Croninger, A. Solaric, S. Suntzeff, V. Cancer, Journal of the American Cancer Society, Combined Action of Cigarette Tar & Beta Radiation of Mice-1961, vol. 14 pp. 344-352. Bock, F. Moore, G. Journal of the National Cancer Institute,

Carcinogenic Activity of Cigarette Smoke Condensate. I.

Effect of Trauma & Remote X-Irritation. Vol. 22 No.

2-1959- pp. 401–411. Lundin, Jr., F. Lloyd, J & Smith, E. and Archer, V. & Holaday, d. Health Physics. Mortality of Uranium in Rela tion to Radiation Exposure, Hard-Rock Mining and Ciga rette Smoke 1950 through Sep. 1967. pp. 571-578. Ethnopharmacology-1994 Testing Garlic for Possible Anti-Ageing Effects on Long-term Growth Charactistics, Morphology and Macro Molecular Synthesis of Human Fibroblasts in Culture- pp. 125-133. Ney, D.M. The Low Oxalate Diet Book for the Prevention of the Oxalate Kidney Stones- pp. 944-945 & Appendix Table 13, University of California, San Diego 1981. U.S. Department of Health & Human Services Public Health

Service National Institutes of Health, NIH Publication, Eat

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3,542,573 11/1970 Biland et al. ........................... 106/186 3,787,589 1/1974 Stephens et al. . ... 426/325 4,156,067 5/1979 Gould ........................................ 528/73 4,285,972 8/1981 Chou et al. 4,340,609 7/1982 Chou ............. 4,760,157 7/1988 Child et al. ... 4,900,746 2/1990 Hanson et al. 5,137,722 8/1992 Costello ........ 5,151,274 9/1992 Saltman et al. 5,175,144 12/1992 Walser .......... 5,183,674 2/1993 Olin .....................

*Oct. 17, 2000

Svendsen, L. Rattan, Surech I.S. Clark, Brian F.C. Journal of

Related U.S. Application Data Provisional application No. 60/006,785, Nov. 15, 1995. Int. Cl." ....................... A61K 31/194; A61K 31/225 U.S. Cl. ............................. 514/574; 514/547; 424/49 Field of Search ...................................... 514/574,547

56)

6,133,317

... ... ... ... ..., ...

424/326 424/322 556/137 514/400 424/195 424/630 ... 514/2 ... 426/2

5,227,248 5.245,095 5,292,511 5,292,773 5,310,554 5,314,686 5,324,443 5.330,972

7/1993 9/1993 3/1994 3/1994 5/1994 5/1994 6/1994 7/1994

Wullschleger et al. ... 426/549 Graves et al. ... ... 585/351 Kim et al...... 424/195.1 Hirsch et al. . ... 514/554 Haigh ............ ... 424/439 Todd, Jr. ................................. 424/401 Arif et al. ............................... 252/142 Cope ........................................... 514/2

5,346,707 5,376,361 5,401,325 5,455,372 5,470,874

9/1994 12/1994 3/1995 10/1995 11/1995

Olin ...... ... 426/69 Perricone .................................. 424/59 Meielic et al. ............................ 134/39 Hirai et al. .............................. 560/179 Lerner ..................................... 514/474

OTHER PUBLICATIONS

The Merck Index, 11th ed, Merck & co., Inc., Rahway, N.J., p. 1093, 1989. Houpis, I., Molina, A., Reamer, R., Lynch, J., Volante, R.P., and Reider, P. Towards the Synthesis of HIV-Protease Inhibitors. Synthesis of Optically Pure 3-Carboxyl-decahy droisoquinolines. Tetrahedron Letters, Vol. 34, No. 16, pp. 2593-2596, 1993. Dyer, An Index of Tumor Chemotherapy, NIH, Mar., 1949,

pp. 10–12 and 72 (No. 2015).

Hodgkinson, A. Oxalic Acid in Biology and Medicine, Academic Press, 1977 pp. 1-3, 16-17, 18-21, 23, 37-38,

49-51, 69–80, 84–88, 100–103, 110-111, 122–124, 130, 133-135, 153–156, 159-164, 168-174, 180-182, 196-207, 216–228, 238.

More Fruits & Vegetables, Oct. 1991. Chem One Corporation. Product Data Sheet, 1995. Occupational Health Services. msds on oxalic acid, 1994. The Merck Manual, Diagnosis and Therapy, 1987 pp. 2465-2466, Oncology pp. 1206-1228.

(List continued on next page.) Primary Examiner-Richard L. Raymond Attorney, Agent, or Firm-Head, Johnson & Kachigian 57

ABSTRACT

An Oxalic acid or oxalate composition and method of treatment of warm blooded animals including humans and pets is provided which includes at least one therapeutically effective form of Oxalic acid or oxalate Selected, for

example, from oxalic acid in a free acid, ester, lactone or Salt form, oxalates including Sodium oxalate, a nutritional Supplement containing oxalic acid or oxalate, Oxalic acid dihydrate, anhydrous Oxalic acid, OXamide, oxalate Salts, natural or processed foods including molds, plants or Veg etables containing Oxalic acid or oxalate, beverages, liquids or juices containing Oxalic acid or oxalate, additives con taining oxalic acid or oxalate, and combinations thereof. The composition may also contain a pharmaceutically acceptable carrier or diluent for the therapeutically effective form of Oxalic acid or oxalate. A method is provided including the Steps of periodically administering a therapeutically effec tive dosage of a composition including at least one thera peutically effective form of Oxalic acid or oxalate and reducing the intake of Oxalic acid or oxalate blockerS Such

as citric acid, ascorbic acid (vitamin C), pyridoxine hydro chloride (vitamin B6), calcium, alcohol, resins, clays, dairy

products containing calcium, fruits, coconut, beverages con taining alcohol, ascorbic acid or citric acid, red meat or white meat of fowl containing pyridoxine hydrochloride, or other foods, nutritional Supplements or beverages containing alcohol, citric acid, ascorbic acid, pyridoxine hydrochloride, or combinations thereof.

Davis, Adelle, Lets Get Well, Penguin Group, 1972 pp. 195, 204-205, 213, 299.

104 Claims, 1 Drawing Sheet

6,133,317 Page 2 OTHER PUBLICATIONS

NIH Specification 11-133 Open Formula Rat and Mouse

Ration 9NIH)0–07) Nov. 1, 1986.

NIH Specification 11-137 Crude Protein Autoclavable

(NIH-31)) Nov., 1986.

Organic Gardening Articles, Rodale Press, Inc. Hurley, J.B. Calcium From the Garden Apr. 1986, pp. 96-98 Duke, L.A. Weeds? or Wonder Drugs? Jul. 1994 pp. 38–39 Duke, J.A. Eat Your Weedies Jul. 1993 pp. 31-35 Mattern, V. Don't Weed 'em, Eat 'em Apr. 1994 pp. 71–74. Better Nutrition-Veggie Corner-Broccoli and Watercress Are Rich Cancer Fighters, Aug. 1994 p. 22 Editors Desk Novel Cancer Therapies Deserve a Fair Hearing, Aug. 1994 p. 6. Parade Magazine Special Intelligence Report, men Should Think Twice Before Eating Steak, Oct. 1994, p. 16. Journal National Cancer Institute, No. 85, Explanation For Link Between Alcohol and Breast-Cancer risk 1993, abstract.

Microsoft Internet Explorer/Open Text Index From: http:// www/mcs/net/joyce/new.html Essiac Tea From Canada Comes A Remedy Called Essiac, Or Ojibwa Tea 1995, pp. 1-7 From: gopher://wiretap/spies/com/oo/ILibrary/Fringe/ Pharm/essiac.txt ESSiac: a natural herbal alternative cancer

treatment. Glum, G.L. Calling of An Angel, Apr. 1993 pp. 1-15.

From:http://www/envirolink/org/arrs/VRG/calcium.html Mangels, R. Calcium in the Vegan Diet 1991 pp. 1-6. Weil, Andrew Natural Health, Natural Medicine, How Not

to Get Cancer, Houghton Mifflin Company 1990 pp. 169-189.

Robbins, J. Diet for a New America. Losing A War We Could Prevent, Stillpoint Publishing 1987, pp. 248-273,

Readers Digest, News From the World of Medicine, Device Spots Colon Cancer & Indoor Tanning? Don't Do It. Mar.

403-409

1994. Sunscreen: Slather It On, Do Fats Fuel Prostate

Berkely, B. Nutritional Protocol for HIV, Project Inform San

Cancer? May 1994. Folic Acid, Superstar, Jun. 1994. Letters, Natural Health. Beta-Carotene Debate Continues,

Francisco 1994.

Nov. 1994.

Nau, Jean-Yves Preventing Spread of BSE, The Lancet Sep. 1994 vol. 344, p. 808. Carper, Jean, Foods That Fight Cancer, Reader's Digest, Jan. 1994, pp. 119-122.

Microsoft Internet Explorer/NECX From Gopher:// gopher.nih. gov/00/clin/cdcs/67. kidney-Prevention and Treatment of Kidney Stones national Institute of Health Consensus Development Conference Statement, Mar. 1988 pp. 1-14.

U.S. Patent

Oct. 17, 2000

6,133,317

FIG. 1 48 ANX107 mol/ml Riso 100mMaxalic acid

A = spectrophotometry O = tritration

6,133,317 1 OXALIC ACID OR OXALATE COMPOSITION AND METHOD OF TREATMENT CROSS REFERENCE TO RELATED APPLICATIONS

This application claims benefit of U.S. Provisional Patent Application Ser. No. 60/006,785, filed Nov. 15, 1995. BACKGROUND OF THE INVENTION

This invention relates to oxalic acid or oxalate

compounds, nutritional Supplements, natural or processed foods, beverages, and methods of treatment utilizing oxalic acid or oxalate compounds, Vitamin B6, vitamin C, alcohol, calcium, and/or foods, nutritional Supplements, beverages, and the like containing one or more of these compounds. The story begins with two toy poodles, Turk and Taka. These animals lived a normal house life. Except for the occasional trip or walk to the nearby reservoir, their territory was the house and backyard. AS young pups they were full of energy and, of course, very spoiled. Habits, mostly bad ones, were easily formed, Such as eating people food, Some of which, according to a veterinarian, would not hurt them. Turk became fond of SNICKERS(R) brand candy bars, espe cially the Small bite-size kind, and also carrots and beets, both of which are appearing in Some commercial dog foods today. During this time, Turk's owner, the present applicant and inventor, was doing a great deal of traveling, averaging one trip a week, and he always kept a small SNICKERS(R) bar

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him about oxalates. The chemist Said that an oxalate is a

compound found in trees, mainly oaks. The owner's curi osity was running high, and as Soon as he could break away from work, he went Straight for a dictionary. Oxalate is defined as a Salt or ester of Oxalic acid, and the acid

near the front door in case he returned home without one.

Another one of Turk's favorite treats was the small soybean crackers in oriental cocktail mix, which Turk's owner ate

constantly when he was home. When Turk was about a year and six or seven months old, Turk began to slow down. Turk's eagerness to play left him, and his appetite diminished except for the little treats mentioned above. Turk was drinking much more water and had frequent accidents in the house, especially at night. Turk's color changed from a parfaittinge to a Solid white, and just before his death, to a dull grayish-white. When Turk began to vomit occasionally after eating or drinking, Turk's owner became concerned and took Turk to the Veterinarian. The examination revealed nothing, and the Veterinarian diagnosed Turk as having indigestion and gave

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Turk Some medicine. Turk's condition worsened, and So Turk was returned to the veterinarian. Blood and urine

Samples were taken, and test results revealed that Turk's urine was watery, but otherwise all right. The blood however, showed a high white cell count, and the Veterinar ian thought there might be an infection and prescribed pills. One Single pill brought on violent Vomiting. Turk's owner Stopped giving Turk the pills and Started Turk on amoxicil

50

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lin.

Turk's condition worsened, so Turk was taken to the

animal hospital center where they determined Turk's kid neys were failing. Turk was put on an IV due to Severe dehydration. The doctors stated that they could not treat Turk unless Turk's owner could tell them what poison or chemical Turk had ingested. For the next several days Turk's

60

owner went on a frantic Search for answers. Turk's owner

contacted a number of agencies for possible clues to the poisoning: Tri-County Health Department; two toxicologists with the EPA; the U.S. Corps of Engineers, who assured him that they test the reservoir daily for contaminants, and

2 UCLA and University of Illinois poison centers. Heavy rains would bring Standing water into the backyard, So Turk's owner tracked down the owners of a stable and a nursery that used to operate in the area before the houses were built, to See if they had used any type of toxic sprayS. Turk's owner contacted nurseries from which he had recently bought plants. Turk's owner even contacted the 3M Company, Since new carpeting with SCOTCHGARD(R) had been installed. Turk's owner asked all neighbors who had pets to find out if their pets had become Sick. Turk's owner also called veterinary clinics to find out if they had diagnosed similar caseS recently. He also Searched every Square foot of the house, garage, and Storage building looking for chemicals, especially antifreeze. Out of desperation, Turk's owner pleaded with the Veterinarians to list poisons that had the same fingerprint, and he would then choose one So Veterinarians could begin treatment. The Veterinarians declined. When blood began to appear in Turk's stool and vomit, and the kidneys had shut down, Turk was put to sleep. Turk's owner vowed that with God's help he would find out what had destroyed Turk. The attending veterinarian at the veterinary hospital was an organ Specialist and professor at Colorado State Univer sity. The Veterinarian extended his Sympathy and after a few other exchanges he informed Turk's owner that there is one Substance very damaging to renal tissue-oxalates. The owner drove directly to his company's quality control department lab where he cornered a chemist and questioned

65

definition refers back to the oak tree. Oxalic acid is further

defined as an industrial chemical used in textile and dye manufacturing as a bleaching agent. From the dictionary, he went to the chemical books, found Oxalic acid and got promptly lost in a maze of formulae and equations. The owner eliminated oxalates or oxalic acid from his mind as a

cause of Turk's death. What did stay in his mind was Turk's death, and again he renewed his vow to find the answer. He could not get Turk out of his thoughts, because every time he looked at Taka, Turk's brother, he wondered why Turk had died and not Taka'?

One outside activity of Turk's owner was, and still is, gardening. Naturally, he had a Subscription for the organic gardening magazine, and perused through every article. In the April 1986 edition he came across an article by Judith Benn Hurley, “Calcium From Your Garden,” and up popped the word oxalate. Imagine his Surprise, an industrial chemical, a poison, in a magazine on organic gardening. Once again the Search was on. The owner wrote a letter to MS. Hurley describing his research, the reason for it, and asked if she had anymore information on oxalates she could share. The reply he received provided him with more information than he could have hoped for. Her reply sent him to the library, to the Section containing books on nutrition. He read many Volumes and was amazed by the amount of information available on plant life and the effects of plant Vitamins on maintaining human life. His effort was rewarded when he found a volume Let's Get Well by Adelle Davis, 1965. It contains the perfect finger print of Turk's death. Chapter 19, page 239 states the following: When both vitamin B6 and magnesium are undersupplied, the kidneys are further damaged by Sharp crystals of Oxalic acid combined with calcium, and as much as

6,133,317 4 Benn Hurley. He explained to her that the reason her red cell count was low was because of her diet. She ate very little meat, a primary Source of pyridoxine (vitamin B6), did not drink much Soda pop, orange or pineapple juice (all high in citric acid), and only consumed alcohol in moderate quan tities. Her diet contained items high in Oxalic acid, like Spinach, her favorite Salad. The owner mentioned that in his

3 three-quarters of the kidney may be replaced by Scar tissue. Children with Oxalic acid kidney Stones fre quently have high blood pressure and kidneys So dam aged that they become progressively worse, causing death from kidney failure early in life. The owner's mind went back to information he had

gathered concerning the use of beagles in testing because their organs are more like those of a child than any other

research he had discovered there were three chemicals that

animal. How true the statements, “love them to death” and

would counteract the Oxalic acid-pyridoxine hydrochloride

also “kill them with kindness.” The owner believed that he

(vitamin B6), citric acid, and alcohol. He gave her a handful

had inadvertently killed Turk by feeding him candy bars, Soybean crackers, beets, carrots, and who-knows-what-else that might have been very high in oxalate, Oxalic acid or both. He believed that these snacks saturated Turk's system to a point where Turk's kidneys could no longer function. When that happened, the acid began to destroy renal tissue. AS the tissue was being destroyed, Turk's condition wors

of 50 mg vitamin B6 pills and Suggested she take one immediately and then one a day for the first week, and then one every other day. Three weeks later she told him that the doctor had just Scheduled her operation.

15

ened until other vital functions were affected. Turk's owner

also believed that Since oxalates and oxalic acid SuppreSS calcium, no healthy red blood cells were being produced. The blood in Turk's system had to have been totally satu rated with oxalic acid. When all the renal tissue was

destroyed, the kidneys shut down and Swelling began due to edema. There was no hope for recovery. Taka was not affected because he did not crave or eat

25

soybean crackers, beets or carrots, nor the SNICKERS(R) brand candy bars with peanuts. When the owner realized what caused Turk's death, he put Taka on an oxalate/oxalic acid-free diet. Some weeks after putting Taka on the diet, the color of Taka's coat, which had faded, began returning to normal. Knowing that a human could Suffer from an exceSS of Oxalates and Oxalic acid, the owner put himself on a Similar diet as well.

Several Significant events occurred beginning with the return of the color of Taka's coat while on the oxalate-free

35

diet. The owner began to watch for Signs in his own hair and noticed that his graying Seemed to have at least Slowed down. Since the owner was due for a physical, he checked into a clinic and Stated he had Some minor pain in his chest on the left Side where he had muscles torn in a car accident

bar meals loaded with oxalic acid. He had his wife imme

40

many years earlier. During the exam, the doctor decided to be safe and ordered an EKG. In prepping for the EKG, the nurse shaved his chest where the transducer cups would be placed, and then with a Small orbital Sander removed Some of the dead skin for better contact. Weeks after the exam

when the hair began growing out, it was black instead of gray or white. Many mornings before starting the oxalate-free diet, the owner would get out of bed with a dull backache, and occasionally it would really spasm when he would lean over the wash basin while brushing his teeth. He complained and Swore he would get a new mattress, believing it to be the cause of the backaches. By the end of the day the ache would be gone and out of mind. When the backaches Stopped, he realized it was his kidneys and knew it was the Soybean

45

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crackers and nuts in the oriental mix and other related items

that had raised his oxalate level to the point it began bothering his kidneyS. After retirement, Turk's owner was planning to move and Some friends Stopped by to visit. One evening while having cocktails with the friends, they began talking about health and age, etc. One of the ladies mentioned she needed bypass Surgery, but it could not be Scheduled because her red blood cell count was low, and the doctors could not get it to rise, even though She was on a third medication. Turk's owner's research had paid off. He gave his organic gardening maga zine to the lady and urged her to read the article by Judith

Turk's owner had also noticed that he did not have the

recurring attacks of heart burn he had prior to changing his diet and taking Vitamin B6. He thought it a great discovery. Then, Turk's owner moved to Arkansas. His Stepdaughter who is married and was living nearby, worked at a local hospital. One day She began running a high fever in the range of 104-106, went home, and went straight to bed. The fever fell, and the next couple of days she returned to work only to have the fever return after a couple of hours. She went home and the cycle repeated. She mentioned this to a doctor in the emergency room and a Series of tests were ordered looking for a virus, an infection, even a tubular conception. Turk's owner became involved, because after listening to long, Sometimes whispered conversations between his wife and Stepdaughter, he asked what the trouble was. His wife explained what had happened and that the doctor was looking for Some type of urinary tract or vaginal infection, but there were no positive cultures. When he heard that the Stepdaughter experienced burning and irritation when urinating, he asked his wife why they did not think about diet. His Stepdaughter was eating primarily Salad

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diately take a bottle of vitamin B6 pills to his stepdaughter with instructions to take two pills immediately, another one after twelve hours, and one a day after that for the next week. In two days her fever was gone, and she went back to work. After the third day all Symptoms were gone and She was back to normal as best they could ascertain. Other people who complained of back pain without having muscle or spine problems found relief after Turk's owner advised taking Vitamin B6. One day while drying off after a shower, Turk's owner noticed a mole-type growth on the inside of his right thigh. He had not noticed it before, and shortly after that, a growth began at the end of his right eyebrow near the bridge of his nose. AS the growth on the thigh became bigger, So did his curiosity. He picked at the growth until Some of it came off and it bled. Now curiosity turned to concern. A month later the growth on the thigh reappeared and the growth on the eyebrow grew larger. He would check both growths every day and they were always on his mind. He believes it was his obsession with Turk that guided his thoughts to Oxalic acid. This acid is readily available in foods people eat, So why would God put a substance in food He provided to Sustain life, if that Same Substance by assaulting the kidneys can kill life? It just did not make Sense. That question constantly ran through his mind begging to be answered. Night after night, hours were spent turning and tossing in restleSS Sleep, Searching and Searching for an answer. He had read every article in every magazine he could get his hands on about foods thought to help in the fight against cancer, antioxidants, free radicals, and anti-rust in the blood. One

night his mind Stopped on one particular item. It was a

6,133,317 S Sentence he had read about foods, and the importance they play in health and healing. “The acid in Strawberries is thought to help prevent prostate cancer.” Acid-there it was, that is the word that halted his mental computer. When he woke up, questions began running through his mind. If Oxalic acid would destroy healthy renal tissue, could it possibly destroy Sick tissue first? Is cancer not considered to

6 of Oxalic acid or oxalate blockerS Such as citric acid,

ascorbic acid (vitamin C), pyridoxine hydrochloride (vitamin B6), calcium, alcohol, resins, clays, and combina

tions thereof. Oxalic acid or oxalate blockerS also include 5

dairy products containing calcium, fruits, coconut, bever ages containing alcohol, ascorbic acid or citric acid, red meat or white meat of fowl containing pyridoxine hydrochloride, or other foods, nutritional Supplements or beverages containing alcohol, citric acid, ascorbic acid, pyridoxine hydrochloride, and combinations thereof. In accordance with the present invention, an “oxalic acid or oxalate blocker' is any mineral, chemical, compound, material, plant, food, beverage, additive, Supplement or the

15

wise reduces or eliminates the beneficial effect of Oxalic acid

be sick cells? Are these free radicals sick cells? What about

antioxidants? Are there really different types of cancer, or are they a similar type of Sick cell just in different parts of the body'? Why are there different types of chemotherapies? There were just too many questions. He had to go back and Start with his initial question. He asked a dear friend, a devout Christian, whether the Bible states that God put everything on earth that man needs? At the same time he went on a very high oxalic acid diet and avoided citric acid and reduced his intake of pyridoxines and alcohol to a minimum. His dear friend came back and Said she told her

Bible class of his request. They searched the Bible and noted three places that mention God providing for all of man's needs. What is significant is that articles describing food groups for cancer prevention, especially the vegetable groups, name those that have significant amounts of Oxalic

acid as per USDA Bulletin #11 (Table I). At this time he became convinced it was not the beta caroteine, the Vitamin

25

C, or anything else that was the cancer fighter-it was Oxalic acid. Once again he started asking himself questions. Would oxalic acid destroy sick cells before healthy cells? The only answer he could come up with is the affirmative. Hence, there is a need for an oxalic acid or oxalate

composition and method of treatment for warm blooded animals including humans and pets. SUMMARY OF THE INVENTION

In accordance with the present invention, an Oxalic acid or oxalate composition and method of treatment of warm blooded animals including humans and pets is provided which includes at least one therapeutically effective form of Oxalic acid or oxalate for controlling, treating, or managing neoplasia, tumors, brain tumors, cancer, growths, and the like, for preventing the new growth of different or abnormal tissues, or for otherwise therapeutically treating warm blooded animals including humans and pets. The therapeu tically effective form of Oxalic acid or oxalate is any oxalic acid or oxalate which provides the beneficial effect and is Selected, for example, from the group of Oxalic acid in a free acid, ester, lactone or Salt form, oxalates including Sodium oxalate, a nutritional Supplement containing at least one form of Oxalic acid or oxalate, Oxalic acid dihydrate, anhy drous Oxalic acid, oxamide, oxalate Salts, natural or pro cessed foods including molds, plants or vegetables Such as parsley, chives, garlic, beets, carrots, Spinach and the like containing at least one form of Oxalic acid or oxalate, beverages, liquids or juices containing at least one form of Oxalic acid or oxalate, additives containing at least one form

35

40

or oxalate. For example, calcium from dairy products tends to bind with oxalic acid in the intestine and prevents the oxalic acid from being absorbed into the blood stream. In accordance with another embodiment of the present invention, a composition is provided for controlling, treating or managing hyperplasia including Swollen or enlarged prostate and the like for preventing new Swelling or enlarge ment of tissues, or for otherwise therapeutically treating warm blooded animals including pets and humans and which includes at least one therapeutically effective form of Oxalic acid or oxalate. Also, a method is provided for controlling, treating or managing hyperplasia including Swollen or enlarged prostate, and the like, for preventing new Swelling or enlargement of tissues, or for otherwise therapeutically treating warm blooded animals including pets and humans including the Steps of periodically admin istering a therapeutically effective dosage of a composition of at least one therapeutically effective form of oxalic acid or oxalate. This method may further include the step of reducing the intake of Oxalic acid or oxalate blockers. In accordance with yet another embodiment of the present invention, a diet is provided for treating, controlling, and preventing cancer, tumors, neoplasia, and the like in warm blooded animals including pets and humans. The diet includes adding to the regular diet a dietary Supplement of at least one therapeutically effective form of Oxalic acid or oxalate. Further, the diet may include reducing the intake of Oxalic acid or oxalate blockers.

45

50

55

of Oxalic acid or oxalate, and combinations thereof. The

composition may also contain a pharmaceutically acceptable carrier or diluent for the therapeutically effective form of Oxalic acid or oxalate.

Also in accordance with the present invention a method is provided for controlling, treating or managing neoplasia, tumors, growths, cancers, abnormal tissues and the like in warm blooded animals including humans and pets including the Steps of periodically administering a therapeutically effective dosage of a composition including at least one therapeutically effective form of oxalic acid or oxalate. The method may include the further Step of reducing the intake

like which blocks, inhibits, reduces, or binds with or other

60

In accordance with still yet another embodiment of the present invention, a veterinary composition is provided for controlling, treating or managing neoplasia, tumors, brain tumors, cancer, growths and the like, for preventing the new growth of different or abnormal tissues, or for otherwise therapeutically treating warm blooded animals including dogs and cats and includes a composition having at least one therapeutically effective form of oxalic acid or oxalate. The composition may further include a pharmaceutically accept able carrier or diluent for the therapeutically effective form of Oxalic acid or oxalate. A method is also provided for controlling, treating or managing neoplasia, tumors, growths, cancers or abnormal tissues in warm blooded animals including dogs and cats and includes the Steps of periodically administering a therapeutically effective dosage of a veterinary composition containing at least one thera peutically effective form of oxalic acid or oxalate. The method may also include the further Step of reducing the intake of Oxalic acid or oxalate blockers.

65

In accordance with a further embodiment of the present invention, a composition for treating auto-immune related diseases such as HIV, SLE, AIDS, BSE, CFS and the like

includes a therapeutically effective amount of at least one

6,133,317 7 therapeutically effective form of Oxalic acid or oxalate. Also, a method of treating, preventing or controlling auto-immune related diseases, preventing, lessening or controlling the destruction of the bodies immune System, or purifying the blood is provided which includes the steps of periodically administering a therapeutically effective amount of at least one therapeutically effective form of Oxalic acid or oxalate. In accordance with another embodiment of the present invention, a composition for counteracting the decomposi tion or reduction of Oxalic acid or oxalate caused by radia tion exposure, radiation treatment, X-rays, Strong electro magnetic waves or fields, and the like, or for returning the bodies oxalic acid or oxalate level to at least a normal level following radiation treatment, X-rays, CAT scans, MRI Scans, and the like is provided which includes a therapeu tically effective amount of at least one therapeutically effec tive form of Oxalic acid or oxalate. Also, a method for counteracting the decomposition or reduction of Oxalic acid or oxalate caused by radiation exposure, radiation treatment, X-rays, Strong electromagnetic waves or fields, and the like or for returning the bodies oxalic acid or oxalate level to at least a normal level following radiation treatment, X-rayS, CAT scans, MRI-scans, and the like is provided which includes the Steps of administering a therapeutically effec tive amount of a composition including a therapeutically effective form of oxalic acid or oxalate following the treat ment or exposure. The method may further include the Steps of administering a therapeutically effective amount of at least one therapeutically effective form of Oxalic acid or oxalate prior to the treatment or exposure. Further, the method may include the Steps of decreasing or eliminating the ingestion or administration of one or more of Oxalic acid

8 A still further embodiment of the present invention includes a method of treating osteoporosis including the Steps of increasing calcium intake while at the same time decreasing or eliminating oxalic acid or oxalate intake. In accordance with still another embodiment of the

15

one form of Oxalic acid or oxalate to raise the blood or urine

In accordance with yet another embodiment of the present users for controlling, treating or managing neoplasia, tumors, cancers, growths and the like, for preventing the new growth of different or abnormal tissues, or for otherwise therapeutically treating the mouth area is provided which includes a dilute Solution of at least one therapeutically effective form of Oxalic acid or oxalate. 25

35

40

cleansing the blood of tumor, cancer, abnormal cells or the like, administering or ingesting a more moderate level of 45

50

present invention, a therapeutic composition in cream or ointment form for topical administration of Oxalic acid or oxalate is provided which includes at least one therapeuti cally effective form of Oxalic acid or oxalate, a Solvent, and a cream or ointment base.

In accordance with another aspect of the present invention, at least one form of Oxalic acid or oxalate is used 55

In accordance with another embodiment of the invention,

effective form of oxalic acid or oxalate in addition to

form of Oxalic acid or oxalate.

In accordance with still yet another embodiment of the present invention, an improved human or pet treat includes the addition of microgram amounts of at least one therapeu tically effective form of Oxalic acid or oxalate. In accordance with another embodiment of the present invention, a composition for improving and maintaining good health in warm blooded animals includes a composi tion containing at least one therapeutically effective form of Oxalic acid or oxalate.

an improved pet food includes at least one therapeutically conventional pet food ingredients. Another improved pet food of the present invention includes conventional pet food ingredients except for the elimination or reduction of Oxalic acid or oxalate blockers. Yet another improved pet food of the present invention includes conventional pet food ingre dients except for the elimination or reduction of Oxalic acid or oxalate blockers and the addition of a therapeutically effective quantity of at least one therapeutically effective

In accordance with another embodiment of the present invention, a pharmaceutical composition to be administered orally to humans is provided which includes a mixture of a nontoxic ingestible carrier and a therapeutically effective form of Oxalic acid or oxalate.

Oxalic acid or oxalate to maintain a normal blood or urine

Oxalic acid or oxalate levels below normal. In accordance with still another embodiment of the

Also in accordance with the present invention, a method of manufacturing a dry processed dog food containing at least one form of Oxalic acid or oxalate is provided which includes the Steps of mixing a first slurry of conventional dog food ingredients together with a dilute Solution of Oxalic acid or oxalate to form an oxalic acid or oxalate containing Second slurry, forming the Second slurry into pellets, and then drying the pellets. In accordance with yet another embodiment of the present invention, a composition for treating parvo virus in animals including canines is provided which includes a therapeuti cally effective amount of at least one therapeutically effec tive form of Oxalic acid or oxalate.

Oxalic acid or oxalate level above normal levels, and after

Oxalic acid or oxalate level. This regimen may further include the Steps of administering or ingesting a moderate level of Oxalic acid or oxalate blockers following the cleans ing of the blood and without reducing the blood or urine

or oxalate.

invention, an oral rinse or mouthwash for SmokerS or Snuff

or oxalate blockers.

In accordance with still yet another embodiment of the present invention, a treatment regimen for treating tumors, cancers, growths, neoplasia and the like including brain tumors, breast cancer, cervical cancer, and otherS is provided which includes the Steps of reducing or eliminating the ingestion or administration of Oxalic acid or oxalate blockers, administering or ingesting high dosages of at least

present invention, a therapeutic composition for purifying the blood, treating BSE, HIV, CFS, AIDS, Hodgkin's disease, Parkinson's disease, multiple Sclerosis, and the like, controlling, treating or eradicating abnormal cells, controlling, treating or effecting cholesterol, plaque and fat buildup in the cardiovascular System or the brain, maintain ing good cardiovascular health and operation, or the like is provided which includes a therapeutically effective amount of at least one therapeutically effective form of Oxalic acid

60

65

as a flavor enhancer, a preservative, a food additive, or a Substitute for citric acid or ascorbic acid.

In accordance with another embodiment of the present invention, a method of enhancing or promoting the growth or the Spread of tumors, growths, neoplasia and the like in warm blooded animals including test animals. Such as mice, rats, and the like is provided which includes the Steps of reducing the intake of Oxalic acid or oxalate, destroying or decomposing the Oxalic acid or oxalate in the animal, and/or increasing the intake of Oxalic acid or oxalate blockers. In accordance with yet another embodiment of the present invention, a diet for promoting and maintaining good health in warm blooded animals including humans is provided

6,133,317 9

10

which includes increasing the intake of foods containing Oxalic acid or oxalate and reducing the intake of Oxalic acid

of a therapeutically effective amount of at least one thera peutically effective form of Oxalic acid or oxalate. Another therapeutic composition of the present invention is a Sour dough bread made from flour, water, yeast, Sourdough Starter, and at least one therapeutically effective form of

or oxalate blockers.

In accordance with yet another embodiment of the present invention, a method of inhibiting the therapeutic effect of Oxalic acid or oxalate in warm blooded animals including test animals. Such as mice, rats, and the like is provided which includes the Steps of increasing the ingestion or

Oxalic acid or oxalate.

administration of Oxalic acid or oxalate blockerS Such as

calcium, alcohol, Vitamin C, Vitamin B6, citric acid, and

destroying or decomposing Some or all of the Oxalic acid or oxalate in the animal. In accordance with still another embodiment of the

present invention, a method for inhibiting, preventing, treating, controlling or reversing the deleterious effects of high levels of Oxalic acid or oxalate is provided which includes the Steps of reducing the ingestion or administration of Oxalic acid or oxalate, increasing the ingestion or admin istration of Oxalic acid or oxalate blockers, monitoring the

15

Oxalic acid or oxalate. In accordance with still another embodiment of the

present invention, a canine and feline urine oxalate level Scales include below normal, normal, and above normal

levels of Oxalic acid or oxalate in the blood or urine, and

adjusting the ingestion or administration of Oxalic acid, oxalate and blockers thereof to achieve the desired Oxalic acid or oxalate blood or urine levels.

Also in accordance with the present invention, a method of counteracting, inhibiting, treating, controlling, or reduc ing the deleterious effects of high levels of Oxalic acid or oxalate is provided which includes the Steps of administer ing or ingesting a therapeutically effective amount of Vita

25

animal including humans is provided which includes the Steps of administering daily doses of a therapeutically effec tive amount of at least one therapeutically effective form of Oxalic acid or oxalate for a Sufficient period to cause the Sloughing off of the interior Surface of the intestinal mem brane and thereby removing old bacteria, food, waste, intes 35

oxalate if the blood and/or urine level is below normal,

reducing the ingestion or administration of Oxalic acid or oxalate blockers if the blood and/or urine level is below

normal, maintaining current ingestion or administration lev

40

els of oxalic acid, oxalate, or blockers thereof if the blood and/or urine oxalic acid or oxalate levels are normal, reduc if the blood and/or urine levels are above normal, and

tinal cells, membrane, and the like.

In accordance with another aspect of the present invention, a method of treating or preventing oxalate neph rosis in animals including dogs, goats, humans, cattle and the like is provided which includes the steps of periodically administering a therapeutically effective amount of at least one therapeutically effective oxalic acid or oxalate blocker. In accordance with another embodiment of the present invention, a dilute Solution of Oxalic acid is used as a

ing the ingestion or administration of Oxalic acid or oxalate increasing the ingestion or administration of Oxalic acid or

level categories depending on the weight and physical condition of the animal and provide a quick-ready reference for a veterinarian or pet owner to test urine oxalate levels and adjust the Oxalic acid or oxalate intake in the diet, food or treatment of the canine or feline accordingly. In accordance with another embodiment of the present invention, a method for causing the Sloughing off of the inner Surface of the intestinal membrane in a warm blooded

min B6.

In accordance with another embodiment of the present invention, a method of treating a warm blooded animal is provided including the Steps of determining the Oxalic acid or oxalate blood and/or urine levels of the animal, compar ing the determined blood and/or urine level with a Scale indicating below normal, normal, and above normal levels, increasing the administration or ingestion of Oxalic acid or

In accordance with another embodiment of the present invention, a method of delaying, preventing, controlling or treating the onset of Alzheimer's Disease, Hodgkin’s Disease, Parkinson's Disease, Multiple Sclerosis, Creutzfeldt-Jakob Disease, and the like, lessening the effects of the disease, or improving the quality of life of a perSon Suffering from the disease is provided which includes the Steps of periodically administering a therapeutically effec tive amount of at least one therapeutically effective form of

45

composition for cleaning oral or dental bridgework, a com position for cleaning a toothbrush, a composition for clean ing and rinsing the interior Surfaces of the mouth and teeth,

oxalate blockers if the blood and/or urine level is above

a mouthwash, a tartar control rinse, an antibacterial rinse, or

normal. This method also includes the adjustment of the

combinations thereof.

below normal, normal and above normal Scale levels or

categories for differing health conditions.

50

In accordance with still another embodiment of the

present invention, a multi-Vitamin includes the addition of at least one therapeutically effective form of Oxalic acid or oxalate in addition to conventional components. Also, a multi-vitamin and mineral Supplement of the present inven tion includes the addition of at least one therapeutically

55

In accordance with still yet another embodiment of the present invention, a test kit for detecting the oxalate level in urine of warm blooded animals including humans is pro Vided which includes a Sample holder and a liquid reagent which upon addition of a Selected quantity of reagent to a Sample of urine in the Sample holder provides a colormetric indication of the presence or absence of oxalate. In accordance with another embodiment of the present

effective form of oxalic acid or oxalate in addition to

invention, a dilute Solution of Oxalic acid is used as a meat

conventional components. An alternative multi-vitamin or multi-vitamin and mineral Supplement of the present inven tion includes not only an addition of at least one therapeu tically effective form of oxalic acid or oxalate but also the

tenderizer. 60

reduction or elimination of Oxalic acid or oxalate blockers

from the conventional components thereof.

In accordance with still another embodiment of the

In accordance with still another embodiment of the

present invention, a therapeutic composition is provided which is made up of a conventional process food item Such as bread, cereal or other prepared food including the addition

In accordance with another embodiment of the present invention, a dietary Supplement for everyday optimum nutri tional balance is provided which includes between 0.5 micrograms to 1.5 grams of Oxalic acid or oxalate.

65

present invention, a test kit for detecting the presence and quantity of Oxalic acid in a blood Sample of a warm blooded animal including humans is provided which includes a Sample Support Surface, a reagent, and a mixing container

6,133,317 11 for mixing together a blood Sample and reagent to allow the reagent to undergo a color change and provide a colormetric determination of the presence and quantity of Oxalic acid in the Sample. In accordance with another embodiment of the present invention, a method of treating warm blooded animals including humans and pets is provided which includes the Steps of testing the animal to determine the blood or urine Oxalic acid or oxalate levels, administering oxalic acid, oxalate, or blockers thereof depending on the tested levels, and periodically monitoring the blood or urine Oxalic acid or oxalate levels and adjusting the administration of Oxalic

12 tumor cells Sensitive to an oxalic acid or oxalate compound including administering to the animal an oncolytic amount of the Oxalic acid or oxalate compound. A more particular object of the present invention is the provision of a novel anti-tumor agent, processes for its preparation, compositions containing it, and methods of treating tumors with it. Another object of the present invention is an Oxalic acid or oxalate composition and method for treating autoimmune related diseases such as AIDS, HIV, SLE, BSE, CFS, and the like.

acid, oxalate, or blockers thereof.

In accordance with an exemplary embodiment of the present invention, at least one form of Oxalic acid or oxalate is used as a nutritional Supplement to aid in the control, treatment or management of neoplasia. In accordance with another exemplary embodiment of the present invention, at least one form of Oxalic acid dihydrate

15

is used to treat tumors in warm blooded animals.

In accordance with another aspect of the present invention, at least one form of Oxalic acid or oxalate is used

to prevent the new growth of different or abnormal cells or tissue.

Oxalic acid or oxalate. 25

In accordance with another embodiment of the present invention, oxalic acid or oxalate is used to increase energy and add to the quality of life in animals including humans. In accordance with another embodiment of the present invention, at least one form of Oxalic acid or oxalate is

administered orally, by direct injection, intravenously, or topically. In accordance with another embodiment of the present invention, Oxalic acid dihydrate is administered as a food additive.

One object of the present invention is the provision of a novel therapeutic composition including a pharmaceutically acceptable carrier or diluent containing a therapeutically effective amount of at least one therapeutically effective form of Oxalic acid or oxalate. Another object of the present invention is the provision of a method of therapeutically treating warm-blooded animals with Such a therapeutic composition. A further object of the present invention is the provision of an oxalic acid or oxalate pharmaceutical. Another object of the invention is the use of Oxalic acid in lieu of citric acid as a flavor enhancer and/or preservative in shelf/prepared food products. Another object of the present invention is the provision of a method of treating animals including humans with at least

Another object of the present invention is the provision of an oxalic acid or oxalate composition and method for counteracting the destruction of Oxalic acid by radiation treatment, X-rays, and the like. Another object of the present invention is the provision of a composition for improving and maintaining good health in warm blooded animals and including at least one therapeu tically effective form of Oxalic acid or oxalate. Still another object of the present invention is the provi Sion of a flavor enhancer, preservative, food additive, citric acid Substitute and the like made up of at least one form of Yet another object of the present invention is the provision of a method of enhancing or promoting the growth or the Spread of tumors, growths, cancers, and the like in warm blooded animals. Such as test animals by reducing the intake of Oxalic acid or oxalate, destroying or decomposing the Oxalic acid or oxalate in the animal, and/or increasing the intake of Oxalic acid or oxalate blockers.

35

A further object of the present invention is the provision of a diet for promoting good health in warm blooded animals including increased quantities of Oxalic acid or oxalate, and/or reducing or eliminating the intake of Oxalic acid or oxalate blockers.

40

Another object of the present invention is the provision of a method of inhibiting the therapeutic effect of Oxalic acid or oxalate in warm blooded animals Such as test animals by increasing the ingestion of Oxalic acid or oxalate blockers, and/or destroying or decomposing Some or all of the Oxalic acid or oxalate in the animal.

45

Still another object of the present invention is the provi Sion of a method for inhibiting, preventing, treating, con trolling or reversing the deleterious effects of high levels of Oxalic acid.

50

A more particular object of the present invention is the provision of a method of counteracting, inhibiting, treating, controlling or reducing the deleterious effects of high levels of Oxalic acid by administering or ingesting a therapeutically

one form of Oxalic acid or oxalate.

effective amount of vitamin B6.

Still another object of the present invention is the provi Sion of a method of treating warm-blooded animals with

Yet another object of the present invention is the provision of a method of treating warm blooded animals including the Steps of determining the Oxalic acid or oxalate blood and/or urine levels of the animal, comparing this determined level with a Scale indicating below normal, normal, and above normal oxalic acid or oxalate levels, and increasing or decreasing the administration or ingestion of Oxalic acid, oxalate, or blockers thereof depending on the determined

Selected levels of Oxalic acid or oxalate, Vitamin B6, citric acid, Vitamin C, calcium, alcohol, and/or combinations

55

thereof.

Another object of the present invention is the provision of a method of treating cancer in humans or other animals with an oxalic acid or oxalate.

60

Yet another object of the present invention is the provision of a veterinary composition of Oxalic acid dihydrate. Another object of the present invention is the provision of a method of treating neoplasia with at least one form of Oxalic acid or oxalate.

Another object of the present invention is the provision of a method of treating a warm-blooded animal afflicted with

Oxalic acid or oxalate levels.

A further object of the present invention is the provision of a multi-Vitamin or multi-Vitamin and mineral Supplement including at least one therapeutically effective form of Oxalic 65

acid or oxalate.

Still another object of the present invention is the provi Sion of a processed food item including a therapeutically

6,133,317 14 Yet another object of the present invention is the process for preparing an anti-tumor agent including the Steps of mixing at least one therapeutically effective form of Oxalic acid or oxalate with a pharmaceutically acceptable carrier or

13 effective amount of at least one therapeutically effective form of Oxalic acid or oxalate.

Yet another object of the present invention is the provision of a method of delaying, preventing, controlling, or treating Alzheimer's Disease, Hodgkin’s Disease, Parkinson's Disease, and the like lessening the effects of the disease, or improving the quality of life of a perSon Suffering from the

diluent.

disease.

A more particular object of the present invention is the provision of a canine and/or feline urine oxalate level Scale providing a quick-ready reference for below normal, normal, and above normal oxalate levels based on the weight and/or condition of the animal.

Another object of the present invention is the provision of a method for causing the Sloughing off of the inner Surface

15

of the intestinal membrane in warm blooded animals.

tive form of Oxalic acid or oxalate.

Still another object of the present invention is a method of treating or preventing oxalate nephrosis in animals. Yet another object of the present invention is the provision of a composition for cleaning oral or dental bridgework,

Still another object of the present invention is the provi Sion of a treatment regimen including the Steps of reducing or eliminating the intake of Oxalic acid or oxalate blockers, administering high dosages of Oxalic acid or oxalate until the

toothbrushes, the interior Surfaces of the mouth and teeth,

blood is cleansed of tumor, cancer or abnormal cells, and

and the like.

thereafter administering a moderate level of Oxalic acid or

A further object of the present invention is the provision of a mouthwash, tartar control rinse, or antibacterial rinse

25

including a Small amount of Oxalic acid. Another object of the present invention is the provision of a test kit for detecting and/or quantifying the Oxalic acid or

oxalate and/or the elimination or reduction of Oxalic acid or

animal.

oxalate blockers.

Still another object of the present invention is the provi Sion of a meat tenderizer made up of a dilute Solution or

A more particular object of the present invention is a composition and method for treating a person Suffering from Osteoporosis and tumors, cancers, growths, neoplasia and

concentration of oxalic acid. 35

effective form of Oxalic acid or oxalate.

the like.

A further object of the present invention is the provision of an oral rinse or wash for SmokerS or Snuff users including a dilute Solution of at least one therapeutically effective form of Oxalic acid or oxalate. 40

Another object of the present invention is a method of manufacturing dog food containing at least one form of Oxalic acid or oxalate.

45

Still another object of the present invention is the provi Sion of a composition and method for treating parvo virus in animals.

50

Yet another object of the present invention is a pharma ceutical composition to be administered orally to humans including a mixture of a non-toxic ingestible carrier and a therapeutically effective form of Oxalic acid or oxalate. Other objects and further scope of the applicability of the present invention will become apparent from the detailed description to follow.

55

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a graphical illustration of a decomposition curve

for a 100 mM oxalic acid solution by 'Co.

acid or oxalate blockers.

Still another object of the present invention is the provi Sion of a veterinary composition and method for controlling, treating or managing neoplasia, tumors, cancers, growths and the like, for preventing the new growth of different or abnormal cells or tissueS or for otherwise therapeutically treating warm blooded animals including dogs and cats utilizing a composition including at least one therapeutically

oxalate to maintain a normal blood or urine oxalic acid or oxalate level.

Yet another object of the present invention is an improved pet food including a therapeutically effective quantity of at least one therapeutically effective form of Oxalic acid or

oxalate level in the blood and/or urine of a warm blooded

Yet another object of the present invention is a dietary Supplement for every day optimum nutritional balance including oxalic acid or oxalate. A more particular object of the present invention is the provision of a composition for controlling, treating or man aging neoplasia, tumors, cancers, growths and the like, for preventing the new growth of different or abnormal cells or tissues, or for otherwise therapeutically treating warm blooded animals including pets and humans utilizing a composition and method including at least one therapeuti cally effective form of Oxalic acid or oxalate. A further object of the present invention is the provision of a composition and method for controlling, treating or managing hyperplasia and the like, for preventing new Swelling or enlargement of tissues, or for otherwise thera peutically treating warm blooded animals including pets and humans using a composition including at least one thera peutically effective form of Oxalic acid or oxalate. Another object of the present invention is the provision of a diet for treating, controlling and preventing cancer, tumors, neoplasia, growths and the like in warm blooded animals including the addition of a dietary Supplement of at least one therapeutically effective form of oxalic acid or oxalate. The diet may also include the reduction in the intake of oxalate

A further object of the present invention is a composition and method for treating autoimmune related diseaseS Such as HIV, SLE, AIDS, BSE, CFS, and the like by administering a therapeutically effective amount of at least one therapeu tically effective form of Oxalic acid or oxalate. Another object of the present invention is the provision of a composition and method for counteracting the decompo Sition or reduction of Oxalic acid or oxalate caused by radiation exposure, radiation treatment, X-rays, Strong elec tromagnetic waves or fields, and the like using a therapeu tically effective amount of at least one therapeutically effec

60

65

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

After placing himself on a high oxalic acid or oxalate diet, the growth on Turk's owner's thigh began to disappear and shortly thereafter the growth on his eyebrow as well. Even tually both growths were completely gone. Another sign of the result of the high oxalic acid diet was the disappearance of a couple of polyps around the anal orifice. These had

6,133,317 15 appeared when he went on the low oxalate/low Oxalic acid diet, and now when he reversed the diet these growths disappeared. Later, his own daughter informed him that her mother was having a lot of Stomach or digestive problems and was due for exploratory Surgery. During the operation they discov ered cancer in the abdominal cavity and removed all possible, estimated at 80w. There was cancer in the bladder, and they planned an extensive chemotherapy program. However, a specialty lab in California which received the tissue sample, determined it was a rare type of cancer, with no known treatment. His daughter, who was at her mother's Side constantly, agreed to try his Oxalic acid procedure. With his instruction and the help of a juicer, she prepared a mixture of carrots, Spinach, parsley, and chives. He Sug gested she try to get her mother to drink Six to eight ounces of the mixture at least three times a day. At the Start, her mother complained of the taste, So he Suggested she mix Some V8(R) juice with the mixture to enhance the flavor. This worked, and her mother began to drink the mixture. He felt that by having it in liquid form, more oxalic acid would enter her System more rapidly and begin to attack the Sick cells. On the third day after her mother began drinking the mixture, his daughter talked with the nurse who said, “In the morning when she took the patient's Vital Signs they were the best Since the patient had come to the hospital. Her temperature was down, blood pressure was down, and pulse rate was near normal.” In addition, the yellowish skin color began to change. Then, for reasons unknown, her mother stopped drinking the mixture. Shortly after that her mother passed away.

16 cancers are due to environment and nutrition. And So, they

embarked on taking the Setter off canned dog food (high in pyridoxines) and feeding a regular dry high protein dog food

15

was varied based on the canine's condition with the mouth

25

count the canine's Oxalic acid urine count was reduced to 24

35

confident, since The Merck Manual does state that 90% of

protein to the diet. A little more than two weeks later the diet was changed to reduce the Oxalic acid dose to 500 mg per

day and the canine was given four beef strips (approximately 25 grams) with 27% protein each evening. Thirty days later

45

the dose was dropped to 300 mg oxalic acid/day. Two weeks later the dose was dropped to 50 mg oxalic acid/day. Two weeks later the dose was dropped to 20 mg oxalic acid per day which was maintained till the animal was euthenized. The canine's mouth tumor had reduced in size in an eleven

50

month period. The Oxalic acid dihydrate was purchased from Swift Chemical Company, Rogers, Ark., and dissolved in water to use as a food additive to the canine diet.

Much to their Surprise, the dog Seemed to crave the carrots and parsley. The Setter's activity increased Steadily to the point where he actively competed with a four-year-old 55

60

a biopsy confirmed to be melanoma (skin cancer). The oral tumor was in an area easily examined. The oral tumor had been removed Several years ago, when it was confirmed as malignant, but it had grown back. The question was posed if a high oxalic acid or oxalate diet Supposedly works on humans, would it not also work on this dog? They felt

mg/L. Three days later, the canine was restarted on a diet having about 1 gram of Oxalic acid added to one pound of dry dog food. A canine urine oxalic acid Scale was calculated based on a Scale of 0–40 mg/L for a 70 kg human, and adjusting this for a 25 kg canine to have a desired range of about 0-14 mg/L. The canine was started on a new diet of approximately one and one-half pounds of dry dog food to 1 gram of Oxalic acid dihydrate dissolved in about three ounces of water and mixed together and adding one-half can

of Pedigree(R) brand canned dog food (6% oz. can) to add

40

acid treatment for the reduction of tumors. The research

associate volunteered his Irish Setter, a 70-75 lb., 14 year old Specimen which had a very noticeable tumor on the mouth and had been diagnosed with multiple tumors which

tumor being measured and recorded by a veterinarian. The mouth tumor exhibited expansion or Swelling and reduction cycles. The canine's urine was tested for oxalate count and a result showed about 50 mg per liter of Oxalic acid. After about five months on this diet, the canine produced feces including mucous and intestinal membrane. Upon this happening all oxalic acid or oxalate addition to the canine's diet was stopped. It is believed that a high level of oxalic acid or oxalate intake causes a Sloughing off of the interior Surface of the Small intestine including old bacteria, food, waste, and intestinal cells and membrane. After about a month, urine was drawn from the canine to test for oxalate

Later, Turk's owner learned of a close friend who had

prostate cancer, initially treated with a radiation implant which failed to keep the growth in check, and now would be undergoing chemotherapy. He urged his friend with prostate cancer to try his Oxalic acid dietary treatment. He sent an explanatory letter with copies of articles about the Veg etables along with a list of items containing oxalates and Oxalic acid. Later, he talked with his friend who gave him Some revealing data. Prior to starting the Oxalic acid dietary treatment, his friend had been to an oncologist because the cancer was spreading into the pelvic area and his PSA count was 350. When his friend returned to his primary care physician months later after being on the Oxalic acid diet, he was feeling better, his PSA was down to 246, and the doctor was Surprised because he did not think his patient would Survive long enough to See him again. It seemed the doctor knew the chemotherapy would not work and it may have been given just So his friend would not despair. Turk's owner sent a copy of the Judith Been Hurley article to his friend and believed that low calcium in the bone marrow was probably the reason his friend with prostate cancer was tired and felt pain in the thigh and pelvic area. A research associate joined Turk's owner, the Applicant, in trying to better establish the relationship between oxalic acid and pyridoxine hydrochloride (vitamin B6) and oxalic

mixed with three or four boiled carrots and topped with chopped parsley. The canine was started on a diet of three or four medium sized boiled carrots, mixed with approximately 1% pounds of dry dog food. Three to five days after starting on the diet, the canine showed an improvement in appetite and energy. After three weeks of being on this diet, there was a noticeable reduction in size and appearance of the tumor on the canine's mouth. Almost a month after Starting on the above diet, the canine's diet was changed to a mixture of about one pound of boiled carrots, one teaspoon of garlic, one-quarter cup chopped fresh parsley, and one and one-half pounds of dry dog food containing no citric acid. This diet

Doberman and a nine-month-old Rottweiler. The diet was

working. What was once a large Saggy Sack of black tissue Visibly hanging from the Setter's mouth changed to a considerably smaller and firmer growth. The reduction in the growth of the oral tumor slowed over time; however, it must be remembered that the tumor took nearly Six years to achieve the mass it once was. They continued to monitor the Setter's condition, and felt that the reduction in the size of

65

the tumor was a positive sign that the Oxalic acid or oxalate was working. An autopsy of the Irish Setter revealed the malignant melanoma with metastasis, adrenal gland pheochromocytoma, acute cystitis, the urinary bladder mucosa appeared diffusely thickened, granular and hemor

6,133,317 17

18

rhagic in appearance with the presence of moderate amounts of a turbid reddish-brown urine, a large encapsulated necrotic mass within the omental adipose tissue, with no other significant groSS lesions noted within other areas of the oral cavity, larynx, esophagus, trachea, lungs, heart, Spleen, kidneys, musculoskeletal System, and gastrointestinal tract. Hence, it appears that the Oxalic acid or oxalate diet did not damage any of the dog's organs or kidneys. It is believed

Stopped chemotherapy treatment. She was told about the possible beneficial effect of Oxalic acid or oxalate and Started on a daily intake of about 1 to 1/2 g/day Oxalic acid or

oxalate and almost no Oxalic acid or oxalate blockers. It was

hard for her to Swallow So she was on a liquid diet because of the Swelling of the lymph nodes in and around her mouth and throat. After 5-7 days of administration of oxalic acid or oxalate the dilute Solution she was able to eat again due to the shrinkage of tumors in the lymph nodes. This dramatic

that the lesions (Scars) in the lungs of the canine, may

indicate that Oxalic acid or oxalate had eliminated growths in the lungs. In accordance with another case Study, a dog at a pound was given one gram of Oxalic acid dihydrate in a gelcap one hour prior to meal time for Seven days with no adverse effects. The dog's appetite increased as well as energy and activity. In accordance with another case Study a human adult female Subject with possible cervical cancer found multiple growths on her cervix by Self-examination. The Subject

effect in Such a short time indicates that the intake of Oxalic

acid was treating her condition or disease and benefiting the individual.

In another case Study, an adult female was diagnosed with

a tumor (endometrial) in the uterus. The tumor was removed

15

and reduced intake of Oxalic acid or oxalate blockers. After

several months of being on the diet, her blood tests were negative on cancer and she did not have to undergo chemo therapy. In accordance with another case Study, a Doberman

Started on an increased Oxalic acid or oxalate and reduced

Oxalic acid or oxalate blocker diet, and in less than one

month She reported that the Smallest growth was reducing in size. The Subject remained very strictly on the diet and a week later reported that the Smallest growth was gone with only a rough Spot remaining. A few days later the Subject reported that the next size growth seemed to be reducing. LeSS than a month later, the Subject reported that the large growth was considerably reduced. This process continued and less than a year after Starting on the increased oxalic acid or oxalate diet, the Subject reported that one Small growth remained which was only noticeable during her menstrual period. In accordance with another case Study, an adult male human Subject Suffering from a brain tumor, had been through all the different conventional treatments including Surgery, chemotherapy, and radiation treatment. The tumor was never totally removed and remained malignant. The subject was told of the possible beneficial effects of oxalic acid or oxalate and began on a treatment regimen of four heaping Soup Spoons of dried parsley daily and a reduction of Oxalic acid or oxalate blockers. This should equate to approximately four grams of Oxalic acid per day. Three to four months later, the subject had a CAT scan where the tumor was examined and did not show any growth. The Subject also had visible signs of noticeable improvement in health. Approximately six months after Starting on the enhanced oxalic acid or oxalate diet, the Subject was much more active and friendly towards others. Approximately eight months after Starting on the enhanced Oxalic acid diet the Subject was very excited about the diet, feeling much better. The Subject had expected and experienced the toxic effects of indigestion, diarrhea, and the Sloughing off of the interior Surface of the intestine. The Subject also indicated that the tumor was in the inactive Stage. Also the Subject indicated that his memory and thinking capability had returned and he could now accomplish functions he could not prior to following the diet. He was in the process of rebuilding an engine, replacing a carburetor, changing an oil pan, changing the oil and Spark plugs, and other activities that prior to Starting on the enhanced Oxalic acid or oxalate diet were impossible. Doctors had not given this patient much time to live, and it is believed that the enhanced Oxalic acid or oxalate diet

with reduced blockers had treated, controlled, or otherwise

beneficially affected his brain tumor and overall health. He was still alive and functioning better after nine months. An adult female in her sixties was terminally ill with leukemia with tumors in her lymph nodes and she had

by laser and she was to undergo chemotherapy. She heard of the Oxalic acid treatment of the present invention, and went on the diet having increased intake of Oxalic acid or oxalate

pincher was diagnosed with bone cancer (sarcoma) of the

left hind leg. The dog had previously been put on medication

25

35

for arthritis because it would not use or lower its left hind

leg. After being diagnosed with cancer confirmed with X-ray, the dog was placed on a diet of Oxalic acid enhanced dogfood containing about 2 grams of Oxalic acid dihydrate dissolved in water and added to conventional dry dogfood. Within 4 days, the dog had lowered its left hind leg and used it frequently in activity with a companion dog. A few days later, the dog began taking Steps on the left hind leg with a Slight limp. The dog's condition continued to improve and it's diet was changed to reduce the Oxalic acid to about 1 gram of Oxalic acid/per day. After a couple of weeks the dog's condition continued to improve So the dosage of Oxalic acid was reduced to about 500 mg/per day. The dog appears to be walking with no pain and an X-ray revealed an increase in bone material in the area of the Sarcoma and a

40

45

decrease or reduction in the size of the area affected by the sarcoma. After being on the oxalic acid diet for about 30 days, the dog appeared to have no pain during physical exam and was walking normally. In another case Study, an adult female was diagnosed with Stomach cancer and Scheduled for Surgery. She began the increased oxalic acid or oxalate and reduced Oxalic acid or oxalate blocker diet and when she went in to have the

50

55

Surgery done, they discovered that her tumor had turned to liquid. Her diet or treatment regimen included a low intake of red meat or white meat of fowl, a low intake of Soda pop or other beverages containing citric acid, a low intake of foods containing citric acid, an intake of about 4 ounces of carrot juice per day with 2 ounces taken in the morning and 2 ounces in the evening, and a low intake of alcohol. Apparently, the Oxalic acid may have turned the tumor cells into a liquid and all that was necessary was for the liquid to be drained.

60

In another case Study, an adult female having breast cancer Started on a high oxalic acid or oxalate and low Oxalic acid or oxalate blocker diet. The growth of the cancer was reduced and in less than 2 months of being on the diet her bloodwork showed a large reduction in the cancer in the blood and that the cancer was in regression. Her condition improved So much So that the doctorS Stopped chemotherapy

65 treatment.

In another case Study an adult female with breast cancer, She went on a diet including an intake of about 4 ounces of

6,133,317 19

20 Oxalic acid or ethanedioic acid (CHO), is a dicarboxy

carrot juice per day along with chicken broth. In about 8 weeks she was Sent home from the hospital, she was walking, went to the mall and was eating potato chips. Previously, she had been hospitalized and on a liquid diet. In accordance with another case Study, an adult female Suffering from breast cancer went on an increased oxalic acid diet, Stopped using the microwave oven to cook foods, Stopped chemotherapy treatments, cut CAT-Scans down to

lic acid and is present in many plants and vegetables, notably

in those of the Oxalis and Rumex families, where it often

occurs in the cell Sap of the plants as the potassium or

calcium salt (oxalate, Tables I-IV). Oxalic acid is also a

product of the metabolism of many molds. Several Species of Penicillum and Aspergillus convert Sugar into calcium oxalate with a 90% yield under optimum conditions. Oxalic acid is also made by passing carbon monoxide into concen trated NaOH or heating sodium formate in the presence of

once a month, and in a short time her blood was tested and showed that it was clean of cancer cells and the breast cancer

NaOH.

appeared to have stopped growing. Based on this history, it is believed that oxalic acid or oxalate will, at a minimum, reduce the Size of tumors,

especially if pyridoxine hydrochloride, citric acid, ascorbic acid, calcium and alcohol are eliminated from the diet as

15

much as possible. This dietary procedure needs to be con tinued until the tumor or growth is eliminated. If the individual experiences backaches due to kidney irritation, urinary tract irritations, and/or Severe heartburn, Vitamin B6

(pyridoxine hydrochloride) can be taken to help eliminate

the discomfort. Since calcium, pyridoxine hydrochloride, citric acid, ascorbic acid and alcohol block oxalic acid or

oxalate, the individual should work his/her dietary therapy up to the point of experiencing the discomforts Stated and then back off Slightly from Oxalic acid or oxalate intake. It

25

is also believed that the converse is also true-insufficient

Oxalic acid or oxalate may allow tumors to grow. This invention relates generally to methods and compo Sitions containing Oxalic acid or oxalate or related com pounds for providing therapeutic effects Such as the control, prevention, or treatment of cancer, tumors, neoplasia, etc. It was initially discovered that a lack of Oxalic acid or oxalate in the diet of a human, allowed or promoted the growth of tumors, growths, or other neoplasia. It was then discovered that the ingestion or administration of a therapeutic quantity of Oxalic acid, oxalate or foods containing high levels of Oxalic acid or oxalate can deter, reduce, or prevent the growth or spread of cancer, tumors, or other neoplasia. It has also been discovered that the therapeutic effect of Oxalic acid or oxalate can be inhibited by an increased ingestion or administration of Oxalic acid or oxalate blockers including, for example, calcium, alcohol, citric acid, ascor

35

malonic acid.

40

As described in “Oxalic Acid in Biology and Medicine” by A. Hodgkinson, 1977, oxalic acid was formerly used intravenously as a hemostatic agent and topically as an antiseptic in man and other animals but this was discontin ued because of its toxicity and the danger of precipitating insoluble calcium oxalate in the tissues. Oxalic acid is a

relatively Strong acid having a first dissociation constant being exceeded by that of only a few halogen-Substituted carboxylic acids. Oxalic acid forms neutral and acid Salts

bic acid (vitamin C), pyridoxine hydrochloride (vitamin B6),

etc. Other oxalic acid or oxalate blockers include binding agents Such as clay, resins, and indigestible fibers. Radiation, Strong electromagnetic waves or fields, electron

45

nesium oxalate, and the like. Oxalic acid also inhibits the

50

55

of Oxalic acid or oxalate. Oxalic acid or oxalate enhancers which increase the beneficial effect of Oxalic acid or oxalate

include longchain fatty acids and the like which bind with or otherwise eliminate Oxalic acid blockerS Such as calcium.

High levels of Oxalic acid or oxalate can produce Side effects of diarrhea, indigestion, damage to the digestive tract, and kidney damage or renal failure. Hence, prolonged ingestion or administration of high quantities of Oxalic acid

60

or oxalate should be avoided so that the beneficial thera

peutic effect of the reduction, control, or treatment of tumors, cancers, and neoplasia can be enjoyed without harm to other Systems or parts of the body.

with monovalent metals and ammonia. Oxalic acid forms a

number of Oxalates or Salts including calcium oxalate, potassium oxalate, Sodium oxalate, Strontium oxalate, mag

bombardment, excessive heat, and bases Such as Sodium

bicarbonate Serve to decompose, neutralize or otherwise reduce the beneficial effect of oxalic acid. There may also be pharmaceuticals which interfere with the absorption or ben eficial activity of Oxalic acid or oxalates. Also, the thera peutic effect of Oxalic acid or oxalate can be enhanced by decreasing or eliminating the ingestion or administration of one or more of these blockers and/or increasing the ingestion

Oxalic acid dihydrate, monoclinic tablets, prisms, and granules are considered poisonous. Anhydrous Oxalic acid is crystallized from glacial acetic acid and is orthorhombic with the crystals being pyramidal or elongated octahedra. Oxalic acid is listed as being caustic and corrosive to the skin and mucous membranes. Ingestion may cause Severe gastroenteritis, with Vomiting, diarrhea, or melena. Renal damage can occur as a result of formation of excessive calcium oxalate crystals. Convulsions, coma, or death from cardiovascular collapse can also occur. Common uses of Oxalic acid include as an analytical reagent, in calico printing and dying, for bleaching Straw and leather, removing paint or varnish, rust or ink Stains, clean ing wood, and manufacturing oxalates, blue ink, celluloid, intermediates and dyes, in metal polishes, in purifying methanol, for decolorizing crude glycerol, for Stabilizing hydrocyanic acid, as a general reducing agent, in ceramics and pigments, in metallurgy as a cleanser, in the paper industry, in photography, in proceSS engraving, in rubber manufacturing, in making glucose from Starch, as a con densing agent in organic chemistry, and as a veterinary hemostatic agent when mixed in 5% solution with 5%

65

activity of a number of enzymes possibly due to the com petition between oxalate and a structurally similar Substrate of the enzyme. Precipitation as the calcium Salt is the classical method of Separating oxalic acid from other Sub stances. Although calcium oxalate is generally considered to be an insoluble salt this is a relative term and its solubility in water is actually 6–7 mg/l at room temperature. Biological fluids contain many substances that affect the solubility or rate of crystallization of calcium oxalate or co-precipitate with the Salt. For example, magnesium, polyphosphates and other polyelectrolytes affect the solubility or rate of crystal lization of calcium oxalate while phosphate and Sulphate ions, uric acid and citric acid co-precipitate with the Salt. Also as described in “Oxalic Acid in Biology and Medicine”, oxalic acid and its salts are widely distributed among the higher plants. Oxalic acid is Sometimes present in plants as the free acid, but more usually, however, it is present as a Soluble or insoluble Salt, for example, the acid and neutral Sodium and potassium Salts and the ammonium

6,133,317 21

22

Salt. Calcium oxalate is the most common insoluble Salt but

"normal” concentration of Oxalic acid in mammalian blood.

relatively large amounts of magnesium oxalate occur together with calcium oxalate in plants Such as beetroot, Spinach, and buckwheat. Under conditions of calcium deficiency, Strontium, magnesium, or barium oxalate can be Substituted for calcium oxalate in a wide variety of plant Species depending upon the mineral environment. Further, as mentioned in “Oxalic Acid in Biology and Medicine”, there have been many studies of the oxalate

Early studies obtain values ranging from 2-4 mg/100 ml of blood. Another study indicated that the normal blood con centration is probably less than 1 mg/100 ml of blood. Improved testing methods have given results in normal values within the range of 100 tug/100 ml to 800 tug/100 ml. More recent tests of human plasma have produced normal Oxalic acid concentration ranging from 11.8-14.3 ug/100 ml of blood in man and 52.6 to 74.4 tug/100 ml of blood in sheep

content of individual foodstuffs (see Tables I-IV), but few estimates have been made of the total daily intake of oxalate by animals or man (see Table V). This is surprising in view

(see Table VI).

of the effect of oxalate on calcium availability and the high incidence of calcium oxalate renal Stones in many parts of the world. As shown in Table V, the reported numbers for daily oxalate intake range from 70-980 mg/per day of anhydrous acid for healthy adult males. However, this information was based on the Study of diets which contain no oxalate-rich foods other than tea which is the largest Single Source of the acid in typical English diets. If an

Feeding experiments and radioisotope Studies have indi cated that a considerable number of compounds are precur Sors of Oxalic acid in animals and man, for example, glycine, glyoxylic acid, glycollic acid, ethyleneglycoll, ascorbic acid,

15

and tryptophan (Oxalic Acid in Biology and Medicine). Studies with ascorbic acid have shown that the main excre

tory products of Vitamin C in man are oxalate, ascorbic acid, and dehydroascorbic acid. From 17-40% of administered ascorbic acid was excreted as Oxalic acid.

As reported in “Oxalic Acid in Biology and Medicine”, a high oxalate intake reduces the intestinal absorption of

average Serving (60 g) of spinach or rhubarb had been included then the oxalate intake would have risen to between

calcium because of the formation of insoluble calcium

400 and 600 mg/day but these levels are not typical for this country. Wide variations in oxalate intake may occur in countries Such as India where vegetables rather than dairy products provide the main Source of minerals and where many of the plants used as Vegetables contain high concen

oxalate and prolonged exposure to Such a diet may lead to loSS of bone mineral, particularly if the diet is also deficient in calcium or Vitamin D. This situation is unlikely to occur very often in Western countries where there is a plentiful Supply of milk and other dairy products and oxalate-rich foods are relative uncommon. However, in developing coun tries Such as India the Situation is often quite different because tropical vegetables frequently with a high oxalate content provide the main Source of minerals and the total oxalate intake may well exceed the calcium intake in certain Seasons. Dietary oxalate is poorly absorbed on a normal diet containing adequate amounts of calcium. Further, as reported in a literature including "Oxalic Acid in Biology and Medicine', poisoning from oxalic acid in animals and man has been recognized since the beginning of the 19th Century. The death rate from oxalate poisoning has declined Supposedly because of a decreased use of Oxalic acid in domestic cleaning fluids. Examples of chronic poi Soning by absorption of Oxalic acid through the Skin and by inhalation have been reported. The range of lethal doses in acute poisoning is wide, varying between 2 and 30 g and depending upon a variety of factorS Such as the form in

25

trations of Oxalate. Some indication of these variations has

been provided by a study which found intakes ranging from 78-2045 mg/day depending on the Season in the rural population of Udaipur, India. A relatively high intake was also found among upper-income groups in urban areas and was attributed to a high intake of tea and green, leafy vegetables, compared with lower-income groups. As reported in “Oxalic Acid in Biology and Medicine”, when taken with food, ingested oxalate is poorly absorbed from the gastrointestinal tract. Although oxalate absorption appears to be unaffected by metabolic inhibitors it is reduced by the presence of calcium which lowers the concentration of free oxalate ions. It is well known, for example that calcium oxalate is absorbed leSS readily than Sodium oxalate and absorption is also reduced by the oral administration of

35

increased when the dietary intake of calcium is reduced and this is reflected in an increased urinary excretion of oxalate.

45

40

cholestyramine (anion exchange resin which has a strong affinity for oxalate ions). Conversely, oxalate absorption is In addition to a low calcium diet, the intake of disodium

ethylenediamine tetraacetic acid (EDTA) appears to increase

the absorption of oxalate by complexing of calcium with EDTA in the intestinal lumen leaving more oxalate free to be

50

absorbed.

Also as reported in “Oxalic Acid in Biology and Medicine', the most important precursors of urinary oxalate in man are ascorbic acid, glycine, and dietary oxalate. Excretion of Oxalate is also increased by the ingestion of a variety of Substances including glycine, glutamic acid, purines, gelatin, and ascorbic acid. Conversely, excretion has been reported to be reduced by the administration of pyridoxine and magnesium oxide. LeSS than half of the normal dietary intake of Oxalic acid can be accounted for by absorption into the body or excretion in the faeces. The remainder of the normal dietary intake of Oxalic acid appears to be destroyed by a bacterial action in the large intestine. With a dietary intake of about 130 mg/day, more than 50 mg/day appears to be destroyed by bacterial action. Also as reported in “Oxalic Acid in Biology and Medicine”, large discrepancies have been reported in the

55

60

65

which the acid or its Salt is taken and the amount of food,

particularly calcium, which is present in the Stomach and intestine. Death has occurred as early as 3 minutes and as late as 14 days after ingestion. Symptoms of acute Oxalic acid toxicity in man can be divided into those caused by a local corrosive action and those resulting from absorption and excretion of the Soluble oxalate. If a high concentration or the Solid form is taken, the local effects may be predomi nant and death may result from acute hemorrhagic gastro enteritis without development of Symptoms depending on absorption. If death does not result from local corrosive action then Symptoms develop from the Systemic effects and from renal insufficiency. The cardiovascular, neuromuscular and central nervous Systems are markedly affected. The skin is pale, cold and clammy, the pulse is weak and the blood preSSure and temperature are low. Numbness and tingling may develop in the extremities and cramp-like muscular and abdominal pain may be extremely Severe. Local or gener alized muscular twitchings occur and may progreSS to marked tetany and convulsive Seizures. The central nervous System may show evidence of excitation or depression, varying from an acute maniacal State to stupor and coma. Death results from cardiovascular collapse or depression of

6,133,317 24

23 the central nervous System. Renal involvement is frequent and even if the patient Survives the Severe local or Systemic effects, death may ultimately occur from renal insufficiency, which dominates the picture from the Second day. Oliguria develops and may progreSS to anuria. Infection with Oxalic acid producing fungi of aspergillus may result in massive deposition of calcium oxalate at the Sight of infection and also renal oxalosis, leading to renal

acid in a Solvent Such as distilled water, ethanol, acetone,

propylene glycol or polySorbate to form a Solution which is then mixed in a conventional manner with a commonly available cream or ointment base Such as hydrophilic oint ment or petrolatum. Therapeutic compositions of the instant invention may also be formulated in gel, lotion, Spray, Stick or powder form. It is believed that the therapeutic effect of the oxalic acid or oxalate in treating tumors, cancers, neoplasia, and other disorders affecting humans involves the administration whether it be oral, by injection, Suppository or the like of a therapeutic and beneficial quantity of Oxalic acid in one of

failure (Oxalic Acid in Biology and Medicine). Patients

undergoing treatment with Steroids, immunosuppressive drugs or cytotoxic agents are particularly liable to develop fungal infections and the increasing use of these drugs in malignancy and organ transplantation may be expected to lead to an increased incidence of aspergillosis infection.

Oxamide (ethanediamide, oxalamide, oxalic acid diamide, or ethanedioic acid diamide, or C2HNO2) is

metabolized in the body to form oxalic acid. In accordance with the present invention, therapeutically effective amounts of at least one therapeutically effective form of oxalate or oxalic acid including, oxalic acid dihydride, anhydrous Oxalic acid, potassium oxalate, Sodium oxalate, oxamide, plants or vegetables containing oxalic acid or the potassium Salt thereof, or combinations thereof are administered periodically to prevent, control, or treat neoplasia, cancers, tumors, and the like. Further, these compounds are administered along with a therapeutically effective reduction in the administration or ingestion of Oxalic acid or oxalate blockerS Such as calcium, potassium,

its free acid, Salt, or other forms to elevate the blood Oxalic 15

7OK human.

Also in accordance with the present invention in the treatment of canines, an oxalic acid or oxalate level chart for canines and felines differs from that for humans in that the

desired therapeutic effect can be produced from 14 mg/L to 50 mg/L, preferably 22 mg/L oxalate level in the urine of a 25 K animal as compared with 40 mg/L to 80 mg/L, preferably 60 mg/L in the human urine. Likewise, the 25

of oxalate in the urine of a 25 Kilogram (K) canine.

thereof.

35

40

45

50

pholate, Vitamin B12, pantothenic acid, iron, iodine, Zinc, and copper. A daily value has not been established for Oxalic acid. Each tablet would contain the following ingredients: Oxalic acid or oxalate, Oxalic acid dihydrate, anhydrous Oxalic acid, or other form of Oxalic acid or oxalate, or

55

spinach, or combinations thereof (see Tables I-IV). Atherapeutic composition of the present invention in the form of a daily Supplement, pill, gelcap, pharmaceutical, or the like is prepared by placing a therapeutically effective amount of Oxalic acid or oxalate compound in pill form for oral ingestion as directed. A therapeutic composition of the present invention in cream or ointment form for topical administration of Oxalic acid is prepared by mixing a dilute concentration of Oxalic

vitamin B6, 400 mcg folate, 6 mcg vitamin B12, 30 mcg biotin, 10 mg pantothenic acid, 162 mg calcium, 18 mg iron, 109 mg phosphorus, 150 mcg iodine, 100 mg magnesium, 15 mg zinc, 20 mcg Selenium, 2 mg copper, 2.5 mg manganese, 25 mcg chromium, 25 mcg molybdenum, 36.3 mg chloride, 40 mg potassium, 5 mcg nickel, 10 mcg tin, 2 mg Silicon, 10 mcg Vanadium, and 150 mcgboron. Such a multiple vitamin formula with added minerals provides a 100% daily value of at least vitamin A, vitamin C, vitamin D, vitamin E, vitamin B1, vitamin B2, niacin, vitamin B6,

like.

In accordance with the present invention, a therapeutic composition may be formed by adding oxalic acid dihydrate to food or drink to provide for the oral ingestion of a therapeutically effective quantity of Oxalic acid. Atherapeutic composition of Oxalic acid or oxalate com pound of the present invention may be prepared by forming a food or drink including plants or vegetables high in Oxalic acid or oxalate, for example carrots, chives, parsley, beets,

In accordance with one embodiment of the present inven tion a multiple Vitamin formula having oil and water Soluble Vitamins with minerals in tablet form with a Suggested use to take one tablet daily with a full glass of distilled water preferably within an hour of a meal or as directed by a physician, includes about 100 mg oxalic acid together with 5,000 IU vitamin A, 60 mg vitamin C, 400 IU vitamin D, 30

IU vitamin E, 25 mcg vitamin K, 1.5 mg thiamin (vitamin B1), 1.7 mg riboflavin (vitamin B2), 20 mg niacin, 2 mg

C, and combinations thereof.

Oxalic acid dihydrate is commercially available in powdered, granular or crystal form for use as an industrial cleanser or Solvent preparation. In accordance with the present invention, oxalic acid may be present in a free acid, ester, lactone, or Salt form. Also, Oxalic acid, oxalate or related compound having the desired beneficial effect may be used as a composition, additive, Supplement, and the like alone or in combination to prevent, control, or treat cancer, tumors, neoplasia, diseases and the

normal blood oxalic acid level of an animal Such as canine or feline differs from that of humans.

Along this line, it has been determined that about 1 gram per day intake of Oxalic acid provides about a 22 mg/L level

Vitamin C, Vitamin B6, citric acid, alcohol, or combinations

Also, in accordance with the present invention, Severe gastrointeritus, vomiting, diarrhea, melena, renal disease, renal damage, convulsions, coma, cardiovascular collapse, and the like caused by Oxalic acid are treated by reducing Oxalic acid or oxalate intake and/or administering therapeu tic quantities of Oxalic acid or oxalate blockerS Such as calcium, alcohol, potassium, citric acid, Vitamin B6, vitamin

acid level to between 350 ug/100 mL and 450 tug/100 mL, preferably 425 ug/100 mL and/or the urine oxalate level to between 40 mg/L and 80 mg/L, preferably 60 mg/L for a

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combinations thereof together with dicalcium phosphate, magnesium oxide, potassium chloride, ascorbic acid, ferrous fumarate, calcium carbonate, gelatin, Starch, cellulose, d1-alpha, to copheryl acetate, hydroxy propyl methylcellulose, croScarmellose Sodium, Sodium Starch glycolate, niacinamide, Zinc oxide, Silicon dioxide, D-calcium pantothenate, Sodium metasilicates and oxides, titanium dioxide, hydroxypropyl cellulose, polyethylene glycol 3350, manganese Sulfate, magnesium Stearate, phar maceutical glaze, polySorbate 80, pyridoxin hydrochloride, copper oxide, poVidone, Sodium and potassium borates, riboflavin, Vitamin A, acetate, thiamin mononitrate, beta

carotene, resin, folic acid, potassium iodide, chromium chloride, ergocalciferol, Sodium molybdate, Sodium

6,133,317 25

26

Selenate, yellow 6 lake, Sodium metavanadate, Stannous

chopped parsley which is mixed with the other ingredients to be disbursed throughout the loaf. These two rounded tableSpoons of dried parsley provide approximately 2 grams

chloride, nickelous Sulfate, phytonadione, biotin (U.S.P. method 2), and cyanocobalamin (U.S.P. method 2). This product would be formulated per official U.S.P standards to meet disintegration or dissolution, weight, purity, and potency requirements. An alternative embodiment of the present invention would include a multiple Vitamin and mineral tablet or daily Supplement including oxalic acid in one of its forms or oxalate together with all the above mentioned Vitamins and minerals except those which Serve as Oxalic acid or oxalate blockers. For example, the inclusion of Oxalic acid or oxalate blockers would be eliminated or greatly reduced So as to prevent blocking the beneficial effect of the Oxalic acid or oxalate. Such blockers include calcium, potassium, Vita min B6, vitamin C, citric acid, alcohol, magnesium, etc. In accordance with at least one embodiment of the present

of oxalic acid or oxalate in the loaf of bread. Hence, half of

the loaf contains about 1 gram, /4 of the loaf contains about /2 gram, /18 of the loaf contains /4 of a gram, and /16 of the loaf contains about /s of a gram of Oxalic acid. In accordance with one embodiment of the present invention, the above described loaf of Oxalic acid or oxalate

15

invention, Oxalic acid or oxalate is used for the treatment of Viral, bacterial, or chemical diseases of warm blooded

animals including humans, dogs, and the like. In accordance with a particular embodiment of the present invention, oxalic acid or oxalate is used in a method of

therapeutically treating a human including administering a therapeutically effective dosage of Oxalic acid, oxalic acid Salt, Oxalic acid ester, or other therapeutically effective form thereof, in an amount and for a period of time Sufficient to provide the desired effect.

25

The method as described above wherein the oxalic acid is in the form of a free acid. The method as described above wherein the acid is in Salt form.

The method described above wherein the oxalic acid, oxalate or other therapeutically effective form thereof is administered periodically for a period of time Sufficient to achieve at least a clinically discernible effect, for example,

Silver, Strontium, alcohol, citric acid, Vitamin B6, vitamin C, 35

a reduction in the size of a tumor.

The method as described above wherein the oxalic acid,

oxalate or other therapeutically effective form thereof is administered periodically for a period of time Sufficient to achieve at least a Substantial therapeutic effect, for example

40

the eradication of a tumor. The method as described above wherein the oxalic acid or

oxalate is administered daily. The method as described above wherein the period of

45

time is at least one month. The method as described above wherein after one month

the Oxalic acid is administered on a weekly basis. The method as described above wherein the oxalic acid,

oxalate or other therapeutically effective form thereof is present in a therapeutically acceptable composition includ ing a carrier. The method as described above wherein the composition is a powder, tablet, gelcap, lotion, cream, gel, ointment, Solution, mixture, food, nutritional Supplement, formulation, transdermal patch, drops, or combination thereof. In accordance with one embodiment of the present invention, a therapeutically effective dosage of Oxalic acid or oxalate is administered on a periodic basis by the ingestion of one or more foods including oxalic acid in one of its therapeutically effective forms including free acid, Salt, ester, lactone, anhydride, dihydrate, diamide, or the like. In accordance with a particular example, a four pound Sourdough bread loaf is made from conventional bread ingredients including flour, water, yeast, and Sourdough and has added thereto two rounded tablespoons of dried,

containing Sourdough bread is used in a method of thera peutically treating a warm blooded animal by having the animal periodically ingest a portion of the loaf. For example, in the treatment of an adult male human, he could ingest daily up to about 72 of a loaf of this bread to achieve a dosage of Oxalic acid of up to about 1 gram oxalic acid per day. This dosage may be reduced after a period of time and given a certain health condition to /2 gram or leSS Oxalic acid per day, and, as Such, 4 loaf or less of the bread per day. The above described Oxalic acid or oxalate containing Sourdough bread does not include any Salt, Sugar or preser Vatives Since the Oxalic acid Serves as a preservative. In using oxalic acid or oxalate as a therapeutic agent, one must be careful to administer the proper dosage given certain health conditions or in order just to maintain a healthy condition Since an overdose of Oxalic acid or oxalate can cause Severe problems. Such as renal failure, heart failure, diarrhea, vomiting, convulsions, melena, and the like. It is believed that a proper balance should be main tained between oxalic acid, oxalate and their blocking agents Such as potassium, barium, calcium, copper, magnesium,

50

55

and the like. If a high dosage of Oxalic acid or oxalate would reduce calcium levels, potassium levels, magnesium levels, and the like necessary for proper heart functioning, it is necessary to limit the administration of Oxalic acid or oxalate to the minimum dosage necessary to provide the desired therapeutic effect without causing undesired side effects or health problems. In accordance with the present invention, the dosage of Oxalic acid or oxalate is monitored and altered as necessary by monitoring the Oxalic acid or oxalate levels in the urine and/or blood in the patient, whether that patient be a human, canine, or the like. Also in accordance with the present invention, the amount of blockerS Such as calcium, Vitamin 26, Vitamin C, citric acid, alcohol, or combinations thereof

are monitored in the urine and/or blood of the patient. It has been discovered that the body of an animal such as human or canine is a complex chemical factory which requires a particular balance of compounds, chemicals, Vitamins, minerals, nutrients, and the like to provide for and maintain optimum health of the animal. It is believed that too little oxalic acid or oxalate in the animal may allow for the advent of neoplasia, tumors, cancers, growths, and the like while too much oxalic acid or oxalate may cause back

pain (due to kidney trouble), heartburn, indigestion, heart trouble, nerve trouble, and the like. Thus, it is recommended

that each individual case be Studied and that the proper dosage of a therapeutically effective amount of Oxalic acid, 60

oxalate, enhancers, and/or blockers be administered on a

periodic basis at one level to maintain proper health by preventing neoplasia, tumors, growths, and the like, at a different level to treat, combat, control, or eradicate tumors,

growths, cancers, neoplasia, or to cleanse the blood, and at 65

a third intermediate level once the blood is clean and

relatively free of cancer, tumor or neoplasia cells, to combat, reduce the size of, or treat an existing tumor, cancer, growth,

6,133,317 27

28

or the like. Since each perSon or animal is different, and their body chemistries operate in at least Some Small fashion differently than other perSons or animals, the administration of a therapeutically effective dosage of Oxalic acid, oxalate, enhancers, and/or blocking agents should be reevaluated and monitored on a regular basis by, for example, physical examination, X-ray, CAT Scan, MRI imaging, Sonogram, biopsy, blood analysis, urine analysis, fecal analysis, as well as other conventional diagnostic techniques. It is believed that a proper balanced diet including foods containing oxalic acid in one of its forms including oxalate which may be metabolized by a human or other warm blooded animal can Serve to maintain proper health, extend life, increase the quality of life, increase energy, increase cranial activity, prevent neoplasia, tumors, cancers, etc., help to combat viruses, bacteria, improve the immune System, and provide other beneficial short term and long term health

mammograms, radiation therapy, CAT-Scans, nuclear or atomic exposure, radiation therapy, chemotherapy, radioac tive pellet treatment, and the like, to prevent the formation of tumors, cancers, neoplasia by counteracting the destruc tion of Oxalic acid or oxalate caused by the exposure or treatment.

It is believed that a dosage of Oxalic acid or oxalate may also provide a reserve of energy or nutrients. Hence, a food or beverage containing oxalic acid or oxalate could be ingested prior to Strenuous activity in order to increase energy, Stamina, Strength and/or mental activity. It is also believed that Oxalic acid or oxalate may prevent or relieve muscle SoreneSS by helping eliminate lactic acid. 15

effects.

Some forms of Oxalic acid or oxalate which may prove

It is also believed that oxalic acid or oxalate should be

administered after exposure to specific oxalic acid or oxalate decomposing bacteria to prevent the onset of tumors. For example, workers at poultry houses may take Oxalic acid or oxalate to maintain a normal level of Oxalic acid or oxalate

beneficial to humans and other warm blooded animals,

to prevent tumor development and counteract exposure to

include ethanedioic acid (free acid), ethanedioic acid

bacteria.

anhydride, ethanedioic acid tripotassium Salt, ethanedioic acid barium Salt, ethanedioic acid copper Salt, ethanedioic

In addition to the administration or ingestion of Oxalic acid or oxalate, it is believed that one should limit the intake

acid diamide, ethanedioic acid diamonium Salt, ethanedioic

acid diethyl ester, ethanedioic acid dimethyl ester, ethanedioic acid disodium Salt, ethanedioic acid magnesium

of dairy products Since these tend to counteract the benefi 25

Salt, ethanedioic acid Silver Salt, ethanedioic acid strontium

Salt, ethaneaioic acid dihydrate, dicarboxylic acid, as well as other forms of Oxalic acid or oxalate which may be metabo lized by the body, injected into the circulatory System, administered by transdermal patch, administered by Suppository, or administered by topical application, and the like, to provide the desired therapeutic effect. Although one or more of the above may be considered poisons to humans or other warm blooded animals, the proper administration of a Selected dosage is believed to be therapeutically effective and instrumental in the treatment, prevention, control, and maintenance of health. It is not uncommon for an agent which is a poison to provide a beneficial effect. Aspirin is one of the myriad of hundreds or thousands of poisons which provide a beneficial effect to warm blooded animals when administered in a proper dosage. It is believed that oxalic acid or oxalate may be one of the primary causes of the onset of Osteoporosis. Too much Oxalic acid or oxalate in the diet may reduce the calcium in the body to a point of causing or aggravating osteoporosis. Hence, the treatment and prevention of Osteoporosis is the

35

decomposition. 40

It is believed that oxalic acid or oxalate should be admin

istered following exposure to X-ray radiation, X-rays,

It is also believed that the administration of oxalic acid or

oxalate may delay, prevent, control, or treat the onset of Alzheimer's Disease, lessen the effects of the disease, or

improve the quality of life of a perSon Suffering from

Alzheimer's Disease. 45

control of the Oxalic acid, oxalate and calcium levels.

or oxalate intake to prevent, treat, or control osteoporosis. It is believed that oxalic acid or oxalate may be a blood purifying agent which in addition to controlling, treating, or eradicating abnormal cells, oxalic acid in the blood may control cholesterol and plaque or fat buildup. Thus, the periodic or daily administration of a certain quantity of Oxalic acid in one of its therapeutically effective forms including oxalate may serve to not only purify the blood, but also control, treat, or effect cholesterol, plaque, and fat buildup in the cardiovascular System or in the brain, and in So doing improve and maintain good cardiovascular health and operation. It is believed that Oxalic acid or oxalate may also be an effective treatment for parve. Also, oxalic acid or oxalate may be used as a hemostatic and antiseptic agent in animals.

istered prior to a transplant operation to purify the blood and improve the immune System. However, it is also possible that just prior to a transplant operation the body should be purged of Oxalic acid to prevent aspergillus fungi infection. It is believed that Strong magnetic fields, MRI imaging, computer terminals, power lines, cellular telephones, elec tronic equipment, microwave Ovens, etc. may decompose oxalic acid or oxalate in the body and blood and allow the formation of tumors, growths, cancers, etc. Hence, those Subjected to Strong magnet fields and the like should increase their oxalic acid or oxalate intake to counteract Such

Women in a high risk group for Osteoporosis should be careful to increase calcium intake and decrease Oxalic acid

cial effect of the Oxalic acid or oxalate. It is believed that oxalic acid or oxalate should be admin

50

It is also believed that Oxalic acid or oxalate may be a control, treatment, or preventative, for autoimmune related diseases such as AIDS, HIV, SLE, BSE, CFS and the like by preventing, lessening, or controlling the destruction of the bodies immune System. Hence, the administration, ingestion, injection, etc. of Oxalic acid in one of its thera peutically effective forms including oxalate may serve to treat, prevent, or control the debilitating effects of autoim mune related diseases, Viral diseases, bacterial infections, and the like.

55

One publication mentioned that human blood typically has a mean value of about 288 ug of anhydrous Oxalic acid per 100 ml of blood. If a subject's blood is tested and their oxalic acid level is below this mean value, it is believed that

60

they should be administered Oxalic acid in one of its forms including oxalate, easily metabolized by the body to increase their blood oxalic acid level. Also it is believed that

if Someone is Suffering from cancer, tumors, AIDS, bacterial infection, etc. that they should be administered Oxalic acid or oxalate in order to increase their blood oxalic acid level to 65

a higher value than the typical mean value. In accordance with one embodiment of the present invention, a new Scale is developed for canine and feline

6,133,317 29

30

urine oxalate level. Since a typical human Scale will not work for a canine or feline due to their different body

Suffering from kidney Stones are told to Stay away from rhubarb leaves, Spinach, Swiss chard, lambSquarter, and beet leaves which contain high amounts of Oxalates. Also, they are told to Stay away from black and green teas and coffee

Structures and metabolism, a need exists for a canine and/or

feline Scale which will provide a quick-ready reference for a veterinarian or pet owner to test urine oxalate levels and adjust the Oxalic acid intake in the diet accordingly. Oxalic acid is a reducing agent, bacterioStatic agent, and may be an antioxidant. In accordance with the present invention, it is believed that five or more items unnaturally constantly consumed are responsible for tumors or cancers and the like. These items,

which also contain oxalic acid. Further, nuts, chocolate and

Strawberries are cited by Some as containing high-oxalate. Opposite conventional thinking, in accordance with the present invention, it is believed that Oxalic acid or oxalate is the “silver bullet”, “hall monitor', or “brevet boule” that

calcium, Vitamin B6, vitamin C, citric acid, and alcohol are believed to be oxalic acid or oxalate blockers. It is interest

ing to note that a variety of prepared foods eaten every day including cookies, cakes, canned foods, Salad dressings, and the like contain these items. Further, it is interesting to note that certain articles have proposed that perSons on a low-fat

15

diet showed leSS tumors or showed tumor reduction. Since red meat Such as beef or liver contains vitamin B6

(pyridoxine hydrochloride) it follows that reduction or elimination from the diet also serves as a reduction or elimination of a blocker of Oxalic acid or oxalate. Tables

VII-XI list the pyridoxine hydrochloride content of meats

electron bombardment, microwaves, and the like reduce the

and other foods.

Although others have indicated that vegetables are cancer fighters, they have listed the cancer fighting agents as

25

antioxidants, beta caroteine, or citric acid. The literature is

Void of a reference to oxalic acid as being a cancer fighter or preventer.

The literature Suggests that tumors occur when the immune System fails to eliminate abnormal cells not con Sumed as a normal biological function of the body Systems. In accordance with the present invention, it is believed that a low intake of Oxalic acid or oxalate or a high intake of Oxalic acid or oxalate blockers including alcohol, citric acid, ascorbic acid, and pyridoxine hydrochloride weakens the immune System or the body's natural cancer fighting ability to the point where the body cannot control abnormal cell growth, tumors, cancer, and the like. Changing the diet to include an increase in the intake of Oxalic acid or oxalate and

35

40

eliminating or drastically reducing the intake of Oxalic acid or oxalate blockers, allows the body's immune System or natural cancer fighting Systems to function and eliminate abnormal cells.

It is believed that carrots, Spinach, parsley, chives, beet leaves, garlic, collards, radishes, and the like are relatively high in Oxalic acid or oxalate and should be eaten in order to build a high concentration of Oxalic acid or oxalate in the body. It is believed that if one can maintain a balanced diet and assure an adequate level of Oxalic acid or oxalate in the System then the body's natural protection mechanisms, immune System, and the like can prevent, treat, and control tumors, growths, cancers, Viral or bacterial diseases, chemi cal toxins, and the like.

45

50

55

Over the years, many claims have been made regarding the beneficial health effects of many fruits, vegetables, plants, molds, etc. For example, garlic is believed to fight infection, cancer, bacteria, Virus, and heart disease. Straw

berries are also believed to help prevent prostate cancer. Tomatoes or Spaghetti Sauce are believed to prevent cancer and heart attacks. A recent Study indicated that two cups of coffee a day can prevent Suicide in Women who work. On the other hand, plants, vegetables and chemicals which contain high levels of Oxalic acid or oxalate are according to conventional wisdom thought to be poisons and to be eliminated from the diet or use. For example, those

treats, kills, controls, manages, or prevents abnormal, tumor, cancer or unspecialized cells and, thereby, treats diseases and maintains good health. Further, it has been discovered that a high oxalic acid or oxalate intake causes a cancer patient to be more talkative, Verbal, have increased dexterity, physical ability, mental ability, and appear invigorated, happier and more outgoing. The conventional treatments for cancer, tumors, growths and the like can themselves cause cancer, tumors, growths and the like. For example, X-rays can trigger malignant growths in certain people. Further, in accordance with the present invention, decomposition or reduction of Oxalic acid or oxalate in the body caused by exposure or treatment of X-rays, CAT-Scans, Strong electromagnetic waves or fields, level of oxalic acid or oxalate in the body and further increase the chance of growths, tumors, cancers, and dis ease. Hence, it is believed that one should not only increase the intake of Oxalic acid or oxalate, but also avoids exposure to or treatment of radiation, X-rays, electromagnetic fields and the like which tend to decompose or reduce the amount of Oxalic acid or oxalate in the body. Along this same line, it is believed that conventional testing techniques, such as the testing of carcinogens on mice may provide faulty results in that the first Step typically in Such testing is to irradiate the mice with radiation to weaken their immune System So that they are more Suscep tible to carcinogens. The radiation to weaken the immune System also causes a reduction or elimination of the Oxalic acid or oxalate in the mice. In accordance with the present invention, it is believed that a normal level of oxalic acid or

oxalate is required in the body to prevent cancers, growths, tumors, and the like. Hence, the researchers unknowingly introduced an additional cancer causing factor into the testing. In accordance with the present invention, an improved testing method would involve determining the normal oxalic acid or oxalate level of the test animal, weakening the immune System of the animal using radiation, and then administering or feeding to the animal a Sufficient quantity of Oxalic acid or oxalate to bring their oxalic acid or oxalate levels back up to normal prior to further testing. Also, in accordance with the present invention, it is believed that testing, research, and examinations which include X-rays or electronic Scans to insure no cancer is present or to check on the size or location of the cancer can themselves bring on cancer by decomposing oxalic acid or oxalate and irritating the skin or tissue. Further, if test animals are fed a diet high in Oxalic acid or oxalate blockers Such as calcium, Vitamin B6, vitamin C, citric acid, and the

60

65

like the effective level of oxalic acid or oxalate in the animal

is reduced and the test results may be skewed and possibly not representative of the natural normal animal biochemistry or System. Hence, it is believed that improved human examination and animal testing involves a reduction in the use of X-ray or electronic Scans, in the incorporation of a balanced diet containing Oxalic acid or oxalate and a reduc tion in Oxalic acid or oxalate blockers.

6,133,317 31

32

In accordance with another embodiment of the present invention, an improved method of testing for cancer includes the elimination of the use of X-rays or electronic Scans during the testing process. In accordance with another embodiment of the present invention, an improved method of testing for cancer allows for the use of X-rays or electronic Scans to detect the presence or absence of cancer, but requires that the Oxalic acid or oxalate decomposed or reduced by the X-ray or electronic Scan be replaced. In accordance with another embodiment of the present invention, an improved method of testing for cancer employs the use of an improved animal feed which includes

a method for measuring radiation dosage in the Sterilization of food and medical products. The absorbed dose is deter

at least one form of Oxalic acid or oxalate and with a reduced amount of Oxalic acid or oxalate blockers from that of conventional feed.

mined from the decrease in Oxalic acid concentration which

occurs during irradiation. In addition to the information provided in Table IV, nuts contain high concentrations of calcium, magnesium, iron and relatively high concentrations of oxalate. For example, almond, cashew, peanut, pecan and walnut all contain Oxalic acid concentrations ranging from 200 mg/100 g-600 mg/100g. Forage grasses and other pasture plants frequently contain high concentrations of minerals but many of them also contain high concentrations of oxalate. Further, many beverages including beers, wines, and fruit drinks contain low concentrations of oxalate but tea, coffee, cocoa, and 15

If one is to administer and ingest Oxalic acid in one of its harsher forms Such as Oxalic acid dihydrate, for example, a gel cap filled with 500 milligrams to 2 grams of Oxalic acid dihydrate, this should be taken one hour before or after a meal and with a Sufficient quantity of water Such as 10 or

According to Occupational Health Services, Inc. (OHS), oxalic acid has a CAS number: 144-62-7A a RTECS num

25

ber: R0245000, trade names or synonyms ethanadoic acid, aktisal, aquisal, dicarboxylic acid, phosphoteX 760 grain refiner, CHO, and OHS17360. Oxalic acid is in the chemical family carboxylic acid, aliphatic and is listed as a poison with a level three out of a scale 0-3 for health, and a level 1 fire rating. In accordance with the present invention it is believed that conventional wisdom that the cause of acorn poisoning is tannic acid is wrong and that it is instead the Oxalic acid which is extremely damaging to renal tissues. It is believed that the Oxalic acid or oxalate level in oak trees is very high, especially in mold that grows on the bark.

35

poisoning is to increase oxalic acid or oxalate blockers, Such as pyridoxine hydrochloride, citric acid, calcium, magnesium, and alcohol Such as ethanol to eliminate or carry the Oxalic acid through the renal System. Oxalate nephrosis is probably the most common cause of toxic death in dogs. Typically, the Source of Oxalate poison

more ounces of distilled water. In order to further reduce the

possibility of harm or irritation to the digestive System, one can line the Stomach before taking Such an oxalic acid pill or gel cap using Pepto Bismol, Tagamet, or Zyntec. In accordance with another aspect of the present invention, workers exposed to X-rays, CAT-Scans, electro magnetic fields or waves, microwaves, radar, high Voltage power lines, electronic equipment and the like are given Sufficient quantities of foods, beverages, Supplements, treats or the like containing at least one beneficial form of Oxalic acid or oxalate to compensate for the decomposition or reduction caused by their working environment and thereby prevent the development of tumors, cancers, diseases, poor health, etc. which may otherwise be caused by their work environment.

Also, it is believed that the treatment for Oxalic acid or oak

In recent history, there has been an increase in breast cancer in Women in the United States. In accordance with

the present invention, it is believed that this increase in breast cancer may be due in part to the use of microwave Ovens which emit microwaves, which when used in cooking or heating decompose the Oxalic acid or oxalate in the food or beverage, use of a myriad of electronic equipment includ ing radios, televisions, computers, etc. and the consumption of processed foods which contain oxalic acid or oxalate

ing is ethylene glycol (antifreeze). The ethylene glycol is 40

metabolized to oxalate and Oxalic acid by an enzyme called alcohol dehydrogenase. Ethylene glycol by itself is not toxic, but when the enzyme, alcohol dehydrogenase, works

on it to produce a toxic material (oxalate), then it becomes toxic. Antifreeze poisoning is treated with alcohol (ethanol) 45

blockerS Such as calcium, citric acid, Vitamin C, Vitamin B6

to keep the alcohol dehydrogenase enzyme busy So that the

antifreeze can be eliminated, unaltered, and in a non-toxic

State. A major contributor to death is also metabolic acidosis caused by Oxalic acid accumulation. It is almost as important to control the acid-based Status as it is worrying about the

and the like.

In accordance with another embodiment of the present invention, a person who believes they have been Subjected to radiation, Strong electromagnetic waves or fields, microwaves, radar, Strong tv or radio waves, or work in a dangerous environment where they may be Subjected to X-rays or other elements which can decompose or reduce the Oxalic acid or oxalate in the body, can test their blood, plasma or urine Oxalic acid or oxalate level and if they find it is below normal, treat themselves with food, beverages, Supplements, pills, capsules, and the like containing oxalic acid or oxalate to bring their level back up to a normal healthy level. Further, Such a person can pre-treat them Selves prior to exposure with Oxalic acid or oxalate to reduce the chance that their levels will drop below normal levels. This should prevent or reduce the increased risk to devel oping cancers, tumors, Viral or bacterial diseases and the like caused by having below normal oxalic acid or oxalate levels in the body. As shown in FIG. 1 of the drawings, solutions of oxalic acid are decomposed by radiation. This has been the basis of

chocolate contain relatively high concentrations of oxalate. Tea, in fact, is listed as being the largest Single Source of oxalate in English diets.

50

accumulation of Oxalate.

There are Several other causes of oxalate nephrosis which are extremely rare. Overdoses of vitamin Chave been shown to cause oxalate nephrosis in humans, and in at least one

goat. Vitamin B6 (pyridoxine hydrochloride) deficiency and 55

60

65

methoxyflurane anesthesia may also induce the condition. Aspergillus sp. fungi also produces high levels of oxalate and these fungi are almost ubiquitous and grow on many feed stuffs. There are a variety of plants other than oak, for example halogenten, greasewood, Sorrel, dock, Setaria grass, Sugar beets, and Several others that contain oxalic acid. Oxalate nephrosis produces a very specific lesion in the kidney when viewed under the microScope. You can actually See the oxalate crystals. A pathologist who is unaware of primary hyperoxaluria would obviously draw the conclusion that the kidney lesions were the result of Oxalate nephrosis. Typically, cancer, tumors, growths, and the like are treated by invasive unnatural techniques, Such as Surgery, biopsy,

6,133,317 33

34

X-ray radiation, chemotherapy, and the like. In accordance with the present invention, it is believed that the primary

EXAMPLE 8

The therapeutic composition of Example 6 including 1 gram or less, preferably 500 milligrams or leSS Oxalic acid, together with conventional quantities of other Vitamins and minerals except that one or more of the Oxalic acid blockers, including Vitamin C, Vitamin B6, calcium, citric acid, and the like, are reduced or eliminated altogether from the pill, Vitamin, multi-mineral, Supplement, etc.

treatment for cancer should be the all natural, non-invasive, use, administration, and the like of Oxalic acid in one of its

therapeutically effective forms including oxalate in a Suff cient quantity and on a periodic basis to provide the desired therapeutic effect. Essiac tea was tested and found to have a pH of about 4.79 when the powder was added to boiling distilled water. The following are illustrative examples of methods, for mulations and compositions according to the present inven tion. Although the examples utilize only Selected com pounds and formulations, it should be understood that the following examples are illustrative and not limiting. Therefore, any of the aforementioned oxalic acids, oxalates, or related compounds may be Substituted according to the teachings of the present invention in the following examples.

EXAMPLE 9

Another therapeutic composition contains Oxalic acid together with conventional pet foods. EXAMPLE 10

15

A conventional pet food mixture is mixed with Oxalic acid in Sufficient quantity to provide the desired therapeutic effect. For example, 1 gram or less, preferably 500 milli grams or less of Oxalic acid dihydrate is mixed with a single Serving quantity or portion of dog food or cat food to provide a daily dosage of one gram or less, preferably 500 milli

EXAMPLE 1.

A therapeutic composition for the treatment of tumors is made up of freeze-dried parsley with a rounded tableSpoon of freeze-dried parsley providing about 1 gram of Oxalic

grams or less of oxalic acid (see Table XII).

acid. EXAMPLE 2

The therapeutic composition of the above example except that one or more ingredients in pet food which are Oxalic acid blockers are eliminated or reduced in quantity from that of conventional pet food. For example, the quantity of

A Sufficient quantity of dried parsley is administered daily to provide the desired therapeutic effect and produce or maintain a desired blood Oxalic acid or oxalate level for

preventing, controlling, or treating tumors.

Vitamin B6, vitamin C, calcium, citric acid, or combinations

thereof are reduced or eliminated from conventional pet food in addition to the admixture of oxalic acid dihydrate.

EXAMPLE 3

A relatively large adult male human having an inoperable brain tumor is administered 4tableSpoonfuls of dried parsley daily, providing approximately 4 grams of Oxalic acid per day, until the growth of the tumor is checked. Thereafter, he is administered 1 tableSpoonful of dried parsley daily, or approximately 1 gram of Oxalic acid per day. In addition to the administration of the dried parsley, his intake of Oxalic acid blockers including calcium, pyridoxines, citric acid, ascorbic acid, alcohol, or combina

EXAMPLE 11

25

EXAMPLE 12 35

40

A therapeutic composition in the form of a pet food that includes a conventional pet food mixed with a Source of Oxalic acid or oxalate Such as carrots, parsley, chives, or combinations thereof to provide a pet food having an Oxalic acid content of 1 gram or less, preferably 500 milligrams or less of Oxalic acid per daily Serving of pet food.

tions thereof is reduced.

EXAMPLE 13

EXAMPLE 4

A therapeutic composition for treating tumors, cancer, neoplasia, and the like, is made up of carrot juice which is administered orally in 2 ounce Servings to provide between 4 and 6 ounces of carrot juice daily to provide the desired therapeutic effect and desired Oxalic acid or oxalate blood or urine level.

45

EXAMPLE 1.4 50

EXAMPLE 5

Carrot juice containing oxalic acid or oxalate is admin istered orally and mixed with other juices and flavoring agents Such as tomato juice, Salt, pepper, parsley, and/or celery to enhance the flavor thereof.

The topical skin treatment composition of Example 13 Serves as an exfoliant, acne treatment, skin cancer treatment,

growth treatment, or combinations thereof. EXAMPLE 1.5

55

A therapeutic composition for the treatment of tumors, cancer, growths, neoplasia, and the like is made up of dried

EXAMPLE 6

A therapeutic composition in the form of a nutritional Supplement or multi-Vitamin, multi-mineral tablet contain ing a Small quantity of Oxalic acid, preferably 500 milli grams or less of Oxalic acid, together with conventional ingredients Such as Vitamins and minerals.

A therapeutic composition containing oxalic acid as a topical skin treatment includes a mixture of 5 grams or leSS of oxalic acid, 40 milliliters distilled water, and 12 milliliters propylene glycol.

chives. 60

EXAMPLE 16

A Sufficient quantity of dried chives is administered on a periodic basis to provide the desired therapeutic effect.

EXAMPLE 7

A treatment regimen or method including the oral admin istration of one Such tablet, pill, multi-Vitamin, or Supple ment of Example 6 daily.

65

EXAMPLE 1.7

A therapeutic composition for the maintenance of good health, prevention, treatment, or control of tumors, growths,

6,133,317 35

36

or cancer, and the like is made up of a food item Such as bread, cereal, or other prepared food including oxalic acid or plant or vegetable containing oxalic acid like parsley or chives, in a quantity to provide the desired therapeutic effect.

containing oxalic acid, a nutritional Supplement containing oxalate, a nutritional Supplement containing Oxalic acid dihydrate, foods containing oxalic acid, foods containing oxalate, foods containing Oxalic acid dihydrate and combi nations thereof, increasing the ingestion or administration of Oxalic acid or oxalate blockers, monitoring the levels of Oxalic acid or oxalate in the blood or urine, adjusting the ingestion or administration of Oxalic acid or oxalate containing compounds and the ingestion or administration

EXAMPLE 1.8

A composition for improving and maintaining good health in warm-blooded animals including humans and pets and having a composition Selected from oxalic acid, oxalate, Oxalic acid dihydrate, a nutritional Supplement containing Oxalic acid, a nutritional Supplement containing oxalate, a nutritional Supplement containing Oxalic acid dihydrate, or

of Oxalic acid or oxalate blockers to achieve the desired Oxalic acid or oxalate levels. EXAMPLE 27

combinations thereof. EXAMPLE 1.9

15

A flavor-enhancer including at least one form of Oxalic acid. EXAMPLE 2.0

EXAMPLE 28

A preservative including at least one form of Oxalic acid. EXAMPLE 21

In a prepared food product, the improvement including at

A method of counteracting, inhibiting, treating, controlling, or reducing the deleterious effects of high levels of Oxalic acid including the Steps of administering or ingest ing a therapeutically effective amount of Vitamin B6, vita min B6-containing nutritional Supplements, foods contain ing Vitamin B6, or combinations thereof.

25

least one form of Oxalic acid. EXAMPLE 22

In a prepared food product, the improvement including

A method of treating a warm-blooded animal including the Steps of determining the Oxalic acid blood level or oxalate urine level of the animal, comparing this level with a Scale indicating below normal, normal, and above normal Oxalic acid or oxalate levels, increasing the administration or ingestion of Oxalic acid or oxalate if the level is below normal, reducing the ingestion or administration of Oxalic acid or oxalate blockers if the level is below normal,

the elimination of citric acid and the addition of at least one form of Oxalic acid.

maintaining current ingestion or administration of Oxalic

EXAMPLE 23

normal, reducing the ingestion or administration of Oxalic acid or oxalate if the level is above normal, or increasing the ingestion or administration of Oxalic acid or oxalate blockers

A method of enhancing or promoting the growth or the Spread of tumors, growths, neoplasia and the like in warm blooded animals Such as test animals including the Steps of reducing the intake of Oxalic acid or oxalate in the diet, destroying the Oxalic acid or oxalate in the animal, and/or increasing the intake of Oxalic acid or oxalate blockers.

acid or oxalate if the Oxalic acid or the Oxalate level is

35

EXAMPLE 29 40

EXAMPLE 30 45

In a multivitamin and mineral Supplement, the improve ment including the addition of at least one therapeutically effective form of oxalic acid.

blockers.

EXAMPLE 31

EXAMPLE 25

A method of inhibiting the therapeutic effect of oxalic acid

The method as described in Example 28 wherein the Oxalic acid or oxalate level Scale has differing below normal, normal, and above normal level categories for different health conditions.

EXAMPLE 24

In a diet for promoting good health in warm-blooded animals including humans, the improvement including increasing the quantity of Oxalic acid or oxalate-containing foods, and reducing the intake of Oxalic acid or oxalate

if the level is above normal.

50

or oxalate in warm-blooded animals. Such as test animals

The multivitamin and mineral Supplement as described in Example 30 further including the improvement of the reduc tion or elimination of Oxalic acid or oxalate blockers therein.

including the Steps of increasing the ingestion of Oxalic acid

EXAMPLE 32

blockerS Such as calcium, alcohol, red meat, citric acid,

Vitamin B6, vitamin C, potassium, dairy products, and the like, administering Oxalic acid blockers, Such as calcium,

55

alcohol, citric acid, Vitamin C, Vitamin B6, and the like,

and/or destroying or decomposing Some or all of the Oxalic

like to enhance the flavor thereof.

acid or oxalate in the animal. EXAMPLE 26

A method for inhibiting, preventing, treating, or control ling the deleterious effects of diarrhea, indigestion, damage to digestive tract, kidney damage, or renal failure caused by high levels of Oxalic acid including the Steps of at least one of reducing the ingestion or administration of Oxalic acid, oxalate, oxalic acid dihydrate, a nutritional Supplement

An oxalic acid treatment method including the Step of mixing carrot juice with other juices and flavoring agents Such as tomato juice, Salt, pepper, parsley, celery, and the EXAMPLE 33

60

65

A therapeutic composition for the maintenance of good health and the prevention, treatment, or control of tumors, growths, cancer, neoplasia and the like of a food or beverage including a therapeutically effective amount of at least one therapeutically effective form of Oxalic acid Such as a plant or vegetable containing oxalic acid or oxalate like parsley or chives.

6,133,317 37

38

EXAMPLE 34

EXAMPLE 44

Atherapeutic composition of Sourdough bread made from flour, water, yeast, Sourdough Starter, and an additional Oxalic acid ingredient Selected from the group of dried, chopped parsley, freeze-dried chives, Oxalic acid, oxalate, foods containing oxalic acid, foods containing oxalate, or combinations thereof to provide approximately 2 g. of Oxalic acid per 4 lb. loaf of Sourdough bread.

In a tartar control rinse, the improvement being the addition of a Small amount of Oxalic acid. EXAMPLE 45

A test kit for detecting the oxalate level in urine of warm-blooded animals including humans having a Sample holder and a liquid reagent which upon addition of a Selected quantity of reagent to a Sample of urine in the Sample holder provides a colormetric indication of the presence or absence

EXAMPLE 35

A method of therapeutically treating a warm-blooded animal including humans having the Steps of periodically administering a portion of the Sourdough bread of Example 34 to provide a dosage of Oxalic acid of up to about 1 g. Oxalic acid per day.

of Oxalate. EXAMPLE 46 15

EXAMPLE 36

A method of delaying, preventing, controlling or treating the onset of Alzheimer's Disease, Hodgkin's Disease, Par kinson's Disease, and the like lessening the effects of the disease, or improving the quality of life of a perSon Suffering from the disease having the Steps of periodically adminis tering a therapeutically effective amount of at least one therapeutically effective form of Oxalic acid or oxalate.

A meat tenderizer composition of a dilute Solution of Oxalic acid. EXAMPLE 47

A dietary Supplement for everyday optimum nutritional balance having between 0.5 to 1.5 g. of Oxalic acid. EXAMPLE 48 25

EXAMPLE 37

A canine and feline urine oxalate level Scale having above normal, normal, and below normal levels by weight of the animal and providing a quick-ready reference for a veteri narian or a pet owner to test urine oxalate levels and adjust

A test kit for detecting the presence and quantity of Oxalic acid in a blood Sample of a warm-blooded animal including humans having a Sample Support Surface, a reagent, and a mixing container for mixing together the blood Sample and reagent to allow the reagent to undergo a color change and provide a colormetric determination of the presence and quantity of Oxalic acid in the Sample.

the Oxalic acid or oxalate intake of the canine or feline

EXAMPLE 49

accordingly. EXAMPLE 38

35

A method for causing the Sloughing off of the inner Surface of the intestinal membrane in a warm-blooded

animal including humans having the Steps of administering daily doses of a therapeutically effective amount of at least one therapeutically effective form of Oxalic acid or oxalate Such as dried parsley for a period of weeks or months thereby causing the Sloughing off of the interior Surface of the intestinal membrane and removing old bacteria, food,

45

A method of treating or preventing oxalate nephrosis in animals including dogs, goats, humans, cattle and the like including periodically administering a therapeutically effec tive amount of at least one oxalic acid or oxalate blocker.

EXAMPLE 51 50

A composition for cleaning oral or dental bridgework made of a dilute Solution of Oxalic acid. 55

A composition for cleaning a toothbrush made of a dilute Solution of Oxalic acid. EXAMPLE 42

60

A composition for cleaning and rinsing the interior Sur faces of the mouth and teeth made of a dilute solution of Oxalic acid and distilled water. EXAMPLE 43

In a mouthwash, the improvement including the addition of a low concentration of Oxalic acid.

A composition for controlling, treating or managing neoplasia, tumors, brain tumors, cancer, growths, and the like, for preventing the new growth of different or abnormal cells or tissues, or for otherwise therapeutically treating warm-blooded animals including pets and humans and including at least one therapeutically effective form of Oxalic acid or oxalate.

EXAMPLE 40

EXAMPLE 41

EXAMPLE 50

40

waste, and intestinal cells and membrane. EXAMPLE 39

A method of treating warm-blooded animals including the Steps of testing the blood or urine oxalic acid or oxalate levels, administering oxalic acid, oxalate or blockers thereof, and monitoring the levels to determine if adjust ments are necessary to achieve a desired level.

The composition as described in Example 50 wherein the therapeutically effective form of Oxalic acid or oxalate is Selected from the group of Oxalic acid in a free acid, ester, lactone or Salt form, oxalates including Sodium oxalate, a nutritional Supplement containing at least one form of Oxalic acid or oxalate, Oxalic acid dihydrate, anhydrous Oxalic acid, oxamide, oxalate Salts, natural or processed foods including molds, plants or vegetables including parsley, chives, garlic, beets, carrots, Spinach, and the like containing at least one form of Oxalic acid or oxalate, beverages, liquids or juices containing at least one form of Oxalic acid or oxalate, additives containing at least one form of Oxalic acid or oxalate, and combinations thereof.

65

EXAMPLE 52

The composition as described in Example 50 wherein the composition is Oxalic acid dihydrate.

6,133,317 39

40

EXAMPLE 53

EXAMPLE 55

including calcium, fruits, coconut, beverages containing alcohol, ascorbic acid or citric acid including adult bever ageS Such as beer, wine, Vodka, gin, and the like, fruit juice based beverages, Soda pop or Soft drinkS containing ascorbic acid or citric acid, other Sports drinks, beverages or refresh ments containing ascorbic acid or citric acid, red meat or white meat of fowl including chicken, turkey, pheasant and the like containing pyridoxines, or other foods or beverages containing alcohol, citric acid, ascorbic acid or pyridoxine hydrochloride including breads or grains, and combinations

The composition as described in Example 54 wherein the carrier or diluent is at least one of a gel cap and distilled

EXAMPLE 65

The composition as described in Example 50 wherein the composition is dried parsley. EXAMPLE 54

The composition as described in Example 50 further having a pharmaceutically acceptable carrier or diluent for the therapeutically effective form of Oxalic acid or oxalate.

thereof.

Water.

EXAMPLE 56

15

A method for controlling, treating or managing neoplasia, tumors, growths, cancers, abnormal cells or tissues and the like in warm-blooded animals including pets and humans having the Steps of periodically administering a therapeuti cally effective dosage of the composition of Example 50.

EXAMPLE 66

EXAMPLE 57

The method as described in Example 56 wherein the composition is administered orally or Sublingually in at least one of gel cap, tablet, powder, food additive, food, drops, liquid, beverage, pill and capsule form.

25

EXAMPLE 58

The method as described in Example 56 wherein the composition is administered by injection including venous injection, injection into the tumor, neoplasia, cancer, or growth, or injection adjacent the tumor, neoplasia, cancer, or growth.

A composition for controlling, treating or managing hyperplasia including Swollen or enlarged prostate, and the like, for preventing new Swelling or enlargement of tissues, or for otherwise therapeutically treating warm-blooded ani mals including pets and humans and including at least one therapeutically effective form of Oxalic acid or oxalate.

35

The composition as described in Example 65 wherein the therapeutically effective form of Oxalic acid or oxalate is Selected from the group of Oxalic acid in a free acid, ester, lactone or Salt form, oxalates including Sodium oxalate, a nutritional Supplement containing at least one form of Oxalic acid or oxalate, Oxalic acid dihydrate, anhydrous Oxalic acid, oxamide, oxalate Salts, natural or processed foods including molds, plants or vegetables including parsley, chives, garlic, beets, carrots, Spinach, and the like containing at least one form of Oxalic acid or oxalate, beverages, liquids or juices containing at least one form of Oxalic acid or oxalate, additives containing at least one form of Oxalic acid or oxalate, and combinations thereof.

EXAMPLE 59

The method as described in Example 56 wherein the composition is administered topically by at least one of transdermal patch, ointment, Salve, cream, lotion, gel, Solution, and the like.

EXAMPLE 67

40

EXAMPLE 60

The method as described in Example 56 wherein the composition is administered internally by at least one of inhalation, Suppository, and Subcutaneous deposit.

45

EXAMPLE 68

EXAMPLE 61

The method as described in Example 56 wherein the composition is administered at least once a day at a dosage of 50 mg to 6 g for humans or 1 mg to 3 g for pets.

The method as described in Example 67 further having the Steps of reducing the intake of Oxalic acid or oxalate 50

blockers. EXAMPLE 69

EXAMPLE 62

The method as described in Example 56 further having the Steps of reducing the intake of Oxalic acid or oxalate blockers and/or increasing the intake of Oxalic acid or

A method for controlling, treating or managing hyperpla sia including Swollen or enlarged prostate, and the like, for preventing new Swelling or enlargement of tissues, or for otherwise therapeutically treating warm-blooded animals including pets and humans having the Steps of periodically administering a therapeutically effective dosage of the com position of Example 65.

55

oxalate enhancers.

A diet for treating, controlling, and preventing cancer, tumors, neoplasia, and the like in warm-blooded animals including pets and humans having the Steps of adding to the regular diet a dietary Supplement of at least one therapeu tically effective form of Oxalic acid or oxalate.

EXAMPLE 63

The method as described in Example 62 wherein the blockers are Selected from the group of citric acid, ascorbic acid, pyridoxine hydrochloride, calcium, alcohol, resins, clayS, and combinations thereof. EXAMPLE 64

The method as described in Example 62 wherein the blockers are Selected from the group of dairy products

EXAMPLE 70 60

65

The diet as described in Example 69 wherein the thera peutically effective form of Oxalic acid or oxalate is Selected from the group of Oxalic acid in a free acid, ester, lactone or Salt form, oxalates including Sodium oxalate, a nutritional Supplement containing at least one form of Oxalic acid or oxalate, Oxalic acid dihydrate, anhydrous Oxalic acid, oxamide, oxalate Salts, natural or processed foods including

6,133,317 41 molds, plants or vegetables including parsley, chives, garlic, beets, carrots, Spinach, and the like containing at least one form of Oxalic acid or oxalate, beverages, liquids or juices containing at least one form of Oxalic acid or oxalate, additives containing at least one form of Oxalic acid or

42 EXAMPLE 78

The veterinary composition as described in Example 75 further having a pharmaceutically acceptable carrier or diluent for the therapeutically effective form of oxalic acid or oxalate.

oxalate, and combinations thereof. EXAMPLE 71

EXAMPLE 79

The diet as described in Example 69 further having the Steps of reducing the intake of Oxalic acid or oxalate

The veterinary composition as described in Example 78 wherein the carrier or diluent is a gel cap or distilled water.

blockers.

EXAMPLE 8O EXAMPLE 72

The diet as described in Example 71 wherein the blockers are Selected from the group of citric acid, ascorbic acid, pyridoxine hydrochloride, calcium, alcohol, resins, clayS,

15

and combinations thereof.

A veterinary method for controlling, treating or managing neoplasia, tumors, growths, cancers or abnormal tissues in warm-blooded animals including dogs and cats having the Steps of periodically administering a therapeutically effec tive dosage of the Veterinary composition of Example 75.

EXAMPLE 73

EXAMPLE 81

The diet as described in Example 71 wherein the blockers are Selected from the group of dairy products including calcium, fruits, coconut, beverages containing alcohol, ascorbic acid or citric acid including adult beverageS Such as beer, wine, Vodka, gin, and the like, fruit juice based beverages, Soda pop or Soft drinkS containing ascorbic acid or citric acid, other Sports drinks, beverages or refreshments containing ascorbic acid or citric acid, red meat or white meat of fowl including chicken, turkey, pheasant, and the like containing pyridoxine, or other foods or beverages containing alcohol, citric acid, ascorbic acid or pyridoxine hydrochloride including breads or grains, and combinations

The veterinary method as described in Example 80 wherein the composition is administered orally or Sublin gually in at least one of gel cap, tablet, powder, food additive, food, beverage, pill and capsule form, by injection including venous injection, injection into the tumor, neoplasia, cancer, or growth, or injection adjacent the tumor, neoplasia, cancer, or growth, topically by at least one of transdermal patch, ointment, Salve, cream, lotion, gel, Solution, and the like, internally by inhalation, Suppository or Subcutaneous deposit, or combinations thereof.

25

EXAMPLE 82

thereof. EXAMPLE 74

A veterinary composition for controlling, treating or man aging neoplasia, tumors, brain tumors, cancer, growths, and the like, for preventing the new growth of different or abnormal cells or tissues, or for otherwise therapeutically treating warm-blooded animals including dogs and cats of a composition including at least one therapeutically effective

35

The veterinary method as described in Example 80 wherein the composition is administered at least once a day at a dosage of about 1 mg to 3 g for dogs and cats. EXAMPLE 83

40

The veterinary method as described in Example 80 further having the Steps of reducing the intake of Oxalic acid or oxalate blockers.

form of Oxalic acid or oxalate. EXAMPLE 84

EXAMPLE 75

The veterinary composition as described in Example 74 wherein the therapeutically effective form of oxalic acid or oxalate is Selected from the group of Oxalic acid in a free acid, ester, lactone or Salt form, oxalates including Sodium oxalate, a nutritional Supplement containing at least one form of Oxalic acid or oxalate, Oxalic acid dihydrate, anhy drous Oxalic acid, oxamide, oxalate Salts, natural or pro cessed foods including molds, plants or vegetables including parsley, chives, garlic, beets, carrots, spinach, and the like containing at least one form of Oxalic acid or oxalate, beverages, liquids or juices containing at least one form of Oxalic acid or oxalate, additives containing at least one form

45

The veterinary method as described in Example 83 wherein the blockers are Selected from the group of citric acid, ascorbic acid, pyridoxine hydrochloride, calcium, alcohol, resins, clays, and combinations thereof. EXAMPLE 85

50

55

A method of treating warm-blooded animals including pets and humans afflicted with tumor cells Sensitive to an Oxalic acid compound including the Steps of periodically administering to the animal an oncolytic amount of at least one therapeutically effective Oxalic acid or oxalate com pound.

of Oxalic acid or oxalate, and combinations thereof.

EXAMPLE 86

EXAMPLE 76

The veterinary composition as described in Example 75 wherein the composition is Oxalic acid dihydrate.

60

A process for preparing an anti-tumor agent including the Steps of mixing at least one therapeutically effective form of Oxalic acid or oxalate with a pharmaceutically acceptable carrier or diluent.

EXAMPLE 77

The veterinary composition as described in Example 75 wherein the composition is at least one of carrots, boiled carrots, and dried parsley.

65

EXAMPLE 87

The process as described in Example 86 wherein the therapeutically effective form of Oxalic acid or oxalate is

6,133,317 44 nating the ingestion or administration of one or more of

43 Selected from the group of Oxalic acid in a free acid, ester, lactone or Salt form, oxalates including Sodium oxalate, a nutritional Supplement containing at least one form of Oxalic acid or oxalate, oxalic acid dihydrate, anhydrous Oxalic acid, oxamide, oxalate Salts, natural or processed foods including molds, plants or vegetables including parsley, chives, garlic, beets, carrots, Spinach, and the like containing at least one form of Oxalic acid or oxalate, beverages, liquids or juices containing at least one form of Oxalic acid or oxalate, additives containing at least one form of Oxalic acid or

Oxalic acid or oxalate blockers. EXAMPLE 95

The method as described in Example 94 wherein the blockers are Selected from the group of calcium, alcohol, citric acid, ascorbic acid, pyridoxine hydrochloride, and combinations thereof. EXAMPLE 96

oxalate, and combinations thereof.

A method of treating brain tumors including the Steps of ingesting or administering a therapeutically effective amount of at least one therapeutically effective form of

EXAMPLE 88

The process as described in Example 86 wherein the pharmaceutically acceptable carrier or diluent is Selected from the group of distilled water, heated water, pharmaceu tically acceptable liquids, nutritional Supplements, natural or processed foods, and the like.

15

EXAMPLE 97

The method as described in Example 96 wherein the therapeutically effective form of Oxalic acid or oxalate is dried chopped parsley.

EXAMPLE 89

A composition for treating autoimmune related diseases such as HIV, SLE, AIDS, BSE, CFS and the like having a therapeutically effective amount of at least one therapeuti cally effective form of Oxalic acid or oxalate.

EXAMPLE 98

25

EXAMPLE 90

A method of treating, preventing or controlling autoimmune-related diseases Such as AIDS, HIV, SLE, BSE,

cleansing the blood of tumor, cancer or abnormal cells, administering or ingesting a more moderate level of Oxalic acid or oxalate to maintain a normal blood or urine Oxalic acid or oxalate level. 35

EXAMPLE 91

Oxalic acid or oxalate.

EXAMPLE 99

The regimen as described in Example 98 further including the Steps of increasing the administration or ingestion of Oxalic acid or oxalate enhancers. 40

Oxalic acid or oxalate level to at least a normal level

following radiation treatment, X-rays, CAT scans, MRI Scans, and the like including a therapeutically effective amount of at least one therapeutically effective form of

A treatment regimen for treating tumors, cancers, growths, neoplasia and the like including brain tumors, breast cancer, cervical cancer, and others including the Steps of reducing or eliminating the ingestion or administration of Oxalic acid or oxalate blockers, administering or ingesting high dosages of Oxalic acid or oxalate to raise the blood or urine oxalic acid or oxalate level above normal, and, after

CFS and the like, preventing, lessening or controlling the destruction of the body's immune System, or purifying the blood including the Steps of periodically administering a therapeutically effective amount of the composition of Example 89. A composition for counteracting the decomposition or reduction of Oxalic acid or oxalate caused by radiation exposure, radiation treatment, X-rays, Strong electromag netic waves or fields, and the like or for returning the body's

Oxalic acid or oxalate.

EXAMPLE 100

A therapeutic composition in cream or ointment form for topical administration of Oxalic acid or oxalate having at least one therapeutically effective form of Oxalic acid or 45

oxalate, a Solvent, and a cream or ointment base.

EXAMPLE 92

EXAMPLE 1.01

A method for counteracting the decomposition or reduc tion of Oxalic acid or oxalate caused by radiation exposure, radiation treatment, X-rays, Strong electromagnetic waves or fields, and the like or for returning the body’s Oxalic acid or oxalate level to at least a normal level following radiation treatment, X-rays, CAT-Scans, MRI-Scans, and the like hav ing the Steps of administering a therapeutically effective amount of the composition of Example 91 following the

The therapeutic composition as described in Example 100 wherein the Solvent is distilled water, acetone, propylene glycol, or polySorbate, and the base is a cream, ointment, gel, lotion, Spray, Stick, or powder base.

50

EXAMPLE 102 55

treatment or exposure.

of Oxalic acid or oxalate with a Solvent Such as distilled

EXAMPLE 93

The method as described in Example 92 further including the Steps of administering a therapeutically effective amount of the composition of Example 91 prior to the treatment or

A method of producing the therapeutic composition as described in Example 100 having the Steps of mixing a dilute concentration of at least one therapeutically effective form

60

eXposure.

water, acetone, propylene glycol, polySorbate or the like to form a Solution, mixing the Solution with a base Such as a hydrophilic petrolatum, cream, ointment, gel, lotion, Spray, Stick, powder or other base. EXAMPLE 103

EXAMPLE 94

A method of enhancing the therapeutic effect of Oxalic acid or oxalate including the Steps of decreasing or elimi

65

In pet food, the improvement of the addition of a thera peutically effective quantity of at least one therapeutically effective form of Oxalic acid or oxalate.

6,133,317 45

46

EXAMPLE 104

EXAMPLE 113

In pet food, the improvement of the elimination or reduc

A pharmaceutical composition to be administered orally to humans of a mixture of a non-toxic ingestible carrier and a therapeutically effective form of Oxalic acid or oxalate.

tion of Oxalic acid or oxalate blockers. EXAMPLE 105

EXAMPLE 114

A method of treating tumors, cancers, growths, neoplasia and the like including brain tumors, breast cancer, cervical cancer, and others in a perSon Suffering from Osteoporosis including the Steps of reducing or eliminating the ingestion

The pharmaceutical composition as described in Example 113 wherein the composition is provided in a form selected from the group of pills, powders, granules, tablets, microcapsules, gel capsules, nutritional Supplements, pro cessed foods, liquids, drops, beverages, additives and Solu

or administration of Oxalic acid or oxalate blockers, admin

istering or ingesting high dosages of Oxalic acid or oxalate to raise the blood or urine Oxalic acid or oxalate level above

normal, and, after cleansing the blood of tumor, cancer or abnormal cells, reducing or eliminating the administration or ingestion of Oxalic acid or oxalate to maintain a below

tions. EXAMPLE 1.15

15

In a pet treat Such as a jerky Strip, dog bone, chew, rawhide, and the like, the improvement of the addition of microgram amounts of at least one therapeutically effective form of Oxalic acid or oxalate, whereby the treats provide for the maintenance of good pet health.

normal blood or urine oxalic acid or oxalate level. EXAMPLE 106

A method of treating osteoporosis including the Steps of increasing calcium intake and decreasing Oxalic acid or oxalate intake.

EXAMPLE 116 EXAMPLE 107

A therapeutic composition for purifying the blood, controlling, treating or eradicating abnormal cells, controlling, treating or affecting cholesterol plaque and fat buildup in the cardiovascular System or in the brain, and maintaining good cardiovascular health and operation hav ing a therapeutically effective amount of at least one thera peutically effective form of Oxalic acid or oxalate.

Treatment For Tumor Reduction 25

Our research indicates the following as a treatment for the reduction of tumors:

Carrots, Spinach, parsley, chives, beets and beet leaves, garlic, collards and radishes are high among vegetables containing Oxalic Acid and should be eaten in order to build a high concentration of acid in the body fluids. Almonds, cashews, peanuts, and, especially walnuts which are high in oleic and linoleic fatty acids and increase oxalic acid absorption may be eaten.

EXAMPLE 108

An oral rinse or wash for SmokerS or Snuff users for

controlling, treating or managing neoplasia, tumors, cancers, growths, and the like, for preventing the new growth of different or abnormal tissues, or for otherwise therapeuti cally treating the mouth area of a dilute Solution of at least one therapeutically effective form of Oxalic acid or oxalate.

35

Red meats, chicken and turkey breasts, (generally white meat) are considered high in Pyridoxine (vitamin B6), and should be avoided during the treatment, alcohol and prod

40

ucts containing Citric Acid (Soda pop, other Soft drinks and thirst quenchers are generally high in citric acid), and Ascorbic Acid (vitamin C) are considered blockers of Oxalic

acid or oxalate in heated water to form an oxalic acid or

Acid and should be avoided since they retard the build up of Oxalic Acid in the System. It is absolutely necessary to read the ingredients on all food and drinkS consumed while on the diet. Citric and AScorbic acids are widely used as a preser Vative in many products, including frozen and bakery goods. All dairy products should also be avoided while following

oxalate containing slurry, forming the Slurry into pellets and drying the pellets.

bined can form calcium oxalate Stones (kidney).

EXAMPLE 109

A method of manufacturing a dry processed dog food containing at least one form of Oxalic acid or oxalate including the Steps of mixing a Slurry of conventional dog food ingredients together with a dilute Solution of Oxalic

EXAMPLE 110

The method as described in Example 109 wherein the Oxalic acid is oxalic acid dihydrate and each pellet contains approximately 1 mg of Oxalic acid So that one pound of dry dog food contains about 1 g of Oxalic acid.

45

the treatment. Calcium inhibits Oxalic Acid and when com 50

should be free of citric acid.

55

EXAMPLE 111

A dietary Supplement for treating a patient diagnosed with an active cancer, tumor, growth, or neoplasia having about 1 g to 6 g, preferably 2 g to 4 g of Oxalic acid per day based on 70 kilograms of body weight and a pharmaceutically acceptable carrier or diluent.

60

AS Oxalic Acid is built up in the System one may experience indigestion known as heart burn or a nagging backache. These indicate that the acid is being ingested in too large a quantity or the System is digesting the acid at a rate faster than it can be absorbed. Indigestion can be relieved by taking 2 or 3 teaspoonful of crushed pineapple. Relief for the backache can be accomplished by taking one 100 mg vitamin B6 pill. A slight reduction of the intake of Oxalic Acid will avoid either of the above conditions. Maximum effect of Oxalic Acid on tumor reduction would

be accomplished ifa acid level can be maintained just below the discomfort level.

EXAMPLE 112

A composition for treating parvo virus in animals includ ing canines of a therapeutically effective amount of at least one therapeutically effective form of Oxalic acid or oxalate.

Coffee, cocoa, regular tea, made with distilled water, and natural fruit juices are acceptable for drinking. All beverages

65

Our research shows that five to seven days after start of the treatment, an increase in energy will be experienced. Some people notice a body weight loSS. Improvement in condition of the tumor should be noticed after 10 to 12 days.

6,133,317 47

48

If there are multiple tumors, the newest tumors will

EXAMPLE 118

regress first, while older (core) tumors will require a longer

time. Once tumors begin to Shrink and disappear and when finally all trace of cancer has been cleared in the blood system a balanced diet of all foods may be resumed while being Sure to maintain an adequate level of Oxalic Acid in the System to prevent resumption of tumor growth. The microwave should not be used for cooking or heating any foods or beverage in the diet because it reduces the Strength or amount of the Oxalic Acid.

Protocol for Treatment of Canine, Equine, Feline

Species for the Control of Neoplasia (tumors)

1O

EXAMPLE 117

Oxalic Acid Dietary Plan Our research indicates the following as a diet for the reduction of tumors:

15

Carrots, Spinach, parsley, chives, beets and beet leaves, garlic, collards and radishes are high among vegetables containing oxalic acid or oxalate and should be eaten in order to build a high concentration of Oxalic acid in the body fluids. Almonds, cashews, peanuts, and, espe cially walnuts which are high in oleic and linoleic fatty acids and increase Oxalic acid absorption may be eaten.

General examination.

Physical examination to determine the location, type, and

size of the tumor(s). MRI, CAT-Scan, or X-ray should

be used if procedure is available.

Blood analysis, including (CBC) liver and kidney pro

Red meats, chicken and turkey breasts, (generally white meat) are considered high in Pyridoxine (vitamin B6), and should be avoided during the treatment, alcohol and prod

files. 25

ucts containing Citric Acid (Soda pop, other Soft drinks and thirst quenchers are generally high in citric acid), and AScorbic Acid (vitamin C) are considered blockers of Oxalic consumed while on the diet. Citric and AScorbic acids are

35

the treatment. Calcium inhibits oxalic acid and when com

bined can form calcium oxalate Stones (kidney).

Coffee, cocoa, regular tea, made with distilled water, and limited amounts of natural fruit juices are acceptable for drinking. All beverages should be free of citric acid. AS oxalic acid is built up in the System one may experi ence indigestion known as heartburn or a nagging backache. These are indicators that the Oxalic acid is being ingested in too large a quantity or the System is digesting the acid at a rate faster than it can be absorbed. Indigestion can be relieved by taking 2 or 3 teaspoonful of crushed pineapple. Relief for the backache can be accomplished by taking one 100 mg vitamin B6 pill. A slight reduction or moderation of

the intake of oxalic acid or oxalate will avoid either of the above conditions. Maximum effect of Oxalic Acid on tumor

reduction would be accomplished if an oxalic acid level can be maintained just below the discomfort level. Our research shows that five to seven days after start of the treatment, an increase in energy will be experienced. Some people notice a body weight loSS. Improvement in condition of the tumor should be noticed after 10 to 12 days. If there are multiple tumors, the newest tumors will

Neoplasia Control Formula will be recommended for the first 14 dayS. At the completion of 14 days, a blood and urine analysis will be completed and if results are Satisfactory, the animal will be placed on a diet, based on the animals weight, of regular dry dog food, Supplemented by Oxalic Acid or Oxalate Neoplasia Control Formula. Dosage will be at the maximum computed on the above blood and urine analysis. Repeat urine checks will be completed, as deter mined by the veterinarian, and the amount of Oxalic Acid or Oxalate Neoplasia Formula will be adjusted as required. After initiation of the protocol the veterinarian will observe the level of oxalates in the urine. The urine oxalate

40

level will be maintained at the desired level, based on the

weight of the animal, using Urine Oxalate Scales of the present invention. EXAMPLE 119

45

50

55

Animal Feed Supplement Mixes The Supplement is to be added to the normal feed/food, by weight, to add the amount of Oxalic acid desired. Equine Mix Ingredients Ground oats, ground corn, ground barley, wheat middlings, Soybean meal, cane molasses, dried hydrolyzed whey, dried whey, Soy flour, animal fat, vegetable fat, dehydrated alfalfa meal, dicalcium phosphate, calciumcarbonate, Salt, magnesium Sulfate, potassium Sulfate, Smectite, Vermiculite, ferrous Sulfate, ferric choline

regress first, while older (core) tumors will require a longer

time. Once tumors begin to Shrink and disappear and when finally all trace of cancer has been cleared in the blood system a balanced diet of all foods may be resumed while being Sure to maintain an adequate level of Oxalic acid or oxalate in the System to prevent resumption of tumor growth. The microwave oven should not be used for cooking or heating any foods or beverage in the diet because it reduces the Strength or amount of the Oxalic acid.

Urine analysis, including analysis for oxalates. Based on Veterinarian's diagnosis of the animal's condition, the maximum amount of Oxalic Acid or Oxalate

acid or oxalate and should be avoided Since they retard the build up of oxalic acid in the system. It is absolutely necessary to read the ingredients on all food and drinkS

Widely used as a preservative in many products, including frozen and bakery goods. All dairy products should also be avoided while following

Research and Development Phase Prior to the commencement of protocola complete exami nation should be accomplished by the attending veterinarian. The examiner should complete and record the following: History Since the onset of the neoplasia based on owners description. Specific diet, to include all treats, and liquid intake. General activity level during previous period. Age. Weight.

60

citrate, Zinc oxide, manganous oxide, copper oxide, copper Sulfate, cobalt carbonate, ethylene diamine dihydroiodide, Sodium Selenite, Oxalic acid. Feline Mix

65

Ingredients Ground corn, poultry by-product meal, corn gluten meal

animal fat, (preserved with BHA propyl gallate), brewers

6,133,317 49

SO

rice, chicken liver digest, potassium chloride, choline

Ingredients Ground corn about 55.99%, soybean meal 8.53%, meat and bone meal 15.85%, soy whole 2.54%, beet pulp 1.9%, salt 0.45%, corn gluten meal 9.35%, Soy oil 1.87%, dical cium phosphate 0.47%, poultry fat 3.00%, oxalic acid

chloride, calcium Sulfate, taurine, ethoxyquin, (a preservative), ferrous Sulfate, Zinc oxide, copper chloride, manganous oxide, cobalt carbonate, calcium iodate, Sodium Selenite, Oxalic acid. Canine Mix

Ingredients Ground corn, Soybean meal, meat and bone meal, Soy whole, beet pulp, Salt, corn gluten meal, Soy oil, dicalcium phosphate, poultry fat, oxalic acid. In each of the above feed Supplements Oxalic acid is added at one gram of Oxalic acid to one pound of dried food. Crude protein, crude fat, crude fiber, and moisture will be blended at different formula for the life stage of the animals. Oxalic acid feed supplement will be added to the daily diet as determined by the attending Veterinarian for each of

0.0023% with moisture about 0–10%.

In the above feed Supplement oxalic acid or oxalate is added at about one gram of Oxalic acid or oxalate to one pound of dried food. Crude protein, crude fat, crude fiber, and moisture will be blended at different formula for the life

Stage of the animals. The feed supplement will be added to the daily diet as recommended by the attending veterinarian. 15

EXAMPLE 122

the above mixeS. EXAMPLE 120

Supplement Mixes The Supplement is to be added to the normal feed/food, by weight, to add the amount of Oxalic acid or oxalate desired. Equine Mix Ingredients Ground oats, ground corn, ground barley, wheat middlings, Soybean meal, cane molasses, dried hydrolyzed whey, dried whey, Soy flour, animal fat, vegetable fat, dehydrated alfalfa meal, dicalcium phosphate, calciumcarbonate, Salt, magnesium Sulfate, potassium

25

EXAMPLE 123

An oxalic acid or oxalate containing bread including about 1 gram of Oxalic acid or oxalate per loaf of bread.

Sulfate, Smectite, Vermiculite, ferrous Sulfate, ferric choline

citrate, Zinc oxide, manganous oxide, copper oxide, copper Sulfate, cobalt carbonate, ethylene diamine dihydroiodide,

35

EXAMPLE 124

Sodium Selenite, oxalic acid or oxalate. Feline Mix

Ingredients Ground corn, poultry by-product meal, corn gluten meal

40

rice, chicken liver digest, potassium chloride, choline 45

Selenite, Oxalic acid or oxalate.

EXAMPLE 126

Canine Mix 50

EXAMPLE 127

The dogfood of Example 126 with the exception that any vitamin B6 is removed from the conventional dry mix. 60

above mixeS. EXAMPLE 121

Canine Supplement Mix The Supplement is to be added to the normal feed/food, by weight, to add the amount of Oxalic acid or oxalate desired.

A dry dogfood is prepared with 300 lbs. of dry dogfood having added thereto 10% ounces of oxalic acid dihydrate to provide about 1 gram of Oxalic acid per pound of dry dogfood. The oxalic acid dihydrate powder is added to 90 C. distilled water and mixed into the conventional dogfood Slurry.

55

and moisture will be blended at different formula for the life

Stage of the animals. The feed supplement will be added to the daily diet as determined by the attending veterinarian for each of the

The bread of Example 124 further containing about 2 cups of trail mix including nuts, dried fruits, and the like per loaf of bread with the trail mix being added during the manu facture of the loaf.

manganous oxide, cobalt carbonate, calcium iodate, Sodium Ingredients Ground corn, Soybean meal, meat and bone meal, Soy whole, beet pulp, Salt, corn gluten meal, Soy oil, dicalcium phosphate, poultry fat, oxalic acid or oxalate. In each of the above feed Supplements oxalic acid or oxalate is added at one gram of Oxalic acid or oxalate to one pound of dried food. Crude protein, crude fat, crude fiber,

The bread of Example 123 wherein the oxalic acid is oxalic acid dihydrate dissolved in distilled water prior to being added to the bread during manufacturing of the loaf. EXAMPLE 125

animal fat, (preserved with BHA propyl gallate), brewers chloride, calcium Sulfate, taurine, ethoxyquin, (a preservative), ferrous Sulfate, Zinc oxide, copper chloride,

A method of counteracting the deleterious effects of a mammogram, CAT-Scan, X-ray and the like exposure or treatment including the Steps of about 3 weeks prior to the exposure increasing the intake of Oxalic acid or oxalate, continuing the increased oxalic acid or oxalate during the treatment and for 3 weeks following treatment. Thereafter, checking the blood or urine oxalic acid or oxalate levels of the patient and if they are normal, continuing with that level of intake of Oxalic acid or oxalate, if they are above normal, reducing the intake of Oxalic acid or oxalate, and if they are below normal, increasing the intake of Oxalic acid or oxalate. Thereafter, monitoring the levels and adjusting the intake on a periodic basis.

65

EXAMPLE 128

An oxalic acid intake adult management control plan includes four phases. In the first phase, the adult is admin istered about 1% to 2 grams of Oxalic acid or oxalate per day for 5-7 days to eliminate abnormal cells or otherwise clean the blood of the patient for a 70 kilogram weight adult. For larger adults, the dosage would have to be increased. Also,

6,133,317 S1

52

Oxalic acid and oxalate levels are checked in the blood,

therapeutically effective form of Oxalic acid or oxalate continuously to the patient in decreasing amounts to treat, control, or prevent cancer, tumors, growths, bacterial

plasma and/or urine to determine the exact amount of Oxalic acid or oxalate required for the individual Subject. In the Second phase of the treatment, the Subject is given about 34 gram of Oxalic acid or oxalate for an additional 15–20 days until the growth or expansion of the tumor or malignancy has stopped and the tumor is in regression or inert. In the third phase the Subject is given about 72 gram of Oxalic acid or oxalate per day to continue tumor reduction or until the body is clean. In the fourth phase or maintenance phase, the Subject is given about 50 mg of Oxalic acid or oxalate per day for maintenance of good health and to keep all cancers in remission or in check. Again, these dosages are provided for an average 70 kilogram adult and the individual’s Oxalic acid or oxalate levels need to be checked periodically and the dosages adjusted as necessary.

disease, Viral disease, chemical disease and the like without

deleteriously affecting normal cells.

EXAMPLE 1.37

A method of enhancing the beneficial effects of Oxalic acid or oxalate in animals including humans and pets including the Steps of eliminating the use of microwave cooking for heating food or drink of the animal to prevent the decomposition or reduction in the amount of Oxalic acid or oxalate in their food or drink. 15

EXAMPLE 1.38

The method of Example 137 further including the step of eliminating the use of the microwave oven for cooking or heating to prevent exposure to microwaves and thereby prevent decomposition or reduction in Oxalic acid or oxalate in the animal being eXposed.

EXAMPLE 129

The control plan of Example 128 wherein a computer model of the chemical balance of the human body is used in addition to the Oxalic acid and oxalate level information to

determine the proper dosage for that individual.

EXAMPLE 139

EXAMPLE 130 25

An animal testing method for testing for example the carcinogenic effect of one or more agents or irritants on an animal Such as a mouse or rat, including the Steps of determining the normal oxalic acid or oxalate blood or urine level of the animal, irradiating the animal to weaken its natural immune System, and administering a dosage of Oxalic acid or oxalate to the animal as necessary to bring its Oxalic acid or oxalate blood or urine level back up to a normal level prior to further testing of the animal. EXAMPLE 1.31

reduce the amount of Oxalic acid or oxalate in the animal. EXAMPLE 140

A mouthwash containing a dilute Solution of Oxalic acid and having a pH of about 2.67. An Oxalic acid or oxalate containing drink including carrot juice having a pH of about 6.41.

Spongiform encephalopathy (BSE) by feeding the animal a

EXAMPLE 142 40

A mouthwash or oral rinse containing a dilute Solution of 500 milligrams of oxalic acid dihydrate per 500 milliliters of

EXAMPLE 132

The method of Example 131 including the step of treating the animal directly by an intraveneous administration of Oxalic acid.

distilled water. EXAMPLE 1.43

45

A method of treating terminally ill animals including adult humans including the Steps of administering a high dosage

EXAMPLE 1.33

A method of treating humans having Creutzfeldt-Jakob

Disease (CFS) by administering a therapeutic quantity of at

EXAMPLE 141

35

A method of treating an animal Suffering from bovine

feed high in Oxalic acid or oxalate, for example Halogeton or Setavia plants or grass.

The method of Example 138 further including the steps of eliminating the use of radiation, X-ray, CAT-Scan, mammogram, Strong electromagnetic waves, excessive heat, or other exposures or treatments which would decompose or

50

of Oxalic acid or oxalate to cleanse the blood and treat the condition or disease.

least one therapeutically effective form of Oxalic acid or

EXAMPLE 1.44

oxalate. EXAMPLE 134

The method of Example 133 including the step of admin istering oxalic acid directly by intravenous administration.

55

The method of Example 143 further including the steps of Stopping chemotherapy treatments to prevent the weakening of the body and prevent the decomposition or reduction of Oxalic acid or oxalate in the body. EXAMPLE 1.45

EXAMPLE 135

A method of preventing BSE or CFS in warm blooded animals including cattle and humans including the Steps of increasing the intake of at least one form of Oxalic acid or

60

has been cleansed and the condition or disease has

improved.

oxalate. EXAMPLE 1.36

A method of treating animals using oxalic acid or oxalate in place of chemotherapy and administering at least one

The method of Example 143 further including the steps of reducing the dosage of Oxalic acid or oxalate after the blood

65

EXAMPLE 1.46

The method of Examples, 143, 144, or 145 further includ ing the Step of reducing the intake of Oxalic acid or oxalate

6,133,317 S3

S4

blockers and increasing the intake of Oxalic acid or oxalate enhancers.

TABLE II-continued Oxalic Acid Contents of Foods

TABLE I

Oxalic acid

Oxalic Acid Content of Selected Vegetables

Method of

Oxalic Acid

Vegetable

(g/100 g)

Amaranth . . .

Asparagus . . . Beans, snap . . .

13 36

Beet leaves . . . Broccoli...

.61 19

Brussels sprouts . . . Cabbage . . .

36 10

Carrot. . . Cassava . . . Cauliflower . . .

15

Corn, Sweet . . .

O1 O2

Eggplant . . .

19

Endive . . . Garlic . . . Kale . . . Lettuce . . . Okra . . . Onion . . .

.11 36 O2 33 O5 O5

Parsley . . . Parsnip . . .

1.70 .04

Pea . . .

O5

Pepper . . .

.04

Potato . . . Purslane . . . Radish . . .

O3 97 O2 .24

Tomato . . .

O5

Turnip . . . Turnip greens . . .

.21 O5

Watercress ...

31

5.3 O.8

Fresh Fresh Fresh Stewed Fresh Fresh Fresh Canned Canned Canned Stewed Fresh Fresh

1.5 2.8 O.7 2.6 0.0-6.6 2.7 6.2 1.2-3.7 1.3-1.7 O.O-3.7 1.1-3.4 2.2 1.9-11.5

Apple Apricot Banana, ripe Gooseberry Grapefruit Melon

Pineapple Plum

Raspberry Strawberry Preserves

Jam, red plum Jam, strawberry Bacon, streaky

Fried Roasted Fresh Roasted Steamed Braised Braised Roasted Roasted

O6-3.3 O.2 O.2 O3-19 0.4-1.6 1.6-5.1 3.6-7.1 1.6 1.7

Chicken (Fray Bentos) Oxtail (Fray Bentos) Dairy products

Heated Heated

3.0 1.O

Butter

Fresh Fresh Boiled Fresh Fresh

Beef

Beef, corned Chicken Ham

Kidney Liver Mutton Pork 35

40

Soups

Cheese, Cheshire

Eggs, whole Margarine Milk, cow TABLE II

Fish

Oxalic Acid Contents of Foods

45 Haddock Plaice Sardines Cereals

Oxalic acid Method of Food

Preparation

(mg/100 g of fresh material)

Vegetables Asparagus Bean, runner Beetroot

Brussels sprouts Cabbage Carrot Cauliflower

Celery Chive Lettuce Marrow Mushroom Onion

Parsley Pea, green Potato Radish Rhubarb

Spinach

Biscuits (Marie) 50

Fresh Boiled Boiled Boiled Boiled Boiled Boiled Fresh Fresh Fresh Fresh Fresh Boiled Fresh Boiled Boiled Fresh Stewed Boiled

0.5 9.4 4.5-10.8

25 Marmalade Meat

O5 1.31 48

Rutabaga. . . Spinach . . . Squash . . . Sweetpotato . . .

Fresh Boiled

Peach Pear

148 45 O1

Cucumbers . . .

Tomato

Orange

19 .21

Chives . . . Collards . . . Coriander . . .

Preparation

Fruit

50 1.26 15

Celery . . . Chicory . . .

Food

Turnip

1.09

(mg/100 g of fresh material)

1.7 7.2-61.8 96.8-121.0 2.1-3.6 0.6-2.0 7.4-22.7 1.1 13.0-17.5 1.1 1.7-2.7 0.5 2.O 3.0 166.O 0.8-1.3 2.3-7.1 O.3 260-62O 356-78O

Bread, white Bread, Allinson's Cake, fruit

Boiled Boiled Canned

Fresh Fresh

Cake, sponge Cornflakes Corn cob 55

Oatmeal porridge Rice pudding

Fresh Cooked Cooked

O.2 O.3 1.6–4.8

4.5-13.8 4.9-8.6 15.8-26.3 11.8 7.4 4.4-5.6 9.1 1.O O.O

Chocolate

60

Cadbury's plain Cadbury's milk Beverages Beer, mild Beer, bitter

65

Beer (Double Diamond) Beer (Double Diamond) Beer (Guinness) Beer (Guinness) Cocoa (Rowntrees)

123.5 56.2

Draught Draught Draught Bottled

Draught Bottled Powder

0.9-1.6 O.9-1.9 O.8 1.9-2.0 1.4 2.8-3.9 623.O

6,133,317 SS

S6

TABLE II-continued

TABLE III-continued

Oxalic Acid Contents of Foods

Oxalate Content of Foods per 100 GM. EDIBLE PORTION

Oxalic acid' Method of

(mg/100 g of

Food

Preparation

fresh material)

Coca Cola

Canned

1.12

Coffee, infusion

2 g per 100 ml,

1.O

infused 5 min.

OXALATE FOOD

Hamburger, grilled Lamb, roast

1O

4.4 g per 100 ml,

7.3

mg.

O.O trace

Liver

7.1

Pork, roast

1.7

Vegetables

infused 13 min.

Coffee essence (Camp) Coffee (Nescafe)

Undiluted Powder

9.O 57.O-23O.O

Dandelion coffee

Powder

25.0

Horlicks

Powder

4.1

Lager (Skol) Lemon squash (Robertson's) Lucozade Orange squash (Robertson's)

Draught

O.6 1.5

Ovaltine Oxo cubes

Powder

Tea, leaves Tea, infusion

Fresh, dried 1 g per 100 ml,

Asparagus Beans, green boiled Beans in tomato sauce

15

O.1

1.2 45.9 1.6

2O

375-1,450 4.6 7.O-10.8 25

2.0 g per 100 ml,

11.5-16.1

2.0 g per 100 ml,

126-17.2

Wine, Beaujolais

3.1

3O

al

Oxalate Content of Foods per 100 GM. EDIBLE PORTION

40

Crackers, soybean

Egg noodle (chow mein) Grits (white corn) Macaroni, boiled

Oatmeal, porridge Spaghetti, boiled Spaghetti in tomato sauce Wheat germ

2.O

2O7.O

1.O 41.O

1.O 24.6

13.0

89.0

Lettuce

3.0

4.3 2.O

Mustard greens Okra

7.7 146.0

Onion, boiled Parsley, raw Parsnips Peas, canned

3.0 1OO.O 1O.O

Pepper, green

16.O

Radishes

1.O 476.O

O.O 56.O O.3

O.O

Rutabagas Spinach, boiled Spinach, frozen

19.O 75O.O 6OOO

Squash, summer

22.0

Tomatoes, raw

45

5.2

Lima beans

Rice, boiled

4.9 11.8 7.4

1.1

74.O

18.0

Potatoes, white boiled Potatoes, sweet

Cereal and Cereal Products

2O.O 645.O

31.0

Pokeweed

OXALATE mg.

4.0 1.O

Escarole

Mushrooms

35

O.O

O.O

Eggplant Kale

Expressed as the anhydrous acid (COOH). From Oxalic Acid in Biology and Medicine, Pgs. 196-199. TABLE III

Dandelion greens

Leek

infused 15 min.

Cornflakes

Carrots, canned Cauliflower, boiled

Cucumber, raw

infused 10 min.

Bread, white Cake, fruit Cake, sponge

SOO.O trace

Corn, yellow

10.1-14.5

infused 5 min.

FOOD

Beetroot, pickled Broccoli, boiled Brussels sprouts, boiled Cabbage, boiled

Collards

infused 2 min.

2.0 g per 100 ml,

-

675.O

Chive

2.0 g per 100 ml,

19.O

Beetroot, boiled

Celery Chard, Swiss

infused 2 min.

5.2 15.O

Turnips, boiled

Watercress, early fine curled Fruits

2.O

1.O

1O.O

1.O

1.O 1.5 4.0 269.O

50

Milk and Milk Products

Apples, raw Apricots Avocado Banana, raw

3.0 2.8 O.O trace

Berries:

Butter

O.O

Black

18.0

Cheese, cheddar Margarine Milk

O.O O.O O.15

Blue Dew Green goose

15.O 14.O 88.0

Raspberries, black Raspberries, red Strawberries, canned

53.0 15.O

55

Meats and Eggs Bacon, streaky fried Beef, canned corned Beef, topside roast Chicken, roast Eggs, boiled

3.3 O.O O.O O.O O.O

60

Fish:

Haddock Plaice Sardines

O.2 O.3 4.8

Ham

1.6

65

Strawberries, raw Cherries:

15.O 1O.O

Bing

O.O

Sour Currants:

1.1

Black Red

4.3 19.O

Fruit salad, canned

12.O

6,133,317 57

58

TABLE III-continued

TABLE III-continued

Oxalate Content of Foods per 100 GM. EDIBLE PORTION FOOD

OXALATE mg.

Oxalate Content of Foods per 100 GM. EDIBLE PORTION 5 OXALATE mg.

FOOD

Grapes:

o

Concord Thompson, seedless Lemon Peel Lime Peel

Tomato juice

25.0 O.O

1O

Beer:

83.O 11.O.O

Mass elons:

O.O

Cantaloupe

O.O

Casaba

O.O

bottled

o

15

1.O

Lager draft, Tuborg Pilsner

4.0

Stout, Guiness Draft

2.O

Cider

O.O

Honeydew

O.O

Sherry, dry

O.O O.O

Wine:

Orange, raw

4.0

o

Alberta canned

Hiley

2O

5.0 1.2

O.O

Stokes

1.2

Pears: Bartlett, canned

3.0 1.7

Pineapple, canned

1.O

Plums: Damson

25

1O.O

Golden gage

1.1

Greengage

O.O

O.O

draft

Watermelon Nectarines Peaches:

5.0

Beverages, alcoholic

trace

Port Rose White Miscellaneous

trace 1.5

Cocoa, dry powder Coffee powder (Nescafe) Chicken noodle soup Lemon juice

623.O 33.O

O.O

1.O 1.O O.O

Lime juice

Ovaltine, powder canned 3O

35.O

Oxtail soup

Preserves:

1.O

Pepper

419.0

Red pl

0.5

Tomato soup

3.0

Strawberry jam

9.4

Vegetable soup

5.0

Prunes, Italian

5.8

ed plum Jam

Rhubarb:

35 From: Krause & Mahen, Food, Nutritient Diet Therapy, 7th ed., 1984, W. B. Saunders, Phila.

canned

8OO.O

stewed, no sugar

86O.O

Nuts

Peanuts, roasted

Pecans

TABLE IV

187.O

2O2.O

40

Concentrations of Oxalic acid, calcium and magnesium in foods

Confectionery

Chocolate, plain Jelly, with allowed fruit Marmalade

Oxalic

117.O O.O

Sweets, boiled (plain candies) Beverages, Non-alcoholic

O.O

Barley water, bottled

O.O

Coffee (0.5 g Nescafe/100 ml) Lemon Squash drink (lemonade) Lucozade, bottled (soda) Orange Squash drink (orangeade) Ovaltine drink, 2 gm in 100 ml Pepsi-Cola

Ribena, concentrate

Calcium

(mmol/kg Magnesium fresh (mmol/kg fresh wt) wt)

10.8

o

Coca-Cola

Food

Acid (mmol/kg fresh wt)

trace

3.2 1.O

45 Vegetables Cabbage

O.11

16.2

Cauliflower

O.12

5.9

6.4

Onion

O.33

7.1

4.8

O.25 O.19 28.9 13.5 86.6

2.2 6.5

O.O 2.5 1O.O

Potato 50 Lettuce Rhubarb Beetroot Spinach

trace

Fruit

3.1 4.7 27.7

8.5

4.1 4.0 15.5 31.6

2.O

0.17

O.85

Tea, Indian:

Orange

O.69

0.87

o

(black currant drink)

Pear

O.19

1.O

1.85

Plum Strawberry Tomato

O.38 O.21 0.59

3.57 4.10 2.50

3.33 4.73 4.11

2 min. infusion 4 min. infusion 6 min. infusion

Tea, rosehip

55 Apple 55.0 72.O 78.0

4.0

2.05 5.70

60 Meat, fish and dairy products

Juices

Apple juice Cranberry juice Grape juice

trace 6.6 5.8

Grapefruit juice Orange juice

O.O 0.5

Pineapple juice

O.O

Beef, roasted

O.04

1.92

11.7

Fish (haddock) Milk (cow) Cereals

O.O2 O.OOS

4.22 28.7

11.6 4.3

O.54

27.0

1O.O

O.62

2.2

14.8

65 Bread, white Cornflakes

6,133,317 59

60

TABLE IV-continued

TABLE VI-continued

Concentrations of Oxalic acid, calcium and magnesium in foods Oxalic

Calcium

fresh wt)

Ovaltine, powder

5.1

Tea (1 g/100 ml,

O.51

infused for 2 min)

Tea (1.5 g/100 ml,

Some recent estimates of the concentration of Oxalic acid in human and animal blood

(mmol/kg Magnesium fresh (mmol/kg fresh

Acid (mmol/kg

Food Beverages

5

wt)

wt)

31.5

Analytical method 10 Fluorimetry

256.O

Chemical kinetics

124.0

Enzymic

118.0

13.6 O.25

O.O7

O.92

Oxalic acid

tig anhydrous acid/100 ml

1.03

O.13

Mean

Decarboxylation

Enzymic

infused for 6 min)

15 decarboxylation

1304

2611

Ton exchange and

Zarembski and Hodgkinson (1962b).

Range

Reference

150-480. Endo (1969) Eswara-Dutt and Mottola

(1974) 80-140 Knowles and Hodgkinson (1972) 73-199b.d Hatch et al. (1977) 136-465b,e 117-250 Krugers Dagneaux

TABLE V

Dietary intake of oxalate by man and animals Oxalic acid (anhydrous Description mg/kg day

Mean

Range

Mean

British British

92O 97

850-98O 70-150

12.3 1.4

British Indian on

1394

Range

Reference

Man

145-175

hospital diet Indian on common rural diet Indian on seasonal rural diet

Indian on urban diet,

10.1-13.6 Archer et al. (1957a) 1.0-2.1 Zarembski and Hodgkinson (1962b) Anderson et al. (1971) Singh et al. (1972)

77.8

Singh et al. (1972)

2045.O

Singh et al. (1972)

168.5

Singh et al. (1972)

lower income group Indian on urban diet,

Singh et al. (1972)

606.4

upper income group Indian from Kashmir

260-450

Sheep

2160-5000

Cow (Heifer)

-

6O7OO

317-73.5 243-286

715OO

Dhar and Kaul (1973) Brune (1955) Talapatra et al. (1942) Talapatra et al. (1942)

Rat

Wistar (300 g)

14-28

Sand rat (200 g)

300-500

46-92

Hodgkinson (unpublished results) Shirley and Schmidt Nielsen (1967).

*Oxalic Acid in Biology and Medicine, pg. 160. 50

TABLE VI

TABLE VI-continued Some recent estimates of the concentration of Oxalic acid in human and animal blood

Some recent estimates of the concentration of Oxalic acid in human and animal blood

Oxalic acid

55 Oxalic acid

(ug anhydrous acid/100 ml) Analytical method

Mean

Range

Reference

Lig anhydrous acid/100 ml Analytical method colorimetry

Mean

'Coxalic acid

16.5 13.0

60 “Coxalic acid Sheep

Man

I'Coxalic acid Fluorimetry

146.0

1OO-235

Hodgkinson and Zarembski 65

169.O

127–254

(1968)

Range

Reference

et al. (1976) Williams et al. (1971) 11.8-14.3 Hodgkinson and Wilkinson (1974) 52.6-74.4 McIntosh and Belling (1975)

*Oxalic Acid In Biology and Medicine, pg. 174.

6,133,317 61

62

TABLE VI-continued

TABLE VIII-continued

Some recent estimates of the concentration of Oxalic acid in human and animal blood

Vitamin B-6 (Pyridoxine) Content of Beef and Beef Products

Oxalic acid

S. anhydrous acid? 100 ml

Analytical method

Range

Mean

Reference

Rib-Eye Small Ribs

38

32

36

Lean and Fat Whole Prime Ribs Lean and Fat

3O

25

29

1O

Plasma

Serum

Mg/100 Grams

Beef

Whole blood

Male Beef Cured Frankfurter

Female 15

Pastrami

TABLE VII

18

Sausage Cooked and Smoked

Cooked

Cooked Cooked

Broiled/Braised Roasted Pan Fried

Kidney Cooked

.445

394

Ground Lean Fried Ground Lean Baked

Leg, Loin & Shoulder .508 Composite of Retail

.434

Raw

Composite of Retail Cuts All Lean and Fat Cuts All Lean and Fat

Leg (Ham) Whole

25

4O1

402

SOO

400

472

460

.382

527

492

.404

.11

Beef Cured and Corned Liver Pan Fried

Vitamin B-6 (Pyridoxine) Content of Pork and Pork Products Pork

.12 .24

Lebanon Bologna

13 1.43

52 28 2O

Source: U.S. Department of Agriculture Agriculture Handbook 8-13 1986

Lean and Fa

Leg (Ham) Whole

Lean Only

TABLE IX

Loin Whole Lean and Fa Loin Whole

Vitamin B-6 (Pyridoxine) Content of Veal and Lamb

Lean Only Back Ribs

395

370

.297 (braised)

Lean and Fa

337

.381 (broiled)

Bacon Cured

Raw

Cooked

Veal All Retail Cuts Lean and Fat Lamb All Retail Cuts Lean and Fat Lamb All Retail Cuts Lean

.41

31

13

13

.16

.16

.307

Lean and Fa

Loin Chops

Meat

.14

27

Canadian Style, Bacon .38

45

Unheated

(unheated)

Ham, Boneless

38

35

35

Extra Lean & Regular (unheated) Ham, Boneless (11%

.34

Fat) Extra Lean and Regular

(unheated)

31

40

Source: USDA Department of Agriculture Agriculture Handbook 8-17-1989

Source: U.S. Department of Agriculture Agriculture Handbook 8-10 Rev. 1992

TABLE X

45

TABLE VIII

Chicken

Vitamin B-6 (Pyridoxine) Content of Beef and Beef Products All Grades

Good

Choice

Prime

Broilers or Fryers

Fried Batter-

Fried Flour

Raw

Dipped

Dipped

34

32

.42

38

22

43

48

53

47

26

48

39

54

52

27

54

63

.65

60

26

25

25

32

31

17

Roasted Stewed

50 All Meat with Skin Beef

Raw Cooked

Raw Cooked

Raw Cooked

Raw

Choice

Broilers or Fryers

All Meat Flesh Only Com-

36

31

37

32

36

31

34

Broilers or Fryers

29

posite Retail Cuts Lean and Fat Com-

Light Meat with Skin 55 Broilers or Fryers

Light Meat Flesh Only

Broilers and Fryers 43

38

.44

38

43

38

43

Dark Meat with Skin

38

posite Retail Cuts Lean

60 Broiler and Fryers

26

26

33

31

17

Broiler and Fryers

29

27

34

.33

18

Only

Leg with Skin 35

39

Thigh with Skin Ground Turkey

Beef

Large Ribs Lean and Fat

Raw

Roasted

Broiled

28

22

26

65

(Cooked) Source: U.S. Department of Agriculture Agriculture Handbook 8-5-1978

6,133,317 63

64

TABLE XI

TABLE XII-continued

VITAMIN B-6 (PYRIDOXINE) CONTENT OF SELECTED BAKED

Dry Dog Food

GOODS

Test Run Data

Mg/100 G

Breads

E325

Bagels: Plain, Onion, Poppy

Processing Conditions:

Run #1

#4 Steamlock

Small

#5 Screw

2 Flight cut flight

#5 Steamlock

Large

#6 Screw

2 Flight cut flight cone Spiral Rib Cone Head

Flight Uncut

Seed, Sesame

Bagels, Date Bran Bagels, Egg Bagels, Cinnamon Raisin Biscuits, Commercially Baked

OOO O84 OOO O47 113 3O4 O43 O48 .333 OOO 126 O75 O64 179

Pumpernickel Rye Bread Wheat Bran Bread Whole Wheat Commercial Bread

Spacer 15 Backup Die

Dieplate Insert

25

TABLE XII

Dry Dog Food Test Run Data

Run #1 Dry Dog Food

Comment

Feeder Speed (RPM)

11 rpm (420 lbs/hr) Cond. Cyl. Temp (F) 206 Cond. Cyl. Water (% 1O gauge) Extruder Speed (RPM) 421 Extruder Current (Amps) 24 Extruder Water (% O gauge) 34.7

Extruder Steam Injection #2 Head Temp. (CW or ST) #3 Head Temp. (CW or ST) #4 Head Temp. (CW or ST) #5 Head Temp. (F) #6 Head Temp. (F)

0 CW

Die Pressure (PSI) Knife Speed (Hertz)

350 55.9

Dryer Retention

17.9

35

(minutes)

40

45

CW 79 deg F. CW 129 deg F. 50

See Dry Feed formula 2.7# OA to 100# water

1. A chemopreventive composition for treating at least one of tumors, brain tumors, cancers, and growths in warm blooded animals sensitive to treatment comprising a com position having an effective amount of at least one thera peutically effective form of at least one of Oxalic acid and amount is less than a lethal dosage of Oxalic acid and wherein Said composition is adapted to be administered to warm-blooded animals on a periodic basis in less than a lethal dosage. 2. The composition as recited in claim 1 wherein Said therapeutically effective form of at least one of Oxalic acid 3. The composition as recited in claim 1 wherein Said therapeutically effective form of at least one of Oxalic acid and oxalate is oxalic acid dihydrate. 4. The composition as recited in claim 1 wherein Said therapeutically effective form of at least one of Oxalic acid and oxalate is dried parsley. 5. The composition as recited in claim 1 further compris ing a pharmaceutically acceptable carrier or diluent. 6. The composition as recited in claim 1 wherein Said carrier or diluent is distilled water.

The oxalic acid

55

solution was made up in hot water (160 F) and pumped into the conditioning cylinder Screw Configuration:

7. The composition as recited in claim 1 wherein said therapeutically effective form of at least one of Oxalic acid and oxalate is a nutritional Supplement containing an effec tive amount of at least one therapeutically effective form of at least one of Oxalic acid and oxalate.

Single Flight Tapered Straight Rib Head

60

8. The composition as recited in claim 1 wherein said therapeutically effective form of at least one of Oxalic acid and oxalate is Selected from the group of natural foods, processed foods, molds, plants, and vegetables containing an effective amount of at least one therapeutically effective

65

form of at least one of Oxalic acid and oxalate.

Inlet

#1 Steamlock

Thus, it will be appreciated that as a result of the present invention, a highly effective oxalic acid or oxalate compo Sition and method is provided by which the principal object, among others, is completely fulfilled. It is contemplated, and will be apparent to those skilled in the art from the preceding description that modifications and/or changes may be made in the prescribed embodiments without departure from the present invention. Accordingly, it is expressly intended that the foregoing description is illustrative of preferred embodi ments only, and not limiting with respect to the true Spirit and Scope of the present invention.

and oxalate is oxalic acid in a free acid form.

CW

Ibs/min

#1 Screw

#101-509

least one of Oxalic acid and oxalate, wherein Said effective

CW

2.2% Oxalic acid solution added at 0.7 Comments:

1f4" round hole

oxalate and at least one of a carrier and diluent for Said at

Dryer Temperature (F) 223

Formula:

#825440-3

What is claimed is:

E325

Feeder Speed (Hertz)

1" thick

No 1 1/4" central insert die

Source: U.S. Deptartment of Agriculture Agriculture Handbook 8-18 Rev. 1992

Product

Straight Rib Head

Die Configuration:

Plain or Buttermilk Cornbread Cracked Wheat Bread French and Vienna Bread Italian Bread Mixed Grains 7 Bread Oat Bran Bread

Processing Conditions:

Comment

Spacer

#2 Screw

Single Flight Uncut

#2 Steamlock

Spacer

#3 Screw

Single Flight Uncut

#3 Steamlock

Spacer

#4 Screw

Single to Double

Spiral Rib Head Spiral Rib Head Straight Rib Head

9. The composition as recited in claim 1 wherein said therapeutically effective form of at least one of Oxalic acid

6,133,317 65

66

and oxalate is Selected from the group of beverages, liquids, and juices containing an effective amount of at least one therapeutically effective form of at least one of Oxalic acid

acetone, propylene glycol, and polySorbate and Said base is at least one of a hydrophilic petrolatum, cream, ointment, gel, lotion, Spray, Stick, and powder. 22. The composition as recited in claim 19, wherein said effective amount is at least one of about 50 mg to 6 g for humans and about 1 mg to 3 g for warm blooded animals

and oxalate.

10. The composition as recited in claim 1 wherein said therapeutically effective form of at least one of Oxalic acid and oxalate is Selected from the group of additives contain ing at least one therapeutically effective form of at least one

other than humans.

23. In a pet food containing at least one of protein, carbohydrates, oils, Vitamins, and minerals, to be used in a method for treating at least one of tumors, growths, and

of Oxalic acid and oxalate.

11. The composition as recited in claim 5, wherein said at least one carrier and diluent is a gel cap. 12. The composition as recited in claim 5, wherein Said at least one carrier and diluent is at least one of a gel cap, distilled water, tablet, powder, food additive, drops, liquid, beverage, rinse, mouthwash, gargle, pill, capsule, lozenge, cough drop, transdermal patch, ointment, Salve, cream, lotion, and gel, adapted for periodically administering a therapeutically effective dosage by at least one of topical, oral, nasal, parenteral, intravenous, and Subcutaneous appli

cancers in warm blooded animals Sensitive to treatment, the

improvement comprising the addition of a therapeutically effective quantity of at least one therapeutically effective form of at least one of Oxalic acid and oxalate. 15

cation.

13. The composition as recited in claim 1, wherein Said effective amount is at least one of about 50 mg to 6 g for humans and about 1 mg to 3 g for warm blooded animals

a dilute Solution of an effective amount of at least one

therapeutically effective form of at least one of Oxalic acid

other than humans.

14. An anti-tumor agent to be used in a method for treating at least one of tumors, growths, and cancers in warm blooded animals Sensitive to treatment comprising a mixture of an effective amount of at least one therapeutically effec

and Oxalate in heated water to form at least one of an Oxalic 25

26. The method as recited in claim 25 wherein said oxalic

least one of a pharmaceutically acceptable carrier and dilu ent.

acid, (vitamin C), pyridoxine hydrochloride (vitamin B6),

35

40

29. The oral rinse or wash as recited in claim 28 com 50 Water.

30. The oral rinse as recited in claim 29, wherein said

rinse contains a Solution ratio of about 150 mg oxalic acid dihydrate in about 300 ml distilled water. 31. The oral rinse as recited in claim 28, wherein said 55

and cancers in warm blooded animals Sensitive to treatment 60

20. The therapeutic composition as recited in claim 19

wherein Said Solvent is at least one of distilled water,

acetone, propylene glycol, and polySorbate, and Said base is at least one of a cream, ointment, gel, lotion, Spray, Stick, and powder. 21. The therapeutic composition as recited in claim 19

wherein Said Solvent is at least one of distilled water,

wherein Said effective amount is less than a lethal dosage of Oxalic acid and wherein Said Solution is adapted to be administered periodically in less than a lethal dosage. prising a dilute Solution of Oxalic acid dihydrate in distilled

comprising an effective amount of at least one therapeuti cally effective form of at least one of Oxalic acid and oxalate, a Solvent, and a base.

calcium, alcohol, resins, clays, foods containing calcium, beverages containing alcohol, citric acid, or ascorbic acid, red meat or white meat of fowl containing pyridoxine hydrochloride, and foods, nutritional Supplements, or bev erages containing oxalic acid or oxalate blockers. 28. An oral rinse or wash for treating at least one of tumors, cancers, and growths in warm blooded animals Sensitive to treatment in the mouth area comprising a dilute Solution of an effective amount of at least one therapeutically effective form of at least one of Oxalic acid and oxalate,

45

humans.

19. A therapeutic composition in cream or ointment form for topical administration of an effective amount of at least one therapeutically effective form of at least one of Oxalic acid and oxalate for treating at least one of tumors, growths,

acid and oxalate containing Slurry, forming the Slurry into pellets and drying the pellets. acid is Oxalic acid dihydrate and each pellet contains approximately 1 mg of Oxalic acid So that one pound of dry dog food contains about 1 g of Oxalic acid. 27. The method as recited in claim 25, further comprising the Steps of reducing the intake of Oxalic acid or oxalate blockerS Selected from at least one of citric acid, ascorbic

tive form of at least one of Oxalic acid and oxalate with at

15. The agent as recited in claim 14 wherein said thera peutically effective form of at least one of Oxalic acid and oxalate is Oxalic acid dihydrate. 16. The agent as recited in claim 14 wherein Said phar maceutically acceptable carrier or diluent is Selected from the group of distilled water, heated water, pharmaceutically acceptable liquids, nutritional Supplements, natural foods and processed foods. 17. The anti-tumor agent as recited in claim 14, wherein Said at least one carrier and diluent is at least one of a gel cap, distilled water, tablet, powder, food additive, drops, liquid, beverage, rinse, mouthwash, gargle, pill, capsule, lozenge, cough drop, transdermal patch, ointment, Salve, cream, lotion, and gel, adapted for periodically administer ing a therapeutically effective dosage by at least one of topical, oral, nasal, parenteral, intravenous, and Subcutane ous application. 18. The agent as recited in 14, wherein said effective amount is at least one of about 50 mg to 6 g for humans and about 1 mg to 3 g for warm blooded animals other than

24. The pet food as recited in claim 23, wherein the effective quantity is about 1 mg to 3 g per pet. 25. In a method of manufacturing a dry process dog food to be used in a method for treating at least one of tumors, growths, and cancers in warm blooded animals Sensitive to treatment, the improvement comprising the Steps of mixing a slurry of conventional dog food ingredients together with

rinse contains a Solution ratio of about 150 mg oxalic acid dihydrate in about 300 ml distilled water. 32. A dietary Supplement for treating a patient diagnosed with at least one of an active cancer, tumor, and growth Sensitive to treatment comprising about 1 g to 6 g of at least one therapeutically effective form of at least one of Oxalic acid and oxalate per day based on 70 kilograms of body weight and at least one of a pharmaceutically acceptable carrier and diluent.

65

33. The dietary supplement as recited in claim 32, wherein Said at least one carrier and diluent is at least one of a gel cap, distilled water, tablet, powder, food additive, drops, liquid, beverage, rinse, mouthwash, gargle, pill, capsule,

6,133,317 67

68 44. The chemopreventive composition as recited in claim

lozenge, cough drop, transdermal patch, ointment, Salve, cream, lotion, and gel, adapted for periodically administer ing a therapeutically effective dosage by at least one of topical, oral, nasal, parenteral, intravenous, and Subcutane ous application. 34. The dietary supplement as recited in claim 32, wherein Said effective amount is at least one of about 50 mg to 6 g for humans and about 1 mg to 3 g for warm blooded animals

43, wherein the effective amount is at least one of about 50

mg to 6 g for humans and about 1 mg to 3 g for warm blooded animals other than humans.

45. In a gel cap, the improvement comprising a therapeu tically effective dosage of Oxalic acid less than a lethal dosage. 46. The gel cap as recited in claim 45, wherein the effective dosage is at least one of about 50 mg to 6 g for humans and about 1 mg to 3 g for warm blooded animals

other than humans.

35. A pharmaceutical composition to be administered orally to humans for treating at least one of tumors, growths,

other than humans.

and cancers in warm blooded animals Sensitive to treatment

comprising a mixture of a non-toxic ingestible carrier and an effective amount of a therapeutically effective form of at least one of Oxalic acid and oxalate.

15

36. The pharmaceutical composition as recited in claim

humans.

35, wherein Said at least one carrier and diluent is at least one

of a gel cap, distilled water, tablet, powder, food additive, drops, liquid, beverage, rinse, mouthwash, gargle, pill, capsule, lozenge, cough drop, transdermal patch, ointment, Salve, cream, lotion, and gel, adapted for periodically admin istering a therapeutically effective dosage by at least one of topical, oral, nasal, parenteral, intravenous, and Subcutane ous application. 37. The composition as recited in claim 35, wherein said effective amount is about 50 mg to 6 g. 38. The pharmaceutical composition as recited in claim 35 wherein Said composition is provided in a form Selected from the group of pills, powders, granules, tablets, microcapsules, gel capsules, nutritional Supplements, pro cessed foods, liquids, drops, beverages, additives, and Solu

49. In a drug delivery System, the improvement compris ing a therapeutically effective dosage of Oxalic acid less than a lethal dosage. 50. The drug delivery system as recited in claim 49, wherein the therapeutically effective dosage is at least one of about 50 mg to 6 g for humans and about 1 mg to 3 g for warm blooded animals other than humans. 25

one tumor in a warm blooded animal Sensitive to treatment

51. A method for treating at least one of tumors, growths, and cancers in warm blooded animals Sensitive to treatment

comprising the Steps of periodically administering a thera peutically effective dosage of at least one composition of a therapeutically effective form of at least one of Oxalic acid and oxalate to Said animal, wherein Said dosage is less than a lethal dosage of Oxalic acid and wherein Said composition is adapted to be administered periodically in less than a lethal dosage.

tions.

39. In a pet treat containing at least one of protein, carbohydrates, and flavorings, to be used in a method for treating at least one of tumors, growths, and cancers in warm blooded animals Sensitive to treatment W, the improvement comprising the addition of microgram amounts of at least one therapeutically effective form of at least one of Oxalic acid and oxalate, whereby the treats provide for the main tenance of good pet health. 40. The pet treat as recited in claim 39, wherein the microgram amount provides for about 1 mg to 3 g perpet per day. 41. A chemopreventive composition for treating at least

47. In a pill, the improvement comprising a therapeuti cally effective dosage of Oxalic acid less than a lethal dosage. 48. The pill as recited in claim 47, wherein the effective dosage is at least one of about 50 mg to 6 g for humans and about 1 mg to 3 g for warm blooded animals other than

52. The method as recited in claim 51 wherein said 35

composition is administered at least one of orally and Sublingually. 53. The method as recited in claim 51 wherein said

composition is administered by injection. 54. The method as recited in claim 51 wherein said 40

composition is administered topically. 55. The method as recited in claim 51 wherein said

composition is administered internally. 56. The method as recited in claim 51 wherein said 45

composition is administered at least once a day at a dosage of at least one of 50 mg to 6 g for humans and 1 mg to 3g

comprising a composition including an effective amount of at least one therapeutically effective form of at least one of

for warm blooded animals other than humans. 57. The method as recited in claim 51 wherein said

Oxalic acid and oxalate and at least one of a carrier and

composition is administered at least once a day at a dosage of about 1 mg to 3 g for dogs and cats.

diluent for Said at least one of Oxalic acid and oxalate,

wherein Said effective amount is less than a lethal dosage of Oxalic acid and wherein Said composition is adapted to be administered to warm-blooded animals on a periodic basis in less than a lethal dosage. 42. The chemopreventive composition as recited in claim

50

41, wherein the effective amount is at least one of about 50

55

blockerS Selected from at least one of citric acid, ascorbic

mg to 6 g for humans and about 1 mg to 3 g for warm blooded animals other than humans.

43. A chemopreventive composition for treating at least one cancer in a warm blooded animal Sensitive to treatment

comprising a composition including an effective amount of at least one therapeutically effective form of at least one of

60

Oxalic acid and oxalate and at least one of a carrier and

acid, (vitamin C), pyridoxine hydrochloride (vitamin B6),

calcium, alcohol, resins, clays, foods containing calcium, beverages containing alcohol, citric acid, or ascorbic acid, red meat or white meat of fowl containing pyridoxine hydrochloride, and foods, nutritional Supplements, or bev erages containing oxalic acid or oxalate blockers. 60. The method as recited in claim 51 further comprising the Steps of reducing the intake of Oxalic acid or oxalate blockers. 61. The method as recited in claim 60 wherein said

diluent for Said at least one of Oxalic acid and oxalate,

wherein Said effective amount is less than a lethal dosage of Oxalic acid and wherein Said composition is adapted to be administered to warm-blooded animals on a periodic basis in less than a lethal dosage.

58. The method as recited in claim 51, wherein said

composition is administered by injection. 59. The method as recited in claim 51, further comprising the Steps of reducing the intake of Oxalic acid or oxalate

65

blockers are Selected from the group of citric acid, ascorbic acid, pyridoxine hydrochloride, calcium, alcohol, resins, clayS, and combinations thereof.

6,133,317 69

70

62. The method as recited in claim 60 wherein said

75. The diet as recited in claim 73 wherein said blockers

blockers are Selected from the group of dairy products containing calcium, fruits, coconut, beverages containing alcohol, ascorbic acid or citric acid including adult bever ageS Such as beer, wine, Vodka, gin, and the like, fruit juice based beverages, Soda pop or Soft drinkS containing ascorbic acid or citric acid, other Sports drinks, beverages or refresh ments containing calcium, ascorbic acid or citric acid, red meat or white meat of fowl including chicken, turkey, pheasant and the like containing pyridoxine hydrochloride, or other foods or beverages containing alcohol, citric acid, ascorbic acid, calcium or pyridoxine hydrochloride includ ing breads or grains, and combinations thereof. 63. A method for treating at least one of cancers, tumors, and growths in warm blooded animals Sensitive to treatment comprising the Steps of adding to the regular diet a dietary Supplement of an effective amount of at least one therapeu tically effective form of at least one of Oxalic acid and

are Selected from the group of dairy products containing calcium, fruits, coconut, beverages containing alcohol, ascorbic acid, or citric acid including adult beverageS Such as beer, wine, Vodka, gin, and the like, fruit juice based beverages, Soda pop or Soft drinkS containing ascorbic acid or citric acid, other Sports drinks, beverages or refreshments containing calcium, ascorbic acid or citric acid, red meat or white meat of fowl including chicken, turkey, pheasant, and the like containing pyridoxine hydrochloride, or other foods or beverages containing alcohol, ascorbic acid, citric acid, calcium or pyridoxine hydrochloride including breads or grains, and combinations thereof. 76. A method of treating warm-blooded animals afflicted 15

with tumor cells Sensitive to an effective amount of at least

one of an oxalic acid and oxalate compound comprising the Steps of periodically administering to the animal an onco lytic amount of at least one therapeutically effective Oxalic acid and oxalate compound. 77. The method as recited in claim 76, further comprising the Steps of reducing the intake of Oxalic acid or oxalate

oxalate. 64. The method as recited in claim 63 wherein said

therapeutically effective form of at least one of Oxalic acid and oxalate is oxalic acid in a free acid form. 65. The method as recited in claim 63 wherein said

blockerS Selected from at least one of citric acid, ascorbic

therapeutically effective form of at least one of Oxalic acid and oxalate is a nutritional Supplement containing at least

calcium, alcohol, resins, clays, foods containing calcium, beverages containing alcohol, citric acid, or ascorbic acid, red meat or white meat of fowl containing pyridoxine hydrochloride, and foods, nutritional Supplements, or bev erages containing oxalic acid or oxalate blockers.

acid, (vitamin C), pyridoxine hydrochloride (vitamin B6),

25

one form of at least one of Oxalic acid and oxalate. 66. The method as recited in claim 63 wherein said

therapeutically effective form of at least one of Oxalic acid and oxalate is oxalic acid dihydrate.

78. The method as recited in claim 76, wherein said

compound is administered at daily dosage of at least one of about 50 mg to 6 g for humans and about 1 mg to 3 g for

67. The method as recited in claim 63 wherein said

therapeutically effective form of at least one of Oxalic acid and oxalate is processed foods containing at least one form

warm blooded animals other than humans.

of at least one of oxalic acid and oxalate. 68. The method as recited in claim 63 wherein said

therapeutically effective form of at least one of Oxalic acid and oxalate is at least one of plants and vegetables contain ing at least one form of at least one of Oxalic acid and

35

least one of Oxalic acid and oxalate. 80. The method as recited in claim 79 wherein the

oxalate. 69. The method as recited in claim 63 wherein said

therapeutically effective form of at least one of Oxalic acid and oxalate is at least one of beverages, liquids, and juices containing at least one form of at least one of Oxalic acid and

40

oxalate. 70. The method as recited in claim 63 wherein said

therapeutically effective form of at least one of Oxalic acid and oxalate is additives containing at least one form of at

therapeutically effective form of at least one of Oxalic acid and oxalate is dried chopped parsley. 81. The method as recited in claim 79, further comprising the Steps of reducing the intake of Oxalic acid or oxalate blockerS Selected from at least one of citric acid, ascorbic

acid, (vitamin C), pyridoxine hydrochloride (vitamin B6),

45

least one of Oxalic acid and oxalate.

71. The method as recited in claim 63, wherein said

effective amount is a daily dosage of at least one of about 50 mg to 6 g for humans and about 1 mg to 3 g for warm

79. A method of treating brain tumors in warm blooded animals Sensitive to treatment comprising the Steps of ingesting or administering a therapeutically effective amount of at least one therapeutically effective form of at

50

calcium, alcohol, resins, clays, foods containing calcium, beverages containing alcohol, citric acid, or ascorbic acid, red meat or white meat of fowl containing pyridoxine hydrochloride, and foods, nutritional Supplements, or bev erages containing oxalic acid or oxalate blockers. 82. The method as recited in claim 79, wherein said

blooded animals other than humans.

effective form of at least one of Oxalic acid and oxalate is

72. The method as recited in claim 63, further comprising the Steps of reducing the intake of Oxalic acid or oxalate

administered at daily dosage of at least one of about 50 mg to 6 g for humans and about 1 mg to 3 g for warm blooded animals other than humans.

blockerS Selected from at least one of citric acid, ascorbic

acid, (vitamin C), pyridoxine hydrochloride (vitamin B6),

calcium, alcohol, resins, clays, foods containing calcium, beverages containing alcohol, citric acid, or ascorbic acid, red meat or white meat of fowl containing pyridoxine hydrochloride, and foods, nutritional Supplements, or bev erages containing Oxalic acid or oxalate blockers. 73. The diet as recited in claim 63 further comprising the Steps of reducing the intake of Oxalic acid or oxalate

55

60

and combinations thereof.

comprising the Steps of periodically administering a thera peutically effective dosage of the composition of claim 1 and adding to the regular diet a dietary Supplement of an effective amount of at least one therapeutically effective form of at least one of Oxalic acid and oxalate.

84. The method as recited in claim 83, further comprising the Steps of reducing the intake of Oxalic acid or oxalate

blockers. 74. The diet as recited in claim 73 wherein said blockers

are Selected from the group of citric acid, ascorbic acid, pyridoxine hydrochloride, calcium, alcohol, resins, clayS,

83. A method for treating at least one of tumors, growths, and cancers in warm-blooded animals Sensitive to treatment

blockerS Selected from at least one of citric acid, ascorbic 65

acid, (vitamin C), pyridoxine hydrochloride (vitamin B6),

calcium, alcohol, resins, clays, foods containing calcium, beverages containing alcohol, citric acid, or ascorbic acid,

6,133,317 71

72

red meat or white meat of fowl containing pyridoxine hydrochloride, and foods, nutritional Supplements, or bev erages containing Oxalic acid or oxalate blockers.

of periodically administering a therapeutically effective doS age of at least one composition of a therapeutically effective form of at least one of Oxalic acid and oxalate and at least one of a carrier and diluent for Said at least one of Oxalic acid

85. The method as recited in claim 83, wherein said

composition is administered at daily dosage of at least one of about 50 mg to 6 g for humans and about 1 mg to 3 g for

and oxalate, wherein Said effective amount is less than a

lethal dosage of Oxalic acid and wherein Said composition is adapted to be administered to warm-blooded animals on a periodic basis in less than a lethal dosage to Said animal. 97. The method as recited in claim 96, further comprising the Steps of reducing the intake of Oxalic acid or oxalate

warm blooded animals other than humans.

86. A method for treating cancer in warm blooded animals Sensitive to treatment, comprising the Steps of: periodically administering a therapeutically effective doS age of at least one therapeutically effective form of at

blockerS Selected from at least one of citric acid, ascorbic

least one of Oxalic acid and oxalate to Said animal,

acid, (vitamin C), pyridoxine hydrochloride (vitamin B6),

wherein Said effective amount is less than a lethal

calcium, alcohol, resins, clays, foods containing calcium, beverages containing alcohol, citric acid, or ascorbic acid, red meat or white meat of fowl containing pyridoxine hydrochloride, and foods, nutritional Supplements, or bev erages containing oxalic acid or oxalate blockers.

dosage of Oxalic acid and wherein Said Solution is adapted to be administered periodically in less than a lethal dosage.

15

87. The method as recited in claim 86, wherein said

composition is administered at least one of orally and Sublingually.

98. The method as recited in claim 96, wherein said

composition is administered at daily dosage of at least one of about 50 mg to 6 g for humans and about 1 mg to 3 g for

88. The method as recited in claim 86, wherein said

composition is administered by injection.

warm blooded animals other than humans.

89. The method as recited in claim 86, wherein said

composition is administered topically.

90. The method as recited in claim 86, wherein said

composition is administered internally.

25

91. The method as recited in claim 86, wherein said

99. A treatment regimen for treating tumors, cancers, growths, and neoplasia in warm blooded animals Sensitive to treatment comprising the Steps of reducing or eliminating the ingestion or administration of Oxalic acid or oxalate blockers, administering or ingesting high dosages of at least

composition is administered at least once a day at a dosage of at least one of 50 mg to 6 g for humans and 1 mg to 3g

one of Oxalic acid and oxalate to raise the blood or urine

for warm blooded animals other than humans.

ing the blood of tumor, cancer or abnormal cells, adminis tering or ingesting a more moderate level of at least one of

Oxalic acid or oxalate level above normal, and, after cleans

92. The method as recited in claim 86, further comprising the Steps of reducing the intake of Oxalic acid or oxalate

Oxalic acid and oxalate to maintain a normal blood or urine Oxalic acid or oxalate level.

blockerS Selected from at least one of citric acid, ascorbic

acid, (vitamin C), pyridoxine hydrochloride (vitamin B6),

calcium, alcohol, resins, clays, foods containing calcium, beverages containing alcohol, citric acid, or ascorbic acid, red meat or white meat of fowl containing pyridoxine hydrochloride, and foods, nutritional Supplements, or bev erages containing Oxalic acid or oxalate blockers. 93. A method for treating at least one tumor in a warm blooded animal Sensitive to treatment comprising the Steps of periodically administering a therapeutically effective doS age of at least one composition of a therapeutically effective

100. The regimen as recited in claim 99 further compris ing the Steps of increasing the administration or ingestion of 35

101. A chemopreventive composition for treating at least one of tumors, brain tumors, cancers, and growths in humans Sensitive to treatment comprising a composition having an effective amount of at least one therapeutically effective 40

and oxalate, wherein Said effective amount is less than a

45

50

acid, (vitamin C), pyridoxine hydrochloride (vitamin B6),

warm blooded animals other than humans.

96. A method for treating at least one cancer in a warm blooded animals Sensitive to treatment comprising the Steps

effective form of at least one of Oxalic acid and oxalate,

103. The method as recited in claim 102 wherein said 55

95. The method as recited in claim 93, wherein said

composition is administered at daily dosage of at least one of about 50 mg to 6 g for humans and about 1 mg to 3 g for

lethal dosage of Oxalic acid and wherein Said composition is adapted to be administered on a periodic basis in less than a lethal dosage. 102. A method for treating at least one of tumors, growths, and cancers in humans Sensitive to treatment comprising the Steps of periodically administering at therapeutically effec tive dosage of at least one composition of a therapeutically wherein Said dosage is less than a lethal dosage of Oxalic acid and wherein Said composition is adapted to be admin istered periodically in less than a lethal dosage.

blockerS Selected from at least one of citric acid, ascorbic

calcium, alcohol, resins, clays, foods containing calcium, beverages containing alcohol, citric acid, or ascorbic acid, red meat or white meat of fowl containing pyridoxine hydrochloride, and foods, nutritional Supplements, or bev erages containing Oxalic acid or oxalate blockers.

form of at least one of Oxalic acid and oxalate and at least one of a carrier and diluent for Said at least one of Oxalic acid

and oxalate, wherein Said effective amount is less than a

form of at least one of Oxalic acid and oxalate and at least one of a carrier and diluent for Said at least one of Oxalic acid

lethal dosage of Oxalic acid and wherein Said composition is adapted to be administered to warm-blooded animals on a periodic basis in less than a lethal dosage to Said animal. 94. The method as recited in claim 93, further comprising the Steps of reducing the intake of Oxalic acid or oxalate

Oxalic acid or oxalate enhancers.

60

composition is administered at least one a day at a dosage of about 50 mg to 6 g. 104. A method for treating at least one of cancers, tumors, and growths in humans Sensitive to treatment comprising the Steps of adding to the regular diet a dietary Supplement of an effective amount of at least one therapeutically effective form of at least one of Oxalic acid and oxalate.

US006133318A

United States Patent (19)

11 Patent Number: (45) Date of Patent:

Hart 54) OXALIC ACID OR OXALATE

COMPOSITIONS AND METHODS FOR

BACTERIAL VIRAL AND OTHER DISEASES OR CONDITIONS

76 Inventor: Francis J. Hart, 390 Ryan Rd., Pea Ridge, Ark. 72751 *

Notice:

This patent is Subject to a terminal dis claimer.

6,133,318 *Oct. 17, 2000

Lundin, Frank; Lloyd, William; Smith, Elizabeth; Archer, Victor; Holaday, Duncan; Health Physics, Mortality of Ura nium Miners in Relation to Radiation Exposure, Hard-Rock Mining and Cigarette Smoking 1950-Sep. 1967, vol. 16, 1969, pp. 571-578. Kotulak, Ron; Van, John; The Chicago Tribune, 1995, p. 127.

Hirsch, Bruce; Weksler, Marc; Organ Systems: Infectious Diseases, at least as early as Feb. 23, 1996, pp. 876-883. Spring Valley Vitamins, nutritional facts on package label, 1997.

21 Appl. No.: 09/014,943 22 Filed: Jan. 28, 1998 Related U.S. Application Data 63 Continuation-in-part of application No. 08/629,538, Apr. 9, 1996. 60 Provisional application No. 60/036,983, Jan. 29, 1997, and provisional application No. 60/006,785, Nov. 15, 1995.

51) Int. Cl." ....................... A61K 31/194; A61K 31/225 52

U.S. Cl. ............................. 514/574; 514/547; 424/49

58

Field of Search ...................................... 514/574,547

56)

References Cited 3,542,573 11/1970 Biland et al. ........................... 106/186 3,787,589 1/1974 Stephens et al. . ... 426/325 4,156,067 5/1979 Gould ........................................ 528/73 4,285,972 8/1981 Chou et al. ... 424/326 4,340,609 7/1982 Chou ....................................... 424/322 4,760,157 7/1988 Child et al. ............................. 556/137 4,900,746 2/1990 Hanson et al. ... 514/400 ... 424/195 5,137,722 8/1992 Costello ............ ... 424/630 5,151,274 9/1992 Saltman et al. 5,175,144 12/1992 Walser .......... ... 514/2 5,183,674 2/1993 Olin ..................... ... 426/2

7/1993 9/1993 3/1994 3/1994 5/1994

Wullschleger et al. Graves et al. ........ Kim et al...... Hirsch et al. . Haigh ............

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5/1994 Todd, Jr. ... 6/1994 Arif et al. ..

Unknown Author; Laurel Farms Believes that the Kom bucha Tea Mushroom is a Gift from God, Unknown Date, pp. 1-12. Smith, G., Toxification and Detoxification of Plant Com

pounds by Ruminants, an Overview, Society for Range Management, 1990, Abstract only.

(List continued on next page.) Primary Examiner Richard L. Raymond

U.S. PATENT DOCUMENTS

5,227,248 5.245,095 5,292,511 5,292,773 5,310,554

Chou, Jane; Feury, Margit; Kidney Stone Question and Answer, Family Circle Magazine, 1995, p. 64. Nichols, Dora; Over the Garden Gate, The Morning News, 1996, pages: Unknown. Raloff, J.; Aged Garlic Could Slow Prostate Cancer, Science News, vol. 151, 1997, p. 239. Unknown Author; Bone Mass, Cancer May be Linked, USA Today, 1997, p. 4D. Berkeley, Barbara; Nutritional Protocol for HIV, San Fran cisco Project Inform, 1994, pp. 1-12.

... 426/549 ... 585/351 424/195.1 ... 514/554 ... 424/439

Attorney, Agent, or Firm-Head, Johnson & Kachigian 57

ABSTRACT

A Single medicine oxalic acid or oxalate composition or “magic bullet” and method of treatment or prevention of warm-blooded animals including humans and pets for infec tious or pathogenic microbial, bacterial, or viral disease, chemopreventiong of bacterial or viral infections, and the like, is provided which includes at least one therapeutically effective form of Oxalic acid or oxalate Selected from oxalic

acid in a free acid, ester, lactone or Salt form and oxalate

OTHER PUBLICATIONS

including Sodium oxalate, Oxalic acid dihydrate, anhydrous Oxalic acid, oxamide, and oxalate Salts, natural or processed foods including molds, plants or vegetables containing Oxalic acid or oxalate, beverages, liquids or juices contain ing oxalic acid or oxalate, additives containing Oxalic acid or oxalate, and combinations thereof. The composition may also contain a pharmaceutically acceptable carrier or diluent for the therapeutically effective form of oxalic acid or oxalate. Methods are provided including the Steps of peri odically administering, by topical, oral, or parenteral application, a therapeutically effective dosage of a compo Sition including at least one therapeutically effective form of Oxalic acid or oxalate and improving chemotherapy reducing

Dyer, An Index of Tumor Chemotheraphy, NIH, pp. 10-12

the intake of Oxalic acid or oxalate blockerS Such as citric

... 424/401 ... 252/142

5.330,972 7/1994 Cope ........................................... 514/2 5,346,707 5,376,361 5,401,325 5,401,326 5,455,372 5,470,874

9/1994 12/1994 3/1995 3/1995 10/1995 11/1995

Olin .......................................... 426/69 Perricone .................................. 424/59 Mihelic et al. ........................... 134/39 Mihelic et al. ........................... 134/40 Hirai et al..... ... 560/179 Lerner ..................................... 514/474

and 72 (No. 2015) 1949.

The Merck Index, 11th Edition, p. 1093 1995. Jawetz, Ernest; Melnick, Joseph; Adelberg, Edward; Review of Medical Microbiology, 8th Edition, 1968, pp. 1-5, 49-51, 84–89, 102-109, 112-116, 117-122, 139, 296–303 344-345, 373-375, 387-393, 434–454. Berkow, Robert; Fletcher, Andrew; The Merck Manual of

acid, ascorbic acid, (vitamin C), pyridoxine hydrochloride (vitamin B6), calcium, alcohol, resins, clays, foods contain

ing calcium, beverages containing alcohol, citric acid, or ascorbic acid, red meat or white meat of fowl containing pyridoxine hydrochloride, or other foods nutritional Supple ments or beverages containing oxalic acid or oxalate block CS.

Diagnosis and Therapy, 15th Edition, 1987, pp. 70-137, 158-197.

87 Claims, 1 Drawing Sheet

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Hart, Francis; The Relationship Between Oxalic Acid and Pyridoine: Treatment for Tumor Reduction, Copyright Application and deposit, 1994, pp. 1-29. Dyer, Helen; An Index of Tumor Chemotherapy, Federal Security Agency, 1949, pp. 1-8. Unknown Author; Cancer Treatments, America's Pharma

ceutical Companies, 1997, pp. 1-7. Berkow, Robert, Editor-In-Chief, The Merck Manual of

Medical Information, Home Edition, 1997, pp. 789–832. Hodgkinson, A. Oxalic Acid in Biology and Medicine, Academic Press, 1977 pp. 1-3, 16-17, 18-21, 23, 37-38, 49-51, 69–80, 84–88, 100–103, 110-111, 122–124, 130, 133-135, 153–156, 159-164, 168-174, 180-182, 196-207, 216–228, 238.

Davis, Adelle, Lets Get Well, Penquin Group, 1972 pp.

Letters, Natural Health. Beta-Carotene Debate Continues, Nov. 1994.

Microsoft Internet Explorer/NECX From Gopher:// gopher.nih. gov/00/clin/cdcs/67. kidney-Prevention and Treatment of Kidney Stones national Institute of Health Consensus Development Conference Statement, Mar. 1988 pp. 1-14. Microsoft Internet Explorer/Open Text Index From: http:// www/mcs/net/-joyce/new.html Essiac Tea From Canada Comes A Remedy Called Essiac, Or Ojibwa Tea 1995, pp. 1-7 From: gopher://wiretap/spies/com/oo/ILibrary/Fringe/ Pharm/essiac.txt ESSiac: a natural herbal alternative cancer

treatment. Glum, G.L. Calling of An Angel, Apr. 1993 pp. 1-15. From: http://www/envirolink/org/arrs/VRG/calcium .html Mangels, R. Calcium in the Vegan Diet 1991 pp. 1-6. Weil, Andrew Natural Health, Natural Medicine. How Not

195, 204-205, 213, 299.

to Get Cancer, Houghton Mifflin Company 1990 pp.

Cowdry, E. Croninger, A. Solaric, S. Suntzeff, V. Cancer, Journal of the American Cancer Society, Combined Action of Cigarette Tar & Beta Radiation of Mice-1961, vol. 14 pp. 344-352.

Robbins, J. Diet for a New America. Losing A War We Could Prevent, Stillpoint Publishing 1987, pp. 248-273, 403-409

Bock, F. Moore, G. Journal of the National Cancer Institute,

Berkely, B. Nutritional Protocol for HIV, Project Inform San

Carcinogenic Activity of Cigarette Smoke Condensate. I.

Effect of Trauma & Remote X-Irriation. Vol. 22 No.

2-1959- pp. 401–411. Svendsen, L. Rattan, Surech I.S. Clark, Brian F.C. Journal of

Ethnopharmacology-1994 Testing Garlic for Possible Anti-Ageing Effects on Long-term Growth Characteristics, Morphology and Macro Molecular Synthesis of Human Fibroblasts in Culture- pp. 125-133. Ney, D.M. The Low Oxalate Diet Book for the Prevention of the Oxalate Kidney Stones- pp. 944-945 & Appendix Table 13, University of California, San Diego 1981. U.S. Department of Health & Human Services Public Health Service National Institutes of Health, NIH Publication, Eat

More Fruits & Vegetables, Oct. 1991. Chem One Corporation. Product Data Sheet, 1995. Occupational Health Services. msds on Oxalic Acid, 1994. The Merck Manual, Diagnosis and Therapy, 1987 pp. 2465-2466, Oncology pp. 1206-1228. NIH Specification 11-133 Open Formula Rat and Mouse

Ration 9NIH)0–07) Nov. 1, 1986.

NIH Specification 11-137 Crude Protein Autoclavable

(NIH-31) Nov., 1986.

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Nau, Jean-Yves Preventing Spread of BSE, The Lancet Sep. 1994 vol. 344, p. 808. Carper, Jean, Foods That Fight Cancer, Reader's Digest, Jan. 1994, pp. 119-122. America's Parmaceutical Research Companies, Health Guide-Seventh in a Series, HIV/AIDS, 1997.

Solaray, Inc., Cran Actin... the One that guarantees bacterial antiadherence properties, 1996. Houpis, Molina, Reamer, Lynch, Volante, and Reider, Towards the Synthesis of HIV-Protease Inhibitors. Synthe sis of Optically Pure 3-Carboxyl-decahydroisoquinolines, Tetrahedron Letter, vol. 34, No. 16, pp. 2593-2596, 1993. Cabbages and Cancer, Kend, Feb. 3-5, 1995. Perspective, The Antioxidant Nutrients, pp. 320-324, The Regulatory Nutrients, 1995. News from the World of Medicine, p. 147, Feb. 1995. The latest findings: Help for Headaches, Family circle, Mar. 14, 1995, p. 53. Health & Healing, Tomorrow's Medicine Today, Feb. 1994,

Organic Gardening Articles, Rodale Press, Inc. Hurley, J.B. Calcium From the Garden Apr. 1986, pp. 96-98 Duke, L.A. Weeds? or Wonder Drugs? Jul. 1994 pp. 38–39 Duke, J.A. Eat Your Weedies Jul. 1993 pp. 31-35 Mattern, V. Don't Weed 'em, Eat 'em Apr. 1994 pp. 71–74. Better Nutrition-Veggie Corner-Broccoli and Watercress Are Rich Cancer Fighters, Aug. 1994 p. 22 Editors Desk-Novel Cancer Therapies Deserve a Fair Hearing, Aug. 1994 p. 6. Parade Magazine Special Intelligence Report, men Should Think Twice Before Eating Steak, Oct. 1994, p. 16. Ferguson, K. VA Hospital Fayetteville, AR. Low Oxalate

vol. 5, No. 2.

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cine, American Heart Association, p. 139, Feb. 1996. Breast Cancer Update, News from the World of Medicine, American Heart Association, p. 108, Sep. 1995. Cancer Update, News from the World of Medicine, Ameri can Heart Association, p. 113, Apr. 1995. Early Alzheimer's Warning? News from the World of Medi cine, American Heart Association, pp. 105-106, Jul. 1995.

Journal National Cancer Institute, No. 85, Explanation For Link Between Alcohol and Breast-Cancer risk 1993, abstract.

Readers Digest, News from the World of Medicine. Device Spots Colon Cancer & Indoor Tanning? Don't Do It. Mar. 1994. Sunscreen: Slather It On, Do Fats Fuel Prostate

Cancer? May 1994. Folic Acid, Superstar, Jun. 1994.

Health & Healing, Tomorrow's Medicine Today, May 1995, vol. 5, No. 5.

Health & Healing, Tomorrow's Medicine Today, Mar. 1995, vol. 5, No. 3.

Health & Healing, Tomorrow's Medicine Today, Feb. 1995 Supplement. Breakthroughs. In Cancer Research, Nathaniel Mead, Natu ral Health, Jan., Feb. 1996.

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6,133,318 Page 3

Reversing Bone Loss, News from the World of Medicine, American Heart Association, pp. 99-100, Jul. 1995. Garlic's Breath of Health, LEND, Mar. 31-Apr. 2, 1995. Older Women: Cut the Fat, Not the Protein Food & Health,

New Method Proposed to Determine Efficacy of Both Ret inoids and Antioxidants in Preventing Cancer, Primary Care & Cancer, Jan. 1996, p. 32. Cancer Facts & Figures-1995, American Cancer Society,

Organic Gardening, p. 20, Feb. 1996.

Revised Jan. 1995.

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On the Cancer Front, News from the World of Medicine, p.

1996.

127, Nov. 1995.-

U.S. Patent

Oct. 17, 2000

FIG. 1

A = spectrophotometry O = tritration

6,133,318

6,133,318 1

2 over 4.5 million lives worldwide. Today, significant strides are being made in understanding the virus and ways to battle the disease. There are at least 42 approved medicines and over 120 drugs currently being developed by pharmaceutical company researchers to fight HIV/AIDS.

OXALIC ACID OR OXALATE COMPOSITIONS AND METHODS FOR

BACTERIAL VIRAL AND OTHER DISEASES OR CONDITIONS CROSS-REFERENCE TO RELATED APPLICATIONS

AS in the treatment of infectious bacterial disease, the

treatment of viruses including HIV/AIDS involves the use of one or more chemotherapeutic agents to prevent, Slow or Stop the reproduction of the bacteria or virus. A new class of medicines called protease inhibitors when

This application claims benefit of U.S. provisional appli cation Ser. No. 60/036,983, filed Jan. 29, 1997, hereby incorporated by reference. Also, this application is a continuation-in-part of U.S. application Ser. No. 08/629, 538, filed Apr. 9, 1996, which claims benefit of U.S. pro visional application Ser. No. 60/006,785, filed Nov. 15, 1995, hereby incorporated by reference.

combined with one or more of the established HIV/AIDS

15

REFERENCE TO A MICROFICHEAPPENDIX

Not Applicable.

the disease.

More than 1.3 million cases of cancer will be diagnosed this year. Over a trillion dollars has been spent on trying to

BACKGROUND OF THE INVENTION

The present invention is directed to Oxalic acid or oxalate compositions and methods of producing Such compositions and for utilizing oxalic acid or oxalate compositions includ ing Solutions, mixtures, products, creams, rinses, and the like, in the treatment, control, prevention, remedy or the like of infectious or pathogenic bacterial, Viral and other diseases

find a cure for cancer. In 1971, the U.S. committed itself to

waging a “war on cancer with the National Cancer Act of 1971. Prior to the advent of the present invention, a so-called “magic bullet' or a single medicine or treatment that will 25

or conditions in humans and in other animals.

Conventional medicine treats infectious or pathogenic bacterial diseases of humans and other warm-blooded ani

mals with antibiotics, Sulfonamides, antiseptic or antibacte rial ointments or creams, and the like.

Further, skin areas are Sanitized or Sterilized following injury or prior to Surgery, for example, with antiseptic or antimicrobial agents Such as alcohol, iodine, hydrogen peroxide, and other antibacterial compounds or chemicals to kill all the bacteria and prevent infection.

like.

35

StreSS.

Oxalic acid or ethanedioic acid (CHO), is a dicarboxy

lic acid and is present in many plants and vegetables, notably

in those of the Oxalis and Rumex families, where it often

occurs in the cell Sap of the plants as the potassium or 40

45

50

help reduce the length of a cold (infectious viral disease) but do not actually cure the disease.

55

attacks certain white blood cells, called T-cells, and weakens

the body's immune system. AIDS occurs when an HIV infected perSon develops a life threatening condition or their number of disease fighting T-cells becomes dangerously low. Recently, it was reported that among perSons ages 25–44 years HIV infection is now the leading cause of death in men and third leading cause in women in the U.S. In 1995, approximately 40,000 Americans contracted HIV. Worldwide, one million people died from AIDS in 1996 and reported cases increased by 19 percent. It has been about 15 years since the HIV/AIDS virus was first identified. Tragically, the AIDS epidemic has claimed

ments include invasive Surgery to remove tumors and can cers and treatment with radioactive or chemical poisonous oncological chemotherapies which cause weakness, hair loSS, weight loSS, reduced immunity, and the like. Much has been published recently about beta carotene, antioxidants, Vitamins, and foods Such as garlic for the treatment of cancer and infection. Also, Studies have been

Recently, it has been advertised that Zinc and echinacea

The Human Immunodeficiency Virus (HIV) causes Acquired Immunodeficiency Syndrome (AIDS). The virus

cure cancer has not been found. Conventional cancer treat

done on the relationship between StreSS and reduced immune System and Susceptibility to disease and cancer because of

Viral infections are more difficult to treat since antibiotics

and other drugs used to treat bacterial infections are admin istered only to boost the immune System and prevent Sec ondary bacterial infections, but do not cure or treat the viral infection. Viral multiplication may be interrupted by a variety of chemicals at various Stages. One group of chemi cals blockS nucleic acid Synthesis while a Second group interferes with protein Synthesis. These known chemicals do not completely eliminate or cure the virus So that Viral infection can recur Such as in herpes simplex. Further, in the treatment of viral infections, the immune System is boosted to help the body's natural immune system fight the virus. For example, the patient is given large doses of Vitamins and the

medicines, have shown to work together to attack the HIV Virus at different Stages of its progression. This combination or “cocktail” therapy has been shown to reduce the level of HIV in the bloodstream by up to 99 percent in some patients, thereby potentially halting or slowing the advancement of

60

65

calcium salt (oxalate, Tables I-IV). Oxalic acid is also a product of the metabolism of many molds. Several Species of Penicillum and Aspergillus convert Sugar into calcium oxalate with a 90 percent yield under optimum conditions. Oxalic acid is also made by passing carbon monoxide into concentrated NaOH or heating Sodium formate in the pres

ence of NaOH.

Oxalic acid dohydrate, monoclinic tablets, prisms, and granules are considered poisonous. Anhydrous Oxalic acid is crystallized from glacial acetic acid and is orthorhombic with the crystals being pyramidal or elongated octahedral. Oxalic acid is listed as being caustic and corrosive to the skin and mucous membranes. Ingestion may cause Severe gastroenteritis, with Vomiting, diarrhea, or melena. Renal damage can occur as a result of formation of excessive calcium oxalate crystals. Convulsions, coma, or death from cardiovascular collapse can also occur. Conventional uses of Oxalic acid include as an analytical reagent, in calico printing and dying, for bleaching Straw and leather, removing paint or varnish, rust or ink Stains, clean ing wood, and manufacturing oxalates, blue ink, celluloid, intermediates and dyes, in metal polishes, in purifying methanol, for decolorizing crude glycerol, for Stabilizing hydrocyanic acid, as a general reducing agent, in ceramics and pigments, in metallurgy as a cleanser, in the paper industry, in photography, in proceSS engraving, in rubber manufacturing, in making glucose from Starch, as a con densing agent in organic chemistry, and as a veterinary

6,133,318 4 treating, preventing, impeding, retarding, delaying, controlling, or the like, infectious or pathogenic microbial, bacterial, Viral disease, cancers, tumors, neoplasms, and other diseases or conditions in warm-blooded animals including humans and pets.

3 hemostatic agent when mixed in 5 percent Solution with 5 percent malonic acid. As described in “Oxalic Acid in Biology and Medicine” by A. Hodgkinson, 1977, oxalic acid was formerly used intravenously as a hemostatic agent and topically as an antiseptic in man and other animals but this was discontin ued because of its toxicity and the danger of precipitating

BRIEF SUMMARY OF THE INVENTION

In accordance with the present invention, oxalic acid or oxalate compositions and methods of producing Such com positions and for treating, preventing, controlling, impeding, and the like infectious or pathogenic bacterial, Viral,

insoluble calcium oxalate in the tissues. Oxalic acid is a

relatively Strong acid having a first dissociation constant being exceeded by that of only a few halogen-Substituted carboxylic acids. Oxalic acid forms neutral and acid Salts

microbial, and other diseases and conditions in warm

with monovalent metals and ammonia. Oxalic acid forms a

blooded animals including humans and pets is provided

number of oxalates or Salts including calcium oxalate, potassium oxalate, Sodium oxalate, Strontium oxalate, mag nesium oxalate, and the like. Oxalic acid also inhibits the

activity of a number of enzymes possibly due to the com petition between oxalate and a structurally similar Substrate of the enzyme. Precipitation as the calcium Salt is the classical method of Separating oxalic acid from other Sub stances. Although calcium oxalate is generally considered to be an insoluble salt this is a relative term and its solubility in water is actually 6–7 mg/l at room temperature. Biological fluids contain many substances that affect the solubility or rate of crystallization of calcium oxalate or co-precipitate with the Salt. For example, magnesium, polyphosphates and other polyelectrolytes affect the solubility or rate of crystal lization of calcium oxalate while phosphate and Sulphate ions, uric acid and citric acid co-precipitate with the Salt. Further, as reported in a literature including “Oxalic Acid in Biology and Medicine”, poisoning from oxalic acid in animals and man has been recognized since the beginning of the 19th Century. The death rate from oxalate poisoning has declined Supposedly because of a decreased use of Oxalic acid in domestic cleaning fluids. Examples of chronic poi Soning by absorption of Oxalic acid through the Skin and by inhalation have been reported. The range of lethal doses in acute poisoning is wide, varying between 2 and 30 g and depending upon a variety of factorS Such as the form in

which includes an effective amount of at least one thera 15

25

35

which the acid or its Salt is taken and the amount of food,

particularly calcium, which is present in the Stomach and intestine. Death has occurred as early as 3 minutes and as late as 14 days after ingestion. Symptoms of acute oxalic acid toxicity in man can be divided into those caused by a local corrosive action and those resulting from absorption and excretion of the Soluble oxalate. If a high concentration or the Solid form is taken, the local effects may be predomi nant and death may result from acute hemorrhagic gastro enteritis without development of Symptoms depending on absorption. If death does not result from local corrosive action then Symptoms develop from the Systemic effects and from renal insufficiency. The cardiovascular, neuromuscular and central nervous Systems are markedly affected. The skin is pale, cold and clammy, the pulse is weak and the blood preSSure and temperature are low. Numbness and tingling may develop in the extremities and cramp-like muscular and abdominal pain may be extremely Severe. Local or gener alized muscular twitchings occur and may progreSS to marked tetany and convulsive Seizures. The central nervous System may show evidence of excitation or depression, varying from an acute maniacal State to stupor and coma. Death results from cardiovascular collapse or depression of the central nervous System. Renal involvement is frequent and even if the patient Survives the Severe local or Systemic effects, death may ultimately occur from renal insufficiency, which dominates the picture from the Second day. Oliguria develops and may progreSS to anuria. Hence, there is a need for Oxalic acid or oxalate compo Sitions and methods of producing Such compositions and for

40

peutically effective form of Oxalic acid or oxalate for controlling, treating, managing, preventing, or the like, diseases caused by germs, bacteria, or viruses Such as Escherichia coli, Salmonella, Staphylococci, Streptococci, colds, influenza, pneumonia, Various blood and urine bac terial infections, and the like, for preventing the reproduc tion or new growth of cancers, tumors, infectious or patho genic bacteria, Viruses, or other disease, or for otherwise therapeutically treating warm-blooded animals including humans and pets. In accordance with the present Invention, an oxalic acid composition or remedy has been shown to reduce the length and Severity of the common cold. An oxalic acid composi tion or remedy may be used as an antibacterial treatment for Moraxella bovis, an agent that causes "pink eye” in cattle. An Oxalic acid composition is an effective anti-adherence agent in the treatment of cryptosporidium protozoa. The therapeutically effective form of oxalic acid or oxalate is an oxalic acid or oxalate which provides the beneficial effect and is Selected, for example, from the group of oxalic acid in a free acid, ester, lactone or salt form, oxalate including Sodium oxalate, a nutritional Supplement containing at least one form of Oxalic acid or oxalate Oxalic acid dihydrate, anhydrous Oxalic acid, oxamide, oxalate Salts, processed foods containing at least one form of Oxalic acid or oxalate, beverages, liquids or juices containing at least one form of Oxalic acid or oxalate additives containing one form of Oxalic acid or oxalate, or combinations thereof,

compositions including oxalic acid or oxalate, a therapeutic quantity of Oxalic acid or oxalate composition, Source of Oxalic acid or oxalate, nutritional product, Supplement, Solution, agent, curative, remedy, control, impediment, food, 45

50

55

60

65

feed Stuff, rinse, mouthwash, mouth rinse, wash,

formulation, dosage, pharmaceutical agent, dietary Supplement, intermediate, product, composition, anti-AIDS or anti-HIV agent, Vaccine, immune System Stimulant, Substance, drug, chemopreventive, chemical, chemoSurgical agent, chemotherapy agent, chemotherapeutic agent, Solution, Solute, Slurry, mixture, medicine, medication, Salve, ointment, balm, cream, analgesic, medicinal agent, treating agent, preventing agent, retarding agent, impeding agent, delaying agent, controlling agent, anabolic agent, health improving agent, health-Supplementary food, enriched fraction, oncological or oncologic agent, tumor treating agent, disease treating agent, infection treating agent, fungal treatment, microbial treatment, bacterial treatment, antimicrobial agent, and the agent for treating, controlling, improving, preventing, the Symptoms of infec tious or pathological diseases Such as bacterial, Viral, microbial, and the like, as well as a Supplemental compo Sition or treatment to be used in conjunction with conven tional compositions and treatments, and the composition may also contain a pharmaceutically acceptable carrier or diluent for the therapeutically effective form of oxalic acid or oxalate.

6,133,318 6

S Also in accordance with the present invention a method is provided for controlling, treating, managing, or the like

In accordance with still another embodiment of the

present invention, a veterinary composition includes con ventional pet food ingredients except for the elimination or

bacteria and virus infections in warm-blooded animals and

pets including the Steps of administering an effective amount of a therapeutically effective form of Oxalic acid or oxalate. The method may include the further step of reducing the

reduction of Oxalic acid or oxalate blockers and the addition

of a therapeutically effective quantity of at least one thera peutically effective form of Oxalic acid or oxalate. In accordance with yet another embodiment of the present invention, an oral rinse, pill, gel cap, tablet, powder, capsule, or the like for controlling, treating or managing bacterial or Viral disease or for otherwise therapeutically treating the mouth area is provided which includes a dilute concentration or Solution of an least one therapeutically effective form of

intake of Oxalic acid or oxalate blockerS Such as citric acid,

ascorbic acid (vitamin C), pyridoxine hydrochloride (vitamin B6), calcium, alcohol, resins, clays, and combina

tions thereof. Oxalic acid or oxalate blockerS also include

dairy products containing calcium, fruits, coconut, bever ages containing alcohol, ascorbic acid or citric acid, red meat or white meat of fowl containing pyridoxine hydrochloride, or other foods, nutritional Supplements or beverages containing alcohol, citric acid, ascorbic acid, pyridoxine hydrochloride, resins, and combinations thereof. In accordance with the present invention, an Oxalic acid or oxalate blocker is any mineral, chemical, compound, material, plant, food, beverage, additive, Supplement, or the

Oxalic acid or oxalate. 15

form of Oxalic acid or oxalate.

like which blocks, inhibits, reduces, or binds with or other wise reduces or eliminates the beneficial effect of Oxalic acid

or oxalate. For example, calcium from dairy products tends

to bind with oxalic acid in the intestine (calcium oxalate) and prevents the oxalic acid from being absorbed into the blood

Stream.

In accordance with yet another embodiment of the present invention, a diet is provided for treating, controlling, preventing, impeding, or the like bacteria or virus infections in warm-blooded animals including pets and humans. The diet includes adding to the regular diet a dietary Supplement of at least one therapeutically effective form of Oxalic acid or oxalate. Further the diet may include reducing the intake

25

35

ointment base.

as distilled water, for the therapeutically effect form of Oxalic acid or oxalate.

45

In yet another embodiment of the present invention, a composition and method are provided for treating, control ling and managing bacterial and Viral infections of the chest with the composition including at least one therapeutically effective form of Oxalic acid or oxalate.

50

In accordance with another embodiment of the present invention, a pharmaceutical composition to be administered orally to humans is provided which includes a mixture of nontoxic ingestible carrier Such as Sorbitol, fructose, Sucrose, lactose or distilled water and a therapeutically effective form of Oxalic acid or oxalate.

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60

In yet still another embodiment of the present invention, a composition is provided for treating, controlling or man aging bacterial and viral diseases of the nasopharynx and Sinuses. Also, a method of treating, lessening or controlling the diseases of the nasopharynx and Sinuses is provided by administering by nasal Spray a composition containing non toxic ingestible carrier and a therapeutically effective form of Oxalic acid or oxalate.

In accordance with still another embodiment of the

present invention, a therapeutic composition in cream or ointment form for topical administration of Oxalic acid or oxalate is provided which includes at least one therapeuti cally effective form of Oxalic acid, a Solvent, and a cream or

In accordance with still yet another embodiment of the present invention, an improved human or pet treat includes the addition of a microgram amount of at least one thera peutically effective form of Oxalic acid or oxalate. In accordance with another embodiment of the present invention, a composition for daily mouth rinse and gargle is provided for treating, controlling or managing bacterial and Viral diseases and includes a nontoxic carrier or diluent, Such

40

related bacterial and viral diseases such as HIV, SLE, AIDS,

and the like include compositions containing a therapeuti cally effective amount of at least one therapeutically effec tive form of Oxalic acid or oxalate. The method of treating, preventing or controlling auto-immune related diseases, preventing, lessening or controlling the destruction of the body's immune System, or purifying the blood includes the Steps of periodically administering a composition having a therapeutically effective amount of at least one therapeuti cally effective form of Oxalic acid or oxalate.

like.

tive form of Oxalic acid or oxalate.

Oxalic acid or oxalate.

In accordance with a further embodiment of the present invention, compositions and methods for treating, preventing, controlling, impeding, or the like auto-immune

In yet another embodiment of the present invention, a therapeutic composition in lozenge or cough drop form for oral administration of Oxalic acid or oxalate is provided which includes at least one therapeutically form of Oxalic acid or oxalate and an ingestible carrier of dextrose, micro crystalline cellulose, povidone, magnesium Stearate, and the In accordance with yet another embodiment of the present invention, a composition for treating parvo virus in animals including canines is provided which includes a therapeuti cally effective amount of at least one therapeutically effec

of Oxalic acid or oxalate blockers.

In accordance with yet still another embodiment of the present invention, a veterinary compositions and methods are provided for controlling, treating, managing, or the like bacterial infections, Viral infections and the like for prevent ing the re-infection of bacterial or viral infections, or for otherwise therapeutically treating warm-blooded animals including cats and dogs. The composition may include a pharmaceutically acceptable carrier or diluent for the thera peutically effective form of oxalic acid or oxalate. The method for controlling, treating, or managing bacterial and Viral infections in warm-blooded animals including dogs and cats includes the Steps of periodically administering a thera peutically effective dosage of a veterinary composition containing at least one therapeutically effective form of

In accordance with yet another embodiment of the present invention, a pharmaceutical composition to be administered orally to humans is provided which includes a mixture of a nontoxic ingestible carrier and a therapeutically effective

65

One object of the present invention is the provision of a novel therapeutic composition including a pharmaceutically acceptable carrier or diluent containing a therapeutically effective amount of at least one therapeutically effective form of Oxalic acid or oxalate. Another object of the present invention is the provision of a method of therapeutically

6,133,318 7 treating warm-blooded animals including humans and pets with Such a therapeutic composition. A further object of the present invention is the provision of an oxalic acid or oxalate pharmaceutical composition, a therapeutic quantity of Oxalic acid or oxalate composition, Source of Oxalic acid or oxalate, nutritional product, Supplement, Solution, agent, curative, control, remedy, impediment, food, feed Stuff, rinse, mouthwash, mouth rinse, wash, formulation, dosage, pharmaceutical agent, dietary Supplement, intermediate, product, composition, anti-AIDS or anti-HIV agent, vaccine, immune System Stimulant, Substance, drug, chemo-preventive, chemical, chemoSurgical agent, chemotherapy agent, chemotherapeu tic agent, Solution, Solute, Slurry, mixture, medicine, medication, Salve, ointment, balm, cream, analgesic, medici nal agent, treating agent, preventing agent, retarding agent, impeding agent, delaying agent, controlling agent, anabolic agent, health improving agent, health-Supplementary food, enriched fraction, oncological or oncologic agent, tumor treating agent, disease treating agent, infection treating agent, fungal treatment, microbial treatment, bacterial treatment, antimicrobial agent, and the agent for treating, controlling, improving, preventing, the Symptoms of infec tions or pathological diseases Such as bacterial, Viral, and the like, as well as a Supplemental composition or treatment to be used in conjunction with conventional compositions and

8 humans including a mixture of a non-toxic ingestible carrier and a therapeutically effective form of Oxalic acid or oxalate. A further object of the present invention is the provision of a multi Vitamin or multi Vitamin and mineral Supplement including at least one therapeutically effective form of Oxalic acid or oxalate.

Still another object of the present invention is the provi Sion of a processed food item including a therapeutically effective amount of at least one therapeutically effective form of Oxalic acid or oxalate.

Other objects and further scope of the applicability of the present invention will become apparent from the detailed description to follow. 15

FIG. 1 is a graphical representation of the decomposition of Oxalic acid. DETAILED DESCRIPTION OF THE INVENTION

25

treatments, or the like.

Another object of the present invention is the provision of a method of treating animals including humans with at least one form of Oxalic acid or oxalate.

Yet another object of the present invention is the provision of a veterinary composition containing oxalic acid dihy drate.

Another object of the present invention is an Oxalic acid or oxalate composition and method for the treating, preventing, controlling, impeding, or the like auto-immune

35

effective amount of Oxalic acid or oxalate.

Still another object of the present invention is the provi Sion of a veterinary composition and method of controlling, treating or managing bacterial diseases, Viral diseases, and the like or for otherwise therapeutically treating warm blooded animals including dogs and cats utilizing a com position including at least one therapeutically effective form

Another one of Turk's favorite treats was the small soybean 40

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of Oxalic acid or oxalate.

Yet another object of the invention is the process for preparing an anti-bacterial and anti-viral agent including the Steps of mixing at least one therapeutically effective form of Oxalic acid or oxalate with a pharmaceutically acceptable

least one form of Oxalic acid or oxalate and/or the elimina

Turk Some medicine. Turk's condition worsened, and So 55

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Turk's condition worsened, so Turk was taken to the

Still another object of the present invention is the provi Sion of a composition and method for treating parvo virus in Yet another object of the present invention is the provision of a pharmaceutical composition to be administered orally to

Samples were taken, and test results revealed that Turk's urine was watery, but otherwise all right. The blood however, showed a high white cell count, and the Veterinar ian thought there might be an infection and prescribed pills. One Single pill brought on violent Vomiting. Turk's owner Stopped giving Turk the pills and Started Turk on amoxicil lin.

tion or reduction of Oxalic acid or oxalate blockers. animals.

crackers in oriental cocktail mix, which Turk's owner ate

constantly when he was home. When Turk was about a year and six or seven months old, Turk began to slow down. Turk's eagerness to play left him, and his appetite diminished except for the little treats mentioned above. Turk was drinking much more water and had frequent accidents in the house, especially at night. Turk's color changed from a parfaittinge to a Solid white, and just before his death, to a dull grayish-white. When Turk began to vomit occasionally after eating or drinking, Turk's owner became concerned and took Turk to the Veterinarian. The examination revealed nothing, and the Veterinarian diagnosed Turk as having indigestion and gave Turk was returned to the veterinarian. Blood and urine

carrier or diluent.

Yet another object of the present invention is an improved pet food including a therapeutically effective quantity of at

The story begins with two toy poodles, Turk and Taka. These animals lived a normal house life. Except for the occasional trip or walk to the nearby reservoir, their territory was the house and backyard. AS young pups they were full of energy and, of course, very spoiled. Habits, mostly bad ones, were easily formed, Such as eating people food, Some of which, according to a veterinarian, would not hurt them. Turk became fond of SNICKERS(R) brand candy bars, espe cially the Small bite-size kind, and also carrots and beets, both of which are appearing in Some commercial dog foods today. During this time, Turk's owner, the present applicant and inventor, was doing a great deal of traveling, averaging one trip a week, and he always kept a small SNICKERS(R) bar near the front door in case he returned home without one.

related diseases such as HIV, AIDS, SLE, and the like.

Yet another object of the present invention is the provision of a method of delaying, preventing, controlling, or treating infectious or pathogenic microbial, bacterial or viral disease, and the like by lessening the effects of the disease. A further object of the invention is the provision of a mouth wash or antibacterial rinse including a therapeutically

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING

65

animal hospital center where they determined Turk's kid neys were failing. Turk was put on an IV due to Severe dehydration. The doctors stated that they could not treat Turk unless Turk's owner could tell them what poison or chemical Turk had ingested. For the next several days Turk's

6,133,318 9

10 When both vitamin B6 and magnesium are undersupplied, the kidneys are further damaged by Sharp crystals of

owner went on a frantic Search for answers. Turk's owner

contacted a number of agencies for possible clues to the poisoning: Tri-County Health Department; two toxicologists with the EPA; the U.S. Corps of Engineers, who assured him that they test the reservoir daily for contaminants, and UCLA and University of Illinois poison centers. Heavy rains would bring Standing water into the backyard, So Turk's owner tracked down the owners of a stable and a nursery that used to operate in the area before the houses were built, to See if they had used any type of toxic sprayS. Turk's owner contacted nurseries from which he had recently bought plants. Turk's owner even contacted the 3M Company, Since new carpeting with SCOTCHGARD(R) had been installed. Turk's owner asked all neighbors who had pets to find out if their pets had become Sick. Turk's owner also called veterinary clinics to find out if they had diagnosed similar caseS recently. He also Searched every Square foot of the house, garage, and Storage building looking for chemicals, especially antifreeze. Out of desperation, Turk's owner pleaded with the Veterinarians to list poisons that had the same fingerprint, and he would then choose one So Veterinarians could begin treatment. The Veterinarians declined. When blood began to appear in Turk's stool and vomit, and the kidneys had shut down, Turk was put to sleep. Turk's owner vowed that with God's help he would find out what had destroyed Turk. The attending veterinarian at the veterinary hospital was an organ Specialist and professor at Colorado State Univer sity. The Veterinarian extended his Sympathy and after a few other eXchanges he informed Turk's owner that there is one Substance very damaging to renal tissue-oxalates. The owner drove directly to his company's quality control department lab where he cornered a chemist and questioned

Oxalic acid combined with calcium, and as much as

three-quarters of the kidney may be replaced by Scar tissue. Children with Oxalic acid kidney Stones fre quently have high blood pressure and kidneyS. So dam aged that they become progressively worse, causing death from kidney failure early in life.

The owner's mind went back to information he had 1O

animal. How true the statements, “love them to death” and also "kill them with kindness.” The owner believed that he 15

also believed that Since oxalates and oxalic acid Suppress calcium, no healthy red blood cells were being produced. The blood in Turk's system had to have been totally satu 25

Taka was not affected because he did not crave or eat

35

Several Significant events occurred beginning with the return of the color of Taka's coat while on the oxalate-free 40

owner eliminated oxalates or Oxalic acid from his mind as a

diet. The owner began to watch for Signs in his own hair and noticed that his graying Seemed to have at least Slowed down. Since the owner was due for a physical, he checked into a clinic and Stated he had Some minor pain in his chest on the left Side where lie had muscles torn in a car accident

45

had died and not Taka'?

One outside activity of Turk's owner was, and still is, gardening. Naturally, he had a Subscription for the organic gardening magazine, and perused through every article. In the April 1986 edition he came across an article by Judith Benn Hurley, “Calcium From Your Garden,” and up popped the word oxalate. Imagine his Surprise, an industrial chemical, a poison, in a magazine on organic gardening. Once again the Search was on. The owner wrote a letter to MS. Hurley describing his research, the reason for it, and asked if she had anymore information on oxalates she could share. The reply he received provided him with more information than he could have hoped for. Her reply sent him to the library, to the Section containing books on nutrition. He read many Volumes and was amazed by the amount of information available on plant life and the effects of plant Vitamins on maintaining human life. His effort was rewarded when he found a volume Let's Get Well by Adelle Davis, 1965. It contains the perfect finger print of Turk's death. Chapter 19, page 239 states the following:

soybean crackers, beets or carrots, nor the SNICKERS(R) brand candy bars with peanuts. When the owner realized what caused Turk's death, he put Taka on an oxalate/oxalic acid-free diet. Some weeks after putting Taka on the diet, the color of Taka's coat, which had faded, began returning to normal. Knowing that a human could Suffer from an exceSS of oxalates and Oxalic acid, the owner put himself on a Similar diet as well.

definition refers back to the oak tree. Oxalic acid is further

cause of Turk's death. What did stay in his mind was Turk's death, and again he renewed his vow to find the answer. He could not get Turk out of his thoughts, because every time he looked at Taka, Turk's brother, he wondered why Turk

rated with oxalic acid. When all the renal tissue was

destroyed, the kidneys shut down and Swelling began due to edema. There was no hope for recovery.

defined as a Salt or ester of Oxalic acid, and the acid

defined as an industrial chemical used in textile and dye manufacturing as a bleaching agent. From the dictionary, he went to the chemical books, found Oxalic acid and got promptly lost in a maze of formulae and equations. The

had inadvertently killed Turk by feeding him candy bars, Soybean crackers, beets, carrots, and who-knows-what-else that might have been very high in oxalate, Oxalic acid or both. He believed that these snacks saturated Turk's system to a point where Turk's kidneys could no longer function. When that happened, the acid began to destroy renal tissue. AS the tissue was being destroyed, Turk's condition wors ened until other vital functions were affected. Turk's owner

him about oxalates. The chemist Said that an oxalate is a

compound found in trees, mainly oaks. The owner's curi osity was running high, and as Soon as he could break away from work, he went Straight for a dictionary. Oxalate is

gathered concerning the use of beagles in testing because their organs are more like those of a child than any other

many years earlier. During the exam, the doctor decided to be safe and ordered an EKG. In prepping for the EKG, the nurse shaved his chest where the transducer cups would be placed, and then with a Small orbital Sander removed Some of the dead skin for better contact. Weeks after the exam

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when the hair began growing out, it was black instead of gray or white. Many mornings before Starting the oxalate-free diet, the owner would get out of bed with a dull backache, and occasionally it would really spasm when he would lean over the wash basin while brushing his teeth. He complained and Swore he would get a new mattress, believing it to be the cause of the backaches. By the end of the day the ache would be gone and out of mind. When the backaches Stopped, he realized it was his kidneys and knew it was the Soybean crackers and nuts in the oriental mix and other related items

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that had raised his oxalate level to the point it began bothering his kidneyS. After retirement, Turk's owner was planning to move and Some friends Stopped by to visit. One evening while having cocktails with the friends, they began talking about health and age, etc. One of the ladies mentioned she needed bypass Surgery, but it could not be Scheduled because her red blood cell count was low, and the doctors could not get it to rise,

6,133,318 11 even though She was on a third medication. Turk's owner's research had paid off. He gave his organic gardening maga zine to the lady and urged her to read the article by Judith Benn Hurley. He explained to her that the reason her red cell count was low was because of her diet. She ate very little meat, a primary Source of pyridoxine (vitamin B6), did not drink much Soda pop, orange or pineapple juice (all high in citric acid), and only consumed alcohol in moderate quan tities. Her diet contained items high in Oxalic acid, like Spinach, her favorite Salad. The owner mentioned that in his

12 on about foods thought to help in the fight against cancer, night his mind Stopped on one particular item. It was a Sentence he had read about foods, and the importance they play in health and healing. “The acid in Strawberries is thought to help prevent prostate cancer.” Acid-there it was, that is the word that halted his mental computer. When he woke up, questions began running through his mind. If Oxalic acid would destroy healthy renal tissue, could it possibly destroy Sick tissue first? Is cancer not considered to

research he had discovered there were three chemicals that

be sick cells? Are these free radicals sick cells? What about

would counteract the Oxalic acid-pyridoxine hydrochloride

antioxidants? Are there really different types of cancer, or are they a similar type of Sick cell just in different parts of the body'? Why are there different types of chemotherapies? There were just too many questions. He had to go back and Start with his initial question. He asked a dear friend, a devout Christian, whether the Bible states that God put everything on earth that man needs? At the same time he went on a very high oxalic acid diet and avoided citric acid and reduced his intake of pyridoxines and alcohol to a

antioxidants, free radicals, and anti-rust in the blood. One

(vitamin B6), citric acid, and alcohol. He gave her a handful

of 50 mg vitamin B6 pills and Suggested she take one immediately and then one a day for the first week, and then one every other day. Three weeks later she told him that the doctor had just Scheduled her operation.

15

Turk's owner had also noticed that he did not have the

recurring attacks of heartburn he had prior to changing his diet and taking Vitamin B6. He thought it a great discovery. Then Turk's owner moved to Arkansas. His stepdaughter, who is married and living nearby, worked at a local hospital. One day she began running a high fever in the range of 104-106, went home, and went straight to bed. The fever fell, and the next couple of days she returned to work only to have the fever return after a couple of hours. She went home and the cycle repeated. She mentioned this to a doctor in the emergency room and a Series of tests were ordered looking for a virus, an infection, even a tubular conception. Turk's owner became involved, because after listening to long, Sometimes whispered conversations between his wife and Stepdaughter, he asked what the trouble was. His wife explained what had happened and that the doctor was looking for Some type of urinary tract or vaginal infection, but there were no positive cultures. When he heard that the Stepdaughter experienced burning and irritation when urinating, he asked his wife why they did not think about diet. His Stepdaughter was eating primarily Salad bar meals loaded with oxalic acid. He had his wife immediately take a bottle of vitamin B6 pills to his stepdaughter with a Suggestion to take two pills immediately, another one after twelve hours, and one a day after that for the next week. In two days her fever was gone, and She went back to work. After the third day all Symptoms were gone and She was back to normal as best they could ascertain. Other people who complained of back pain without having muscle or Spine problems found relief after Turk's owner Suggested taking Vitamin B6. One day while drying off after a shower, Turk's owner noticed a mole-type growth on the inside of his right thigh. He had not noticed it before, and shortly after that, a growth began at the end of his right eyebrow near the bridge of his nose. AS the growth on the thigh became bigger, So did his curiosity. He picked at the growth until Some of it came off and it bled. Now curiosity turned to concern. A month later the growth on the thigh reappeared and the growth on the eyebrow grew larger. He would check both growths every day and they were always on his mind. He believes it was his obsession with Turk that guided his thoughts to Oxalic acid. This acid is readily available in foods people eat, So why would God put a substance in food He provided to Sustain life, if that Same Substance by assaulting the kidneys can kill life? It just did not make Sense. That question constantly ran through his mind begging to be answered. Night after night, hours were spent turning and tossing in restleSS Sleep, Searching and Searching for an answer. He had read every article in every magazine he could get his hands

minimum. His dear friend came back and Said she told her

25

Bible class of his request. They searched the Bible and noted three places that mention God providing for all of man's needs. What is significant is that articles describing food groups for cancer prevention, especially the vegetable groups, name those that have significant amounts of Oxalic

acid as per USDA Bulletin #11 (Table I). At this time he

became convinced it was not the beta carotene, the Vitamin

35

C, or anything else that was the cancer fighter-it was Oxalic acid. Once again he started asking himself questions. Would oxalic acid destroy sick cells before healthy cells? The only answer he could come up with is the affirmative. The Story continues with the Submittal of U.S. provisional application Ser. No. 60/006,785, filed Nov. 15, 1995, U.S. patent application Ser. No. 08/629,538, filed Apr. 9, 1996, and U.S. provisional application Ser. No. 60/036,983, filed Jan. 29, 1997, entitled OXALIC ACID OR OXALATE COMPOSITIONS AND METHODS OF TREATMENT FOR BACTERIAL DISEASES AND VIRAL DISEASES

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INHUMANS AND ANIMALS, by Francis J. Hart, all three applications being hereby incorporated by reference. After placing himself on a high oxalic acid or oxalate diet, the growth on Turk's owner's thigh began to disappear and shortly thereafter the growth on his eyebrow as well. Even tually both growths were completely gone. Another sign of the result of the high oxalic acid diet was the disappearance of a couple of polyps around the anal orifice. These had appeared when he went on the low oxalate/low Oxalic acid diet, and now when he reversed the diet these growths disappeared. Later, his own daughter informed him that her mother was having a lot of Stomach or digestive problems and was due for exploratory Surgery. During the operation they discov ered cancer in the abdominal cavity and removed all possible, estimated at 80 percent. There was cancer in the bladder, and they planned an extensive chemotherapy pro gram. However, a specialty lab in California which received the tissue Sample, determined it was a rare type of cancer, with no known treatment. His daughter, who was at her mother's Side constantly, agreed to try his Oxalic acid procedure. With his Suggestion and the help of a juicer, she prepared a mixture of carrots, Spinach, parsley, and chives. He Suggested She try to get her mother to drink Six to eight ounces of the mixture at least three times a day. At the Start, her mother complained of the taste, Sohe Suggested She mix Some V8(R) juice with the mixture to enhance the flavor. This worked, and her mother began to drink the mixture. He felt

6,133,318 14 After about five months on this diet, the canine produced feces including mucous and intestinal membrane. Upon this happening all oxalic acid or oxalate addition to the canine's diet was stopped. It is believed that a high level of oxalic acid or oxalate intake causes a Sloughing off of the interior Surface of the Small intestine including old bacteria, food,

13 that by having it in liquid form, more oxalic acid would enter her System more rapidly and begin to attack the Sick cells. On the third day after her mother began drinking the mixture, his daughter talked with the nurse who said, “In the morning when she took the patient's Vital Signs they were the best Since the patient had come to the hospital. Her temperature was down, blood pressure was down, and pulse rate was near normal.” In addition, the yellowish skin color began to change. Then, for reasons unknown, her mother stopped drinking the mixture. Shortly after that her mother passed away.

waste, and intestinal cells and membrane. After about a month, urine was drawn from the canine to test for oxalate count the canine's Oxalic acid urine count was reduced to 24

Later, Turk's owner learned of a close friend who had

prostate cancer, initially treated with a radiation implant which failed to keep the growth in check, and now would be undergoing chemotherapy. He urged his friend with prostate cancer to try his Oxalic acid dietary treatment. He sent an explanatory letter with copies of articles about the Veg etables along with a list of items containing oxalates and Oxalic acid. Later, he talked with his friend who gave him Some revealing data. Prior to starting the Oxalic acid dietary treatment, his friend had been to an oncologist because the cancer was spreading into the pelvic area and his PSA count was 350. When his friend returned to his primary care physician months later after being on the Oxalic acid diet, he was feeling better, his PSA was down to 246, and the doctor was Surprised because he did not think his patient would Survive long enough to See him again. It seemed the doctor knew the chemotherapy would not work and it may have been given just So his friend would not despair. Turk's owner sent a copy of the Judith Been Hurley article to his friend and believed that low calcium in the bone marrow was probably the reason his friend with prostate cancer was tired and felt pain in the thigh and pelvic area. Turk's owner, the Applicant, further investigated to try to better establish the relationship between oxalic acid and

15

mg/L. Three days later, the canine was restarted on a diet having about 1 gram of Oxalic acid added to one pound of dry dog food. A canine urine oxalic acid Scale was calculated based on a scale of 0-40 mg/L for a 70 kg human, and adjusting this for a 25 kg canine to have a desired range of about 0-14 mg/L. The canine was started on a new diet of approximately one and one-half pounds of dry dog food to 1 gram of Oxalic acid dihydrate dissolved in about three ounces of water and mixed together and adding one-half can

of Pedigree(R) brand canned dog food (6% oz. can) to add

protein to the diet. A little more than two weeks later the diet was changed to reduce the Oxalic acid dose to 500 mg per

day and the canine was given four beef strips (approximately 25 grams) with 27 percent protein each evening. Thirty days

25

later the dose was dropped to 300 mg oxalic acid/day. Two weeks later the dose was dropped to 50 mg oxalic acid/day. Two weeks later the dose was dropped to 20 mg oxalic acid per day which was maintained till the animal was eutha nized. The canine's mouth tumor had reduced in size in an

eleven month period. The Oxalic acid dihydrate was pur chased from Swift Chemical Company, Rogers, Arkansas, and dissolved in water to use as a food additive to the canine diet. 35

Much to their Surprise, the dog seemed to crave the carrots and parsley. The Setter's activity increased Steadily to the point where he actively competed with a four-year old

pyridoxine hydrochloride (vitamin B6) and oxalic acid treat

Doberman and a nine-month old Rottweiler. The diet was

ment for the reduction of tumors. An Irish Setter, a 70-75 lb.,

working. What was once a large Saggy Sack of black tissue Visibly hanging from the Setter's mouth changed to a considerably smaller and firmer growth. The reduction in the growth of the oral tumor slowed over time; however, it must be remembered that the tumor took nearly Six years to achieve the mass it once was. They continued to monitor the

14 year-old Specimen, had a very noticeable tumor on the mouth, had been diagnosed with multiple tumors which a

biopsy confirmed to be melanoma (skin cancer), and was to be euthanized. The oral tumor was in an area easily exam ined. The oral tumor had been removed Several years ago, when it was confirmed as malignant, but it had grown back. The question was posed if a high oxalic acid or oxalate diet Supposedly works on humans, would it not also work on this dog? They felt confident, since The Merck Manual does state that 90 percent of cancers are due to environment and nutrition. And So, they embarked on taking the Setter off

40

Setter's condition, and felt that the reduction in the size of 45

canned dog food (high in pyridoxines) and feeding a regular

dry high protein dog food mixed with three or four boiled carrots and topped with chopped parsley. The canine was

50

Started on a diet of three or four medium sized boiled carrots,

mixed with approximately 1/2 pounds of dry dog food. Three to five days after Starting on the diet, the canine showed an improvement in appetite and energy. After three weeks of being on this diet, there was a noticeable reduction in size and appearance of the tumor on the canine's mouth. Almost a month after Starting on the above diet, the canine's diet was changed to a mixture of about one pound of boiled carrots, one teaspoon of garlic, one-quarter cup chopped fresh parsley, and one and one-half pounds of dry dog food containing no citric acid. This diet was varied based on the canine's condition with the mouth tumor being measured and recorded by a veterinarian. The mouth tumor exhibited expansion or Swelling and reduction cycles. The canine's urine was tested for oxalate count and a result showed about

50 mg per liter of Oxalic acid.

55

the tumor was a positive sign that the Oxalic acid or oxalate was working. An autopsy of the Irish Setter revealed the malignant melanoma with metastasis, adrenal gland pheochromocytoma, acute cystitis, the urinary bladder mucosa appeared diffusely thickened, granular and hemor rhagic in appearance with the presence of moderate amounts of a turbid reddish-brown urine, a large encapsulated necrotic mass within the omental adipose tissue, with no other significant groSS lesions noted within other areas of the oral cavity, larynx, esophagus, trachea, lungs, heart, Spleen, kidneys, musculoskeletal System, and gastrointestinal tract. Hence, it appears that the Oxalic acid or oxalate diet did not damage any of the dog's organs or kidneyS. It is believed

that the lesions (Scars) in the lungs of the canine, may 60

65

indicate that Oxalic acid or oxalate had eliminated growths in the lungs. In accordance with another case Study, a dog at a pound was given one gram of Oxalic acid dihydrate in a gel cap one hour prior to meal time for Seven days with no adverse effects. The dog's appetite increased as well as energy and activity. In accordance with another case Study a human adult female Subject with possible cervical cancer found multiple growths on her cervix by Self-examination. The Subject

6,133,318 15

16

Started on an increased Oxalic acid or oxalate and reduced

several months of being on the diet, her blood tests were negative on cancer and she did not have to undergo con ventional oncological chemotherapy. In accordance with another case Study, a Doberman

Oxalic acid or oxalate blocker diet, and in less than one

month She reported that the Smallest growth was reducing in size. The Subject remained very strictly on the diet and a week later reported that the Smallest growth was gone with only a rough Spot remaining. A few days later the Subject reported that the next size growth seemed to be reducing. LeSS than a month later, the Subject reported that the large growth was considerably reduced. This process continued and less than a year after Starting on the increased oxalic acid or oxalate diet, the Subject reported that one Small growth remained which was only noticeable during her menstrual period. In accordance with another case Study, an adult male human Subject Suffering from a brain tumor, had been through all the different conventional treatments including Surgery, chemotherapy, and radiation treatment. The tumor was never totally removed and remained malignant. The subject was told of the possible beneficial effects of oxalic acid or oxalate and began on a treatment regimen of four heaping Soup Spoons of dried parsley daily and a reduction of Oxalic acid or oxalate blockers. This should equate to approximately four grams of Oxalic acid per day. Three to four months later, the subject had a CAT scan where the tumor was examined and did not show any growth. The Subject also had visible signs of noticeable improvement in health. Approximately six months after Starting on the enhanced oxalic acid or oxalate diet, the Subject was much more active and friendly towards others. Approximately eight months after Starting on the enhanced Oxalic acid diet the Subject was very excited about the diet, feeling much better. The Subject had expected and experienced the toxic effects of indigestion, diarrhea, and the Sloughing off of the interior Surface of the intestine. The Subject also indicated that the tumor was in the inactive Stage. Also the Subject indicated that his memory and thinking capability had returned and he could now accomplish functions he could not prior to following the diet. He was in the process of rebuilding an engine, replacing a carburetor, changing an oil pan, changing the oil and Spark plugs, and other activities that prior to Starting on the enhanced Oxalic acid or oxalate diet were impossible. Doctors had not given this patient much time to live, and

pincher was diagnosed with bone cancer (sarcoma) of the

left hind leg. The dog had previously been put on medication

for arthritis because it would not use or lower its left hind

15

increase in bone material in the area of the Sarcoma and a

25

beneficially affected his brain tumor and overall health. He was still alive and functioning better after nine months. An adult female in her sixties was terminally ill with leukemia with tumors in her lymph nodes and she had Stopped chemotherapy treatment. She was told about the possible beneficial effect of Oxalic acid or oxalate and Started on a daily intake of about 1 to 1/2 g/day Oxalic acid or

35

40

45

50

oxalate and almost no oxalic acid or oxalate blockers. It was

hard for her to Swallow So she was on a liquid diet because of the Swelling of the lymph nodes in and around her mouth and throat. After 5-7 days of administration of oxalic acid or oxalate in dilute Solution she was able to eat again due to the Shrinkage of tumors in the lymph nodes. This dramatic effect

55

showed that it was clean of cancer cells and the breast cancer 60

individual.

In another case Study, an adult female was diagnosed with

and reduced intake of Oxalic acid or oxalate blockers. After

appeared to have stopped growing. Based on this history, it is believed that oxalic acid or oxalate will, at a minimum, reduce the Size of tumors,

especially if pyridoxine hydrochloride, citric acid, ascorbic

a tumor (endometrial) in the uterus. The tumor was removed

by laser and she was to undergo chemotherapy. She heard of the Oxalic acid treatment of the present invention, and went on the diet having increased intake of Oxalic acid or oxalate

Surgery done, they discovered that her tumor had turned to liquid. Her diet or treatment regimen included a low intake of red meat or white meat of fowl, a low intake of Soda pop or other beverages containing citric acid, a low intake of foods containing citric acid, an intake of about 4 ounces of carrot juice per day with 2 ounces taken in the morning and 2 ounces in the evening, and a low intake of alcohol. Apparently, the Oxalic acid in the carrot juice may have turned the tumor cells into a liquid and all that was necessary was for the liquid to be drained. In another case Study, an adult female having breast cancer Started on a high oxalic acid or oxalate and low Oxalic acid or oxalate blocker diet. The growth of the cancer was reduced and in less than 2 months of being on the diet her blood work showed a large reduction in the cancer in the blood and that the cancer was in regression. Her condition improved So much So that the doctorS Stopped conventional chemotherapy treatment. In another case Study, an adult female with breast cancer went on a diet including an intake of about 4 ounces of carrot juice per day along with chicken broth. In about 8 weeks she was sent home from the hospital, she was walking, went to the mall and was eating potato chips. Previously, she had been hospitalized and on a liquid diet. In accordance with another case Study, an adult female Suffering from breast cancer went on an increased Oxalic acid diet, Stopped using the microwave oven to cook foods, Stopped chemotherapy treatments, cut CAT-Scans down to once a month, and in a short time her blood was tested and

in Such a short time indicates that the intake of Oxalic acid

was treating her condition or disease and benefiting the

decrease or reduction in the size of the area affected by the sarcoma. After being on the oxalic acid diet for about 30 days, the dog appeared to have no pain during physical exam and was walking normally. In another case Study, an adult female was diagnosed with Stomach cancer and Scheduled for Surgery. She began the increased oxalic acid or oxalate and reduced Oxalic acid or oxalate blocker diet and when she went in to have the

it is believed that the enhanced Oxalic acid or oxalate diet

with reduced blockers had treated, controlled, or otherwise

leg. After being diagnosed with cancer confirmed with X-ray, the dog was placed on a diet of Oxalic acid enhanced dogfood containing about 2 grams of Oxalic acid dihydrate dissolved in water and added to conventional dry dogfood. Within 4 days, the dog had lowered its left hind leg and used it frequently in activity with a companion dog. A few days later, the dog began taking Steps on the left hind leg with a Slight limp. The dog's condition continued to improve and it's diet was changed to reduce the Oxalic acid to about 1 gram of Oxalic acid/per day. After a couple of weeks the dog's condition continued to improve So the dosage of Oxalic acid was reduced to about 500 mg/per day. The dog appears to be walking with no pain and an X-ray revealed an

acid, calcium and alcohol are eliminated from the diet as 65

much as possible. This dietary procedure needs to be con tinued until the tumor or growth is eliminated. If the individual experiences backaches due to kidney irritation,

6,133,318 17

18

urinary tract irritations, and/or Severe heartburn, Vitamin B6

under optimum conditions. Oxalic acid is also made by passing carbon monoxide into concentrated NaOH or heat ing sodium formate in the presence of NaOH. Oxalic acid dihydrate, monoclinic tablets, prisms, and granules are considered poisonous. Anhydrous Oxalic acid is crystallized from glacial acetic acid and is orthorhombic with the crystals being pyramidal or elongated octahedral. Oxalic acid is listed as being caustic and corrosive to the skin and mucous membranes. Ingestion may cause Severe gastroenteritis, with Vomiting, diarrhea, or melena. Renal damage can occur as a result of formation of excessive calcium oxalate crystals. Convulsions, coma, or death from cardiovascular collapse can also occur. Common uses of Oxalic acid include as an analytical reagent, in calico printing and dying, for bleaching Straw and leather, removing paint or varnish, rust or ink Stains, clean ing wood, and manufacturing oxalates, blue ink, celluloid, intermediates and dyes, in metal polishes, in purifying methanol, for decolorizing crude glycerol, for Stabilizing hydrocyanic acid, as a general reducing agent, in ceramics and pigments, in metallurgy as a cleanser, in the paper industry, in photography, in proceSS engraving, in rubber manufacturing, in making glucose from Starch, as a con densing agent in organic chemistry, and as a veterinary hemostatic agent when mixed in 5 percent Solution with 5 percent malonic acid. As described in “Oxalic Acid in Biology and Medicine” by A. Hodgkinson, 1977, oxalic acid was formerly used intravenously as a hemostatic agent and topically as an antiseptic in man and other animals but this was discontin ued because of its toxicity and the danger of precipitating

(pyridoxine hydrochloride) can be taken to help eliminate

the discomfort. Since calcium, pyridoxine hydrochloride, citric acid, ascorbic acid and alcohol block oxalic acid or

oxalate, the individual should work his/her dietary therapy up to the point of experiencing the discomforts Stated and then back off Slightly from Oxalic acid or oxalate intake. It is also believed that the converse is also true - inSufficient

Oxalic acid or oxalate may allow tumors to grow. Since certain cancers in animals are believed to be caused

by viruses, it was postulated by the present inventor, that Oxalic acid or oxalate may be useful in treating infectious or pathogenic bacterial, Viral, or other microbial diseases in addition to treating cancers, tumors, neoplasms, and the like. This invention relates generally to methods and compo Sitions containing Oxalic acid or oxalate or related com pounds for providing therapeutic effects Such as the control, prevention, or treatment of cancer, tumors, neoplasia, infec tious or pathogenic bacterial, Viral, or other microbial diseases, etc. It was initially discovered that a lack of Oxalic acid or oxalate in the diet of a human, allowed or promoted the growth of tumors, growths, or other neoplasia. It was then discovered that the ingestion or administration of a therapeutic quantity of Oxalic acid, oxalate or foods con taining high levels of Oxalic acid or oxalate can deter, reduce, or prevent the growth or spread of cancer, tumors, or other neoplasia. Then, it was discovered that an Oxalic acid Solution controlled, prevented, or treated infectious or patho genic bacterial or viral diseaseS Such as colds, flu, Sore

15

25

throat, and the like.

It has also been discovered that the therapeutic effect of Oxalic acid or oxalate can be inhibited by an increased ingestion or administration of oxalic acid or oxalate blockers including, for example, calcium, alcohol, citric acid, ascor

bic acid (vitamin C), pyridoxine hydrochloride (vitamin B6),

insoluble calcium oxalate in the tissues. Oxalic acid is a 35

etc. Other oxalic acid or oxalate blockers include binding agents Such as clay, resins, and indigestible fibers. Radiation, Strong electromagnetic waves or fields, electron

with monovalent metals and ammonia. Oxalic acid forms a

number of Oxalates or Salts including calcium oxalate, potassium oxalate, Sodium oxalate, Strontium oxalate, mag

bombardment, excessive heat, and bases Such as Sodium

bicarbonate Serve to decompose, neutralize or otherwise reduce the beneficial effect of oxalic acid. There may also be pharmaceuticals which interfere with the absorption or ben eficial activity of Oxalic acid or oxalates. Also, the thera peutic effect of Oxalic acid or oxalate can be enhanced by decreasing or eliminating the ingestion or administration of one or more of these blockers and/or increasing the ingestion

nesium oxalate, and the like. Oxalic acid also inhibits the

40

45

of Oxalic acid or oxalate. Oxalic acid or oxalate enhancers which increase the beneficial effect of Oxalic acid or oxalate

include long chain fatty acids and the like which bind with or otherwise eliminate oxalic acid blockerS Such as calcium.

50

High levels of Oxalic acid or oxalate can produce Side effects of diarrhea, indigestion, damage to the digestive tract, and kidney damage or renal failure. Hence, prolonged ingestion or administration of high quantities of Oxalic acid or oxalate should be avoided so that the beneficial thera

55

peutic effect of the reduction, control, or treatment of tumors, cancers, neoplasia, neoplasms, infectious or patho genic bacterial, Viral, or other disease can be enjoyed without harm to other systems or parts of the body. AS mentioned above, Oxalic acid or ethanedioic acid

plants and vegetables, notably in those of the Oxalis and Rumex families, where it often occurs in the cell Sap of the many molds. Several Species of Penicillum and Aspergillus convert Sugar into calcium oxalate with a 90 percent yield

activity of a number of enzymes possibly due to the com petition between oxalate and a structurally similar Substrate of the enzyme. Precipitation as the calcium Salt is the classical method of Separating oxalic acid from other Sub stances. Although calcium oxalate is generally considered to be an insoluble salt this is a relative term and its solubility in water is actually 6–7 mg/l at room temperature. Biological fluids contain many substances that affect the solubility or rate of crystallization of calcium oxalate or co-precipitate with the Salt. For example, magnesium, polyphosphates and other polyclectrolytes affect the solubility or rate of crystal lization of calcium oxalate while phosphate and Sulphate ions, uric acid and citric acid co-precipitate with the Salt. Also as described in “Oxalic Acid in Biology and Medicine”, oxalic acid and its salts are widely distributed among the higher plants. Oxalic acid is Sometimes present in plants as the free acid, but more usually, however, it is present as a Soluble or insoluble Salt, for example, the acid and neutral Sodium and potassium Salts and the ammonium Salt. Calcium oxalate is the most common insoluble Salt but

60

(CHO), is a dicarboxylic acid and is present in many

plants as the potassium or calcium Salt (oxalate, Tables I-IV). Oxalic acid is also a product of the metabolism of

relatively strong acid having a first dissociation constant being exceeded by that of only a few halogen-Substituted carboxylic acids. Oxalic acid forms neutral and acid Salts

65

relatively large amounts of magnesium oxalate occur together with calcium oxalate in plants Such as beet root, Spinach, and buckwheat. Under conditions of calcium deficiency, Strontium, magnesium, or barium oxalate can be Substituted for calcium oxalate in a wide variety of plant Species depending upon the mineral environment. Further, as mentioned in “Oxalic Acid in Biology and Medicine”, there have been many studies of the oxalate

6,133,318 19 content of individual foodstuffs (see Tables I-IV), but few estimates have been made of the total daily intake of oxalate by animals or man (see Table V). This is surprising in view

of the effect of oxalate on calcium availability and the high incidence of calcium oxalate renal Stones in many parts of the world. As shown in Table V, the reported numbers for daily oxalate intake range from 70-980 mg/per day of anhydrous acid for healthy adult males. However, this information was based on the Study of diets which contain no oxalate-rich foods other than tea which is the largest Single Source of the acid in typical English diets. If an

20 (see Table VI). A mean value of 288 ug of anhydrous oxalic

5

acid/100 ml was reported for normal human blood, a figure which is probably much nearer to the normal value. Feeding experiments and radioisotope Studies have indi cated that a considerable number of compounds are precur Sors of Oxalic acid in animals and man, for example, glycine, glyoxylic acid, glycolic acid, ethyleneglycol, ascorbic acid,

and tryptophan (Oxalic Acid in Biology and Medicine). Studies with ascorbic acid have shown that the main excre

tory products of Vitamin C in man are oxalate, ascorbic acid, and dehydroascorbic acid. From 17-40 percent of adminis

average Serving (60 g) of spinach or rhubarb had been

tered ascorbic acid was excreted as Oxalic acid.

included then the oxalate intake would have risen to between

As reported in “Oxalic Acid in Biology and Medicine”, a high oxalate intake reduces the intestinal absorption of

400 and 600 mg/day but these levels are not typical for this country. Wide variations in oxalate intake may occur in countries Such as India where vegetables rather than dairy products provide the main Source of minerals and where many of the plants used as Vegetables contain high concen

15

trations of Oxalate. Some indication of these variations has

been provided by a study which found intakes ranging from 78-2045 mg/day depending on the Season in the rural population of Udaipur, India. A relatively high intake was also found among upper-income groups in urban areas and was attributed to a high intake of tea and green, leafy vegetables, compared with lower-income groups. As reported in “Oxalic Acid in Biology and Medicine”, when taken with food, ingested oxalate is poorly absorbed from the gastrointestinal tract. Although oxalate absorption appears to be unaffected by metabolic inhibitors it is reduced by the presence of calcium which lowers the concentration of free oxalate ions. It is well known, for example that calcium oxalate is absorbed leSS readily than Sodium oxalate and absorption is also reduced by the oral administration of

cholestyramine (anion exchange resin which has a strong affinity for oxalate ions). Conversely, oxalate absorption is

25

35

increased when the dietary intake of calcium is reduced and this is reflected in an increased urinary excretion of oxalate. In addition to a low calcium diet, the intake of dySodium 40

to be absorbed.

Also as reported in “Oxalic Acid in Biology and Medicine', the most important precursors of urinary oxalate in man are ascorbic acid, glycine, and dietary oxalate. Excretion of Oxalate is also increased by the ingestion of a variety of Substances including glycine, glutamic acid, purines, gelatin, and ascorbic acid. Conversely, excretion has been reported to be reduced by the administration of pyridoxine and magnesium oxide. LeSS than half of the normal dietary intake of Oxalic acid can be accounted for by absorption into the body or excretion in the faces. The remainder of the normal dietary intake of Oxalic acid appears to be destroyed by a bacterial action in the large intestine. With a dietary intake of about 130 mg/day, more than 50 mg/day appears to be destroyed by bacterial action. Also as reported in “Oxalic Acid in Biology and Medicine”, large discrepancies have been reported in the

45

50

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"normal” concentration of Oxalic acid in mammalian blood.

Early studies obtain values ranging from 2-4 mg/100 ml of blood. Another study indicated that the normal blood con centration is probably less than 1 mg/100 ml of blood. Improved testing methods have given results in normal values within the range of 100 tug/100 ml to 800 tug/100 ml. More recent tests of human plasma have produced normal Oxalic acid concentration ranging from 11.8-14.3 ug/100 ml of blood in man and 52.6 to 74.4 ug/100 ml of blood in sheep

oxalate and prolonged exposure to Such a diet may lead to loSS of bone mineral, particularly if the diet is also deficient in calcium or Vitamin D. This situation is unlikely to occur very often in Western countries where there is a plentiful Supply of milk and other dairy products and oxalate-rich foods are relative uncommon. However, in developing coun tries Such as India the Situation is often quite different because tropical vegetables frequently with a high oxalate content provide the main Source of minerals and the total oxalate intake may well exceed the calcium intake in certain Seasons. Dietary Oxalate is poorly absorbed on a normal diet containing adequate amounts of calcium. Further, as reported in literature including "Oxalic Acid in Biology and Medicine”, poisoning from Oxalic acid in animals and man has been recognized since the beginning of the 19th Century. The death rate from oxalate poisoning has declined Supposedly because of a decreased use of Oxalic acid in domestic cleaning fluids. Examples of chronic poi Soning by absorption of Oxalic acid through the Skin and by inhalation have been reported. The range of lethal doses in acute poisoning is wide, varying between 2 and 30 g and depending upon a variety of factorS Such as the form in which the acid or its Salt is taken and the amount of food,

ethylenediamine tetra-acetic acid (EDTA) appears to

increase the absorption of oxalate by complexing of calcium with EDTA in the intestinal lumen leaving more oxalate free

calcium because of the formation of insoluble calcium

60

65

particularly calcium, which is present in the Stomach and intestine. Death has occurred as early as 3 minutes and as late as 14 days after ingestion. Symptoms of acute Oxalic acid toxicity in man can be divided into those caused by a local corrosive action and those resulting from absorption and excretion of the Soluble oxalate. If a high concentration or the Solid form is taken, the local effects may be predomi nant and death may result from acute hemorrhagic gastro enteritis without development of Symptoms depending on absorption. If death does not result from local corrosive action then Symptoms develop from the Systemic effects and from renal insufficiency. The cardiovascular, neuromuscular and central nervous Systems are markedly affected. The skin is pale, cold and clammy, the pulse is weak and the blood preSSure and temperature are low. Numbness and tingling may develop in the extremities and cramp-like muscular and abdominal pain may be extremely Severe. Local or gener alized muscular twitchings occur and may progreSS to marked tetany and convulsive Seizures. The central nervous System may show evidence of excitation or depression, varying from an acute maniacal State to stupor and coma. Death results from cardiovascular collapse or depression of the central nervous System. Renal involvement is frequent and even if the patient Survives the Severe local or Systemic effects, death may ultimately occur from renal insufficiency, which dominates the picture from the Second day. Oliguria developS and may progreSS to anuria. Infection with Oxalic acid producing fungi of aspergillus may result in massive deposition of calcium oxalate at the

6,133,318 21 Sight of infection and also renal oxalosis, leading to renal failure (Oxalic Acid in Biology and Medicine). Patients undergoing treatment with Steroids, immunosuppressive drugs or cytotoxic agents are particularly liable to develop fungal infections and the increasing use of these drugs in malignancy and organ transplantation may be expected to lead to an increased incidence of aspergillosis infection. Oxamide (ethanediamide, oxalamide, oxalic acid diamide, or ethanedioic acid diamide, or C2HNO2) is metabolized in the body to form oxalic acid. In accordance with the present invention, therapeutically effective amounts of at least one therapeutically effective form of oxalate or oxalic acid including, oxalic acid dihydride, anhydrous Oxalic acid, potassium oxalate, Sodium oxalate, oxamide, plants or vegetables containing oxalic acid or the potassium Salt thereof, or combinations thereof are administered periodically to prevent, control, or treat infec tious or pathogenic bacterial, Viral, or other microbial dis eases or conditions and/or neoplasia, cancers, tumors, neoplasms, and the like. Further, these compounds are administered along with a therapeutically effective reduction in the administration or ingestion of Oxalic acid or oxalate blockerS Such as calcium, potassium, Vitamin C, Vitamin B6,

22 It is believed that the therapeutic effect of the oxalic acid or oxalate in treating tumors, cancers, neoplasia, neoplasms, infectious or pathogenic microbial, bacterial or viral diseases, and other disorders affecting humans involves the administration whether it be topical, oral, by injection, Suppository, or the like of a therapeutic and beneficial quantity of Oxalic acid in one of its free acid, Salt, or other

forms to cause contact of Oxalic acid with the bacteria or

virus, and/or to elevate the blood oxalic acid level to

between 350 tug/100 mL and 450 tug/100 mL, preferably 425 lug/100 mL and/or the urine oxalate level to between 40 mg/L and 80 mg/L, preferably 60 mg/L for a 70K human. Also in accordance with the present invention in the

treatment of canines, an oxalic acid or oxalate level chart for

canines and felines differs from that for humans in that the 15

normal blood oxalic acid level of an animal Such as canine or feline differs from that of humans.

Along this line, it has been determined that about 1 gram per day intake of Oxalic acid provides about a 22 mg/L level

of oxalate in the urine of a 25 Kilogram (K) canine.

citric acid, alcohol, or combinations thereof.

Also, in accordance with the present invention, Severe gastroenteritis, Vomiting, diarrhea, melena, renal disease, renal damage, convulsions, coma, cardiovascular collapse, and the like caused by Oxalic acid are treated or prevented by limiting or by reducing oxalic acid or oxalate intake and/or administering therapeutic quantities of Oxalic acid or oxalate blockerS Such as calcium, alcohol, potassium, citric

25

acid, Vitamin B6, vitamin C, and combinations thereof.

Oxalic acid dihydrate is commercially available in powdered, granular or crystal form or in liquid form for use as an industrial cleanser or Solvent preparation. In accordance with the present invention, oxalic acid may be present in a free acid, ester, lactone, or Salt form. Also, Oxalic acid, oxalate or related compound having the desired beneficial effect may be used as a composition, additive, Supplement, remedy, and the like alone or in combination to prevent, control, or treat cancer, tumors, neoplasia, neoplasms, infectious or pathogenic bacterial or viral

desired therapeutic effect can be produced from 14 mg/L to 50 mg/L, preferably 22 mg/L oxalate level in the urine of a 25 K animal as compared with 40 mg/L to 80 mg/L, preferably 60 mg/L in the human urine. Likewise, the

In accordance with one embodiment of the present invention, a multiple Vitamin formula having oil and water soluble vitamins with minerals in tablet form with a Sug gested use to take one tablet daily with a full glass of distilled water preferably within an hour of a meal or as directed by a physician, includes about 100 mg oxalic acid together with 5,000 IU vitamin A, 60 mcg vitamin C, 400 IU vitamin D, 30 IU vitamin E, 25 mg vitamin K, 1.5 mg

thiamin (vitamin B1), 1.7 mg riboflavin (vitamin B2), 20 mg niacin, 2 mg vitamin B6, 400 mcg folate, 6 mcg vitamin 35

40

B12, 30 mcg biotin, 10 mg pantothenic acid, 162 mg calcium, 18 mg iron, 109 mg phosphorus, 150 mcg iodine, 100 mg magnesium, 15 mg zinc, 20 mcg Selenium, 2 mg copper, 2.5 mg manganese, 25 mcg chromium, 25 mcg molybdenum, 36.3 mg chloride, 40 mg potassium, 5 mcg nickel, 10 mcg tin, 2 mg Silicon, 10 mcg Vanadium, and 150 mcg boron. Such a multiple vitamin formula with added minerals provides a 100% daily value of at least vitamin A,

diseases, and the like.

vitamin C, vitamin D, vitamin E, vitamin B1, vitamin B2,

In accordance with the present invention, a therapeutic composition may be formed by adding oxalic acid dihydrate to food or drink to provide for the oral ingestion of a therapeutically effective quantity of Oxalic acid. Atherapeutic composition of Oxalic acid or oxalate com pound of the present invention may be prepared by forming a food or drink including plants or vegetables high in Oxalic acid or oxalate, for example carrots, carrot juice, chives,

niacin, Vitamin B6, pholate, Vitamin B12, pantothenic acid, iron, iodine, Zinc, and copper. A daily value has not been 45

50

parsley, beets, spinach, or combinations thereof (see Tables I–IV).

Atherapeutic composition of the present invention in the form of a daily Supplement, pill, gel cap, pharmaceutical, or the like is prepared by placing a therapeutically effective amount of Oxalic acid or oxalate compound in pill form for oral ingestion as directed. A therapeutic composition of the present invention in cream or ointment form for topical administration of Oxalic acid is prepared by mixing a dilute concentration of Oxalic

55

following ingredients: Oxalic acid or oxalate, Oxalic acid dihydrate, anhydrous Oxalic acid, or other form of Oxalic acid or oxalate, or combinations thereof together with dical cium phosphate, magnesium oxide, potassium chloride, ascorbic acid, ferrous fumarate, calcium carbonate, gelatin, Starch, cellulose, dl-alpha, tocopherol acetate, hydroxypro pyl methylcellulose, croScarmellose Sodium, Sodium Starch glycolate, niacinamide, Zinc oxide, Silicon dioxide, D-calcium pantothenate, Sodium metasilicates and oxides, titanium dioxide, hydroxypropyl cellulose, polyethylene glycol 3350, manganese Sulfate, magnesium Stearate, phar maceutical glaze, polySorbate 80, pyridoxin hydrochloride, copper oxide, poVidone, Sodium and potassium borates, riboflavin, Vitamin A, acetate, thiamin mononitrate, beta

60

acid in a Solvent Such as distilled water, ethanol, acetone,

propylene glycol or polySorbate to form a Solution which is then mixed in a conventional manner with a commonly available cream or ointment base Such as hydrophilic oint ment or petrolatum. Therapeutic compositions of the instant invention may also be formulated in gel, lotion, Spray, Stick or powder form.

established for oxalic acid. Each tablet would contain the

carotene, resin, folic acid, potassium iodide, chromium chloride, ergocalciferol, Sodium molybdate, Sodium Selenate, yellow 6 lake, Sodium metavanadate, Stannous

chloride, nickelous Sulfate, phytonadione, biotin (U.S.P. method 2), and cyanocobalamin (U.S.P. method 2). This 65

product would be formulated per official U.S.P standards to meet disintegration or dissolution, weight, purity, and potency requirements.

6,133,318 24 In accordance with one embodiment of the present

23 An alternative embodiment of the present invention would include a multiple Vitamin and mineral tablet or daily Supplement including oxalic acid in one of its forms or oxalate together with all the above mentioned Vitamins and minerals except those which Serve as Oxalic acid or oxalate blockers. For example, the inclusion of Oxalic acid or oxalate blockers would be eliminated or greatly reduced So as to prevent blocking the beneficial effect of the Oxalic acid or oxalate. Such blockers include calcium, potassium, Vita min B6, vitamin C, citric acid, alcohol, magnesium, resin,

invention, the above described loaf of Oxalic acid or oxalate

etc.

In accordance with at least one embodiment of the present invention, Oxalic acid or oxalate is used for the treatment of

infectious or pathogenic microbial, Viral, bacterial, or other diseases of warm-blooded animals including humans, dogs, and the like.

15

In accordance with a particular embodiment of the present invention, oxalic acid or oxalate is used in a method of therapeutically treating a human including administering a therapeutically effective dosage of Oxalic acid, oxalic acid Salt, Oxalic acid ester, or other therapeutically effective form thereof, in an amount and for a period of time Sufficient to provide the desired effect. The method as described above wherein the oxalic acid is in the form of a free acid. The method as described above wherein the acid is in Salt form.

25

containing Sourdough bread is used in a method of thera peutically treating a warm-blooded animal by having the animal periodically ingest a portion of the loaf. For example, in the treatment of an adult male human, he could ingest daily up to about 72 of a loaf of this bread to achieve a dosage of Oxalic acid of up to about 1 gram oxalic acid per day. This dosage may be reduced after a period of time and given a certain health condition to /2 gram or leSS Oxalic acid per day, and, as Such, 4 loaf or less of the bread per day. The above described Oxalic acid or oxalate containing Sourdough bread does not include any Salt, Sugar or preser Vatives Since the Oxalic acid Serves as a preservative. In using oxalic acid or oxalate as a therapeutic agent, one must be careful to administer the proper dosage given certain health conditions or in order just to maintain a healthy condition Since an overdose of Oxalic acid or oxalate can cause indigestion, to heartburn, backache, or Severe problems Such as renal failure, heart failure, diarrhea, Vomiting, convulsions, melena, and the like. It is believed that a proper balance should be maintained between Oxalic acid, oxalate and their blocking agents Such as potassium, barium, calcium, copper, magnesium, Silver, Strontium, alcohol, citric acid, vitamin B6, vitamin C, and the like. If

a high dosage of Oxalic acid or oxalate would reduce calcium levels, potassium levels, magnesium levels, and the like necessary for proper heart functioning, it is necessary to

The method described above wherein the oxalic acid,

oxalate or other therapeutically effective form thereof is administered periodically for a period of time Sufficient to achieve at least a clinically discernible effect, for example,

limit the administration of Oxalic acid or oxalate to the

the eradication of infection or a tumor. The method as described above wherein the oxalic acid or

minimum dosage necessary to provide the desired therapeu tic effect without causing undesired Side effects or health problems. In accordance with the present invention, the dosage of Oxalic acid or oxalate is monitored and altered as necessary by monitoring the Oxalic acid or oxalate levels in the urine and/or blood in the patient, whether that patient be a human, canine, or the like. Also in accordance with the present

oxalate is administered daily. The method as described above wherein the period of

invention, the amount of blockerS Such as calcium, Vitamin B6, vitamin C, citric acid, alcohol, or combinations thereof

a reduction in infection or the size of a tumor.

The method as described above wherein the oxalic acid,

oxalate or other therapeutically effective form thereof is administered periodically for a period of time Sufficient to achieve at least a Substantial therapeutic effect, for example

time is at least one month. The method as described above wherein after one month

35

40

the Oxalic acid is administered on a weekly basis. The method as described above wherein the oxalic acid,

oxalate or other therapeutically effective form thereof is present in a therapeutically acceptable composition includ ing a carrier. The method as described above wherein the composition is a powder, tablet, gel cap, lotion, cream, gel, ointment, Solution, mixture, food, nutritional Supplement, formulation, transdermal patch, drops, or combination thereof. In accordance with one embodiment of the present invention, a therapeutically effective dosage of Oxalic acid or oxalate is administered on a periodic basis by the ingestion of one or more foods including oxalic acid in one of its therapeutically effective forms including free acid, Salt, ester, lactone, anhydride, dihydrate, diamide, or the like. In accordance with a particular example, a four pound Sourdough bread loaf is made from conventional bread ingredients including flour, water, yeast, and Sourdough and has added thereto two rounded tablespoons of dried, chopped parsley which is mixed with the other ingredients to be disbursed throughout the loaf. These two rounded tableSpoons of dried parsley provide approximately 2 grams

45

50

much oxalic acid or oxalate may cause back pain (due to kidney trouble), heartburn, indigestion, heart trouble, nerve trouble, and the like. Thus, it is recommended that each

55

individual case be Studied and that the proper dosage of a therapeutically effective amount of Oxalic acid, oxalate, enhancers, and/or blockers be administered on a periodic basis at one level to maintain proper health by preventing neoplasia, tumors, growths, neoplasms, bacterial or viral disease, and the like, at a different level to treat, combat,

control, or eradicate tumors, growths, cancers, neoplasia, bacterial or viral disease, or to cleanse the blood, and at a 60

of oxalic acid or oxalate in the loaf of bread. Hence, half of

the loaf contains about 1 gram, /4 of the loaf contains about /2 gram, /18 of the loaf contains /4 of a gram, and /16 of the loaf contains about /s of a gram of Oxalic acid.

are monitored in the urine and/or blood of the patient. It has been discovered that the body of an animal such as human or canine is a complex chemical factory which requires a particular balance of compounds, chemicals, Vitamins, minerals, nutrients, and the like to provide for and maintain optimum health of the animal. It is believed that too little oxalic acid or oxalate in the animal may allow for the advent of neoplasia, tumors, cancers, growths, neoplasms, bacterial or viral disease, and the like, while too

65

third intermediate level once the blood is clean and rela

tively free of infectious or pathogenic bacteria or viruses, cancer, tumor, neoplasm or neoplasia cells, to combat, reduce the size of, or treat an existing tumor, cancer, growth, neoplasm or infectious bacterial or viral disease, or the like. Since each perSon or animal is different, and their body chemistries operate in at least Some Small fashion differently than other perSons or animals, the administration of a

6,133,318 25

26

therapeutically effective dosage of Oxalic acid, oxalate, enhancers, and/or blocking agents should be reevaluated and monitored on a regular basis by, for example, physical examination, X-ray, CAT Scan, MRI imaging, Sonogram, biopsy, blood analysis, urine analysis, fecal analysis, as well as other conventional diagnostic techniques. It is believed that a proper balanced diet including foods containing oxalic acid in one of its forms including oxalate which may be metabolized by a human or other warm-blooded animal can Serve to maintain proper health, extend life, increase the quality of life, increase energy, increase cranial activity, prevent neoplasia, tumors, cancers, neoplasms, infectious bacterial, Viral, or microbial disease, etc., help to combat Viruses, bacteria, improve the immune System, and provide other beneficial short term and long term health effects. Some forms of Oxalic acid or oxalate which may prove

atomic exposure, radiation therapy, chemotherapy, radioac tive pellet treatment, and the like, to prevent infectious or pathogenic bacterial or viral disease, or the formation of neoplasms, tumors, cancers, neoplasia by counteracting the destruction of Oxalic acid or oxalate caused by the exposure Or treatment.

It is believed that a dosage of Oxalic acid or oxalate may also provide a reserve of energy or nutrients. Hence, a food or beverage containing oxalic acid or oxalate could be ingested prior to Strenuous activity in order to increase energy, Stamina, Strength and/or mental activity. It is also believed that Oxalic acid or oxalate may prevent or relieve muscle SoreneSS by helping eliminate lactic acid. It is also believed that oxalic acid or oxalate should be

15

beneficial to humans and other warm-blooded animals,

include ethanedioic acid (free acid), ethanedioic acid

anhydride, ethanedioic acid tri-potassium Salt, ethanedioic acid barium Salt, ethanedioic acid copper Salt, ethanedioic

administered after exposure to specific oxalic acid or oxalate decomposing bacteria to prevent infectious bacterial or viral disease or the onset of tumors. For example, workers at poultry houses may take Oxalic acid or oxalate to maintain a normal level of Oxalic acid or oxalate to prevent tumor development and counteract exposure to bacteria. In addition to the administration or ingestion of Oxalic

acid diamide, ethanedioic acid diamonium Salt, ethanedioic

acid or oxalate, it is believed that one should limit the intake

acid diethyl ester, ethanedioic acid dimethyl ester, ethanedioic acid disodium Salt, ethanedioic acid magnesium

of dairy products Since these tend to counteract the benefi cial effect of the Oxalic acid or oxalate. It is believed that oxalic acid or oxalate should be admin

Salt, ethanedioic acid Silver Salt, ethanedioic acid strontium

Salt, ethanedioic acid dihydrate, dicarboxylic acid, as well as other forms of Oxalic acid or oxalate which may be metabo lized by the body, injected into the circulatory System, administered by transdermal patch, administered by Suppository, administered by topical application, wash, gargle, ointment, and the like, to provide the desired thera peutic effect. Although one or more of the above may be considered poisons to humans or other warm-blooded animals, the proper administration of a Selected dosage is believed to be therapeutically effective and instrumental in the treatment, prevention, and control of disease, and main tenance of good health. It is not uncommon for an agent which is a poison to provide a beneficial effect. Aspirin is one of the myriad of hundreds or thousands of poisons which provide a beneficial effect to warm-blooded animals when administered in a proper dosage. It is believed that oxalic acid or oxalate may be one of the primary causes of the onset of Osteoporosis. Too much Oxalic acid or oxalate in the diet may reduce the calcium in the body to a point of causing or aggravating osteoporosis. Hence, the treatment and prevention of Osteoporosis is the

25

35

their oxalic acid or oxalate intake to counteract Such decom

position. It is also believed that the administration of oxalic acid or

oxalate may delay, prevent, control, or treat the onset of 40

improve the quality of life of a perSon Suffering from

It is also believed that Oxalic acid or oxalate may be a control, treatment, remedy, or preventative for viral or auto 45

Women in a high risk group for Osteoporosis should be careful to increase calcium intake and decrease Oxalic acid

animals. It is believed that oxalic acid or oxalate should be admin

istered following exposure to X-ray radiation, X-rays, mammograms, radiation therapy, CAT-Scans, nuclear or

Alzheimer's Disease, lessen the effects of the disease, or Alzheimer's Disease.

control of the Oxalic acid, oxalate and calcium levels.

or oxalate intake to prevent, treat, or control osteoporosis. It is believed that oxalic acid or oxalate may be a blood purifying agent which in addition to controlling, treating, or eradicating infectious bacteria or viruses and abnormal cells, Oxalic acid in the blood may control cholesterol and plaque or fat buildup. Thus, the periodic or daily administration of a certain quantity of Oxalic acid in one of its therapeutically effective forms including oxalate may serve to not only purify the blood, but also control, treat, or effect cholesterol, plaque, and fat buildup in the cardiovascular System or in the brain, and in So doing improve and maintain good cardio vascular health and operation. It is believed that Oxalic acid or oxalate may also be an effective treatment for parvo. Also, Oxalic acid or oxalate may be used as a hemostatic and antiseptic agent in and on

istered prior to a transplant operation to purify the blood and improve the immune System. However, it is also possible that just prior to a transplant operation the body should be purged of Oxalic acid to prevent aspergillis fungi infection. It is believed that Strong magnetic fields, MRI imaging, computer terminals, power lines, cellular telephones, elec tronic equipment, microwave Ovens, etc. may decompose oxalic acid or oxalate in the body and blood and allow the spread of infectious bacterial or viral disease and the for mation of tumors, growths, cancers, etc. Hence, those Sub jected to Strong magnetic fields and the like Should increase

50

immune-related diseases Such as AIDS, HIV, SLE, BSE,

CFS, and the like by preventing, lessening, or controlling the destruction of the bodies immune System. Hence, the administration, ingestion, injection, etc. of an effective amount of Oxalic acid in one of its therapeutically effective forms including oxalate may serve to treat, prevent, or control the debilitating effects of auto-immune related diseases, Viral diseases, bacterial infections, and the like.

55

As described in “Oxalic Acid in Biology and Medicine”, normal human blood typically has a mean value of about 288 lug of anhydrous oxalic acid per 100 ml of blood. In accordance with the present invention, if a Subject's blood is tested and their oxalic acid level is below this mean value,

60

it is believed that they should be administered oxalic acid in one of its forms including oxalate, easily metabolized by the body to increase their blood oxalic acid level. Also it is believed that if Someone is Suffering from cancer, tumors, AIDS, bacterial, viral, or microbial infection, etc. that they should be administered Oxalic acid or oxalate in order to

65

increase their blood oxalic acid level to a higher value than the typical mean value. In accordance with one embodiment of the present invention, a new Scale is developed for canine and feline

6,133,318 27

28

urine oxalate level. Since a typical human Scale will not work for a canine or feline due to their different body

On the other hand, plants, vegetables and chemicals which contain high levels of Oxalic acid or oxalate are according to conventional wisdom thought to be poisons and to be eliminated from the diet or use. For example, those Suffering from kidney Stones are told to Stay away from rhubarb leaves, Spinach, Swiss chard, lambs quarter, and beet leaves which contain high amounts of oxalates. Also, they are told to Stay away from black and green teas, and

Structures and metabolism, a need exists for a canine and/or

feline Scale which will provide a quick-ready reference for a veterinarian or pet owner to test urine oxalate levels and adjust the Oxalic acid intake in the diet accordingly. Oxalic acid is believed to be a reducing agent, bactericidal agent, Sterilizing agent, disinfectant, bacterioStatic agent, chemopreventive, chemotherapeutic agent, curative drug, antimicrobial agent, and may be an antioxidant. In accordance with the present invention, it is believed that five or more items unnaturally constantly consumed are responsible for at least Some bacterial or viral infectious disease, tumors or cancers, and the like. These items, calcium, Vitamin B6, vitamin C, citric acid, and alcohol are

coffee which also contain oxalic acid. Further, nuts, choco

late and Strawberries are cited by Some as containing high oxalate.

Opposite conventional thinking, in accordance with the present invention, it is believed that Oxalic acid or oxalate is the “miracle bullet”, “silver bullet”, “hall monitor', or 15

believed to be oxalic acid or oxalate blockers. It is interest

vents infectious bacterial or viral disease, abnormal, tumor,

ing to note that a variety of prepared foods eaten every day including cookies, cakes, canned foods, Salad dressings, and the like, contain these items. Further, it is interesting to note that certain articles have proposed that perSons on a low-fat diet showed leSS tumors or showed tumor reduction. Since red meat Such as beef or liver contains vitamin B6

(pyridoxine hydrochloride) it follows that reduction or elimination from the diet also serves as a reduction or elimination of a blocker of Oxalic acid or oxalate. Tables

25

VII-XI list the pyridoxine hydrochloride content of meats and other foods.

antioxidants, beta caroteine, or citric acid. The literature is

Void of a reference to oxalic acid as being a cancer fighter or preventer. 35

40

45

who work.

exposure to or treatment of radiation, X-rays, electromag netic fields and the like which tend to decompose or reduce the amount of Oxalic acid or oxalate in the body. Along this same line, it is believed that conventional testing techniques, Such as the testing of carcinogens on mice may provide faulty results in that the first Step typically in Such testing is to irradiate the mice with radiation to weaken their immune System So that they are more Suscep tible to disease and carcinogens. The radiation to weaken the immune System also causes a reduction or elimination of the Oxalic acid or oxalate in the mice. In accordance with the

50

55

bacterial diseases, chemical toxins, and the like.

Over the years, many claims have been made regarding the beneficial health effects of many fruits, vegetables, plants, molds, etc. Recently, it has been claimed that garlic is believed to fight infection, cancer, bacteria, Virus, and heart disease, Strawberries are believed to help prevent prostate cancer, and tomatoes or Spaghetti Sauce are believed to prevent cancer and heart attacks. A recent Study indicated that two cups of coffee a day can prevent Suicide in women

example, X-rays can trigger malignant growths in certain people. Further, in accordance with the present invention, decomposition or reduction of Oxalic acid or oxalate in the body caused by exposure or treatment of X-rays, CAT-Scans, Strong electromagnetic waves or fields, electron bombardment, microwaves, and the like reduce the level of Oxalic acid or oxalate in the body and further increase the chance of growths, tumors, cancers, and bacterial or viral disease. Hence, it is believed that one should not only increase the intake of Oxalic acid or oxalate, but also avoids

include an increase in the intake of Oxalic acid or oxalate and

eliminating or drastically reducing the intake of Oxalic acid or oxalate blockers, allows the body's immune System or natural cancer and disease fighting Systems to function and eliminate abnormal cells and prevent disease. It is believed that carrots, Spinach, parsley, chives, beet leaves, garlic, collards, radishes, carrot juice, and the like are relatively high in Oxalic acid or oxalate and should be eaten or consumed in order to build a high concentration of Oxalic acid or oxalate in the body. It is believed that if one can maintain a balanced diet and assure an adequate level of Oxalic acid or oxalate in the System then the body's natural protection mechanisms, immune System, and the like can prevent, treat, and control tumors, growths, cancers, Viral or

cancer or unspecialized cells and, thereby, treats cancers, tumors, neoplasms, infectious or pathogenic bacterial, Viral, or other microbial diseases, and maintains good health. Further, it has been discovered that a high oxalic acid or oxalate intake causes a disease or cancer patient to be more talkative, Verbal, have increased dexterity, physical ability, mental ability, and appear invigorated, happier and more outgoing. The conventional treatments for cancer, tumors, growths and the like can themselves cause cancer, tumors, growths, infectious bacterial or viral disease, and the like. For

Although others have indicated that vegetables are cancer fighters, they have listed the cancer fighting agents as

The literature Suggests that tumors occur when the immune System fails to eliminate abnormal cells not con Sumed as a normal biological function of the body Systems. In accordance with the present invention, it is believed that a low intake of Oxalic acid or oxalate or a high intake of Oxalic acid or oxalate blockers including alcohol, citric acid, ascorbic acid, and pyridoxine hydrochloride weakens the immune System or the body's natural cancer and disease fighting ability to the point where the body cannot control abnormal cell growth, tumors, cancer, neoplasms, bacterial or viral infectious disease, and the like. Changing the diet to

“brevet boule’ that treats, kills, controls, manages, or pre

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65

present invention, it is believed that a normal level of Oxalic acid or oxalate is required in the body to prevent cancers, growths, tumors, bacterial or viral disease, and the like. Hence, the researchers unknowingly introduced additional cancer and disease causing factor into the testing. In accordance with the present invention, an improved testing method would involve determining the normal oxalic acid or oxalate level of the test animal, weakening the immune System of the animal using radiation, and then administering or feeding to the animal a Sufficient quantity of Oxalic acid or oxalate to bring their oxalic acid or oxalate levels back up to normal prior to further testing. Also, in accordance with the present invention, it is believed that testing, research, and examinations which include X-rays or electronic Scans to insure no cancer is present or to check on the size or location of the cancer can themselves bring on disease or cancer by decomposing Oxalic acid or oxalate and irritating the Skin or tissue. Further, if test animals are fed a diet high in Oxalic acid or

6,133,318 29

30

oxalate blockerS Such as calcium, Vitamin B6, vitamin C, citric acid, and the like the effective level of oxalic acid or

phones, and the like, as well as the consumption of pro cessed foods which contain oxalic acid or oxalate blockers

oxalate in the animal is reduced and the test results may be skewed and possibly not representative of the natural normal animal biochemistry or system. Hence, it is believed that improved human examination and animal testing involves a reduction in the use of X-ray or electronic Scans, and the incorporation of a balanced diet containing oxalic acid or

Such as calcium, citric acid, Vitamin C, Vitamin B6, and

combinations thereof, and an increased consumption of alcoholic beverages. In accordance with the present invention, it is respectfully believed that oxalic acid or oxalate is a natural

chemopreventive, chemotherapeutic, bactericidal, Viricidal, antiviral, and disease preventing, treating, and controlling agent. Because it is natural, it destroys, kills, and/or controls

oxalate and a reduction in Oxalic acid or oxalate blockers.

In accordance with another embodiment of the present invention, an improved method of testing for disease or capcer includes the elimination of the use of X-rays or electronic Scans during the testing process. In accordance with another embodiment of the present invention, an improved method of testing for disease or cancer allows for the use of X-rays or electronic Scans to detect the presence or absence of disease or cancer, but requires that the Oxalic acid or oxalate decomposed or reduced by the X-ray or electronic Scan be replaced. In accordance with another embodiment of the present invention, an improved method of testing for disease or cancer employs the use of an improved animal feed which includes at least one form of Oxalic acid or oxalate and with a reduced amount of Oxalic acid or oxalate blockers from that of conventional feed.

“bad” or harmful bacteria, Viruses, microbes, cancer cells,

15

forms is believed to be a natural disease and cancer

preventing, controlling, or treating agent, it is believed that the diseases or cancers being treated, controlled, or prevented, do not become immune to the Oxalic acid or 25

If one is to administer and ingest Oxalic acid in one of its harsher forms Such as Oxalic acid dihydrate, for example, a gel cap filled with 500 milligrams to 2 grams of Oxalic acid dihydrate, this should be taken one hour before or after a meal and with a Sufficient quantity of water Such as 10 or more ounces of distilled water. In order to further reduce the

possibility of harm or irritation to the digestive System, one can line the Stomach before taking Such an oxalic acid pill or gel cap using PeptoBismol, Tagamet, or Zyntec. In accordance with another aspect of the present invention, workers exposed to X-rays, CAT-Scans, electro magnetic fields or waves, microwaves, radar, high Voltage power lines, electronic equipment and the like are given Sufficient quantities of foods, beverages, Supplements, treats or the like containing an effective amount of at least one beneficial form of Oxalic acid or oxalate to compensate for the decomposition or reduction caused by their working environment and thereby prevent the development of

35

40

tumors, cancers, infections bacterial or viral disease, other

diseases, poor health, etc. which may otherwise be caused by

45

their work environment.

In recent history, there has been an increase in breast 50

55

cessed foods which contain oxalic acid or oxalate blockers

Such as calcium, citric acid, Vitamin C, Vitamin B6, and the like. mouth cancer in men in the United States. In accordance

In addition to the information provided in Table IV, nuts contain high concentrations of calcium, magnesium, iron and relatively high concentrations of oxalate. For example, almond, cashew, peanut, pecan, and walnut all contain Oxalic acid concentrations ranging from 200 mg/100 g-600 mg/100g. Forage grasses and other pasture plants frequently contain high concentrations of minerals but many of them also contain high concentrations of oxalate. Further, many beverages including beers, wines, and fruit drinks contain low concentrations of oxalate but tea, coffee, cocoa, and

In recent history, there has been an increase in throat and with the present invention, it is believed that this increase in throat and mouth cancer may be due in part to the use of microwave ovens which, when used in cooking or heating, decompose the Oxalic acid or oxalate in the food or beverage, the use of a myriad of electronic equipment including electric blankets, electric razors, electric hair blowerS or dryers, radios, televisions, computers, cell

In accordance with another embodiment of the present invention, a person who believes they have been Subjected to radiation, Strong electromagnetic waves or fields, microwaves, radar, Strong TV or radio waves, or work in a dangerous environment where they may be Subjected to X-rays or other elements which can decompose or reduce the Oxalic acid or oxalate in the body, can test their blood, plasma or urine oxalic acid or oxalate level and if they find it is below normal, treat themselves with food, beverages, Supplements, pills, capsules, and the like containing Oxalic acid or oxalate to bring their level back up to a normal healthy level. Further, Such a person can pre-treat them Selves prior to exposure with Oxalic acid or oxalate to reduce the chance that their levels will drop below normal levels. This should prevent or reduce the increased risk to devel oping cancers, tumors, Viral or bacterial and viral diseases, and the like caused by having below normal oxalic acid or oxalate levels in the body. Solutions of Oxalic acid are decomposed by radiation. This has been the basis of a method for measuring radiation dosage in the Sterilization of food and medical products. The absorbed dose is determined from the decrease in Oxalic acid

Ovens which emit microwaves (usually at about chest height), which when used in cooking or heating decompose the Oxalic acid or oxalate in the food or beverage, the use of a myriad of electronic equipment including radios, televisions, computers, etc., and the consumption of pro

oxalate.

concentration which occurs during irradiation (FIG. 1).

cancer in Women in the United States. In accordance with

the present invention, it is believed that this increase in breast cancer may be due in part to the use of microwave

abnormal cells, growths, and the like, while allowing "good’ or healthy bacteria, Viruses, microbes, cells, and tissues to thrive. For example, if one kills all the bacteria in the mouth of a human or other animal, they can develop a fungus or fungal infection referred to as thrush. Using the natural therapeutic oxalic acid or oxalate Solution as a mouth rinse or gargle only kills the “bad” or infectious bacteria and, therefore, does not lead to an unwanted fungal infection. Further, Since Oxalic acid or oxalate in one of its therapeutic

60

chocolate contain relatively high concentrations of oxalate. Tea, in fact, is listed as being the largest Single Source of oxalate in English diets.

According to Occupational Health Services, Inc. (OHS),

oxalic acid has a CAS number: 144-62-7A a RTECS num 65

ber: R0245000, trade names or synonyms ethanadoic acid, aktisal, aquisal, dicarboxylic acid, phosphoteX 760 grain refiner, CHO, and OHS17360. Oxalic acid is in the chemical family carboxylic acid, aliphatic and is listed as a

6,133,318 31

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poison with a level three out of a scale 0-3 for health, and a level 1 fire rating. In accordance with the present invention it is believed that conventional wisdom that the cause of acorn poisoning is tannic acid is wrong and that it is instead the Oxalic acid which is extremely damaging to renal tissues. It is believed that the Oxalic acid or oxalate level in oak trees is very high, especially in mold that grows on the bark.

treat Small tumors on the Skin Surface of the inventors toy poodle. Following examination and application of the com position to 3 tumors on the poodle, the Veterinarian applied the cream to a Sore on his own hand having a red appearance and Soreness of infection. Following one application of the cream the infection in the Sore on the hand was eliminated

Also, it is believed that the treatment for Oxalic acid or oak

poisoning is to increase oxalic acid or oxalate blockers, Such as pyridoxine hydrochloride, citric acid, calcium, magnesium, and alcohol Such as ethanol to eliminate or carry the Oxalic acid through the renal System. Oxalate nephrosis is probably the most common cause of toxic death in dogs. Typically, the Source of oxalate poison

ing is ethylene glycol (antifreeze). The ethylene glycol is

15

metabolized to oxalate and Oxalic acid by an enzyme called alcohol dehydrogenasc. Ethylene glycol by itself is not toxic, but when the enzyme, alcohol dehydrogenase, works

on it to produce a toxic material (oxalate), then it becomes toxic. Antifreeze poisoning is treated with alcohol (ethanol) to keep the alcohol dehydrogenase enzyme busy So that the

antifreeze can be eliminated, unaltered, and in a non-toxic

State. A major contributor to death is also metabolic acidosis caused by Oxalic acid accumulation. It is almost as important to control the acid-based Status as it is worrying about the

25

accumulation of Oxalate.

toenail which became infected. The infection was in an

There are Several other causes of oxalate nephrosis which are extremely rare. Overdoses of vitamin Chave been shown to cause oxalate nephrosis in humans, and in at least one

goat. Vitamin B6 (pyridoxine hydrochloride) deficiency and methoxyflurane anesthesia may also induce the condition. Aspergillus sp. fungi also produces high levels of oxalate and these fungi are almost ubiquitous and grow on many feed stuffs. There are a variety of plants other than oak, for example halogenten, greasewood, Sorrel, dock, Setaria grass, Sugar beets, and Several others that contain oxalic acid. Oxalate nephrosis produces a very specific lesion in the kidney when viewed under the microScope. You can actually See the oxalate crystals. A pathologist who is unaware of primary hyperoxaluria would obviously draw the conclusion that the kidney lesions were the result of Oxalate nephrosis. Typically, cancer, tumors, growths, and the like are treated by invasive unnatural techniques, Such as Surgery, biopsy, X-ray radiation, oncological chemotherapy, and the like. In accordance with the present invention, it is believed that the primary treatment for cancer should be the all natural,

35

40

45

non-invasive, use, administration, and the like of Oxalic acid

in one of its therapeutically effective forms including oxalate in a Sufficient quantity and on a periodic basis to provide the desired therapeutic effect. Essiac tea was tested and found to have a pH of about 4.79 when the powder was added to boiling distilled water.

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(150 mg diluted in 300 ml of distilled water) on a disciplined daily schedule and noticed that besides the removal of and prevention of any build up of tarter or plaque in the mouth, that there was also a remarkable improvement in the con dition of his gums and mouth tissue, including the tongue Surface. There was no more occasional bleeding of the gums during daily brushing, and the Surface of the tongue appeared to be more Smooth with an even coloring acroSS the Surface.

On another occasion, the inventor formulated a cream of

powdered Oxalic acid and a hydrophilic cream to topically

advanced Stage which was extremely Sensitive and the poodle would not use the leg while walking. The poodle was examined by the veterinarian, received an injection of a antibiotic, and oral capsules were to be given. The inventor began an immediate Soaking of the paw in a composition or solution of 150 mg of oxalic acid in 300 ml of distilled water twice a day. After just two soakings the infection had improved dramatically, and the poodle used the leg without any signs of a limp. On another occasion while Visiting the Veterinary clinic, the inventor noticed the receptionist had Symptoms of a cold, and upon questioning the receptionist learned she was treating a cold which was into the Start of the Second week. When the inventor Suggested the receptionist use the Solu tion formulated for dental hygiene as a remedy for the cold, the receptionist agreed to do so. The inventor advised the receptionist that, each morning immediately upon rising, and prior to any other Substance being put into the mouth, she should take approximately one teaspoon of the Solution in her mouth, holding it for a minimum of two minutes, Swishing the Solution gently around the mouth, then dis carding the Solution and rinsing the mouth with warm water two or three times. The procedure began Friday night and the following Monday morning the cold was gone. On another occasion the inventor's private attorney

reported that canker Sores (ulcers) inside his mouth which he

The inventor continued to search for other uses of the

“miracle bullet' oxalic acid or oxalate compositions for treating the body and immune System. The inventor used a dental hygiene composition of Oxalic acid and distilled water

and the Sore healed quickly. During a veterinarian dental examination of the inventor's pet dogs, one dog had a moderate build up of tarter and plaque on the teeth and gingivitis in the upper gums, both Sides of the mouth. At the completion of the exam, rather than treat the gingivitis with an injection of antibacterial medication followed by oral medication, it was agreed the inventor would commence daily brushing of the dog's teeth. The formula used for the brushing was a mix of 150 mg. of oxalic acid in 300 ml of distilled water. The inventor began a daily brushing of the dog's teeth paying particular atten tion to the upper gums. The brushing was done first thing in the morning before the dog had anything to eat or drink. After the fourth day of brushing, the inventor/owner of the dog, noticed the redness of the gingivitis was disappearing and after one week returned the dog to the veterinarian for a follow-up exam. The exam revealed no more evidence of gingivitis and no tarter but moderate plaque remained. The Veterinarian recommended cleaning one Side of the dogs upper teeth and continuing with the daily brushing routine. On another occasion, the inventor's pet poodle had torn a

had been experiencing over an extended period of time, disappeared one week after he began using the inventor's dental hygiene rinse on a once-a-day use of the composition. Also of Significance was the attorney's Q-Tip application of the composition to a persistent Sore on the inside of a nostril of his nose, and the Sore healed.

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On yet another occasion a Subject who complained of continuously being prescribed antibiotic pills without any improvement in continuous flu and cold-like Symptoms began the present method of mouth rinse and gargle first thing each morning and last thing at night before retiring each day and reported experiencing Significant improvement in the Symptoms after three days of following the recom mended usage. The dilute Solution was the bench mark Solution.

6,133,318 33

34 from 1 mg in a pill to about 1 gram of Oxalic acid and

On Still another occasion a pharmacist, consultant to the inventor, awoke at 2:30 a.m. with a very Sore throat, unable to Swallow without severe pain, remembered the inventor's description of his own experience, mixed two teaspoons of the bench mark mixture and two teaspoons of warm water, held the mixture in the mouth for two minutes and gargled well. After a 15-minute wait, repeated the procedure and then retired. Upon arising at 6:30 a.m., repeated the proce dure one time before leaving for the pharmacy. The phar macist reported that at 11:30 a.m. all Symptoms of the Sore throat and flu virus were gone. On yet another occasion, a veterinarian associate on a call

dihydrate (gr) in a gelcap. The exact concentration of Oxalic

to a horse ranch for the birth of a foal encountered some

complications during delivery and required assistance by the Veterinarian and an extended Stay following the birth and a delay in effecting personal hygiene which resulted in Staph

15

infection in Scratches and skin abrasions which were treated

by a topical application of a cream composition of Velvachol cream and Oxalic acid and the disease and SoreneSS was relieved.

acids like emu oil.

Two cases are recorded where use of the present dilute Solution of Oxalic acid and distilled water composition showed remarkable reduction of the effects of the flu virus.

Rinsing of the mouth for a minimum of two minutes followed by a lengthy gargle three times a day for a period of four days completely removes all Soreness of throat and nose and periodic use of a teaspoon of dried parsley placed between the lower lip and teeth, as one would use Snuff, acted immediately as a decongestive agent to relieve Sore neSS and congestion of the chest and further acted as an expectorant of heavy phlegm and an agent for drying of

25

include ethanedioic acid (free acid), ethanedioic acid anhydride, ethanedioic acid tri-potassium Salt, ethanedioic

150 mg of oxalic acid in solution in 300 ml of distilled water is the preferred and bench mark Solution or compo present invention, an oxalic acid and distilled water Solution or composition may contain anywhere from greater than Zero to less than about 500 mg of oxalic acid per 300 ml of distilled water, preferably 50 to 425 mg of oxalic acid dihydrate per 300 mls of distilled water. Depending on the disease or condition being treated, the amount of Oxalic acid may be increased or reduced from the bench mark Solution of 150 milligrams of oxalic acid in solution in 300 ml liters of distilled water. For example, in treating a strong flu, one may dissolve 400 milligrams of oxalic acid in a solution of 300 milliliters of distilled water. In treating a normal cold, one may use the bench mark Solution of 150 mg of Oxalic acid in Solution in 300 ml of distilled water. For treating an

acid barium Salt, ethanedioic acid cooper Salt, ethanedioic 35

ethanedioic acid Silver Salt, ethanedioic acid Strontium Salt, 40

45

55

ml of distilled water and have the same concentration of Oxalic acid in Solution.

Also in accordance with the present invention, it is contemplated that one may use 0.05 percent Oxalic acid in a distilled water Solution for use as eye drops, nose spray, and topical or cream applications. Also, a high level of 8 grams of Oxalic acid in Solution may be used in intravenous injection over a 24-hour period. The bench mark mouth rinse having 150 mg of oxalic acid in 300 ml of distilled water has a pH of about 2.3. In accordance with the present invention, a mouth rinse mats have a pH of about 6 to 1 depending on the application. Further, gelcaps and pills can be filled with

ethanedioic acid dihydrate, dicarboxylic acid as well as other forms of oxalic acid or oxalate which may be metabolized by the body, injected into the circulatory System, administered by transdermal patch, administered by Suppository, admin istered by topical application, or administered orally, and the like, to provide the desired therapeutic effect. Although one or more of the above may be considered poisons to humans and other warm-blooded animals, the proper administration of a Selected dosage is believed to be therapeutically effec tive and instrumental in the treatment, prevention, control, and cure of infectious bacterial, Viral or microbial disease

50

oxalic acid in Solution in 300 ml of distilled water to form

the bench mark Solution, it is to be understood that one may use, for example, 250 mg of oxalic acid in Solution in 500

acid diamide, ethanedioic acid diamonium Salt, ethanedioic

acid diethyl ester, ethanedioic acid diethyl ester, ethanedioic acid disodium Salt, ethanedioic acid magnesium Salt,

infectious bacterial condition or disease, Such as infection of

a Small cut or Sore, one may use 50 to 75 mg of Oxalic acid in solution in 300 ml of distilled water. Although there is mention of the use of a particular amount of 150 mg of

In accordance with the present invention, it is believed that an adult human may be treated with an effective amount of Oxalic acid or oxalate ranging from about 0.05 mg to about 8.0 gr per 24-hour period. In accordance with the present invention, those undergo ing treatment with Oxalic acid or oxalate in one of its therapeutic effective forms experience a return of good color to the skin, a boosting in the immune System, an increased Vigor. Some forms of Oxalic acid or oxalate which may prove beneficial to humans and other warm-blooded animals,

UCS.

Sition in the uses described above. In accordance with the

acid required for treatment depends on the particular perSon being treated, the particular viral or bacterial infection, the Stage of infection or treatment, and the like. If one undergoing treatment with Oxalic acid or oxalate in one of its therapeutically effective forms experiences Symp toms or believes that they have ingested too high a dosage of Oxalic acid, they may eat 2 to 3 spoons of crushed pineapple to reduce heartburn or indigestion. In accordance with the present invention. it is preferred to use pure carrot juice as a dietary Supplement or composition for administering oxalic acid to one undergoing treatment. One brand of frozen pure carrot juice has a pH of about 6.2. Another brand of canned pure carrot juice has a pH of 5.5. In accordance with another embodiment of the present invention, an oxalic acid or oxalate composition takes the form of a gelcap or capsule containing an effective amount of dried parsley in a fatty acid Such as oleic and linoleic fatty

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and the maintenance of good health. It is not uncommon to provide a beneficial effect from an agent which is known as a poison. There is a myriad of hundreds or thousands of poisons which provide a beneficial effect to warm-blooded animals when administered in a proper dosage. In accordance with the present invention, a method of impeding the apoptosis of CD4 cells and perSons infected with human immunodeficiency virus includes the Steps of externally feeding or otherwise administering to the infected perSon or other animal a nutritional product which contains Oxalic acid or oxalate in a therapeutic quantity Sufficient to impede apoptosis of CD4 cells. In accordance with another embodiment of the present invention, oxalic acid or oxalate compositions and methods are used to treat, prevent, or control AIDS and HIV infection in humans and other animals by administering a therapeutic quantity of Oxalic acid or oxalate composition, Source of Oxalic acid or oxalate, nutritional product, Supplement,

6,133,318 35

36

Solution, agent, curative, control, impediment, food, feed Stuff, rinse, mouthwash, mouth rinse, wash, formulation, dosage, pharmaceutical agent, dietary Supplement, intermediate, product, composition, anti-AIDS or anti-HIV agent, Vaccine, immune System Stimulant, Substance, drug, chemopreventive, chemical, chemoSurgical agent, chemo therapy agent, chemotherapeutic agent, Solution, Solute, Slurry, mixture, medicine, remedy, medication, Salve, ointment, balm, cream, analgesic, medicinal agent, treating agent, preventing agent, retarding agent, impeding agent, delaying agent, controlling agent, anabolic agent, health improving agent, health-Supplementary food, enriched fraction, Oncological or oncologic agent, tumor treating agent, disease treating agent, infection treating agent, fungal treatment, remedy, antimicrobial agent, microbial treatment, bacterial treatment, and the agent for treating, controlling, improving, preventing, the Symptoms of pathological dis

In accordance with the present invention, oxalic acid or oxalate compositions are used alone or combined with one or more of the established HIV/AIDS medicines to work

easeS Such as bacterial, Viral, and the like, as well as a

together to inhibit, impede, fight, or the like, the HIV virus at one or more Stages of its progression or development. Hence, a new combination or “cocktail” therapy includes protease inhibitors established HIV/AIDS medicines, and Oxalic acid or oxalate compositions. Also in accordance with the present invention, oxalic acid or oxalate compositions alone or together with established HIV/AIDS medicines can be used to treat the symptoms of HIV/AIDS infection including Swollen lymph glands, fever or night Sweats, weight loss, fatigue, diarrhea, Skin problems, Sores in the mouth, cough, ShortneSS of breath, vaginal yeast infections, and the like. Further, Oxalic acid or oxalate compositions can be used to treat the Serious ill neSSes that occur with AIDS including pneumonia, pneu

the like. In accordance with still another embodiment of the

skin cancer, organ tumors, infections of the nervous System which can damage the brain and Spinal cord, opportunistic infections, including fungal, parasitic, viral, and bacterial

15

mocystis carinii pneumonia (PCP), kaposi's Sarcoma (KS),

Supplemental composition or treatment to be used in con junction with conventional compositions and treatments, or

present invention, oxalic acid or oxalate compositions and methods are used to improve Sustained energy and as anabolic compositions and methods in humans and other warm-blooded animals. Oxalic acid or oxalate compositions provide for Sustained energy and nutrition to Support an anabolic physiological State in humans and other animals by providing or otherwise administering to the human or other animal a therapeutic quantity of Oxalic acid or oxalate. The Oxalic acid or oxalate compositions and methods may Supplement other conventional compositions and methods Such as lipids, bio-available minerals in the form of amino acid chelates, anabolic nutrients, Vitamins, antioxidants, and lipotropic agents to provide an optimal Sustained energy and anabolic nutrition formulation. When administered, it is

believed that the Oxalic acid or oxalate compositions facili tate Sustained energy and delivery of nutrients to appropriate sites within the body for efficient utilization in the anabolic physiology.

infections, tuberculosis, and the like. 25

off HIV/AIDS infection. Further, oxalic acid or oxalate

compositions and methods are used as antimicrobial agents, antibacterial agents, anti-virals, therapies, anti-infectives, anti-microbials, and anti-cancer drugs or agents to treat the diseases and opportunistic infections associated with HIV/ AIDS.

35

It is believed that the oxalic acid and oxalate compositions and methods of the present invention will help HIV/infected people and other animals to be able to live longer, more productive and relatively Symptom-free lives. In accordance with another embodiment of the present

40

Oxalic acid or oxalate as the Solute in distilled water. Such a Solution of a dilute concentration of Oxalic acid or oxalate in distilled water can be bottled and sold as a health

invention, a Solution or mixture has a dilute concentration of

The Human Immunodeficiency V'virus (HIV) causes

AIDS. The virus attacks certain white blood cells, called

T-cells and weakens the body's immune System. Acquired

Immunodeficiency Syndrome (AIDS) occurs when an HIV

infected perSon develops a life-threatening condition or their number of disease fighting T-cells becomes dangerously low. Current data indicates that among perSons age 25-44 years old, HIV infection is now the leading cause of death in men and is the third leading cause of death in women in the U.S. In 1995, approximately 40,000 Americans con tracted HIV. Worldwide, one million people died from AIDS last year and reported cases increased by 19 percent. It has been about 15 years since the HIV/AIDS virus was first identified. Tragically, the AIDS epidemic has claimed 4.5 million lives, worldwide. Today, Significant Strides are being made in understanding the virus and ways to battle the disease. There are 42 approved medicines and over 120 drugs currently being developed by pharmaceutical compa nies to fight HIV/AIDS. One promising advance in newly developed pharmaceu ticals for fighting HIV/AIDS is a new class of medicines called protease inhibitors. Studies show that when a protease

Also in accordance with the present invention, oxalic acid or oxalate compositions are used as Vaccines, immunomodulators, or immunosystem Stimulant that help Strengthen the immune System, thus helping the body fight

45

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improving, disease preventing, disease treating, controlling, impeding, delaying, or the like agent, pharmyiaceutical, Supplement, chemotherapy, etc. Such a dilute oxalic acid or oxalate Solution can be administered or given to, for example, astronauts prior to space travel, HIV or AIDS patients, perSons or other animals Suffering from bacterial, Viral, microbiological, or other conditions or diseases, can cer patients, tumor patients, perSons Subjected to high levels of radiation or electric fields, and the like. The concentration

of Oxalic acid or oxalate in the Solution is determined by the use of the Solution or disease being treated, controlled, impeded, delayed, and the like. In accordance with another embodiment of the present invention, bottled water, Sports drinks, electrolyte Solutions, fruit drinks and the like are improved by adding a dilute concentration of Oxalic acid or oxalate therein. The Oxalic acid or oxalate is added to either counteract Some of the

60

negative effects of the items contained in these drinks and/or to supplement or improve the healthful benefit of Such

inhibitor is combined with one or more of the established

drinkS.

HIV/AIDS medicines, they work together to attach the HIV Virus at different Stages of its progression. This combination or “cocktail” therapy has been shown to reduce the level of HIV in the bloodstream by up to 99 percent in some patients and, thereby, potentially halting or slowing the advancement

In accordance with another aspect of the present invention, oxalic acid or oxalate compositions and treat ments are used in canine care by dissolving a therapeutic quantity of Oxalic acid in distilled water to form an Oxalic acid treatment Solution for treating gingivitis, tartar build-up on the teeth, general health of teeth and gums, and as a

of the disease.

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38

topical antiseptic or antibiotic. For example, a half dachs hund and half beagle canine was examined and found to have a build up of tartar on the teeth and gingivitis active with a slight pocket with one tooth with puS. The canine's teeth and gums were brushed regularly with the Oxalic acid Solution for dental hygiene and was returned to the Veteri

for removing, for examples growths, lesions, from the skin in warm-blooded animals including dogs. Also, in accordance with the present invention, a liquid subcue injection solution of 0.1% oxalic acid in distilled water is used for Subcutaneous injection treatment of, for example, skin lesions, tumors, infections, and the like, in warm-blooded animals including dogs. In accordance with a particular example of the present

narian for examination.

In accordance with another example, a poodle having a torn toenail which has become infected received an injection of antibiotic and capsules of AMP-250 to be given three times daily. Also, the poodle's injured paw was Soaked three times daily in an oxalic acid/distilled water Solution the Same Strength as the dental hygiene Solution. In accordance with still yet another embodiment of the present invention, it is believed that Oxalic acid or oxalate compositions can be used to prevent Strokes in humans and other animals. An Oct. 29, 1996 ABC Evening News Report indicated that a group of Seniors over age 60 had a very low rate of Strokes compared to the national average. This group of Some 80 people were reported to have been on a special diet high in fruit and vegetables which were high in potas sium. The report theorized that the potassium was respon sible for a lower level of blood pressure in the diet group and

invention, a 10% oxalic acid cream was used to treat a

15

distilled water, the other tumor was treated with direct

thus a lower incidence of Strokes. In accordance with the

present invention, it is respectfully believed that the lower incidents of Strokes was due to oxalic acid in the Special diet high in fruit and vegetables rather than the potassium. Potassium oxalate and potassium oxalate monohydrate con tain large amounts of Oxalic acid which in accordance with the present invention the Oxalic acid Serves as the “hall monitor' of the blood system keeping the blood clean of plaque and abnormal cells. Hence, it is believed that the high level of oxalic acid in the potassium rich diet high in fruit and vegetables which led to the very low rate of strokes compared to the national average. In accordance with the present invention, oxalic acid or oxalate compositions and methods are used to treat, prevent, impede, delay, control, or the like Strokes in humans and other warm-blooded animals by administering a therapeutic quantity of Oxalic acid or oxalate on a periodic basis, for example, daily. In accordance with another embodiment of the present invention, an adult female human has been following a diet protocol to assist in the absorption of calcium to prevent Osteoporosis. The female has also had operations to remove breast tumors which also required removal of the thyroid gland. The following protocol is designed to take calcium Supplements and to add oxalic acid to a normal daily diet

25

allows for vegetables and beverages (such as carrots, carrot juice, parsley) with Oxalic acid in significant amounts to

In accordance with another embodiment of the present invention, a mouth rinse, wash, mouthwash, cleanser

Solution, gargle, or the like, contain about 150 milligram of

oxalic acid dihydrate (from Chem One) dissolved in 300

milliliters of distilled water. This solution is produced by heating the distilled water to boiling, mixing in the 150 milligrams oxalic acid with the warm water to form the Solution. The Solution is placed in Sterile containers for later

35

Sc.

In accordance with another embodiment of the present invention, a therapeutically effective form of Oxalic acid or oxalate may be used in treating AIDS, HIV, bacterial disease, Viral disease, or the like when the disease, 40

condition, or Symptoms have become immune to other conventional treatments.

45

In accordance with another embodiment of the present invention, an oxalic acid Solution of 150 milligrams of oxalic acid dihydrate dissolved in 300 milliliters of distilled water is used as a topical agent, mouth rinse or wash, dental cleanser, or the like for treating the flu, common cold, Sore throat, bronchitis, and other infections, viral or bacterial diseases.

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assure a constant normal or above normal oxalic acid level

in the blood to prevent the growth of tumors. An elderly adult female with severe arthritis and low level

of bone mineral (described as looking like Swiss cheese)

began following a diet protocol to assist in the absorption of calcium to prevent osteoporosis and to increase bone min eral buildup. The elderly female reduced protein intake and increased carbohydrate intake using corn oil as a Supplement for the carbohydrate intake. In accordance with another embodiment of the present invention, an oxalic acid cream made up of Velvachol cream plus 10% oxalic acid Solution is used for topical application

injection of a prescription drug. In accordance with another particular example of the present invention, two adult humans are using a mouthwash mixture of 150 milligrams oxalic acid in 300 milliliters of distilled water as a dental cleaner.

intake.

Calcium Supplements arc taken in the morning with water only. No foods or beverages containing oxalic acid are taken for two hours to allow for maximum calcium absorption without inhibiting by oxalic acid. The normal diet each day

poodle. In accordance with another particular example of the present invention, a 0.1% oxalic acid injection Solution was used to treat a quarter horse. In accordance with another particular example of the present invention, a horse with benign skin tumors was treated by adding parsley to the feed and carrots Separately. In accordance with another particular example of the present invention, a horse with two viral tumors was treated by treating one tumor with direct injection of 30 cc of a mixture of 500 miligrams oxalic acid in 500 milliliters of

60

The second weekend of November, 1997, a woman prop erly in her early 60's agreed that she would go on the Oxalic acid diet of the present invention as near to 100% as possible. She had cancer of the pancreas and the liver. In both of these cancers, her prognosis was very poor. This woman had been through the conventional treatments and nothing more held any hope for her. At the time she started on the diet, she was showing a very slight yellowing of the skin. On Jan. 26, 1998, there was a call from a gentleman to report that she is doing just great. Her color has returned to normal, a very recent test showed the liver at 60% of normal and the tumors are in regression and her blood is clean. She told the gentleman who called to say she had passed the 600 pound mark of carrots. One more Success for the present invention.

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In accordance with another embodiment of the present invention, astronauts and other space travellers who will be Subjected to extreme magnetic forces, radiation, Solar radiation, and the like, are given an effective amount of a

6,133,318 39

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therapeutically effective form of Oxalic acid or oxalate prior to, during, and after Space travel to maintain normal or above normal oxalic acid blood levels and thereby counteract the decomposition of Oxalic acid caused by Space travel, expo

was 500 mg oxalic acid, 500 ml distilled water, gradually reduced to 250 mg oxalic acid in 500 ml distilled water. George, an adult male, is a special case because he has just finished his first week of radiation and chemotherapy treat ments at the Mayo Clinic, Rochester MN. He has a malig nant tumor about grape size by an inner ear at the back of the

Sure to radiation, and the like.

A man described a condition currently existing with his one year old child which Sounded like the typical child's persistent low level cold. Mild chest congestion that would interfere with normal breathing at night, congested cough in the morning and persistent runny nose. We talked about what might help relieve the cold and discussed the possibility of a Small amount of freeze-dried parsley placed in the child's mouth to work as a decongestant and an anti-Viral biotic, It was agreed that having the child take a Small amount of the parsley without water before going to Sleep would be an effective way of providing Oxalic acid without any side

skull. He receives 15 seconds of radiation from each side of

15

effects. He called on October 24 to tell me that on the 18th he did

have Success with having his daughter eat with him a Small amount of the dried parsley and has done So each night Since the 18th. There is no more congestion or running nose and the child is sleeping peacefully through the night. We agreed that lie Should discontinue the procedure to avoid irritating the membrane of the mouth or throat. And if the symptoms do not return in the next couple of days the viral infection

Medicine that tobacco contains Oxalic acid. 25

was cleared.

We also discussed his using the procedure with an amount of 2 teaspoons every third night during the flu Season as a protective measure. An adult male who has Hepatitis C has recently started on a high oxalic acid diet and trying hard to avoid the blockers. He has been infected for Some time and knows the Symp toms preceding the times when he has periods of effects from the virus. With careful monitoring, we will be able to tell if the oxalic acid is having the effect of killing the virus by either the period between attacks are longer or the effects

35

rinse is used to brush the teeth and dentures to remove tartar

40

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rising, a Small amount of Solution (approximately 2 teaspoons) is held in the mouth and Swished around teeth for

dentures, upper and lower, may be cleaned using the rinse then removing the dentures to clean. Initially, the Solution

treatment and did tell his doctor he was on a diet, not what diet, and he wanted to see the results. He scheduled an MRI

for the May 16. I called him May 17 and he was a very happy person. The technician, in Jon's words, “could not find the spots he was looking for”. Another MRI was done later the afternoon of the 16th, with a higher radiation factor. Fol lowing the second MRI the technician told Jon, he could not give him the results, the “developer had troubles”. The trouble was, he still could not find the spots and wanted to tell the oncologist first. I called Jon later and heard in his words “the SPOTS ARE sized.

He is continuing on the diet to make Sure the blood is 60

clean and the Oxalic acid blood level is increased, and once

a week will just before retiring with nothing taken for one hour before, take a calcium Supplement to build up bone

retaining maximum amount of rinse in mouth, teeth are then brushed outside and inside, Specifically between teeth and at gum line, and the tongue is brushed. The rinse is then discarded and the mouth flushed 2 or more times with tap water. A denture brush is then used to clean the denture. Full

he was given a large container of Tone's dried parsley, cans of carrots and beets and advised to Start immediately on the diet. In fact, while we were continuing to talk, he started eating the parsley and washing it down with distilled water. I then called Jon each Subsequent Saturday morning to check on his feelings and to remind him of the diet, Specifically the blockers. He delayed a Scheduled Second

GONE'. His oncologist tried to get him to take another chemo treatment, Saying the cancer had probably metasta

and eliminate bacteria in the mouth and gums. The proce dure being followed is, each morning immediately after a minimum of 2 minutes, removable dentures are removed,

diet information. I told them I would not provide it unless they were willing to spend the time to not only listen, but to read the applicable research data also. They agreed. We spent 4 hours reviewing the data, and in questions and answers. Jon's bone cancer was verified by MRI and he had just previously had the first chemo treatment from his oncologist. And, in his words, “very painful and debilitating, and he did not want to take any more if it could be avoided. He was provided with the diet and lists of food and drink with oxalic acid, and list of foods with B6. Also,

150 mg of oxalic acid (OA) in 300 ml of distilled water. She

Started the recommended procedure of approximately 2 teaspoons of Wash, holding in mouth for 2 minutes then gargle, Spit out wash, then rinsing mouth at least twice with warm tap water. The procedure was repeated first thing in the morning immediately after rising and before anything else was put in mouth. It was done mid-day with nothing in mouth one hour prior to wash. At night, the procedure was repeated as the last item before retiring. By Sunday afternoon, the wife experienced nearly complete relief from the effects of the viral pneumonia. The following is a procedure using a mouth rinse of distilled water with oxalic acid dihydrate in solution. The

On Apr. 4, 1997, I had a visit with two gentlemen, Ken and his friend, Jon. They found out about the present research on Oxalic acid. Jon had bone cancer and wanted the

themselves are leSS Severe, or both.

Also, his wife was diagnosed with Viral pneumonia by X-ray examination. She was given antibiotics to ward off infections because of a weakened immune System. On Friday, September 26, she was provided the mouthwash of

his face and 30 seconds through the back of his throat and he will receive the treatment for 7 weeks, 5 treatments per week, with 6 chemotherapy treatments spaced through the Same period. George Started the Oxalic acid diet on October 9, had his first radiation on October 14, and began the oxalic acid rinse procedure on October 25. George is keeping a detailed log of his diet and will document any Side effects and will ask the doctors each week about the progreSS in eliminating the tumor. I believe the tumor will be reduced more rapidly than the rate calculated by the radiologist and the doctor. A very significant item happened Thursday. October 24. On the evening news, there was an announcement that in clinical testing, nicotine may remove plaque in the brain and may reduce the effects of loss of memory of Alzheimer Victims. We describe that Oxalic acid may remove plaque from the blood. It is reported in Oxalic Acid in Biology and

minerals. 65

On CNN Prime Time News, there was a very short news item about a recent Study that showed people with Strong bones had a higher incident of cancer than people with weak bones.

6,133,318 41 The Study is very Significant because oxalic acid inhibits calcium absorption by the body. High calcium absorption is necessary for development and maintenance of Strong bones, and would not be possible if the body was high in Oxalic acid. However, high oxalic acid in the body System would not only inhibit calcium absorption but also would prevent the development of cancer. Too high levels of Oxalic acid could mean weak bones and Osteoporosis. First, my dog Missy, half dachshund and halfbeagle, had a dental exam and found to have a build up of tartar on the teeth and gingivitis active with a slight pocket by one tooth with pus. Her teeth and gums will be brushed daily with the Solution used for human dental hygiene and returned to the Veterinarian for examination weekly. Second, my poodle, Turk, had a torn toenail which had become infected. He received an injection of an antibiotic, and capsules of Amp-250 to be given 3 times daily. Also, his injured paw will be Soaked 3 times daily in an oxalic acid Solution the same Strength as the dental hygiene Solution. During the week following May 16, 1996, an adult female who is assisting me in documenting the history of my discovery, has been following a diet protocol as follows to assist in the absorption of calcium to prevent osteoporosis. She has also had operations to remove breast tumors which also required removal of the thyroid gland. The protocol is designed to add calcium Supplements to a normal daily diet

42 Adelbert, 8th Edition, 1968, writes on the general properties of tumor viruses. The tumor inducing viruses can be clas sified into two main groups, those which contain RNA as their generic material and those that contain DNA. DNA papilloma viruses as benign warts and molluscum contagio Sum have been classed as natural tumors in man and Serve

as models in the quest for knowledge of viral carcinogenesis in man.

When the inventor discovered the bactericidal activity of Oxalic acid in the gingivitis reduction in his pet dog. The entire spectrum of the effect of Oxalic acid in application for infectious bacterial and infectious viral conditions was

Studied, and many case Studies were conducted with human Volunteers among his peers. The observed interaction of 15

during these Studies reveals that Oxalic acid is indeed bactericidal and viricidal. It is stated in Medical Microbiol

25

intake.

Calcium Supplements are taken in the morning with water only. No foods or beverages containing oxalic acid are taken for 2 hours to allow maximum calcium absorption without inhibiting by Oxalic acid. The normal diet each day allows for vegetables and beverages with Oxalic acid in significant 35

level of bone mineral (described as looking like Swiss cheese) was started on the above protocol as related to calcium and Oxalic acid to increase bone mineral build up and was advised to reduce protein intake and increase carbohydrate intake using corn oil as a Supplement for the carbohydrate intake.

40

I received another call from a woman who went on the

oxalic acid diet Jan. 3, 1998 because there is an unidentified

mass in her breast. She called today to tell me that she was

45

diagnosed a year ago last October (1997) with diverticulitis

and has had irritable bowel syndrome most of her life. She has not had attacks from eating foods now that before would cause diverticula attacks prior to Starting on the diet. Her husband has been troubled for years with reflux from a hiatal hernia and constantly consumed Rolaids. He went on the Oxalic acid diet with his wife to lose Some weight and has discovered the reflux has disappeared and he has stopped using Rolaids. Oxalic acid must be clearing up any bacteria in both husband and wife. This stuff is amazing. The present invention is directed to Oxalic acid or oxalate compositions and methods and formula for producing Such compositions and for the utilizing Oxalic acid or oxalate compositions including Solutions, mixtures, products, creams, rinses, and the like, in the management, control, prevention, or the like, of infectious bacterial and infectious

50

In accordance with the present invention, antimicrobial oxalic acid or oxalate compositions and methods of treat ment of warm-blooded animals including humans and pets is provided which includes at least one therapeutically effective form of Oxalic acid or oxalate for controlling treating, or managing bacterial diseases and Viral diseases caused by germs of infectious bacteria and infectious virus. The present invention encompasses treatment of the follow ing: Bacterial diseases caused by Gram-Positive Cocci Such as Staphylococcal infections of Pneumonia, Bacteremia, Osteomyelitis, Enterocolitis, and the like. Streptococcal infections Such as Hemolytic, Viridans, Enterococci, Lactic, and the like. pneumococcal infections Such as Pneumonia, Sinusitis, Otitis, Meningitis, and the like. Also bacterial diseases caused by Gram-Negative Cocci, Neisseria Aerobic infections Such as Meningococcus, Gonococcus, and the like. Also bacterial diseases caused by Gram-Positive Bacilli infections Such as Erysipelothricosis, Listeriosis, Anthrax, Nocardiosis, and the like.

Also bacterial diseases caused by Gram-Negative Bacilli infections Such as Enterobacteriaceac Salmonella,

55

Shigellosis, Hemophilus, Tularemia, Plaque, Melioidosis, Bartonellosis, Campylobacter, and Noncholera Vibrio, and the like. Also bacterial diseases caused by Anaerobic Bacilli infections such as Clostridium Botulinum, Clostridium

60

Viral diseases or conditions in humans and other animals.

Even though a viral origin for cancer has not been demonstrated in man, the inventor conducted investigative research on oncogenic viruses and their relationship to man, during development of U.S. patent application Ser. No. 08/629,538. Medical Microbiology by Jawets, Melnick &

ogy that the fundamental principal of chemotherapy is the principal of Selective toxicity, which bay be Stated as follows, “In order to be useful for systemic treatment of infectious disease, a Substance must be harmful to parasites but relatively innocuous to host cells.” Oxalic acid as a natural chemotherapy meets the Stated principle. It can be administered at therapeutically accept able levels sufficient to kill the bacterial and viral organisms and be completely innocuous to the host cells. Oxalic acid can be administered at the therapeutically acceptable levels for the time necessary to kill the organisms without any effect on host cells. It is believed that Oxalic acid penetrates the encasing shell of the host cell and kills the viral nucleic acid core.

amounts to assure a constant normal or above oxalic acid

level in the blood to prevent the growth of tumors. On Sep. 20, 1996, her mother with severe arthritis and low

Oxalic acid and the infectious bacteria and infectious virus

65

Tetany, Clostridia of Gas Gangrene Bacteroides, Mixed Anaerobic, Actinomycosis, and the like. Also diseases caused by Mycobacteria, infections Such as Tuberculosis and Leprosy, and the like. Also bacterial diseases caused by Spirochetes Such as LeptoSpirosis Lyme Disease, and Endemic Treponematoses. Further in accordance with the present invention, Oxalic acid or oxalate composition and methods of treatment for infectious nucleic acid type Viral diseaseS Such as deoxyri

bonucleic acid types (DNA), and ribonucleic acid (RNA), with natural cycle chiefly in humans, spread by perSon-to

6,133,318 44 waging a “war on cancer with the National Cancer Act of

43 perSon contact, and transmitted from nature to man and may also infect animals. Also, diseases Such as Human Immu

1971. As described in the recent Cancer Treatments

nodeficiency Virus infection (HIV) and Acquired Immuno deficiency Syndrome (AIDS).

publication, a So-called “magic bullet'-a single medicine or treatment-that will cure cancer has not been found. Appli cant respectfully believes that Oxalic acid in one of its therapeutic forms may be the “magic bullet” that is being Sought and may improve and extend lives when it is used as described in the present application. Although the activity of Oxalic acid is not completely understood, Applicant respect fully believes that Oxalic acid attacks the nucleic acid center of tumor, cancer, neoplasm, or growth cells or tissues and thereby kills or prevents the growth of the tumor, cancer, neoplasm, growth, or the like, Applicant respectfully believes that warm-blooded animals including humans, dogs, cats, horses, and the like will benefit from the use of Oxalic acid in one of its therapeutic forms as described in the present application including as a composition, nutritional Supplement, diet, food additive, dental prophylactic, preventative, control factor, treatment agent, or the like. Even further, in accordance with the present invention, it is contemplated that many different oxalic acid or oxalate containing compounds, foods, vegetables, and the like may be used in the controlling, managing, treatment, prevention, or the like of neoplasms, neoplasia, cancers, tumors, growths, abnormal cells and tissues, infectious bacterial or Viral diseases, and the like. For example, Oxalic acid dihydrate, dried parsley, dried chives, foods containing these items, nutritional Supplements containing these items, juices Such as carrot juice containing these items, and combina tions thereof may be used to provide the desired chemo therapeutic affect. Applicant respectfully believes that Oxalic acid in at least one of its therapeutically effective forms is a general, nonselective, chemotherapeutic or chemopreventive agent, factor, or compound and has described numerous compositions, methods, protocols, regimens, diets, nutri tional Supplements, rinses, washes, topical ointments, and the like for Supplying oxalic acid in an effective amount and a beneficial form to a warm-blooded animal including humans and pets. The following are illustrative examples of methods, for mulations and compositions according to the present inven tion. Although the examples utilize only Selected com pounds and formulations, it should be understood that the following examples are illustrative and are not limiting. Therefore, any of the aforementioned Oxalic acids, oxalate, or related compounds may be Substituted according to the teachings of the present invention in the following examples.

Also Respiratory Tract Viral diseases, all Serotypes, caused by Influenza, A, B, and C, Parainfluenza viruses 1-4,

Rhonoviruses (common cold), Mumps virus, Adenoviruses,

Reoviruses, and Epstein-Barr virus, and Infants and Adult Syncytial virus, also primary Atypical pneumonias and others.

Also Nervous System Viral diseases, all Serotypes, Such as Polioviruses, Coxsackieviruses, Echoviruses and high numbered viruses, Epidemic gastroenteritis viruses, Rubeola Virus, Rubella virus, Varicella-Zoster virus, Herpes simplex, Human herpes virus type 6, Human Parvovirus B19, Cytomegalovirus, Hepatitis viruses Types A, B, C, D, Human Papillomavirus, Molluscum contagioSum virus, and

15

also viruses transmitted from nature to man Such as the

Arboviruses, togaviruses, alphaviruses, flaviviruses, bunyaviruses, and the Orbivirus, Rabies virus, Herpesvirus Simiae, Arenaviruses, Filoviruses, and the like.

By way of general definition, "cancer' is any of various malignant neoplasms, a "tumor is a neoplasm or abnormal growth of tissue, and a "neoplasm' is an abnormal new growth of tissue, or a tumor. Hence, it is respectfully believed that the words neoplasm and tumor are essentially Synonymous and that a cancer is essentially any of various malignant neoplasms, tumors, or growths. AS described in the present application, Oxalic acid in one

25

of its beneficial forms was used in connection with the

treatment, management, control, or the like of a growth on a thigh, a growth on an eyebrow, polyps, abdominal cancer, bladder cancer, prostate cancer, mouth tumor, melanoma

(skin cancer), oral tumor, cervical cancer, brain tumor,

lymph node tumors, uterine tumor, bone cancer, Stomach

35

cancer, and breast cancer. Further, as described in the

Examples of the present application, Oxalic acid in one of its

beneficial forms is used in connection with the treatment,

control, management, or prevention of tumors, brain tumors, cancers, neoplasia, acne, Skin cancer, growths, breast cancer, cervical cancer, and the like. It is respectfully believed that Oxalic acid in one of its therapeutic forms is a natural chemotherapy which can be used to treat all types of tumors, growths, neoplasms, infectious bacterial or viral diseases, and the like, in warm-blooded animals, regardless of loca

40

45

tion or classification thereof. The oxalic acid diet of the

present invention provides a natural chemotherapy which has been beneficial in the treatment, control, management, or prevention of growths, tumors, cancers, leukemia, bronchitis, and bacterial and viral infections, In other words,

50

EXAMPLE 1.

it is believed that Oxalic acid in one of its therapeutic forms is a general or non-Selective chemotherapeutic or chemo preventive agent, factor, or compound. In a recent Cancer Treatments publication, “chemoprevention' is described as an exciting new area of pharmaceutical cancer research that focuses on the prevention of cancer through a diverse group of natural and Synthetic agents. It is respectfully believed that this publication indicates that chemoprevention is new and that prior to the invention by Applicant, one of ordinary

55

skill in the art would not have known of the use of oxalic

60

A therapeutic composition in the form of a nutritional Supplement or multi-Vitamin tablet containing an effective ventional ingredients Such as Vitamins and minerals. EXAMPLE 2

acid as a chemoprevention and it would not have been obvious to use oxalic acid as a chemoprevention. Further, if the use of Oxalic acid as a cancer treatment or

cure were known prior to the invention by Applicant, why will more than 1.3 million cases of cancer be diagnosed this year, why has over a trillion dollars been spent on trying to find a cure for cancer, and why did the U.S. commit itself to

amount of Oxalic acid, 8 grams (gr) or less, preferably 500 milligrams (mg) or less of Oxalic acid, together with con

A treatment regimen or method including the oral admin istration of one Such tablet, pill, multi-Vitamin or Supplement of Example 1 daily. EXAMPLE 3

65

The therapeutic composition of Example 1 including 1 gram or less, preferably 500 milligrams or less of Oxalic acid, together with conventional quantities of other Vitamins

6,133,318 45

46

and minerals except that one or more of the Oxalic acid blockers, including Vitamin C, Vitamin B6, calcium, citric

EXAMPLE 13

The composition a described in Example 12 wherein the carrier or diluent is at least one of a gel cap and distilled

acid, alcohol, resin, and the like are reduced or eliminated

altogether from the pill, Vitamin, multi-Vitamin, Supplement,

Water.

etc.

EXAMPLE 4

EXAMPLE 1.4

A therapeutic composition containing oxalic acid as a topical skin treatment includes a mixture of 5 grams or leSS of oxalic acid, 40 milliliters distilled water, and 5 milliliters propylene glycol.

A method for controlling, treating, or managing infectious or pathogenic bacterial or viral disease in warm-blooded animals including pets and humans having the Steps of periodically administering a therapeutically effective dosage of the composition of Example 9.

EXAMPLE 5

The topical Skin treatment composition of Example 4

EXAMPLE 1.5 15

Serves as an exfoliate, anti-bacteria treatment, infectious skin bacteria disease treatment, infectious skin virus disease treatment, or combinations thereof.

The method as described in Example 14 wherein the composition is administered orally or Sublingually in at least one of a gel cap, tablet, powder, food additive, food, drops, liquid, beverage, pill, and capsule form.

EXAMPLE 6

EXAMPLE 16

A composition rinse, or gargle for rinsing the interior Surfaces of the mouth and throat made of a dilute Solution of

oxalic acid in distilled water, preferably less than 500 mg of oxalic acid in 300 ml of distilled water.

25

tissue.

EXAMPLE 7

A method of treating humans for the treating, controlling and managing mouth and throat bacteria and virus infections using the mouth rinse and throat gargle of Example 6.

EXAMPLE 1.7

The method as described in Example 14 wherein the composition is administered topically by at least one of transdermal patch, ointment, Salve, cream lotion, gel,

EXAMPLE 8

A method of treating warm-blooded animals including the Steps of testing the blood or urine oxalic acid or oxalate levels, administering an effective amount of Oxalic acid, oxalate or blockers thereof, and monitoring the levels to determine if adjustments are necessary to achieve a desired

Solution, and the like.

A single medicine, “silver bullet” or “magic bullet”, composition for controlling, treating or managing infectious or pathogenic bacterial and Viral disease, and the like, for preventing the spread or for otherwise therapeutically treat ing warm-blooded animals including pets and humans and including an effective amount of at least one therapeutically

The method as described in Example 14 wherein the composition is administered internally by at least one of inhalation, Suppository, or Subcutaneous deposit.

The composition as described in Example 9 wherein the therapeutically effective form of Oxalic acid or oxalate is Selected from the group of Oxalic acid in a free acid, ester, lactone or Salt form, oxalate including Sodium oxalate, a nutritional Supplement containing at least one form of Oxalic acid or oxalate, oxalic acid dihydrate, anhydrous Oxalic acid,

The method described in Example 14 wherein the com position is administered at least once a day at a dosage of 50 mg to 6 g for humans or 1 mg to 3 g for pets. 45

50

oxalate enhancers. EXAMPLE 21

55

The method as described in Example 20 wherein the blockers are Selected from the group of citric acid, ascorbic acid, pyridoxine hydrochloride, calcium, alcohol, resins, clayS, and combinations thereof. EXAMPLE 22

EXAMPLE 11 60

EXAMPLE 12

The composition as described in Example 9 further hav ing a pharmaceutically acceptable carrier or diluent for the therapeutically effective form of Oxalic acid or oxalate.

EXAMPLE 2.0

The method as described in Example 14 further having the Steps of reducing the intake of Oxalic acid or oxalate blockers and/or increasing the intake of Oxalic acid or

oxamide, oxalate Salts, and combinations thereof.

The composition as described in Example 9 wherein the composition is Oxalic acid dihydrate.

EXAMPLE 1.9

40

effective form of Oxalic acid or oxalate. EXAMPLE 10

EXAMPLE 1.8

35

level. EXAMPLE 9

The method as described in Example 14 wherein the composition is administered by injection including venous injection, injection into the bacteria or virus infected tissue and/or injected adjacent to the bacterial or virus infected

65

The method as described in Example 20 wherein the blockers are Selected from the group of dairy products containing calcium, fruits, coconut, beverages containing alcohol, ascorbic acid or citric acid including beverageS Such as beer, wine, Vodka, gin, and the like, fruit juice based beverages, Soda pop or Soft drinkS containing ascorbic acid or citric acid, other Sports drinks, beverages or refreshments containing ascorbic acid or citric acid, red meats, or white

6,133,318 47

48

meat of fowl including chicken, turkey, pheasant and the like containing pyridoxine, or other foods or beverages contain ing alcohol, citric acid, ascorbic acid or pyridoxine hydro chloride including breads or grains, resins, and combinations

form of Oxalic acid or oxalate, beverages, liquids or juices containing at least one form of Oxalic acid or oxalate, additives containing at least one form of Oxalic acid or oxalate, and combinations thereof.

thereof. EXAMPLE 30 EXAMPLE 23

The veterinary composition as described in Example 29 wherein the composition is Oxalic acid dihydrate.

A diet for treating, controlling, and managing or prevent ing infectious bacterial or viral disease and the like in warm-blooded animals including pets and humans having the Steps of adding to the regular diet a dietary Supplement of an effective amount of at least one therapeutically effec

EXAMPLE 31

The veterinary composition as described in Example 29 wherein the composition is at least one of carrots, boiled carrots, and parsley.

tive form of Oxalic acid or oxalate. EXAMPLE 24

15

The veterinary composition as described in Example 29 further having a pharmaceutically acceptable carrier or diluent for the therapeutically effective form of oxalic acid

The diet as described in Example 23 wherein the effective form of Oxalic acid or oxalate is Selected from the group of Oxalic acid in a free acid, ester, lactone, or Salt form, oxalate

including Sodium oxalate, a nutritional Supplement contain ing at least one form of Oxalic acid or oxalate oxalic acid dihydrate, anhydrous Oxalic acid, OXamide, oxalate Salts, natural or processed foods including plants or vegetables including parsley, chives, garlic, beets, carrots, Spinach, and the like containing at least one form of Oxalic acid or oxalate, beverages, liquids or juices Such as carrot juice containing at

EXAMPLE 32

or oxalate. EXAMPLE 33

25

The veterinary composition as described in Example 32 wherein the carrier is a gel cap or distilled water. EXAMPLE 34

least one form of Oxalic acid or oxalate, and combinations

A veterinary method for controlling, treating, or managing infectious or pathogenic bacterial and Viral disease in warm blooded animals including dogs and cats having the Steps of periodically administering a therapeutically effective dosage of the veterinary composition of Example 29.

thereof. EXAMPLE 25

The diet as described in Example 23 further having the Steps of reducing the intake of Oxalic acid or oxalate blockers.

EXAMPLE 35 EXAMPLE 26

The diet as described in Example 25 wherein the blockers are Selected from the group of dairy products containing calcium, fruits, coconut, beverages containing alcohol, ascorbic acid, or citric acid including adult beverageS Such as beer, wine, Vodka, gin, and the like, fruit juice based beverages, Soda pop or Soft drinkS containing ascorbic acid or citric acid, other Sports drinks, beverages or refreshments containing ascorbic acid or citric acid or pyridoxine hydro chloride including breads or grains, resins, and combinations

35

40

The veterinary method as described in Example 34 wherein the composition is administered at least once a day at a dosage of about 1 mg to 3 g for dogs and cats.

EXAMPLE 28

oxalate.

EXAMPLE 37

50

The veterinary method as described in Example 34 further having the Steps of reducing the intake of Oxalic acid or oxalate blockers. 55

EXAMPLE 38

60

The veterinary method as described in Example 37 wherein the blockers are Selected from the group of citric acid, ascorbic acid, pyridoxine hydrochloride, calcium, alcohol, resins, clays, and combinations thereof.

EXAMPLE 29

The Veterinary composition as described in Example 28 wherein the therapeutically effective form of oxalic acid or oxalate is Selected from a group of Oxalic acid in a free acid, ester, lactone or Salt form, oxalate including Sodium oxalate, a nutritional Supplement containing at least one form of Oxalic acid or oxalate, Oxalic acid dihydrate, anhydrous acid, oxamide, oxalate Salts, natural or processed foods including molds, plants or vegetables including parsley, chives, garlic, beets, carrots, Spinach, and the like containing at least one

EXAMPLE 36

45

thereof.

A Single medicine Veterinary composition for controlling, treating or managing infectious bacterial or viral disease and the like, preventing reinfection or for otherwise therapeuti cally treating warm-blooded animals including cats, dogs, horses, cattle, or the like, including an effective amount of at least one therapeutically effective form of Oxalic acid or

The veterinary method as described in Example 34 wherein the composition is administered orally or Sublin gually in at least one of gel cap, tablet, powder, food additive, food, beverage, pill and capsule form, by injection including venous injection injected into the infected area or injection adjacent to the infected area, topically by at least one of transdermal patch, ointment, Salve, cream, lotion, gel, Solution, and the like, internally by inhalation, Suppository or Subcutaneous deposit, or combinations thereof.

EXAMPLE 39

65

A therapeutic composition in cream or ointment form for topical administration of Oxalic acid or oxalate having an effective amount of at least one therapeutically effective form of Oxalic acid or oxalate, a Solvent, and a cream or ointment base.

6,133,318 49

SO

EXAMPLE 40

EXAMPLE 49

The therapeutic composition as described in Example 39 wherein the Solvent is distilled water, acetone, propylene glycol, or polySorbate, and the base is a cream, ointment, gel, lotion, Spray, Stick, or powder.

The pharmaceutical composition as described in Example 48 wherein the composition is provided in a form Selected from the group of pills, powders, granules, tablets, micro capsules, gel capsules nutritional Supplements, processed foods, liquids, drops, beverages, additives, and Solutions.

EXAMPLE 41

EXAMPLE 50

A method of producing the therapeutic composition as described in Example 39 having the Steps of mixing a dilute concentration of at least one therapeutically effective form

A Protocol for Treatment of Canine, Equine, Feline Species for the Control of Infectious Bacterial and

of Oxalic acid or oxalate with a Solvent Such as distilled

Viral Disease

water, acetone, propylene glycol, polySorbate, or the like to form a Solution, mixing the Solution with a base Such as a hydrophilic petrolatum, cream, ointment, gel, lotion, Spray, Stick powder or other base.

Prior to the commencement of Protocol, a complete examination should be accomplished by the attending vet erinarian. The examiner should complete and record the following: History Since onset of the bacterial disease or Virus infection based on Owner's description; Specific diet to include all treats, and liquid intake; general activity level during previous period, age; Weight, general examination; blood analysis, and urine analysis. Thereafter, administering the veterinary composition of at least one of Examples 28-33 by the method of at least one of Examples 34-38.

15

EXAMPLE 42

In pet food, the improvement of the addition of a thera peutically effective quantity of at least one therapeutically effective form of Oxalic acid or oxalate. EXAMPLE 43

In pet food, the improvement of the elimination or reduc tion of Oxalic acid or oxalate blockers.

A method of treating animals using oxalic acid or oxalate in place of general antibiotics by administering at least one therapeutically effective form of Oxalic acid or oxalate continuously to the patient in decreasing amounts to treat, control, and manage infectious bacterial and viral disease, and the like without deleteriously affecting normal cells.

EXAMPLE 44

A method of treating infectious or pathogenic microbial, bacterial and viral disease, and the like including the Steps of reducing or eliminating the ingestion or administration of Oxalic acid or oxalate blockers, administering or ingesting high dosages of Oxalic acid or oxalate to raise the blood or

EXAMPLE 52

urine oxalic acid or oxalate level above normal, and, after

cleansing the infectious microbial, bacteria or virus infected blood, reducing or eliminating the administration or inges

35

tion of Oxalic acid or oxalate to maintain a normal blood or urine oxalic acid or oxalate level. EXAMPLE 45

fields or radiation in the examination, treatment or diet

40

position or reduction in the amount of Oxalic acid or oxalate during treatment. EXAMPLE 53

A mouthwash, gargle or oral rinse containing a dilute solution of oxalic acid and having a pH of 2.67.

microbial, bacterial or viral disease from the cardiovascular 45

EXAMPLE 54

The mouthwash, gargle or oral rinse of Example 53 containing a dilute Solution of 150 mg of Oxalic acid dihydrate per 300 ml of distilled water.

Oxalic acid or oxalate. EXAMPLE 46

An oral rinse, wash or gargle for controlling, treating or managing infectious bacterial or viral disease, and the like, for preventing new infections of bacterial or viral disease, or for otherwise therapeutically treating the mouth area, made up of a dilute Solution of an effective amount of at least one therapeutically effective form of Oxalic acid or oxalate.

A method of enhancing the beneficial effects of Oxalic acid or oxalate in animals including humans and pets including the Steps of eliminating the use of Strong magnetic

(heating of food or drink) of the animal to prevent decom

A therapeutic composition for purifying the blood, controlling, treating or eradicating infectious or pathogenic System or in the brain, and maintaining good cardiovascular health and operation, having a therapeutically effective amount of at least one therapeutically effective form of

EXAMPLE 51

25

50

EXAMPLE 55

A method of treating terminally ill animals including humans including the Steps of administering a high dosage 55

of Oxalic acid or oxalate to cleanse the blood and treat the condition or disease. EXAMPLE 56

EXAMPLE 47

A composition for treating parvo virus in animals includ ing canines of a therapeutically effective amount of at least one therapeutically effective form of Oxalic acid or oxalate.

60

The method of Example 55 further including the steps of Stopping other chemical or radiation treatments to prevent weakening of the body and prevent the decomposition or reduction of Oxalic acid or oxalate in the body.

EXAMPLE 48

A pharmaceutical composition to be administered orally to humans of a mixture of a non-toxic ingestible carrier and an effective amount of a therapeutically effective form of Oxalic acid or oxalate.

EXAMPLE 57 65

The method of Example 55 further including the steps of reducing the dosage of Oxalic acid or oxalate after the blood has been cleansed and the condition or disease has

improved.

6,133,318 S1

52

EXAMPLE 58

including Vitamin C, Vitamin B6, calcium citric acid, resins, and the like, are reduced or eliminated altogether from the pill, Vitamin, multi-mineral, Supplement, etc.

The method of Examples 55, 56, 57, further including the Steps of reducing the intake of Oxalic acid or oxalate blockers and increasing the intake of Oxalic acid or oxalate

EXAMPLE 67

enhancers.

Another therapeutic composition contains an effective amount of Oxalic acid together with conventional pet foods.

EXAMPLE 59

Atherapeutic composition for the treatment of infectious or pathogenic microbial, bacterial, Viral or other disease, cancers, neopiasms, or tumors is made up of freeze-dried parsley with a rounded tableSpoon of freeze-dried parsley providing about 1 gram of Oxalic acid. EXAMPLE 60

EXAMPLE 68

15

A Sufficient quantity of dried parsley is administered daily to provide the desired therapeutic effect and produce or

A conventional pet food mixture is mixed with Oxalic acid in Sufficient quantity to provide the desired therapeutic effect. For example, 3 grams or less, preferably 500 milli grams or less of Oxalic acid dihydrate is mixed with a single Serving quantity or portion of dog food or cat food to provide a daily dosage of 3 grams or less, preferably 500 milligrams

or less of oxalic acid (see Table XII).

maintain a desired blood Oxalic acid or oxalate level for

EXAMPLE 69

preventing, controlling, or treating infectious bacterial, Viral or microbial disease, neoplasms, cancers, tumors, or the like.

The therapeutic composition of the above example except that one or more ingredients in pet food which are Oxalic acid blockers are eliminated or reduced in quantity from that of conventional pet food. For example, the quantity of

EXAMPLE 61

A relatively large adult male human having an inoperable brain tumor is administered 4tableSpoonfuls of dried parsley daily, providing approximately 4 grams of Oxalic acid per day, until the growth of the tumor is checked. Thereafter, he is administered 1 tableSpoonful of dried parsley daily, or approximately 1 gram of Oxalic acid per day. In addition to the administration of the dried parsley, his intake of Oxalic acid blockers including calcium, pyridoxines, citric acid, ascorbic acid, alcohol, or combina

25

Atherapeutic composition for treating infectious or patho genic microbial, bacterial, Viral, or other disease, neoplasms, tumors, cancer, neoplasia, and the like, is made up of pure carrot juice which is administered orally in 2 ounce Servings to provide between 4 and 6 ounces of carrot juice daily to provide the desired therapeutic effect and desired Oxalic acid

35

EXAMPLE 71 40

A therapeutic composition in the form of a nutritional Supplement or multi-Vitamin, multi-mineral tablet contain ing a Small quantity of Oxalic acid, preferably 500 milli grams or less of Oxalic acid, together with conventional ingredients Such as Vitamins and minerals.

EXAMPLE 72

The topical skin treatment composition of Example 71 Serves as an exfoliate, acne treatment, skin cancer treatment,

growth treatment, treatment for infectious microbial, bacte rial or viral disease, or combinations thereof. 50

55

60

A therapeutic composition for the treatment of infectious bacterial or viral disease, neoplasms, tumors, cancer, growths, neoplasia, and the like is made up of an effective amount of dried chives.

A sufficient quantity of the dried chives of Example 73 is administered on a periodic basis to provide the desired therapeutic effect. EXAMPLE 75

EXAMPLE 66

The therapeutic composition of Example 64 including 8 grams or less, preferably 500 milligrams or leSS Oxalic acid, together with conventional quantities of other Vitamins and minerals except that one or more of the Oxalic acid blockers,

EXAMPLE 73

EXAMPLE 74

EXAMPLE 65

A treatment regimen or method including the oral admin istration of one Such tablet, pill, multi-Vitamin, or Supple ment of Example 64 daily.

A therapeutic composition containing oxalic acid as a topical skin treatment includes a mixture of 5 grams or leSS of oxalic acid, 40 milliliters distilled water, and 12 milliliters propylene glycol.

45

The carrot juice of Example 63 is mixed with other juices and flavoring agents Such as tomato juice, Salt, pepper, parsley, and/or celery to enhance the flavor thereof. EXAMPLE 64

A therapeutic composition in the form of a pet food that includes a conventional pet food mixed with a Source of Oxalic acid or oxalate Such as carrot juice, carrots, parsley, chives, or combinations thereof to provide a pet food having an oxalic acid content of 3 grams or less, preferably 500 milligrams or less of Oxalic acid per daily Serving of pet food.

or oxalate blood or urine level. EXAMPLE 63

thereof are reduced or eliminated from conventional pet food in addition to the admixture of oxalic acid dihydrate. EXAMPLE 70

tions thereof is reduced. EXAMPLE 62

Vitamin B6, vitamin C, calcium, citric acid, or combinations

65

Atherapeutic composition or remedy for the maintenance of good health, prevention, treatment, or control of infec tious bacterial or viral disease, neoplasms, tumors, growths, or cancer, and the like is made up of a food item Such as

6,133,318 S3

S4

bread, cereal, or other prepared food including oxalic acid or plant or vegetable containing oxalic acid like parsley or chives, in a Sufficient quantity to provide the desired thera peutic effect.

oxalate, oxalic acid dihydrate, a nutritional Supplement containing oxalic acid, a nutritional Supplement containing oxalate, a nutritional Supplement containing Oxalic acid dihydrate, foods containing oxalic acid, foods containing oxalate, foods containing Oxalic acid dihydrate, carrot juice, and combinations thereof, increasing the ingestion or admin istration of Oxalic acid or oxalate blockers including crushed pineapple, monitoring the levels of Oxalic acid or oxalate in the blood or urine, adjusting the ingestion or administration of Oxalic acid or oxalate-containing compounds and the ingestion or administration of Oxalic acid or oxalate blockers

EXAMPLE 76

A composition for improving and maintaining good health in warm-blooded animals including humans and pets and having a composition Selected from oxalic acid, oxalate, Oxalic acid dihydrate, a nutritional Supplement containing Oxalic acid, a nutritional Supplement containing oxalate, a nutritional Supplement containing Oxalic acid dihydrate, or

to achieve the desired Oxalic acid or oxalate levels.

combinations thereof.

EXAMPLE 85 EXAMPLE 77

15

A flavor enhancer including at least one form of Oxalic acid. EXAMPLE 78

A preservative including at least one form of Oxalic acid.

EXAMPLE 86

EXAMPLE 79

In a prepared food product, the improvement including an

25

effective amount of at least one form of Oxalic acid. EXAMPLE 8O

In a prepared food product, the improvement including the elimination of citric acid and the addition of an effective amount of at least one form of Oxalic acid.

acid or oxalate blockers if the level is below normal, acid or oxalate if the Oxalic acid or the oxalate level is 35

normal, reducing the ingestion or administration of Oxalic acid or oxalate if the level is above normal, or increasing the ingestion or administration of Oxalic acid or oxalate blockers if the level is above normal. EXAMPLE 87

40

intake of Oxalic acid or oxalate blockers. EXAMPLE 82

In a diet for promoting good health in warm-blooded animals including humans, the improvement including increasing the quantity of Oxalic acid or oxalate-containing foods, and reducing the intake of Oxalic acid or oxalate

A method of treating a warm-blooded animal including the Steps of determining the Oxalic acid blood level or oxalate urine level of the animal, comparing this level with a Scale indicating below normal, normal, and above normal Oxalic acid or oxalate levels, increasing the administration or ingestion of Oxalic acid or oxalate if the level is below normal, reducing the ingestion or administration of Oxalic maintaining current ingestion or administration of Oxalic

EXAMPLE 81

A method of enhancing or promoting the growth or the Spread of infectious bacterial or viral disease, neoplasms, tumors, growths, neoplasia, and the like in warm-blooded animals Such as test animals including the Steps of reducing the intake of Oxalic acid or oxalate in the diet, destroying the Oxalic acid or oxalate in the animal, and/or increasing the

A method of counteracting, inhibiting, treating, controlling, or reducing the deleterious effects of high levels of Oxalic acid including the Steps of administering or ingest ing a therapeutically effective amount of Vitamin B6, vita min B6-containing nutritional Supplements, foods contain ing Vitamin B6, or combinations thereof.

The method as described in Example 86 wherein the Oxalic acid or oxalate level Scale has differing below normal, normal, and above normal level categories for different health conditions.

45

EXAMPLE 88

In a multivitamin and mineral Supplement, the improve ment including the addition of at least one therapeutically

blockers.

effective form of oxalic acid. EXAMPLE 83

50

A method of inhibiting the therapeutic effect of oxalic acid

The multivitamin and mineral Supplement as described in Example 88 further including the improvement of the reduc

or oxalate in warm-blooded animals. Such as test animals

including the Steps of increasing the ingestion of Oxalic acid blockerS Such as calcium, alcohol, red meat, citric acid,

Vitamin B6, vitamin C, potassium, dairy products, resins, and the like, administering oxalic acid blockers, Such as

tion or elimination of Oxalic acid or oxalate blockers therein. 55

EXAMPLE 90

calcium, alcohol, citric acid, Vitamin C. Vitamin B6, and the

like, and/or destroying or decomposing Some or all of the Oxalic acid or oxalate in the animal.

EXAMPLE 89

60

An oxalic acid treatment method including the Step of mixing carrot juice with other juices and flavoring agents Such as tomato juice, Salt, pepper, parsley, celery, and the like to enhance the flavor thereof.

EXAMPLE 84

A method for inhibiting, preventing, treating, or control ling the deleterious effects of diarrhea, indigestion, damage to digestive tract, kidney damage, or renal failure caused by high levels of Oxalic acid including the Steps of at least one of reducing the ingestion or administration of Oxalic acid,

EXAMPLE 91 65

A therapeutic composition for the maintenance of good health and the prevention, treatment, or control of infectious or pathogenic microbial, bacterial, or viral disease, neoplasms, tumors, growths, cancer, neoplasia, and the like

6,133,318 S6

SS of a food or beverage including a therapeutically effective amount of at least one therapeutically effective form of Oxalic acid Such as a plant or vegetable containing oxalic acid or oxalate like carrot, carrot juice, parsley, or chives.

EXAMPLE 100

A composition for cleaning and rinsing the interior Sur faces of the mouth and teeth made of a dilute solution of

oxalic acid and distilled water, for example, less than 500 mg oxalic acid dihydrate in 300 ml of distilled water.

EXAMPLE 92

Atherapeutic composition of Sourdough bread made from flour, water, yeast, Sourdough Starter, and an additional Oxalic acid ingredient Selected from the group of dried, chopped parsley, freeze-dried chives, Oxalic acid, oxalate, foods containing oxalic acid, foods containing oxalate, Veg etable juice Such as carrot juice, or combinations thereof to provide approximately 2 g. of Oxalic acid per 4 lb. loaf of Sourdough bread.

EXAMPLE 1.01

In a mouthwash, the improvement including the addition of a low concentration of Oxalic acid. EXAMPLE 102

In a tartar control rinse, the improvement being the addition of a Small amount of Oxalic acid. 15

EXAMPLE 103

EXAMPLE 93

A test kit for detecting the oxalate level in urine of warm-blooded animals including humans having a Sample holder and a liquid reagent which upon addition of a Selected quantity of reagent to a Sample of urine in the Sample holder provides a colormetric indication of the presence or absence

A method of therapeutically treating a warm-blooded animals including humans having the Steps of periodically administering a portion of the Sourdough bread of Example 92 to provide a dosage of Oxalic acid of up to about 1 g. Oxalic acid per day.

of Oxalate.

EXAMPLE 94

A method of delaying, preventing, controlling or treating the onset of Alzheimer's Disease, Hodgkin's Disease, Par kinson's Disease, and the like, lessening the effects of the disease, or improving the quality of life of a perSon Suffering from the disease having the Steps of periodically adminis tering a therapeutically effective amount of at least one therapeutically effective form of Oxalic acid or oxalate.

EXAMPLE 104 25

Blockers

EXAMPLE 95

A canine and feline urine oxalate level Scale having above normal, normal, and below normal levels by weight of the animal and providing a quick-ready reference for a veteri narian or a pet owner to test urine oxalate levels and adjust the Oxalic acid or oxalate intake of the canine or feline accordingly.

35

40

EXAMPLE 96

A method for causing the Sloughing off of the inner Surface of the intestinal membrane in a warm-blooded

animal including humans having the Steps of administering daily doses of a therapeutically effective amount of at least one therapeutically effective form of Oxalic acid or oxalate Such as carrots or dried parsley for a period of weeks or months thereby causing the Sloughing off of the interior Surface of the intestinal membrane and removing old

45

eaten. Coffee, tea, cocoa made with distilled water, and

50

55

60

A composition for cleaning oral or dental bridgework

Solution of Oxalic acid and distilled water.

Stones. All red meats, chicken and turkey breasts (generally white meat) are high in pyridoxin (B6), and should be avoided. No alcohol should be consumed. Excessive intake

made of a dilute Solution of Oxalic acid and distilled water.

A composition for cleaning a toothbrush made of a dilute

pyridoxine (Vitamin B6), alcohol, and in certain instances AScorbic acid (Vitamin C), Soda pop, thirst-Quenchers, Sport

drinks and flavored drinking waters, should absolutely be avoided as they are high in citric acid. All dairy products must be avoided as calcium prevents absorption of Oxalic acid, and when combined form calcium-oxalate kidney

tive amount of at least one oxalic acid or oxalate blocker.

EXAMPLE 99

There are certain items in the normal diet that are blockers

to absorption of Oxalic acid which reduces the acid available in the System for reducing tumors and preventing the form ing of tumors. These items arc citric acid, -calcium

EXAMPLE 97

EXAMPLE 98

A Program For Tumor Reduction Improved Dietary Procedure Plan This Dietary Procedure Plan is drawn from research data in the United States patent application for Oxalic Acid or Oxalate Composition and Method of Treatment for Tumors. Oxalic acid is considered to be a natural chemotherapy in the reduction and prevention of tumor growth. Certain vegetables Such as carrots, carrot juice, Spinach, parsley, chives, beets and beet leaves, garlic, collards, and radishes are high among vegetables containing oxalic acid and should be eaten or drank in order to build a high concentration of Oxalic acid in the body fluids. Almonds, cashews, peanuts, walnuts, and many other nuts and Seeds contain oxalic acid and may be eaten. Especially walnuts which are high in oleic and linoleic fatty acids and increase Oxalic acid absorption in the lower intestine and should be natural fruit juices are acceptable for drinking, especially cocoa which is very high in Oxalic acid content. All bever ages should be free of citric acid.

bacteria, food, waste, and intestinal cells and membrane.

A method of treating or preventing oxalate nephrosis in animals including dogs, goats, humans, cattle, and the like, including periodically administering a therapeutically effec

The Relationship Between Oxalic Acid and

65

of ascorbic acid should be avoided. It is absolutely necessary to read the ingredients on all food and drink items consumed while on the diet. Citric and ascorbic acids are widely used as a preservative in many products, including frozen and bakery goods.

6,133,318 58

57 AS oxalic acid is built up In the System, one may expe rience indigestion known as heartburn or a nagging back ache. These are indicators that the acid is being ingested in too large a quantity, or the System is absorbing the acid at a rate faster than it can be utilized. Indigestion or heartburn can be relieved by taking 2 or 3 teaspoonful of crushed pineapple. Relief for the backache can be accomplished by taking one 100 mg B6 pill. You will learn a slight modera

Selected from the group of Oxalic acid in a free acid, ester, lactone or Salt form, oxalates including Sodium oxaliate, a nutritional Supplement containing at least one form of Oxalic acid or oxalate, Oxalic acid dihydrate, anhydrous Oxalic acid, oxamide, oxalate Salts, natural or processed foods including molds, plants or vegetables including parsley, chives, garlic, beets, carrots, Spinach, and the like containing at least one form of Oxalic acid or oxalate, beverages, liquids or juices Such as carrot juice containing at least one form of Oxalic acid or oxalate, additives containing at least one form of

tion of the diet will avoid either of the above conditions. Maximum effect of oxalic acid on tumor reduction would be

accomplished if an acid level can be maintained just below the discomfort level. Research shows that 5 to 7 days after Start of the diet, an increase in energy may be experienced. Some people notice a body weight loSS. Improvement in condition of visible tumors may be noticed after 12 to 15 days. If there are multiple tumors, the

Oxalic acid or oxalate, and combinations thereof. EXAMPLE 110 15

The composition as described in Example 109 wherein the composition is Oxalic acid dihydrate. EXAMPLE 111

newest tumors will regress first, and the core (first) tumor

will require a longer diet time. Once tumors begin to Shrink and disappear and when finally all trace of cancer has been cleared in the blood System, a balanced diet of all foods may be resumed while being Sure to maintain an adequate level of Oxalic acid in the System to prevent resumption of tumor growth. The microwave should not be used for cooking or heating any foods or beverage in the diet because it reduces the Strength of the acid. Also, do not use electric blanket, electric razor, and electric hair blower/dryer because Strong electric

The composition as described in Example 109 wherein the composition is carrots, carrot juice or dried parsley. EXAMPLE 112

25

The composition as described in Example 109 further having a pharmaceutically acceptable carrier or diluent for the therapeutically effective form of Oxalic acid or oxalate. EXAMPLE 113

The composition as described in Example 112 wherein the carrier or diluent is at least one of a gel cap and distilled

fields can reduce the acid.

This Same procedure can be used to treat other infections

Water.

and disease.

EXAMPLE 114

EXAMPLE 105

A dietary Supplement for everyday optimum nutritional balance having between 0.5 to 1.5 g. of Oxalic acid.

35

EXAMPLE 106

A test kit for detecting the presence and quantity of Oxalic acid in a blood Sample of a warm-blooded animal including humans having a Sample Support Surface, a reagent, and a mixing container for mixing together the blood Sample and reagent to allow the reagent to undergo a color change and provide a colormetric determination of the presence and quantity of Oxalic acid in the Sample.

EXAMPLE 1.15 40

The method as described in Example 114 wherein the composition is administered orally or Sublingually in at least one of gel cap, tablet, powder, food additive, food, drops, liquid, beverage, pill and capsule form. 45

EXAMPLE 107

A method of treating warm-blooded animals including the Steps of testing the blood or urine oxalic acid or oxalate levels, administering oxalic acid, oxalate or blockers thereof, and monitoring the levels to determine if adjust ments are necessary to achieve a desired level.

50

of disease or different or abnormal cells or tissues, or for

otherwise therapeutically treating warm-blooded animals including pets and humans and including at least one thera peutically effective form of Oxalic acid or oxalate. EXAMPLE 109

The composition as described in Example 108 wherein the therapeutically effective form of Oxalic acid or oxalate is

EXAMPLE 116

The method as described in Example 114 wherein the composition is administered by injection including venous injection, injection into the diseased area, tumor, neoplasia, cancer, or growth, or injection adjacent the diseased area, tumor, neoplasia, cancer, or growth. EXAMPLE 117

EXAMPLE 108

A composition remedy or agent for controlling, treating or managing infectious or pathogenic microbial, bacterial, or Viral disease, neoplasms, neoplasia, tumors, brain tumors, cancer, growths, and the like, for preventing the new growth

A method for controlling, treating or managing infectious bacterial or viral disease, neoplasms, neoplasia, tumors, growths, cancers, abnormal cells or tissues, and the like, in warm-blooded animals including pets and humans having the Steps of periodically administering a therapeutically effective dosage of the composition of Example 108.

55

The method as described in Example 114 wherein the composition is administered topically by at least one of transdermal patch, ointment, Salve, cream, lotion, gel, Solution, and the like. EXAMPLE 118

60

65

The method as described in Example 114 wherein the composition is administered internally by at least one of Swallowing, inhalation, Suppository, and Subcutaneous deposit. EXAMPLE 119

The method as described in Example 114 wherein the composition is administered at least once a day at a dosage

6,133,318 59

60

of up to 8 g., preferably 50 mg to 6 g for humans or up to 4 g, preferably 1 mg to 3 g for pets.

EXAMPLE 127

A diet for treating, controlling, and preventing infectious or pathogenic microbial, bacterial, or viral disease, neoplasms, cancer, tumors, neoplasia, and the like in warm blooded animals including pets and humans having the Steps of adding to the regular diet a dietary Supplement of at least one therapeutically effective form of Oxalic acid or oxalate.

EXAMPLE 120

The method as described in Example 114 further having the Steps of reducing the intake of Oxalic acid or oxalate blockers and/or increasing the intake of Oxalic acid or oxalate enhancers. EXAMPLE 121

EXAMPLE 128

The method as described in Example 120 wherein the blockers are Selected from the group of citric acid, ascorbic acid, pyridoxine hydrochloride, calcium, alcohol, resins, clayS, and combinations thereof.

The diet as described in Example 127 wherein the thera peutically effective form of Oxalic acid or oxalate is Selected from the group of Oxalic acid in a free acid, ester, lactone or Salt form, oxalates including Sodium oxalate, a nutritional Supplement containing at least one form of Oxalic acid or oxalate, Oxalic acid dihydrate, anhydrous Oxalic acid, oxamide, oxalate Salts, natural or processed foods including molds, plants or vegetables including parsley, chives, garlic, beets, carrots, Spinach, and the like containing at least one form of Oxalic acid or oxalate, beverages, liquids or juices Such as carrot juice containing at least one form of Oxalic acid or oxalate, additives containing at least one form of

EXAMPLE 122

The method as described in Example 120 wherein the blockers are Selected from the group of dairy products including calcium, fruits, coconut, beverages containing alcohol, ascorbic acid or citric acid including adult bever ageS Such as beer, wine, Vodka, gin, and the like, fruit juice based beverages, Soda pop or Soft drinkS containing ascorbic acid or citric acid, other Sports drinks, beverages or refresh ments containing ascorbic acid or citric acid, red meat or white meat of fowl including chicken, turkey, pheasant and the like containing pyridoxines, or other foods or beverages containing alcohol, citric acid, ascorbic acid or pyridoxine hydrochloride including breads or grains, resins, and com

15

Oxalic acid or oxalate, and combinations thereof. EXAMPLE 129

25

The diet as described in Example 127 further having the Steps of reducing the intake of Oxalic acid or oxalate blockers.

binations thereof. EXAMPLE 123

EXAMPLE 130

A composition for controlling, treating or managing infec tious disease or hyperplasia including SWOllen or enlarged prostate, and the like, for preventing new Swelling or enlargement of tissues, or for otherwise therapeutically treating warm-blooded animals including pets and humans and including at least one therapeutically effective form of

The diet as described in Example 129 wherein the block ers are selected from the group of citric acid, ascorbic acid, pyridoxine hydrochloride, calcium, alcohol, resins, clayS, 35

EXAMPLE 1.31

Oxalic acid or oxalate. EXAMPLE 124

The composition as described in Example 123 wherein the therapeutically effective form of Oxalic acid or oxalate is Selected from the group of Oxalic acid in a free acid, ester, lactone or Salt form, oxalates including Sodium oxalate, a nutritional Supplement containing at least one form of Oxalic acid or oxalate, oxalic acid dihydrate, anhydrous Oxalic acid, oxamide, oxalate Salts, natural or processed foods including molds, plants or vegetables including parsley, chives, garlic, beets, carrots, Spinach, and the like containing at least one form of Oxalic acid or oxalate, beverages, liquids or juices Such as carrot juice containing at least one form of Oxalic acid or oxalate, additives containing at least one form of

40

45

50

A method for controlling, treating or managing infectious disease or hyperplasia including Swollen or enlarged prostate, and the like for preventing new Swelling or enlarge ment of tissues, or for otherwise therapeutically treating warm-blooded animals including pets and humans having the Steps of periodically administering a therapeutically effective dosage of the composition of Example 123.

55

60

blockers.

binations thereof.

A veterinary composition for controlling, treating or man aging infectious disease, neoplasms, neoplasia, tumors, brain tumors, cancer, growths, and the like, for preventing the new growth of different or abnormal cells or tissues, or for otherwise therapeutically treating warm-blooded animals including dogs and cats of a composition including at least one therapeutically effective form of Oxalic acid or oxalate. EXAMPLE 1.33

EXAMPLE 126

The method as described in Example 125 further having the Steps of reducing the intake of Oxalic acid or oxalate

The diet as described in Example 129 wherein the block erS are Selected from the group of dairy products including calcium, fruits, coconut, beverages containing alcohol, ascorbic acid or citric acid including adult beverageS Such as beer, wine, Vodka, gin, and the like, fruit juice based beverages, Soda pop or Soft drinkS containing ascorbic acid or citric acid, other Sports drinks, beverages or refreshments containing ascorbic acid or citric acid, red meat or white meat of fowl including chicken, turkey, pheasant, and the like containing pyridoxine, or other foods or beverages containing alcohol, citric acid, ascorbic acid or pyridoxine hydrochloride including breads or grains, resins, and com EXAMPLE 132

Oxalic acid or oxalate, and combinations thereof. EXAMPLE 125

and combinations thereof.

65

The veterinary composition as described in Example 132 wherein the therapeutically effective form of oxalic acid or oxalate is Selected from the group of Oxalic acid in a free acid, ester, lactone or Salt form, oxalates including Sodium oxalate, a nutritional Supplement containing at least one

6,133,318 61

62

form of Oxalic acid or oxalate, Oxalic acid dihydrate, anhy drous Oxalic acid, oxamide, oxalate Salts, natural or pro cessed foods including molds, plants or vegetables including parsley, chives, garlic, beets, carrots, spinach, and the like containing at least one form of Oxalic acid or oxalate, beverages, liquids or juices Such as carrot juice containing at least one form of Oxalic acid or oxalate, additives containing

acid, ascorbic acid, pyridoxine hydrochloride, calcium, alcohol, resins, clavs, and combinations thereof. EXAMPLE 1.43

A method of treating warm-blooded animals including pets and humans afflicted with bacteria, Virus, or tumor cells Sensitive to an oxalic acid compound including the Steps of periodically administering to the animal an oncolytic amount of at least one therapeutically effective oxalic acid or oxalate compound.

at least one form of Oxalic acid or oxalate, and combinations thereof. EXAMPLE 134

EXAMPLE 1.44

The veterinary composition as described in Example 133 wherein the composition is Oxalic acid dihydrate. EXAMPLE 135

15

The veterinary composition as described in Example 133 wherein the composition is at least one of carrots, boiled carrots, carrot juice, and dried parsley.

EXAMPLE 1.45

EXAMPLE 1.36

The veterinary composition as described in Example 133 further having a pharmaceutically acceptable carrier or diluent for the therapeutically effective form of oxalic acid or oxalate.

25

EXAMPLE 1.37

The veterinary composition as described in Example 136 wherein the carrier or diluent is a gel cap or distilled water. EXAMPLE 1.38

A veterinary method for codestrolling, treating or man aging infectious disease, neoplasms, oneoplasia, tumors, growths, cancers or abnormal tissues in warm-blooded ani mals including dogs and cats having the Steps of periodically administering a therapeutically effective dosage of the vet erinary composition of Example 133. EXAMPLE 139

A process for preparing an antimicrobial or anti-tumor agent including the Steps of mixing at least one therapeuti cally effective form of Oxalic acid or oxalate with a phar maceutically acceptable carrier or diluent. The process as described in Example 144 wherein the therapeutically effective form of Oxalic acid or oxalate is Selected from the group of Oxalic acid in a free acid, ester, lactone or Salt form, oxalates including Sodium oxalate, a nutritional Supplement containing at least one form of Oxalic acid or oxalate, Oxalic acid dihydrate, anhydrous Oxalic acid, oxamide, oxalate Salts, natural or processed foods including molds, plants or vegetables including parsley, chives, garlic, beets, carrots, Spinach, and the like containing at least one form of Oxalic acid or oxalate, beverages, liquids or juices Such as carrot juice containing at least one form of Oxalic acid or oxalate, additives containing at least one form of Oxalic acid or oxalate, and combinations thereof. EXAMPLE 1.46

35

40

The process as described in Example 144 wherein the pharmaceutically acceptable carrier or diluent is Selected from the group of distilled water, heated water, pharmaceu tically acceptable liquids, nutritional Supplements, natural or processed foods, and the like. EXAMPLE 1.47

The veterinary method as described in Example 138 w herein the composition is administered orally or Saeblin gually in at least one of gel cap, tablet, powder, food additive, food, beverage, pill and capsule form, by injection including venous injection, injection into the tumor, neoplasia, cancer, or growth, or injection adjacent the tumor, neoplasia, cancer, or growth, topically by at least one of transdermal patch, ointment, Salve, cream, lotion, gel, Solution, wash, gargle, rinse, and the like, internally by Swallowing, inhalation, Suppository or Subcutaneous deposit, or combinations thereof.

A composition for treating infectious viral or auto immune-related diseases Such as HIV, SLE, AIDS, BSE, 45

Oxalic acid or oxalate. EXAMPLE 1.48 50

55

60

The veterinary method as described in Example 141 wherein the blockers are Selected from the group of citric

A composition for counteracting the decomposition or reduction of Oxalic acid or oxalate caused by radiation exposure, radiation treatment, X-rays, Strong electromag netic waves or fields, microwaves, and the like or for

or oxalate blockers. EXAMPLE 142

SLE, BSE, CFS, and the like, preventing, lessening or controlling the destruction of the body's immune System, or purifying the blood including the Steps of periodically administering a therapeutically effective amount of the com position of Example 147. EXAMPLE 1.49

EXAMPLE 141

The veterinary method as described in Example 138 further having the Steps of reducing the intake of Oxalic acid

A method of treating, preventing or controlling infectious viral or auto immune-related diseases Such as AIDS, HIV,

EXAMPLE 140

The veterinary method as described in Example 138 wherein the composition is administered at least once a day at a dosage of about 1 mg to 3 g for dogs and cats.

CFS, and the like, and having a therapeutically effective amount of at least one therapeutically effective form of

65

returning the body's Oxalic acid or oxalate level to at least a normal level following radiation treatment, X-rays, CAT Scans, MRI-Scans, and the like including a therapeutically effective amount of at least one therapeutically effective form of Oxalic acid or oxalate.

6,133,318 63

64

EXAMPLE 150

least one therapeutically effective form of Oxalic acid or oxalate, a Solvent, and a cream or ointment base.

A method for counteracting the decomposition or reduc tion of Oxalic acid or oxalate caused by radiation exposure, radiation treatment, X-rays, Strong electromagnetic waves or fields, microwaves, and the like or for returning the body's

EXAMPLE 1.59

The therapeutic composition as described in Example 158 wherein the Solvent is distilled water, acetone, propylene glycol, or polySorbate, and the base is a cream, ointment, gel, lotion, Spray, Stick, or powder base.

Oxalic acid or oxalate level to at least a normal level

following radiation treatment, X-rays, CAT scans, MRI Scans, and the like having the Steps of administering a therapeutically effective amount of the composition of Example 149 following the treatment or exposure.

EXAMPLE 160

A method of producing the therapeutic composition as described in Example 158 having the Steps of mixing a dilute concentration of at least one therapeutically effective form

EXAMPLE 1.51

The method as described in Example 150 further includ ing the Steps of administering a therapeutically effective amount of the composition of Example 149 prior to the

15

treatment or exposure. EXAMPLE 1.52

A method of enhancing the therapeutic effect of Oxalic acid or oxalate including the Steps of decreasing or elimi nating the ingestion or administration of one or more of

EXAMPLE 161

Oxalic acid or oxalate blockers. EXAMPLE 153

of Oxalic acid or oxalate with a Solvent Such as distilled

water, acetone, propylene glycol, polySorbate or the like to form a Solution, mixing the Solution with a base Such as a hydrophilic petrolatum, cream, ointment, gel, lotion, Spray, Stick, powder or other base.

25

The method as descril Red in Example 152 wherein the blockers are Selected from the group of calcium, alcohol, citric acid, ascorbic acid, pyridoxine hydrochloride, resins,

An improved canned or dry pet food including conven tional ingredients along with the addition of a therapeuti cally effective quantity of at least one therapeutically effec tive form of Oxalic acid or oxalate. EXAMPLE 162

The improved pet food of Example 161 including the

and combinations thereof.

elimination or reduction of Oxalic acid or oxalate blockers

EXAMPLE 1.54

A method of treating brain tumors, infectious disease, including the Steps of ingesting or administering a therapeu tically effective amount of at least one therapeutically effec colds, flu, diverticulitis, acid reflux, infection, and the like,

EXAMPLE 163

35

tive form of Oxalic acid or oxalate. EXAMPLE 155 40

The method as described in Example 154 wherein the therapeutically effective form of Oxalic acid or oxalate is dried chopped parsley. EXAMPLE 1.56

and others, including the Steps of reducing or eliminating the ingestion or administration of Oxalic acid or oxalate blockers, administering or ingesting high dosages of Oxalic

infectious disease, microbial disease, tumor, cancer, or 45

50

55

60

A therapeutic composition for purifying the blood, controlling, treating or eradicating infectious disease, micro bial disease, abnormal cells, controlling, treating or affecting cholesterol plaque and fat buildup in the cardiovascular System or in the brain, and maintaining good cardiovascular health and operation, having a therapeutically effective amount of at least one therapeutically effective form of Oxalic acid or oxalate.

Oxalic acid or oxalate enhancers.

Atherapeutic composition in cream or ointment form for topical administration of Oxalic acid or oxalate having at

A method of treating osteoporosis including the Steps of increasing calcium intake and decreasing Oxalic acid or EXAMPLE 1.65

EXAMPLE 1.57

EXAMPLE 158

normal blood or urine oxalic acid or oxalate level.

oxalate intake.

a more moderate level of Oxalic acid or oxalate to maintain a normal blood or urine oxalic acid or oxalate level.

The regimen as described in Example 156 further includ ing the Steps of increasing the administration or ingestion of

abnormal cells, reducing or eliminating the administration or ingestion of Oxalic acid or oxalate to maintain a below EXAMPLE 164

acid or oxalate to raise the blood or urine oxalic acid or

oxalate level above normal, and, after cleansing the blood of tumor, cancer or abnormal cells, administering or ingesting

acid or oxalate to raise the blood or urine Oxalic acid or

oxalate level above normal, and, after cleansing the blood of

A treatment regimen for treating infectious disease, microbial disease, neoplasms, tumors, cancers, growths, neoplasia, and the like, including infectious bacterial and Viral disease, brain tumors, breast cancer cervical cancer,

A method of treating infectious disease, microbial disease, neoplasms, tumors, cancers, growths, neoplasia and the like including bacterial and viral infections, brain tumors, breast cancer, cervical cancer, and others in a perSon Suffering from Osteoporosis including the Steps of reducing or eliminating the ingestion or administration of Oxalic acid or oxalate blockers, administering or ingesting high dosages of Oxalic

EXAMPLE 166 65

An oral rinse or wash for SmokerS or Snuff users for

controlling, treating or managing infectious or pathogenic bacterial or viral disease, neoplasms, neoplasia, tumors,

6,133,318 65

66

cancers, growths, and the like, for preventing the new growth of infectious disease, different or abnormal tissues, or for otherwise therapeutically treating the mouth area, having a dilute Solution of at least one therapeutically

drank in order to build a high concentration of acid in the body fluids. Almonds, cashews, peanuts, and, especially walnuts which are high in oleic and linoleic fatty acids and increase oxalic acid absorption may be eaten.

effective form of Oxalic acid or oxalate.

Red meats, chicken and turkey breasts, (generally white meat) are considered high in Pyridoxine (Vitamin B6), and

EXAMPLE 167

should be avoided during the treatment. Alcohol and prod

ucts containing citric acid (Soda pop, other Soft drinks, and thirst quenchers are generally high in citric acid), and ascorbic acid (Vitamin C) are considered blockers of oxalic

A method of manufacturing a dry processed dog food containing at least one form of Oxalic acid or oxalate including the Steps of mixing a Slurry of conventional dog food ingredients together with a dilute Solution of Oxalic acid or oxalate in heated water to form an oxalic acid or

oxalate containing slurry, forming the Slurry into pellets and drying the pellets.

15

EXAMPLE 1.68

The method as described in Example 167 wherein the Oxalic acid is oxalic acid dihydrate and each pellet contains approximately 1 mg of Oxalic acid So that one pound of dry dog food contains about 1 g of Oxalic acid.

the treatment. Calcium inhibits oxalic acid and when com

bined can form calcium oxalate Stones (kidney). Coffee, cocoa, regular tea, made with distilled water, and natural fruit juices are acceptable for drinking. All beverages should be free of citric acid.

EXAMPLE 169

A dietary Supplement for treating a patient diagnosed with infectious bacterial or viral disease or an active cancer,

25

tumor, growth, or neoplasia having about 1 g to 6 g, preferably 2 g to 4 g of Oxalic acid per day based on 70 kilograms of body weight and a pharmaceutically acceptable carrier or diluent. EXAMPLE 170

A composition for treating parvo virus in animals includ ing canines of a therapeutically effective amount of at least one therapeutically effective form of Oxalic acid or oxalate.

plished if a acid level can be maintained just below the 35

40

45

Solutions 50

EXAMPLE 173

In a pet treat Such as a jerky Strip, dog bone, chew, rawhide, and the like, the improvement of the addition of microgram amounts of at least one therapeutically effective form of Oxalic acid or oxalate, whereby the treats provide for the maintenance of good pet health.

55

60

Reduction

Our research indicates the following as a treatment for infectious disease and the reduction of cancers or tumors:

Carrots, carrot juice, Spinach, parsley, chives, beets and beet leaves, garlic, collards and radishes are high among vegetables containing Oxalic Acid and should be eaten or

Our research shows that five to seven days after start of the treatment, an increase in energy will be experienced. Some people notice a body weight loSS. Improvement in condition of the tumor should be noticed after 10 to 12 days. If there are multiple tumors, the newest tumors will

time. Once tumors begin to Shrink and disappear and when finally all trace of cancer has been cleared in the blood system a balanced diet of all foods may be resumed while being Sure to maintain an adequate level of Oxalic acid in the System to prevent resumption of tumor growth. The microwave should not be used for cooking or heating any foods or beverage in the diet because it reduces the Strength or amount of the Oxalic acid. EXAMPLE 1.75

EXAMPLE 174

Treatment For Infectious Disease, Cancer or Tumor

discomfort level.

regress first, while older (core) tumors will require a longer

EXAMPLE 172

The pharmaceutical composition as described in Example 171 wherein the composition is provided in a form selected from the group of pills, powders, granules, tablets, microcapsules, gel capsules, nutritional Supplements, pro cessed foods, liquids, juices, drops, beverages, additives and

AS oxalic acid is built up in the System one may experi ence indigestion known as heartburn or a nagging backache. These indicate that the acid is being ingested in too large a quantity or the System is digesting the acid at a rate faster than it can be absorbed. Indigestion can be relieved by taking 2 or 3 teaspoonfuls of crushed pineapple. Relief for the backache can be accomplished by taking one 100 mg Vitamin B6 pill. A slight reduction of the intake of oxalic acid will avoid either of the above conditions. Maximum effect of Oxalic acid on tumor reduction would be accom

EXAMPLE 171

A pharmaceutical composition to be administered orally to humans of a mixture of a non-toxic ingestible carrier and a therapeutically effective form of Oxalic acid or oxalate.

acid and should be avoided since they retard the build up of Oxalic acid in the System. It is absolutely necessary to read the ingredients on all food and drinkS consumed while on the treatment. Citric and ascorbic acids are widely used as a preservative in many products, including frozen and bakery goods. All dairy products should also be avoided while following

65

Oxalic Acid Dietary Plan Our research indicates the following as a diet for the treatment of infectious disease or the reduction of tumors:

Carrots, carrot juice, Spinach, parsley, chives, beets and beet leaves, garlic, collards and radishes are high among vegetables containing oxalic acid or oxalate and should be eaten or drank in order to build a high concentration of Oxalic acid in the body fluids. Almonds, cashews, peanuts, and, especially walnuts which are high in oleic and linoleic fatty acids and increase oxalic acid absorption may be eaten.

Red meats, chicken and turkey breasts, (generally white meat) are considered high in Pyridoxine (Vitamin B6), and

should be avoided during the treatment. Alcohol and prod

ucts containing citric acid (Soda pop, other Soft drinks and

6,133,318 67 thirst quenchers are generally high in citric acid), and ascorbic acid (Vitamin C) are considered blockers of oxalic

68 dog food, Supplemented by Oxalic acid or oxalate formula. Dosage will be at the maximum computed on the above blood and urine analysis. Repeat urine checks will be completed, as determined by the veterinarian, and the amount of Oxalic acid or oxalate formula will be adjusted as required. After initiation of the protocol the veterinarian will

acid or oxalate and should be avoided Since they retard the build up of oxalic acid in the system. It is absolutely necessary to read the ingredients on all food and drinkS consumed while on the diet. Citric and ascorbic acids are

widely used as a preservative in many products, including frozen and bakery goods. All dairy products should also be avoided while following

observe the level of oxalates in the urine. The urine oxalate

level will be maintained at the desired level, based on the

weight of the animal, using urine oxalate Scales of the present invention.

the treatment. Calcium inhibits oxalic acid and when com

bined can form calcium oxalate Stones (kidney). Coffee, cocoa, regular tea, made with distilled water, and limited amounts of natural fruit juices are acceptable for drinking. All beverages should be free of citric acid. AS oxalic acid is built up in the System one may experi ence indigestion known as heartburn or a nagging backache. These are indicators that the Oxalic acid is being ingested in too large a quantity or the System is digesting the acid at a rate faster than it can be absorbed. Indigestion can be relieved by taking 2 or 3 teaspoonfuls of crushed pineapple. Relief for the backache can be accomplished by taking one 100 mg Vitamin B6 pill. A slight reduction or moderation of the intake of oxalic acid or oxalate will avoid either of the above conditions. Maximum effect of oxalic acid on tumor

reduction would be accomplished if an oxalic acid level can be maintained just below the discomfort level. Our research shows that five to seven days after start of the treatment, an increase in energy will be experienced. Some people notice a body weight loSS. Improvement in condition of the tumor should be noticed after 10 to 12 days. If there are multiple tumors, the newest tumors will

EXAMPLE 177 15

25

Sulfate, Smectite, Vermiculite, ferrous Sulfate, ferric choline

citrate, Zinc oxide, manganous oxide, copper oxide, copper Sulfate, cobalt carbonate, ethylene diamine dihydroiodide, Sodium Selenite, and Oxalic acid. Feline Mix

regress first, while older (core) tumors will require a longer

time. Once tumors begin to Shrink and disappear and when finally all trace of cancer has been cleared in the blood system a balanced diet of all foods may be resumed while being Sure to maintain an adequate level of Oxalic acid or oxalate in the System to prevent resumption of tumor growth. The microwave oven should not be used for cooking or heating any foods or beverage in the diet because it reduces the Strength or amount of the Oxalic acid.

35

animal fat, (preserved with BHA propyl gallate), brewers chloride, calcium Sulfate, taurine, ethoxyquin, (a preservative), ferrous Sulfate, Zinc oxide, copper chloride, 40

Canine Mix

Protocol for Treatment of Canine, Equine, Feline Species for the Control of Infectious Disease or

Neoplasia (Tumors) Research and Development Phase

and urine analysis, including analysis for oxalates. Based on Veterinarian's diagnosis of the animal's

50

55

Ingredients Ground corn, Soybean meal, meat and bone meal, Soy whole, beet pulp, Salt, corn gluten meal, Soy oil, dicalcium phosphate, poultry fat, and Oxalic acid. In each of the above feed Supplements oxalic acid is added at one gram of Oxalic acid to one pound of dried food. Crude protein, crude fat, crude fiber, and moisture will be blended at different formula for the life stage of the animals. Oxalic acid feed supplement will be added to the daily diet as determined by the attending veterinarian for each of the above mixeS. EXAMPLE 1.78

60

condition, the maximum amount of Oxalic acid or oxalate

formula will be recommended for the first 14 days. At the completion of 14 days, a blood and urine analysis will be completed and if results are Satisfactory, the animal will be placed on a diet, based on the animals weight, of regular dry

manganous oxide, cobalt carbonate, calcium iodate, Sodium Selenite, and Oxalic acid.

45

mine the location, type, and size of the tumor(s); MRI, CAT scan, or X-ray should be used if procedure is available; blood analysis, including (CBC) liver and kidney profiles;

Ingredients Ground corn, poultry by-product meal, corn gluten meal

rice, chicken liver digest, potassium chloride, choline

EXAMPLE 176

Prior to the commencement of protocola complete exami nation should be accomplished by the attending veterinarian. The examiner should complete and record the following: History Since the onset of the neoplasia based on owners description; Specific diet, to include all treats, and liquid intake; general activity level during previous period; age; weight, general examination; physical examination to deter

Animal Feed Supplement Mixes The Supplement is to be added to the normal feed/food, by weight, to add the amount of Oxalic acid desired. Equine Mix Ingredients Ground oats, ground corn, ground barley, wheat middlings, Soybean meal, cane molasses, dried hydrolyzed whey, dried whey, Soy flour, animal fat, vegetable fat, dehydrated alfalfa meal, dicalcium phosphate, calciumcarbonate, Salt, magnesium Sulfate, potassium

65

Supplement Mixes The Supplement is to be added to the normal feed/food, by weight, to add the amount of Oxalic acid or oxalate desired. Equine Mix Ingredients Ground oats, ground corn, ground barley, wheat middlings, Soybean meal, cane molasses, dried hydrolyzed

6,133,318 69

70

whey, dried whey, Soy flour, animal fat, vegetable fat, dehydrated alfalfa meal, dicalcium phosphate, calciumcarbonate, Salt, magnesium Sulfate, potassium

EXAMPLE 181

An oxalic acid or oxalate containing bread including about 1 gram of Oxalic acid or oxalate per loaf of bread.

Sulfate, Smectite, Vermiculite, ferrous Sulfate, ferric choline

citrate, Zinc oxide, manganous oxide, copper oxide, copper Sulfate, cobalt carbonate, ethylene diamine dihydroiodide,

EXAMPLE 182

The bread of Example 181 wherein the oxalic acid is oxalic acid dihydrate dissolved in distilled water prior to being added to the bread during manufacturing of the loaf.

Sodium Selenite, and Oxalic acid or oxalate. Feline Mix

Ingredients Ground corn, poultry by-product meal, corn gluten meal

animal fat, (preserved with BHA propyl gallate), brewers rice, chicken liver digest, potassium chloride, choline chloride, calcium Sulfate, taurine, ethoxyquin, (a preservative), ferrous Sulfate, Zinc oxide, copper chloride,

EXAMPLE 1.83

The bread of Example 182 further containing about 2 cups of trail mix including nuts, dried fruits, and the like, per loaf of bread with the trail mix being added during the manu

15

manganous oxide, cobalt carbonate, calcium iodate, Sodium

EXAMPLE 1.84

Selenite, and Oxalic acid or oxalate.

A dry dogfood is prepared with 300 lbs. of dry dogfood having added thereto 10% ounces of oxalic acid dihydrate to provide about 1 gram of Oxalic acid per pound of dry dogfood. The oxalic acid dihydrate powder is added to 90 C. distilled water and mixed into the conventional dogfood Slurry.

Canine Mix

Ingredients Ground corn, Soybean meal, meat and bone meal, Soy whole, beet pulp, Salt, corn gluten meal, Soy oil, dicalcium phosphate, poultry fat, and oxalic acid or oxalate. In each of the above feed Supplements oxalic acid or oxalate is added at one gram of Oxalic acid or oxalate to one pound of dried food. Crude protein, crude fat, crude fiber,

facture of the loaf.

25

EXAMPLE 1.85

The dogfood of Example 184 with the exception that any Vitamin B6 is removed from the conventional dry mix.

and moisture will be blended at different formula for the life

EXAMPLE 1.86

Stage of the animals. The feed supplement will be added to the daily diet as determined by the attending veterinarian for each of the above mixeS. EXAMPLE 1.79 35

Canine Supplement Mix The Supplement is to be added to the normal feed/food, by weight, to add the amount of Oxalic acid or oxalate desired. Ingredients Ground corn about 55.99%, soybean meal 8.53%, meat and bone meal 15.85%, soy whole 2.54%, beet pulp 1.9%, salt 0.45%, corn gluten meal 9.35%, soy oil 1.87%, dical cium phosphate 0.47%, poultry fat 3.00%, and oxalic acid 0.0023%, with moisture about 0–10%.

40

45

In the above feed Supplement oxalic acid or oxalate is added at about one gram of Oxalic acid or oxalate to one pound of dried food. Crude protein, crude fat, crude fiber, and moisture will be blended at different formula for the life

Stage of the animals. The feed supplement will be added to the daily diet as recommended by the attending veterinarian.

50

EXAMPLE 18O

A method of counteracting the deleterious effects of a mammogram, CAT-Scan, X-ray, and the like, exposure or treatment including the Steps of about 3 weeks prior to the exposure increasing the intake of Oxalic acid or oxalate continuing the increased oxalic acid or oxalate during the treatment and for 3 weeks following treatment. Thereafter, checking the blood or urine Oxalic acid or oxalate levels of the patient and if they are normal, continuing with that level of intake of Oxalic acid or oxalate, if they are above normal, reducing the intake of Oxalic acid or oxalate, and if they are below normal, increasing the intake of Oxalic acid or oxalate. Thereafter, monitoring the levels and adjusting the intake on a periodic basis.

55

An oxalic acid intake adult management control plan includes four phases. In the first phase, the adult is admin istered about 1% to 2 grams of Oxalic acid or oxalate per day for 5-7 days to eliminate infectious disease, microbial disease, abnormal cells, or otherwise clean the blood of the patient for a 70 kilogram weight adult. For larger adults, the dosage would have to be increased. Also, Oxalic acid and oxalate levels are checked in the blood, plasma and/or urine to determine the exact amount of Oxalic acid or oxalate required for the individual Subject. In the Second phase of the treatment, the Subject is given about 34 gram of Oxalic acid or oxalate for an additional 15-20 days until the infectious disease, microbial disease, or the growth or expansion of the tumor or malignancy has stopped and the tumor is in regression, eliminated, or inert. In the third phase the Subject is given about 72 gram of Oxalic acid or oxalate per day to continue infectious disease, microbial disease or tumor reduction or until the body is clean. In the fourth phase or maintenance phase, the Subject is given about 50 mg of Oxalic acid or oxalate per day for maintenance of good health and to keep all disease or cancers in remission or in check. Again, these dosages arc provided for an average 70 kilogram adult and the individual’s Oxalic acid or oxalate levels need to be checked periodically and the dosages adjusted as necessary. EXAMPLE 1.87

The control plan of Example 186 wherein a computer model of the chemical balance of the human body is used in addition to the Oxalic acid and oxalate level information to

60

determine the proper dosage for that individual. EXAMPLE 1.88

65

An animal testing method for testing, for example, the disease or carcinogenic effect of one or more agents or irritants on an animal Such as a mouse or rat, including the Steps of determining the normal oxalic acid or oxalate blood or urine level of the animal, irradiating the animal to weaken

6,133,318 71

72

its natural immune System and administering a dosage of Oxalic acid or oxalate to the animal as necessary to bring its Oxalic acid or oxalate blood or urine level back up to a normal level prior to further testing of the animal.

EXAMPLE 1.99

An Oxalic acid or oxalate containing drink including carrot juice having a pH of about 5.5. EXAMPLE 200

EXAMPLE 1.89

A mouthwash or oral rinse containing a dilute Solution of 500 milligrams or less of oxalic acid dihydrate per 500

A method of treating an animal Suffering from bovine

Spongiform encephalopathy (BSE) by feeding the animal a

milliliters of distilled water.

feed high in Oxalic acid or oxalate, for example Halogeton or Setavia plants or grass.

EXAMPLE 2.01

A method of treating terminally ill animals including adult humans including the Steps of administering a high dosage

EXAMPLE 190

The method of Example 189 including the step of treating the animal directly by an intravenous administration of

Oxalic acid.

15

of Oxalic acid or oxalate to cleanse the blood and treat the condition or disease. EXAMPLE 202

EXAMPLE 191

The method of Example 201 further including the steps of Stopping conventional oncological chemotherapy treatments to prevent the weakening of the body and prevent the decomposition or reduction of Oxalic acid or oxalate in the body.

A method of treating humans having Creutzfeldt-Jakob

Disease (CFS) by administering a therapeutic quantity of at least one therapeutically effective form of Oxalic acid or oxalate. EXAMPLE 192

The method of Example 191 including the step of admin istering oxalic acid directly by intravenous administration.

EXAMPLE 203 25

EXAMPLE 1.93

A method of preventing BSE or CFS in warm-blooded animals including cattle and humans including the Steps of increasing the intake of at least one form of Oxalic acid or

EXAMPLE 2.04

The method of Examples, 201, 202, or 203 further includ ing the Step of reducing the intake of Oxalic acid or oxalate blockers and increasing the intake of Oxalic acid or oxalate

oxalate.

enhancers.

EXAMPLE 1.94

A method of treating animals using oxalic acid or oxalate in place of or in addition to conventional chemotherapy and administering at least one therapeutically effective form of Oxalic acid or oxalate continuously to the patient in decreas ing amounts to treat, control, or prevent cancer, tumors, growths, bacterial disease, Viral disease, chemical disease, and the like without deleteriously affecting normal cells.

35

40

EXAMPLE 195

A method of enhancing the beneficial effects of Oxalic acid or oxalate in animals including humans and pets including the Steps of eliminating the use of microwave cooking for heating food or drink of the animal to prevent the decomposition or reduction in the amount of Oxalic acid

45

The method of Example 195 further including the step of eliminating the use of the microwave oven for cooking or heating to prevent exposure to microwaves and thereby prevent decomposition or reduction in Oxalic acid or oxalate in the animal being eXposed.

50

55

EXAMPLE 1.97

The method of Example 196 further including the steps of eliminating the use of radiation, X-ray, CAT-Scan, mammogram, Strong electromagnetic waves, excessive heat, or other exposures or treatments which would decompose or

60

reduce the amount of Oxalic acid or oxalate in the animal. EXAMPLE 1.98

A mouthwash containing a dilute Solution of Oxalic acid and having a pH of about 2.3.

EXAMPLE 2.05

Antimicrobial Oxalic acid or oxalate compositions and methods of treatment or prevention of warm-blooded ani mals including humans and pets is provided which includes at least one therapeutically effective form of Oxalic acid or Oxalate for controlling, treating, preventing, or managing bacterial diseases and viral diseases caused by germs of infectious bacteria, including bacterial diseases caused by Gram-Positive Cocci such as Staphylococcal infections of Pneumonia, Bacteremia, Osteomyelitis, Enterocolitis, and the like, Streptococcal infections Such as Homolytic, Viridans, Enterococci, lactic, and the like, Pneumococcal

or oxalate in their food or drink.

EXAMPLE 1.96

The method of Example 201 further including the steps of reducing the dosage of Oxalic acid or oxalate after the blood has been cleansed and the condition or disease has improved.

65

infections Such as Pneumonia, Sinusitis, Otitis, Meningitis, and the like, also bacterial diseases caused by Gram Negative Cocci, Neisseria Aerobic infections Such as Meningococcus, Gonococcus, and the like, also bacterial diseases caused by Gram-Positive Bacilli infections such as Erysipelothricosis, Listeriosis, Anthrax, Nocardiosis, and the like, also bacterial diseases caused by Gram-Negative Bacilli infections Such as Enterobacteriaceac Salmonella, Shigellosis, Hemophilus, Tularemia, Plaque, Melioidosis, Bartonellosis, Campylobacter, and Noncholera Vibrio, and the like, also bacterial diseases caused by Anaerobic Bacilli infections such as Clostridium Botulinum, Clostridium Tetany, Clostridia of Gas Gangrene Bacteroides, Mixed Anaerobic, Actinomycosis, and the like, also diseases caused by Mycobacteria, infections Such as Tuberculosis and Leprosy, and the like, and also bacterial diseases caused by Spirochetes Such as LeptoSpirosis Lyme Disease, and Endemic Treponematoses. EXAMPLE 2.06

Antimicrobial Oxalic acid or oxalate compositions and methods of treatment or prevention of warm-blooded ani

6,133,318 73

74

mals including humans and pets is provided which includes at least one therapeutically effective form of Oxalic acid or Oxalate for controlling, treating, preventing, or managing bacterial diseases and viral diseases caused by infectious Viruses, including infectious nucleic acid type Viral diseases

TABLE II Oxalic Acid Contents of Foods 5

Such as deoxyribonucleic acid types (DNA), and ribonucleic acid (RNA), with natural cycle chiefly in humans, spread by

Oxalic acid Method of Food

perSon-to-person contact, and transmitted from nature to man and may also infect animals, diseases Such as Human

Vegetables

Immunodeficiency Virus infection (HIV) and Acquired Immunodeficiency Syndrome (AIDS), also Respiratory

Asparagus

Tract Viral diseases, all Serotypes, caused by Influenza, A, B,

Brussels sprouts Cabbage

and C, Parainfluenza viruses 1-4, Rhonoviruses (common cold), Mumps virus, Adenoviruses, Reoviruses, and Epstein

Barr virus, and Infants and Adult Syncytial virus, also primary Atypical pneumonias and others, also Nervous System Viral diseases, all Serotypes, Such as Polioviruses, Coxsackieviruses, Echoviruses and high numbered viruses, Epidemic gastroenteritis viruses, Rubeola Virus, Rubella Virus, Varicella-Zoster virus, Herpes Simplex, Human herpes virus type 6, Human Parvovirus B19, Cytomegalovirus, Hepatitis viruses Types A, B, C, D, Human Papillomavirus, Molluscum contagiosum virus, and also viruses transmitted from nature to man Such as the Arboviruses, togaviruses, alphaviruses, flaviviruses, bunyaviruses, and the Orbivirus, Rabies virus, Herpesvirus Simiae, Arenaviruses, Filoviruses,

Beet root

Carrot 15 Cauliflower

Celery

Chive Lettuce Marrow Mushroom Onion

Parsley Pea, green Potato Radish Rhubarb

Spinach

25 Tomato

Turnip Fruit

Apple Apricot Banana, ripe Gooseberry Grapefruit

TABLE I

Oxalic Acid Content of Selected Vegetables Oxalic Acid

(g/100 g)

Amaranth

1.09

Asparagus Beans, snap

13 36

Beet leaves Broccoli

.61 19

Brussels sprouts

36

Cabbage Carrot Cassava Cauliflower

Celery Chicory Chives Collards Coriander

10 50 1.26 15

Corn, Sweet

O1

Cucumbers

O2

Eggplant

19

Endive Garlic Kale Lettuce Okra Onion

.11 36 O2 33 O5 O5

Parsley Parsnip

1.70 .04

Pea

O5

Pepper

.04

Potato Purslane Radish

Orange 35

O3 97 O2 .24

Tomato

O5

Turnip

.21

Turnip greens

O5

Watercress

31

Peach Pear

Pineapple Plum

Raspberry Strawberry 40 Preserves

Jam, red plum Jam, strawberry

0.5 9.4 4.5-10.8

Marmalade Meat 45

Bacon, streaky

Fried Roasted Fresh Roasted Steamed Braised Braised Roasted Roasted

O6-3.3 O.2 O.2 O3-19 0.4-1.6 1.6-5.1 3.6-7.1 1.6 1.7

Chicken (Fray Bentos) Oxtail (Fray Bentos) Dairy products

Heated Heated

3.0 1.O

Butter

Fresh Fresh Boiled Fresh Fresh

Beef

Beef, corned Chicken Ham 50

Kidney Liver Mutton Pork

Soups 55

O5 1.31 48

Rutabaga Spinach Squash Sweetpotato

1.5 2.8 O.7 2.6 0.0-6.6 2.7 6.2 1.2-3.7 1.3-1.7 O.O-3.7 1.1-3.4 2.2 1.9-11.5

Melon

19 .21 148 45 O1

1.7 7.2-618 96.8-121.0 2.1-3.6 0.6-2.0 7.4-22.7 1.1 13.0-17.5 1.1 1.7-2.7 0.5 2.O 3.0 166.O 0.8-1.3 2.3-7.1 O.3 260-62O 356-78O 5.3 O.8

Bean, runner

and the like.

Vegetable

Preparation

(mg/100 g of fresh material)

Cheese, Cheshire 60

Eggs, whole Margarine Milk, cow Fish

Haddock 65 Plaice Sardines

Boiled Boiled Canned

6,133,318 75

76

TABLE II-continued

TABLE III-continued

Oxalic Acid Contents of Foods

Oxalate Content of Foods per 100 GM. EDIBLE PORTION

Oxalic acid' Food

Method of

(mg/100 g of

Preparation

fresh material)

OXALATE FOOD

Cereals

Biscuits (Marie)

4.5-13.8

Bread, white

Fresh

4.9-8.6

Bread, Allinson's

Fresh

15.8-26.3

Cake, fruit Cake, sponge Cornflakes

1O

mg.

Macaroni, boiled Oatmeal, porridge

1.O 1.O

Spaghetti, boiled Spaghetti in tomato sauce

1.5 4.0

Wheat germ

269.O

Milk and Milk Products

11.8 7.4 4.4-5.6

Corn cob

Fresh

9.1

Oatmeal porridge

Cooked

1.O

Butter Cheese, cheddar Margarine Milk

Rice pudding

Cooked

O.O

Meats and Eggs

15

O.O O.O O.O O.15

Chocolate

Cadbury's plain Cadbury's milk Beverages

123.5 56.2

2O

Bacon, streaky fried Beef, canned corned Beef, topside roast Chicken, roast Eggs, boiled

3.3 O.O O.O O.O O.O

Beer, mild Beer, bitter Beer (Double Diamond) Beer (Double Diamond) Beer (Guinness)

Draught Draught Draught Bottled Draught

0.9-1.6 O.9-1.9 O.8 1.9-2.0 1.4

Fish:

Beer (Guinness)

Bottled

2.8-3.9

Ham

1.6

Cocoa (Rowntrees)

Powder

623.0

Hamburger, grilled

O.O

25

Haddock Plaice Sardines

O.2 O.3 4.8

Coca Cola

Canned

1.12

Lamb, roast

Coffee, infusion

2 g per 100 ml,

1.O

Liver

7.1

Pork, roast

1.7

infused 5 min.

4.4 g per 100 ml,

7.3

3O

trace

Vegetables

infused 13 min.

Coffee essence (Camp) Coffee (Nescafe)

Undiluted Powder

9.O 57.O-23O.O

Dandelion coffee Horlicks

Powder Powder

25.0 4.1

Lager (Skol) Lemon squash (Robertson's) Lucozade Orange squash (Robertson's)

Draught

O.6 1.5

Ovaltine Oxo cubes

Powder

Tea, leaves Tea, infusion

Fresh, dried 1 g per 100 ml,

Asparagus Beans, green boiled

35

infused 5 min.

2.0 g per 100 ml,

Beet root, pickled Broccoli, boiled

SOO.O trace

Brussels sprouts, boiled

O.O

Cabbage, boiled

O.O

Carrots, canned Cauliflower, boiled

4.0 1.O

45.9 1.6

375-1450 4.6

40

Celery Chard, Swiss Chive

7.O-10.8

Collards Corn, yellow

10.1-14.5 11.5-16.1

Cucumber, raw

45

infused 10 min.

2.0 g per 100 ml,

19.0 675.O

1.2

infused 2 min.

2.0 g per 100 ml,

Beans in tomato sauce Beet root, boiled

O.1

infused 2 min.

2.0 g per 100 ml,

126-17.2

infused 15 min.

Wine, Beaujolais

3.1

- 50

Leek

89.0

Lettuce

3.0

Lima beans

4.3

Mushrooms

2.O

Onion, boiled

Parsley, raw Parsnips

Cereal and Cereal Products

3.0

1OO.O 1.O.O

Peas, canned

1.O

16.0

Potatoes, white boiled Potatoes, sweet 60

7.7 146.0

Pepper, green Pokeweed

OXALATE mg.

1.O

Kale

Okra

55

5.2 18.0 31.O 13.0

and Medicine, Pgs. 196-199.

Oxalate Content of Foods per 100 GM. EDIBLE PORTION

1.1

74.O

24.6

Mustard greens

TABLE III

2O.O 645.O

Dandelion greens Eggplant SSP Escarole

Expressed as the anhydrous acid (COOH)2. From Oxalic Acid in Biology

FOOD

5.2 15.O

Radishes

Rice, boiled

476.O

O.O 56.O O.3

O.O

Bread, white

4.9

Rutabagas

Cake, fruit Cake, sponge

11.8 7.4

Spinach, boiled Spinach, frozen

75O.O 6OOO

2.O 2O7.O

Squash, summer Tomatoes, raw

22.O 2.O

Turnips, boiled Watercress, early fine curled

1.O 1.O.O

Cornflakes Crackers, soybean

Egg noodle (chow mein) Grits (white corn)

1.O 41.O

65

19.0

6,133,318 77

78

TABLE III-continued

TABLE III-continued

Oxalate Content of Foods per 100 GM. EDIBLE PORTION

Oxalate Content of Foods per 100 GM. EDIBLE PORTION

FOOD

OXALATE mg.

Beverages, Non-alcoholic

Fruits

Apples, raw Apricots Avocado

Banana, raw

3.0 2.8 O.O

Barley water, bottled 1O

Coca-Cola

15

Coffee (0.5 g Nescafe/100 ml) Lemon Squash drink (lemonade) Lucozade, bottled (soda) Orange Squash drink (orangeade) Ovaltine drink, 2 gm in 100 ml Pepsi-Cola

trace

Berries: Black Blue Dew

Green goose Raspberries, black Raspberries, red Strawberries, canned Strawberries, raw

18.0 15.O 14.O 88.0 53.0 15.O 15.O 1O.O

Sour Currants:

Black Red

Fruit salad, canned Grapes: Concord

Thompson, seedless Lemon Peel Lime Peel

Mangoes

Juices

4.3 19.O 12.O

Apple juice Cranberry juice Grape juice Grapefruit juice Orange juice Pineapple juice Tomato juice Beverages, alcoholic

25

25.0 O.O 83.O 11.O.O O.O

O.O 1.O 4.0 2.O O.O

Stout, Guiness Draft Cider

35

Sherry, dry

trace

Wine:

Peaches:

40

5.0 1.2 O.O 1.2 3.0 1.7 1.O

45

Plums:

Golden gage Greengage

6.6 5.8 O.O 0.5 O.O 5.0

Lager draft, Tuborg Pilsner

Orange, raw

Damson

trace

Beer: bottled draft

Watermelon Nectarines

Bartlett, canned

55.0 72.O 78.0 4.0

Tea, rosehip

Casaba

Pineapple, canned

2.O

2 min. infusion 4 min. infusion 6 min. infusion

Honeydew

Stokes Pears:

trace

Tea, Indian:

O.O 1.1

Cantaloupe

Hiley

3.2 1.O O.O 2.5 1O.O

(black currant drink)

Melons:

Alberta canned

O.O trace

Ribena, concentrate

Cherries:

Bing

OXALATE mg.

FOOD

1O.O 1.1 O.O

Port Rose White Miscellaneous

trace

Cocoa, dry powder Coffee powder (Nescafe) Chicken noodle soup Lemon juice Lime juice Ovaltine, powder canned Oxtail soup

623.O 33.O 1.O 1.O O.O 35.O 1.O 419.0 3.0 5.0

1.5 O.O

Pepper Tomato soup Vegetable soup

50

Preserves:

From: Krause & Mahen, Food, Nutritient Diet Therapy, 7th ed., 1984, W. Red plum jam Strawberry jam Prunes, Italian

B. Saunders, Phila.

0.5 9.4 5.8

Rhubarb:

TABLE IV

55

Concentrations of Oxalic acid, calcium and magnesium in foods

canned

stewed, no sugar

Oxalic Acid

Nuts

Peanuts, roasted Pecans

187.O 2O2.O

Confectionery Chocolate, plain Jelly, with allowed fruit Marmalade

Sweets, boiled (plain candies)

Calcium

Magnesium

(mmol/kg fresh (mmol/kg fresh (mmol/kg fresh

117.O O.O 10.8 O.O

Food Vegetables

wt)

wt)

wt)

Cabbage

O.11

16.2

8.5

Cauliflower Onion 65 Potato Lettuce

O.12 O.33 O.25 O.19

5.9 7.1 2.2 6.5

6.4 4.8

60

4.1

6,133,318 79

80

TABLE IV-continued

TABLE V-continued

Concentrations of oxalic acid, calcium and magnesium in foods

Dietary intake of Oxalate by man and animals

Oxalic Acid

Calcium

Oxalic acid (anhydrous) mg/kg day

Magnesium

(mmol/kg fresh (mmol/kg fresh (mmol/kg fresh Food

wt)

wt)

wt)

Rhubarb Beet root

28.9 13.5

3.1 4.7

4.0 15.5

Spinach Fruit

86.6

27.7

31.6

Apple Orange

0.17 O.69

O.85 0.87

2.05 5.7O

Pear Plum

O.19 O.38

1.O 3.57

1.85 3.33

Strawberry

O.21

4.10

4.73

Tomato

0.59

2.50

4.11

Beef, roasted

O.04

1.92

11.7

Fish (haddock) Milk (cow)

O.O2 O.OOS

4.22 28.7

11.6 4.3

Description

Mean Range

Mean Range

Reference

- 46-92

Hodgkinson

Rat

Wistar (300 g)

-

14-28

(unpublished results) Sand rat (200 g)

-

300-

- 1500-

500

2500

Shirley and Schmidt

15

Nielsen (1967). *Oxalic Acid in Biology and Medicine, pg. 160.

Meat, fish and

dairy products

TABLE VI Some recent estimates of the concentration of Oxalic acid in human and animal blood

Cereals

Oxalic acid

Bread, white

O.54

27.0

1O.O

Cornflakes

O.62

2.2

14.8

(ug anhydrous 25

Beverages

acid/100 ml Analytical method

Ovaltine, powder

5.1

Tea (1 g/100 ml,

O.51

31.5

O.O7

O.25

O.92

O.13

1.03

Fluorimetry

infused for 6 min) Zarembski and Hodgkinson (1962b). 35

Mean Range

Hodgkinson and Zarembski

Fluorimetry

256.O 150-480

(1968)

Chemical kinetics

124.0

-

Eswara-Dutt and Mottola

Enzymic

118.0

80-140

130.4

73-199:

Endo (1969)

(1974) Knowles and Hodgkinson (1972) Hatch et al. (1977)

Decarboxylation

Enzymic

261.1 136-465:e - 117-250

Krugers Dagneaux

colorimetry

Dietary intake of Oxalate by man and animals

Description

146.O 1 OO-235

169.0 127–254

decarboxylation Ion exchange and

TABLE V

Oxalic acid (anhydrous) mg/kg day

Reference

Man

13.6

infused for 2 min) Tea (1.5 g/100 ml,

Mean Range

40

I'Coxalic acid I'Coxalic acid

et al. (1976) 16.5 13.0 11.8-14.3

Williams et al. (1971) Hodgkinson and Wilkinson

(1974)

Sheep

Mean Range

Reference

12.3 10.1-

Archer et al.

I'Coxalic acid

- 52.6-74.4

McIntosh and Belling (1975)

Man

British

92O

850-

98O British

97

70-150

13.6

45

Serum

1.4 1.0-2.1 Zarembski and

Whole blood

Hodgkinson (1962b) British

Indian on

-

145-

Anderson et al.

175

(1971) Singh et al

139.4

hospital diet Indian on common rural diet Indian on seasonal rural diet Indian on urban

*Oxalic Acid In Biology and Medicine, pg. 174. Plasma

(1957a)

Male Female 50

(1972) 77.8 -

Singh et al. (1972) Singh et al. (1972) Singh et al.

2045.0 168.5 -

diet, lower income

TABLE VII

Vitamin B-6 (Pyridoxine) Content of Pork and Pork Products Cooked

55

(1972)

Broiled,

Cooked

Roasted Pan Fried

Pork

Raw

Braised

Singh et al.

Composite of Retail Cuts

.445

394

(1972)

All Lean and Fat

508

.434

4O1

4O2

group

Indian on urban

606.4 -

diet, upper income group Indian from

-

Kashmir

Sheep

260-

450

-

21605OOO

Cow (Heifer)

Dhar and Kaul

-

607OO

715OO

- 31.7-

Leg, Loin & Shoulder

Composite of Retail Cuts

(1973)

All Lean and Fat

Brune (1955)

Leg (Ham) Whole

73.5

- 243286

60

Lean and Fat

Talapatra et al. (1942)

Talapatra et al.

(1942)

Leg (Ham) Whole

SOO

400

.472

460

Lean Only

65 Loin Whole Lean and Fat

.382

Cooked

6,133,318 81

82

TABLE VII-continued

TABLE IX-continued

Vitamin B-6 (Pyridoxine) Content of Pork and Pork Products

Vitamin B-6 (Pyridoxine) Content of Veal and Lamb

Cooked

5

Broiled,

Cooked

Pork

Raw

Braised

Roasted Pan Fried

Cooked

Loin Whole

527

492

.404

Lean Only Back Ribs Lean and Fat

395

Loin Chops

370

3O7

Raw

Cooked

Lamb All Retail Cuts Lean

.16

.16

1O

297

Source:

337

USDA Department of Agriculture Agriculture Handbook 8-17-1989

(braised)

Lean and Fat

Meat

381

(broiled) Bacon Cured

Canadian Style, Bacon Unheated Ham, Boneless

.14

27

38 (unheated)

45

TABLE X

15

VITAMIN B-6 (PYRIDOXINE) CONTENT OF CHICKEN

38

35

Extra Lean & Regular

(unheated)

Ham, Boneless (11% Fat) Extra Lean and Regular

34 (unheated)

Fried Batter-

31

2O Chicken

Source:

Broilers or Fryers

U.S. Department of Agriculture Agriculture Handbook 8-10 Rev. 1992

All Meat with Skin

Raw

Dipped

34

32

Fried Flour

Dipped Roasted Stewed .42

38

22

TABLE VIII

Vitamin B-6 (Pyridoxine) Content of Beef and Beef Products All Grades

Good

Choice

Prime

Beef

Raw Cooked

Raw Cooked

Raw Cooked

Composite Retail Cuts

.36

31

37

32

36

.43

38

.44

38

43

Raw

Choice

31

34

29

38

43

38

Lean and Fat

Composite Retail Cuts

Lean Only Beef

Raw

Roasted

Broiled

28

22

26

Rib-Eye Small Ribs

38

32

36

Lean and Fat Whole Prime Ribs Lean and Fat

3O

25

29

Large Ribs Lean and Fat

Beef

Mg/100 Grams

Beef Cured Frankfurter

.12

Lebanon Bologna

.24

Pastrami

18

Sausage Cooked and Smoked

.11

Beef Cured and Corned Liver Pan Fried

13 1.43

Kidney Cooked

52

Ground Lean Fried Ground Lean Baked

28 2O

Source:

U.S. Department of Agriculture Agriculture Handbook 8-13 1986 55

TABLE IX

TABLE X-continued

Vitamin B-6 (Pyridoxine) Content of Veal and Lamb

VITAMIN B-6 (PYRIDOXINE) CONTENT OF CHICKEN

Meat

Raw

Cooked

Veal

.41

31

13

13

60

Fried Batter-

Chicken

Fried Flour

Raw

Dipped

Dipped Roasted Stewed

Broilers or Fryers

43

48

53

47

26

All Meat Flesh Only 65 Broilers or Fryers Light Meat with Skin

48

39

54

52

27

All Retail Cuts

Lean and Fat

Lamb All Retail Cuts Lean and Fat

6,133,318 83

84

TABLE X-continued

TABLE XII-continued

VITAMIN B-6 (PYRIDOXINE) CONTENT OF CHICKEN

Dry Dog Food, Test Run Data

Fried Batter

Chicken

E325 Processing

Fried Flour

Conditions:

Run #1

#5 Head Temp.

CW 79 deg F.

#6 Head Temp.

CW 129 deg F.

Raw

Dipped

54

63

.65

60

26

25

25

32

31

17

Die Pressure (PSI)

26

26

33

31

17

29

27

34

.33

18

Broilers or Fryers

Dipped Roasted Stewed

Light Meat Flesh. Only Broilers and Fryers Dark Meat with Skin

Broiler and Fryers Broiler and Fryers

Leg with Skin Ground Turkey

35

15

39

350

Knife Speed (Hertz)

55.9

Dryer Retention

17.9

Dryer Temperature

Thigh with Skin

(minutes)

Formula:

(Cooked)

Comment

223

See Dry Feed formula

2.7# OA to

2.2% Oxalic acid solution added at 0.7

100+ water

Ibs/min

Source:

Comments:

U.S. Department of Agriculture Agriculture Handbook 8-5-1978

The Oxalic acid

solution was made up in hot water (160 F) and pumped into conditioning cylinder

TABLE XI

Screw Configuration:

VITAMIN B-6 (PYRIDOXINE) CONTENT OF #1 Screw

SELECTED BAKED GOODS

25 #1 Steamlock

Mg/100 G

Breads

Bagels: Plain, Onion, Poppy Seed, Sesame

Bagels, Date Bran Bagels, Egg Bagels, Cinnamon Raisin Biscuits, Commercially Baked Plain or Buttermilk Cornbread Cracked Wheat Bread French and Vienna Bread Italian Bread Mixed Grains 7 Bread Oat Bran Bread

Pumpernickel Rye Bread Wheat Bran Bread Whole Wheat Commercial Bread

OOO O84 OOO O47

.113 3O4 O43 O48 .333 OOO 126 O75 O64 179

35

40

45

Dry Dog Food, Test Run Data Comment

50

Dry Dog Food Feeder Speed (RPM) 11 rpm (420 lbs/hr) Feeder Speed (Hertz) 34.7

Product

Cond. Cyl. Temp

2O6

(°F) Cond. Cyl. Water 1O (% gauge) Extruder Speed (RPM) 421 Extruder Current 24 (Amps) Extruder Water Extruder Steam

55

O

(% gauge) O

60

Injection #2 Head Temp.

(CW or ST)

#3 Head Temp.

(CW or ST)

#4 Head Temp.

(CW or ST)

CW

Spacer

#3 Screw

Single Flight Uncut

#3 Steamlock

Spacer

Spiral Rib Head Spiral Rib Head

#4 Screw

Single to Double Flight Uncut Straight Rib Head

#4 Steamlock

Small

#5 Screw

2 Flight cut flight

#5 Steamlock

Large

#6 Screw

2 Flight cut flight cone

Straight Rib Head Spiral Rib Cone

Spacer

1" thick

Backup Die

No

Dieplate

1/4" central insert die

#825440-3

Insert

/4" round hole

#101-509

GOTTEXT

What is claimed is:

1. A bactericidal composition for treating infectious or pathogenic bacterial diseases or conditions in warm blooded animals Sensitive to treatment comprising: a bactericidal composition including an effective amount of at least one therapeutically effective bactericidal

form of at least one of Oxalic acid and oxalate and at least one of a carrier and diluent for Said at least one of

is less than a lethal dosage of Oxalic acid and wherein Said bactericidal composition is adapted to be admin istered to warm-blooded animals on a periodic basis in less than a lethal dosage. 2. The bactericidal composition as recited in claim 1, wherein said therapeutically effective bactericidal form of at least one of Oxalic acid and oxalate is Selected from the group of Oxalic acid in a free acid, ester, lactone and Salt form. 3. The bactericidal composition as recited in claim 1, wherein said therapeutically effective bactericidal form of at least one of Oxalic acid and oxalate is Selected from the group of natural foods, for processed foods, beverages, liquids, and juices, containing at least one of Oxalic acid and oxalate. 4. The bactericidal composition of claim 1, wherein the composition is at least one of a therapeutic quantity of Oxalic acid and oxalate from a natural Source of at least one of Oxalic acid and oxalate.

CW CW

Single Flight Uncut

#2 Steamlock

Oxalic acid and oxalate, wherein Said effective amount

E325 Processing Run #1

#2 Screw

Head

U.S. Department of Agriculture Agriculture Handbook 8-18 Rev. 1992

Conditions:

Straight Rib Head

Spacer

Die Configuration:

Source:

TABLE XII

Single Flight Tapered Inlet

65

5. The bactericidal composition as recited in claim 1, wherein the Said composition is Oxalic acid dihydrate and the at least one of a carrier and diluent.

6,133,318 85

86

6. The bactericidal composition as recited in claim 1, of a gelcap, distilled water, tablet, powder, food additive, drops, liquid, beverage, rinse, mouthwash, gargle, pill, capsule, lozenge, cough drop, transdermal patch, ointment, Salve, cream, lotion, and gel adapted for periodically admin istering a therapeutically effective dosage at least one of topically, orally, nasally, parenterally, intravenously, and Subcutaneously. 7. A virucidal composition for treating infectious or pathogenic viral diseases and conditions in warm-blooded animals Sensitive to treatment, comprising: a Virucidal composition including an effective amount of at least one therapeutically effective virucidal form of

in a form Selected from the group of pills, powders granules, tablets, micro capsules, gelcaps, nutritional Supplements, processed foods, liquids, drops, juices, beverages, additives, rinses, mouthwashes, and Solutions. 17. A virucidal composition for treating AIDS, HIV, AIDS/HIV, the symptoms of HIV/AIDS infection, and ill nesses that occur with AIDS in warm-blooded animals Sensitive to treatment, comprising a virucidal composition including an effective amount of at least one therapeutically

wherein Said at least one of carrier and diluent is at least one

at least one of Oxalic acid and oxalate and at least one

of a carrier and diluent, wherein Said effective amount

effective virucidal form of at least one of oxalic acid and

oxalate and at least one of a carrier and diluent, wherein Said

15

is less than a lethal dosage of Oxalic acid and wherein Said Virucidal composition is adapted to be adminis tered to warm-blooded animals on a periodic basis in less than a lethal dosage. 8. The virucidal composition as recited in claim 7, wherein said therapeutically effective virucidal form of at least one of Oxalic acid and oxalate is Selected from the

group of Oxalic acid in a free acid, ester, lactone or Salt form. 9. The virucidal composition as recited in claim 7, wherein said therapeutically effective virucidal form of at least one of Oxalic acid and oxalate is Selected from the group of natural foods, processed foods, beverages, liquids, and juices, containing at least one of Oxalic acid and oxalate. 10. The virucidal composition as recited in claim 7, wherein the Virucidal composition is at least one of a therapeutic quantity of at least one of Oxalic acid and oxalate

25

from a natural Source of at least one of Oxalic acid and oxalate.

11. The virucidal composition as recited in claim 7, wherein the Said Virucidal composition is Oxalic acid dihy drate and at least one of a carrier and diluent.

least one of Oxalic acid and oxalate and at least one of a

35

12. The virucidal composition as recited in claim 7,

wherein Said at least one of carrier and diluent is at least one

of a gelcap, distilled water, tablet, powder, food additive, drops, liquid, beverage, rinse, mouthwash, gargle, pill, capsule, lozenge, cough drop, transdermal patch, ointment, Salve, cream, lotion, and gel adapted for periodically admin istering a therapeutically effective dosage at least one of topically, orally, nasally, parenterally, intravenously, and Subcutaneously. 13. Atherapeutic composition in at least one of cream and ointment form for topical administration of an effective amount of at least one of Oxalic acid and oxalate comprising at least one therapeutically effective form of at least one of

effective amount is less than a lethal dosage of Oxalic acid and wherein Said Virucidal composition is adapted to be administered to warm-blooded animals on a periodic basis in less than a lethal dosage. 18. The virucidal composition as recited in claim 17, wherein said therapeutically effective virucidal form of at least one of Oxalic acid and oxalate is Selected from the group of Oxalic acid in a free acid, ester, lactone or Salt form. 19. The virucidal composition as recited in claim 17, wherein Said Virucidal composition is Oxalic acid dihydrate and at least one of a carrier and diluent. 20. The virucidal composition as recited in claim 17, wherein Said at least one of carrier and diluent is at least one of a gelcap, distilled water, tablet, powder, food additive, drops, liquid, beverage, rinse, mouthwash, gargle, pill, capsule, lozenge, cough drop, transdermal patch, ointment, Salve, cream, lotion, and gel adapted for periodically admin istering a therapeutically effective dosage at least one of topically, orally, nasally, parenterally, intravenously, and Subcutaneously. 21. A biocidal composition for treating infectious or pathogenic microbial, bacterial or viral diseases or condi tions in warm-blooded animals Sensitive to treatment, com prising a biocidal composition including an effective amount of at least one therapeutically effective biocidal form of at

40

45

carrier and diluent, wherein Said effective amount is leSS

than a lethal dosage of Oxalic acid and wherein Said biocidal composition is adapted to be administered periodically in less than a lethal dosage. 22. The biocidal composition as recited in claim 21, wherein said therapeutically effective biocidal form of at least one of Oxalic acid and oxalate is Selected from the

group of Oxalic acid in a free acid, ester, lactone or Salt form. 23. A veterinary Single medicine composition for treating infectious or pathogenic microbial, bacterial, or viral disease in warm-blooded animals Sensitive to treatment, comprising a veterinary composition including an effective amount of at least one therapeutically effective form of at least one of Oxalic acid and oxalate and at least one of a carrier and

diluent, wherein Said effective amount is less than a lethal

and diluent, wherein Said effective amount is less than a

dosage of Oxalic acid and wherein Said veterinary compo Sition is adapted to be administered periodically in less than a lethal dosage. 24. The Veterinary composition as recited in claim 23, wherein said therapeutically effective form of at least one of Oxalic acid and oxalate is Selected from the group of Oxalic acid in a free acid, ester, lactone or Salt form. 25. The veterinary composition as recited in claim 23, wherein Said composition is Oxalic acid dihydrate and at least one of a carrier and diluent. 26. An immunotherapeutic composition for treating for preventing viral or auto immune-related diseases in warm blooded animals Sensitive to treatment, comprising a thera peutically effective amount of at least one therapeutically effective immunotherapeutic form of at least one of Oxalic

lethal dosage of Oxalic acid and wherein Said hemothera peutic composition is adapted to be administered on a periodic basis in less than a lethal dosage. 16. The hemotherapeutic composition as recited in claim 15, wherein Said hemotherapeutic composition is provided

wherein Said effective amount is less than a lethal dosage of Oxalic acid and wherein Said immunotherapeutic composi tion is adapted to be administered periodically in less than a lethal dosage.

Oxalic acid and oxalate, a Solvent, and a base.

14. The therapeutic composition as recited in claim 13,

50

wherein Said Solvent is at least one of distilled water,

acetone, propylene glycol, and polySorbate and Said base is at least one of a cream, ointment, gel, lotion, Spray, Stick, and powder. 15. A hemotherapeutic composition for treating infectious or pathogenic microbial, bacterial or viral disease, treating plaque or fatty buildup in the cardiovascular System, or the brain, and maintaining good cardiovascular health and operation in warm-blooded animals Sensitive to treatment, comprising a therapeutically effective amount of at least one therapeutically effective hemotherapeutic form of at least

55

60

one of Oxalic acid and oxalate and at least one of a carrier

acid and oxalate and at least one of a carrier and diluent,

65

6,133,318 87

88

27. The biocidal composition as recited in claim 21, a gelcap, distilled water, tablet, powder, food additive, drops, liquid, beverage, rinse, mouthwash, gargle, pill, capsule, lozenge, cough drop, transdermal patch, ointment, Salve, cream, lotion, and gel adapted for periodically admin istering a therapeutically effective dosage at least one of topically, orally, nasally, parenterally, intravenously, and Subcutaneously. 28. The veterinary composition as recited in claim 23,

mouthwash, mouth rinse, and wash adapted for periodically administering a therapeutically effective dosage at least one of topically, orally, nasally, parenterally, intravenously, and Subcutaneously. 36. The immunotherapeutic composition as recited in claim 26, wherein Said therapeutically effective immuno therapeutic form of Oxalic acid is Oxalic acid dihydrate which is dissolved in distilled water to produce at least one of a mixture, Solution, rinse, mouthwash, mouth rinse, and wash adapted for periodically administering a therapeuti cally effective dosage at least one of topically, orally, nasally, parenterally, intravenously, and Subcutaneously. 37. The bactericidal composition as recited in claim 1, wherein the effective amount is at least one of up to 8 g for humans and up to 4 g for warm-blooded animals other than

wherein Said at lest one carrier and diluent is at least one of

wherein Said at least one carrier and diluent is at least one of

a gelcap, distilled water, tablet, powder, food additive, drops, liquid, beverage, rinse, mouthwash, gargle, pill, capsule, lozenge, cough drop, transdermal patch, ointment, Salve, cream, lotion, and gel adapted for periodically admin istering a therapeutically effective dosage at least one of topically, orally, nasally, parenterally, intravenously, and Subcutaneously. 29. The immunotherapeutic composition as recited in

15

claim 26, wherein Said at least one carrier and diluent is at

least one of a gelcap, distilled water, tablet, powder, food additive, drops, liquid, beverage, rinse, mouthwash, gargle, pill, capsule, lozenge, cough drop, transdermal patch, ointment, Salve, cream, lotion, and gel adapted for periodi cally administering a therapeutically effective dosage at least one of topically, orally, nasally, parenterally, intravenously, and Subcutaneously. 30. The bactericidal composition as recited in claim 1, wherein said therapeutically effective bactericidal form of Oxalic acid is Oxalic acid dihydrate which is dissolved in distilled water to produce at least one of a mixture, Solution, rinse, mouthwash, mouth rinse, and wash adapted for peri odically administering a therapeutically effective dosage at least one of topically, orally, nasally, parenterally, intravenously, and Subcutaneously. 31. The virucidal composition as recited in claim 7, wherein said therapeutically effective virucidal form of Oxalic acid is Oxalic acid dihydrate which is dissolved in distilled water to produce at least one of a mixture, Solution, rinse, mouthwash, mouth rinse, and wash adapted for peri odically administering a therapeutically effective dosage at least one of topically, orally, nasally, parenterally, intravenously, and Subcutaneously. 32. The hemotherapeutic composition as recited in claim 15, wherein said therapeutically effective hemotherapeutic form of Oxalic acid is Oxalic acid dihydrate which is dis Solved in distilled water to produce at least one of a mixture, Solution, rinse, mouthwash, mouth rinse, and wash adapted for periodically administering a therapeutically effective dosage at least one of topically, orally, nasally, parenterally, intravenously, and Subcutaneously. 33. The virucidal composition as recited in claim 17, wherein said therapeutically effective virucidal form of Oxalic acid is Oxalic acid dihydrate which is dissolved in distilled water to produce at least one of a mixture, Solution, rinse, mouthwash, mouth rinse, and wash adapted for peri odically administering a therapeutically effective dosage at least one of topically, orally, nasally, parenterally, intravenously, and Subcutaneously. 34. The biocidal composition as recited in claim 21, wherein said therapeutically effective biocidal form of Oxalic acid is Oxalic acid dihydrate which is dissolved in distilled water to produce at least one of a mixture, Solution, rinse, mouthwash, mouth rinse, and wash adapted for peri odically administering a therapeutically effective dosage at least one of topically, orally, nasally, parenterally, intravenously, and Subcutaneously. 35. The veterinary composition as recited in claim 23, wherein Said therapeutically effective form of Oxalic acid is oxalic acid dihydrate which is dissolved in distilled water to produce at least one of a mixture, Solution, rinse,

25

humans.

38. The virucidal composition as recited in claim 7, wherein the effective amount is at least one of up to 8 g for humans and up to 4 g for warm-blooded animals other than humans. 39. The therapeutic composition as recited in claim 13, wherein the effective amount is at least one of up to 8 g for humans and up to 4 g for warm-blooded animals other than humans. 40. The hemotherapeutic composition as recited in claim 15, wherein the effective amount is at least one of up to 8 g for humans and up to 4 g for warm-blooded animals other than humans.

41. The virucidal composition as recited in claim 17, wherein the effective amount is at least one of up to 8 g for humans and up to 4 g for warm-blooded animals other than humans.

35

40

45

42. The biocidal composition as recited in claim 21, wherein the effective amount is at least one of up to 8 g for humans and up to 4 g for warm-blooded animals other than humans. 43. The veterinary composition as recited in claim 23, wherein the effective amount is at least one of up to 8 g for humans and up to 4 g for warm-blooded animals other than humans. 44. The immunotherapeutic composition as recited in claim 26, wherein the therapeutically effective amount is at least one of up to 8 g for humans and up to 4 g for warm-blooded animals other than humans. 45. A process for preparing the bactericidal composition of claim 1, comprising the Steps of mixing at least one therapeutically effective form of at least one of Oxalic acid and oxalate with a pharmaceutically acceptable carrier or diluent.

50

55

60

46. The process as recited in claim 45, wherein said pharmaceutically acceptable carrier or diluent is Selected from the group of distilled water, heated water, pharmaceu tically acceptable liquids, nutritional Supplements, natural or processed foods, and juices. 47. A method of producing the therapeutic composition as recited in claim 13, comprising the Steps of mixing a dilute concentration of at least one therapeutically effective form

of at least one of Oxalic acid and oxalate with a Solvent

Selected from at least one of distilled water, acetone, pro pylene glycol, and polySorbate to form a Solution, and mixing the Solution with a base Selected from at least one of hydrophilic petrolatum, cream, ointment, gel, lotion, Spray, Stick, and powder. 48. A method for treating bacterial infections and condi tions in warm-blooded animals Sensitive to treatment, com prising the Steps of periodically administering a therapeuti cally effective dosage of the bactericidal composition of claim 1.

65

49. The method as recited in claim 48, wherein said

bactericidal composition is administered by at least one of orally and Sublingually.

6,133,318 89

90

50. The method as recited in claim 48, wherein said

bactericidal composition is administered by at least one of a lozenge and cough drop containing a therapeutically effec

tive form of at least one of Oxalic acid and oxalate and a carrier.

51. The method as recited in claim 48, wherein said

bactericidal composition is administered by injection. 52. The method as recited in claim 48, wherein said bactericidal composition is administered topically. 53. The method as recited in claim 48, wherein said bactericidal composition is administered internally. 54. The method as recited in claim 53, wherein said

administration of a therapeutically effective dosage is administered by a nose spray inhalation.

55. The method as recited in claim 48, wherein said

composition is administered by at least one of topical, oral, and parenteral application. 56. A method for treating viral infections or conditions in warm-blooded animals Sensitive to treatment, comprising the Steps of periodically administering a therapeutically effective dosage of the virucidal composition of claim 55.

15

57. The method as recited in claim 56, wherein said

Virucidal composition is administered at least one of orally and Sublingually.

58. The method as recited in claim 56, wherein said

Virucidal composition is administered by at least one of a lozenge and cough drop containing a therapeutically effec

25

tive form of at least one of Oxalic acid and oxalate and a carrier.

59. The method as recited in claim 56, wherein said 60. The method as recited in claim 56, wherein said

Virucidal composition is administered topically.

Virucidal composition is administered internally.

62. The method as recited in claim 61, wherein said 35

63. The method as recited in claim 56, wherein said

acid, (vitamin C), pyridoxine hydrochloride (vitamin B6),

40

82. The method as recited in claim 10, wherein said at 45

66. The method as recited in claim 64, wherein said

Virucidal composition is administered by injection.

68. The method as recited in claim 64, wherein said

Virucidal composition is administered internally.

69. The method as recited in claim 64, wherein said 55

microbial, bacterial or viral disease, in warm-blooded ani

mals Sensitive to treatment, comprising the Steps of adding to the regular diet a dietary Supplement having an effective amount less than a lethal dose of at least one therapeutically

60

84. The method as recited in claim 77, wherein said

immunotherapeutic composition is administered at least once a day at a dosage of at least one of up to 8 g for humans and up to 4 g for warm-blooded animals other than humans. 85. The method as recited in claim 77, further comprising the Steps of reducing the intake of Oxalic acid or oxalate

acid, (vitamin C), pyridoxine hydrochloride (vitamin B6),

71. The method as recited in claim 70, wherein said

acid in a free acid, ester, lactone or Salt form.

acid, (vitamin C), pyridoxine hydrochloride (vitamin B6),

calcium, alcohol, resins, clays, foods containing calcium, beverages containing alcohol, citric acid, or ascorbic acid, red meat or white meat of fowl containing pyridoxine hydrochloride, and foods, nutritional Supplements, or bev erages containing oxalic acid or oxalate blockers.

blockerS Selected from at least one of citric acid, ascorbic

effective biocidal form of at least one of oxalic acid and oxalate.

therapeutically effective biocidal form of at least one of Oxalic acid and oxalate is Selected from the group of Oxalic

once a day at a dosage of at least one of up to 8 g for humans and up to 4 g for warm-blooded animals other than humans. 83. The method as recited in claim 70, further comprising the Steps of reducing the intake of Oxalic acid or oxalate blockerS Selected from at least one of citric acid, ascorbic

50

Virucidal composition is administered topically.

Virucidal composition is administered at least once a day at a dosage of at least one of up to 8 g for humans and up to 4 g for warm-blooded animals other than humans. 70. A method for treating infectious or pathogenic

calcium, alcohol, resins, clays, foods containing calcium, beverages containing alcohol, citric acid, or ascorbic acid, red meat or white meat of fowl containing pyridoxine hydrochloride, and foods, nutritional Supplements, or bev erages containing oxalic acid or oxalate blockers. least one of Oxalic acid and oxalate is administered at least

Virucidal composition is administered at least one of orally and Sublingually.

67. The method as recited in claim 64, wherein said

Virucidal composition is administered at least once a day at a dosage of at least one of up to 8 g for humans and up to 4 g for warm-blooded animals other than humans. 81. The method as recited in claim 56, further comprising the Steps of reducing the intake of Oxalic acid or oxalate blockerS Selected from at least one of citric acid, ascorbic

claim 17.

65. The method as recited in claim 64, wherein said

acid, (vitamin C), pyridoxine hydrochloride (vitamin B6),

80. The method as recited in claim 56, wherein said

61. The method as recited in claim 56, wherein said

Virucidal composition is administered by at least one of topical, oral, and parenteral application. 64. A method for treating AIDS, HIV, AIDS/HIV, the symptoms of HIV/AIDS infection, and illnesses that occur with AIDS in warm-blooded animals sensitive to treatment comprising the Steps of periodically administering a thera peutically effective dosage of the Virucidal composition of

blockerS Selected from at least one of citric acid, ascorbic

calcium, alcohol, resins, clays, foods containing calcium, beverages containing alcohol, citric acid, or ascorbic acid, red meat or white meat of fowl containing pyridoxine hydrochloride, and foods, nutritional Supplements, or bev erages containing oxalic acid or oxalate blockers.

Virucidal composition is administered by injection.

administration of a therapeutically effective dosage is administered by a nose spray inhalation.

72. A veterinary method for treating infectious or patho genic microbial, bacterial, or viral disease in warm-blooded animals Sensitive to treatment, comprising the Steps of periodically administering a therapeutically effective dosage of the Veterinary Single medicine composition of claim 51. 73. The veterinary method as recited in claim 72, wherein Said composition is administered at least one of orally and Sublingually. 74. The veterinary method as recited in claim 72, wherein Said composition is administered by injection. 75. The veterinary method as recited in claim 72, wherein Said composition is administered topically. 76. The veterinary method as recited in claim 72, wherein Said composition is administered at least once a day at a dosage of about 1 mg to 3 g for dogs and cats. 77. A method of treating viral or auto immune-related diseases and the destruction of the body's immune System, comprising the Steps of periodically administering a thera peutically effective amount of the immunotherapeutic com position of claim 26. 78. The method as recited in claim 48, wherein said bactericidal composition is administered at least once a day at a dosage of at least one of up to 8 g for humans and up to 4 g for warm-blooded animals other than humans. 79. The method as recited in claim 48, further comprising the Steps of reducing the intake of Oxalic acid or oxalate

65

calcium, alcohol, resins, clays, foods containing calcium, beverages containing alcohol, citric acid, or ascorbic acid, red meat or white meat of fowl containing pyridoxine hydrochloride, and foods, nutritional Supplements, or bev erages containing oxalic acid or oxalate blockers.

6,133,318 91 86. A method for treating infectious or pathogenic micro bial bacterial or viral diseases and conditions in humans

Sensitive to treatment, comprising the Steps of periodically administering a therapeutically effective dosage of the bio cidal composition of claim 21. 87. The method as recited in claim 70, further comprising the Steps of reducing the intake of Oxalic acid or oxalate blockerS Selected from at least one of citric acid, ascorbic

92 acid, (vitamin C), pyridoxine hydrochloride (vitamin B6),

calcium alcohol, resins, claims, foods containing calcium, beverages containing alcohol, citric acid, or ascorbic acid, red meat or white meat of fowl containing pyridoxine hydrochloride, and foods, nutritional Supplements, or bev erages containing oxalic acid or oxalate blockers. k

k

k

k

k

USOO6407141B1

(12) United States Patent

(10) Patent No.: US 6,407,141 B1 (45) Date of Patent: *Jun. 18, 2002

Hart

(54) OXALIC ACID OR OXALATE

COMPOSITIONS AND METHODS FOR

133-135, 153–156, 159-164, 168-174, 180-182, 196-207, 216–228, 238.

VASCULAR DISORDERS, DISEASES, AND

Davis, Adelle, Lets Get Well, Penquin Group, 1972 pp.

CALCEROUS CONDITIONS

195, 204-205, 213, 299.

(76) Inventor: Francis J. Hart, 390 Ryan Rd., Pea Ridge, AR (US) 72751 (*) Notice: Subject to any disclaimer, the term of this

Cowdry, E. Croninger, A. Solaric, S. Suntzeff, V. Cancer, Journal of the American Cancer Society, Combined Action of Cigarette Tar & Beta Radiation of Mice-1961, vol. 14 pp. 344-352.

U.S.C. 154(b) by 0 days.

Carcinogenic Activity of Cigarette Smoke Condensate. I.

This patent is Subject to a terminal dis

2-1959- pp. 401–411.

patent is extended or adjusted under 35

Bock, F. Moore, G. Journal of the National Cancer Institute,

Effect of Trauma & Remote X-Irriation. Vol. 22 No.

claimer.

(21) Appl. No.: 09/535,572 (22) Filed: Mar 27, 2000 Related U.S. Application Data

(63) Continuation-in-part of application No. 09/014,943, filed on Jan. 28, 1998, now Pat. No. 6,133,318, and a continuation in-part of application No. 08/629,538, filed on Apr. 9, 1996, now Pat. No. 6,133,317.

(60) Provisional application No. 60/036,983, filed on Jan. 29,

1997, and provisional application No. 60/006,785, filed on

Nov. 15, 1995.

Svendsen, L. Rattan Surech I.S. Clark, Brian F.C. Journal of

Ethnopharmacology-1994 Testing Gar for Possible Anti Ageing Effects on Long-term Growth Characteristics, Mor phology and Macro Molecu Synthesis of Human Fibroblasts in Culture- pp. 125-133. Ney, D.M. The Low Oxalate Diet Book for the Prevention of the Oxalate Kidney Stones- pp. 944-945 & Appendix Table 13, University of California, San Diego 1981. U.S. Department of Health & Human Services Public Health

Service National Institutes of Health, NIH Publication, Eat

More Fruits & Vegetables, Oct. 1991. Chem One Corporation. Product Data Sheet, 1995. Occupational Health Services. msds on oxalic acid, 1994.

(51) Int. Cl...................... A61K 31/194; A61K 31/225 (52) U.S. Cl. ........................................ 514/574; 514/547 (58) Field of Search .................................. 514/574,547

Primary Examiner Richard L. Raymond

(56)

(57)

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3,542,573 A

3,787,589 A 4,156,067 4,285,972 4,340,609 4,760,157 4,900,746 5,137,722 5,151.274 5,175,144. 5,183,674.

A A A A A A A A A

11/1970 Biland et al. ............... 106/186

1/1974 Stephens et al. ............ 426/325 5/1979 8/1981 7/1982 7/1988 2/1990 8/1992 9/1992 12/1992 2/1993

Gould ......................... 528/73 Chou et al. ... 424/326 Chou ........ ... 424/322 Child et al. .... ... 556/137 Hanson et al. .............. 514/400 Costello ..................... 424/195 Saltman et al. ... 424/630

Walser .........

... 514/2

Olin ....................

... 426/2

5,227,248 A

7/1993 Wullschleger et al. ...... 426/549

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9/1993 Graves et al. .............. 585/351

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3/1994 Hirsch et al. ..

... 514/554

5,310,554. 5,314.686 5,324,443 5,330,972 5,346,707 5,376,361 5,401,325 5,401,326 5,455,372 5,470,874 6,133,317 6,133,318

A 5/1994 A 5/1994 A 6/1994 A 7/1994 A 9/1994 A 12/1994 A 3/1995 A 3/1995 A 10/1995 A 11/1995 A * 10/2000 A * 10/2000

Haigh .......... ... 424/439 Todd, Jr. ... ... 424/401 Arif et al. .. ... 252/142 Cope ............................. 514/2 Olin .......... 426/69 Perricone ..................... 424/59 Mihelic et al. ............... 134/39 Mihelic et al. ............... 134/40 Hirai et al. .... ... 560/179 Lerner ....... ... 514/474 Hart ....... ... 514/574 Hart ........................... 514/574

OTHER PUBLICATIONS

Hodgkinson, A. Oxalic Acid in Biology and Medicine, Academic Press, 1977 pp. 1-3, 16-17, 18-21, 23, 37-38, 49-51, 69–80, 84–88, 100–103, 110-111, 122–124, 130,

(List continued on next page.) ABSTRACT

A Single medicine oxalic acid or oxalate compositions, or “magic bullet” and methods of treatment and prevention of warm-blooded animals including humans and pets for vas cular diseases, disorders, and calcerous conditions, chemo

prevention of vascular diseases, disorders, and calcerous conditions, is provided which includes at least one thera peutically effective form of Oxalic acid or oxalate Selected from oxalic acid in a free acid, ester, lactone or Salt form and

oxalate including Sodium oxalate, Oxalic acid dihydrate, anhydrous Oxalic acid, oxamide, and oxalate Salts, natural or processed foods including molds, plants or vegetables con taining oxalic acid or oxalate, beverages, liquids or juices containing oxalic acid or oxalate, additives containing Oxalic acid or oxalate, and combinations thereof. The compositions may also contain a pharmaceutically acceptable carrier or diluent for the therapeutically effective form of oxalic acid or oxalate. Methods are provided including the Steps of periodically administering, by topical, oral, or parenteral application, a therapeutically effective dosage of a compo Sition including at least one therapeutically effective form of Oxalic acid or oxalate in less than a lethal dosage and improving chemotherapy by reducing the intake of Oxalic acid or oxalate blockerS Such as citric acid, ascorbic acid

(vitamin C), pyridoxine hydrochloride (vitamin B6),

calcium, alcohol, resins, clays, foods containing calcium, beverages containing alcohol, citric, or ascorbic acid, red meat or white meat of fowl containing pyridoxine hydrochloride, or other foods, nutritional Supplements or beverages containing oxalic acid or oxalate blockers. 20 Claims, 1 Drawing Sheet

US 6,407,141 B1 Page 2

OTHER PUBLICATIONS

The Merck Manual, Diagnosis and Therapy, 1987 pp. 2465-2466, Oncology pp. 1206-1228. NIH Specification 11-133 Open Formula Rat and Mouse

Ration 9NIH)0–07) Nov. 1, 1986.

NIH Specification 11-137 Crude Protein Autoclavable

(NIH-31) Nov., 1986.

Organic Gardening Articles, Rodale Press, Inc. Hurley, J.B. Calcium From the Garden Apr. 1986, pp. 96-98 Duke, L.A. Weeds? or Wonder Drugs? Jul. 1994 pp. 38–39 Duke, J.A. Eat Your Weedies Jul. 1993 pp. 31-35 Mattern, V. Don't Weed 'em, Eat 'em Apr. 1994 pp. 71–74. Better Nutrition-Veggie Corner-Broccoli and Watercress Are Rich Cancer Fighters, Aug. 1994 p. 22 Editors Desk Novel Cancer Therapies Deserve a Fair Hearing, Aug. 1994 p. 6. Parade Magazine Special Intelligence Report, man Should Think Twice Before Eating Steak, Oct. 1994, p. 16. Ferguson, K. VA Hospital Fayetteville, AR. Low Oxalate Diet, undated.

Journal National Cancer Institute, No. 85, Explanation For Link Between Alcohol and Breast-Cancer risk 1993, abstract.

Readers Digest, News from the World of Medicine. Device Spots Colon Cancer & Indoor Tanning? Don't Do It. Mar. 1994. Sunscreen: Slather It On, Do Fats Fuel Prostate

Cancer? May 1994. Folic Acid, Superstar, Jun. 1994. Letters, Natural Health. Beta-Carotene Debate Continues, Nov. 1994.

Microsoft Internet Explorer/NECX From Gopher:// gopher.nih. gov/00/clin/cdcs/67. kidney-Prevention and Treatment of Kidney Stones national Institute of Health Consensus Development Conference Statement, Mar. 1988 pp. 1-14. Microsoft Internet Explorer/Open Text Index From:http:// www/mcs/net/joyce/new.html Essiac Tea From Canada Comes A Remedy Called Essiac, Or Ojibwa Tea 1995, pp. 1-7. From: gopher://wiretap/Spies/com/oo/1 Library/Fringe/ Pharm/essiac.txt ESSiac: a natural herbal alternative cancer

treatment. Glum, G.L. Calling of An Angel, Apr. 1993 pp. 1-15. From:http://www/envirolink/org/arrS/VRG/calcium. html Mangels, R. Calcium in the Vegan Diet 1991 pp. 1-6. Weil, Andrew Natural Health, Natural Medicine. hCW nCT

to gET cANCER, h0UGHTON mIFFLIN coMPANY 1990 pp. 169-189. Robbins, J. Diet for a New America. Losing A War We Could Prevent, Stillpoint Publishing 1987, pp. 248-273, 403-409

Berkely, B. Nutritional Protocol for HIV, Project Inform San Francisco 1994.

NAU, Jean-Yves Preventing Spread of BSE, The Lancet Sep. 1994 vol. 344, p. 808. Carper, Jean, Foods That Fight Cancer, Reader's Digest, Jan. 1994, pp. 119-122. America's Parmaceutical Research Companies, Health Guide-Seventh in a Series, HIV/AIDS, 1997.

Solaray, Inc., CranActin . . . the one that gurantees bacterial antiadherence properties, 1996. Houple, Molina, Reamer, Lynch, Volante, and Reider, Towards the Sythesis of HIV-Protease Inhibitors. Synthesis of Optically Pure 3-Carboxyl-decahydroisoquinolines,Tet rahedron Letter, vol. 34, No. 16, pp. 2593-2596, 1993. Cabbages and Cancer, KEND, Feb. 3-5, 1995. Perspective, The Antioxidant Nutrients, p. 320-324, The Regulatory Nutrients, 1995. News from the World of Medicine, p. 147, Feb. 1995. The latest findings: Help for Headaches, Family circle, Mar. 14, 1995, p. 53. Health & Healing, Tomorrow's Medicine Today, Feb. 1994, vol. 5, No. 2.

Health & Healing, Tomorrow's Medicine Today, May 1995, vol. 5, No. 5.

Health & Healing, Tomorrow's Medicine Today, Mar. 1995, vol. 5, No. 3.

Health & Healing, Tomorrow's Medicine Today, Feb. 1995 Supplement. Breakthroughs. In Cancer Research, Nathaniel Mead, Natu ral Health, Jan., Feb. 1996.

More power to the people? AARP Bulletin, Mar. 1995, vol. 36, No. 3, Washington, D.C. Cancer Treatment Choices, News from the World of Medi

cine, American Heart Association, p. 139, Feb. 1996. Breast Cancer Update, News from the World of Medicine, American Heart Association, p. 108, Sep. 1995. Cancer Update, News from the World of Medicine, Ameri can Heart Association, p. 113, Apr. 1995. Early Alzheimer's Warning? News from the World of Medi cine, American Heart Association, pp. 105-106, Jul. 1995. Reversing Bone Loss, News from the World of Medicine, American Heart Association, pp. 99-100, Jul. 1995. Garlic's Breath of Health, LEND, Mar. 31-Apr. 2, 1995. Older Women: Cut the Fat, Not the Protein Food & Health,

Organic Gardening, p. 20, Feb. 1996. Mood Foods, Food & Health, Organic Gardening, p. 22, Jan. 1996.

New Method Proposed to Determine Efficacy of Both Ret inoids and Antioxidants in Preventing Cancer, Primary Care & Cancer, Jan. 1996, p. 32. Cancer Facts & Figures-1995, American Cancer Society, Revised Jan. 1995.

On the Cancer Front, News from the World of Medicine, p. 127, Nov. 1995.

Merch Manual Home Edition-1997 pp. 121-126. Merch Manual Diagnosis and Therapy 1987 pp. 477-499. Commercial Mixture of Flavonoids, Provex PlusTM, Sep. 1997.

Journal of Investigative Medicine, Sep.1997, vol. 45, No. 7. Commercial Mixture of Flavonoids, Provex CVTM, Mar. 1998.

Journal of Investigative Medicine, Mar., 1998, vol. 46, No. 3.

* cited by examiner

U.S. Patent

Jun. 18, 2002

US 6,407,141 B1

A = Spectrophotometry O = tritration

US 6,407,141 B1 1 OXALIC ACID OR OXALATE COMPOSITIONS AND METHODS FOR

VASCULAR DISORDERS, DISEASES, AND CALCEROUS CONDITIONS CROSS-REFERENCE TO RELATED APPLICATIONS

This Application is a Continuation-in-Part of U.S. appli cation Ser. No. 09/014,943, filed Jan. 28, 1998, now U.S.

Pat. No. 6,133,318, hereby incorporated by reference. Also this Application is a Continuation-in-Part of U.S. Provi sional Application Serial No. 60/036,983, filed Jan. 29, 1997, hereby incorporated by reference. Also, this Applica tion is a Continuation-in-Part of U.S. application Ser. No. 08/629,538, filed Apr. 9, 1996, now U.S. Pat. No. 6,133,317 which is a Continuation-in-Part of U.S. Provisional Appli cation Serial No. 60/006,785, filed Nov. 15, 1995, hereby incorporated by reference.

15

malonic acid.

As described in “Oxalic Acid in Biology and Medicine” by A. Hodgkinson, 1977, oxalic acid was formerly used intravenously as a hemostatic agent and topically as an antiseptic in man and other animals but this was discontin ued because of its toxicity and the danger of precipitating

BACKGROUND OF THE INVENTION

The present invention is directed to Oxalic acid or oxalate compositions and methods of producing Such compositions and for the utilization of Oxalic acid or oxalate compositions, including Solutions, mixtures, products, rinses, and carriers in the treatment, control, remedy, and prevention of Vascular disorders, diseases, and calcerous conditions in patients.

insoluble calcium oxalate in the tissues. Oxalic acid is a 25

number of Oxalates or Salts including calcium oxalate, potassium oxalate, Sodium oxalate, Strontium oxalate, mag

and calcerous conditions with cholesterol lowering drugs, diet, and exercise programs, as well as life Style changes Such as quitting Smoking. Coronary artery bypass Surgery is preformed when conditions are not Suited to artery angio plasty. Angiography is used to determine which invasive treatment may be feasible. There has recently been devel oped a new procedure involving the placement of Stints in

nesium oxalate, and the like. Oxalic acid also inhibits the

35

The cause of Alzheimer's disease is currently not known, and treatment is limited to drugs that may slow the progres Sion of the disease.

In the case of vascular disease, artherosclerosis plaque develops in the arteries causing blockage. Plaque results when calcification takes place in the cholesterol developed gummy Substances in the inner lining of the arteries. Recent news articles reveal researchers Suspect that for mation of plaque in the brain interferes with normal activity. In the early Stages of research and development of the parent patent, U.S. application Ser. No. 08/629,538, filed Apr. 9, 1996, now U.S. Pat. No. 6,133,317, the inventor became aware of the decalcifying effect of Oxalic acid on calcerous matter.

40

45

50

lic acid and is present in many plants and vegetables, notably in those of the Oxalis and Rumex families, where it often

occurs in the cell Sap of the plants as the potassium or product of the metabolism of many molds. Several Species of Penicillum and Aspergillus convert Sugar into calcium oxalate with a 90 percent yield under optimum conditions. Oxalic acid is also made by passing carbon monoxide into concentrated NaOH or heating Sodium formate in the pres

declined Supposedly because of a decreased use of Oxalic acid in domestic cleaning fluids. Examples of chronic poi Soning by absorption of Oxalic acid through the Skin and by inhalation have been reported. The range of lethal doses in acute poisoning is wide, varying between 2 and 30 g and depending upon a variety of factorS Such as the form in which the acid or its Salt is taken and the amount of food,

55

60

ence of NaOH.

Oxalic acid dihydrate, monoclinic tablets, prisms, and granules are considered poisonous. Anhydrous Oxalic acid is crystallized from glacial acetic acid and is orthorhombic with the crystals being pyramidal or elongated octahedral. Oxalic acid is listed as being caustic and corrosive to the skin and mucous membranes. Ingestion may cause Severe

activity of a number of enzymes possibly due to the com petition between oxalate and a structurally similar Substrate of the enzyme. Precipitation as the calcium salt is the classical method of Separating oxalic acid from other Sub stances. Although calcium oxalate is generally considered to be an insoluble salt this is a relative term and its solubility in water is actually 6–7 mg/l at room temperature. Biological fluids contain many substances that affect the solubility or rate of crystallization of calcium oxalate or co-precipitate with the Salt For example, magnesium, polyphosphates and other polyelectrolytes affect the solubility or rate of crystal lization of calcium oxalate while phosphate and Sulphate ions, uric acid and citric acid co-precipitate with the Salt. Further, as reported in a literature including "Oxalic Acid in Biology and Medicine', poisoning from oxalic acid in animals and man has been recognized since the beginning of

the 19” Century. The death rate from oxalate poisoning has

Oxalic acid or ethanedioic acid (CHO) is a dicarboxy

calcium salt (oxalate, Tables I-IV). Oxalic acid is also a

relatively Strong acid having a first dissociation constant being exceeded by that of only a few halogen-Substituted carboxylic acids. Oxalic acid forms neutral and acid Salts with monovalent metals and ammonia. Oxalic acid forms a

Conventional medicine treats vascular disorders, diseases,

restricted arteries.

2 gastroenteritis, with Vomiting, diarrhea, or melena. Renal damage can occur as a result of formation of excessive calcium oxalate crystals. Convulsions, coma, or death from cardiovascular collapse can also occur. Conventional uses of Oxalic acid include as an analytical reagent, in calico printing and dying, for bleaching Straw and leather, removing paint or varnish, rust or ink Stains, clean ing wood, and manufacturing oxalates, blue ink, celluloid, intermediates and dyes, in metal polishes, in purifying methanol, for decolorizing crude gycerol, for Stabilizing hydrocyanic acid, as a general reducing agent, in ceramics and pigments, in metallurgy as a cleanser, in the paper industry, in photography, in proceSS engraving, in rubber manufacturing, in making glucose from Starch, as a con densing agent in organic chemistry, and a veterinary hemo Static agent when mixed in 5 percent Solution with 5 percent

65

particularly calcium, which is present in the Stomach and intestine. Death has occurred as early as 3 minutes and as late as 14 days after ingestion. Symptoms of acute Oxalic acid toxicity in man can be divided into those caused by a local corrosive action and those resulting from absorption and excretion of the Soluble oxalate. If a high concentration or the Solid form is taken, the local effects may be predomi nant and death may result from acute hemorrhagic gastro enteritis without development of Symptoms depending on absorption. If death does not result from local corrosive action then Symptoms develop from the Systemic effects and from renal insufficiency. The cardiovascular, neuromuscular and central nervous Systems are markedly affected. The skin

US 6,407,141 B1 3 is pale, cold and clammy, the pulse is weak and the blood preSSure and temperature are low. Numbness and tingling may develop in the extremities and cramp-like muscular and abdominal pain may be extremely Severe. Local or gener alized muscular twitching occur and may progreSS to marked tetany and convulsive Seizures. The central nervous System may show evidence of excitation or depression, varying from an acute maniacal State to Stupor and coma. Death results from cardiovascular collapse or depression of the central nervous System. Renal involvement is frequent and even if the patient Survives the Severe local or Systemic effects, death may ultimately occur from renal insufficiency, which dominates the picture from the Second day. Oliguria develops and may progreSS to anuria. Hence, there is a need for Oxalic acid or oxalate compositions and methods of producing Such compositions and for treating, preventing, impeding, retarding, delaying, and controlling vascular disorders, diseases, and calcerous conditions in patients.

15

like which blocks, inhibits, reduces, or binds with or other wise reduces or eliminates the beneficial effect of Oxalic acid

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING

or oxalate. For example, calcium from dairy products tends

to bind with Oxalic acid in the intestine (calcium oxalate) and prevents the oxalic acid from being absorbed into the blood

FIG. 1 is a graphical representation of the decomposition

Stream.

of Oxalic acid. BRIEF SUMMARY OF THE INVENTION

25

In accordance with the present invention, oxalic acid or oxalate compositions and methods of producing Such com positions and for treating, preventing, controlling, impeding, cardiovascular disorders, diseases, and calcerous conditions

35

of Oxalic acid in a free acid, ester, lactone or Salt form,

40

a composition and method for treating fatty Substance and plaque related to dementia conditions of a patient.

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feed Stuff, rinse, mouthwash, mouth rinse, wash,

formulation, dosage, pharmaceutical agent, dietary Supplement, intermediate, product, composition, immune System Stimulant, Substance, drug, chemopreventive, chemical, chemoSurgical agent, chemotherapy agent, che motherapeutic agent, Solution, Solute, slurry, mixture, medicine, medication, analgesic, medicinal agent, treating agent, preventing agent, retarding agent, impeding agent, delaying agent, controlling agent, anabolic agent, health improving agent, health-Supplementary food, enriched fraction, Vascular disease treating agent, as ell as a Supple mental composition or treatment to be used in conjunction with conventional compositions and treatments, and the composition may also contain a pharmaceutically acceptable carrier or diluent for the therapeutically effective form of Oxalic acid or oxalate.

In accordance with still another embodiment of the

present invention, a veterinary composition includes con ventional pet food ingredients except for the elimination or reduction of Oxalic acid or oxalate blockers and the addition

one form of Oxalic acid or oxalate, or combinations thereof,

compositions including Oxalic acid or oxalate, a therapeutic quantity of Oxalic acid or oxalate composition, Source of Oxalic acid or oxalate, nutritional product, Supplement, Solution, agent, curative, remedy, control, impediment, food,

In accordance with yet another embodiment of the present invention, a diet is provided for treating, controlling, preventing, impeding, cardioSclerosis in patients. The diet includes adding to the regular diet a dietary Supplement of at least one therapeutically effective form of Oxalic acid or oxalate. Further the diet may include reducing the intake of Oxalic acid or oxalate blockers. In accordance with another embodiment of the invention

in warm-blooded animals is provided which includes an effective amount of at least one therapeutically effective form of Oxalic acid or oxalate for controlling, treating, managing, preventing the diseases caused by other blood disorders, or for otherwise therapeutically treating patients including humans and pets. The therapeutically effective form of oxalic acid or oxalate is an oxalic acid or oxalate which provides the beneficial effect and is Selected, for example, from the group oxalate including Sodium oxalate, a nutritional Supplement containing at least one form of Oxalic acid or oxalate, Oxalic acid dihydrate, anhydrous Oxalic acid, oxamide, oxalate Salts, processed foods containing at least one form of Oxalic acid or oxalate, beverages, liquids or juices containing at least one form of Oxalic acid or oxalate additives containing

4 Also in accordance with the present invention a method is provided for controlling, treating, managing cardiovascular disorders in patients including the Steps of administering an effective amount of a therapeutically effective form of oxalic add or oxalate. The method may include the further step of reducing the intake of Oxalic acid or oxalate blockerS Such as citric acid, ascorbic acid (vitamin C), pyridoxine hydro chloride (vitamin B6), calcium, alcohol, resins, clays, and combinations thereof. Oxalic acid or oxalate blockerS also include dairy products containing calcium, fruits, coconut, beverages containing alcohol, ascorbic acid or citric acid, red meat or white meat of fowl containing pyridoxine hydrochloride, or other foods, nutritional Supplements or beverages containing alcohol, citric acid, ascorbic acid, pyridoxine hydrochloride, resins, and combinations thereof. In accordance with the present invention, an oxalic add or oxalate blocker is any mineral, chemical, compound, material, plant, food, beverage, additive, Supplement, or the

55

of a therapeutically effective quantity of at least one thera peutically effective form of Oxalic acid or oxalate. In accordance with yet another embodiment of the present invention, an oral rinse, pill, gel cap, tablet, powder, or capsule for controlling, treating or managing cardiovascular disorders and diseases is provided which includes a dilute concentration or Solution of at least one therapeutically effective form of oxalate.

In accordance with yet another embodiment of the present invention, a pharmaceutical composition to be administered orally to patients is provided which includes a mixture of a nontoxic ingestible carrier and a therapeutically effective form of Oxalic acid or oxalate in less than a lethal dosage. In yet another embodiment of the present invention, a therapeutic composition in lozenge or cough drop form for oral administration of Oxalic acid or oxalate is provided which includes at least one therapeutically form of Oxalic acid or oxalate and an ingestible carrier of dextrose, micro crystalline cellulose, povidone, magnesium Stearate, and the like.

60

In accordance with another embodiment of the present invention, a pharmaceutical composition to be administered orally to patients is provided which includes a mixture of nontoxic ingestible carrier Such as Sorbitol, fructose, Sucrose, lactose or distilled water and a therapeutically effective form of Oxalic acid or oxalate in less than a lethal

65

dosage. One object of the present invention is the provision of a novel therapeutic composition including a pharmaceutically

US 6,407,141 B1 S acceptable carrier or diluent containing a therapeutically effective amount of at least one therapeutically effective form of Oxalic acid or oxalate. Another object of the present invention is the provision of a method of therapeutically treating patients with Such a therapeutic composition. A further object of the present invention is the provision of an oxalic acid or oxalate pharmaceutical composition, a therapeutic quantity of Oxalic acid or oxalate composition, Source of Oxalic acid or oxalate, nutritional product, Supplement, Solution, agent, curative, control, remedy, impediment, food, feed Stuff, rinse, mouthwash, mouth rinse, formulation, dosage, pharmaceutical agent, dietary Supplement, intermediate, product, composition, immune System Stimulant, Substance, drug, chemopreventative, chemical, chemoSurgical agent, chemotherapy agent, che motherapeutic agent, Solution, Solute, slurry, mixture, medicine, medication, analgesic, medicinal agent, treating agent, preventing agent, retarding agent, impeding agent, delaying agent, controlling agent, anabolic agent, health improving agent, health-Supplementary food, enriched fraction, as well as a Supplemental composition or treatment to be used in conjunction with conventional compositions

6 and his appetite diminished except for the little treats mentioned above. Turk was drinking much more water and had frequent accidents in the house, especially at night. Turk's color changed from a parfaittinge to a Solid white, and just before his death, to a dull grayish-white. When Turk began to vomit occasionally after eating or drinking, Turk's owner became concerned and took Turk to the Veterinarian. The examination revealed nothing, and the Veterinarian diagnosed Turk as having indigestion and gave Turk Some medicine. Turk's condition worsened, and So Turk was returned to the veterinarian. Blood and urine

15

lin.

Turk's condition worsened, so Turk was taken to the

animal hospital center where they determined Turk's kid neys were failing. Turk was put on an IV due to Severe dehydration. The doctors stated that they could not treat Turk unless Turk's owner could tell them what poison or chemical Turk had ingested. For the next several days Turk's

and treatment.

Another object of the present invention is the provision of a method of treating patients with at least one form of Oxalic

25

acid or oxalate.

Yet another object of the present invention is the provision of a pharmaceutical composition to be administered orally to patients including a mixture of a non-toxic ingestible carrier and a therapeutically effective form of Oxalic acid or oxalate in less than a lethal dosage. A further object of the present invention is the provision of a multi-Vitamin or multi-Vitamin and mineral Supplement including at least one therapeutically effective form of Oxalic

35

acid or oxalate.

Still another object of the present invention is the provi Sion of a processed food item including a therapeutically effective amount of at least one therapeutically effective form of Oxalic acid or oxalate.

40

Other objects and further scope of the applicability of the present invention will become apparent from the detailed description to follow. DETAILED DESCRIPTION OF THE INVENTION

The story begins with two toy poodles, Turk and Taka. These animals lived a normal house life. Except for the occasional trip or walk to the nearby reservoir, their territory was the house and backyard. AS young pups they were full of energy and, of course, very spoiled. Habits, mostly bad ones, were easily formed. Such as eating people food, Some of which, according to a veterinarian, would not hurt them. Turk became fond of SNICKERS(R) brand candy bars, espe cially the Small bite-size kind, and also carrots and beets, both of which are appearing in Some commercial dog foods today. During this time, Turk's owner, the present applicant and inventor, was doing a great deal of traveling, averaging one trip a week, and he always kept a small SNICKERS(R) bar

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owner went on a frantic Search for answers. Turk's owner

contacted a number of agencies for possible clues to the poisoning: Tri-County Health Department; two toxicologists with the EPA; the U.S. Corps of Engineers, who assured him that they test the reservoir daily for contaminants, and UCLA and University of Illinois poison centers. Heavy rains would bring Standing water into the backyard, So Turk's owner tracked down the owners of a stable and a nursery that used to operate in the area before the houses were built, to See if they had used any type of toxic sprayS. Turk's owner contacted nurseries from which he had recently bought plants. Turk's owner even contacted the 3M Company, Since new carpeting with SCOTCHGARD(R) had been installed. Turk's owner asked all neighbors who had pets to find out if their pets had become Sick. Turk's owner also called veterinary clinics to find out if they had diagnosed similar caseS recently. He also Searched every Square foot of the house, garage, and Storage building looking for chemicals, especially antifreeze. Out of desperation, Turk's owner pleaded with the Veterinarians to list poisons that had the same fingerprint, and he would then choose one So Veterinarians could begin treatment. The Veterinarians declined. When blood began to appear in Turk's stool and vomit, and the kidneys had shut down, Turk was put to sleep. Turk's owner vowed that with God's help he would find out what had destroyed Turk. The attending veterinarian at the veterinary hospital was an organ Specialist and professor at Colorado State Univer sity. The Veterinarian extended his Sympathy and after a few other exchanges he informed Turk's owner that there is one Substance very damaging to renal tissue-oxalates. The owner drove directly to his company's quality control department lab where he cornered a chemist and questioned him about oxalates. The chemist Said that an oxalate is a

60

near the front door in case he returned home without one.

compound found in trees, mainly oaks. The owner's curi osity was running high, and as Soon as he could break away from work, he went Straight for a dictionary. Oxalate is defined as a Salt or ester of Oxalic acid, and the acid

Another one of Turk's favorite treats was the small soybean

definition refers back to the oak tree. Oxalic acid is further

crackers in oriental cocktail mix, which Turk's owner ate

constantly when he was home. When Turk was about a year and six or seven months old, Turk began to slow down. Turk's eagerness to play left him,

Samples were taken, and test results revealed that Turk's urine was watery, but otherwise all right. The blood however, showed a high white cell count, and the Veterinar ian thought there might be an infection and prescribed pills. One Single pill brought on violent Vomiting. Turk's owner Stopped giving Turk the pills and Started Turk on amoxicil

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defined as an industrial chemical used in textile and dye manufacturing as a bleaching agent. From the dictionary, he went to the chemical books, found Oxalic acid and got promptly lost in a maze of formulae and equations. The

US 6,407,141 B1 7

8

owner eliminated oxalates or Oxalic acid from his mind as a

on the left Side where he had muscles torn in a car accident

cause of Turk's death. What did stay in his mind was Turk's death, and again he renewed his vow to find the answer. He could not get Turk out of his thoughts, because every time he looked at Taka, Turk's brother, he wondered why Turk

many years earlier. During the exam, the doctor decided to be safe and ordered an EKG. In prepping for the EKG, the nurse shaved his chest where the transducer cups would be placed, and then with a Small orbital Sander removed Some

One outside activity of Turk's owner was, and still is, gardening. Naturally, he had a Subscription for the organic gardening magazine, and perused through every article. In the April 1986 edition he came across an article by Judith Benn Hurley, “Calcium From Your Garden,” and up popped the word oxalate. Imagine his Surprise, an industrial chemical, a poison, in a magazine on organic gardening. Once again the Search was on. The owner wrote a letter to MS. Hurley describing his research, the reason for it, and asked if she had anymore information on oxalates she could share. The reply he received provided him with more information than he could have hoped for. Her reply sent him to the library, to the Section containing books on nutrition. He read many Volumes and was amazed by the amount of information available on plant life and the effects of plant Vitamins on maintaining human life. His effort was rewarded when he found a volume Let's Get Well by Adelle Davis, 1965. It contains the perfect finger print of Turk's death. Chapter 19, page 239 states the following: When both vitamin B6 and magnesium are undersupplied, the kidneys are further damaged by Sharp crystals of

when the hair began growing out, it was black instead of gray or white. Many mornings before Starting the oxalate-free diet, the owner would get out of bed with a dull backache, and occasionally it would really spasm when he would lean over the wash basin while brushing his teeth. He complained and Swore he would get a new mattress, believing it to be the cause of the backaches. By the end of the day the ache would be gone and out of mind. When the backaches Stopped, he realized it was his kidneys and knew it was the Soybean

had died and not Taka'?

of the dead skin for better contact. Weeks after the exam

15

crackers and nuts in the oriental mix and other related items

25

Oxalic acid combined with calcium, and as much as

three-quarters of the kidney may be replaced by Scar tissue. Children with Oxalic acid kidney Stones fre quently have high blood pressure and kidneys So dam aged that they become progressively worse, causing death from kidney failure early in life.

meat, a primary Source of pyridoxine (vitamin B6), did not drink much Soda pop, orange or pineapple juice (all high in citric acid), and only consumed alcohol in moderate quan

The owner's mind went back to information he had

gathered concerning the use of beagles in testing because their organs are more like those of a child than any other

that had raised his oxalate level to the point it began bothering his kidneyS. After retirement, Turk's owner was planning to move and Some friends Stopped by to visit. One evening while having cocktails with the friends, they began talking about health and age, etc. One of the ladies mentioned she needed bypass Surgery, but it could not be Scheduled because her red blood cell count was low, and the doctors could not get it to rise, even though She was on a third medication. Turk's owner's research had paid off. He gave his organic gardening maga zine to the lady and urged her to read the article by Judith Benn Hurley. He explained to her that the reason her red cell count was low was because of her diet. She ate very little

35

tities. Her diet contained items high in Oxalic acid, like Spinach, her favorite Salad. The owner mentioned that in his research he had discovered there were three chemicals that

animal. How true the statements, “love them to death” and

would counteract the Oxalic acid-pyridoxine hydrochloride

also “kill them with kindness.” The owner believed that he

(vitamin B6), citric acid, and alcohol. He gave her a handful

had inadvertently killed Turk by feeding him candy bars, Soybean crackers, beets, carrots, and who-knows-what-else that might have been very high in oxalate, Oxalic acid or both. He believed that these snacks saturated Turk's system to a point where Turk's kidneys could no longer function. When that happened, the acid began to destroy renal tissue. AS the tissue was being destroyed, Turk's condition wors

40

Turk's owner had also noticed that he did not have the 45

ened until other vital functions were affected. Turk's owner

also believed that Since oxalates and oxalic acid SuppreSS calcium, no healthy red blood cells were being produced. The blood in Turk's system had to have been totally satu rated with oxalic acid. When all the renal tissue was

50

destroyed, the kidneys shut down and Swelling began due to edema. There was no hope for recovery. Taka was not affected because he did not crave or eat

soybean crackers, beets or carrots, nor the SNICKERS(R) brand candy bars with peanuts. When the owner realized what caused Turk's death, he put Taka on an oxalate/oxalic acid-free diet. Some weeks after putting Taka on the diet, the color of Taka's coat, which had faded, began returning to normal. Knowing that a human could Suffer from an exceSS of Oxalates and Oxalic acid, the owner put himself on a

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Similar diet as well.

Several Significant events occurred beginning with the return of the color of Taka's coat while on the oxalate-free

diet. The owner began to watch for Signs in his own hair and noticed that his graying Seemed to have at least Slowed down. Since the owner was due for a physical, he checked into a clinic and Stated he had Some minor pain in his chest

of 50 mg vitamin B6 pills and Suggested she take one immediately and then one a day for the first week, and then one every other day. Three weeks later she told him that the doctor had just Scheduled her operation.

65

recurring attacks of heartburn he had prior to changing his diet and taking Vitamin B6. He thought it a great discovery. Then Turk's owner moved to Arkansas. His stepdaughter, who is married and living nearby, worked at a local hospital. One day she began running a high fever in the range of 104 -106, went home, and went straight to bed. The fever fell, and the next couple of days she returned to work only to have the fever return after a couple of hours. She went home and the cycle repeated. She mentioned this to a doctor in the emergency room and a Series of tests were ordered looking for a virus, an infection, even a tubular conception. Turk's owner became involved, because after listening to long, Sometimes whispered conversations between his wife and Stepdaughter, he asked what the trouble was. His wife explained what had happened and that the doctor was looking for Some type of urinary tract or vaginal infection, but there were no positive cultures. When he heard that the Stepdaughter experienced burning and irritation when urinating, he asked his wife why they did not think about diet. His Stepdaughter was eating primarily Salad bar meals loaded with oxalic acid. He had his wife immediately take a bottle of vitamin B6 pills to his stepdaughter with a Suggestion to take two pills immediately, another one after twelve hours, and one a day after that for the next week. In

US 6,407,141 B1 10 two days her fever was gone, and She went back to work. After the third day all Symptoms were gone and She was back to normal as best they could ascertain. Other people who complained of back pain without having muscle or Spine problems found relief after Turk's owner Suggested taking Vitamin B6. One day while drying off after a shower, Turk's owner noticed a mole-type growth on the inside of his right thigh. He had not noticed it before, and shortly after that, a growth began at the end of his right eyebrow near the bridge of his nose. AS the growth on the thigh became bigger, So did his curiosity. He picked at the growth until Some of it came off and it bled. Now curiosity turned to concern. A month later the growth on the thigh reappeared and the growth on the eyebrow grew larger. He would check both growths every day and they were always on his mind. He believes it was his obsession with Turk that guided his thoughts to Oxalic acid. This acid is readily available in foods people eat, So why would God put a substance in food He provided to Sustain life, if that Same Substance by assaulting the kidneys can kill life? It just did not make Sense. That question constantly ran through his mind begging to be answered. Night after night, hours were spent turning and tossing in restleSS Sleep, Searching and Searching for an answer. He had read every article in every magazine he could get his hands on about foods thought to help in the fight against cancer,

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anitioxidants, free radicals, and anti-rust in the blood. One

night his mind Stopped on one particular item. It was a Sentence he had read about foods, and the importance they play in health and healing. “The acid in Strawberries is thought to help prevent prostate cancer.” Acid-there it was, that is the word that halted his mental computer. When he Woke up, questions began running through his mind. If Oxalic acid would destroy healthy renal tissue, could it possibly destroy Sick tissue first? Is cancer not considered to

35

be sick cells? Are these free radicals sick cells? What about

antioxidants? Are there really different types of cancer, or are they a similar type of Sick cell just in different parts of the body'? Why are there different types of chemotherapies? There were just too many questions. He had to go back and Start with his initial question. He asked a dear friend, a devout Christian, whether the Bible states that God put everything on earth that man needs? At the same time he went on a very high oxalic acid diet and avoided citric acid and reduced his intake of pyridoxines and alcohol to a

Later, Turk's owner learned of a close friend who had 40

45

minimum. His dear friend came back and Said she told her

Bible class of his request. They searched the Bible and noted three places that mention God providing for all of man's needs. What is significant is that articles describing food groups for cancer prevention, especially the vegetable groups, name those that have significant amounts of Oxalic

50

acid as per USDA Bulletin #11 (Table I). At this time he became convinced it was not the beta caroteine, the Vitamin

C, or anything else that was the cancer fighter-it was Oxalic acid. Once again he started asking himself questions. Would oxalic acid destroy sick cells before healthy cells? The only answer he could come up with is the affirmative. The story continues with the Submittal of U.S. provisional application Serial No. 60/006,785, filed Nov. 15, 1995, U.S. patent application Ser. No. 08/629,538, filed Apr. 9, 1996, now U.S. Pat. No. 6,133,317 and U.S. provisional applica

After placing himself on a high oxalic acid or oxalate diet, the growth on Turk's owner's thigh began to disappear and shortly thereafter the growth on his eyebrow as well. Even tually both growths were completely gone. Another sign of the result of the high oxalic acid diet was the disappearance of a couple of polyps around the anal orifice. These had appeared when he went on the low oxalate/low Oxalic acid diet, and now when he reversed the diet these growths disappeared. Later, his own daughter informed him that her mother was having a lot of Stomach or digestive problems and was due for exploratory Surgery. During the operation they discov ered cancer in the abdominal cavity and removed all possible, estimated at 80 percent. There was cancer in the bladder, and they planned an extensive chemotherapy pro gram. However, a specialty lab in California which received the tissue Sample, determined it was a rare type of cancer, with no known treatment. His daughter, who was at her mother's Side constantly, agreed to try his Oxalic acid procedure. With his Suggestion and the help of a juicer, she prepared a mixture of carrots, Spinach, parsley, and chives. He Suggested She try to get her mother to drink Six to eight ounces of the mixture at least three times a day. At the Start, her mother complained of the taste, Sohe Suggested She mix Some V8(R) juice with the mixture to enhance the flavor. This worked, and her mother began to drink the mixture. He felt that by having it in liquid form, more oxalic acid would enter her System more rapidly and begin to attack the Sick cells. On the third day after her mother began drinking the mixture, his daughter talked with the nurse who said, “In the morning when she took the patient's Vital Signs they were the best Since the patient had come to the hospital. Her temperature was down, blood pressure was down, and pulse rate was near normal.” In addition, the yellowish skin color began to change. Then, for reasons unknown, her mother stopped drinking the mixture. Shortly after that her mother passed away.

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prostate cancer, initially treated with a radiation implant which failed to keep the growth in check, and now would be undergoing chemotherapy. He urged his friend with prostate cancer to try his Oxalic acid dietary treatment. He sent an explanatory letter with copies of articles about the Veg etables along with a list of items containing oxalates and Oxalic acid. Later, he talked with his friend who gave him Some revealing data. Prior to starting the Oxalic acid dietary treatment, his friend had been to an oncologist because the cancer was spreading into the pelvic area and his PSA count was 350. When his friend returned to his primary care physician months later after being on the Oxalic acid diet, he was feeling better, his PSA was down to 246, and the doctor was Surprised because he did not think his patient would Survive long enough to See him again. It seemed the doctor knew the chemotherapy would not work and it may have been given just So his friend would not despair. Turk's owner sent a copy of the Judith Been Hurley article to his friend and believed that low calcium in the bone marrow was probably the reason his friend with prostate cancer was tired and felt pain in the thigh and pelvic area. Turk's owner, the Applicant, further investigated to try to better establish the relationship between oxalic acid and

tion Ser. No. 60/036,983, filed Jan. 29, 1997, entitled

pyridoxine hydrochloride (vitamin B6) and oxalic acid treat

OXALIC ACID OR OXALATE COMPOSITIONS AND METHODS OF TREATMENT FOR BACTERIAL DIS EASES AND VIRAL DISEASES IN HUMANS AND 65

14 year-old Specimen, had a very noticeable tumor on the mouth, had been diagnosed with multiple tumors which a

ANIMALS, by Francis J. Hart, all three applications being hereby incorporated by reference.

ment for the reduction of tumors. An Irish Setter, a 70-75 lb.,

biopsy confirmed to be melanoma (skin cancer), and was to be euthanized. The oral tumor was in an area easily exam

US 6,407,141 B1 11 ined. The oral tumor had been removed Several years ago, when it was confirmed as malignant, but it had grown back. The question was posed if a high oxalic acid or oxalate diet Supposedly works on humans, would it not also work on this dog? They felt confident, since The Merck Manual does state that 90 percent of cancers are due to environment and nutrition. And So, they embarked on taking the Setter off canned dog food (high in pyridoxines) and feeding a regular dry high protein dog food mixed with three or four boiled carrots and topped with chopped parsley. The canine was

12 Setter's condition, and felt that the reduction in the size of

the tumor was a positive sign that the Oxalic acid or oxalate was working. An autopsy of the Irish Setter revealed the malignant melanoma with metastasis, adrenal gland pheochromocytoma, acute cystitis, the urinary bladder mucosa appeared diffusely thickened, granular and hemor rhagic in appearance with the presence of moderate amounts of a turbid reddish-brown urine, a large encapsulated necrotic mass within the omental adipose tissue, with no other significant groSS lesions noted within other areas of the oral cavity, larynx, esophagus, trachea, lungs, heart, Spleen, kidneys, musculoskeletal System, and gastrointestinal tract. Hence, it appears that the Oxalic acid or oxalate diet did not damage any of the dog's organs or kidneyS. It is believed

Started on a diet of three or four medium sized boiled carrots,

mixed with approximately 1/2 pounds of dry dog food. Three to five days after Starting on the diet, the canine showed an improvement in appetite and energy. After three weeks of being on this diet, there was a noticeable reduction in size and appearance of the tumor on the canine's mouth. Almost a month after Starting on the above diet, the canine's diet was changed to a mixture of about one pound of boiled carrots, one teaspoon of garlic, one-quarter cup chopped fresh parsley, and one and one-half pounds of dry dog food containing no citric acid. This diet was varied based on the canine's condition with the mouth tumor being measured and recorded by a veterinarian. The mouth tumor exhibited expansion or Swelling and reduction cycles. The canine's urine was tested for oxalate count and a result showed about

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50 mg per liter of Oxalic acid. After about five months on this diet, the canine produced feces including mucous and intestinal membrane. Upon this happening all oxalic acid or oxalate addition to the canine's diet was stopped. It is believed that a high level of oxalic acid or oxalate intake causes a Sloughing off of the interior Surface of the Small intestine including old bacteria, food, Waste, and intestinal cells and membrane. After about a

Oxalic acid or oxalate blocker diet, and in less than one

month, urine was drawn from the canine to test for oxalate 35

mg/L. Three days later, the canine was restarted on a diet having about 1 gram of Oxalic acid added to one pound of dry dog food. A canine urine oxalic acid Scale was calculated based on a scale of 0-40 mg/L for a 70 kg human, and adjusting this for a 25 kg canine to have a desired range of about 0-14 mg/L. The canine was started on a new diet of approximately one and one-half pounds of dry dog food to 1 gram of Oxalic acid dihydrate dissolved in about three ounces of water and mixed together and adding one-half can

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protein to the diet. A little more than two weeks later the diet was changed to reduce the Oxalic acid dose to 500 mg per

day and the canine was given four beef strips (approximately 25 grams) with 27 percent protein each evening. Thirty days

later the dose was dropped to 300 mg oxalic acid/day. Two weeks later the dose was dropped to 50 mg oxalic acid/day. Two weeks later the dose was dropped to 20 mg oxalic acid per day which was maintained till the animal was eutha

50

nized. The canine's mouth tumor had reduced in size in an

eleven month period. The Oxalic acid dihydrate was pur chased from Swift Chemical Company, Rogers, Ark., and

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dissolved in water to use as a food additive to the canine diet.

Much to their Surprise, the dog Seemed to crave the carrots and parsley. The Setter's activity increased Steadily to the point where he actively competed with a four-year old

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Doberman and a nine-month old Rottweiler. The diet was

working. What was once a large Saggy Sack of black tissue Visibly hanging from the Setter's mouth changed to a considerably smaller and firmer growth. The reduction in the growth of the oral tumor slowed over time; however, it must be remembered that the tumor took nearly Six years to achieve the mass it once was. They continued to monitor the

indicate that Oxalic acid or oxalate had eliminated growths in the lungs. In accordance with another case Study, a dog at a pound was given one gram of Oxalic acid dihydrate in a gel cap one hour prior to meal time for Seven days with no adverse effects. The dog's appetite increased as well as energy and activity. In accordance with another case Study a human adult female Subject with possible cervical cancer found multiple growths on her cervix by Self-examination. The Subject Started on an increased Oxalic acid or oxalate and reduced

count the canine's Oxalic acid urine count was reduced to 24

of Pedigree brand canned dog food (6% oz. can) to add

that the lesions (Scars) in the lungs of the canine, may

65

month She reported that the Smallest growth was reducing in size. The Subject remained very strictly on the diet and a week later reported that the Smallest growth was gone with only a rough Spot remaining. A few days later the Subject reported that the next size growth seemed to be reducing. Less than a month later, the Subject reported that the large growth was considerably reduced. This process continued and less than a year after Starting on the increased oxalic acid or oxalate diet, the Subject reported that one Small growth remained which was only noticeable during her menstrual period. In accordance with another case Study, an adult male human Subject Suffering from a brain tumor, had been through all the different conventional treatments including Surgery chemotherapy, and radiation treatment. The tumor was never totally removed and remained malignant. The subject was told of the possible beneficial effects of oxalic acid or oxalate and began on a treatment regimen of four heaping Soup Spoons of dried parsley daily and a reduction of Oxalic acid or oxalate blockers. This should equate to approximately four grams of Oxalic acid per day. Three to four months later, the subject had a CAT scan where the tumor was examined and did not show any growth. The Subject also had visible signs of noticeable improvement in health. Approximately six months after Starting on the enhanced oxalic acid or oxalate diet, the Subject was much more active and friendly towards others. Approximately eight months after Starting on the enhanced oxalic acid diet the Subject was very excited about the diet, feeling much better. The Subject had expected and experienced the toxic effects of indigestion, diarrhea, and the Sloughing off of the interior Surface of the intestine. The Subject also indicated that the tumor was in the inactive Stage. Also the Subject indicated that his memory and thinking capability had returned and he could now accomplish functions he could not prior to following the diet. He was in the process of rebuilding an engine, replacing a carburetor, changing an oil pan. changing the oil and Spark plugs, and other activities that prior to Starting on the enhanced Oxalic acid or oxalate diet were impossible.

US 6,407,141 B1 13 Doctors had not given this patient much time to live, and it is believed that the enhanced Oxalic acid or oxalate diet

with reduced blockers had treated, controlled, or otherwise

beneficially affected his brain tumor and overall health. He was still alive and functioning better after nine months. An adult female in her sixties was terminally ill with leukemia with tumors in her lymph nodes and she had Stopped chemotherapy treatment. She was told about the possible beneficial effect of Oxalic acid or oxalate and Started on a daily intake of about 1 to 1/2 g/day Oxalic acid or oxalate and almost no oxalic acid or oxalate blockers. It was

hard for her to Swallow So she was on a liquid diet because of the Swelling of the lymph nodes in and around her mouth and throat. After 5-7 days of administration of oxalic acid or oxalate in dilute Solution she was able to eat again due to the Shrinkage of tumors in the lymph nodes. This dramatic effect

15

14 reduced and in less than 2 months of being on the diet her blood work showed a large reduction in the cancer in the blood and that the cancer was in regression. Her condition improved So much So that the doctorS Stopped conventional chemotherapy treatment. In another case Study, an adult female with breast cancer went on a diet including an intake of about 4 ounces of carrot juice per day along with chicken broth. In about Sweeks she was sent home from the hospital. She was walking, went to the mall and was eating potato chips. Previously, she had been hospitalized and on a liquid diet. In accordance with another case Study, an adult female Suffering from breast cancer went on an increased Oxalic acid diet, Stopped using the microwave oven to cook foods, Stopped chemotherapy treatments, cut CAT-Scans down to once a month, and in a short time her blood was tested and

in Such a short time indicates that the intake of Oxalic acid

showed that it was clean of cancer cells and the breast cancer

was treating her condition or disease and benefiting the

appeared to have stopped growing. Based on this history, it is believed that oxalic acid or

individual.

In another case Study, an adult female was diagnosed with

oxalate will, at a minimum. reduce the Size of tumors,

a tumor (endometrial) in the uterus. The tumor was removed

especially if pyridoxine hydrochloride, citric acid, ascorbic

and reduced intake of Oxalic acid or oxalate blockers. After

much as possible. This dietary procedure needs to be con tinued until the tumor or growth is eliminated. If the individual experiences backaches due to kidney irritation, urinary tract irritations, and/or Severe heartburn, Vitamin B6

by laser and she was to undergo chemotherapy. She heard of the Oxalic acid treatment of the present invention, and went on the diet having increased intake of Oxalic acid or oxalate

acid. calcium and alcohol are eliminated from the diet as 25

several months of being on the diet, her blood tests were negative on cancer and she did not have to undergo con ventional oncological chemotherapy. In accordance with another case Study, a Doberman

(pyridoxine hydrochloride) can be taken to help eliminate

the discomfort. Since calcium, pyridoxine hydrochloride, citric acid, ascorbic acid and alcohol block oxalic acid or

pincher was diagnosed with bone cancer (sarcoma) of the

oxalate, the individual should work his/her dietary therapy up to the point of experiencing the discomforts Stated and then back off Slightly from oxalic acid or oxalate intake. It

left hind leg. The dog had previously been put on medication

for arthritis because it would not use or lower its left hind

leg. After being diagnosed with cancer confirmed with X-ray, the dog was placed on a diet of Oxalic acid enhanced dogfood containing about 2 grams of Oxalic acid dihydrate dissolved in water and added to conventional dry dogfood. Within 4 days, the dog had lowered its left hind leg and used it frequently in activity with a companion dog. A few days later, the dog began taking Steps on the left hind leg with a Slight limp. The dog's condition continued to improve and it's diet was changed to reduce the Oxalic acid to about 1 gram of Oxalic acid/per day. After a couple of weeks the dog's condition continued to improve So the dosage of Oxalic acid was reduced to about 500 mg/per day. The dog appears to be walking with no pain and an X-ray revealed an

is also believed that the converse is also true-insufficient

Oxalic acid or oxalate may allow tumors to grow. 35

40

45

increase in bone material in the area of the Sarcoma and a

decrease or reduction in the size of the area affected by the sarcoma. After being on the oxalic acid diet for about 30 days, the dog appeared to have no pain during physical exam and was walking normally. In another case Study, an adult female was diagnosed with Stomach cancer and Scheduled for Surgery. She began the

50

increased oxalic acid or oxalate and reduced Oxalic acid or oxalate blocker diet and when she went in to have the

Surgery done, they discovered that her tumor had turned to liquid. Her diet or treatment regimen included a low intake of red meat or white meat of fowl, a low intake of Soda pop or other beverages containing citric acid, a low intake of foods containing citric acid, an intake of about 4 ounces of carrot juice per day with 2 ounces taken in the morning and 2 ounces in the evening, and a low intake of alcohol. Apparently, the Oxalic acid in the carrot juice may have turned the tumor cells into a liquid and all that was necessary was for the liquid to be drained. In another case Study, an adult female having breast cancer Started on a high oxalic acid or oxalate and low Oxalic acid or oxalate blocker diet. The growth of the cancer was

55

Since certain cancers in animals are believed to be caused

by viruses, it was postulated by the present inventor. that Oxalic acid or oxalate may be useful in treating infectious or pathogenic bacterial, Viral. or other microbial diseases in addition to treating cancers, tumors, neoplasms, and the like. This invention relates generally to methods and compo Sitions containing Oxalic acid or oxalate or related com pounds for providing therapeutic effects Such as the control. prevention, or treatment of cancer, tumors, neoplasia, infec tious or pathogenic bacterial, Viral, or other microbial diseases, etc. It was initially discovered that a lack of Oxalic acid or oxalate in the diet of a human, allowed or promoted the growth of tumors, growths, or other neoplasia. It was then discovered that the ingestion or administration of a therapeutic quantity of Oxalic acid, oxalate or foods con taining high levels of Oxalic acid or oxalate can deter, reduce, or prevent the growth or spread of cancer, tumors, or other neoplasia. Then, it was discovered that an oxalic acid Solution controlled, prevented, or treated infectious or patho genic bacterial or viral diseaseS Such as colds, flu, Sore throat, and the like.

It has also been discovered that the therapeutic effect of Oxalic acid or oxalate can be inhibited by an increased ingestion or administration of Oxalic acid or oxalate blockers including, for example, calcium, alcohol, citric acid, ascor 60

bic acid (vitamin C), pyridoxine hydrochloride (vitamin B6), etc. Other oxalic acid or oxalate blockers include binding agents Such as clay, resins, and indigestible fibers. Radiation, Strong electromagnetic waves or fields, electron bombardment, excessive heat, and bases Such as Sodium

65

bicarbonate Serve to decompose, neutralize or otherwise reduce the beneficial effect of oxalic acid. There may also be pharmaceuticals which interfere with the absorption or ben

US 6,407,141 B1 15

16

eficial activity of Oxalic acid or oxalates. Also, the thera peutic effect of Oxalic acid or oxalate can be enhanced by decreasing or eliminating the ingestion or administration of one or more of these blockers and/or increasing the ingestion

classical method of Separating oxalic acid from other Sub stances. Although calcium oxalate is generally considered to be an insoluble salt this is a relative term and its solubility in water is actually 6–7 mg/l at room temperature. Biological fluids contain many substances that affect the solubility or rate of crystallization of calcium oxalate or co-precipitate with the Salt. For example, magnesium, polyphosphates and other polyelectrolytes affect the solubility or rate of crystal lization of calcium oxalate while phosphate and Sulphate ions, uric acid and citric acid co-precipitate with the Salt. Also as described in “Oxalic Acid in Biology and Medicine”, oxalic acid and its salts are widely distributed among the higher plants. Oxalic acid is Sometimes present in plants as the free acid, but more usually, however, it is present as a Soluble or insoluble Salt, for example, the acid and neutral Sodium and potassium Salts and the ammonium

of Oxalic acid or oxalate. Oxalic acid or oxalate enhancers which increase the beneficial effect of Oxalic acid or oxalate

include long chain fatty acids and the like which bind with or otherwise eliminate oxalic acid blockerS Such as calcium.

High levels of Oxalic acid or oxalate can produce Side effects of diarrhea, indigestion, damage to the digestive tract, and kidney damage or renal failure. Hence, prolonged ingestion or administration of high quantities of Oxalic acid or oxalate should be avoided so that the beneficial thera

peutic effect of the reduction, control, or treatment of tumors, cancers, neoplasia, neoplasms, infectious or patho genic bacterial, Viral, or other disease can be enjoyed without harm to other systems or parts of the body.

15

Salt. Calcium oxalate is the most common insoluble Salt but

AS mentioned above, Oxalic acid or ethanedioic acid

(CHO), is a dicarboxylic acid and is present in many

plants and vegetables, notably in those of the Oxalis and Rumex families, where it often occurs in the cell Sap of the

plants as the potassium or calcium Salt (oxalate, Tables I-IV). Oxalic acid is also a product of the metabolism of

many molds. Several Species of Penicillim and Aspergillis convert Sugar into calcium oxalate with a 90 percent yield under optimum conditions. Oxalic acid is also made by passing carbon monoxide into concentrated NaOH or heat ing sodium formate in the presence of NaOH. Oxalic acid dihydrate, monoclinic tablets, prisms, and granules are considered poisonous. Anhydrous Oxalic acid is crystallized from glacial acetic acid and is orthorhombic with the crystals being pyramidal or elongated octahedral. Oxalic acid is listed as being caustic and corrosive to the skin and mucous membranes. Ingestion may cause Severe gastroenteritis, with Vomiting, diarrhea, or melena. Renal damage can occur as a result of formation of excessive calcium oxalate crystals. Convulsions, coma. or death from cardiovascular collapse can also occur. Common uses of Oxalic acid include as an analytical reagent, in calico printing and dying, for bleaching Straw and leather, removing paint or varnish, rust or ink Stains, clean ing wood, and manufacturing oxalates, blue ink, celluloid, intermediates and dyes, in metal polishes, in purifying methanol, for decolorizing crude glycerol, for Stabilizing hydrocyanic acid, as a general reducing agent, in ceramics and pigments, in metallurgy as a cleanser, in the paper industry, in photography, in process engraving, in rubber manufacturing, in making glucose from Starch, as a con densing agent in organic chemistry, and as a veterinary hemostatic agent when mixed in 5 percent Solution with 5 percent malonic acid. As described in “Oxalic Acid in Biology and Medicine” by A. Hodgkinson, 1977, oxalic acid was formerly used intravenously as a hemostatic agent and topically as an antiseptic in man and other animals but this was discontin ued because of its toxicity and the danger of precipitating

25

content of individual foodstuffs (see Tables I-IV), but few estimates have been made of the total daily intake of oxalate by animals or man (see Table V). This is surprising in view

35

average Serving (60 g) of spinach or rhubarb had been 40

400 and 600 mg/day but these levels are not typical for this country. Wide variations in oxalate intake may occur in countries Such as India where vegetables rather than dairy products provide the main Source of minerals and where many of the plants used as Vegetables contain high concen trations of Oxalate. Some indication of these variations has

45

50

55

60

been provided by a study which found intakes ranging from 78-2045 mg/day depending on the Season in the rural population of Udaipur, India. A relatively high intake was also found among upper-income groups in urban areas and was attributed to a high intake of tea and green, leafy vegetables, compared with lower-income groups. As reported in “Oxalic Acid in Biology and Medicine”, when taken with food, ingested oxalate is poorly absorbed from the gastrointestinal tract. Although oxalate absorption appears to be unaffected by metabolic inhibitors it is reduced by the presence of calcium which lowers the concentration of free oxalate ions. It is well known, for example that calcium oxalate is absorbed less readily than Sodium oxalate and absorption is also reduced by the oral administration of

cholestyramine (anion exchange resin which has a strong affinity for oxalate ions). Conversely, oxalate absorption is increased when the dietary intake of calcium is reduced and this is reflected in an increased urinary excretion of Oxalate. In addition to a low calcium diet, the intake of dySodium

with monovalent metals and ammonia. Oxalic acid forms a

number of oxalates or Salts including calcium oxalate. potassium oxalate, Sodium oxalate, Strontium oxalate, mag

ethylene diamine tetra-acetic acid (EDTA) appears to

nesium oxalate, and the like. Oxalic acid also inhibits the

activity of a number of enzymes possibly due to the com petition between oxalate and a structurally similar Substrate of the enzyme. Precipitation as the calcium Salt is the

of the effect of oxalate on calcium availability and the high incidence of calcium oxalate renal Stones in many parts of the world. As shown in Table V, the reported numbers for daily oxalate intake range from 70-980 mg/per day of anhydrous acid for healthy adult males. However, this information was based on the Study of diets which contain no oxalate-rich foods other than tea which is the largest Single Source of the acid in typical English diets. If an

included then the oxalate intake would have risen to between

insoluble calcium oxalate in the tissues. Oxalic acid is a

relatively Strong acid having a first dissociation constant being exceeded by that of only a few halogen-Substituted carboxylic acids. Oxalic acid forms neutral and acid Salts

relatively large amounts of magnesium oxalate occur together with calcium oxalate in plants Such as beet root, Spinach, and buckwheat. Under conditions of calcium deficiency, Strontium, magnesium, or barium oxalate can be Substituted for calcium oxalate in a wide variety of plant Species depending upon the mineral environment. Further, as mentioned in “Oxalic Acid in Biology and Medicine”, there have been many studies of the oxalate

65

increase the absorption of oxalate by complexing of calcium with EDTA in the intestinal lumen leaving more oxalate free to be absorbed.

US 6,407,141 B1 17

18

Also as reported in “Oxalic Acid in Biology and Medicine', the most important precursors of urinary oxalate in man are ascorbic acid, glycine, and dietary oxalate. Excretion of Oxalate is also increased by the ingestion of a variety of Substances including glycine, alutamic acid, purines, gelatin, and ascorbic acid. Conversely, excretion has been reported to be reduced by the administration of pyridoxine and magnesium oxide. LeSS than half of the normal dietary intake of Oxalic acid can be accounted for by absorption into the body or excretion in the faeces. The remainder of the normal dietary intake of Oxalic acid appears to be destroyed by a bacterial action in the large intestine. With a dietary intake of about 130 mg/day, more than 50 mg/day appears to be destroyed by bacterial action. Also as reported in “Oxalic Acid in Biology and Medicine”, large discrepancies have been reported in the

local corrosive action and those resulting from absorption and excretion of the Soluble oxalate. If a high concentration or the Solid form is taken, the local effects may be predomi nant and death may result from acute hemorrhagic gastro enteritis without development of Symptoms depending on absorption. If death does not result from local corrosive action then Symptoms develop from the Systemic effects and from renal insufficiency. The cardiovascular, neuromuscular and central nervous Systems are markedly affected. The skin is pale, cold and clammy, the pulse is weak and the blood preSSure and temperature are low. Numbness and tingling may develop in the extremities and cramp-like muscular and abdominal pain may be extremely Severe. Local or gener alized muscular twitchings occur and may progreSS to marked tetany and convulsive Seizures. The central nervous System may show evidence of excitation or depression, varying from an acute maniacal State to stupor and coma. Death results from cardiovascular collapse or depression of the central nervous System. Renal involvement is frequent and even if the patient Survives the Severe local or Systemic effects, death may ultimately occur from renal insufficiency, which dominates the picture from the Second day. Oliguria developS and may progreSS to anuria. Infection with Oxalic acid producing fungi of aspergillus may result in massive deposition of calcium oxalate at the Sight of infection and also renal oxalosis, leading to renal

15

"normal” concentration of Oxalic acid in mammalian blood.

Early studies obtain values ranging from 2-4 mg/100 ml of blood. Another study indicated that the normal blood con centration is probably less than 1 mg/100 ml of blood. Improved testing methods have given results in normal values within the range of 100 tug/100 ml to 800 tug/100 ml. More recent tests of human plasma have produced normal Oxalic acid concentration ranging from 11.8-14.3 ug/100 ml of blood in man and 52.6 to 74.4 ug/100 ml of blood in sheep

25

(see Table VI). A mean value of 288 ug of anhydrous oxalic

failure (Oxalic Acid in Biology and Medicine). Patients

undergoing treatment with Steroids, immunosuppressive drugs or cytotoxic agents are particularly liable to develop fungal infections and the increasing use of these drugs in malignancy and organ transplantation may be expected to lead to an increased incidence of aspergillosis infection.

acid/100 ml was reported for normal human blood, a figure which is probably much nearer to the normal value. Feeding experiments and radioisotope Studies have indi cated that a considerable number of compounds are precur Sors of Oxalic acid in animals and man, for example, glycine, glyoxylic acid, glycolic acid, ethyleneglycol, ascorbic acid,

Oxamide (ethanediamide, oxalamide, oxalic acid diamide, or ethanedioic acid diamide, or CHNO) is

and tryptophan (Oxalic Acid in Biology and Medicine). Studies with ascorbic acid have shown that the main excre

tory products of Vitamin C in man are oxalate, ascorbic acid, and dehydroascorbic acid. From 17-40 percent of adminis

35

tered ascorbic acid was excreted as Oxalic acid.

As reported in “Oxalic Acid in Biology and Medicine”, a high oxalate intake reduces the intestinal absorption of calcium because of the formation of insoluble calcium

oxalate and prolonged exposure to Such a diet may lead to loSS of bone mineral, particularly if the diet is also deficient in calcium or Vitamin D. This situation is unlikely to occur very often in Western countries where there is a plentiful Supply of milk and other dairy products and oxalate-rich foods are relative uncommon. However, in developing coun tries Such as India the Situation is often quite different because tropical vegetables frequently with a high oxalate content provide the main Source of minerals and the total oxalate intake may well exceed the calcium intake in certain Seasons. Dietary oxalate is poorly absorbed on a normal diet containing adequate amounts of calcium. Further, as reported in literature including "Oxalic Acid in Biology and Medicine”, poisoning from Oxalic acid in animals and man has been recognized since the beginning of the 19th Century. The death rate from oxalate poisoning has declined Supposedly because of a decreased use of Oxalic acid in domestic cleaning fluids. Examples of chronic poi Soning by absorption of Oxalic acid through the Skin and by inhalation have been reported. The range of lethal doses in acute poisoning is wide, varying between 2 and 30 g and depending upon a variety of factorS Such as the form in

40

45

citric acid, alcohol, or combinations thereof. 50

55

Also, in accordance with the present invention, Severe gastroenteritis, vomiting, diarrhea, melena, renal disease, renal damage, convulsions, coma, cardiovascular collapse, and the like caused by Oxalic acid are treated or prevented by limiting or by reducing oxalic acid or oxalate intake and/or administering therapeutic quantities of Oxalic acid or oxalate blockerS Such as calcium, alcohol, potassium, citric acid, Vitamin B6, vitamin C, and combinations thereof.

60

which the acid or its Salt is taken and the amount of food,

particularly calcium, which is present in the Stomach and intestine. Death has occurred as early as 3 minutes and as late as 14 days after ingestion. Symptoms of acute oxalic acid toxicity in man can be divided into those caused by a

metabolized in the body to form oxalic acid. In accordance with the present invention, therapeutically effective amounts of at least one therapeutically effective form of oxalate or oxalic acid including, oxalic acid dihydride, anhydrous Oxalic acid, potassium oxalate, Sodium oxalate, oxamide, plants or vegetables containing oxalic acid or the potassium Salt thereof, or combinations thereof are administered periodically to prevent, control, or treat infec tious or pathogenic bacterial, Viral, or other microbial dis eases or conditions and/or neoplasia, cancers, tumors, neoplasms, and the like. Further, these compounds are administered along with a therapeutically effective reduction in the administration or ingestion of Oxalic acid or oxalate blockerS Such as calcium, potassium, Vitamin C, Vitamin B6,

65

Oxalic acid dihydrate is commercially available in powdered, granular or crystal form or in liquid form for use as an industrial cleanser or Solvent preparation. In accordance with the present invention, oxalic acid may be present in a free acid, ester, lactone, or Salt form. Also, Oxalic acid, oxalate or related compound having the desired beneficial effect may be used as a composition, additive, Supplement, remedy, and the like alone or in combination to prevent, control, or treat cancer, tumors, neoplasia, neoplasms, infectious or pathogenic bacterial or viral diseases, and the like.

US 6,407,141 B1 19

20

In accordance with the present invention, a therapeutic composition may be formed by adding oxalic acid dihydrate to food or drink to provide for the oral ingestion of a therapeutically effective quantity of Oxalic acid. Atherapeutic composition of Oxalic acid or oxalate com pound of the present invention may be prepared by forming a food or drink including plants or vegetables high in Oxalic acid or oxalate, for example carrots, carrot juice, chives,

vitamin C, vitamin D, vitamin E, vitamin B1, vitamin B2,

niacin. Vitamin B6, pholate, Vitamin B12, pantothenic acid, iron, iodine, Zinc, and copper. A daily value has not been established for oxalic acid. Each tablet would contain the

parsley, beets, spinach, or combinations thereof (see Tables I–IV).

Atherapeutic composition of the present invention in the form of a daily Supplement, pill, gel cap, pharmaceutical, or the like is prepared by placing a therapeutically effective amount of Oxalic acid or oxalate compound in pill form for oral ingestion as directed. A therapeutic composition of the present invention in cream or ointment form for topical administration of Oxalic acid is prepared by mixing a dilute concentration of Oxalic

15

riboflavin, Vitamin A, acetate, thiamin mononitrate, beta

carotene, resin, folic acid, potassium iodide, chromium chloride, ergocalciferol, Sodium molybdate, Sodium Selenate, yellow 6 lake, Sodium metavanadate, Stannous

acid in a Solvent Such as distilled water, ethanol, acetone,

propylene glycol or polySorbate to form a Solution which is then mixed in a conventional manner with a commonly available cream or ointment base Such as hydrophilic oint ment or petrolatum. Therapeutic compositions of the instant invention may also be formulated in gel, lotion, Spray, Stick or powder form. It is believed that the therapeutic effect of the oxalic acid or oxalate in treating tumors, cancers, neoplasia, neoplasms, infectious or pathogenic microbial, bacterial or viral diseases, and other disorders affecting humans involves the administration whether it be topical, oral, by injection, Suppository, or the like of a therapeutic and beneficial quantity of Oxalic acid in one of its free acid, Salt, or other

chloride, nickelous Sulfate. phytonadione, biotin (U.S.P. method 2), and cyanocobalamin (U.S.P. method 2). This 25

forms to cause contact of Oxalic acid with the bacteria or

virus, and/or to elevate the blood oxalic acid level to

between 350 ug/100 mL and 450 4tug/100 mL, preferably 425 ug/100 mL and/or the urine oxalate level to between 40 mg/L and 80 mg/L, preferably 60 mg/L for a 70K human. Also in accordance with the present invention in the

35

In accordance with at least one embodiment of the present invention, Oxalic acid or oxalate is used for the treatment of 40

desired therapeutic effect can be produced from 14 mg/L to 50 mg/L, preferably 22 mg/L oxalate level in the urine of a 25 K animal as compared with 40 mg/L to 80 mg/L, preferably 60 mg/L in the human urine. Likewise, the normal blood oxalic acid level of an animal Such as canine or feline differs from that of humans.

In accordance with a particular embodiment of the present invention, oxalic acid or oxalate is used in a method of

45

therapeutically treating a human including administering a therapeutically effective dosage of Oxalic acid, Oxalic acid Salt, oxalic acid ester, or other therapeutically effective form thereof, in an amount and for a period of time Sufficient to provide the desired effect.

50

The method as described above wherein the oxalic acid is in the form of a free acid. The method as described above wherein the acid is in Salt form.

55

oxalate or other therapeutically effective form thereof is administered periodically for a period of time Sufficient to achieve at least a clinically discernible effect, for example,

of oxalate in the urine of a 25 Kilogram (K) canine.

The method described above wherein the oxalic acid,

thiamin (vitamin B1), 1.7 mg riboflavin (vitamin B2), 20 mg

niacin, 2 mg vitamin B6, 400 mcg folate, 6 mcg Vitamin B12, 30 mcg biotin, 10 mg pantothenic acid, 162 mg calcium, 18 mg iron, 109 mg phosphorus, 150 mcg iodine, 100 mg magnesium, 15 mg zinc, 20 mcg Selenium, 2 mg copper, 2.5 mg manganese, 25 mcg chromium, 25 mcg molybdenum, 36.3 mg chloride, 40 mg potassium, 5 mcg nickel, 10 mcg tin, 2 mg Silicon, 10 mcg Vanadium, and 150 mcg boron. Such a multiple vitamin formula with added minerals provides a 100% daily value of at least vitamin A,

infectious or pathogenic microbial, Viral, bacterial, or other diseases of warm-blooded animals including humans, dogs, and the like.

Along this line, it has been determined that about 1 gram per day intake of Oxalic acid provides about a 22 mg/L level In accordance with one embodiment of the present invention, a multiple Vitamin formula having oil and water soluble vitamins with minerals in tablet form with a Sug gested use to take one tablet daily with a full glass of distilled water preferably within an hour of a meal or as directed by a physician, includes about 100 mg oxalic acid together with 5,000 IU vitamin A, 60 mg vitamin C, 400 IU vitamin D, 30 IU vitamin E, 25 mcg vitamin K, 1.5 mg

product would be formulated per official U.S.P standards to meet disintegration or dissolution, weight, purity, and potency requirements. An alternative embodiment of the present invention would include a multiple Vitamin and mineral tablet or daily Supplement including oxalic acid in one of its forms or oxalate together with all the above mentioned Vitamins and minerals except those which Serve as Oxalic acid or oxalate blockers. For example, the inclusion of Oxalic acid or oxalate blockers would be eliminated or greatly reduced So as to prevent blocking the beneficial effect of the Oxalic acid or oxalate. Such blockers include calcium, potassium, Vita min B6, vitamin C, citric acid, alcohol, magnesium, resin, etc.

treatment of canines, an oxalic acid or oxalate level chart for canines and felines differs from that for humans in that the

following ingredients: Oxalic acid or oxalate, Oxalic acid dihydrate, anhydrous Oxalic acid, or other form of Oxalic acid or oxalate, or combinations thereof together with dical cium phosphate, magnesium oxide, potassium chloride, ascorbic acid, ferrous fumarate, calcium carbonate, gelatin, Starch, cellulose, dl-alpha, tocopherol acetate, hydroxypro pyl methylcellulose, croScarmellose Sodium, Sodium Starch glycolate, niacinamide, Zinc oxide, Silicon dioxide, D-calcium pantothenate, Sodium metasilicates and oxides, titanium dioxide, hydroxypropyl cellulose, polyethylene glycol 3350, manganese Sulfate, magnesium Stearate, phar maceutical glaze, polySorbate 80, pyridoxin hydrochloride, copper oxide, poVidone, Sodium and potassium borates,

a reduction in infection or the size of a tumor.

The method as described above wherein the oxalic acid, 60

oxalate or other therapeutically effective form thereof is administered periodically for a period of time Sufficient to achieve at least a Substantial therapeutic effect, for example the eradication of infection or a tumor. The method as described above wherein the oxalic acid or

65

oxalate is administered daily. The method as described above wherein the period of time is at least one month.

US 6,407,141 B1 21

22 requires a particular balance of compounds, chemicals, Vitamins, minerals, nutrients, and the like to provide for and maintain optimum health of the animal. It is believed that too little oxalic acid or oxalate in the animal may allow for the advent of neoplasia, tumors, cancers, growths, neoplasms, bacterial or viral disease, and the like, while too

The method as described above wherein after one month

the Oxalic acid is administered on a weekly basis. The method as described above wherein the oxalic acid,

oxalate or other therapeutically effective form thereof is present in a therapeutically acceptable composition includ ing a carrier. The method as described above wherein the composition is a powder, tablet. gel cap, lotion, cream, gel, ointment, Solution, mixture, food, nutritional Supplement, formulation, transdermal patch, drops, or combination thereof. In accordance with one embodiment of the present invention, a therapeutically effective dosage of Oxalic acid or oxalate is administered on a periodic basis by the ingestion of one or more foods including oxalic acid in one of its therapeutically effective forms including free acid, Salt, ester, lactone, anhydride, dihydrate, diamide, or the like. In accordance with a particular example, a four pound Sourdough bread loaf is made from conventional bread ingredients including flour, water, yeast, and Sourdough and has added thereto two rounded tablespoons of dried, chopped parsley which is mixed with the other ingredients to be disbursed throughout the loaf. These two rounded tableSpoons of dried parsley provide approximately 2 grams

much oxalic acid or oxalate may cause back pain (due to kidney trouble), heartburn, indigestion, heart trouble, nerve trouble, and the like. Thus, it is recommended that each

individual case be Studied and that the proper dosage of a therapeutically effective amount of Oxalic acid, oxalate, enhancers, and/or blockers be administered on a periodic basis at one level to maintain proper health by preventing neoplasia, tumors, growths. neoplasms, bacterial or viral 15

bacterial or viral disease, or to cleanse the blood, and at a third intermediate level once the blood is clean and rela

of oxalic acid or oxalate in the loaf of bread. Hence, half of

the loaf contains about 1 gram, /4 of the loaf contains about /2 gram, /18 of the loaf contains /4 of a gram, and /16 of the loaf contains about /s of a gram of Oxalic acid. In accordance with one embodiment of the present

25

invention, the above described loaf of Oxalic acid or oxalate

containing Sourdough bread is used in a method of thera peutically treating a warm-blooded animal by having the animal periodically ingest a portion of the loaf. For example, in the treatment of an adult male human, he could ingest daily up to about/2 of a loaf of this bread to achieve a dosage of Oxalic acid of up to about 1 gram Oxalic acid per day. This dosage may be reduced after a period of time and given a certain health condition to /2 gram or leSS Oxalic acid per day, and, as Such, 4 loaf or less of the bread per day. The above described Oxalic acid or oxalate containing Sourdough bread does not include any Salt, Sugar or preser Vatives Since the Oxalic acid Serves as a preservative. In using oxalic acid or oxalate as a therapeutic agent, one must be careful to administer the proper dosage given certain health conditions or in order just to maintain a healthy condition Since an overdose of Oxalic acid or oxalate can cause indigestion, heartburn, backache, or Severe prob lems. Such as renal failure, heart failure, diarrhea, vomiting, convulsions, melena, and the like. It is believed that a proper

35

40

include ethanedioic acid (free acid), ethanedioic acid 45

acid diamide, ethanedioic acid diamonium Salt, ethanedioic Salt, ethanedioic acid Silver Salt, ethanedioic acid strontium 50

of Oxalic acid or oxalate would reduce calcium levels, administration of Oxalic acid or oxalate to the minimum

55

60

invention, the amount of blockerS Such as calcium, Vitamin B6, vitamin C, citric acid, alcohol, or combinations thereof

are monitored in the urine and/or blood of the patient. It has been discovered that the body of an animal such as human or canine is a complex chemical factory which

anhydride, ethanedioic acid tri-potassium Salt, ethanedioic acid barium Salt, ethanedioic acid copper Salt, ethanedioic

acid diethyl ester, ethanedioic acid dimethyl ester, ethanedioic acid disodium Salt, ethanedioic acid magnesium

potassium levels, magnesium levels, and the like necessary for proper heart functioning, it is necessary to limit the dosage necessary to provide the desired therapeutic effect without causing undesired Side effects or health problems. In accordance with the present invention, the dosage of Oxalic acid or oxalate is monitored and altered as necessary by monitoring the Oxalic acid or oxalate levels in the urine and/or blood in the patient, whether that patient be a human, canine, or the like. Also in accordance with the present

tively free of infectious or pathogenic bacteria or viruses, cancer, tumor, neoplasm or neoplasia cells, to combat, reduce the size of, or treat an existing tumor, cancer, growth, neoplasm or infectious bacterial or viral disease. or the like. Since each perSon or animal is different. and their body chemistries operate in at least Some Small fashion differently than other perSons or animals, the administration of a therapeutically effective dosage of Oxalic acid, oxalate, enhancers, and/or blocking agents should be reevaluated and monitored on a regular basis by, for example, physical examination, X-ray, CAT Scan, MRI imaging, Sonogram. biopsy, blood analysis, urine analysis, fecal analysis, as well as other conventional diagnostic techniques. It is believed that a proper balanced diet including foods containing Oxalic acid in one of its forms including oxalate which may be metabolized by a human or other warm-blooded animal can Serve to maintain proper health, extend life, increase the quality of life, increase energy, increase cranial activity, prevent neoplasia, tumors, cancers, neoplasms, infectious bacterial, Viral, or microbial disease, etc., help to combat Viruses, bacteria, improve the immune System, and provide other beneficial short term and long term health effects. Some forms of Oxalic acid or oxalate which may prove beneficial to humans and other warm-blooded animals,

balance should be maintained between oxalic acid, oxalate

and their blocking agents Such as potassium, barium, calcium, copper, magnesium, Silver, Strontium, alcohol, cit ric acid, Vitamin B6, vitamin C, and the like. If a high dosage

disease, and the like, at a different level to treat, combat,

control, or eradicate tumors, growths, cancers, neoplasia,

65

Salt, ethanedioic acid dihydrate, dicarboxylic acid. as well as other forms of Oxalic acid or oxalate which may be metabo lized by the body, injected into the circulatory System, administered by transdermal patch, administered by Suppository, administered by topical application, wash, gargle, ointment, and the like, to provide the desired thera peutic effect. Although one or more of the above may be considered poisons to humans or other warm-blooded ani mals. the proper administration of a Selected dosage is believed to be therapeutically effective and instrumental in the treatment, prevention, and control of disease, and main tenance of good health. It is not uncommon for an agent which is a poison to provide a beneficial effect. Aspirin is one of the myriad of hundreds or thousands of poisons which provide a beneficial effect to warm-blooded animals when administered in a proper dosage. It is believed that oxalic acid or oxalate may be one of the primary causes of the onset of Osteoporosis. Too much

US 6,407,141 B1 24 It is also believed that Oxalic acid or oxalate may be a control, treatment, remedy, or preventative for viral or auto

23 Oxalic acid or oxalate in the diet may reduce the calcium in the body to a point of causing or aggravating osteoporosis. Hence, the treatment and prevention of Osteoporosis is the

immune-related diseases Such as AIDS, HIV, SLE, BSE,

control of the Oxalic acid, oxalate and calcium levels.

CFS, and the like by preventing, lessening, or controlling the destruction of the bodies immune System. Hence, the administration, ingestion, injection, etc. of an effective amount of Oxalic acid in one of its therapeutically effective forms including oxalate may serve to treat, prevent, or control the debilitating effects of auto-immune related

Women in a high risk group for Osteoporosis should be careful to increase calcium intake and decrease Oxalic acid

or oxalate intake to prevent, treat, or control osteoporosis. It is believed that oxalic acid or oxalate may be a blood purifying agent which in addition to controlling, treating, or eradicating infectious bacteria or viruses and abnormal cells, Oxalic acid in the blood may control cholesterol and plaque or fat buildup. Thus, the periodic or daily administration of a certain quantity of Oxalic acid in one of its therapeutically effective forms including oxalate may serve to not only purify the blood, but also control, treat, or effect cholesterol, plaque, and fat buildup in the cardiovascular System or in the brain, and in So doing improve and maintain good cardio vascular health and operation. It is believed that Oxalic acid or oxalate may also be an effective treatment for parvo. Also, Oxalic acid or oxalate may be used as a hemostatic and antiseptic agent in and on

diseases, Viral diseases, bacterial infections, and the like.

As described in “Oxalic Acid in Biology and Medicine”, normal human blood typically has a mean value of about 288 lug of anhydrous oxalic acid per 100 ml of blood. In accordance with the present invention, if a Subject's blood is 15

animals. It is believed that oxalic acid or oxalate should be admin

istered following exposure to X-ray radiation, X-rays, mammograms, radiation therapy, CAT-Scans, nuclear or atomic exposure, radiation therapy, chemotherapy, radioac tive pellet treatment, and the like, to prevent infectious or pathogenic bacterial or viral disease, or the formation of neoplasms, tumors, cancers, neoplasia by counteracting the destruction of Oxalic acid or oxalate caused by the exposure

should be administered Oxalic acid or oxalate in order to

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35

It is also believed that oxalic acid or oxalate should be

administered after exposure to Specific oxalic acid or oxalate decomposing bacteria to prevent infectious bacterial or viral disease or the onset of tumors. For example, workers at poultry houses may take Oxalic acid or oxalate to maintain a normal level of Oxalic acid or oxalate to prevent tumor development and counteract exposure to bacteria. In addition to the administration or ingestion of Oxalic

40

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50

elimination from the diet also serves as a reduction or elimination of a blocker of Oxalic acid or oxalate. Tables

VII-XI list the pyridoxine hydrochloride content of meats and other foods.

Although others have indicated that vegetables are cancer fighters, they have listed the cancer fighting agents as 55

antioxidants, beta caroteine, or citric acid. The literature is

Void of a reference to oxalic acid as being a cancer fighter or preventer. 60

their oxalic acid or oxalate intake to counteract Such decom

position. It is also believed that the administration of oxalic acid or

oxalate may delay, prevent, control, or treat the onset of Alzheimer's Disease.

ing to note that a variety of prepared foods eaten every day including cookies, cakes, canned foods, Salad dressings, and the like, contain these items. Further, it is interesting to note that certain articles have proposed that perSons on a low-fat

(pyridoxine hydrochloride) it follows that reduction or

cial effect of the Oxalic acid or oxalate. It is believed that oxalic acid or oxalate should be admin

improve the quality of life of a perSon Suffering from

disease, tumors or cancers, and the like. These items, calcium, Vitamin B6, vitamin C, citric acid, and alcohol are

diet showed leSS tumors or showed tumor reduction. Since red meat Such as beef or liver contains vitamin B6

of dairy products Since these tend to counteract the benefi

Alzheimer's Disease, lessen the effects of the disease, or

feline Scale which will provide a quick-ready reference for a veterinarian or pet owner to test urine oxalate levels and adjust the Oxalic acid intake in the diet accordingly. Oxalic acid is believed to be a reducing agent, bactericidal agent, Sterilizing agent, disinfectant, bacterioStatic agent, chemopreventive, chemotherapeutic agent, curative drug, antimicrobial agent, and may be an antioxidant. In accordance with the present invention, it is believed that five or more items unnaturally constantly consumed are responsible for at least Some bacterial or viral infectious believed to be oxalic acid or oxalate blockers. It is interest

acid or oxalate, it is believed that one should limit the intake

istered prior to a transplant operation to purify the blood and improve the immune System. However, it is also possible that just prior to a transplant operation the body should be purged of Oxalic acid to prevent aspergillus fungi infection. It is believed that Strong magnetic fields, MRI imaging, computer terminals, power lines, cellular telephones, elec tronic equipment, microwave Ovens, etc. may decompose oxalic acid or oxalate in the body and blood and allow the Spread of infectious bacterial or viral disease and the for mation of tumors, growths, cancers, etc. Hence, those Sub jected to Strong magnetic fields and the like Should increase

increase their blood oxalic acid level to a higher value than the typical mean value. In accordance with one embodiment of the present invention, a new Scale is developed for canine and feline urine oxalate level. Since a typical human Scale will not work for a canine or feline due to their different body Structures and metabolism, a need exists for a canine and/or

Or treatment.

It is believed that a dosage of Oxalic acid or oxalate may also provide a reserve of energy or nutrients. Hence, a food or beverage containing oxalic acid or oxalate could be ingested prior to Strenuous activity in order to increase energy, Stamina, Strength and/or mental activity. It is also believed that Oxalic acid or oxalate may prevent or relieve muscle SoreneSS by helping eliminate lactic acid.

tested and their oxalic acid level is below this mean value,

it is believed that they should be administered oxalic acid in one of its forms including oxalate, easily metabolized by the body to increase their blood oxalic acid level. Also it is believed that if Someone is Suffering from cancer, tumors, AIDS, bacterial, viral, or microbial infection, etc. that they

65

The literature Suggests that tumors occur when the immune System fails to eliminate abnormal cells not con Sumed as a normal biological function of the body Systems. In accordance with the present invention, it is believed that a low intake of Oxalic acid or oxalate or a high intake of Oxalic acid or oxalate blockers including alcohol, citric acid, ascorbic acid, and pyridoxine hydrochloride weakens the immune System or the body's natural cancer and disease fighting ability to the point where the body cannot control abnormal cell growth, tumors, cancer, neoplasms, bacterial

US 6,407,141 B1 25

26

or viral infectious disease, and the like. Changing the diet to

mice may provide faulty results in that the first Step typically in Such testing is to irradiate the mice with radiation to weaken their immune System So that they are more Suscep tible to disease and carcinogens. The radiation to weaken the immune System also causes a reduction or elimination of the

include an increase in the intake of Oxalic acid or oxalate and

eliminating or drastically reducing the intake of Oxalic acid or oxalate blockers, allows the body's immune System or natural cancer and disease fighting Systems to function and eliminate abnormal cells and prevent disease. It is believed that carrots, Spinach, parsley, chives, beet leaves, garlic, collards, radishes, carrot juice, and the like are relatively high in Oxalic acid or oxalate and should be eaten or consumed in order to build a high concentration of Oxalic acid or oxalate in the body. It is believed that if one can maintain a balanced diet and assure an adequate level of Oxalic acid or oxalate in the System then the body's natural protection mechanisms, immune System, and the like can prevent, treat, and control tumors, growths, cancers, Viral or

Oxalic acid or oxalate in the mice. In accordance with the

15

bacterial diseases, chemical toxins, and the like.

Over the years, many claims have been made regarding the beneficial health effects of many fruits, vegetables, plants, molds, etc. Recently, it has been claimed that garlic is believed to fight infection, cancer, bacteria, Virus, and heart disease, Strawberries are believed to help prevent prostate cancer, and tomatoes or Spaghetti Sauce are believed to prevent cancer and heart attacks. A recent Study indicated that two cups of coffee a day can prevent Suicide in women who work.

25

On the other hand, plants, vegetables and chemicals which contain high levels of Oxalic acid or oxalate are according to conventional wisdom thought to be poisons and to be eliminated from the diet or use. For example, those Suffering from kidney Stones are told to Stay away from rhubarb leaves, Spinach, Swiss chard, lambs quarter, and beet leaves which contain high amounts of oxalates. Also, they are told to stay away from black and green teas, and

oxalate blockerS Such as calcium, Vitamin B6, vitamin C, citric acid, and the like the effective level of oxalic acid or

oxalate in the animal is reduced and the test results may be skewed and possibly not representative of the natural normal animal biochemistry or system. Hence, it is believed that improved human examination and animal testing involves a reduction in the use of X-ray or electronic Scans, and the incorporation of a balanced diet containing oxalic acid or oxalate and a reduction in Oxalic acid or oxalate blockers.

coffee which also contain oxalic acid. Further, nuts, choco

late and Strawberries are cited by Some as containing high

35

oxalate.

Opposite conventional thinking, in accordance with the present invention. it is believed that Oxalic acid or oxalate is the “miracle bullet”, “silver bullet”, “hall monitor', or

“brevet boule’ that treats, kills, controls, manages, or pre

40

vents infectious bacterial or viral disease, abnormal, tumor,

cancer or unspecialized cells and, thereby, treats cancers, tumors, neoplasms, infectious or pathogenic bacterial, Viral, or other microbial diseases, and maintains good health. Further, it has been discovered that a high oxalic acid or oxalate intake causes a disease or cancer patient to be more talkative, Verbal, have increased dexterity, physical ability, mental ability, and appear invigorated, happier and more outgoing. The conventional treatments for cancer, tumors, growths and the like can themselves cause cancer, tumors, growths,

45

50

55

If one is to administer and ingest Oxalic acid in one of its harsher forms Such as Oxalic acid dihydrate, for example, a gel cap filled with 500 milligrams to 2 grams of Oxalic acid dihydrate, this should be taken one hour before or after a meal and with a Sufficient quantity of water Such as 10 or more ounces of distilled water. In order to further reduce the

bombardment, microwaves, and the like reduce the level of

Oxalic acid or oxalate in the body and further increase the chance of growths, tumors, cancers, and bacterial or viral disease. Hence, it is believed that one should not only

60

increase the intake of Oxalic acid or oxalate, but also avoids

exposure to or treatment of radiation, X-rays, electromag netic fields and the like which tend to decompose or reduce the amount of Oxalic acid or oxalate in the body. Along this Same line, it is believed that conventional testing techniques, Such as the testing of carcinogens on

In accordance with another embodiment of the present invention, an improved method of testing for disease or cancer includes the elimination of the use of X-rays or electronic Scans during the testing process. In accordance with another embodiment of the present invention, an improved method of testing for disease or cancer allows for the use of X-rays or electronic Scans to detect the presence or absence of disease or cancer, but requires that the Oxalic acid or oxalate decomposed or reduced by the X-ray or electronic Scan be replaced. In accordance with another embodiment of the present invention, an improved method of testing for disease or cancer employs the use of an improved animal feed which includes at least one form of Oxalic acid or oxalate and with a reduced amount of Oxalic acid or oxalate blockers from that of conventional feed.

infectious bacterial or viral disease, and the like. For

example, X-rays can trigger malignant growths in certain people. Further, in accordance with the present invention, decomposition or reduction of Oxalic acid or oxalate in the body caused by exposure or treatment of X-rays, CAT-Scans, Strong electromagnetic waves or fields, electron

present invention, it is believed that a normal level of Oxalic acid or oxalate is required in the body to prevent cancers, growths, tumors, bacterial or viral disease. Brand the like. Hence, the researchers unknowingly introduced additional cancer and disease causing factor into the testing. In accordance with the present invention, an improved testing method would involve determining the normal oxalic acid or oxalate level of the test animal, weakening the immune System of the animal using radiation, and then administering or feeding to the animal a Sufficient quantity of Oxalic acid or oxalate to bring their oxalic acid or oxalate levels back up to normal prior to further testing. Also, in accordance with the present invention, it is believed that testing, research, and examinations which include X-rays or electronic Scans to insure no cancer is present or to check on the size or location of the cancer can themselves bring on disease or cancer by decomposing Oxalic acid or oxalate and irritating the Skin or tissue. Further, if test animals are fed a diet high in Oxalic acid or

65

possibility of harm or irritation to the digestive System, one can line the Stomach before taking Such an oxalic acid pill or gel cap using PeptoBismol, Tagamet, or Zyntec. In accordance with another aspect of the present invention, workers exposed to X-rays, CAT-Scans, electro magnetic fields or waves, microwaves, radar, high Voltage power lines, electronic equipment and the like are given Sufficient quantities of foods, beverages, Supplements, treats or the like containing an effective amount of at least one beneficial form of Oxalic acid or oxalate to compensate for the decomposition or reduction caused by their working

US 6,407,141 B1 27

28

environment and thereby prevent the development of diseases, poor health, etc. which may otherwise be caused by

Solutions of Oxalic acid are decomposed by radiation. This has been the basis of a method for measuring radiation dosage in the Sterilization of food and medical products. The

In recent history, there has been an increase in breast

concentration which Reoccurs during irradiation (FIG. 1).

tumors, cancers, infections bacterial or viral disease, other their work environment.

absorbed dose is determined from the decrease in Oxalic acid

In addition to the information provided in Table IV, nuts contain high concentrations of calcium, magnesium, iron and relatively high concentrations of oxalate. For example, almond, cashew, peanut, pecan, and walnut all contain Oxalic acid concentrations ranging from 200 mg/100 g-600 mg/100g. Forage grasses and other pasture plants frequently contain high concentrations of minerals but many of them also contain high concentrations of oxalate. Further, many beverages including beers, wines, and fruit drinks contain

cancer in Women in the United States. In accordance with

the present invention, it is believed that this increase in breast cancer may be due in part to the use of microwave

Ovens which emit microwaves (usually at about chest height), which when used in cooking or heating decompose the Oxalic acid or oxalate in the food or beverage, the use of a myriad of electronic equipment including radios, televisions, computers, etc., and the consumption of pro cessed foods which contain oxalic acid or oxalate blockers

Such as calcium, citric acid, Vitamin C, Vitamin B6, and the like.

15

In recent history, there has been an increase in throat and

mouth cancer in men in the United States. In accordance

with the present invention, it is believed that this increase in throat and mouth cancer may be due in part to the use of microwave ovens which, when used in cooking or heating, decompose the Oxalic acid or oxalate in the food or beverage, the use of a myriad of electronic equipment including electric blankets, electric razors, electric hair blowerS or dryers, radios, televisions, computers, cell phones, and the like, as well as the consumption of pro

According to Occupational Health Services, Inc. (OHS),

oxalic acid has a CAS number: 144-62-7A a RTECS num

25

cessed foods which contain oxalic acid or oxalate blockers

Such as calcium, citric acid, Vitamin C, Vitamin B6, and

combinations thereof, and an increased consumption of alcoholic beverages. In accordance with the present invention, it is respectfully believed that oxalic acid or oxalate is a natural

chemopreventive, chemotherapeutic, bactericidal, Viricidal, antiviral, and disease preventing, treating, and controlling agent. Because it is natural, it destroys, kills, and/or controls

ber: R0245000, trade names or synonyms ethanadoic acid, aktisal, aquisal, dicarboxylic acid, phosphoteX 760 grain refiner, CHO, and OHS17360. Oxalic acid is in the chemical family carboxylic acid, aliphatic and is listed as a poison with a level three out of a scale 0-3 for health, and a level 1 fire rating. In accordance with the present invention it is believed that conventional wisdom that the cause of acorn poisoning is tannic acid is wrong and that it is instead the Oxalic acid which is extremely damaging to renal tissues. It is believed that the Oxalic acid or oxalate level in oak trees is very high, especially in mold that grows on the bark. Also, it is believed that the treatment for Oxalic acid or oak

“bad” or harmful bacteria, Viruses, microbes, cancer cells,

35

abnormal cells, growths, and the like, while allowing "good’ or healthy bacteria, Viruses, microbes, cells, and tissues to thrive. For example, if one kills all the bacteria in the mouth of a human or other animal, they can develop a fungus or fungal infection referred to as thrush. Using the natural therapeutic oxalic acid or oxalate Solution as a mouth rinse or gargle only kills the “bad” or infectious bacteria and, therefore, does not lead to an unwanted fungal infection. Further, Since oxalic acid or oxalate in one of its therapeutic

40

forms is believed to be a natural disease and cancer

45

preventing, controlling, or treating agent, it is believed that the diseases or cancers being treated, controlled, or prevented, do not become immune to the Oxalic acid or

poisoning is to increase Oxalic acid or oxalate blockers, Such as pyridoxine hydrochloride, citric acid, calcium, magnesium, and alcohol Such as ethanol to eliminate or carry the Oxalic acid through the renal System. Oxalate nephrosis is probably the most common cause of toxic death in dogs. Typically, the Source of Oxalate poison ing is ethylene glycol (antifreeze). The ethylene glycol is metabolized to oxalate and Oxalic acid by an enzyme called alcohol dehydrogenase. Ethylene glycol by itself is not toxic, but when the enzyme, alcohol dehydrogenase, works on it to produce a toxic material (oxalate), then it becomes toxic. Antifreeze poisoning is treated with alcohol (ethanol) to keep the alcohol dehydrogenase enzyme busy So that the antifreeze can be eliminated, unaltered, and in a non-toxic

State. A major contributor to death is also metabolic acidosis caused by Oxalic acid accumulation. It is almost as important to control the acid-based Status as it is worrying about the

oxalate.

In accordance with another embodiment of the present invention, a person who believes they have been Subjected to radiation, Strong electromagnetic waves or fields, microwaves, radar, Strong TV or radio waves, or work in a dangerous environment where they may be Subjected to X-rays or other elements which can decompose or reduce the Oxalic acid or oxalate in the body, can test their blood, plasma or urine Oxalic acid or oxalate level and if they find it is below normal, treat themselves with food, beverages, Supplements, pills, capsules, and the like containing oxalic acid or oxalate to bring their level back up to a normal healthy level. Further, Such a person can pre-treat them Selves prior to exposure with Oxalic acid or oxalate to reduce the chance that their levels will drop below normal levels. This should prevent or reduce the increased risk to devel oping cancers, tumors, viral or bacterial and viral diseases, and the like caused by having below normal oxalic acid or oxalate levels in the body.

low concentrations of oxalate but tea, coffee, cocoa, and

chocolate contain relatively high concentrations of oxalate. Tea, in fact, is listed as being the largest Single Source of oxalate in English diets.

50

accumulation of Oxalate.

There are Several other causes of oxalate nephrosis which are extremely rare. Overdoses of vitamin Chave been shown to cause oxalate nephrosis in humans, and in at least one

goat. Vitamin B6 (pyridoxine hydrochloride) deficiency and 55

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methoxyflurane anesthesia may also induce the condition. Aspergillus sp. fungi also produces high levels of oxalate and these fungi are almost ubiquitous and grow on many feed stuffs. There are a variety of plants other than oak, for example halogenten, greasewood, Sorrel, dock, Setaria grass, Sugar beets, and Several others that contain oxalic acid. Oxalate nephrosis produces a very specific lesion in the kidney when viewed under the microScope. You can actually See the oxalate crystals. A pathologist who is unaware of primary hyperoxaluria would obviously draw the conclusion that the kidney lesions were the result of Oxalate nephrosis. Typically, cancer, tumors, growths, and the like are treated by invasive unnatural techniques, Such as Surgery, biopsy,

US 6,407,141 B1 29

30

X-ray radiation, oncological chemotherapy, and the like. In accordance with the present invention, it is believed that the primary treatment for cancer should be the all natural.

the receptionist agreed to do so. The inventor advised the receptionist that, each morning immediately upon rising, and prior to any other Substance being put into the mouth, she should take approximately one teaspoon of the Solution in her mouth, holding it for a minimum of two minutes, Swishing the Solution gently around the mouth, then dis carding the Solution and rinsing the mouth with warm water two or three times. The procedure began Friday night and the following Monday morning the cold was gone. On another occasion the inventor's private attorney

non-invasive, use, administration, and the like of Oxalic acid

in one of its therapeutically effective forms including oxalate in a Sufficient quantity and on a periodic basis to provide the desired therapeutic effect. Essiac tea was tested and found to have a pH of about 4.79 when the powder was added to boiling distilled water. The inventor continued to search for other uses of the

“miracle bullet' oxalic acid or oxalate compositions for treating the body and immune System. The inventor used a dental hygiene composition of Oxalic acid and distilled water

reported that canker Sores (ulcers) inside his mouth which he

(150 mg diluted in 300 ml of distilled water) on a disciplined daily schedule and noticed that besides the removal of and prevention of any build up of tarter or plaque in the mouth, that there was also a remarkable improvement in the con dition of his gums and mouth tissue, including the tongue Surface. There was no more occasional bleeding of the gums during daily brushing, and the Surface of the tongue appeared to be more Smooth with an even coloring acroSS the

15

of his nose, and the Sore healed.

Surface.

On another occasion, the inventor formulated a cream of

powdered Oxalic acid and a hydrophilic cream to topically treat Small tumors on the Skin Surface of the inventors toy poodle. Following examination and application of the com position to 3 tumors on the poodle, the Veterinarian applied the cream to a Sore on his own hand having a red appearance and Soreness of infection. Following one application of the

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On Still another occasion a pharmacist, consultant to the inventor, awoke at 2:30 a.m. with a very Sore throat, unable to Swallow without severe pain, remembered the inventor's description of his own experience, mixed two teaspoons of the bench mark mixture and two teaspoons of warm water, held the mixture in the mouth for two minutes and gargled well. After a 15-minute wait, repeated the procedure and then retired. Upon arising at 6:30 a.m., repeated the proce dure one time before leaving for the pharmacy. The phar macist reported that at 11:30 a.m. all Symptoms of the Sore throat and flu virus were gone. On yet another occasion, a veterinarian associate on a call to a horse ranch for the birth of a foal encountered some

40

complications during delivery and required assistance by the Veterinarian and an extended Stay following the birth and a delay in effecting personal hygiene which resulted in Staph infection in Scratches and skin abrasions which were treated

by a topical application of a cream composition of Velvachol 45

cream and Oxalic acid and the disease and Soreness was relieved.

Two cases are recorded where use of the present dilute Solution or Oxalic acid and distilled water composition showed remarkable reduction of the effects of the flu virus. 50

toenail which became infected. The infection was in an

advanced Stage which was extremely Sensitive and the poodle would not use the leg while walking. The poodle was examined by the Veterinarian, received an injection of a antibiotic, and oral capsules were to be given. The inventor began an immediate Soaking of the paw in a composition or solution of 150 mg of oxalic acid in 300 ml of distilled water twice a day. After just two Soakings the infection had improved dramatically, and the poodle used the leg without any signs of a limp. On another occasion while Visiting the veterinary clinic, the inventor noticed the receptionist had Symptoms of a cold, and upon questioning the receptionist learned she was treating a cold which was into the Start of the Second week. When the inventor Suggested the receptionist use the Solu tion formulated for dental hygiene as a remedy for the cold,

On yet another occasion a Subject who complained of continuously being prescribed antibiotic pills without any improvement in continuous flu and cold-like Symptoms began the present method of mouth rinse and gargle first thing each morning and last thing at night before retiring each day and reported experiencing Significant improvement in the Symptoms after three days of following the recom mended usage. The dilute Solution was the bench mark Solution.

cream the infection in the Sore on the hand was eliminated

and the Sore healed quickly. During a veterinarian dental examination of the inventor's pet dogs, one dog had a moderate build up of tarter and plaque on the teeth and gingivitis in the upper gums, both Sides of the mouth. At the completion of the exam, rather than treat the gingivitis with an injection of antibacterial medication followed by oral medication, it was agreed the inventor would commence daily brushing of the dog's teeth. The formula used for the brushing was a mix of 150 mg. of oxalic acid in 300 ml of distilled water. The inventor began a daily brushing of the dog's teeth paying particular atten tion to the upper gums. The brushing was done first thing in the morning before the dog had anything to eat or drink. After the fourth day of brushing, the inventor/owner of the dog, noticed the redness of the gingivitis was disappearing and after one week returned the dog to the veterinarian for a follow-up exam. The exam revealed no more evidence of gingivitis and no tarter but moderate plaque remained. The Veterinarian recommended cleaning one Side of the dogs upper teeth and continuing with the daily brushing routine. On another occasion, the inventor's pet poodle had torn a

had been experiencing over an extended period of time, disappeared one week after he began using the inventor's dental hygiene rinse on a once-a-day use of the composition. Also of Significance was the attorney's Q-Tip application of the composition to a persistent Sore on the inside of a nostril

55

Rinsing of the mouth for a minimum of two minutes followed by a lengthy gargle three times a day for a period of four days completely removes all Soreness of throat and nose and periodic use of a teaspoon of dried parsley placed between the lower lip and teeth, as one would use Snuff, acted immediately as a decongestive agent to relieve Sore neSS and congestion of the chest and further acted as an expectorant of heavy phlegm and an agent for drying of UCUS.

60

150 mg of oxalic acid in solution in 300 ml of distilled water is the preferred and bench mark Solution or compo Sition in the uses described above. In accordance with the

65

present invention, an oxalic acid and distilled water Solution or composition may contain anywhere from greater than Zero to less than about 500 mg of oxalic acid per 300 ml of distilled water, preferably 50 to 425 mg of oxalic acid dihydrate per 300 mls of distilled water. Depending on the disease or condition being treated, the amount of Oxalic acid

US 6,407,141 B1 31

32

may be increased or reduced from the bench mark Solution of 150 milligrams of oxalic acid in solution in 300 ml liters of distilled water. For example, in treating a strong flu, one may dissolve 400 milligrams of oxalic acid in a solution of 300 milliliters of distilled water. In treating a normal cold, one may use the bench mark Solution of 150 mg of Oxalic acid in Solution in 300 ml of distilled water. For treating an

by transdermal patch, administered by Suppository, admin istered by topical application, or administered orally, and the like, to provide the desired therapeutic effect. Although one or more of the above may be considered poisons to humans and other warm-blooded animals, the proper administration of a Selected dosage is believed to be therapeutically effec tive and instrumental in the treatment, prevention, control, and cure of infectious bacterial, Viral or microbial disease

infectious bacterial condition or disease, Such as infection of

a Small cut or Sore, one may use 50 to 75 mg of Oxalic acid in solution in 300 ml of distilled water. Although there is mention of the use of a particular amount of 150 mg of oxalic acid in Solution in 300 ml of distilled water to form

the bench mark Solution, it is to be understood that one may use, for example, 250 mg of oxalic acid in Solution in 500 ml of distilled water and have the same concentration of Oxalic acid in Solution.

Also in accordance with the present invention, it is contemplated that one may use 0.05 percent Oxalic acid in a distilled water Solution for use as eye drops, nose spray, and topical or cream applications. Also, a high level of 8 grams of Oxalic acid in Solution may be used in intravenous injection over a 24-hour period. The bench mark mouth rinse having 150 mg of oxalic acid in 300 ml of distilled water has a pH of about 2.3. In accordance with the present invention, a mouth rinse may have a pH of about 6 to 1 depending on the application. Further, gelcaps and pills can be filled with from 1 mg in a pill to about 1 gram of Oxalic acid and

15

25

Stuff, rinse, mouthwash, mouth rinse, wash, formulation,

dihydrate (gr) in a gelcap. The exact concentration of Oxalic

acid required for treatment depends on the particular perSon being treated, the particular viral or bacterial infection, the Stage of infection or treatment, and the like. If one undergoing treatment with Oxalic acid or oxalate in one of its therapeutically effective forms experiences Symp toms or believes that they have ingested too high a dosage of Oxalic acid, they may eat 2 to 3 Spoons of crushed pineapple to reduce heartburn or indigestion. In accordance with the present invention, it is preferred to use pure carrot juice as a dietary Supplement or composition for administering Oxalic acid to one undergoing treatment. One brand of frozen pure carrot juice has a pH of about 6.2. Another brand of canned pure carrot juice has a pH of 5.5. In accordance with another embodiment of the present invention, an oxalic acid or oxalate composition takes the form of a gelcap or capsule containing an effective amount of dried parsley in a fatty acid Such as oleic and linoleic fatty

35

40

45

Supplemental composition or treatment to be used in con junction with conventional compositions and treatments, or the like. In accordance with still another embodiment of the

50

55

beneficial to humans and other warm-blooded animals,

include ethanedioic acid (free acid), ethanedioic acid

anhydride, ethanedioic acid tri-potassium Salt, ethanedioic acid barium Salt, ethanedioic acid cooper Salt ethanedioic

dosage, pharmaceutical agent, dietary Supplement, intermediate, product, composition, anti-AIDS or anti-HIV agent, Vaccine, immune System Stimulant, Substance, drug, chemopreventive, chemical, chemoSurgical agent, chemo therapy agent, chemotherapeutic agent, Solution, Solute, Slurry, mixture, medicine, remedy, medication, Salve, ointment, balm, cream, analgesic, medicinal agent, treating agent, preventing agent. retarding agent, impeding agent, delaying agent, controlling agent, anabolic agent, health improving agent, health-Supplementary food, enriched fraction, Oncological or oncologic agent, tumor treating agent, disease treating agent, infection treating agent, fungal treatment, remedy, antimicrobial agent, microbial treatment, bacterial treatment, and the agent for treating, controlling, improving, preventing, the Symptoms of pathological dis easeS Such as bacterial, Viral, and the like, as well as a

acids like emu oil.

In accordance with the present invention, it is believed that an adult human may be treated with an effective amount of Oxalic acid or oxalate ranging from about 0.05 mg to about 8.0 gr per 24-hour period. In accordance with the present invention, those undergo ing treatment with Oxalic acid or oxalate in one of its therapeutic effective forms experience a return of good color to the skin, a boosting in the immune System. an increased Vigor. Some forms of Oxalic acid or oxalate which may prove

and the maintenance of good health. It is not uncommon to provide a beneficial effect from an agent which is known as a poison. There is a myriad of hundreds or thousands of poisons which provide a beneficial effect to warm-blooded animals when administered in a proper dosage. In accordance with the present invention, a method of impeding the apoptosis of CD4 cells and perSons infected with human immunodeficiency virus includes the Steps of externally feeding or otherwise administering to the infected perSon or other animal a nutritional product which contains Oxalic acid or oxalate in a therapeutic quantity Sufficient to impede apoptosis of CD4 cells. In accordance with another embodiment of the present invention, oxalic acid or oxalate compositions and methods are used to treat, prevent, or control AIDS and HIV infection in humans and other animals by administering a therapeutic quantity of Oxalic acid or oxalate composition. Source of Oxalic acid or oxalate, nutritional product, Supplement. Solution, agent, curative, control, impediment, food, feed

present invention, oxalic acid or oxalate compositions and methods are used to improve Sustained energy and as anabolic compositions and methods in humans and other warm-blooded animals. Oxalic acid or oxalate compositions provide for Sustained energy and nutrition to Support an anabolic physiological State in humans and other animals by providing or otherwise administering to the human or other animal a therapeutic quantity of Oxalic acid or oxalate. The Oxalic acid or oxalate compositions and methods may Supplement other conventional compositions and methods Such as lipids, bio-available minerals in the form of amino acid chelates, anabolic nutrients, Vitamins, antioxidants, and

60

lipotropic agents to provide an optimal Sustained energy and

acid diamide, ethanedioic acid diamonium Salt, ethanedioic

anabolic nutrition formulation. When administered, it is

acid diethyl ester, ethanedioic acid diethyl ester, ethanedioic acid disodium Salt, ethanedioic acid magnesium Salt, 65

believed that the Oxalic acid or oxalate compositions facili tate Sustained energy and delivery of nutrients to appropriate sites within the body for efficient utilization in the anabolic physiology.

ethanedioic acid Silver Salt, ethanedioic acid Strontium Salt,

ethanedioic acid dihydrate, dicarboxylic acid as well as other forms of oxalic acid or oxalate which may be metabolized by the body, injected into the circulatory System, administered

The Human Immunodeficiency Virus(HIV) causes AIDS. The virus attacks certain white blood cells, called T-cells and

US 6,407,141 B1 33

34

weakens the body's immune System. Acquired Immunode

in distilled water can be bottled and sold as a health

improving, disease preventing, disease treating, controlling, impeding, delaying, or the like agent, pharmaceutical, Supplement, chemotherapy, etc. Such a dilute oxalic acid or oxalate Solution can be administered or given to, for example, astronauts prior to space travel, HIV or AIDS patients, perSons or other animals Suffering from bacterial, Viral, microbiological, or other conditions or diseases, can cer patients, tumor patients, perSons Subjected to high levels

ficiency Syndrome (AIDS) occurs when an HIV-infected

perSon develops a life-threatening condition or their number of disease fighting T-cells becomes dangerously low. Cur rent data indicates that among perSons age 25–44 years old, HIV infection is now the leading cause of death in men and is the third leading cause of death in women in the U.S. In 1995, approximately 40,000 Americans contracted HIV. Worldwide, one million people died from AIDS last year and reported cases increased by 19 percent. It has been about 15 years since the HIV/AIDS virus was first identified. Tragically the AIDS epidemic has claimed 4.5 million lives, worldwide. Today, Significant Strides are being made in understanding the virus and ways to battle the disease. There are 42 approved medicines and over 120 drugs currently being developed by pharmaceutical compa nies to fight HIV/AIDS. One promising advance in newly developed pharmaceu ticals for fighting HIV/AIDS is a new class of medicines called protease inhibitors. Studies show that when a protease

of radiation or electric fields, and the like. The concentration

15

concentration of Oxalic acid or oxalate therein. The Oxalic acid or oxalate is added to either counteract Some of the

negative effects of the items contained in these drinks and/or to supplement or improve the healthful benefit of Such drinkS.

inhibitor is combined with one or more of the established

HIV/AIDS medicines, they work A together to attach the HIV virus at different stages of its progression. This com bination or “cocktail” therapy has been shown to reduce the level of HIV in the bloodstream by up to 99 percent in some patients and, thereby. potentially halting or slowing the

25

advancement of the disease.

In accordance with the present invention, oxalic acid or oxalate compositions are used alone or combined with one or more of the established HIV/AIDS medicines to work

together to inhibit, impede, fight, or the like, the HIV virus at one or more Stages of its progression or development. Hence, a new combination or “cocktail therapy includes protease inhibitors, established HIV/AIDS medicines, and Oxalic acid or oxalate compositions. Also in accordance with the present invention, oxalic acid or oxalate compositions alone or together with established HIV/AIDS medicines can be used to treat the symptoms of HIV/AIDS infection including Swollen lymph glands, fever or night Sweats, weight loss, fatigue, diarrhea, Skin problems, Sores in the mouth, cough, ShortneSS of breath, vaginal yeast infections, and the like. Further, Oxalic acid or oxalate compositions can be used to treat the Serious ill nesses that occur with AIDS including pneumonia, pneu

mocystis carinii pneumonia (PCP), kaposi's Sarcoma (KS),

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40

45

infections, tuberculosis, and the like. 50

off HIV/AIDS infection. Further, oxalic acid or oxalate

compositions and methods are used as antimicrobial agents, antibacterial agents. anti-virals, therapies, anti-infectives, anti-microbials, and anti-cancer drugs or agents to treat the diseases and opportunistic infections associated with HIV/

55

AIDS.

It is believed that the Oxalic acid and oxalate compositions and methods of the present invention will help HIV/infected people and other animals to be able to live longer, more productive and relatively Symptom-free lives. In accordance with another embodiment of the present

60

invention, a Solution or mixture has a dilute concentration of

65

Oxalic acid or oxalate as the Solute in distilled water. Such a Solution of a dilute concentration of Oxalic acid or oxalate

In accordance with another aspect of the present invention, oxalic acid or oxalate compositions and treat ments are used in canine care by dissolving a therapeutic quantity of Oxalic acid in distilled water to form an Oxalic acid treatment Solution for treating gingivitis, tartar build-up on the teeth, general health of teeth and gums, and as a topical antiseptic or antibiotic. For example, a half dachs hund and half beagle canine was examined and found to have a build up of tartar on the teeth and gingivitis active with a slight pocket with one tooth with pus. The canine's teeth and gums were brushed regularly with the Oxalic acid Solution for dental hygiene and was returned to the Veteri narian for examination.

skin cancer, organ tumors, infections of the nervous System which can damage the brain and Spinal cord, opportunistic infections, including fungal, parasitic, viral, and bacterial Also in accordance with the present invention, oxalic acid or oxalate compositions are used as Vaccines, immunomodulators, or immunosystem Stimulant that help Strengthen the immune System, thus helping the body fight

of Oxalic acid or oxalate in the Solution is determined by the use of the Solution or disease being treated, controlled, impeded, delayed, and the like. In accordance with another embodiment of the present invention, bottled water, Sports drinks, electrolyte Solutions, fruit drinks and the like are improved by adding a dilute

In accordance with another example, a poodle having a torn toenail which has become infected received an injection of antibiotic and capsules of AMP-250 to be given three times daily. Also, the poodle's injured paw was Soaked three times daily in an oxalic acid/distilled water Solution the Same Strength as the dental hygiene Solution. In accordance with still yet another embodiment of the present invention, it is believed that Oxalic acid or oxalate compositions can be used to prevent Strokes in humans and other animals. An Oct. 29, 1996 ABC Evening News Report indicated that a group of Seniors over age 60 had a very low rate of Strokes compared to the national average. This group of Some 80 people were reported to have been on a special diet high in fruit and vegetables which were high in potas sium. The report theorized that the potassium was respon sible for a lower level of blood pressure in the diet group and thus a lower incidence of Strokes. In accordance with the

present invention, it is respectfully believed that the lower incidents of Strokes was due to oxalic acid in the Special diet high in fruit and vegetables rather than the potassium. Potassium oxalate and potassium oxalate monohydrate con tain large amounts of Oxalic acid which in accordance with the present invention the Oxalic acid Serves as the “hall monitor of the blood system keeping the blood en clean of plaque and abnormal cells. Hence, it is believed that the high level of Oxalic acid in the potassium rich diet high in fruit and vegetables which led to the very low rate of strokes compared to the national average. In accordance with the present invention, oxalic acid or oxalate compositions and methods are used to treat, prevent, impede, delay, control, or the like Strokes in humans and other warm-blooded animals by administering a therapeutic quantity of Oxalic acid or oxalate on a periodic basis, for example, daily.

US 6,407,141 B1 35

36

In accordance with another embodiment of the present invention, an adult female human has been following a diet protocol to assist in the absorption of calcium to prevent Osteoporosis. The female has also had operations to remove breast tumors which also required removal of the thyroid gland. The following protocol is designed to take calcium Supplements and to add oxalic acid to a normal daily diet

In accordance with another embodiment of the present invention, an oxalic acid Solution of 150 milligrams of oxalic acid dihydrate dissolved in 300 milliliters of distilled water is used as a topical agent, mouth rinse or wash, dental cleanser, or the like for treating the flu, common cold, Sore

intake.

The second weekend of November, 1997, a woman prop erly in her early 60's agreed that she would go on the Oxalic acid diet of the present invention as near to 100% as possible. She had cancer of the pancreas and the liver. In both of these cancers, her prognosis was very poor. This woman had been through the conventional treatments and nothing more held any hope for her. At the time she started on the diet, she was showing a very slight yellowing of the skin. On Jan. 26, 1998, there was a call from a gentleman to report that she is doing just great. Her color has returned to normal, a very recent test showed the liver at 60% of normal and the tumors are in regression and her blood is clean. She told the gentleman who called to say she had passed the 600 pound mark of carrots. One more Success for the present

throat, bronchitis, and other infections, viral or bacterial diseases.

Calcium Supplements are taken in the morning with water only. No foods or beverages containing oxalic acid are taken for two hours to allow for maximum calcium absorption without inhibiting by oxalic acid. The normal diet each day

allows for vegetables and beverages (such as carrots, carrot juice, parsley) with Oxalic acid in significant amounts to assure a constant normal or above normal oxalic acid level

15

in the blood to prevent the growth of tumors. An elderly adult female with severe arthritis and low level

of bone mineral (described as looking like Swiss cheese)

began following a diet protocol to assist in the absorption of calcium to prevent osteoporosis and to increase bone min eral buildup. The elderly female reduced protein intake and increased carbohydrate intake using corn oil as a Supplement for the carbohydrate intake. In accordance with another embodiment of the present invention, an oxalic acid cream made up of Velvachol cream plus 10% oxalic acid Solution is used for topical application for removing, for examples, growths, lesions. from the skin in warm-blooded animals including dogs. Also, in accordance with the present invention, a liquid subcue injection solution of 0.1% oxalic acid in distilled water is used for Subcutaneous injection treatment of, for example, skin lesions, tumors, infections, and the like, in warm-blooded animals including dogs. In accordance with a particular example of the present invention, a 10% oxalic acid cream was used to treat a

poodle. In accordance with another particular example of the present invention, a 0.1% oxalic acid injection Solution was used to treat a quarter horse. In accordance with another particular example of the present invention, a horse with benign skin tumors was treated by adding parsley to the feed and carrots Separately. In accordance with another particular example of the present invention, a horse with two viral tumors was treated by treating one tumor with direct injection of 30 cc of a mixture of 500 miligrams oxalic acid in 500 milliliters of

invention. 25

Sure to radiation, and the like.

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40

45

50

distilled water as a dental cleaner.

invention, a mouth rinse, wash, mouthwash, cleanser 55

oxalic acid dihydrate (from Chem One) dissolved in 300

milliliters of distilled water. This solution is produced by heating the distilled water to boiling, mixing in the 150 milligrams oxalic acid with the warm water to form the Solution. The Solution is placed in Sterile containers for later

60

Sc.

In accordance with another embodiment of the present invention, a therapeutically effective form of Oxalic acid or oxalate may be used in treating AIDS, HIV, bacterial disease, Viral disease, or the like when the disease,

condition, or Symptoms have become immune to other conventional treatments.

have Success with having his daughter eat with him a Small amount of the dried parsley and has done So each night Since the 18th. There is no more congestion or running nose and the child is sleeping peacefully through the night. We agreed that he should discontinue the procedure to avoid irritating the membrane of the mouth or throat. And if the symptoms do not return in the next couple of days the viral infection was cleared.

In accordance with another embodiment of the present Solution, gargle, or the like, contain about 150 milligram of

A man described a condition currently existing with his one year old child which Sounded like the typical child's persistent low level cold. Mild chest congestion that would interfere with normal breathing at night, congested cough in the morning and persistent runny nose. We talked about what might help relieve the cold and discussed the possibility of a Small amount of freeze-dried parsley placed in the child's mouth to work as a decongestant and an anti-Viral biotic. It was agreed that having the child take a Small amount of the parsley without water before going to sleep would be an effective way of providing Oxalic acid without any Side effects. He called on October 24 to tell me that on the 18th he did

distilled water, the other tumor was treated with direct

injection of a prescription drug. In accordance with another particular example of the present invention, two adult humans are using a mouthwash mixture of 150 milligrams oxalic acid in 300 milliliters of

In accordance with another embodiment of the present invention, astronauts and other space travellers who will be Subjected to extreme magnetic forces, radiation, Solar radiation, and the like, are given an effective amount of a therapeutically effective form of Oxalic acid or oxalate prior to, during, and after Space travel to maintain normal or above normal oxalic acid blood levels and thereby counteract the decomposition of Oxalic acid caused by Space travel, expo

We also discussed his using the procedure with an amount of 2 teaspoons every third night during the flu Season as a protective measure. An adult male who has Hepatitis C has recently started on a high oxalic acid diet and trying hard to avoid the blockers. He has been infected for Some time and knows the Symp toms preceding the times when he has periods of effects from the virus. With careful monitoring, we will be able to tell if the oxalic acid is having the effect of killing the virus by either the period between attacks are longer or the effects themselves are leSS Severe, or both.

65

Also, his wife was diagnosed with viral pneumonia by X-ray examination. She was given antibiotics to ward off infections because of a weakened immune System. On Friday, September 26, she was provided the mouthwash of

US 6,407,141 B1 37 150 mg of oxalic acid (OA) in 300 ml of distilled water. She

38 I then called Jon each Subsequent Saturday morning to check on his feelings and to remind him of the diet, Specifically the blockers. He delayed a Scheduled Second

Started the recommended procedure of approximately 2 teaspoons of Wash, holding in mouth for 2 minutes then gargle, Spit out wash, then rinsing mouth at least twice with warm tap water. The procedure was repeated first thing in the morning immediately after rising and before anything else was put in mouth. It was done mid-day with nothing in mouth one hour prior to wash. At night, the procedure was repeated as the last item before retiring. By Sunday afternoon, the wife experienced nearly complete relief from the effects of the viral pneumonia. The following is a procedure using a mouth rinse of distilled water with oxalic acid dihydrate in solution. The

treatment and did tell his doctor he was on a diet, not what diet, and he wanted to see the results. He scheduled an MRI

for the May 16. I called him May 17 and he was a very happy person. The technician, in Jon's words, “could not find the spots he was looking for”. Another MRI was done later the afternoon of the 16th, with a higher radiation factor. Fol lowing the second MRI the technician told Jon, he could not give him the results, the “developer had troubles”. The trouble was, he still could not find the spots and wanted to tell the oncologist first.

rinse is used to brush the teeth and dentures to remove tartar

I called Jon later and heard in his words “the SPOTS ARE

and eliminate bacteria in the mouth and gums. The proce dure being followed is, each morning immediately after

GONE'. His oncologist tried to get him to take another chemo treatment, Saying the cancer had probably metasta

15

rising, a Small amount of Solution (approximately 2 teaspoons) is held in the mouth and Swished around teeth for

sized.

retaining maximum amount of rinse in mouth, teeth are then brushed outside and inside, Specifically between teeth and at gum line, and the tongue is brushed. The rinse is then discarded and the mouth flushed 2 or more times with tap

a week will just before retiring with nothing taken for one hour before, take a calcium Supplement to build up bone

He is continuing on the diet to make Sure the blood is

a minimum of 2 minutes, removable dentures are removed,

clean and the Oxalic acid blood level is increased, and once

minerals.

On CNN Prime Time News, there was a very short news item about a recent Study that showed people with Strong bones had a higher incident of cancer than people with weak

water. A denture brush is then used to clean the denture. Full

dentures, upper and lower, may be cleaned using the rinse then removing the dentures to clean. Initially, the Solution was 500 mg oxalic acid, 500 ml distilled water, gradually reduced to 250 mg oxalic acid in 500 ml distilled water. George, an adult male, is a special case because he has just finished his first week of radiation and chemotherapy treat ments at the Mayo Clinic, Rochester Minn. He has a malignant tumor about grape Size by an inner ear at the back

25

bones.

On Apr. 4, 1997, I had a visit with two gentlemen, Ken and his friend, Jon. They found out about the present

The Study is very Significant because Oxalic acid inhibits calcium absorption by the body. High calcium absorption is necessary for development and maintenance of Strong bones, and would not be possible if the body was high in Oxalic acid. However, high oxalic acid in the body System would not only inhibit calcium absorption but also would prevent the development of cancer. Too high levels of oxalic acid could mean weak bones and Osteoporosis. First, my dog Missy, half dachshund and halfbeagle, had a dental exam and found to have a build up of tartar on the teeth and gingivitis active with a slight pocket by one tooth with pus. Her teeth and gums will be brushed daily with the Solution used for human dental hygiene and returned to the Veterinarian for examination weekly. Second, my poodle, Turk, had a torn toenail which had become infected. He received an injection of an antibiotic, and capsules of Amp-250 to be given 3 times daily. Also, his injured paw will be Soaked 3 times daily in an Oxalic acid Solution the same Strength as the dental hygiene Solution. During the week following May 16, 1996, an adult female who is assisting me in documenting the history of my discovery, has been following a diet protocol as follows to assist in the absorption of calcium to prevent Osteoporosis. She has also had operations to remove breast tumors which also required removal of the thyroid gland. The protocol is designed to add calcium Supplements to a normal daily diet

research on Oxalic acid. Jon had bone cancer and wanted the

intake.

of the skull. He receives 15 seconds of radiation from each

Side of his face and 30 Seconds through the back of his throat and he will receive the treatment for 7 weeks, 5 treatments

per week, with 6 chemotherapy treatments Spaced through the same period. George Started the Oxalic acid diet on October 9, had his first radiation on October 14, and began the Oxalic acid rinse procedure on October 25. George is keeping a detailed log of his diet and will document any Side effects and will ask the doctors each week about the progreSS in eliminating the tumor. I believe the tumor will be reduced more rapidly than the rate calculated by the radiologist and

35

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the doctor.

A very significant item happened Thursday, October 24. On the evening news, there was an announcement that in clinical testing, nicotine may remove plaque in the brain and may reduce the effects of loss of memory of Alzheimer Victims. We describe that Oxalic acid may remove plaque from the blood. It is reported in Oxalic Acid in Biology and Medicine that tobacco contains Oxalic acid.

diet information. I told them I would not provide it unless they were willing to spend the time to not only listen, but to read the applicable research data also. They agreed. We spent 4 hours reviewing the data, and in questions and answers. Jon's bone cancer was verified by MRI and he had just previously had the first chemo treatment from his oncologist. And, in his words, “very painful and debilitating, and he did not want to take any more if it could be avoided. He was provided with the diet and lists of food

45

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55

amounts to assure a constant normal or above oxalic acid 60

level in the blood to prevent the growth of tumors. On Sep. 20, 1996, her mother with severe arthritis and low

level of bone mineral (described as looking like Swiss cheese) was started on the above protocol as related to

and drink with oxalic acid, and list of foods with B6. Also,

he was given a large container of Tone's dried parsley, cans of carrots and beets and advised to Start immediately on the diet. In fact, while we were continuing to talk, he started eating the parsley and washing it down with distilled water.

Calcium Supplements are taken in the morning with water only. No foods or beverages containing oxalic acid are taken for 2 hours to allow maximum calcium absorption without inhibiting by Oxalic acid. The normal diet each day allows for vegetables and beverages with oxalic acid in Significant

65

calcium and Oxalic acid to increase bone mineral build up and was advised to reduce protein intake and increase carbohydrate intake using corn oil as a Supplement for the carbohydrate intake.

US 6,407,141 B1 39

40 infections Such as Hemolytic, Viridans, Enterococci, Lactic, and the like. pneumococcal infections Such as Pneumonia. Sinusitis, Otitis, Meningitis, and the like. Also bacterial diseases caused by Gram-Negative Cocci, Neisseria Aerobic infections Such as Meningococcus, Gonococcus, and the like. Also bacterial diseases caused by Gram-Positive Bacilli infections Such as Erysipelothricosis, Listeriosis, Anthrax,

I received another call from a woman who went on the

oxalic acid diet Jan. 3, 1998 because there is an unidentified

mass in her breast. She called today to tell me that she was

diagnosed a year ago last October (1997) with diverticulitis

and has had irritable bowel syndrome most of her life. She has not had attacks from eating foods now that before would cause diverticula attacks prior to Starting on the diet. Her husband has been troubled for years with reflux from a hiatal hernia and constantly consumed Rolaids. He went on the Oxalic acid diet with his wife to lose Some weight and has discovered the reflux has disappeared and he has stopped using Rolaids. Oxalic acid must be clearing up any bacteria in both husband and wife. This stuff is amazing. The present invention is directed to Oxalic acid or oxalate compositions and methods and formula for producing Such compositions and for the utilizing Oxalic acid or oxalate compositions including Solutions, mixtures, products, creams, rinses, and the like, in the management, control, prevention, or the like, of infectious bacterial and infectious

Nocardiosis, and the like.

Also bacterial diseases caused by Gram-Negative Bacilli infections Such as Enterobacteriaceae Salmonella,

Shigellosis, Hemophilus, Tularemia, Plaque, Melioidosis, Bartonellosis, Campylobacter, and Noncholera Vibrio, and the like. Also bacterial diseases caused by Anaerobic Bacilli infections such as Clostridium Botulinum, Clostridium 15

Viral diseases or conditions in humans and other animals.

Even though a viral origin for cancer has not been demonstrated in man, the inventor conducted investigative research on oncogenic viruses and their relationship to man, during development of U.S. patent application Ser. No. 08/629,538. Medical Microbiology by Jawets, Melnick & Adelbert, 8th Edition, 1968, writes on the general properties of tumor viruses. The tumor inducing viruses can be clas sified into two main groups, those which contain RNA as their generic material and those that contain DNA. DNA papilloma viruses as benign warts and molluscum contagio

bonucleic acid types (DNA), and ribonucleic acid (RNA), 25

also infect animals. Also, diseases Such as Human Immu

Also Respiratory Tract Viral diseases, all Serotypes, caused by Influenza, A, B. and C, Parainfluenza viruses 1-4,

as models in the quest for knowledge of Viral carcinogenesis

Rhonoviruses (common cold), Mumps virus, Adenoviruses, Reoviruses, and Epstein-Barr virus, and Infants and Adult

in man.

Syncytial virus, also primary Atypical pneumonias and 35

infectious bacterial and infectious viral conditions was

Studied, and many case Studies were conducted with human Volunteers among his peers. The observed interaction of Oxalic acid and the infectious bacteria and infectious virus

40

during these Studies reveals that Oxalic acid is indeed bactericidal and viricidal. It is stated in Medical Microbiol

Ogy that the fundamental principal of chemotherapy is the principal of Selective toxicity, which may be Stated as follows, “In order to be useful for systemic treatment of infectious disease, a Substance must be harmful to parasites but relatively innocuous to host cells.” Oxalic acid as a natural chemotherapy meets the Stated principle. It can be administered at therapeutically accept able levels sufficient to kill the bacterial and viral organisms and be completely innocuous to the host cells. Oxalic acid can be administered at the therapeutically acceptable levels for the time necessary to kill the organisms without any effect on host cells. It is believed that Oxalic acid penetrates the encasing Shell of the host cell and kills the viral nucleic

others.

Also Nervous System Viral diseases, all Serotypes, Such as Polioviruses, Coxsackieviruses, Echoviruses and high numbered viruses, Epidemic gastroenteritis viruses, Rubeola Virus, Rubella virus, Varicella-Zoster virus, Herpes simplex, Human herpes virus type 6, Human Parvovirus B19, Cytomegalovirus, Hepatitis viruses Types A, B, C, D, Human Papillomavirus, Molluscum contagioSum virus, and also viruses transmitted from nature to man Such as the

45

Arboviruses, togaviruses, alphaviruses, flaviviruses, bunyaviruses, and the Orbivirus, Rabies virus, Herpesvirus Simiae, Arenaviruses, Filoviruses, and the like.

50

55

By way of general definition, "cancer' is any of various malignant neoplasms, a "tumor is a neoplasm or abnormal growth of tissue, and a "neoplasm' is an abnormal new growth of tissue, or a tumor. Hence, it is respectfully believed that the words neoplasm and tumor are essentially Synonymous and that a cancer is essentially any of various malignant neoplasms, tumors, or growths. AS described in the present application, oxalic acid in one of its beneficial forms was used in connection with the

treatment, management, control, or the like of a growth on a thigh, a growth on an eyebrow, polyps, abdominal cancer, bladder cancer, proState cancer, mouth tumor, melanoma

acid core.

In accordance with the present invention, antimicrobial Oxalic acid or oxalate compositions and methods of treat ment of warm-blooded animals including humans and pets is provided which includes at least one therapeutically effective form of Oxalic acid or oxalate for controlling treating, or managing bacterial diseases and Viral diseases caused by germs of infectious bacteria and infectious virus. The present invention encompasses treatment of the follow ing: Bacterial diseases caused by Gram-Positive Cocci Such as Staphylococcal infections of Pneumonia, Bacteremia, Osteomyelitis, Enterocolitis, and the like. Streptococcal

with natural cycle chiefly in humans, spread by perSon-to perSon contact, and transmitted from nature to man and may

nodeficiency Virus infection (HIV) and Acquired Immuno deficiency Syndrome (AIDS).

Sum have been classed as natural tumors in man and Serve

When the inventor discovered the bactericidal activity of Oxalic acid in the gingivitis reduction in his pet dog. The entire spectrum of the effect of Oxalic acid in application for

Tetany, Clostridia of Gas Gangrene Bacteroides, Mixed Anaerobic, Actinomycosis, and the like. Also diseases caused by Mycobacteria, infections Such as Tuberculosis and Leprosy, and the like. Also bacterial diseases caused by Spirochetes Such as LeptoSpirosis Lyme Disease, and Endemic Treponematoses. Further in accordance with the present invention, Oxalic acid or oxalate composition and methods of treatment for infectious nucleic acid type Viral diseaseS Such as deoxyri

(skin cancer), oral tumor, cervical cancer, brain tumor, 60

lymph node tumors, uterine tumor, bone cancer, Stomach cancer, and breast cancer. Further, as described in the

Examples of the present application, oxalic acid in one of its

beneficial forms is used in connection with the treatment, 65

control, management, or prevention of tumors, brain tumors, cancers, neoplasia, acne, Skin cancer, growths, breast cancer, cervical cancer, and the like. It is respectfully believed that Oxalic acid in one of its therapeutic forms is a natural

US 6,407,141 B1 41 chemotherapy which can be used to treat all types of tumors, growths, neoplasms, infectious bacterial or viral diseases, and the like, in warm-blooded animals, regardless of loca

42 The Spouse was able to Stop taking medicine she had taken for Several years. In another case, a patient learned of the diet when the inventor recommended a diet Schedule for the patient's dog. The patient was ill with artherosclerosis and had received relief from bypass Surgery. The patient was taking drug therapy for a condition of 80 percent blockage of an artery. Approximately three months after following the diet, an arteriography test revealed the blockage was reduced to 53 percent. The patient is continuing the diet

tion or classification thereof. The oxalic acid diet of the

present invention provides a natural chemotherapy which has been beneficial in the treatment, control, management, or prevention of growths, tumors, cancers, leukemia, bronchitis, and bacterial and viral infections. In other words,

it is believed that Oxalic acid in one of its therapeutic forms is a general or non-Selective chemotherapeutic or chemo preventive agent, factor, or compound. In a recent Cancer Treatments publication, “chemoprevention' is described as an exciting new area of pharmaceutical cancer research that focuses on the prevention of cancer through a diverse group of natural and Synthetic agents. It is respectfully believed that this publication indicates that chemoprevention is new and that prior to the invention by Applicant, one of ordinary

In another case, a veterinarian used an oxalic acid cream

15

skill in the art would not have known of the use of oxalic

acid as a chemoprevention and it would not have been obvious to use oxalic acid as a chemoprevention.

restricted.

Further, if the use of Oxalic acid as a cancer treatment or

cure were known prior to the invention by Applicant, why will more than 1.3 million cases of cancer be diagnosed this year, why has over a trillion dollars been spent on trying to find a cure for cancer, and why did the U.S. commit itself to waging a “war on cancer with the National Cancer Act of

25

1971. As described in the recent Cancer Treatments

publication, a So-called “magic bullet'-a single medicine or treatment-that will cure cancer has not been found. Appli cant respectfully believes that Oxalic acid in one of its therapeutic forms may be the “magic bullet” that is being Sought and may improve and extend lives when it is used as described in the present application. Although the activity of Oxalic acid is not completely understood, Applicant respect fully believes that Oxalic acid attacks the nucleic acid center of tumor, cancer, neoplasm, or growth cells or tissues and thereby kills or prevents the growth of the tumor, cancer, neoplasm, growth, or the like. Applicant respectfully believes that warm-blooded animals including humans, dogs, cats, horses, and the like will benefit from the use of Oxalic acid in one of its therapeutic forms as described in the present application including as a composition, nutritional Supplement, diet, food additive, dental prophylactic, preventative, control factor, treatment agent, or the like. Even further, in accordance with the present invention, it is contemplated that many different oxalic acid or oxalate containing compounds, foods, vegetables, and the like may be used in the controlling, managing, treatment, prevention, or the like of neoplasms, Neoplasia, cancers, tumors, growths, abnormal cells and tissues, infectious bacterial or

35

40

45

ventional ingredients Such as Vitamins and minerals. EXAMPLE 2

50

A treatment regimen or method including the oral admin istration of one Such tablet, pill, multi-Vitamin or Supplement of Example 1 daily. EXAMPLE 3

55

In accordance with the Detailed Description of the Invention, the following case Studies confirm the therapeutic In one case, the Spouse of a patient on the diet also followed the diet. The spouse was very pleased to learn from later blood tests, a condition of high blood pressure, high cholesterol, and abnormal platelets was normal, bad choles terol levels were down, good cholesterol levels were up, and the platelet level was steady and within the desired value.

A therapeutic composition in the form of a nutritional Supplement or multi-Vitamin tablet containing an effective

amount of Oxalic acid, 8 grams (g) or less, preferably 500 milligrams (mg) or less of Oxalic acid, together with con

affect

action of Oxalic acid and oxalates on vascular disorders, diseases, and other conditions.

The decalcification of calcareous matter by Oxalic acid has been repeatedly demonstrated. There is no drug therapy currently available capable of removing plaque and restoring the inner lining of the artery to a healthy condition. Applicant respectfully believes that Oxalic acid in at least one of its therapeutically effective forms is a general, nonselective, chemotherapeutic or chemopreventive agent, factor, or compound and has described numerous compositions, methods, protocols, regimens, diets nutri tional Supplements, rinses, washes, topical ointments, and the like for Supplying oxalic acid in an effective amount and a beneficial form to patients. The following are illustrative examples of methods, for mulations and compositions according to the present inven tion. Although the examples utilize only Selected com pounds and formulations, it should be understood that the following examples are illustrative and are not limiting. Therefore, any of the aforementioned Oxalic acids, oxalate, or related compounds may be Substituted according to the teachings of the present invention in the following examples. EXAMPLE 1.

Viral diseases, and Vascular disorders, diseases, and other

conditions. For example, Oxalic acid dihydrate, dried parsley, dried chives, foods containing these items, nutri tional Supplements containing these items, juices Such as carrot juice containing these items, and combinations thereof may be used to provide the desired chemotherapeutic

Solution in treating viral oral plaques in the ears of horses. It is the only treatment he has found to be successful. Following removal of the plaque, the skin was normal, healthy, and pink in texture. In Several cases, patients Suffering for years with rheu matoid arthritis who were taking drug therapy, received total relief by following the diet procedure. Complete mobility was restored in joints whereas mobility had been Severely

60

The therapeutic composition of Example 1 including 1 gram or less, preferably 500 milligrams or less of Oxalic acid, together with conventional quantities of other Vitamins and minerals except that one or more of the Oxalic acid blockers, including Vitamin C, Vitamin B6, calcium, citric acid, alcohol, resin, and the like are reduced or eliminated

altogether from the pill, Vitamin, multi-Vitamin, Supplement, etc. 65

EXAMPLE 4

A composition rinse, or gargle for rinsing the interior Surfaces of the mouth and throat made of a dilute Solution of

US 6,407,141 B1 43

44

oxalic acid in distilled water, preferably less than 500 mg of

EXAMPLE 1.5

oxalic acid in 300 ml of distilled water.

The method described in Example 11 wherein the com position is administered at last once a day at a dosage of 50 mg to 6 g for patients.

EXAMPLE 5

Amethod of treating patients including the Steps of testing the blood or urine oxalic acid or oxalate levels, administer

ing an effective amount of Oxalic acid, oxalate or blockers thereof, and monitoring the levels to determine if adjust ments are necessary to achieve a desired level.

EXAMPLE 16

1O

oxalate enhancers.

EXAMPLE 6

A single medicine, “silver bullet” or “magic bullet”, composition for controlling, treating or managing vascular disorders, diseases, and other conditions or for otherwise

The method as described in Example 11 further having the Steps of reducing the intake of Oxalic acid or oxalate blockers and/or increasing the intake of Oxalic acid or EXAMPLE 1.7

15

therapeutically treating patients and including an effective amount of at least one therapeutically effective form of Oxalic acid or oxalate.

The method as described in Example 16 wherein the blockers are Selected from the group of citric acid, ascorbic acid, pyridoxine hydrochloride, calcium, alcohol, resins, clayS, and combinations thereof.

EXAMPLE 7

EXAMPLE 1.8

The composition as described in Example 6 wherein the therapeutically effective form of Oxalic acid or oxalate is Selected from the group of Oxalic acid in a free acid, ester, lactone or Salt form, oxalate including Sodium oxalate, a nutritional Supplement containing at least one form of Oxalic acid or oxalate, oxalic acid dihydrate, anhydrous Oxalic acid,

The method as described in Example 16 wherein the blockers are Selected from the group of dairy products containing calcium, fruits, coconut, beverages containing alcohol, ascorbic acid or citric acid including beverageS Such as beer, wine, Vodka, gin, and the like, fruit juice based beverages, Soda pop or Soft drinkS containing ascorbic acid or citric acid, other Sports drinks, beverages or refreshments containing ascorbic acid or citric acid, red meats, or white meat of fowl including chicken, turkey, pheasant and the like containing pyridoxine, or other foods or beverages contain ing alcohol, citric acid, ascorbic acid or pyridoxine hydro chloride including breads or grains, resins, and combination

25

oxamide, oxalate Salts, and combinations thereof. EXAMPLE 8

The composition as described in Example 6 wherein the composition is Oxalic acid dihydrate.

thereof EXAMPLE 9

The composition as described in Example 6 further hav ing a pharmaceutically acceptable carrier or diluent for the therapeutically effective form of Oxalic acid or oxalate.

EXAMPLE 1.9

35

EXAMPLE 10 40

The composition as described in Example 9 wherein the carrier or diluent is at least one of a gel cap and distilled

A diet for treating, controlling, and managing or prevent ing vascular disorders, diseases, and other conditions in patients having the Steps of adding to the regular diet a dietary Supplement of an effective amount of at least one therapeutically effective form of Oxalic acid or oxalate. EXAMPLE 2.0

Water.

EXAMPLE 11

A method for controlling, treating, or managing vascular disorders, diseases, and other conditions in patients having the Steps of periodically administering a therapeutically effective dosage of the composition of Example 6.

45

The diet as described in Example 19 wherein the effective form of Oxalic acid or oxalate is Selected from the group of

50

including Sodium oxalate, a nutritional Supplement contain ing at least one form of Oxalic acid or oxalate, Oxalic acid dihydrate, anhydrous Oxalic acid, OXamide, oxalate Salts, natural or processed foods including plants or vegetables including parsley, chives, garlic, beets, carrots, Spinach, and the like containing at least one form of Oxalic acid or oxalate, beverages, liquids or juices Such a carrot juice containing at

55

thereof.

Oxalic acid in a free acid, ester, lactone, or Salt form, oxalate

EXAMPLE 12

The method as described in Example 11 wherein the composition is administered orally or Sublingually in at least one of a gel cap, tablet, powder, food additive, food, drops, liquid, beverage, pill, and capsule form.

least one form of Oxalic acid or oxalate, and combinations EXAMPLE 21

EXAMPLE 13

A method as described in Example 11 wherein the com position is administered by injection including venous injec

60

The diet as described in Example 19 further having the Steps of reducing the intake of Oxalic acid or oxalate blockers.

tion. EXAMPLE 22 EXAMPLE 1.4

The method as described in Example 11 wherein the composition is administered internally by at least one of inhalation, Suppository, or Subcutaneous deposit.

65

The diet as described in Example 21 wherein the blockers are Selected from the group of dairy products containing calcium, fruits, coconut, beverages containing alcohol, ascorbic acid, or citric acid including adult beverageS Such

US 6,407,141 B1 45

46

as beer, wine, Vodka, gin, and the like, fruit juice based beverages, Soda pop or Soft drinkS containing ascorbic acid or citric acid, other Sports drinks, beverages or refreshments containing ascorbic acid or citric acid or pyridoxine hydro chloride including breads or grains, resins, and combinations

EXAMPLE 31

The method of Example 30 further including the steps of Stopping other chemical treatments to prevent weakening of the body or prevent the reduction of Oxalic acid or oxalate in the body.

thereof.

EXAMPLE 32

EXAMPLE 23

The method of Example 30 further including the steps of reducing the dosage of Oxalic acid or oxalate after the blood

A method of treating vascular disorders, diseases, and other conditions including the Steps of reducing or elimi nating the ingestion or administration of Oxalic acid or oxalate blockers, administering or ingesting high dosages of

has been cleansed and the condition or disease has

improved.

Oxalic acid or oxalate to raise the blood or urine oxalic acid

or oxalate level above normal, and, after cleansing the infectious microbial, bacteria or virus infected blood, reduc

EXAMPLE 33 15

ing or eliminating the administration or ingestion of Oxalic acid or oxalate to maintain a normal blood or urine oxalic acid or oxalate level.

The method of Examples 30, 31, 32, further including the Steps of reducing the intake of Oxalic acid or oxalate blockers and increasing the intake of Oxalic acid or oxalate enhancers. EXAMPLE 34

EXAMPLE 24

A therapeutic composition for purifying the blood, controlling, treating or eradicating infectious or pathogenic microbial, bacterial or viral disease from the cardiovascular

System or in the brain, and maintaining good cardiovascular health and operation, having a therapeutically effective amount of at least one therapeutically effective form of

25

blood or urine level.

Oxalic acid or oxalate.

EXAMPLE 35

The carrot juice of Example 34 is mixed with other juices and flavoring agents Such as tomato juice, Salt, pepper, parsley, and/or celery to enhance the flavor thereof.

EXAMPLE 25

A pharmaceutical composition to be administered orally to patients of a mixture of a non-toxic ingestible carrier and an effective amount of a therapeutically effective form of Oxalic acid or oxalate.

EXAMPLE 36 35

EXAMPLE 26

The pharmaceutical composition as described in Example 25 wherein the composition is provided in a form Selected from the group of pills, powders, granules, tablets, microcapsules, gel capsules nutritional Supplements, pro cessed foods, liquids, drops, beverages, additives, and Solu

EXAMPLE 37

45

the patient to prevent decomposition or reduction in the amount of Oxalic acid or oxalate during treatment.

50

EXAMPLE 28

A mouthwash, gargle or oral rinse containing a dilute solution of oxalic acid and having a pH of 2.67.

EXAMPLE 39

60

Atherapeutic composition or remedy for the maintenance of good health, prevention, treatment, or control of vascular disorders, diseases, and other conditions is made up of a food item Such as bread, cereal, or other prepared food including oxalic acid or plant or vegetable containing Oxalic acid like parsley or chives, in a Sufficient quantity to provide the desired therapeutic effect.

EXAMPLE 30

A method of treating terminally ill patients including the Steps of administering a high dosage of Oxalic acid or oxalate to cleanse the blood and treat the condition or disease.

The therapeutic composition of Example 36 including 8 grams or less, preferably 500 milligrams or leSS Oxalic acid, together with conventional quantities of other Vitamins and minerals except that one or more of the Oxalic acid blockers, including Vitamin C, Vitamin B6, calcium, citric acid, resins, and the like, are reduced or eliminated altogether from the pill, Vitamin, multi-mineral, Supplement, etc.

55

EXAMPLE 29

The mouthwash, gargle or oral rinse of Example 28 containing a dilute Solution of 150 mg of Oxalic acid dihydrate per 300 ml of distilled water.

A treatment regimen or method including the oral admin istration of one Such tablet, pill, multi-Vitamin, or Supple ment of Example 36 daily. EXAMPLE 38

A method of enhancing the beneficial effects of Oxalic acid or oxalate in patients including the Steps of eliminating the use of Strong magnetic fields or radiation in the

examination, treatment or diet (heating of food or drink) of

A therapeutic composition in the form of a nutritional Supplement or multi-Vitamin, multi-mineral tablet contain ing a Small quantity of Oxalic acid, preferably 500 milli grams or less of Oxalic acid, together with conventional ingredients Such as Vitamins and minerals.

40

tions. EXAMPLE 27

Atherapeutic composition for treating vascular disorders, diseases and other conditions made up of pure carrot juice which is administered orally in 2 ounce Servings to provide between 4 and 6 ounces of carrot juice daily to provide the desired therapeutic effect and desired Oxalic acid or oxalate

65

EXAMPLE 40

A composition for improving and maintaining good health in patients and having a composition Selected from

US 6,407,141 B1 47

48

Oxalic acid, oxalate, oxalic acid dihydrate, a nutritional Supplement containing oxalic acid, a nutritional Supplement containing oxalate, a nutritional Supplement containing Oxalic acid dihydrate, or combinations thereof.

blockers if the level is below normal, maintaining current ingestion or administration of Oxalic acid or oxalate if the Oxalic acid or the oxalate level is normal, reducing the ingestion or administration of Oxalic acid or oxalate if the level is above normal, or increasing the ingestion or admin

EXAMPLE 41

istration of oxalic acid or oxalate blockers if the level is above normal.

A flavor enhancer including at least one form of Oxalic acid.

EXAMPLE 49 EXAMPLE 42

The method as described in Example 48 wherein the Oxalic acid or oxalate level Scale has differing below normal, normal, and above normal level categories for different

A preservative including at least one form of Oxalic acid.

health conditions.

EXAMPLE 43

In a prepared food product, the improvement including an

15

effective amount of at least one form of Oxalic acid.

EXAMPLE 50

In a multi-Vitamin and mineral Supplement, the improve ment including the addition of at least one therapeutically

EXAMPLE 44

effective form of oxalic acid.

In a prepared food product, the improvement including EXAMPLE 51

the elimination of citric acid and the addition of an effective amount of at least one form of Oxalic acid.

The multi-Vitamin and mineral Supplement as described in Example 50 further including the improvement of the reduc

EXAMPLE 45

In a diet for promoting good health in warm-blooded animals including humans, the improvement including increasing the quantity of Oxalic acid or oxalate-containing foods, and reducing the intake of Oxalic acid or oxalate

25

EXAMPLE 52

An oxalic acid treatment method including the Step of mixing carrot juice with other juices and flavoring agents Such as tomato juice, Salt, pepper, parsley, celery, and the

blockers.

like to enhance the flavor thereof.

EXAMPLE 46

A method for inhibiting, preventing, treating, or control ling the deleterious effects of diarrhea, indigestion, damage to digestive tract, kidney damage, or renal failure caused by high levels of Oxalic acid including the Steps of at least one of reducing the ingestion or administration of Oxalic acid, oxalate, oxalic acid dihydrate, a nutritional Supplement containing oxalic acid, a nutritional Supplement containing oxalate, a nutritional Supplement containing oxalic acid dihydrate, foods containing oxalic acid, foods containing oxalate, foods containing oxalic acid dihydrate, carrot juice, and combinations thereof, increasing the ingestion or admin istration of Oxalic acid or oxalate blockers including crushed pineapple, monitoring the levels of Oxalic acid or oxalate in the blood or urine, adjusting the ingestion or administration of Oxalic acid or oxalate-containing compounds and the ingestion or administration of Oxalic acid or oxalate blockers

tion or elimination of Oxalic acid or oxalate blockers therein.

EXAMPLE 53 35

40

Atherapeutic composition of Sourdough bread made from flour, water, yeast, Sourdough Starter, and an additional Oxalic acid ingredient Selected from the group of dried chopped parsley, freeze-dried chives, Oxalic acid, oxalate, foods containing oxalic acid, foods containing oxalate, Veg etable juice Such as carrot juice, or combinations thereof to provide approximately 2 g. of Oxalic acid per 4 lb. Loaf of Sourdough bread. EXAMPLE 54

45

A method of therapeutically treating a patient having the Steps of periodically administering a portion of the Sour dough bread of Example 53 to provide a dosage of Oxalic acid of up to about 1 g. oxalic acid per day.

to achieve the desired Oxalic acid or oxalate levels.

EXAMPLE 55

50

EXAMPLE 47

A method of counteracting, inhibiting, treating, controlling, or reducing the deleterious effects of high levels of Oxalic acid including the Steps of administering or ingest ing a therapeutically effective amount of Vitamin B6, vita min B6-containing nutritional Supplements, foods contain ing Vitamin B6, or combinations thereof.

55

EXAMPLE 56

EXAMPLE 48 60

A method of treating a patient including the Steps of determining the Oxalic acid blood level or oxalate urine level of the patient comparing this level with a Scale indicating

A method of treating or preventing oxalate nephrosis in patients including periodically administering a therapeuti cally effective amount of at least one oxalic acid or oxalate blocker.

below normal, normal, and above normal oxalic acid or

oxalate levels, increasing the administration or ingestion of Oxalic acid or oxalate if the level is below normal, reducing the ingestion or administration of Oxalic acid or oxalate

A method of delaying, preventing, controlling, or treating the onset of Alzheimer's Disease lessening the effects of the disease, or improving the quality of life of a perSon Suffering from the disease having the Steps of periodically adminis tering a therapeutically effective amount of at least one therapeutically effective form of Oxalic acid or oxalate.

65

EXAMPLE 57

A test kit for detecting the oxalate level in urine of patients having a Sample holder and a liquid reagent which upon

US 6,407,141 B1 49

SO

addition of a Selected quantity of reagent to a Sample of urine in the Sample holder provides a colormetric indication of the presence or absence of Oxalate.

and disappear and when finally all trace of cancer has been cleared in the blood System, a balanced diet of all foods may be resumed while being Sure to maintain an adequate level of Oxalic acid in the System to prevent resumption of tumor growth. The microwave should not be used for cooking or heating any foods or beverages in the diet because it reduces the Strength of the acid. Also, do not use electric blankets, electric razors, and electric hair blower/dryers because Strong electric fields can reduce the acid. Avoidance of excessive and/or extended use of a cellular phone should

EXAMPLE 58

The Relationship Between Oxalic Acid and Blockers

A Program For Tumor Reduction Improved Dietary Procedure Plan This Dietary Procedure Plan is drawn from research data in the United States patent application for Oxalic Acid or Oxalate Composition and Method of Treatment for Tumors. Oxalic acid is considered to be a natural chemotherapy in the reduction and prevention of tumor growth. Certain vegetable Such as carrots, carrot juice, Spinach, parsley, chives, beets and beet leaves, garlic, collards, and radishes are high among vegetables containing oxalic acid and should be eaten or drank in order to build a high concentration of Oxalic acid in the body fluids. Almonds, cashews, peanuts, walnuts, and many other nuts and Seeds contain oxalic acid and may be eaten. Especially walnuts, which are high in oleic and linoleic fatty acids and increase Oxalic acid absorption in the lower intestine, should be

also be exercised.

This Same procedure can be used to treat vascular 15

EXAMPLE 59

A dietary Supplement for everyday optimum nutritional balance having between 0.5 to 1.5 g. of Oxalic acid. EXAMPLE 60

25

eaten. Coffee, tea, cocoa made with distilled water, and

natural fruit juices are acceptable for drinking, especially cocoa which is very high in Oxalic acid content. All bever ages should be free of citric acid.

(vitamin B6), alcohol, and in certain instances ascorbic acid (vitamin C), Soda pop, thirst-quenchers, Sport drinks and flavored drinking waters, should absolutely be avoided as they are high in citric acid. All dairy products must be avoided as calcium prevents absorption of Oxalic acid, and when combined form calcium-oxalate kidney Stones. All red

35

EXAMPLE 62 40

should be consumed. Excessive intake of ascorbic acid 45

50

55

taking one (1) 100 mg B6 pill. You will learn a slight moderation of the diet will avoid either of the above con ditions. Maximum effect of Oxalic acid on tumor reduction

would be accomplished if an acid level can be maintained just below the discomfort level. Research shows that 5 to 7 days after the Start of the diet, an increase in energy may be experienced. Some people notice a body weight loSS. Improvement in condition of visible tumors may be noticed after 12 to 15 days. If there are multiple tumors, the

newest tumors will regress first, and the core (first) tumor

will require a longer diet time. Once tumors begin to Shrink

A method of treating patients including the Steps of testing the blood or urine oxalic acid or oxalate levels, administer ing oxalic acid, oxalate or blockers thereof, and monitoring the levels to determine if adjustments are necessary to achieve a desired level.

meats, chicken and turkey breast (generally white meat) are high in pyridoxine (B6), and should be avoided. No alcohol

should be avoided. It is absolutely necessary to read the ingredients on all food and drink items consumed while on the diet. Citric and ascorbic acids are widely used as a preservative in many products, including frozen and bakery goods. AS oxalic acid is built up in the System, one may expe rience indigestion known as heartburn or a nagging back ache. These are indicators that the acid is being ingested in too large a quantity, or the System is absorbing the acid at a rate faster than it can be utilized. Indigestion or heartburn can be relieved by taking 2 or 3 teaspoonfuls of crushed pineapple. Relief for the backache can be accomplished by

A test kit for detecting the presence and quantity of Oxalic acid in a blood Sample of a patient having a Sample Support Surface, a reagent, and a mixing container for mixing together the blood Sample and reagent to allow the reagent to undergo a color change and provide a colormetric deter mination of the presence and quantity of Oxalic acid in the Sample. EXAMPLE 61

There are certain items in the normal diet that are blockers

to absorption of Oxalic acid which reduces the acid available in the System to treat vascular disorders, diseases and other conditions. These items are citric acid, calcium, pyridoxine

disorders, diseases, and other conditions.

A composition for controlling, treating or managing vas cular disorders, diseases, and other conditions for preventing new Swelling or enlargement of tissues, or for otherwise therapeutically treating patients and including at least one therapeutically effective form of Oxalic acid or oxalate. EXAMPLE 63

The composition as described in Example 62 wherein the therapeutically effective form of Oxalic acid or oxalate is Selected from the group of Oxalic acid in a free acid, ester, lactone or Salt form, oxalates including Sodium oxalate, a nutritional Supplement containing at least one form of Oxalic acid or oxalate, Oxalic acid dihydrate, anhydrous Oxalic acid, oxamide, oxalate Salts, natural or processed foods including molds, plants or vegetables including parsley, chives, garlic, beets, carrots, Spinach, and the like containing at least one form of Oxalic acid or oxalate, beverages, liquids or juices Such as carrot juice containing at least one form of Oxalic acid or oxalate, additives containing at least one form of Oxalic acid or oxalate, and combinations thereof.

60

65

EXAMPLE 64

A method for controlling, treating or managing vascular disorders, diseases, and other conditions for preventing new Swelling or enlargement of tissues, or for otherwise thera peutically treating patients having the Steps of periodically administering a therapeutically effective dosage of the com position of Example 62

US 6,407,141 B1 S1

52

EXAMPLE 65

drous Oxalic acid, oxamide, oxalate Salts, natural or pro cessed foods including molds, plants or vegetables including parsley, chives, garlic, beets, carrots, spinach, and the like containing at least one form of Oxalic acid or oxalate, beverages, liquids or juices Such as carrot juice containing at least one form of Oxalic acid or oxalate, additives containing

The method as described in Example 64 further having the Steps of reducing the intake of Oxalic acid or oxalate blockers. EXAMPLE 66

at least one form of Oxalic acid or oxalate, and combinations thereof.

A diet for treating, controlling, and preventing vascular disorders, diseases, and other conditions in patients having the Steps of adding to the regular diet a dietary Supplement of at least one therapeutically effective form of Oxalic acid

EXAMPLE 73

The veterinary composition as described in Example 72 wherein the composition is Oxalic acid dihydrate.

or oxalate. EXAMPLE 67

The diet as described in Example 66 wherein the thera peutically effective form of Oxalic acid or oxalate is Selected from the group of Oxalic acid in a free acid, ester, lactone or Salt form, oxalates including Sodium oxalate, a nutritional Supplement containing at least one form of Oxalic acid or oxalate, Oxalic acid dihydrate, anhydrous Oxalic acid, oxamide, oxalate Salts, natural or processed foods including molds, plants or vegetables including parsley, chives, garlic, beets, carrots, Spinach, and the like containing at least one form of Oxalic acid or oxalate, beverages, liquids or juices Such as carrot juice containing at least one form of Oxalic acid or oxalate, additives containing at least one form of

EXAMPLE 74 15

The veterinary composition as described in Example 72 wherein the composition is at least one of carrots, boiled carrots, carrot juice, and dried parsley. EXAMPLE 75

The veterinary composition as described in Example 72 further having a pharmaceutically acceptable carrier or diluent for the therapeutically effective form of oxalic acid or oxalate. 25

EXAMPLE 76

The veterinary composition as described in Example 75 wherein the carrier or diluent is a gel cap or distilled water.

Oxalic acid or oxalate, and combinations thereof. EXAMPLE 68

EXAMPLE 77

The diet described in Example 66 further having the steps of reducing the intake of Oxalic acid or oxalate blockers.

A composition for counteracting the decomposition or reduction of Oxalic acid or oxalate caused by radiation exposure, radiation treatment, X-rays, Strong electromag

EXAMPLE 69

The diet as described in Example 68 wherein the blockers are Selected from the group of citric acid, ascorbic acid, pyridoxine hydrochloride, calcium, alcohol, resins, clayS,

35

and combinations thereof. EXAMPLE 70

The diet as described in Example 68 wherein the blockers are Selected from the group of dairy products including calcium, fruits, coconut, beverages containing alcohol, ascorbic acid or citric acid including adult beverageS Such as beer, wine, Vodka, gin, and the like, fruit juice based beverages, Soda pop or Soft drinkS containing ascorbic acid or citric acid, other Sports drinks, beverages containing alcohol, citric acid, ascorbic acid or pyridoxine hydrochlo ride including breads or grains, resins, and combinations

netic waves or fields, microwaves, and the like or for

returning the body's Oxalic acid or oxalate level to at least a normal level following radiation treatment, X-rays, CAT Scans, MRI-Scans, and the like including a therapeutically effective amount of at least one therapeutically effective form of Oxalic acid or oxalate.

40

EXAMPLE 78

45

A method for counteracting the decomposition or reduc tion of Oxalic acid or oxalate caused by radiation exposure, radiation treatment, X-rays, Strong electromagnetic waves or fields, microwaves, and the like or for returning the body's Oxalic acid or oxalate level to at least a normal level

50

thereof.

following radiation treatment, X-rays, CAT scans, MRI Scans, and the like having the Steps of administering a therapeutically effective amount of the composition of Example 77 following the treatment or exposure. EXAMPLE 79

EXAMPLE 71

A veterinary composition for controlling, treating or man aging vascular disorders, diseases, and other conditions, for preventing disease, or for otherwise therapeutically treating warm-blooded animals of a composition including at least one therapeutically effective form of Oxalic acid or oxalate. EXAMPLE 72

The veterinary composition as described in Example 71 wherein the therapeutically effective form of oxalic acid or oxalate is Selected from the group of Oxalic acid in a free acid, ester, lactone or Salt form, oxalates including Sodium oxalate, a nutritional Supplement containing at least one form of Oxalic acid or oxalate, Oxalic acid dihydrate, anhy

55

The method as described in Example 78 further including the Steps of administering a therapeutically effective amount of the composition of Example 77 prior to the treatment or eXposure. EXAMPLE 8O

60

A method of enhancing the therapeutic effect of Oxalic acid or oxalate including the Steps of decreasing or elimi nating the ingestion or administration of one or more of Oxalic acid or oxalate blockers.

65

EXAMPLE 81

The method as described in Example 80 wherein the blockers are Selected from the group of calcium, alcohol,

US 6,407,141 B1 S3

S4

citric acid, ascorbic acid, pyridoxine hydrochloride, resins,

Coffee, cocoa, regular tea made with distilled water, and natural fruit juices are acceptable for drinking. All beverages

and combinations thereof.

should be free of citric acid. EXAMPLE 82

AS oxalic acid is built up in the System one may experi ence indigestion known as heartburn or a nagging backache. These indicate that the acid is being ingested in too large a quantity or the System is digesting the acid at a rate faster than it can be absorbed. Indigestion can be relieved by taking 2 or 3 teaspoons of crushed pineapple. Relief for the

A method of manufacturing a dry processed dog food containing at least one form of Oxalic acid or oxalate including the Steps of mixing a Slurry of conventional dog food ingredients together with a dilute Solution of Oxalic acid or oxalate in heated water to form an oxalic acid or

backache can be accomplished by taking one (1) 100 mg

oxalate containing slurry, forming the Slurry into pellets and drying the pellets.

Vitamin B6 pill. A slight reduction of the intake of oxalic acid will avoid either of the above conditions. Maximum

effect of vascular disorders, diseases, and other conditions

EXAMPLE 83

The method as described in Example 82 wherein the Oxalic acid is oxalic acid dihydrate and each pellet contains approximately 1 mg of Oxalic acid So that one pound of dry dog food contains about 1 g of Oxalic acid.

15

EXAMPLE 84

A dietary Supplement for treating a patient diagnosed with vascular disorders, diseases, and other conditions having about 1 g to 6 g, preferably 2 g to 4 g of Oxalic acid per day based on 70 kilograms of body weight and a pharmaceuti cally acceptable carrier or diluent.

EXAMPLE 88 25

EXAMPLE 85

A pharmaceutical composition to be administered orally to humans of a mixture of a non-toxic ingestible carrier and a therapeutically effective form of Oxalic acid or oxalate. EXAMPLE 86

The pharmaceutical composition as described in Example 85 wherein the composition is provided in a form selected from the group of pills, powders, granules, tablets, microcapsules, gel capsules, nutritional Supplements, pro cessed foods, liquids, juices, drops, beverages, additives and

treatment would be accomplished if an acid level can be maintained just below the discomfort level. Our research shows that five to seven days after the start of the treatment, an increase in energy will be experienced. Some people notice a body weight loSS. The microwave oven should not be used for cooking or heating any foods or beverages in the diet because it reduces the Strength or amount of the Oxalic acid.

35

A method of counteracting the deleterious effects of a mammogram, CAT-Scan, X-ray, and the like, exposure or treatment including the Steps of about 3 weeks prior to the exposure increasing the intake of Oxalic acid or oxalate, continuing the increased oxalic acid or oxalate during the treatment and for 3 weeks following treatment Thereafter, checking the blood or urine oxalic acid or oxalate levels of the patient and if they are normal, continuing with that level of intake of Oxalic acid or oxalate, if they are above normal, reducing the intake of Oxalic acid or oxalate, and if they are below normal, increasing the intake of Oxalic acid or oxalate. Thereafter, monitoring the levels and adjusting the intake on a periodic basis. EXAMPLE 89

40

An oxalic acid or oxalate containing bread including about 1 gram of Oxalic acid or oxalate per loaf of bread.

45

The bread of Example 89 wherein the oxalic acid is oxalic acid dihydrate dissolved in distilled water prior to being added to the bread during manufacturing of the loaf.

Solutions. EXAMPLE 87

EXAMPLE 90

Treatment For Vascular Disorders, Diseases, And Other Conditions

Our research indicates the following as a treatment for vascular disorders, diseases, and other conditions:

Carrots, carrot juice, Spinach, parsley, chives, beets and beet leaves, garlic, collards and radishes are high among vegetables containing Oxalic Acid and should be eaten or drank in order to build a high concentration of acid in the body fluids. Almonds, cashews, peanuts, and, especially walnuts which are high in oleic and linoleic fatty acids and increase oxalic acid absorption may be eaten.

EXAMPLE 91

50

facture of the loaf. EXAMPLE 92

Red meats, chicken and turkey breasts, (generally white meat) are considered high in Pyridoxine (Vitamin B6), and should be avoided during the treatment. Alcohol and prod

55

ucts containing citric acid (Soda pop, other Soft drinks, and thirst quenchers are generally high in citric acid), and ascorbic acid (Vitamin C) are considered blockers of oxalic

acid and should be avoided since they retard the build up of Oxalic acid in the System. It is absolutely necessary to read the ingredients on all food and drinkS consumed while on the treatment Citric and ascorbic acids are widely used as a preservative in many products, including frozen and bakery goods. All dairy products should also be avoided while following

the treatment. Calcium inhibits oxalic acid and when com

bined can form calcium oxalate Stones (kidney).

The bread of Example 90 further containing about 2 cups of trail mix including nuts, dried fruits, and the like, per loaf of bread with the trail mix being added during the manu

60

A dry dogfood is prepared with 300 lbs. Of dry dogfood having added thereto 10% ounces of oxalic acid dihydrate to provide about 1 gram of Oxalic acid per pound of dry dogfood. The oxalic acid dihydrate powder is added to 90 degree Celsius distilled water and mixed into the conven tional dogfood slurry. EXAMPLE 93

The dogfood of Example 92 with the exception that any Vitamin B6 is removed from the conventional dry mix. 65

EXAMPLE 94

An oxalic acid intake adult management control plan includes four phases. In the first phase, the adult is admin

US 6,407,141 B1 SS istered about 1% to 2 grams of Oxalic acid or oxalate per day, for 5 to 7 days to cleanse the blood of the patient for a 70-kilogram weight adult. For larger adults, the dosage

to cleanse the blood and treat the vascular disorder, disease, or other condition.

would have to be increased. Also, oxalic acid and oxalate

EXAMPLE 103

levels are checked in the blood, plasma and/or urine to determine the exact amount of Oxalic acid or oxalate

The method of Example 102 further including the steps of Stopping conventional oncological chemotherapy treatments to prevent the weakening of the body and prevent the decomposition or reduction of Oxalic acid or oxalate in the body.

required for the individual Subject. In the Second phase of the treatment, the Subject is given about 34 gram of Oxalic acid or oxalate for an additional 15 to 20 days until the vascular disorder, disease or other condition shows improve ment by change in blood pressure and/or laboratory tests. In the third phase the Subject is given about 72 gram of Oxalic acid or oxalate per day to continue correction of the vascular

EXAMPLE 104

disorder, disease, or other condition, or until the disease is

eliminated. In the fourth phase or maintenance phase, the Subject is given about 50 mg of Oxalic acid or oxalate per day for maintenance of good health. Again, these dosages are provided for an average 70-kilogram adult and the individu al’s Oxalic acid or oxalate levels need to be checked peri odically and the dosages adjusted as necessary.

15

The method of Example 102 further including the steps of reducing the dosage of Oxalic acid or oxalate after the blood has been cleansed and the vascular disorder, disease, or other

condition has improved. EXAMPLE 105

EXAMPLE 95

The control plan of Example 94 wherein a computer model of the chemical balance of the human body is used in addition to the Oxalic acid and oxalate level information to

25

determine the proper dosage for that individual.

The method of Examples 102, 103, or 104 further includ ing the Step of reducing the intake of Oxalic acid or oxalate blockers and increasing the intake of Oxalic acid or oxalate enhancers.

EXAMPLE 96

TABLE I

A method of enhancing the beneficial effects of Oxalic acid or oxalate in patients including the Steps of eliminating the use of microwave cooking for heating food or drink of the patient to prevent the decomposition or reduction in the

Oxalic Acid Content of Selected Vegetables Oxalic Acid

amount of Oxalic acid or oxalate in their food or drink. EXAMPLE 97

The method of Example 96 further including the step of eliminating the use of the microwave oven for cooking or heating to prevent exposure to microwaves and thereby prevent decomposition or reduction in Oxalic acid or oxalate in the patient being eXposed.

35

EXAMPLE 99

40

45

50

55

60

milliliters of distilled water.

A method of treating terminally ill patients including the Steps of administering a high dosage of Oxalic acid or oxalate

Beet leaves Broccoli

.61 19

Carrot Cassava Cauliflower Chives Collards Coriander

65

36 10 50 1.26 15

19 .21 148 45 O1

Corn, Sweet

O1

Cucumbers

O2

Eggplant

19

Endive Garlic Kale Lettuce Okra Onion

.11 36 O2 33 O5 O5

Parsley Parsnip

1.70 .04

Pea

O5

Pepper

.04

Potato Purslane Radish

EXAMPLE 101

EXAMPLE 102

13 36

Celery Chicory

An Oxalic acid or oxalate containing drink including carrot juice have a pH of about 5.5. A mouthwash or oral rinse containing a dilute Solution of 500 milligrams or less of oxalic acid dihydrate per 500

1.09

Asparagus Beans, snap

Cabbage

A mouthwash containing a dilute Solution of Oxalic acid and having a pH of about 2.3. EXAMPLE 100

(g/100 g)

Amaranth

Brussels sprouts

EXAMPLE 98

The method of Example 97 further including the steps of eliminating the use of radiation, X-ray, CAT-Scan, mammogram, Strong electromagnetic waves, excessive heat, or other exposures or treatments which would decompose or reduce the amount of Oxalic acid or oxalate in the patient.

Vegetable

Rutabaga Spinach Squash Sweetpotato

O5 1.31 48

O3 97 O2 .24

Tomato

O5

Turnip

.21

Turnip greens

O5

Watercress

31

US 6,407,141 B1 57

58

TABLE II

TABLE II-continued

Oxalic Acid Contents of Foods

Oxalic Acid Contents of Foods

Oxalic acid Method of Food

Preparation

Oxalic acid

(mg/100 g of fresh material)

Method of

Vegetables Asparagus

1.7 7.2-618 96.8-121.0 2.1-3.6 0.6-2.0 7.4-22.7 1.1 13.0-17.5 1.1 1.7-2.7 0.5 2.O 3.0 166.O 0.8-1.3 2.3-7.1 O.3 260-62O 356-78O 5.3 O.8

Bean, runner Beet root

Brussels sprouts Cabbage Carrot Cauliflower

Celery Chive Lettuce Marrow Mushroom Onion

Parsley Pea, green Potato Radish Rhubarb

Spinach Tomato

Turnip

Food

Preparation

Bread, white Bread, Allinson's Cake, fruit

Fresh Fresh

Fresh Cooked Cooked

Oatmeal porridge Rice pudding 15 Chocolate

Cadbury's plain Cadbury's milk Beverages

123.5 56.2

Draught Draught Draught

Beer, mild Beer, bitter

Beer (Double Diamond) Beer (Double Diamond) Beer (Guinness) Beer (Guinness) Cocoa (Rowntrees)

Bottled

Draught Bottled Powder Canned

25 Coca Cola

2 g per 100 ml,

Coffee, infusion

4.4 g per 100 ml, 1.5 2.8 O.7 2.6 0.0-6.6 2.7 6.2 1.2-3.7 1.3-1.7 O.O-3.7 1.1-3.4 2.2 1.9-11.5

Melon

Orange Peach Pear

Pineapple Plum

Raspberry Strawberry

Coffee essence (Camp) Coffee (Nescafe) Dandelion coffee Horlicks

35

Lager (Skol) Lemon squash (Robertson's) Lucozade Orange squash (Robertson's)

Draught

Ovaltine Oxo cubes

Powder

Tea, leaves Tea, infusion

0.5 9.4 4.5-10.8

Marmalade Meat

Fresh, dried

O.6-3.3 O.2 O.2 O3-19 0.4-1.6 1.6-5.1 3.6-7.1 1.6 1.7

Chicken (Fray Bentos) Oxtail (Fray Bentos) Dairy products

Heated Heated

3.0 1.O

Butter

Fresh Fresh Boiled Fresh Fresh

Kidney

Milk, cow

2.0 g per 100 ml,

11.5-16.1

infused 10 min.

2.0 g per 100 ml,

45

126-17.2

infused 15 min.

Wine, Beaujolais

3.1

Expressed as the anhydrous acid (COOH). From Oxalic Acid in Biology and Medicine, Pgs.196-199. 50

Oxalate Content of Foods per 100 GM. EDIBLE PORTION 55

Boiled Boiled Canned

OXALATE mg.

Cereal and Cereal Products

60

Bread, white Cake, fruit

Cake, sponge Cornflakes

Crackers, soybean Egg noodle (chow mein) Grits (white corn)

O.2 O.3 1.6–4.8

65

Biscuits (Marie)

10.1-14.5

infused 5 min.

TABLE III

Fish Haddock Plaice Sardines Cereals

7.O-10.8

infused 2 min.

FOOD

Cheese, Cheshire

4.6

2.0 g per 100 ml,

40

Soups

Eggs, whole Margarine

375-1450

1 g per 100 ml,

2.0 g per 100 ml, Fried Roasted Fresh Roasted Steamed Braised Braised Roasted Roasted

Liver Mutton Pork

57.O-23O.O 25.0 4.1 O6 1.5 O1 1.2 45.9 1.6

infused 2 min.

Jam, red plum Jam, strawberry

Beef, corned

7.3

infused 13 min. Undiluted Powder Powder Powder

Preserves

Chicken Ham

0.9-1.6 O.9-1.9 O.8 1.9-2.0 1.4 2.8-3.9 623.O 1.12 1.O

infused 5 min.

Apple Apricot Banana, ripe Gooseberry Grapefruit

Beef

4.9-8.6 15.8-26.3 11.8 7.4 4.4-5.6 9.1 1.O O.O

Cake, sponge

Cornflakes Corn cob

Fruit

Bacon, streaky

(mg/100 g of fresh material)

4.5-13.8

Macaroni, boiled

Oatmeal, porridge Spaghetti, boiled

4.9 11.8 7.4 2.O 2O7.O 1.O 41.O 1.O 1.O 1.5

US 6,407,141 B1 59

60

TABLE III-continued

TABLE III-continued

Oxalate Content of Foods per 100 GM. EDIBLE PORTION

Oxalate Content of Foods per 100 GM. EDIBLE PORTION

FOOD

Spaghetti in tomato sauce Wheat germ

OXALATE mg.

5 FOOD

4.0

Banana, raw

269.O

Milk and Milk Products 1O Butter

O.O

Cheese, cheddar

O.O O.O O.15

Margarine

Milk

Meats and Eggs 15

Bacon, streaky fried

3.3

Berries: Black Blue Dew

Green goose Raspberries, black Raspberries, red Strawberries, canned Strawberries, raw

O.O

Bing

Beef, topside roast

O.O O.O O.O

Sour Currants: Black Red

Eggs, boiled Fish: Haddock Plaice Sardines Ham

Hamburger, grilled Lamb, roast

O.2 O.3

2O

Fruit salad, canned Grapes:

4.8

Concord

1.6

Thompson, seedless

O.O trace

Liver

7.1

Pork, roast

1.7

trace

18.0 15.O 14.O 88.0 53.0 15.O 15.O 1O.O

Cherries:

Beef, canned corned Chicken, roast

OXALATE mg.

Lemon Peel Lime Peel

25

Mangoes

O.O 1.1 4.3 19.O 12.O

25.0 O.O 83.O 11.O.O O.O

Melons:

Vegetables

Cantaloupe Casaba

Asparagus Beans, green boiled Beans in tomato sauce

5.2 15.O 19.O

Honeydew 3O

Watermelon Nectarines

Beet root, boiled

675.O

Orange, raw

Beet root, pickled

SOO.O

Peaches:

Broccoli, boiled

trace

Alberta

Brussels sprouts, boiled Cabbage, boiled

O.O

canned

Carrots, canned Cauliflower, boiled

4.0 1.O

Celery

Chard, Swiss Chive Collards

Corn, yellow Cucumber, raw

Dandelion greens Eggplant Escarole Kale Leek Lettuce Lima beans Mushrooms

Mustard greens Okra

Onion, boiled

O.O 2O.O

Bartlett, canned

Pineapple, canned

1.1 74.O

5.2 1.O

Rutabagas Spinach, boiled Spinach, frozen Squash, summer

Tomatoes, raw

Turnips, boiled Watercress, early fine curled

Red plum jam Strawberry jam Prunes, Italian 45

4.3

Apples, raw Apricots

0.5 9.4 5.8

Rhubarb: canned

stewed, no sugar

2.O 7.7

Nuts

146.0

Peanuts, roasted

3.0

Pecans

50

187.O 2O2.O

Confectionery

1O.O

Chocolate, plain Jelly, with allowed fruit

476.O

Marmalade

O.O 56.O

Sweets, boiled (plain candies) 55

117.O O.O 10.8 O.O

Beverages, Non-alcoholic

O.3

O.O

Barley water, bottled

19.O

Coca-Cola

75O.O 6OOO 22.0

2.O 1.O

Coffee (0.5 g Nescafe/100 ml) Lemon Squash drink (lemonade) 60

1O.O

Lucozade, bottled (soda)

Orange Squash drink (orangeade) Ovaltine drink, 2 gm in 100 ml Pepsi-Coia

Fruits

Avocado

Golden gage Greengage Preserves:

13.0 89.0 3.0

1.O 16.O

Rice, boiled

40

18.0 31.0

Peas, canned Pepper, green

Radishes

Plums: Damson

24.6

1OO.O

Potatoes, white boiled Potatoes, sweet

Stokes Pears:

645.O

Parsley, raw Parsnips

Pokeweed

Hiley 35

5.0 1.2 O.O 1.2 3.0 1.7 1.O

Ribena, concentrate

O.O trace

3.2 1.O O.O 2.5 1O.O trace

2.O

(black currant drink) 3.0 2.8 O.O

Tea, Indian: 65

2 min.intusicn 4 min.infusion

55.0 72.O

US 6,407,141 B1 TABLE III-continued

TABLE IV

Oxalate Content of Foods per 100 GM. EDIBLE PORTION

Concentrations of Oxalic acid, calcium and magnesium in foods 5

OXALATE

FOOD

Oxalic Acid

mg. -w

6 min.infusion

Tea, rosehip

Food

4.0

wt)

wt)

Cabbage

O.11

16.2

8.5

Cauliflower Onion 15 Potato Lettuce Rhubarb Beet root Spinach

O.12 O.33 O.25 O.19 28.9 13.5 86.6

5.9 7.1 2.2 6.5 3.1 4.7 27.7

6.4 4.8

10 Vegetables o

trace 6.6 5.8 O.O 0.5

O

Beverages, alcoholic

Lager draft, Tuborg Pilsner Stout, Guiness Draft Cider Sherry, dry

O.O 1.O

Rose White Miscellaneous

Apple

0.17

O.85

2.05

O

O.69

0.87

5.70

O.19 O.38 O.21 0.59

1.O 3.57 4.10 2.50

1.85 3.33 4.73 4.11

O.04 O.O2 O.OOS

1.92 4.22 28.7

11.7 11.6 4.3

range

4.0 2.O O.O trace

25 Pear Plum

trace

3O

Strawberry Tomato

Wine: Port

4.1 4.0 15.5 31.6

2O Fruit

Beer:

bottled draft

Magnesiutn

wt)

78.0

Juices

Apple juice Cranberry juice Grape juice Grapefruit juice Orange juice Pineapple juice Tomato juice

Calcium

(mmol/kg fresh (mmol/kg fresh (mmol/kg fresh

Meat, fish and dairy products 1.5 O.O

Beef, roasted Fish (haddock) Milk (cow) Cereals

Cocoa, dry powder Coffee powder (Nescafe) Chicken noodle soup

Lemon juice Lime juice Ovaline, powder canned Oxtail soup

Pepper Tomato soup Vegetable soup

623.O 33.O

35 Bread, white

O.54

27.0

1O.O

1.O

Cornflakes

O.62

2.2

14.8

1.O O.O 35.O 1.O

Beverayes

5.1

31.5

13.6

40 Ovaltine, powder Tea (1 g/100 ml,

419.0

infused for 2 min)

3.0 5.0

Tea (1.5 g/100 ml,

O.51

O.O7

O.25

O.92

O.13

1.03

infused for 6 min)

From: Krause & Mahen, Food, Nutritient Diet Therapy, 7th ed., 1984, W. B. Saunders, Phila.

45

Zarembski and Hodgkinson (1962b).

TABLE V

Dietary intake of Oxalate by man and animals

Oxalic acid (anhydrous) mg/kg day Description

Mean

Range

Mean Range

Reference

British

92O

British

97

850-980

12.3

10.1-13.6

Archer et al. (1957a)

70-150

1.4

1.0-2.1

Man

Zarembski and

Hodgkinson (1962b) British Indian on

1394

145-175

-

Anderson et al. (1971) Singh et al. (1972)

77.8

Singh et al. (1972)

2045.0 -

Singh et al. (1972)

hospital diet Indian on common rural diet

Indian on seasonal rural diet

US 6,407,141 B1 63

64

TABLE V-continued

Dietary intake of Oxalate by man and animals

Oxalic acid (anhydrous) mg/kg day Description

Mean

Indian on urban diet,

168.5

Singh et al. (1972)

606.4

Singh et al. (1972)

Range

Mean Range

lower income group Indian on urban diet,

upper income group

Reference

Sheep

260-450 2160

317-73.5

Dhar and Kaul (1973) Brune (1955)

Cow (Heifer)

5000 6O7OO

243-286

Talapatra et al. (1942)

Indian from Kashmir

Talapatra et al. (1942)

71500 Rat

Wistar (300 g)

14-28

46-92

Sand rat (200 g)

300-500

1SOO-2SOO

Hodgkinson (unpublished results) Shirley and Schmidt Nielsen (1967)

*Oxalic Acid in Biology and Medicine, pg. 160. 25

TABLE VI

TABLE VI-continued

Some recent estimates of the concentration of Oxalic acid in human and aniinal blood

Some recent estimates of the concentration of Oxalic acid in human and aniinal blood

Oxalic acid

Oxalic acid

(ug anhydrous acid/100 ml)

(ug anhydrous acid/100 ml) 35

Analytical method

Mean

Range

Reference

Man

Fluorimetry

146.0 169.O

1OO-235 127-25.4° 150-480

Fluorimetry

256.O

Chemical kinetics

124.0

Enzymic Decarboxylation Enzymic decarboxylation Ion exchange and colorimetry

118.0

80-140

1304

73-199b.c 136-465b-e

2611

Analytical method

Mean

Range

Reference

I'Coxalic acid 'Cloxalic acid

16.5 13.0

11.8-14.3

Williams et al. (1971) Hodgkinson and Wilkinson (1974)

Hodgkinson and Zarembski 40 Sheep (1968) Endo (1969) I'Coxalic acid

52.6-74.4

Eswara-Dutt and Mottola

117-250a

(1974) Knowles and Hodgkinson (1972) Hatch et al. (1977)

McIntosh and Belling (1975)

45

*Oxalic Acid In Biology and Medicine, pg. 174. Plasma

Serum Whole blood

Krugers Dagneaux

50

Male Female

et al. (1976)

TABLE VII

Vitamin B-6 (Pyridoxine) Content of Pork and Pork Products Cooked Pork

Raw

Composite of Retail Cuts

.445

All Lean and Fat

Leg, Loin & Shoulder Composite of Retail Cuts

508

All Lean and Fat

Leg (Ham) Whole Lean and Fat

Leg (Ham) Whole Lean Only

SOO

Cooked

Broiled/Braised Roasted

Cooked Pan Fried

US 6,407,141 B1 65

66

TABLE VII-continued

Vitamin B-6 (Pyridoxine) Content of Pork and Pork Products Pork

Raw

Cooked Cooked Broiled/Braised Roasted

Loin Whole Lean and Fat Loin Whole

.472

460

.382

527

492

.404

Cooked Pan Fried

Lean Only Back Ribs Lean and Fat

.395

Loin Chops

370

3O7

.297 (braised)

Lean and Fat

.337

.381 (broiled)

Bacon Cured

.14

Canadian Style, Bacon

.38 (unheated) .45

27

Unheated

Ham, Boneless

Extra Lean & Regular Ham, Boneless (11% Fat) Extra Lean and Regular

.38 (unheated)

35

.34 (unheated)

31

Source: U.S. Department of Agriculture Agriculture Handbook 8-10 Rev. 1992 TABLE VIII

Vitamin B-6 (Pyridoxine) Content of Beef and Beef Products All Grades

Good

Choice

Prime

Beef

Raw

Cooked Raw

Cooked Raw

Cooked Raw

Choice

Composite Retail

36

.31

37

.32

36

31

34

.29

43

38

44

.38

43

38

43

38

Cuts Lean and Fat

Composite Retail Cuts

Lean Only Beef

Raw

Roasted

Broiled

Large Ribs

28

22

26

Rib-Eye Small Ribs

38

32

36

Lean and Fat Whole Prime Ribs Lean and Fat

30

25

29

Lean and Fat

Beef

Mg/100 Grams

Beef Cured Frankfurter

.12

Lebanon Bologna

.24

Pastrami

18

Sausage Cooked and Smoked

.11

Beef Cured and Corned Liver Pan Fried

13 1.43

Kidney Cooked

52

Ground Lean Fried Ground Lean Baked

28 2O

Source: U.S Department of Agriculture Agriculture Handbook 8-13 1986 55

TABLE IX

TABLE IX-continued

Vitamin B-6 (Pyridoxine) Content of Veal and Lamb

Vitamin B-6 (Pyridoxine) Content of Veal and Lamb 60

Meat

Raw

Cooked

Veal

.41

31

13

13

All Retail Cuts Lean and Fat Lamb All Retail Cuts Lean and Fat

Meat

Raw

Cooked

Lamb All Retail Cuts Lean

.16

.16

05 Source: USDA Department of Agriculture Agriculture Handbook 8-17 1989

US 6,407,141 B1 67

68

TABLE X

VITAMIN B-6 (PYRIDOXINE) CONTENT OF CHICKEN Fried Batter- Fried Flour

Chicken

Raw

Dipped

Dipped

Roasted

Stewed

Broilers or Fryers

34

32

.42

38

22

43

48

53

47

26

48

39

54

52

27

54

63

.65

60

26

25

25

32

31

17

26

26

.33

31

17

Broiler and Fryers

29

27

34

33

18

Leg with Skin Ground Turkey

35

.39 (Cooked)

All Meat with Skin

Broilers or Fryers

All Meat Flesh Only Broilers or Fryers

Light Meat with Skin Broilers or Fryers

Light Meat Flesh. Only Broilers and Fryers Dark Meat with Skin

Broiler and Fryers

Thigh with Skin

Source: U.S. Department of Agriculture Agriculture Handbook 8-5-1976

TABLE XI

25

TABLE XI-continued

VITAMIN B-6 (PYRIDOXINE) CONTENT OF

VITAMIN B-6 (PYRIDOXINE) CONTENT OF

SELECTED BAKED GOODS

SELECTED BAKED GOODS 3O

Breads

Bagels: Plain, Onion, Poppy

Mg/100 G

Breads

O51

Seed, Sesame s

Mg/100 G

Italian Bread

.048

Mixed Grains 7 Bread

.333

OOO

35

Bagels, Date Bran

OOO

Oat Bran Bread

Bagels, Egg

O84

Pumpernickel

126

Bagels, Cinnamon Raisin

OOO

Rye Bread

O75

Biscuits, Commercially Baked

O47

Wheat Bran Bread

O64

Whole Wheat Commercial Bread

179

40

Plain or Buttermilk Cornbread

113

Cracked Wheat Bread

3O4

French and Vienna Bread

O43

Source: U.S. Department of Agriculture Agriculture Handbook 8-18 Rev 1992

TABLE XII

Dry Dog Food, Test Run Data E325 Processing Conditions: Run #1 Product Dry Dog Food

Feeder Speed (RPM)

11 rpm (420 lbs/hr)

Feeder Speed (Hertz) Cond. Cyl. Temp (F)

34.7 2O6

Cond. Cyl. Water (% gauge) 10 Extruder Speed (RPM) Extruder Current (Amps) Extruder Water (% gauge) Extruder Steam Injection

421 24 O O

#2 Head Temp. (CW or ST) #3 Head Temp. (CW or ST) #4 Head Temp. (CW or ST) #5 Head Temp. (F) #6 Head Temp. (F)

CW CW CW CW 79 deg F CW 129 deg F

Die Pressure (PSI) Knife Speed (Hertz)

350 55.9

Comment

US 6,407,141 B1 69

70

TABLE XII-continued

Dry Dog Food, Test Run Data E325 Processing Conditions: Dryer Temperature (F) Dryer Retention (minutes) Formula:

Run #1 223 17.9 See Dry Feed formula

Comment 2.7i OA to 100+ water

2.2% Oxalic acid solution

added at 0.7 lbs/min Comments:

The oxalic acid solution

was made up in hot water (160 F) and pumped into the conditioning cylinder Screw Configuration: #1 Screw

Single Flight Tapered Inlet

#1 Steamlock

Spacer

#2 Screw

Single Flight Uncut

#2 Steamlock

Spacer

Straight Rib Head Spiral Rib Head

#3 Screw

Single Flight Uncut

#3 Steamlock

Spacer

Spiral Rib Head

#4 Screw

Single to Double Flight Uncut Straight Rib Head

#4 Steamlock

Small

#5 Screw

2 Flight cut flight

#5 Steamlock

Large

#6 Screw

2 Flight cut flight cone

Straight Rib Head

Spiral Rib Cone Head

Die Configuration: Spacer

1" thick

Backup Die

No

Dieplate

1/4" central insert die

#825440-3

Insert

/4" round hole

#101-509

I claim:

1. A hemotherapeutic chemopreventative composition for treating vascular diseases of at least one of arteriosclerosis, atheroslerosis, endocarditis, treating plaque, fatty buildup,

35

microbial infections, and calcerous conditions, in the car

diovascular System, or the brain, and maintaining good cardiovascular health in patients Sensitive to treatment com prising a composition having an effective amount of at least one therapeutically effective form of at least one of Oxalic

40

acid and oxalate and at least one of a carrier and diluent for

Said at least one of Oxalic acid and oxalate, wherein Said

effective amount is less than a lethal dosage of Oxalic acid and oxalate wherein Said hemotherapeutic composition is adapted to be administered to patients on a periodic basis in less than a lethal dosage. 2. The composition as recited in claim 1 wherein Said therapeutically effective form of at least one of Oxalic acid and oxalate is Selected from the group of Oxalic acid in a free

45

50

acid, ester, lactone, and Salt form.

3. The composition as recited in claim 1 wherein Said therapeutically effective form of at least one of Oxalic acid and oxalate is Selected from the group of natural foods, processed foods, molds, plants, vegetables and beverages, juices, and liquids containing an effective amount of at least one therapeutically effective form of at least one of Oxalic

55

distilled water, Saline Solution, gel cap, tablet, powder, drops, liquid, pill, capsule, lozenge, cough drops, transder mal patch, rinse, mouthwash, food additive, beverage, and gel for periodically administering a therapeutically effective dosage of at least one of topically, orally, nasally, parenteral, intravenously, and Subcutaneously in less than a lethal dosage. 7. The method of producing the hemotherapeutic compo Sition as recited in claim 5 comprising the Steps of mixing at least one therapeutically effective form of Oxalic acid wherein Said acid is Oxalic acid dihydrate which is dissolved in distilled water to produce at least one of a mixture of a mixture, Solution, rinse, mouthwash, mouth rinse, and wash adapted for periodically administering a hemotherapeuti cally effective dosage of at least one of topically, orally, nasally, parenterally, intravenously and Subcutaneously in less than a lethal dosage. 8. A method of treating vascular diseases, plaque, micro bial infections, fatty buildup, and calcification in patients Sensitive to treatment comprising the Steps of periodically administering a therapeutically effective dosage of the hemotherapeutic composition of claim 1. 9. The method as recited in claim 8 wherein said hemo

therapeutic composition is administered by at least one of orally and Sublingually.

acid and oxalate.

4. The composition as recited in claim 1 wherein Said therapeutically effective oxalic acid, oxalate composition is Selected from a natural food or beverage Source of at least one of Oxalic acid, and oxalate. 5. The hemotherapeutic composition as recited in claim 1, wherein Said composition is Oxalic acid dehydrate and at least one of a carrier and diluent. 6. The hemotherapeutic composition for treating vascular disease, fatty buildup, microbial infections, and calcerous

conditions as recited in claim 1 wherein Said at least one of

60

10. The method as recited in claim 8 wherein said

hemotherapeutic composition is administered by injection. 11. The method as recited in claim 8 wherein said

hemotherapeutic composition is administered topically. 12. The method as recited in claim 8 wherein said 65

hemotherapeutic composition is administered internally. 13. The method as recited in claim 8 wherein said

hemotherapeutic composition is administered at least once a

US 6,407,141 B1 71

72

day at a dosage of at least one of up to 8 grams for humans and up to 4 grams for warm blooded animals other than

19. The method as recited in claim 17 further comprising the Steps of reducing the intake of Oxalic acid or oxalate blockerS Selected from at least one of dairy products con taining calcium, beverages containing alcohol, ascorbic acid

humans.

14. A method for treating diseases of the vascular System, and the brain in patients Sensitive to treatment comprising of 5 (vitamin C), citric acid, pyridoxine hydrochloride (vitamin the Steps of adding to the regular diet a dietary Supplement B6), foods containing calcium, ascorbic acid or citric acid, having an effective amount less than a lethal dose of at least red meat, or white meat of fowl containing pyridoxine one hemotherapeutic form of at least one of Oxalic acid and hydrochloride, and foods, beverages, or nutritional Supple oxalate in less than a lethal dosage. ments containing oxalic acid or oxalate blockers. 15. The method as recited in claim 14 wherein said 20. A method for treating vascular diseases, plaque, hemotherapeutic effective form of at least one of Oxalic acid microbial infections, fatty buildup, and calcerous conditions and oxalate is Selected from the group of Oxalic acid in a free of the vascular System and the brain in patients Sensitive to acid, ester, lactone, or Salt form. treatment comprising the Steps of reducing or eliminating 16. The method as recited in claim 14 wherein said at least one of Oxalic acid and oxalate is administered at least once 15 the ingestion or administration of Oxalic acid or oxalate a day at a dosage of at least of up to 8 grams for humans and blockers, administering or ingesting high dosages in leSS than a lethal dosage of at least one of Oxalic acid and oxalate up to 4 grams for warm-blooded animals other than humans. to raise the blood or urine oxalic or oxalate level above 17. The method as recited in claim 14 further comprising the Steps of reducing the intake of Oxalic acid or oxalate normal, and, after cleansing the blood of diseases and other conditions administering or ingesting a more moderate level blockers. 18. The method as recited in claim 17 wherein said

blockers are Selected from the group of citric acid, ascorbic acid, pyridoxine, calcium, alcohol, resins, clays, and com binations thereof.

of at least one of Oxalic acid and oxalate to maintain a normal blood or urine level of Oxalic acid or oxalate.