Drug – bio-affecting and body treating compositions – Inorganic active ingredient containing – Heavy metal or compound thereof
Reexamination Certificate
2000-04-13
2002-03-26
Jones, Dwayne C. (Department: 1614)
Drug, bio-affecting and body treating compositions
Inorganic active ingredient containing
Heavy metal or compound thereof
C424S641000, C424S655000, C424S669000, C424S677000, C424S702000
Reexamination Certificate
active
06361800
ABSTRACT:
BACKGROUND OF THE INVENTION
This invention relates to multi-vitamin and mineral supplements. In particular, this invention relates to multi-vitamin and mineral supplements for improving health by insuring adequate intake of micronutrients needed for disease prevention and protection against nutritional losses and deficiencies due to such factors as lifestyle patterns and common inadequate dietary patterns.
Vitamin and mineral preparations are commonly administered to treat specific medical conditions or as general nutritional supplements. Micronutrients are elements or compounds which are present in foods in small or trace amounts and includes vitamins, minerals, or other elements, and compounds found in foods for which a Recommended Daily Allowance (RDA) has not yet been determined. The macronutrients consist of carbohydrates, fats, and proteins which supply nutrients and calories. Some elements such as calcium, sodium, potassium, chloride, and phosphorus are consumed in relatively large amounts, while many such as iron, iodine, and zinc are consumed in small amounts. vitamins such as B12 and folic acid and the minerals cooper, selenium, and chromium are consumed in very small or trace amounts. In as much as the human body does not synthesize many compounds which are essential to the human body, these specific vitamins and minerals can be obtained from only two sources: food and supplements. The primary source of all nutrients is food. However, the majority of people do not meet the RDA of the foods containing these essential compounds and elements. Thus vitamin and mineral supplementation has become a recognized method of meeting accepted medical and health standards.
An international panel of diet and cancer experts announced in London on Sep. 30, 1997, that as many as 30 to 40 percent of all cancer cases worldwide—3 to 4 million a year—could be avoided if people ate a healthy diet and got enough exercise.
USA Today
, Oct. 1, 1997. However, for some nutrients, the amounts proposed as being healthy apparently cannot be provided by a reasonable quantity and variety of natural foods. Thus nutrient supplements may be important for health promotion and prevention of chronic diseases.
Journal of the American Medical Association
, May 7, 1997.
Recent studies have illustrated the important physiological roles played by vitamins and minerals and established a correlation between deficiencies or excesses of these nutrients and the etiologies of certain disease states in humans. Homocysteine is a homolog of cysteine and is produced by the demetbylation of methionine, and is an intermediate in the biosynthesis of cysteine from methionine via cystathionine. Homocysteine is being referred to as the “cholesterol of the 21
st
century.” Homocysteine is not inherently bad, as it is a necessary by-product in the break down of the essential amino acid methionine, which is found primarily in red meat and diary products. However, as with cholesterol, homocysteine may get out of balance as a result of genetics or poor diet. The main concern is having too much homocysteine.
As stated in the
Journal of the American Medical Association
, “A high level of homocysteine confers a risk of vascular disease similar to that of cigarette smoking, elevated cholesterol, and other blood lipids. Also, it increases the risk associated with smoking and high blood pressure.”
Journal of the American Medical Association
, Jun. 11, 1997. Elevated blood levels of homocysteine increase the risk of atherosclerosis, a clogging of the arteries that is the main factor in the majority of heart attacks and strokes. Elevated homocysteine levels are found in 25% of heart attack patients, 40% of stroke patients, and may also be associated with Alzheimer's disease.
It has recently been discovered that folic acid, when combined with vitamins B6 and B12, has the potential of dramatically lower the homocysteine levels, thereby protecting against high homocysteine-related diseases.
Journal of the American Medical Association
, Oct. 4, 1995.
Coronary artery disease is one of the major causes of heart attacks and occurs when there is atherosclerosis in the vital coronary arteries, which supply the nutrient rich blood to the interior of the heart muscle. High levels of LDL cholesterol have been linked to the development of atherosclerosis in the coronary arteries. However, free radicals have received more attention as the culprit of the disease. It appears that clogging occurs after the LDL cholesterol is oxidized within the wall of the blood vessel by exposure to free radicals. The white blood cells attempt to remove the damaged LDL cholesterol by engulfing them. Unfortunately, after ingesting the LDL cholesterol, the cells cannot rid themselves of the cholesterol portion and swell up, thus the process of atherosclerosis (thickening of the artery wall and narrowing of the coronary arteries) begins. Therefore, it is not the LDL cholesterol that blocks the artery, but the oxidized LDL that has been engulfed by the white blood cells that actually causes the damage.
Free radicals may be activated by factors such as cigarette smoke, pollution, excessive exercise, and other stressors. The LDL cholesterol can fight these free radicals with antioxidants such as vitamins C and E, but before long the LDL's antioxidants are depleted and the LDL is left defenseless. It has been discovered that 1000 mg of vitamin C coupled with 1000 I.U. of vitamin E (d-alpha tocopherol) taken in conjunction with a 900-calorie meal containing 50 grams of fat blocked the detrimental effects of a fatty meal on blood circulation.
Journal of the American Medical Association
, Nov. 26, 1997. In addition, it has been discovered that 100 I.U. of vitamin E supplements taken for two years or longer reduced deaths of coronary artery disease by 40% in 87,245 nurses and by 37% in 39,910 male health professionals.
New England Journal of Medicine
, May 20, 1993.
There exists a need for a nutritional supplement which supplies the right amount of the right micronutrients at the right time to assure adequate intake of micronutrients needed for disease prevention and protection against nutritional losses and deficiencies due to lifestyle factors and common inadequate dietary patterns.
SUMMARY OF THE INVENTION
In accordance with the present invention, there is provided a multi-vitamin and mineral supplement which supplies the right amount of the right micronutrients at the right time to assure adequate intake of micronutrients needed for disease prevention and protection against nutritional losses and deficiencies due to lifestyle factors and common inadequate dietary patterns.
Further, in accordance with the present invention, there is provided a new and improved multi-vitamin and mineral supplement which can be used for providing the necessary nutrients to allow the users of such supplement to maintain their present health and positively influence their future health.
Still further in accordance with the present invention, there is provided a multi-vitamin and mineral supplement wherein the supplement is comprised of about 5000 I.U. of vitamin A; about 1000 mg of vitamin C; about 400 I.U. of vitamin D; about 400 I.U. of vitamin E; about 25 mg of vitamin K; about 3 mg of vitamin B1; about 10 mg of vitamin B2; about 20 mg of niacinamide; about 50 mg of vitamin B6; about 800 mcg of folic acid; about 400 mcg of vitamin B12; about 300 mcg of biotin; about 10 mg of pantothenic acid; about 18 mg of iron dosed in the form of a pharmaceutically acceptable iron compound; dosed in the form of a pharmaceutically acceptable phosphorus compound; about 150 mcg of iodine dosed in the form of a pharmaceutically acceptable iodine compound; about 400 mg of magnesium dosed in the form of a pharmaceutically acceptable magnesium compound; about 15 mg of zinc dosed in the form of a pharmaceutically acceptable zinc compound; about 100 mcg of selenium; about 2 mg of copper dosed in the form of a pharmaceutically acceptable copper compound; about 65 mcg of chromium dosed in the form of a
Cooper Kenneth H.
Grundy Scott Montgomery
Jialal Ishwarlal
Selhub Jacob
Willett Walter Churchill
Arter & Hadden LLP
Cooper Concepts, Inc.
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