Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Food or edible as carrier for pharmaceutical
Reexamination Certificate
2001-07-02
2002-08-20
Pak, John (Department: 1616)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Food or edible as carrier for pharmaceutical
Reexamination Certificate
active
06436431
ABSTRACT:
BACKGROUND OF THE INVENTION
This invention relates to a fortified food product which can be used as a dietary supplement or as an added ingredient for fortifying various food components. More particularly, this invention relates to a fortified rice bran food product that is capable of preventing and/or treating cardiovascular disease including, e.g., hypertension. In addition, this invention relates to a method of preventing and/or treating cardiovascular disease involving oral ingestion of the food product of this invention.
Cardiovascular disease is a major health issue in the United States. Several compositions and methods have been developed over the years in an attempt to prevent or treat this disease.
U.S. Pat. No. 6,126,943 (Cheruvanky et al.) discloses a method for reducing mammalian serum total cholesterol, LDL cholesterol, apolipoprotein B and triglyceride levels, by ingesting a stabilized rice bran derivative selected from the group consisting of an enzyme treated stabilized rice bran, an insolubilized fraction and mixtures thereof. The patent teaches that the rice bran used therein is rich in B-complex vitamins, vitamin E and its isomers, minerals like potassium, magnesium, and phosphorous, and several potent antioxidants.
U.S. Pat. No. 5,962,062 (Carrie, et al.) discloses a dietetically balanced milk product containing a lipid mixture based on a combination of milk fats and vegetable oils formulated so as to obtain an optimum balance of active substances in order to prevent unbalanced metabolic charges, in particular cardiovascular risks, and so that its organoleptic properties are close to those of milk. The lipid mixture may contain fatty acid oils such as EPA and DHA. The composition may also contain oils rich in vitamin E, oils rich in non-vitamin antioxidants (e.g., rice bran oil). The milk product may also be enriched with vitamins, e.g., E, A, D, C, B
6
, B
12
, folate and trace elements, e.g., iron, magnesium, and zinc.
U.S. Pat. No. 5,948,443 (Riley, et al.) discloses a total modular system of multivitamin and mineral supplementation composed of seven distinct modules for improving public health by insuring adequate intake of micronutrients needed for disease prevention and protection against nutritional losses and deficiencies. Module
4
contains aspirin or the like and is directed primarily for persons known to be at risk of coronary heart disease. The patent teaches that specific antioxidant micronutrients such as vitamins C, E, beta-carotene, selenium, copper, manganese, magnesium, folic acid, vitamin B
6
, and vitamin B
12
enhance aspirin's ability to reduce risk of coronary heart disease.
WO 91/17670 discloses a foodstuff which is said to have prophylactic and/or curative effects and is suitable for use in the prevention and/or cure for diseases such as cardiovascular disease and cancer. The foodstuff is composed of at least one combination of at least polyunsaturated omega-3 fatty acid and/or its esters and one or more vitamins and pro-vitamins. The omega-3 fatty acid is preferably eicosapentaenoic acid (EPA) and/or docosahexaenoic acid (DHA) or their esters. The vitamin component is preferably made up of beta-carotene, vitamin C and vitamin E.
EP 0699437 discloses pharmaceutical preparations containing polyunsaturated fatty acids (e.g., EPA and DHA), their esters or salts, together with antioxidant vitamins or provitamins (e.g., vitamins E, A and C and carotenes, wherein the preparations are said to be useful in the prevention and/or treatment of atherosclerosis and of cardiovascular, nervous system, skin and malignant pathologies.
U.S. Pat. No. 6,210,686 (Bell et al.) discloses a dietary supplement and method for lowering risk of heart disease, wherein the supplement includes yeast fiber, folic acid or a salt thereof, vitamin B
6
, vitamin B
12
, and vitamin E. Optionally, the supplement may contain one or a combination of other vitamins (e.g., niacinamide, vitamin C), minerals, antioxidants, fibers and other dietary supplements (e.g., protein, amino acids, choline, lecithin, omega-3 fatty acids). The patent to Bell et al. teaches that, due to the presence of folate and vitamin B
6
, the dietary supplement provides a second benefit of suppressing the level of homocysteine in the blood. The supplement provides a third benefit due to the presence of vitamin E which, according to the patent, preserves low density lipoproteins from oxidation.
U.S. Pat. No. 5,952,393 (Sorkin, Jr.) discloses a composition for reducing serum cholesterol in humans and animals, wherein the composition includes phytosterol and policosanol which together produce a synergistic effect in lowering serum cholesterol levels. The patent teaches that the policosanol used in the preferred embodiment of the invention is obtained from rice bran wax.
U.S. Pat. No. 6,180,660 (Whitney et al.) discloses a method for reducing or preventing the risk of first occurrence of a cardiovascular event in a subject having an average to mildly elevated level of LDL cholesterol and below average high-density lipoprotein ML) cholesterol, with no clinical evidence of coronary heart disease, comprising administering a prophylactically effective amount of a lipid altering agent such as a 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor alone or in combination with another lipid altering agent such as a fibrate, or niacin, to the subject. The active ingredients used in the method can be administered in oral forms such as tablets, capsules, pills, powders, granules, elixirs, tinctures, suspensions, syrups and emulsions.
Studies have shown that folic acid and vitamin B
6
, taken in excess of recommended daily allowance, reduce the risk for developing heart disease by reducing levels of homocysteine. Homocysteine is associated with arterial occlusive disease.
Rice bran in and of itself has been considered for several years as an ingredient for food use because of the health benefits derived from its consumption. The bran as a by-product of rice milling has been used in the feed industry for many years, but with advanced techniques has only been recently considered as a food for human consumption. The nature of the bran is such that the remaining rice oils become rapidly oxidized so as to render it unacceptable for food. New and advanced techniques for stabilizing rice bran in the past ten years have altered its perception as an acceptable food grade product.
Several components of rice bran are desirable for the human diet. Rice bran protein has a high nutritional value that is highly digestible and is hypoallergenic. The proximate composition of stabilized, parboiled, defatted rice bran as stated in Saunders, R. M., “The Properties of Rice Bran as a Foodstuff”,
Cereal Foods World,
35:632 (1990), is as follows: moisture—6 to 9%, protein—23 to 27%; fat—0.5 to 1.5%, crude fiber—16 to 20%, and ash—11 to 14%. The fatty acid composition of the rice bran oil consists mainly of oleic, palmitic, and linoleic acids. In addition to the fatty acids, naturally occurring vitamins and minerals are present in varying amounts depending on growing conditions and milling methods. Vitamins and minerals present include vitamin A, thiamine, riboflavin, niacin, pyridoxine, panothenic acid, biotin, myoinositol, choline, para-aminobenzoic acid, folic acid, vitamin B
12
, vitamin E, calcium, iron, magnesium, manganese, phosphorus, potassium and zinc. The major carbohydrates present are cellulose, hemicelluloses (pentosans), and starch. Beta-glucans are also present, forming part of the dietary fiber complex. Total dietary fiber content ranges from about 44% to about 51%, with the soluble fiber constituting from 2.4% to 2.9% of that total (see Marshall, W. E. and Wadsworth, J. J (editors),
Rice Science and Technology
, Marcel Dekker, Inc., New York, pp. 384-389 (1994)).
Due to the overall nutritional value of rice bran due to the high dietary fiber and low fat concentration, there has been considerable research in the last ten years on the use of rice bran in the diet for reducing the risk of cardiovascu
Hoffpauer Diane Wright
Wright, lll Salmon L.
Donnelly Laura
Pak John
Patton & Boggs LLP
Platt Michael
LandOfFree
Fortified rice bran food product and method for promoting... does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Fortified rice bran food product and method for promoting..., we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Fortified rice bran food product and method for promoting... will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-2888736