Drug – bio-affecting and body treating compositions – Plant material or plant extract of undetermined constitution... – Containing or obtained from panax or acanthopanax
Reexamination Certificate
2000-09-26
2002-10-15
Tate, Christopher R. (Department: 1651)
Drug, bio-affecting and body treating compositions
Plant material or plant extract of undetermined constitution...
Containing or obtained from panax or acanthopanax
C424S725000, C424S773000, C426S648000, C426S810000, C514S962000, C562S563000
Reexamination Certificate
active
06465018
ABSTRACT:
TECHNICAL FIELD
The present invention relates generally to dietary supplements, and, more particularly, to a blend of creatine, ginseng, and astragalus, and, optionally, glutamine for increasing energy, strength, and immune function.
BACKGROUND ART
As we age, our bodies undergo a variety of changes. We often lose strength and energy due to declines in hormone levels and a more sedentary lifestyle. These changes can frequently interact with each other to produce compounding effects. For example, the loss in muscle strength increases the likelihood of falls and broken bones, which can lead to further declines in physical activity and strength. While some of these declines in strength and energy levels are inevitable, they can also result from nutritional deficiencies and changes in lifestyle patterns. This is partly responsible for the greater utilization of medical resources by senior citizens and consequent impacts on Medicare expenditures.
One muscle-building substance which does not typically exhibit any significant side effects is creatine, which is derived from reactions involving the amino acids arginine, glycine, and methionine:
Creatine
Creatine is a nutrient that increases protein synthesis and intra-cellular water levels within the muscle fibers, resulting in greater strength and muscle mass. This boosts daily caloric expenditure, which will lower body-fat stores if food intake is unchanged. A discussion of the benefits may be found in a book by Ray Sahelian and Dave Tuttle, entitled
Creatine: Nature's Muscle Builder
, Avery Publishing Group (1997).
Given the well-established, beneficial effects of creatine for adding strength and power, building lean muscle mass, boosting sports endurance, and helping to reduce body fat, and the rare incidence of associated side effects, it would be desirable to provide creatine in a dietary supplement improved over that already commercially available. Such a dietary supplement should enhance the general energy-boosting and muscular strength-increasing qualities offered by creatine without introducing any harmful side effects. It should be inexpensively manufactured, and comply with all applicable government regulations.
U.S. Pat. No. 5,308,627, entitled “Nutritional Supplement for Optimizing Cellular Health” and issued to A. J. Umbdenstock, Jr., on May 3, 1994, is directed to a nutritional supplement, functioning as a food for special dietary use, to enhance diets and assist persons recovering from addiction to health-damaging substances. The nutritional supplement consists of a mixture of nutrients, specifically, minerals, vitamins, anti-oxidants, amino acids, herbs, and/or other nutrients, which are said to cooperate synergistically in enhancing cellular metabolic pathways and to assist in normalization of cellular function and optimization of cellular health. In one embodiment, the supplement comprises at least one amino acid and at least one herbal antispasmodic substance.
While the '627 patent teaches the use of an “herbal antispasmodic substance” in the treatment of alcoholism (Col. 3, lines 52-65), there is no evidence that ginseng and astragalus (two herbs employed in the present invention), despite centuries of use as individual herbs, have antispasmodic properties. Nor is there any indication that combining aqueous extracts of these herbs with creatine, and, optionally, glutamine, also employed in the practice of the present invention, would produce such antispasmodic properties. Ginseng and astragalus simply are not known to reduce spasms, although they are well-known for many other benefits.
Moreover, Umbdenstock teaches a supplement with at least one enzyme-activating substance and at least one enzyme cofactor. This enzyme-activating substance is a mineral (Col. 6, line 18-19), while the enzyme cofactor is a vitamin (Col. 6, 38-39). There are no vitamins or minerals in the present invention.
Further, while glutamine is included in the dietary supplement taught by the '627 patent (Col. 10, line 12), its function is to permit degradation of harmful NH
4
to NH
3
for removal in the urine of alcoholics. The present application teaches the use of glutamine to promote the release of growth hormone and to provide a source of energy for the cells of the immune system and the mucosal cells of the intestinal tract in combination with creatine and herbal extracts that are not taught in the '627 patent. Therefore, this patent does not teach art relevant to the present invention.
Further, Umbdenstock proposes the use of an amino acid that “produces an enzyme that acts as a catalyst for the normalized cellular chemical reaction” (Col. 3, lines 54-56). To the best of the present inventor's knowledge, creatine, which is an amino acid, does not produce such an enzyme. Rather, creatine provides an additional substrate for increased resynthesis of ATP by boosting levels of creatine phosphate; see, e.g.,
Creatine
, supra, pp. 75-82. While the enzyme creatine kinase does facilitate this reaction, the present inventor does not know of any evidence that supplemental creatine increases levels of creatine kinase, nor is there any reason to suppose that this should occur, inasmuch as creatine kinase is not used up in the reaction.
U.S. Pat. No. 4,708,949, entitled “Therapeutic Composition from Plant Extracts” and issued to Y. Liu on Nov. 24, 1987, discloses a therapeutic composition composed of four plant extracts: ginsenoside, tetramethyl pyrazine, astragalan, and atractylol. These four ingredients are said to be highly effective in treating cerebral vascular disease and the sequelae thereof, whereas the present invention teaches a method for enhancing energy, strength and immune function.
Moreover, the composition taught by the '949 patent is comprised of specific plant chemicals, not extracts of whole herbs. While ginsenoside is contained in ginseng and astragalan is found in astragalus, there are many other active chemicals in each of these herbs. Although ginsenoside content is used as a quality marker in the present invention, it is not the only component with therapeutic properties. In fact, a polysaccharide marker is included in the preferred composition of the present invention so that a range of plant chemicals will be included instead of simply ginsenoside. Tetramethyl pyrazine and atractylol, the other two extracts in the '949 patent, are not found in the present invention. Therefore, this patent does not teach art relevant to the present invention.
Further, Liu's extraction process involves ethanol. The preferred composition of the present invention utilizes only aqueous extraction to ensure that older individuals with possibly compromised immune systems do not consume a dietary supplement with solvent residues.
Thus, a need remains for a creatine-based supplement for increasing energy, strength, and immune function.
DISCLOSURE OF INVENTION
In accordance with the present invention, a dietary supplement is provided that comprises creatine combined with ginseng and astragalus and, optionally, glutamine. The present supplement therefore enhances the general energy boost and muscular strength increase achieved from the consumption of creatine alone, while also increasing immune function. The components are provided together in at least one capsule.
More particularly, the dietary supplement of the present invention will help mature individuals overcome the problems noted above by providing the specified nutrients that work together to boost energy and enhance muscle growth. The dietary supplement will also increase the strength and sense of vitality of such mature individuals.
BEST MODES FOR CARRYING OUT THE INVENTION
Reference is now made in detail to a specific embodiment of the present invention, which illustrates the best mode presently contemplated by the inventor for practicing the invention. Alternative embodiments are also briefly described as applicable.
The dietary supplement of the invention comprises creatine, ginseng, and astragalus, optionally combined with glutamine. The dietary
Jacobs Marvin E.
Tate Christopher R.
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