Drug – bio-affecting and body treating compositions – Extract or material containing or obtained from a...
Reexamination Certificate
2002-09-23
2004-10-19
Tate, Christopher R. (Department: 1654)
Drug, bio-affecting and body treating compositions
Extract or material containing or obtained from a...
C514S885000
Reexamination Certificate
active
06805866
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to an oral supplement composition and to a process for the production of the same. More particularly, fourteen different species of mushrooms are disclosed that exert enhanced immune function when taken together as a daily supplement.
2. Description of Related Art
The immune system is the body's basic protection and serves as both its essential mechanism for healing and its defense against premature aging. In general, it is believed that foodstuffs such as mushrooms, garlic, ginseng, American aloe and the like are effective in the promotion of human health, typically by enhancing immune function. It is well known there are many vitamins and minerals, essential fatty acids, proteins and carbohydrates which are required to sustain immune function. Recently the inadequate consumption of vitamins, minerals and essential-unsaturated fatty acids has been linked to various diseases, particularly those diseases of aging such as arthritis and cancer as well as others. A number of naturally-occurring ingredients in substances not normally included in the diet are known to inhibit or to reduce the growth of tumor cells, which suggests their immune-enhancing effect. Some examples of these items include herbs, edible fungus, e.g. mushrooms and antioxidants from natural raw sources such as grape seed or the Merritime pine bark.
Indeed, various mushroom species have been employed for centuries in Asian medicine, and their role in supporting immune function is currently being investigated in the scientific community. All plants produce certain kinds of sugars that are a source of energy and that form the cell walls in some plants. Some of the complex sugars in mushrooms are called alpha and beta glucans and are the focus of studies concerning their effects on the human immune system. Beta glucans are not produced naturally in humans, and must therefore come from plant and animal sources. Maitake mushrooms, for example, are exceptionally high in beta glucans, while shiitake mushrooms have high concentrations of alpha glucans.
Oral nutraceuticals have become very popular in recent years as research uncovers those specific compounds contained in food that have immunomodulatory effects. Thus, there is a continuing need for an oral supplement that exerts enhancement of the immune system in new and unexpected ways.
SUMMARY OF THE INVENTION
Accordingly, it is the object of the present invention to provide an oral supplement that contains a novel composition of mushroom species, which species have been shown to enhance immune function via bio-directed immunity. The oral supplement composition of the invention comprises a unique blend of fourteen different mushroom (fungi) species, each having its own properties that have been shown to have beneficial effects on the immune system. Moreover, when taken together, the combination of mushroom species exerts a potentiated, synergistic effect that boosts immune function to an extent greater than the sum of each mushroom species' immunomodulatory effect.
The oral supplement can be prepared into a variety of dosage forms, such as capsules, caplets, tablets, pills, dispersions, suspensions, solution, powders, teas, or syrup concentrates, and can be packaged in bottles or other packaging for sale. The advantages of such an oral composition will be more fully apparent in view of the following detailed description.
DESCRIPTION OF THE PREFERRED EMBODIMENT
The novel composition of the present invention is a nutraceutical created as an oral supplement composition containing a specialized blend of fourteen different mushroom (fungi) species that support and enhance the body's natural defenses via bio-directed immunity. The oral supplement provides a unique combination of natural organic compounds, based on extensive research in mushroom science, that includes rare varieties and specialized mushroom species, each having it own properties, some of which are found naturally only in hard-to-access regions, such as tropical rainforests and other remote areas of the world. For instance,
Ganoderma lucidum
has been traditionally known and used in oriental medicine for its antitumor effects but is unfamiliar and difficult to find in the United States.
The different specialized mushroom species of the present invention are grown in Hawaii under laboratory conditions for consistent results. Following is a list of the fourteen species of mushrooms and their active ingredient weight percentages:
Cordyceps sinensis:
6% to 14%, more preferably 8% to 12%, most preferably 10%;
Agaricus blazei
: 4% to 12%, more preferably 6% to 10%, most preferably 8%;
Grifola frondosus:
4% to 12%, more preferably 6% to 10%, most preferably 8%;
Ganoderma lucidum:
4% to 12%, more preferably 6% to 10%, most preferably 8%;
Trametes versicolor:
4% to 12%, more preferably 6% to 10%, most preferably 8%;
Lentinula edodes:
4% to 12%, more preferably 6% to 10%, most preferably 8%;
Hericium erinaceus
: 4% to 12%, more preferably 6% to 10%, most preferably 8%;
Tremella mesenterica
: 2% to 10%, more preferably 4% to 8%, most preferably 6%;
Phellinus linteus
: 2% to 10%, more preferably 4% to 8%, most preferably 6%;
Pleurotus tuber
-
regium
: 2% to 10%, more preferably 4% to 8%, most preferably 6%;
Pleurotus ostreatus:
2% to 10%, more preferably 4% to 8%, most preferably 6%;
Inonotus obliquus
: 2% to 10%, more preferably 4% to 8%, most preferably 6%;
Lepiota procera
: 2% to 10%, more preferably 4% to 8%, most preferably 6%; and
Flammulina velutipes:
2% to 10%, more preferably 4% to 8%, most preferably 6%.
The fourteen mushroom species are grown under axenic (meaning only one life form) conditions in the vegetative state and on a sterile substrate of organic whole grain. The optimal growing temperature is between 60° C. and 70° C. After harvesting, each mushroom species is individually dried (to a moisture content less than 5%). The dried mushroom is then formed into a powder and mixed with the other similarly prepared thirteen mushroom species to form an admixture. The admixture is ground to between 60 and 80 mesh and autoclave sterilized. After sterilization, the admixture can be prepared into dosage forms that include, without limitation, capsules, caplets, tablets, pills, dispersions, suspensions, solution, powders, teas, or syrup concentrates. The final product can then be packaged in bottles or other packaging for sale. When the final product is provided in capsule form, it also typically contains up to five parts by weight of the inactive ingredient magnesium stearate encapsulated in a vegetarian cellulose derivative, such as hydroxypropyl methylcellulose. When the final product is packaged as tablet, it also typically contains inactive ingredients, such as up to 2.5 parts by weight of acacia-based gum and up to 2.5 parts by weight of silicon dioxide. Alternative standard pharmaceutical ingredients may be substituted for the cellulose derivates, magnesium stearate, acacia-based gum and silicon dioxide according to the ordinary skill in the pharmaceutical arts.
Mushrooms are in the fungi phylum and have complex life cycles containing both a vegetative and a sexual cycle. During the sexual cycle the typical mushroom-shaped structure is produced containing spores. The spores germinate and grow producing 1 N hyphae. Later, opposite mating types of germ hyphae will fuse and produce a 2 N structure that is then in the vegetative growth phase. The vegetative growth continues until some great stress occurs interfering with their growth. This stressful condition induces the fungus (mushroom) to enter the sexual phase.
It has become apparent that different mushroom species vary substantially in their respective chemical fingerprints, and each species chosen for bio-directed immunity has unique chemical and immunomodulatory properties. Each of the mushroom species has a unique polysaccharide fraction that has been shown to have beneficial effects on the immune system. The purpose of preparing a coc
Gaisford Kelly N.
Keith Alec D.
Miller Andrew H.
Gaisford and Miller, Inc.
Webb Ziesenheim & Logsdon Orkin & Hanson, P.C.
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