Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Capsules
Reexamination Certificate
2000-09-05
2003-10-07
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Capsules
C424S464000, C424S489000, C424S702000, C424S729000, C424S754000
Reexamination Certificate
active
06630160
ABSTRACT:
STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT
Not applicable
REFERENCE TO A MICROFICHE APPENDIX
Not applicable
BACKGROUND OF INVENTION
Cancer care is reported to have cost Americans more than $110 billion in 1992, more than 11% of all expenditures spent on diseases in America. Researchers have indicated that from 50-90% of all cancers could be prevented through proper nutrition. There has evolved a new professional descriptive term “nutraceuticals” which combines the term “nutrient” and the term “pharmaceuticals” to describe this genre of medicinal agents that may be comprised of one or more complex combinations of ingredients made from nutrients, vitamins, minerals, herbs, and food and plant derivatives. We shall employ this term “nutraceutical” to refer to such a composition of one or more ingredients.
This invention addresses the need for a dietary supplement that can reduce risk of disease, particularly cancer risk, that will be efficacious for a significant segment of the population. There have been tests and clinical trials on numerous individual agents for their role as cancer preventatives, such as coenzyme Q10 or selenium, but the daunting task of intelligently combining complex compositions has precluded exploration of complex compositions of nutraceuticals for cancer risk reduction. Thus in the past, one single ingredient would be selected and tested for its role as a cancer preventative for some specific cancer, usually in individuals who already had cancer. For example, selenium was tested for cancer prevention in patients who had had carcinoma of the skin [Clark, L. C., Combs; G. F., Jr., Turnbull, B. W., Slate, E. H., Chalker, D. K., Chow, J., Davis, L. S., Glover, R. A., Graham, G. F., Gross, E. G., Krongrad, A., Lesher, J. L., Park, H. K., Sanders, B. B., Jr., Smith, C. L., Taylor, J. R. Effects of selenium supplementation for cancer prevention in patients with carcinoma of the skin. A randomized controlled trial. JAMA. 276 (24): 1957-1963, Dec. 1996]. Similarly the effects of coenzyme Q10 suggested possible efficacious results in limited case studies with individuals with breast cancer [Lockwood, K., Moesgaard, S., Folkers, K. Partial and complete regression of breast cancer in patients in relation to dosage of coenzyme Q10. Biochem Biophys Res Comm. 199: 1504-1508, 1994]. However researchers as noted have been preoccupied with traditional experimental design methodology whereby these investigators wish to determine whether one specific ingredient is effective or not, usually for one specific cancer, and even then, as a treatment rather than a preventative. Another reason single individual ingredients were selected is because researchers have focused on just one of the following biologic, cancer-fighting, etiologically-oriented domains of interest: (1) anti-tumor activity, or (2) immune stimulating activity, or (3) anti-viral activity, or (4) anti-inflammatory activity, or (5) antimutagenic activity, or (6) antiproliferative activity, or (7) anti-free-radical development. This micro-focus has precluded the realization that by combining all those ingredients which work for one subset or another of the population, for one type of cancer or another, for one etiological reason or another, a powerful net effect can be achieved, along with the synergy of the ingredients working together.
BRIEF SUMMARY OF THE INVENTION
The present invention provides a complex composition (a “nutraceutical”) comprising material from known nutrients, vitamins, herbs, minerals, and food and plant substances and food and plant derivatives which are useful to reduce risk of disease, particularly cancer risk, for one or more of all the known etiological factors that affect cancer development and hence yields cancer prevention for the consumer of this nutraceutical. This nutraceutical profoundly reduces risk of cancers through the multiple actions of all the etiological factors addressing cancer-causing conditions, such as providing (1) anti-tumor activity, and (2) immune stimulating activity, and (3) anti-viral activity, and (4) anti-inflammatory activity, and (5) antimutagenic activity, and (6) antiproliferative activity, and (7) anti-free-radical development. The nutraceutical is comprised of lycopene, vitamin E, selenium, green tea polyphenols, Coenzyme Q-10, garlic, folic acid, vitamin C, curcumin, seaweed, Cordyceps sinsensis mushroom, Lentinus edodes (shiitake) mushroom, and Ganoderma lucidum (reishi) mushroom. Preferably the material from each of such entries is in dried powder form.
The composition is administered orally. The nutraceutical of the invention is preferably provided in an ingestible form, such as, for example, a powder, capsule, or tablet.
The invention provides a nutraceutical composition for reducing risk of disease in individuals who are in need theroef, particularly cancer risk, which includes those who have never had cancer, may have had cancer but who wish to prevent reoccurrences, or for reducing cancer risk in individuals who already have cancer but who wish to prevent metastasis of such cancer(s).
BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING
Not applicable
DETAILED DESCRIPTION OF THE INVENTION
In this invention, ingredients were specifically chosen and combined according to their individual science, peer-reviewed journal support for a role in disease prevention, particularly cancer prevention, related to one or more of the etiologic domains of interest affecting cancer development. Although each ingredient selected for the preferred embodiment has been used before for possible cancer prevention and cancer risk reduction, their total combination as a holistic approach for cancer prevention is a new concept. The individual ingredients were selected because there is scientific evidence to indicate they each possess one or more of the following biologic etiologic disease-prevention, cancer-prevention activities: (1) anti-tumor activity, (2) immune stimulating activity, (3) anti-viral activity, (4) anti-inflammatory activity, (5) antimutagenic activity, (6) antiproliferative activity, and (7) anti-free-radical development activity.
Since each ingredient may exhibit one or more of the following attributes, we present key scientific data for each ingredient, organized by ingredient.
Coenzyme Q10
1. Ames, B. N., Shigenaga, M. K., Hagen, T. M. Oxidants, antioxidants, and the degenerative diseases of aging. Proc. Natl. Acad. Sci. USA. 90: 7915-7922, Sep. 1993.
2. Lockwood, K., Moesgaard, S., Folkers, K. Partial and complete regression of breast cancer in patients in relation to dosage of coenzyme Q10. Biochem Biophys Res Comm. 199: 1504-1508, 1994.
3. Lockwood, K., Moesgaard, S., Yamamoto, T., Folkers, K. Progress on therapy of breast cancer in vitamin Q10 and regression of metastases, Biochem Biophys Res Comm. 212: 172-177, 1995.
4. Ren, S., Lien, E. J. Natural products and their derivatives as cancer chemopreventive agents. Prog Drug Res. 48: 147-71, 1997.
Cordyceps sinensis
1. Chiu, J. H., Ju; C. H., Wu, L. H., Lui, W. Y., Wu, C. W., Shiao, M. S., Hong, C. Y. Cordyceps sinsensis increases the expression of major histocompatibility complex class II antigens on human hepatoma cell line HA22T/VGH cells. Am J Chin Med. 26 (2): 159-70, 1998.
2. Chen, Y. J., Shiao, M. S., Lee, S. S., Wang, S. Y. Effect of Cordyceps sinensis on the proliferation and differentiation of human leukemic U937 cells. Life Sci. 60 (25): 2349-59, 1997.
3. Kuo, Y. C., Lin, C. Y., Tsai, W. J., Wu, C. L., Chen, C. F., Shiao, M. S. Growth inhibitors against tumor cells in Cordyceps sinensis other than cordycepin and polysaccharides. Cancer Invest. 12 (6): 611-5, 1994.
4. Nakamura, K., Yamaguchi, Y., Kagota, S., Kwon, Y. M., Shinozuka, K., Kunimoto, M. Inhibitory effect of Cordyceps sinensis on spontaneous liver metastasis of Lewis lung carcinoma and B16 melanoma cells in syngeneic mice. Jpn J Pharmacol. 79 (3): 335-41, Mar. 1999.
5. Ohmori, T., Tamura, K., Fukui, K., Kawanishi, G., Mitsuyama, M., Nomoto, K., Miyazaki, T. Isolation of galactosaminoglycan
Block Jerome Bernard
Evans Steven
Di Nola-Baron Liliana
Genetic Services Management, Inc.
Page Thurman K.
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