Dietary food supplement containing natural cyclooxygenase...

Drug – bio-affecting and body treating compositions – Plant material or plant extract of undetermined constitution... – Containing or obtained from a fruit – including berry

Reexamination Certificate

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C424S732000, C424S725000, C514S816000

Reexamination Certificate

active

06818234

ABSTRACT:

BACKGROUND
The present invention relates to dietary food supplements that are useful for the relief of pain or inflammation, and also for the inhibition of biochemical pathways related to pain or inflammation transmission. These food supplements contain flavonoids, and more particularly, certain anthocyanins.
Today, many consumers seek natural alternatives to synthetic pharmaceutical products to aid with a variety of ailments experienced during daily life. Thus, dietary food supplements containing natural substances such as St. Johns wort, gingko biloba, ginseng, and others have recently been marketed for a variety of purposes. To date, however, it is believed that no product containing natural substances is available to provide for the relief of pain and/or inflammation equivalent to non-steroidal anti-inflammatory drugs (“NSAIDs”).
At the present, pain and inflammation are commonly treated by the use of aspirin, ibuprofen (Motrin®, Advil®), and other similar substances commonly known as NSAIDs. Inflammation is transmitted, in part, by a class of compounds known as prostaglandins, which are released by a host in response to mechanical, thermal, chemical, bacterial, and other insults (Moncada et al., Handbook of Exp. Pharm. Vol 50-1, Springer Verlag, pp 588-616, 1978; Samuelsson, Science, 220: 568-575, 1983; Davies et al, Ann. Rev. Immunol. 2:335-357, 1984). Prostaglandin synthesis is accomplished in a stepwise manner by a ubiquitous complex of microsomal enzymes. The first enzyme in this biosynthetic pathway is prostaglandin endoperoxide synthase. This enzyme also is referred to in the art as fatty acid cyclooxygenase. There are two isoforms of this enzyme known as cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2), respectively (Smith, Am. J. Physiol., 268:F181-F191, 1992).
Although substances such as aspirin inhibit prostaglandin production and thus, pain and/or inflammation, they may cause stomach problems and or ulcers. To address these problems, drugs have been developed to target specific pain pathways in the hope that some of the problems associated with aspirin, ibuprofen, and other similar substances will be reduced if not completely eliminated. One such drug is Celebrex™, which apparently targets a specific pain pathway and thus, does not have some of the disadvantages associated with substances such as aspirin. In particular, NSAIDs prevent the production of prostaglandins by inhibiting enzymes in the human arachidonic acid/prostaglandin pathway. Drugs like Celebrex™, however, distinguish between COX-1 and COX-2 and are touted as having less of the side effects associated with normal NSAIDs.
As noted above, many consumers prefer natural substances to synthetic drugs. Therefore, it is clear that there is a need for a natural and pharmacologically acceptable composition for use in relieving or alleviating pain, inflammation, and the symptoms associated with these conditions. In addition, there is a need for a natural composition that provides relief from pain and inflammation with minimal side effects to the gastrointestinal system. The present invention addresses that need by providing a dietary food supplement containing an extract from one or more anthocyanin-containing plants having a native active fraction that provides pain relief, anti-inflammation activity, and/or preferential COX-2 inhibition. The supplement contains an amount of the fraction in a proportion by dry weight of other components that significantly exceeds a proportion of the fraction present by dry weight in juice obtained from the plant material. In general, the active fraction includes flavonoids, and in particular, anthocyanins.
Unless otherwise specifically stated, all percentages used in the specification and claims are weight percentages.


REFERENCES:
patent: 07101836 (1995-04-01), None
patent: 113712 (1998-10-01), None
Hirschhorn, H. The Home Herbal Doctor. 1982. Publ: Perker Publishing Co., Inc. NY; pp. 52-53.*
Internet publication titled “Sanbucol Black Elderberry Extract—The Original Nature'Way” at www.betterlife.com; first published on internet in 1996, 2 pages.*
Internet publication titled “Elixir of Elderberry” at http://www.mothernature.com; first published on internet in 1995, 2 pages.*
Internet publication titled “Sambucol Black Elderberry” at http://www.mothernature.com; first published on internet in 1995, 2 pages.*
Keville, K. Vegetarian times. 1990. No. 154, pp. 62-65.*
Brown, Jr, T. Tom Brown's Guide to Wild Edible and Medicinal Plants. 1985. Publ: Berkely Brooks, NY; pp. 114-117.

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