Drug – bio-affecting and body treating compositions – Plant material or plant extract of undetermined constitution... – Containing or obtained from prunus
Reexamination Certificate
2000-05-22
2002-02-26
Lilling, Herbert J. (Department: 1651)
Drug, bio-affecting and body treating compositions
Plant material or plant extract of undetermined constitution...
Containing or obtained from prunus
C424S455000, C424S465000, C424S489000, C424S537000, C424S452000, C424S757000, C424S759000, C424S760000, C424S773000, C424S775000, C424S776000, C424S777000, C424S779000, C514S825000, C514S886000, C514S916000
Reexamination Certificate
active
06350476
ABSTRACT:
FIELD OF THE INVENTION
The present invention pertains, in general, to the field of dietary supplements and therapeutic compounds for the treatment of pain, fever and inflammation. In particular, the present invention pertains to compositions comprising various herbs, wherein such compositions are useful for improving joint health and flexibility, for the control of swelling, and for the maintenance of healthy, mobile joint function and connective tissue health. In addition, the compositions of the present invention are useful for the treatment of rheumatoid and/or arthritic conditions.
BACKGROUND OF THE INVENTION
All publications and patent applications herein are incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.
Rheumatism refers to any of several pathological conditions of the muscles, tendons, joints, bones, or nerves, characterized by discomfort and disability. It is estimated that over 100 rheumatic diseases affect the joints and other connective tissues of animals.
Arthritis generally refers to the inflammation of a joint or joints which results in pain and swelling. The two most common forms of arthritis are osteoarthritis and rheumatoid arthritis. Osteoarthritis is characterized by chronic degeneration of the cartilage of the joints, mainly in older persons. Rheumatoid arthritis, sometimes called arthritis deformans, is a chronic and progressive systemic disease, especially common in women, characterized by stiffness, swelling and inflammation of the joints and sometimes leading to deformity and permanent disability. Sufferers of rheumatoid arthritis may also have general symptoms of fatigue, weakness, and loss of appetite. While there is no cure, these diseases can sometimes be managed by lifestyle and diet changes, including the intake of dietary supplements.
Many other diseases and conditions also cause pain, inflammation and fevers. Rheumatic fever is an acute inflammatory disease occurring during recovery from infection with group A streptococci, having an onset marked by fever and joint pain. It is associated with polyarthritis, Sydenham's chorea, and endocarditis, and is frequently followed by scarring of the heart valves. Lupus erythematosus, also known as systemic lupus erythematosus, is a chronic disease of unknown origin characterized by red, scaly lesions or patches on the face and upper portion of the trunk. Erythema nodosum is a skin disease associated with joint pain, fever, hypersensitivity, or infection, and characterized by small, painful, pink to blue nodules under the skin and on the shins that tend to recur. Gout is an inherited disorder of uric-acid metabolism occurring predominantly in men, characterized by painful inflammation of the joints, especially of the feet and hands, and arthritic attacks resulting from elevated levels of uric acid in the blood and the deposition of urate crystals around the joints. The condition can become chronic and result in deformity.
Dietary supplements are known to relieve the pain and swelling associated with various joint and connective tissue conditions. When diet and lifestyle changes are not sufficient to alleviate the symptoms of rheumatism and rheumatoid-like diseases, pharmaceuticals are often used for relief from the resultant pain, discomfort, and fever. The antiinflammatory, analgesic and antipyretic agents and drugs often employed for this purpose are a heterogeneous group of compounds, often chemically unrelated, which nevertheless share certain therapeutic actions and side effects. For a comprehensive discussion of such drugs see Insel, P. A.,
Analgesic
-
Antipyretic and Antiinflammatory Agents and Drugs Employed in the Treatment of Gout
, In Goodman & Gilman's The Pharmacological Basis of Therapeutics, Ninth Edition, Chapter 27 (1996).
Herbal Dietary Supplements
Traditionally, dietary supplements referred to products made of one or more of the essential nutrients, such as vitamins, minerals, and protein. Passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA) broadened the definition to include, with some exceptions, any product intended for ingestion as a supplement to the diet. This includes vitamins; minerals; herbs, botanicals, and other plant-derived substances; and amino acids (the individual building blocks of protein) and concentrates, metabolites, constituents and extracts of these substances. Dietary supplements are usually in a dosage form such as capsules, tablets, liquids, powders, soft gels, etc. and generally are not represented as a conventional food or as a sole item of a meal or of the diet (Dietary Supplement Health and Education Act of 1994, Section Three).
The passage of DSHEA established a new regulatory framework for dietary supplements (Dietary Supplement Health and Education Act, Public L. No. 103-417, 108 Stat. 4325 (1994)). DSHEA, which amends the Federal Food Drug and Cosmetic Act, allows supplement manufacturers to make certain limited statements of nutritional support for dietary supplements including a statement that: (1) claims a benefit to a classical nutrient deficiency disease and discloses the prevalence of such disease in the U.S.; (2) describes the role of a nutrient or dietary ingredient intended to affect the structure or function in humans; (3) characterizes the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function; or (4) describes general well-being from consumption of a nutrient or dietary ingredient (Dietary Supplement Health and Education Act, Public L. No. 103-417 § 6, 108 Stat. 4325, 4329 (1994)).
Dietary supplements are available widely through many commercial sources including health food stores, grocery stores, pharmacies, and by mail. Historically in the United States, the most prevalent type of dietary supplement was a multivitamin/mineral tablet or capsule that was available in pharmacies by prescription or “over the counter.” Supplements containing strictly herbal preparations were less widely available. Currently in the United States, a wide array of supplement products are available and they include vitamin, mineral, other nutrients, and botanical supplements as well as ingredients and extracts of animal and plant origin.
Herbal Compositions
It is estimated that approximately 50 percent of the thousands of drugs commonly used and prescribed today are either derived from a plant source or contain chemical imitations of a plant compound (Mindell, E. R.,
Earl Mindell 's Herb Bible
, A Fireside Book (1992)). Currently, a number of medicinal formulations contain herbal components or extracts from herbs. Technically speaking an herb is a small, non-woody (i.e., fleshy stemmed), annual or perennial seed-bearing plant in which all the aerial parts die back at the end of each growing season. As the word is more generally used and as it is used herein, an herb is any plant or plant part which has a medicinal use. Thus, the term herb is also generally used to refer to the seeds, leaves, stems, flowers, roots, berries, bark, or any other plant parts that are used for healing.
Herbal medicines have been used for treating various diseases of humans and animals in many different countries for a very long period of time (see, e.g., Kessler et al.,
The Doctor's Complete Guide to Healing Medicines
, Berkley Health/Reference Books (1996); Mindell, supra). Herbal medications are available in many forms, including capsules, tablets, or coated tablets; pellets; extracts or tinctures; powders; fresh or dried plants or plant parts; prepared teas; juices; creams and ointments; essential oils; or, as combinations of any of these forms. Herbal medicines are administered by any one of various methods, including orally, rectally, parenterally, enterally, transdermally, intravenously, via feeding tubes, and topically.
The bark of the willow tree has been used to treat fever since the mid-eighteenth century in England. The active ingredient in willow bar
Lilling Herbert J.
Morgan Lewis & Bockius
Shanxi Zhengzhon Pharmaceutical Co., Ltd.
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