Drug – bio-affecting and body treating compositions – Live hair or scalp treating compositions
Reexamination Certificate
1996-05-14
2001-03-20
Criares, Theodore J. (Department: 1617)
Drug, bio-affecting and body treating compositions
Live hair or scalp treating compositions
C514S880000, C514S852000, C424S074000
Reexamination Certificate
active
06203782
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present intention relates to methods and products for treating hair and skin conditions. Hair treatments include promoting hair growth in general and, in particular, promoting growth of hair transplants, preventing, stopping or minimizing hair loss, reducing and/or preventing hair fallout during chemotherapy, conditioning the hair and scalp, thickening the hair, eyebrows and eyelashes, treating dandruff, etc. Treatments for skin conditions include smoothing of the skin, treating seborrheic dermatitis, treating cuticles, nails, and nail fungus, treating psoriasis, healing of wounds in the skin, etc.
2. Discussion of the Background
Treatments for hair loss and other scalp and hair disorders addressed by the invention have long been sought, and many treatments utilizing compositions based on extracts from naturally-occurring herbs have been proposed. However, conclusive evidence of the efficacy of known compositions has been hard to find, and many of the reported or suggested results achieved with the prior art compositions lack scientific credibility.
The present inventors, however, have discovered a composition which has been conclusively demonstrated to produce a significant improvement in the conditions for which it is used as a treatment. Most unexpectedly, the composition has been found to be effective for treating hair loss in women, as well as in men. The present inventors have conducted scientific studies demonstrating the effectiveness of the composition of the invention.
A number of treatment agents are disclosed in U.S. Pat. No. 4,874,791 which describes a hair-growing agent containing as an effective ingredient an aliphatic carboxylic acid having an odd number of carbon atoms or a derivative thereof.
U.S. Pat. No. 4,814,351 discloses yet another scalp treatment for reducing average daily hair loss by periodically applying to the scalp a composition containing an active chelating agent. The background discussion of this reference sets forth various theories for enhancement or restoration of hair color to its natural or pre-gray color or, in other words, remelanization of the hair.
U.S. Pat. No. 4,769,231 discloses a hair tonic composition containing an extract from dong chong xia cao.
U.S. Pat. No. 4,853,216 discloses a topical composition containing an alpha adrenergic agonist using a pilomotor effect to enhance shaving.
Still other references disclose active agents for treating various skin conditions. U.S. Pat. No. 4,719,226 discloses a percutaneous absorption preparation and a process for preparing the product. U.S. Pat. No. 4,725,609 discloses a topical nicotinamide composition for promoting angiogenesis, re-epithelialization and wound healing. U.S. Pat. No. 4,656,192 discloses tropolone esters as anti-microbial agents, hair growth stimulants and dental medicines.
JP-2048514 discloses a hair-growth promoting agent which contains a crude extract, an anionic surfactant and a surfactant having nitrogen, and not being an anionic surfactant.
JP-60-146829 discloses a testosterone 5-&agr;-reductase inhibitor for use as an anti-androgen. The disclosed compositions contain an extract of a herb selected from a list of 26 ingredients, together with a solvent. The composition is disclosed as a cosmetic for use as a hair tonic or skin care.
The Kosmetika Aerosole Riechstoffe discloses a variety of uses of herbal products. Fennel is mentioned for use in mouth and eye care and in bathing preparations. Hops, camomile, rosemary and yarrow are mentioned as having applications including hair or scalp care, or shampoos.
FR-2424024 discloses a composition for inhibiting hair loss using a lotion of artemesia, parsley and 36-hour fermented grapes brewed in a particular fashion requiring maceration prior to filtration. Fennel and orange flower may be added to the mixing pot as optional ingredients.
In addition, various herbs have long been known in chinese herbology or medicine as having various medicinal or physiological applications. Various herbs have been discussed as being effective for controlling the quality and color of hair as well being effective hair growth agents. In this connection, different herbs have been disclosed for treating pre-mature graying of hair. These herbs include:
1. He shou wu—Radix polygoni multiform;
2. Hei zhi ma—Semen sesami indici; and
3. Gou gi zi—Fructus lycii chinensis.
These herbs were used particularly in oral applications such as in teas, but were sometimes employed as local external or topical applications.
The following herbs have also been considered suitable for treating baldness in local or topical applications:
1. Gu sui bu—Rhizoma gusuibu (drynaria);
2. Ce bai ye—Cacumen biotae orientalis.
Ce bai ye, according to Chinese literature, when made in a tincture from the fresh plant, has been tested and found to produce sprouting of hair on bald people, reportedly in at least thirteen cases. (Chinese Herbal Medicine, Material Medica—Bensky Gamble, page 370.)
Prior art attempts to produce a hair growth promotor have investigated a large number of compounds as candidates but have generally considered factors such as a particular mixture of surfactants or a specific process to be essential. The near-alchemical requirements of the prior art for special process features and the long lists of potential ingredients, coupled with failure to provide conclusive scientifically proven results clearly indicates that prior art compositions and methods are problematic and do not provide the desired results. Notwithstanding significant efforts to develop compositions which promote hair growth, a need continues to exist for compositions and methods with provable results.
Further, new problems associated with hair growth have arisen as a result of the advent of new medical techniques. For example, surgical hair transplants are now well known. However, hair transplant grafts often fall out after about 2-4 weeks. Although most grafts grow back after 3-4 months, additional transplant surgery may be needed. A need exists, therefore, for a specific treatment of hair transplant patients by conditioning the scalp, preventing or reducing hair fall out, promoting fast healing of the surgical sites and the prevention and shortening of hair shock time.
The widespread use of chemotherapy to treat cancers is also well known. However, conventional chemotherapy often results in hair fall out during chemotherapeutic treatment. Significant time is required for the lost hair to regrow producing social stigma and discomfort. A need exists for a treatment to overcome these problems with chemotherapeutic hair fall out.
Efforts to discover or develop such materials demonstrate a continuing need for compositions or materials which are effective for promoting hair growth, preventing or minimizing hair loss and for treating various skin conditions. It is of course particularly important that such materials or compositions be uniformly effective and safe to use in order to enhance their effectiveness for use by large numbers of people.
SUMMARY OF THE INVENTION
Accordingly, a need continues to exist for improved methods and products for treating hair and skin conditions including promoting new hair growth, promoting hair growth before, during or after chemotherapy, for promoting hair growth in hair transplant patients, preventing, stopping or minimizing hair fall out, conditioning the hair and scalp, thickening the hair, treating dandruff, smoothing the skin, treating seborrheic dermatitis, treating psoriasis, treating cuticles, nails, and nail fungus, healing of wounds in the skin, etc. Such a wide variety of applications is contemplated by the present invention and is to be understood as being intended by references to methods and/or products for treating hair and skin conditions.
The invention specifically contemplates the enhancement or restoration of hair color to its natural or “pre-gray” color or, in other words, remelanization of the hair. This has been found to result in a change in the hair color and enrichment of the hair
Eliaz Isaac G.
Gonen Shmuel
Criares Theodore J.
Kelber Steven B.
Piper Marbury Rudnick & Wolfe LLP
Universal Biologics, Inc.
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