Drug – bio-affecting and body treating compositions – Effervescent or pressurized fluid containing – Organic pressurized fluid
Reexamination Certificate
2002-03-15
2003-12-23
Hartley, Michael G. (Department: 1616)
Drug, bio-affecting and body treating compositions
Effervescent or pressurized fluid containing
Organic pressurized fluid
C424S725000, C424S771000, C424S776000, C514S178000, C514S724000, C514S731000, C514S862000
Reexamination Certificate
active
06667026
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to a treatment for allergic contact dermatitis. More particularly, the invention relates to a dermatitis treatment with a topical composition having an active ingredient of an acorn derivative, namely, a powdered acorn or an acorn extract from acorn ash, acorn mash, or roasted acorn.
2. Background Information
Poison ivy, poison oak, or poison sumac dermatitis is often referred to as rhus dermatitis and is a common, seasonal, allergic contact dermatitis. In the United States, poison ivy (
Toxicodendron radicans
) and poison oak (
Toxicodendron diversilobum
or
quercifolium
) are the main causes of rhus dermatitis. Poison ivy, which is particularly abundant in eastern United States and southeastern Canada, is found as either a shrub or a vine.
Before contact dermatitis develops, sensitization is experienced whereby, upon exposure to the toxic agent, toxicodendrol, the individual acquires hypersensitivity thereto. Therefore, not everyone who is exposed to the plants has an allergic reaction. However, it is estimated that at least 70% of the U.S. population could react after casual exposure to the plants.
Toxicodendrol, the previously mentioned toxic agent, is a phenolic oleoresin that is present in all the poisonous species. Toxicodendrol contains the complex active principle urushiol, which, in turn, is distributed widely in the roots, stems, leaves, and fruit of the plant, but not in the flower, pollen, or plant epidermis. Therefore, contact with the intact epidermis of the plant is harmless and contact dermatitis occurs only upon contact with a bruised or injured plant or with a carrier of the juices therefrom, e.g. from the coat of a dog. As little as 1 &mgr;g of crude urushiol causes dermatitis in sensitive individuals.
The natural course of contact dermatitis is divided into two phases; a sensitization phase, during which a specific hypersensitivity to the allergen is acquired, supra, and an elicitation phase, during which subsequent contact with the allergen elicits a visible dermatologic response. The reaction time—the interval between contact with the allergen and the appearance of the response—varies with the degree of sensitivity and the amount of allergen contacted. Reaction time is usually between 12 hours and up to 2 to 3 days. This interval is a result of delayed hypersensitivity reactions involving cell-mediated immunity.
In the elicitation phase, following exposure to the antigen, there develops an initial reaction, namely, an erythema or rash. This is followed by the development of raised lesions (erythematous macules and papules). Finally, fluid accumulation causes the formation of vesicles and bullae in the epidermis.
In preparing for this application several references became known to the inventors hereof. Both chemical and medical databases revealed sparse information on the principal active ingredient hereof, namely, acorn derivatives; however, the U.S. Department of Agriculture (USDA) and the International Food Ingredient Council Foundation (IFIC) have ascertained basic nutritional information for the acorn. According to the analysis provided, the acorn, like other nuts, is composed or water, protein, lipid, carbohydrate, minerals, and vitamins. For a more detailed account as to content of this ingredient, see infra.
Further and also in preparing for this application several patents became known to the inventors hereof in which oak bark ash is described as a therapeutic agent in treating poison ivy symptoms. R. Thomas Stanley in U.S. Pat. No. 5,080,900 describes the use of oak bark ash and later technical developments are described by David N. Hon and R. Thomas Stanley in U.S. Pat. No. 6,149,947. Although reported as having therapeutic advantages, Karl in U.S. Pat. No. 6,113,929 indicates that the tannic acid in the oak bark ash formulations acts as an astringent and does not remove all the oleoresin, toxicodendrol, from the skin, However, when used after an alkaline cleanser, removes some of the resin, the oak bark preparation removes the remaining resin portion and closes the skin pores to prevent residual resin working its way into the pores. There is thus some question as to the efficacy of astringent preparations, particularly oak bark ash, and the methodology with which the same should be used.
By way of further background as to the active ingredient, the acorn derivative, the heating of acorns generate, as would be expected, Maillard reaction products. Initial reactions of Maillard reaction involves condensation, enolization, and Amadori rearrangement of proteins, sugars, and free amino groups. Intermediate reactions involve sugar dehydration, sugar fragmentation, formations of dicarbonyl compounds, reductones, and pigments. During the final stages of Maillard reactions, red-brown and dark brown color is generated. The reactions involved in the final stages of Maillard reaction involve aldol condensation, polymerization, and Strecker degradation. Roasted aromas develop as well as colloidal and insoluble melanoidins also form. The acorn derivatives herein, including those from roasted acorns, are differentiated from oak bark and tannic-acid-containing products by the constituents mentioned and by a pH above 4.5. are above what would be expected for a high tannic acid material. It is believed that trace amounts of tannins occur in acorn derivatives and are believed to stem from the shells and hats of the acorn.
West U.S. Pat. No. 5,443,847 identified a detoxification agent for urushiol using divalent metals such as manganese. West '847 indicates that organic molecules containing hydroxyl (—OH) and carboxyl (—COOH) groups are reactive to polyvalent metals and that urushiol has two hydroxyl groups that can form stable chelates by replacing the hydrogens with divalent metals that are present in the agent. West claims the use and method of manganese salts (0.01 to 10.0 percent Mn) in an aqueous solution between pH 5 and 7.
The discussion of the above documents is not intended as an admission that any such document constitutes prior art against the claims of the present application. Applicant does not waive any right to take any action that would be appropriate to antedate or otherwise remove any listed document as a competent reference against the claims of the present application.
SUMMARY AND DESCRIPTION OF THE PREFERRED EMBODIMENT
Introduction
In general terms, the invention disclosed hereby includes an aqueous solution of an acorn derivative suitable for application to the site of contact dermatitis. The acorn derivatives as discussed hereinbelow are extracts, suspensions, and dispersions prepared from acorn ash, acorn mash, and roasted acorns. Acorns utilized in the present invention are from Red Oak (
Quercus rupra
), Black Oak (
Quercus shumardi
i Buckl.) Scarlet Oak (
Quercus coccinea
Muenchb.), Willow Oak (
Quercus phellos
L.) and other species of the Erythrobalanus group.
In the description which follows the term treating preparations is defined as solutions, suspensions, or emulsions in the form of topical ointments, creams, lotions and sprays. In the formulations of the present invention varying amounts of acorn derivatives have been found to be efficacious in treating the allergic response induced by the urushiol resin and the dermatitis arising therefrom. Thus, treating preparations having from 0.1 to 50 percent by weight of acorn derivative are set forth. The treating preparations, namely solutions, suspensions, and emulsions hereof have, in addition to the acorn derivative, a nontoxic dermatologically acceptable aqueous dispersion material.
Various topical compositions forming sprays, creams and ointments require in addition to the acorn derivative and water such inactive components as surfactants, antioxidants, emulsifiers, stabilizers, dispersants, and preservatives. In another aspect of the invention additional active components of the topical composition are disclosed such as anesthetics, antipruritics and antihistamines.
The Prophylactic Effect and t
Goldman Gavriel
Lapidus Mitchell
Hartley Michael G.
Lamm Marina
Pocono Falls, Inc.
Silber, Esq. Siegmar
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