In re Herschler

591 F.2d 693, 200 U.S.P.Q. (BNA) 711, 1979 CCPA LEXIS 313
Court of Customs and Patent Appeals·Decided February 1, 1979·No. Appeal No. 78-548·Published·Cited by 20 cases

Opinion

BALDWIN, Judge.

This appeal is from the decision of the Patent and Trademark Office (PTO) Board of Appeals (board) affirming the rejection of claims 1-5 and 9-13 in appellant’s application serial No. 304,283,1 filed November 6, [695]*6951972, for “Enhancing Tissue Penetration of Physiologically Active Steroidal Agents with DMSO.”2

The board affirmed the examiner’s rejection of all claims under 35 U.S.C. § 103 as unpatentable over Lubowe in view of Faust, Marson or Brown. The board also affirmed a rejection, first entered pursuant to its authority under 37 C.F.R. § 1.196(b),3 of each of the claims under 35 U.S.C. §§ 102(b) or 103 over Stroughton et al., Stroughton or Kligman.4 We reverse.

The Invention

The appellant has found that DMSO enhances the penetration of a number of materials through skin tissue. In the application at hand, a mixture of DMSO and a “physiologically active steroidal agent” is administered to skin (or a mucous membrane) with the result that the steroid penetrates the membrane. The claimed process provides such advantages as the elimination of injection by needle and the ability to administer localized doses of the drug without resort to a systemic dose.

Claim 1 is typical of the invention:

1. A method of enhancing the penetration into and across an external membrane barrier of a human or animal subject of a physiologically active steroidal agent capable of eliciting a physiological effect upon topical application thereof, which comprises the concurrent topical administration to the external membrane of an amount of said steroidal agent effective to produce the desired physiological effect and an amount of DMSO sufficient to effectively enhance penetration of said steroidal agent to achieve the desired physiological effect.

The Prior Art

The following references were relied upon to support the rejection under § 103:

Lubowe Patent No. 2,942,008 issued on June 21, 1960.
Brown et al., “A Note on the Toxicity and Solvent Properties of Dimethyl Sulfoxide,” 15 J. Pharm. Pharma. Col. 688-692 (Oct. 1963).
Faust, “Some New Components for Cosmetic and Dermatologic Vehicles,” 77 American Perfumer 23-26 (Jan. 1962).
Marson, “II Dimetilsolfossido Solvente Aquo-Mimetico,” 102 Boll. Chimicofarm. 109-124 (Feb. 1963).

Lubowe is a patent directed to compositions with large amounts of mineral, vegetable or animal oils solubilized in short chain alcohols. The oils are maintained in solution by the addition of fatty alcohols having 10 to 24 carbon atoms. The resulting compositions may be used as a base in a number of further cosmetic and pharmaceutical compositions. When the composition is used in a hair lotion, Lubowe indicates that “estrogenic hormones, methyl sulfoxide” may be added. Example XII shows a hair lotion containing 0.1% estrogenic hormone in 50% ethyl alcohol but without DMSO.

[696] Brown et al. shows DMSO to be a solvent in which many classes of compounds are soluble and, further, is of low toxicity.

Faust suggests that DMSO is a “safe and effective solubilizing” agent suitable for use as a cosmetic or dermatologic vehicle.

Marson cites Faust saying “the cosmetic literature has recently cited its [DMSO’s] employment as simple, non-gelated components of dermatological vehicles” and describes the usefulness of DMSO in preparing pharmaceutical compositions containing, inter alia, the thickening agents such as recited in the claims.

Background

The examiner indicated in the Final Rejection and in his Answer that the claims were rejected under 35 U.S.C. § 103 since “the Lubowe patent describes, inter alia, DMSO added to Ex. XII, an anti-seborrheic hair lotion containing Vio part by weight of estrogenic hormone,” and that, “we have, inherently, the same process involved here as described in Lubowe, notwithstanding applicant’s observation of percutaneous absorption from the DMSO (apparently added as a vehicle or solvent, according to Faust, Marson or Brown).”

The board, in a first opinion, agreed with the Examiner’s position and amplified it, stating:

We note that the secondary references make it clear that DMSO is an effective solubilizing agent for various drugs, including those to be applied topically and along with the examiner we emphasize that “. .an amount of DMSO sufficient to effectively enhance penetration . ” of the steroid is also an amount effective for solubilization of the steroid; compare with page 19 of the specification. Therefore, we find that it would be obvious to add DMSO to the steroid containing formulation of Example XII of Lubowe in amounts large enough to enhance penetration of said steroid, in view of the teachings of the secondary references regarding DMSO’s utility as a solvent for topical drug formulations.

The board made an additional rejection:

Under the provisions of 37 C.F.R. § 1.196(b) we make new grounds of rejection under 35 U.S.C. § 102(b) and 35 U.S.C. § 103 against claims 1 to 5 and 9 to 13.

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In re Herschler, 591 F.2d 693, 200 U.S.P.Q. (BNA) 711, 1979 CCPA LEXIS 313 (ccpa 1979).

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