Application of Herschler

• Decision Date: 01 February 1979
• Docket Number: Appeal No. 78-548.
• Citation: 591 F.2d 693
• Parties: In the Matter of the Application of Robert J. HERSCHLER.
• Court: U.S. Court of Customs and Patent Appeals (CCPA)

591 F.2d 693

In the Matter of the Application of Robert J. HERSCHLER.

Appeal No. 78-548.

United States Court of Customs and Patent Appeals.

February 1, 1979.

Stanley M. Teigland, attorney of record, San Francisco, Cal., for appellant.

Joseph F. Nakamura, Washington, D. C., for the Commissioner of Patents; Fred W. Sherling, Associate Sol. Ernest G. Therkorn, Washington, D. C., of counsel.

Before RICH, BALDWIN and MILLER, Judges, and KASHIWA^* and FORD,^** Judges.

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, 1972, 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, "I1 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.

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 1/10 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.

Claims 1 to 5 and 9 to 13 are rejected under 35 U.S.C. § 102 and 35 U.S.C. § 103 as unpatentable over any one of Stoughton et al, Stoughton or Kligman. All of the above publications were made of record by appellant's counsel in Paper No. 6 of great-grandparent case Serial No. 329,151 filed December 9, 1963. The above articles were described in detail by appellant's counsel in said Paper No. 6 (pages 8 to 12) and we will not, therefore, elaborate on the disclosure of the articles. It is sufficient to note that each of the articles teaches the enhanced penetration of various steroids resulting from topical application of DMSO concurrently with the steroid — the heart of appellant's inventive concept. All of the above articles were published in 1964 or 1965, more than one year prior to the filing date of appellant's grandparent case Serial No. 753,231, filed August 16, 1968. Hence the articles are statutory bars against the present claims under 35 U.S.C. §§ 102(b) and 103 unless appellant's claimed invention was described in great-grandparent case Serial No. 329,151 filed December 9, 1963; see 35 U.S.C. § 120 and 35 U.S.C. § 112, first paragraph.

We have carefully considered the great-grandparent case but the only disclosure relating to steroids (pages 34-35) is limited to glucocorticosteroids whereas all of the present claims on appeal are drawn either to steroids in general or to steroids not limited to glucocorticosteroids (claims 4-5). It is now well settled law that disclosure of a species is insufficient to provide descriptive support for a generic or sub-generic claim; In re Ruscetta et al, 45 CCPA 968, 255 F.2d 687, 118 USPQ 101 (1958), In re Lukach, 58 CCPA 1233, 442 F.2d 967, 169 USPQ 795 (1971) and In re Smith, 59 CCPA 1025, 458 F.2d 1389, 173 USPQ 679 (1972).

Hence, appellant may not rely upon his great-grandparent case to support any of the claims on appeal and thus the above articles are prior art and can be properly applied against the claims under 35 U.S.C. §§ 102(b) and 103. We note also that the great-grandparent case was filed in the name of Jacob and Herschler, whereas the present case was filed by Herschler alone. Since the inventive entities are different, we do not see how appellant can claim priority under 35 U.S.C. § 120 based upon the great-grandparent case; note the requirement that the applications be ". . . filed by the same inventor. . . ." Emphasis in original.

Appellant thereupon submitted a Request for Reconsideration accompanied by two attachments and requested that the examiner consider them. The first attachment was a portion of a 508 page collection of papers given at a conference entitled Conference on Biological Actions of Dimethyl Sulfoxide held by the New York Academy of Sciences in 1974. The second enclosure was a copy of a Rule 45 declaration⁵ submitted in the great-grandparent application purporting to amend the inventorship from Jacob and Herschler joint to Herschler sole.

In support of the Rule 45 affidavit, appellant argued:

With respect to the first reason, submitted herewith are copies of papers filed under Rule 45 in the great-grandparent application, and a copy of a postcard receipt indicating that the papers were received by the Patent Office. The papers include an amendment under Rule 45 to change the inventorship of the great-grandparent application to correspond to the inventorship of this application. No notice was received that entry of the amendment was refused. Moreover, the Rule 45 papers were filed simultaneously with a continuing application in the name of the new inventorship and the Patent Office accorded continuation-in-part status to the application, which issued as U.S.P. 3,551,554. Hence, it is evident that the examiner considered the papers filed under Rule 45 and acknowledged that they were legally sufficient to change the inventorship. However, if the examiner believes it is necessary to formally change the inventorship of the great-grandparent application, he is invited to enter the Rule 45 amendment nunc pro tunc.

Appellant further argued that the written description in the great-grandparent was adequate for the subgenus now claimed:

As clearly indicated in the great-grandparent application, appellant recognized from the start that the invention was applicable to physiologically active agents in general. * * * Thus, the Board's contention that "the only disclosure in the great-grandparent application relating to steroids is limited to glucocorticosteroids" is incorrect. The great-grandparent application discloses that the invention

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