Ex Parte Brewer et alDownload PDFPatent Trial and Appeal BoardMar 8, 201712782584 (P.T.A.B. Mar. 8, 2017) Copy Citation United States Patent and Trademark Office UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS P.O.Box 1450 Alexandria, Virginia 22313-1450 www.uspto.gov APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 12/782,584 05/18/2010 Francesca Mary Brewer 001255/0006 4944 26610 7590 03/10/2017 STROOCK & STROOCK & LA VAN LLP 180 MAIDEN LANE NEW YORK, NY 10038 EXAMINER DRAPER, LESLIE A ROYDS ART UNIT PAPER NUMBER 1629 NOTIFICATION DATE DELIVERY MODE 03/10/2017 ELECTRONIC Please find below and/or attached an Office communication concerning this application or proceeding. The time period for reply, if any, is set in the attached communication. Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address(es): u spatents @ stroock. com jmann @ stroock.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte FRANCESCA MARY BREWER, EDWARD STEWART JOHNSON, and ANTHONY CLARKE1 Appeal 2016-004620 Application 12/782,584 Technology Center 1600 Before DONALD E. ADAMS, RICHARD J. SMITH, and JOHN E. SCHNEIDER, Administrative Patent Judges. SMITH, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35U.S.C. § 134 involving claims to an oral solid dosage form. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. 1 According to Appellants, the real party in interest is Catalent Pharma Solutions. (Appeal Br. 3.) Appeal 2016-004620 Application 12/782,584 STATEMENT OF THE CASE Claims on Appeal Claims 1, 6—12, 16, 18—24, 28, and 35 are on appeal.2 (Claims Appendix, Appeal Br. 21—24.) Claims 1 and 35, the only independent claims on appeal, are illustrative and read as follows: 1. A fast disintegrating oral solid dosage form formulated for pre-gastric absorption, the dosage form consisting essentially of selegiline as the active ingredient and comprising selegiline and a carrier in a freeze-dried form having a porous network structure. (Id. at 21.) 35. A fast disintegrating oral solid dosage form for the treatment of a subject having Parkinson’s disease consisting essentially of selegiline or a salt thereof or a combination thereof as the active ingredient, and one or more matrix forming agents, in a freeze dried form having a porous network structure, whereby the selegiline is absorbed through the pre-gastric mucosa of the subject when the solid dosage form is placed into the oral cavity. (Id. at 23-24.) Examiner’s Rejections 1. Claims 1, 6—12, 16, 18—24, 28, and 35 stand rejected under 35 U.S.C. § 112 (b) or 35 U.S.C. § 112 (pre-AIA), second paragraph, as indefinite. (Ans. 2-3.) 2. Claims 1, 6—12, 16, 18—24, 28, and 35 stand rejected under pre-AIA 35 U.S.C. § 103(a) as unpatentable over Chiesi,3 citing to the Merck Index4 to show a fact, and Gregory.5 (Id. at 4—9.) 2 Claims 17, 27, and 29—34 are withdrawn from consideration. (Non-Final Act. dated Oct. 19, 2013, at 2.) 3 Chiesi, US 5,017,607, issued May 21, 1991 (“Chiesi”). 4 The Merck Index, Monograph 2893 (11th ed.), 458 (1989) (“Merck Index”). 5 Gregory et al., US 4,371,516, issued Feb. 1, 1983 (“Gregory”). 2 Appeal 2016-004620 Application 12/782,584 DISCUSSION We begin with claim construction. See In re Hiniker, 150 F.3d. 1362, 1369 (Fed. Cir. 1998) (“the name of the game is the claim”). Here, we construe claim 1 as directed to an oral solid dosage form comprising an active ingredient and a carrier in a freeze-dried form having a porous network structure, wherein the active ingredient consists essentially of selegiline. Similarly, we construe claim 35 as directed to an oral solid dosage form comprising an active ingredient and one or more matrix forming agents, in a freeze dried form having a porous network structure, wherein the active ingredient consists essentially of selegiline or a salt thereof or a combination thereof. Moreover, consistent with claim construction principles, the active ingredient in the claims is limited to selegiline (claim 1), or selegiline or a salt thereof or a combination thereof (claim 35), “and those [e.g. ingredients] that do not materially affect the basic and novel characteristic(s)” of the claimed invention. In re Herz, 537 F.2d 549, 551-52 (CCPA 1976). Issue—112 Whether a preponderance of the evidence of record supports the Examiner’s conclusion that claims 1, 6—12, 16, 18—24, 28, and 35 fail to comply with 35 U.S.C. § 112 as indefinite. Analysis The Examiner rejects (a) claim 1 as indefinite because selegiline is recited twice, and therefor redundant, and because conflicting transitional language is used (“consisting essentially of selegiline” and “comprising selegiline”), and (b) claims 1 and 35 as indefinite because the claims imply that the carrier is presumably not considered “active,” and because there is 3 Appeal 2016-004620 Application 12/782,584 insufficient antecedent basis for the term “the active ingredient.” (Ans. 2— 3.) Appellants argue that one of ordinary skill in the art would understand what is claimed. (Appeal Br. 10-13; Reply Br. 1—6.) Based on our construction of claims 1 and 35, we find that the claim language is sufficiently clear. See In re Packard, 751 F.3d 1307, 1313 (Fed. Cir. 2014) (“[H]ow much clarity is required necessarily invokes some standard of reasonable precision in the use of language in the context of the circumstances.”). Accordingly, we reverse the Examiner’s rejection under 35 U.S.C. § 112(b) or 35 U.S.C. § 112 (pre-AIA), second paragraph. Conclusion A preponderance of the evidence of record fails to support the Examiner’s conclusion that claims 1, 6—12, 16, 18—24, 28, and 35 fail to comply with 35 U.S.C. § 112 as indefinite. Issue — Obviousness Whether a preponderance of the evidence of record supports the Examiner’s conclusion of obviousness under 35 U.S.C. § 103(a). Analysis The Examiner relies on Chiesi for its teachings of compositions for treating Parkinson’s disease comprising levodopa methyl ester (LDME) in combination with deprenyl (selegiline),6 that the compositions can be administered via oral, buccal or sublingual routes, and that the compositions may be formulated for immediate release of active principles. (Ans. 4—5.) 6 The Merck Index is relied upon for teaching that deprenyl is synonymous with selegiline. (Ans. 5.) 4 Appeal 2016-004620 Application 12/782,584 The Examiner relies on Gregory for teaching the claimed carrier and matrix forming agent.7 (Ans. 6—7.) Appellants argue that Chiesi “always include [s] LDME” and “does not teach or suggest a dosage form consisting essentially of selegiline as the active ingredient.” (Appeal Br. 14.) Appellants further argue that the claimed invention uses selegiline “alone, without the co-administration of a second or other active ingredient.” (Id., citing Spec. 17,11. 4—10, emphasis added.) Moreover, according to Appellants, one of ordinary skill in the art would understand that LDME “is an active principle [in Chiesi] for treatment of Parkinson’s disease” that would “certainly materially affect the basic and novel characteristic(s) of a composition having a different active ingredient.” (Reply Br. 8.) We find that Appellants have the better position. Chiesi describes the combination of LDME and “other active principles,” such as selegiline, as “improve [ing] the therapeutic action” and otherwise interacting in a manner that achieves results from the combination of LDME and selegiline. (Chiesi col. 3,11. 4—18.) From this description, we find that LDME would materially affect the basic and novel characteristics of the claimed invention. Accordingly, the rejection for obviousness is reversed. Conclusion of Law A preponderance of the evidence of record fails to support the Examiner’s conclusion that claims 1, 6—12, 16, 18—24, 28, and 35 are obvious under 35 U.S.C. § 103(a). 7 Appellants acknowledge that “Gregory is the U.S. counterpart of UK Patent No. 1,548,022, which is described in Appellants’] specification as a particularly preferred dosage form.” (Appeal Br. 15.) 5 Appeal 2016-004620 Application 12/782,584 SUMMARY We reverse the rejections of all claims on appeal. REVERSED 6 Copy with citationCopy as parenthetical citation