Ex Parte Burke et alDownload PDFPatent Trial and Appeal BoardFeb 25, 201612598476 (P.T.A.B. Feb. 25, 2016) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 12/598,476 11102/2009 22186 7590 02/25/2016 MENDELSOHN DUNLEAVY, P.C. 1500 JOHN F. KENNEDY BL VD., SUITE 312 PHILADELPHIA, PA 19102 FIRST NAMED INVENTOR Matthew D. Burke 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 ATTORNEY DOCKET NO. CONFIRMATION NO. PU62936 1645 EXAMINER DEVITO, ALEX T ART UNIT PAPER NUMBER 2855 MAILDATE DELIVERY MODE 02/25/2016 PAPER 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. PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte MATTHEW D. BURKE, LIDA KALANTZI, and ALAN FRANK PARR Appeal2014-004344 Application 12/598,476 1 Technology Center 2800 Before BEYERL YA. FRANKLIN, MICHAEL P. COLAIANNI, and CHRISTOPHER L. OGDEN, Administrative Patent Judges. COLAIANNI, Administrative Patent Judge. DECISION ON APPEAL 1 According to Appellants, the real party in interest is Glaxo Group Limited. Br. 3. Appeal2014-004344 Application 12/598,476 Appellants appeal under 35 U.S.C. § 134 the final rejection of claims 13-15, 17-26, and 28. We have jurisdiction over the appeal pursuant to 35 U.S.C. § 6(b). We AFFIRM. Appellants' invention is directed to a method and an apparatus for analyzing and/or predicting the release of active agents in pharmaceutical and pharmaceutical-like products (Spec. 1:10-13). Claim 13 is illustrative: 13. A method of analyzing the release of an active agent from a dosage form in a GI tract, the method comprising: positioning the dosage form in a medium; circulating the medium; applying at least one of multiple compression forces and/ or compression angles to the dosage form to simulate conditions in the GI tract; and collecting data representative of the release of the active agent from the dosage form. Appellants appeal the following rejections: 1. Claims 13-15 and 17 are rejected under 35 U.S.C. § 102(b) as unpatentable over Sinnreich et al. (US 5,827 ,984 issued Oct. 27, 1998 (hereinafter "Sinnreich") ). 2. Claims 20-26 and 28 are rejected under 35 U.S.C. § 103(a) as unpatentable over Sinnreich. 3. Claims 18 and 19 are rejected under 35 U.S.C. § 103(a) as unpatentable over Sinnreich in view of Hu (US 5,807,115 issued Sept. 15, 1998). 2 Appeal2014-004344 Application 12/598,476 Appellants' arguments focus on the subject matter of claim 13 (Br. 12). Regarding rejections (2) and (3), Appellants rely on the same arguments made regarding claim 13 (id. at 13-14). Accordingly, claims 14, 15, 17-26, and 28 will stand or fall with our analysis of the rejection of claim 13. FINDINGS OF FACT & ANALYSIS Appellants argue that Sinnreich fails to teach applying at least one of multiple compression forces and/or compression angles in a dissolution device to analyze the release of an active agent from a dosage form (Br. 12). Appellants contend that Sinnreich cannot anticipate the subject matter of claim 13 because not all limitations are taught by Sinnreich (id.). Contrary to Appellants' argument, the Examiner finds that Sinnreich teaches, at column 6, lines 55-59 and column 7, lines 1-5, applying multiple compressions to a dosage form to analyze the release of active agent from the dosage form (Final Act. 2; Ans. 2). Appellants do not specifically challenge or otherwise show reversible error with the Examiner's findings regarding Sinnreich's columns 6 and 7 disclosures teaching the use of multiple compressions on a dosage form to assess its release of active agent (Br. 12; No Reply Br.). Based upon our review of Sinnreich's column 6 and 7 disclosures, we find that Sinnreich teaches that the agitator 23 can be moved into and back out of beaker 21 periodically, preferably vertically, as indicated by double arrow V in Figure 2. By moving the agitator 23 into and out of the beaker 21, the piston-shaped head portion 24 applies compression forces on dosage form Din and via test medium P (col. 6, 11. 50-67; col. 7, 11. 1-5). The flow patterns formed in the test medium P by agitator 23 apply a compression force to the dosage form D to simulate pressure and kneading 3 Appeal2014-004344 Application 12/598,476 forces in the gastrointestinal tract on the dosage form. Id. ivioreover, Sinnreich discloses that the piston 24 may contact the dosage form to exert a compression force on the dosage (col. 8, 11. 39-48). For these reasons and on this record, we affirm the Examiner's§ 102 and § 103 rejection over Sinnreich, and the § 103 rejection over Sinnreich in view of Hu. DECISION The Examiner's decision is affirmed. No time period for taking any subsequent action in connection with this appeal maybe extended under 37 C.F.R. § 1.136(a)(l). ORDER AFFIRMED 4 Copy with citationCopy as parenthetical citation