11125531 (P.T.A.B. Feb. 27, 2013)

Ex Parte Welch et al

Patent Trial and Appeal BoardFeb 27, 2013

11125531 (P.T.A.B. Feb. 27, 2013)

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. 11/125,531 05/10/2005 Eric D. Welch 1001.1783101 2412 11050 7590 02/27/2013 SEAGER, TUFTE & WICKHEM, LLC 1221 Nicollet Avenue Suite 800 Minneapolis, MN 55403 EXAMINER OU, JING RUI ART UNIT PAPER NUMBER 3773 MAIL DATE DELIVERY MODE 02/27/2013 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 EIRC D. WELCH, TIMOTHY S. GIRTON, and JOEL M. WASDYKE ____________ Appeal 2011-003807 Application 11/125,531 Technology Center 3700 ____________ Before DONALD E. ADAMS, FRANCISCO C. PRATS, and STEPHEN WALSH, Administrative Patent Judges. ADAMS, Administrative Patent Judge. DECISION ON APPEAL This appeal under 35 U.S.C. § 134 involves claims 1-5, 7, and 13-17 (App. Br. 3; Ans. 2). We have jurisdiction under 35 U.S.C. § 6(b). STATEMENT OF THE CASE The claims are directed to an intravascular filter (claims 1-5, 7, and 13-16) and a method of dissolving embolic debris within a vasculature (claim 17). Claims 1 and 17 are representative and are reproduced in the Claims Appendix of Appellants’ Brief. Appeal 2011-003807 Application 11/125,531 2 Claims 1-5, 7, and 13-17 stand rejected under the written description provision of 35 U.S.C. § 112, first paragraph. Claims 1-5, 7, and 13-17 stand rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Humes1 and Schwarz.2 Claims 1-5, 7, and 13-17 stand rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Mouw3 and Schwarz. We reverse. Written Description: Does the preponderance of evidence on this record support Examiner’s finding that Appellants’ Specification fails to provide written descriptive support for the claimed invention? FACTUAL FINDINGS (FF) FF 1. Examiner finds that Appellants’ Specification fails to provide written descriptive support for the requirement in Appellants’ claims of a “drug reservoir comprising a … drug dispersed only within poly(styrene-b- isobutylene-b-styrene)” (Ans. 3-4). FF 2. Appellants’ Specification discloses that “the drug reservoir may be formed from a therapeutic agent that is dispersed within a polymer that is designed to permit elution of the therapeutic agent,” wherein “the polymer may be poly(styrene-b-isobutylene-b-styrene)” (Spec. 5: 14-17). 1 Humes, US 5,911,704, issued June 15, 1999. 2 Schwarz, US 2003/0235602 A1, published December 25, 2003. 3 Mouw, US 2002/0161390 A1, published October 31, 2002. Appeal 2011-003807 Application 11/125,531 3 ANALYSIS We are not persuaded by Examiner’s finding that Appellants’ Specification lacks written descriptive support for the claimed invention (FF 1; Cf. FF 2). CONCLUSION OF LAW The preponderance of evidence on this record fails to support Examiner’s finding that Appellants’ Specification fails to provide written descriptive support for the claimed invention. The rejection of claims 1-5, 7, and 13-17 under the written description provision of 35 U.S.C. § 112, first paragraph is reversed. The combination of Humes and Schwarz: Does the preponderance of evidence on this record support a conclusion of obviousness? FACTUAL FINDINGS (FF) FF 3. Humes suggests an implantable device that comprises a “capsule enclos[ing] viable cells which produce and secrete … [a] preselected molecule into blood passing the capsule” (Humes, Abstract; Ans. 4). FF 4. Humes suggests that “it is an object of the present invention to provide an easily implantable device for delivering, over long periods of time, a pre-selected molecule into the systemic circulation of a mammal” (Humes, col. 1, l. 67 - col. 2, l. 3). FF 5. Examiner finds that “Humes does not appear to disclose that the therapeutic drug dispersed only within poly(styrene-b-isobutylene-b- styrene)” (Ans. 5). Appeal 2011-003807 Application 11/125,531 4 FF 6. Examiner finds that “Schwarz explicitly teaches that the therapeutic drug dispersed only within poly(styrene-b-isobutylene-b-styrene) on an implantable medical device” (id.). ANALYSIS Based on the combination of Humes and Schwarz, Examiner concludes that, at the time Appellants’ invention was made, it would have been prima facie obvious to “modify the device of Humes by replacing the cells that produce[] the drug with a polymer that is impregnated with the drug as taught by Schwarz” (Ans. 11). We are not persuaded. As Appellants explain, “[t]he modification proposed by the Examiner replaces the viable cells as the continuous source of the drug with a … continuously declining level of delivered drug” (Reply Br. 3; see also FF 3- 6). “Accordingly the combination of Humes in view of Schwarz as proposed by the Examiner renders the device of Humes unsatisfactory for providing a continuous and demand responsive source of a therapeutic agent for a prolonged period of time” (id. at 4; FF 3-4; Cf. FF 6). CONCLUSION OF LAW The preponderance of evidence on this record fails to support a conclusion of obviousness. The rejection of claims 1-5, 7, and 13-17 under 35 U.S.C. § 103(a) as unpatentable over the combination of Humes and Schwarz is reversed. The combination of Mouw and Schwarz: ISSUE Does the preponderance of evidence on this record support a conclusion of obviousness? Appeal 2011-003807 Application 11/125,531 5 FACTUAL FINDINGS (FF) FF 7. Mouw suggests an implantable device that comprises a drug covalently bonded to the device (see Mouw 3-4: ¶ [0035]). FF 8. Examiner finds that “Mouw does not appear to disclose that the therapeutic drug [is] dispersed only within poly(styrene-b-isobutylene-b- styrene)” (Ans. 8). FF 9. Examiner relies on Schwarz to make up for the deficiencies in Mouw (id.; FF 6). ANALYSIS Based on the combination of Mouw and Schwarz, Examiner concludes that, at the time Appellants’ invention was made, it would have been prima facie obvious to “modify the device of Mouw to include the therapeutic drug dispersed only within poly(styrene-b-isobutylene-b-styrene) as taught by Schwarz … to control the release of therapeutic agent from the implantable medical device” (Ans. 13). In support of this conclusion, Examiner reasons that while Mouw device would not “readily release [the covalently bonded, heparin, drug] by mere[] immersion within a bodily fluid, [but] some heparin molecules would be released by the blood flow in an uncontrolled manner” (id.). We are not persuaded. While Examiner may be correct in that some heparin molecules may inadvertently be released from Mouw’s device, it would seem implicit from Mouw’s disclosure that by covalently bonding the drug to the device, Mouw was not directed to the controlled release of the drug from the implanted device (see e.g., Reply Br. 6-7). Therefore, we agree with Appellants’ contention that the modification proposed by Examiner would Appeal 2011-003807 Application 11/125,531 6 “impermissibly altering the principle of operation [of Mouw’s device], the use of covalently bound agents, upon which Mouw depends” (id. at 7). CONCLUSION OF LAW The preponderance of evidence on this record fails to support a conclusion of obviousness. The rejection of claims 1-5, 7, and 13-17 under 35 U.S.C. § 103(a) as unpatentable over the combination of Mouw and Schwarz is reversed. REVERSED lp