Ex Parte Herrmann

Patent Trial and Appeal BoardSep 24, 2012

10977695 (P.T.A.B. Sep. 24, 2012)

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. 10/977,695 10/29/2004 Robert A. Herrmann 04-0027 (4010/120) 9736 27774 7590 09/24/2012 MAYER & WILLIAMS PC 251 NORTH AVENUE WEST Suite 201 WESTFIELD, NJ 07090 EXAMINER TYSON, MELANIE RUANO ART UNIT PAPER NUMBER 3773 MAIL DATE DELIVERY MODE 09/24/2012 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 ROBERT A. HERRMANN ____________________ Appeal 2010-003371 Application 10/977,695 Technology Center 3700 ____________________ Before EDWARD A. BROWN, MICHELLE R. OSINSKI, and SCOTT E. KAMHOLZ, Administrative Patent Judges. BROWN, Administrative Patent Judge. DECISION ON APPEAL Appeal 2010-003371 Application 10/977,695 2 STATEMENT OF THE CASE Appellant appeals under 35 U.S.C. Â§ 134(a) from the Examiner's decision rejecting claims 1 and 3-28 under 35 U.S.C. Â§ 103(a) as unpatentable over Jayaraman (US 2005/0220835 A1; pub. Oct. 6, 2005) and Pinchuk (US 2002/0107330 A1; pub. Aug. 8, 2002). (App. Br. 2). We have jurisdiction over this appeal under 35 U.S.C. Â§ 6(b). We reverse. THE CLAIMED SUBJECT MATTER Claim 1, which is reproduced below (paragraphing added), is illustrative of the appealed subject matter. 1. An implantable or insertable medical device comprising: (a) a metallic substrate and (b) a coating comprising; (1) a lower polymeric layer provided over the substrate, said lower polymeric layer comprising a nitric oxide donor and a polymer; and (2) an upper polymeric layer provided over the lower polymer layer, said upper polymeric layer comprising a polymer and an anti-restenotic agent, wherein the medical device is adapted for implantation or insertion into the vasculature. ANALYSIS The Examiner found Jayaraman discloses an implantable medical device comprising a substrate, a lower layer comprising a therapeutic agent and a polymer, and an upper layer comprising a polymer and an anti- restenotic agent, but does not disclose that the substrate comprises metallic Appeal 2010-003371 Application 10/977,695 3 material, and that the therapeutic agent comprises a nitric oxide donor. (Ans. 3). The Examiner found Pinchuk discloses an implantable medical device including a metallic substrate, and a coating that may comprise a therapeutic-agent-loaded block copolymer, in which the therapeutic agent may comprise a nitric oxide donor. (Ans. 3-4). The Examiner concluded that it would have been obvious to try a nitric oxide donor and a block polymer in Jayaraman's agent loaded polymeric layer (i.e., lower layer) as taught by Pinchuk, to provide a device that is effective in preventing or delaying cell division in proliferating cells. (Ans. 4). The Examiner also concluded that it would have been obvious to form Jayaraman's stent of metallic material. (Ans. 4-5). Jayaraman discloses a device including an intimal layer forming the lumen; an intermediate layer; and an adventitial layer attached to the intermediate layer and that contacts tissue. (See para. [0040]). Jayaraman also discloses that "[m]any agent possibilities exist as well. For example, a porous intimal layer may be loaded with an anti-thrombotic agent and an outer porous layer could be loaded with an anti-restenotic or anti- inflammatory agent." (See para. [0042]). Appellant contends that Jayaraman teaches an anti-thrombotic agent in the innermost, intimal layer so that the agent can be released at the inner surface. (App. Br. 5). Appellant contends that, in contrast, the invention does not place the nitric oxide containing layer at a surface of the device, but rather, places it between the substrate and the anti-restenotic layer. (App. Br. 5-6). According to Appellant, providing the upper polymeric layer over the nitric-oxide-donor-containing polymeric layer facilitates a slow and Appeal 2010-003371 Application 10/977,695 4 steady release of the nitric oxide donor and/or its products, to maintain an anti-thrombogenic surface until normal endothelium has healed over the medical device. (App. Br. 3). Jayaraman also discloses that "a porous outer adventitial layer may contain an agent for immediate release and an intermediate layer may contain an agent for sustained or controlled release." (See para. [0042]). Appellant contends, however, that there is no teaching or suggestion in Jayaraman that the "agent for sustained or controlled release" of the intermediate layer is an anti-thrombotic agent (App. Br. 6; Reply Br. 8). We agree. We also agree with Appellant that Jayaraman only discloses embodiments in which the anti-thrombotic agent is in the intimal layer, not in a layer between the intimal layer and an outer anti-restenotic layer. (Id.). Appellant also contends that Pinchuk "never states that nitric oxide is an anti-thrombotic agent," and does not include nitric oxide in the listing of anti-thrombotic agents at paragraph [0062]. (App. Br. 8; see also Reply Br. 8). In response to this contention, the Examiner stated that "this argument is moot since Jayaraman does not require that only anti-thrombogenic agents may be utilized in the disclosed polymer/agent layers." (Ans. 6). In response, however, Appellant stated that it " is not claiming that any therapeutic agent can be employed in any layer, but rather claimed certain agents in a certain order." (Reply Br. 8). The Examiner did not make any finding supported by a preponderance of the evidence that Jayaraman or Pinchuk recognized that nitric oxide donors are an anti-thrombotic agent, and would provide sustained or controlled release if placed in Jayaraman's intermediate polymer layer, nor did the Examiner provide any other evidence of this recognition in the art. The Examiner has not articulated an Appeal 2010-003371 Application 10/977,695 5 adequate reason with a rational underpinning why one of ordinary skill in the art would have modified Jayaraman's intermediate layer to comprise a nitric oxide donor, much less where Jayaraman's device specifically comprises an adjacent outer porous layer loaded with an anti-restenotic agent. The Examiner also has not shown that the results of such modification would have been predictable and have had a reasonable expectation of success. Accordingly, we do not sustain the rejection of claims 1 and 3-28. DECISION The Examiner's decision rejecting claims 1 and 3-28 is REVERSED. REVERSED mls