Ex Parte Hunter et al

Patent Trial and Appeal BoardJan 19, 2017

13488323 (P.T.A.B. Jan. 19, 2017)

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. 13/488,323 06/04/2012 Gordon Hunter PT-2756-US-CNT 1721 23715 7590 01/23/2017 SARRTNA fTT A MRFRS EXAMINER SMITH & NEPHEW, INC. ZHU, WEIPING 1450 EAST BROOKS ROAD MEMPHIS, TN 38116 ART UNIT PAPER NUMBER 1733 NOTIFICATION DATE DELIVERY MODE 01/23/2017 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): uspto @ smith-nephew.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte GORDON HUNTER, VIVEK PAWAR, DANIEL A. HEUER, ABRAHAM SALEHI, and MICHAEL B. COOPER1 Appeal 2015-001565 Application 13/488,323 Technology Center 1700 Before JEFFREY T. SMITH, JEFFREY R. SNAY, and BRIAN D. RANGE, Administrative Patent Judges. SMITH, Administrative Patent Judge. DECISION ON APPEAL This is a decision on an appeal under 35 U.S.C. § 134(a) from the Examiner’s final rejection of claims 1, 3, 4, 6—11, 13—38, 40-53, and 58—61. An oral hearing was held on January 6, 2017.2 We have jurisdiction pursuant to 35 U.S.C. § 6(b). We REVERSE. 1 According to the Appeal Brief, the Real Party in Interest is Smith & Nephew, Inc. (App. Br. 2). 2 A written transcript of the oral hearing will be entered into the record when the transcript is made available. Appeal 2015-001565 Application 13/488,323 BACKGROUND Appellants’ invention relates to a method of making a medical implant having a porous surface and a solid substrate comprising applying pulsed electrical energy across at least a portion of an aggregate mass of individual metallic bodies and a solid metallic substrate thereby creating a cohesive porous structure on the solid metallic substrate wherein the resulting solid substrate possesses substantially the same bulk mechanical and tribological properties after the attachment of the first material to the solid substrate as existed prior to the attachment the first material to the solid substrate. (See independent claims 1 and 32). Claim 1 is reproduced below from the Claims Appendix to the principal Brief: 1. A method of making a medical implant having a porous surface and a solid substrate, comprising the steps of: placing a finite number of individual metallic bodies in continuous contact with one another at a first interface, said finite number of individual metallic bodies comprising a first material; sintering said first material at the first interface by applying pulsed electrical energy across at least a portion of the aggregate mass of said individual metallic bodies, thereby creating a cohesive porous structure; placing the sintered first material in continuous contact with a second material at a second interface, said second material comprising a solid metallic substrate; and 2 Appeal 2015-001565 Application 13/488,323 sintering said first material to the second material at the second interface by applying pulsed electrical energy across at least a portion of the aggregate mass of the first material and the second material; wherein the solid substrate possesses substantially the same bulk mechanical and tribological properties after the act of attaching the first material to the solid substrate as existed prior to the act of attaching the first material to the solid substrate. The Examiner maintains, and Appellants appeal, the following rejections: Claims 1, 3, 4, 6—11, 13—26, 32—38, 40-48, and 58—61under 35 U.S.C. § 103(a) as unpatentable over the combination of Krebs et al. (US 5,734,959, Mar. 31, 1998) (“Krebs”) in view of Japanese Publication No. JP 11-35379 Al, Feb. 9,1999) (“JP’379”). Claims 27—31 and 49-53 are rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Krebs, JP ’379 and Rolfe (US 7,208,222 B2, Apr. 24, 2007) (“Rolfe”). 3 Appeal 2015-001565 Application 13/488,323 OPINION3 The dispositive issue on appeal is: Did the Examiner err in determining that the combination of Krebs and JP ’379 would have suggested a method of making a medical implant having a porous surface and a solid substrate comprising applying pulsed electrical energy across at least a portion of an aggregate mass of individual metallic bodies and a solid metallic substrate thereby creating a cohesive porous structure on the solid metallic substrate wherein the resulting solid substrate possesses substantially the same bulk mechanical and tribological properties after the attachment of the first material to the solid substrate as existed prior to the attachment the first material to the solid substrate as required by independent claims 1 and 32? After review of the respective positions provided by Appellants and the Examiner, we agree with Appellants that the Examiner did not establish that the combination of Krebs and JP ’379 would have suggested a method of making a medical implant having a porous surface and a solid substrate wherein the process results in the solid substrate possesses substantially the same bulk mechanical and tribological properties after the attachment of the first material to the solid substrate as existed prior to the attachment the first material to the solid substrate as required by independent claims 1 and 32.4 According to the Specification, the general technique of sintering with pulsed electrical current “produce high quality sintered materials in short periods by charging the intervals between powder particles (or other material 3 We limit our discussion to independent claims 1 and 32. 4 The statement of the rejections on appeal appear in the November 30, 2012 Non-Final Office Action. 4 Appeal 2015-001565 Application 13/488,323 forms) with energy and, in some cases high mechanical loads between the materials to be sintered.” (Spec. 130). The Specification further states “[sjintering techniques which utilize the application of pulsed electrical energy are known by a variety of names, including spark plasma sintering (SPS), pulsed electric current sintering (PECS), and field activated sintering technique (FAST).” (Id.). The Examiner found5 Krebs is directed to a method of making a medical implant having a porous surface and a solid base comprising sintering a porous layer on the surface of an implant to form a porous layer comprising alloyed metal particles and simultaneously or sequentially attaching the porous layer comprising the alloyed metal particles to the implant; and thereby providing an implant having a porous coating with a desired porosity for bone ingrowth. (Final Act. 3). The Examiner found Krebs does not specify that sintering is achieved by applying pulsed electrical energy across at least a portion of the aggregated mass of the metal particles as required independent claims 1 and 32. (Id.) The Examiner found JP ’379 discloses sintering ceramic powders by applying pulsed electrical energy. The Examiner concluded it would have been obvious to perform Krebs’ sintering by applying pulsed electrical energy in order to produce a sintered implant having a homogeneous porous coating with strong bonds among metal particles and a porosity of 20-65%. (Id. at 3 4) The Examiner contends the medical implants resulting from the combination of Krebs and JP ’379 would have the grain size and microstructures [sic, 5 We refer to the Examiner’s Final Action for a complete statement of the rejections. Final Act. 3—6. 5 Appeal 2015-001565 Application 13/488,323 tribiological properties] as the claimed invention because the implants resulting from the combination are produced by identical or substantially identical processes as the claimed invention. {Id. at 4). Appellants argue the independent claims require the solid substrate to possess substantially the same bulk mechanical and tribological properties after sintering while the thrust of Krebs is directed towards altering the metallurgical properties of the mesh in order to achieve faster sintering times. (App. Br. 11; Krebs, col 1, In 60-67 and col 2,11 1—43). Appellants further argue the Examiner does not have a factual basis to support the position that Krebs’ shorter sintering cycle would have suggested lessening the changes in the implants microstructure because Krebs discussion is directed towards the melting point of the wires which make up the porous part of the implant not the substrate itself. {Id. 12—13). We agree with Appellants. The Examiner has not adequately addressed how the medical implant resulting from the combined process of Krebs and JP ’379 would have resulted in the solid substrate possessing substantially the same bulk mechanical and tribological properties after sintering as required by the independent claims. The Examiner has not established that Krebs’s shorter sintering cycle refers to the use of pulsed sintering on both the porous material in the underlying substrate which would have necessarily resulted in the solid substrate possessing substantially the same bulk mechanical and tribological properties after sintering as required by the independent claims. The present record contains insufficient discussion and analysis of the evidence presented to support the Examiner’s rejections. Furthermore, the Examiner has not identified the conditions in Krebs and JP ’379 that if combined would have resulted in a 6 Appeal 2015-001565 Application 13/488,323 process that was identical or substantially identical to the process required by the claimed invention. Consequently, the Examiner has not established that the disclosures of Krebs and JP ’379 are sufficient to support obviousness of the Appellants’ claimed invention. See In re Warner, 379 F.2d 1011, 1017 (CCPA 1967) (“A rejection based on section 103 clearly must rest on a factual basis, and these facts must be interpreted without hindsight reconstruction of the invention from the prior art”). Accordingly, we reverse the appealed rejections. Since we reverse because the Examiner has not established that the disclosures of Krebs and JP ’379 are sufficient to support obviousness, we need not reach the issue of the sufficiency of the Declarations presented by Appellants. Cf. In re Geiger, 815 F.2d 686, 688 (Fed. Cir. 1987). We reverse the appealed prior art rejections. REVERSED 7