Kelyniam Global, Inc.

Patent Trials and Appeals BoardAug 20, 2021

2021001737 (P.T.A.B. Aug. 20, 2021)

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. 14/577,667 12/19/2014 Nicholas Breault 512218 5520 53609 7590 08/20/2021 REINHART BOERNER VAN DEUREN P.C. 2215 PERRYGREEN WAY ROCKFORD, IL 61107 EXAMINER COLEY, ZADE JAMES ART UNIT PAPER NUMBER 3775 NOTIFICATION DATE DELIVERY MODE 08/20/2021 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): RockMail@reinhartlaw.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte NICHOLAS BREAULT, MERWIN SCHAEFER, and CHRISTOPHER J. BREAULT Appeal 2021-001737 Application 14/577,667 Technology Center 3700 Before MICHAEL C. ASTORINO, JAMES A. WORTH, and KENNETH G. SCHOPFER, Administrative Patent Judges. WORTH, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Appellant1, 2 appeals under 35 U.S.C. § 134(a) from the Examiner’s final rejection of claims 1–6 and 8–12. Claim 7 is withdrawn from consideration. Final Act. 1. We have jurisdiction under 35 U.S.C. § 6(b). 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies the real party in interest as Kelyniam Global, Inc. by virtue of assignment. See Appeal Br. 2. 2 Our Decision refers to Appellant’s Appeal Brief (“Appeal Br.,” filed Oct. 12, 2020) and Reply Brief (“Reply Br.,” filed Dec. 30, 2020), as well as Appeal 2021-001737 Application 14/577,667 2 We REVERSE. BACKGROUND Appellant’s application relates “generally to an implant and more particularly to a fixation tab for use with cranial and other biological implants.” Spec. ¶ 2. CLAIMED SUBJECT MATTER Claim 1, the sole independent claim on appeal, is representative of the subject matter: 1. A cranial implant for associating with the skull of a living body, wherein the skull includes a skull outer surface, the cranial implant comprising: an implant body configured to fit within a skull opening in the skull, wherein the skull includes a skull opening edge which defines the skull opening, and wherein the implant body includes an implant body top surface and an implant body edge, wherein, when the implant body edge is pre-fabricated and pre-shaped responsive to the skull opening edge, wherein when the implant body is located within the skull opening, the implant body edge is located adjacent the skull opening edge to be in contact with the skull opening edge, and the implant body top surface is substantially flush with the skull outer surface such that the transition between the skull outer surface and the implant body top surface is substantially smooth; and the Examiner’s Final Office Action (“Final Act.,” mailed May 27, 2020), and Answer (“Ans.,” mailed Nov. 13, 2020). Appeal 2021-001737 Application 14/577,667 3 at least one fixation tab for anchoring the implant body to the skull, wherein the at least one fixation tab is integral with the implant body, and includes a tab connecting shaft and a tab anchoring end, wherein the tab anchoring end includes at least one anchor opening, wherein the at least one fixation tab is pre- shaped to approximate the shape of the skull. Appeal Br., Claims App. 1. REFERENCES The prior art relied upon by the Examiner is: Name Reference Date Luhr US 5,372,598 Dec. 13, 1994 Wellisz US 2003/0100898 A1 May 29, 2003 Posnick US 2006/0287654 A1 Dec. 21, 2006 Antonyshyn US 2012/0010711 A1 Jan. 12, 2012 REJECTIONS 1. Claims 1–6, 8, 9, and 12 stand rejected under 35 U.S.C. § 103 as being unpatentable over Wellisz and Posnick. 2. Claims 8–10 stand rejected under 35 U.S.C. § 103 as being unpatentable over Wellisz, Posnick, and Antonyshyn. 3. Claim 11 stands rejected under 35 U.S.C. § 103 as being unpatentable over Wellisz, Posnick, and Luhr. OPINION We are persuaded by Appellant’s argument that the fixation plate of Wellisz is not substantially flush with the skull outer service, as recited in claim 1, i.e., “the implant body top surface is substantially flush with the skull outer surface such that the transition between the skull outer surface and the implant body top surface is substantially smooth.” See Appeal Br. 8. Appeal 2021-001737 Application 14/577,667 4 Appellant’s argument is supported by the May 1, 2020 Declaration of Mark V. Smith, M.D. (“Smith Decl.”), a neurosurgeon, who avers that “the fixation plate taught by Wellisz is not designed to fit within a skull opening, but rather to cover a skull opening as shown in the drawings of Wellisz.” Smith Decl. ¶ 6. The Examiner cites Figures 5 and 6 of Wellisz for the Examiner’s finding that the implant body top surface is substantially flush with the outer skull surface and the implant body top surface is substantially smooth. Final Act. 3. On review of the evidence, we determine that the Examiner’s finding is not supported by Figures 5 and 6, which are instead consistent with the averment in the Smith Declaration. Figure 6 of Wellisz shows plate 100 and tabs 104 in a different layer than the skull, as tabs 104 cover the skull, and plate 100 is coplanar with tabs 104. See In re Mraz, 455 F.2d 1069, 1072 (CCPA 1972) (clear teaching of figures cannot be ignored). Thus Wellisz does not necessarily show plate 100 flush or substantially flush with the skull bone. Figure 5 of Wellisz also shows plate 100 to be higher than bone zones 15 and 12, and at a minimum does not provide support for the Examiner’s finding that plate 100 is flush or substantially flush with bone zone 12. We also note that Figure 5 shows a gap between plate 100 and bone zone 12, and the two structures are not substantially flush for this additional reason. This gap would not be eliminated even if plate 100 were pushed down because of the curved profile of plate 100. The Examiner reasons: While Wellisz might not directly say it, the plate/implant is designed to fill and cover the hole in the skull and it is completely understood that they would not want the plate/implant to be bulging above the surface of the skull once the patient’s head is Appeal 2021-001737 Application 14/577,667 5 sewed back up. It is only reasonable to believe that they would want the plate to fit flat and look as natural as possible once the procedure is done. Ans. 4–5. However, it is not necessarily inherent in Wellisz that the plate does not bulge (see In re Oelrich, 666 F.2d 578, 581 (CCPA 1981)), and the Examiner’s reasoning in this regard is not consistent with the direct evidence of Figures 5 and 6. The Examiner also reasons that “the plate is configured such that if the plate were only slightly moved down the tab 25 would still be able to poke in the desired diploe region 16 and the top edge of the plate would be perfectly flush with the top edge of the skull.” Ans. 3. However, the Examiner has provided insufficient evidence for the proposition that a neurosurgeon would have sought to push down on plate 100 to make it flush with bone zone 12. In this connection, we observe that it is an object of Wellisz to provide a device and installation that aligns one cortex of a primary zone with one cortex of a secondary zone. Wellisz ¶ 10. The background section of Wellisz indicates that it was a known danger for the primary bone zone to fall too deeply into the defect in the secondary bone zone. See id. ¶ 5; see also id. at 10. The Examiner has not adequately shown that a person of ordinary skill would have pushed the plate further down without disturbing the alignment of the primary and secondary bone zones 12 and 15. Accordingly, we do not sustain the rejection of independent claim 1 under § 103 over Wellisz and Posnick. For the same reason, we do not sustain the rejection of dependent claims 2–6, 8, 9, and 12 under § 103 over Wellisz and Posnick. Appeal 2021-001737 Application 14/577,667 6 Claims 8–11 stand rejected under § 103 over Wellisz and Posnick, further in view of one of Antonyshyn and Luhr. The Examiner does not rely on Antonyshyn or Luhr to remedy the above-identified deficiency in the rejection of independent claim 1 under § 103 over Wellisz and Posnick. Accordingly, we do not sustain the rejections under § 103 of claims 8–11 over Wellisz and Posnick further in view of one of Antonyshyn and Luhr. CONCLUSION In summary: Claim(s) Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1–6, 8, 9, 12 103 Wellisz, Posnick 1–6, 8, 9, 12 8–10 103 Wellisz, Posnick, Antonyshyn 8–10 11 103 Wellisz, Posnick, Luhr 11 Overall Outcome 1–6, 8–12 REVERSED