Covidien LPDownload PDFPatent Trials and Appeals BoardMay 26, 20202019006173 (P.T.A.B. May. 26, 2020) Copy Citation 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. 15/049,503 02/22/2016 Frank Viola H- US-02355DIV(203-7045D) 4534 50855 7590 05/26/2020 Covidien LP 60 Middletown Avenue Mailstop 54, Legal Dept. North Haven, CT 06473 EXAMINER DAVID, SHAUN L ART UNIT PAPER NUMBER 3771 NOTIFICATION DATE DELIVERY MODE 05/26/2020 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): docket@carterdeluca.com rs.patents.two@medtronic.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________________ Ex parte FRANK VIOLA and GERALD HODGKINSON ____________ Appeal 2019-006173 Application 15/049,503 Technology Center 3700 ____________ Before JAMES P. CALVE, WILLIAM A. CAPP, and JEREMY M. PLENZLER, Administrative Patent Judges. CAPP, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Appellant1 seeks our review under 35 U.S.C. § 134(a) of the final rejection of claims 12–23. We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE. 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42(a). Appellant identifies Covidien LP as the applicant and real party in interest. Appeal Br. 1. Appeal 2019-006173 Application 15/049,503 2 THE INVENTION Appellant’s invention relates to surgical fasteners. Spec. ¶ 2. Claim 12, reproduced below, is illustrative of the subject matter on appeal. 12. A method of inserting a surgical fastener to close an opening through tissue, the method comprising: providing an insertion instrument including a surgical fastener integrally formed with and configured to break-away from a distal end of the insertion instrument, the surgical fastener having an open configuration and being closable; inserting the distal end of the insertion instrument into the opening through tissue; approximating at least one of tissue or the distal end of the insertion instrument towards the other of the distal end of the insertion instrument or tissue; retracting the insertion instrument proximally through the opening such that legs of the surgical fastener engage tissue; closing the surgical fastener within tissue; disengaging the insertion instrument from the surgical fastener such that the surgical fastener breaks-away from the insertion instrument; and withdrawing the insertion instrument from the opening. THE REJECTIONS The Examiner relies upon the following as evidence in support of the rejections: NAME REFERENCE DATE Kawai US 4,950,258 Aug. 21, 1990 Tovey US 5,478,354 Dec. 26, 1995 Allen US 6,626,930 Bl Sept. 30, 2003 Ainsworth US 2005/0021054 Al Jan. 27, 2005 Bolduc US 2005/0187613 Al Aug. 25, 2005 Appeal 2019-006173 Application 15/049,503 3 The following rejections are before us for review: 1. Claims 12, 14, 16, 17, 19, 20, 22, and 23 are rejected under 35 U.S.C. § 103 as being unpatentable over Ainsworth and Bolduc. 2. Claims 12 and 15 are rejected under 35 U.S.C. § 103 as being unpatentable over Tovey and Bolduc. 3. Claims 13 and 21 are rejected under 35 U.S.C. § 103 as being unpatentable over Ainsworth, Bolduc, and Allen. 4. Claim 18 is rejected under 35 U.S.C. § 103 as being unpatentable over Ainsworth, Bolduc, and Kawai. OPINION Unpatentability of Claims 12, 14, 16, 17, 19, 20, 22, and 23 over Ainsworth and Bolduc Claim 12, 14, 16, 17, 19, and 23 The Examiner finds that Ainsworth discloses the invention of claim 12 substantially as claimed except for the break-away feature, for which the Examiner relies on Bolduc. Final Act. 3–4. The Examiner concludes that it would have been obvious to a person of ordinary skill in the art at the time of the invention to include a break-away feature in Ainsworth. Id. at 4. According to the Examiner, a person of ordinary skill in the art would have done this, among other things, to require a deliberate act by the physician as a final step to the implantation process. Id. at 5. Appellant argues that a person of ordinary skill in the art would not have combined the teachings of Ainsworth and Bolduc to achieve the claimed invention. Appeal Br. 3. According to Appellant: [T]he particular manner in which a fastener is implanted greatly effects retrievability of the fastener, and options available for retrieving the fastener. Appeal 2019-006173 Application 15/049,503 4 Id. at 6. In response, the Examiner finds that the proposed combination would prevent inadvertent release of Ainsworth’s clip. Ans. 7. According to the Examiner, the only thing preventing the clip from sliding out of the insertion instrument is engagement by the clip holder’s arms. Ans. 6. In reply, Appellant considers the Examiner’s concern regarding inadvertent release of the clip “unrealistic.” Reply Br. 3. Ainsworth is directed to a surgical clip for sealing perforations in body organs or vessels. Ainsworth ¶ 1. Ainsworth discloses clip 510 that resembles a staple in shape and has piercing members 501 on the ends of each leg of the staple. Id. ¶ 54, Figs. 5A–C. In order to deliver and engage clip 510, Ainsworth discloses clip holding and release mechanism 600 which is placed in sheath 301 of clip delivery apparatus 300. Id. ¶ 59. Clip release mechanism 600 comprises actuator controller 620 with clip holder 611 slidably mounted in bore 621. Id. Ainsworth also discloses clip delivery apparatus 300, which is secured to the proximal end of clip holder 611. Id. Controller 620 and delivery apparatus 300 have corresponding slots to slidingly accommodate the legs of clip 510. Id. ¶ 59, Figs. 6, 7. Clip holder 611 comprises a spring clamp with arms 602 that hold clip 510. Id. ¶ 61, Figs. 6, 7. In operation, inner wall surfaces 650 of body member 620 bias the clamp to a closed position. Id. As clip holder 611 is retracted, the clamp arms relax, thereby allowing the clip to pass through. Id. ¶¶ 61–67, Figs. 8A–E. Bolduc is directed to deployment of a prosthesis into a blood vessel or hollow body organ. Bolduc, Abstract. Bolduc’s prosthesis 10 features fastening region 26 that accommodates fasteners 28 to anchor the prosthesis Appeal 2019-006173 Application 15/049,503 5 in place. Id. ¶ 72. Fastener 28 is deployed into tissue by means of applier 38 that includes carrier 128. Id. ¶ 124, Figs. 16A–C. Applier 38 includes tether 140 which connects fastener 28 to applier 38 even after fastener 28 has otherwise been separated from applier 38. Id. ¶ 132, Fig. 17A. Tether 140 serves as a “life line,” maintaining a connection of last resort between applier 38 and fastener 28. Id. Tether 140 allows fastener 28 to be retrieved after implantation. The connection between tether 140 and applier 38 requires a deliberate act of the physician to be broken, adding a confirming, final step to the implantation process. Id. ¶ 132, Fig. 17B. In the instant case, claim 12 is a method claim. Claims App. In the claimed method, the legs of Appellant’s surgical fastener engage tissue when the insertion instrument is being retracted. Spec. ¶¶ 41–43 Figs. 6–10. This step in the claimed method is recited as follows: retracting the insertion instrument proximally through the opening such that legs of the surgical fastener engage tissue. Claims App. In Appellant’s invention, the distal end of tapered extension 64 is integrally formed with faster 110 and is configured to break-away from fastener 110. Spec. ¶ 39, Fig. 5. The detachable connection is configured to operate in connection with deploying the legs of the fastener via a pulling motion and accompanying force. The design of the detachable connection, therefore, contemplates detachment after tissue engagement using a pulling motion and accompanying force. Thus, both: (1) tissue engagement; and (2) separation of the detachable connection; are accomplished with pulling motions and accompanying forces. In contrast, Bolduc’s spiral fastener is deployed using rotational motion and an accompanying “pushing” force. Bolduc ¶¶ 125–130. After deployment and implantation in tissue, fastener 28 automatically separates Appeal 2019-006173 Application 15/049,503 6 from carrier 128, except for tether 140. Bolduc ¶¶ 125–133. Tether 140 is frangible and is separated from fastener 128 by force. Id. ¶ 133. Thus, Appellant’s break-away feature is integrated into its mechanism for engaging tissue. Bolduc’s frangible tether element is not. Operation of Bolduc’s frangible tether “life line” entails motions and forces in the opposite direction of that involved with engaging tissue. Taking the foregoing into account, we are unable to agree with the Examiner’s position that a person of ordinary skill in the art would have been motivated to modify Ainsworth with Bolduc’s “life line” feature. Operating Bolduc’s “life line” in Ainsworth would necessarily entail applying a pulling force on the tether that acts in the same direction as the pulling force that engages Ainsworth’s clip. Ainsworth ¶¶ 58–66, Figs. 6–8E. Given the manner in which Ainsworth deploys its clip by penetrating an incision with an entire assembly comprising holder 611, controller 620, clip 510, and delivery apparatus 300, and then engaging tissue via retraction where clip 510 remains imbedded in tissue and the remainder of the assembly is retracted through the incision, we are unable to ascertain when, if ever, a Bolduc “life line” would contribute to the successful operation of Ainsworth. The Examiner’s concern regarding “inadvertent premature retraction” in Ainsworth cannot be reconciled with the actual structure and method of operation disclosed by Ainsworth. Ans. 6. Retraction that is performed before clip 510 engages tissue would result in no deployment of the clip and recovery of the entire assembly including the clip. Retraction that is performed after clip 510 engages tissue would render any “life line” incapable of recovering the clip. Appeal 2019-006173 Application 15/049,503 7 “An obviousness determination requires finding that a person of ordinary skill in the art would have been motivated to combine or modify the teachings in the prior art and would have had a reasonable expectation of success in doing so.” Regents of Univ. of Cal. v. Broad Inst., Inc., 903 F.3d 1286, 1291 (Fed. Cir. 2018). The mere fact that the prior art may be modified in the manner suggested by the Examiner does not necessarily make the modification obvious. In re Fritch, 972 F.2d 1260, 1266 (Fed. Cir. 1992). The Examiner’s alleged motivation for making the proposed modification lacks rational underpinning. See In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006)(requiring an obviousness conclusion to be based on explicit articulated reasoning with rational underpinning) cited with approval in KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007) . In view of the foregoing, we do not sustain the Examiner’s unpatentability rejection of claim 12. Claims 14, 16, 17, 19, and 23 These claims depend from claim 12. Claims App. The Examiner’s rejection of these claims suffers from the same infirmity that was identified above with respect to claim 12 and, for essentially the same reason expressed above in connection with claim 12, we do not sustain the rejection of claims 14, 16, 17, 19, and 23. Claims 20 and 22 Claim 20 is an independent claim that is substantially similar in scope to claim 12. Claims App. The Examiner’s rejection of these claims suffers from the same infirmity that was identified above with respect to claim 12. Thus, we do not sustain the rejection of claims 20 and 22. Appeal 2019-006173 Application 15/049,503 8 Unpatentability of Claims 12 and 15 over Tovey and Bolduc In this ground of rejection, the Examiner, once again, relies on Bolduc’s life line feature. Final Act. 8–9. However, Tovey’s fastener engages tissue via a pulling motion much in the same manner as Ainsworth discussed above. Tovey, col. 6, ll. 60–67, Fig. 27. Thus, the Examiner’s rejection of these claims suffers from essentially the same infirmity that was identified above with respect to the grounds of rejection of claim 12 over Ainsworth discussed above. Accordingly, we do not sustain the rejection of claims 12 and 15. Unpatentability of Claims 13 and 21 over Ainsworth, Bolduc, and Allen Claim 13 depends from claim 12 and claim 21 depends from claim 20. Claims App. The Examiner’s reliance on Allen for the vacuum element of claim 13 does not cure the “life line” deficiency that we have previously discussed. Final Act. 10. We do not sustain the Examiner’s unpatentability rejection of claims 13 and 21. Unpatentability of Claim 18 over Ainsworth, Bolduc, and Kawai Claim 18 depends from claim 12. Claims App. The Examiner’s reliance on Kawai for the shape memory heating element of claim 18 does not cure the “life line” deficiency that we have previously discussed. Final Act. 11. We do not sustain the Examiner’s unpatentability rejection of claim 18. Appeal 2019-006173 Application 15/049,503 9 CONCLUSION Claims Rejected § References Aff’d Rev’d 12, 14, 16, 17, 19, 20, 22, 23 103 Ainsworth, Bolduc 12, 14, 16, 17 19, 20, 22, 23 12, 15 103 Tovey, Bolduc 12, 15 13, 21 103 Ainsworth, Bolduc, Allen 13, 21 18 103 Ainsworth, Bolduc, Kawai 18 Overall Outcome 12–23 REVERSED Copy with citationCopy as parenthetical citation