12793776 (P.T.A.B. Mar. 18, 2016)

Ex Parte Stopek

Patent Trial and Appeal BoardMar 18, 2016

12793776 (P.T.A.B. Mar. 18, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 121793,776 06/04/2010 50855 7590 03/22/2016 Covidien LP 555 Long Wharf Drive Mail Stop SN-I, Legal Department New Haven, CT 06511 FIRST NAMED INVENTOR Joshua Stopek 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 ATTORNEY DOCKET NO. CONFIRMATION NO. H-US-01521 7386 EXAMINER FISHBACK, ASHLEY LAUREN ART UNIT PAPER NUMBER 3731 NOTIFICATION DATE DELIVERY MODE 03/22/2016 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): mail@cdfslaw.com SurgicalUS@covidien.com medtronic_mitg-si_docketing@cardinal-ip.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte JOSHUA STOPEK Appeal2014-000825 Application 12/793,776 Technology Center 3700 Before MICHAEL L. HOELTER, LYNNE H. BROWNE, and JASON W. MELVIN, Administrative Patent Judges. BROWNE, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Joshua Stopek (Appellant) appeals under 35 U.S.C. Â§ 134 from the Examiner's decision rejecting claims 1 and 3-24. We have jurisdiction under 35 U.S.C. Â§ 6(b). We AFFIRM-IN-PART. CLAIMED SUBJECT MATTER Claim 1, reproduced below, is illustrative of the claimed subject matter: Appeal2014-000825 Application 12/793,776 1. A self-sealing implant comprising: at least one wound closure device selected from the group consisting of staples, sutures, clips, tacks, screws, pins, anchors, fasteners, sheaths, shunts, stents and grafts and a reinforcing polymeric material, wherein the wound closure device comprises a first reactive component and the reinforcing polymeric material comprises a second, complementary reactive component, wherein the first reactive component and the second, complementary reactive component are selected from the group consisting of electrophilic functional groups and nucleophilic functional groups. REFERENCES The prior art relied upon by the Examiner in rejecting the claims on appeal is: Wallace Nelson Hunt Ladet US 6,495, 127B1 US 2007 /0089756 Al US 2008/0114383 Al US 2011/0251699 Al REJECTIONS Dec. 17, 2002 Apr. 26, 2007 May 15, 2008 Oct. 13, 2011 I. Claims 1, 3-5, 7, 9, and 12-17 stand rejected under 35 U.S.C. Â§ 103 (a) as being unpatentable over Hunt and Ladet. 1 II. Claims 10 and 11 stand rejected under 35 U.S.C. Â§ 103(a) as being unpatentable over Hunt, Ladet, and Wallace. 1 In the Advisory Action mailed May 6, 2013, the Examiner authorized the entry of an after-final amendment for purposes of appeal. Adv. Act. i-f 7. In view of this amendment, the Examiner withdraws the rejection of claims 1, 3-5, and 17 under 35 U.S.C. Â§ 102(b) as anticipated by Hunt and adds a different ground of rejection for these claims under 35 U.S.C. Â§ 103(a) as unpatentable over Hunt and Ladet. See Adv. Act. i-f 13; see also Ex. Ans. 3, 10. 2 Appeal2014-000825 Application 12/793,776 III. Claims 18-24 stand rejected under 35 U.S.C. Â§ 103(a) as being unpatentable over Nelson and Ladet. DISCUSSION Rejection I Appellant argues claims 1, 3-5, 7, 9, and 12-17 together. See Reply Br. 4--8. We select independent claim 1 as the illustrative claim, and claims 2-5, 7, 9, and 12-17, stand or fall with claim 1. The Examiner determines that the combined teachings of Hunt and Ladat disclose or suggest each and every limitation of claim 1. See Ans. 2- 4. In particular, the Examiner finds that Hunt discloses the first and second reactive components explaining that "the point 68 of the member 65 may be doped with an initiator such that engagement of the point 68 with the adhesive 67 causes the adhesive to bond the fastener 60." Ans. 3--4 (citing Hunt i-f 25). In addition, the Examiner further finds that Ladet teaches a self- sealing implant "wherein the first reactive component is selected from the group consisting of electrophilic functional groups and nucleophilic functional groups; and wherein the second reactive component is selected from the group consisting of electrophilic functional groups and nucleophilic functional groups." Id. (citations omitted). Appellant argues that "Hunt fails to disclose that the adhesive is located on both the first and second clamp members 65, 70 of the two-part fastener 60." Appeal Br. 8, 9. Although, Appellant is correct, Appellant does not apprise us of error, as claim 1 does not require adhesive on two separate devices. See Appeal Br. 20. Rather, claim 1 merely requires two reactive components on two separate devices. See id. 3 Appeal2014-000825 Application 12/793,776 Appellant further argues that "according to Hunt, an initiator is not an adhesive, but rather an additive, similar to a catalyst, buffer, thickener, solvent, etc." Id. at 9. Again, Appellant does not apprise us of error, as claim 1 does not require that either or both of the reactive components be adhesive. Id. at 20. In addition, Appellant argues that: Hunt fails to disclose or suggest a first reactive component such as a nucleophilic functional group on a wound closure device (allegedly the first clamp member of Hunt) and a second complimentary reactive component such as an electrophilic functional group on a reinforcing polymeric material (allegedly the second clamp member of Hunt), as provided by claim 1. Id. at 9-10. Appellant's argument is not responsive to the rejection, which relies upon Ladet, not Hunt, to teach a "first reactive component [] selected from the group consisting of electrophilic functional groups and nucleophilic functional groups; and [a] second reactive component is selected from the group consisting of electrophilic functional groups and nucleophilic functional groups." Ans. 4 (citations omitted). Thus, Appellant fails to apprise us of error. In the Reply Brief, Appellant contends that an initiator is not a reactive component because "[ o ]ne skilled in the art understands that complementary reactive components do not need initiators for polymerization, rather polymerization of complementary reactive components proceeds spontaneously." Reply Br. 5. In support of this contention, Appellant cites U.S. Patent No. 6,165,201 which states, "[i]n this case, no external initiators of polymerization are needed and polymerization proceeds spontaneously when two complementary reactive functional groups 4 Appeal2014-000825 Application 12/793,776 containing moieties interact at the application site." Id. (quoting U.S. Patent No. 6,165,201, 3:50-53). Although U.S. Patent No. 6,165,201 is incorporated by reference in the instant Specification, we do not read limitations from the Specification into the claims. In re Van Geuns, 988 F.2d 1181, 1184 (Fed. Cir. 1993). Moreover, even if we understand this quote to define reactive components as components that spontaneously react when they interact, Hunt's initiator and adhesive meet this definition. As noted by the Examiner, Hunt states, "the point 68 of the first clamp member 65 may be doped with an initiator such that engagement of the point 68 with the adhesive 67 causes the adhesive 67 to solidify and bond the fastener 60." Hunt i-f 25. Thus, Appellant does not apprise us of error. Turning to the combined teachings of Hunt and Ladet, Appellant argues that: any allegation that the dual part adhesive of Hunt may be substituted with the alleged first and second reactive components of Ladet (see, e.g., page 6 of the Final Office Action), would result in the alleged first and second reactive components of Ladet positioned together on a single clamp member and not on two different devices as provided by the pending claims. Reply Br. 5. Again, Appellant's argument is not responsive to the rejection as articulated by the Examiner. The rejection does not contemplate substitution of Ladet's reactive components for the dual parts of Hunt's adhesive. Rather, the rejection proposes substitution of one of Ladet's reactive components for Hunt's initiator and substitution of the other of Ladet's reactive components for Hunt's adhesive. See Ans. 4 (Ladet's teachings can be utilized to provide the self-sealing dual part mechanism). Thus, Appellant does not apprise us of error. 5 Appeal2014-000825 Application 12/793,776 Appellant further argues that "[ n ]othing in Ladet suggests that the multilayer implant of Ladet is more than one device and/or separatable into two or more devices." Reply Br. 6. Appellant's argument is inapposite, as the rejection does not rely on Ladet to teach two or more devices. As discussed supra, Ladet is only relied upon to teach the specific reactive components claimed. Accordingly, Appellant does not apprise us of error. For these reasons, we sustain the Examiner's decision rejecting claims 1, 3-5, 7, 9, and 12-17. Rejection II Appellant argues that Wallace does not overcome the deficiencies in Hunt and Ladet. See Appeal Br. 12-13. As we find no deficiencies in the combination of Hunt and Ladet, Appellant's argument is not persuasive. We sustain the Examiner's decision rejecting claims 10 and 11. Rejection III The Examiner finds that the combined teachings of Nelson and Ladet disclose or suggest all of the limitations of independent claim 18. See Final Act. 7-9. In particular, the Examiner finds that Nelson discloses "a staple 102" and that "Ladat teaches the use of two layers of hydrogel precursors wherein when the layers are brought into contact with one another a hydrogel is formed." Id. at 7, 8 (citation omitted). The Examiner further determines that it would have been obvious "to modify the hydrogel coating of Nelson et al.' s assembly to be formed by the use of two layers of hydro gel precursors between the staple and the buttress, as suggested and taught by Ladet, for the purpose of creating an auto sealing implant for tissue repair/ regeneration." Id. at 8. Noting that, in Nelson, "a hydrogel is simply added to the magnet- staple assembly of Nelson," Appellant argues that "Nelson does not disclose 6 Appeal2014-000825 Application 12/793,776 a self-sealing implant wherein a hydro gel is formed by the interaction of the magnet (alleged buttress) and the staple flange (alleged staple)." Appeal Br. 14. Appellant further argues that Ladat does not cure this deficiency, because "[ n Jo where does Ladet disclose a self-sealing implant which includes a staple and a polymeric buttress, wherein a hydrogel is formed by the interaction of the staple and the buttress." Id. Nelson describes "a magnet-staple assembly 98 comprising a permanent magnet 62 or soft ferromagnetic material 66 that includes an attached or integrated stapling flange 100." Nelson i-f 137. Nelson further indicates that reference numeral 102 indicates a "staple component" of flange 100 as shown in Figure 15C. See id. at i-f 141. Thus, Nelson's element 102 is a component that can be stapled, not a staple. Nelson further states that: the magnet-staple assembly 98 could be stapled directly to targeted pharyngeal structures and anatomic components within the pharyngeal conduit, leaving most of the magnet-staple assembly 98 exposed. In this situation, tissue healing can be encouraged by coating the magnet-staple assembly 98, e.g., with a hydrogel doped with or treated with a wound-healing drug. Nelson i-f 139. Accordingly, although Nelson discloses a manner of interconnection that can involve a staple, Appellant is correct that "Nelson does not disclose a self-sealing implant wherein a hydrogel is formed by the interaction of the magnet (alleged buttress) and the staple flange (alleged staple)." Appeal Br. 14. Furthermore, although Ladat describes an implant having "a first hydrogel precursor, [and] a second hydrogel precursor," which [ u ]pon contact with tissue, such as, for example, dural defect, the implant will soak up physiological fluid and the second hydrogel precursor will be dissolved by the fluid. As the 7 Appeal2014-000825 Application 12/793,776 fluid wicks into and migrates across the implant, it will carry the dissolved second hydrogel precursor along through the implant. Eventually, the fluid will migrate through the implant sufficiently to reach the portion to which the first hydrogel precursor is applied, thereby dissolving the first hydrogel precursor. The first and second hydrogel precursors will then react to form a biocompatible cross linked material, Ladat does not disclose or suggest "[a] self-sealing implant comprising: at least one staple and a polymeric buttress, wherein upon interaction of the at least one staple and buttress, a hydrogel is formed," as required by claim 18. Ladat i-fi-14 and 138. Thus, Appellant is also correct, that "Ladat fails to cure the deficiencies ofNelson." Appeal Br. 14. For these reasons, we do not sustain the Examiner's decision rejecting claim 18, and claims 19 and 20, which depend therefrom. Independent claims 21 and 24 similarly require "a polymeric buttress comprising a first reactive component on a tissue" and "second, complementary reactive component from a stapler." Appeal Br. 23. For the reasons discussed supra, the combined teachings of Nelson and Ladat do not disclose or suggest these limitations. Accordingly, we do not sustain the Examiner's decision rejecting claims 21 and 24, and claims 22 and 23, which depend from claim 21. DECISION The Examiner's rejection of claims 1, 3-5, 7, and 9-17 is AFFIRMED. The Examiner's rejection of claims 18-24 is REVERSED. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. Â§ 1.136(a). See 37 C.F.R. Â§ 1.136(a)(l )(iv). 8 Appeal2014-000825 Application 12/793,776 AFFIRMED-IN-PART 9