Ex Parte Seifert et alDownload PDFPatent Trial and Appeal BoardJun 2, 201612627052 (P.T.A.B. Jun. 2, 2016) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 12/627,052 11130/2009 27581 7590 06/06/2016 Medtronic, Inc. (CRDM) 710 MEDTRONIC PARKWAY NE MS: LC340 Legal Patents MINNEAPOLIS, MN 55432-9924 FIRST NAMED INVENTOR Kevin R. Seifert 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. P0029206.0 l/LGl 0126 3345 EXAMINER SLAWSKI, BRIAN R ART UNIT PAPER NUMBER 1745 NOTIFICATION DATE DELIVERY MODE 06/06/2016 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): medtronic_crdm_docketing@cardinal-ip.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte1 KEVIN R. SEIFERT and KATHLEEN M. GRENZ Appeal2013-009209 Application 12/627,052 Technology Center 1700 Before CHUNG K. PAK, JEFFREY W. ABRAHAM, and ELIZABETH M. ROESEL, Administrative Patent Judges. PAK, Administrative Patent Judge. DECISION ON APPEAL This is a decision on an appeal under 35 U.S.C. § 134(a) from the Examiner's decision2 finally rejecting claims 9-14, which are all of the claims pending in the above-identified application. We have jurisdiction under 35 U.S.C. § 6(b ). We AFFIRM. 1 The real party in interest is said to be Medtronic, Inc. Appeal Brief filed December 12, 2012 ("App. Br.") at 2. 2 Final Action entered July 20, 2012 ("Final Act.") at 1-8 and the Examiner's Answer entered April 22, 2013 ("Ans.") at 3-10. Appeal2013-009209 Application 12/627,052 STATEMENT OF THE CASE The subject matter on appeal is directed to a method of manufacturing a joint in a medical electrical lead. Spec. 1, 11. 10-11 and 2, 11. 7-16; and claim 9. Figures 2A-D illustrating such method are reproduced below: ( \ / FIG.2B l / ~'~r''''''''''''''''''''''""''''''''''''''''''''''''''''''''. 10'1 FIG.2C FIG.2D "Figures 2A-D are schematics outlining a sequence of steps for manufacturing a joint, according to a preferred embodiment of the invention." Spec. 3, 11. 9-10. Figure 2A shows assembling section 371 made of a commercially available thermoplastic material, such as fluorinated ethylene propylene (PEP), onto inner insulation layer 110 made of fluoropolymer material, such as polytetrafluoroethylene (PTFE) tube, for thermal bonding thereto. Spec. 4, 11. 5-9, 5, ll.14-21, 6, 11. 8-10, and 7, 11. 23-25. Figure 2B shows thermally bonded section 371 within forming fixture 307 depicted by the dashed lines. Spec. 6, 11. 10-11. Figure 2C shows first section 171 having groove 107 formed from section 2 Appeal2013-009209 Application 12/627,052 371 via forming fixture 307 and second section 172 formed from, for example, adhesive deposited into groove 107 via syringe 30. Spec. 6, 11. 12-14 and 7, 11. 17- 18. The die of forming fixture 307 can be heated so that it may be used to form groove 107 on the outer surface of section 371 and/or thermally bond section 371 to inner insulation layer 110. Spec. 7, 11. 24-30. Figure 2D shows "insulative sidewall 132 of electrode subassembly 130 placed about first and second sections 171, 172 .... " Spec. 6, 11. 14-16. Once second section 172 is cured, "joint 170 may be completed ... by applying adhesive 37 between the inner surface of the insulation side wall 132 and outer surfaces of sections 171, 172." Spec. 8, 11. 25- 27. Second section 172 and insulative sidewall 132 may be formed from a polyurethane material. Spec. 8, 1. 29-9, 1. 1. According to the Specification, "[t]he [above] ... detailed description is exemplary in nature and is not intended to limit the scope, applicability, or configuration of the invention in any way. Rather, the [above] ... description provides practical illustrations for implementing exemplary embodiments." Spec. 3, 11. 13-16. Details of the appealed subject matter are recited in illustrative claim 9, which is reproduced below from the Claims Appendix of the Appeal Brief (with bracketed reference characters of Figure 2A-D): 9. A method for manufacturing a joint in a medical electrical lead, the joint being between an inner surface of an insulative sidewall [132] of the lead and an outer surface of a fluoropolymer layer [110], a subassembly of the lead comprising a conductive member mounted about the insulative sidewall [132], and the conductive member including an exposed electrical contact surface; the method compnsmg: thermally bonding a thermoplastic fluoropolymer layer [ 171] to the outer surface of the fluoropolymer layer [110]; assembling another material layer [ 172] over the outer surface of the fluoropolymer layer [110] and adjacent to the thermoplastic fluoropolymer layer [ 171]; and 3 Appeal2013-009209 Application 12/627,052 adhesively bonding the other material layer [172] to the inner surface of the insulative sidewall [132] of the subassembly; wherein the other material layer [172] and the insulative sidewall [132] of the subassembly are formed from a material that does not comprise a fluoropolymer. App. Br. 13, Claims Appendix (emphasis added). The Examiner has maintained the following grounds of rejection: 1. Claims 9 and 10 under 35 U.S.C. § 103(a) as unpatentable over the combined teachings of Soukup3 and Telly;4 2. Claim 11under35 U.S.C. §103(a) as unpatentable over the combined teachings of Soukup, Telly, and either Hall, 5 Barker,6 or Quinci;7 3. Claims 12 and 14 under 35 U.S.C. §103(a) as unpatentable over the combined teachings of Soukup, Telly, any one of Barker or Zarembo; 8 and 4. Claim 13 under 35 U.S.C. §103(a) as unpatentable over the combined teachings of Soukup, Telly, Barker, optionally Zarembo, and either Hall or Quinci. 3 US 6,704,604 B2 issued in the name of Soukup et al. on March 9, 2004 ("Soukup"). 4 US 4,549,684 issued in the name of Telly et al. on October 29, 1985 ("Telly"). 5 US 2009/0318999 Al published in the name of Hall on December 24, 2009 ("Hall"). 6 US 2009/0012591 Al published in the name of Barker on January 8, 2009 ("Barker"). 7 US 2009/0254162 Al published in the name of Quinci et al. on October 8, 2009 ("Quinci"). 8 US 2008/0057784 Al published in the name of Zarembo et al. on March 6, 2008 ("Zarembo"). 4 Appeal2013-009209 Application 12/627,052 See Final Act. 2-8 and Ans. 3-10. Appellants seek review of the above grounds of rejection. 9 App. Br. 3--4. DISCUSSION Upon consideration of the evidence on this appeal record in light of the respective positions advanced by the Examiner and Appellants, we find no reversible error in the Examiner's § 103 (a) rejections of claims 9-14 for the reasons set forth in the Final Action and the Answer. We add the following primarily for emphasis. 10 Appellants do not dispute the Examiner's finding that Soukup teaches a method for manufacturing a joint in a medical electrical lead used for defibrillation, comprising bonding outer layer 310 of porous PTFE (corresponding to the recited thermoplastic fluoropolymer layer) on the outer surface of inner layer 308 of porous PTFE (corresponding to the recited fluoropolymer layer), where layer 308 surrounds defibrillation coil 306 (corresponding to the recited conductive member). Compare Final Act. 3--4 and Ans. 5-6 with App. Br. 4-11; see also Soukup, col. 5, 1. 7 to col. 6. 1. 42 and Figs. 3 and 4. Appellants also do not dispute the Examiner's finding that Soukup teaches placing at least portion of such bonded 9 Appellants inadvertently refer to claim 13 rejected as indicated above as claim 14 in the Appeal Brief. App. Br. 4 and 11. 10 Appellants argue for the patentability of independent claim 9, but do not separately argue for the patentability of dependent claim 10 subjected to the same obviousness rejection. App. Br. 4-11. Appellants also rely upon the same arguments raised in connection with claim 9 for the patentability of claims 11-14 subjected to different obviousness rejections involving the same main prior art references, namely Soukup and Telly, used in rejecting claim 9. App. Br. 11. Therefore, for purposes of this appeal, we limit our discussion to claim 9. 37 C.F.R. § 41.37(c)(l)(iv) (2012). 5 Appeal2013-009209 Application 12/627,052 tluoropolymer and thermoplastic tluoropolymer layers 308 and 310 within the inner surface of sleeves 312 and 314 made of silicone (corresponding to the recited insulative side wall formed from a material that does not comprise a fluoropolymer). Compare Final Act. 3--4 and Ans. 5-6 with App. Br. 4-11; see also Soukup, col. 5, 1. 7 to col. 6. 1. 42 and Figs. 3 and 4. Nor do Appellants dispute the Examiner's finding that Soukup, as explained by Telly, teaches using ultrasonic welding to thermally bond outer layer 310 of porous PTFE (corresponding to the recited thermoplastic fluoropolymer layer) on the outer surface of inner layer 308 of porous PTFE (corresponding to the recited fluoropolymer layer). Compare Final Act. 3 and Ans. 5 with App. Br. 4-11; see also Soukup, col. 6, 11. 4-8 and Telly, col. 1, 11. 16-20. Rather, Appellants contend that: [T]he Examiner has designated an adhesive located between sleeves 312 and 314 and layer 310 as being both the "other material" and as "adhesively bonding the other material" to the inner surfaces of sleeves 314 and 312. Applicants leave the question of whether it is permissible to interpret the adhesive, by itself, as meeting both elements of the claim to the Board. Applicant's [sic.] problem with the rejection is that there is no actual disclosure of an adhesive in this location in the first place. [App. Br. 7.] In support of the latter contention, Appellants refer to Soukup' s other alternative embodiments, including one which is said to be directed to bonding sleeves 312 and 314 (the recited insulative sidewall) to lead body 302, while only overlapping (not bonding to) the ends of outer layer 310 (the recited thermoplastic fluoropolymer layer) with sleeves 312 and 314 (the recited insulative sidewall). App. Br. 8-9 (citing Soukup's Abstract, background of the invention, and col. 3, 11. 5-18 and col. 6, 11. 14-25). According to Appellants, these embodiments indicate 6 Appeal2013-009209 Application 12/627,052 that no adhesive is used between outer layer 310 (the recited thermoplastic fluoropolymer layer) and sleeves 312 and 314 (the recited insulative sidewall) and that optional sleeves 312 and 314 (the recited insulative sidewall) would not be needed. App. Br. 9. Thus, the dispositive question here is: Has the Examiner correctly found that Soukup teaches or would have suggested "another material layer" that is adhesively bonded to the inner surface of an insulative sidewall and that does not comprise a fluoropolymer, as recited in claim 9? On this record, we answer this question in the affirmative. As correctly found by the Examiner, Soukup teaches that "assembling another material layer (adhesive, not depicted, used to secure sleeves 312, 314) over the outer surface of the fluoropolymer layer 308 and adjacent to the thermoplastic fluoropolymer layer 31 O; and adhesively bonding the other material layer (adhesive) to the inner surface of the insulative sidewall 312, 314 of the subassembly." Final Act. 3, citing Soukup, col. 6, 11. 9-14. In particular, Soukup teaches (id.) that: According to one construction of a lead employing the current invention, sleeves 312 and 314, which may be formed of silicone or other biocompatible material, may be applied over the edges of the layers 308 and 310 and held in place by an adhesive to further secure these structures. As recognized by the Examiner, the other material layer recited in claim 9 can be an adhesive layer. See Spec. 6, 11. 12-14 and 7, 11. 17-18; see also Ans. 10. Appellants also do not contest the Examiner's finding that Soukup teaches or would have suggested using a silicon adhesive-a material that does not comprise a fluoropolymer-to form the above adhesive layer (the recited other material layer). Compare Final Act. 4 and Ans. 6 with App. Br. 4-11. The adhesive layer 7 Appeal2013-009209 Application 12/627,052 (the recited other material layer) taught or suggested by Soukup, by virtue of its adhesive property, is reasonably expected to be adhesively bonded to the inner surface of sleeves 312 and 314 (the recited insulative sidewall) as found by the Examiner. Ans. 11. The fact that Soukup describes additional alternative embodiments, including one in which sleeves 3 12 and 314 are bonded to lead body 302, rather than to the ends of outer layer 310, does not change Soukup's disclosure of the embodiment cited by the Examiner involving the use of an adhesive layer between outer layer 310 (the recited thermoplastic fluoropolymer layer) and sleeves 312 and 314 (the recited insulative sidewall) to further secure these structures, as discussed supra. 11 See also Soukup Figs. 4 and 5 (illustrating sleeves 312 (the recited insulative sidewall) or sleeves 510 and 512 (the recited insulative sidewall) directly on or directly secured to outer layer 310 (the recited thermoplastic fluoropolymer layer) or outer layer 506 (the recited thermoplastic fluoropolymer layer). Accordingly, we find no reversible error in the Examiner's finding that Soukup teaches or would have suggested adhesively bonding its adhesive layer (the recited other material layer) to the inner surface of sleeves 312 and 314 (the recited insulative sidewall) as recited in claim 9. 11 Even if we agreed with Appellants' argument that Soukup's alternative embodiments indicate or imply that the adhesive that "further secure[ s ]" sleeves 312 and 314 and layers 308 and 310, Soukup, col. 6, 11. 9-14, is actually between lead body 302 (an interfering layer) and sleeves 312 and 314 (the recited insulative sidewall of the subassembly), rather than between outer layer 310 (the recited thermoplastic fluoropolymer layer) and sleeves 312 and 314 (the recited insulative sidewall of the subassembly), the outcome would not be altered. The silicone adhesive taught or suggested by Soukup is still over the outer surface of inner fluoropolymer layer 308, is adjacent to outer thermoplastic fluoropolymer layer 310, and adhesively bonded to the inner surface of sleeves 312 and 314 (the recited insulative sidewall of the subassembly), as required by claim 9. 8 Appeal2013-009209 Application 12/627,052 ORDER In view of the foregoing, the decision of the Examiner to reject claims 9-14 under 35 U.S.C. §103(a) is AFFIRMED. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § l.136(a)(l)(iv). AFFIRMED 9 Copy with citationCopy as parenthetical citation