Ex Parte Hotter et alDownload PDFPatent Trial and Appeal BoardJul 18, 201612986203 (P.T.A.B. Jul. 18, 2016) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 12/986,203 01107/2011 50855 7590 07/20/2016 Covidien LP 555 Long Wharf Drive Mail Stop SN-I, Legal Department New Haven, CT 06511 FIRST NAMED INVENTOR Joseph Hotter 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-02037 (203-7183) 5866 EXAMINER LYNCH, ROBERT A ART UNIT PAPER NUMBER 3731 NOTIFICATION DATE DELIVERY MODE 07/20/2016 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 JOSEPH HOTTER, JON REINPRECHT, NORMAN AMINUDDIN, and JONATHAN THOMAS Appeal2014-003696 Application 12/986,203 Technology Center 3700 Before: BRANDON J. WARNER, LEE L. STEPINA, and ARTHUR M. PESLAK, Administrative Patent Judges. STEPINA, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF CASE Appellants appeal under 35 U.S.C. § 134 from the Examiner's final rejection of claims 1-7 and 14--30. We have jurisdiction under 35 U.S.C. § 6(b ). We AFFIRM-IN-PART. The claims are directed to implants including a yam. Spec. i-f 6. Claim 1, reproduced below, is illustrative of the claimed subject matter: Appeal2014-003696 Application 12/986,203 1. An implant comprising: a central portion composed of at least one yam interconnected to form openings therein; and a peripheral portion extending around the central portion, the peripheral portion formed solely from at least one high strength yam interconnected to form openings therein. Appeal Br. 15 (Claims App.). REFERENCES The prior art relied upon by the Examiner in rejecting the claims on appeal is: Shikinami Rabinowicz Snijder Ethicon1 Proxy2 Tyco3 us 5,711,960 US 2004/0009731 Al US 2006/0014459 Al EP 0 523 743 Bl WO 2005/094 721 Al WO 2006/102374 A2 Jan.27, 1998 Jan. 15,2004 Jan. 19,2006 July 7, 1992 Oct. 13, 2005 Sept. 28, 2006 1 Although the first-named inventor on this European patent is Mark Steckel, the Examiner and Appellants refer to this reference by the name of the listed proprietor, Ethicon Inc. ("Ethicon"). See, e.g., Final Act. 8; see also, e.g., Appeal Br. 3. We continue this practice for clarity. 2 Although the first-named inventor on this WIPO publication is Peter Gingras, the Examiner refers to this reference by a shortened version of the name of the listed applicant, Proxy Biomedical Limited ("Proxy"). See, e.g., Final Act. 2; see also, e.g., Appeal Br. 3. We continue this practice for clarity. 3 Although the first-named inventor on this WIPO publication is Lesley Fronio, the Examiner and Appellants refer to this reference by a shortened version of the name of the listed applicant, Tyco Healthcare Group LP ("Tyco"). See, e.g., Final Act. 2; see also, e.g., Appeal Br. 3. We continue this practice for clarity. 2 Appeal2014-003696 Application 12/986,203 REJECTIONS (I) Claims 1-3, 5-7, 14--16, 21, 22, and 25-27 are rejected under 35 U.S.C. § 103(a) as unpatentable over Tyco and Proxy. (II) Claims 4, 17, and 18 are rejected under 35 U.S.C. § 103(a) as unpatentable over Tyco, Proxy, and Snijder. (III) Claims 19, 20, and 24 are rejected under 35 U.S.C. § 103(a) as unpatentable over Tyco, Proxy, and Shikinami. (IV) Claim 23 is rejected under 35 U.S.C. § 103(a) as unpatentable over Tyco, Proxy, and Ethicon. (V) Claims 28-30 are rejected under 35 U.S.C. § 103(a) as unpatentable over Tyco, Proxy, and Rabinowicz. OPINION Rejection(!) Claim 1 The Examiner finds that Tyco discloses most of the features required by claim 1, but does not disclose a peripheral portion formed solely from at least one high strength yam. Final Act. 4. Nonetheless, the Examiner finds that "Proxy teaches a soft tissue implant or mesh (p. 4, paragraph 1) comprising a peripheral portion including at least one higher strength yam in order to improve the physical properties of this region by preventing pull out and failure of fixation members (p. 27, paragraph 1)." Final Act. 4--5. The Examiner reasons that it would have been obvious to provide the periphery of the device of Tyco with a high strength yam because "it would provide improved physical properties of this region by preventing pull out and failure of fixation members, as taught by Proxy." Final Act. 5. 3 Appeal2014-003696 Application 12/986,203 Appellants argue that "Proxy discloses achieving increased strength by condensing or increasing the material content in part of the mesh, and not by utilizing at least one high strength yam in his mesh." Appeal Br. 6 (referring to Proxy, 26:26-27:9). Therefore, according to Appellants, "Proxy does not disclose or suggest, inter alia, a peripheral portion formed solely from at least one high strength yam interconnected to form openings therein, as recited in claim 1." Appeal Br. 6-7. Appellants further contend that modifying Tyco in view of Proxy would not result in the device recited in claim 1 because "[ c ]ombining the references would produce, at best, an implant including the mesh of Tyco having condensed regions formed by the method of Proxy." Appeal Br. 7. We do not find Appellants' arguments to be persuasive. Although Appellants quote a portion of Proxy discussing the strength of the material used in Proxy's device (Appeal Br. 6 (quoting Proxy 26:26-27:9)), Appellants do not explain persuasively why this portion of Proxy fails to disclose a peripheral portion formed with high strength yam. Indeed, the above-noted portion of Proxy states, "[t]he strength of material along the peripheral edges (e.g., the tensile strength), or at other selected points within the device, may be higher to improve the physical properties in this region so that sutures or other fixation devices do not pull out and cause failure." Proxy 27:4--7. Even assuming, for the purpose of argument, that the increased strength discussed in the portion of Proxy quoted above is due to condensing or increasing the material content in this part of the mesh, Appellants do not explain persuasively why such condensed material (or higher content of material) does not meet the requirement for high strength yam. In this regard, we note that claim 1 does not limit how the "high" strength in the yam is achieved, and Appellants do not explain persuasively 4 Appeal2014-003696 Application 12/986,203 why condensed material or a higher content of material fails to qualify as providing high strength yam. 4 Moreover, Proxy teaches that the tensile strength of the material in the peripheral portion may be higher than other portions of the device. See Proxy 27:4--7. Accordingly, a preponderance of the evidence supports the Examiner's finding that Proxy teaches a peripheral portion formed of high strength yam as required by claim 1, and we sustain the Examiner's rejection of claim 1 as unpatentable over Tyco and Proxy. Claim 3 Dependent claim 3 recites, "[ t ]he implant according to claim 1, wherein the central portion is composed of at least two yams including at least one primary yam and at least one high strength yam." Appeal Br. 15 (Claims App.). We construe this claim to require two yams of different strengths composing the central portion. 5 The Examiner finds that Tyco discloses that its central portion "may comprise at least two yams (p. 7, lines 13-16; p. 9, line 22-p. 10, line 1) including at least one primary yam and at least one high strength yarn/transverse member (76; p. 20, lines 17-23)." Final Act. 4. Appellants argue that Tyco merely discloses two filaments, which do not correspond to one high strength yam and one primary yam. Appeal Br. 8. We agree with Appellants on this point, inasmuch as the Examiner does not identify any disclosure in Tyco supporting a finding that the two filaments necessarily have different strengths. 4 For example, other factors being equal, a thicker of two ropes will have a higher tensile strength than the other, even if the material of the two ropes is identical. 5 Paragraph 55 of Appellants' Specification states, "[t]he high strength yams are stronger than the primary yams used to construct the bulk of the mesh." 5 Appeal2014-003696 Application 12/986,203 As for transverse members 7 6 in Tyco, Appellants assert that these members would not be understood by a person of skill in the art to be a high strength yam. In response, the Examiner states: Tyco teaches (see Fig. 9b) transverse members 7 6 extending across and within the central portion of the mesh to provide added structural strength to the mesh implant (page 20, lines 21- 23). Such higher strength transverse members 76 may connect and meet the outermost circumferential member 70 composed of high strength material as taught by Proxy (see above) to comprise at least one (i.e. one or more) high strength yam at the periphery. Ans. 4 (emphasis added). With regard to transverse members 7 6, the portion of Tyco cited by the Examiner states: The circumferential members can also be arranged to join with one another in order to form an integral mesh. Alternatively, the mesh may additionally comprise transverse members which extend across the circumferential members joining the circumferential members. The transverse members may extend radially from a central point to the perimeter of the implant. The transverse members may be arranged to provide substantially even structural strength and rigidity to the implant. Tyco, 20: 17-23. Although Tyco discloses that the transverse members provide substantially even structural strength, Tyco does not teach that the members themselves have a different strength than yam in any other portion of the mesh disclosed in Tyco, much less teach that the transverse members have a different strength than another yam within the central portion, as the claim requires. Accordingly, the Examiner's finding that Tyco discloses a central portion composed of at least two yams including at least one primary yam and at least one high strength yam is not supported by a preponderance 6 Appeal2014-003696 Application 12/986,203 of the evidence. Further, the Examiner has not explained whether it would have been obvious to provide two yams of different strength within the central portion of the implant disclosed in Tyco. Accordingly, we do not sustain the Examiner's rejection of claim 3 as unpatentable over Tyco and Proxy. Rejection (II) Claim 4, 17, and 18 Dependent claim 4 recites, "[ t ]he implant according to claim 1, wherein the at least one high strength yam has a tensile strength of at least 1 Gpa." Appeal Br. 15 (Claims App.). Dependent claims 17 and 18 recite, respectively, "[t] he implant according to claim 1, wherein the at least one high strength yam is a monofilament yam" and "[t]he implant according to claim 1, wherein the at least one high strength yam is a multifilament yam." Id. at 16. The Examiner relies on Snijder to teach "a surgical soft tissue mesh compnsmg a high strength yam having a tensile strength of at least l Gpa," monofilament yam, and multifilament yam. Final Act. 6. The Examiner reasons that it would have been obvious to further modify the proposed combination of Tyco and Proxy to have "a high strength yam having a tensile strength of at least 1 Gpa and being either a monofilament yam or multifilament yam as it would provide for high fatigue strength and either improved resistance to infectious matter or a softer and more flexible mesh, as taught by Snijder." Final Act. 6. Appellants argue that the Examiner's rationale for further modifying the proposed combination of Tyco and Proxy is deficient. Appeal Br. 9-10. Specifically, Appellants state, "a person of ordinary skill in the art would not have understood providing higher fatigue strength, improved resistance to 7 Appeal2014-003696 Application 12/986,203 infectious matter, or a softer and more flexible mesh to be issues that remained to be improved upon with respect to Proxy's implant." Appeal Br. 10. In this regard, Appellants contend that it would not have been obvious to "modify the implant of Tyco in view of Proxy to improve characteristics of the implant which have already been provided by the method of Proxy." Appeal Br. 10. In response, the Examiner states, "Snijder is cited as being a prior art reference that teaches the benefits of incorporating such additional specific tensile strengths and filamentary compositions to one of ordinary skill in the art." Ans. 5. We are not persuaded by Appellants' argument on this point. Snijder suggests that higher tensile strengths in a surgical soft tissue mesh are preferred. See Snijder i-f 11 (stating "[t]he mesh comprises polyethylene yams having a tensile strength of more than 1.0 GP a, preferably more than 1.5, 2.0 or even more than 3.0 GPa"). Snijder also discusses the advantages and disadvantages of each of monofilament and multifilament yam. Snijder i-f 13. Thus, the Examiner's reasoning is supported by rational underpinnings. Appellants do not explain persuasively why yam with a tensile strength as taught by Snijder would not benefit the Examiner's proposed combination of Tyco and Proxy. In this regard, we note that Proxy recognizes the importance of tensile strength in affecting performance of its soft tissue implant. See Proxy 27:4--7. Appellants identify no persuasive evidence that the teachings of Tyco or Proxy in any way conflict with further modifying the Examiner's proposed combination of Tyco and Proxy to provide the yams having a tensile strength of more than 1.0 GPa and 8 Appeal2014-003696 Application 12/986,203 monofilament or multifilament yam.6 Accordingly, we sustain the Examiner's rejection of claims 4, 17, and 18 as unpatentable over Tyco, Proxy, and Snijder. Rejection (III) Claim 19 recites, "[t ]he implant according to claim 1, wherein the at least one high strength yam is composed of ultra high molecular weight polyethylene." Appeal Br. 16. Claim 20 recites, "[t]he implant according to claim 1, wherein the at least one high strength yam is composed of high molecular weight polyethylene terephthalate." Id. Claim 24 recites, "[t]he implant according to claim 22, wherein the non-absorbable core is ultra high molecular weight polyethylene." Id. at 17. The Examiner finds that Shikinami discloses a woven or knitted implant material comprising polymer fiber components that may be composed of ultra high molecular weight polyethylene or high molecular weight polyethylene terephthalate in order to provide a body implant material having beneficial properties such as flexibility, abrasion resistance, impact absorbability, and durability for either replacement or substitution of soft tissue (Abstract; col. 2, lines 21-27). Final Act. 7. The Examiner further states: Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the device of Tyco in view of Proxy to have at least one high strength yam composed of ultra high molecular weight polyethylene or high molecular weight polyethylene terephthalate and a non- absorbable core comprising ultra high molecular weight 6 See Tyco 7: 13-19 (stating "[t]he strands of the wide-weave mesh may be formed by at least two filaments, the major spaces formed between the strands providing the surgical implant with the necessary strength, the filaments arranged such that pores are formed in the strands themselves. Alternatively the strands may be formed by monofilaments that are arranged to form loops that give rise to the pores in the strands"). 9 Appeal2014-003696 Application 12/986,203 polyethylene as it would provide for a body implant material having beneficial properties such as flexibility, abrasion resistance, impact absorbability, and durability for either replacement or substitution of soft tissue, as taught by Shikinami. Final Act. 7 (emphasis added). Appellants argue that the Examiner's rationale for combining Shikinami with the teachings of Tyco and Proxy is deficient. Appeal Br. 11. Specifically, Appellants contend that "Proxy describes methods of making soft tissue implants that have the 'beneficial properties' the Examiner asserts would be provided by the teachings of Shikinami," and "a person of ordinary skill in the art would not have understood providing an implant with those 'beneficial properties' to be an issue that remained to be improved upon with respect to Proxy's implant." Appeal Br. 11-12. We are not persuaded by Appellants' arguments. The Examiner found that the materials and fiber structure taught by Shikinami provide certain benefits. See Final Act. 7. Appellants identify no persuasive evidence that the teachings of Proxy and the above-noted teachings of Shikinami regarding materials and fiber structure in any way conflict or that the proposed combination of Tyco and Proxy would not benefit from incorporating these teachings from Shikinami as proposed by the Examiner. Accordingly, we sustain the Examiner's rejection of claims 19, 20, and 24 as unpatentable over Tyco, Proxy, and Shikinami. Rejection (IV) Appellants rely on the same arguments for the patentability of claim 23 as discussed above regarding the rejection of claim 1. See Appeal Br. 12-13. Accordingly, for the same reasons discussed above regarding the rejection of claim 1, we sustain the Examiner's rejection of claim 23 as unpatentable over Tyco, Proxy, and Ethicon. 10 Appeal2014-003696 Application 12/986,203 Rejection (V) Appellants rely on the same arguments for the patentability of claims 28-30 as discussed above regarding the rejection of claim 1. See Appeal Br. 13-14. Accordingly, for the same reasons discussed above regarding the rejection of claim 1, we sustain the Examiner's rejection of claims 28-30 as unpatentable over Tyco, Proxy, and Rabinowicz. DECISION (I) The Examiner's rejection of claims 1-3, 5-7, 14--16, 21, 22, and 25-27 as unpatentable over Tyco and Proxy is affirmed as to claims 1, 2, 5-7, 14--16, 21, 22, and 25-27, and is reversed as to claim 3. (II) The Examiner's rejection of claims 4, 17, and 18 as unpatentable over Tyco, Proxy, and Snijder is affirmed. (III) The Examiner's rejection of claims 19, 20, and 24 as unpatentable over Tyco, Proxy, and Shikinami is affirmed. (IV) The Examiner's rejection of claim 23 as unpatentable over Tyco, Proxy, and Ethicon is affirmed. (V) The Examiner's rejection of claims 28-30 as unpatentable over Tyco, Proxy, and Rabinowicz is affirmed. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R. § 1.136(a)(l )(iv). AFFIRMED-IN-PART 11 Copy with citationCopy as parenthetical citation