Ex Parte Stopek et alDownload PDFPatent Trial and Appeal BoardAug 9, 201612721937 (P.T.A.B. Aug. 9, 2016) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 121721,937 03/11/2010 50855 7590 08/11/2016 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-02029 (203-6825) 2106 EXAMINER HARVEY, TIJLIANNA NANCY ART UNIT PAPER NUMBER 3733 NOTIFICATION DATE DELIVERY MODE 08/11/2016 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 and JONATHAN D. THOMAS 1 Appeal 2014-004883 Application 12/721,937 Technology Center 3700 Before EDWARD A. BROWN, AMANDA F. WIEKER, and SEAN P. O'HANLON, Administrative Patent Judges. WIEKER, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Joshua Stopek and Jonathan D. Thomas ("Appellants") appeal under 35 U.S.C. § 134(a) from the Examiner's final rejection of claims 1, 4-8, and 11-19. 2 We have jurisdiction over the appeal under 35 U.S.C. § 6(b). We REVERSE. 1 According to Appellants, the Real Party in Interest is Covidien LP. Appeal Br. 2. 2 Claims 2, 3, 9, and 10 have been cancelled. Id. Appeal2014-004883 Application 12/721,93 7 CLAIMED SUBJECT MATTER The invention concerns "degradable implants, and more specifically, [] medical devices having more than one degradation zone." Spec. 1. Claims 1 and 19 are illustrative of the subject matter on appeal, and recite: 1. A fixation device comprising at least two homogeneous degradation zones fabricated from polymeric materials that are not reinforced with ceramic or particulate fillers, the at least two homogeneous degradation zones including a first degradation zone having a first degradation rate and a second degradation zone having a second degradation rate that is different from the first degradation rate, and an interphase providing a gradient or gradual transition between the first degradation zone and the second degradation zone, wherein a region of the interphase closer to the first homogeneous degradation zone comprises more of the polymeric material of the first degradation zone than a region of the interphase closer to the second homogeneous degradation zone. 19. A fixation device comprising at least two homogeneous degradation zones fabricated from polymeric materials that are not reinforced with ceramic or particulate fillers, the at least two homogeneous zones including a first degradation zone comprising a copolymer having a first ratio of monomers and a second degradation zone comprising the copolymer at a second ratio of monomers that is different from the first ratio of the first degradation zone, and an interphase providing a transition between the first degradation zone and the second degradation zone, wherein a region of the interphase proximal to the first homogeneous degradation zone comprises a ratio of 2 Appeal2014-004883 Application 12/721,93 7 monomers of the copolymer closer to the first ratio of the copolymer of the first degradation zone and a region of the interphase proximal to the second homogeneous degradation zone comprises a ratio of monomers of the copolymer closer to the second ratio of the second degradation zone. Appeal Br. 16, 18 (Claims App.) (emphases and paragraph structure added). REJECTIONS The claims stand rejected as follows: I. Claims 1, 4---6, 11, 12, and 14--18 under 35 U.S.C. § 103(a) as unpatentable over Athanasiou (US 6,013,853, iss. Jan. 11, 2000), Brown (US 6,626,950 B2, iss. Sept. 30, 2003), Jarrett (US 5,342,395, iss. Aug. 30, 1994), and Leitao (US 6,069,295, iss. May 30, 2000). 3 II. Claims 7, 8, and 13 under 35 U.S.C. § 103(a) as unpatentable over Athanasiou, Brown, Jarrett, Leitao, and uave (US 2005/0267565 Al, pub. Dec. 1, 2005). III. Claim 19 under 35 U.S.C. § 103(a) as unpatentable over Athanasiou, Brown, Leitao, Walter (US 2001/0051833 Al, pub. Dec. 13, 2001), and Alford (US 2005/0090828 Al, pub. Apr. 28, 2005). 3 Although the Examiner lists claim 13 as part of Rejection I, the subject matter of claim 13 is addressed in the rejection over Athanasiou, Brown, Jarrett, Leitao, and Dave (Rejection II). See Final Act. 5-7. 3 Appeal2014-004883 Application 12/721,93 7 ANALYSIS Re} ections I-II Independent claim 1 requires, inter alia, "an interphase providing a gradient or gradual transition" between the claimed first and second degradation zones, wherein the portion of the interphase that is closer to the first zone comprises more of the first zone's polymeric material than the portion of the interphase that is closer to the second zone. Appeal Br. 16 (Claims App.). The Examiner finds Athanasiou discloses, inter alia, first and second degradation zones (12, 14) formed from polymeric materials that lack ceramic or particulate filler reinforcement, as claimed. Final Act. 2 (citing Athanasiou, 10:61-11 :4). The Examiner finds Athanasiou fails to disclose, inter alia, the claimed interphase, but finds Leitao teaches an interphase that "provides a gradient or gradual transition between [its] first and second zones, wherein a region of the interphase closer to the first zone comprises more of the material of the first zone than a region of the interphase closer to the second zone." Id. at 3--4 (citing Leitao, 6:59-7:19). The Examiner also finds Brown teaches an interphase (26) that "creates a strong mechanical junction while simultaneously providing a gradual change in material properties for the purpose of regenerating different tissues in intimate contact with one another." Id. at 4 (citing Brown, 3:49-55, Fig. 1). The Examiner concludes it would have been obvious to a person of ordinary skill in the art to modify Athanasiou to include an interphase that provides "a gradient or gradual transition between [Athanasiou's first and second zones] wherein a region of the interphase closer to the first 4 Appeal2014-004883 Application 12/721,93 7 homogeneous degradation zone comprises more of the polymeric material of the first degradation zone than a region of the interphase closer to the second homogeneous degradation zone," as taught by Leitao, in order to "create a strong mechanical junction while simultaneously providing a gradual change in material properties for the purpose of regenerating different tissues in intimate contact with one another, as taught by [Brown]." Id. at 5. Appellants contend that the asserted prior art fails to teach the claimed interphase. Appeal Br. 6. Specifically, Appellants argue Leitao discloses a calcium phosphate coating on a titanium substrate, which is formed by "the reaction chemistry between the calcium phosphate (i.e., a ceramic) and the titanium (i.e., a non-degradable, non-polymeric material)." Id. at 7-8. According to Appellants, "a person of ordinary skill in the art would not have understood Leitao to have taught a gradual transition between any two different materials, but rather, a gradual transition of calcium and phosphorous from a calcium phosphate coating to a substrate." Reply Br. 2. Furthermore, Appellants argue that if the references were combined as proposed by the Examiner, the combination "would produce an implant including the implant materials of Athanasiou having the surface roughness of Leitao so that the implant can 'very efficiently be coated with a layer of calcium phosphate, either in vitro, or in vivo."' Id. at 3 (citing Leitao, 2: 16- 17). The Examiner responds that Appellants' claim 1 does not limit the process used to create the interphase 's gradual transition, and that a person skilled in the art "would know how to combine the materials in the zones of [Athanasiou] to create the gradual transition." Ans. 10. Further, the 5 Appeal2014-004883 Application 12/721,93 7 Examiner responds that "Leitao was not relied upon for the teaching of specific materials but was instead relied upon to teach providing a gradual transition between two different materials." Id. We agree with Appellants. Leitao discloses a solid implant having a particular surface roughness such that, when placed in solutions of bone- forming components, a coating of calcium phosphate forms on the implant's surface. Leitao, 1:37--42, 2:15-17. 4 Leitao discloses that, in one example, the depth profile of this surface coating presents "a gradual transition of calcium and phosphorous from the coating to the substrate, indicating the incorporation of these elements in the surface (oxide layer), and thus a chemical bonding between coating and substrate." Id. at 6:59---67; see also id. at 7 :21-23. The portions of Leitao cited by the Examiner do not disclose a "gradual transition between two different materials," as the Examiner asserts (Ans. 10). Instead, Leitao teaches a surface coating on a substrate (i.e., on a solid implant), but does not teach a "gradual transition" between different zones in that underlying substrate. Therefore, we agree with Appellants that if the references were combined as proposed by the Examiner, the result would be to modify Athanasiou's implant to include a coating, as taught by Leitao, bonded to Athanasiou's implant. This combination does not satisfy claim 1 's requirement that the device include "an interphase providing a gradient or gradual transition" between the claimed first and second degradation zones. Accordingly, we cannot sustain the Examiner's rejection of independent claim 1, or the rejections of 4 Contrary to Appellants' suggestion, (Appeal Br. 8), Leitao's implant may be formed from "biodegradable polymers." Leitao, 1:66-2:9. 6 Appeal2014-004883 Application 12/721,93 7 dependent claims 4--8 and 11-18, which depend directly or indirectly from claim 1. Re} ection III Independent claim 19 requires, inter alia, "an interphase providing a transition" between the claimed first and second degradation zones, wherein the portion of the interphase proximal the first zone comprises a ratio of monomers closer to the first zone's ratio and the portion of the interphase proximal the second zone comprises a ratio of monomers closer to the second zone's ratio. Appeal Br. 18 (Claims App.). The Examiner finds Athanasiou discloses, inter alia, first and second degradation zones formed from polymeric materials that lack ceramic or particulate filler reinforcement, as claimed. Final Act. 7. The Examiner relies on Leitao and Brown, as in claim 1, as teaching an interphase. The Examiner also relies on Alford as teaching "a device made from a copolymer comprising PGA and PLA has a PLA to PGA ratio of 82: 18 as such a ratio is advantageous when the surrounding tissue is bone," and relies on Walter as teaching "a device made from a copolymer comprising PGA and PLA has a PLA to PGA ratio of 7 5 :25 as such a ratio is advantageous when the surrounding tissue is cartilage." Id. at 8 (citing Alford i-f 29; Walter ,-r 72). The Examiner concludes it would have been obvious to a person of ordinary skill in the art to modify Athanasiou to include an interphase that provides "a transition between [Athanasiou's first and second zones] wherein a region of the interphase proximal to the first homogeneous degradation zone comprises more of the polymeric material of the first 7 Appeal2014-004883 Application 12/721,93 7 degradation zone than a region of the interphase closer to the second homogeneous degradation zone," and vice versa with respect to the second homogenous degradation zone, as taught by Leitao, in order to "create a strong mechanical junction while simultaneously providing a gradual change in material properties for the purpose of regenerating different tissues in intimate contact with one another, as taught by [Brown]." Id. at 8-9. The Examiner also concludes it would have been obvious to a person of ordinary skill in the art to modify Athanasiou, in light of Alford and Walter, "such that the second ratio of monomers is different from the first ratio of monomers ... as the different ratios are advantageous for different types of tissue, such as bone and cartilage," which would lead to the distribution of monomer ratios as claimed. Id. at 9. Appellants rely on the arguments presented, and found persuasive, with respect to claim 1, and contend that Alford and Walter fail to cure the deficiencies of Athanasiou, Brown, and Leitao. Appeal Br. 13-14. We agree with Appellants for the reasons discussed with respect to claim 1, namely, that Athanasiou, Brown, and Leitao fail to render obvious "an interphase providing a transition" between the claimed first and second degradation zones. The Examiner's application of Alford and Walter does not cure these deficiencies. Accordingly, we cannot sustain the Examiner's rejection of claim 19. DECISION The rejections of claims 1, 4--8, and 11-19 are REVERSED. REVERSED 8 Copy with citationCopy as parenthetical citation