Ex Parte Cambronne et alDownload PDFPatent Trial and Appeal BoardMar 14, 201611780060 (P.T.A.B. Mar. 14, 2016) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE FIRST NAMED INVENTOR 111780,060 07/19/2007 62058 7590 03/16/2016 PAULY, DEVRIES SMITH & DEFFNER, L.L.C. TCF Tower-Suite 900 121 South 8th Street MINNEAPOLIS, MN 55402-2481 Matthew Cambronne 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. l 15.0242USU1 3354 EXAMINER ROE, JESSEE RANDALL ART UNIT PAPER NUMBER 1733 NOTIFICATION DATE DELIVERY MODE 03/16/2016 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): docketing@pdsdlaw.com kds@pdsdlaw.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte MATTHEW CAMBRONNE and BARRY O'BRIEN Appeal2014-007588 Application 11/780,060 Technology Center 1700 Before ROMULO H. DELMENDO, LINDA M. GAUDETTE, and ELIZABETH M. ROESEL, Administrative Patent Judges. ROESEL, Administrative Patent Judge. DECISION ON APPEAL Appellants 1 appeal under 35 U.S.C. § 134(a) from the Examiner's decision rejecting claims 1-13 and 88-127. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. 1 Appellants identify Boston Scientific Scimed, Inc. as the real party in interest. Br. 1. Appeal2014-007588 Application 11/780,060 STATEMENT OF THE CASE Claimed Invention Appellants claim a medical device. Claims 1, 9, and 88, the sole independent claims, are representative of the subject matter on appeal, and are reproduced below from Appellants' Claims Appendix: 1. A medical device, comprising: a eutectoid Ti or Zr alloy having at least two phases and including one or more of Ir, Pt, Cr, Au, Ag, Bi, Mn, Pd, Co, Ni, Cu, and Fe, the eutectoid Ti or Zr alloy having a eutectoid composition. 9. A medical device, comprising: a eutectoid alloy having a lamellae microstructure with a width of about 0.1 to about 10 microns. 88. A medical device comprising a metal mixture, the metal mixture comprising: a first phase consisting essentially of Ti or Zr; and a plurality of dispersed second phases within a matrix of the first phase, the second phases comprising at least one binary intermetallic compound, the at least one binary intermetallic compound comprising Ti or Zr and a first element selected from the group consisting of Ir, Pt, Cr, Au, Ag, Bi, Mn, Pd, Co, Ni, Cu, and Fe, the dispersed second phases having an average width of from approximately 0.1 µm to approximately 10 µm. Br. 12-14. Steinemann et al. Wood et al. Schutz et al. Van Dijk et al. Evidence us 4,040, 129 us 4,568,398 US 6,409,792 Bl US 7,087,077 Bl 2 Aug. 9, 1977 Feb.4, 1986 June 25, 2002 Aug. 8, 2006 ("Steinemann") ("Wood") ("Schutz") ("Van Dijk") Appeal2014-007588 Application 11/780,060 J.L. Murray, The Co-Ti (Cobalt-Titanium) System, 3(1) BULLETIN OF ALLOY PHASE DIAGRAMS 74-82 (1982) ("Murray I") J.L. Murray, The Ir-Ti (Iridium-Titanium) System, 3(2) BULLETIN OF ALLOY PHASE DIAGRAMS 205-211 (1982) ("Murray II") J.L. Murray, The Pd-Ti (Palladium-Titanium) System, 3(3) BULLETIN OF ALLOY PHASE DIAGRAMS 321-329 (1982) ("Murray III") Hugh Baker, ed., ASM HANDBOOK, Vol. 3 Alloy Phase Diagrams (1992) ("ASM Handbook") Giovanni D. De Palma et al., Plastic Prosthesis Versus Expandable Metal Stents for Palliation of Inoperable Esophageal Thoracic Carcinoma: A Controlled Prospective Study, 43(5) GASTROINTESTINAL ENDOSCOPY 478- 482 (1996) ("De Palma") The Rejections 1. Claims 1-7, 9-12, 88-101, 103-109, and 124-126 are rejected under 35 U.S.C. § 103(a) as unpatentable over ASM Handbook in view of Wood. Non-Final Action 3-6, 18-22.2 2. Claims 8, 13, and 127 are rejected under 35 U.S.C. § 103(a) as unpatentable over ASM Handbook in view of Wood, as applied to claims 1, 9, and 88, and further in view of De Palma. Id. at 7, 25-26. 3. Claims 110-117 and 119-126 are rejected under 35 U.S.C. § 103(a) as unpatentable over ASM Handbook in view of Wood, as applied to claim 88, and further in view of Steinemann. Id. at 22-25. 4. Claims 1-13, 88-98, and 102 are rejected under 35 U.S.C. § 103(a) as unpatentable over Schutz in view of De Palma. Id. at 7-11, 26-29. 2 Non-Final Action dated August 12, 2013. 3 Appeal2014-007588 Application 11/780,060 5. Claims 1, 3-11, 13, 88, 91-99, 102-104, 109-115, 118, 119, and 124-127 are rejected under 35 U.S.C. § 103(a) as unpatentable over Van Dijk. Id. at 11-18. ANALYSIS Appellants' arguments are directed to independent claims 1, 9, and 88 only. The dependent claims, including separately rejected dependent claims 8, 13, 110-117, and 119-127, are not separately argued. See Br. 2-11. As a consequence, the dependent claims stand or fall with their parent independent claims, and we confine our discussion to the independent claims. Obviousness over ASM Handbook and Wood-New Ground of Rejection The Examiner finds that the ASM Handbook discloses binary alloy phase diagrams for titanium-cobalt and other binary titanium alloys, each having a eutectoid composition. Non-Final Action 3 (claim 1 ), id. at 5 (claim 9), id. at 18 (claim 88). The Examiner finds that Wood discloses titanium alloys containing one or more other metals, such as cobalt, for fabrication of orthopaedic endoprostheses. Id. (citing Wood 1:4-13, 2:27- 40). The Examiner concludes that it would have been obvious to use binary titanium alloys, including eutectoid alloys, as disclosed by the ASM Handbook, for fabrication of orthopaedic endoprostheses, as disclosed in Wood. Id. at 3--4, 5-6, 18-19. The Examiner determines that, because the ASM Handbook in view of Wood teaches substantially the same composition and processing as Appellants, such alloys would have been expected to have the properties 4 Appeal2014-007588 Application 11/780,060 recited in each of claim 1 (at least two phases), claim 9 (lamellae microstructure with a width of about 0.1 to about 10 microns), and claim 88 (the dispersed second phases having an average width of from approximately 0.1 µm to approximately 10 µm). Id. at 4, 6, 19; see also Ans. 5, 20-21 (width limitations of claims 9 and 88 "would naturally flow from the teachings of the prior art"). With respect to claim 88, the Examiner further finds that Wood discloses processing steps that would have resulted in the first and second phases, as recited in the claim, and also discloses a range of solid phase sizes that encompasses the recited range. Non-Final Action at 19 (citing Wood 3:43-68). Appellants argue that neither the ASM Handbook nor Wood discloses, suggests, or renders obvious a eutectoid alloy in a medical device. Br. 4-6 (claim l); id. at 7 (claim 9); id. at 10 (claim 88). Appellants further argue that the recited lamellae microstructure (claim 9) and second phase size / 1. {"){")"\ ~. 1 ~ ~· .. 11 1 • ~ ~ • 1 ~crn1m l'Sl'SJ are nm mnerem propen1es ror auoys navmg a emecw10 composition. Id. at 7, 10. Appellants acknowledge that Figure 1 of Wood is a phase diagram for a Ti-Co system having a eutectoid point at about 8 atomic percent cobalt. Br. 5. Appellants nevertheless argue that Wood does not disclose or suggest a binary alloy of Ti and Co having a composition of 8 atomic percent cobalt, citing Wood's teaching of an "optimum region" in the phase diagram that does not include the eutectoid point. Id. (citing Wood Fig. 1, 5: 14-17). We are not persuaded. A preponderance of the evidence supports the Examiner's finding that Wood discloses a range of titanium alloy compositions that includes Appellants' claimed alloys, and Appellants fail to 5 Appeal2014-007588 Application 11/780,060 establish criticality for their selected composition. Ans. 36-38.3 More particularly, Wood discloses a binary alloy of titanium (Ti) and cobalt (Co) containing 10 wt.% to 23 wt.% cobalt. Wood 2:41-47. Using a weight percent to atomic percent converter, http://www.asminternational.org/asnienterprise/apdlJYeightConverter.aspx, we find that the lower end of Wood's disclosed range (10 wt.% cobalt) corresponds to 8.28 atomic percent cobalt. Wood thus discloses a range that includes a binary alloy of Ti and Co containing 8 atomic percent cobalt, which Appellants acknowledge is a eutectoid alloy having a eutectoid composition. Br. 5. Although Wood discloses an "optimum region" of the phase diagram that does not include the eutectoid point, Wood Fig. 1, 5: 14- 17, Wood also teaches a range of binary titanium-cobalt alloy compositions that includes a eutectoid alloy having a eutectoid composition, id. at 2:41- 47. A. 1 • 1 ~ 1 1 • 1 I' "T"T T 1 1 • 1 • ~ • • ~ 1 Accormng1y, me msc10sures or w ooa, a10ne or m comomanon wnn the ASM Handbook, are sufficient to establish prima facie obviousness of a medical device comprising a eutectoid alloy composition. In re Malagari, 499 F.2d 1297, 1303 (CCPA 1974) (claimed invention is rendered prima facie obvious by the teachings of a prior art reference that discloses a range that touches the range recited in the claim). Appellants do not attempt to rebut prima facie obviousness, arguing instead that they do not need to establish criticality or unexpected results for the claimed eutectoid alloys in 3 The Answer cites Murray I to show a phase diagram and eutectoid points for a titanium-cobalt alloy. Ans. 35-37. We find it unnecessary to rely on Murray I, however, because Wood Figure 1 discloses a titanium-cobalt phase diagram with a eutectoid point at 8 atomic percent cobalt. 6 Appeal2014-007588 Application 11/780,060 medical devices. Br. 5-6. Regarding claims 9 and 88, Appellants argue that the microstructure limitations are not inherent properties of eutectoid alloys, asserting: "While an alloy composition can impact the microstructure of a material, the heat treatments, cooling rates, and working of an alloy will impact the sizes of the lamellae in metal alloy." Br. 7. The Examiner, however, finds that Appellants' Specification teaches that aging treatments can be used to control the lamellae width, length, and microstructure, but does not indicate that the recited microstructure would not be present without aging treatments or heat treatments. Ans. 46 (citing Spec. 24). Appellants' cursory argument is not sufficient to identify reversible error in the Examiner's finding that the microstructure recited in claims 9 and 88 would flow naturally from the binary alloy composition and processing steps disclosed in Wood. Ans. 5, 20-21. At best, Appellants identify three factors-heat treatments, cooling rates, and working of a metal alloy-that will impact the sizes of the lamellae. Br. 7, 10 ("same reasons discussed above"). Appellants do not, however, assert that the heating, cooling, and working steps disclosed in Wood, Wood 2:41--47, 3:34-57, would not result in a microstructure that satisfies the limitations of claims 9 and 88. Appellants also do not distinguish the microstructure limitations of claims 9 and 88 from the microstructure described in Wood. Id. at 1 :55-66, 3:58-68. We are persuaded that the Examiner's findings are sufficient to support a reasonable inference that a binary titanium alloy as taught and suggested by Wood would have a microstructure as recited in claims 8 and 88, and Appellants' arguments are not sufficient to persuade us, either that the Examiner's basis is unsound or that the claimed microstructure differs 7 Appeal2014-007588 Application 11/780,060 from the microstructure of prior art alloys. In re Spada, 911 F.2d 705, 708 (Fed. Cir. 1990) ("when the PTO shows sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not"); Ex parte Obiaya, 227 USPQ 58, 60 (BP AI 1985) ("The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious."). We therefore affirm the obviousness rejections based upon the ASM Handbook and Wood. Because the Examiner does not rely on the titanium- cobalt binary phase diagram in Wood Figure 1 or Wood's disclosure of a binary titanium-cobalt alloy containing 10 to 23 wt.% cobalt, Wood 2:41- 4 7, and does not calculate the atomic percent cobalt based on the lower end of this range or the weight percent cobalt based on the eutectoid point shown • "T"T T 1 T""'I • '1 1 • ~ 1"1"9 I" ~ 1 -y--i • ' m w ooa t< igure i, we aes1gnaie our arnrmance or me bXammer s obviousness rejections based on the ASM Handbook and Wood as a new ground of rejection. 37 C.F.R. § 41.50(b). Obviousness over Schutz and De Palma The Examiner finds that Schutz discloses titanium-iridium master alloys containing 0.5 to 61 weight percent iridium, Schutz 3:54-4:4, and that Schutz Figure 2 and Table 3 disclose that this range includes a eutectoid alloy having a eutectoid composition having at least two phases. Non-Final Action 8 (claim 1), id. at 9-10 (claim 9), id. at 27 (claim 88). The Examiner finds that De Palma teaches that titanium-based alloy stents have favorable properties, including cross-sectional elasticity allowing compression of the 8 Appeal2014-007588 Application 11/780,060 prosthesis into small delivery systems and reduced complications and mortality related to implantation. Id. at 8, 10, 27 (citing De Palma Abstract and page 479, left column). The Examiner concludes that it would have been obvious to use the titanium-based alloys, as disclosed in Schutz, in prosthetic applications including stents, as disclosed in De Palma, in order to obtain the favorable properties disclosed by De Palma. Id. at 8-9, 10, 27- 28. The Examiner determines that, because Schutz and Appellants disclose the same composition and substantially similar processing, Schutz' s disclosed alloys would have been expected to have a microstructure meeting the width limitations of claims 9 and 88. Id. at 10, 28; see also Ans. 10, 29- 30 (width limitations of claims 9 and 88 "would naturally flow from the teachings of the prior art"). Appellants argue that neither Schutz nor De Palma discloses, suggests, or renders obvious a eutectoid alloy in a medical device. Br. 6 (claim 1 ); id. at 7-8 (claim 9); id. at 10 (claim 88). Appellants further argue that the recited lamellae microstructure (claim 9) and second phase size (claim 88) are neither disclosed, nor inherent in the combination of Schutz and De Palma. Id. at 8, 10. We are not persuaded. A preponderance of the evidence supports the Examiner's finding that Schutz discloses a range of titanium alloy compositions that includes Appellants' claimed alloys, and Appellants fail to establish criticality for their selected composition. Ans. 41-42. 4 More 4 The Answer cites Murray II to show a phase diagram and eutectoid points for a titanium-iridium alloy. Ans. 40--42. We find it unnecessary to rely on Murray II, however, because Schutz Figure 2, which was cited by the 9 Appeal2014-007588 Application 11/780,060 particularly, Schutz Table 3 discloses binary titanium-iridium (Ti-Ir) alloys containing 10 wt.% and 20 wt.% iridium, respectively, and shows that these two alloys have favorable properties (gross impact toughness and as-cast button condition), as compared with alloys containing a higher percentage of iridium. Schutz 7:55-8: 17 (Table 3); see also id. at 8:55-66 (Table 4 listing desirable features of disclosed Ti-Ir alloys). Schutz Figure 2 is a titanium- iridium binary alloy phase diagram showing a eutectoid point at 1 7 wt.% iridium and a preferred range of compositions from 10 wt.% to 5 8 wt.% iridium. Id. Fig. 2. Thus, Appellants' claimed eutectoid alloys fall squarely within a range of preferred compositions disclosed by Schutz, yet Appellants do not show criticality, e.g., unexpected results, for their claimed compositions. In re Geisler, 116 F.3d 1465, 1469, 1470 (Fed. Cir. 1997) (when the prior art discloses a range that touches or overlaps the range recited in the claim, the burden is on applicant to rebut prima facie 1 • 1 1 • ~ 1 ~· ·~1. ~1 1 • 1 oov10usness, e.g., oy snowmg unexpeciea propen1es wnnm me crn1mea range). Appellants do not dispute the Examiner's conclusion that De Palma's disclosure that titanium-based alloys are useful in stents, De Palma 4 79, is sufficient to suggest that titanium-iridium alloys, such as those disclosed in Schutz, be used in stents. Non-Final Action 8-9, 10, 27-28. Appellants' argument that De Palma does not disclose or suggest that a eutectoid alloy should be selected, Br. 6, is not persuasive because selection of a eutectoid composition would have been obvious in view of Schutz for the reasons Examiner, discloses a titanium-iridium phase diagram with a eutectoid point at 17 wt.% iridium. 10 Appeal2014-007588 Application 11/780,060 discussed above. Regarding claims 9 and 88, Appellants repeat their argument that the microstructure limitations are not inherent properties of eutectoid alloys. Compare Br. 8 (discussing impact of heat treatments, cooling rates, and working of an alloy on sizes of the lamellae), with id. at 7 (same). Appellants' argument is not persuasive of reversible error for the reasons discussed in the preceding section. See pages 7-8, supra. Appellants do not assert that the processing steps disclosed in Schutz, Schutz 3:54-64, 6:40- 47, would not result in a microstructure that satisfies the limitations of claims 9 and 88, nor explain how or why that is the case. We therefore sustain the rejections of claims 1-13, 88-98, and 102 as unpatentable over Schutz in view of De Palma. Obviousness over Van Dijk The Examiner finds that Van Dijk discloses a stent manufactured from an alloy containing one or more of gold, platinum, palladium, and silver, where the alloy may also contain up to 30 weight percent iridium, up to 40 weight percent titanium, and up to 5 weight percent zirconium, citing Van Dijk Abstract, 2:64-65, 3:5-6, and 3:50-51. Non-Final Action 11(claims1 and 88), id. at 13 (claim 9). The Examiner cites Murray III to show a phase diagram and eutectoid points for a titanium-palladium alloy. Ans. 43--45, 50-52 (reproducing Fig. 1 and Table 1 of Murray III). According to the Examiner, Murray III shows there would be at least two eutectoid points within the ranges disclosed by Van Dijk. Id. at 43--44. The Examiner determines that, because Van Dijk discloses substantially the same composition and substantially similar processing as Appellants, Van Dijk's 11 Appeal2014-007588 Application 11/780,060 disclosed alloys would have been expected to have the phases and microstructure recited in each of claims 1, 9, and 88. Non-Final Action 11- 13; see also Ans. 48, 53 (width limitations of claims 9 and 88 "would naturally flow from the teachings of the prior art"). Appellants argue that Van Dijk discloses alloys including at least 60 weight percent gold, platinum, palladium, or silver, and optionally including up to 30 weight percent iridium, up to 40 weight percent titanium, and up to 5 weight percent zirconium, but does not disclose or suggest a eutectoid alloy or eutectoid composition. Br. 6 (claim 1 ), id. at 8 (claim 9). Regarding claim 88, Appellants argue that an alloy including a majority of gold, silver, platinum, or palladium, as disclosed in Van Dijk, cannot possibly include a primary phase that consists essentially of titanium as well as the recited binary intermetallic compounds. Id. at 10. According to Appellants, the intermetallic compound ThAg by itself exceeds Van Dijk' s 40 weight percent limit for the amount of Ti in the alloy. Id. Appellants further argue that the recited lamellae microstructure (claim 9) and second phase size (claim 88) are neither disclosed, nor inherent in the alloys of Van Dijk. Id. at 8-10. We are not persuaded. A preponderance of the evidence supports the Examiner's finding that Van Dijk discloses a range of compositions that would include eutectoid compositions, and Appellants fail to establish criticality for their selected composition. Ans. 43--44, 46. More particularly, Table 1 of Murray III lists two eutectoid points, one at 595°C and another at 820 or 805°C. Figure 1 of Murray III shows that the second of these eutectoid points has a composition of 65 weight percent palladium and 35 weight percent titanium, as shown below: 12 Appeal2014-007588 Application 11/780,060 The Pd ... Ti (PaHadium*Titanium) System Figure 1 of Murray III, above, is annotated by the Board to identify the two eutectoid points listed in Table 1 of Murray III and the composition of the second eutectoid point, as found by the Examiner, Ans. 43. 5 Appellants do not dispute that a eutectoid composition of 65 weight percent palladium and 35 weight percent titanium is within the range of compositions disclosed by Van Dijk. Yet Appellants do not show criticality, e.g., unexpected results, for this or any other composition within the scope of claims 1 and 9. In re Geisler, 116 F.3d at 1469, 1470. As correctly noted by the Examiner, Figure 1 and Table 1 of Murray 5 The Examiner finds that, according to Figure 1 and Table 1 of Murray III, a titanium-palladium alloy has a eutectoid point at 64.5 weight percent palladium. Ans. 43. 13 Appeal2014-007588 Application 11/780,060 show that, at the second eutectoid point (at 820 or 805°C), beta titanium (BTi) is in equilibrium with two binary intermetallic compounds of titanium and palladium (TbPd and aTiPd). Ans. 53; Murray III, Fig. 1 and Table 1. Appellants submit no reply brief and do not contest the Examiner's finding that this equilibrium composition satisfies the first phase and plurality of second phases recited in claim 88. Ans. 53. Appellants' argument that the intermetallic compound ThAg contains more than Van Dijk's upper limit of 40 wt.% titanium is not persuasive because that compound is nowhere disclosed or claimed by Appellants. Cf Br. 15 (claim 98) and Spec. 3 :28 (listing TbAg, not ThAg). Moreover, that argument does not identify error in the Examiner's finding that Van Dijk's disclosed ranges encompass a eutectoid composition containing 65 weight percent palladium and 35 weight percent titanium and two binary intermetallic compounds (Ti2Pd and aTiPd). Ans. 51-53. Regarding claims 9 and 88, Appellants repeat their argument that the microstructure limitations are not inherent properties of eutectoid alloys. Compare Br. 9 (discussing impact of heat treatments, cooling rates, and working of an alloy on sizes of the lamellae ), with id. at 7 (same). Appellants' argument is not persuasive of reversible error for the reasons discussed above. See pages 7-8, supra. Appellants do not assert that the melting, cooling, tempering, and working steps disclosed in Van Dijk, Van Dijk 4:45-60, would not result in a microstructure that satisfies the limitations of claims 9 and 88, nor explain how or why that is the case. We therefore sustain the rejection of 1, 3-11, 13, 88, 91-99, 102-104, 109-115, 118-119, and 124-127 over Van Dijk. 14 Appeal2014-007588 Application 11/780,060 ORDER The rejections of claims 1-13, 88-101, 103-117, and 119-127 based on the ASM Handbook and Yoon are affirmed and designated a new ground of rejection pursuant to 37 C.F.R. § 41.50(b). The rejections of claims 1-13, 88-98, and 102 over Schutz and De Palma are affirmed. The rejection of claims 1, 3-11, 13, 88, 91-99, 102-104, 109-115, 118, 119, and 124-127 over Van Dijk is affirmed. 37 C.F.R. § 41.50(b) provides that the appellant, WITHIN TWO MONTHS FROM THE DATE OF THE DECISION, must exercise one of the following two options with respect to the new grounds of rejection to avoid termination of the appeal as to the rejected claims: (1) Reopen prosecution. Submit an appropriate amendment of the claims so rejected or new evidence relating to the claims so rejected, or both, and have the matter • 1 1 1 ~1 • • 1 • 1 ~ ~1 ~. recons10erea oy me exammer, m wmcn evem me prosecunon will be remanded to the examiner. ... (2) Request rehearing. Request that the proceeding be reheard under§ 41.52 by the Board upon the same record .... No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136 AFFIRMED; 37 C.F.R. § 41.50(b) 15 Copy with citationCopy as parenthetical citation