Ex Parte Gunday et al

Patent Trial and Appeal BoardNov 30, 2018

12906736 (P.T.A.B. Nov. 30, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 12/906,736 10/18/2010 151971 7590 12/04/2018 Forge IP, PLLC 1077 Bridgeport Ave Suite 301 Shelton, CT 06484 UNITED ST A TES OF AMERICA FIRST NAMED INVENTOR Erhan H. Gunday 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. 04530-P0012A 1675 EXAMINER NEAL, TIMOTHY JAY ART UNIT PAPER NUMBER 3795 NOTIFICATION DATE DELIVERY MODE 12/04/2018 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): patent@forge-ip.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte ERHAN H. GUNDA Y and LAWRENCE J. GERRANS Appeal2017-002399 Application 12/906, 73 6 Technology Center 3700 Before WILLIAM A. CAPP, BRANDON J. WARNER, and ERIC C. JESCHKE, Administrative Patent Judges. CAPP, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Appellants seek our review under 35 U.S.C. Â§ 134(a) of the final rejection of claims 1-10, 13-26, and 40. We have jurisdiction under 35 U.S.C. Â§ 6(b). We AFFIRM. Appeal2017-002399 Application 12/906,736 THE INVENTION Appellants' invention relates to guide wires for catheters. Spec. ,r 1. Claim 1, reproduced below, is illustrative of the subject matter on appeal. 1. An anchored guide wire for use in a bodily cavity compnsmg: at least one expansion apparatus; a mesh disposed on and fixedly mounted to an outer wall of said at least one expansion apparatus, wherein the mesh creates a textured surface that prevents slippage of the expansion apparatus on surrounding tissue and wherein said mesh extends around an entire circumference of the apparatus when the apparatus is in an expanded state; an elongated guide wire having at least one lumen therein for supplying fluid to said at least one expansion apparatus; and a pump that supplies fluid to said lumen to inflate said at least one expansion apparatus. THE REJECTIONS The Examiner relies upon the following as evidence in support of the rejections: Cohen Todd Marcadis Bertolero Durcan Mashimo Saadat us 5,167,239 us 5,423,745 us 5,720,726 US 2005/0159645 Al US 2007/0142771 Al WO 2008/042347 A2 US 2010/0004506 Al Dec. 1, 1992 June 13, 1995 Feb.24, 1998 July 21, 2005 June 21, 2007 Apr. 10, 2008 Jan. 7,2010 The following rejections are before us for review: 1. Claims 1, 10, 13, 20, 23, and 24 are rejected are rejected under 35 U.S.C. Â§ I03(a) as being unpatentable over Todd and Durcan. 2. Claims 2-9 are rejected are rejected under 35 U.S.C. Â§ I03(a) as being unpatentable over Todd, Durcan, and Saadat. 2 Appeal2017-002399 Application 12/906,736 3. Claims 14, 15, 18, 19, 22, and 40 are rejected under 35 U.S.C. Â§ 103(a) as being unpatentable over Todd, Durcan, and Mashimo. 4. Claims 16 and 17 are rejected under 35 U.S.C. Â§ 103(a) as being unpatentable over Todd, Durcan, and Bertolero. 5. Claims 21 and 25 are rejected under 35 U.S.C. Â§ 103(a) as being unpatentable over Todd, Durcan, and Cohen. 6. Claim 26 is rejected under 35 U.S.C. Â§ 103(a) as being unpatentable over Todd, Durcan, Cohen, and Saadat. 7. Claims 1, 10, 13, 20, 23, and 24 are rejected are rejected under 35 U.S.C. Â§ 103(a) as being unpatentable over Marcadis and Todd. 8. Claims 2-9 are rejected are rejected under 35 U.S.C. Â§ 103(a) as being unpatentable over Marcadis, Todd, and Saadat. 9. Claims 14, 15, 18, 19, 22, and 40 are rejected under 35 U.S.C. Â§ 103(a) as being unpatentable over Marcadis, Todd, and Mashimo. 10. Claims 16 and 17 are rejected under 35 U.S.C. Â§ 103(a) as being unpatentable over Marcadis, Todd, and Bertolero. 11. Claims 21 and 25 are rejected under 35 U.S.C. Â§ 103(a) as being unpatentable over Marcadis, Todd, and Cohen. 12. Claim 26 is rejected under 35 U.S.C. Â§ 103(a) as being unpatentable over Marcadis, Todd, Cohen, and Saadat. OPINION Unpatentability of Claims 1-10, 13-26, and 40 over Combinations Based on Todd and Durcan Appellants argue all pending claims rejected over combinations based on Todd and Durcan (grounds 1---6 above) as a group. Appeal Br. 7-12. We select claim 1 as representative. See 37 C.F.R. Â§ 4I.37(c)(l)(iv). 3 Appeal2017-002399 Application 12/906,736 The Examiner finds that Todd discloses the invention except for a mesh that is separate from the expandable member, for which the Examiner relies on Durcan. Final Action 2-3. The Examiner concludes that it would have been obvious to a person of ordinary skill in the art at the time of the invention to attach a mesh to Todd's balloon as taught by Durcan. Id. at 3. According to the Examiner, a person of ordinary skill in the art would have done this as it merely entails use of an old and well-known technique of securely attaching layers to a balloon and it provides a highly predictable means to create a textured surface on the balloon. Id. Appellants argue that Todd does not explicitly disclose a mesh disposed on and fixedly mounted to a balloon as claimed. Appeal Br. 8. Appellants argue that Durcan merely discloses a multi-layered balloon, the objective of which is to produce a balloon that has noncompliant limited radial expansion to prevent rupture during an angioplasty procedure. Id. at 9. Appellants contend that Durcan does not teach that any of the balloon layers comprise a "mesh." Id. Finally, even if Durcan is found to disclose a mesh, Appellants argue that the Examiner has not provided an adequate reason as to why a person of ordinary skill in the art would have modified Todd with the teachings of Durcan in the manner proposed by the Examiner. Id. at 10. In response, the Examiner states that Durcan is merely used to teach making a balloon from multiple layers instead of a single layer. Ans. 24. However, the crux of the Examiner's Answer is perhaps best relayed using the Examiner's own words: A person having ordinary skill in the art would need to identify the difference between Todd and the claimed invention. That difference is Todd's mesh structure is arguably part of the 4 Appeal2017-002399 Application 12/906,736 balloon and not a separate structure. The next question is whether or not that difference is non-obvious. The Examiner holds that because it is known in the art to make multi-layer balloons, the difference is obvious. Simple substitution of one known element for another to obtain predictable results (see MPEP 2143.I.B). Going from a single layer to a dual layer balloon does not yield different results. Applicant has not argued that the claimed device ( or disclosed device) solves some problem not addressed by Todd. Both devices provide the same function (anti-slip) in the same manner ( an exterior mesh). Using a separate mesh layer also allows for a different material to be used for the mesh and for different manufacturing techniques used to create the mesh. The primary issue for the Examiner is that Todd discloses a substantially similar balloon having a gripping structure for performing the exact same function as Applicant's device. The gripping structure in Figs. 6 ( and 7) appear to be separate structures from the balloon itself ( the figures suggests a sleeve is slipped around the balloon). Todd does not provide much direction as to how to make ... the protuberances and requires only that they project outwardly from the outer surface of the balloon (see Col 6 Lines 58-60). A person having ordinary skill in the art would view this lack of detail as informative in that Todd is not particularly concerned with how the protuberances arrive on the outside of the balloon. Changing how the protuberances are formed without changing their function does not teach away from Todd, does not solve a problem created by Todd, and does not solve the problem addressed by Todd in a materially different way. The Examiner does not see the separate nature of the mesh as being a patentable distinction. To find a patentable distinction would be to reduce the person having ordinary skill in the art to an automaton instead of a person with ordinary creativity. Id. 24--25. In reply, Appellants reiterate their arguments that neither Todd nor Durcan discloses a mesh that is "separate." Reply Br. 2. Appellants then argue essentially that the law of obviousness always requires a finding that a 5 Appeal2017-002399 Application 12/906,736 person of ordinary skill in the art would have had a reason to combine the teaching of the prior art references to achieve the claimed invention. Id. at 3 ( citing In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litig., 676 F.3d 1063, 1068---69 (Fed. Cir. 2012)). Appellants further argue that a coextrusion technique, as taught by Durcan, is not capable of adding a mesh like texture to Todd's balloon. Reply Br. 4. "The mesh cannot be coextruded with the balloon tube - it has to be adhered to the balloon after it has been molded." Id. (emphasis added). Todd discloses a balloon catheter that exhibits protuberances projecting outwardly from the outer surface of the balloon for the purpose of firmly gripping the walls of the body passageway so as to secure placement of the catheter in the passageway. Todd, Abstract. The Figure 6 embodiment of Todd features a cross-hatched pattern 44 projecting outwardly from the exterior of the balloon. Id., Fig. 6, col. 7, 11. 33-35. The Examiner finds that such cross-hatched pattern constitutes a "mesh" within the meaning of claim 1. Final Action 2. Having reviewed Figure 6, we determine that the Examiner's finding that pattern 44 constitutes a mesh is consistent with the ordinary and customary meaning of "mesh" and is supported by a preponderance of the evidence. With respect to Appellants' argument that the mesh is required to be "separate" from the expansion apparatus (see Appeal Br. 8 - "not a separate mesh"), we note that the term "separate" does not appear anywhere in claim 1. Claims App. Rather, the mesh is merely required to be "disposed on" and also "fixedly mounted to" the expansion apparatus. Id. We note the apparent incongruity between explicitly reciting in the claim that the mesh is "fixedly mounted" while simultaneously arguing that it must be "separate." 6 Appeal2017-002399 Application 12/906,736 We agree with the Examiner that Todd's pattern 44 ( or "mesh") is "disposed on" the balloon. Todd, Fig. 6. Thus, the issue presented is whether pattern 44 is "fixedly mounted" to the balloon, which is largely a matter of claim construction. During examination of a patent application, pending claims are given their broadest reasonable construction consistent with the specification. In re Am. Acad. of Sci. Tech Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004). Under the broadest reasonable interpretation standard, claim terms are given their ordinary and customary meaning as would be understood by one of ordinary skill in the art in the context of the entire disclosure. In re Trans logic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). Construing claims broadly during prosecution is not unfair to the applicant, because the applicant has the opportunity to amend the claims to obtain more precise claim coverage. Am. Acad. of Sci., 367 F.3d at 1364. We look to the specification to see ifit provides a definition for "fixedly mounted," either expressly or by implication, but otherwise apply a broad interpretation. See In re ICON Health and Fitness, Inc., 496 F.3d 1374, 1379 (Fed. Cir. 2007); see also Irdeto Access, Inc. v. Echostar Satellite Corp., 383 F.3d 1295, 1300 (Fed. Cir. 2004) (explaining that even when guidance is not provided in explicit definitional format, the specification may define claim terms by implication). Paragraph 59 of Appellants' Specification provides the following teaching disclosure regarding the mesh: Figure 2 illustrates an end view of the inflated balloon (3) of the anchored guide wire (1). The outer surface (7) of the balloon (3) includes a fiber mesh affixed to the surface of the balloon during the molding process, which produces outwardly facing protrusions (9) on the surface of the balloon (3) that assist in 7 Appeal2017-002399 Application 12/906,736 gripping of the balloon to the surrounding tissue. The fiber mesh may be made of LYCRA (polyurethane-polyurea copolymer), polyurethane, composite springs, or other appropriate material. In other embodiments, dimensional surface structures or inflatable sinuses that are encapsulated in the surface substrate of the balloon (3) may be used to produce the surface protrusions. Spec. ,r 59 (Amendment dated Sept. 2, 2014). Appellants' Specification further indicates that the inflatable balloon may be comprised of Yulex, polyethylene, nylon, or "other suitable material." Spec. ,r 58. We note, however, that none of the materials specified in either paragraphs 58 or 59 of the Specification are actually recited as limitations in claim 1. Broadly but reasonably construed, the "mesh" that is "fixedly mounted" on the expansion apparatus may be comprised of any suitable material. Appellants present neither evidence nor persuasive technical reasoning that supports a finding that the material of Todd's balloon and pattern 44 (mesh) is not suitable. Furthermore, Appellants present neither evidence nor persuasive technical reasoning that supports a finding that the material used for the mesh must be a material that is different from the material that is used to form the balloon. Moreover, Appellants' own Specification teaches that the mesh may be added to the balloon "during the molding process." Spec. ,r 59. However, we do not view "fixedly mounted" as a product-by-process limitation and Appellants do not take a contrary position. In any event, we look to the structure to determine the patentability of the claimed product. See In re Thorpe, 777 F.2d 695, 697 (Fed. Cir. 1985) (explaining that the patentability of a product does not depend on its method of production). We discern no patentable distinction between the structure of Todd and the 8 Appeal2017-002399 Application 12/906,736 product claimed by Appellants in claim 1. We consider pattern 44 (mesh) as being "fixedly mounted" to Todd's balloon using a broad, but reasonable, construction of the term. In that regard, although Todd does not expressly disclose how pattern 44 (mesh) is formed on balloon 26, we are persuaded: (1) that the pattern is mounted "fixedly" to the balloon; 1 and (2) the balloon and pattern do not fall outside of the scope of claim 1 even if the pattern is formed "by the balloon wall" as argued by Appellants. Appeal Br. 8. Although we do not find that claim 1 requires the mesh to be formed of a different material than the balloon, we, nevertheless, agree with the Examiner that Durcan is useful for teaching that balloons may be made from multiple layers of different material and that Durcan's teaching is combinable with Todd. Ans. 24. Appellants' effort to distinguish Durcan as limited to forming the mesh by coextrusion is not persuasive. Reply Br. 4. Although Durcan does teach forming additional layers by coextrusion, it also teaches that additional layers may be formed by means such as adhesive, fusion bonding, or frictional engagement. Durcan ,r 3 5. Appellants' argument that the "mesh ... has to be adhered to the balloon after it has been molded" is belied by Appellants' own Specification that the mesh is affixed "during the molding process." Spec. ,r 59. In any event, Appellants may not patentably distinguish their apparatus invention by relying on process limitations. Thorpe, 777 F .2d at 697. Appellants' argument that Durcan is not a combinable reference because it teaches a way of making a "non-compliant reinforced balloon" is not persuasive. "A reference may be read for all that it teaches, including 1 In other words, the pattern 44 (mesh) material is not readily detachable from the balloon structure. 9 Appeal2017-002399 Application 12/906,736 uses beyond its primary purpose." In re Mouttet, 686 F.3d 1322, 1331 (Fed. Cir. 2012). Therefore, it is not necessary for the prior art to serve the same purpose as that disclosed in Appellants' Specification in order to support the conclusion that the claimed subject matter would have been obvious. See In re Lintner, 458 F.2d 1013, 1016 (CCPA 1972). Furthermore, it is common sense that familiar items may have obvious uses beyond their primary purposes. KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398,420 (2007). Here, it is sufficient that Durcan teaches adding layers to a balloon by means such as adhesive bonding. Durcan ,r 35. A person of ordinary skill in the art would have readily understood that such means to add layers to a balloon have broad application other than just non-compliant reinforced balloons. In their Reply Brief, Appellants take the Examiner to task for relying on "Official Notice" that gripping patterns may be formed by "adding a layer." Reply Br. 5. This argument does not apprise us of Examiner error. The Examiner's alternative ground ofunpatentability relies on the Marcadis reference. Final Action 13. Marcadis uses felt strip retention means 90 that is affixed to the outer surface of a balloon catheter. Marcadis, col. 8, 11. 35--41, Figs. 14--15. Although Marcadis may not be relied on as applied art in the instant ground of rejection, it is, nevertheless, useful as evidence of the background knowledge of a person of ordinary skill in the art. See Randall v. Rea, 733 F.3d 1355, 1361-63 (Fed. Cir. 2013). Thus, we agree with the Examiner that a person of ordinary skill in the art would have readily known how to add a pattern layer made out of a different material to Todd's balloon. Lastly, we address Appellants' arguments that a skilled artisan would not have combined the teachings of Todd and Durcan in the matter proposed 10 Appeal2017-002399 Application 12/906,736 by the Examiner. Appeal Br. 10-11. "[T]here is no suggestion in the prior art for the combination proposed by the Examiner." Id. at 11. In our view, the Examiner has supplied sufficient articulated reasoning with rational underpinning to support the rejection. Among other things, this can be found in the passage from pages 24--25 of the Answer quoted above. It is well settled that the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results. KSR, 550 U.S. at 416. Here, Appellants provide no persuasive evidence that the claim elements are not familiar, or are not combined by known methods, or yield anything other than predictable results. We find Appellants' argument that "there is no suggestion in the prior art" particularly unpersuasive in view of the Supreme Court's decision in KSR, which explains that "the analysis need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ." KSR, at 418. Finally, we are not persuaded by Appellants' argument that the Cyclobenzaprine case absolutely mandates an express finding of a specific motivation to combine references in every conceivable situation. Reply Br. 3. The Federal Circuit's decision in Cyclobenzaprine does not overrule or otherwise abrogate binding precedent issued by the Supreme Court, which merely explains that, in a proper case, "it can be important to identify a reason" for combining in the manner claimed. KSR, 550 U.S. 418--419 ( emphasis added). The Supreme Court also explained that when a claim "simply arranges old elements with each performing the same function it had been known to perform" and yields no more than one would expect from 11 Appeal2017-002399 Application 12/906,736 such an arrangement, the combination is obvious. KSR at 417 ( quoting Sakraida v. Ag Pro, Inc., 425 U.S. 273, 282 (1976)). The Supreme Court, in such circumstance, explained that "the combination is obvious," not that the combination would be obvious only if there is also a reason for arranging the old elements. Id. "Thus, under KSR, the existence of a known problem solved by the combination can render that combination obvious as a matter of law and without further evidence of a specific motivation to combine." Apple Inc. v. Samsung Elecs. Co., Ltd., 839 F.3d 1034, 1078 (2016) (Dyk, J., dissenting) (emphasis added). In any event, we reiterate that we find the Examiner's reasoning set forth in pages 24--25 of the Answer as sufficient to support the rejection. In view of the foregoing discussion, we determine that the Examiner's findings of fact are supported by a preponderance of the evidence and that the Examiner's legal conclusion of unpatentability is well-founded. Accordingly, we sustain the Examiner's unpatentability rejections of claims 1-10, 13-26, and 40 over combinations based on Todd and Durcan. Unpatentability of Claims 1-10, 13-26, and 40 over Combinations Based on Marcadis and Todd Appellants argue all pending claims rejected over combinations based on Marcadis and Todd (grounds 7-12 above) as a group. Appeal Br. 12-16. We select claim 1 as representative. See 37 C.F.R. Â§ 4I.37(c)(l)(iv). Having reviewed Marcadis and Todd and the Examiner's findings of fact and conclusion of unpatentability set forth in the Final Action, we hereby sustain the Examiner's rejection of claims 1-10, 13-26, and 40 over combinations based on Marcadis and Todd. In so doing, we hereby 12 Appeal2017-002399 Application 12/906,736 incorporate, and adopt as our own, the Examiner's findings and conclusions set forth in the Examiner's well-reasoned Final Action and Answer. We have reviewed Appellants' arguments in traverse of the Examiner's rejections and find them unpersuasive. In particular, we find unpersuasive Appellants' argument that Marcadis does not disclose a "mesh" based on a dictionary definition of "mesh." Appeal Br. 13. As previously discussed, Todd discloses a "mesh," a fact that Appellants failed to challenge under the previous ground of rejection. Non-obviousness cannot be established by attacking references individually where the rejection is based upon the teachings of a combination of references. In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986); In re Keller, 642 F.2d 413,425 (CCPA 1981). Furthermore, we find unpersuasive Appellants' argument that modifying Marcadis' s zig-zag pattern to the mesh pattern of Todd would change the operation of Marcadis and render it unsatisfactory for its intended purposes. Appeal Br. 14. Specifically, Appellants' argument that Marcadis' s felt strip is so "inelastic" that it would not permit expansion of the balloon if formed into a mesh pattern amounts to no more than unsubstantiated attorney argument. See Invitrogen Corp. v. Clontech Labs, Inc., 429 F.3d 1052, 1068 (Fed. Cir. 2005) (unsubstantiated attorney argument is no substitute for competent evidence); see also Icon Health & Fitness, Inc. v. Strava, Inc., 894 F.3d 1034, 1043 (Fed. Cir. 2017) (unsworn attorney argument is not evidence); In re Cole, 326 F.2d 769, 773 (CCPA 1964) ( explaining that statements by counsel in the brief cannot take the place of evidence). We sustain the Examiner's rejection of claims 1-10, 13-26, and 40 over combinations based on Marcadis and Todd. 13 Appeal2017-002399 Application 12/906,736 DECISION The decision of the Examiner to reject claims 1-10, 13-26, and 40 is affirmed. 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)(l )(iv). AFFIRMED 14