Ex Parte KAPLAN et alDownload PDFPatent Trial and Appeal BoardAug 28, 201814861647 (P.T.A.B. Aug. 28, 2018) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE FIRST NAMED INVENTOR 14/861,647 09/22/2015 Gary S. KAPLAN 109610 7590 08/30/2018 Bookoff McAndrews, PLLC 2020 K Street, NW Suite 400 Washington, DC 20006 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. 11710-0040-07000 3889 EXAMINER A VIG AN, ADAM JOSEPH ART UNIT PAPER NUMBER 3739 NOTIFICATION DATE DELIVERY MODE 08/30/2018 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): usptomail@bomcip.com Kross@bomcip.com eofficeaction@appcoll.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte GARY S. KAPLAN, CHRISTOPHER J. DANEK, WILLIAM J. WIZEMAN, TIMOTHY R. DALBEC, NOAH D. WEBSTER, and HUY D. PHAN (APPLICANT: Asthmatx, Inc.) Appeal2017-008365 Application 14/861,647 1 Technology Center 3700 Before DONALD E. ADAMS, DEMETRA J. MILLS, and JOHN E. SCHNEIDER, Administrative Patent Judges. ADAMS, Administrative Patent Judge. DECISION ON APPEAL This Appeal under 35 U.S.C. § 134(a) involves claims 26, 31, 32, 34, 39, and 40 (App. Br. 4). Examiner entered rejections under 35 U.S.C. § 103(a). We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE. 1 Appellants identify "Asthmatx, Inc." as the real party in interest (App. Br. 2). Appeal2017-008365 Application 14/861,64 7 STATEMENT OF THE CASE Appellants disclose, inter alia, "devices configured to treat the airways or other anatomical structures, and may be especially useful in tortuous anatomy" (Spec. ,r 15). Claim 26 is representative and reproduced below: 26. A medical device, comprising: a catheter extending from a proximal end toward a distal end, the catheter including an inflow lumen and an outflow lumen separate from the inflow lumen; a balloon at the distal end of the catheter, the balloon being movable between a collapsed configuration and an expanded configuration; and one or more electrodes disposed on an outer swface of the balloon, the one or more electrodes being configured to contact tissues defining a body lumen when the balloon is in the expanded configuration, the one or more electrodes being configured to deliver radiofrequency energy to the tissues defining the body lumen, wherein the inflow lumen is configured to deliver a fluid to the balloon, and the outflow lumen is configured to simultaneously convey the fluid from the balloon, wherein: along a given circuniferential path that extends around an entirety of the balloon, each of the one or more electrodes has a circuniferential length extending circuniferentially along the circuniferential path; and the sum of all of the circuniferential lengths of the one or more electrodes covers only a minority of the circuniference of the balloon when the balloon is in a maximally-expanded configuration. (App. Br. 18 ( emphasis added).) 2 Appeal2017-008365 Application 14/861,64 7 The claims stand rejected as follows: Claims 26, 31, 34, and 39 stand rejected under 35 U.S.C. § I03(a) as unpatentable over the combination of Danaek2 and Gowda. 3 Claims 32 and 40 stand rejected under 35 U.S.C. § I03(a) as unpatentable over the combination of Danaek, Gowda, and Ingle. 4 ISSUE Does the preponderance of evidence relied upon by Examiner support a conclusion of obviousness? ANALYSIS The rejection over the combination of Danaek and Gowda: Examiner finds that Danaek discloses Appellants' claimed invention with the exception of a "catheter including an inflow lumen and an outflow lumen separate from the inflow lumen, wherein the inflow lumen is configured to deliver a fluid to the balloon, and the outflow lumen is configured to simultaneously convey the fluid from the balloon" (Final Act. 5 2--4). Examiner relies on Gowda to make up for the foregoing deficiency in Danaek (id. at 5). Therefore, based on the combination of Danaek and Gowda, Examiner concludes that, at the time Appellants' invention was made, it would have been prima facie obvious "to modify Danaek by providing separate inflow and outflow lumens into the balloon, as taught by Gowda, in order to configure Danaek to circulate cooling fluid through the balloon so that delivery of energy to a specific depth of target tissue can be 2 Danaek et al., US 2003/0233099 Al, published Dec. 18, 2003. 3 Gowda et al., US 6,755,849 Bl, issued June 29, 2004. 4 Ingle et al., US 6,216,704 Bl, issued Apr. 17, 2001. 5 Office Action mailed August 11, 2016. 3 Appeal2017-008365 Application 14/861,64 7 optimized, as taught by Gowda" (id. at 5---6). In reaching this conclusion, Examiner finds that Danaek discloses one or more electrodes disposed on an outer surface of [a] balloon ... , wherein: along a given circumferential path that extends around an entirety of the balloon, each of the one or more electrodes has a circumferential length along the circumferential path; and the sum of all of the circumferential lengths of the one or more electrodes covers a minority of the circumference of the balloon when the balloon is in a maximally-expanded configuration .... (Final Act. 3 (citing Danaek ,r 175 and FIG. 10).) In this regard, Examiner finds that "[ t ]he sum of the circumferential lengths of the electrodes at a given cross-section does not change when the balloon is moved between the collapsed and expanded configurations" (id.). We are not persuaded. As Appellants explain, Examiner's conclusion of obviousness is based on a finding that the "sum of the circumferential lengths of [Danaek' s] electrodes at a given cross-section does not change when the balloon is moved between the collapsed and expanded configuration" (App. Br. 15; see id. at 13-15; cf Final Act. 3). "For this to be true, and for Danaek to teach the claimed relationship, [Danaek's] electrode ... must be inelastic in the circumferential direction, so that its circumferential length does not change when expanded" (App. Br. 15). Appellants' contend, however, that "Danaek implicitly discloses that the electrode(s) ... are elastic and expandable in the circuniferential direction" (id.). In support of this contention, Appellants direct attention to Danaek' s disclosure and assert that [Danaek's] balloon 150 is filled with a fluid to bring the electrode 154 in contact with the airway wall. . . . Thus, when a single electrode 154 continuously surrounds the circumference of balloon 150, that electrode 154 must be elastic if the balloon 4 Appeal2017-008365 Application 14/861,64 7 150 must be inflated and expanded to bring the continuous electrode 154 in contact with the airway wall. (Id. (citing Danaek ,r 175).)6 We find no error in Appellants' rationale. Thus, we agree with Appellants' contention that Examiner failed to establish that the combination of Danaek and Gowda makes obvious a device, as set forth in Appellants' independent claims, wherein, along a given circumferential path that extends around an entirety of the balloon [ or expandable member], each of the one or more electrodes [ or energy delivery elements] has a circumferential length extending circumferentially along the circumferential path; and the sum of all of the circumferential lengths of the one or more electrodes [ or energy delivery elements] covers only a minority of the circumference of the balloon [ or expandable member] when the balloon [ or expandable member] is in a maximally-expanded configuration. (see App. Br. 18 (Appellants' independent claim 26); see also id. at 19--20 (Appellants' independent claim 34); App. Br. 15-16.) We are not persuaded by Examiner's interpretation of Appellants' claimed invention to require a "physical connection between [a] balloon and the electrodes" (Ans. 3--4). As Appellants explain, their claimed invention does "not state that there is a 'physical connection' between the balloon and the electrodes" (see Reply Br. 2--4 (citing Appellants' Spec. ,r 84 and FIGs 5M and 5N)). 6 Appellants recognize that Danaek discloses an alternative embodiment, specifically "a single electrode that 'continuously surround[s] a circumference of a balloon'," but correctly contend that such a configuration "cannot 'cover[] only a minority of the circumference of the balloon,"' as required by Appellants' claimed invention (App. Br. 14 (alteration original)). 5 Appeal2017-008365 Application 14/861,64 7 We are also not persuaded by Examiner's assertions regarding Danek. 7 Examiner recognizes that Danek was "incorporated into [Appellants'] specification by reference" and asserts that FIG. 10 of Danek provides "support for electrodes disposed on an outer surface of a balloon" ((see Ans. 4 (citing Appellants' Spec. ,r 80)); see also id. at 5). Therefore, Examiner finds that because "Danaek and [Danek] provide identical disclosures with reference to their respective [F]ig[]. 10, it is unclear why the inelasticity of the electrodes should be considered inherent with respect to appellant's [sic] disclosure while not extending the same interpretation to Danaek" (id. (citingDanaeki-f 175 and FIG. 10; and Danek 19: 16-31 and FIG. 10)). We are not persuaded. Initially, we note Appellants' contention that they never relied upon or alleged that Danek's FIG. 10 supports their claimed invention (Reply Br. 4). Further, as Appellants explain, FIG. 10 of the '212 patent is identical to FIG. 10 of Danaek and, as discussed above, Danaek's FIG. 10 fails to make obvious Appellants' claimed invention (id.). The rejection over the combination of Danaek, Gowda, and Ingle: Examiner finds that the combination of Danaek and Gowda fails to disclose a catheter that "includes an activation lumen separate from both the inflow lumen and the outflow lumen, and the medical device further includes an energizing member extending from an RF source through the activation lumen to the one or more electrodes/energy delivery elements" (Final Act. 6). Examiner relies on Ingle to make up for this deficiency in the combination of Danaek and Gowda (id.). Based on the combination of 7 Danek et al., US 7,425,212 Bl, issued Sept. 16, 2008. 6 Appeal2017-008365 Application 14/861,64 7 Danaek, Gowda, and Ingle, Examiner concludes that, at the time Appellants' invention was made, it would have been prima facie obvious to modify the device suggested by the combination of Danaek and Gowda to "provid[ e] a separate lumen for an electrical lead connecting the RF source to the electrode, as taught by Ingle, in order to prevent damage to the electrical lead by the cooling fluid" (id.). We are not persuaded. Examiner failed to establish that Ingle makes up for the deficiency in the combination of Danaek and Gowda discussed above (see App. Br. 17 ("Ingle does not cure the deficiencies of Danaek and Gowda with respect to independent claims 26 and 34, nor was it cited for such disclosure")). CONCLUSION The preponderance of evidence relied upon by Examiner fails to support a conclusion of obviousness. The rejection of claims 26, 31, 34, and 39 under 35 U.S.C. § 103(a) as unpatentable over the combination of Danaek and Gowda is reversed. The rejection of claims 32 and 40 under 35 U.S.C. § 103(a) as unpatentable over the combination ofDanaek, Gowda, and Ingle is reversed. REVERSED 7 Copy with citationCopy as parenthetical citation