Ex Parte MinDownload PDFPatent Trial and Appeal BoardMar 22, 201612639881 (P.T.A.B. Mar. 22, 2016) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 12/639,881 12/16/2009 36802 7590 03/24/2016 PACESETTER, INC 15900 VALLEY VIEW COURT SYLMAR, CA 91392-9221 FIRST NAMED INVENTOR XiaoyiMin 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. A09Pl034US01 7653 EXAMINER FAIRCHILD, MALLIKA DIPAYAN ART UNIT PAPER NUMBER 3762 NOTIFICATION DATE DELIVERY MODE 03/24/2016 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): Patent.CRMDSylmar@sjm.com lcancino-zepeda@sjm.com epineiro@sjm.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte XIAOYI MIN Appeal2013-008401 Application 12/639,881 Technology Center 3700 Before NEALE. ABRAMS, THOMAS F. SMEGAL, and MICHAEL L. WOODS, Administrative Patent Judges. ABRAMS, Administrative Patent Judge. DECISION ON APPEAL STATEivIENT OF THE CASE Xiaoyi Min (Appellant) seeks our review under 35 U.S.C. § 134 from the Examiner's decision rejecting claims 1, 2, and 11-14. We have jurisdiction over the appeal under 35 U.S.C. § 6(b ). We REVERSE. Appeal2013-008401 Application 12/639,881 THE INVENTION The claimed invention is directed to a method for controlling multi- site ventricular pacing for use by an implantable cardiac rhythm management device, and to systems for implementing this method. Claim 1, reproduced below, is illustrative of the subject matter on appeal. 1. A method for controlling multi-site ventricular pacing for use by an implantable cardiac rhythm management device equipped with a multi-pole ventricular lead having a plurality of electrodes, the method comprising: determining an interventricular conduction time delay value ( £ 1) for each of the plurality of electrodes; determining preliminary multi-site interventricular pacing delays (VVT) for the plurality of electrodes of the multi-pole lead based, at least in part, on the multi-site interventricular conduction time delay values ( £ 1) determined for the electrodes; determining multi-site interelectrode pacing delays (IVV) for the plurality of electrodes of the multi-pole lead based on the preliminary interventricular pacing delays (VVT); determining an order by which the electrodes of the multi- pole lead are to be used to deliver a set of multi-site pacing pulses, with the order determined based on the interelectrode pacing time delays (IW); and delivering multi-site ventricular pacing by delivering a set of pulses using the electrodes of the multi-pole lead in the determined order. 2 Appeal2013-008401 Application 12/639,881 THE PRIOR ART The Examiner relied upon the following as evidence of unpatentability: Ding Hine US 2002/0177879 Al US 2005/0090870 Al THE REJECTION Nov. 28, 2002 Apr. 28, 2005 Claims 1, 2, and 11-14 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Ding and Hine. 1 OPINION The Examiner found all of the subject matter recited in the method set forth in Appellant's claim 1 to be disclosed in Ding, except that Ding et al do not disclose that the system is configured to determine multi-site interelectrode pacing delays (IVV) for the plurality of electrodes of the multi-pole lead based the preliminary interventricular pacing delays (VVT) and determine an order of applying pacing pulses based on the interelectrode pacing time delay (IVV). Final Act. 6. However, the Examiner finds that Hine et al disclose a system and method for controlling biventricular pacing therapy for use by an implantable cardiac rhythm management device ( e.g. 14, Fig. 1) equipped with a multi-pole ventricular lead ( e.g. 52, Fig. I) having a plurality of electrodes (e.g. 1-5, Fig.I, [0064]). The system is configured to determine multi-site interelectrode pacing delays (IVV) for the plurality of electrodes of the multi-pole lead and to determine an 1 The Examiner has indicated that claims 3-10 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form. Final Act. 7. 3 Appeal2013-008401 Application 12/639,881 Id. order by which the electrodes of the multi-pole lead are to be used to deliver a set of multi- site pacing pulses, with the order determined based on the interelectrode pacing time delays (IVV) (e.g. Fig.15). Based upon these findings, the Examiner concludes that it would have been obvious "to modify the invention of Ding et al with the teachings of Hine et al in order to provide the predictable results of improving the performance of the system by selecting optimal pacing locations." Id. Among the arguments presented by Appellant, in response to the positions set out by the Examiner in the Final Action, are the following: Hine does not teach or suggest determining the interelectrode pacing delays based on interventricular pacing delays, which in tum are based on the multi-site interventricular conduction time delay values; rather Hine determines the pacing times by performing the various pacing tests and selecting the one that achieves the desired cardiac output. One of ordinary skill in the art would not be motivated to combine these references, since Ding teaches selecting a single site for delivering left ventricular stimulation, and Hine teaches multi-site pacing. Moreover, even if one were to combine the references, neither reference teaches or suggests the limitation "determining multisite interelectrode pacing delays (IW) for the plurality of electrodes of the multi-pole lead based on the preliminary interventricular pacing delays (VVT). In addition, the Examiner fails to point out exactly how one of ordinary skill would be motivated to modifY Ding based on the teachings of Hine. Ding teaches selecting a single electrode based on intrinsic activation times, whereas Hine teaches testing various multi-site pacing configurations, monitoring the resulting cardiac output results, and selecting the electrode configuration that achieves the desired cardiac output. 4 Appeal2013-008401 Application 12/639,881 As is established by MPEP §§ 2142 and 2143, the Examiner must do more than point to the elements of Appellant's claim in various references. Id. at 8 (emphasis in italics added). Continuing the theme of the passage recited immediately above, Appellant emphasizes that "[a]ccording to MPEP §§ 2142 and 2143, an examiner seeking to establish a prima facie case of obviousness must clearly articulate reasons with rational, factual underpinnings to support the conclusion of obviousness." Id. at 9. A prima facie case of obviousness is established when the teachings from the prior art itself would appear to have established the claimed subject matter to a person of ordinary skill in the art. In re Rinehart, 531 F.2d 1048, 1051(CCPA1976). As explained in MPEP § 2142: The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR Int'! Co. v. Telej1ex Inc., 550 U.S. 538, 418, 82 USPQ2d 1385, 1396 (2007) noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit. The Federal Circuit has stated that "rejections on obviousness cannot be sustained with mere conc1usory statements; instead~ there must be some miiculated reasoning with some rational underpinning to support the legal conclusion of obviousness.'' Jn re Kahn, 441 F ,3d 977, QSR '"' 0 u·-='pc· ) ~ 11"9 11" , .F, d c-,. JOC) ---\ i KPJ) - ~o __ 0~ lo ',:) )~Ci -~ , __ 16 ( e'. -"lL ~ 01; see a so ,) \, )) LL S. at 418, 82 USPQ2d at 1396 (quoting Federal Circuit statement with approval), The rejection does not meet these requirements. On pages 5-8 of the Answer, the Examiner has taken issue with the arguments raised by Appellant. However, the Examiner has not explained precisely how the Ding system would be modified in view of the teachings of Hine, in order to 5 Appeal2013-008401 Application 12/639,881 render obvious the subject matter recited in Appellant's independent claims 1, 13, and 14. Nor has the Examiner explained why one of ordinary skill in the art would have been motivated to combine the teachings of the two references in such a manner as to meet the terms of Appellant's claims, or provided argument in support of the conclusion set forth on page 8 of the Answer that the resulting method and apparatus would "provide the predictable results of improving the performance of the system by selecting optimal pacing locations and pacing intervals to maximize safe, efficacious and continuous therapy delivery to the patient." Thus, a prima facie case of obviousness has not been established, and this rejection is not sustained. DECISION The rejection of claims 1, 2, and 11-14 is not sustained. The decision of the Examiner is reversed. REVERSED 6 Copy with citationCopy as parenthetical citation