Ex Parte Warren et alDownload PDFPatent Trial and Appeal BoardJan 25, 201813588808 (P.T.A.B. Jan. 25, 2018) Copy Citation United States Patent and Trademark Office 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 APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 13/588,808 08/17/2012 Jay A. Warren 1001.3677103 2794 11050 7590 01/29/2018 SEAGER, TUFTE & WICKHEM, LLP 100 South 5th Street Suite 600 Minneapolis, MN 55402 EXAMINER MALAMUD, DEBORAH LESLIE ART UNIT PAPER NUMBER 3766 NOTIFICATION DATE DELIVERY MODE 01/29/2018 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): BSC.USPTO@stwiplaw.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte JAY A. WARREN and GUST H. BARDY Appeal 2017-002759 Application 13/588,808 Technology Center 3700 Before DEMETRA J. MILLS, ERIC B. GRIMES, and RYAN H. FLAX, Administrative Patent Judges. MILLS, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE This is an appeal under 35 U.S.C. § 134(a). The Examiner has rejected the claims for anticipation and obviousness. We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE. Appeal 2017-002759 Application 13/588,808 NATURE OF THE INVENTION According to the Specification, page 1, “[t]he present invention relates generally to implantable cardiac systems that detect, sense and classify cardiac signals. More particularly, the present invention relates to implantable medical devices that can adapt the initiation of a therapeutic therapy for patients who experience recurring non-sustained arrhythmic episodes.” CLAIMED SUBJECT MATTER The following claim is representative. 1. A method of avoiding inappropriate therapy delivery to a patient in an implantable defibrillator, the implantable defibrillator comprising a number of implantable electrodes and operational circuitry for performing cardiac signal analysis and therapy delivery using the implantable electrodes, the method comprising, at a first time: detecting cardiac events in a patient using the implantable electrodes; filling an X-out-of-Y filter with data related to the detected cardiac events and using the X-out-of-Y filter to determine that X exceeds a predetermined treatment threshold; when X exceeds the predetermined treatment threshold, using a predetermined persistence threshold, N, and applying a persistence rule calling for X to exceed the predetermined treatment threshold for at least N consecutive cardiac events; when the persistence rule is met, initiating a charging sequence to charge a capacitor for therapy delivery, after initiating the charging sequence but before therapy delivery, determining that the cardiac signal data of the patient no longer indicates a need for therapy; and upon determining, after initiating the charging sequence but before therapy delivery, that the cardiac signal data of the patient no longer indicates a need for therapy, modifying N to 2 Appeal 2017-002759 Application 13/588,808 increase the quantity of consecutive cardiac events required to meet the persistence threshold and storing N for use in the future; and the method further comprising, at a second time: detecting cardiac events in the patient using the implantable electrodes; filling the X-out-of-Y filter with data related to the detected cardiac events and using the X-out-of-Y filter to determine that X exceeds a predetermined treatment threshold; when X exceeds the predetermined treatment threshold, applying the persistence rule calling for X to exceed the predetermined treatment threshold for at least N consecutive cardiac events, wherein N, when applied at the second time, is modified in view of the occurrence of the first time; and finding that the persistence rule is not met due to the increase in N at least once.1 Cited Reference Stadler US 6,567,691 B1 May 20,2003 Grounds of Rejection Claims 1,3,7, 9, and 12—15 are rejected under pre-AIA 35 U.S.C. § 102(b) as being anticipated by Stadler. Claims 6 and 10 are rejected under pre-AIA 35 U.S.C. §103(a) as being unpatentable over Stadler. 1 Italicized emphasis added. 3 Appeal 2017-002759 Application 13/588,808 FINDINGS OF FACT The Examiner’s findings of fact are set forth in the Final Action at pages 2—13. PRINCIPLES OF LAW In making our determination, we apply the preponderance of the evidence standard. See, e.g., Ethicon, Inc. v. Quigg, 849 F.2d 1422, 1427 (Fed. Cir. 1988) (explaining the general evidentiary standard for proceedings before the Office). In order for a prior art reference to serve as an anticipatory reference, it must disclose every limitation of the claimed invention, either explicitly or inherently. See In re Schreiber, 128 F.3d 1473 (Fed. Cir. 1997). In determining obviousness “[t]he combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). However, “[i]n rejecting claims under 35 U.S.C. § 103, the examiner bears the initial burden of presenting a prima facie case of obviousness. Only if that burden is met, does the burden of coming forward with evidence or argument shift to the applicant.” In re Rijckaert, 9 F.3d 1531, 1532 (Fed. Cir. 1993) (citation omitted). “[Tjhere must be a showing of a suggestion or motivation to modify the teachings of [a] reference.” In re Kotzab, 217 F.3d 1365, 1370 (Fed. Cir. 2000). “[Rejections on obviousness grounds cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.” KSR, 550 U.S. at 418 (quoting In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006)). When 4 Appeal 2017-002759 Application 13/588,808 a prima facie case of obviousness has not been established, the rejection must be reversed. In re Fine, 837 F.2d 1071, 1075 (Fed. Cir. 1988). “[Dependent claims are nonobvious [or not anticipated] if the independent claims from which they depend are nonobvious [or not anticipated].” In reFritch, 972 F.2d 1260, 1266 (Fed. Cir. 1992). ANALYSIS Anticipation Rejection The Examiner finds that Stadler teaches each element claimed. Ans. 2-3. Appellants contend that they have: repeatedly shown - by detailed analysis of the Stadler reference, that Stadler does not show several individual elements of the independent claims: - Appellant has argued that X-out-of-Y filters are not used at all in the portions of Stadler that have been cited in the rejection [.] - Appellant has argued that the reference fails to disclose a Persistence Rule as recited in the claim[.] - Appellant has argued that the reference fails to apply such concepts after charging has begun and/or in the order and sequence recited[.] Reply Br. 3. We find that the Examiner has not provided evidence to support a prima facie case of anticipation. Appellants argue, in particular, that the reference fails to apply the claimed concept of, “when the persistence rule is met, initiating a charging sequence to charge a capacitor for therapy delivery; [and] after initiating the charging sequence but before therapy delivery, determining that the cardiac 5 Appeal 2017-002759 Application 13/588,808 signal data of the patient no longer indicates a need for therapy.” App. Br. 4; claim 1. We do not find that the Examiner has adequately shown that Stadler describes the claim element that “when the persistence rule is met, initiating a charging sequence to charge a capacitor for therapy delivery, after initiating the charging sequence but before therapy delivery, determining that the cardiac signal data of the patient no longer indicates a need for therapy,” as recited in claim 1. While we agree with the Examiner that Stadler does describe rules which block the delivery of therapies and which adapt therapies based on patient need, we do not find that the Examiner has specifically indicated where the cited prior art discloses the initiation of a charge sequence to charge a capacitor and then determining that the cardiac signal data of the patient no longer indicates a need for therapy. The Examiner’s statement of the rejection fails to mention anything about Stadler describing “initiating a charging sequence” before therapy delivery and determining that the cardiac signal data of the patient no longer indicates a need for therapy. Thus, the Examiner has not shown that Stadler teaches each element claimed and the anticipation rejection is reversed. Obviousness Rejection The Examiner determined that claims 6 and 10 would have been obvious over Stadler, stating: Stadler discloses the claimed invention except for the X-out-of- Y filter is applied by using an 18-out-of-24 rule as the predetermined treatment threshold. It would have been obvious to one having ordinary skill in the art at the time the invention was made to provide an X of 18 and a Y of 24, since it has been held that discovering the optimum value of a result of effective 6 Appeal 2017-002759 Application 13/588,808 variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980). Answer 4. Claim 6 depends from independent claim 1, which we addressed above and concluded it was not anticipated because the Examiner did not identify how Stadler disclosed the limitation, “after initiating the charging sequence but before therapy delivery, determining that the cardiac signal data of the patient no longer indicates a need for therapy.” Claim 10 depends from independent claim 7, which also recites, “after initiating the charging sequence but before therapy delivery, determining that the cardiac signal data of the patient no longer indicates a need for therapy.” The Examiner has not explained why this limitation would have been taught or suggested by Stadler; therefore, we conclude no prima facie case has been established for obviousness. See App. Br. 29-30. CONCLUSION OF LAW The cited reference fails support the Examiner’s anticipation and obviousness rejections, which are each reversed. REVERSED 7 Copy with citationCopy as parenthetical citation