CARDIAC PACEMAKERS, INC.

Patent Trials and Appeals BoardAug 9, 2021

2021000935 (P.T.A.B. Aug. 9, 2021)

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. 15/642,121 07/05/2017 Qi An 2001.1325101 8904 11050 7590 08/09/2021 SEAGER, TUFTE & WICKHEM, LLP 100 South 5th Street Suite 600 Minneapolis, MN 55402 EXAMINER MALAMUD, DEBORAH LESLIE ART UNIT PAPER NUMBER 3792 NOTIFICATION DATE DELIVERY MODE 08/09/2021 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 QI AN, YINGHONG YU, PRAMODSINGH HIRASINGH THAKUR, and KRZYSZTOF Z. SIEJKO ____________ Appeal 2021-000935 Application 15/642,121 Technology Center 3700 ____________ Before NATHAN A. ENGELS, JAMES W. DEJMEK, and AMEE A. SHAH, Administrative Patent Judges. SHAH, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Pursuant to 35 U.S.C. § 134(a), the Appellant1 appeals from the Examiner’s final decision to reject claims 1–3 and 5–11.2 We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE. 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42 (2019). The Appellant identifies the real party in interest as Cardiac Pacemakers, Inc. Appeal Br. 3. 2 Claims 21–30 are withdrawn. Appeal Br. 19–21, Claims App. Appeal 2021-000935 Application 15/642,121 2 CLAIMED SUBJECT MATTER The Appellant’s invention “generally relates to implantable medical devices, and more particularly, to systems that use a leadless cardiac pacemaker for monitoring, pacing and/or defibrillating a patient’s heart.” Spec. ¶ 2. Independent claim 1 is the only independent claim on appeal, is representative of the subject matter on appeal, and is reproduced below (with added lettered bracketing for reference): 1. A method for generating a ventricle pacing pulse, comprising: [(a)] sensing for a mechanical response to an atrial contraction of a patient's heart; [(b)] sensing for an electrical cardiac signal associated with the atrial contraction of the patient’s heart via an electrode arrangement; [(c)] weighting a timing associated with the sensed mechanical response to the atrial contraction with a first weight; [(d)] weighting a timing associated with the sensed electrical cardiac signal associated with the atrial contraction with a second weight different from the first weight; [(e)] determining an atrial contraction timing fiducial based at least in part on the weighted timing associated with the sensed mechanical response to the atrial contraction and the weighted timing associated with the sensed electrical cardiac signal associated with the atrial contraction; and [(f)] generating the ventricle pacing pulse after an A-V delay following the atrial contraction timing fiducial. Appeal Br. 16, Claims App. Appeal 2021-000935 Application 15/642,121 3 THE REJECTION Claims 1–3 and 5–11 stand rejected under 35 U.S.C. § 102(a)(1) as anticipated by Karst et al. (US 8,996,109 B2, iss. Mar. 31. 2015) (“Karst”). OPINION We agree with the Appellant’s contention that the Examiner’s rejection of independent claim 1 is in error because the Examiner does not adequately show how limitations (c) and (d) of weighting timings are anticipated by Karst. See Appeal Br. 7–9; Reply Br. 4–6. In the Final Action, the Examiner provides a citation to Karst, column 12, line 48 through column 13, line 21, for disclosing limitation (a) of sensing for a mechanical response and to column 16, line 41 through column 17, line 18, for disclosing limitation (c) of weighting a timing associated with the sensed mechanical response. Final Act. 3–4. The Examiner does not provide specific citations to Karst for the remaining limitations of the claim of sensing for an electrical cardiac signal, weighting a timing associated with that sensed signal, determining an atrial contraction fiducial based on the weighted timings associated with the sensed mechanical response and sensed electrical cardiac signal, and generating a ventricle pacing pulse, i.e., limitations (b), (d), (e), and (f). See id. The Examiner makes no other specific findings. See id. The Appellant argues that the Examiner has not met “the initial burden of showing where each and every claimed element and feature is disclosed within the cited reference,” and the Appellant “does not see where each and every element of claim 1 can be found in the cited passages of Karst.” Appeal Br. 7. Specifically referring to the weighting and Appeal 2021-000935 Application 15/642,121 4 determining limitations (c), (d), and (e), the Appellant argues that “[t]he cited passages of Karst do not disclose these features, particularly in combination with the other features and elements recited in claim 1.” Id. at 8. Further, “[a]fter review, the lengthy passages of Karst et al. cannot be seen to disclose many of the features of claim 1, at least not in a way understood by the [Appellant].” Id. In the Answer, the Examiner attempts to explain how Karst discloses the weighting limitations. The Examiner determines that “[s]ince the [d]isclosure of the instantly filed application does not provide a special definition for the term ‘weighting’, the Examiner has concluded that the common understanding of that word is to be applied herein,” that understanding being that “weighting a timing with a first or second weight, as in the claimed invention, is interpreted as constituting sorting these measurements based on relevant factors of interest.” Ans. 7; see also id. at 6. The Examiner then cites to Karst at column 16, lines 60–65 and column 17, lines 2–18 for disclosing “the presence of a higher percentage of other atrial-to-ventricular event timing intervals [that] may be indicative of a degree of heart block” and the use of “a ‘5:4’ or ‘2:1’ correlation to weight atrial to ventricular events as of interest, rather than a normal ‘1: 1’ ratio for these events.” Id. at 7. The Examiner cites to Karst at column 13, lines 12–21 for disclosing “the use of the AV delay following the atrial contraction timing fiducial (first-, second-, or third-degree heart block) to time the ventricular pacing pulse.” Id. However, we do not understand how these portions disclose weighting the timing associated with the sensed mechanical response with a first weight and weighting the timing associated with the sensed electrical cardiac Appeal 2021-000935 Application 15/642,121 5 signal with a second weight different from the first weight. The Examiner cites to a correlation between atrial and ventricular events, but fails to explain how such a correlation would act to sort or prioritize measurements, i.e., timings associated with mechanical responses and electrical cardiac signals associated with atrial contractions, based on a factor of interest. To the extent the Examiner considers the ratio of events relevant, the Examiner does not explain, with sufficient specificity, how the ratio indicates a sorting of timings based on a relevant factor. Based on the record before us, we are persuaded of Examiner error. Thus, we do not sustain the Examiner’s rejection under 35 U.S.C. § 102 of independent claim 1 and of dependent claims 2, 3, and 5–11. CONCLUSION The Examiner’s decision to reject claims 1–3 and 5–11 is not sustained. In summary: Claim(s) Rejected 35 U.S.C. § Reference(s)/ Basis Affirmed Reversed 1–3, 5–11 102(a)(1) Karst 1–3, 5–11 REVERSED