CARDIAC PACEMAKERS, INC.Download PDFPatent Trials and Appeals BoardDec 14, 20202020003567 (P.T.A.B. Dec. 14, 2020) 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. 15/951,982 04/12/2018 Michael J. Kane 1001.3556102 1033 11050 7590 12/14/2020 SEAGER, TUFTE & WICKHEM, LLP 100 South 5th Street Suite 600 Minneapolis, MN 55402 EXAMINER LEVICKY, WILLIAM J ART UNIT PAPER NUMBER 3792 NOTIFICATION DATE DELIVERY MODE 12/14/2020 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 MICHAEL J. KANE, JEFFREY E. STAHMANN, and KEITH R. MAILE __________ Appeal 2020-003567 Application 15/951,982 Technology Center 3700 __________ Before CHARLES N. GREENHUT, MICHAEL L. HOELTER, and ANNETTE R. REIMERS, Administrative Patent Judges. HOELTER, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s decision to reject claims 1–20. Final Act. 1 (Office Action Summary). We have jurisdiction under 35 U.S.C. § 6(b). For the reasons explained below, we AFFIRM the Examiner’s rejections of these claims. 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies the real party in interest as “Cardiac Pacemakers, Inc.” Appeal Br. 3. Appeal 2020-003567 Application 15/951,982 2 CLAIMED SUBJECT MATTER The disclosed subject matter “generally relates to systems, devices, and methods for delivering pacing pulses to a heart and, more specifically to systems, devices, and methods for performing rate responsive pacing with a Leadless Cardiac Pacemaker (LCP).” Spec. 1:12–14. Method claim 1 and system claims 13 and 18 are independent. Appeal Br. 3–5. Claim 1 is illustrative of the claims on appeal and is reproduced below. 1. A method for providing rate responsive pacing therapy to a heart of a patient, the method comprising: sensing cardiac electrical data with a leadless cardiac pacemaker (LCP) implanted within and directly coupled to a wall of the heart of the patient such that the LCP moves with the wall of the heart of the patient; providing pacing therapy to the heart of the patient with the LCP based at least in part on the sensed cardiac electrical data, the pacing therapy including a pacing rate; sensing patient activity of the patient using an accelerometer that is housed in a remote device that is separate from the LCP and not directly coupled to the heart of the patient, and determining a patient activity data signal based at least in part upon the patient activity sensed by the accelerometer; wirelessly communicating the patient activity data signal from the remote device to the LCP; and the LCP adjusting the pacing rate of the provided pacing therapy based at least in part on the received patient activity data signal. REFERENCES Name Reference Date Condie et al. (“Condie”) US 7,031,772 B2 Apr. 18, 2006 Kroll et al. (“Kroll”) US 7,634,313 B1 Dec. 15, 2009 Appeal 2020-003567 Application 15/951,982 3 Greenhut et al. (“Greenhut”)2 US 8,744,572 B2 June 3, 2014 Kane et al. (“Kane”) US 9,962,550 B2 May 8, 2018 Demmer et al. (“Demmer”) US 2015/0173655 A1 June 25, 2015 THE REJECTIONS ON APPEAL Claim 10 is rejected under 35 U.S.C. § 112(b) as indefinite. Final Act. 6. Claims 1, 3, 4, 6–13, and 15–20 are rejected under 35 U.S.C. § 103 as unpatentable over Demmer and Kroll. Final Act. 6. Claims 2, 5, and 14 are rejected under 35 U.S.C. § 103 as unpatentable over Demmer, Kroll, and Greenhut. Final Act. 9. Claims 1–12 are rejected on the ground of non-statutory double patenting as unpatentable over claims 9–19 of Kane. Final Act. 11. ANALYSIS The rejection of claim 10 as being indefinite Claim 10, which indirectly depends from claim 1, recites “further comprising determining a measure related to a respiratory rate of the patient based, at least in part, on a difference in an amplitude of the patient activity data signal communicated by the remote device and an amplitude of the patient activity data signal received at the LCP.” Appeal Br. 15 (Claims App., emphasis added). The Examiner determines that this limitation “is unclear because there is no step of sensing/determining patient activity at the LCP.” Final Act. 6; emphasis added. In the Answer, the Examiner states 2 No known relation to Administrative Patent Judge Greenhut. Appeal 2020-003567 Application 15/951,982 4 that “there is no indication that the LCP, as claimed, identifies this variable amplitude (the amplitude of the remote device) or that the LCP measures the amplitude of the patient activity signal to determine the respiratory rate of the patient based on the difference of amplitude.” Ans. 4. We first note that this “at the LCP” language is recited as identifying one of the two amplitude values being contrasted. Claim 10 does not recite that the determining step is undertaken “at the LCP.” Further, parent claim 1 merely requires the step of determining an amplitude difference, and it is the Examiner that presupposes this determining step occurs “at the LCP.”3 Final Act. 6. Hence, as per the Examiner, because “there is no indication that the LCP, as claimed, identifies this variable amplitude” (Ans. 4), the Examiner finds claim 10 to be “unclear because there is no step of sensing/determining patient activity at the LCP.” Final Act. 6. The Examiner’s imposition of an unclaimed limitation (i.e., “at the LCP”), and then rendering a rejection based thereon, is not indicative that claim 10 is, in fact, “unclear,” and thus indefinite. Final Act. 6. Furthermore, and presuming this determining step indeed occurs “at the LCP” as expressed by the Examiner (which Appellant concurs (see Appeal Br. 6)), we note that parent claim 1 recites “wirelessly communicating the patient activity data signal from the remote device to the LCP,” which thereafter employs this signal to adjust the pacing rate. Appeal Br. 14 (Claims App., emphasis added). Thus, if the patient activity data signal is communicated to the LCP and thereafter acted upon, then the LCP 3 Appellant also indicates that this determining step occurs at the LCP as well. See Appeal Br. 6. Claim 10, however, is not so expressive on this point. Appeal 2020-003567 Application 15/951,982 5 would also, it appears, be likewise in receipt of the amplitude of that signal. The Examiner does not explain how this received signal is unable to be compared “at the LCP” to the originating or sent signal, or how such comparison, even “at the LCP,” is unclear. The manner by which such a situation may occur is expressly discussed in Appellant’s Specification. See Spec. 24:5–20; see also Appeal Br. 6. Accordingly, we reverse the Examiner’s rejection of claim 10 as being indefinite. The rejection of claims 1, 3, 4, 6–13, and 15–20 as obvious over Demmer and Kroll Appellant argues claims 1, 3, 4, and 6–12 together. See Appeal Br. 6– 10. Appellant also argues claims 13 and 15–17 together. See Appeal Br. 10–11. Finally, Appellant argues claims 18–20 together. See Appeal Br. 11–12. We select claims 1, 13, and 18 for review, with the remaining claims standing or falling with their respectively grouped claim. See 37 C.F.R. § 41.37(c)(1)(iv)(2019). Claim 1 Claim 1 recites sensing patient activity “using an accelerometer that is housed in a remote device that is separate from the LCP.” The Examiner relies on Demmer for such teachings.4 Final Act. 7. Appellant disagrees stating, “in Demmer, the IMD 16 [i.e., the implantable medical device, or pacemaker] itself includes the accelerometer 94 (see Figure 3 of Demmer),” and as such, it is not “remote” as recited. 4 The Examiner relies on Kroll for teaching that it would have been obvious to “wirelessly” communicate patient activity data from the remote accelerometer to the LCP, as recited. Final Act. 7. Appeal 2020-003567 Application 15/951,982 6 Appeal Br. 7; see also Reply Br. 4. Indeed, Figure 3 of Demmer illustrates Demmer’s accelerometer as part of Demmer’s LCP, and not as a remote device. However, the Examiner also references Paragraph 32 of Demmer as support, which addresses Demmer’s accelerometer and states, “[c]ontrol of rate responsive pacing using an activity sensor is generally disclosed in commonly-assigned U.S. Pat. No. 7,031,772 (Condie, et al.), hereby incorporated herein by reference in its entirety.” Demmer ¶ 32; emphases added. It is Condie’s incorporated teachings the Examiner specifically relies upon for disclosing a separate accelerometer, not Demmer’s Figure 3 as presumed by Appellant. See Final Act. 7 (referencing Condie 7:1–14, Fig. 4). Condie states, “data from an external sensor (e.g. an accelerometer attached onto a patient’s body 105) is acquired by the external data processing unit 420” of Condie’s implantable medical device (i.e., pacemaker). Condie 7:12–14. Thus, paragraph 32 of Demmer, via its incorporation of the teachings of Condie discussed above, discloses use of a remote device (i.e., an accelerometer) that is separate from a pacemaker or other implantable medical device. See Condie 1:18–19. Consequently, Demmer discloses a remote device that is not directly coupled to the heart of the patient, as recited. Furthermore, the Examiner alternatively indicates that Demmer itself (i.e., no reliance on Condie) teaches a situation when “the accelerometer is positioned outside the heart, such as in a pectoral, abdominal or peripheral site.” See Ans. 4 (referencing Demmer ¶ 64). Regardless, Appellant replies that “what the Examiner appears to be ignoring is [] why would one of skill in the art rely upon accelerometer data communicated from a remote device when the device in the heart already Appeal 2020-003567 Application 15/951,982 7 has an accelerometer itself.” Reply Br. 5. Thus, as per Appellant, “[t]he Examiner’s assertions regarding Condie et al. are little more than reconstructive hindsight.” Reply Br. 5; see also Appeal Br. 9. However, this “hindsight” argument is not persuasive because Demmer itself, whether via paragraph 32 or paragraph 64, expressly teaches the use of a remote accelerometer. Thus, no such teaching can be said to be gleaned only from Appellant’s disclosure as a result of improper hindsight since Demmer already and expressly discloses this feature. As a result, Appellant’s argument concerning improper hindsight reconstruction is unpersuasive. Concerning Appellant’s intimation that Demmer does not disclose a patient activity data signal that is “subsequently wirelessly communicated to” an LCP (see Appeal Br. 7, 9; see also Reply Br. 4), the Examiner relies on Kroll, rather than Demmer, for this “wirelessly” limitation. Final Act. 7. Appellant argues that Kroll does not disclose that which Appellant contends is missing from Demmer. See Appeal Br. 9; Reply Br. 5–6. However, this argument is not persuasive because it is not apparent that Demmer is deficient or otherwise fails to disclose the teachings it was relied upon for. Accordingly, we sustain the Examiner’s rejection of claims 1, 3, 4, and 6–12 as being unpatentable over the combination of Demmer and Kroll. Claim 13 Appellant repeats the above argument that Demmer in view of Kroll fails to teach the recited “remote device.” Appeal Br. 11; Reply Br. 8. For similar reasons as already discussed, Appellant’s contention is not persuasive. We sustain the Examiner’s rejection of claims 13 and 15–17. Appeal 2020-003567 Application 15/951,982 8 Claim 18 As above, Appellant repeats the argument that Demmer in view of Kroll fails to teach an implantable device “configured to be implantable at a location and remote from and not directly coupled to the heart of the patient.” Appeal Br. 12; Reply Br. 8. This argument is not persuasive of Examiner error for the reasons already discussed. We sustain the Examiner’s rejection of claims 18–20 as being unpatentable over Demmer and Kroll. The rejection of claims 2, 5, and 14 as obvious over Demmer, Kroll, and Greenhut With respect to these claims, Appellant relies on the same arguments presented above regarding independent claim 1. See Appeal Br. 12–13. Consequently, we likewise sustain the Examiner’s rejection of claims 2, 5, and 14 as being unpatentable over Demmer, Kroll, and Greenhut. Obviousness-Type Double Patenting Regarding this rejection, Appellant states that “[w]hile not conceding to the correctness of this double patenting rejection, Applicants will consider filing an appropriate Terminal Disclaimer once the claims are otherwise indicated as being in condition for allowance.” Appeal Br. 13. Thus, Appellant does not present arguments directed to the rejection, and has waived or forfeited any such arguments. Accordingly, this rejection is summarily affirmed. Appeal 2020-003567 Application 15/951,982 9 CONCLUSION In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 10 112(b) Indefiniteness 10 1, 3, 4, 6– 13, 15–20 103 Demmer, Kroll 1, 3, 4, 6– 13, 15–20 2, 5, 14 103 Demmer, Kroll, Greenhut 2, 5, 14 1–12 Non- statutory Double Patenting Kane 1–12 Overall Outcome5 1–20 No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv). AFFIRMED 5 37 C.F.R. § 41.50(a)(1) states: “The affirmance of the rejection of a claim on any of the grounds specified constitutes a general affirmance of the decision of the examiner on that claim.” Copy with citationCopy as parenthetical citation