Cardiac Pacemakers, Inc.Download PDFPatent Trials and Appeals BoardJan 28, 20212020003514 (P.T.A.B. Jan. 28, 2021) 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. 14/618,396 02/10/2015 Jeffrey E. Stahmann 1001.3493101 2530 11050 7590 01/28/2021 SEAGER, TUFTE & WICKHEM, LLP 100 South 5th Street Suite 600 Minneapolis, MN 55402 EXAMINER GETZOW, SCOTT M ART UNIT PAPER NUMBER 3792 NOTIFICATION DATE DELIVERY MODE 01/28/2021 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 JEFFREY E. STAHMANN Appeal 2020-003514 Application 14/618,396 Technology Center 3700 Before CHARLES N. GREENHUT, MICHAEL J. FITZPATRICK, and JEREMY M. PLENZLER, Administrative Patent Judges. GREENHUT, 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, 3–6, and 8–21, which constitute all the claims pending in this application. See Final Act. 1. Claims 2 and 7 have been cancelled. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. 1 We use the term “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 2020-003514 Application 14/618,396 2 CLAIMED SUBJECT MATTER The claims are directed to a multi-chamber leadless pacemaker system with inter-device communication. Claim 1, reproduced below, is illustrative of the claimed subject matter: 1. A medical system comprising: a first leadless cardiac pacemaker (LCP) implantable at a first heart site; a second leadless cardiac pacemaker (LCP) implantable at a second heart site; the first LCP is configured to communicate a detected intrinsic cardiac event that is sensed by the first LCP at the first heart site to the second LCP using one or more non-capture communication pulses, wherein the one or more non-capture communication pulses: lack sufficient energy to capture the first heart site regardless of whether the first heart site is in a refractory state or not; and are not modulated by the first LCP to encode information beyond the detection of the intrinsic cardiac event; the first LCP is configured to deliver one or more non- encoded cardiac pacing pulses with sufficient energy to capture the heart at the first heart site if the first LCP does not sense an expected intrinsic cardiac event at the first heart site; the second LCP is configured to receive and interpret the one or more non-capture communication pulses from the first LCP as indicating an intrinsic cardiac event at the first heart site; the second LCP is configured to receive and interpret the one or more non-encoded cardiac pacing pulses delivered at the first heart site by the first LCP as indicating a paced cardiac event at the first heart site; and the second LCP is configured to deliver one or more cardiac pacing pulses to one or more pacing electrodes of the second LCP at the second heart site based, at least in part, on the received one or more non-capture communication pulses from the first LCP that indicate an intrinsic cardiac event at the first heart site and the one or more non-encoded cardiac pacing pulses Appeal 2020-003514 Application 14/618,396 3 delivered at the first heart site by the first LCP that indicate a paced cardiac event at the first heart site. REFERENCES The prior art relied upon by the Examiner is: Name Reference Date Jacobson US 2007/0088394 A1 Apr. 19, 2007 Haubrich US 2008/0071328 A1 Mar. 20, 2008 Von Arx US 2014/0379048 A1 Dec. 25, 2014 Schulman EP 1 702 648 A2 Mar. 26, 1998 Bodner WO 2006/065394 A1 June 22, 2006 REJECTIONS Claim 1, 3–6, 8–20, and 21 are rejected under 35 U.S.C. § 103 as being unpatentable over Jacobson and either Schulman or Von Arx or Bodner. Final Act.2 5. Claim 1, 3–6, 8–20, and 21 are rejected under 35 U.S.C. § 103 as being unpatentable over Jacobson and Haubrich. Final Act. 6. OPINION Appellant argues the rejection of claims 1, 3–6, and 8–21 over Jacobson and any one of Schulman or Von Arx or Bodner as a group (Appeal Br. 6–11) for which claim 1 is representative. Appellant reiterates the same arguments regarding method claims 12–19. Appeal Br. 11–18. 2 References to “Final Act.” that do not include a specific date refer to the June 20, 2019 Final Action from which this appeal was taken. In this Final Action the Examiner refers to a number of other Office Actions by date. See Final Act. 5, 6. Appeal 2020-003514 Application 14/618,396 4 Appellant relies on those same arguments with regard to the rejection predicated on Jacobson and Haubrich. Appeal Br. 19. The Examiner found Jacobson to disclose the basic device of claims 1 and 20 and the basic method of claim 12 including a plurality of leadless cardiac pacemakers that wirelessly communicate information with one another. Final Act. 5–6 (citing Jacobson paras. 92, 107, 112, 115, 120). Appellant correctly and repeatedly points to the fact that Jacobson uses “encoded pacing pulses” to transmit that information. Appeal Br. 7–8; Reply Br 2–4. Appellant repeatedly asserts the shortcomings of Jacobson alone with little or no regard for the other references cited by the Examiner. However, it is well-established that “[n]on-obviousness cannot be shown by attacking references individually when the rejection is predicated upon the teachings of a combination of references.” See In re Merck & Co. Inc., 800 F.2d 1091, 1097 (Fed. Cir. 1986). Each of the four secondary references cited by the Examiner discloses a form of wireless communication between pacemakers that does not use “capture communication pulses” like Jacobson. Even to the extent “non- capture communication pulses” is narrowly construed to require current pulses from the leads similar in nature to capture pulses, but lower in magnitude,3 at least Von Arx (paras. 21–224) and Bodner (p. 16, ll. 5–105) clearly disclose such an arrangement and the Examiner’s findings in that 3 Appellant does not appear to take issue with the construction of “non- capture communication pulses” on the record presently before us. 4 Cited in the April 28, 2017 Final Office Action referenced by the Examiner at Final Act. 5; see also Ans. 4. 5 Cited in the September 26, 2017 Non-Final Office Action referenced by the Examiner at Final Act. 5. Appeal 2020-003514 Application 14/618,396 5 regard stand uncontroverted. Appellant also does challenge the Examiner’s alternate reliance on Schulman (abst.6) or Haubrich (paras. 17, 19, 207) as disclosing an arrangement meeting this limitation. By pointing out the power requirements of Jacobson and reproducing paragraph 44 of Jacobson (Appeal Br. 8–9; Reply Br. 4), Appellant lends more support to the Examiner’s position. Paragraph 44 demonstrates that Jacobson considers the approach of combining the communications signal with the pacing signal beneficial from the standpoint of energy conservation, something obviously always pertinent to battery operated cardiac pacing devices. However, as the Examiner points out, Jacobson is considering the case of a triggered pacing arrangement where the pacing pulse is triggered even when an intrinsic heartbeat is sensed despite the fact that it may be unnecessary for pacing the heart.8 Final Act. 3. Although this enables 6 (“implemented via a modulated sound signal, AC magnetic field, RF signal, or electrical conduction”) Cited in the April 28, 2017 Final Office Action referenced by the Examiner at Final Act. 5. 7 (“acoustic or RF”) Cited in the January 22, 2019 Final Office Action referenced by the Examiner at Final Act. 5. 8 As Jacobson’s device also provides pacing at the expiration of a set time period (Jacobson para. 112), Jacobson’s device also provides pacing pulses “if the first LCP does not sense an expected intrinsic cardiac event at the first heart site.” The breadth of this limitation does not appear to be a point of contention raised by Appellant. However, it is noted that it would require language such as “only if” in place of “if” to refer to an exclusively inhibited pacing arrangement. Thus, while the Examiner proposes such an arrangement for the purpose of saving energy as part of the Examiner’s reasoning for separating the pacing and communication pulses (Final Act. 3; Ans. 6), we do not regard an inhibited pacing arrangement as a necessary requirement of the claim language presently before us for review. In any case, Bodner (p. 15, ll. 1–5) clearly demonstrates such an alternative, an inhibited pacing arrangement, was well-known in the art. Appeal 2020-003514 Application 14/618,396 6 Jacobson to still communicate information, as the Examiner points out, it clearly consumes more energy than is necessary for communication alone. As paragraph 44 of Jacobson alludes to, energy conservation being of paramount importance, there would seem to exist a strong motivation, if not a suggestion, to modify Jacobson as the Examiner proposes (Final Act. 3; Ans. 6) by using a non-capture pulse to communicate information when a capture pulse is unnecessary. Appellant further argues that the Examiner’s proposed modification to Jacobson invites communication difficulties due to noise and interference. Appeal Br. 8–9. This argument essentially amounts to an assertion that Von Arx, Bodner, Schulman, and Haubrich are all inoperable for their intended purposes. The Examiner points out there is no reason to conclude the prior art devices do not work as intended due to noise or interference. Ans. 4–5 (discussing Von Arx, in particular). There is a strong presumption that the subject matter of references cited as prior art are operable. See MPEP § 716.07; see also Amgen Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313 (Fed. Cir. 2003) (this presumption is not limited to issued patents). Overcoming that presumption requires some strong showing of evidence and/or technical reasoning. Neither of those are provided by the Appellant here. Appellant’s final argument regarding the “encoded” nature of Jacobson’s pulses (Appeal Br. 9–10; Reply Br. 5–6) is not entirely clear. Appellant does not direct our attention to specific claim language or specific shortcomings in the cited prior art. The Examiner responds to the argument by treating it as an argument that Jacobson encodes information “beyond the Appeal 2020-003514 Application 14/618,396 7 detection of the intrinsic cardiac event.”9 Ans. 5. The Examiner is correct that although Jacobson includes an embodiment “encoding the atrial pacing pulse with a code signifying an atrial location and a sensed event type,” Jacobson goes on to indicate, in that very same paragraph, that the “encoding may be omitted” for example, where event location information is not needed because there are only two pacemakers. Ans. 5 (citing Jacobson 112). We are not apprised of any reasons why this subject matter would not satisfy the claim limitations related to encoding that Appellant appears to be arguing. For the foregoing reasons, we sustain the Examiner’s rejections. CONCLUSION The Examiner’s rejections are AFFIRMED. 9 It is noted that this limitation, in and of itself, is not very clear because it implies “the detection” is “information” which it does not appear to be. The detection is a type of event. There may be information concerning or related to that event but it is not clear how the event itself can constitute information. This issue does not appear to require further development for purposes of reaching a decision on this appeal based on the issues raised by Appellant. For purposes of our prior-art analysis, we will regard this limitation as intending to refer to the subject matter described in Appellant’s Specification (p. 12, ll. 23–26), to mean that the signal produced by the intrinsic event is communicated, but without any further information related thereto. Appeal 2020-003514 Application 14/618,396 8 DECISION SUMMARY Claim(s) Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1, 3–6, 8– 20, 21 103 Jacobson, and any one of: Schulman, Von, Arx, or Bodner 1, 3–6, 8– 20, 21 1, 3–6, 8– 20, 21 103 Jacobson, Haubrich 1, 3–6, 8– 20, 21 Overall Outcome 1, 3–6, 8–21 RESPONSE No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R. § 1.136(a)(1)(iv). AFFIRMED Copy with citationCopy as parenthetical citation