Ex Parte Gunderson et alDownload PDFPatent Trial and Appeal BoardNov 14, 201712262443 (P.T.A.B. Nov. 14, 2017) 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. 12/262,443 10/31/2008 Bruce D. Gunderson P0025046.00/1111-080US01 6218 11/16/201727581 7590 Medtronic, Inc. (CRDM) 710 MEDTRONIC PARKWAY NE MS: LC340 Legal Patents MINNEAPOLIS, MN 55432-9924 EXAMINER FAIRCHILD, MALLIKA DIPAYAN ART UNIT PAPER NUMBER 3762 NOTIFICATION DATE DELIVERY MODE 11/16/2017 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): medtronic_crdm_docketing @ c ardinal-ip .com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte BRUCE D. GUNDERSON and WILLIAM J. HAVEL Appeal 2015-006194 Application 12/262,443 Technology Center 3700 Before STEVEN D.A. McCARTHY, MICHAEL L. HOELTER, and JEFFREY A. STEPHENS, Administrative Patent Judges. STEPHENS, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE We vacate the Decision mailed September 29, 2017, in favor of this substitute decision to provide additional discussion regarding dependent claims 9 and 21. Appellants1 seek our review under 35 U.S.C. § 134(a) from the Examiner’s Final Office Action (“Final Act.”) rejecting claims 1, 2, and 4— 1 The real party in interest is identified as Medtronic, Inc. App. Br. 3. Appeal 2015-006194 Application 12/262,443 24, which are all the claims pending in the application.2 We have jurisdiction under 35 U.S.C. § 6(b). We affirm-in-part. Claimed Subject Matter Claims 1,10, 22, and 23 are independent. Claim 1, reproduced below, illustrates the claimed subject matter. 1. A method comprising: sensing a cardiac electrogram (EGM) signal of a patient via one or more electrodes on at least one implantable medical lead; detecting an asystolic EGM signal from the patient, wherein detecting the asystolic EGM signal comprises detecting an absence of a cardiac depolarization in the cardiac EGM signal for at least a threshold time, and the threshold time is at least one second; and initiating a lead integrity test of the at least one implantable medical lead in response to detecting the asystolic EGM signal. Rejections3 I. Claims 1, 2, 4—6, 8, 10—15, 17—20, and 22—24 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Schuelke et al. (US 2 The Final Action is supplemented by an Advisory Action (mailed Nov. 14, 2014). 3 The Final Action provisionally rejects claims 1,2, and 4—24 on the ground of nonstatutory obviousness-type double patenting over claims 1—25 of co pending Application No. 12/180,911. Final Act. 12—13. The Examiner’s Answer, however, restates the grounds of rejection applicable to the appealed claims, and does not include the double patenting rejection. Ans. 3. In this case, we will consider the provisional double patenting rejection withdrawn. Should there be further prosecution, the Examiner may wish to consider whether a double patenting rejection should be entered again. 2 Appeal 2015-006194 Application 12/262,443 5,755,742, issued May 26, 1998) (“Schuelke”) and Sun et al. (US 6,129,745, issued Oct. 10, 2000) (“Sun”). Final Act. 4—9. II. Claims 7 and 16 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Schuelke, Sun, and Drew (US 2006/0264777 Al, published Nov. 23, 2006). Final Act. 9-10. III. Claims 9 and 21 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Schuelke, Sun, and Roberts et al. (US 2007/0265671 Al, published Nov. 15, 2007) (“Roberts”). Final Act. 10. DISCUSSION Rejection I Claims 1, 2, 5, 6, 10—13, 15, 17—19, and 22—24 Appellants argue that Schuelke and Sun do not teach or suggest “initiating a lead integrity test of the at least one implantable medical lead in response to detecting the asystolic EGM signal” (the “initiating step”), as recited in method claim 1. App. Br. 10. “Sun fails to disclose initiating a lead integrity test at all, much less in response to the detection of an asystolic signal,” Appellants contend. Id. Thus, Appellants argue, because the Examiner admits Schuelke also does not teach the recited limitation, “even when combined, Schuelke and Sun still fail to teach or suggest all of the recitations of claim 1.” Id. Although Appellants refer to the combination of Schuelke and Sun, Appellants’ arguments do not identify error in the Examiner’s finding that the combination teaches the initiating step. The Examiner finds Schuelke teaches initiating a lead integrity test of an implantable medical lead, Final Act. 4—5, and Appellants do not dispute this finding. Schuelke teaches that 3 Appeal 2015-006194 Application 12/262,443 “the lead integrity test sequence is initiated by microprocessor 224 at a specified time each day or other interval or upon receipt of a programmed-in command.” Schuelke col. 19,11. 43^46; see Final Act. 3. As to the condition for initiating the test, i.e., “in response to detecting the asystolic EGM signal,” the Examiner relies on Sun’s teaching of detecting the asystolic signal, and finds one of ordinary skill in the art would have performed a device integrity test by initiating a lead integrity test in response to the detection of an asystolic signal “in order to provide the predictable results of improving pacemaker response by initiating a lead integrity test when necessary[,] especially after detecting an asystolic signal to confirm if the device is working properly when the signal is detected.” Final Act. 3,5. Therefore, the Examiner’s rejection addresses the entire initiating step of claim 1. Appellants do not persuasively challenge the Examiner’s finding that Sun teaches detecting the asystolic EGM signal, and instead argue one of ordinary skill in the art would have no reason to perform Schuelke’s lead integrity test in response to detection of atrial undersensing, “at least because Sun does not disclose or suggest anything about lead integrity, a lead integrity test, or that atrial undersensing is caused by an issue with the integrity of a lead.” App. Br. 11. As the Examiner points out, Sun teaches that undersensing may arise from atrial lead dislodgment, and undersensing can compromise pacemaker response. Ans. 6 (citing Sun col. 1,11. 47—59). Appellants argue, however, that “an intact lead may be dislodged and, consequently, lead dislodgement is not the same as a problem with the integrity of the lead itself.” Reply Br. 4 Appeal 2015-006194 Application 12/262,443 7. In addition, Appellants argue, neither Schuelke nor Sun teaches that lead integrity tests would result in pacemaker response being improved. Id. Neither claim 1 nor Appellants’ Specification defines the scope of “lead integrity.” It is reasonable to consider lead integrity within the context of claim 1 to refer to the completeness of the electrical path from a sensing device to the heart tissue to be sensed. Lead dislodgment, as taught by Sun, would disrupt the electrical path from the device to the heart tissue, and would, therefore, be considered a problem related to lead integrity. Thus, Appellants’ argument that Sun does not relate to lead integrity fails to identify error in the Examiner’s rejection. In addition, even if lead integrity includes only such circumstances as a fracture in the lead or electrode, as Appellants suggest, Reply Br. 7, we agree with the Examiner’s finding that one of ordinary skill in the art would have had reason to perform Schuelke’s lead integrity test in response to detecting the asystolic EGM signal taught in Sun, Final Act. 6. Sun generally confirms the understanding of one of ordinary skill in the art that a perceived asystolic EGM signal may be due to problems with the sensor, rather than the heart. Sun col. 1,11. 38—41 (“A problem that may compromise reliable atrial sensing is that of atrial undersensing, i.e., failure to sense an atrial depolarization signal.”). One of ordinary skill in the art would have recognized that Schuelke’s lead integrity test would help to confirm that the sensor is working properly. Therefore, when an asystolic signal is detected, one of ordinary skill in the art would have wanted to perform Schuelke’s lead integrity test “to confirm if the device is working properly.” Final Act. 6. In addition, Sun teaches that “failure to detect an atrial sense compromises pacemaker response,” id. at col. 1,11. 58—59, which 5 Appeal 2015-006194 Application 12/262,443 evidences concern with reliable sensing generally, and further supports the Examiner’s finding that one of ordinary skill in the art would not have considered Sun’s reference to lead dislodgment to mean this is the only potential problem with the device leads. Accordingly, for the reasons discussed above and by the Examiner, we are not informed of error in the Examiner’s rejection of claim 1 under 35 U.S.C. § 103(a) as unpatentable over Schuelke and Sun. Thus, we sustain the rejection of claim 1, and, for the same reasons, the rejection of claims 2, 5, 6, 10-13, 15, 17—19, and 22—24, which Appellants argue are patentable for the same reasons as claim 1, App. Br. 12—13, 16—17. Claims 4 and 14 Claim 4 depends from claim 1, and recites “wherein initiating the lead integrity test comprises initiating the lead integrity test during the asystolic EGM signal.” Appellants contend “[t]he Examiner has cited no teaching of this feature in either Schuelke or Sun,” or found a reason for initiating the test at the recited time. App. Br. 13. The Examiner finds Schuelke teaches the lead integrity test does not occur if an anti-arrhythmic regimen is in progress and instead times the lead integrity test to occur “within a measurement duration of 61 microseconds or after a measurement delay of 59 microseconds.” Ans. 8. The Examiner explains that “since [Schuelke] teaches that the system has a measurement delay of 59 microseconds, they teach that the lead integrity test has been initiated/started during the asystolic signal since the claim as recited does not state what is meant by ‘initiating the lead integrity test.’” Id. 6 Appeal 2015-006194 Application 12/262,443 We agree with Appellants that Schuelke’s teaching of a 59 microsecond delay does not teach the limitations of claim 4. See Reply Br. 9. At column 19, lines 46—52, Schuelke teaches that the lead integrity test occurs within a specific measurement duration, but that this duration only begins after a “measurement delay from a preceding paced or sensed event.” Thus, rather than teach immediately initiating the lead integrity test during the asystolic EGM signal, Schuelke teaches to wait until a sensed event has concluded. The Examiner has not provided a reasonable interpretation of when “initiating the lead integrity test” is to occur that would encompass Schuelke’s teachings regarding an intentional delay, nor does the Examiner articulate reasoning with rational underpinning for modifying Schuelke and Sun to initiate the test at the recited time. Accordingly, we do not sustain the Examiner’s rejection of claim 4 under 35 U.S.C. § 103(a) as unpatentable over Schuelke and Sun. Claim 14, which depends from claim 10, recites limitations commensurate in scope with claim 4, and we do not sustain the rejection of claim 14 for the same reasons. Claims 8 and 20 Claim 8 depends from claim 1, and recites, in part, “receiving a signal that varies based on mechanical activity of the heart” and “wherein initiating the lead integrity test comprises initiating the lead integrity test in response to the asystolic EGM signal when the signal that varies based on mechanical activity of the heart does not indicate asystole.” The Examiner finds the claimed “signal that varies based on mechanical activity of the heart” is Schuelke’s EGM signal. Final Act. 7. 7 Appeal 2015-006194 Application 12/262,443 Appellants contend the Examiner’s finding is in error because an EGM signal varies based on the electrical activity of the heart, and because the claim requires two different signals. App. Br. 15. We agree with Appellants. We interpret a signal that “varies based on mechanical activity of the heart” to require sensing the mechanical activity of the heart, not merely the electrical activity sensed by an EGM. For example, the Specification describes a pressure sensor that can “monitor cardiovascular pressure associated with mechanical contraction of the heart,” Spec. para. 35, and using the pressure sensor “to confirm an EGM indication of asystole,” id. at para. 129. Thus, although an EGM signal can correlate with mechanical activity of the heart, it is not “a signal that varies based on mechanical activity of the heart” in the context of claim 8 and the Specification. Accordingly, we do not sustain the Examiner’s rejection of claim 8 under 35 U.S.C. § 103(a) as unpatentable over Schuelke and Sun. Claim 20, which depends from claim 10, recites limitations commensurate in scope with claim 8, and we do not sustain the rejection of claim 20 for the same reasons.4 4 Should there be further prosecution in the case, including any review for allowance, the Examiner is free to consider all prior art as it may apply to these claims. In addition, although the Board is authorized to reject claims under 37 C.F.R. § 41.50(b), no inference should be drawn when the Board elects not to do so. See Manual of Patent Examining Procedure (MPEP) § 1213.02. 8 Appeal 2015-006194 Application 12/262,443 Rejection II Appellants argue the rejection of dependent claims 7 and 16 set forth in Rejection II is in error for the same reasons argued in support of independent claims 1 and 10. App. Br. 17—18. For the same reasons discussed above for claims 1 and 10, we sustain the rejections of claims 7 and 16 under 35 U.S.C. § 103(a) as unpatentable over Schuelke, Sun, and Drew. Rejection III Appellants argue the rejection of dependent claims 9 and 21 set forth in Rejection III is in error for the same reasons argued in support of independent claims 1 and 10. App. Br. 18—19. Appellants also contend that the Examiner’s reliance on Roberts in rejecting these claims “does not overcome this deficiency of Schuelke in view of Sun with respect to the independent claims.” Id. at 18. For the same reasons discussed above for claims 1 and 10, these arguments do not inform us of error in the rejection of claims 9 and 21. Claims 9 and 21, however, do not depend directly from claims 1 and 10 but also depend from claims 8 and 20, respectively. In addition to the limitations of claim 8, claim 9 recites “wherein receiving a signal that varies based on mechanical activity of the heart comprises receiving a cardiac pressure signal.” The Examiner finds “Roberts teaches a system wherein an [Implantable Medical Device (IMD)] is coupled with a lead which has a pressure sensor and the system is configured to measure the mechanical activity of the heart based on the cardiac pressure signal.” Final Act. 10 9 Appeal 2015-006194 Application 12/262,443 (citing Roberts para. 27). Appellants do not dispute this finding, thereby waiving any challenge to it. The Examiner determines: Therefore it would have been obvious to a person having ordinary skill in the art at the time the invention was made to modify the teachings of [Schuelke] in view of Sun with the pressure sensor as taught by Roberts in order to provide the predictable results of accurately identifying the heart signals based on the activity of the heart. Id. Appellants also do not challenge the Examiner’s reasoning regarding Roberts’ sensing of mechanical activity of the heart and the factual findings implicit therein, thereby waiving such arguments. Appellants’ Specification and the language of claim 9 itself confirm that a pressure sensor produces a cardiac pressure signal that varies based on mechanical activity of the heart. See Spec. para. 35. Because the Examiner finds for independent claim 1 that one of skill in the art would have wanted to initiate a lead integrity test “after detecting an asystolic [EGM] signal to confirm if the device [was] working properly when the signal [was] detected,” Final Act. 6, the lead integrity test would have been initiated in response to the asystolic EGM signal when the pressure signal did not indicate asystole. In addition, because the Examiner finds one of skill in the art would have used both EGM and pressure signals for “accurately identifying the heart signals based on the activity of the heart,” Final Act. 10, we understand the Examiner’s rejection to indicate that one of skill in the art would have had reason to initiate a lead integrity test when the signals based on electrical activity and mechanical activity were in conflict. Thus, Appellants do not explain how the teachings of Roberts, in combination with the teachings of Schuelke and Sun discussed above, fail to suggest the 10 Appeal 2015-006194 Application 12/262,443 intermediate mechanical limitations recited in claim 8, or those recited in claim 9. Accordingly, we are not informed of error in the rejection of claim 9 under 35 U.S.C. § 103(a) as unpatentable over Schuelke, Sun, and Roberts. Claim 21 is argued together with claim 9 and, therefore, falls with claim 9. 37 C.F.R. §41.37(c)(l)(iv). DECISION We affirm the Examiner’s rejections of claims 1, 2, 5—7, 9-13, 15—19, and 21-24. We reverse the Examiner’s rejection of claims 4, 8, 14, and 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). See 37 C.F.R. § 1.136(a)(l)(iv). AFFIRMED-IN-PART 11 Copy with citationCopy as parenthetical citation