Ex Parte Snell et alDownload PDFPatent Trial and Appeal BoardSep 6, 201713622919 (P.T.A.B. Sep. 6, 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. 13/622,919 09/19/2012 Jay Snell A12P1040 7723 36802 7590 09/08/2017 PACESETTER, INC. 15900 VALLEY VIEW COURT SYLMAR, CA 91392-9221 EXAMINER PATTON, AMANDA K ART UNIT PAPER NUMBER 3762 NOTIFICATION DATE DELIVERY MODE 09/08/2017 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): Patent.CRMDSylmar@sjm.com lcancino-zepeda@sjm.com epineiro @ sj m. com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte JAY SNELL, CAROL HUDGINS, and KATHLEEN KRESGE Appeal 2016-001396 Application 13/622,9191 Technology Center 3700 Before FRANCISCO C. PRATS, RACHEL H. TOWNSEND, and DEVON ZASTROW NEWMAN, Administrative Patent Judges. NEWMAN, Administrative Patent Judge. DECISION ON APPEAL This appeal under 35 U.S.C. § 134(a) involves claims to a method for discriminating the morphology of the ST segment of a heartbeat. The Examiner entered final rejections for obviousness. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. STATEMENT OF THE CASE Background The Specification discloses: 1 Appellants identify the Real Party in Interest as Pacesetter, Inc., dba St. Jude Medical, Cardiac Rhythm Management Division. Br. 3. Appeal 2016-001396 Application 13/622,919 The ST segment represents the portion of the cardiac signal between ventricular depolarization and ventricular repolarization .... Deviation of the ST segment during an ST episode from a baseline is a result of injury to cardiac muscle, variations in the synchronization of ventricular muscle depolarization, drug or electrolyte influences, or the like. Various morphology discrimination techniques have been proposed that utilize ST segment shifts to identify ST episodes. Spec. 14. “However, conventional morphology discrimination techniques declare an unduly false positive ST episode.” Id. 1 5. A need remains for an ST monitoring method and system able to reduce or prevent false positive ST episode detections caused by rate dependent bundle branch blocks, posture-related axis changes of the EGM signal and other non-ST segment related physiologic behavior. Id. 1 6. The disclosure of the Specification relates to “morphology discrimination, and more particularly to methods and systems that utilize reference morphology templates to validate ST morphology discrimination.” Id.^l. “Embodiments are described herein for an ST morphology discrimination (MD) system and method that are utilized to help distinguish a normally conducted intrinsic ventricular beat from one with delayed conduction.” Id. 126. The Claims Claims 1—18 are on appeal. Claim 1 is illustrative and reads as follows: 1. A method for ST morphology discrimination, comprising: sensing cardiac signals of a heart; 2 Appeal 2016-001396 Application 13/622,919 obtaining a reference morphology template based on at least one baseline cardiac signal associated with a normal physiology waveform; identifying a potential ST segment shift from the cardiac signals; comparing the cardiac signals to the reference morphology template to derive a morphology indicator representing a degree to which the cardiac signals match the reference morphology template in response to the identification of a potential ST segment shift; and declaring the potential ST segment shift to be an actual ST segment shift based on the morphology indicator. Br. 12 (Appendix of Claims). Appellants seek our review of the Examiner’s rejection of claims 1—18 under pre-AIA 35 U.S.C. § 103(a) as obvious over Snell,2 Kroll,3 Zhang,4 Dong,5 6 7and Gilkerson.6 7 OBVIOUSNESS In rejecting the claims, the Examiner finds that Kroll discloses a “method for us[ing] ST morphology discrimination comprising: sensing cardiac signals of the heart (i.e. [,] ventricular intracardiac electrogram (IEGM) signal) and identifying ST segments within the ventricular IEGM 2 US 2011/0245699 Al, published October 6, 2011 (“Snell”). 3 US 6,865,420 Bl, issued March 8, 2005 (“Kroll”). 4 US 2008/0177194 Al, issued July 24, 2008 (“Zhang”). 5 US 2012/0035489 Al, published February 9, 2012 (“Dong”). 6 US 6,493,579 Bl, issued December 10, 2002 (“Gilkerson”). 7 We note that, while Dong and Gilkerson are not formally included in the Examiner’s statement of rejection, the Examiner cited the teachings of Dong and Gilkerson in the Final Office Action (mailed October 27, 2014). See Final Act. 4. Accordingly, we treat them as part of the rejection herein. 3 Appeal 2016-001396 Application 13/622,919 signal; and analyzing the ST segments to detect an indication of a possible cardiac ischemic event within the patient.” Ans. 2 (citation omitted). The Examiner finds Kroll applies the method to confirm the existence of myocardial ischemia in order to recommend a treatment or continue monitoring where no ischemia is detected. Id. at 2—3. The Examiner finds Snell discloses a method of identifying the ST segments with a ventricular IEGM signal that is detected by an implanted medical device, and analyzing the ST segments to detect “an indication of a possible cardiac ischemic event within the patient.” Id. at 3. The Examiner finds Snell discloses that stability of the ST segment can be used to characterize heart defects including arrhythmia and ischemia and to recommend types of therapy. Id. The Examiner finds Snell discloses “obtaining baseline ST segment morphology data based on at least one baseline (i.e. [,] non-shifted ST segment(s)) associated with a normal physiology waveform” and using identified shifted ST-segments for comparison with the baseline data in the method. Id. The Examiner finds Zhang discloses utilizing a ischemia trigger event detector to detect an indication of possible ischemia (ST deviation) based on a first condition and an ischemia detector to detect a second condition (R-R interval stability) to confirm or reject a determination of ischemia based on ST deviation by whether R-R interval stability is also detected. Id. The Examiner finds that none of Kroll, Snell, or Zhang discloses “obtaining a reference morphology template based on at least on[e] baseline cardiac signal associated with a normal physiology waveform, wherein the reference morphology template is utilized to derive a morphology indicator 4 Appeal 2016-001396 Application 13/622,919 representing a degree to which the cardiac signals match the reference morphology template in response to the identification of a potential segment shift.” Id. at 3^4. Accordingly, the Examiner turns to Dong and Gilkerson, for additional information regarding the prior art. The Examiner finds Dong discloses using “morphology template comparisons” to “determine stability of rhythms during detected cardiac episodes and alters therapy depending upon the additional stability measure.” Ans. 4. The Examiner finds Gilkerson also discloses “use of stability measures to inhibit therapy depending on [whether] ventricular rhythms are found to be stable or unstable during initial detection of problematic cardiac rhythms.” Id. The Examiner concludes that the ordinarily skilled artisan would have found it obvious at the time of the invention to modify Kroll to explicitly provide stimulation therapy for ischemia where ischemia is detected based on both ST segment deviations and verified through stability measurement determination utilizing morphology template comparisons, as taught by Snell, Zhang, Dong and Gilkerson, in order to detect ischemia through ST segment deviations by verifying said deviations are likely attributed to ischemia rather than other factors (e.g.[,] variations in patient activity). Id. ISSUE The issue with respect to this rejection is whether a preponderance of the evidence supports the Examiner’s conclusion that Snell, Kroll, and Zhang as informed by Dong and Gilkerson suggest the claimed subject matter. We select claim 1 as representative of the claims subject to this ground of rejection. 37 C.F.R. § 41.37(c)(l)(iv). ANALYSIS 5 Appeal 2016-001396 Application 13/622,919 Appellants raise several arguments in support of their position that the Examiner erred in rejecting the claims over the cited prior art. Br. 6—10. As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992): [T]he examiner bears the initial burden ... of presenting a prima facie case of unpatentability. . . . After evidence or argument is submitted by the applicant in response, patentability is determined on the totality of the record, by a preponderance of evidence with due consideration to persuasiveness of argument. In the present case, Appellants do not persuade us that a preponderance of the evidence fails to support the Examiner’s conclusion that the method for discriminating the morphology of the ST segment of a heartbeat of claim 1 would have been obvious to an ordinary artisan. As required by claim 1, Kroll discloses a method of detecting differences in ST morphology “by identifying changes in the ST-segment of the intracardiac electrogram (EGM) sensed using large sensing electrode surfaces created by electrically coupling one or more cardiac electrodes or by using larger surface area shocking coils.” Kroll Abstract. The Kroll method is summarized in Figures 5 and 6, reproduced below: 6 Appeal 2016-001396 Application 13/622,919 .m ifia 420 . V DETECT { ftlYOCAflDlAt. \ ISCHEMIA? NO oexecr ' DECREASEM CARDIAC OUTPUT DEMAND? , F!G- 5 FIG, 6 Figure 5 is “a flow chart illustrating a method of performing myocardial ischemia detection.” Id. at 3:46-48. Figure 6 is “a flow chart illustrating a method of monitoring myocardial ischemia and providing a stimulation response aimed at alleviating the ischemia.” Id. at 3:49—51. As the Examiner found, Kroll discloses detecting ST morphology by analyzing the sensed ST segment deviations and using the morphology as a predictor of ischemia as well as a treatment guide. Kroll 10:21—53 (e.g., “The three EGM signals received from ischemia sensing circuit 150 are therefore processed in any combination to confirm the presence or absence of ischemia based on the predetermined criteria defining expected deviations of the ST-segmenf’). Figures 5 and 6 show the detection method and the therapy monitoring procedure. 7 Appeal 2016-001396 Application 13/622,919 As the Examiner notes (Ans. 3), Kroll does not specifically disclose using a “reference morphology template based on at least one baseline cardiac signal associated with a normal physiology waveform” despite that the steps of “analyze EGM signals for ST-segment deviation” and “ST- segment deviation detected?” suggest that the method disclosed by Kroll includes comparing ST-segments against a baseline to confirm whether a deviation is detected. As the Examiner found, though, and we agree, Dong discloses using “morphology template comparisons” to “determine stability of rhythms during detected cardiac episodes and alters therapy depending upon the additional stability measure.” Ans. 4. Dong discloses the use of templates in discriminating heart rhythms, including tachycardia. Dong, || 90-98. Dong discloses a method for obtaining a reference morphology template as follows: a template can be generated from a snapshot representative of one of the patient’s normal supra-ventricular conducted beats. Cardiac signals are sensed from pacing leads (rate channel) and shock leads (shock channel). A fiducial point is determined from the signals sensed on the rate channels and is used to align signals sensed on the shock channels. A template for a patient is generated using the aligned shock channel signals. The template is representative of one of the patient’s normal supra-ventricular conducted beats. Subsequently detected beats are then used to confirm that the generated template is representative of one of the patient’s normal supra-ventricular conducted beats. Dong 192. Furthermore, as the Examiner found, Gilkerson discloses analyzing the stability of ventricular rhythms “to distinguish unstable (irregular) ventricular rhythms from stable (regular) ventricular rhythms [by] measuring the degree of variability of the tachycardia R-R intervals.” Gilkerson 7:40— 8 Appeal 2016-001396 Application 13/622,919 43. Once variability is calculated, the treating physician decides whether to inhibit therapy for atrial fibrillation, or to use stability analysis to determine the therapy to be delivered, such as applying shock to an unstable patient. Id. at 7:50—54. We agree with the Examiner (Ans. 4) that, in light of the teachings of Kroll, Dong, and Gilkerson, the skilled artisan would have found it obvious to determine ST morphology by comparing sensed cardiac signals to a predetermined reference morphology template and measuring any detected shift in the ST segment. Although not required by claim 1, we further agree with the Examiner that these references would have guided the skilled artisan to modify Kroll to provide stimulation therapy for ischemia where ST segment stability analysis indicated the subject was experiencing ischemia. Id. We further find that Kroll, Dong, and Gilkerson alone provide sufficient teaching to support the Examiner’s conclusion of obviousness. See In re May, 574 F.2d 1082, 1090 (CCPA 1978) (the Board may rely upon fewer than all the references cited by the Examiner). Nevertheless, we agree with, and adopt as our own, the Examiner’s findings and conclusions regarding the teachings of Snell and Zhang. Ans. 4. These findings further support the Examiner’s conclusion of obviousness as they evidence that ordinarily skilled artisans at the time of the invention would have known that cardiac ST segments should be analyzed for stability to detect arrhythmia or ischemia and in assessing the necessary type of therapy. See Snell H 13, 35, 43, 49-59, 68—78, and 88—101, and Zhang || 5—15. 9 Appeal 2016-001396 Application 13/622,919 Appellants argue that none of the cited references perform all steps of the claimed method. Appellants argue: neither Kroll nor Snell disclose or suggest comparing a cardiac signal to a reference morphology template to derive a morphology indicator representing a degree to which the cardiac signals match the reference morphology template in response to the identification of a potential ST segment shift and declaring the potential ST segment shift to be an actual ST segment shift based on the morphology indicator as recited in the claimed invention. Br. 8. See also Br. 7 regarding Kroll alone. Appellants further argue that Zhang “does not disclose comparing a cardiac signal to a reference morphology template as recited in the claimed invention.” Id. at 9. These arguments are not persuasive as the Examiner’s rejection is based on the combined teachings of Kroll, Snell, Zhang, Dong, and Gilkerson. See Ans. 4. Nonobviousness cannot be established by attacking the references individually when the rejection is predicated upon a combination of prior art disclosures. In re Merck & Co. Inc., 800 F.2d 1091, 1097 (Fed. Cir. 1986); see also In re Keller, 642 F.2d 413, 426 (CCPA 1981) (finding “one cannot show nonobviousness by attacking references individually where, as here, the rejections are based on combinations of references” (citations omitted)). Thus, whether any of the references individually fails to teach determining ST morphology by comparing sensed cardiac signals to a predetermined reference morphology template and measuring any detected shift in the ST segment is not dispositive as to whether the combination of teachings of the references renders the claimed invention obvious. As stated by the Examiner, Dong, and Gilkerson provide motivation for the skilled artisan to apply the ST morphology discrimination 10 Appeal 2016-001396 Application 13/622,919 methods disclosed in Kroll (along with Snell and Zhang, which further illustrate the knowledge in the art), and Gilkerson provides motivation to modify Kroll to use a template for comparison of the detected ST segment to a normal baseline template. Ans. 4. The Examiner sufficiently establishes that an ordinary artisan reading Kroll, Snell, Zhang, Dong, and Gilkerson would have reasonably expected that the templates disclosed in Dong and Gilkerson could be used to assess ST-segment morphology in the methods disclosed by Kroll, Snell, and Zhang. We are further unpersuaded by Appellants’ argument that “Dong and Gilkerson, like Kroll, disclose the use of morphology as an arrhythmia discriminator and provide no teaching or indication that morphology may be useful in verifying the presence of an ischemic event” or that none of the references “disclose or suggest comparing the morphology of a current cardiac signal within a shifted set of cardiac signals to a stored morphology template as recited in the claimed invention to confirm the detection of ischemia as indicated by ST segment deviations.” Br. 10. Although we find Kroll teaches ischemic prediction as discussed above, claim 1 does not require either a stored morphology template or verification of the presence of an ischemic event. See Super Guide Corp. v. DirecTV Enters., Inc., 358 F.3d 870, 875 (Fed. Cir. 2004). (“Though understanding the claim language may be aided by the explanations contained in the written description, it is important not to import into a claim limitations that are not a part of the claim.”). Claim 1 recites discrimination of ST morphology through use of a reference morphology template to assess the shift, which we find is obvious in light of the cited references. 11 Appeal 2016-001396 Application 13/622,919 Claims 2—18 have not been argued separately8 and therefore fall with claim 1. 37 C.F.R. § 41.37(c)(l)(iv). SUMMARY We affirm the rejection of claims 1—18 under pre-AIA 35 U.S.C. § 103(a) as obvious over Snell, Kroll, Zhang, Dong, and Gilkerson. TIME PERIOD FOR 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)(l)(iv). AFFIRMED 8 Appellants argue independent claims 1 and 10 together and do not raise arguments specific to claim 10. Br. 6—10. Likewise, Appellants do not raise arguments with respect to the dependent claims, but rely on arguments raised with respect to the independent claims. Id. at 10. 12 Copy with citationCopy as parenthetical citation