Ex Parte Meyer et alDownload PDFPatent Trial and Appeal BoardFeb 24, 201712818066 (P.T.A.B. Feb. 24, 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. 12/818,066 06/17/2010 Scott A. Meyer 279.N30US2 6911 45458 7590 02/28/2017 SCHWEGMAN LUNDBERG & WOESSNER/BSC PO BOX 2938 MINNEAPOLIS, MN 55402 EXAMINER ALTER MORSCHAUSE, ALYSSA MARGO ART UNIT PAPER NUMBER 3762 NOTIFICATION DATE DELIVERY MODE 02/28/2017 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): uspto@slwip.com SLW @blackhillsip.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte SCOTT A. MEYER, YANTING DONG, JEREMY MANIAK, DOUG BIRHOLZ, and JOHN VOEGELE Appeal 2015-005490 Application 12/818,066 Technology Center 3700 Before EDWARD A. BROWN, JAMES P. CALVE, and GEORGE R. HOSKINS, Administrative Patent Judges. CALVE, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Appellants appeal under 35U.S.C. § 134 from the final rejection of claims 1—23. Appeal Br. 3. We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE. Appeal 2015-005490 Application 12/818,066 CLAIMED SUBJECT MATTER Claims 1, 10, 17, 21, and 23 are independent. Claim 1 is reproduced below. 1. A method of classifying a cardiac response to a pacing stimulation, comprising: delivering the pacing stimulation to a heart chamber; sensing a cardiac signal of the heart chamber following delivery of the pacing stimulation; detecting a first trigger feature of the cardiac signal within a first predetermined capture detection region; in response to detecting the first trigger feature of the cardiac signal within the first predetermined capture detection region, continuing to evaluate at least a portion of a QRS waveform of the cardiac signal that occurs after the first trigger feature; classifying the cardiac response as fusion or capture of the heart chamber based on at least a portion of the QRS waveform of the cardiac signal that occurs after the first trigger feature; and delivering pacing therapy based on the classification of the cardiac response as fusion or capture. REJECTIONS Claims 1—23 are rejected under 35 U.S.C. § 112, first paragraph, as lacking an adequate written description. Claims 1—7 and 10—23 are rejected under 35 U.S.C. § 103(a) as unpatentable over Florio (US 6,324,427 Bl, iss. Nov. 27, 2001) and Hochberg (US 3,782,367, iss. Jan. 1, 1974). Claims 8 and 9 are rejected under 35 U.S.C. § 103(a) as unpatentable over Florio, Hochberg, and Zhu (US 6,038,474, iss. Mar. 14, 2000). 2 Appeal 2015-005490 Application 12/818,066 ANALYSIS Claims 1—23 for lack of written description The Examiner found that Appellants’ Specification did not provide an adequate written description of the limitation of evaluating a cardiac signal based on the portion of the QRS waveform of the cardiac signal that occurs after the first or determined trigger feature. Final Act. 8. This limitation is recited in various forms in each of independent claims 1, 10, 17, 21, and 23. The Examiner found that Appellants’ Specification describes a cardiac signal being evaluated but does not support the limitation of classifying the cardiac response based on an evaluation of the QRS waveform after the first trigger feature. Id. at 3. In particular, the Examiner found that the claimed feature of‘“continuing to evaluate at least a portion of a QRS waveform of the cardiac signal that occurs after the first trigger feature’ is not reasonably described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor .. . had possession of the claimed invention.” Id.', Ans. 9—11. We agree with Appellants that a skilled artisan would understand that Appellants were in possession of the claimed subject matter of “continuing to evaluate at least a portion of a QRS waveform of the cardiac signal that occurs after” the first trigger feature (claims 1 and 10), the first classification window (claim 17), the determined trigger feature (claim 21), and the first capture detection region (claim 23). The Specification does not have to provide literal or verbatim support for claimed subject matter. See Union Oil Co. of Cal. v. Atl. Richfield Co., 208 F.3d 989, 997 (Fed. Cir. 2000); In re Gosteli, 872 F.2d 1008, 1012 (Fed. Cir. 1989); In re Kaslow, 707 F.2d 1366, 1375 (Fed. Cir. 1983); MPEP § 2163.02 (9th Ed. Rev. 7, Nov. 2015). 3 Appeal 2015-005490 Application 12/818,066 We are persuaded by the Declaration of Scott A. Meyer, PhD, one of the named inventors, that skilled artisans would understand Figures 4A, 4B, 5, 9, and 16A of Appellants’ original disclosure to depict the portion of the cardiac waveform that is evaluated after the first trigger feature as the QRS waveform. Declaration of Scott A. Meyer, Ph.D., 25 July 2013,1 8; Appeal Br. 11—12, 15—16. The Examiner has not provided persuasive evidence or argument to contradict Dr. Meyer’s testimony. See Ans. 8—11. Drawings can provide an adequate description of what is claimed and convey to skilled artisans that an inventor actually invented what is claimed. E.g., Bradford Co. v. Conteyor N. Am., Inc., 603 F.3d 1262, 1269 (Fed. Cir. 2010). Figures 4A and 16A of Appellants’ disclosure are reproduced below. Figure 4A shows superimposed captured responses 410, non-captured responses 420, and fusion/pseudofusion beats 430. Spec. 25:5—6. Figure 16A shows five cardiac waveforms 1605 that represent captured responses. Id. at 34:12—14. Dr. Meyer testifies that a skilled artisan would expect the QRS complex of a cardiac signal to occur in a window of up to 150-200 ms. Meyer | 6. This region of Figure 4A includes a downward dip followed by an upward deflection and then followed by another downward deflection. 4 Appeal 2015-005490 Application 12/818,066 Dr. Meyer testifies that the T-wave would follows the QRS response at approximately 250-450 ms as shown in Figure 4A. Id. This region of Figure 4A has a downward deflection below “0” amplitude followed by an upward deflection toward “0” amplitude. Appellants argue that skilled artisans understand the QRS complex to involve an initial downward deflection followed by an upward deflection to another downward deflection. Appeal Br. 15. Appellants argue that skilled artisans would recognize this portion of Figure 4A as a QRS complex based on this understanding as evidenced by Dr. Meyer’s testimony. Id. Appellants describe detecting a first cardiac response (the first trigger feature) in response to ventricular stimulation (Figs. 4A, 4B) by detecting an amplitude of cardiac signal 1610 in a first capture detection region 1650 of a first classification window 1690. Spec. 25:5—12, 34:12—20, Fig. 16A. This cardiac signal waveform is monitored after the first trigger feature 1650 to classify the cardiac response as fusion or capture of the heart chamber based on the detection of peaks 1620 in a second capture detection region 1640 of second classification window 1680. Id.', Meyer || 6—8; Appeal Br. 15—16. Appellants’ Specification provides an adequate written description of this claimed subject matter. In addition to Dr. Meyer’s declaration, the Examiner and Appellants agree that a complete cardiac signal waveform includes a P-wave for contraction of the atrial chambers, a QRS-waveform for contraction of the ventricular chambers, and a T-wave when ventricular muscles relax so blood can refill those chambers. Appeal Br. 14; Ans. 10. Figures 4A and 16A depict the downward-upward-downward deflection of the QRS waveform followed by a T-wave waveform. Dr. Meyer identifies this QRS wave as originating in a RV shock channel. Meyer 14 (Fig. A). 5 Appeal 2015-005490 Application 12/818,066 Appellants disclose the detected cardiac signals as resulting from a stimulation to the right ventricle. Spec. 25:5—18, Figs. 4A-AC. Dr. Meyer identifies the QRS waveforms in Figures 4A and 16A as responses to the pacing pulses delivered internally on the right ventricular (RV) rate channel and sensed on the RV shock channel of the pacemaker. Meyer || 6—8. The Examiner’s dismissal of Dr. Meyer’s testimony because Dr. Meyer is named as an inventor (Final Act. 2; Ans. 9) does not explain what waveforms are shown in Figures 4A and 16A besides QRS waveforms for contraction of the ventricles and T- waves for their relaxation. Appellants disclose monitoring part of the QRS waveform for a first trigger feature and another part of the QRS waveform thereafter to classify the cardiac signal, as claimed. Thus, we do not sustain this rejection. Claims 1—7 and 10—23 as unpatentable over Florio and Hochberg The Examiner found that Florio teaches the methods and devices of independent claims 1, 10, 17, 21, and 23 by delivering a pacing pulse to the heart (V-pulse 60 in Fig. 3 and V-pulse 76 in Fig. 4), and sensing a cardiac signal (evoked R-wave 64 in Fig. 3 and fusion wave 82 in Fig. 4) following the delivery and detection of a first peak in a first capture region (window 68 in Figure 3 and window 88 in Figure 4). Final Act. 9. The Examiner found that Florio does not evaluate the QRS waveform after the first trigger, but determined this feature would have been a design choice because Appellants have not disclosed the advantages of evaluating the QRS waveform, and the invention would work equally well with a T-wave. Id. at 10. The Examiner found that Hochberg uses a QRS detector and determined it would have been obvious to include this on Florio for predictable results. Id. at 10-11. 6 Appeal 2015-005490 Application 12/818,066 Appellants argue persuasively that it would not have been obvious to modify Florio to use a QRS waveform as a matter of design choice or based on teachings of Hochberg, because Florio teaches that the T-wave provides superior results to the QRS waveform in detecting the evoked responses of a capture. Appeal Br. 28—29. Appellants argue that Florio touts advantages of using the T-wave compared to the QRS portion of the waveform to detect a capture because the first evoked response after a pulse may be an artifact rather than the QRS response, and T-waves exhibit consistent and repeatable patterns. Id. at 28—31. The Examiner has not explained sufficiently why a skilled artisan would have been motivated to modify Florio to use a QRS waveform when Florio expresses a preference for using the T-wave as a superior means of confirming capture to a QRS waveform. Ans. 11—12. In effect, the Examiner proposes to modify Florio to use a less reliable prior art QRS waveform rather than the T waveform, which Florio teaches is an improvement over the QRS waveform. Florio, 6:65—7:32, 10:43—64. Thus, we do not sustain this rejection. Claims 8 and 9 as unpatentable over Florio, Hochberg, and Zhu The Examiner’s reliance on Zhu to teach features of dependent claims 8 and 9 does not cure the deficiencies of Florio and Hochberg discussed above as to claim 1, from which these claims depend. Appeal Br. 36. Thus, we do not sustain the rejection of these claims. DECISION We reverse the rejections of claims 1—23. REVERSED 7 Copy with citationCopy as parenthetical citation