Ex Parte Kornet et alDownload PDFPatent Trial and Appeal BoardJan 30, 201712608855 (P.T.A.B. Jan. 30, 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. 12/608,855 10/29/2009 Lilian Kornet P0027512.00/1111-174US01 7259 27581 7590 Medtronic, Inc. (CRDM) 710 MEDTRONIC PARKWAY NE MS: LC340 Legal Patents MINNEAPOLIS, MN 55432-9924 EXAMINER MORALES, JON ERIC C ART UNIT PAPER NUMBER 3766 NOTIFICATION DATE DELIVERY MODE 02/01/2017 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 LILIAN KORNET and RAPHAEL SCHNEIDER Appeal 2015-000856 Application 12/608,855 Technology Center 3700 Before MICHAEL L. HOELTER, JILL D. HILL, and GORDON D. KINDER, Administrative Patent Judges. HILL, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Lilian Komet and Raphael Schneider (“Appellants”) appeal under 35 U.S.C. § 134(a) from the Examiner’s decision to reject claims 1, 4—11, 14, 15, 17—24, and 27—36. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. Appeal 2015-000856 Application 12/608,855 CLAIMED SUBJECT MATTER Independent claims 1, 4, 5, 11, 14, and 15 are pending. Claim 1, reproduced below, illustrates the claimed subject matter. 1. A method comprising: sensing a parameter indicative of heart rate turbulence; measuring heart rate turbulence based on the sensed parameter; and predicting an occurrence of an arrhythmia based on the measured heart rate turbulence; and wherein the sensed parameter comprises cardiac contractility, the method further comprising deriving a plurality of values of an interval between cardiac contractions from the sensed parameter, and wherein measuring heart rate turbulence comprises calculating heart rate turbulence based on the interval values. REJECTION I. Claims 1, 4—11, 14, 15, 17—24, and 27—36 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Farazi (US 7,580,747 Bl; iss. Aug. 25, 2009) and Dalai (US 2008/0004672 Al; pub. Jan. 3, 2008). Final Act. 2. ANALYSIS Claim 1 recites: (1) sensing cardiac contractility; (2) deriving a plurality of values of an interval between cardiac contractions from the sensed cardiac contractility; (3) measuring heart rate turbulence based on the cardiac contraction interval values; and (4) predicting an occurrence of an arrhythmia based on the measured heart rate turbulence. Regarding independent claims 1 and 11, the Examiner finds that Farazi senses “a parameter indicative of heart rate turbulence,” “measures heart rate turbulence based on the sensed parameter 406,” and “predicts an 2 Appeal 2015-000856 Application 12/608,855 occurrence of an arrhythmia based on the measured heart rate turbulence.” Final Act. 2. The Examiner finds that Farazi does not disclose the sensed parameter being cardiac contractility, and therefore does not disclose (1) deriving cardiac contraction interval values from cardiac contractility, and (2) calculating heart rate turbulence based on the cardiac contraction interval values. Id. at 2—3. The Examiner finds, however, that Dalai discloses the cardiac contractility limitations missing from Farazi. Id. at 3. The Examiner concludes that it would have been obvious to modify Farazi to derive cardiac contraction interval values to measure heart rate turbulence as taught by Dalai “to facilitate proper [] detection of heart rate turbulence and sensing of arrhythmia.” Id. Regarding independent claims 4 and 14, the Examiner again finds that Farazi senses “a parameter indicative of heart rate turbulence,” “measures heart rate turbulence based on the sensed parameter 406,” and “predicts an occurrence of an arrhythmia based on the measured heart rate turbulence.” Id. The Examiner also finds that Farazi discloses “charging a therapy delivery circuit in response to predicting the occurrence of the arrhythmia.” Id. (citing Farazi 7:7—32). The Examiner makes no findings regarding the disclosure of Dalai, and does not propose combining Farazi and Dalai. Id. Regarding independent claims 5 and 15, the Examiner again finds that Farazi senses “a parameter indicative of heart rate turbulence,” “measures heart rate turbulence based on the sensed parameter 406,” and “predicts an occurrence of an arrhythmia based on the measured heart rate turbulence.” Id. at 3^4. The Examiner also finds that Farazi discloses “identifying an abnormal heartbeat, [and] measuring heart rate turbulence resulting from the abnormal heartbeat.” Id. at 4—5 (citing Farazi 7:34-45). The Examiner 3 Appeal 2015-000856 Application 12/608,855 makes no findings regarding the disclosure of Dalai, and does not propose combining Farazi and Dalai. Id. at 5. Claims 1 and 28 Appellants argue claims 1 and 28 as a group. We select claim 1 as representative, and claim 28 stands or falls with claim 1. Cardiac Contractility Regarding independent claim 1, Appellants argue that the Examiner failed to indicate what parameter, sensed by Dalai, measures “cardiac contractility.” Appeal Br. 8. Appellants contend that Dalai fails to disclose any sensing of cardiac contractility. Id. Regarding sensing of “cardiac contractility,” the Examiner appears to define “cardiac contractility” as cardiac contractions. The term is only used twice in Appellants’ original disclosure, and is never defined. See Spec. 26 (original claim 9) and Spec. 27 (original claim 19). The Examiner’s definition of “cardiac contractility” is consistent with Appellants’ Specification, and Appellants have not offered an alternative definition. Spec 125 (disclosing the use of “sensors capable of sensing mechanical cardiac contractions” and R-R intervals, and explaining that “R-R interval values may be used to calculate a heart rate turbulence related parameter.”). We thus find no error in the Examiner’s definition of “cardiac contractility” as “cardiac contractions.” Farazi discloses using heart rate turbulence to predict sudden cardiac death, and appreciates that arrhythmia is an event that can cause sudden cardiac death — thus Farazi uses heart rate turbulence to predict arrhythmia. See Farazi Background, 14:52—62. Regarding sensing of cardiac contractions, Farazi discloses two sensors 82, 84 to predict arrhythmia by 4 Appeal 2015-000856 Application 12/608,855 classifying time intervals between sensed events via comparison of the intervals to “rate zone limit[s].” Farazi 6:52—7:6, 7:19—32. One skilled in the art would understand that Farazi senses cardiac contractions to derive the intervals therebetween. Farazi discloses in its step 404, recording R-R intervals following a premature contraction, which Farazi also refers to as “measuring one or more degrees of heart rate turbulence.” Farazi 13:42-45, 13:48—50. Similar to disclosure found in the discussion of Appellants’ Figure 9, Farazi’s measured heart rate turbulence parameters can include turbulence onset and slope. The measured degree of heart rate turbulence is used to classify the risk of sudden cardiac death (e.g., arrhythmia). Farazi 13:45—48. Farazi therefore discloses sensing cardiac contractions, recording intervals between cardiac contractions, measuring heart rate turbulence based on the recorded intervals, and predicting arrhythmia based on the measured heart rate turbulence. Dalai discloses diabetic therapy that includes anti-arrhythmia therapy (Dalai 15), wherein sensors measure cardiac contraction intervals (Dalai H 34—35 (such as R-R intervals)), which are used to quantifying heart rate turbulence (Dalai 136). One skilled in the art would understand that Dalai senses cardiac contractions to derive the intervals therebetween. Dalai provides a more detailed explanation of how heart rate turbulence is measured from R-R intervals. Dalai 136. Given the Examiner’s definition of “cardiac contractility” as “cardiac contractions,” we discern no error in the Examiner’s finding that Dalai discloses sensing cardiac contractility. 5 Appeal 2015-000856 Application 12/608,855 Predicting Arrhythmia Appellants also argue that neither Farazi nor Dalai discloses predicting an occurrence of an arrhythmia based on []measured heart rate turbulence,” because Farazi is directed to sudden cardiac death (SCD) and Dalai discloses using heart rate turbulence to determine Heart failure (HF), and predicting SCD and HF are different than predicting an arrhythmia. Appeal Br. 8—9. We are not persuaded by this argument because, as explained above, Farazi recognizes that arrhythmia is a cause of SCD, and Dalai recognizes that arrhythmia is a cause of HF. Reasoning Appellants next argue that the Examiner’s proposed reason for combining Farazi and Dalai lacks a rational basis, because neither Farazi nor Dalai discloses mechanical sensing of cardiac contractions, “let alone that mechanical sensing of cardiac contractions either facilitates proper detection of [heart rate turbulence] or aids in the sensing of arrhythmia.” Appeal Br. 9. “Mechanical” sensing is not recited in claim 1. Further, as explained above, both Farazi and Dalai disclose sensing cardiac contractions to ascertain intervals therebetween to measure heart rate turbulence and predict arrhythmia. We therefore are not persuaded by Appellants’ argument. Claim 27 Claim 27 depends from claim 1, and recites various sensor types to sense cardiac contractility. The Examiner finds that Farazi discloses this limitation. Final Act. 5. Appellants argue that the Examiner’s finding is 6 Appeal 2015-000856 Application 12/608,855 necessarily erroneous, because the Examiner acknowledges, in rejecting claim 1, that Farazi does not disclose “the ‘sensed parameter’ being cardiac contractility.” Appeal Br. 10; Final Act. 2. We are not persuaded by this argument because, for the reasons set forth above regarding claim 1, we determined that Farazi senses R-R intervals, and one skilled in the art would understand that Farazi senses cardiac contractions to derive the intervals therebetween. Appellants also argue that Farazi only discloses a physiological sensor 108 detecting “changes in cardiac performance or changes in a physiological condition of the heart,” and an activity sensor 116 determining the activity and posture of the patient, none of these sensed parameters being cardiac contractility. Appeal Br. 10; Reply Br. 3^4. The Examiner clarifies that it is Dalai that discloses sensing “intracardiac or intravascular pressure, an accelerometer or other sensor capable of detecting heart or blood sounds, vibrations, or motion, an intra cardiac or intra-arterial impedance, [etc.].” Ans. 6 (citing Dalai 134 (sensing and analyzing parameters such as “heart rate variability (HRV), heart rate turbulence (HRT), heart sounds, electrogram features, activity, respiration and pulmonary artery pressure”) and 140 (respiration detection)). We are not persuaded that the Examiner’s finding regarding Dalai is in error. Claims 4, 33, and 34 Appellants argue claims 4, 33, and 34 as a group. We select independent claim 4 as representative. Claims 33 and 34 stand or falls with claim 4. The Examiner finds that Farazi discloses the limitations of claim 4. Final Act. 3. 7 Appeal 2015-000856 Application 12/608,855 Regarding independent claim 4, Appellants argue that “the portions of Farazi relied upon as disclosing charging a therapy delivery circuit in response to predicting the occurrence of the arrhythmia, make no mention of’ using heart rate turbulence to predict arrhythmia. Appeal Br. 11. According to Appellants, Farazi detects arrhythmia, rather than predicting the occurrence thereof. Id. at 12. Further, there is no suggestion that Farazi’s arrhythmia detector 75 utilizes heart rate turbulence to detect arrhythmias. Id. Thus, although Farazi discloses charging a therapy delivery circuit, Appellants contend that such charging “cannot reasonably be considered to be in response to predicting the occurrence of an arrhythmia based on heart rate turbulence” as claimed. Id. For the reasons set forth above regarding claim 1, we agree with the Examiner that Farazi uses the intervals between cardiac contractions to measure heart rate turbulence, which is then used to predict the occurrence of arrhythmia. We therefore are not persuaded by this argument. Claims 5—8 and 31 Appellants argue claims 5—8 and 31 as a group. We select independent claim 5 as representative. Claims 6—8 and 31 stand or fall with claim 5. The Examiner finds that Farazi discloses the limitations of independent claim 5, including “measuring heart rate turbulence resulting from the abnormal heartbeat.” Final Act 3^4 (citing Farazi 7:34-45). Regarding independent claim 5, Appellants argue that Farazi fails to disclose “measuring heart rate turbulence resulting from an abnormal heart beat.” Appeal Br. 13. 8 Appeal 2015-000856 Application 12/608,855 The Examiner finds that Farazi’s “ventricular premature beat” (or premature ventricular contraction) is an abnormal heart beat. Ans. 7. Appellants do not refute this finding, and we are not persuaded that it is in error. Claim 9 Claim 9 depends from claim 5, and recites that the sensed parameter comprises cardiac contractility, deriving a plurality of values of an interval between cardiac contractions from the sensed parameter, and calculating heart rate turbulence based on the interval values. The Examiner relies on Dalai for this disclosure. Final Act 4. Appellants argue that “the Examiner has failed to provide any explanation as to why one of ordinary skill in the art would have found it obvious to modify Farazi to include the relied upon disclosure of Dalai.” Appeal Br. 14. Although the Examiner does not restate a reason for combining Farazi and Dalai in addressing independent claim 5 or dependent claim 9 (Final Act 3—4), the Examiner’s reasoning is set forth in the analysis of claim 1 (id. at 3) and, as explained above regarding claim 1, we are not persuaded that the Examiner’s reasoning lacks a rational basis. Claim 10 Claim 10 depends from claim 5 and recites “comparing the measured heart rate turbulence to a threshold value” and predicting arrhythmia “based on the comparison.” The Examiner finds this disclosure in Farazi. Final Act. 4—5 (citing Farazi 13:42—50 (measuring heart rate turbulence and assessing risk of sudden cardiac death based thereon), 18:5—23 (measuring 9 Appeal 2015-000856 Application 12/608,855 heart rate turbulence, and comparing heart rate turbulence to a threshold to assess autonomic tone)). Appellants argue that the cited portions of Farazi do not disclose using heart rate turbulence to predict an occurrence of arrhythmia. Appeal Br. 14. As set forth above regarding claim 1, Farazi discloses using heart rate turbulence to predict arrhythmia. We therefore are not persuaded by this argument. Claims 11 and 30 Appellants reiterate the arguments set forth regarding claim 1. Appeal Br. 15. For the reasons set forth above, we are not persuaded by these arguments. Claim 29 Appellants reiterate the arguments set forth regarding claims 1 and 27. Appeal Br 15—16. For the reasons set forth above, we are not persuaded by these arguments. Claims 14, 35, and 36 Appellants reiterate the arguments set forth regarding claim 4. Appeal Br. 16—17. For the reasons set forth above, we are not persuaded by these arguments. Claims 15—18, and 33 Appellants reiterate the arguments set forth regarding claim 5. Appeal Br. 17. For the reasons set forth above, we are not persuaded by these arguments. 10 Appeal 2015-000856 Application 12/608,855 Claim 19 Appellants reiterate the arguments set forth regarding claim 9. Appeal Br. 17—18. For the reasons set forth above, we are not persuaded by these arguments. Claim 20 Appellants reiterate the arguments set forth regarding claims 5 and 10. Appel Br. 18. For the reasons set forth above, we are not persuaded by these arguments. DECISION We AFFIRM the rejection claims 1, 4—11, 14, 15, 17—24, and 27—36 under 35 U.S.C. § 103(a) as unpatentable over Farazi and Dalai. AFFIRM 11 Copy with citationCopy as parenthetical citation