Ex Parte Schecter et alDownload PDFPatent Trial and Appeal BoardJan 5, 201612267376 (P.T.A.B. Jan. 5, 2016) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 12/267,376 11/07/2008 36802 7590 06/22/2016 PACESETTER, INC. 15900 VALLEY VIEW COURT SYLMAR, CA 91392-9221 FIRST NAMED INVENTOR Stuart 0. Schecter 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 ATTORNEY DOCKET NO. CONFIRMATION NO. A08Pl062 5988 EXAMINER VOORHEES, CATHERINE M ART UNIT PAPER NUMBER 3762 NOTIFICATION DATE DELIVERY MODE 06/22/2016 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@sjm.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte STUART 0. SCHECTER and XIAOYI MIN Appeal2013-002548 Application 12/267,376 Technology Center 3700 Before MICHAEL L. HOELTER, BRANDON J. WARNER, and JAMES J. MAYBERRY, Administrative Patent Judges. MAYBERRY, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Stuart 0. Schecter and Xiaoyi Min (Appellants) seek our review under 35 U.S.C. § 134 of the Examiner's rejections of claims 1-5, 7, and 8. 1 We have jurisdiction under 35 U.S.C. § 6(b ). We REVERSE. CLAIMED SUBJECT MATTER The claims are directed to an implantable cardiac therapy device that identifies patients exhibiting electro-mechanical dysynchrony. 2 Spec. i-f 1. 1 Claim 6 is canceled and claims 9-19 are withdrawn. Br. 3. 2 We note that "dysynchrony" is alternatively spelled "dyssynchrony." See, e.g., Zhang i-f 48. Appeal2013-002548 Application 12/267,376 Claim 1, the sole independent claim on appeal, is illustrative of the claimed subject matter and is reproduced below: 1. An implantable cardiac therapy device comprising: an implantable stimulation pulse generator; one or more implantable leads defining sensing and stimulation circuits adapted to sense and deliver therapy in at least one right side heart chamber; and an implantable controller in communication with the stimulation pulse generator and the one or more leads so as to receive sensed signals indicative of a patient's physiologic activity, the controller being adapted to evaluate the patient's physiologic activity as indicated by the received sensed signals and to induce the stimulation pulse generator to deliver therapeutic stimulation via the one or more leads and wherein the controller is further adapted to monitor at least one indicator of electro-mechanical cardiac dysynchrony and to compare the at least one indicator to a determined electromechanical dysynchrony threshold wherein the threshold is determined for indications that the patient be further evaluated for cardiac resynchronization therapy and wherein the controller is further adapted to set an alert when the at least one indicator exceeds the threshold; wherein the one or more implantable leads are adapted to deliver pacing therapy to the right ventricle and wherein the controller monitors a frequency of right ventricle pacing therapy delivery and wherein the controller evaluates dysynchrony at least partially as a function of the frequency of right ventricle pacing therapy delivery. Br. 9, Claims App. REJECTIONS I. Claims 1--4 and 8 stand rejected under 35 U.S.C. § 102(a) as anticipated by Zhang (US 2008/0114256 Al, published May 15, 2008). 2 Appeal2013-002548 Application 12/267,376 II. Claims 5 and 7 stand rejected under 35 U.S.C. § 103(a) as being unpatentable over Zhang and Li (US 2007/0249945 Al, published Oct. 25, 2007). ANALYSIS Rejection I Independent claim 1 recites, in relevant part, "wherein the controller monitors a frequency of right ventricle pacing therapy delivery and wherein the controller evaluates dysynchrony at least partially as a function of the frequency of right ventricle pacing therapy delivery." Br. 9, Claims App. The Examiner finds that Zhang discloses each and every element of claim 1, including a controller that monitors the frequency in which right ventricle pacing therapy is delivered and evaluates dysynchrony, at least in part, as a function of this monitored frequency. Final Act. 4 (referencing Zhang i-fi-1 48, 49, 58, 59, and 61). Specifically, the Examiner finds: With respect to Zhang, paragraphs [0048]-[0049] of Zhang disclose[] an example of determining interventricular dyssynchrony by employing force sensors to determine respective heart wall force signals (or alternatively heart chamber expansion forces (breathing, which occurs at a lower frequency than heart rate-paragraph [0059] of Zhang)) or the heart rate (e.g., paragraph [0060] of Zhang). Thus, Zhang teaches evaluating dysynchrony at least partially as a function of the frequency of the right ventricle pacing therapy delivery (a component of heart rate would include frequency of the right ventricle and pacing causes the ventricle to contract thereby producing part of the heart rate). Final Act. 2-3. Appellants argue that Zhang fails to disclose a "controller monitor[ing] a frequency of right ventricle pacing therapy delivery and ... 3 Appeal2013-002548 Application 12/267,376 evaluat[ing] dysynchrony at least partially as a function of the frequency of right ventricle pacing therapy delivery," as required by claim 1. Br. 5. Appellants contend that, contrary to the position taken by the Examiner, monitoring a heart rate is not the same as monitoring the frequency of right ventricle pacing therapy delivery-"there is no way of discerning, from a heart rate, how many of the detected beats were caused by pacing pulses, let alone from [right ventricle] pacing pulses." Id. (emphasis added). Thus, Appellants dispute the Examiner's finding that, by monitoring heart rate, Zhang inherently monitors right ventricle pacing therapy. Id. at 6. Appellants explain that Zhang' s paragraph 59 discloses determining a respiratory rate from heart wall force signals in order to detect respiratory problems, not dysynchrony. Br. 5. Appellants further explain that Zhang's paragraph 60 concerns detecting arrhythmias, not dysynchrony. Id. at 6. Further, Zhang's paragraph 60 merely discloses measuring heart rates using heart wall force sensors and an electrogram signal, and comparing the two measurements. Id. Appellants continue that this disclosed process is not directed to determining dysynchrony, nor does it monitor right ventricle pacing therapy. Id. The Examiner responds that Zhang's paragraph 48 discloses: monitoring force sensors at different locations within the same chamber (as explained in paragraph [0054], the one or more force sensors are used to determine an indication of ventricular output) and evaluating/ determining [ dysynchrony] at least partially as a function of the ventricle pacing therapy delivery (as determined by the respective heart wall signals). Answer 3. The Examiner further states that Zhang's paragraph 52 discloses that bi-ventrical pacing or other response parameters (including left ventricle offset-the timing between left and right ventricle paces) may be initiated or 4 Appeal2013-002548 Application 12/267,376 adjusted if dysynchrony is indicated. Id. The Examiner states that this disclosure indicates that Zhang monitors right ventricle paces for timing or frequency and evaluates dysynchrony based on this frequency. Id. The Examiner then reiterates that Zhang, at paragraphs 48 and 49, discloses determining dysynchrony by using force sensors to determine heart wall forces and further discloses, at paragraph 61, that heart rate can be determined from the force signals. Answer at 3--4. The Examiner states that right ventricle pacing would cause the ventricle to contract, which would be measured by the sensors-"[ c ]onsequently, when the frequency of heart contractions are monitored, so is the right ventricle pacing therapy delivery." Id. at 4. In making the rejection, the Examiner determines that claim 1 does "not require the frequency of [right ventricle] pacing to be determined, just monitored." Answer 4. The Examiner also determines that claim 1 does "not require the derivation of the frequency of [right ventricle] pacing as dysynchrony is evaluated 'at least partially as a function of the frequency of the right ventricle pacing therapy delivery,' ... which could be the heart rate." Id. That is, the Examiner's position is that, because the amount of right ventricle pacing could be the same as the heart rate, then an evaluation of dysynchrony that is based, at least in part, on monitoring the heart rate would also be based on the amount of right ventricle pacing. We agree with Appellants that Zhang fails to disclose a cardiac therapy device with an implantable controller "wherein the controller monitors a frequency of right ventricle pacing therapy delivery and wherein the controller evaluates dysynchrony at least partially as a function of the frequency of right ventricle pacing therapy delivery," as required by claim 1. First, the Examiner has failed to establish that Zhang monitors the frequency 5 Appeal2013-002548 Application 12/267,376 of right ventricle pacing therapy delivery or how this parameter can be determined from a heart rate measurement. See Br. 5---6. Claim 1 expressly requires the controller to monitor the frequency of right ventricle pacing therapy that is delivered, not just to determine a heart rate that may include a right ventricle pacing component. Similarly, it is not sufficient that Zhang discloses that right ventricle pacing is a controllable parameter (see Zhang i-f 52}---claim 1 requires the controller to evaluate dysynchrony based, in part, on the monitored frequency of the pacing therapy. Second, even if the Examiner's position that monitoring heart rate is a proper surrogate for monitoring the frequency of right ventricle pacing therapy delivery is correct, the Examiner fails to adequately explain how Zhang discloses that dysynchrony is evaluated, at least partially, as a function of the monitored heart rate. See Br. 5---6 (arguing that the paragraphs in Zhang relied on by the Examiner address respiratory problems or arrhythmia, not dysynchrony). Instead, Zhang measures the differences in force signals from different force sensors in the heart to evaluate dysynchrony and fails to disclose that this evaluation is at least partially a function of a monitored heart rate therapy. See Zhang i-f 48--49. Zhang's disclosure related to heart rate is directed to evaluating arrhythmia (Zhang i-f 60) or tachyarrhythmia (Zhang i-f 61 ), not dysynchrony. "[T]he prior art reference-in order to anticipate under 35 U.S.C. § 102-must not only disclose all elements of the claim within the four comers of the document, but must also disclose those elements 'arranged as in the claim."' Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1369 (Fed. Cir. 2008). The Examiner has failed to adequately explain how Zhang meets this requirement. 6 Appeal2013-002548 Application 12/267,376 For the reasons above, we do not sustain the rejection of independent claim 1 under 35 U.S.C. § 102(a) as anticipated by Zhang. We also do not sustain the rejection of claims 2--4 and 8 under 35 U.S.C. § 102(a) as anticipated by Zhang for at least the reason that these claims depend from claim 1. Rejection II In rejecting dependent claims 5 and 7, each of which depends directly from claim 1, the Examiner relies on the position that Zhang discloses each and every element of independent claim 1. See Final Act. 6. As we find that the Examiner's position as to claim 1 is deficient and the Examiner fails to explain how Li remedies this deficiency, we do not sustain the rejection of claims 5 and 7 under 35 U.S.C. § 103(a) as being unpatentable over Zhang and Li. DECISION We reverse the Examiner's rejection of claims 1-5, 7, and 8. REVERSED tkl 7 Copy with citationCopy as parenthetical citation