Ex Parte Ghosh et alDownload PDFPatent Trial and Appeal BoardSep 28, 201713706472 (P.T.A.B. Sep. 28, 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. 13/706,472 12/06/2012 Subham Ghosh P0042129.USU2/LG10126 7151 27581 7590 Medtronic, Inc. (CRDM) 710 MEDTRONIC PARKWAY NE MS: LC340 Legal Patents MINNEAPOLIS, MN 55432-9924 EXAMINER KAHELIN, MICHAEL WILLIAM ART UNIT PAPER NUMBER 3762 NOTIFICATION DATE DELIVERY MODE 10/02/2017 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 SUBHAM GHOSH and ROBERT W. STADLER1 Appeal 2016-002816 Application 13/706,472 Technology Center 3700 Before RICHARD M. LEBOVITZ, TAWEN CHANG, and DEVON ZASTROW NEWMAN, Administrative Patent Judges. CHANG, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134(a) involving claims to an implantable medical device and method for tracking effectiveness of pacing therapy, which have been rejected as anticipated. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM-IN-PART. 1 Appellants identify the Real Party in Interest as Medtronic, Inc. (Appeal Br. 2.) 1 Appeal 2016-002816 Application 13/706,472 STATEMENT OF THE CASE Arrhythmia is a general term used to describe heart rhythm irregularities arising from a variety of physical conditions and disease processes. Cardiac rhythm management systems, such as implantable pacemakers and cardiac defibrillators[,] have been used as an effective treatment for patients with serious arrhythmias. These systems typically comprise circuitry to sense electrical signals from the heart and a pulse generator for delivering electrical stimulation pulses to the heart. (Kim212.) “When a pace pulse produces a contraction in the heart tissue, the electrical cardiac signal following the contraction is denoted the captured response (CR).” (Id. 14.) “A common cause for ineffective pacing may be loss of capture due to, e.g., lead dislodgement, extracardiac stimulation, exit block, pacing from a suboptimal location, etc.” (Spec. 1:24—26.) According to the Specification, “[cjurrent devices may temporarily suspend, or interrupt, pacing therapy for one or more heart beats to determine if one or more pacing electrodes are effectively capturing cardiac tissue for delivery of pacing therapy.” (Id. at 1:26—2:2.) Further according to the Specification, the Specification describes “diagnostic methods and devices that can perform a beat-to-beat monitoring of effective pacing, without interruption of pacing therapy.” (Id. at 2:14—16.) Claims 1—6 and 8—20 are on appeal.3 Claim 1 is illustrative and reproduced below: 1. An implantable medical device for tracking effectiveness of pacing therapy to a patient comprising: 2 Kim et al., US 2005/0131478 Al, published June 16, 2005, (hereinafter “Kim”). 3 Claim 7 has been withdrawn from consideration. (Appeal Br. Claims App.) 2 Appeal 2016-002816 Application 13/706,472 a therapy delivery module configured to deliver pacing therapy to a patient's heart using at least a first electrode; a sensing module configured to sense electrical activity of the patient's heart using a second electrode during the delivery of pacing therapy using at least the first electrode; and a control module coupled to the therapy delivery module and to the sensing module and configured to: measure an activation time for each of a plurality of heart beats between the delivery of a pacing stimulus of the pacing therapy using the first electrode and a selected fiducial point of the sensed electrical activity resulting from the delivered pacing stimulus of the pacing therapy; determine beat-to-beat data representative of whether the pacing stimulus of the delivered pacing therapy for each heart beat of the plurality of heart beats was effective or ineffective based on the measured activation times, wherein the determination of whether the pacing stimulus of the delivered pacing therapy for each heart beat was effective or ineffective is indicative of whether capture occurred as a result of the delivered pacing stimulus; and use the beat-to-beat data to determine if the pacing therapy was effective or ineffective for the patient. (Appeal Br. Claims App. (formatting modified for clarity).) The Examiner rejects claims 1—6 and 8—20 under pre-AIA 35 U.S.C. § 102(b) as anticipated by Kim. (Ans. 2.) DISCUSSION Issue The Examiner finds that Kim discloses each limitation of the claims on appeal. (Ans. 2-4.) Appellants contend that Kim does not describe a control module configured to measure an activation time and then to use the measured activation times to determine “beat-to-beat data representative of whether the pacing stimulus . . . was effective or ineffective.” (Appeal Br. 8; see also Reply Br. 2—5.) With respect to claims 10 and 20, Appellants 3 Appeal 2016-002816 Application 13/706,472 additionally argue that Kim does not describe classifying the measured activation time for each heartbeat as being characteristic of one of a plurality of types of pacing therapy and an intrinsic activation, and determining that the delivered therapy was ineffective if the classification is not the same as the therapy delivered. (Appeal Br. 13; see also Reply Br. 5—6.) The issues with respect to this rejection are (1) whether Kim discloses a control module configured to measure an activation time and then, using such measured activation time, to determine “beat-to-beat data representative of whether the pacing stimulus . . . was effective or ineffective,” and (2) whether Kim discloses the control module configured to “classify, for each heart beat, the measured activation time as being characteristic of one of a plurality of types of pacing therapy and an intrinsic activation” and “determining that the delivered therapy was ineffective if the classification is not the same as the pacing therapy programmed to be delivered.” Findings of Fact 1. The Specification teaches that, for purposes of its invention, “[t]he fiducial point may be selected to be a characteristic of the sensed electrical activity resulting from (e.g., a product of) the pacing therapy that is repeatable or consistently measurable such that, e.g., the measured activation times may be a reliable indicator of effectiveness.” (Spec. 19:13—16.) The Specification states that, for at least one embodiment, the fiducial point may be a peak in the waveform sensed by the sensing electrode. {Id. at 19:16— 18.) 2. Kim teaches “[mjethods and devices for classifying a cardiac pacing response involving] using a first electrode combination for pacing 4 Appeal 2016-002816 Application 13/706,472 and a second electrode combination for sensing a cardiac signal following pacing.” (Kim Abstract.) 3. Kim teaches using the sensed cardiac signal to classify the cardiac response to pacing as, for example, a captured response, a non- captured response, a non-captured response and an intrinsic beat, a near non capture response, a fusion/pseudo fusion beat, and/or an intrinsic beat. {Id. 11 12, 52, 89, 100, 111, and 158.) 4. Kim teaches that cardiac response classification may be accomplished by comparing the cardiac signal to one or more references to classify the cardiac response. For example the cardiac response may be compared to an amplitude reference, a slope or rise time reference, a curvature reference, a peak width reference, among other reference types. In addition, samples or features of the cardiac signal may be compared to a template to classify the cardiac response. {Id. 191.) 5. Kim teaches defining “[a] plurality of classification windows . . . relative to and subsequent to the pacing pulse,” detecting “[a] characteristic of the cardiac signal within a particular classification window,” and classifying “[t]he cardiac response to the pacing pulse . . . based on the detected characteristic and the particular classification window.” {Id. 14, 92, and 113.) Kim teaches that such characteristics of cardiac signal may be, “for example, a peak, slope, curvature, [or] sequence of feature points.” {Id. H 52, 113.) 5 Appeal 2016-002816 Application 13/706,472 6. Kim’s Figure 7A is reproduced below: r' Pace Putee Delivered JH } —^ Time ofCR Template Characteristic ^ 720 r™ 7 40 Classification Window 2 Classification Window 1 Classification VWndow 3 Time of Characteristic Figure 7A Kim’s Figure 7A illustrates the establishment of a set of classification windows relative and subsequent to the pacing stimulation and based on a captured response (CR) template, wherein the template exemplifies a waveform representative of a captured response. {Id. 1115.) In particular, Kim teaches that classification windows may be established based on a feature or features of the captured response (CR) template. . . . [A] first classification window 730 may be established based on the time 750 of a selected characteristic of a captured response (CR) template. In one example, the first classification window 730 is established based on a timing of the peak of the CR template. . . . The first classification window 730 represents a time interval defined in relation to the timing of the selected characteristic of the CR template 750 from a pacing stimulation 710. In the example illustrated in FIG. 7A, the first classification window 730 comprises a time interval, e.g., a time interval of about 20 ms, centered at the time 750 of the selected CR template characteristic with respect to the time of the delivery of the pacing pulse. 6 Appeal 2016-002816 Application 13/706,472 In this example, a second classification window 720 may be defined subsequent to the time 710 of the delivery of the pacing pulse and prior to the beginning of the first classification window 730. A third classification window 740 may be defined following the end of the first classification window 730. (Id. at 11 128-129.) 7. Kim’s Figure 8A is reproduced below: Provide Captured Response Template I X ■aejgrisiie Parang X Deliver Pacing Pulse Establish Classification WmJows 112 - 814 ai« X xr SIB Sense Cardiac Signs! IWtewng Pacing Pulse Detect Second Cardiac Signal Feature in Second Classification window Figure 8A ’Compare First Card®!: Signal feature to First sncoftstswot with JL Reference Second Cerdtab Signal Feature to Sesoff' Reference :iassify as First Candied Response Type XL S3Q Classify as Second Cardiac Response Type Classify as Third Cardiac Response Type r 7 Appeal 2016-002816 Application 13/706,472 Figure 8 A “illustrates a method of cardiac response classification utilizing a captured response (CR) template to define multiple classification windows according to embodiments of the invention.” {Id. 1145.) 8. Kim teaches that classification windows may also be established and the cardiac responses classified using an evoked response (ER) template rather than a CR template in the methods set forth above, where an evoked response template may be obtained by cancelling the pacing artifact from the captured response. {Id. Tflf 131—132, 134—135, 149— 151, Figs. 7C and 8B.) 9. Kim’s Figure 10 is reproduced below: *1040 Determine Cardiac Response Based on the Peak and the Classification Window Figure 10 Kim’s Figure 10 depicts “a method for performing cardiac response classification that is particularly suitable for implementation in an autocapture process,” where “[classification of the cardiac response is 8 Appeal 2016-002816 Application 13/706,472 performed 1040 based on the amplitude of the peak and the particular classification window in which the peak is sensed.” {Id. 1153.) 10. Kim’s Figure 11 is reproduced below: Pace Pufse DefivefSd Ctessff&slsOfi VUnctew TkRlfc r 1120 t;R Template Pea* rmA rn Capture- Window TtffHj. Characteristic ......... » iotnns>GCia^siftiai:cCopy with citationCopy as parenthetical citation