Ex Parte Goetz et alDownload PDFPatent Trial and Appeal BoardOct 25, 201711414786 (P.T.A.B. Oct. 25, 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. 11/414,786 04/28/2006 Steven M. Goetz 1023-478US01 1167 71996 7590 10/27/2017 SHUMAKER & SIEFFERT , P.A 1625 RADIO DRIVE , SUITE 100 WOODBURY, MN 55125 EXAMINER D ABREU, MICHAEL JOSEPH ART UNIT PAPER NUMBER 3762 NOTIFICATION DATE DELIVERY MODE 10/27/2017 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): pairdocketing @ ssiplaw.com medtronic_neuro_docketing @ cardinal-ip.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte STEVEN M. GOETZ, NATHAN A. TORGERSON, and MICHAEL T. LEE1 Appeal 2016-007770 Application 11/414,786 Technology Center 3700 Before ERIC B. GRIMES, ULRIKE W. JENKS, and RACHEL H. TOWNSEND, Administrative Patent Judges. GRIMES, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35U.S.C. § 134 involving claims to a method and system for determining the functionality of a lead of an implanted medical device, which have been rejected as being directed to patent- ineligible subject matter and as anticipated. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. 1 Appellants identify the real parties in interest as Medtronic, Inc. and Medtronic pic. (Appeal Br. 3.) Appeal 2016-007770 Application 11/414,786 STATEMENT OF THE CASE “Implantable medical devices may be used to deliver therapeutic electrical stimulation to patients to treat a variety of symptoms or conditions.” (Spec. 13.) “The impedance of the various electrical paths provided by a lead may vary over the life of an implantable medical device,” due to material degradation, insulation failure, or fracture. {Id. 14.) “Changes in lead impedance impair the ability of an implantable medical device to effectively sense electrical activity and/or deliver stimulation. Consequently, it may be desired to identity such changes in order to take corrective action.” {Id. 15.) “Traditionally, clinicians have used a programming device during an office visit to manually direct an implantable medical device to perform a lead integrity or functionality test.” {Id.) However, “a conductor short or fracture may be intermittent, and more likely to manifest during periods when the patient is changing posture, within a particular posture, or otherwise active. In such cases, a clinician may not be able to detect a conductor problem with a manual lead functionality test performed during an office visit.” {Id. 1 8.) The Specification discloses “techniques for testing the functionality of implanted electrical leads. . . . The medical device may automatically perform a lead functionality test, e.g., without receiving a command to perform the test from a user or programming device, outside of a clinic setting.” {Id. 19.) 2 Appeal 2016-007770 Application 11/414,786 Claims 1—3, 6—12, 15—21, and 24—31 are on appeal. Claim 1 is illustrative and reads as follows: Claim 1: A method comprising: determining whether a patient is within at least one of a target activity state or a target posture based on a physiological sensor signal, wherein determining whether the patient is within the target activity state comprises determining at least one of whether body movement of the patient exceeds a threshold, whether the patient is changing postures, or whether the patient is exercising; automatically performing a lead functionality test for at least one electrical lead implanted within the patient in response to the physiological sensor signal indicating that the patient is within the target activity state or target posture, wherein automatically performing the lead functionality test comprises measuring an electrical parameter for at least two different combinations of electrodes; and generating information that indicates at least one of whether the functionality of the at least one electrical lead has degraded or whether the at least one electrical lead has failed based on the measurements of the electrical parameter for the at least two different combination of electrodes, wherein at least one of the determining, automatically performing, or generating is performed via a processor. Claims 10, 21, and 26 are also independent and each is directed to a system for carrying out the method of claim 1. Claims 10 and 26 require a processor that, among other things, “measures an electrical parameter for at least two different combinations of electrodes to perform [a] lead functionality test.” (Appeal Br. 28, 31 (Claims App’x).) Claim 21 requires a “means for performing the lead functionality test [that] comprises means 3 Appeal 2016-007770 Application 11/414,786 for measuring an electrical parameter for at least two different combinations of electrodes.” {Id. at 30.) The claims stand rejected as follows: Claims 1—3, 6—12, 15—21, and 24—31 under 35 U.S.C. § 101 as being directed to patent-ineligible subject matter (Final Action2 2), and Claims 1-3, 6-12, 15-21, and 24—31 under 35 U.S.C. § 102(b) as anticipated by Lu3 (Final Action 3). I The Examiner has rejected claims 1—3, 6—12, 15—21, and 24—31 on the basis that they are directed to an abstract idea: The method/system in the independent claims include elements which receive and process information; however, there is no tangible result or end goal and the claim does not include additional elements sufficient to amount to significantly more than the judicial exception. There is only the receipt of information and the processing of that information involving the broad determining lead degradation. Accordingly, the system simply appears to be an abstract idea, similar to a mathematical algorithm, which does not actively accomplish anything or have an end result or purpose. (Final Action 2.) We agree with Appellants, however, that “claim 1 is directed to a specific solution that is necessarily rooted in receiving and processing information to overcome a problem in the field of delivering therapy to a patient using one or more leads of a medical device implanted in a patient.” (Appeal Br. 10.) Specifically, the Specification states that 2 Office Action mailed May 21, 2015. 3 Lu et al., US 6,188,927 Bl, issued Feb. 13, 2001 (“Lu”). 4 Appeal 2016-007770 Application 11/414,786 some lead functionality problems, such as, e.g., conductor short or fracture, may be intermittent and more likely to manifest during periods when the patient is changing posture, within a particular posture, or otherwise active. . . . Independent claim 1 is directed to providing a solution through determining whether a patient is within at least one of a target activity state or a target posture based on a physiological sensor signal, [and] automatically performing a lead functionality test. {Id. at 10—11. See also Spec. 1 8.) The Examiner reasons that [t]he method includes a determination step which does not actively require any acquisition of data but rather a determining step “based on a physiological sensor” which does not require sensing of a physiological parameter but could be performed by an individual simply watching a screen or light; therefore, it is considered insignificant pre-solution activity. As to the performing of a lead functionality test, this element/step is still merely a computational algorithm stored on a tangible medium. (Ans. 2.) The Specification discloses, however, that lead functionality testing is a known technique: For example, to perform lead impedance testing, the IMD may deliver a non-therapeutic pulse via a combination of two electrodes, measure final voltage or current amplitude for the pulse, and determine an impedance for the combination based on the measured final amplitude. Testing may be repeated for a plurality of electrode combinations. (Spec. 165.) Thus, the “determining” step of claim 1 requires actively delivering an electric current to electrodes and measuring the voltage or amplitude in order to determine the impedance for a combination of electrodes. We do not agree with the Examiner’s reasoning that this step does not actively require acquisition of data. 5 Appeal 2016-007770 Application 11/414,786 In summary, the Examiner has not persuasively shown that the claimed method and system amount to no more than an abstract idea. We therefore reverse the rejection of claims 1—3, 6—12, 15—21, and 24—31 under 35 U.S.C. § 101. II The Examiner has rejected claims 1—3, 6—12, 15—21, and 24—31 as anticipated by Lu. The Examiner finds that Lu discloses a method and system meeting all of the limitations of the independent claims, including “automatically performing lead functionality test compris[ing] measuring an electrical parameter for at least two different combinations of electrodes (e.g. Col 3,11 62-67 - where the protection/switching network necessarily switches between the different combinations of electrodes when calculating impedance values).” (Final Action 3.) Appellants argue that “Lu fails to describe wherein automatically performing the lead functionality test comprises measuring an electrical parameter for at least two different combinations of electrodes.” (Appeal Br. 17.) Appellants also argue that the Examiner has not established that this limitation is inherent in Lu’s method and system. {Id. at 17—19.) We agree with Appellants that the Examiner has not established that Lu expressly or inherently describes “automatically performing the lead functionality test comprises measuring an electrical parameter for at least two different combinations of electrodes,” as required by claim 1. Lu describes “[a]n implantable cardiac stimulation system . . . which automatically optimizes its ability to rate-responsively pace by enabling calibration when the patient is at rest and has a functioning lead.” (Lu, abstract.) 6 Appeal 2016-007770 Application 11/414,786 As relevant to the disputed limitation, Lu states that its system includes “leads 12,14 [that] are electrically and physically connected to the pacemaker 10 through a connector 16.” {Id. at 3:58—59.) “The connector 16 is electrically connected to a protection/switching network 17, which network 17 switchably couples the electrodes to the appropriate sensing and pacing configuration and to the appropriate measurement circuitry (such as . . . physicologic sensor 70).” {Id. at 3:62 to 4:1.) Lu states that “[t]he network 17 further electrically protects circuits within the pacemaker 10 from excessive shocks or voltages that could appear on the electrodes 18, 20 in the event such electrodes 18, 20 were to come in contact with a high voltage signal, e.g., from a defibrillator shock.” (Id. at 4:1—6.) The Examiner reasons that “the protection/switching network necessarily switches between the different combinations of electrodes when calculating impedance values.” (Final Action 3.) We agree with Appellants, however, that this finding is not supported by the reference. Lu states that “the second sensor 70 generates an excitation signal between ring electrode 21 and the case electrode and then senses the voltage between the tip electrode 20 and the case electrode. The resultant voltage is then transmitted to control system 32 for determination of the impedance value.” {Id. at 6:16—20.) Lu thus describes measuring impedance (in order to determine whether it is within an acceptable tolerance range; see id. at 6:35 40) using only a single combination of electrodes. Lu states: “For a more detailed description of this method of monitoring minute ventilation, see, for example, U.S. Pat. No. 5,562,712, issued Oct. 8, 1996 to Steinhaus et al.” {Id. at 6:22—25.) The Examiner reasons that Steinhaus describes using more than one combination of 7 Appeal 2016-007770 Application 11/414,786 electrodes. (Ans. 5—6.) However, the passages from Steinhaus that are reproduced in the Answer describe using either the combination of “pacemaker case 5 and tip electrode 11” or the combination of “electrode 13 and case 30.” The quoted passages thus do not describe testing lead functionality using at least two different combinations of electrodes, as required by the claims on appeal. Because the Examiner has not shown that Lu discloses a method and system meeting all of the limitations of the claims, we reverse the rejection of claims 1—3, 6—12, 15—21, and 24—31 as anticipated by Lu. SUMMARY We reverse both of the rejections on appeal. REVERSED 8 Copy with citationCopy as parenthetical citation