Ex Parte SkeltonDownload PDFPatent Trial and Appeal BoardAug 28, 201813958405 (P.T.A.B. Aug. 28, 2018) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 13/958,405 08/02/2013 71996 7590 08/30/2018 SHUMAKER & SIEFFERT, P.A 1625 RADIO DRIVE, SUITE 100 WOODBURY, MN 55125 FIRST NAMED INVENTOR Dennis M. Skelton 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. 1123-075US02/P034919.USC2 2244 EXAMINER WEHRHEIM, LINDSEY GAIL ART UNIT PAPER NUMBER 3762 NOTIFICATION DATE DELIVERY MODE 08/30/2018 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 rs.patents.five@medtronic.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte DENNIS M. SKELTON Appeal2017-008575 Application 13/958,405 Technology Center 1600 Before DEMETRA J. MILLS, RICHARD M. LEBOVITZ, and DAVID COTTA, Administrative Patent Judges. MILLS, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134. The Examiner has rejected the claims for obviousness. We have jurisdiction under 35 U.S.C. § 6(b ). We reverse. Appeal2017-008575 Application 13/958,405 STATEMENT OF CASE A variety of medical devices are used for chronic, e.g., long- term, delivery of therapy to patients suffering from a variety of conditions, such as chronic pain, tremor, Parkinson's disease, epilepsy, urinary or fecal incontinence, sexual dysfunction, obesity, or gastroparesis. As examples, electrical stimulation generators are used for chronic delivery of electrical stimulation therapies such as cardiac pacing, neurostimulation, muscle stimulation, or the like. Pumps or other fluid delivery devices may be used for chronic delivery of therapeutic agents, such as drugs. Typically, such devices provide therapy continuously or periodically according to parameters contained within a program. A program may comprise respective values for each of a plurality of parameters, specified by a clinician. In some cases, the patient may be allowed to activate and/or modify the therapy delivered by the medical device. For example, a patient may be provided with a patient programming device. The patient programming device communicates with a medical device to allow the patient to activate therapy and/or adjust therapy parameters. For example, an implantable medical device (IMD), such as an implantable neurostimulator, may be accompanied by an external patient programmer that permits the patient to activate and deactivate neurostimulation therapy and/or adjust the intensity of the delivered neurostimulation. Spec. 1. The following claims are representative. 21. A method comprising: receiving an indication of an adjustment to one or more parameters of electrical stimulation therapy delivered to a patient, wherein the adjustment is made by the patient while occupying a first posture state and prior to the patient occupying a second posture state; receiving an indication that the patient is occupying the second posture state; and responsive to receiving the indication that the patient is occupying the second posture state, associating, by a processor, 2 Appeal2017-008575 Application 13/958,405 the adjustment to the one or more parameters with the second posture state, wherein the adjustment to the one or more parameters is not associated with the first posture state. 22. The method of claim 21, further comprising: receiving an indication of sensing the second posture state; determining that the second posture state does not change within a period of time subsequent to receiving the indication of the adjustment; responsive to the determination, determining that the patient is occupying the second posture state; and responsive to determining that the patient is occupying the second posture state, generating the indication that the patient is occupying the second posture state. Cited References Singhal Sloman Grounds of Rejection US 2005/0060001 Al US 6,975,904 Bl Mar. 17,2005 Dec. 13, 2005 1. Claims 21, 23-26, 29-31, 33-36, and 39-41 are rejected underpre- AIA 35 U.S.C. § I03(a) as being unpatentable over Singhal in view of Sloman. Final Act. 2. 2. Claims 22, 27, 28, 32, 37, and 38 are rejected under pre-AIA 35 U.S.C. § I03(a) as being unpatentable over the modified Singhal ( e.g., Singhal in view of Sloman). Final Act. 5. FINDINGS OF FACT The Examiner's findings of fact are set forth in the Final Action at pages 2-9. The following facts are highlighted. 3 Appeal2017-008575 Application 13/958,405 1. Figure 6 of Singhal is reproduced below. [ PA ••ENT R:EQUES rs Ll$-">.RN,NG MOO~------------· 80 --r r·······-·· R EGOR~;:,g~f~;,;~~<'n"U$S!i,o-·······-···l------- 82 l FtG. S Figure 6 of Singhal shows a flow diagram of an exemplary mode of implanted medical device (IMD) 12 to learn a therapy for an event that is defined by IMD 12 based on the output of a sensor 40. Processor 34 enters the learning mode in response to receiving a command from patient 14 (80). 2. Singhal discloses that, in the medical device, The output of the sensor may reflect motion, posture, and/or one or more physiological parameters of patient 14. Consequently, events defined by IMD 12 based on the sensor output may correspond to an activity undertaken by patient 14. For example, patient 14 may direct IMD 12 to enter the learning mode via patient programmer 20 when patient 14 is about to undertake an activity, such as running. IMD 12 may record the output of the sensor in response to the command, and, when no longer in the learning mode, use the recorded exemplar to detect when patient 14 is running so as to automatically provide an appropriate therapy adjustment according to therapy information stored in association with the exemplar. Singhal ,r 33; Ans. 7. 4 Appeal2017-008575 Application 13/958,405 PRINCIPLES OF LAW In making our determination, we apply the preponderance of the evidence standard. See, e.g., Ethicon, Inc. v. Quigg, 849 F.2d 1422, 1427 (Fed. Cir. 1988) (explaining the general evidentiary standard for proceedings before the Office). "[O]bviousness requires a suggestion of all limitations in a claim." CFMT, Inc. v. Yieldup Intern. Corp., 349 F.3d 1333, 1342 (Fed. Cir. 2003) ( citing In re Royka, 490 F .2d 981, 985 ( CCP A 197 4) ). When determining whether a claim is obvious, an Examiner must make "a searching comparison of the claimed invention - including all its limitations - with the teachings of the prior art." In re Ochiai, 71 F.3d 1565, 1572 (Fed. Cir. 1995). Obviousness Rejection According to the Examiner, Singhal discloses each claimed element except that Singhal does not explicitly disclose that the adjustment to the one or more parameters is not associated with the first posture state. Final Act. 3. In particular, Singhal discloses a medical device, with an output of the sensor that may reflect motion, posture, and/or one or more physiological parameters of patient 14, including cardiac pacing or neurostimulation. Singhal ,r 33; Ans. 7. Events defined by the device based on the sensor output may correspond to an activity/posture undertaken by patient 14. Id. For example, the patient may direct the device to enter the learning mode via patient programmer when patient is about to undertake an activity, such as running. Id. The device may record the output of the sensor in response to the command, and, when no longer in the learning mode, use the recorded 5 Appeal2017-008575 Application 13/958,405 exemplar to detect when patient is running. Id. This can automatically provide an appropriate therapy adjustment according to therapy information stored in association with the exemplar activity. Id .. The device memory stores events defined by processor during operation in the learning mode, and learned therapies, i.e., the therapy information collected during operation in the learning mode. Singhal ,I49. As explained by Singhal: [ A ]n event 52 may be an activity or posture undertaken by patient 14. For example, an event 52 may be patient 14 running, and the learned therapy 54 may include changes to stimulation parameters occurring at associated times during the "running" event such that effective and comfortable therapy is maintained. Other activities and postures that may effect the symptoms experienced by patient 14, or the effectiveness and side effects of the stimulation may include golfing, gardening, driving a car, sitting in a chair, twisting, or bending over. In some cases the duration of a particular activity or posture may affect the symptoms experienced by patient 14, or the effectiveness and side effects of the stimulation. In such cases an event 52 may be defined as occurring after patient 14 maintains an activity or posture for a defined duration. Singhal i-f 66. The Examiner relies on Sloman to make up for the deficiency of Singhal in failing to disclose an adjustment to the one or more parameters that is associated with a second posture state and that is not associated with a first posture state. The Examiner finds that Sloman was relied on to more clearly show how a system can monitor parameters and store said parameters into memory, where said parameters are related to a specific posture state the patient is in and therefore excludes other possible postures the patient assumed prior. The Sloman reference was cited to explicitly show association of parameters with a particular desired posture state, such that a different posture state ( such as that assumed before correlation of the parameters with a second 6 Appeal2017-008575 Application 13/958,405 posture state) is basically excluded from being associated with the parameters. Sloman was cited because the disclosure of Singhal does not explicitly differentiate between a posture before the learning mode and a posture during which the learning mode is enabled. Ans. 5. In addition, the Examiner argues that Sloman discloses it was known in the art to calibrat[ e] parameter settings in a stimulation system, such that programming includes adjustment to one or more parameters for a second posture state that is not associated with the first posture state ( col 14, ln 13-51 ). Applied to the invention of Singhal above, the features of Sloman provide means to adjust parameters as known in the art such that adjustment to the one or more parameters is not associated with the first posture state. It would have been obvious to one of ordinary skill the art at the time the invention was made to include the features of Sloman in the invention of Singhal, since such a modification would provide the predictable results of improved device efficiency by reducing the amount of energy wasted by the IMD and unnecessary battery drain. Final Act. 3. Appellant argues: (see page 8, second paragraph) that The Examiner has not shown that the Sloman reference discloses that an "adjustment is made by [a] patient while occupying a first posture state" and that the adjustment to one or more parameters is not associated with the first posture state as recited in independent claim 21. App. Br. 8. 7 Appeal2017-008575 Application 13/958,405 ANALYSIS The claims before us are very broad. In this case, neither the Examiner nor the Appellant did a clear job of explaining where the pending claim limitations are found in the prior art and/or Appellant's Specification. Notwithstanding the lack of clarity in development of the record before us, we do not find that the Examiner has provided evidence to support a prima facie case of obviousness. The Examiner has not provided evidence in the prior art of the claim 21 method step of "receiving an indication of an adjustment to one or more parameters of electrical stimulation therapy delivered to a patient, wherein the adjustment is made by the patient while occupying a first posture state and prior to the patient occupying a second posture state." Emphasis added. Singhal paragraphs 33-34 relied on by the Examiner disclose that A medical device detects a previously defined event, and controls delivery of therapy to a patient according to therapy information associated with the previously defined event. In exemplary embodiments, the medical device enters a learning mode in response to a command received from a user, e.g., the patient or a clinician. In such embodiments, the medical device defines the event, collects the therapy information, and associates the therapy information with the defined event while operating in the learning mode. In some embodiments, the medical device defines the event based on the output of a sensor that indicates a physiological parameter of the patient during the learning mode. See also, Abstract. In sum, in Singhal, the learning mode of the computer changes the patient therapy. Sloman describes an implantable device capable of recognizing a first set of parameter values that correspond with a first 8 Appeal2017-008575 Application 13/958,405 orientation of the patient; and a second set of parameter values that correspond with a second orientation of the patient; and wherein the set of parameter values is modified to the first set or the second set based on the detected orientation of the patient. ( Claim 19.) Appellant argues, however, that The Examiner has erred in rejecting claim 21 for at least the following reasons. For example, the Examiner has not shown that Sloman discloses that an "adjustment is made by [a] patient while occupying [a] first posture state" and that "the adjustment to one or more parameters is not associated with the first posture state," as recited by claim 21. Reply Br. 8, emphasis added. We find that the Examiner did not meet the burden of establishing that the claimed limitation of "wherein the adjustment is made by the patient while occupying a first posture state and prior to the patient occupying a second posture state," is met by Sloman, alone, or in combination with Singhal. What is missing from the Examiner's analysis is a specific indication where the prior art discloses the patient making adjustments to one or more parameters of electrical stimulation therapy delivered to a patient. While the Examiner finds that paragraphs 33-34 of Singhal disclose that the patient may direct the implantable medical device to enter a learning mode via a patient programmer when the patient is ready to undertake an activity, we do not find this disclosure to be equivalent to the claim limitation that, "the patient makes adjustments to parameters of electrical stimulation therapy or that the adjustment is made by the patient while occupying a first posture state and prior to the patient occupying a second posture state." 9 Appeal2017-008575 Application 13/958,405 Thus, the Examiner has not provided evidence of each claimed element in the prior art. Remaining independent claims 3 1, and 41 also contain the same limitation that the "adjustment is made by the patient while occupying a first posture state and prior to the patient occupying a second posture state." For this reason, the obviousness rejection of these claims and their dependent claims is also reversed. Rejection 2 is also reversed for the same reasons. CONCLUSION OF LAW The cited references do not support the Examiner's obviousness rejections, which are reversed. REVERSED 10 Copy with citationCopy as parenthetical citation