Ex Parte GerberDownload PDFPatent Trial and Appeal BoardFeb 28, 201813968290 (P.T.A.B. Feb. 28, 2018) 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. 13/968,290 08/15/2013 Martin T. Gerber 1023-482US02/P022581.USC1 7104 71996 7590 03/02/2018 SHUMAKER & SIEFFERT , P.A 1625 RADIO DRIVE , SUITE 100 WOODBURY, MN 55125 EXAMINER BERTRAM, ERIC D ART UNIT PAPER NUMBER 3766 NOTIFICATION DATE DELIVERY MODE 03/02/2018 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 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 MARTIN T. GERBER Appeal 2017-002690 Application 13/968,2901 Technology Center 3700 Before RICHARD M. LEBOVITZ, FRANCISCO C. PRATS, and DAVID COTTA, Administrative Patent Judges. COTTA, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 relating to implantable medical devices for delivery of neurostimulation therapy. Spec. 12. The Examiner rejected the claims on appeal under 35 U.S.C. § 112(a) as failing to comply with the written description requirement and under 35 U.S.C. § 103(a) as obvious. We REVERSE. 1 According to Appellant, the real party in interest is Medtronic pic, which is the ultimate parent of the assignee, Medtronic, Inc. App. Br. 3. Appeal 2017-002690 Application 13/968,290 STATEMENT OF THE CASE The Specification discloses that “[ejlectrical stimulation of the sacral nerves, pudendal nerves, and other nerves of the pelvic floor has been found to offer relief for many pelvic floor disorders.” Spec. 14. The Specification discloses that an implantable pulse generator may be used to “stimulate the sacral nerves, and thereby restore or control bodily functions affected by pelvic floor disorders.” Id. “Chronic implantation of a pulse generator and lead for sacral nerve stimulation is typically preceded by a trial period.” Id. | 5. “In most cases, the trial period is successful, in which case the trial stimulator is explanted and replaced with a permanent, i.e., ‘chronic,’ implantable stimulator.” Id. 19. The Specification discloses: “In accordance with the invention, an implantable neurostimulator supports both trial neurostimulation and chronic neurostimulation. In the event trial stimulation is successful, the need for explant and replacement is eliminated.” Id. 110. “Upon expiration of the trial period, the implantable neurostimulator stops operating, unless it receives additional authorization to either extend the trial mode or enter a chronic mode of operation.” Id. 111. Claims 9—15 and 28-48 are on appeal. Claims 9 and 46 are illustrative and read as follows (emphasis added to highlight limitation at issue): 9. A system comprising: an electrical stimulator including: a pulse generator configured to be coupled to an electrode; and a processor configured to activate the pulse generator to deliver electrical stimulation for a first authorized use of the pulse generator, and to 2 Appeal 2017-002690 Application 13/968,290 disable the pulse generator to stop the delivery of electrical stimulation after the first authorized use; and an external computing device configured to transmit an authorization to the processor, wherein upon being disabled, the pulse generator is prevented from being reactivated in response to patient input until the processor receives the authorization from the external computing device, and wherein the processor is configured to reactivate the pulse generator to deliver electrical stimulation for a second authorized use of operation following the first authorized use in response to receiving the authorization. 46. A system comprising: a pulse generator configured to generate electrical stimulation therapy; and a processor configured to activate the pulse generator to deliver electrical stimulation during a first authorized use of the pulse generator, and to disable the pulse generator to stop the delivery of electrical stimulation after the first authorized use until an authorization from an external computing device is received, wherein the processor is configured to, after disabling the pulse generator after the first authorized use, receive the authorization from the external computing device, and reactivate the pulse generator to deliver electrical stimulation during a second authorized use following the first authorized use in response to receiving the authorization, wherein the authorization authorizes use of a different mode of operation than the first authorized use, and wherein the pulse generator is configured to generate electrical stimulation according to the different mode of operating during the second authorized use. App. Br. 17, 24. 3 Appeal 2017-002690 Application 13/968,290 The claims stand rejected by the Examiner as follows: I. Claims 9—15 and 28-45 under 35 U.S.C. § 112(a) as failing to comply with the written description requirement. II. Claims 46-48 under 35 U.S.C. § 103(a) as obvious over Rutecki.2 III. Claims 9—15 and 28—45 under 35 U.S.C. § 112(a) as failing to comply with the enablement requirement. IV. Claims 46-48 on the ground of non-statutory obviousness-type double patenting over claims 1—33 ofU.S. Patent No. 8,774,912. V. Claims 46-48 on the ground of non-statutory obviousness-type double patenting over claims 1—26 ofU.S. Patent No. 8,768,452.3 FINDINGS OF FACT 1. The Specification states: The implantable neurostimulator invokes a trial mode of neurostimulation in which the device is partially or fully operable, but only operates for a trial period of finite duration. Upon expiration of the trial period, the implantable neurostimulator stops operating, unless it receives additional authorization to either extend the trial mode or enter a chronic mode of operation. Spec. 111. 2. The Specification states: The authorization to continue use in a chronic mode may be provided in a variety of ways. For example, the clinician may 2 Rutecki et al., U.S. Patent No. 5,330,515, issued July 19, 1994 (“Rutecki”). 3 In the Examiner’s Answer, Rejections III—V were withdrawn. Ans. 3—4. Rejection III was withdrawn after consideration of Appellant’s arguments. Id. Rejections IV and V were withdrawn due to the submittal of a Terminal Disclaimer. Id. 4 Appeal 2017-002690 Application 13/968,290 simply download an authorization code to the implanted neurostimulator, which authorizes the neurostimulator to continue operation. The authorization code may unlock the neurostimulator from a frozen state, or unlock parameters or programs necessary for chronic operation. Alternatively, the clinician may reprogram the implanted neurostimulation device by downloading new parameters or programs that govern the chronic mode. In general, the chronic mode is intended for relatively long term stimulation therapy over an extended, indefinite time period. However, it may be possible for a patient to discontinue the therapy at any time using a patient programmer. Id. 114. 3. The Specification states: Upon disablement, neurostimulator 24 may remain idle until it is explanted, in the case of an unsuccessful trial, or until a clinician transmits an authorization command via the clinician programmer 34 or patient programmer 36 to enter the chronic mode, in the case of a successful trial. In the chronic mode, neurostimulator 24 is reactivated and enabled for continued delivery of neurostimulation therapy. In this case, neurostimulator 24 may receive simply the authorization command to invoke a set of parameters or a program stored in the neurostimulator to support the chronic mode. Alternatively, neurostimulator 24 may receive a new parameter or program via the clinician programmer 34 or patient programmer 36, or be entirely reprogrammed. In each case, there is no need for another surgical procedure. Instead, the provisioning of neurostimulator 24 is accomplished by wireless telemetry. Id. 1 59. 4. The Specification states: In some embodiments, when timer 48 expires, processor 42 responds by disabling therapy delivery circuit 36 to terminate the trial mode. In other words, processor 42 stops the trial period by 5 Appeal 2017-002690 Application 13/968,290 stopping delivery of neurostimulation therapy to patient 12 by trial neurostimulator 24A. In this manner, implantable neurostimulator 24A can be configured to prevent patient 12 or a physician from prolonging the trial period beyond a prescribed period of time. Rather, implantable neurostimulator 24A has a finite period of operation, determined by a maximum trial period that may be specified by the manufacturer or in a programmable manner by a clinician. In chronic mode, timer 48 may be used in some embodiments to serve as a method to ensure clinician evaluation of stimulation throughout chronic therapy. In other words, the chronic mode may be periodically disabled, e.g., with advance warning to the patient through patient programmer 36, to compel a clinical visit by the patient for periodic evaluation. Timer 48 may be implemented in hardware using a real-time clock, in software by processor 42, or a combination thereof. Accordingly, timer 48 is illustrated as a separate component in FIG. 2 merely for exemplary purposes. Id. 11 67-68. WRITTEN DESCRIPTION Independent claims 9 and 37 recite that “the pulse generator is prevented from being reactivated in response to patient input until the processor receives the authorization from the external computing device.” Claim 28 similarly recites that “the means for delivering electrical stimulation is prevented from being reactivated in response to patient input until the means for activating receives the authorization from the means for transmitting.” The Examiner rejects claims 9—15 and 28-45, because the Examiner does not consider the Specification to provide support for preventing reactivation. The Examiner contends that “the only mention of preventing patient input occurs in paragraph 0068, which discloses that the implantable neurostimulator can prevent a patient from prolonging a trial 6 Appeal 2017-002690 Application 13/968,290 period” which, according to the Examiner, “is not the same as what is currently recited.” Ans. 2. Appellant cites to paragraphs 11, 14, 59, 67, and 68 (reproduced as FF1—FF4) as providing support for this claim element. Appellant argues that “[w]hen viewed as a whole, these and other portions of the application as originally filed would ‘convey with reasonable clarity to those skilled in the art that, as of the filing date sought, [Appellant] was in possession of the invention as now claimed.’” Reply Br. 3^4. We find that Appellant’s arguments are supported by the evidence before us. The Specification discloses a neurostimulator with a trial mode and a chronic mode. FF1. When the trial mode expires, the neurostimulator ceases operating. Id. The Specification teaches that the neurostimulator is “configured to prevent patient 12 . . . from prolonging the trial period” by “terminating the trial mode,” i.e., “stopping delivery of neurostimulation therapy.” FF4. The neurostimulator cannot be reactivated until it receives additional authorization. FF1; FF3. The neurostimulator may be reactivated by a clinician who “download[s] an authorization code” or “download[s] new parameters or programs.” FF2. While the term “external computing device” is not explicitly recited in the passages referred to by Appellant, the Specification describes downloading codes (FF2), indicating they come from an external source. We find that these disclosures would have reasonably conveyed to the skilled artisan that Appellant was in possession of a neurotransmitter in which “the pulse generator is prevented from being reactivated in response to patient input until the processor receives the authorization from the external computing device” as recited in claims 9 and 37. Similarly, we find 7 Appeal 2017-002690 Application 13/968,290 that these disclosures would have reasonably conveyed to the skilled artisan that Appellants was in possession of a neurotransmitter in which the “means for delivering electrical stimulation is prevented from being reactivated in response to patient input until the means for activating receives the authorization from the means for transmitting” as recited in claim 28. The Examiner points to deficiencies in each of the individual paragraphs cited by Appellant as supporting the above claim element. Ans. 4—6. We are not persuaded because the Examiner’s criticism does not address the disclosure of the Specification as a whole. Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (the written description test “requires an objective inquiry into the four comers of the specification from the perspective of a person of ordinary skill in the art”). Accordingly, we reverse the Examiner’s rejection of claims 9—15 and 28-45 as failing to comply with the written description requirement. OBVIOUSNESS Claim 46 requires “a processor configured ... to disable the pulse generator to stop the delivery of electrical stimulation after the first authorized use until an authorization from an external computing device is received.” In finding claims 46-48 obvious, the Examiner acknowledges that “Rutecki doesn’t specifically disclose that the neurostimulation device is disabled to stop the delivery of electrical stimulation during this reprogramming.” Ans. 3. The Examiner contends, however, that this step would have been obvious because “it would not make sense to allow the device to continue to deliver stimulation using the old, sub-optimal stimulation parameters” and because “changing the parameters while the device is actually delivering stimulation could cause the stimulation 8 Appeal 2017-002690 Application 13/968,290 parameters to instantly change, which would be uncomfortable for the patient, [and] Rutecki discloses that gradual stimulation changes are preferable.” Id. Appellant argues, inter alia, that “the Examiner’s assertion that it would be obvious to disable the neurostimulation device to stop the delivery of electrical stimulation during reprogramming is in direct contradiction to the disclosure provided by Rutecki.” Reply Br. 10. As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992): “[T]he examiner bears the initial burden ... of presenting a prima facie case of unpatentability.” Appellant has persuaded us that the Examiner has not carried the burden of establishing that Rutecki renders the claimed system obvious. Rutecki discloses “methods and apparatus for treating or controlling medical, psychiatric or neurological disorders by application of modulating electrical signals to a selected nerve or nerve bundle of the patient.” Rutecki col. 1,11. 6—10. While Rutecki discloses that its device can be reprogrammed by a physician or technician, it also states that “[o]nce the system is programmed, it operates continuously at the programmed settings until they are reprogrammed.” Id. at col. 10:67—11:4. As noted by Appellants, “reprogrammed” is past tense, suggesting that device operates continuously until reprogramming has been completed. Reply. Br. 10. The Examiner asserts that it would be obvious to stop stimulation while reprogramming because “it would not make sense to . . . continue,” but the Examiner does not provide persuasive evidence in support of this assertion. Ans. 3. Given Rutecki’s disclosure of continuous operation, the Examiner’s unsupported assertion that it “would not make sense to . . . continue” — while seeming supported by common sense — is insufficient to carry the 9 Appeal 2017-002690 Application 13/968,290 burden of establishing that the claimed system would have been obvious. Accordingly, we reverse the Examiner’s rejection of claims 46-48 as obvious. SUMMARY For the reasons set forth herein: We reverse the Examiner rejection of claims 9—15 and 28-45 under 35 U.S.C. § 112(a) as failing to comply with the written description requirement. We reverse the Examiner’s rejection of claims 46-48 under 35 U.S.C. § 103(a) as obvious over Rutecki. REVERSED 10 Copy with citationCopy as parenthetical citation