MEDTRONIC, INC.Download PDFPatent Trials and Appeals BoardJun 2, 20212020005418 (P.T.A.B. Jun. 2, 2021) 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. 13/749,237 01/24/2013 Jamu Alford C00004225.USU2/ LG10137L33 1910 71996 7590 06/02/2021 SHUMAKER & SIEFFERT , P.A 1625 RADIO DRIVE , SUITE 100 WOODBURY, MN 55125 EXAMINER MEHL, PATRICK M ART UNIT PAPER NUMBER 3793 NOTIFICATION DATE DELIVERY MODE 06/02/2021 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 JAMU ALFORD, STEVEN M. GEOTZ, LOTHAR KRINKE, MARK S. LENT, ERIK R. SCOTT, XUAN K. WEI, and JOHN D. WELTER1 Appeal 2020-005418 Application 13/749,237 Technology Center 3700 Before ERIC B. GRIMES, JEFFREY N. FREDMAN and DEVON ZASTROW NEWMAN, Administrative Patent Judges. GRIMES, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134(a) involving claims relating to planning and delivery of neuromodulation therapy, which have been rejected as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE. 1 Appellant identifies the real party in interest as Medtronic, Inc. Appeal Br. 3. We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appeal 2020-005418 Application 13/749,237 2 STATEMENT OF THE CASE “The disclosure relates generally to a medical diagnostic and therapy management system, and, more specifically, a medical diagnostic and therapy management system that uses ultrasound waveforms focused on neural targets.” Spec. 1. The Specification states that [b]ecause the ultrasonic stimulation can be used to activate or inhibit or block neural activity, ultrasound waveforms may be focused at dual or multi-site locations to simulate the effects of cathodes and anodes. Therefore, focusing of ultrasound energy at multiple sites (one or more sites to stimulate the tissue and one or more other sites to inhibit stimulation) can be used to determine effective electrode combinations and the types of leads that should be used for delivering or steering electrical stimulation with implanted electrodes. Id. at 35. Claims 1–15, 17–40, and 50–54 are on appeal. Claim 50, reproduced below, is illustrative (emphasis added): 50: A method comprising: identifying, using a neuromodulation therapy planning system that includes an ultrasound transducer array externally positioned relative to a patient, one or more therapy parameters, wherein identifying the one or more therapy parameters comprises causing, at a first time, the ultrasound transducer array to deliver ultrasound waveforms for causing neuromodulation of neural tissue in the patient that simulates neuromodulation of the neural tissue that would be caused by electrical stimulation via an implantable electrical stimulation system; and causing, at a second time that is after than the first time, the implantable electrical stimulation system implanted in the patient to deliver neuromodulation therapy to the patient using the identified one or more therapy parameters. Appeal 2020-005418 Application 13/749,237 3 Claims 1 and 21 are the other independent claims and are directed to a system and method, respectively. Both claim 1 and claim 21 recite “delivery of [or delivering] ultrasound waveforms for causing neuromodulation of neural tissue in a patient that simulates neuromodulation of the neural tissue that would be caused by electrical stimulation via an implantable electrical stimulation system.” The claims stand rejected as follows: Claims 50–54 under 35 U.S.C. § 103(a) as obvious based on Wagner2 and Dilorenzo3 (Final Action4 14); Claims 1–12, 15, 17–32, and 35–40 under 35 U.S.C. § 103(a) as obvious based on Wagner, Macé,5 and Dilorenzo (Final Action 3); Claims 13 and 33 under 35 U.S.C. § 103(a) as obvious based on Wagner, Macé, Dilorenzo, and Ishibashi6 (Final Action 12); and Claims 14 and 34 under 35 U.S.C. § 103(a) as obvious based on Wagner, Macé, Dilorenzo, and Cupples7 (Final Action 13). OPINION Claims 50–54 Claims 50–54 stand rejected as obvious based on Wagner and Dilorenzo. The Examiner finds that Wagner discloses almost all of the limitations of claim 50, including 2 US 2011/0245734 A1, pub. Oct. 6, 2011. 3 US 2007/0150025 A1, pub. June 28, 2007. 4 Office Action mailed August 28, 2019. 5 Emilie Macé et al. Functional ultrasound imaging of the brain, NATURE METHODS 8:662–664 (2011). 6 US 6,267,734 B1, iss. July 31, 2001. 7 US 6,675,038 B2, iss. Jan. 6, 2004. Appeal 2020-005418 Application 13/749,237 4 causing, at a first time, the ultrasound transducer array to deliver ultrasound waveforms for causing neuromodulation of neural tissue in the patient (determining/identifying one or more parameters to apply ultrasonic stimulation or electrical stimulation application to a targeted region of interest [0067]- [0069] the determination being made either pre, during or post stimulation, wherein the determination/identification of the one or more therapy parameters before the application to the cause the neuromodulation of the neural tissue in the patient is a matter of choice of engineering design as taught by Wagner for the purpose of applying the right stimulation to the right location with the right amplitude as suggested by Wagner ([0080] for causing the ultrasound transducer array to deliver ultrasound waveforms for causing neuromodulation of neural tissue in the patient), ]) that simulates neuromodulation of the neural tissue that would be caused by electrical stimulation via an implantable electrical stimulation system of the neuromodulation therapy delivery system ([0073] implanted Deep Brain Stimulation DBS and Ultrasound stimulation both being used for neurostimulation wherein both are directed to the similar region of interest as in Figs.1 and 2 and wherein the computer/processor can calculated the stimulation characteristics for the different modes of stimulation, as in [0067]-[0069], therefore the neurostimulation performed using the ultrasound can be correlated and translated into neurostimulation performed using the implanted DBS reading therefore on the ultrasound causing neuromodulation that simulates neuromodulation of the neural tissue that would be caused by electrical stimulation via an implantable electrical stimulation system of the neuromodulation therapy delivery system as claimed). Final Action 15–16. “Appellant respectfully disagrees with the position advanced by the Examiner.” Appeal Br. 7. Appellant argues that “Wagner describes ‘methods for treating osteoarthritis,’” in which “a ‘mechanical source such as an Appeal 2020-005418 Application 13/749,237 5 ultrasound source 16 is applied on the scalp and provides concentrated acoustic energy 18.’” Id. Appellant argues that Wagner further provides that “the targeted region can be imaged with any imaging modality that provides anatomical information about the region.” Wagner states that the “image could then be used to determine the placement of the stimulation source.” According to Wagner, “with an electrosonic (electrical source and mechanical (i.e., sonic/ultrasound) . . . ) approach one would determine placement of the electrical source and the ultrasound source to target the desired regions. . . .” Id. at 8 (footnote omitted, alteration in original). Appellant concludes that Wagner fails to disclose or suggest anything even remotely similar to “simulat[ing] neuromodulation of the neural tissue that would be caused by electrical stimulation via an implantable electrical stimulation system,” as recited by claim 50. In particular, Wagner makes absolutely no mention of any simulation of neuromodulation, much less using ultrasonic waveforms to simulate neuromodulation “that would be caused by electrical stimulation via an implantable electrical stimulation system,” as claimed. Id. (alteration in original). Appellant reasons that, “[a]s such, even taking the Examiner’s unsupported statement that ‘the neurostimulation performed using the ultrasound can be correlated and translated into neurostimulation performed using the implanted DBS’ as true, Wagner provides no disclosure or suggestion of performing such a correlation and translation.” Id. at 9. Finally, Appellant argues that “Dilorenzo fails to cure this deficiency of Wagner.” Id. We agree with Appellant that the Examiner has not persuasively shown that the disputed limitation—“deliver[ing] ultrasound waveforms for Appeal 2020-005418 Application 13/749,237 6 causing neuromodulation of neural tissue in the patient that simulates neuromodulation of the neural tissue that would be caused by electrical stimulation via an implantable electrical stimulation system”—would have been obvious based on Wagner.8 Wagner states that its invention “relates to methods for treating osteoarthritis.” Wagner ¶ 5. Specifically, the methods “focus stimulation in select regions of the central nervous system (e.g., brain and/or spinal cord) to block processing of pain signals received by the brain from an injured joint.” Id. With regard to providing ultrasound that “simulates neuromodulation of the neural tissue that would be caused by electrical stimulation via an implantable electrical stimulation system,” as recited in all of the independent claims, the Examiner cites Wagner’s disclosure of “implanted Deep Brain Stimulation DBS and Ultrasound stimulation both being used for neurostimulation” (Final Action 15, citing Wagner ¶ 73), “wherein both are directed to the similar region of interest as in Figs.1 and 2 and wherein the computer/processor can calculate[] the stimulation characteristics for the different modes of stimulation” (id. at 15–16, citing Wagner’s ¶¶ 67–69). See also Final Action 4 (citing the same disclosures with respect to the analogous limitations in independent claims 1 and 21). 8 The Examiner relies on Dilorenzo only for the claim limitation requiring “causing, at a second time that is after than the first time, the implantable electrical stimulation system implanted in the patient to deliver neuromodulation therapy to the patient using the identified one or more therapy parameters.” Final Action 17. Therefore, we will not further discuss Dilorenzo. Appeal 2020-005418 Application 13/749,237 7 We have reviewed the cited passages but do not find any description in them of “deliver[ing] ultrasound waveforms for causing neuromodulation . . . that simulates neuromodulation . . . that would be caused by electrical stimulation via an implantable electrical stimulation system,” as recited in all of the independent claims. The Examiner’s explanation also does not persuade us that Wagner discloses the disputed limitation. Claim 50 does not recite “implanted Deep Brain Stimulation DBS and Ultrasound stimulation both being used for neurostimulation.” Final Action 15. It recites first delivering ultrasound waveforms that cause neurostimulation that simulates the neurostimulation that would be caused by an implantable electrical system, and then delivering neurostimulation by the implantable electrical system. The Examiner’s explanation does not account for either the “simulating” or sequential administration required by the claim. The Examiner’s reasoning that both the DBS and ultrasound “are directed to the similar region of interest” and “the computer/processor can calculate[] the stimulation characteristics for the different modes of stimulation” (Final Action 15–16) also does not persuade us that Wagner discloses delivering ultrasound waveforms that cause neurostimulation that simulates the neurostimulation that would be caused by an implantable electrical system, as required by claim 50. Nor does the Examiner’s reasoning persuade us that the disputed limitation would have been obvious to a person of ordinary skill in the art, despite not being expressly disclosed. And, as noted above (footnote 8), the Examiner does not point to any disclosure of this limitation in Dilorenzo. Appeal 2020-005418 Application 13/749,237 8 We conclude that the Examiner has not shown, by a preponderance of the evidence, that a method meeting all of the limitations of claim 50 would have been obvious based on Wagner and Dilorenzo. We therefore reverse the rejection of claim 50 under 35 U.S.C. § 103(a), as well as the rejection of dependent claims 51–54. Claims 1–15 and 17–40 Claims 1–15 and 17–40 stand rejected as obvious based on Wagner and Dilorenzo, combined with other references, as follows: (a) claims 1–12, 15, 17–32, and 35–40 based on Wagner, Macé, and Dilorenzo; (b) claims 13 and 33 based on Wagner, Macé, Dilorenzo, and Ishibashi; and (c) claims 14 and 34 based on Wagner, Macé, Dilorenzo, and Cupples. As noted above, independent claims 1 and 21 also require “delivery of [or delivering] ultrasound waveforms for causing neuromodulation of neural tissue in a patient that simulates neuromodulation of the neural tissue that would be caused by electrical stimulation via an implantable electrical stimulation system.” The Examiner relies on the same paragraphs in Wagner with respect to this limitation for claims 1 and 21 as for claim 50. Final Action 4. The Examiner does not point to any disclosure of this limitation in Dilorenzo or Macé. See Final Action 5, 6. The Examiner relies on Ishibashi and Cupples only for limitations of dependent claims. Id. at 13, 14. For the reasons explained above with respect to claim 50, neither the Examiner’s explanation nor Wagner’s disclosure persuade us that Wagner discloses “delivery of [or delivering] ultrasound waveforms for causing neuromodulation . . . that simulates neuromodulation . . . that would be caused by electrical stimulation via an implantable electrical stimulation system,” as required by independent claims 1 and 21. Appeal 2020-005418 Application 13/749,237 9 We therefore reverse the rejection of claims 1 and 21 under 35 U.S.C. § 103(a), as well as the rejection of dependent claims 2–15, 17–20, and 22– 40. DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/ Basis Affirmed Reversed 50–54 103(a) Wagner, Dilorenzo 50–54 1–12, 15, 17–32, 35– 40 103(a) Wagner, Macé, Dilorenzo 1–12, 15, 17– 32, 35–40 13, 33 103(a) Wagner, Macé, Dilorenzo, Ishibashi 13, 33 14, 34 103(a) Wagner, Macé, Dilorenzo, Cupples 14, 34 Overall Outcome 1–15, 17–40, 50–54 REVERSED Copy with citationCopy as parenthetical citation