Gary W. King et al.Download PDFPatent Trials and Appeals BoardMar 27, 202014454427 - (D) (P.T.A.B. Mar. 27, 2020) 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. 14/454,427 08/07/2014 Gary W. King 1023-777US02/ P025549.USV4 7460 71996 7590 03/27/2020 SHUMAKER & SIEFFERT , P.A 1625 RADIO DRIVE , SUITE 100 WOODBURY, MN 55125 EXAMINER ALTER MORSCHAUSE, ALYSSA MARGO ART UNIT PAPER NUMBER 3792 NOTIFICATION DATE DELIVERY MODE 03/27/2020 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 GARY W. KING, STEVEN M. GOETZ, ANDREW H. HOUCHINS, JEFFREY T. KEACHER, JORDAN J. GREENBERG, KENNETH T. HERUTH, MARK S. LENT, and PAUL W. WACNIK ____________ Appeal 2019-002296 Application 14/454,427 Technology Center 3700 ____________ Before HUBERT C. LORIN, NINA L. MEDLOCK, and MATTHEW S. MEYERS, Administrative Patent Judges. LORIN, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Appellant1 seeks our review under 35 U.S.C. § 134(a) of the Final Rejection of claims 1–6, 8–15, and 17–20. We have jurisdiction under 35 U.S.C. § 6(b) (2002). 1 We use the word Appellant to refer to “applicant” as defined in 37 C.F.R. § 1.42(a). The Appellant identifies Medtronic, Inc., as the real party in interest. Appeal Br. 3. Appeal 2019-002296 Application 14/454,427 2 THE INVENTION The claimed subject matter “relates to medical devices, and, more particularly, to control of therapy delivery by medical devices” (Spec. para. 2). Claim 1 is illustrative, and is reproduced below: 1. A method comprising: controlling a medical device to deliver peripheral nerve field stimulation to a region of a body of a patient in which the patient experiences pain via at least one electrode implanted in the region; detecting, with sensing circuitry, an efferent response of the patient to the delivery of the peripheral nerve field stimulation; controlling, with the processor, the delivery of the peripheral nerve field stimulation by the medical device based on the efferent response detected by the sensing circuitry, wherein controlling the delivery of the peripheral nerve field stimulation based on the efferent response detected by the sensing circuitry comprises: determining, with the processor, a characteristic of a physiological parameter indicative of the efferent response of the patient to the delivery of the peripheral nerve field stimulation; comparing, with the processor, the characteristic of the physiological parameter with a range of values associated with the physiological parameter, wherein the range of values comprises an upper threshold value and a lower threshold value, wherein the upper threshold value and the lower threshold value indicate a predetermined physiological response of the patient; and controlling, with the processor, the delivery of the peripheral nerve field stimulation to modify the efferent response such that the characteristic is within the range of values. Appeal 2019-002296 Application 14/454,427 3 REFERENCES The prior art relied upon by the Examiner is: Name Reference Date Osorio US 2004/0138517 A1 July 15, 2004 Whitehurst US 2005/0143789 A1 June 30, 2005 Begnaud US 2007/0255351 A1 Nov. 1, 2007 THE REJECTION The following rejection is before us for review: Claims 1–6, 8–15, and 17–20 are rejected under 35 U.S.C. § 103(a) as unpatentable over Whitehurst, Begnaud, and Osorio. ANALYSIS The rejection of claims 1–6, 8–15, and 17–20 under 35 U.S.C. § 103(a) as unpatentable over Whitehurst, Begnaud, and Osorio. Claims 1, 8, and 17 are the independent claims. Claim 1 recites “detecting, with sensing circuitry, an efferent response of the patient to the delivery of the peripheral nerve field stimulation.” Claims 8 and 17 contain similar limitations. The Examiner’s initial position is that Whitehurst’s disclosure in paragraph 58 of “sensing the amount of neural activity within a patient” is equivalent to sensing a physiological parameter indicative of an efferent response of a patient (Final Act. 11) (addressing dependent claims 4 and 13). According to the Examiner, “pain sensations are delivered to the brain through afferent nerve pathways” and “[a]s a result, providing stimulation to treat pain will necessarily activate ‘afferent never fibers’ from delivering a ‘pain’ signal to the brain” (id.) (addressing dependent claims 3 and 12). Appeal 2019-002296 Application 14/454,427 4 The Appellant disagrees, arguing with respect to claim 1 that “the Examiner failed to establish that Whitehurst actually discloses an efferent response, whether expressly, or inherently” (Appeal Br. 12). Responding to the Appellant’s arguments in the Answer (Ans. 7), the Examiner points out that paragraph 44 of the Specification states that “[e]fferent responses may include motor response[s] that result from nerve impulses traveling from the central nervous system effectors, such as muscles, glands and the like.” The Examiner then reproduces the rejection of dependent claim 2 from the Final Action: Whitehurst et al. discloses the device substantially as claimed but does not specifically discloses [sic] the sensed physiological parameters indicative of an efferent response that are “at least one of heart rate, respiratory rate, electrodermal activity, muscle activity, blood flow rate, sweat gland activity, pilomotor reflect or thermal activity of the patient.” Osorio et al. discloses providing treatment to a nervous system disorder using closed- loop feedback control with the sensing of neurological signals, such as temperature signals, heart rate signals and respiratory signals (page 2, paragraph 40). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the parameters sensed in the closed loop regulation of electrical stimulation applied by Whitehurst et al. with the parameters of temperature signals, heart rate signals and respiratory signals as disclosed by Osorio et al. since it was known in the art that such parameters are good indicators of patients physical wellbeing. Id. at 7–8. And the Examiner concludes that “for the reasons previously made of record, and detailed above, the modified Whitehurst et al. does in fact disclose sensing an efferent response” (id. at 8). We have reviewed Whitehurst and Osorio and agree with the Appellant. Appeal 2019-002296 Application 14/454,427 5 Although the Examiner correctly points out that Whitehurst discloses delivering electrical stimulation to a patient and sensing the patient’s response, including sensing “an amount of neural activity within a patient” (Whitehurst para. 58), we do not see that as disclosing or suggesting detecting an efferent response of the patient as claimed. The Examiner does not direct us to any suggestion in Whitehurst that sensing neural activity within a patient involves detecting an efferent response of the patient. The Examiner’s reliance on the Specification’s teaching, in paragraph 44, that “[e]fferent responses may include motor responses that result from nerve impulses traveling from the central nervous system to effectors, such as muscle, glands, and the like” does not support the Examiner’s position. As Appellant points out (Appeal Br. 12), the fact that an efferent response may involve nerve impulses traveling from the central nervous system does not imply that sensing neural activity necessarily involves the detection of an efferent response. In fact, paragraph 44 indicates that an efferent response is a response to “recruitment of the efferent nerves.” The Examiner has not cited any evidence to establish that the neural activity in Whitehurst occurs in response to recruitment of the efferent nerves. To the extent that the Examiner’s position is that sensing a patient’s neural activity inherently involves detecting an efferent response of the patient,2 we agree with the Appellant that the Examiner has not adequately shown that this is necessarily the case. It is possible that Whitehurst’s sensing of a patient’s neural activity may detect an efferent response, in the 2 See, e.g., Final Act. 11 (“providing stimulation to treat pain will necessarily activate ‘afferent never fibers’ from delivering a ‘pain’ signal to the brain”). Appeal 2019-002296 Application 14/454,427 6 event that an efferent response is generated in the patient and the efferent response causes a change in the patient’s neural activity that is detected by Whitehurst’s sensing devices. “Inherency, however, may not be established by probabilities or possibilities. The mere fact that a certain thing may result from a given set of circumstances is not sufficient.” Hansgirg v. Kemmer, 102 F.2d 212, 214 (CCPA 1939), quoted in Continental Can Co. USA v. Monsanto Co., 948 F.2d 1264, 1269 (Fed. Cir. 1991). For example, the Examiner does not direct us to any evidence that Whitehurst’s sensing devices for sensing neural activity are configured to detect an efferent response of a patient. The Examiner’s reliance on Osorio’s disclosure of sensing a patient’s neurological signals such as heart rate (Ans. 7–8) does not remedy the deficiency in the rejection. The Examiner does not direct us to any suggestion in Osorio that sensing a patient’s neurological signals (e.g., heart rate) involves detecting an efferent response of the patient. To the extent that the Examiner’s position is that sensing a patient’s neurological signals (e.g., heart rate) inherently involves detecting an efferent response of the patient, that position is deficient for the same reason discussed above. Namely, it is possible that Osorio’s sensing of a patient’s neurological signals may detect an efferent response. However, that possibility is not sufficient to establish inherency. For example, the Examiner does not direct us to any evidence that Osorio’s monitoring elements for monitoring neurological signals are configured to detect an efferent response of a patient. For the foregoing reasons, the rejection of claims 1, 8, and 17 and the claims depending therefrom is not sustained. Appeal 2019-002296 Application 14/454,427 7 CONCLUSION In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1–6, 8–15, 17–20 103(a) Whitehurst, Begnaud, Osorio 1–6, 8–15, 17–20 REVERSED Copy with citationCopy as parenthetical citation