Ex Parte Libbus et alDownload PDFPatent Trial and Appeal BoardOct 12, 201713792805 (P.T.A.B. Oct. 12, 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. 13/792,805 03/11/2013 Imad Libbus 279.763US2 6171 45458 7590 10/16/2017 SCHWEGMAN LUNDBERG & WOESSNER/BSC PO BOX 2938 MINNEAPOLIS, MN 55402 EXAMINER ALTER MORSCHAUSER, ALYSSA MARGO ART UNIT PAPER NUMBER 3762 NOTIFICATION DATE DELIVERY MODE 10/16/2017 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): uspto@slwip.com SLW @blackhillsip.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte IMAD LIBBUS, ANDREW P. KRAMER, and JULIA MOFFITT Appeal 2016-001464 Application 13/792,8051 Technology Center 3700 Before ULRIKE W. JENKS, RICHARD J. SMITH, and DEVON ZASTROW NEWMAN, Administrative Patent Judges. NEWMAN, Administrative Patent Judge. DECISION ON APPEAL This appeal under 35U.S.C. § 134 involves claims to a device and methods for achieving neural stimulation. The Examiner entered final rejections for anticipation and obviousness. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM-IN- PART. 1 Appellants identify the Real Party in Interest as Cardiac Pacemakers, Inc. App. Br. 2. The inventors to the application are listed as Imad Libbus, Andrew P. Kramer, and Julia Moffitt. Bib. Data Sheet. Appeal 2016-001464 Application 13/792,805 STATEMENT OF THE CASE Background “Neural stimulators are used to treat a variety of disorders, such as epilepsy, obesity, and breathing disorders. Experimentally, neural stimulation has been shown to have a significant effect on several cardiovascular conditions, and has been proposed to treat hypertension, post myocardial infarction (MI) remodeling and heart failure.” Spec. 1:24—28. “Neural stimulators that rely on continuous or intermittent open-loop stimulation do not adapt to physiologic changes during therapy.” Id. at 2:19-20. The Specification discloses: Systems and methods are provided for monitoring nerve traffic for use to deliver appropriate neural stimulation. Monitored nerve traffic is used to accurately provide autonomic modulation for accurate and appropriate delivery of neural stimulation. Thus, the present subject mat[t]er provides a closed-loop neural stimulation system that allows the neural stimulation device to monitor nerve traffic and continuously provide appropriate therapy. A neural sensing lead is used to record nerve traffic from the peripheral nervous system (such as baroreceptors, afferent nerves and/or efferent nerves) to guide neural stimulation therapy, to record physiologic parameters such as pressure for diagnostic purposes, and/or to guide CRM therapy. Id. at 6:3—12. 2 Appeal 2016-001464 Application 13/792,805 The Claims Claims 1—3 and 5—21 are on appeal. Final Act. I.2 Claim 1 is illustrative and reads as follows: I. A device for delivering a closed-loop neural stimulation therapy with a reflex neural response feedback to a desired neural target in an autonomic nervous system to elicit a desired reflex neural response, comprising: a pulse generator configured to generate a neural stimulation signal for delivery to the desired neural target in the autonomic nervous system for eliciting the desired reflex neural response by the central nervous system; a nerve sensor configured to sense a nerve traffic signal in a centrally-mediated reflex pathway; a signal processor configured to process the nerve traffic signal into a signal indicative of a detected reflex neural response to stimulating the neural target; and a controller connected to the pulse generator and the signal processor, wherein the controller is configured to control the pulse generator to generate the neural stimulation signal to cause a sympathetic or parasympathetic neural response for the neural stimulation therapy, and use the detected reflex neural response to adjust at least one stimulation parameter of the neural stimulation signal based on the detected reflex neural response to provide the desired reflex neural response to the neural stimulation therapy. II. A method, comprising: delivering a neural stimulation therapy to a neural target in an autonomic nervous system; sensing a reflex response to the neural stimulation therapy, including sensing a nerve traffic signal from the autonomic nervous system, and processing the sensed nerve 2 Examiner’s Final Action, mailed July 18, 2014. 3 Appeal 2016-001464 Application 13/792,805 traffic signal into a signal indicative of the reflex response to the neural stimulation therapy; and adjusting the neural stimulation therapy based on the at least one feature of the nerve traffic signal to cause the neural stimulation therapy to elicit a desired reflex neural response to the neural stimulation therapy. App. Br. 21—22 (Claims Appendix) (emphases added). The Issues The following rejections are before us to review: Claims 1—3, 5—8, 11—17, and 21 are rejected under pre-AIA 35 U.S.C. § 102(b) as anticipated by King.3 Ans. 2.4 Claim 18 is rejected under pre-AIA 35 U.S.C. § 103(a) as obvious over King in view of Bourgeois.5 Id. at 7. Claims 9, 10, 19, and 20 are rejected under pre-AIA 35 U.S.C. § 103(a) as obvious over King in view of Hill.6 Id. at 8. I The Examiner rejects claims 1—3, 5—8, 11—17, and 21 as anticipated by King. The Examiner finds that King discloses a device meeting all of the limitations of independent claims 1,11, and 21. Ans. 2—A. Specific to the issues on appeal, the Examiner finds: King discloses a device for delivering a closed-loop neural stimulation therapy with a reflex neural response feedback (The examiner considers a response of the nerve to stimulation to be a “reflex neural response”. Thus, since the electrical 3 US 5,913,882, issued June 22, 1999 (“King”). 4 Although claim 4 is included in the Examiner’s statement of rejection, claim 4 is not on appeal. App. Br. 21 (Claims Appendix). 5 US 5,836,994, issued November 17, 1998 (“Bourgeois”). 6 US 2002/0165586 Al, published November 7, 2002 (“Hill”). 4 Appeal 2016-001464 Application 13/792,805 stimulation to the nerves of King cause a response by the nerves, that is then recorded by the recoding electrodes, the examiner considers King to disclose providing stimulation to elicit a desired reflex neural response.) to a desired neural target in an autonomic nervous system (ANS is the part of the peripheral nervous system. Thus, stimulation of a peripheral nerve (part of the peripheral nervous system) would necessarily stimulate the autonomic nervous system[)]. Therefore, since King stimulates a peripheral nerve (see col. 3, lines 19-26, for example), King stimulates the autonomic nervous system) to elicit a desired neural response (e.g., col. 1, lines 45-59). Ans. 2—3. Appellants argue that King does not anticipate because King’s device “does not account for” an Autonomic Nervous System reflex circuit, unlike the claimed subject matter. App. Br. 12. According to Appellants, a “reflex response is a response from the central nervous system to a stimuli [that is] ... . mediated through the central nervous system” and the claimed subject matter “does not sense the same action potentials that are produced by the stimulation electrode” but instead relies on a different feedback signal than King discloses. Id. “[A] control system configured to detect the same action potentials on the same nerve will be different than a control system configured to detect a reflex response.” Id. at 8. The central nervous system does not simply reflect the same action potential as was received. Therefore, the reflex response to neural stimulation is not the same action potentials as were generated by the neural stimulation. As such, the feedback signals to the control systems are different which require Appellant’s control system ... to be different than King’s control system ... in order to process the different feedback signal. Reply Br. 3. 5 Appeal 2016-001464 Application 13/792,805 Does the preponderance of the evidence of record support the Examiner’s finding that King anticipates the device and methods as claimed? Claims 11—17 We agree with Appellants that King’s device does not meet the limitations of method claims 11—17. Claim 11 requires “sensing a reflex response to the neural stimulation therapy” and “adjusting the neural stimulation therapy based on the at least one feature of the nerve traffic signal to cause the neural stimulation therapy to elicit a desired reflex neural response to the neural stimulation therapy.” App. Br. 22. King discloses a stimulating lead “positioned so that stimulating electrodes 18-21 are at the optimal sites adjacent electrically excitable tissue for control of conscious paresthesia into the painful area of a patient.” King 3:16—18. King discloses: the positions of stimulating electrodes 18-21 and recording electrodes 25-26 must be fine-tuned to obtain the correct paresthesia and extra-cellular recordings. Recordings of potentials evoked in the nerve fibers adjacent lead 10 are picked up at the recording sites and analyzed to see if there is sufficient potential received from large diameter afferents in the dorsal columns or peripheral nerve. Id. at 3:63—4:3 (emphasis added). Accordingly, we agree with the Appellants’ characterization of King’s device as eliciting “action potentials using an electrode, and [recording] these same action potentials in the nerve.” Reply Br. 7. Indeed, the Examiner acknowledges that King’s disclosure does not involve mediation through the central nervous system, but finds that while a “reflex response” can be mediated through the central 6 Appeal 2016-001464 Application 13/792,805 nervous system, the Specification does not support exclusive mediation through the central nervous system. Ans. 11. We are persuaded by Appellants’ argument that the skilled artisan “understands that reflex response is, by definition, a response from the central nervous system[,] .... that a baroreflex is a reflex response mediated through the central nervous system, and that central mediated reflex pathways refer to pathways that are mediated by the central nervous system.”7 Reply Br. 5. Positioning of the electrode alongside the peripheral nerves in King would not inherently result in induction of a reflex response that must be mediated through the central nervous system. “[T]he examiner must provide some evidence or scientific reasoning to establish the reasonableness of the examiner’s belief that the functional limitation is an inherent characteristic of the prior art” before the burden is shifted to Applicants to disprove the inherency. Ex parte Skinner, 2 USPQ2d 1788, 1789 (BPAI 1986). Here, the Examiner has not established how placing the electrodes adjacent to the lead and recording the potentials evoked in the 7 See, e.g., the definition of “reflex”: a :an automatic and often inborn response to a stimulus that typically involves a nerve impulse passing inward from a receptor to the spinal cord and then passing outward from the spinal cord to an effector (such as a muscle or gland) without reaching the level of consciousness and often without passing to the brain; the knee-jerk reflex b :the process that culminates in a reflex and comprises reception, transmission, and reaction — called also reflex action (https://www.merriam-webster.com/dictionary/reflex, last visited October 3, 2017). 7 Appeal 2016-001464 Application 13/792,805 nerve fibers will necessarily capture a reflex neural response, or how the device in King could “cause the neural stimulation therapy to elicit a desired [reflex] neural response to the neural stimulation therapy.” In short, King does not disclose the claimed method. We reverse the rejection of claims 11-17 under 35 U.S.C. § 102(b). Claims 1—3, 5—8, and 21 We agree with the Examiner that King’s device anticipates claims 1— 3, 5—8, and 21. Claims 1 and 21 require “a device for delivering a closed- loop neural stimulation therapy” comprising a pulse generator, nerve sensor, signal processor, and controller. King discloses a neural stimulation and recording device comprising these elements. Ans. 2-4; King 1:45—59; 2:62:3—2, 3:26—29 and Figure 1. To distinguish over the prior art, the limitations of a device must recite a structural difference between the claimed subject matter and the prior art. See In re Lowry, 32 F.3d 1579, 1583—84 (Fed. Cir. 1994) (finding the claim limitations regarding organization of data in memory distinguished over the prior art); In re Noll, 545 F.2d 141, 148 (CCPA 1976) (“[T]he [claimed invention] . . . comprises physical structure, including storage devices and electrical components uniquely configured to perform specified functions through the physical properties of electrical circuits to achieve controlled results. Appellants’ programmed machine is structurally different from a machine without that program.”). Appellants do not identify any structural limitation required by claims 1—3, 5—8, and 21 that is not disclosed in King. Rather, Appellants’ argument focuses on the difference in the type of response to the neural stimulation effected by and recorded by King. App. Br. 11—16. Notably, Appellants do 8 Appeal 2016-001464 Application 13/792,805 not argue that the pulse generator of King cannot induce a reflex response, only that it does not “necessarily” do so because “King does not expressly refer to the autonomic nervous system.” Id. at 11. Moreover, we are not persuaded that the preamble of claims 1 or 21 is essential to interpretation of the claims. “Where a patentee uses the claim preamble to recite structural limitations of his claimed invention, the PTO and courts give effect to that usage. . . . Conversely, where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation.” Rowe v. Dror, 112 F.3d 473, 478 (Fed. Cir. 1997). Here, the preamble “for delivering a closed-loop neural stimulation therapy with a reflex neural response feedback to a desired neural target in an autonomic nervous system to elicit a desired reflex neural response” does not contain structural limitations, but instead recites an intended use. Accordingly, we affirm the rejection of claims 1 and 21. Claims 2, 3, and 5—8 have not been argued separately and therefore fall with claims 1 and 21. 37 C.F.R. § 41.37(c)(l)(iv). II The Examiner rejected claim 18 as obvious based on King in view of Bourgeois. This rejection, however, is based on the Examiner’s finding that King anticipates claim 11. See Ans. 7—8. The rejection therefore suffers from the same deficiency discussed above with respect to King’s anticipation of claims 11—17, and is reversed for the same reason. III The Examiner rejected claims 9, 10, 19, and 20 as obvious based on King in view of Hill. The Examiner finds that King discloses all of the 9 Appeal 2016-001464 Application 13/792,805 limitations of claims 9, 10, 19, and 20 “but does not explicitly disclose the neural stimulation therapy is an anti-hypertension therapy or heart failure therapy.” Ans. 8. The Examiner finds that Hill “discloses that it is well known to apply stimulation to the spinal cord, vagus and other nerves for providing heart failure treatment (e.g., page 1, paragraph 12) and antihypertension treatment (e.g., page 1, paragraph 15), as well as providing paresthesia (e.g., page 8, paragraph 88).” Id. The Examiner concludes it would have been obvious to the skilled artisan “to modify the paresthesia neural stimulation of King with the ability to also provide anti-hypertension therapy or heart failure therapy as disclosed by Hill et al. in order to provide the predictable results of modifying the treatment to meet specific patient therapeutic needs and requirements.” Id. at 8—9. We adopt as our own the Examiner’s findings of fact and conclusions regarding the teachings of King and Hill with regard to claims 9, 10, 19, and 20. Ans. 8—9. Appellants do not advance any arguments regarding this rejection. Accordingly, we affirm the rejection. See 37 C.F.R. § 41.37(c)(l)(iv) (2015). SUMMARY We affirm the rejection of claims 1—3, 5—8, and 21 under pre-AIA 35 U.S.C. § 102(b) as anticipated by King. We reverse the rejection of claims 11—17 under pre-AIA 35 U.S.C. § 102(b) as anticipated by King. We reverse the rejection of claim 18 under pre-AIA 35 U.S.C. § 103(a) as obvious over King in view of Bourgeois. We affirm the rejection of claims 9—10 and 19—20 under pre-AIA 35 U.S.C. § 103(a) as obvious over King in view of Hill. 10 Appeal 2016-001464 Application 13/792,805 TIME PERIOD FOR RESPONSE No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). AFFIRMED-IN-PART 11 Copy with citationCopy as parenthetical citation