CTNF 18/784,471 CTNF 88743 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. 07-06 AIA 15-10-15 In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status. 12-151 AIA 26-51 12-51 Status of Claims Claims 1-20 are pending and under consideration for patentability. Information Disclosure Statement The Information Disclosure Statements submitted on 25 July 2024 and 26 December 2025 have been acknowledged and considered by the Examiner. Claim Rejections - 35 USC § 102 07-07-aia AIA 07-07 The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – 07-08-aia AIA (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention. 07-12-aia AIA (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. 07-15 AIA Claim s 1, 3, 4, 9, 10, 11, 13, 14, 19, and 20 are rejected under 35 U.S.C. 102( a)(1) and 35 U.S.C. 102(a)(2 ) as being anticipated by Keel et al. (US 2014/0277278 A1) . Regarding claims 1, 11, and 20, Keel describes an implantable medical device ([0029]: “implantable medical system 8”), a method, and a non-transitory computer readable media comprising sensing circuitry configured to sense, via at least a first set of electrodes of a plurality of electrodes ([0029]: “the far-field signals, which emanate from the heart of the patient…are sensed via an SCS [spinal cord stimulation] lead or lead array 12”), an electrical signal during delivery of a spinal cord stimulation signal to a patient ([0029]: “an implantable medical system 8 having an SCS device 10 equipped to sense far-field electrical cardiac signals…”), wherein the SCS signal is delivered via a second set of electrodes of the plurality of electrodes ([0029]: “the SCS device also delivers neurostimulation via lead 12 using a variety of combinations of neurostimulation control parameters…while (or after) far-field cardiac signals are sensed”), and wherein the plurality of electrodes are configured to be disposed on one or more leads ([0029], lead 12) implantable within an epidural space of the patient ([0033]: “dual array 12 is implanted in the epidural space of the upper thoracic region”) circuitry configured to filter the electrical signal to obtain a cardiac signal comprising one or more cardiac features indicative of activity of a heart of the patient ([0049]: “the device may need to filter a single wide band signal to extract the cardiac signals components”; [0050]: “the SCS device then determines cardiac rhythm parameters such as HRV…HF, LF and VLF components of HRV can be extracted or isolated using any suitable filtering technique”) processing circuitry configured to control subsequent delivery of the SCS signal to the patient based at least in part on the one or more cardiac features indicative of activity of the heart of the patient ([0029]: “an SCS device 10 equipped to sense far-field electrical cardiac signals and to automatically adjust SCS control parameters to address cardiovascular disorders or other conditions detected based on the far-field signals”) Regarding claims 3 and 13, Keel describes wherein the electrical signal further comprises the SCS signal ([0049], [0076]) wherein to filter the electrical signal to obtain the cardiac signal, the circuitry is configured to filter the SCS signal from the electrical signal to obtain the cardiac signal ([0049], [0076]) Regarding claims 4 and 14, Keel describes wherein the electrical signal further comprises noise ([0055]) wherein to filter the electrical signal to obtain the cardiac signal, the circuitry is configured to filter the noise from the electrical signal to obtain the cardiac signal ([0055]) Regarding claims 9 and 19, Keel describes wherein, to control subsequent delivery of the SCS signal to the patient based at least in part on the one or more cardiac features indicative of activity of the heart of the patient, the processing circuity is configured to perform delivery of the SCS signal at a particular point in a cardiac cycle of the heart of the patient ([0007], [0047]). Regarding claim 10, Keel describes wherein the one or more cardiac features comprise one or more of a heart rate of the heart of the patient ([0007]) a heart rate variability of the heart of the patient ([0007]) frequency domain information of the heart of the patient ([0007]) a QT duration ([0057]) a PR interval ([0057]) Claim Rejections - 35 USC § 103 07-20-aia AIA The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action: A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made. 07-20-02-aia AIA This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. 07-21-aia AIA Claim s 2 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Keel in view of Giovangrandi et al. (US 2014/0228837 A1) Regarding claims 2 and 12, Keel describes the IMD of claim 1 and the method of claim 11, but Keel does not explicitly disclose wherein the electrical signal further comprises an evoked compound action potential (ECAP) response to the SCS signal wherein to filter the electrical signal to obtain the cardiac signal, the circuitry is configured to filter the ECAP response from the electrical signal to obtain the cardiac signal However, Giovangrandi also describes an implantable medical device comprising sensing and stimulation electrodes ([0051]), including wherein the device may be used for neural stimulation ([0099]). Giovangrandi further describes wherein an electrical signal comprises an evoked compound action potential response to the stimulation signal ([0054], [0059]) wherein to filter the electrical signal to obtain a cardiac signal, circuitry is configured to filter the ECAP response from the electrical signal to obtain the cardiac signal ([0086], [0088]) As Giovangrandi is also directed towards an IMD configured to control stimulation and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to measure an evoked response, in a manner similar to that described by Giovangrandi, when using the device described by Keel, as doing so advantageously allows the resulting system to monitor the effectiveness of the stimulation . 07-21-aia AIA Claim s 5 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Keel in view of Brisben et al. (US 2017/0112399 A1) . Regarding claims 5 and 15, Keel describes the IMD of claim 1 and the method of claim 11, but Keel does not explicitly disclose wherein to filter the electrical signal to obtain the cardiac signal, the circuitry is configured to apply a low-pass filter with a cutoff frequency of about 25 Hertz to the electrical signal to obtain the cardiac signal. However, Birsben also describes extracting cardiac signals obtained from an implantable medical device, including wherein circuitry is configured to apply a low-pass filter with a cutoff frequency of about 25 Hertz to an electrical signal to obtain a cardiac signal ([0029]). As Brisben is also directed towards an processing cardiac signals and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to use a low-pass filter with a cutoff frequency of about 25 Hz, similar to that described by Brisben, when using the device described by Keel, as doing so advantageously allows the resulting system to extract the cardiac signals of interest . 07-21-aia AIA Claim s 6-8 and 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Keel in view of Moffitt (US 2020/0147391 A1) . Regarding claims 6 and 16, Keel describes the IMD of claim 1 and the method of claim 11, but Keel but does not explicitly disclose wherein the processing circuitry is further configured to estimate, based at least in part on the one or more cardiac features indicative of activity of the heart of the patient, a wash-in period of the SCS signal, wherein the wash-in period of the SCS signal comprises a period of time during which a body of the patient adapts to the SCS signal. However, Moffitt also describes an implantable medical device comprising sensing electrodes and spinal cord stimulation electrodes ([0071], [0078]), including processing circuitry configured to estimate, based at least in part on cardiac features, a wash-in period of the SCS signal ([0070], [0078], sensing physiological signals such as ECAPs), wherein the wash-in period of the SCS signal comprises a period of time during which a body of the patient adapts to the SCS signal ([0070], [0129]). As Moffitt is also directed towards controlling stimulation and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to incorporate a step of monitoring the wash-in period of the therapy, similar to that described by Moffitt, when using the device described by Keel, as doing so advantageously enhances the responsiveness of the resulting device to changing patient perceptions. Regarding claims 7 and 17, Keel describes wherein the IMD further comprises an accelerometer ([0069]). Moffitt describes wherein the processing circuitry is configured to estimate the wash-in period of the SCS signal based at least in part on the one or more cardiac features indicative of activity of the heart of the patient and a signal obtained by the accelerometer ([0071], automatically adjusting stimulation parameters based on electrode position; [0101], use of an accelerometer to determine patient position, posture, and activity and providing sub-perception stimulation based on the accelerometer measurements). Regarding claims 8 and 18, Moffitt describes wherein, to control subsequent delivery of the SCS signal to the patient, the processing circuity is configured to adjust subsequent delivery of the SCS signal to the patient after the estimated wash-in period and not prior to the estimated wash-in period ([0133], monitoring the wash-in period of the slow-action sub-perception neuromodulation and adjusting the fast-action sub-perception neuromodulation in response to determining that the wash-in period has ended). Statement on Communication via Internet Communications via Internet e-mail are at the discretion of the applicant. Without a written authorization by applicant in place, the USPTO will not respond via Internet e-mail to any Internet correspondence which contains information subject to the confidentiality requirement as set forth in 35 U.S.C. 122. Where a written authorization is given by the applicant, communications via Internet e-mail, other than those under 35 U.S.C. 132 or which otherwise require a signature, may be used. USPTO employees are NOT permitted to initiate communications with applicants via Internet e-mail unless there is a written authorization of record in the patent application by the applicant. The following is a sample authorization form which may be used by applicant: “Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file.” Please refer to MPEP 502.03 for guidance on Communications via Internet. Conclusion Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Ankit D. Tejani, whose telephone number is 571-272-5140. The Examiner may normally be reached on Monday through Friday, 8:30AM through 5:00PM EST. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, Applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the Examiner by telephone are unsuccessful, the examiner’s supervisor, Carl Layno, can be reached by telephone at 571-272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (in USA or Canada) or 571-272-1000. /Ankit D Tejani/ Primary Examiner, Art Unit 3796 Application/Control Number: 18/784,471 Page 2 Art Unit: 3796 Application/Control Number: 18/784,471 Page 3 Art Unit: 3796 Application/Control Number: 18/784,471 Page 4 Art Unit: 3796
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