DETAILED ACTION
This Office Action is in response to the communication dated 11 August 2026 concerning Application No. 18/784,471 filed on 25 July 2024.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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.
Status of Claims
Claims 1, 2, 4-12, and 14-22 are pending and currently under consideration for patentability; claims 1, 2, 4, 5, 11, 12 ,14, 15, and 20 have been amended; claims 3 and 13 have been cancelled; claims 21 and 22 have been added as new claims.
Response to Arguments
Applicant’s arguments dated 11 August 2026 have been fully considered, but they are not persuasive or moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
The Examiner has addressed the amended limitations in the updated text of the rejection below
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 4, 9, 10, 11, 14, 19, 20, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Keel et al. (US 2014/0277278 A1) in view of Donofrio et al. (US 2010/0114189 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
stimulation generation circuitry configured to deliver, via a second set of electrodes of a plurality of electrodes and according to one or more parameters, a spinal cord stimulation signal to a patient ([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”), 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”)
sensing circuitry configured to sense, via at least a first set of electrodes of the 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 the SCS signal to the patient ([0029]: “an implantable medical system 8 having an SCS device 10 equipped to sense far-field electrical cardiac signals…”)
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 1, 11, and 20, although Keel also describes circuitry configured to filter the electrical signal ([0049] - [0050]), Keel does not explicitly disclose circuitry configured to filter the electrical signal to remove one or more stimulation artifacts resulting from delivery of the SCS signal and obtain a cardiac signal comprising one or more cardiac features indicative of activity of a heart of the patient. However, Donofrio also describes an implantable medical device ([0044]) comprising stimulation generation circuitry configured to deliver a spinal cord stimulation signal to a patient ([0017], [0101]) via one or more electrodes disposed on one or more leads implantable within an epidural space of the patient ([0101]), sensing circuitry configured to sense an electrical signal during delivery of the SCS signal to the patient ([0017]), and circuitry configured to filter the electrical signal to remove one or more stimulation artifacts resulting from delivery of the SCS signal and obtain a cardiac signal comprising one or more cardiac features indicative of activity of a heart of the patient ([0017] - [0018], [0087]). As Donofrio is also directed towards delivering spinal cord stimulation and sensing electrical 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 incorporate filtering circuitry similar to that described by Donofrio when using the device described by Keel, as doing so advantageously allows the resulting device to obtain a cleaner and more accurate cardiac signal from the patient.
Regarding claims 4 and 14, Keel describes
wherein the electrical signal further comprises noise ([0055])
wherein to filter the electrical signal, the circuitry is configured to remove 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])
Regarding claim 22, Donofrio describes wherein the plurality of electrodes are configured to be disposed on one or more leads implantable within a lumbar region of the epidural space of the patient ([0101]).
Claims 2 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Keel in view of Donofrio, further in view of Giovangrandi et al. (US 2014/0228837 A1)
Regarding claims 2 and 12, Keel in view of Donofrio suggests the IMD of claim 1 and the method of claim 11, but Keel and Donofrio do 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, the circuitry is configured to remove 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, the circuitry is configured to remove 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 and Donofrio, as doing so advantageously allows the resulting system to monitor the effectiveness of the stimulation.
Claims 5 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Keel in view of Donofrio, further in view of Brisben et al. (US 2017/0112399 A1).
Regarding claims 5 and 15, Keel in view of Donofrio suggests the IMD of claim 1 and the method of claim 11, but Keel and Donofrio do not explicitly disclose wherein to filter the electrical 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 and Donofrio, as doing so advantageously allows the resulting system to extract the cardiac signals of interest.
Claims 6-8 and 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Keel in view of Donofrio, further in view of Moffitt (US 2020/0147391 A1).
Regarding claims 6 and 16, Keel in view of Donofrio suggests the IMD of claim 1 and the method of claim 11, but Keel and Donofrio do 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 and Donofrio, 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).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Keel in view of Donofrio, further in view of Huertas Fernandez et al. (US 2020/0147388 A1).
Regarding claim 21, Keel in view of Donofrio suggests the IMD of claim 1. Keel further describes wherein the stimulation generation circuitry is configured to deliver the SCS signal to improve a pain condition of the patient ([0069]), wherein the processing circuitry is further configured to determine that the one or more cardiac features are indicative of a change in an amount of pain experienced by the patient ([0069]), and wherein, to control subsequent delivery of the SCS signal, the processing circuitry is configured to adjust one or more parameters defining subsequent delivery 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 ([0069] - [0070]). Neither Keel nor Donofrio explicitly disclose wherein the change in the amount of pain corresponds to a change in an efficacy of the SCS signal in improving the pain condition of the patient, and wherein the SCS therapy is adjusted to increase the efficacy of the SCS signal in improving the pain condition of the patient. However, Huertas Fernandez also describes the use of an implantable medical device configured to deliver spinal cord stimulation to improve a pain condition of a patient ([0006]), including wherein a change in the amount of pain corresponds to a change in an efficacy of the SCS signal in improving the pain condition of the patient ([0063] - [0065]), and wherein the SCS therapy is adjusted to increase the efficacy of the SCS signal in improving the pain condition of the patient ([0063] - [0065]). As Huertas Fernandez is also directed towards using spinal cord stimulation for improving pain 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 associate changes in the patient’s pain perception with the efficacy of the stimulation, in a manner similar to that described by Huertas Fernandez, when using the device described by Keel and Donofrio, as doing so advantageously allows the resulting device to manage the patient’s pain more effectively.
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
Applicant’s amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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, Niketa Patel, can be reached by telephone at 571-272-4156. 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 3792
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