DETAILED ACTION
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/25/2025 has been entered.
Remarks
This action is in response to the RCE filed 11/25/2025.
Claims 27-46 are pending.
Response to Arguments
Applicant’s arguments, see pages 6-12, filed 11/25/2025, with respect to the rejection of claims 27-46 under 35 U.S.C. 103 have been fully considered and are persuasive. Independent claims 27 and 36 have been amended to clarify the modulation function. Applicant argues that Parker or Parker in view of Doan does not disclose the modulation function as claimed. Examiner agrees. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made, as explained in the office action below.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
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.
Claims 27-46 are rejected under 35 U.S.C. 103 as being unpatentable over Parker (US Patent Application Publication 2015/0335893, of record), further in view of Doan et al. (US Patent Application Publication 2019/0046800, of record), hereinafter Doan, and further in view of Peterson et al. (US Patent Application Publication 2019/0160294), hereinafter Peterson.
Regarding claims 27 and 36, Parker discloses a system and method comprising:
a stimulator device implantable in a patient and comprising a plurality of electrodes (e.g. Pars. [0016]-[0018]: implantable delivery device with leads); and
an external device, wherein the external device is configured to determine, for the patient, first stimulation parameters defining first stimulation pulses (e.g. Par. [0022]: determining modulation parameters),
wherein the external device is further configured to determine a modulation function to be applied to the first stimulation parameters to form modulated stimulation pulses, wherein the modulation function modulates a charge delivered to the patient by the modulated stimulation pulses as a function of time (e.g. Pars. [0022]-[0024]: the modulator is used to determine stimulation parameters; Fig. 4: step 404 mapping the pulse widths/amplitudes and then using the map to identify patient specific values at step 406, steps 420, 437, and 447 discuss increasing the amplitude of the signal based on user feedback; Pars. [0033]-[0034]),
wherein the external device is configured to transmit information to the stimulator device to cause the stimulator device to provide the modulated stimulation pulses at one or more of the electrodes (e.g. Fig. 4: steps 418, 434, 444: administering signal to patient; Pars. [0022]-[0024]).
However, Parker fails to specifically disclose the external device programmed with a model that is used to determine stimulation parameters, and wherein the external device is further configured to determine a modulation function as a function of time to be applied to the first stimulation parameters to form modulated stimulation pulses, wherein the modulation function modulates a charge delivered to the patient by the modulated stimulation pulses as a function of time. Doan, in a similar field of endeavor, is directed towards spinal cord stimulation. Doan discloses a device programmed with a model that is used to determine stimulation parameters (e.g. Pars. [0252]-[0253]: optimizing the frequency of the therapy).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Parker to include the model as taught by Doan in order to determine optimal stimulation parameters.
However, Parker in view of Doan fails to disclose wherein the external device is further configured to determine a modulation function as a function of time to be applied to the first stimulation parameters to form modulated stimulation pulses, wherein the modulation function modulates a charge delivered to the patient by the modulated stimulation pulses as a function of time.
Peterson, in a similar field of endeavor, is directed towards a device for storing stimulation waveforms. Peterson discloses a device configured to determine a modulation function as a function of time to be applied to the first stimulation parameters to form modulated stimulation pulses, wherein the modulation function modulates a charge delivered to the patient by the modulated stimulation pulses as a function of time (e.g. Par. [0018]: the stimulation provided to the user can be changed based on a time based modulating function; Par. [0075]: modulation function used to implement complex pulse trains).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Parker in view of Doan to include the modulation function as a function of time as taught by Peterson because doing so would allow implementation of modulated and complex pulse trains to the user (e.g. Peterson, par. [0075]).
Regarding claims 28 and 37, Parker in view of Doan and Peterson discloses using a model (e.g. Doan, Pars. [0252]-[0253]: optimizing the frequency of the therapy). Parker further discloses wherein the function is derived for the patient based on data taken from the patient (e.g. Par. [0022]; Par. [0054]).
Regarding claims 29 and 38, Parker in view of Doan and Peterson discloses using a model (e.g. Doan, Pars. [0252]-[0253]: optimizing the frequency of the therapy). Parker further discloses wherein the device is configured to determine the first stimulation parameters such that the modulated stimulation pulses provide sub-perception stimulation to the patient (e.g. Par. [0040]: parameters selected to provide stimulation without paresthesia).
Regarding claims 30 and 39, Parker in view of Doan and Peterson discloses the modulation function (e.g. Peterson, Par. [0018]: the stimulation provided to the user can be changed based on a time based modulating function; Par. [0075]: modulation function used to implement complex pulse trains). Parker further discloses wherein the external device is configured to apply the function to the first stimulation parameters (e.g. Par. [0022]).
Regarding claims 31 and 40, Parker in view of Doan and Peterson discloses the modulated stimulation pulses as a function of time (e.g. Peterson, Par. [0018]: the stimulation provided to the user can be changed based on a time based modulating function; Par. [0075]: modulation function used to implement complex pulse trains). Parker further discloses wherein the information transmitted to the stimulator device comprises the first stimulation parameters, wherein the modulated stimulation pulses at the one or more of the electrodes comprises stimulation pulses formed at the one or more electrodes in accordance with the first stimulation parameters (e.g. Pars. [0022]-[0024]).
However, Parker fails to disclose an on/off schedule or a duty cycle, wherein the on/off schedule or duty cycle modulates the charge delivered to the patient by the modulated stimulation pulses as the function of time, wherein the stimulation pulses are formed in accordance with the first stimulation parameters as modulated by the on/off schedule of the duty cycle. Doan, in a similar field of endeavor, is directed towards spinal cord stimulation. Doan discloses an on/off schedule or a duty cycle, wherein the on/off schedule or duty cycle modulates the charge delivered to the patient by the modulated stimulation pulses as the function of time, wherein the stimulation pulses are formed in accordance with the first stimulation parameters as modulated by the on/off schedule of the duty cycle (e.g. Par. [0023]: duty cycle can be set; Pars. [0252]-[0253]: optimizing the frequency of the therapy).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Parker in view of Doan and Peterson to include the on/off schedule or duty cycle and wherein the stimulation pulses are formed in accordance with the first stimulation parameters as modulated by the on/off schedule of the duty cycle as taught by Doan in order to determine optimal stimulation parameters.
Regarding claim 32, Parker in view of Doan and Peterson discloses the modulated stimulation pulses (e.g. Peterson, Par. [0018]: the stimulation provided to the user can be changed based on a time based modulating function; Par. [0075]: modulation function used to implement complex pulse trains). Parker further discloses wherein the information transmitted to the stimulator device comprises modified stimulation parameters, wherein the modulated stimulation parameters determine the modified stimulation pulses in accordance with the modulation function (e.g. Pars. [0022]-[0024]: the modulator is used to determine stimulation parameters; Fig. 4: step 404 mapping the pulse widths/amplitudes and then using the map to identify patient specific values at step 406; Pars. [0033]-[0034]). However, Parker fails to specifically disclose wherein the modulated stimulation parameters are determined in accordance with a model. Doan, in a similar field of endeavor, is directed towards spinal cord stimulation. Doan discloses a device programmed with a model that is used to determine stimulation parameters (e.g. Par. [0252]: optimizing the frequency of the therapy).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Parker in view of Doan and Peterson to include the model as taught by Doan in order to determine optimal stimulation parameters.
Regarding claims 33 and 43, Parker fails to disclose wherein the information transmitted to the stimulator device comprises the modulated stimulation parameters as updated as a function of time in accordance with the modulation function. Peterson, in a similar field of endeavor, is directed towards a device for storing stimulation waveforms. Peterson discloses transmitting the modulated stimulation parameters as updated as a function of time in accordance with the modulation function (e.g. Par. [0018]: the stimulation provided to the user can be changed based on a time based modulating function; Par. [0075]: modulation function used to implement complex pulse trains).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Parker in view of Doan and Peterson to include transmitting the modulated stimulation parameters as taught by Peterson because doing so would allow implementation of modulated and complex pulse trains to the user (e.g. Peterson, par. [0075]).
Regarding claim 34, Parker fails to disclose wherein the stimulator device is configured to apply the modulation function to the first stimulation parameters to provide the modulated stimulation pulses, wherein the information transmitted to the stimulator device comprises the modulation function and the first stimulation parameters. Peterson, in a similar field of endeavor, is directed towards a device for storing stimulation waveforms. Peterson discloses applying the modulation function to the stimulation parameters to provide the modulated stimulation pulses, wherein the information transmitted to the stimulator device comprises the modulation function and the stimulation parameters (e.g. Par. [0018]: the stimulation provided to the user can be changed based on a time based modulating function; Par. [0075]: modulation function used to implement complex pulse trains).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Parker in view of Doan and Peterson to include applying the modulation function to the stimulation parameters as taught by Peterson because doing so would allow implementation of modulated and complex pulse trains to the user (e.g. Peterson, par. [0075]).
Regarding claims 35 and 46, Parker fails to disclose wherein the modulation function comprises an on/off schedule or a duty cycle, wherein the on/off schedule or duty cycle modulates the charge delivered to the patient by the modulated stimulation pulses as the function of time, wherein the modulated stimulation pulses comprise stimulation pulses formed at the one or more electrodes in accordance with the first stimulation parameters as modulated by the on/off schedule of the duty cycle. Doan, in a similar field of endeavor, is directed towards spinal cord stimulation. Doan discloses an on/off schedule or a duty cycle, wherein the on/off schedule or duty cycle modulates the charge delivered to the patient by the modulated stimulation pulses as the function of time, wherein the stimulation pulses are formed in accordance with the first stimulation parameters as modulated by the on/off schedule of the duty cycle (e.g. Par. [0023]: duty cycle can be set; Par. [0252]: optimizing the frequency of the therapy).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Parker in view of Doan and Peterson to include the on/off schedule or duty cycle and wherein the stimulation pulses are formed in accordance with the first stimulation parameters as modulated by the on/off schedule of the duty cycle as taught by Doan in order to determine optimal stimulation parameters.
Regarding claim 41, Parker fails to disclose transmitting to the stimulator device modified stimulation parameters from the external device, wherein the modulated stimulation parameters determine the modified stimulation pulses in accordance with the modulation function. Peterson, in a similar field of endeavor, is directed towards a device for storing stimulation waveforms. Peterson discloses transmitting the modulated stimulation parameters, wherein the modulated stimulation parameters determine the modified stimulation pulses in accordance with the modulation function (e.g. Par. [0018]: the stimulation provided to the user can be changed based on a time based modulating function; Par. [0075]: modulation function used to implement complex pulse trains).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Parker in view of Doan and Peterson to include transmitting the modulated stimulation parameters as taught by Peterson because doing so would allow implementation of modulated and complex pulse trains to the user (e.g. Peterson, par. [0075]).
Regarding claim 42, Parker fails to specifically disclose wherein the modulated stimulation parameters are determined in accordance with a model. Doan, in a similar field of endeavor, is directed towards spinal cord stimulation. Doan discloses a device programmed with a model that is used to determine stimulation parameters (e.g. Par. [0252]: optimizing the frequency of the therapy).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Parker in view of Doan and Peterson to include the model as taught by Doan in order to determine optimal stimulation parameters.
Regarding claim 44, Parker fails to disclose wherein the modulation function is applied to the first stimulation parameters in the stimulator device. Peterson, in a similar field of endeavor, is directed towards a device for storing stimulation waveforms. Peterson discloses the modulation function being applied to the stimulation parameters in the stimulator device (e.g. Par. [0018]: the stimulation provided to the user can be changed based on a time based modulating function; Par. [0075]: modulation function used to implement complex pulse trains).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Parker in view of Doan and Peterson to include the modulation function being applied to the stimulation parameters as taught by Peterson because doing so would allow implementation of modulated and complex pulse trains to the user (e.g. Peterson, par. [0075]).
Regarding claim 45, Parker further discloses transmitting the modulation function and the first stimulation parameters to the stimulator device. Peterson, in a similar field of endeavor, is directed towards a device for storing stimulation waveforms. Peterson discloses transmitting modulation function and the stimulation parameters to the stimulator device (e.g. Par. [0018]: the stimulation provided to the user can be changed based on a time based modulating function; Par. [0075]: modulation function used to implement complex pulse trains).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Parker in view of Doan and Peterson to include transmitting the modulated stimulation parameters as taught by Peterson because doing so would allow implementation of modulated and complex pulse trains to the user (e.g. Peterson, par. [0075])
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Yakovlev et al. (US 2020/0101291 – of record) is directed towards methods and apparatus for neuromodulation treatments.
Hershey et al. (US 2016/0082252 – of record) is directed towards a modulation device.
Schmidt et al. (US 2019/0117969) is directed towards medical devices for the treatment of cancer with electric fields (e.g. par. [0183]: modulating pulse width as a function of time).
Michaeli et al. (US 2018/0185649) is directed towards feedback driven neuromodulation.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHREYA P ANJARIA whose telephone number is (571)272-9083. The examiner can normally be reached M-F: 8:00-5:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached at 571-270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHREYA ANJARIA/Examiner, Art Unit 3796
/PAMELA M. BAYS/Primary Examiner, Art Unit 3796