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 .
Response to Arguments
Rejections under 35 USC 101 and 112
Applicant’s arguments, see page 10, filed on 12/16/2025, with respect to the 35 USC 101 rejection of claim 25 and the 35 USC 112 rejection of claim 10 have been fully considered and are persuasive. The 101 rejection of claim 25 and the 112 rejection of claim 10 has been withdrawn.
Rejections under 35 USC 103
Applicant's arguments filed on 12/16/2025 have been fully considered but they are not persuasive. Applicant argues that Examiner failed to explain why one of ordinary skill in the art would have considered using an ECAP signal elicited by stimulation pulses delivered to a second target tissue to adjust a parameter of stimulation pulses delivered to a first target tissue that is different than the second target tissue. Examiner respectfully disagrees and maintains that it would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method/systems as taught by Dinsmoor with delivering the second train to a second target tissue different from the first target tissue. Such a modification would provide the predictable results of delivering treatment to multiple sites in order to alleviate pain.
Dinsmoor discloses “adjusting electrical stimulation therapy delivered to a patient based on one or more characteristics of evoked compound action potentials (ECAPs)”, wherein the “electrical stimulation therapy is typically delivered to a target tissue (e.g. one or more nerves or muscles)” [0031]. In order to adjust an electrical stimulation therapy to a muscle based on ECAPs as taught by Dinsmoor, a system would necessarily have to use an ECAP signal elicited by stimulation pulses delivered to a second target tissue (nerve) to adjust a parameter of stimulation pulses delivered to a first target tissue that is different than the second target tissue (muscle). Dinsmoor further discloses using the system to treat pain [0049]. Therefore, one of ordinary skill in the art would have considered using an ECAP signal elicited by stimulation pulses delivered to a second target tissue to adjust a parameter of stimulation pulses delivered to a first target tissue that is different than the second target tissue in order to measure neural recruitment in response to stimulation at a first tissue and adjust the stimulation being delivered to a second different tissue as disclosed by Dinsmoor [0031] in order to alleviate pain [0049].
Claim Rejections - 35 USC § 103
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.
Claim(s) 1-7, 10-12, 14, 16-22, and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Dinsmoor et al (US Publication 2019/0388695).
Regarding claims 1, 16, and 25, Dinsmoor discloses a system (Figure 2A) comprising:
processing circuitry ([0069] Processing circuitry 214 also controls stimulation generator 211) configured to:
control delivery of a first train of electrical stimulation pulses at a first frequency to a first target tissue; control delivery of a second train of electrical stimulation pulses at a second frequency, wherein at least some electrical stimulation pulses of the first train of electrical stimulation pulses are interleaved with at least some electrical stimulation pulses of the second train of electrical stimulation pulses ([0077] deliver a plurality of control pulses (second train) interleaved with at least some of the plurality of informed pulses (first train)), and
wherein the first frequency is greater than the second frequency ([0080] the frequency of the control pulses (second train) may be delivered at a lower frequency than the informed pulses (first train) when at least some informed pulses are delivered without a control pulse delivered between them);
receive an evoked compound action potential (ECAP) signal elicited by a pulse of the second train of electrical stimulation pulses ([0077] Processing circuitry 214 may receive, via an electrical signal sensed by sensing circuitry 212, information indicative of an ECAP signal (e.g., a numerical value indicating a characteristic of the ECAP in electrical units such as voltage or power) produced in response to the control stimulation (second stimulation));
adjust, based on the ECAP signal, a first value of a parameter that at least partially defines the first train of electrical stimulation pulses to a second value ([0077] Therapy stimulation programs 217 may be updated according to the ECAPs recorded at sensing circuitry 212); and
responsive to adjusting the first value of the parameter to the second value, control delivery of subsequent pulses of the first train of electrical stimulation pulses according to the second value of the parameter ([0084] processing circuitry 214 may adjust one or more of therapy stimulation programs 217 and ECAP test stimulation programs 218 to decrease/increase the amplitude of informed pulses and control pulses following the at least one respective ECAP).
Dinsmoor fails to explicitly disclose delivering the second train to a second target tissue different from the first target tissue, but further discloses implantable leads, each coupled to the IMD and directed to different target tissue sites [0044] in an alternative embodiment. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method/systems as taught by Dinsmoor with delivering the second train to a second target tissue different from the first target tissue. Such a modification would provide the predictable results of delivering treatment to multiple sites in order to alleviate pain.
Regarding claims 2 and 17, Dinsmoor discloses stimulation generation circuitry configured to deliver the first train of electrical stimulation pulses and the second train of electrical stimulation pulses, and wherein the processing circuitry is configured to control the stimulation generation circuitry to deliver the first train of electrical stimulation pulses and the second train of electrical stimulation pulses ([0069] Processing circuitry 214 also controls stimulation generator 211; Figure 2A shows processing circuitry 214 being in communication with stimulation generator 211; [0084] processing circuitry 214 may adjust therapy stimulation programs 217 and ECAP test stimulation programs 218, and the programs 217 and 218 may instruct stimulation generator 211 to increase the amplitude of informed pulses and control pulses following the at least one respective ECAP).
Regarding claims 3 and 18, Dinsmoor discloses an electrode combination of the first train of electrical stimulation pulses; a number of pulses in the first train during a duty cycle; the first frequency of pulses in the first train; an amplitude of pulses in the first train; a pulse width of pulses in the first train; a frequency modulation factor that modulates the first frequency of the first train; an amplitude modulation factor that modulates the amplitude of the pulses in the first train; an interphase interval of the pulses in the first train; a pulse shape of the pulses in the first train; or a polarity of electrodes of the first train ([0084] processing circuitry 214 may adjust one or more of therapy stimulation programs 217 and ECAP test stimulation programs 218 to decrease/increase the amplitude of informed pulses and control pulses following the at least one respective ECAP).
Regarding claims 4 and 19, Dinsmoor discloses comprising sensing circuitry configured to sense the ECAP signal elicited by the pulse of the second train of electrical stimulation pulses ([0077] Processing circuitry 214 may receive, via an electrical signal sensed by sensing circuitry 212, information indicative of an ECAP signal (e.g., a numerical value indicating a characteristic of the ECAP in electrical units such as voltage or power) produced in response to the control stimulation).
Regarding claims 5 and 20, Dinsmoor discloses wherein the processing circuitry is configured to determine, from the ECAP signal, a characteristic value which is an ECAP amplitude of a portion of the ECAP signal ([0131] Processing circuitry 214 may then control sensing circuitry 212 to sense an ECAP signal elicited by the control pulse and then identify a characteristic of the ECAP signal (e.g., an amplitude of the ECAP signal),
wherein the parameter comprises a first train amplitude of pulses of the first train ([0131] Processing circuitry 214 may then determine, based on the characteristic of the ECAP signal and a gain value, a parameter value (e.g., an amplitude, pulse width value, pulse frequency value, and/or slew rate value) that at least partially defines an informed pulse),
wherein pulses of the second train comprise a second train amplitude ([0133] ECAP pulse amplitude (e.g., the control pulse amplitude)),
and wherein the processing circuitry is further configured to adjust the first value of the parameter to the second value of the parameter by at least: subtracting the ECAP amplitude from a target ECAP amplitude value for the patient to generate a differential amplitude ([0132] The measured amplitude (or average measured amplitude) is then subtracted from the selected target ECAP amplitude 1010 to generate a differential amplitude);
multiplying the differential amplitude by a gain value to generate a preliminary differential value ([0133] The differential amplitude is then multiplied by the gain value for the patient to generate a preliminary differential value 1012);
multiplying the preliminary differential value by a scaling factor to generate an informed differential value ([0134] To adjust the informed pulse amplitude, the differential value is multiplied by a scaling factor 1018 to generate the therapy differential value), wherein the scaling factor represents the ratio ([0134] the scaling factor may be the ratio of the previously delivered informed pulse amplitude to the previously delivered control pulse amplitude);
adding the informed differential value to the first value of first train amplitude to generate the second value of the first train amplitude ([0134] The therapy differential value is then added to the previously delivered informed pulse amplitude 1020 to generate the new, or adjusted, informed pulse amplitude that at least partially defines the next informed pulse 1022); and
adding the preliminary differential value to the first value of the second train amplitude to generate a second value of the second train amplitude for subsequent pulses of the second train ([0133] The preliminary differential value is added to the ECAP pulse amplitude (e.g., the control pulse amplitude) to generate the new, or adjusted, ECAP pulse amplitude that at least partially defines the next control pulse 1016).
Regarding claims 6 and 21, Dinsmoor discloses herein the processing circuitry: determines a characteristic value of the ECAP signal; and adjusts, based on the characteristic value, the first value of the parameter that at least partially defines the first train of electrical stimulation pulses to the second value, wherein the characteristic value comprises: an ECAP amplitude between two peaks of the ECAP signal; an area under a curve of at least a portion of the ECAP signal; a latency of at least one feature of the ECAP signal; a spectral content of the ECAP signal; a presence of one or more features of the ECAP signal; an absence of one or more features of the ECAP signal; or a combination of at least one peak and at least one trough of the ECAP signal ([0032] Changes in a characteristic (e.g., an amplitude of a portion of the signal, an area under one or more peaks, frequency content, and/or maximum and/or minimum peak timing) of an ECAP signals occur as a function of how many axons have been activated by the delivered stimulation pulse. A system can monitor changes in the characteristic of the ECAP signal and use that change in the characteristic to adjust one or more stimulation parameter of the informed pulses and/or control pulses delivered to the patient).
Regarding claims 7 and 22, Dinsmoor discloses wherein the processing circuitry is further configured to adjust, based on the ECAP signal, at least one of: a gain value that at least partially determines adjustment of the parameter; one or more filtering characteristics of the ECAP signal; or a sensing electrode combination used to sense the ECAP signal ([0137] electrode combinations may be adjusted in order to deliver different amounts of charge and modify the number of neurons being recruited by each informed pulse; gain values may need to be determined that are specific for each type of parameter in order to appropriately adjust that type of parameter).
Regarding claim 10, Dinsmoor discloses wherein the first frequency is greater than the second frequency ([0080] the frequency of the control pulses (second train) may be delivered at a lower frequency than the informed pulses (first train) when at least some informed pulses are delivered without a control pulse delivered between them).
Regarding claim 11, Dinsmoor discloses wherein the processing circuitry is configured to control delivery the first train and deliver the second train by at least controlling delivery of the first train and the second train of electrical stimulation pulses in a repeatable series of slots, the repeatable series of slots being repeatable over time for delivery of the first train of electrical stimulation pulses and the second train of electrical stimulation pulses ([0077] ECAP test stimulation programs 218 may instruct stimulation generator 211 to deliver a plurality of control pulses interleaved with at least some of the plurality of informed pulses; Figure 2A shows stimulation programs 218 being in communication with processor 214 which instructs the stimulation generator 211), and wherein: delivery of the first train of electrical stimulation pulses comprises generating one pulse for a first slot of at least some of the repeatable series of slots that achieves the first frequency, and delivery of the second train of electrical stimulation pulses comprises generating one pulse for a second slot of at least some of the repeatable series of slots that achieves the second frequency ([0134] The next informed pulse 1022 (or pulses if multiple stimulation programs are involved in therapy) is then delivered, interleaved with control pulse 1016; Figure 10B: ECAP pulse amplitude 1014, informed pulse amplitude 1020).
Regarding claim 12, Dinsmoor discloses wherein the second frequency is selected from a frequency range from approximately 40 Hz to approximately 60 Hz ([0078] informed pulses have a pulse width of approximately 450 μs and a pulse frequency of approximately 60 Hertz).
Regarding claim 14, Dinsmoor discloses an implantable medical device comprising the processing circuitry ([0065] FIG. 2A, IMD 200 includes processing circuitry 214).
Claim(s) 8-9, 15, and 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over Dinsmoor et al (US Publication 2019/0388695) in view of Vallejo et al (US Publication 2020/0353256).
Regarding claims 8 and 23, Dinsmoor discloses the system and method of claims 1 and 16 a discussed above, but fails to disclose wherein the first train of electrical stimulation pulses comprises two or more pulse trains that have an average frequency less than the first frequency and greater than the second frequency. However, Vallejo discloses wherein the first train of electrical stimulation pulses comprises two or more pulse trains that have an average frequency less than the first frequency and greater than the second frequency ([0096] multiple signals can be multiplexed within a repeating set of N pulse spaces. Each pulse space within the pattern can correspond to a different electrical signal with respective parameters. The lower average frequency can be generated by multiplexing a second, tonic signal component in one of the N pulses). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system/method as taught by Dinsmoor with the first train of electrical stimulation pulses comprises two or more pulse trains that have an average frequency less than the first frequency and greater than the second frequency as taught by Vallejo. Such a modification would provide the predictable results of using a multiplexed modulation/stimulation signal to provide pain relief during spinal cord stimulation or peripheral nerve stimulation (Abstract).
Regarding claims 9 and 24, Dinsmoor discloses the system of claim 8 and the method of claim 23 as discussed above, but fails to disclose wherein the average frequency is selected from a frequency range from approximately 150 Hz to approximately 900 Hz. However, Vallejo discloses wherein the average frequency is selected from a frequency range from approximately 150 Hz to approximately 900 Hz ([0096] a first or priming frequency is between 1000 Hz and 1400 Hz (burst), or between 750 Hz and 1050 Hz (average)). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system/method as taught by Dinsmoor with the average frequency is selected from a frequency range from approximately 150 Hz to approximately 900 Hz as taught by Vallejo. Such a modification would provide the predictable results of using a multiplexed modulation/stimulation signal to provide pain relief during spinal cord stimulation or peripheral nerve stimulation (Abstract).
Regarding claim 15, Dinsmoor discloses the system and method of claims 1 and 16 a discussed above, but fails to disclose wherein the first target tissue comprises glial cells, and wherein the second target tissue comprises neurons ([0009] targeted modulation of the different types of target cells (glial cells and neurons)). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system/method as taught by Dinsmoor with the first target tissue comprises glial cells, and wherein the second target tissue comprises neurons as taught by Vallejo. Such a modification would provide the predictable results of helping normalize neuroglia interactions that have been affected by the development of a chronic pain state as a result of sensitization of the nervous system [0009].
Claim(s) 13 is rejected under 35 U.S.C. 103 as being unpatentable over Dinsmoor et al (US Publication 2019/0388695) in view of Torgerson (US Publication 2018/0056073).
Regarding claim 13, Dinsmoor discloses wherein the parameter comprises an amplitude ([0084] processing circuitry 214 may adjust one or more of therapy stimulation programs 217 and ECAP test stimulation programs 218 to decrease/increase the amplitude of informed pulses and control pulses following the at least one respective ECAP), but fails to disclose wherein the first value of the amplitude that at least partially defines the first train of electrical stimulation pulses is below at least one of a perception threshold or a sensory threshold of a patient.
However, Torgerson discloses the first value of the amplitude that at least partially defines the first train of electrical stimulation pulses is below at least one of a perception threshold or a sensory threshold of a patient ([0071] The amplitude and pulse width of the electrical stimulation signal are selected such that a stimulation intensity level of the electrical stimulation signal is less than a perception or paresthesia threshold intensity level for patient 12). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method/system as taught by Dinsmoor with the first value of the amplitude that at least partially defines the first train of electrical stimulation pulses is below at least one of a perception threshold or a sensory threshold of a patient as taught by Torgerson. Such a modification would provide the predictable results of avoiding causing the patient pain during treatment.
Conclusion
THIS ACTION IS MADE FINAL. 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 WILLOW GRACE WELCH whose telephone number is (703)756-1596. The examiner can normally be reached Usually M-F 8:00am - 4:00pm.
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, Benjamin Klein can be reached at 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WILLOW GRACE WELCH/Examiner, Art Unit 3792
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792