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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 07/07/2026 has been entered.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 and 15 have been considered but are 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.
Claim Rejections - 35 USC § 102
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 –
(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.
Claim(s) 1-2, 5, 14-15, 28, and 30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Baynham et al (US 2015/0032181) hereinafter Baynham.
Regarding claim 1, Baynham discloses a method of controlling a neural stimulus, the neural stimulus being defined by at least one stimulus intensity parameter (Fig. 5), the method comprising:
generating a stimulus intensity parameter (amplitude) to control a stimulator that generates a stimulus pulse for application to a tissue ([0082] system 10 delivers an electrical pulse train of a specified amplitude);
measuring a response of the tissue (eCAP), evoked by the stimulus pulse ([0082] eCAP measurements are made for at least one pulse of the delivered electrical pulse train);
determining a forward adjustment parameter (increase in amplitude) by applying a predetermined forward adjustment function to the stimulus intensity parameter ([0083] system 10 increases the amplitude of the delivered electrical energy by a step size);
determining a feedback parameter (computing a decreased amplitude value as a function of the amplitude value indicative of the perception threshold) derived from the measured response and the forward adjustment parameter [0083]; and
adjusting the stimulus intensity parameter according to the feedback parameter ([0083] SCM system 10 then modifies the sub-threshold modulation program with the computed amplitude value).
Regarding claim 2, Baynham discloses wherein the forward adjustment parameter is non- zero when the stimulus intensity parameter is non-zero ([0083] system 10 increases the amplitude of the delivered electrical energy by a step size).
Regarding claims 5 and 28, Baynham discloses wherein the predetermined adjustment function defines a monotonically increasing relationship between the forward adjustment parameter and the stimulus intensity parameter ([0083] system 10 increases the amplitude of the delivered electrical energy by a step size).
Regarding claims 14 and 30, Baynham discloses wherein adjusting the stimulus intensity parameter according to the feedback parameter derived from the measured response comprises:
in response to the measured response being greater than a target value (perception threshold), reducing the stimulus intensity parameter in accordance with a reduction rate ([0083] If the eCAP comparison reveals that the perception threshold of the patient has been reached (step 314), the SCM system 10 computes a decreased amplitude value as a function of the amplitude value indicative of the perception threshold (step 318)); and
in response to the measured response being less than the target value, increasing the stimulus intensity parameter in accordance with a growth rate ([0083] If the eCAP comparison reveals that the perception threshold of the patient has not been reached (step 314), the SCM system 10 increases the amplitude of the delivered electrical energy by a step size (step 316)),
wherein a magnitude of the reduction rate is not equal to a magnitude of the growth rate ([0083] growth rate is step size increases and reduction rate is a percentage of the determined perception threshold).
Regarding claim 15, Baynham discloses an implantable device for controllably applying a neural stimulus defined by at least one stimulus intensity parameter ([0038] IPG 14), the device comprising:
one or more stimulus electrodes (electrodes E1-E6) to deliver a stimulus pulse to a tissue to evoke a compound action potential response of the tissue [0066];
a stimulator (modulation output circuitry 50) for controlling the one or more stimulus electrodes in accordance with the at least one stimulus intensity parameter [0066];
measurement circuitry (monitoring circuitry 60) for measuring an evoked compound action potential response of the tissue [0071]; and
a control unit ([0072] control/processing circuitry 64) configured to,
generate the stimulus intensity parameter ([0073] microcontroller 64 to control the operation of the IPG 14 in accordance with a selected operating program and modulation parameters),
measure the response of the tissue, evoked by the stimulus pulse ([0074] directing the monitoring circuitry 60 to sense any eCAPs in response to the delivered electrical energy),
determine a forward adjustment parameter by applying a predetermined forward adjustment function to the stimulus intensity parameter ([0074] directing the modulation output circuitry 50 to deliver the electrical energy at increasing amplitude levels),
determine a feedback parameter derived from the measured response and the forward adjustment parameter ([0074] computing a decreased amplitude suitable for sub-threshold modulation therapy based on the perception threshold), and
adjust the stimulus intensity parameter according to the feedback parameter ([0075] microcontroller 64, in combination with the memory 70 and oscillator and clock circuit 72, thus include a microprocessor system that carries out a program function in accordance with a suitable program stored in the memory 70).
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) 3 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Baynham (US 2015/0032181) in view of Dinsmoor et al (US 2019/0388692) hereinafter Dinsmoor.
Regarding claims 3 and 26, Baynham discloses the method of claim 1 and system of claim 15 as discussed above, but fails to disclose providing a target response level, wherein determining a feedback parameter comprises: adjusting the target response level in accordance with the forward adjustment parameter to produce an adjusted target response level; and deriving the feedback parameter from a difference between the measured response and the adjusted target response level.
However, Dinsmoor discloses providing a target response level ([0138] targe ECAP amp 1010),
wherein determining a feedback parameter comprises:
adjusting the target response level in accordance with the forward adjustment parameter to produce an adjusted target response level ([0138] target ECAP amplitude 1010 may be adjusted by the difference between the target ECAP amplitude and the most recent sensed ECAP amplitude); and
deriving the feedback parameter from a difference between the measured response and the adjusted target response level ([0132] The measured amplitude (or average measured amplitude) is then subtracted from the selected target ECAP amplitude 1010 to generate a differential amplitude (1032)).
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 Baynham with providing a target response level, wherein determining a feedback parameter comprises: adjusting the target response level in accordance with the forward adjustment parameter to produce an adjusted target response level; and deriving the feedback parameter from a difference between the measured response and the adjusted target response level as taught by Dinsmoor. Such a modification would provide the predictable results of using the sensed ECAP amplitude to detect a change in the electrode-to-nerve distance (Dinsmoor, [0138]).
Claim(s) 4, 11-12, 27, and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Baynham (US 2015/0032181) in view of Buddha et al (US 2022/0118251) hereinafter Buddha.
Regarding claims 4 and 27, Baynham discloses the method of claim 1 and system of claim 15 as discussed above, but fails to disclose wherein determining a feedback parameter comprises adjusting the measured response according to the forward adjustment parameter to produce an adjusted response.
However, Buddha discloses adjusting a measured response according to a forward adjustment parameter to produce an adjusted response ([0592] While the ECAP signal is recorded, the previously-stored inverted artifact signal can be played back from RAM 2140, converted to an analog signal by DAC 2130, and applied to an offset pin of amplifier 2110. This playback can be synchronous with the sampling of the input signal. The offset pin can be positioned at a front end of amplifier 2110, where gain is low, and both input and offset are within a linear operating range. The previously recorded offset can be configured to negate the artifact component in the input signal).
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 Baynham with adjusting a measured response according to a forward adjustment parameter to produce an adjusted response as taught by Buddha. Such a modification would provide the predictable results of significantly reducing artifact amplitude in a sensed ECAP signal (Buddha, [0592]).
Regarding claims 11 and 29, Baynham discloses the method of claim 1 and the system of claim 15 as discussed above, but fails to disclose determining an artefact compensation component based on an artefact component of the measured response of the tissue; and adjusting the measured response based on the artefact compensation component.
However, Buddha discloses determining an artefact compensation component based on an artefact component of the measured response of the tissue ([0591] artifact output from amplifier 2110 can be digitized by ADC 2120. The output from ADC 2120 can then be inverted (e.g. negated) such that the artifact and its inverse sum to zero); and
adjusting the measured response based on the artefact compensation component ([0592] The previously recorded offset can be configured to negate the artifact component in the input signal).
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 Baynham with determining an artefact compensation component based on an artefact component of the measured response of the tissue; and adjusting the measured response based on the artefact compensation component as taught by Buddha. Such a modification would provide the predictable results of significantly reducing artifact amplitude in a sensed ECAP signal (Buddha, [0592]).
Regarding claim 12, the modified Baynham discloses the method of claim 11 as discussed above, but fails to disclose determining the artefact compensation component as a function of the stimulus intensity parameter.
However, Buddha discloses determining the artefact compensation component as a function of the stimulus intensity parameter ([0591] To record the artifact without the ECAP signal, one stimulation pulse can be followed by a second pulse within the refractory period of the neurons, such that there is minimal or no ECAP signal following the second pulse. The artifact from that second pulse is recorded. The low-gain artifact output from amplifier 2110 can be digitized by ADC 2120. The output from ADC 2120 can then be inverted (e.g. negated) such that the artifact and its inverse sum to zero).
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 as taught by Baynham with determining the artefact compensation component as a function of the stimulus intensity parameter as taught by Buddha. Such a modification would provide the predictable results of recording an artifact with minimal or no ECAP signal following a delivered pulse and inverting it in order to negate an artifact component in an input signal (Buddha, [0591-0592]).
Claim(s) 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Baynham (US 2015/0032181) in view of Kajimoto (US 2013/0093501).
Regarding claim 6, Baynham discloses the method of claim 1 as discussed above, but fails to disclose determining a change in an impedance level of the tissue; and adjusting a gradient of the predetermined forward adjustment function based on the change the impedance level.
However, Kajimoto discloses determining a change in an impedance level of the tissue ([0102] FIG. 8 is a graph showing the correlation between the threshold .DELTA.Tth of the pulse width of the stimulation pulse and the skin impedance Z); and
adjusting a gradient of the predetermined forward adjustment function based on the change the impedance level ([0102] the adjustment curve group shown in FIG. 8 is an adjustment curve group of the stimulation intensity used when controlling the stimulation intensity with the pulse width of the stimulation pulse).
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 as taught by Baynham with determining a change in an impedance level of the tissue; and adjusting a gradient of the predetermined forward adjustment function based on the change the impedance level as taught by Kajimoto. Such a modification would yield the predictable results of providing the user with optimum electrical stimulation stably (Kajimoto, [0108]).
Regarding claim 7, the modified Baynham discloses the method of claim 6 as discussed above, but fails to disclose wherein adjusting the gradient of the predetermined forward adjustment function comprises: in response to an increase in the impedance level, reducing the gradient of the predetermined forward adjustment function; and in response to a decrease in the impedance level, increasing the gradient of the predetermined forward adjustment function.
However, Kajimoto discloses wherein adjusting the gradient of the predetermined forward adjustment function comprises: in response to an increase in the impedance level, reducing the gradient of the predetermined forward adjustment function; and in response to a decrease in the impedance level, increasing the gradient of the predetermined forward adjustment function (Figure 8; [0102] FIG. 8 is a graph showing the correlation between the threshold .DELTA.Tth of the pulse width of the stimulation pulse and the skin impedance Z; the adjustment curve group shown in FIG. 8 is an adjustment curve group of the stimulation intensity used when controlling the stimulation intensity with the pulse width of the stimulation pulse).
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 as taught by Baynham with in response to an increase in the impedance level, reducing the gradient of the predetermined forward adjustment function; and in response to a decrease in the impedance level, increasing the gradient of the predetermined forward adjustment function as taught by Kajimoto. Such a modification would yield the predictable results of providing the user with optimum electrical stimulation stably (Kajimoto, [0108]).
Claim(s) 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Baynham (US 2015/0032181) in view of Buddha (US 2022/0118251) and further in view of Dinsmoor (US 2019/0388692).
Regarding claim 8, the modified Baynham discloses the method of claim 4 as discussed above, but fails to disclose wherein the feedback parameter is derived according to a difference between a target response level and the adjusted response.
However, Dinsmoor discloses wherein the feedback parameter is derived according to the difference between a target response level and the adjusted response ([0132] The measured amplitude (or average measured amplitude) is then subtracted from the selected target ECAP amplitude 1010 to generate a differential amplitude; Examiner notes this would require the measured response to be adjusted since Figure 10B teaches a loop where a control pulse 1016 is adjusted based off of a forward adjustment parameter 1012, and then new ECAPs are measured based off of the adjusted control pulse 1032).
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 as taught by Baynham with the feedback parameter is derived according to a difference between a target response level and the adjusted response as taught by Dinsmoor. Such a modification would provide the predictable results of adjusting a stimulation intensity based on a distance between the stimulation electrodes and the target neurons (Dinsmoor, [0132]).
Regarding claim 9, Baynham discloses determining an adjusted target response level (sub-threshold modulation) based on the target response level (perception threshold/super-threshold modulation) and the predetermined forward adjustment function ([0083] system 10 increases the amplitude of the delivered electrical energy by a step size (step 316), and returns to making eCAP measurements) in response to the delivered electrical energy at the increased amplitude (step 310). If the eCAP comparison reveals that the perception threshold of the patient has been reached (step 314), the SCM system 10 computes a decreased amplitude value as a function of the amplitude value indicative of the perception threshold (step 318); system 10 then modifies the sub-threshold modulation program with the computed amplitude value (step 320)).
Claim(s) 10 is rejected under 35 U.S.C. 103 as being unpatentable over Baynham (US 2015/0032181) in view of Buddha (US 2022/0118251) and Dinsmoor (US 2019/0388692) and further in view of Walker et al (US Publication 2011/0029040) hereinafter Walker.
Regarding claim 10, the modified Baynham discloses the method of claim 9 as discussed above, but fails to disclose further comprising adjusting the predetermined forward adjustment function to increase a difference between the adjusted target response level and a comfort stimulus response threshold. However, Walker discloses further comprising adjusting the predetermined forward adjustment function to increase a difference between the adjusted target response level and a comfort stimulus response threshold ([0051] the scaling factor allows the intensity of the parameter to be increased differently across the areas depending on the different pain thresholds. This enables some areas to receive more intense stimulation that would otherwise cause pain in areas with lower pain threshold).
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 as taught by Baynham with adjusting the predetermined forward adjustment function to increase a difference between the adjusted target response level and a comfort stimulus response threshold as taught by Walker. Such a modification would provide the predictable results of simplifying the ongoing modulation of waveform parameters and enhance the efficacy of managing pain (Walker, [0051]).
Claim(s) 13 is rejected under 35 U.S.C. 103 as being unpatentable over Baynham (US 2015/0032181) in view of Buddha (US 2022/0118251) and further in view of Min et al (US Publication 2016/0157769) hereinafter Min.
Regarding claim 13, the modified Baynham discloses the method of claim 11 as discussed above, but fails to disclose wherein adjusting the measured response based on the artefact compensation component comprises adjusting the forward adjustment parameter based on the artefact compensation component.
However, Min discloses adjusting a forward adjustment parameter based on an artefact compensation component ([0080] The controller 251 and/or sensing circuitry 158 may filter out the component 608 by automatically adjusting the gain concurrently when the drive signal(s) are delivered to the electrodes 511).
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 as taught by Baynham with adjusting a forward adjustment parameter based on an artefact compensation component as taught by Min. Such a modification would provide the predictable results of automatically filtering out the artefact component (Min, [0080]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Jaxx et al (US 2014/0277282) discloses adjusting stimulation parameters based on ECAP comparisons (Fig. 5).
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.
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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
/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796
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