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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/04/2026 has been entered.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 11, and 17 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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 12 and 14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 12, the limitation of “wherein the physiological event comprises a lead migration” renders the claim unclear since the system of claim 11 does not require a lead. Examiner suggests amending the system of claim 11 to recite a lead in order to help overcome the pending 112 rejection. Dependent claims inherit the same deficiencies.
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) 1-11, 13, 15, and 17-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yoo et al (US 2019/0001135) hereinafter Yoo.
Regarding claim 1, Yoo discloses a system for neuromodulation therapy (Fig. 1), the system comprising:
a processor ([0061] at least one processor of control module 40); and
a memory storing data for processing by the processor ([0061] non-transitory computer-readable medium in the control modules 40 that is configured for storing one or more instructions configured to be executed as part of system operation by at least one processor of the system), the data, when processed, causes the processor to:
receive one or more first physiological-based inputs of a user measured during a first time period ([0180] users provides user input indicating when the thresholds are met);
determine a first therapy response score based on the one or more first physiological-based inputs ([0190] sleep protocol uses the first stimulation level (e.g. 5) for the sleeping protocol);
generate at least one first adjustment for one or more parameters of neuromodulation therapy based on the first therapy response score ([0190] Adjustment includes increasing stimulation intensity such as to the discomfort threshold (e.g. 7) of the awake protocol, or just below that); and
cause, during a second time period after the first time period, a therapy system to deliver to the user the neuromodulation therapy having the at least one first adjustment for the one or more parameters ([0190] increasing stimulation intensity during sleep protocol),
wherein the first time period is while the user is awake and the second time period is while the user is asleep ([0190] adjustment of stimulation, is set to occur after the user has fallen asleep).
Regarding claim 2, Yoo discloses wherein the first time period corresponds to a period of higher activity for the user than the second time period ([0190] stimulation protocols used for treatment during sleep (second time period) are initially derived from a user's awake threshold values (determined during first time period)), and
wherein the one or more parameters are adjusted automatically or manually ([0190] Adjustment includes increasing stimulation intensity such as to the discomfort threshold (e.g. 7) of the awake protocol).
Regarding claim 3, Yoo discloses wherein the memory stores further data for processing by the processor that, when processed, causes the processor to:
receive information about a state of the therapy system ([0190] Assessment of initial protocol parameters set for the user during sleep includes a method which determines if the increase in intensity causes a user to wakes up; This process can be repeated until the user sleeps or until the stimulation level goes below the nerve recruitment threshold); and
generate a notification based on at least one of the state of the therapy system, the first therapy response score, or the one or more first physiological-based inputs ([0190] In the case where the user is not able to tolerate the stimulation provided even at the recruitment threshold then the device provides notification that the sleep protocol is not suitable).
Regarding claim 4, Yoo discloses wherein the one or more parameters comprises at least one of increasing or decreasing a stimulation amplitude of a signal, increasing or decreasing a pulse width of a signal, increasing or decreasing a frequency of a signal, increasing or decreasing a number of electrode contacts, changing the electrode contacts that provide stimulation, starting or stopping the neuromodulation therapy, increasing or decreasing a cycling of the neuromodulation therapy, increasing or decreasing the cycling of high frequency components of the neuromodulation therapy independently of low frequency components of the neuromodulation therapy, adjustment of charge balancing strategy, or changing an on/off cycling time while maintaining a cycling ratio ([0190] Adjustment includes increasing stimulation intensity).
Regarding claim 5, Yoo discloses wherein the memory stores further data for processing by the processor that, when processed, causes the processor to receive one or more additional inputs and the first therapy response score may be further based on the one or more additional inputs ([0188] an assessment procedure 510 can be repeated across a plurality of trials to obtain a statistically based assessment of the intensities associated with at least one of the 4 thresholds shown in FIG. 10A. The mean or median results of the 2 or more trials can be used, while measures of variance (e.g. standard deviation) may serve as important indicators of the variability of a user, and can be used in setting the offset 514),
wherein the one or more additional inputs comprises at least one of user feedback or an environmental signal ([0188] During the assessment 510 if the device's accelerometer module 47 detects a strong tap or stamp by the patient it will immediately pause stimulation to deter patient discomfort).
Regarding claim 6, Yoo discloses wherein the one or more first physiological-based inputs comprises at least one of an activity or accelerometer signal, a cardiac-derived metric, a sleep score, a pain score, CMAP, EMG, respiration, an eCAP signal, posture, and/or other autonomic measures including organ sensing respiration ([0180] users provides user input indicating when the thresholds are met; Examiner notes that inputting when a pain threshold is met would be inputting a pain score).
Regarding claim 7, Yoo discloses wherein the one or more first physiological-based inputs are received from at least one of a wearable device, a user device, or the therapy system ([0180] patient input is only prompted for by the user device 32 on the upward slope).
Regarding claim 8, Yoo discloses wherein the memory stores further data for processing by the processor that, when processed, causes the processor to:
receive one or more second physiological-based inputs of the user measured while the user is asleep during the second time period and also receiving the neuromodulation therapy with the at least one first adjustment for the one or more parameters ([0190] a method which determines if the increase in intensity causes a user to wakes up (actigraphy data indicates this interruption)),
wherein at least one of the one or more second physiological-based inputs is different than the one or more first physiological- based inputs ([0190] actigraphy data);
determine a second therapy response score based on the one or more second physiological-based inputs ([0190] determines if the increase in intensity causes a user to wakes up to determine patient tolerance);
generate at least one second adjustment for the one or more parameters of the neuromodulation therapy based on the second therapy response score ([0190] If intensity increase interrupt sleeps then the device decreases the stimulation level by 1); and
cause, during a third time period after the user awakes from being asleep during the second time period, the therapy system to deliver to the user the neuromodulation therapy having the at least one second adjustment for the one or more parameters ([0190] If intensity increase interrupt sleeps then the device decreases the stimulation level by 1; Examiner notes the user would be awake since the sleep interruption triggered the decrease in stimulation level).
Regarding claim 9, Yoo discloses wherein the memory stores further data for processing by the processor that, when processed, causes the processor to map the one or more first physiological-based inputs to one or more events ([0180] users provides user input indicating when the thresholds are met).
Regarding claim 10, Yoo discloses wherein the memory stores further data for processing by the processor that, when processed, causes the processor to generate a notification when at least one of the one or more events is determined to be a risk to the user ([0190] In the case where the user is not able to tolerate the stimulation provided even at the recruitment threshold then the device provides notification that the sleep protocol is not suitable).
Regarding claim 11, Yoo discloses A system for neuromodulation therapy, the system comprising:
a processor ([0061] at least one processor of control module 40); and
a memory storing data for processing by the processor ([0061] non-transitory computer-readable medium in the control modules 40 that is configured for storing one or more instructions configured to be executed as part of system operation by at least one processor of the system), the data, when processed, causes the processor to:
receive one or more first physiological-based inputs of a user measured during a first time period ([0180] users provides user input indicating when the thresholds are met);
determine a first therapy response score based on the one or more first physiological-based inputs ([0190] sleep protocol uses the first stimulation level (e.g. 5) for the sleeping protocol);
generate at least one first adjustment for one or more parameters of neuromodulation therapy based on the first therapy response score ([0190] Adjustment includes increasing stimulation intensity such as to the discomfort threshold (e.g. 7) of the awake protocol, or just below that);
cause, during a second time period after the first time period, a therapy system ([0209] stimulation assessment device 210; Fig. 12B) to deliver to the user the neuromodulation therapy having the at least one first adjustment for the one or more parameters ([0190] increasing stimulation intensity during sleep protocol),
track, during the second time period, one or more second physiological-based inputs of the user measured while the user is receiving the neuromodulation therapy with the at least one first adjustment for the one or more parameters ([0190] actigraphy data),
wherein the first time period is while the user is awake and the second time period is while the user is asleep ([0190] adjustment of stimulation, is set to occur after the user has fallen asleep);
determine one or more physiological responses (pain/sensation response) based on a difference between the one or more first physiological-based inputs and the one or more second physiological-based inputs ([0180] patient provides input when pain threshold is met; Fig. 10A; [0190] actigraphy indicates that the intensity increase interrupts sleep); and
determine if a physiological event (sleep interruption) has occurred based on the one or more physiological responses ([0190] determines if the increase in intensity causes a user to wakes up (patient input or actigraphy data indicates this interruption)).
Regarding claim 13, Yoo discloses a pulse generator configured to generate an electrical signal ([0047] stimulation module 48); and
a lead (lead 234) in communication with the pulse generator and configured to transmit the electrical signal to an anatomical element ([0209-0210] assessment device 210 has circuitry, software, memory, processors, amplifiers, power regulation, and signal conditioning circuitry needed to provide its functionality and incorporates all of the modules disclosed in FIG. 2 for the device 12).
Regarding claim 15, Yoo discloses wherein the memory stores further data for processing by the processor that, when processed, causes the processor to:
determine a second therapy response score based on the one or more second physiological-based inputs ([0190] determines if the increase in intensity causes a user to wakes up to determine patient tolerance);
generate at least one second adjustment for the one or more parameters of the neuromodulation therapy based on the second therapy response score ([0190] If intensity increase interrupt sleeps then the device decreases the stimulation level by 1); and
cause, during a third time period after the second time period, the therapy system to deliver to the user the neuromodulation therapy having the at least one second adjustment for the one or more parameters ([0190] If intensity increase interrupt sleeps then the device decreases the stimulation level by 1; Examiner notes the user would be awake (third time period) since the sleep interruption triggered the decrease in stimulation level).
Regarding claim 17, Yoo discloses a system for neuromodulation therapy, the system comprising:
a processor ([0061] at least one processor of control module 40); and
a memory storing data for processing by the processor ([0061] non-transitory computer-readable medium in the control modules 40 that is configured for storing one or more instructions configured to be executed as part of system operation by at least one processor of the system), the data, when processed, causes the processor to:
track one or more first physiological-based parameters (pain) of a user during a first time period ([0180] users provides user input indicating when recruitment, sensation, discomfort, and pain thresholds are met);
determine a first therapy response score based on the one or more first physiological-based parameters ([0190] sleep protocol uses the first stimulation level (recruitment threshold, e.g. 5) for the sleeping protocol); and
cause, during a second time period after the first time period, a therapy system ([0209] stimulation assessment device; Fig. 12B) to deliver the neuromodulation therapy to the user based on the first therapy response score ([0190] The start of stimulation, or adjustment of stimulation, is set to occur after the user has fallen asleep),
wherein the first time period is while the user is awake and the second time period is while the user is asleep ([0190] stimulation protocols used for treatment during sleep are initially derived from a user's awake threshold values).
Regarding claim 18, Yoo discloses wherein the memory stores further data for processing by the processor that, when processed, causes the processor to:
track one or more second physiological-based parameters (movement/activity) of the user while the user is asleep during the second time period and also receiving the neuromodulation therapy that is based on the first therapy response score ([0190] determines if the increase in intensity causes a user to wakes up (patient input or actigraphy data indicates this interruption));
determine a second therapy response score based on the one or more second physiological-based parameters ([0190] If intensity increase interrupt sleeps then the device decreases the stimulation level by 1),
wherein at least one of the one or more second physiological- based parameters is different than the one or more first physiological-based parameters ([0190] actigraphy data); and
cause, during a third time period after the user awakes from being asleep during the second time period ([0190] actigraphy data indicates this interruption), the therapy system to deliver the neuromodulation therapy to the user based on the second therapy response score ([0190] If intensity increase interrupt sleeps then the device decreases the stimulation level by 1; Examiner notes that the user would be awake due to the sleep interruption that triggered the decrease in stimulation level).
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) 12 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Yoo (US 2019/0001135) in view of Krause et al (US 2010/0114221) hereinafter Krause.
Regarding claim 12, Yoo discloses wherein the first time period corresponds to a period of higher activity for the user than the second time period ([0190] stimulation protocols used for treatment during sleep (second time period) are initially derived from a user's awake threshold values (determined during first time period)), but fails to disclose wherein the physiological event comprises a lead migration.
However, Yoo further discloses stimulation device (stimulation assessment device 210) incorporating all of the modules for the device 12 [0209] and containing a lead connected to a TENS pad ([0210] lead 234 connected to TENS pad 236) and Krause discloses wherein a physiological event comprises a lead migration ([0126] lead migration detection module 120 may control operation of neurostimulation therapy module 106 to determine whether lead 28 has migrated to the extent that there is loss of nerve capture by electrodes 80-83). 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 as taught by Yoo with the physiological event comprises a lead migration as taught by Krause. Such a modification would provide the predictable results of detecting a loss of nerve capture due to lead migration [0136].
Regarding claim 14, Yoo discloses wherein the one or more second physiological-based inputs are tracked with at least one of stimulation or without stimulation ([0190] determines if the increase in intensity causes a user to wake up (patient input or actigraphy data indicates this interruption)).
Claim(s) 20 is rejected under 35 U.S.C. 103 as being unpatentable over Yoo (US 2019/0001135) in view of Libbus et al (US 2014/0135864) hereinafter Libbus.
Regarding claim 20, Yoo discloses the system of claim 18 as discussed above, but fails to disclose wherein the one or more second physiological-based parameters comprises one or more cardiac signals. However, Libbus discloses wherein the one or more second physiological-based parameters comprises one or more cardiac signals ([0058] The normative heart rate of the patient 10 is monitored and recorded periodically while asleep to determine whether the patient 10 is awakening). 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 as taught by Yoo with one or more second physiological-based parameters comprises one or more cardiac signals as taught by Libbus. Such a modification would provide the predictable results of determining whether or not the patient is awakening (Libbus, [0058]).
Claim(s) 21 and 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Yoo (US 2019/0001135) in view of Pepin et al (US 2021/0052900) hereinafter Pepin.
Regarding claim 21, Yoo discloses the system of claim 11 as discussed above, but fails to disclose wherein the memory stores further data for processing by the processor that, when processed, causes the processor to send data collected during the tracking of the one or more second physiological-based inputs to a therapy response model for training the therapy response model. However, Pepin discloses the memory stores further data for processing by the processor that, when processed, causes the processor to send data collected during the tracking the one or more second physiological-based inputs to a therapy response model for training the therapy response model ([0087] as the subject's therapy parameters are adjusted at each cycle of the loop in FIG. 5B, a machine-learning model may be trained on the previous inputs and their known outputs (e.g., resulting subject biomarkers).
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 as taught by Yoo with the memory stores further data for processing by the processor that, when processed, causes the processor to send data collected during the tracking the one or more second physiological-based inputs to a therapy response model for training the therapy response model as taught by Pepin. Such a modification would provide the predictable results of using the trained models to predict the subject state for various possible adjustments (Pepin, [0087]).
Regarding claim 25, Yoo discloses the system of claim 15 as discussed above, but fails to disclose wherein the memory stores further data for processing by the processor that, when processed, causes the processor to: send data collected during the tracking of the one or more second physiological-based inputs to a therapy response model for training the therapy response model. However, Pepin discloses the memory stores further data for processing by the processor that, when processed, causes the processor to: send data collected during the tracking of the one or more second physiological-based inputs to a therapy response model for training the therapy response model ([0087] as the subject's therapy parameters are adjusted at each cycle of the loop in FIG. 5B, a machine-learning model may be trained on the previous inputs and their known outputs (e.g., resulting subject biomarkers).
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 as taught by Yoo with the memory stores further data for processing by the processor that, when processed, causes the processor to: send data collected during the tracking of the one or more second physiological-based inputs to a therapy response model for training the therapy response model as taught by Pepin. Such a modification would provide the predictable results of using the trained models to predict the subject state for various possible adjustments (Pepin, [0087]).
Regarding claim 26, the modified Yoo discloses the system of claim 25 as discussed above, but fails to disclose wherein the at least one second adjustment is based on output of the therapy response model. However, Pepin discloses wherein the at least one second adjustment is based on output of the therapy response model ([0087] The trained model then may be used to predict the subject state for various possible adjustments, all of which may be used as inputs to an SGD algorithm to search for the optimal subject parameters to try as the next iteration of the processing loop in FIG. 5B).
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 as taught by Yoo with the at least one second adjustment is based on output of the therapy response model as taught by Pepin. Such a modification would provide the predictable results of improving the probability that the next adjustment will move toward the optimal set of therapy parameters for the subject (Pepin, [0087]).
Conclusion
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
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792
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