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
Applicant’s arguments, filed on February 10, 2026 with respect to the 102 rejections of claims 1-2, 10, 14-15, and 23 and the 103 rejections of claims 3-9, 11-13, 16-22, and 24-26 have been fully considered and are persuasive. Therefore, the rejections have been withdrawn. However, upon further consideration, a new ground(s) of rejection have been made in view of the applicant’s amendments as can be further seen below.
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.
Claims 1-2, 10, 14-15, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2012/155188 A1 to Parker et al. (hereinafter “Parker”) in view of Parker’005 ( WO 2020/087135 A1 with citations to the corresponding US Publication No. US 2021/0387005 A1).
Regarding claim 1, Parker teaches:
An implantable device for controllably delivering a neural stimulus (page 9, line 9), the device comprising:
a plurality of electrodes including one or more stimulus electrodes and one or more measurement electrodes (claim 19);
a stimulus source configured to provide neural stimuli to be delivered via the one or more stimulus electrodes to a neural pathway of a patient in order to evoke a neural response on the neural pathway (abstract and claim 19);
measurement circuitry configured to capture signal windows sensed on the neural pathway via the one or more measurement electrodes (abstract, page 4, lines 15-16, and page 5, lines 19-23);
and a control unit configured to implement closed-loop/ feedback loop neurostimulation therapy (abstract and page 32, bullet point three) by:
controlling the stimulus source to provide a neural stimulus according to a stimulus intensity parameter/control variable parameter values (abstract, page 4-5, lines 29-34 and lines 1-3, and claim 1);
measuring a characteristic of the signal window (page 5, lines 19-27);
computing a feedback variable from an intensity of an evoked neural response in the signal window (abstract and page 5, lines 19-27);
adjusting the stimulus intensity parameter/control variable using the feedback variable (abstract, page 4-5, lines 29-34 and lines 1-3, and claim 1);
and repeating the controlling, measuring, computing, and adjusting so as to maintain the feedback variable at a target (abstract and claim 1),
thereby obtaining multiple measures (fig. 16 and page 22, lines 18-25),
but does not explicitly disclose wherein:
the control unit is configured to implement closed-loop neurostimulation therapy by:
controlling the measurement circuitry to capture a signal window of the signal windows subsequent to the neural stimulus, repeating the controlling, measuring, computing, and adjusting, thereby obtaining multiple measured characteristics of signal windows, wherein the control unit is further configured to compute one or more quantitative indicators of efficacy of the closed-loop neurostimulation therapy using the measured characteristics of the signal windows.
However, Parker’005 teaches a system for assessing the therapeutic efficacy of electrical neurostimulation therapy (see abstract, first sentence and figs. 1-2). The system (figs. 1-2) teach wherein the control unit/processor implements closed-loop neurostimulation therapy by controlling the measurement circuitry to capture a signal window (a single neural response) of the signal windows (of the plurality of neural responses) subsequent to the neural stimulus (see abstract),
repeating the controlling, measuring, computing, and adjusting, thereby obtaining multiple measured characteristics of signal windows (see abstract, para [0029], and para [0040]-[0041]), wherein the control unit/processor is further configured to compute one or more quantitative indicators (such as a statistical measure of neural activation) of efficacy of the closed-loop neurostimulation therapy using the measured characteristics of the signal windows/plurality of neural responses (see abstract and para [0040] – “The indication of therapeutic efficacy in some embodiments may be used to optimise therapy by guiding changes to selection of feedback loop parameters, such as feedback loop gain, feedback loop noise bandwidth, and feedback loop instant backoff threshold. Additionally or alternatively, the indication of therapeutic efficacy in some embodiments may be used to optimise therapy by identifying a patient as a responder or a non-responder, and/or may be used to guide a decision as to whether to continue or cease treatment.”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Parker with the teachings of Parker’005 to arrive at the claimed invention. Such combination would improve the system by allowing a very accurate indication of the therapeutic efficacy of the neurostimulation treatment used for the patient, ultimately improving therapeutic outcomes.
Regarding claim 2, Parker as modified teaches the implantable device of claim 1, wherein the characteristic of the signal window is the intensity of the evoked neural response in the signal window (page 4, lines 29-34 and page 5, lines 19-27).
Regarding claim 10, Parker as modified teaches the implantable device of claim 1, wherein the control unit is further configured to adjust a parameter of the closed-loop/feedback loop neurostimulation therapy before computing the one or more quantitative indicators (such patient response/pain effects from the patient – see parker’005, abstract)
Regarding claim 14, Parker teaches:
An automated method providing closed-loop neurostimulation therapy (see Parker, page 32, lines 13-17), the method comprising:
controlling a stimulus source to provide a neural stimulus to be delivered, via one or more stimulus electrodes, to a neural pathway of a patient in order to evoke a neural response on the neural pathway (abstract, page 3, lines 27-29),
the neural stimulus being delivered according to a stimulus intensity parameter/control variable parameter values (abstract, page 4-5, lines 29-34 and lines 1-3, and claim 1);
capturing a signal window sensed on the neural pathway, via one or more measurement electrodes, subsequent to the neural stimulus (abstract, page 3, lines 25-33, and page 5, lines 19-27);
measuring a characteristic of the signal window (page 5, lines 19-27);
computing a feedback variable from an intensity of an evoked neural response in the signal window (abstract and page 5, lines 19-27);
adjusting the stimulus intensity parameter/control variable using the feedback variable (abstract, page 4-5, lines 29-34 and lines 1-3, and claim 1);
and repeating the controlling, measuring, computing, and adjusting so as to maintain the feedback variable at a target (abstract and claim 1),
thereby obtaining multiple measures (fig. 16 and page 22, lines 18-25),
but does not explicitly disclose wherein:
the control unit is configured to implement closed-loop neurostimulation therapy by:
controlling the measurement circuitry to capture a signal window of the signal windows subsequent to the neural stimulus, repeating the controlling, measuring, computing, and adjusting, thereby obtaining multiple measured characteristics of signal windows, wherein the control unit is further configured to compute one or more quantitative indicators of efficacy of the closed-loop neurostimulation therapy using the measured characteristics of the signal windows.
However, Parker’005 teaches a system for assessing the therapeutic efficacy of electrical neurostimulation therapy (see abstract, first sentence and figs. 1-2). The system (figs. 1-2) teach wherein the control unit/processor implements closed-loop neurostimulation therapy by controlling the measurement circuitry to capture a signal window (a single neural response) of the signal windows (of the plurality of neural responses) subsequent to the neural stimulus (see abstract),
repeating the controlling, measuring, computing, and adjusting, thereby obtaining multiple measured characteristics of signal windows (see abstract, para [0029], and para [0040]-[0041]), wherein the control unit/processor is further configured to compute one or more quantitative indicators (such as a statistical measure of neural activation) of efficacy of the closed-loop neurostimulation therapy using the measured characteristics of the signal windows/plurality of neural responses (see abstract and para [0040] – “The indication of therapeutic efficacy in some embodiments may be used to optimise therapy by guiding changes to selection of feedback loop parameters, such as feedback loop gain, feedback loop noise bandwidth, and feedback loop instant backoff threshold. Additionally or alternatively, the indication of therapeutic efficacy in some embodiments may be used to optimise therapy by identifying a patient as a responder or a non-responder, and/or may be used to guide a decision as to whether to continue or cease treatment.”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Parker with the teachings of Parker’005 to arrive at the claimed invention. Such combination would improve the system by allowing a very accurate indication of the therapeutic efficacy of the neurostimulation treatment used for the patient, ultimately improving therapeutic outcomes.
Regarding claim 15, Parker as modified teaches the method of claim 14, wherein the characteristic of the signal window is the intensity of the evoked neural response in the signal window (page 4, lines 29-34 and page 5, lines 19-27).
Regarding claim 23, Parker as modified teaches the method of claim 14, further comprising adjusting a parameter of the closed-loop/feedback loop neurostimulation therapy before computing the one or more quantitative indicators (such patient response/pain effects from the patient) (abstract, page 13, lines 24-34, page 14, lines 1-2, page 31, lines 4-14, and page 32, point 3 and lines 20-26).
Claims 3, 7-9, 11-13, 16, 20-22, 24-26 are rejected under 35 U.S.C. 103 as being unpatentable over Parker in view of Parker’005, and further in view of US 2018/0192942 A1 to Clark et al. (hereinafter “Clark”).
Regarding claim 3, Parker as modified teaches the implantable device of claim 2, but does not explicitly disclose wherein the control unit is configured to compute the one or more quantitative indicators by:
estimating a posture of the patient during an interval of a night using the intensities/strength of the evoked neural responses and corresponding values of the stimulus intensity parameter over the interval;
and
analysing a plurality of posture estimates during respective intervals of the night to compute an indicator of sleep quality for the night.
However, Clark teaches systems and methods for managing pain of a subject (see abstract., lines 1-2). The system (fig. 1) teaches computing one or more quantitative indicators (pain score) by estimating a posture of the patient during an interval of a night using the intensities/strength of the evoked neural responses/neural physiological signals and corresponding values/sleep state signal metrics of the stimulus intensity parameter over the time interval (see para 0008-0009, para 0054-0055, para 0058-0060, and para 0087-0088), and analyzing a plurality of posture/motion estimates during respective intervals of the night to compute an indicator of sleep quality for the night (para 0055, para 0058, and para 0087-0088).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Parker with the teachings of Clark to arrive at the claimed invention. Such modification would improve the system by ensuring the stimulator is not causing unwanted pain to the patient during their rest periods, ultimately preserving patient safety when sleeping with the device and improving overall stimulation therapy and device efficacy.
Regarding claim 7, Parker as modified teaches the implantable device of claim 1,
wherein the control unit is further configured to compare the neural fibre conduction velocity with a respective range (page 6, lines 8-13), but does not explicitly disclose
wherein the control unit is further configured to compare the one or more quantitative indicators (such patient response/pain effects from the patient) with respective ranges.
However, Clark teaches comparing a quantitative indicator (pain score) with respective ranges (also referred to as an upper bound and lower bound of one or more threshold values) (para 0012, para 0021, para 0027, para 0059, and para 0071-0072).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified system of Parker with the
teachings of Clark to arrive at the claimed invention. Such modification would improve the system by allowing the user and/or clinician to identify the quantitative indicator associated with painful stimulation, ultimately allowing for proper adjusting of the stimulation therapy while also preserving patient comfort and safety.
Regarding claim 8, Parker as modified teaches the implantable device of claim 7, wherein the control unit is further configured compare the feedback variable to a therapy map (abstract), and transmitting an indication to a user, based on the comparing (page 16, lines 1-7).
Regarding claim 9, Parker as modified teaches the implantable device of claim 7, wherein the control unit is further configured to adjust a parameter of the closed-loop/feedback loop neurostimulation therapy, based on the comparing (abstract and claim 1).
Regarding claim 11, Parker as modified teaches the implantable device of claim 10, wherein the control unit is further configured to compare the neural fibre conduction velocity with a respective range (page 6, lines 8-13), but does not explicitly disclose
wherein the control unit is further configured to compare the one or more quantitative indicators (such patient response/pain effects from the patient) with respective ranges.
However, Clark teaches comparing a quantitative indicator (pain score) with respective ranges (also referred to as an upper bound and lower bound of one or more threshold values) (para 0012, para 0021, para 0027, para 0059, and para 0071-0072).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified system of Parker with the
teachings of Clark to arrive at the claimed invention. Such modification would improve the system by allowing the user and/or clinician to identify the quantitative indicator associated with painful stimulation, ultimately allowing for proper adjusting of the stimulation therapy while also preserving patient comfort and safety.
Regarding claim 12, Parker as modified teaches the implantable device of claim 11, wherein the control unit is further configured to confirm the adjustment to the parameter, based on the comparing (abstract, page 35, lines 14-32, and claim 1).
Regarding claim 13, Parker as modified teaches the implantable device of claim 11 containing a control unit (abstract), but does not explicitly disclose wherein the control unit is further configured to cancel the adjustment to the parameter, based on the comparing.
However, Clark teaches wherein the control unit/controller circuit is further configured to cancel/withhold the adjustment to the parameter, based on the comparing (see para 0071-0072).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified system of Parker with the
teachings of Clark to arrive at the claimed invention. Such modification would improve the system by preventing the adjustment of stimulation parameters if the stimulation is beneficial for the patient, ultimately preserving the stimulation therapy efficiency and accuracy of the neurostimulation system.
Regarding claim 16, Parker as modified teaches the method of claim 15, but does not disclose wherein the computing the one or more quantitative indicators comprises:
estimating a posture of the patient during an interval of a night using the intensities/strength of the evoked neural responses and corresponding values of the stimulus intensity parameter over the interval;
and
analyzing a plurality of posture estimates during respective intervals of the night to compute an indicator of sleep quality for the night.
However, Clark teaches systems and methods for managing pain of a subject (see abstract., lines 1-2). The system (fig. 1) teaches computing one or more quantitative indicators (pain score) by estimating a posture of the patient during an interval of a night using the intensities/strength of the evoked neural responses/neural physiological signals and corresponding values/sleep state signal metrics of the stimulus intensity parameter over the time interval (see para 0008-0009, para 0054-0055, para 0058-0060, and para 0087-0088), and analyzing a plurality of posture/motion estimates during respective intervals of the night to compute an indicator of sleep quality for the night (para 0055, para 0058, and para 0087-0088).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Parker with the teachings of Clark to arrive at the claimed invention. Such modification would improve the system by ensuring the stimulator is not causing unwanted pain to the patient during their rest periods, ultimately preserving patient safety when sleeping with the device and improving overall stimulation therapy and device efficacy.
Regarding claim 20, Parker as modified teaches the method of claim 14, further comprising comparing the neural fibre conduction velocity with a respective range (page 6, lines 8-13), but does not explicitly disclose comparing the one or more quantitative indicators (such patient response/pain effects from the patient) with respective ranges.
However, Clark teaches comparing a quantitative indicator (pain score) with respective ranges (also referred to as an upper bound and lower bound of one or more threshold values) (para 0012, para 0021, para 0027, para 0059, and para 0071-0072).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified system of Parker with the
teachings of Clark to arrive at the claimed invention. Such modification would improve the system by allowing the user and/or clinician to identify the quantitative indicator associated with painful stimulation, ultimately allowing for proper adjusting of the stimulation therapy while also preserving patient comfort and safety.
Regarding claim 21, Parker as modified teaches the method of claim 20, further comprising comparing the feedback variable to a therapy map (abstract), and transmitting an indication to a user, based on the comparing (page 16, lines 1-7).
Regarding claim 22, Parker as modified teaches the method of claim 20, further comprising adjusting a parameter of the closed-loop/feedback loop neurostimulation therapy, based on the comparing (abstract and claim 1).
Regarding claim 24, Parker as modified teaches the method of claim 23, further comprising comparing the neural fibre conduction velocity with a respective range (page 6, lines 8-13), but does not explicitly disclose comparing the one or more quantitative indicators (such patient response/pain effects from the patient) with respective ranges.
However, Clark teaches comparing a quantitative indicator (pain score) with respective ranges (also referred to as an upper bound and lower bound of one or more threshold values) (para 0012, para 0021, para 0027, para 0059, and para 0071-0072).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified system of Parker with the
teachings of Clark to arrive at the claimed invention. Such modification would improve the system by allowing the user and/or clinician to identify the quantitative indicator associated with painful stimulation, ultimately allowing for proper adjusting of the stimulation therapy while also preserving patient comfort and safety.
Regarding claim 25, Parker as modified teaches the method of claim 24, further comprising confirming the adjustment to the parameter, based on the comparing (abstract, page 35, lines 14-32, and claim 1).
Regarding claim 26, Parker as modified teaches the method of claim 24, further comprising but does not explicitly disclose further comprising discarding the adjustment to the parameter, based on the comparing.
However, Clark teaches wherein the control unit/controller circuit is further configured to discard/withhold the adjustment to the parameter, based on the comparing (see para 0071-0072).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified system of Parker with the
teachings of Clark to arrive at the claimed invention. Such modification would improve the system by preventing the adjustment of stimulation parameters if the stimulation is beneficial for the patient, ultimately preserving the stimulation therapy efficiency and accuracy of the neurostimulation system.
Claims 4 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Parker in view of Parker’005 and Clark, and further in view of US 2006/0161208 A1 to Pastore et al. (hereinafter “Pastore”).
Regarding claim 4, Parker as modified teaches the implantable device of claim 2 containing a control unit (see abstract), but does not explicitly disclose wherein the control unit is configured to compute the one or more quantitative indicators by:
estimating a heart rate variability of the patient using the intensities of the evoked neural responses;
and computing the one or more quantitative indicators/patient responses from the estimated heart rate variability.
However, Pastore teaches a cardiac rhythm management system for modulating the delivery of pacing or autonomic neurostimulation pulses based on Heart rate variability (abstract). The system (fig. 1) contains a control unit/controller configured to compute one or more quantitative indicators/optimal stimulation parameter by
estimating a heart rate variability of the patient using the intensities of the evoked neural responses (cardiac signal in response to the autonomic stimulation pulse and pacing output) (para 0006-0008);
and computing the one or more quantitative indicators/optimal stimulation parameter from the estimated heart rate variability (abstract and para 0006-0008).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified system of Parker with the teachings of Pastore to arrive at the claimed invention, since such modification would improve the system by ensuring the neurostimulation provided to the patient at an appropriate intensity level that does not interfere or adversely affect each patient’s heart functionality, ultimately preserving the health and safety of the patient when using the neurostimulation device.
Regarding claim 17, Parker as modified teaches The method of claim 15, wherein the computing the one or more quantitative indicators comprises:
estimating a heart rate variability of the patient using the intensities of the evoked neural responses;
and
computing the one or more quantitative indicators/patient responses from the estimated heart rate variability.
However, Pastore teaches a cardiac rhythm management system for modulating the delivery of pacing or autonomic neurostimulation pulses based on Heart rate variability (abstract). The system (fig. 1) contains a control unit/controller configured to compute one or more quantitative indicators/optimal stimulation parameter by
estimating a heart rate variability of the patient using the intensities of the evoked neural responses (cardiac signal in response to the autonomic stimulation pulse and pacing output) (para 0006-0008);
and computing the one or more quantitative indicators/optimal stimulation parameter from the estimated heart rate variability (abstract and para 0006-0008).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified system of Parker with the teachings of Pastore to arrive at the claimed invention, since such modification would improve the system by ensuring the neurostimulation provided to the patient at an appropriate intensity level that does not interfere or adversely affect each patient’s heart functionality, ultimately preserving the health and safety of the patient when using the neurostimulation device.
Claims 5 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Parker in view of Parker’005, Clark, and Pastore, and further in view of US 2017/0216587 A1 to Parker (hereinafter “Parker’587”).
Regarding claim 5, Parker as modified teaches the implantable device of claim 1, wherein the characteristic of the signal window is an intensity/strength of an evoked neural response in the signal window (page 4, lines 29-34 and page 5, lines 19-27), but does not disclose wherein the characteristic of the signal window/period is an intensity/strength of a non-evoked neural response in the signal window/period.
However, Parker’587 teaches wherein the characteristic of the signal window/period is an intensity/strength of a non-evoked neural response in the signal window/period (para 0018-0021).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified system of Parker with the teachings of Parker’587 to arrive at the claimed invention, since such modification would improve the system by allowing proper evaluation of sleep quality in response to non-evoked neural responses during REM periods, ultimately allowing further validation of beneficial on non-beneficial stimulation therapy effects on the patient.
Regarding claim 18, Parker as modified teaches the method of claim 14, wherein the characteristic of the signal window is an intensity/strength of an evoked neural response in the signal window (page 4, lines 29-34 and page 5, lines 19-27), but does not disclose wherein the characteristic of the signal window/period is an intensity/strength of a non-evoked neural response in the signal window/period.
However, Parker’587 teaches wherein the characteristic of the signal window/period is an intensity/strength of a non-evoked neural response in the signal window/period (para 0018-0021).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified system of Parker with the teachings of Parker’587 to arrive at the claimed invention, since such modification would improve the system by allowing proper evaluation of sleep quality in response to non-evoked neural responses during REM periods, ultimately allowing further validation of beneficial on non-beneficial stimulation therapy effects on the patient.
Claims 6 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Parker in view of Parker’005, Clark, Pastore, and Parker’587, and further in view of US 8,688,221 B2 to Miesel et al. (hereinafter “Miesel”) and US 2020/0147376 A1 to Dieken et al. (hereinafter “Dieken”).
Regarding claim 6, Parker as modified teaches the implantable device of claim 5, but does not disclose wherein the control unit is configured to compute the one or more quantitative indicators by:
determining an amount of non-evoked neural activity during an interval of a night using the intensities of non-evoked neural responses over the interval;
detecting REM sleep over the interval from the amount of non-evoked neural activity;
and
analysing a plurality of intervals to compute an amount of REM sleep for the night,
and computing an indicator of sleep quality for the night from the amount of REM sleep for the night.
However, Miesel teaches determining an amount of non-evoked neural activity during an interval of a night using the intensities of non-evoked neural responses (non-elicited and monitored EEG neural signals) over the interval (col. 14, lines 49-67, col. 15, lines 20-50);
detecting REM sleep over the interval from the amount of non-evoked neural activity (non-elicited and monitored EEG neural signals) (col. 15, lines 20-45), but does not explicitly disclose
analysing a plurality of intervals (REM periods) to compute an amount of REM sleep for the night,
and computing an indicator of sleep quality for the night from the amount of REM sleep for the night.
However, Dieken teaches a method for delivering stimulation to an upper airway to cause contraction to of the upper airway patency-related muscles (abstract, lines 1-4). The method (figs. 1-4) further teaches analyzing a plurality of intervals (number and depth of REM periods) to compute an amount of REM sleep for the night (para 0228),
and computing an indicator of sleep quality for the night from the amount of REM sleep for the night (para 0228).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified system of Parker with the teachings of Dieken and Miesel to arrive at the claimed invention, since such modification would improve the system by allowing proper evaluation of sleep quality in response to non-evoked neural responses during REM periods, ultimately allowing further validation of beneficial on non-beneficial stimulation therapy effects on the patient.
Regarding claim 19, Parker as modified teaches the method of claim 18, wherein the computing the one or more quantitative indicators comprises:
determining an amount of non-evoked neural activity during an interval of a night using the intensities of non-evoked neural responses over the interval;
detecting REM sleep over the interval from the amount of non-evoked neural activity;
and
analysing a plurality of intervals to compute an amount of REM sleep for the night,
and computing an indicator of sleep quality for the night from the amount of REM sleep for the night.
However, Miesel teaches determining an amount of non-evoked neural activity during an interval of a night using the intensities of non-evoked neural responses (non-elicited and monitored EEG neural signals) over the interval (col. 14, lines 49-67, col. 15, lines 20-50);
detecting REM sleep over the interval from the amount of non-evoked neural activity (non-elicited and monitored EEG neural signals) (col. 15, lines 20-45), but does not explicitly disclose
analysing a plurality of intervals (REM periods) to compute an amount of REM sleep for the night,
and computing an indicator of sleep quality for the night from the amount of REM sleep for the night.
However, Dieken teaches a method for delivering stimulation to an upper airway to cause contraction to of the upper airway patency-related muscles (abstract, lines 1-4). The method (figs. 1-4) further teaches analyzing a plurality of intervals (number and depth of REM periods) to compute an amount of REM sleep for the night (para 0228),
and computing an indicator of sleep quality for the night from the amount of REM sleep for the night (para 0228).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified system of Parker with the teachings of Dieken and Miesel to arrive at the claimed invention, since such modification would improve the system by allowing proper evaluation of sleep quality in response to non-evoked neural responses during REM periods, ultimately allowing further validation of beneficial on non-beneficial stimulation therapy effects on the patient.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kremen et al. (US 2020/0337645 A1) teaches a system and method for automatically classifying brain behavioral state (such as an awake state or sleep state).
Osorio (US 2014/0276194 A1) teaches a method for automated means for optimizing the therapeutic efficacy following repetitive electrical stimulation delivered to a neural structure.
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.
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/K.J.W./Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792
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