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 August 11, 2026 with respect to the rejection(s) of claims 1-26 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of 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) and US 2019/0344081 A1 to Moffitt et al. (hereinafter “Moffitt”).
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 associated with respective stimulus intensity parameter values, wherein the control unit is further configured to determine one or more quantitative indicators of efficacy of the closed-loop neurostimulation therapy using the stimulus intensity parameter values associated with the signal windows, and wherein the one or more quantitative indicators of efficacy are determined by estimating a heart rate variability of the patient.
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 associated with respective stimulus intensity parameter values (see abstract, para [0025], para [0029], and para [0040]- whole paragraph, but emphasis on the following sentence : “The indication of therapeutic efficacy in some embodiments may be used to optimise therapy by guiding changes to selection of a stimulus intensity, selection of a stimulus current, or selection of stimulus pulse width(s)”, and para [0041]),
wherein the control unit/processor is further configured to determine one or more quantitative indicators (such as a statistical measure of neural activation) of efficacy of the closed-loop neurostimulation therapy using the stimulus intensity parameter values associated with the signal windows/plurality of neural responses (see abstract and para [0040] – emphasis on the following sentences: “The indication of therapeutic efficacy in some embodiments may be used to optimise therapy by guiding changes to selection of a stimulus intensity, selection of a stimulus current, or selection of stimulus pulse width(s). The indication of therapeutic efficacy in some embodiments may be used to optimise therapy by guiding changes to selection of measurement amplifier settings. The indication of therapeutic efficacy in some embodiments may be used to optimise therapy by guiding changes to selection of a target level of neural activation for example based on a pre-determined relationship relative to the statistical measure(s), a threshold level and a patient comfort level. The indication of therapeutic efficacy in some embodiments may be used to optimise therapy by guiding changes to selection of feedback loop implementation such as selection among feedback loop implementations…….. 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”, and para [0041]).
However, Parker’005 does not teach wherein the one or more quantitative indicators of efficacy are determined by estimating a heart rate variability of the patient.
However, Moffitt teaches a system for modeling the wellness of an implantable medical device (IPG) (see abstract). The system (fig. 6) teaches wherein the one or more quantitative indicators of efficacy are determined by estimating a heart rate variability of the patient (see figs. 6 & 8, para [0039], para [0041] – “Quantitative measurements to gauge the effectiveness of SCS therapy are not known to be in widespread use, but several quantitative measurements of pain exist that could be used to gauge therapy effectiveness in an SCS system. Quantitative measurements rely on objective measurements taken from a patient. Examples of objective measurements that have shown promise as reliable indicators of pain include……. heart rate, heart rate variability, and/or EKG measurements.”, para [0051]).
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 and Moffitt to arrive at the claimed invention. Such combination would improve the system by providing a more reliable indication of the effectiveness of the spinal cord stimulation therapy for the patient (as indicated by Moffitt), ultimately improving therapeutic outcomes for each patient.
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 associated with respective stimulus intensity parameter values, and determining one or more quantitative indicators of efficacy of the closed-loop neurostimulation therapy using the stimulus intensity parameter values associated with the signal windows, wherein the one or more quantitative indicators of efficacy are determined by estimating a heart rate variability of the patient.
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 associated with respective stimulus intensity parameter values (see abstract, para [0025], para [0029], and para [0040]- whole paragraph, but emphasis on the following sentence : “The indication of therapeutic efficacy in some embodiments may be used to optimise therapy by guiding changes to selection of a stimulus intensity, selection of a stimulus current, or selection of stimulus pulse width(s)”, and para [0041]),
wherein the control unit/processor is further configured to determine one or more quantitative indicators (such as a statistical measure of neural activation) of efficacy of the closed-loop neurostimulation therapy using the stimulus intensity parameter values associated with the signal windows/plurality of neural responses (see abstract and para [0040] – emphasis on the following sentences: “The indication of therapeutic efficacy in some embodiments may be used to optimise therapy by guiding changes to selection of a stimulus intensity, selection of a stimulus current, or selection of stimulus pulse width(s). The indication of therapeutic efficacy in some embodiments may be used to optimise therapy by guiding changes to selection of measurement amplifier settings. The indication of therapeutic efficacy in some embodiments may be used to optimise therapy by guiding changes to selection of a target level of neural activation for example based on a pre-determined relationship relative to the statistical measure(s), a threshold level and a patient comfort level. The indication of therapeutic efficacy in some embodiments may be used to optimise therapy by guiding changes to selection of feedback loop implementation such as selection among feedback loop implementations…….. 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”, and para [0041]).
However, Parker’005 does not teach wherein the one or more quantitative indicators of efficacy are determined by estimating a heart rate variability of the patient.
However, Moffitt teaches a system for modeling the wellness of an implantable medical device (IPG) (see abstract). The system (fig. 6) teaches wherein the one or more quantitative indicators of efficacy are determined by estimating a heart rate variability of the patient (see figs. 6 & 8, para [0039], para [0041] – “Quantitative measurements to gauge the effectiveness of SCS therapy are not known to be in widespread use, but several quantitative measurements of pain exist that could be used to gauge therapy effectiveness in an SCS system. Quantitative measurements rely on objective measurements taken from a patient. Examples of objective measurements that have shown promise as reliable indicators of pain include……. heart rate, heart rate variability, and/or EKG measurements.”, para [0051]).
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 and Moffitt to arrive at the claimed invention. Such combination would improve the system by providing a more reliable indication of the effectiveness of the spinal cord stimulation therapy for the patient (as indicated by Moffitt), ultimately improving therapeutic outcomes for each patient.
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 – see 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 Moffitt, 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 the associated stimulus intensity parameter values 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 as well as the associated stimulus intensity parameter values and the sleep state signal metric(s) 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 – see 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 – see 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 the associated stimulus intensity parameter values 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 as well as the associated stimulus intensity parameter values and the sleep state signal metric(s) 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 – see 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 –see 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 Moffitt, and further in view of US 9,119,965 B2 to Xi et al. (hereinafter “Xi”).
Regarding claim 4, Parker as modified teaches the implantable device of claim 2 containing a control unit (see abstract), and determining the one or more quantitative indicators from the estimated heart rate variability (See Moffitt in claims 1 and 14 above), but does not explicitly disclose wherein the control unit is configured to compute the one or more quantitative indicators by:
estimating the heart rate variability of the patient using a frequency of variation of the stimulus intensities.
However, Xi teaches techniques for controlling spinal cord stimulation/neurostimulation (see abstract). The system (fig. 1) teaches wherein heart rate variability is used for controlling spinal cord stimulation, and wherein the control unit is configured to utilize a quantitative technique of estimating the heart rate variability of the patient using a frequency of variation of the stimulus intensities (see fig. 5, col. 1, lines 61-67, col. 2, lines 1-6, col. 3, lines 25-60, col. 11, lines 49-67, col. 12, lines 14-67, col. 13, lines 1-31, and col. 15, lines 39-55).
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 Xi to arrive at the claimed invention. Such modification would improve the system by providing a more reliable indication of the effectiveness of the spinal cord stimulation therapy for the patient (as indicated by the patient’s mood and pain level following stimulation), ultimately optimizing the therapeutic benefit when providing stimulation to each patient.
Regarding claim 17, Parker as modified teaches The method of claim 15, comprising determining the one or more quantitative indicators from the estimated heart rate variability (See Moffitt in claims 1 and 14 above), but does not explicitly disclose wherein the control unit is configured to compute the one or more quantitative indicators by:
estimating the heart rate variability of the patient using a frequency of variation of the stimulus intensities.
However, Xi teaches techniques for controlling spinal cord stimulation/neurostimulation (see abstract). The system (fig. 1) teaches wherein heart rate variability is used for controlling spinal cord stimulation, and wherein the control unit is configured to utilize a quantitative technique of estimating the heart rate variability of the patient using a frequency of variation of the stimulus intensities (see fig. 5, col. 1, lines 61-67, col. 2, lines 1-6, col. 3, lines 25-60, col. 11, lines 49-67, col. 12, lines 14-67, col. 13, lines 1-31, and col. 15, lines 39-55).
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 Xi to arrive at the claimed invention. Such modification would improve the system by providing a more reliable indication of the effectiveness of the spinal cord stimulation therapy for the patient (as indicated by the patient’s mood and pain level following stimulation), ultimately optimizing the therapeutic benefit when providing stimulation to each patient.
Claims 5 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Parker in view of Parker’005 and Moffitt, 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, Moffitt, 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, wherein one of the assessed quantitative measurements include sleep data measurements (see Moffitt – para [0041], para [0043], para [0051], para [0055], and para [0062]), but does not explicitly 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 – see 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 – see 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARMEL J WEBSTER whose telephone number is (703)756-5960. The examiner can normally be reached Monday-Friday 7:30am-5:00pm.
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/K.J.W./Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792
