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 .
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 34-39 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 claims 34 and 37, the claims recite, “adjust a further second stimulus parameter of the one or more second stimulus parameters…” (see last paragraph of claims 34 and 36). However, it is unclear if a “further second stimulus parameter” is the same “the one or more second stimulus parameters” previously recited in the claim; If they are different second stimulus parameters, it is then unclear how you can only have one second stimulus parameter. As recited, the claim gives an option for there to be one second stimulation parameter, which is not possible if further second stimulus parameter is a different stimulus parameter than the second stimulus parameter. For this reason, the claim is indefinite. For examination purposes, it will be interpreted that the second stimulus parameter is a different parameter.
Claims 35 and 36 are rejected for their dependency on claim 34; Claims 38 and 39 are rejected for their dependency on claim 37.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 30-39 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Wah et al. (WO 2022040757 A1, "Wah").
Regarding claim 30, Wah teaches an implantable device for controllably delivering neural stimuli (abstract: "An implantable device is configured to control application of a neural stimulus as defined by a stimulus parameter"), the device comprising: a stimulus source (Fig. 2; para. [0052]: "pulse generator 124") configured to provide neural stimuli to be delivered according to one of a plurality of stimulation sets to a neural pathway of a patient in order to evoke neural responses from the neural pathway (para. [0031]: "and the control unit further configured to store a plurality of multidimensional datasets over time in respect of a plurality of neural stimuli and respective associated measured evoked responses, by updating a multidimensional histogram to reflect each multidimensional dataset after it is obtained…"), wherein each stimulation set comprises one or more stimulus electrodes (para. [0052]: "Electrode selection module 126 switches the generated pulses to the appropriate electrode(s) of electrode array 150, for delivery of the current pulse to the tissue surrounding the selected electrode(s)."); measurement circuitry (para. [0011]: "measurement circuitry for recording a neural compound action potential signal sensed at the one or more sense electrodes") configured to capture signal windows sensed on the neural pathway subsequent to respective neural stimuli (para. [0043] disclose a "measurement window"), each signal window sensed via one or more measurement electrodes (para. [0039]: " measurement circuitry for recording a neural compound action potential signal sensed at the one or more sense electrodes"); and a control unit configured to: control the stimulus source (para. [0011]: "a control unit configured to: control application of a neural stimulus as defined by a stimulus parameter…") to provide a first neural stimulus according to a first stimulation set of the plurality of stimulation sets and according to one or more first stimulus parameters (para. [0039]: "stimulus source for providing a stimulus to be delivered from the one or more stimulus electrodes to a neural pathway in order to give rise to an evoked action potential on the neural pathway." The first set of parameters for evoking an action potential is considered to be the first stimulation set and parameters; Additionally, the stimulation is closed-loop, so any stimulation set prior to adjusting stimulation parameters is considered a first stimulation); control the stimulus source to provide a second neural stimulus according to a second stimulation set of the plurality of stimulation sets and according to one or more second stimulus parameters (The adjusted stimulation parameters based on feedback from the measured response in para. [0039] are considered a second stimulus parameter and second stimulation set. Para. [0056] discloses closed loop feedback, meaning the stimulation sets are updated: "The stimulator 100 operates on a closed loop basis, in that the recorded neural responses are used in a feedback arrangement to control stimulation settings of future stimuli on a continuous or ongoing basis."); measure a first characteristic of a first evoked neural response in a first captured signal window subsequent to the first neural stimulus (abstract: "measure via the measurement circuitry a characteristic of a neural compound action potential response evoked by the stimulus"; para. [0011]: "measure via the measurement circuitry a characteristic of a neural compound action potential response evoked by the stimulus; compute, using the stimulus parameter and the measured characteristic of the evoked neural compound action potential response…"); measure a second characteristic of a second evoked neural response in a second captured signal window subsequent to the second neural stimulus (para. [0011]: "a characteristic of an evoked response that would be obtained from the neural stimulus if the patient were in a reference posture"; para. [0043]: "The feedback variable could in some embodiments be any one of: an amplitude; an energy; a power; an integral; a signal strength; or a derivative, of any one of: the whole evoked compound action potential; the fast neural response for example in the measurement window 0-2 ms after stimulus; the slow neural response for example in the measurement window 2-6 ms after stimulus; or of a filtered version of the response. The feedback variable could in some embodiments be an average of any such characteristic determined over multiple stimulus/measurement cycles. The feedback variable may in some embodiments be the zero intercept, or the slope, of a linear portion of the response of ECAP amplitude to varying stimulus current. In some embodiments the feedback variable may be derived from more than one of the preceding characteristics."); adjust, using a feedback controller (para. [0041]: "feedback controller"): the one or more first stimulus parameters so as to maintain the first measured characteristic at or near a first target value (para. [0041]: "In some embodiments of the seventh and eighth aspects the feedback controller completes the feedback loop by using the feedback variable to control the at least one stimulus parameter so as to maintain the feedback variable at a constant level."), and the one or more second stimulus parameters so as to maintain the second measured characteristic at or near a second target value (para. [0041]: " In some embodiments of the seventh and eighth aspects the feedback controller completes the feedback loop by using the feedback variable to control the at least one stimulus parameter so as to maintain the feedback variable at a constant level."; para. [0043]: "The feedback variable could in some embodiments be any one of: an amplitude; an energy; a power; an integral; a signal strength; or a derivative, of any one of: the whole evoked compound action potential; the fast neural response for example in the measurement window 0-2 ms after stimulus; the slow neural response for example in the measurement window 2-6 ms after stimulus; or of a filtered version of the response. The feedback variable could in some embodiments be an average of any such characteristic determined over multiple stimulus/measurement cycles."); and adjust the second target value based on the first measured characteristic. (para. [0061]: "At therapeutic levels, an observed CAP signal will typically have a maximum amplitude in the range of tens of microvolts. With increasing stimulus current I, the ECAP amplitude V typically follows a growth curve. Fig. 5 illustrates a range of growth curves which may arise in a single patient, one for each posture. A typical growth curve is characterized by a first portion below a threshold, in which a non-zero stimulus current elicits no ECAP, and a second portion above the threshold in which further increases in stimulus current above the threshold give rise to linearly increasing ECAP amplitude. The threshold T, and the slope M of the second portion of the growth curve, both depend on the electrode-to-fibre distance and thus both vary with posture. For example, as can be seen in Fig. 5, a supine posture has a lower threshold and a larger slope, as compared to a prone posture."; para. [0061] discloses changing the threshold, T, and characteristic slope M depending on the posture, which is based on ECAP amplitude).
Regarding claim 31, Wah teaches the implantable device of claim 30 (see above), wherein the control unit is configured to adjust the second target value such that the second target value plus a predetermined proportion of the first measured characteristic is equal to a predetermined constant (para. [0041] discloses where neural recruitment is at a constant level (predetermined constant): " In some embodiments of the seventh and eighth aspects the feedback controller completes the feedback loop by using the feedback variable to control the at least one stimulus parameter so as to maintain the feedback variable at a constant level." Additionally, para. [0070]-[0086] discloses equations used for constant neural recruitment, where the threshold amplitude (based on current and voltage parameters) changes depending on an estimate of an Evoked response of a patient posture (the posture is an estimate of a predetermined portion of the reference posture, which a measured characteristic). The disclosure adjusts the target amplitude/threshold for an action potential based on the characteristics of the evoked response for changing postures; Additionally, see that para. [0024] discloses an addition of a threshold (target) in the equation to determine a constant recruitment).).
Regarding claim 32, Wah teaches an automated method of controllably delivering neural stimuli (abstract: "An implantable device is configured to control application of a neural stimulus as defined by a stimulus parameter"; para. [0012]: “According to a second aspect the present invention provides an automated method of controlling a neural stimulus.”), the method comprising: controlling a stimulus source (Fig. 2; para. [0052]: "pulse generator 124") to deliver a first neural stimulus via a first stimulation set of a plurality of stimulation sets according to one or more first stimulus parameters to a neural pathway of a patient in order to evoke a first neural response from the neural pathway (para. [0039]: "stimulus source for providing a stimulus to be delivered from the one or more stimulus electrodes to a neural pathway in order to give rise to an evoked action potential on the neural pathway." The first set of parameters for evoking an action potential is considered to be the first stimulation set and parameters; )controlling the stimulus source to deliver a second neural stimulus via a second stimulation set of the plurality of stimulation sets according to one or more second stimulus parameters to a neural pathway of a patient in order to evoke a second neural response from the neural pathway (The adjusted stimulation parameters after adjusting parameters based on feedback from the measured response in para. [0039] are considered a second stimulus parameter and second stimulation set. Para. [0056] discloses closed loop feedback, meaning the stimulation sets are updated: "The stimulator 100 operates on a closed loop basis, in that the recorded neural responses are used in a feedback arrangement to control stimulation settings of future stimuli on a continuous or ongoing basis."); capturing a plurality of signal windows sensed on the neural pathway subsequent to the delivered neural stimuli (para. [0041]: “The feedback variable could in some embodiments be any one of: an amplitude; an energy; a power; an integral; a signal strength; or a derivative, of any one of: the whole evoked compound action potential; the fast neural response for example in the measurement window 0-2 ms after stimulus; the slow neural response for example in the measurement window 2-6 ms after stimulus; or of a filtered version of the response.”); measuring a first characteristic of the first evoked neural response in a first captured signal window of the plurality of signal windows subsequent to the first neural stimulus (abstract: "measure via the measurement circuitry a characteristic of a neural compound action potential response evoked by the stimulus"; para. [0011]: "measure via the measurement circuitry a characteristic of a neural compound action potential response evoked by the stimulus; compute, using the stimulus parameter and the measured characteristic of the evoked neural compound action potential response…"); measuring a second characteristic of the second evoked neural response in a second captured signal window of the plurality of signal windows subsequent to the second neural stimulus (para. [0011]: "a characteristic of an evoked response that would be obtained from the neural stimulus if the patient were in a reference posture"; para. [0043]: "The feedback variable could in some embodiments be any one of: an amplitude; an energy; a power; an integral; a signal strength; or a derivative, of any one of: the whole evoked compound action potential; the fast neural response for example in the measurement window 0-2 ms after stimulus; the slow neural response for example in the measurement window 2-6 ms after stimulus; or of a filtered version of the response. The feedback variable could in some embodiments be an average of any such characteristic determined over multiple stimulus/measurement cycles. The feedback variable may in some embodiments be the zero intercept, or the slope, of a linear portion of the response of ECAP amplitude to varying stimulus current. In some embodiments the feedback variable may be derived from more than one of the preceding characteristics."); adjusting the one or more first stimulus parameters so as to maintain the first measured characteristic at a first target value (para. [0041]: "In some embodiments of the seventh and eighth aspects the feedback controller completes the feedback loop by using the feedback variable to control the at least one stimulus parameter so as to maintain the feedback variable at a constant level."); and adjusting the one or more second stimulus parameters so as to maintain the second measured characteristic at a second target value ((para. [0041]: " In some embodiments of the seventh and eighth aspects the feedback controller completes the feedback loop by using the feedback variable to control the at least one stimulus parameter so as to maintain the feedback variable at a constant level."; para. [0043]: "The feedback variable could in some embodiments be any one of: an amplitude; an energy; a power; an integral; a signal strength; or a derivative, of any one of: the whole evoked compound action potential; the fast neural response for example in the measurement window 0-2 ms after stimulus; the slow neural response for example in the measurement window 2-6 ms after stimulus; or of a filtered version of the response. The feedback variable could in some embodiments be an average of any such characteristic determined over multiple stimulus/measurement cycles."); and adjusting the second target value based on the first measured characteristic (para. [0061]: "At therapeutic levels, an observed CAP signal will typically have a maximum amplitude in the range of tens of microvolts. With increasing stimulus current I, the ECAP amplitude V typically follows a growth curve. Fig. 5 illustrates a range of growth curves which may arise in a single patient, one for each posture. A typical growth curve is characterized by a first portion below a threshold, in which a non-zero stimulus current elicits no ECAP, and a second portion above the threshold in which further increases in stimulus current above the threshold give rise to linearly increasing ECAP amplitude. The threshold T, and the slope M of the second portion of the growth curve, both depend on the electrode-to-fibre distance and thus both vary with posture. For example, as can be seen in Fig. 5, a supine posture has a lower threshold and a larger slope, as compared to a prone posture."; para. [0061] discloses changing the threshold, T, and characteristic slope M depending on the posture, which is based on ECAP amplitude).
Regarding claim 33, Wah teaches the method of claim 32 (see above), wherein adjusting the second target value comprises adjusting the second target value such that the second target value plus a predetermined proportion of the first measured characteristic is equal to a predetermined constant (para. [0041] discloses where neural recruitment is at a constant level (predetermined constant): " In some embodiments of the seventh and eighth aspects the feedback controller completes the feedback loop by using the feedback variable to control the at least one stimulus parameter so as to maintain the feedback variable at a constant level." Additionally, para. [0070]-[0086] discloses equations used for constant neural recruitment, where the threshold amplitude (based on current and voltage parameters) changes depending on an estimate of an Evoked response of a patient posture (the posture is an estimate of a predetermined portion of the reference posture, which a measured characteristic). The disclosure adjusts the target amplitude/threshold for an action potential based on the characteristics of the evoked response for changing postures; Additionally, see that para. [0024] discloses an addition of a threshold (target) in the equation to determine a constant recruitment).
Regarding claim 34, Wah teaches an implantable device for controllably delivering neural stimuli (abstract: "An implantable device is configured to control application of a neural stimulus as defined by a stimulus parameter"), the device comprising: a stimulus source (Fig. 2; para. [0052]: "pulse generator 124") configured to provide neural stimuli to be delivered via one of a plurality of stimulation sets to a neural pathway of a patient in order to evoke neural responses from the neural pathway (para. [0031]: "and the control unit further configured to store a plurality of multidimensional datasets over time in respect of a plurality of neural stimuli and respective associated measured evoked responses, by updating a multidimensional histogram to reflect each multidimensional dataset after it is obtained…"), wherein each stimulation set comprises one or more stimulus electrodes (para. [0052]: "Electrode selection module 126 switches the generated pulses to the appropriate electrode(s) of electrode array 150, for delivery of the current pulse to the tissue surrounding the selected electrode(s)."); measurement circuitry (para. [0011]: "measurement circuitry for recording a neural compound action potential signal sensed at the one or more sense electrodes") configured to capture signal windows sensed on the neural pathway subsequent to respective neural stimuli (para. [0043] disclose a "measurement window"), each signal window sensed via one or more measurement electrodes (para. [0039]: " measurement circuitry for recording a neural compound action potential signal sensed at the one or more sense electrodes"); and a control unit configured to: control the stimulus source (para. [0011]: "a control unit configured to: control application of a neural stimulus as defined by a stimulus parameter…") to provide a first neural stimulus according to a first stimulation set of the plurality of stimulation sets and according to one or more first stimulus parameters (para. [0039]: "stimulus source for providing a stimulus to be delivered from the one or more stimulus electrodes to a neural pathway in order to give rise to an evoked action potential on the neural pathway." The first set of parameters for evoking an action potential is considered to be the first stimulation set and parameters; ); control the stimulus source to provide a second neural stimulus according to a second stimulation set of the plurality of stimulation sets and according to one or more second stimulus parameters (The adjusted stimulation parameters after adjusting parameters based on feedback from the measured response in para. [0039] are considered a second stimulus parameter and second stimulation set. Para. [0056] discloses closed loop feedback, meaning the stimulation sets are updated: "The stimulator 100 operates on a closed loop basis, in that the recorded neural responses are used in a feedback arrangement to control stimulation settings of future stimuli on a continuous or ongoing basis."); measure a first characteristic of a first evoked neural response in a first captured signal window subsequent to the first neural stimulus (abstract: "measure via the measurement circuitry a characteristic of a neural compound action potential response evoked by the stimulus"; para. [0011]: "measure via the measurement circuitry a characteristic of a neural compound action potential response evoked by the stimulus; compute, using the stimulus parameter and the measured characteristic of the evoked neural compound action potential response…"); measure a second characteristic of a second evoked neural response in a second captured signal window subsequent to the second neural stimulus (para. [0011]: "a characteristic of an evoked response that would be obtained from the neural stimulus if the patient were in a reference posture"; para. [0043]: "The feedback variable could in some embodiments be any one of: an amplitude; an energy; a power; an integral; a signal strength; or a derivative, of any one of: the whole evoked compound action potential; the fast neural response for example in the measurement window 0-2 ms after stimulus; the slow neural response for example in the measurement window 2-6 ms after stimulus; or of a filtered version of the response. The feedback variable could in some embodiments be an average of any such characteristic determined over multiple stimulus/measurement cycles. The feedback variable may in some embodiments be the zero intercept, or the slope, of a linear portion of the response of ECAP amplitude to varying stimulus current. In some embodiments the feedback variable may be derived from more than one of the preceding characteristics."); and adjust, using a feedback controller (para. [0041]: "feedback controller"): the one or more first stimulus parameters so as to maintain the first measured characteristic at or near a first target value (para. [0041]: "In some embodiments of the seventh and eighth aspects the feedback controller completes the feedback loop by using the feedback variable to control the at least one stimulus parameter so as to maintain the feedback variable at a constant level."), a second stimulus parameter of the one or more second stimulus parameters so as to maintain the second measured characteristic at a second target value (para. [0041]: " In some embodiments of the seventh and eighth aspects the feedback controller completes the feedback loop by using the feedback variable to control the at least one stimulus parameter so as to maintain the feedback variable at a constant level."; para. [0043]: "The feedback variable could in some embodiments be any one of: an amplitude; an energy; a power; an integral; a signal strength; or a derivative, of any one of: the whole evoked compound action potential; the fast neural response for example in the measurement window 0-2 ms after stimulus; the slow neural response for example in the measurement window 2-6 ms after stimulus; or of a filtered version of the response. The feedback variable could in some embodiments be an average of any such characteristic determined over multiple stimulus/measurement cycles."), and adjust a further second stimulus parameter of the one or more second stimulus parameters based on the adjustment to the one or more first stimulus parameters. (para. [0061]: "At therapeutic levels, an observed CAP signal will typically have a maximum amplitude in the range of tens of microvolts. With increasing stimulus current I, the ECAP amplitude V typically follows a growth curve. Fig. 5 illustrates a range of growth curves which may arise in a single patient, one for each posture. A typical growth curve is characterized by a first portion below a threshold, in which a non-zero stimulus current elicits no ECAP, and a second portion above the threshold in which further increases in stimulus current above the threshold give rise to linearly increasing ECAP amplitude. The threshold T, and the slope M of the second portion of the growth curve, both depend on the electrode-to-fibre distance and thus both vary with posture. For example, as can be seen in Fig. 5, a supine posture has a lower threshold and a larger slope, as compared to a prone posture."; para. [0061] discloses changing the threshold, T, and characteristic slope M depending on the posture, which is based on ECAP amplitude. Changing the voltage parameter is dependent on changes to the slope and threshold parameters based the changes in recordings measured from a patient’s posture).
Regarding claim 35, Wah teaches the implantable device of claim 34 (see above), wherein the second stimulus parameter is a stimulus period (para. [0044]: “The control variable, or stimulus parameter, could in some embodiments be one or more of the total stimulus charge, stimulus current, pulse amplitude, phase duration, interphase gap duration or pulse shape, or a combination of these.”; para. [0054]: "To this end the stimulus electrodes are used to deliver stimuli at any therapeutically suitable frequency, for example 30 Hz, although other frequencies may be used including as high as the kHz range, and/or stimuli may be delivered in a non-periodic manner such as in bursts, or sporadically, as appropriate for the patient."; Changing the frequency would also be a change in stimulus period).
Regarding claim 36, Wah teaches the implantable device of claim 35 (see above), wherein the further second stimulus parameter is stimulus intensity (para. [0044]: “The control variable, or stimulus parameter, could in some embodiments be one or more of the total stimulus charge, stimulus current, pulse amplitude, phase duration, interphase gap duration or pulse shape, or a combination of these.”; Changing the current and/or amplitude would change the stimulus intensity).
Regarding claim 37, Wah teaches an automated method of controllably delivering neural stimuli (abstract: "An implantable device is configured to control application of a neural stimulus as defined by a stimulus parameter"; para. [0012]: “According to a second aspect the present invention provides an automated method of controlling a neural stimulus.”), the method comprising: controlling a stimulus source (Fig. 2; para. [0052]: "pulse generator 124") to deliver a first neural stimulus via a first stimulation set of a plurality of stimulation sets according to one or more first stimulus parameters to a neural pathway of a patient in order to evoke a first neural response from the neural pathway (para. [0039]: "stimulus source for providing a stimulus to be delivered from the one or more stimulus electrodes to a neural pathway in order to give rise to an evoked action potential on the neural pathway." The first set of parameters for evoking an action potential is considered to be the first stimulation set and parameters; )controlling the stimulus source to deliver a second neural stimulus via a second stimulation set of the plurality of stimulation sets according to one or more second stimulus parameters to a neural pathway of a patient in order to evoke a second neural response from the neural pathway (The adjusted stimulation parameters after adjusting parameters based on feedback from the measured response in para. [0039] are considered a second stimulus parameter and second stimulation set. Para. [0056] discloses closed loop feedback, meaning the stimulation sets are updated: "The stimulator 100 operates on a closed loop basis, in that the recorded neural responses are used in a feedback arrangement to control stimulation settings of future stimuli on a continuous or ongoing basis."); capturing a plurality of signal windows sensed on the neural pathway subsequent to the delivered neural stimuli (para. [0041]: “The feedback variable could in some embodiments be any one of: an amplitude; an energy; a power; an integral; a signal strength; or a derivative, of any one of: the whole evoked compound action potential; the fast neural response for example in the measurement window 0-2 ms after stimulus; the slow neural response for example in the measurement window 2-6 ms after stimulus; or of a filtered version of the response.”); measuring a first characteristic of the first evoked neural response in a first captured signal window of the plurality of signal windows subsequent to the first neural stimulus (abstract: "measure via the measurement circuitry a characteristic of a neural compound action potential response evoked by the stimulus"; para. [0011]: "measure via the measurement circuitry a characteristic of a neural compound action potential response evoked by the stimulus; compute, using the stimulus parameter and the measured characteristic of the evoked neural compound action potential response…"); measuring a second characteristic of the second evoked neural response in a second captured signal window of the plurality of signal windows subsequent to the second neural stimulus (para. [0011]: "a characteristic of an evoked response that would be obtained from the neural stimulus if the patient were in a reference posture"; para. [0043]: "The feedback variable could in some embodiments be any one of: an amplitude; an energy; a power; an integral; a signal strength; or a derivative, of any one of: the whole evoked compound action potential; the fast neural response for example in the measurement window 0-2 ms after stimulus; the slow neural response for example in the measurement window 2-6 ms after stimulus; or of a filtered version of the response. The feedback variable could in some embodiments be an average of any such characteristic determined over multiple stimulus/measurement cycles. The feedback variable may in some embodiments be the zero intercept, or the slope, of a linear portion of the response of ECAP amplitude to varying stimulus current. In some embodiments the feedback variable may be derived from more than one of the preceding characteristics."); adjusting the one or more first stimulus parameters so as to maintain the first measured characteristic at a first target value (para. [0041]: "In some embodiments of the seventh and eighth aspects the feedback controller completes the feedback loop by using the feedback variable to control the at least one stimulus parameter so as to maintain the feedback variable at a constant level."); adjusting the one or more second stimulus parameters so as to maintain the second measured characteristic at a second target value (para. [0041]: " In some embodiments of the seventh and eighth aspects the feedback controller completes the feedback loop by using the feedback variable to control the at least one stimulus parameter so as to maintain the feedback variable at a constant level."; para. [0043]: "The feedback variable could in some embodiments be any one of: an amplitude; an energy; a power; an integral; a signal strength; or a derivative, of any one of: the whole evoked compound action potential; the fast neural response for example in the measurement window 0-2 ms after stimulus; the slow neural response for example in the measurement window 2-6 ms after stimulus; or of a filtered version of the response. The feedback variable could in some embodiments be an average of any such characteristic determined over multiple stimulus/measurement cycles."); and adjusting a further second stimulus parameter of the one or more second stimulus parameters based on the adjustment to the one or more first stimulus parameters (para. [0061]: "At therapeutic levels, an observed CAP signal will typically have a maximum amplitude in the range of tens of microvolts. With increasing stimulus current I, the ECAP amplitude V typically follows a growth curve. Fig. 5 illustrates a range of growth curves which may arise in a single patient, one for each posture. A typical growth curve is characterized by a first portion below a threshold, in which a non-zero stimulus current elicits no ECAP, and a second portion above the threshold in which further increases in stimulus current above the threshold give rise to linearly increasing ECAP amplitude. The threshold T, and the slope M of the second portion of the growth curve, both depend on the electrode-to-fibre distance and thus both vary with posture. For example, as can be seen in Fig. 5, a supine posture has a lower threshold and a larger slope, as compared to a prone posture."; para. [0061] discloses changing the threshold, T, and characteristic slope M depending on the posture, which is based on ECAP amplitude. Changing the voltage parameter is dependent on changes to the slope and threshold parameters based the changes in recordings measured from a patient’s posture).
Regarding claim 38, Wah teaches the implantable device of claim 37 (see above), wherein the second stimulus parameter is a stimulus period (para. [0044]: “The control variable, or stimulus parameter, could in some embodiments be one or more of the total stimulus charge, stimulus current, pulse amplitude, phase duration, interphase gap duration or pulse shape, or a combination of these.”; para. [0054]: "To this end the stimulus electrodes are used to deliver stimuli at any therapeutically suitable frequency, for example 30 Hz, although other frequencies may be used including as high as the kHz range, and/or stimuli may be delivered in a non-periodic manner such as in bursts, or sporadically, as appropriate for the patient."; Changing the frequency would also be a change in stimulus period).
Regarding claim 39, Wah teaches the implantable device of claim 37 (see above), wherein the further second stimulus parameter is stimulus intensity (para. [0044]: “The control variable, or stimulus parameter, could in some embodiments be one or more of the total stimulus charge, stimulus current, pulse amplitude, phase duration, interphase gap duration or pulse shape, or a combination of these.”; Changing the current and/or amplitude would change the stimulus intensity).
Claims 30-39 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Li et al. (US 20220096840 A1, "Li").
Regarding claim 30, Li teaches an implantable device for controllably delivering neural stimuli (para. [0003]: "A medical (an implantable medical device) device may deliver one or more stimulation signals (e.g., one or more pulses) to the patient via one or more leads, and the medical device may sense signals which may include respective ECAPs elicited by the pulses."), the device comprising: a stimulus source (Fig. 1; IMD 110; para. [0023]: "implantable medical device (IMD) 110 configured to deliver spinal cord stimulation (SCS) therapy") configured to provide neural stimuli to be delivered according to one of a plurality of stimulation sets to a neural pathway of a patient in order to evoke neural responses from the neural pathway (para. [0029]: "These stimulation parameters of stimulation pulses (e.g., control pulses and/or informed pulses) are typically predetermined parameter values determined prior to delivery of the stimulation pulses (e.g., set according to a stimulation program). However, in some examples, system 100 changes one or more parameter values automatically based on one or more factors or based on user input."; see para. [0003], which mentions the signals are ECAPs (evoked neural responses), wherein each stimulation set comprises one or more stimulus electrodes (para. [0024]: "In the example of FIG. 1, IMD 110 is an implantable electrical stimulator that is configured to generate and deliver electrical stimulation therapy to patient 105 via one or more electrodes of leads 130A and/or 130B (collectively, “leads 130”),"; para. [0029]: "The stimulation parameter of a therapy stimulation program that defines the stimulation pulses of electrical stimulation therapy by IMD 110 through the electrodes of leads 130 may include information identifying which electrodes have been selected for delivery of stimulation according to a stimulation program, the polarities of the selected electrodes, i.e., the electrode combination for the program, and voltage or current amplitude, pulse frequency, pulse width, pulse shape of stimulation delivered by the electrodes.); measurement circuitry (Fig. 2; sensing circuitry 206) configured to capture signal windows sensed on the neural pathway subsequent to respective neural stimuli (Fig. 4 shows a signal of an ECAP in a time window; para. [0083] further discloses an "interval" of the signal), each signal window sensed via one or more measurement electrodes (para. [0083] discloses that the signal is obtained with "sensing electrodes"; para. [0089] discloses a first and second channel, meaning the signal is for each respective electrode); and a control unit (para. [005]:" Processing circuitry 210 of IMD 200"; para. [0006]: "stimulation generation circuitry 202") configured to: control the stimulus source to provide a first neural stimulus according to a first stimulation set of the plurality of stimulation sets and according to one or more first stimulus parameters (para. [0006]: "In some examples, the disclosure relates to a medical device comprising stimulation generation circuitry configured to deliver a first stimulation pulse to a patient. Sensing circuitry of the medical device is configured to sense information indicative of one or more evoked compound action potential (ECAP) signals, where the sensing circuitry comprises at least one electrode carried by a medical lead. Processing circuitry of the medical device is configured to receive information indicative of the one or more ECAP signals sensed by the at least one electrode carried by the medical lead. The processing circuitry determines that at least one characteristic value of the one or more ECAP signals is outside of an expected range."); control the stimulus source to provide a second neural stimulus according to a second stimulation set of the plurality of stimulation sets and according to one or more second stimulus parameters (The stimulation based on adjusted parameters in para. [0048] can be considered to be a second stimulation: "In this alternative example, IMD 110 functions to relay sensed signals to external programmer 150 for analysis, and external programmer 150 transmits instructions to IMD 110 to adjust the one or more parameters defining the electrical stimulation therapy based on analysis of the sensed signals. For example, IMD 110 may relay the sensed signal indicative of a ECAP signal to external programmer 150. External programmer 150 may compare a characteristic value of the ECAP signal to the respective expected range of characteristic values, and in response to the comparison, external programmer 150 may instruct IMD 110 to adjust one or more parameters that define the electrical stimulation pulses delivered to patient 105."); measure a first characteristic of a first evoked neural response in a first captured signal window subsequent to the first neural stimulus (para. [0045] discloses a magnitude as a signal characteristic); measure a second characteristic of a second evoked neural response in a second captured signal window subsequent to the second neural stimulus (para. [0046] discloses obtaining a slope as a second characteristic value: "In some examples, a standing posture is associated with a first transfer function including a first slope, a sitting posture is associated with a second transfer function including a second slope, and a supine posture is associated with a third transfer function including a third slope. In some examples, the first transfer function, the second transfer function may each represent functions where an expected range of characteristic values of one or more ECAP signal are plotted against a magnitude of a stimulation pulse which causes IMD 110 to sense the respective ECAP signal, where the expected range of characteristic values are plotted on a y-axis of a graph, and the stimulation magnitude is plotted on an x-axis of the graph."; Additionally, Fig. 6 discloses a closed loop system, so the adjusted stimulation would also measure for a characteristics of an ECAP (see Fig. 6 where 610 loops back around to step 602 and repeats steps 602-610); adjust, using a feedback controller: the one or more first stimulus parameters so as to maintain the first measured characteristic at or near a first target value (Fig. 6; step 608; para. [0047]: "For example, in response to IMD 110 determining that patient 105 is standing, IMD 110 may select a first expected range including a first lower-bound value and a first upper-bound value. If stimulation magnitude is held constant and in response to IMD 110 determining that patient 105 is sitting, IMD 110 may select a second expected range including a second lower-bound value and a second upper-bound value."), and the one or more second stimulus parameters so as to maintain the second measured characteristic at or near a second target value (para. [0046] discloses a second transfer function and associated slope, which is a signal characteristic: "a sitting posture is associated with a second transfer function including a second slope"; para. [0046] also discloses a second expected range that is adjusted based on the posture and associated function); and adjust the second target value based on the first measured characteristic (para. [0046]: "Consequently, at times when patient 105 is occupying a supine posture, the target ECAP value (e.g., an expected range of characteristic values) is more sensitive to changes in stimulation amplitude as compared with times when patient 105 is standing or sitting."; para. [0047]: " Since the first transfer function, the second transfer function, and the third transfer function each have different slopes, IMD 110 may change the target ECAP value (e.g., the expected range of characteristic values) based on detecting a change in the posture of patient 105. For example, in response to IMD 110 determining that patient 105 is standing, IMD 110 may select a first expected range including a first lower-bound value and a first upper-bound value. If stimulation magnitude is held constant and in response to IMD 110 determining that patient 105 is sitting, IMD 110 may select a second expected range including a second lower-bound value and a second upper-bound value.").
Regarding claim 31, Li teaches the implantable device of claim 30 (see above), wherein the control unit is configured to adjust the second target value such that the second target value plus a predetermined proportion of the first measured characteristic is equal to a predetermined constant (para. [0046]-[0047] describe the target ranges being adjusted for each posture slope, as well as where the magnitude is held constant: “ In some examples, a standing posture is associated with a first transfer function including a first slope, a sitting posture is associated with a second transfer function including a second slope, and a supine posture is associated with a third transfer function including a third slope. In some examples, the first transfer function, the second transfer function may each represent functions where an expected range of characteristic values of one or more ECAP signal are plotted against a magnitude of a stimulation pulse which causes IMD 110 to sense the respective ECAP signal, where the expected range of characteristic values are plotted on a y-axis of a graph, and the stimulation magnitude is plotted on an x-axis of the graph.).
Regarding claim 32, Li teaches an automated method of controllably delivering neural stimuli (para. [0003]: "A medical device (an implantable medical device) may deliver one or more stimulation signals (e.g., one or more pulses) to the patient via one or more leads, and the medical device may sense signals which may include respective ECAPs elicited by the pulses."), the method comprising: controlling a stimulus source (Fig. 1; IMD 110; para. [0023]: "implantable medical device (IMD) 110 configured to deliver spinal cord stimulation (SCS) therapy") to deliver a first neural stimulus via a first stimulation set of a plurality of stimulation sets according to one or more first stimulus parameters to a neural pathway of a patient in order to evoke a first neural response from the neural pathway (para. [0006]: "In some examples, the disclosure relates to a medical device comprising stimulation generation circuitry configured to deliver a first stimulation pulse to a patient. Sensing circuitry of the medical device is configured to sense information indicative of one or more evoked compound action potential (ECAP) signals, where the sensing circuitry comprises at least one electrode carried by a medical lead. Processing circuitry of the medical device is configured to receive information indicative of the one or more ECAP signals sensed by the at least one electrode carried by the medical lead. The processing circuitry determines that at least one characteristic value of the one or more ECAP signals is outside of an expected range."); controlling the stimulus source to deliver a second neural stimulus via a second stimulation set of the plurality of stimulation sets according to one or more second stimulus parameters to a neural pathway of a patient in order to evoke a second neural response from the neural pathway (The stimulation based on adjusted parameters in para. [0048] can be considered to be a second stimulation: "In this alternative example, IMD 110 functions to relay sensed signals to external programmer 150 for analysis, and external programmer 150 transmits instructions to IMD 110 to adjust the one or more parameters defining the electrical stimulation therapy based on analysis of the sensed signals. For example, IMD 110 may relay the sensed signal indicative of a ECAP signal to external programmer 150. External programmer 150 may compare a characteristic value of the ECAP signal to the respective expected range of characteristic values, and in response to the comparison, external programmer 150 may instruct IMD 110 to adjust one or more parameters that define the electrical stimulation pulses delivered to patient 105."); capturing a plurality of signal windows sensed on the neural pathway subsequent to the delivered neural stimuli (Fig. 4 shows a signal of an ECAP in a time window; para. [0083] further discloses an "interval" of the signal); measuring a first characteristic of the first evoked neural response in a first captured signal window of the plurality of signal windows subsequent to the first neural stimulus (para. [0045] discloses a magnitude as a signal characteristic); measuring a second characteristic of the second evoked neural response in a second captured signal window of the plurality of signal windows subsequent to the second neural stimulus (para. [0046] discloses obtaining a slope as a second characteristic value: "In some examples, a standing posture is associated with a first transfer function including a first slope, a sitting posture is associated with a second transfer function including a second slope, and a supine posture is associated with a third transfer function including a third slope. In some examples, the first transfer function, the second transfer function may each represent functions where an expected range of characteristic values of one or more ECAP signal are plotted against a magnitude of a stimulation pulse which causes IMD 110 to sense the respective ECAP signal, where the expected range of characteristic values are plotted on a y-axis of a graph, and the stimulation magnitude is plotted on an x-axis of the graph."; Additionally, Fig. 6 discloses a closed loop system, so the adjusted stimulation would also measure for a characteristics of an ECAP (see Fig. 6 where 610 loops back around to step 602 and repeats steps 602-610); adjusting the one or more first stimulus parameters so as to maintain the first measured characteristic at a first target value (Fig. 6; step 608; para. [0047]: "For example, in response to IMD 110 determining that patient 105 is standing, IMD 110 may select a first expected range including a first lower-bound value and a first upper-bound value. If stimulation magnitude is held constant and in response to IMD 110 determining that patient 105 is sitting, IMD 110 may select a second expected range including a second lower-bound value and a second upper-bound value."); and adjusting the one or more second stimulus parameters so as to maintain the second measured characteristic at a second target value (para. [0046] discloses a second transfer function and associated slope, which is a signal characteristic: "a sitting posture is associated with a second transfer function including a second slope"; para. [0046] also discloses a second expected range that is adjusted based on the posture and associated function); and adjusting the second target value based on the first measured characteristic (para. [0046]: "Consequently, at times when patient 105 is occupying a supine posture, the target ECAP value (e.g., an expected range of characteristic values) is more sensitive to changes in stimulation amplitude as compared with times when patient 105 is standing or sitting."; para. [0047]: " Since the first transfer function, the second transfer function, and the third transfer function each have different slopes, IMD 110 may change the target ECAP value (e.g., the expected range of characteristic values) based on detecting a change in the posture of patient 105. For example, in response to IMD 110 determining that patient 105 is standing, IMD 110 may select a first expected range including a first lower-bound value and a first upper-bound value. If stimulation magnitude is held constant and in response to IMD 110 determining that patient 105 is sitting, IMD 110 may select a second expected range including a second lower-bound value and a second upper-bound value.").
Regarding claim 33, Li teaches the method of claim 32 (see above), wherein adjusting the second target value comprises adjusting the second target value such that the second target value plus a predetermined proportion of the first measured characteristic is equal to a predetermined constant (para. [0046]-[0047] describe the target ranges being adjusted for each posture slope, as well as where the magnitude is held constant: “ In some examples, a standing posture is associated with a first transfer function including a first slope, a sitting posture is associated with a second transfer function including a second slope, and a supine posture is associated with a third transfer function including a third slope. In some examples, the first transfer function, the second transfer function may each represent functions where an expected range of characteristic values of one or more ECAP signal are plotted against a magnitude of a stimulation pulse which causes IMD 110 to sense the respective ECAP signal, where the expected range of characteristic values are plotted on a y-axis of a graph, and the stimulation magnitude is plotted on an x-axis of the graph.).
Regarding claim 34, Li teaches an implantable device for controllably delivering neural stimuli (para. [0003]: "A medical (an implantable medical device) device may deliver one or more stimulation signals (e.g., one or more pulses) to the patient via one or more leads, and the medical device may sense signals which may include respective ECAPs elicited by the pulses."), the device comprising: a stimulus source (Fig. 1; IMD 110; para. [0023]: "implantable medical device (IMD) 110 configured to deliver spinal cord stimulation (SCS) therapy") configured to provide neural stimuli to be delivered according to one of a plurality of stimulation sets to a neural pathway of a patient in order to evoke neural responses from the neural pathway (para. [0029]: "These stimulation parameters of stimulation pulses (e.g., control pulses and/or informed pulses) are typically predetermined parameter values determined prior to delivery of the stimulation pulses (e.g., set according to a stimulation program). However, in some examples, system 100 changes one or more parameter values automatically based on one or more factors or based on user input."; see para. [0003], which mentions the signals are ECAPs (evoked neural responses), wherein each stimulation set comprises one or more stimulus electrodes (para. [0024]: "In the example of FIG. 1, IMD 110 is an implantable electrical stimulator that is configured to generate and deliver electrical stimulation therapy to patient 105 via one or more electrodes of leads 130A and/or 130B (collectively, “leads 130”),"; para. [0029]: "The stimulation parameter of a therapy stimulation program that defines the stimulation pulses of electrical stimulation therapy by IMD 110 through the electrodes of leads 130 may include information identifying which electrodes have been selected for delivery of stimulation according to a stimulation program, the polarities of the selected electrodes, i.e., the electrode combination for the program, and voltage or current amplitude, pulse frequency, pulse width, pulse shape of stimulation delivered by the electrodes.); measurement circuitry (Fig. 2; sensing circuitry 206) configured to capture signal windows sensed on the neural pathway subsequent to respective neural stimuli (Fig. 4 shows a signal of an ECAP in a time window; para. [0083] further discloses an "interval" of the signal), each signal window sensed via one or more measurement electrodes (para. [0083] discloses that the signal is obtained with "sensing electrodes"; para. [0089] discloses a first and second channel, meaning the signal is for each respective electrode); and a control unit (para. [005]:" Processing circuitry 210 of IMD 200"; para. [0006]: "stimulation generation circuitry 202") configured to: control the stimulus source to provide a first neural stimulus according to a first stimulation set of the plurality of stimulation sets and according to one or more first stimulus parameters (para. [0006]: "In some examples, the disclosure relates to a medical device comprising stimulation generation circuitry configured to deliver a first stimulation pulse to a patient. Sensing circuitry of the medical device is configured to sense information indicative of one or more evoked compound action potential (ECAP) signals, where the sensing circuitry comprises at least one electrode carried by a medical lead. Processing circuitry of the medical device is configured to receive information indicative of the one or more ECAP signals sensed by the at least one electrode carried by the medical lead. The processing circuitry determines that at least one characteristic value of the one or more ECAP signals is outside of an expected range."); control the stimulus source to provide a second neural stimulus according to a second stimulation set of the plurality of stimulation sets and according to one or more second stimulus parameters (The stimulation based on adjusted parameters in para. [0048] can be considered to be a second stimulation: "In this alternative example, IMD 110 functions to relay sensed signals to external programmer 150 for analysis, and external programmer 150 transmits instructions to IMD 110 to adjust the one or more parameters defining the electrical stimulation therapy based on analysis of the sensed signals. For example, IMD 110 may relay the sensed signal indicative of a ECAP signal to external programmer 150. External programmer 150 may compare a characteristic value of the ECAP signal to the respective expected range of characteristic values, and in response to the comparison, external programmer 150 may instruct IMD 110 to adjust one or more parameters that define the electrical stimulation pulses delivered to patient 105."); measure a first characteristic of a first evoked neural response in a first captured signal window subsequent to the first neural stimulus (para. [0045] discloses a magnitude as a signal characteristic); measure a second characteristic of a second evoked neural response in a second captured signal window subsequent to the second neural stimulus (para. [0046] discloses obtaining a slope as a second characteristic value: "In some examples, a standing posture is associated with a first transfer function including a first slope, a sitting posture is associated with a second transfer function including a second slope, and a supine posture is associated with a third transfer function including a third slope. In some examples, the first transfer function, the second transfer function may each represent functions where an expected range of characteristic values of one or more ECAP signal are plotted against a magnitude of a stimulation pulse which causes IMD 110 to sense the respective ECAP signal, where the expected range of characteristic values are plotted on a y-axis of a graph, and the stimulation magnitude is plotted on an x-axis of the graph."; Additionally, Fig. 6 discloses a closed loop system, so the adjusted stimulation would also measure for a characteristics of an ECAP (see Fig. 6 where 610 loops back around to step 602 and repeats steps 602-610); adjust, using a feedback controller: the one or more first stimulus parameters so as to maintain the first measured characteristic at or near a first target value (Fig. 6; step 608; para. [0047]: "For example, in response to IMD 110 determining that patient 105 is standing, IMD 110 may select a first expected range including a first lower-bound value and a first upper-bound value. If stimulation magnitude is held constant and in response to IMD 110 determining that patient 105 is sitting, IMD 110 may select a second expected range including a second lower-bound value and a second upper-bound value."), a second stimulus parameter of the one or more stimulus parameters so as to maintain the second measured characteristic at or near a second target value (para. [0046] discloses a second transfer function and associated slope, which is a signal characteristic: "a sitting posture is associated with a second transfer function including a second slope"; para. [0046] also discloses a second expected range that is adjusted based on the posture and associated function); and adjust a further second stimulus parameter of the one or more second stimulus parameters based on the adjustment to the one or more first stimulus parameters (para. [0037]; “In some examples, the closed-loop stimulation program defines the amplitude of the control and/or informed pukes in response to one or more characteristics of the ECAP signal. For example, an increased amplitude of the ECAP signal may cause the closed-loop stimulation program to reduce the amplitude of the informed pulses and/or control pulses. In other examples, the closed-loop stimulation program may define other parameter values, such as pulse frequency, pulse width, inter-pulse intervals, etc., based on the one or more characteristics of the ECAP signal.”; Additionally, para. [0047] discloses where the slope parameters change depending on the posture of the patient, and where the target ECAP parameters change as a result of the changes to the slope parameter (in the case of constant stimulation magnitude).
Regarding claim 35, Li teaches the implantable device of claim 34 (see above), wherein the second stimulus parameter is a stimulus period (para. [0030]: “These stimulation parameter values may include information identifying which electrodes have been selected for delivery of stimulation pulses, the polarities of the selected electrodes, i.e., the electrode combination for the program, and voltage or current amplitude, pulse frequency, pulse width, and pulse shape of stimulation delivered by the electrodes.”; a change in pulse frequency changes the stimulus period).
Regarding claim 36, Li teaches the implantable device of claim 35 (see above), wherein the further second stimulus parameter is stimulus intensity (para. [0043]: “. The amount of action potentials (e.g., number of neurons propagating action potential signals) that are evoked may be based on the various parameters of electrical stimulation pulses such as amplitude, pulse width, frequency, pulse shape (e.g., slew rate at the beginning and/or end of the pulse)…In some examples, these parameters contribute to an intensity of the electrical stimulation.”).
Regarding claim 37, Li teaches an automated method of controllably delivering neural stimuli (para. [0003]: "A medical device (an implantable medical device) may deliver one or more stimulation signals (e.g., one or more pulses) to the patient via one or more leads, and the medical device may sense signals which may include respective ECAPs elicited by the pulses."), the method comprising: controlling a stimulus source (Fig. 1; IMD 110; para. [0023]: "implantable medical device (IMD) 110 configured to deliver spinal cord stimulation (SCS) therapy") to deliver a first neural stimulus via a first stimulation set of a plurality of stimulation sets according to one or more first stimulus parameters to a neural pathway of a patient in order to evoke a first neural response from the neural pathway (para. [0006]: "In some examples, the disclosure relates to a medical device comprising stimulation generation circuitry configured to deliver a first stimulation pulse to a patient. Sensing circuitry of the medical device is configured to sense information indicative of one or more evoked compound action potential (ECAP) signals, where the sensing circuitry comprises at least one electrode carried by a medical lead. Processing circuitry of the medical device is configured to receive information indicative of the one or more ECAP signals sensed by the at least one electrode carried by the medical lead. The processing circuitry determines that at least one characteristic value of the one or more ECAP signals is outside of an expected range."); controlling the stimulus source to deliver a second neural stimulus via a second stimulation set of the plurality of stimulation sets according to one or more second stimulus parameters to a neural pathway of a patient in order to evoke a second neural response from the neural pathway (The stimulation based on adjusted parameters in para. [0048] can be considered to be a second stimulation: "In this alternative example, IMD 110 functions to relay sensed signals to external programmer 150 for analysis, and external programmer 150 transmits instructions to IMD 110 to adjust the one or more parameters defining the electrical stimulation therapy based on analysis of the sensed signals. For example, IMD 110 may relay the sensed signal indicative of a ECAP signal to external programmer 150. External programmer 150 may compare a characteristic value of the ECAP signal to the respective expected range of characteristic values, and in response to the comparison, external programmer 150 may instruct IMD 110 to adjust one or more parameters that define the electrical stimulation pulses delivered to patient 105."); capturing a plurality of signal windows sensed on the neural pathway subsequent to the delivered neural stimuli (Fig. 4 shows a signal of an ECAP in a time window; para. [0083] further discloses an "interval" of the signal); measuring a first characteristic of the first evoked neural response in a first captured signal window of the plurality of signal windows subsequent to the first neural stimulus (para. [0045] discloses a magnitude as a signal characteristic); measuring a second characteristic of the second evoked neural response in a second captured signal window of the plurality of signal windows subsequent to the second neural stimulus (para. [0046] discloses obtaining a slope as a second characteristic value: "In some examples, a standing posture is associated with a first transfer function including a first slope, a sitting posture is associated with a second transfer function including a second slope, and a supine posture is associated with a third transfer function including a third slope. In some examples, the first transfer function, the second transfer function may each represent functions where an expected range of characteristic values of one or more ECAP signal are plotted against a magnitude of a stimulation pulse which causes IMD 110 to sense the respective ECAP signal, where the expected range of characteristic values are plotted on a y-axis of a graph, and the stimulation magnitude is plotted on an x-axis of the graph."; Additionally, Fig. 6 discloses a closed loop system, so the adjusted stimulation would also measure for a characteristics of an ECAP (see Fig. 6 where 610 loops back around to step 602 and repeats steps 602-610); adjusting the one or more first stimulus parameters so as to maintain the first measured characteristic at a first target value (Fig. 6; step 608; para. [0047]: "For example, in response to IMD 110 determining that patient 105 is standing, IMD 110 may select a first expected range including a first lower-bound value and a first upper-bound value. If stimulation magnitude is held constant and in response to IMD 110 determining that patient 105 is sitting, IMD 110 may select a second expected range including a second lower-bound value and a second upper-bound value."); and adjusting the one or more second stimulus parameters so as to maintain the second measured characteristic at a second target value (para. [0046] discloses a second transfer function and associated slope, which is a signal characteristic: "a sitting posture is associated with a second transfer function including a second slope"; para. [0046] also discloses a second expected range that is adjusted based on the posture and associated function); and adjusting a further second stimulus parameter of the one or more stimuls parameters based on the adjustment to the one or more first stimulus parameters (para. [0037]; “In some examples, the closed-loop stimulation program defines the amplitude of the control and/or informed pukes in response to one or more characteristics of the ECAP signal. For example, an increased amplitude of the ECAP signal may cause the closed-loop stimulation program to reduce the amplitude of the informed pulses and/or control pulses. In other examples, the closed-loop stimulation program may define other parameter values, such as pulse frequency, pulse width, inter-pulse intervals, etc., based on the one or more characteristics of the ECAP signal.”; Additionally, para. [0047] discloses where the slope parameters change depending on the posture of the patient, and where the target ECAP parameters change as a result of the changes to the slope parameter (in the case of constant stimulation magnitude).
Regarding claim 38, Li teaches the implantable device of claim 37 (see above), wherein the second stimulus parameter is a stimulus period (para. [0030]: “These stimulation parameter values may include information identifying which electrodes have been selected for delivery of stimulation pulses, the polarities of the selected electrodes, i.e., the electrode combination for the program, and voltage or current amplitude, pulse frequency, pulse width, and pulse shape of stimulation delivered by the electrodes.”; a change in pulse frequency changes the stimulus period).
Regarding claim 39, Li teaches the implantable device of claim 37 (see above), wherein the further second stimulus parameter is stimulus intensity (para. [0043]: “The amount of action potentials (e.g., number of neurons propagating action potential signals) that are evoked may be based on the various parameters of electrical stimulation pulses such as amplitude, pulse width, frequency, pulse shape (e.g., slew rate at the beginning and/or end of the pulse)…In some examples, these parameters contribute to an intensity of the electrical stimulation.”).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Zhang et al. (US 20190298992 A1) and Jaxx (US 20140277282 A1). The prior art is relevant to claims 30-39.
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/O.L.M./Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796
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