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 .
DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 6/16/2025 has been entered. Claims 1-21 are currently pending.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0303376 to Dinsmoor et al. (Dinsmoor) in view of US 2005/0049645 to Meier (Meier), US 2018/0078769 to Dinsmoor et al. (Dinsmoor ‘769) and US 2003/0153957 to Bradley (Bradley) (all previously cited).
In reference to at least claim 1
Dinsmoor discloses a system (e.g. system including programmer 20 and implanted device 14, Figs. 1-3) comprising: at least one sensor (e.g. eCMAP sensor, 92, Fig. 3) configured to measure a motor response of a patient (e.g. detect an eCMAP biomarker “motor response” that corresponds to desired outcome, 230, Fig. 12, para. [0078], [0129]); and a device comprising: electrical stimulation circuitry (e.g. stimulation generator, 84, Fig. 3) configured to output electrical stimulation therapy to a target nerve of the patient (e.g. stimulation generator delivers electrical stimulation via electrode combinations, para. [0062], [0074]); and processing circuitry (e.g. processor 80, Fig. 3) operatively coupled to the electrical stimulation circuitry (e.g. processor 80 is coupled to stimulation generator 84, Fig. 3), the processing circuitry configured to: receive an indication from the at least one sensor indicating the motor response (e.g. detects an eCMAP biomarker from eCMAP sensor 92, Fig. 3, para. [0129]); measure a time interval value between an output of an electrical stimulation therapy event from the electrical stimulation circuitry and the received indication of the motor response (e.g. determining time between the application of the stimulation pulse and the receipt of the eCMAP biomarker, para. [0129]); determine whether a magnitude of the received indication of the motor response satisfies a target (e.g. determining an amplitude “magnitude” of the eCMAP biomarker to determine whether the eCMAP biomarker corresponds to a desired outcome, para. [0123], [0129]); and responsive to the magnitude of the received indication of the motor response failing to satisfy the target (e.g. amplitude of eCMAP does not correspond to desired outcome adjusting at least one stimulation parameter 232, Fig. 12, para. [0123], [0130]), cause the electrical stimulation circuitry to adjust at least one parameter of a subsequent electrical stimulation therapy event (e.g. adjusting at least one stimulation parameter 232, Fig. 12, para. [0123], [0130]).
Dinsmoor discloses a determination of whether an eCMAP biomarker is present including whether a desired eCMAP (e.g. “desired eCMAP”, para. [0129], [0133]) and determining the time between the application of the stimulation pulse and the receipt of the eCMAP biomarker “measure a time interval value between an output of an electrical stimulation therapy event from the electrical stimulation circuitry and the received indication of the motor response” (e.g. “determining the time between the application of the stimulation pulse and the receipt of the eCMAP biomarker by eCMAP sensor 92”, para. [0129]). However, Dinsmoor does not explicitly disclose using the measured time interval value to determine whether the received indication of the motor response is valid based on a comparison of the measured time interval value to an expected timing window.
Meier, in the same field of endeavor of electrostimulation, discloses a system that includes at least one sensor (e.g. detection unit 18) configured to measure a stimulation response (e.g. “occurrence of the stimulus response”, para. Fig. 5, [0048]) in which a reference time value is set for the spacing between stimulation and the occurrence of the stimulus response, i.e. the reference time value indicates” an expected timing window” set for the spacing between stimulation and the occurrence of the stimulus response, to regularly ensure successful stimulation (e.g. “sets a reference time value for the spacing in respect of time between stimulation pulse delivery and the occurrence of the stimulus response”, para. [0048]).
Since Dinsmoor discloses measuring the time interval value between the application of the stimulation pulse and the receipt of the eCMAP biomarker, it would have been obvious to one having ordinary skill in the art to use a reference time interval value, as taught by Meier, and comparing the measured time value of Dinsmoor with the reference time value indicating the spacing between stimulation and the occurrence of the stimulus response “an expected timing window” in order to ensure successful stimulation is being applied (‘645, para. [0048]). Further, it was well known in the art before the effective filing date of the claimed invention to sense a response to an applied stimulation at a predetermined interval or period of time after the stimulation during which a response is expected to occur as evidence by Dinsmoor ‘769, (e.g. [0211]) or Bradley (e.g. “a predetermined period of time during which an evoked response is expected to occur, typically within 150 ms of the stimulation pulse”, para. [0071]) , therefore it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use a time interval value between the application of the stimulation pulse and a predetermined interval or period of time after the stimulation during which a response is expected to occur as the reference time interval value and determine a response is valid based on a comparison of the measured time interval value with the reference time interval value to ensure the response occurred during the predetermined interval or period of time in order to improve system performance by efficient energy usage and targeted therapy delivery to desired tissue (‘769, para. [0032]).
In reference to at least claim 2
Dinsmoor modified by Meier renders obvious a system according to claim 1. Dinsmoor further discloses wherein the device comprises a housing (e.g. IMD 14 includes a housing, Figs. 1,3, para. [0039]); wherein the device comprises at least one electrode attached to the housing in contact with tissue of the patient (e.g. can include leadless stimulator with one or more arrays of electrodes arranged on the housing, para. [0039]); and wherein the at least one electrode delivers the electrical stimulation therapy to the target nerve of the patient (e.g. electrodes are placed adjacent to the target tissue, para. [0039]).
In reference to at least claim 3
Dinsmoor modified by Meier renders obvious a system according to claim 1. Dinsmoor further discloses wherein the at least one sensor is external to and separate from a housing that includes the electrical stimulation circuitry (e.g. eCMAP sensor 92 can be located on a lead or be carried by an additional sensor lead positioned somewhere within the patient, Fig. 3, para. [0096]).
In reference to at least claim 4
Dinsmoor modified by Meier renders obvious a system according to claim 1. Dinsmoor further discloses wherein the at least one sensor is a wearable sensor (e.g. eCMAP sensor can even be an independent sensor or even worn on the patient, para. [0096]).
In reference to at least claim 5
Dinsmoor modified by Meier renders obvious a system according to claim 1. Dinsmoor further discloses wherein the at least one sensor (e.g. eCMAP sensor 92, Fig. 3) is configured to measure an H-reflex and wherein to determine whether the received indication of the motor response is valid, the processing circuitry is configured to determine at least whether the H-reflex is a reflex muscle response recorded from a muscle based on the comparison of the measured time interval value to the expected timing window (e.g. detects far-field eCMAP signals, para. [0096]).
In reference to at least claim 6
Dinsmoor modified by Meier renders obvious a system according to claim 1. Dinsmoor further discloses wherein the at least one sensor is attached to a housing that is in contact with tissue of the patient and that includes the electrical stimulation circuitry (e.g. eCMAP sensor may include additional electrode on the housing of the IMD, para. [0096]).
In reference to at least claim 7
Dinsmoor modified by Meier renders obvious a system according to claim 1. Dinsmoor further discloses wherein the processing circuitry is configured to cause the electrical stimulation circuitry to output the electrical stimulation therapy event that causes an afferent response in the target nerve (e.g. applied to one or more sacral nerves causing an afferent response, para. [0062])
In reference to at least claim 8
Dinsmoor modified by Meier renders obvious a system according to claim 1. Dinsmoor further discloses wherein the motor response measured by the at least one sensor is an evoked motor response caused by the electrical stimulation therapy event (e.g. eCMAP sensor detects evoked compound muscle action potential, para. [0026], [0033]).
In reference to at least claim 9
Dinsmoor modified by Meier renders obvious a system according to claim 1. Dinsmoor further discloses wherein responsive to the magnitude of the received indication of the motor response being less than the target, cause the electrical stimulation circuitry to increase a stimulation level of the subsequent electrical stimulation therapy event (e.g. adjust one stimulation therapy parameter including increasing a totally intensity, para. [0028], [0130], [0134]).
In reference to at least claim 10
Dinsmoor modified by Meier renders obvious a system according to claim 1. Dinsmoor further discloses wherein the at least one sensor is configured to measure at least one electromyography (EMG) response (e.g. posture module can sense one or more physiological parameters in EMG, para. [0091]). Dinsmoor also discloses that sensing an EMG signal is known and is a signal indicative of electrical activity generated by muscle tissue (e.g. para. [0034]), therefore providing a sensor that senses such activity would have been well within the level of ordinary skill in the art in order to sense a signal indicative of electrical activity
In reference to at least claim 11
Dinsmoor teaches a system (e.g. system including programmer 20 and implanted device 14, Figs. 1-3) comprising: a device comprising: electrical stimulation circuitry (e.g. stimulation generator, 84, Fig. 3) configured to output electrical stimulation therapy to a target nerve of the patient (e.g. stimulation generator delivers electrical stimulation via electrode combinations, para. [0062], [0074]); and processing circuitry (e.g. processor 80, Fig. 3) operatively coupled to the electrical stimulation circuitry (e.g. processor 80 is coupled to stimulation generator 84, Fig. 3), the processing circuitry configured to: receive an indication from at least one sensor indicating a motor response (e.g. detects an eCMAP biomarker “indication of a motor response” from eCMAP sensor 92, Fig. 3, para. [0129]); measure a time interval value between an output of an electrical stimulation therapy event from the electrical stimulation circuitry and the received indication of the motor response (e.g. determining time between the application of the stimulation pulse and the receipt of the eCMAP biomarker, para. [0129]); determine whether a magnitude of the received indication of the motor response satisfies a target (e.g. determining an amplitude “magnitude” of the eCMAP biomarker to determine whether the eCMAP biomarker corresponds to a desired outcome, para. [0123], [0129]); and responsive to the magnitude of the received indication of the motor response failing to satisfy the target (e.g. amplitude of eCMAP does not correspond to desired outcome adjusting at least one stimulation parameter 232, Fig. 12, para. [0123], [0130]), cause the electrical stimulation circuitry to adjust at least one parameter of a subsequent electrical stimulation therapy event (e.g. adjusting at least one stimulation parameter 232, Fig. 12, para. [0123], [0130]).
Dinsmoor discloses a determination of whether an eCMAP biomarker is present including whether a desired eCMAP (e.g. “desired eCMAP”, para. [0129], [0133]) and determining the time between the application of the stimulation pulse and the receipt of the eCMAP biomarker “measure a time interval value between an output of an electrical stimulation therapy event from the electrical stimulation circuitry and the received indication of the motor response” (e.g. “determining the time between the application of the stimulation pulse and the receipt of the eCMAP biomarker by eCMAP sensor 92”, para. [0129]). However, Dinsmoor does not explicitly disclose using the measured time interval value to determine whether the received indication of the motor response is valid based on a comparison of the measured time interval value to an expected timing window.
Meier, in the same field of endeavor of electrostimulation, discloses a system that includes at least one sensor (e.g. detection unit 18) configured to measure a stimulation response (e.g. “occurrence of the stimulus response”, para. Fig. 5, [0048]) in which a reference time value is set for the spacing between stimulation and the occurrence of the stimulus response, i.e. the reference time value indicates” an expected timing window” set for the spacing between stimulation and the occurrence of the stimulus response, to regularly ensure successful stimulation (e.g. “sets a reference time value for the spacing in respect of time between stimulation pulse delivery and the occurrence of the stimulus response”, para. [0048]).
Since Dinsmoor discloses measuring the time interval value between the application of the stimulation pulse and the receipt of the eCMAP biomarker, it would have been obvious to one having ordinary skill in the art to use a reference time interval value, as taught by Meier, and comparing the measured time value of Dinsmoor with the reference time value indicating the spacing between stimulation and the occurrence of the stimulus response “an expected timing window” in order to ensure successful stimulation is being applied (‘645, para. [0048]). Further, it was well known in the art before the effective filing date of the claimed invention to sense a response to an applied stimulation at a predetermined interval or period of time after the stimulation during which a response is expected to occur as evidence by Dinsmoor ‘769, (e.g. [0211]) or Bradley (e.g. “a predetermined period of time during which an evoked response is expected to occur, typically within 150 ms of the stimulation pulse”, para. [0071]) , therefore it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use a time interval value between the application of the stimulation pulse and a predetermined interval or period of time after the stimulation during which a response is expected to occur as the reference time interval value and determine a response is valid based on a comparison of the measured time interval value with the reference time interval value to ensure the response occurred during the predetermined interval or period of time in order to improve system performance by efficient energy usage and targeted therapy delivery to desired tissue (‘769, para. [0032]).
In reference to at least claim 12
Dinsmoor modified by Meier renders obvious a device according to claim 11. Dinsmoor further discloses wherein the device comprises a housing (e.g. IMD 14 includes a housing, Figs. 1,3, para. [0039]); wherein the device comprises at least one electrode attached to the housing in contact with tissue of the patient (e.g. can include leadless stimulator with one or more arrays of electrodes arranged on the housing, para. [0039]); and wherein the at least one electrode delivers the electrical stimulation therapy to the target nerve of the patient (e.g. electrodes are placed adjacent to the target tissue, para. [0039]).
In reference to at least claim 13
Dinsmoor modified by Meier renders obvious a device according to claim 11. Dinsmoor further discloses wherein the at least one sensor is attached to a housing that is in contact with tissue of the patient and that includes the electrical stimulation circuitry (e.g. eCMAP sensor may include additional electrode on the housing of the IMD, para. [0096]).
In reference to at least claim 14
Dinsmoor modified by Meier renders obvious a device according to claim 11. Dinsmoor further discloses wherein the at least one sensor (e.g. eCMAP sensor 92, Fig. 3) is configured to measure an H-reflex and wherein to determine whether the received indication of the motor response is valid, the processing circuitry is configured to determine at least whether the H-reflex is a reflex muscle response recorded from a muscle based on the measured time interval value (e.g. detects far-field eCMAP signals, para. [0096]).
In reference to at least claim 15
Dinsmoor modified by Meier renders obvious a device according to claim 11. Dinsmoor further discloses wherein the motor response measured by the at least one sensor is an evoked motor response caused by the electrical stimulation therapy (e.g. eCMAP response measured by eCMAP sensor 92, Fig. 3, para. [0033], [0129]); and wherein the evoked motor response is an efferent alpha motor neuron excitation through a spinal synapse (e.g. measure of a muscular response signal generated by the aggregate activity of a group of muscle tissue firing in response to the applied electrical stimulation such as the excitation, para. [0027], [0033]).
In reference to at least claim 16
Dinsmoor modified by Meier renders obvious a device according to claim 11. Dinsmoor further discloses wherein responsive to the magnitude of the received indication of the motor response being less than the target, cause the electrical stimulation circuitry to increase a stimulation level of the subsequent electrical stimulation therapy event (e.g. adjust one stimulation therapy parameter including increasing a totally intensity, para. [0028], [0130], [0134]).
In reference to at least claim 17
Dinsmoor teaches method comprising: delivering, by electrical stimulation circuitry of an implantable medical device (e.g. IMD 14 containing stimulation generator 84, Figs. 1,3), electrical stimulation therapy to a target nerve of a patient (e.g. stimulation generator delivers electrical stimulation via electrode combinations, para. [0062], [0074]); receiving, by processing circuitry of the implantable medical device (e.g. IMD 14 containing processor 80, Figs. 1,3), an indication from at least one sensor indicating a motor response of the patient (e.g. detects an eCMAP biomarker “indication of a motor response” from eCMAP sensor 92, Fig. 3, para. [0129]); measuring, by the processing circuitry, a time interval value between the delivered electrical stimulation therapy from the electrical stimulation circuitry and the received indication of the motor response (e.g. determining time between the application of the stimulation pulse and the receipt of the eCMAP biomarker, para. [0129]); determining, by the processing circuitry, whether a magnitude of the received indication of the motor response satisfies a target (e.g. determining an amplitude “magnitude” of the eCMAP biomarker to determine whether the eCMAP biomarker corresponds to a desired outcome, para. [0123], [0129]); and responsive to the magnitude of the received indication of the motor response failing to satisfy the target (e.g. amplitude of eCMAP does not correspond to desired outcome adjusting at least one stimulation parameter 232, Fig. 12, para. [0123], [0130]), causing, by the processing circuitry, the electrical stimulation circuitry to adjust at least one parameter of a subsequent electrical stimulation therapy event (e.g. adjusting at least one stimulation parameter 232, Fig. 12, para. [0123], [0130]).
Dinsmoor discloses a determination of whether an eCMAP biomarker is present including whether a desired eCMAP (e.g. “desired eCMAP”, para. [0129], [0133]) and determining the time between the application of the stimulation pulse and the receipt of the eCMAP biomarker “measure a time interval value between an output of an electrical stimulation therapy event from the electrical stimulation circuitry and the received indication of the motor response” (e.g. “determining the time between the application of the stimulation pulse and the receipt of the eCMAP biomarker by eCMAP sensor 92”, para. [0129]). However, Dinsmoor does not explicitly disclose using the measured time interval value to determine whether the received indication of the motor response is valid based on a comparison of the measured time interval value to an expected timing window.
Meier, in the same field of endeavor of electrostimulation, discloses a system that includes at least one sensor (e.g. detection unit 18) configured to measure a stimulation response (e.g. “occurrence of the stimulus response”, para. Fig. 5, [0048]) in which a reference time value is set for the spacing between stimulation and the occurrence of the stimulus response, i.e. the reference time value indicates” an expected timing window” set for the spacing between stimulation and the occurrence of the stimulus response, to regularly ensure successful stimulation (e.g. “sets a reference time value for the spacing in respect of time between stimulation pulse delivery and the occurrence of the stimulus response”, para. [0048]).
Since Dinsmoor discloses measuring the time interval value between the application of the stimulation pulse and the receipt of the eCMAP biomarker, it would have been obvious to one having ordinary skill in the art to use a reference time interval value, as taught by Meier, and comparing the measured time value of Dinsmoor with the reference time value indicating the spacing between stimulation and the occurrence of the stimulus response “an expected timing window” in order to ensure successful stimulation is being applied (‘645, para. [0048]). Further, it was well known in the art before the effective filing date of the claimed invention to sense a response to an applied stimulation at a predetermined interval or period of time after the stimulation during which a response is expected to occur as evidence by Dinsmoor ‘769, (e.g. [0211]) or Bradley (e.g. “a predetermined period of time during which an evoked response is expected to occur, typically within 150 ms of the stimulation pulse”, para. [0071]), therefore it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use a time interval value between the application of the stimulation pulse and a predetermined interval or period of time after the stimulation during which a response is expected to occur as the reference time interval value and determine a response is valid based on a comparison of the measured time interval value with the reference time interval value to ensure the response occurred during the predetermined interval or period of time in order to improve system performance by efficient energy usage and targeted therapy delivery to desired tissue (‘769, para. [0032]).
In reference to at least claim 18
Dinsmoor modified by Meier renders obvious a method according to claim 17. Dinsmoor further discloses wherein the device comprises a housing (e.g. IMD 14 includes a housing, Figs. 1,3, para. [0039]); wherein the device comprises at least one electrode attached to the housing in contact with tissue of the patient (e.g. can include leadless stimulator with one or more arrays of electrodes arranged on the housing, para. [0039]); and wherein the at least one electrode delivers the electrical stimulation therapy to the target nerve of the patient (e.g. electrodes are placed adjacent to the target tissue, para. [0039]).
In reference to at least claim 19
Dinsmoor modified by Meier renders obvious a method according to claim 17. Dinsmoor further discloses wherein the at least one sensor is external to and separate from a housing that includes the electrical stimulation circuitry (e.g. eCMAP sensor 92 can be located on a lead or be carried by an additional sensor lead positioned somewhere within the patient, Fig. 3, para. [0096]).
In reference to at least claim 20
Dinsmoor modified by Meier renders obvious a method according to claim 17. Dinsmoor further discloses wherein the motor response measured by the at least one sensor is an evoked motor response caused by the electrical stimulation therapy (e.g. eCMAP response measured by eCMAP sensor 92, Fig. 3, para. [0033], [0129]); and wherein the evoked motor response is an efferent alpha motor neuron excitation through a spinal synapse (e.g. measure of a muscular response signal generated by the aggregate activity of a group of muscle tissue firing in response to the applied electrical stimulation such as the excitation, para. [0027], [0033]).
In reference to at least claim 21
Dinsmoor modified by Meier renders obvious a system according to claim 1. Dinsmoor further discloses the processing circuitry configured to: receive an indication from the at least one sensor indicating the motor response (e.g. detects an eCMAP biomarker from eCMAP sensor 92, Fig. 3, para. [0129]); measure a time interval value between an output of an electrical stimulation therapy event from the electrical stimulation circuitry and the received indication of the motor response (e.g. determining time between the application of the stimulation pulse and the receipt of the eCMAP biomarker, para. [0129]). As stated above within the rejection of claim 1, Dinsmoor in combination with Meier render obvious a comparison of the measured time interval value to the reference time value set for the spacing between stimulation and the occurrence of the stimulus response, i.e. an expected timing window, see rejection above. Any time interval measurement value within Dinsmoor which is not within the reference time value set for the spacing between stimulation and the occurrence of the stimulus response would not be considered valid, i.e. invalid.
Response to Arguments
Applicant's arguments filed 6/4/2025 have been fully considered but they are not persuasive.
Applicant argues that Dinsmoor does not teach “the processing circuitry of Applicant’s claim 1 “may further determine whether the received indication of the motor response is valid based on comparing the measured time interval to the stored timing limits. Sensed bioelectrical signals outside of the expected timing window may be based on some other cause other than the electrical stimulation therapy.”, see pg. 9 of the response filed 6/4/2025, the examiner respectfully disagrees. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the processing circuitry may further determine whether the received indication of the motor response is valid based on comparing the measured time interval to the stored timing limits. Sensed bioelectrical signals outside of the expected timing window may be based on some other cause other than the electrical stimulation therapy) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant argues the combination of Dinsmoor and Meier would result in a system configured to capture data within “a predetermined amount of time” or a “window” and would not capture data outside of the window. Therefore, a system combining Dinsmoor and Meier would not “determine whether the received indication of the motor response is valid based on a comparison of the measured time interval to an expected timing window,” because any data collected by Dinsmoor in view of Meier would be within the expected timing window, see pg. 10 of the response filed 6/4/2025, the examiner respectfully disagrees. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., capturing data outside of the window) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Dinsmoor discloses measuring a time interval value between an output of an electrical stimulation therapy event from the electrical stimulation circuitry and the received indication of the motor response, see para. [0129] – “determining time between the application of the stimulation pulse and the receipt of the eCMAP biomarker”. Meier discloses a reference time value is set for the spacing between stimulation and the occurrence of the stimulus response, i.e. the reference time value indicates” an expected timing window” set for the spacing between stimulation and the occurrence of the stimulus response, see para. [0048]- “sets a reference time value for the spacing in respect of time between stimulation pulse delivery and the occurrence of the stimulus response”. Therefore, Meier does disclose setting a reference time value “an expected timing window” for the spacing between stimulation and the occurrence of the stimulus response which can be compared to a measured time interval to make sure that the response is within a time window that ensures successful stimulation.
Applicant argues that Dinsmoor ‘769 and Bradley disclose sensing the evoked response solely within a predetermined time window and therefore do not disclose or suggest “determine whether the received indication of the motor response is valid based on a comparison of the measured time interval value to an expected timing window.”, see pg. 10-11 of the response filed 6/4/2025, the examiner respectfully disagrees. Dinsmoor ‘769 and Bradley both disclose sensing a response to an applied stimulation at a predetermined interval or period of time, i.e. an expected timing window, after the stimulation during which a response is expected to occur, therefore using a time interval value between the application of the stimulation pulse and a predetermined interval or period of time after the stimulation during which a response is expected to occur, i.e. an expected timing window, as a reference time interval value which can be compared to a measured time interval value to ensure the response occurred during the predetermined interval or period of time set as the reference time interval would have been obvious.
Conclusion
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