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 § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-3, 5-6, 12-14, 16-17, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0243564 A1 to Stanslaski et al. (hereinafter “Stanslaski”) in view of US 2019/0388692 A1 to Dinsmoor et al. (hereinafter “Dinsmoor”).
Regarding claims 1 and 12, Stanslaski teaches:
A device and method (abstract, lines 1-5) comprising:
stimulation generation circuitry (the stimulation engine – see fig. 2, 206 and para 0034) configured to generate a first stimulation signal according to a set of parameters to be delivered to target anatomy of a patient via a stimulation electrode configuration from a plurality of electrodes (see para 0032, 0034-0039, claim 1),
the set of parameters comprising a first stimulation recharge parameter (such as amplitude – see fig. 4, para 0006-0008, and para 0047);
sensing circuitry (see fig. 2, 204) configured to sense an evoked response signal (neurological signal) responsive to the first stimulation signal (see fig. 2, para 0003, para 0006, para 0027, and para 0034—the first stimulation pulse/signal results in the application of the first active recharge pulse, followed by passive recharge and then no recharge, where the first neurological signal is sensed after a period of time following the “no recharge” phase);
processing circuitry ( a controller/processor – see fig. 2 - 202) communicatively coupled to the stimulation generation circuitry (stimulation engine – fig. 2, 206) and the sensing circuitry (see fig. 2 – 202,204, and 206, and para 0042),
the processing circuitry being configured to:
control the stimulation generation circuitry to generate the first stimulation signal having the first stimulation recharge parameter for delivery to the target anatomy (see figs. 1-2, para 0002, para 0006, para 0026, and para 0042);
receive from the sensing circuitry the sensed evoked response signal (neurological signals – see para 0005 and para 0034)
analyze the sensed evoked response signal (physiological/ neurological signals) for one or more artifacts (where artifacts are the non-neurological signals that produce these unwanted artifacts – see abstract and para 0005);
adjust, based on the one or more artifacts, the first stimulation recharge parameter to determine a second stimulation recharge parameter (the second stimulation recharge parameter is the subsequent recharge parameter delivered after the first recharge parameter is delivered an evaluated – see para 0025, para 0047-0048);
and control the stimulation generation circuitry/stimulation engine to generate a second stimulation signal having the second stimulation recharge parameter for delivery to the target anatomy/brain or spinal cord (see para 0002, para 0006-0008, and para 0046-0049). Due to the adjustment of the recharge parameter (amplitude ratio) occurring repeatedly until the stimulation artifact is minimized, the stimulation engine generates a second stimulation signal having a second stimulation recharge parameter that is modified in response to the first stimulation recharge parameter.
However, Stanslaski does not explicitly disclose wherein the sensing circuitry is configured to sense an evoked response signal responsive to the first stimulation signal.
Yet, Dinsmoor teaches devices, system and methods for controlling stimulation therapy delivered to a patient (see abstract, lines 1-4). The system (figs. 1-2A) teach wherein the sensing circuitry is configured to sense an evoked response signal responsive to the first stimulation signal (see abstract, last sentence: “The system may also be configured to sense, after one or more control pulses and prior to an immediately subsequent therapy pulse of the plurality of therapy pulses, a respective evoked compound action potential (ECAP), adjust, based on at least one respective ECAP, one or more parameter values that at least partially defines the plurality of therapy pulses, and deliver the electrical stimulation therapy to the patient according to the adjusted one or more parameter values.”, fig. 2A – 212, para 0065).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Stanslaski with the teachings of Dinsmoor to arrive at the claimed invention. Such combination would result in a reasonable expectation for success, since the prior art of Stanslaski in combination with Dinsmoor discusses minimizing and eliminating the measurement of one or more artifacts (unwanted physiological signals) in order to improving sensing capabilities of the target neurological signals (such as ECAPs discussed by Dinsmoor), ultimately improving stimulation therapy for precise stimulation to the target anatomy.
Regarding claims 2 and 13, Stanslaski as modified teaches:
The device and method of claims 1 and 12, wherein each of the first stimulation signal and the second stimulation signal comprises one of an active recharge phase, a passive recharge phase, or a hybrid active/passive recharge phase (see abstract, see para 0002, para 0006-0008, and para 0046-0049— active and/or passive recharge phase is comparable to the recharge time period and continuous adjustment of the recharge ratio to minimize the artifacts).
Regarding claims 3 and 14, Stanslaski as modified teaches:
The device and method of claims 2 and 13, wherein the first stimulation signal comprises one of the active recharge phase, the passive recharge phase, or the hybrid active/passive recharge phase (see abstract, see para 0002, para 0006-0008, and para 0047-0049),
and wherein the second stimulation signal comprises a different one of the active recharge phase, the passive recharge phase, or the hybrid active/passive recharge phase (see claim 8).
Regarding claims 5 and 16, Stanslaski as modified teaches:
The device and method of claims 1 and 12, wherein at least one of the first stimulation recharge parameter or the second stimulation recharge parameter comprises a duration of passive recharge, a duration of a recharge pulse, an amplitude of the recharge pulse, or a shape of the recharge pulse (duration of passive recharge – see abstract and claims 1-3).
Regarding claims 6 and 17, Stanslaski as modified teaches:
The device and method of claims 1 and 12, wherein the processing circuitry (controller/processor) is further configured to recursively analyze the sensed evoked response signal/neurological signal (or physiological signal) for one or more artifacts (artifacts being the unwanted cardiac signals in this case – see para 0003, 0006-0008, para 0065, and para 0069-0073),
wherein a time period between consecutive recursive analyses varies (see para 0069-0073 and claims 23-24 – the cardiac signals can be evaluated during a no recharge phase and/or passive recharge phase, where the passive recharge phase can vary (ranging from 264-396 microseconds)).
Regarding claim 23, Stanslaski teaches:
processing circuitry configured to:
control the stimulation generation circuitry to generate the first stimulation signal having the first stimulation recharge parameter for delivery to the target anatomy (see figs. 1-2, para 0002, para 0006, para 0026, and para 0042);
receive from the sensing circuitry the sensed evoked response signal (neurological signals – see para 0005 and para 0034)
analyze the sensed evoked response signal (physiological/ neurological signals) for one or more artifacts (where artifacts are the non-neurological signals that produce these unwanted artifacts – see abstract and para 0005);
adjust, based on the one or more artifacts, the first stimulation recharge parameter to determine a second stimulation recharge parameter (the second stimulation recharge parameter is the subsequent recharge parameter delivered after the first recharge parameter is delivered an evaluated – see para 0025, para 0047-0048);
and control the stimulation generation circuitry/stimulation engine to generate a second stimulation signal having the second stimulation recharge parameter for delivery to the target anatomy/brain or spinal cord (see para 0002, para 0006-0008, and para 0046-0049). Due to the adjustment of the recharge parameter (amplitude ratio) occurring repeatedly until the stimulation artifact is minimized, the stimulation engine generates a second stimulation signal having a second stimulation recharge parameter that is modified in response to the first stimulation recharge parameter.
However, Stanslaski does not explicitly disclose a non-transitory computer-readable storage medium including instructions, which, when executed, cause the processing circuitry configured to perform and control the device and method, and wherein the sensing circuitry is configured to sense an evoked response signal responsive to the first stimulation signal.
Yet, Dinsmoor teaches devices, system and methods for controlling stimulation therapy delivered to a patient (see abstract, lines 1-4). The system (figs. 1-2A) teaches a non-transitory computer-readable storage medium including instructions, which, when executed, cause the processing circuitry to perform the method in order to control the device (see para 0065-0066 and para 0208), and wherein the sensing circuitry is configured to sense an evoked response signal responsive to the first stimulation signal (see abstract, last sentence: “The system may also be configured to sense, after one or more control pulses and prior to an immediately subsequent therapy pulse of the plurality of therapy pulses, a respective evoked compound action potential (ECAP), adjust, based on at least one respective ECAP, one or more parameter values that at least partially defines the plurality of therapy pulses, and deliver the electrical stimulation therapy to the patient according to the adjusted one or more parameter values.”, fig. 2A – 212, para 0065).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Stanslaski with the teachings of Dinsmoor to arrive at the claimed invention. Such combination would result in a reasonable expectation for success, since the prior art of Stanslaski in combination with Dinsmoor discusses minimizing and eliminating the measurement of one or more artifacts (unwanted physiological signals) in order to improving sensing capabilities of the target neurological signals (such as ECAPs discussed by Dinsmoor), ultimately improving stimulation therapy for precise stimulation to the target anatomy.
Claims 7 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Stanslaski in view of Dinsmoor, and further in view US 2006/0224199 A1 to Zeijlemaker et al. (hereinafter “Zeijlemaker”).
Regarding claims 7 and 18, Stanslaski as modified teaches:
The device and method of claims 1 and 12, but does not explicitly disclose wherein the device and method comprises recharge adjustments prompted by the processing circuitry, further comprises telemetry circuitry,
and wherein the processing circuitry is further configured to determine that a request to perform a recharge adjustment has been received by the telemetry circuitry (prior to analyzing the sensed evoked response signal for one or more artifacts) to trigger analyzing the sensed evoked response signal for one or more artifacts, and wherein the processing circuitry analyzes the sensed evoked response signal for the one or more artifacts based on the received request to perform the recharge adjustment.
However, Dinsmoor teaches wherein a clinician or patient interfaces with an external programmer to transmit therapy stimulation program, ECAP test stimulation programs, and stimulation parameter adjustments through the use of wireless telemetry (see para 0055 and para 0057), and wherein the telemetry circuitry is configured to receive signals from the external programmer and transmit them to the processing circuitry in regards to updates/adjustments to the programs (such as the ECAP therapy programs) for updating/adjusting values for stimulation parameters via the telemetry circuitry (see para 0065 and para 0075), and wherein the system is configured to identify stimulation artifacts in the stimulation signal (para 0062, para 0106), but does not explicitly disclose wherein the processing circuitry is further configured to determine that a request to perform a recharge adjustment has been received by the telemetry circuitry to trigger analyzing the sensed evoked response signal for one or more artifacts,
and wherein the processing circuitry analyzes the sensed evoked response signal for the one or more artifacts based on the received request to perform the recharge adjustment.
However, Zeijlemaker teaches an Implantable medical device (IMD) for providing pacing therapy to the heart (see abstract and para 0001). The system (fig. 2) comprises programming circuitry, telemetry circuitry (see para 0028 and para 0031: “ It is generally preferred that the particular programming and telemetry scheme selected permit the entry and storage of cardiac rate-response parameters. The specific embodiments of antenna 56, input/output circuit 54 and telemetry unit 78 presented herein are shown for illustrative purposes only, and are not intended to limit the scope of the present invention.”), and processing circuitry (processor – see para 0012, emphasis on first sentence and last two sentences), and wherein the processing circuitry/processor is further configured to determine that a request to perform a recharge adjustment has been received by the telemetry circuitry to trigger analyzing the sensed cardiac signal for one or more artifacts (see para 0031, last sentence: “It is generally preferred that the particular programming and telemetry scheme selected permit the entry and storage of cardiac rate-response parameters.”, para 0060-0061, and para 0065). The telemetry circuitry/scheme can be configured to permit entry and storage of the cardiac rate-responsive parameters, while the processor (which is included in the IMD) contains memory that is configured to make a determination as to whether or not compensation is needed based on a comparison measured polarization and the stored polarization. If it is determined that the pacing polarization artifact amplitude is at a desirable level, the process (shown in fig. 6) loops back to step 100 to deliver stimulation pulses, but if the artifact is not at the desired level, a recharge amplitude is subsequently adjusted for the subsequent recharge pulse (as shown and explained is fig. 6—steps 104,106,108,110, and 112, fig. 8, para 0065, and para 0071).
and wherein the processing circuitry analyzes the sensed cardiac signal for the one or more artifacts based on the received request to perform the recharge adjustment (instructions that determine if a recharge adjustment is necessary or not based on a determination of satisfying one or more desirable levels—see para 0013, para 0065, and para 0071).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the modified system of Stanslaski with the telemetry circuitry, programming circuitry, adjustment system of Dinsmoor and the adjustment system of Zeijlemaker to arrive at the claimed invention. Such modifications would improve the system by allowing the system to compensate for unwanted artifacts present in the sensed ECAP signal, ultimately allowing for more accurate and precise stimulation treatment for the patient.
Claims 8 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Stanslaski in view of Dinsmoor, and further in view US 2021/0187302 A1 to Pulliam et al. (hereinafter “Pulliam”).
Regarding claims 8 and 19, Stanslaski as modified teaches:
The device and method of claims 1 and 12, but does not explicitly disclose wherein the processing circuitry is further configured to determine to analyze the sensed evoked response signal in response to at least one of a change in stimulation parameters, a change in patient posture, or a change in patient activity level.
However, Pulliam teaches systems and techniques for adjusting electrical stimulation based on a patient’s posture state (see abstract, lines 1-3). The system and technique/method (see figs. 1-2, figs. 7-8) teach wherein the processing circuitry is further configured to determine to analyze the sensed evoked response signal in response to at least one of a change in stimulation parameters, a change in patient posture, or a change in patient activity level (see abstract, last sentence: “ The processing circuitry may also be configured to receive, from a sensor, a posture state signal representing a posture state of the patient, determine, based on the posture state signal, a gain value for the stimulation parameter, adjust, based on the characteristic value of the ECAP signal and the gain value, the first value of the stimulation parameter to a second value of the stimulation parameter, and control delivery of the electrical stimulation according to the second value of the stimulation parameter.” And para 0007).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified teachings of Stanslaski with the method and system of Pulliam to arrive at the claimed invention. Such modification would improve the system by ensuring the proper stimulation level is being applied to the patient based on activity and/or posture of the patient, therefore preventing painful and/or improper stimulation treatment to the patient.
Claims 9 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Stanslaski in view of Dinsmoor, and further in view of US 2010/0168814 A1 to Kim et al. (hereinafter “Kim”).
Regarding claims 9 and 20, Stanslaski as modified teaches:
The device and method of claims 1 and 12, wherein the one or more artifacts comprises a plurality of artifacts (see abstract: “Non-neurological sources of artifacts within the sensed physiological signal may be handled by providing a brief period of passive recharge followed by a lengthy period of no recharge, which is made possible by the use of the active recharge pulse prior to the passive recharge. ”, and para 0025), but does not disclose wherein the processing circuitry is further configured to independently evaluate each of the plurality of artifacts.
However, Kim teaches methods and systems for detecting and cancelling pacing artifacts from a cardiac signal (see abstract). The system (figs. 1 and 4-5) teaches wherein the processing circuitry is further configured to independently evaluate each of the plurality of artifacts (see fig. 4, 420-450, para 0050, para 0058, and claims 5 and 16).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified teachings of Stanslaski with the teachings of Kim to arrive at the claimed invention. Such modification would improve the system by ensuring the proper artifacts are accurately differentiated from the ECAP signal, ultimately allowing for improved stimulation therapy for the patient.
Allowable Subject Matter
Claims 4, 10-11, 15, and 21-22 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
The closest Prior Art of record is considered is US 2018/0243564 A1 to Stanslaski, US 2019/0388692 A1 to Dinsmoor, and US 2010/0168814 A1 to Kim et al. (hereinafter “Kim”).
Regarding claims 4 and 15, Stanslaski as modified teaches the device and method of claims 3 and 14, wherein the first stimulation signal comprises one of the active recharge phase, the passive recharge phase, or the hybrid active/passive recharge phase (active recharge phase – abstract and claim 1), but does not disclose
wherein the passive recharge phase comprises a truncated or paused passive recharge phase and the hybrid active/passive recharge phase comprises a hybrid active/truncated passive recharge phase or a hybrid active/paused passive recharge phase,
wherein the processing circuitry is further configured to determine that delivery of stimulation is not time constrained
and wherein the second stimulation signal is a full passive recharge phase
and wherein the processing circuitry adapts the first stimulation signal to be the full passive recharge phase based on the determination that the delivery of stimulation is not time constrained.
Dinsmoor teaches a passive recharge phase (see para 0053: “Like the electrical stimulation therapy, the control stimulation may be in the form of electrical stimulation pulses or continuous waveforms. In one example, each control pulse may include a balanced, bi-phasic square pulse that employs an active recharge phase. However, in other examples, the control pulses may include a monophasic pulse followed by a passive recharge phase. In other examples, a control pulse may include an imbalanced bi-phasic portion and a passive recharge portion. ”),
but does not explicitly disclose wherein the second stimulation signal is a full passive recharge phase, and wherein the processing circuitry adapts the first stimulation signal to be the full passive recharge phase based on the determination that the delivery of stimulation is not time constrained.
Regarding claims 10 and 21, Stanslaski as modified teaches the device and method of claims 9 and 12, but does not disclose wherein as part of independently evaluating each of the plurality of artifacts, the processing circuitry is configured to use superposition of each of the plurality of artifacts by toggling on and off specific stimulus one at a time.
Kim teaches independently evaluating each of the plurality of artifacts (see fig. 4, 420-450, para 0058, and claims 5 and 16), but does not disclose wherein the processing circuitry is configured to use superposition of each of the plurality of artifacts by toggling on and off specific stimulus one at a time.
Regarding claims 11 and 22, Stanslaski as modified teaches:
The device and method of claims 1 and 12, but does not disclose wherein as part of analyzing the sensed evoked response signal for the one or more artifacts, the processing circuitry if configured to:
determine at least one of a slope of an artifact, a total area under a curve of the artifact, a curvature of the artifact, a time constant of the artifact, or a presence or absence of amplifier saturation;
and compare the at least one of the slope of an artifact, the total area under the curve of the artifact, the curvature of the artifact, the time constant of the artifact, or the presence or absence of amplifier saturation to a respective threshold,
wherein adjusting the first stimulation recharge parameter to determine a second stimulation recharge parameter is based on the comparison.
Kim teaches wherein as part of analyzing the sensed evoked response signal for the one or more artifacts, the processing circuitry if configured to:
determine at least one of a slope of an artifact, a total area under a curve of the artifact, a curvature of the artifact, a time constant of the artifact, or a presence or absence of amplifier saturation (see para 0041 and para 0058), but does not explicitly disclose
comparing the at least one of the slope of an artifact, the total area under the curve of the artifact, the curvature of the artifact, the time constant of the artifact, or the presence or absence of amplifier saturation to a respective threshold, wherein adjusting the first stimulation recharge parameter to determine a second stimulation recharge parameter is based on the comparison.
After further search and consideration, no single reference or combination of references could be found which could properly reject any of the pending claims. As such, claims 4, 10-11, 15, and 21-22 are allowed.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 2016/0303376 A1 to Dinsmoor et al. teaches systems, devices, and methods for delivering and adjusting stimulation therapy applied to a patient (abstract).
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/K.J.W./Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792