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 § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea (i.e. specifically a mental process) without significantly more.
Regarding claim 1:
The claim(s) recite(s): “determine a measure based on the ECAP response and the evoked stimulation response; and to determine whether to adjust one or more of the plurality of stimulation parameters of the stimulation therapy based on the measure.”. This is a mental process because the human mind is fully capable of determining a measure and adjusting parameters on this measure. This judicial exception is not integrated into a practical application because the additional limitations of “output a stimulation therapy through the electrode platform, wherein the stimulation therapy is defined by a plurality of stimulation parameters”, “process the plurality of stimulation parameters to determine if the stimulation therapy is above a known activation threshold that elicits an evoked compound action potential (ECAP) response”, “in response to the stimulation therapy being above the known activation threshold, sense electrical activity of tissue resulting from a delivery of a stimulation therapy to the tissue, wherein the sensed electrical activity includes a stimulation response comprising an evoked stimulation response, a stimulation artifact and an ECAP response, and “in response to the stimulation therapy being below the known activation threshold, refrain from sensing electrical activity of the tissue resulting from the stimulation therapy, and adjusting one or more of the plurality of stimulation parameters until the stimulation therapy is above a known activation threshold” are merely gathering information and therefore are insignificant pre-solution activity. As ruled by Parker v. Flook, 437 U.S. 584, 588-89, 198 USPQ 193, 196 (1978) in MPEP 2106.05(g) such insignificant extra-solution activity does not integrate the judicial exception into a practical application. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims merely recite a generic electrode platform which is interpreted as some type of generic electric lead, a generic sensor/recorder, generic transceivers and a generic processor. These elements are well known and conventional in the field of electrical stimulation devices as evidenced by disclosure in Buddha et al (US 20220118251) hereafter known as Buddha [see Fig. 1 element 265 and para 97 for the electrode platform, see Fig. 1 element 233 and see para 200 for pulse generator, see Fig. 1 element 260 and see para 97 for sensor/recorder, and see Fig. 1 element 230 and 240 and para 163 for transceivers, and Fig. 1 element 550 and para 121 for controller (i.e. processor)] and Offutt et al (US-20220331586) hereafter known as Offutt [see Fig. 2A elements 230 for electrode platform, see Fig. 2A element 202 for pulse generator, see Fig. 2A elements 222 for sensor/recorder, see para 67… “wirelessly transmit a signal” and Fig. 2A element 210 for processor]. Thus, because these additional elements are well known and conventional these structures don’t amount to significantly more than the judicial exception Therefore, as the mental process (i.e. the judicial exception) is not integrated into a practical application and the additional structures do not amount to significantly more than the judicial exception. Thus, claim 1 is rejected under 101.
Regarding claims 2-10, these limitations only further define the mental process and do not further integrate the judicial exception into a practical application or amount to significantly more than the judicial exception. Thus, claims 2-10 are rejected under 35 USC 101 for similar reasons as claim 1.
Regarding claim 12, the claim(s) recite(s):
“b) in response to the stimulation therapy being above the known activation threshold:
i) electrical activity of the tissue resulting from a delivery of a stimulation therapy to the tissue through the implanted neurostimulation device, wherein the sensed electrical activity includes a stimulation response comprising an evoked stimulation response, a stimulation artifact and an ECAP response;
ii) determining a measure based on the ECAP response and the evoked stimulation response; and
iii) determining whether to adjust one or more of the plurality of stimulation parameters of the stimulation therapy based on the measure; and
c) in response to the stimulation therapy being below the known activation
threshold:
i) refraining from sensing electrical activity of the tissue resulting from the stimulation therapy; and
ii) adjusting one or more of the plurality of stimulation parameters until the stimulation therapy is above a known activation threshold.”
This is a mental process because the human mind is fully capable of reading data to determine whether parameters need to be adjusted and/or sensing stopped. This judicial exception is not integrated into a practical application because the additional limitation of “processing the plurality of stimulation parameters to determine if the stimulation therapy is above a known activation threshold that elicits an evoked compound action potential (ECAP) response” is merely gathering information and therefore is insignificant pre-solution activity. As ruled by Parker v. Flook, 437 U.S. 584, 588-89, 198 USPQ 193, 196 (1978) in MPEP 2106.05(g) such insignificant extra-solution activity does not integrate the judicial exception into a practical application. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claim doesn’t positively recite any additional structures. However, at most there is recited the use of a generic stimulation device and a generic sensor. These elements are well known and conventional in the field of electrical stimulation devices as evidenced by disclosure in Buddha [see Fig. 1 element 265 and para 97 for the electrical stimulation device and see Fig. 1 element 260 and see para 97 for sensor/recorder] and Offutt [see Fig. 2A elements 230 for the electrical stimulation device, and see Fig. 2A elements 222 for sensor/recorder]. Thus, because these additional elements are well known and conventional these structures don’t amount to significantly more than the judicial exception Therefore, as the mental process (i.e. the judicial exception) is not integrated into a practical application and the additional structures do not amount to significantly more than the judicial exception. Thus, claim 12 is rejected under 101.
Regarding claims 13-22, these limitations only further define the mental process and do not further integrate the judicial exception into a practical application or amount to significantly more than the judicial exception. Thus, claims 2-10 are rejected under 35 USC 101 for similar reasons as claim 12.
Claim Rejections - 35 USC § 102
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.
(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.
Claim(s) 1-2, 9, 12-13, 20 and 22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Buddha et al (US 20220118251) hereafter known as Buddha.
Independent claim
Regarding claim 1:
A neuromodulation system [see Fig. 1 element 10 and para 105… “Apparatus 10 can be configured to stimulate tissue (e.g. stimulate nerve tissue such as tissue of the central nervous system or tissue of the peripheral nervous system, such as to neuromodulate nerve tissue),”] comprising:
an implantable neuromodulation [see Fig. 1 element 200 and para 105… “one or more implantable devices 200 deliver and/or otherwise provide energy (hereinafter “deliver energy”)”] device comprising:
an electrode platform [see Fig. 1 element 265 and para 97… “stimulation element 260 shown, where stimulation elements 260 are configured to deliver stimulation energy, a stimulating drug or other agent, and/or another form of stimulation (e.g. another form of tissue stimulation) to the patient. In some embodiments, one or more stimulation elements 260 are further configured as a sensor (e.g. when comprising an electrode configured to both deliver electrical energy and record electrical signals). Each implantable device 200 can include one or more leads, lead 265 shown, and each lead 265 can include one or more stimulation elements 260. Alternatively or additionally, one or more stimulation elements 260 can be positioned on housing 210 or one or more other components of implantable device 200.”];
an pulse generator coupled to the electrode platform and configured to output a
stimulation therapy through the electrode platform [see Fig. 1 element 233 and para 200… “Power converter 233 can comprise one or more voltage conversion elements such as DC-DC converters that boost or otherwise change the voltage to a desired level. In some embodiments, voltage conversion is achieved with a buck-boost converter, a boost converter, a switched capacitor, and/or charge pumps. One or more power converters 233 can interface with energy storage assembly 270 and charge up associated energy storage components to desired voltages.”],
wherein the stimulation therapy is defined by a plurality of stimulation parameters [see para 87…. “The terms “stimulation parameter”, “stimulation signal parameter” or “stimulation waveform parameter” where used herein can be taken to refer to one or more parameters of a stimulation waveform (also referred to as a stimulation signal). Applicable stimulation parameters of the present inventive concepts shall include but are not limited to: amplitude (e.g. amplitude of voltage and/or current); average amplitude; peak amplitude; frequency; average frequency; pulse width (also referred to as “pulse pattern on time”); period;”],
a sensor/recorder coupled to the electrode platform [see Fig. 1 element 260 and para 97… “one or more stimulation elements 260 are further configured as a sensor (e.g. when comprising an electrode configured to both deliver electrical energy and record electrical signals).”] and configured to:
process the plurality of stimulation parameters to determine if the stimulation therapy is above a known activation threshold that elicits an evoked compound action potential (ECAP) response [see para 96… “a medical apparatus comprises a stimulation apparatus for activating, blocking, affecting or otherwise stimulating (hereinafter “stimulate” or “stimulating”) tissue of a patient, such as nerve tissue or nerve root tissue (hereinafter “nerve”, “nerves”, “nerve tissue” or “nervous system tissue”).” And para 226… “Stimulation elements 260 can be positioned to: depolarize, hyperpolarize and/or block innervated sections of the muscle that will then propagate an activating and/or inhibiting stimulus along the nerve fibers recruiting muscle tissue remote from the site of stimulation and/or modulate nerve activity (including inhibiting nerve conduction, improving nerve conduction and/or improving muscle activity).” And para 591… “a stimulation waveform is applied and the artifact is recorded with amplifier 2110 in a low gain setting, such that the artifact falls within an amplifier 2110 dynamic range. To record the artifact without the ECAP signal, one stimulation pulse can be followed by a second pulse within the refractory period of the neurons, such that there is minimal or no ECAP signal following the second pulse.” ];
in response to the stimulation therapy being above the known activation threshold, sense electrical activity of tissue resulting from a delivery of a stimulation therapy to the tissue [see para 96… “a medical apparatus comprises a stimulation apparatus for activating, blocking, affecting or otherwise stimulating (hereinafter “stimulate” or “stimulating”) tissue of a patient, such as nerve tissue or nerve root tissue (hereinafter “nerve”, “nerves”, “nerve tissue” or “nervous system tissue”).” And para 226… “Stimulation elements 260 can be positioned to: depolarize, hyperpolarize and/or block innervated sections of the muscle that will then propagate an activating and/or inhibiting stimulus along the nerve fibers recruiting muscle tissue remote from the site of stimulation and/or modulate nerve activity (including inhibiting nerve conduction, improving nerve conduction and/or improving muscle activity).” And para 591… “a stimulation waveform is applied and the artifact is recorded with amplifier 2110 in a low gain setting, such that the artifact falls within an amplifier 2110 dynamic range. To record the artifact without the ECAP signal, one stimulation pulse can be followed by a second pulse within the refractory period of the neurons, such that there is minimal or no ECAP signal following the second pulse.” A stimulation pulse is applied that is above a threshold to activate an ECAP response],
wherein the sensed electrical activity includes a stimulation response comprising an evoked stimulation response, a stimulation artifact and an ECAP response [see Fig. 31A & 310-H and para 59… “FIG. 31A is two graphs of electrically-evoked compound
action potential signals, consistent with the present inventive concepts.'; [0061]. 'FIG. 31 D-H are graphs of artifact recordings and electrically-evoked compound action potential signals, consistent with the present inventive concepts.” And para 270… “Implantable device 200 can deliver stimulation energy to the stimulation elements 260 comprising low-voltage electrical stimulation configured to produce sensor and/or motor responses” and para 400… “A check of a desired physiologic response can be performed during the test stimulation” and para 567… “The ratio between WDR responses before and after SCS was taken as a metric of neural inhibition in five WDR cells, such that a lower value corresponds to increased inhibition” and para 584… “In the field of neurostimulation and neuromodulation, a recurring challenge is the measurement of electrically-evoked compound action potential (ECAP) signals. ECAPs are small voltage transients that are produced by neural tissue in response to electrical stimulation. These signals can be observed near the site of the applied stimulation, at roughly 200
μsec after the onset of the stimulation pulse. The magnitude of the ECAP, as well as the timing between peaks in the ECAP waveform, vary with the number of neurons recruited by the stimulation pulse. Thus, ECAP recordings can be an objective measure of the effectiveness of the stimulation” The stimulation response is how the patient responds to the stimulation and is slightly different than the measured ECAP]; and
in response to the stimulation therapy being below the known activation threshold, refrain from sensing electrical activity of the tissue resulting from the stimulation therapy, [see para 96… “a medical apparatus comprises a stimulation apparatus for activating, blocking, affecting or otherwise stimulating (hereinafter “stimulate” or “stimulating”) tissue of a patient, such as nerve tissue or nerve root tissue (hereinafter “nerve”, “nerves”, “nerve tissue” or “nervous system tissue”).” And para 226… “Stimulation elements 260 can be positioned to: depolarize, hyperpolarize and/or block innervated sections of the muscle that will then propagate an activating and/or inhibiting stimulus along the nerve fibers recruiting muscle tissue remote from the site of stimulation and/or modulate nerve activity (including inhibiting nerve conduction, improving nerve conduction and/or improving muscle activity).” And para 591… “a stimulation waveform is applied and the artifact is recorded with amplifier 2110 in a low gain setting, such that the artifact falls within an amplifier 2110 dynamic range. To record the artifact without the ECAP signal, one stimulation pulse can be followed by a second pulse within the refractory period of the neurons, such that there is minimal or no ECAP signal following the second pulse.” If a stimulation pulse is applied that is below a threshold to activate an ECAP response, then there is no ECAP to sense and transmit] and adjusting one or more of the plurality of stimulation parameters until the stimulation therapy is above a known activation threshold [Fig. 1 and para 95… “The collected information and/or diagnosis can be used to adjust treatment or other operating parameters of the medical apparatus” and para 109… “the parameters of the stimulation signal can be changed” and para 114… “one or more functional elements of
apparatus 10 (e.g. one or more stimulation elements 260, functional elements 299, functional elements 599 and/or other functional elements of implantable system 20) are configured (e.g. further configured) to record a patient parameter (e.g. stimulation element 260, functional element 299, functional element 599, and/or another functional element of apparatus 10 are configured as a sensor), ... and the information recorded is used to adjust the delivered stimulation signals” and para 217… “the medical therapy can be performed in a closed-loop fashion, such as when energy and/or agent delivery is modified based on the measured one or more patient physiologic parameters” and para 313… “The stimulation waveform frequency or other stimulation parameter can be set and/or adjusted (hereinafter "adjusted") to optimize therapeutic benefit to the patient and minimize undesired effects (e.g. paresthesia or other patient discomfort). In some embodiments, a stimulation waveform is adjusted based on a signal produced by a sensor of apparatus 10 (e.g. a sensor of implantable device 200, such as a stimulation element 260 configured as a sensor or other sensor of implantable device 200 as described hereabove). Adjustment of a stimulation waveform parameter can be performed automatically by the implantable device 200 and/or via an external device 500 and/or programmer 600).” And para 584… “For example, ECAP recordings have been used ... to adaptively control stimulation amplitude in response to anatomical movement in spinal cord stimulation (SCS) systems”]
a transceiver [see Fig. 1 elements 230 and 240] coupled to the sensor/recorder [see Fig. 1 element 260] and configured to transmit a sensed signal corresponding to the electrical activity [see Fig. 1 and para 163… “Each implantable device 200 can comprise one or more stimulation elements 260, configured to stimulate, deliver energy to, deliver an agent to, record information from and/or otherwise interface with the patient. Alternatively or additionally, the one or more stimulation elements 260 can be configured as a sensor, such as to record patient information. Each implantable device 200 can comprise housing 210, receiver 230, controller 250, energy storage assembly 270 and/or one or more antennas 240, each described in detail herein.” And para 164… “one or more implantable devices 2oo·are further configured to transmit data to one or more external devices 500, such as via one or more antennas 240 transmitting a signal to one or more antennas 540, or otherwise. Data transmitted by an implantable device 200 can comprise patient information (e.g. patient physiologic information recorded oy one or more stimulation elements 260 configured as a physiologic sensor);” and para 187… “data rate of data transmitted by the first implantable device 200 at least one implantable antenna 240” and para 201… “Alternatively or additionally, lead 265 can comprise one or more stimulation elements 260 and/or functional elements 299b that is configured as a physiologic sensor (e.g. an electrode configured to record electrical activity of tissue or another physiologic sensor as described herein)”]; and
an external unit [see Fig. 1 element 50 and para 109… “apparatus 10 is configured as a stimulation apparatus in which external system 50 transmits a power signal to one or more implantable devices 200, and the one or more implantable devices 200”] comprising:
a transceiver [see Fig. 1 elements 530 and 540] configured to receive the sensed signal from the implantable neuromodulation device [see para 136… “Transmitter 530 is operably attached to antenna 540 and is configured to provide one or more drive signals to antenna 540, such as one or more power signals and/or data signals transmitted to one or more implantable devices 200 of implantable system 20;” and para 139 “In some embodiments, transmitter 530 (and/or another component of external system 50) is further configured as a receiver (e.g. can further include a receiver, in addition to a transmitter or include a transmitter that further functions as a receiver), such as to receive data from implantable system 20. For example, a transmitter 530 can be configured to receive data via one or more antennas 240 of one or more implantable devices 200. Data received can include patient information (e.g. patient physiologic information, patient environment information or other patient information)” and para 186… “the power signal and/or the RF path for the power signal can be adjusted to optimize power efficiency (e;g. by tuning matching network on transmitter 530 and/or receiver 230; configuring antennas 540 and/or 240 in an array; tuning operating frequency; duty cycling the power signal; adjusting antenna 540 and/or 240 position; and the like)”]; and
a processor [see Fig. 1 element 550] configured to determine a measure based on the ECAP response and the evoked stimulation response; and to determine whether to adjust one or more of the plurality of stimulation parameters of the stimulation therapy based on the measure [see Fig. 1 and para 567… “Applicant monitored both the spontaneous activity and evoked activity of the rat WDR cells before and after spinal
cord stimulation (SGS) was delivered in the form of ·NTS 1 and Burst1. The ratio between WDR responses before and after SGS was taken as a metric of neural inhibition in five WDR cells, such that a lower value corresponds to increased inhibition” and para 584… “These signals can be observed near the site of the applied stimulation, at roughly 200 micro sec after the onset of the stimulation pulse. The magnitude of
the ECAP, as well as the liming between peaks in the ECAP waveform, vary with the number of neurons recruited by the stimulation pulse” and 592… “Next, a recording of the ECAP signal can be performed, with amplifier 2110 at a high gain setting (e.g.
a setting configured to provide sufficient resolution to the ECAP signal) ... The ECAP signal, with a small residual artifact, can be accurately digitized by ADC 2120. Conventional artifact cancellation techniques, such as forward masking or template subtraction, can then be applied to fully extract the ECAP signal” The spontaneous activity and evoked activity where both measures, and the responses can form a
ratio [measure]]; and to determine whether to adjust one or more of the plurality of stimulation parameters of the stimulation therapy based on the measure [see Fig.
1 and para 95… “The collected information and/or diagnosis can be used to adjust treatment or other operating parameters of the medical apparatus” and para 109… “the parameters of the stimulation signal can be changed” and para 114… “one or more functional elements of apparatus 10 (e.g. one or more stimulation elements 260, functional elements 299, functional elements 599 and/or other functional elements of implantable system 20) are configured (e.g. further configured) to record a patient parameter (e.g. stimulation element 260, functional element 299, functional element 599, and/or another functional element of apparatus 10 are configured as a sensor), ... and the information recorded is used to adjust the delivered stimulation signals” and para 217… “the medical therapy can be performed in a closed-loop fashion, such as when energy and/or agent delivery is modified based on the measured one or more patient physiologic parameters” and para 313… “The stimulation waveform frequency or other stimulation parameter can be set and/or adjusted (hereinafter "adjusted") to optimize therapeutic benefit to the patient and minimize undesired effects (e.g. paresthesia or other patient discomfort). In some embodiments, a stimulation waveform is adjusted based on a signal produced by a sensor of apparatus 10 (e.g. a sensor of implantable device 200, such as a stimulation element 260 configured as a sensor or other sensor of implantable device 200 as described hereabove). Adjustment of a stimulation waveform parameter can be performed automatically by the implantable device 200 and/or via an external device 500 and/or programmer 600” and para 584… “For example, ECAP recordings have been used to perform objective fitting in cochlear implant systems, and to adaptively control stimulation amplitude in response to anatomical movement in spinal cord stimulation (SCS) systems”].
Independent claim:
Regarding claim 12:
A method of adjusting stimulation therapy delivered to tissue of a patient by an implanted neuromodulation device, the method [see Fig. 1 and para 95… “The collected information and/or diagnosis can be used to adjust treatment or other operating parameters of the medical apparatus.”],
wherein the stimulation therapy is defined by a plurality of stimulation parameters, the method comprising:
a) processing the plurality of stimulation parameters to determine if the stimulation therapy is above a known activation threshold that elicits an evoked compound action potential (ECAP) response [see para 96… “a medical apparatus comprises a stimulation apparatus for activating, blocking, affecting or otherwise stimulating (hereinafter “stimulate” or “stimulating”) tissue of a patient, such as nerve tissue or nerve root tissue (hereinafter “nerve”, “nerves”, “nerve tissue” or “nervous system tissue”).” And para 226… “Stimulation elements 260 can be positioned to: depolarize, hyperpolarize and/or block innervated sections of the muscle that will then propagate an activating and/or inhibiting stimulus along the nerve fibers recruiting muscle tissue remote from the site of stimulation and/or modulate nerve activity (including inhibiting nerve conduction, improving nerve conduction and/or improving muscle activity).” And para 591… “a stimulation waveform is applied and the artifact is recorded with amplifier 2110 in a low gain setting, such that the artifact falls within an amplifier 2110 dynamic range. To record the artifact without the ECAP signal, one stimulation pulse can be followed by a second pulse within the refractory period of the neurons, such that there is minimal or no ECAP signal following the second pulse.” ];
b) in response to the stimulation therapy being above the known activation threshold:
i) sensing electrical activity of the tissue resulting from a delivery of a stimulation therapy to the tissue through the implanted neurostimulation device [see Fig. 1 element 260 and para 97… “one or more stimulation elements 260 are further configured as a sensor (e.g. when comprising an electrode configured to both deliver electrical energy and record electrical signals).”], wherein the sensed electrical activity includes a stimulation response comprising an evoked stimulation response, a stimulation artifact and an ECAP response [see Fig. 31A & 310-H and para 59… “FIG. 31A is two graphs of electrically-evoked compound
action potential signals, consistent with the present inventive concepts.” And para 61… “FIG. 31 D-H are graphs of artifact recordings and electrically-evoked compound action potential signals, consistent with the present inventive concepts.” And para 270… “Implantable device 200 can deliver stimulation energy to the stimulation elements 260 comprising low-voltage electrical stimulation configured to produce sensor and/or motor responses” and para 400… “A check of a desired physiologic response can be performed during the test stimulation” and para 567… “The ratio between WDR responses before and after SCS was taken as a metric of neural inhibition in five WDR cells, such that a lower value corresponds to increased inhibition” and para 584… “In the field of neurostimulation and neuromodulation, a recurring challenge is the measurement of electrically-evoked compound action potential (ECAP) signals. ECAPs are small voltage transients that are produced by neural tissue in response to electrical stimulation. These signals can be observed near the site of the applied stimulation, at roughly 200 μsec after the onset of the stimulation pulse. The magnitude of the ECAP, as well as the timing between peaks in the ECAP waveform, vary with the number of neurons recruited by the stimulation pulse. Thus, ECAP recordings can be an objective measure of the effectiveness of the stimulation”; The stimulation response is how the patient responds to the stimulation and is slightly different than the measured ECAP);];
ii) determining a measure based on the ECAP response and the evoked stimulation response [see Fig. 1 and para 567… “Applicant monitored both the spontaneous activity and evoked activity of the rat WDR cells before and after spinal
cord stimulation (SGS) was delivered in the form of ·NTS 1 and Burst1. The ratio between WDR responses before and after SGS was taken as a metric of neural inhibition in five WDR cells, such that a lower value corresponds to increased inhibition” and para 584… “These signals can be observed near the site of the applied stimulation, at roughly 200 micro sec after the onset of the stimulation pulse. The magnitude of
the ECAP, as well as the liming between peaks in the ECAP waveform, vary with the number of neurons recruited by the stimulation pulse” and 592… “Next, a recording of the ECAP signal can be performed, with amplifier 2110 at a high gain setting (e.g.
a setting configured to provide sufficient resolution to the ECAP signal) ... The ECAP signal, with a small residual artifact, can be accurately digitized by ADC 2120. Conventional artifact cancellation techniques, such as forward masking or template subtraction, can then be applied to fully extract the ECAP signal” The spontaneous activity and evoked activity where both measures, and the responses can form a ratio [measure]] ; and
iii) determining whether to adjust one or more of the plurality of stimulation parameters of the stimulation therapy based on the measure [see Fig. 1 and para 95… “The collected information and/or diagnosis can be used to adjust treatment or other operating parameters of the medical apparatus” and para 109… “the parameters of the stimulation signal can be changed” and para 114… “one or more functional elements of apparatus 10 (e.g. one or more stimulation elements 260, functional elements 299, functional elements 599 and/or other functional elements of implantable system 20) are configured (e.g. further configured) to record a patient parameter (e.g. stimulation element 260, functional element 299, functional element 599, and/or another functional element of apparatus 10 are configured as a sensor), ... and the information recorded is used to adjust the delivered stimulation signals” and para 217… “the medical therapy can be performed in a closed-loop fashion, such as when energy and/or agent delivery is modified based on the measured one or more patient physiologic parameters” and para 313… “The stimulation waveform frequency or other stimulation parameter can be set and/or adjusted (hereinafter "adjusted") to optimize therapeutic benefit to the patient and minimize undesired effects (e.g. paresthesia or other patient discomfort). In some embodiments, a stimulation waveform is adjusted based on a signal produced by a sensor of apparatus 10 (e.g. a sensor of implantable device 200, such as a stimulation element 260 configured as a sensor or other sensor of implantable device 200 as described hereabove). Adjustment of a stimulation waveform parameter can be performed automatically by the implantable device 200 and/or via an external device 500 and/or programmer 600” and para 584… “For example, ECAP recordings have been used to perform objective fitting in cochlear implant systems, and to adaptively control stimulation amplitude in response to anatomical movement in spinal cord stimulation (SCS) systems”]; and
c) in response to the stimulation therapy being below the known activation threshold:
i) refraining from sensing electrical activity of the tissue resulting from the
stimulation therapy [see para 96… “a medical apparatus comprises a stimulation apparatus for activating, blocking, affecting or otherwise stimulating (hereinafter "stimulate" or "stimulating") tissue of a patient, such as nerve tissue or nerve root tissue” and para 226… “Stimulation elements 260 can be positioned to: depolarize, hyperpolarize and/or block innervated sections of the muscle that will then propagate an activating and/or inhibiting stimulus along the nerve fibers recruiting muscle tissue remote from the site of stimulation and/or modulate nerve activity (including inhibiting nerve conduction, improving nerve conduction and/or improving muscle activity)” and para 591… “a stimulation waveform is applied and the artifact is recorded with amplifier 2110 in a low gain setting, such that the artifact falls within an amplifier 2110 dynamic range. To record the artifact without the ECAP signal, one stimulation pulse can be followed by a second pulse within the refractory period of the neurons, such that there is minimal or no ECAP signal following the second pulse” If a stimulation pulse is applied that is below a threshold to activate an ECAP response, then there is no ECAP to sense and transmit]; and
ii) adjusting one or more of the plurality of stimulation parameters until the stimulation therapy is above a known activation threshold [Fig. 1 and para 95… “The collected information and/or diagnosis can be used to adjust treatment or other operating parameters of the medical apparatus” and para 109… “the parameters of the stimulation signal can be changed” and para 114… “one or more functional elements of
apparatus 10 (e.g. one or more stimulation elements 260, functional elements 299, functional elements 599 and/or other functional elements of implantable system 20) are configured (e.g. further configured) to record a patient parameter (e.g. stimulation element 260, functional element 299, functional element 599, and/or another functional element of apparatus 10 are configured as a sensor), ... and the information recorded is used to adjust the delivered stimulation signals” and para 217… “the medical therapy can be performed in a closed-loop fashion, such as when energy and/or agent delivery is modified based on the measured one or more patient physiologic parameters” and para 313… “The stimulation waveform frequency or other stimulation parameter can be set and/or adjusted (hereinafter "adjusted") to optimize therapeutic benefit to the patient and minimize undesired effects (e.g. paresthesia or other patient discomfort). In some embodiments, a stimulation waveform is adjusted based on a signal produced by a sensor of apparatus 10 (e.g. a sensor of implantable device 200, such as a stimulation element 260 configured as a sensor or other sensor of implantable device 200 as described hereabove). Adjustment of a stimulation waveform parameter can be performed automatically by the implantable device 200 and/or via an external device 500 and/or programmer 600).” And para 584… “For example, ECAP recordings have been used ... to adaptively control stimulation amplitude in response to anatomical movement in spinal cord stimulation (SCS) systems”].
Dependent claims:
Regarding claims 2 and 13:
obtain an amplitude of the ECAP response [see Fig. 31A shows an amplitude of ECAP response and para 584… “These signals can be observed near the site of the applied stimulation, at roughly 200 μsec after the onset of the stimulation pulse. The magnitude of the ECAP, as well as the timing between peaks in the ECAP waveform, vary with the number of neurons recruited by the stimulation pulse”]; and
obtain an amplitude of the evoked stimulation response [see para 211… “stimulation element 260 and/or functional element 299 comprises one or more sensors configured to record data representing a physiologic parameter of the patient. Stimulation element 260 and/or functional element 299 can comprise one or more sensors selected from the group consisting of: ... neural activity sensor; neural spike sensor” and para 567… “Applicant monitored both the spontaneous activity and evoked activity of the rat WDR cells before and after spinal cord stimulation (SGS) was delivered in the form of NTS1 and Burst1. The ratio between WDR responses before and after SCS was taken as a metric of neural inhibition in five WDR cells, such that a lower value corresponds to increased inhibition” A neural activity can be measured as it responds to stimulation],
wherein the measure is a relationship between the amplitude of the ECAP response and the amplitude of the evoked stimulation response [see Fig. 31A & 31D-H and 270… “Implantable device 200 can deliver stimulation energy to the stimulation elements 260 comprising low-voltage electrical stimulation configured to produce sensor and/or motor responses” and para 400… “A check of a desired physiologic response can be performed during the test stimulation” and para 567… “Applicant monitored both the spontaneous activity and evoked activity of the rat WDR cells before and after spinal cord stimulation (SCS) was delivered in the form of NTS 1 and Burst1. The ratio between WDR responses before and after SGS was taken as a metric of neural inhibition in five WDR cells, such that a lower value _corresponds to increased
inhibition” and para 584… “These signals can be observed near the site of the applied stimulation, at roughly 200 μsec after the onset of the stimulation pulse. The magnitude of the ECAP, as well as the timing between peaks in the ECAP waveform, vary with the number of neurons recruited by the stimulation pulse” The spontaneous activity and evoked activity where both measures, and the responses can
form a ratio [measure]).]
Regarding claims 9 and 20:
See Fig. 1, para 114 [see… “one or more functional elements of apparatus 10(e.g. one or more stimulation elements 260, functional elements 299, functional elements 599 and/or other functional elements of implantable system 20) are configured (e.g. further configured) to record a patient parameter (e.g. stimulation element 260, functional element 299, functional element 599, and/or another functional element of apparatus 10 are configured as a sensor), ... and the information recorded is used to adjust the delivered stimulation signals”], para 217 [see… “the medical therapy can be performed in a closed-loop fashion, such as when energy and/or agent delivery is modified based on the measured one or more patient physiologic parameters], see para 313 [see… “The stimulation waveform frequency or other stimulation parameter can be set and/or adjusted (hereinafter "adjusted") to optimize therapeutic benefit to the patient and minimize undesired effects (e.g. paresthesia or other patient discomfort). In some embodiments, a stimulation waveform is adjusted based on a signal produced by a sensor of apparatus 10 (e.g. a sensor of implantable device 200, such as a stimulation element 260 configured as a sensor or other sensor of implantable device 200 as described hereabove). Adjustment of a stimulation waveform parameter can be performed automatically by the implantable ·device 200 and/or via an external device 500 and/or programmer 600).”], para 584 [see…“The magnitude of the ECAP, as well as the timing between peaks in the 'ECAP waveform; vary with the number of neurons recruited by the stimulation pulse. Thus, ECAP recordings can be an objective measure of the effectiveness of the-stimulation. For example, ECAP recordings have been used ... to adaptively control stimulation amplitude in response to anatomical movement in spinal cord stimulation (SCS) systems”], para 608 [see… “The amplitude of the stimulation is increased (e.g. to well above a threshold) to check for left versus right paresthesia”, para 610 [see… “A "staircase" method to identify a paresthesia threshold can be used, where amplitudes are increased and/or decreased (e.g. in a step-wise fashion), and the patient is queried as to whether they are feeling paresthesia. In some embodiments, at least three thresholds of paresthesia are identified (e.g. the lowest amplitude in which paresthesia is felt by the patient), such as when apparatus 10 performs a check for consistency of these thresholds. A 70% level is calculated, correlating to 0.7 times the paresthesia threshold. In some embodiments, a patient may
not provide feedback that correlates to a consistent paresthesia threshold. In these embodiments, amplitude of stimulation can be increased until a strong sensation of paresthesia is confirmed, after which the amplitude is decreased (e.g. slowly decreased) while monitoring just that particular location of paresthesia occurrence, and noting the threshold at which paresthesia is no longer present”] which describe how the ECAP-based measurement can be used to measure the effectiveness of the stimulation, Also, the control-adjustments follow the same principles as when determining paresthesia as if the measurement is too high [first threshold], the stimulation amplitude is lowed and if the measurement is too low [second threshold], then the stimulation amplitude is increased; when a proper stimulation is reached, the stimulation remains the same. Therefore, Buddha recites the limitations of claims 9 and 20.
Regarding claim 22
see Fig. 1 element 200 and para 186… “'One or more controllers 250 (singly or collectively controller 250) can be configured to control one or more stimulation elements 260, such as a stimulation element 260 comprising a stimulation-based transducer (e.g. an electrode or other energy delivery element) and/or a sensor (e.g. a physiologic sensor and/or a sensor configured to monitor an implantable device 200 parameter).” And para 213… “'Apparatus 10 can be configured to analyze (e.g. via implantable controller 250, programmer 600 and/or diagnostic assembly 62 described herebelow) the data recorded by stimulation element 260” And para 313… “therapeutic benefit to the patient and minimize undesired effects (e.g. paresthesia or other patient discomfort). In some embodiments, a stimulation waveform is adjusted based on a signal produced by a sensor of apparatus 10 (e.g. a sensor of implantable device 200, such as a stimulation element 260 configured as a sensor or other sensor of implantable device 200 as described hereabove). Which disclose how analysis and adjustment of a stimulation waveform parameter can be performed automatically by the implantable device 200. and/or via an external device 500 and/or programmer 600.” which recite the steps being performed by the implanted neuromodulation device and external unit as claimed. Additionally, as analysis can be performed on the external unit this demonstrates signals sensed from the device including sensed electrical activity being sent to the external device.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 3-8, 10, 14-19 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Buddha in view of Tsai et al (listed as citation 2 under non-patent literature on IDS received on 10/21/2024 with copy provided by applicant).
Regarding claims 3 and 14
Buddha discloses the invention substantially as claimed including all the limitations of claims 1-2 and claims 12-13 as outlined above.
However, Buddha fails to disclose: “wherein to obtain an amplitude of the ECAP response, the processor is configured to: apply a filter to the stimulation response, locate the ECAP response in the filtered stimulation response; and derive the amplitude from a waveform corresponding to the ECAP response” as recited by claim 3 or “wherein obtaining an amplitude of the ECAP response comprises: applying a filter to the stimulation response; locating the ECAP response in the filtered stimulation response; and deriving the amplitude from a waveform corresponding to the ECAP response” as recited by claim 14.
Tsai discloses in the analogous field of determining evoked compound action potentials [see title and see abstract… “This paper presents a digital signal processing (DSP) architecture for real-time and distortion-free recovery of electrically-evoked compound action potentials (ECAPs)”] wherein to obtain an amplitude of an ECAP response, a processor [see Fig. 1c] is configured to: apply/applying a filter to a stimulation response; locate/locating the ECAP response in the filtered stimulation response; and derive/deriving the amplitude from a waveform corresponding to the ECAP response [see Fig. 2c which shows the raw data of the stimulation response and see Fig. 2e which shows the data forming the ECAP before and after it has been filtered, where the amplitude of the waveform is shown and see pg. 31… “Recorded raw neural data from the AFE, as plotted in Fig. 2(b), consists of a series of ECAP responses evoked by an AP stimulus pulse train, as well as stimulus artifacts and periodic noise interferences. The raw data (RD) is continuously filtered by filter H(z), whose outcome versus raw data before filtering are plotted in Fig. 2(c). For each AP stimulus cycle, both the cathodal and anodal parts of continuously filtered raw data are sampled with a window time-locked to stimulus pulses, and the windowed data are reversed in time domain as shown in Fig. 2(d). By summing windowed cathodal and anodal responses, the stimulus artifacts, which are symmetric and aligned on the time axis, are cancelled to restore the ECAP within an AP stimulus period. The ECAP response to applied stimulus train is computed by averaging ECAP of all AP stimulus cycles, referred as the mean ECAP (µCAP) response. The above-mentioned process is equivalent to the coherent averaging of continuously-filtered and lime-reversed raw data, as illustrated in Fig. 2(a). The µCAP response in reverse-time order is filtered with the same response H(z), as shown in Fig. 2(e), and converted back to continuous-time order with another TR operation.”] for the purpose of eliminating noise interference [see pg. 31… “A programmable linear-phase filter is applicable to eliminate periodic noise interferences whereas avoid distorting ECAP waveforms in recorded raw neural data [34].”]
It would have been obvious to one of ordinary skill in the art at the lime of the invention was filed to modify Buddha by including the filter of Tsai similarly to that described by Tsai (i.e. thereby reciting claims 3 and 14) for the purpose of eliminating noises that would reduce the accuracy of the determination.
Regarding claims 4 and 15
Buddha in view of Tsai discloses the invention substantially as claimed including all the limitations of claims 1-3 and claims 12-14 as outlined above.
However, Buddha in view of Tsai fails to disclose: “wherein to locate the ECAP response, the processor is configured to locate the ECAP response relative to the evoked stimulation response based on a known time offset” as recited by claim 4 or “wherein locating the ECAP response comprises locating the ECAP response relative to the evoked stimulation response based on a known time offset” as recited by claim 15.
Tsai discloses in the analogous field of determining evoked compound action potentials [see title and see abstract… “This paper presents a digital signal processing (DSP) architecture for real-time and distortion-free recovery of electrically-evoked compound action potentials (ECAPs)”] wherein to locate the ECAP response, a processor [Fig. 1 c] is configured to locate the ECAP response relative to the evoked stimulation response based on a known time offset [Fig. 4 and pg. 31… “For each AP stimulus cycle, both the cathodal and anodal parts of continuously filtered raw data are sampled with a window time-locked to stimulus pulses, and the windowed
data are reversed in time domain, as shown in Fig. 2(d). By summing windowed cathodal and anodal responses, the stimulus artifacts, which are symmetric and aligned on the time axis, are cancelled to restore the ECAP within an AP stimulus period.” and
see pg. 33… “The control signal for time-locked windowing of cathodal and anodal responses in digitized raw data is also generated in the stimulation controller. As seen in Fig. 4, a windowing-start signal WINEN is launched at the rising edge of each stimulus pulse to start the windowing of recorded raw data. The cathodal and anodal stimulus artifacts of each AP stimulus pulse can thus be aligned on the time axis, as seen in Fig. 2(d), and cancelled during the coherent averaging process.” And pg. 34… “The windowing length Nwin is determined by the IPD of the AP stimulus. At 50-kHz sampling frequency, the value of Nwin is programmable from 256 to 1024 to support a maximum PRF of 80 Hz, and the maximum windowing length is 20.48 ms, which is sufficient to cover nerve fiber responses with the slowest conduction velocity in ECAP responses given a conduction distance less than 10mm”] for the purpose of locating the ECAP [see pg. 31 and 33]
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify Buddha with the time offset of Tsai similarly to that described by Tsai (i.e. thereby reciting claims 4 and 15) for the purpose of locating the ECAP, thereby compensating for time delay in ECAP response after a stimulation has been performed.
Regarding claims 5 and 16
Buddha in view of Tsai discloses the invention substantially as claimed including all the limitations of claims 1-4 and claims 12-15 as outlined above.
However, Buddha in view of Tsai fails to disclose: “wherein the processor is further configured to determine the known time offset based on previously sensed electrical activity of the tissue resulting from the stimulation therapy” as recited by claim 5 or “determining the known time offset based on previously sensed electrical activity of the tissue resulting from the stimulation therapy” as recited by claim 16.
Tsai discloses in the analogous field of determining evoked compound action potentials [see title and see abstract… “This paper presents a digital signal processing (DSP) architecture for real-time and distortion-free recovery of electrically-evoked compound action potentials (ECAPs)”] a processor [Fig. 1 c] is further configured to determine the known time offset based on previously sensed electrical activity of a tissue resulting from a stimulation therapy [Fig. 4 and pg. 31… “For each AP stimulus cycle, both the cathodal and anodal parts of continuously filtered raw data are sampled with a window time-locked to stimulus pulses, and the windowed data are reversed in time domain, as shown in Fig. 2(d). By summing windowed cathodal and anodal responses, the stimulus artifacts, which are symmetric and aligned on the time axis, are cancelled to restore the ECAP within an AP stimulus period.” And see pg. 33… “The control signal for time-locked windowing of cathodal and anodal responses in digitized raw data is also generated in the stimulation controller. As seen in Fig. 4, a windowing-start signal WINEN is launched at the rising edge of each stimulus pulse to start the windowing of recorded raw data. The cathodal and anodal stimulus artifacts of each AP stimulus pulse can thus be aligned on the time axis, as seen in Fig. 2(d), and cancelled during the coherent averaging process.” And pg. 34… “The signed raw data are continuously filtered with the forward filter (ForFilt), and its cathodal and anodal parts are windowed and stored into two last-in-first-out (LIFO) registers LIFO_CA and LIFO_AN, respectively. Note that the windowing of the filtered raw data is started after the settling cycles NSET, when the outputs of the forward filter are settled.”... “The windowing length Nwin is determined by the IPD of the AP stimulus. At 50-kHz sampling frequency, the value of Nwin is programmable from 256 to 1024 to support a maximum PRF of 80 Hz, and the maximum windowing length is 20.48 ms, which is sufficient to cover nerve fiber responses with the slowest conduction velocity in ECAP responses given a conduction distance less than 10mm”] for the purpose of locating the ECAP [see pgs. 31 and 33 of Tsai].
It would have been obvious to one of ordinary skill in the art at the time of the invention was made to modify Buddha in view of Tsai with the time offset based upon previously sensed activity of Tsai (i.e. thereby reciting claims 5 and 16) for the purpose of locating the ECAP, thereby compensating for the delay in ECAP response after a stimulation has been performed.
Regarding claims 6 and 17
Buddha in view of Tsai discloses the invention substantially as claimed including all the limitations of claims 1-3 and claims 12-14 as outlined above.
However, Buddha in view of Tsai fails to disclose “wherein to derive the amplitude from a waveform corresponding to the ECAP response, the processor is configured to: calculate an average waveform from a plurality of ECAP responses; and derive the amplitude from the average waveform” as recited by claim 6 or “wherein deriving the amplitude from a waveform corresponding to the ECAP response comprises: calculating an average waveform from a plurality of ECAP responses; and deriving the amplitude from the average waveform” as recited by claim 17.
Tsai discloses in the analogous field of determining evoked compound action potentials [see title and see abstract… “This paper presents a digital signal processing (DSP) architecture for real-time and distortion-free recovery of electrically-evoked compound action potentials (ECAPs)”] wherein to derive/deriving the amplitude from
a waveform corresponding to the ECAP response, a processor [Fig. 1 c] is configured to: calculate an average waveform from a plurality of ECAP responses; and derive the amplitude from the average waveform [see Fig. 2c which shows the raw data of the stimulation response and see Fig. 2e which shows the data forming the ECAP before and after it has been filtered, where the amplitude of the waveform is shown, where the signals can be averaged signals and see pg. 31… “An ECAP response to a stimulus train is obtained by systematically aligning and averaging of all evoked responses to a single stimulus pulse. During the averaging process, random noise components recorded with ECAPs are summed toward zero, contributing to a higher signal-to-noise ratio (SNR). Coherent averaging can be easily combined with the AP stimulation method for SAR, in which an artifact-free ECAP response is attained by first aligning and summing the cathodal and anodal responses within an AP stimulus period and coherently averaging the summed waveform of all AP stimulus cycles ... Recorded raw neural data from the AFE, as plotted in Fig. 2(b), consists of a series of ECAP responses evoked by an AP stimulus pulse train, as well as stimulus artifacts and periodic noise interferences. The raw data (RD) is continuously filtered by filter H(z), whose outcome versus raw data before filtering are plotted in Fig. 2(c). For each AP stimulus cycle; both the cathodal and anodal parts of continuously filtered raw data are sampled with a window time-locked to stimulus pulses, and the windowed data are reversed in lime domain, as shown in Fig. 2(d). By summing windowed cathodal and anodal responses, the stimulus artifacts, which are symmetric and aligned on the lime axis, are cancelled to restore the ECAP within an AP stimulus period. The ECAP response to applied stimulus train is computed by averaging ECAP of all AP stimulus
cycles, referred as the mean ECAP (µCAP) ·response. The above-mentioned process is equivalent to the coherent averaging of continuously filtered and time-reversed raw data, as illustrated in Fig. 2(a). The µCAP response in reverse-time order is filtered with the same response H(z), as-shown in Fig. 2(e), and converted back to continuous-time order with another TR operation.”] for the purpose locating and determining the amplitude of the ECAP [see pg. 31].
It would have been obvious to one of ordinary skill in the art at the time of the invention was made to modify Buddha in view of Tsai to obtaining an amplitude derived from an average waveform similarly to that disclosed by Tsai (i.e. thereby reciting claims 6 and 17) for the purpose of locating the ECAP, thereby compensating for the delay in ECAP response after a stimulation has been performed.
Regarding claims 7 and 18
Buddha in view of Tsai discloses the invention substantially as claimed including all the limitations of claims 1-3 and claims 12-14 as outlined above.
However, Buddha in view of Tsai fails to disclose: “wherein the filter is an adaptive filter having a plurality of filter weights, and the processor is further configured to, in response to the stimulation therapy being below an activation threshold that elicits an ECAP response: update the plurality of filter weights” as recited by claim 7 or “wherein the filter is an adaptive filter having a plurality of filter weights, and further comprising, in response to the stimulation therapy being below an activation threshold that elicits an ECAP response for the patient: updating the plurality of filter weights.” as recited by claim 18.
Tsai discloses in the analogous field of determining evoked compound action potentials [see title and see abstract… “This paper presents a digital signal processing (DSP) architecture for real-time and distortion-free recovery of electrically-evoked compound action potentials (ECAPs)”] wherein the filter is an adaptive filter having a plurality of filter weights, and a processor [Fig. 1 c] is further configured to, in response to the stimulation therapy being below an activation threshold that elicits an· ECAP response: update the plurality of filter weights [see Fig. 15a which shows plots of stimulation amplitudes that start below, and are gradually raised until an ECAP is detected and see Fig. 16a & 16b show a similar graph of that shows the stimulation amplitudes where ECAP becomes detected and see pg. 29-30, “ECAP responses to a pre-defined stimulus are decoded to identify nerve fiber responses, and the stimulation parameters are constantly updated according to a patient-specific nerve activation profile to control the activation level of targeted nerve fibers.” And pg. 30… “A bidirectional neural interface circuit with active SAR is presented in [18], which utilizes an adaptive-filtering based template subtraction method. The 64-contact neuromodulation system-on-chip (SoC) in [19] uses a blind adaptive SAR method [20] which improves the convergence time of the adaptive-filtering based template subtraction.” And pg. 34… “The µCAP is calculated by averaging SWs of all AP stimulation cycles using exponentially-weighted moving averaging (EWMA), whose principle will be described later. The updated averaging of SW from EWMA, denoted as the averaged wave (AW), is stored into the LIFO register LIFO_AVG.” and pg. 36… “The µCAP response is thus the EMWA of SWs from all AP stimulus cycles, i.e., µCAP(n) = AW(NST, n). The weighting coefficient of EWMA in (13), KEWA, is adjusted to the number of AP stimulus cycles (NST)” and pg. 38… “Clearly, linear-phase filtering of ECAP responses using the proposed BFCA method can effectively reduce periodic noise interferences and preserve the waveform of ECAP responses, especially the amplitude and latency of peaks on ECAP waveforms representing the activation level of certain nerve fiber groups… Fig. 15 (a) plots the linear-phase filtered ECAP responses computed by the FPGA against stimulus amplitude, where twenty ECAP responses are collected per stimulus amplitude. It can be seen that consistent ECAP waveforms are measured under the same stimulus amplitude, and that the responses of activated nerve fiber groups, distinguished by positive and negative peaks with constant latency and amplitude proportional to the applied stimulus strength, are also visible on measured ECAP waveforms. Fig. 15 (b) plots the amplitude growth function (i.e., peak-to-peak amplitude versus stimulus strength) of fiber responses marked in Fig. 15 (a)” and pg. 39… “The efficacy of stimulus artifact rejection using the AP stimulation method is demonstrated by evaluating the stimulus artifact amplitude of raw data and ECAP responses from the total 220 stimulation trials in Fig. 15 (a) ... While the stimulus artifacts in raw data grow proportionally with the applied stimulus amplitude as plotted in Fig. 16 (a), the rms values of the stimulus artifact on recovered ECAP responses are approximately 1.6 times higher than that of the noise floor for stimulus amplitude below 0.15 mA.” As discussed here, the adaptive filter uses a weighted moving average component that changes as data from stimulation cycles are received; therefore, any stimulation under the activation threshold will be recorded, and used to update the filter based upon the weighted moving average] for the purpose of updating the filter weights to improve accuracy [see pgs. 30-31].
It would have been obvious to one of ordinary skill in the art at the time of the invention was filed to modify Buddha in view of Tsai with the adaptive filter of Tsai (i.e. thereby reciting claims 7 and 18) for the purpose of updating the filter weights, thereby adjusting the filter to the individual while eliminating noises that would reduce the accuracy of the determination.
Regarding claims 8 and 19
Buddha in view of Tsai discloses the invention substantially as claimed including all the limitations of claims 1-3, 7, 12-14 and 17 as outlined above.
However, Buddha in view of Tsai fails to disclose: “wherein to update the plurality of filter weights the processor is configured to: incrementally increase at least one of the plurality of stimulation parameters and update the plurality of filter weights until the stimulation therapy is not below the activation threshold that elicits an ECAP response” as recited by claim 8 or “wherein updating the plurality of filter weights comprises: incrementally increasing at least one of the plurality of stimulation parameters and updating the plurality of filter weights until the stimulation therapy is not below the activation threshold that elicits an ECAP response for the patient” as recited by claim 19.
Tsai discloses in the analogous field of determining evoked compound action potentials [see title and see abstract… “This paper presents a digital signal processing (DSP) architecture for real-time and distortion-free recovery of electrically-evoked compound action potentials (ECAPs)”] incrementally increasing at least one of the plurality of stimulation parameters and update the plurality of filter weights until the stimulation therapy is not below the activation threshold that elicits an ECAP response [see Fig. 15a which shows plots of stimulation amplitudes that start below, and are gradually raised until an ECAP is detected and Fig. 16a & 16b which shows 'the stimulation amplitudes where ECAP becomes detected and see pg. 29-30… “ECAP responses to a pre-defined stimulus are decoded to identify nerve fiber responses, and the stimulation parameters are constantly updated according to a patient-specific nerve activation profile to control the activation level off targeted nerve fibers.” and pg. 30… “A bidirectional neural interface circuit with active SAR is presented in [18], which utilizes an adaptive-filtering based template subtraction method. The 64- contact neuromodulation system-on-chip (SoC) in [19] uses a blind adaptive SAR method [20] which improves the convergence lime of the adaptive-filtering based template subtraction.” and pg. 34… “The µCAP is calculated by averaging SWs of all AP stimulation cycles using exponentially-weighted moving averaging (EWMA), whose principle will be described later. The updated averaging of SW from EWMA, denoted as the averaged wave (AW), is stored into the LIFO register LIFO_AVG. When the averaging process is completed at the end of a stimulus train, the AW is filtered in time-reversed order by the reverse filter (RevFilt). The outcome of the reverse filter, denoted as the filtered wave (FW), is stored back to the LIFO_AVG and converted to a forward-time ECAP response as plotted in Fig. 2(f).” and pg. 36… “The µCAP response is thus the EMWA of SWs from all AP stimulus cycles, i.e., µCAP(n) = AW(NST, n). The weighting coefficient of EWMA in (13), KEWA, is adjusted to the number of AP stimulus cycles (NST)” and pg. 38… “Clearly, linear-phase filtering of ECAP responses using the proposed BFCA method can effectively reduce periodic noise interferences and preserve the waveform of ECAP responses, especially the amplitude and latency of peaks on ECAP waveforms representing the activation level of certain nerve fiber groups ... Fig. 15 (a) plots the linear-phase filtered ECAP responses computed by the FPGA against stimulus amplitude, where twenty ECAP responses are collected per
stimulus amplitude. It can be seen that consistent ECAP waveforms are measured under the same stimulus amplitude, and that the responses of activated nerve fiber groups, distinguished by positive and negative peaks with constant latency and amplitude proportional to the applied stimulus strength, are also visible on measured ECAP waveforms. Fig. 15 (b) plots the amplitude growth function (i.e., peak-to-peak amplitude versus stimulus strength) of fiber responses marked in Fig. 15 (a).” and pg. 39… “The efficacy of stimulus artifact rejection using the AP stimulation method is demonstrated by evaluating the stimulus artifact amplitude of raw data and· ECAP responses from the total 220 stimulation trials in Fig. 15 (a) ... While the stimulus artifacts in raw data grow proportionally with the applied stimulus amplitude as plotted in Fig. 16 (a), the. rms values of the stimulus artifact on recovered ECAP responses are approximately 1.6 times higher than that of the noise floor for stimulus amplitude below 0.15 mA.” The adaptive filter uses a weighted moving average component that changes as data from stimulation cycles are received; therefore, any stimulation under the activation threshold will be recorded, and used to update the filter based upon the weighted moving average; this will continue to occur as the stimulation is increased toward the activation threshold] for the purpose of eliminating noise [see pgs. 30-31].
It would have been obvious to one of ordinary skill in the art at the lime of the invention to modify Buddha in view of Tsai by adding the filter weights of Tsai (i.e. thereby reciting claims 8 and 19) for the purpose of continually updating the filter weights as the stimulation increases lo give less value to stimulation below the activation threshold, thereby adjusting the filter to the individual through the stimulation while eliminating noises that would reduce the accuracy of the determination.
Regarding claims 10 and 21
Buddha discloses the invention substantially as claimed including all the limitations of claims 1-2, 9, 12-13 and 20 as outlined above.
However, Buddha fails to disclose: “wherein the processor is further configured to, in response to one of decreasing at least one of the stimulation parameters or increasing at least one of the stimulation parameters, resetting one or more of a plurality of filter weights of an adaptive filter configured to be applied to the stimulation response.” as recited by claim 10 or “further comprising, in response to one of decreasing at least one of the stimulation parameters or increasing at least one of the stimulation parameters, resetting one or more of a plurality of filter weights of an adaptive filter configured to be applied to the stimulation response” as recited by claim 21.
Tsai discloses in the analogous field of determining evoked compound action potentials [see title and see abstract… “This paper presents a digital signal processing (DSP) architecture for real-time and distortion-free recovery of electrically-evoked compound action potentials (ECAPs)”] a processor [Fig. 1 c] is further configured to, in response to one of decreasing at least one of the stimulation parameters or increasing at least one of the stimulation parameters, resetting one or more of a plurality of filter weights of an adaptive filter configured to be applied to the stimulation response [see Fig. 15a which shows plots of stimulation amplitudes that start below, and are gradually raised until an ECAP is detected and see Fig. 16a & 16b that shows the stimulation amplitudes where ECAP becomes detected and see pg. 29-30, “ECAP responses to a pre-defined stimulus are decoded to identify nerve fiber responses, and the stimulation parameters are constantly updated according to a patient-specific nerve activation profile to control the activation level of targeted nerve fibers.” and pg. 30… “A bidirectional neural interface circuit with active SAR is presented in [18], which utilizes an adaptive-filtering based template subtraction method. The 64- contact neuromodulation system-on-chip (SoC) in [19] uses a blind adaptive SAR method [20] which improves the convergence time of the adaptive-filtering based template subtraction.” and see pg. 34… “The µCAP is calculated by averaging SWs of all AP stimulation cycles using exponentially-weighted moving averaging (EWMA), whose principle will be described later. The updated averaging of SW from EWMA, denoted as the averaged wave (AW), is stored into the LIFO register UFO_AVG. When the averaging process is completed at the end of a stimulus train, the AW is filtered in time-reversed order by the reverse filter (RevFilt). The outcome of the reverse filter, denoted as the filtered wave (FW), is stored back to the LIFO_AVG and converted to a forward-time ECAP response as plotted in Fig. 2 (f).” and see pg. 36, “The µCAP response is thus the EMWA of SWs from all AP stimulus cycles, i.e., µCAP(n) = AW(NST, n). The weighting coefficient of EWMA in (13), KEWA, is adjusted to the number of AP stimulus cycles (NST)” and see pg. 38… “Clearly, linear-phase filtering of ECAP responses using the proposed BFCA method can effectively reduce periodic noise interferences and preserve the waveform or ECAP responses, especially the amplitude and latency of peaks on ECAP waveforms representing the activation level of certain nerve fiber groups ... Fig. 15 (a) plots the linear-phase filtered ECAP responses computed by the FPGA against stimulus amplitude, where twenty ECAP responses are collected per stimulus amplitude. It can be seen that consistent ECAP waveforms are measured under the same stimulus amplitude, and that the responses of activated nerve fiber groups, distinguished by positive and negative peaks with constant latency and amplitude proportional to the applied stimulus strength, are also visible on measured ECAP waveforms. Fig. 15 (b) plots the amplitude growth function (i.e., peak-to-peak amplitude versus stimulus strength) of fiber responses marked in Fig. 15 (a).” and pg. 39… “The efficacy of stimulus artifact rejection using the AP stimulation method is demonstrated by evaluating the stimulus artifact amplitude of raw data and ECAP responses from the total 220 stimulation trials in Fig. 15 (a) ... While the stimulus artifacts in raw data grow proportionally with the applied stimulus amplitude as plotted in Fig. 16 (a), the rms values of the stimulus artifact on recovered ECAP responses are approximately 1.6 times higher than that of the noise floor for stimulus amplitude below 0.15 mA.” The adaptive filter uses a weighted moving average component that changes as data from stimulation cycles are received; each set of stimulus cycles at a given amplitude has a weighting coefficient based upon the number of cycles and when the stimulation amplitude increases or decreases, the number of cycles resets, thereby also resetting the weighting coefficient used in the filter] for the purpose of eliminating noises [see pgs. 30-31 and 36 of Tsai].
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Buddha with resetting the filter weights similar to that of Tsai for the purpose of resetting the filter when the stimulation changes, thereby adjusting the filter to the individual through the stimulation levels while also eliminating noises that would reduce the accuracy of the determination.
Conclusion
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SEBASTIAN X LUKJAN
/SXL/Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792
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