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 .
Information Disclosure Statement
The Information Disclosure Statement (IDS) dated 12/19/2024 has been considered by the Examiner.
Claim Rejections - 35 USC § 112
Claims 6, 7, and 9 -14 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The following claims recite the listed limitations in which there is insufficient antecedent basis for this limitation in the claim.
‘the process variable – amplitude transfer function’ in claim 6
‘the process variable – amplitude transfer function’ and ‘the process variable’ in claim 7
‘the actual value of the process variable’ in claim 9
‘the antidromic and/or orthodromic ECAP signals’ in claims 10-14
‘the process variable’ and ‘the remnant stimulation artifacts’ in claims 13 and 14
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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 2, 10, and 15-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhang et al (US 20190298992 A1).
Regarding claim 1, Zhang teaches a neurostimulation device (10/100), comprising a plurality of Z electrodes (16), wherein Z is an integer number and equal or larger than 3 (see [0008]; leads 14 or 15 with electrodes 16 on the distal ends, Fig. 3 pictures two leads 14 with 16 electrodes 16 total),
the neurostimulation device being configured to deliver in a cycle (T) via each electrode (E1-8) of a group of N electrodes of said plurality of Z electrodes (Fig. 5B),
wherein N is an integer number being smaller or equal to Z (see Fig. 5B, [0041]; Fig. 5B shows two electrodes E4 and E5 delivering stimulation pulses, but more than two electrodes may be active during the stimulation cycle, for example in Fig. 7B),
wherein a set of electric pulses including one therapeutic electric pulse, and a number of N or N-1 charge balancing pulses (see annotated Fig. 5B below),
wherein the charge balancing pulses each have a polarity that is opposite a polarity of the therapeutic electric pulse (see Fig. 5B where the charge balancing pulses and the therapeutic electric pulse have opposite polarities),
wherein the integrated current delivered of the therapeutic electric pulse and charge balancing pulses is zero over time (see [0041]; the pulses comprise constant current with an equal and opposite amplitude, so that the current injected into the patient's tissue by one electrode is removed by the other electrode),
wherein the respective therapeutic electric pulse comprises an amplitude (see Fig. 5B, [0041]; amplitude A of the pulses is shown),
wherein the neurostimulation device (10/100) is configured to record for the respective therapeutic electric pulse at least one ECAP signal (see [0050]; sense electrode S has been chosen to sense the ECAP as it moves past), and
wherein the neurostimulation device (10/100) comprises a closed-loop control system (1200) configured to update the amplitude (A) of the therapeutic electric pulse based on said ECAP signal (see [0075]; ECAP algorithm 124b is included in the external device which can receive information from IPG 100 regarding the ECAPs it measures, process the ECAP, and send a stimulation program or adjustment to the IPG, [0046]; the stimulation program is defined by various parameters to form stimulation pulses including the amplitude at the selected electrodes).
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Regarding claim 2, Zhang teaches the neurostimulation device according to claim 1, wherein the ECAP signal comprises one or both of an antidromic ECAP signal or an orthodromic ECAP signal (see [0045]; the orthodromic and/or antidromic propagation of action potentials can be senses at electrodes of the lead 14), and
wherein the amplitude (A) of the therapeutic electric pulse is updated based on said ECAP signal by changing an absolute amplitude value or a percentage amplitude value (see [0075]; ECAP algorithm 124b is included in the external device which can receive information from IPG 100 regarding the ECAPs it measures, process the ECAP, and send a stimulation program or adjustment to the IPG, [0046]; the stimulation program is defined by various parameters to form stimulation pulses including the amplitude at the selected electrodes).
Regarding claim 10, Zhang teaches the neurostimulation system according to claim 1, wherein the neurostimulation system comprises at least two electronic circuit front-ends (110) for recording the antidromic and/or orthodromic ECAP signals (see [0056]; one or more of the electrodes 16 can be used to sense the ECAP described earlier, and thus each electrode is further coupleable to at least one sense amp 110).
Regarding claim 15, Zhang teaches a method for controlling neurostimulation using a plurality of Z electrodes (16), wherein Z is an integer number and equal or larger than 3 (see [0008]; leads 14 or 15 with electrodes 16 on the distal ends, Fig. 3 pictures two leads 14 with 16 electrodes 16 total),
wherein in a cycle (T), via each electrode of a group of N electrodes (E1-8) of said plurality of Z electrodes (Fig. 5B),
wherein N is an integer number being smaller or equal to Z (see Fig. 5B, [0041]; Fig. 5B shows two electrodes E4 and E5 delivering stimulation pulses, but more than two electrodes may be active during the stimulation cycle, for example in Fig. 7B),
wherein a set of electric pulses is generated including at least one therapeutic electric pulse (see annotated Fig. 5 below), and a number of N or N-1 charge balancing pulses (see annotated Fig. 5B below),
wherein the charge balancing pulses each have a polarity that is opposite a polarity of the therapeutic electric pulse (see Fig. 5B where the charge balancing pulses and the therapeutic electric pulse have opposite polarities),
wherein the integrated current delivered of the therapeutic electric pulse and charge balancing pulses is zero over time (see [0041]; the pulses comprise constant current with an equal and opposite amplitude, so that the current injected into the patient's tissue by one electrode is removed by the other electrode),
wherein the respective therapeutic electric pulse comprises an amplitude (see Fig. 5B, [0041]; amplitude A of the pulses is shown),
wherein at least one ECAP signal is recorded for the respective therapeutic electric pulse (see [0050]; sense electrode S has been chosen to sense the ECAP as it moves past), and
wherein the amplitude (A) of the therapeutic electric pulse is updated based on said ECAP signal (see [0075]; ECAP algorithm 124b is included in the external device which can receive information from IPG 100 regarding the ECAPs it measures, process the ECAP, and send a stimulation program or adjustment to the IPG, [0046]; the stimulation program is defined by various parameters to form stimulation pulses including the amplitude at the selected electrodes).
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Regarding claims 16 and 17, Zhang teaches the neurostimulation device of claim 1 and the method of claim 15, wherein N is equal to 3 and Z is equal to three (see Fig. 7A, [0045]; electrodes E3, E4, and E5 are used to produce pulses in a bipolar mode of stimulation).
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.
Claims 3-8 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al (US 20190298992 A1) in view of Dinsmoor et al (US 20190388695 A1).
Regarding claim 3, Zhang teaches the neurostimulation device according to claim 2, wherein the closed-loop control system (1200) is configured to update said amplitude (A) of the therapeutic electric pulse based on said ECAP signal (see Zhang [0075]; ECAP algorithm 124b is included in the external device which can receive information from IPG 100 regarding the ECAPs it measures, process the ECAP, and send a stimulation program or adjustment to the IPG, [0046]; the stimulation program is defined by various parameters to form stimulation pulses including the amplitude at the selected electrodes).
Zhang is silent regarding updating the amplitude of the therapeutic pulse such that one or more process variables approaches a pre-defined set value, and
wherein the control system is configured to calculate an actual value of the process variable using the antidromic and/or orthodromic ECAP signals.
Dinsmoor teaches a neurostimulation device (110) comprising a plurality of Z electrodes (232 and 234),
configured to delivered a balanced bi-phasic square pulse that employs an active recharge phase (Dinsmoor [0053]) having an amplitude (see Dinsmoor [0004]; parameters that define the electrical stimulation therapy may include a frequency, an amplitude, a pulse width, and a pulse shape),
wherein the neurostimulation device (110) is configured to record for the respective therapeutic electric pulse at least one ECAP signal (see Dinsmoor Fig. 9; at step 920 deliver informed pulse and control pulse and sense ECAP), and
wherein the neurostimulation device (110) comprises a closed-loop control system (900/1000/1100) configured to update the amplitude of the therapeutic electric pulse based on said ECAP signal (see Dinsmoor Fig. 9; steps 940, 950, 960, and 970 wherein the amplitude of the informed pulses and control pulses are updated based on the ECAP signal),
such that one or more process variables (see Dinsmoor Fig. 11, [0141]; measured amplitude from the previously sensed ECAP signal) approaches a pre-defined set value (see Dinsmoor Fig. 11, [0140]; target ECAP amplitude), and
wherein the control system (900/100/1100) is configured to calculate an actual value of the process variable (measured AMP) using the antidromic and/or orthodromic ECAP signals (see Dinsmoor Fig. 11, [0141]; processing circuitry 214 receives a measured amplitude from the previously sensed ECAP signal).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the closed-loop control system of Zhang’s neurostimulation device with Dinsmoor’s processes variables and pre-defined set values as target variable thresholds. One of ordinary skill in the art would have been motivated to make this modification in order to adjust the delivered therapeutic pulses in order to meet a target therapeutic value to maintain a volume of neural activation that provides efficacious therapy for the patient (Dinsmoor [0035]).
Regarding claim 4, Zhang and Dinsmoor teach the neurostimulation device according to claim 3. Zhang is silent regarding wherein the closed-loop control system is configured to subtract the actual value of the process variable from a pre-defined set value to calculate an error e.
Dinsmoor teaches wherein the closed-loop control system (1100) is configured to subtract the actual value of the process variable from a pre-defined set value to calculate an error e (see Dinsmoor Fig. 11; at step 1104 subtract measured amplitude from target ECAP amplitude to generate differential amplitude).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the closed-loop control system of Zhang’s neurostimulation device with Dinsmoor’s error value which is equal to the difference between the measured ECAP amplitude and the target ECAP amplitude. One of ordinary skill in the art would have been motivated to make this modification in order to adjust the stimulation parameters in response to the difference between the measured amplitude and the target amplitude, wherein the adjustments may be different depending on if the error determines that the measured amplitude is too high or too low in comparison to the target (Dinsmoor [0037-0038]).
Regarding claims 5 and 6, Zhang and Dinsmoor teach the neurostimulation device according to claim 4, wherein the control system (1200) comprises a controller (124b) configured to calculate the amplitude of at least one next therapeutic electric pulse (see Zhang [0075]; ECAP algorithm 124b is included in the external device which can receive information from IPG 100 regarding the ECAPs it measures, process the ECAP, and send a stimulation program or adjustment to the IPG, [0046]; the stimulation program is defined by various parameters to form stimulation pulses including the amplitude at the selected electrodes).
Zhang is silent regarding wherein the adjustment is proportional to the error multiplied with a factor (1/m),
wherein the factor (1/m) is the inverse of a slope m of an approximation of the process variable - amplitude transfer function.
Dinsmoor teaches wherein the control system (1100) comprises a controller (214) configured to calculate the amplitude of at least one next therapeutic electric pulse (see Dinsmoor Fig. 11; at step 1108 add prelim differential value to control pulse amp to generate new control pulse amp), and
wherein the adjustment is proportional to the error multiplied with a factor (see Dinsmoor Fig. 11, [0142]; at step 1106 multiply the differential amp by the gain value to generate prelim differential value),
wherein the factor is the slope m (see Dinsmoor [0142]; the gain value may represent the slope of the growth curve for the patient) of an approximation of the process variable – amplitude transfer function (see Dinsmoor Fig. 10A picturing growth curve 1002 of sensed ECAPs from respective stimulation pulse amplitudes).
Dinsmoor is silent regarding wherein the factor is 1/m which represents the inverse of a slope m, in this instance wherein the slope m is the gain (Dinsmoor [0130]).
However, it can be appreciated that Dinsmoor discloses the general conditions of the claim wherein the error or measured difference because the measured variable (in this case amplitude) and a threshold variable is multiplied by a factor in order to determine the amount that a subsequent therapeutic pulse amplitude is adjusted. MPEP 2144.05(II)(A) states that: "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Multiplying the error by the inverse of the slope rather than the slope in order to find the optimum adjustment for each cycle of therapeutic pulses would have been obvious to one of ordinary skill in the art, as using the inverse of the slope rather than the slope itself would result in a more gentle adjustment between cycles.
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the closed-loop control system of Zhang’s neurostimulation device with Dinsmoor’s method of calculating the adjustments between pulses as being proportional to the error multiplied by a factor. One of ordinary skill in the art would have been motivated to make this modification in order to respond quickly to large ECAP signal variations and reset the informed pulses and control pulses to the target ECAP (Dinsmoor [0038]).
Regarding claim 7, Zhang and Dinsmoor teach the neurostimulation device according to claim 1. Zhang is silent regarding wherein the control system is configured to approximate the process variable - amplitude transfer function, that assigns a value of the process variable to each value of the amplitude, by at least a first linear portion and a subsequent second linear portion,
the first linear portion comprising a first slope m1 and the second linear portion comprising a different second slope m2, and
wherein the first portion includes values of the process variable smaller or equal to a threshold, and the second portion includes values of the process variable above the threshold.
Dinsmoor teaches wherein the control system (1100) is configured to approximate the process variable - amplitude transfer function (1002), that assigns a value of the process variable to each value of the amplitude, by at least a first linear portion and a subsequent second linear portion (Dinsmoor Fig. 10A),
the first linear portion comprising a first slope m1 and the second linear portion comprising a different second slope m2 (see annotated Dinsmoor Fig. 10A below), and
wherein the first portion includes values of the process variable smaller or equal to a threshold (see Dinsmoor [0129]; typically ECAPs will not be generated until the stimulation pulse amplitude reaches a threshold, approximately at 4.5 mA; the first portion of the process variable located to the left of the threshold value), and the second portion includes values of the process variable above the threshold (see Dinsmoor Fig. 10A; the second portion of the process variable located to the right of the threshold value).
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It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the closed-loop control system of Zhang’s neurostimulation device with Dinsmoor’s growth curve representing the relationship between a process variable and amplitude. One of ordinary skill in the art would have been motivated to make this modification in order to determine the rate at which the sensed ECAP changes in response to different stimulation pulse amplitudes and establish a threshold process variable at which ECAPs start to be generated (Dinsmoor [0129]).
Regarding claim 8, Zhang and Dinsmoor teach the neurostimulation device according to claim 6. Zhang is silent regarding wherein the control system is configured to approximate the process variable - amplitude transfer function, that assigns a value of the process variable to each value of the amplitude, by at least a first linear portion and a subsequent second linear portion,
the first linear portion comprising a first slope m1 and the second linear portion comprising a different second slope m2, and
wherein the first portion includes values of the process variable smaller or equal to a threshold, and the second portion includes values of the process variable above the threshold, and
wherein the control system comprises a processing unit configured to select as said slope m the first slope m1 in case the actual value of the process variable is below or equal to the threshold, and
to select as said slope m the second slope m2 in case the actual value of the process variable is above the threshold.
Dinsmoor teaches wherein the control system (1100) is configured to approximate the process variable - amplitude transfer function (1002), that assigns a value of the process variable to each value of the amplitude, by at least a first linear portion and a subsequent second linear portion (Dinsmoor Fig. 10A),
the first linear portion comprising a first slope m1 and the second linear portion comprising a different second slope m2 (see annotated Dinsmoor Fig. 10A below), and
wherein the first portion includes values of the process variable smaller or equal to a threshold (see Dinsmoor [0129]; typically ECAPs will not be generated until the stimulation pulse amplitude reaches a threshold, approximately at 4.5 mA; the first portion of the process variable located to the left of the threshold value), and the second portion includes values of the process variable above the threshold (see Dinsmoor Fig. 10A; the second portion of the process variable located to the right of the threshold value), and
wherein the control system (1100) comprises a processing unit (214) configured to select as said slope m the first slope m1 in case the actual value of the process variable is below or equal to the threshold and to select as said slope m the second slope m2 in case the actual value of the process variable is above the threshold (see Dinsmoor [0142]; processing circuitry 214 then multiplies the differential amplitude by a gain value for the patient to generate a preliminary differential value, then uses the preliminary differential value to adjust the amplitudes of both subsequent informed pulses and control pulses).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the closed-loop control system of Zhang’s neurostimulation device with Dinsmoor’s growth curve representing the relationship between a process variable and amplitude. One of ordinary skill in the art would have been motivated to make this modification in order to determine the rate at which the sensed ECAP changes in response to different stimulation pulse amplitudes and establish a threshold process variable at which ECAPs start to be generated (Dinsmoor [0129]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al (US 20190298992 A1) in view of Esteller (US 20210252289 A1).
Regarding claim 9, Zhang teaches the neurostimulation device according to claim 1. Zhang is silent regarding wherein the neurostimulation device is configured to remove a remnant stimulation artefact from the respective ECAP signal prior to calculating the actual value of the process variable.
Esteller teaches a neurostimulation device (10/100) which comprises a plurality of electrodes (E1-12) to deliver therapeutic pulses in a cycle (Fig. 5) wherein the delivered pulses are charge balanced (Esteller [0015]) and comprising a closed loop control system (700) configured to update stimulation parameters based on a measured ECAP signal (Esteller [0091]),
wherein the neurostimulation device (10/100) is configured to remove a remnant stimulation artefact from the respective ECAP signal prior to calculating the actual value of the process variable (see Esteller [0050]; the ESG feature inclusive of any detected ECAPs and stimulation artifacts is received at a feature extraction algorithm 140 which analyzes the digitized sensed signals to determine one or more ECAP signals - separate from one or more stimulation artifact features).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify Zhang’s neurostimulation device with Esteller’s stimulation artifact removal in order to isolate an ECAP signal. One of ordinary skill in the art would have been motivated to make this modification in order to determine characteristic features of the isolated ECAP signal in order to adjust stimulation parameters for subsequent therapeutic pulses (Esteller [0025]).
Claims 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al (US 20190298992 A1) in view of Esteller (US 20210252289 A1) and Liu et al (US 20170273594 A1).
Regarding claim 11, Zhang and Esteller teach the neurostimulation device according to claim 9. Zhang is silent regarding wherein the neurostimulation system comprises at least two electronic circuit front- ends for recording the antidromic and/or orthodromic ECAP signals,
wherein in a calibration cycle the neurostimulation device is configured to convert a differential output of each recording front-end to a single- ended output, digitize the single-ended output, and
store the digitized single-ended output,
wherein the neurostimulation device is configured to generate and fit a remnant stimulation artifact template to the respective digitized single-ended output, and
wherein during recording of the respective ECAP signal, the neurostimulation device is configured to convert the respective remnant stimulation artifact template via a digital-to- analog converter to yield an analog template and to subtract the analog template from the single-ended output (containing the respective remnant stimulation artifact and ECAP signal) for generating the respective ECAP signal with removed remnant stimulation artifact (SA).
Esteller teaches wherein the neurostimulation system comprises at least two electronic circuit front- ends (110) for recording the antidromic and/or orthodromic ECAP signals (see Esteller Fig. 5 wherein showing the ECAP traveling in a caudal and/or rostral direction, [0047]; IPG 100 includes sensing circuitry 115 which uses one or more of the electrodes 16 to sense signals in the ESG signals and is further couplable to sense amp circuit 110 via electrode node 39),
wherein in a calibration cycle the neurostimulation device is configured to convert a differential output of each recording front-end (see Esteller [0049]; the differential amplifier with subtract S- from S+ at its output and cancel out any common mode voltage from both inputs, which can be useful to subtract relatively large scale stimulation artifacts 134) to a single-ended output (ESP), digitize the single-ended output (see Esteller [0047]; the sensed signals output by the sense amp circuitry are preferably converted to digital signals by one or more analog-to-digital converters), and
store the digitized single-ended output (see Esteller [0050]; the digitized ESG signal is received at a feature extraction algorithm 140),
wherein the neurostimulation device is configured to generate and fit a remnant stimulation artifact template to the respective digitized single-ended output (see Esteller [0050]; the digitized ESG signal including stimulation artifacts is received at a feature extraction algorithm 140).
Esteller is silent regarding wherein during recording of the respective ECAP signal, the neurostimulation device is configured to convert the respective remnant stimulation artifact template via a digital-to-analog converter to yield an analog template and to subtract the analog template from the single-ended output for generating the respective ECAP signal with removed remnant stimulation artifact, and
wherein the neurostimulation device is configured to convert a differential output of each recording front-end to a single-ended output, to digitize an initial remnant stimulation artifact comprised therein by means of an analog-to-digital converter and
wherein the neurostimulation device configured to iteratively update the initial template by subtracting the single-ended output from an analog conversion of the stored template generated by an digital-to-analog converter to yield a present template until an incoming remnant stimulation artifact and the present template converge within the resolution of the analog-to-digital converter and digital-to-analog converter, and
wherein the present template is then subtracted from all following recorded ECAP signals.
Liu teaches a system and method for real-time stimulation artifact suppression wherein in a calibration cycle (90/110) the neurostimulation device is configured to convert a differential output of each recording front-end to a single- ended output, digitize the single-ended output and store the digitized single-ended output (see Liu Figs. 3A-3B, [0047-0048]; Figs. 3A and 3B illustrate Phase 1 and Phase 2 paths comprising Phase 1 path 92 to acquire the first artifact template and Phase 2 path 116 in which calibration of the artifact template is performed and the output signal 46 is digitized by ADC 112 circuit and stored in the MCU),
wherein the neurostimulation device is configured to generate and fit a remnant stimulation artifact template to the respective digitized single-ended output (see Liu [0043]; in the process of artifact acquisition, switches 42b and 72 are on, and the selected input of MUX 60 is connected to amplifier 37 to read the artifact signal, ADC 58 then digitizes the artifact and stored it in the memory 56), and
wherein during recording of the respective ECAP signal, the neurostimulation device is configured to convert the respective remnant stimulation artifact template via a digital-to- analog converter to yield an analog template and to subtract the analog template from the single-ended output (containing the respective remnant stimulation artifact and ECAP signal) for generating the respective ECAP signal with removed remnant stimulation artifact (SA) (see Liu Figs. 3A-3B, [0047-0048]; the stored artifact is converted to an analog waveform via DAC 62 and passed 64 to the positive terminal of the second amplifier 44, this, the artifact signal and the reconstructed artifact are subsequently subtracted inside amplifier 44 with its output digitized by ADC 112 circuit and stored in the MCU).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify Zhang and Esteller’s neurostimulation device configured to remove a remnant stimulation artifact with Liu’s method of artifact template subtraction. One of ordinary skill in the art would have been motivated to make this modification in order to remove stimulation artifacts utilizing lower resolution DAC and ADC which can perform cancelations in real-time and prevent amplifier oversaturation (Liu [0018]).
Regarding claim 12, Zhang and Esteller teach the neurostimulation device according to claim 9. Zhang is silent regarding wherein the neurostimulation system comprises at least two electronic circuit front- ends for recording the antidromic and/or orthodromic ECAP signals,
wherein the neurostimulation device is configured to convert a differential output of each recording front-end to a single-ended output, to digitize an initial remnant stimulation artifact comprised therein by means of an analog-to-digital converter and to store it as an initial template in a memory,
wherein the neurostimulation device configured to iteratively update the initial template by subtracting the single-ended output from an analog conversion of the stored template generated by an digital-to-analog converter to yield a present template until an incoming remnant stimulation artifact and the present template converge within the resolution of the analog-to-digital converter and digital-to-analog converter, and
wherein the present template is then subtracted from all following recorded ECAP signals
Esteller teaches wherein the neurostimulation system comprises at least two electronic circuit front- ends (110) for recording the antidromic and/or orthodromic ECAP signals (see Esteller Fig. 5 wherein showing the ECAP traveling in a caudal and/or rostral direction, [0047]; IPG 100 includes sensing circuitry 115 which uses one or more of the electrodes 16 to sense signals in the ESG signals and is further couplable to sense amp circuit 110 via electrode node 39),
wherein the neurostimulation device is configured to convert a differential output of each recording front-end (see Esteller [0049]; the differential amplifier with subtract S- from S+ at its output and cancel out any common mode voltage from both inputs, which can be useful to subtract relatively large scale stimulation artifacts 134) to a single-ended output (ESP), digitize the single-ended output (see Esteller [0047]; the sensed signals output by the sense amp circuitry are preferably converted to digital signals by one or more analog-to-digital converters), and
store the digitized single-ended output (see Esteller [0050]; the digitized ESG signal is received at a feature extraction algorithm 140),
wherein the neurostimulation device is configured to generate and fit a remnant stimulation artifact template to the respective digitized single-ended output (see Esteller [0050]; the digitized ESG signal including stimulation artifacts is received at a feature extraction algorithm 140).
Esteller is silent regarding wherein the neurostimulation device configured to iteratively update the initial template by subtracting the single-ended output from an analog conversion of the stored template generated by an digital-to-analog converter to yield a present template until an incoming remnant stimulation artifact and the present template converge within the resolution of the analog-to-digital converter and digital-to-analog converter, and
wherein the present template is then subtracted from all following recorded ECAP signals.
Liu teaches a system and method for real-time stimulation artifact suppression wherein the neurostimulation device configured to iteratively update the initial template by subtracting the single-ended output from an analog conversion of the stored template generated by an digital-to-analog converter to yield a present template (see Liu Figs. 3A-3B, [0047-0049]; the stored artifact is converted to an analog waveform via DAC 62 and passes 64 to the positive terminal of the second amplifier 44, this the artifact signal and the reconstructed artifact are subsequently subtracted inside amplifier 44 with its output 46 digitized by ADC 112 and stored in the MCU) until an incoming remnant stimulation artifact and the present template converge within the resolution of the analog-to-digital converter and digital-to-analog converter and wherein the present template is then subtracted from all following recorded ECAP signals (see Liu [0048-0049]; multiple calibration oases may be performed as desired until a desired accuracy is verified, and the artifact templates can be adjusted; after an accurate artifact is derived, the gain of amplifier 44 can be modified based on the signals of interest to record artifact-free neural signals; see Fig. 4, [0049]; it can be seen in Fig. 4 that a large residual artifact 127 remains if the artifact template acquired in Phase 1 is directly applies, to overcome this challenge, the apparatus utilizes this difference information to calibrate the first artifact template by performing a subtraction inside MCU, in the next step, the MCU updates the initial artifact template with the calibrated template).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify Zhang and Esteller’s neurostimulation device configured to remove a remnant stimulation artifact with Liu’s method of artifact template subtraction. One of ordinary skill in the art would have been motivated to make this modification in order to remove stimulation artifacts utilizing lower resolution DAC and ADC which can perform cancelations in real-time and prevent amplifier oversaturation (Liu [0018]).
Allowable Subject Matter
Claims 13-14 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.
Regarding claims 13 and 14, Zhang teaches the neurostimulation device of claim 1. None of Zhang, Dinsmoor, or Esteller each wherein the process variable corresponds to a total therapy dose wherein the control system is configured to calculate an actual value of process variable from the antidromic and orthodromic ECAP signals after removal of the remnant stimulation artifacts of the antidromic and orthodromic ECAP signals,
by fully- wave rectifying the respective ECAP signal,
averaging the respective ECAP signal,
generating a weighted sum of the averaged antidromic ECAP signals,
wherein the weights account for different spacings between electrodes used for recording the respective antidromic ECAP signal,
generating a weighted sum of the averaged orthodromic ECAP signals, and
wherein the weights account for different spacings between electrodes used for recording the respective orthodromic ECAP signal,
adding the two weighted sums to generate a final sum, and squaring the final sum which generates the actual value of the process variable; and/or
wherein the process variable corresponds to an antidromic therapy sensation dose,
wherein the control system is configured to calculate an actual value of the process variable from the antidromic ECAP signals after removal of the remnant stimulation artifacts from the antidromic ECAP signals,
by fully-wave rectifying the respective antidromic ECAP signal,
averaging the respective antidromic ECAP signal,
generating a weighted sum of the averaged antidromic ECAP signals, and
wherein the weights account for different spacings between electrodes used for recording the respective antidromic ECAP signal, and
squaring the weighted sum which generates the actual value of the process variable.
Conclusion
The following prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Corey et al (US 20220008726 A1) which teaches a system for analyzing ECAP signals for parameter adjustment of electrical stimulation therapy.
Kibler et al (US 20180272124 A1) which teaches a system for multi-electrode stimulation therapy with reduced energy.
Esteller et al (US 20220323764 A1) which teaches a posture determination and stimulation adjustment in a spinal cord stimulator system using sensed stimulation artifacts.
Esteller et al (US 20190209844 A1) which teaches automatic adjustment of sub-perception therapy in an implantable stimulator using detected compound action potentials.
Dinsmoor et al (US 20230381521 A1) which teaches a system for directional activation with electrical stimulation.
Weerakoon et al (US 20200305744 A1) which teaches circuitry to assist with neural sensing in an implantable stimulator device in the presence of stimulation artifacts.
Zhang et al (US 20210236829 A1) which teaches the selection of sensing electrodes in a spinal cord stimulator system using sensed stimulation artifacts.
Sabes et al (US 20200129766 A1) which teaches the removal of stimulation artifacts in multi-channel neural recordings.
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/A.J.S./Examiner, Art Unit 3792
/ALLEN PORTER/Primary Examiner, Art Unit 3796
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