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 .
Response to Arguments
Applicant’s arguments, see pages 9-11, filed 10/28/2025, with respect to the rejection(s) of Claim 1 under 35 U.S.C. § 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Min, Xiang, Yang and Sabes. All other rejections have been updated accordingly.
Claim Interpretation
The Examiner makes note of the following claim interpretations:
Claim 2, line 2: “a plurality of stimuli” is being interpreted as referring to multiple instances of “a processor configured to: apply from the at least one stimulus electrode to a stimulus site of a nerve at least one stimulus” in Claim 1, lines 6-8.
Claim 2, lines 2-3: “a plurality of measurements” is being interpreted as referring to multiple instances of either “obtaining a neural measurement from the measurement electrode” recited in Claim 1, lines 4-5 or “obtain from the measurement circuitry the digitised neural measurement of at least one compound action potential evoked by the at least one stimulus” recited in Claim 1, lines 9-10.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-4, 6-7, 9-12 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Min et al (US 2017/0173335 A1, hereinafter Min) in view of Yang et al (US 20140073982 A1, hereinafter Yang) Xiang et al (US 20160331326 A1, hereinafter Xiang) and Sabes et al (WO 2018170141 A1, cited in applicant’s IDS, hereinafter Sabes).
Regarding Claim 1, Min discloses an implantable device (Element 100, Fig. 1; “The NS system 100 includes an implantable pulse generator (IPG) 150”, [0041]) for estimating a nerve conduction velocity (Examiner’s Note: This clause is being construed as functional language, meaning only an apparatus capable of performing the functional language is needed), the implantable device comprising:
at least one stimulus electrode (Elements 121, Figs. 1-2) and at least one measurement electrode (“The electrodes 121 may also sense action potential signals for a data collection cluster”, [0043]; “one group of electrodes may be used for sensing, while a different group of electrodes are used for stimulation”, [0104]);
measurement circuitry for obtaining a digitized neural measurement from the at least one measurement electrode (“the controller 151 senses an ECAP signal at one or more sensing electrodes located proximate to the nervous tissue of interest”, [0088]); and
a processor (“The method comprises under control of one or more processors configured with program instructions”, [0008]) configured to:
apply from the at least one stimulus electrode at least one stimulus to a stimulus site of a nerve (Step 702, Fig. 7; “The method delivers a candidate stimulation waveform to at least one electrode located proximate to nervous tissue of interest”, [0087]),
obtain from the measurement circuitry the digitised neural measurement of at least one compound action potential (“At 704, the controller 151 senses an ECAP signal at one or more sensing electrodes located proximate to the nervous tissue of interest”, [0088]) evoked by the at least one stimulus, the digitised neural measurement comprising a plurality of data sample points (“The ECAP signal represents ECAP recorded activity from afferent neurons carrying both painful stimuli, generally within the Aδ and C fibers, and non-painful stimuli, generally within the Aβ fibers”, [0088]), the data sample points representing the at least one compound action potential at respective distinct successive sample times (“The memory 158 also stores ECAP signals, therapy parameters, ECAP activity level data, sensory scores, pain scales and the like. For example, the memory 158 may save ECAP activity level data for various different candidate waveforms as applied over a short or extended period of time”, [0053]), and
process the digitised neural measurement (Steps 706-716, Fig. 7; “The operations of FIG. 7 may be implemented by one or more processors”, [0086]) to thereby estimate a temporal position of a feature of interest of the at least one compound action potential (“When processing the conduction ECAP data in the time domain, the operations may include a binning operation, in which the conduction ECAP data is segmented into a series of temporal bins. Each temporal bin may include one or more occurrences of the feature of interest (e.g. spikes or peaks). The method counts a number of occurrences of the feature of interest (FOI) within each temporal bin”, [0106]).
Min discloses the claimed invention except for expressly disclosing the data sample points representing the at least one compound action potential separated by a predetermined sampling period;
a processor configured to:
scrub artefact from the digitized neural measurement using an artefact scrubber;
estimate, to a predetermined temporal resolution that is less than the predetermined sampling period, a temporal position of a feature of interest of the at least one compound action potential; and
determine from the estimated temporal position of the feature of interest and from a propagation distance of the at least one compound action potential a nerve conduction velocity of the compound action potential.
However, Sabes teaches a processor (Element 308, Fig. 3) configured to ([0019]):
scrub artefact (“The invention encompasses novel methods of estimating stimulation artifacts in measurements attained by recording electrodes and the effective removal of these artifacts”, Abstract) from the digitized neural measurement (“The system comprises an array of implanted recording electrodes (304), implanted in a target structure (305) of the brain (301). Signals received from the electrodes are amplified by amplifiers (306, shown a single element although each electrode may have its own amplifier), passed through ADC elements (307, shown a single element although each electrode may have its own ADC) with ADC output to a processor (308)”, [0019]) using an artefact scrubber (“Signals received from the electrodes are amplified by amplifiers (306, shown a single element although each electrode may have its own amplifier), passed through ADC elements (307, shown a single element although each electrode may have its own ADC) with ADC output to a processor (308) which calculates stimulation artifact and calculates artifact-removed neural response signals”, [0019]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add the processor configuration and artefact scrubber of Sabes to the processor configuration of Min, because these artefacts must be removed to effectively measure neural response signals, as taught by Sabes ([0005]).
Yang teaches the data sample points representing a signal separated by a predetermined sampling period (“a wireless sensor device detects an analog ECG signal of a user at a lower sampling rate. In one embodiment, the analog ECG signal is sampled at 125 Hz”, [0029]);
a processor (Element 104, Fig. 1) configured to:
estimate, to a predetermined temporal resolution that is less than the predetermined sampling period, a temporal position of a feature of interest of the signal (“A high resolution peak is determined by choosing a span of points to the left and to the right of the detected low resolution peak 510 and by obtaining higher time resolution ECG samples by interpolating between these points, via step 512”, [0030]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the processor configuration of Min, by modifying the data sample points representing the at least one compound action potential to be separated by a predetermined sampling period and estimating, to a predetermined temporal resolution that is less than the predetermined sampling period, a temporal position of a feature of interest of the at least one compound action potential, as suggested by Yang, because this offers a power reduction by utilizing a lower analog power (lower sampling rate) while maintaining accuracy (Yang, [0014], [0032]).
Xiang, which is also directed towards neural stimulation (“Embodiments in accordance with the present disclosure are directed to … applying stimulation signals to peripheral nerves.”, Abstract; this corresponds to the abstract of Min teaching their device being directed to neural stimulation), teaches the processing step: determine from the estimated temporal position of the feature of interest (“The latency of peak of the CNAP…”, [0063]; the feature of interest in the instant application is a peak of the signal as disclosed by Claim 9 and [0034]; a latency of a peak is a temporal position under broadest reasonable interpretation) and from a propagation distance of the at least one compound action potential a conduction velocity of the compound action potential (“During an acute test, the latency value and the distance between the stimulating sites and recording electrodes 220 was also measured to calculate nerve conduction velocity”, [0091]; the compound action potential travels between the stimulus electrode and the recording electrode). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add the estimation of conduction velocity of Xiang to the processor configuration of Min, because knowing the nerve conduction velocity of the signals helps to identify the classification of the nerves by fiber size, as taught by Min ([0092]).
Regarding Claim 2, modified Min discloses the implantable device of claim 1 wherein the processor is further configured to apply a plurality of stimuli (“Different burst and/or high frequency pulses on different stimulation electrodes 121 may be generated using a single set of the pulse generating circuitry 152 using consecutively generated pulses according to a “multi-stimset program” as is known in the art”, [0048]) and to obtain from the measurement circuitry a plurality of measurements each comprising a digitised neural measurement of a respective evoked compound action potential (ECAP) arising from each such stimuli (“The conduction ECAP data exhibits a number of spikes/peaks within each temporal bin, where the number of spikes/peaks is indicative of, and proportional to, an amount of sensory activity conveyed along the corresponding conduction nervous fibers”, [0106]).
Regarding Claim 3, modified Min discloses the implantable device of claim 2 wherein the at least one measurement electrode comprises a single measurement electrode (“At 704, the controller 151 senses an ECAP signal at one or more sensing electrodes located proximate to the nervous tissue of interest”, [0088]), or comprises two measurement electrodes.
Regarding Claim 4, modified Min discloses the implantable device of claim 2 wherein the processor is configured to process the plurality of measurements in order to locate the ECAP feature temporally in each of the plurality of measurements (“Each temporal bin may include one or more occurrences of the feature of interest (e.g. spikes or peaks). The method counts a number of occurrences of the feature of interest (FOI) within each temporal bin”, [0106]). Modified Min discloses the claimed invention except for expressly disclosing wherein the processor is further configured to process the located ECAP features from the plurality of measurements in order to produce an improved temporal location of the feature to within the predetermined resolution. However, Yang teaches wherein the processor is further configured to process the located features from the plurality of measurements in order to produce an improved temporal location of the feature to within the predetermined resolution (“After interpolation, the wireless sensor device searches for the high resolution peak at a higher time resolution over a span of points to the left and to the right of the previously detected peak among the interpolated ECG samples, via step 514… The determined high resolution peak is utilized in combination with a previously and/or subsequently determined high resolution peak to calculate an R-R interval, via step 516”, [0031]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the processor configuration of Min to process the located ECAP features from the plurality of measurements in order to produce an improved temporal location of the feature to within the predetermined resolution as suggested by Yang, because this offers a power reduction by utilizing a lower analog power (lower sampling rate) while maintaining accuracy (Yang, [0014], [0032]).
Regarding Claim 6, modified Min discloses the implantable device of claim 2, wherein the processor is configured to temporally separate the data sample points of each measurement from the data sample points of the other measurements relative to the respective ECAP (“When processing the conduction ECAP data in the time domain, the operations may include a binning operation, in which the conduction ECAP data is segmented into a series of temporal bins”, [0106]), by changing a sampling start time by an amount that is less than the predetermined sampling period (“each temporal bin may correspond to ½-1 milliseconds of ECAP data”, [0106]; the examiner notes a predetermined sampling period was added in the modification of parent Claim 1) between obtaining each such measurement (“When processing the conduction ECAP data in the time domain, the operations may include a binning operation, in which the conduction ECAP data is segmented into a series of temporal bins”, [0106]; by segmenting the data into temporal bins, the sampling start time of each bin is also changed).
Regarding Claim 7, modified Min discloses the implantable device of claim 2 wherein the processor is further configured to obtain at least one digitised neural measurement of at least one compound action potential evoked by the at least one stimulus (“At 704, the controller 151 senses an ECAP signal at one or more sensing electrodes located proximate to the nervous tissue of interest”, [0088]) from a second measurement electrode, the second measurement electrode being at a different distance from the stimulus site than a first measurement electrode (“In one embodiment, one lead stimulates the dorsal column, the second lead senses from DRG or DR, vice versa”, [0040]; by being different leads, the electrodes would also be in different positions in space, i.e. the second measurement electrode in the second lead would be at a different distance from the stimulus site where the dorsal column stimulating lead is).
Regarding Claim 9, modified Min discloses the implantable device of claim 1 wherein the feature of interest of the compound action potential comprises at least one of: a first positive peak, a first negative peak, a second positive peak (“For example, the ECAP feature of interest may represent a number of positive and negative peaks within the conduction ECAP data for a select period of time”, [0106]), an evoked compound action potential (ECAP) onset, and an ECAP zero crossing.
Regarding Claim 10, modified Min discloses the implantable device of claim 1 wherein the processor is further configured to estimate from the conduction velocity of the compound action potential, or from changes in the conduction velocity of the compound action potential as detected from one measurement to a next measurement, a proportion of fibre classes recruited to produce the compound action potential (“The conduction velocity of action potentials is positively related to fiber diameter, with velocities ranging between 35-75 m/s across Aβ fiber sizes. In part, because of this difference in conduction velocity, the ECAP generated by the largest Aβ fibers may have the shortest latency and duration, whereas ECAPs generated by smaller fibers may have a longer latency and duration. When viewed from the frequency domain, the ECAP signal components resulting from large fibers would be at the higher end of the frequency distribution, lower for medium fibers, and at the low end for small fibers. Activation of different fiber sizes could therefore be distinguished in ECAPs recorded from either the DC or DRG by frequency components.”, [0092]).
Regarding Claim 11, modified Min discloses the implantable device of claim 10 wherein the processor is further configured to apply feedback control of an applied stimulus (“methods and systems are described that select and manage stimulation parameters to entirely of substantially block large diameter A-beta fibers that otherwise transmit paresthesia (thereby achieving a paresthesia-abatement effect), while continuing to activate medium diameter Aβ fibers to achieve a desired analgesia effect”, [0036]) based on the estimated proportion of fibre classes recruited (Step 706, Fig. 7; [0089], Fig. 8), the feedback control being configured to selectively recruit one or more fibre types (“Embodiments of the present disclosure generally relate to neurostimulation (NS), and more particularly to managing stimulation to block certain components of A-beta fibers, while stimulating other components of A-beta fibers within spinal cord structures”, [0001]) to achieve predetermined therapeutic effects (“methods and systems are described that select and manage stimulation parameters to entirely of substantially block large diameter A-beta fibers that otherwise transmit paresthesia (thereby achieving a paresthesia-abatement effect), while continuing to activate medium diameter Aβ fibers to achieve a desired analgesia effect”, [0036]).
Regarding Claim 12, modified Min discloses the implantable device of claim 1 wherein the processor is further configured to apply feedback control (Step 718, Fig. 7) of an applied stimulus based on the nerve conduction velocity of the compound action potential (The frequency spectrum shown in Fig. 8 is based on conduction velocity, [0092]; this frequency decomposition, which is done in Step 706 in Fig. 7, is used as part of the feedback control process (e.g. step 718) of Fig. 7).
Regarding Claim 27, modified Min discloses the implantable device of claim 1. Modified Min discloses the claimed invention except for expressly disclosing wherein the processor is further configured to estimate the temporal position of the feature of interest to the predetermined precision by interpolating the compound action potential between the data sample points. However, Yang teaches wherein the processor is further configured to estimate the temporal position of the feature of interest to the predetermined precision by interpolating the signal between the data sample points(“A high resolution peak is determined by choosing a span of points to the left and to the right of the detected low resolution peak 510 and by obtaining higher time resolution ECG samples by interpolating between these points, via step 512”, [0030]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the processor configuration of Min to estimate the temporal position of the feature of interest to the predetermined precision by interpolating the compound action potential between the data sample points as suggested by Yang, because this offers a power reduction by utilizing a lower analog power (lower sampling rate) while maintaining accuracy (Yang, [0014], [0032]).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Min in view of Sabes, Yang and Xiang, and further in view of Crosby et al (WO 2016059556 A1, cited in applicant’s IDS, hereinafter Crosby).
Regarding Claim 5, modified Min discloses the implantable device of claim 4 wherein the processor is configured to process the located features from the plurality of measurements (“Each temporal bin may include one or more occurrences of the feature of interest (e.g. spikes or peaks). The method counts a number of occurrences of the feature of interest (FOI) within each temporal bin”, [0106]). Modified Min discloses the claimed invention except for expressly disclosing wherein the processor is configured to process the located features from the plurality of measurements by finding the temporal mean of the located features in order to produce the improved temporal location of the feature to the predetermined resolution. However, Crosby, which is also directed towards an implantable device for nerve stimulation and monitoring ([0036]-[0037]), teaches wherein the processor is configured to process the located features from the plurality of measurements (“Such processing of the recorded response signal creates a processed signal, which may be analyzed to identify and provide measurements of interest to the clinician.”, [0074]) by finding the temporal mean of the located features (“such processing may be performed by NMES device 30 and/or programming computer 50. The signal processing may include: amplification, for example, by an operational amplifier; filtering, for example, by a low-pass, high-pass, and/or band-pass filter; digitizing; and averaging, for example, by temporal averaging.”, [0074]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the processor configuration of Min by finding the temporal mean of the located features as taught by Crosby (in order to produce the improved temporal location of the feature to the predetermined resolution, as already taught by modified Min in [0106] and in the modification of Claim 1 by Yang) because finding the temporal mean of the located features also allows for extraction of the features from background noise, as taught by Crosby ([0025]).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Min in view of Sabes, Yang and Xiang, and further in view of DiLorenzo (US 20050021104 A1, hereinafter DiLorenzo).
Regarding Claim 8, modified Min discloses the implantable device of claim 2 wherein the processor is further configured to obtain neural response measurements at a first sampling rate (“At 704, the controller 151 senses an ECAP signal at one or more sensing electrodes located proximate to the nervous tissue of interest”, [0088]; by sensing the digitized signal, the controller must be sensing the signal at a sampling rate). Modified Min discloses the claimed invention except for expressly disclosing wherein the processor is further configured to obtain neural response measurements at a second sampling rate. However, DiLorenzo, which is also directed towards an implantable device (“FIG. 1 is a schematic diagram of one embodiment of the present invention implanted bilaterally in a human patient.”, [0035]) for nerve stimulation (“it should become apparent to those of ordinary skill in the relevant art after reading the present disclosure that the stimulating electrodes may also be extracranial; that is, attached to a peripheral nerve…”, [0085]) and monitoring (“FIG. 9 is block diagram of one embodiment of a peripheral nerve electrode (PNE) signal processor 237 that is implemented in certain embodiments of signal processor 71”, [0043]), teaches wherein the processor is further configured to obtain neural response measurements at a second sampling rate (“Additionally, signal processing algorithms the said sensory input modalities 247 may be coupled, such that the processing of one of the sensory input modalities 247 is dependent on another of the sensory input modalities 247. Adjustments may additionally include modification of actual signal processor parameters and allowable ranges thereof, including but not limited to gains, filter cutoff frequencies, filter time constants, thresholds, and sampling rates”, [0114]; adjusting sampling rates includes increasing the sampling rate). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the method of Min, wherein the processor is further configured to obtain neural response measurements at a second sampling rate as taught by DiLorenzo, because all of the claimed elements were known in the prior art before the effective filing date of the claimed invention, and one with ordinary skill in the art could have combined all the claimed elements by known methods, and the result would have been obvious to one of ordinary skill in the art.
Claim 28-29 are rejected under 35 U.S.C. 103 as being unpatentable over Min in view of Sabes, Yang and Xiang, and further in view of Tauro et al (US 20140063484 A1, hereinafter Tauro).
Regarding Claim 28, modified Min discloses the implantable device of claim 27. Modified Min discloses the claimed invention except for expressly disclosing wherein the interpolating is non-linear. However, Tauro teaches wherein the interpolating is non-linear (“at step 132, a curve fitting step is performed to generate a curve passing by the peaks of the time segments A and A'. It should be understood that any suitable interpolation method may be used. In the present example, a Gaussian fitting is performed to obtain a Gaussian curve 133 passing through the peaks of the time segments A and A'”, [0163]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the processor configuration of Min, such that the interpolating is non-linear as taught by Tauro, because all of the claimed interpolation methods were known in the prior art before the effective filing date of the claimed invention, and one with ordinary skill in the art could have chosen any suitable interpolation method, and the result would have been obvious to one of ordinary skill in the art.
Regarding Claim 29, modified Min discloses the implantable device of claim 28. Modified Min discloses the claimed invention except for expressly disclosing wherein the interpolating comprises performing Gaussian fitting of the feature of interest based on the data sample points, to yield an interpolated position. However, Tauro teaches wherein the interpolating comprises performing Gaussian fitting to yield an interpolated position (“at step 132, a curve fitting step is performed to generate a curve passing by the peaks of the time segments A and A'. It should be understood that any suitable interpolation method may be used. In the present example, a Gaussian fitting is performed to obtain a Gaussian curve 133 passing through the peaks of the time segments A and A'”, [0163]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the processor configuration of Min, such that the interpolating comprises performing Gaussian fitting taught by Tauro (of the feature of interest based on the data sample points of modified Min), to yield an interpolated position, because all of the claimed interpolation methods were known in the prior art before the effective filing date of the claimed invention, and one with ordinary skill in the art could have chosen any suitable interpolation method, and the result would have been obvious to one of ordinary skill in the art.
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Min in view of Sabes, Yang and Xiang, and further in view of Donega (US 20200324111 A1, hereinafter Donega).
Regarding Claim 30, modified Min discloses the implantable device of claim 1. Modified Min discloses the claimed invention except for expressly disclosing wherein the predetermined sampling period is less than 0.5 milliseconds. However, Donega teaches wherein the predetermined sampling period is less than 0.5 milliseconds ("Recorded eCAP were amplified and filtered (100-1000 Hz) using an 1800 2-Channel Microelectrode AC Amplifier (A-M system). Nerve activity was monitored continuously using an oscilloscope and recorded to a computer using a 16 channels PowerLab (AD Instruments) acquisition system and LabChart 8 software using a sampling rate of 20 kHz…”, [0251]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the processor configuration of Min wherein the predetermined sampling period is less than 0.5 milliseconds, as taught by Donega, because this is another way to calculate the conduction velocity of ECAP components, as taught by Donega ([0251]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
See Lagree (US 20160361602 A1) ([0080]).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/JONATHAN E. COOPER/Examiner, Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791
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