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 filed 7/7/2026 have been fully considered but they are not persuasive.
Rejections under 35 USC § 102
Applicant argues on pages 8-10 that Min does not teach the steps of “analysing one or more selected characteristics of the recording to determine whether a recruitment of a first fibre type by the electrical stimulus has occurred” and “based on the recruitment determination, refining the stimulus parameters in a manner to effect selective recruitment of the first fibre type relative to other fibre types of the mixed nerve”. Specifically, the applicant argues the prior art does not properly address the phrase “recruitment” within those 2 steps.
The examiner believes the applicant is fundamentally misunderstanding and/or misinterpreting the Min reference. Min states:
[0067] At 404, the method senses an evoked compound action potential (ECAP) signal from the nervous tissue of interest. The ECAP signal represents ECAP recorded activity from afferent neurons carrying both painful stimuli, within the Aδ and C fibers, and non-painful stimuli, within the Aβ fibers.
[0070] The frequency spectrum 502 includes ECAP frequency data that comprises a C fiber component 504, an Aδ fiber component 506 and an Aβ fiber component 508. Each of the components 504-508 comprise individual frequency bins grouped closely with one another in ranges along the frequency spectrum, where the individual frequency bins have associated different amplitudes. The fast Fourier transform converts the ECAP signals to ECAP frequency data that is separated into distinct frequency clusters 512-516 associated with frequency domain components 504-508, where each of the clusters 512-516 has a separate and distinct frequency range. For example, the cluster 512 (associated with the C fiber component 504) may be located in a lower frequency range, while the cluster 514 (associated with the Aδ fiber component 506) is located in a central frequency range, and the cluster 516 (associated with the Aβ fiber component 508) is located in a higher frequency range (the terms lower, central and higher being relative to one another).
[0073] FIG. 5B illustrates an example of a frequency spectrum 522 that is generated, when applying an FFT analysis, to an ECAP signal that is produced in response to a fiber targeted stimulation waveform. A fiber targeted stimulation waveform has been set to target stimulation of a select fiber such as the Aβ fibers. The frequency spectrum 522 includes a C fiber frequency component 524, an Aδ fiber frequency component 526 and an Aβ fiber frequency component 528. The frequency components 524, 526 and 528 are separated from one another and distributed along the frequency spectrum within clusters 532-534. The C and Aδ fiber frequency components 524, 526 include a relatively small amount of action potential activity, as compared to the larger amount of action potential activity exhibited by the Aβ fiber frequency component 528. The Aβ fiber frequency component 528 has a larger amount of action potential activity due to the Aβ fiber targeted stimulation waveform that was used to generate the ECAP signal.
[0074] Returning to FIG. 4, at 408, the method determines the type of nerve fibers that were activated by the stimulation waveform based on the ECAP frequency data. For example, the determining operation may identify an amount of activity exhibited by the frequency bins or factors in one or more of the C, Aδ and Aβ fiber components 504-508. In the example of FIG. 5A, the determination would indicate that a somewhat equal amount of activity is exhibited by each of the components 504-508. In the example of FIG. 5B, the determination would indicate that the Aβ fiber component 536 exhibits a substantially larger amount of action potential activity than in components 524 and 526.
[0076] At 412, the method adjusts at least one of the therapy parameters to change the stimulation waveform based on the ECAP frequency data. The adjusting operation may adjust the stimulation parameters based on the clusters 512-516 of frequency domain components 504-508 to maintain a select amount of activation for a select one or more of the types of nerve fibers based on the determination at 410. For example, when it is desirable to increase the amount of action potential activity associated with the Aβ fibers, the parameters may be adjusted to increase the pulse width and increase the pulse amplitude. When it is desirable to increase the amount of action potential activity associated with the C fibers, the parameters may be adjusted to increase the pulse frequency. Additionally or alternatively, the type of stimulation waveform may be changed, such as adding burst of stimulation or switching to high frequency stimulation to activate A8 fibers while avoiding activation of Aδ and C fibers. As another alternative, a random pulse patterns may be utilized. In a random pattern, multiple different types of waveforms are used, with a 1.sup.st type of waveform used in a 1.sup.st segment of the pattern and a different type of waveform used in a 2.sup.nd segment of the pattern, and the like. As an example, a 1.sup.st segment may deliver pulses in a 1.sup.st frequency, while a 2.sup.nd segment of a pulse pattern may deliver pulses at a 2.sup.nd different frequency. As a further example, the pulse to pulse interval may be varied as another parameter.
The underlined portions of [0067], [0070], and [0073]-[0074] clearly teach grouping the nerve fiber types into subgroups based on the ECAP response. The underlined portions of [0076] are the most telling as they illustrate the final objective is selective recruitment/activation of only selected fiber subgroups. Selectively activating only certain nerve fiber subgroups will read on “ratio”, “proportion” and/or “population”, which are terms the applicant uses in traversing the rejection. Regarding the refinement step in the claims, figure 4 step 412, [0076] read on the refinement as the stimulation is adjusted or “refined” after the initial stimulation.
Rejections under 35 USC § 103
Applicant argues on pages 12-13:
“As such, Parker uses the slow neural response to determine recruitment of Aδ fibers (i.e., "fibre classes other than the target Aß fibres", the "other fibre types" of parent claim 1) and not the Aß fibers (e.g., the target fibers, the "first fibre type" of parent claim 1). In other words, Parker uses the slow neural response to determine recruitment of fiber types other than the target fiber types, not the first fiber type. As such, the cited portions of Parker do not teach or suggest "assessing the one or more selected characteristics of each of the myoelectric response and the neural response to determine whether the recruitment of the first fibre type by the electrical stimulus has occurred," as recited by claim 11.
Furthermore, because the combined references use muscle potentials as a binary upper limit safety shutoff rather than evaluating response features to calculate and guide selective biological recruitment, the combination fails to teach or suggest the claimed steps”.
The examiner is not persuaded. Regarding the arguments in the first paragraph above, the applicant is mischaracterizing the prior art. Parker determines the recruitment of both types of fibers (fast and slow) in cited [0054], [0079], [0088], thus the prior art is determining “whether recruitment of the first fibre type by the electrical stimulus has occurred”. Regarding the arguments in the second paragraph above, Parker is only being relied on to illustrate that the neural activation/recruitment can be assessed via EMG in addition to a neural response. Min teaches “evaluating response features to calculate and guide selective biological recruitment”.
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.
Claim(s) 1-9, 12-19, and 21-22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Min et al. (Pub. No.: US 2016/0175594 A1); hereinafter referred to as “Min”.
Regarding claim 1, Min discloses a method of neurostimulation of a mixed nerve comprising a plurality of nerve fibre types (e.g. see abstract, [0065]), the method comprising: delivering to the mixed nerve an electrical stimulus from at least one implantable nominal stimulus electrode, the electrical stimulus being delivered in accordance with a set of stimulus parameters (e.g. see figure 4 step 402, [0065]-[0066]); obtaining from at least one implantable nominal recording electrode a recording of an electrophysiological response evoked by the electrical stimulus (e.g. see figure 4 step 404, [0067]); analysing one or more selected characteristics of the recording to determine whether a recruitment of a first fibre type by the electrical stimulus has occurred (e.g. see figure 4 steps 406, 408, 410, [0068]-[0075]); and based on the recruitment determination, refining the stimulus parameters in a manner to effect selective recruitment of the first fibre type relative to other fibre types of the mixed nerve (e.g. see figure 4 step 412, [0076]-[0078]).
Regarding claims 2 and 13, Min discloses the one or more selected characteristics comprise propagation or non-propagation of the recording of the electrophysiological response (e.g. see figure 4 steps 406, 408, 410, [0068]-[0075]. Specifically, [0074] states “Returning to FIG. 4, at 408, the method determines the type of nerve fibers that were activated by the stimulation waveform based on the ECAP frequency data”. Determination of activation of a type of nerve fiber will read on propogation and non-propagation).
Regarding claims 3 and 14, Min discloses the stimulus parameters are refined to effect selective recruitment of the first fibre type while further effecting selective non-recruitment or diminished recruitment of at least one other fibre type (e.g. see figure 4 step 412, [0076]-[0078]).
Regarding claims 4 and 15, Min discloses the stimulus parameters are varied and a change in morphology of the electrophysiological response with the varied stimulus parameters enables determination of whether recruitment of the first fibre type or the other fibre types has occurred (e.g. see [0069]-[0070], [0098] frequency and amplitude will read on “morphology”, [0098] states “the frequency locations and frequency ranges associated with each cluster, and the amplitudes of the frequency bins therein are generally referred to as a frequency distribution morphology of the ECAP frequency data”).
Regarding claims 5, Min discloses the electrophysiological response comprises a neural response without defined peaks (e.g. see [0069]-[0070], the bins are grouped by frequency, frequency doesn’t rely on peak analysis).
Regarding claims 6 and 16, Min discloses the varied stimulus parameters comprise a stimulation current (e.g. see [0077]) and the one or more selected characteristics comprise evoked compound action potential (ECAP) shape (e.g. see [0069]-[0070], [0098], frequency and amplitude will read on “shape”), and the method further comprises incrementally increasing the stimulation current (e.g. see [0105], [0107]) and observing a change in the ECAP shape resulting from the incrementally increasing stimulation current (e.g. see figure 8 element 812, 814, 816).
Regarding claims 7 and 17, Min discloses observing the change in ECAP morphology at higher amplitudes (e.g. see [0105], [0107]) enables determination that a second fibre type is recruited (e.g. see [0102], “the activity data corresponds to activity for the fiber of interest, such as at least one of the ECAP A-fiber components, ECAP C-fiber components and/or ECAP Aδ fiber components”).
Regarding claims 8 and 18, Min discloses the varied stimulus parameters comprise stimulation frequency (e.g. see [0077]), and the one or more selected characteristics comprise an evoked compound action potential (ECAP) shape (e.g. see [0069]-[0070], [0098], frequency and amplitude will read on “shape”), and the method further comprises increasing the stimulation frequency (e.g. see [0105], [0107]) and observing a change in the ECAP shape (e.g. see figure 8 element 812, 814, 816).
Regarding claims 9 and 19, Min discloses the method comprises assessing a plurality of the selected characteristics of the recording to determine whether the recruitment of the first fibre type by the electrical stimulus has occurred, the plurality of the selected characteristics of the recording comprising two or more of: one or more electrophysiological response peak positions (e.g. see [0098]); one or more electrophysiological response peak amplitudes (e.g. see [0098]); number of electrophysiological response peaks (e.g. see [0098]) with increasing stimulus current (e.g. see [0105], [0107]); response properties of the electrophysiological response to varying stimulus frequencies (e.g. see [0105], [0107]).
Regarding claim 12, Min discloses the steps (see the rejection for claim 1 above) and further discloses a control unit (e.g. see [0088], figure 7 element 702).
Regarding claims 21 and 22, Min discloses the invention (see the rejection for claims 1 and 12 above) and further discloses issuing an alert (e.g. see [0088], figure 7 elements 710 and 742. [0088] discloses “speaker 710 provides an audible warning (e.g., sounds and tones 742) to the user”).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 10, 11, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Min in view of Parker et al. (Pub. No.: US 2014/0236257 A1); hereinafter referred to as “Parker”.
Regarding claims 10, 11, and 20, Min discloses determining whether the recruitment of the first fibre type by the electrical stimulus has occurred (e.g. see figure 4 steps 406, 408, 410, [0068]-[0075]) but is silent as to recording of the evoked electrophysiological response comprises a myoelectric response in addition to a neural response and assessing the one or more selected characteristics of each of the myoelectric response and the neural response. Parker teaches it is known to use such a modification as set forth in [0054], [0079], [0088] (Note: The examiner’s understanding is myoelectric is EMG) to determine the allowable dynamic range of stimulation which is available to the patient, and further may be used to verify that ongoing stimuli are delivering a desired therapy [0089]. It would have been obvious to one having ordinary skill in the art at the time the invention was made to use EMG in addition to ECAP sensing as taught by Parker in the system/method of Min, since said modification would provide the predictable results of determining the allowable dynamic range of stimulation which is available to the patient, and further may be used to verify that ongoing stimuli are delivering a desired therapy.
Conclusion
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHILIP C EDWARDS whose telephone number is (571)270-1804. The examiner can normally be reached Mon-Fri, 9:00-5:00 EST.
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/P.C.E/Examiner, Art Unit 3792
/AMANDA L STEINBERG/Examiner, Art Unit 3792
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