DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 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
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/P.C.E/Examiner, Art Unit 3792
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792
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