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 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 1-3, 6-12, 15-21, 24 and 25 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Carcieri (2014/0243926).
Regarding Claims 1, 10 and 19, Carcieri discloses a system and method for automatically adjusting stimulation parameters based off of measured evoked action potentials (Title; Abstract). Specifically, Carcieri discloses providing a lead 12 coupled to an IPG 14, the IPG 14 having a processor 64 (Fig. 3, 4; par. [0050] )and the lead 12 includes at least one electrode 26 (par. [0031]) and is configured to be implanted at a target position proximate to or within nerve tissue of interest, such as spinal nerve tissue (par. [0045]). Carcieri discloses the processor 64 is configured to deliver a series of SCS pulses from the at least one electrode. The SCS pulses can be a variety of different waveforms with different amplitudes as well as pulse widths, duty cycle, etc. The pulses are applied in an iterative manner and an action potential is detected for each different amplitude and compared to a template action potential (par. [0068]). The stimulation parameters are continually adjusted until the measured action potential matches the baseline (par. [0070-0071]), wherein matching criteria can be a peak delay (Applicant’s claimed time delay), see par. [0065-0066]; Fig. 8). Once a match is determined, the parameters are saved and set thus defining a stimulation threshold (such as a stimulation energy threshold, see par. [0067]) based on the time delay associated with the action potential.
In regards to Claims 2, 11 and 20, Carcieri discloses that stimulation parameters can be applied in which the action potential peak time delay either precedes or occurs after the peak time delay of the template action potential (e.g. does not match the timing of the template) and the results can be stored in a database (par. [0067, 0083]) thus meeting the “identifying the stimulation amplitude” step in the claim (par. [0065-0066]).
With regards to Claims 3, 12 and 21 Carcieri discloses the timing delay begins at point t1 where a stimulus is applied (par. [0065]; Fig. 8).
In regards to Claims 6 and 15, Carcieri discloses that if the initial stimulus provides under-stimulation, the stimulation level is iteratively increased until the desired action potential is generated (par. [0070]).
Regarding Claims 7 and 16, Carcieri discloses the stimulation waveforms can be biphasic (par. [0043]).
In regards to Claims 8, 17 and 25, Carcieri discloses measuring action potentials near spinal nerve tissue to determine levels of paresthesia which relate to sensory fibers and therefore such measures are made near or proximate AB nerve tissues (par. [0066]).
With regards to Claims 9, 18 and 24, Carcieri discloses transmitting an alert notification responsive to defining the stimulation threshold, such as an alert can be sent if the action potential does not match the template and parameters need to be adjusted (par. [0067]) and a table of matched action potentials and their corresponding stimulation parameters can be stored and transmitted (par. [0067]).
Claim Rejections - 35 USC § 103
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 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 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.
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 4, 5, 13, 14, 22 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Carcieri (2014/0243926) in view of Single (2017/0361101). Carcieri discloses adjusting stimulation parameters based on wave morphology features of an action potential waveform (par. [0065]) but fails to explicitly note that slope is the particular waveform morphology feature relied upon. Carcieri further discloses the stimulation parameters are selected to optimize power consumption by delivering the stimulation parameters that deliver the desired action potential response with the least amount of power consumed (par. [0074]).
In the same field of endeavor, Single discloses that the slope of an action potential waveform can be used to adjust stimulation parameters since the slope of the action potential waveform indicates a distance of the stimulation electrode to the nerve tissue of interest (par. [0035]) and that the slope of the action potential waveform can be expressed as a function of a stimulation threshold T (par. [0036]). As such, a measurement of the action potential slope can be an indicator as to how much to increase or decrease an applied stimulus to obtain a desired amplitude as defined by an action potential template (see Fig. 6), much like in the manner disclosed by Carcieri. As a result the slope of the action potential waveform can indicate what levels of stimulation current need to be applied to reach a desired action potential amplitude and in the case where multiple different parameters can achieve the same result, the parameter set that utilizes the least amount of energy (such as threshold 1 versus threshold 2 in Fig. 6) can be selected as the set that best optimizes power consumption.
Therefore 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 device in the Carcieri reference to include measuring the slope of the action potential waveforms, as taught and suggested by Single, for the purpose of determining the stimulation values that need to be applied to reach a desired action potential value as well as for the purpose of optimizing power consumption in the device by selecting the electrode or electrode set that utilizes the least amount of energy for the same result.
Conclusion
This is a Continuation of applicant's earlier Application No. 16/359790. All claims are identical to, patentably indistinct from, or have unity of invention with the invention claimed in the earlier application, see claim set filed 3/20/2019 and rejected in the Non-Final Rejection dated 12/4/2020 (that is, restriction (including lack of unity) would not be proper) and could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the earlier application. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action in this case. See MPEP § 706.07(b). 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.
/ALLEN PORTER/ Primary Examiner, Art Unit 3796