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 § 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.
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.
Claim(s) 1-6 and 8-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Starkebaum (U.S. Patent Application Publication No. 2011/0071589) hereinafter referred to as Starkebaum; in view of Corndorf et al. (U.S. Patent Application Publication No. 2019/0329041) hereinafter referred to as Corndorf.
Regarding claim 1, Starkebaum teaches a system for neurostimulation (¶[0081]) of a patient's body (¶[0007] tissues), wherein the system comprises a plurality of Z electrodes (¶¶[0098-0099], ¶[0104] any number of electrodes) and a device (¶[0081] IMD), wherein for the number of the plurality of electrodes Z > 3 applies (¶[0098] each array comprises 5 electrodes, 2 arrays), wherein the device (¶[0101] IMD) is configured to deliver via each electrode of a group of N electrodes (N < Z and if Z = 3 then N = Z) a set of electric pulses including one therapeutic electric pulse (¶[0101] one or more electrodes, fewer than 5 or 10, ¶[0103]) having an amplitude I1,12, ... IN, and a number of (N-1) charge balancing electric pulses during one cycle (¶[0107] therapeutic and charge balanced pulses are paired), wherein the charge balancing electric pulses each have a polarity being opposite a polarity of the therapeutic electric pulse (¶[0107] opposite polarity), and wherein each charge balancing electric pulse has a non-rectangular shape (Figs. 8-9 the charge balancing pulses each have a non-rectangular shape).
Starkebaum does not teach the therapeutic electric pulse having a non-rectangular shape.
Attention is drawn to the Corndorf reference, which teaches a therapeutic and charge-balancing pulse pair, each therapeutic pulse and each charge balancing electric pulse have a non-rectangular shape (Fig. 6-8, pulses are each non-rectangular).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the pulse shapes of Starkebaum to use non-rectangular pulses for therapeutic pulses, as taught by Corndorf, because Corndorf teaches pulse parameters that are beneficial in any medical device that delivers electrical stimulation pulses, particularly when using charge-balancing pulse pairs (Corndorf ¶[0026]).
Regarding claim 2, Starkebaum as modified teaches the system of claim 1.
Starkebaum further teaches wherein the non-rectangular shape has a leading edge, a trailing edge and a plateau between the leading edge and the trailing edge, wherein at least one section of the leading edge and/or the trailing edge forms a linear curve or an exponential curve, wherein the plateau has a changing or constant amplitude (Figs. 8-9).
Regarding claim 3, Starkebaum as modified teaches the system of claim 2.
Starkebaum further teaches wherein the plateau has the changing amplitude, and the changing amplitude comprises at least two periodic oscillations between a first amplitude value and a second amplitude value (Fig. 9, both pulses, therapeutic and charge balancing, have an oscillating amplitude) and the first amplitude value and the second amplitude value have the same sign (Fig. 9m at least two of the periodic oscillations have the same sign, the examiner is considering the oscillations to be between the pulse amplitude and the zero axis, not between the positive pulse amplitude and negative pulse amplitude).
Starkebaum does not teach the absolute values of the first and second amplitude values are greater than zero.
Corndorf further teaches wherein the plateau has the changing amplitude, the absolute values of the first and the second amplitude values are greater than zero and the first amplitude value and the second amplitude value have the same sign (Figs. 6-8, the pulse amplitude does not reach zero between first and second amplitudes of the Corndorf pulses).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the pulse shapes of Starkebaum to use non-rectangular pulses that do not zero before the end of the pulse, as taught by Corndorf, because Corndorf teaches pulse parameters that are beneficial in any medical device that delivers electrical stimulation pulses, particularly when using charge-balancing pulse pairs (Corndorf ¶[0026]).
Regarding claim 4, Starkebaum as modified teaches the system of claim 1.
Starkebaum further teaches wherein a current of the therapeutic electric pulse is equal to a sum of currents of the charge balancing electric pulses (¶[0050] net charge from current controlled therapy is zero).
Regarding claim 5, Starkebaum as modified teaches the system of claim 1.
Starkebaum further teaches wherein the non-rectangular shape of the therapeutic electric pulses and the charge balancing electric pulse comprises:
a) the leading edge having a fast edge shape, an exponential shape or a linear shape (Figs. 8-9), and
b) the trailing edge having a linear shape or a section running exponentially (Figs. 8-9).
Regarding claim 6, Starkebaum as modified teaches the system of claim 1.
Starkebaum further teaches wherein device is configured to deliver the therapeutic electric pulse of one electrode such that it has a plateau amplitude value I1,12, ... IN specific to this electrode (¶[0160] detected and delivered per electrode as each output capacitor is monitored).
Regarding claim 8, Starkebaum as modified teaches the system of claim 1.
Starkebaum further teaches wherein the device is configured such that during one phase each electrode of the group delivers an electrical pulse with a plateau amplitude value that establishes charge neutrality on each respective electrode based on pulses of the N-1 other phases of the same electrode (¶[0050] net charge from current controlled therapy is zero, ¶[0160] provide a substantial charge balance with respect to a positive polarity pulse).
Regarding claims 9-14, the claims are directed to a method comprising substantially the same subject matter as claims 1-6, and are rejected under substantially the same sections of Starkebaum and Corndorf.
Claim(s) 7 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Starkebaum and Corndorf as applied to claims 6 and 14 above, and further in view of Johanek et al. (U.S. Patent Application Publication No. 2017/0173341) hereinafter referred to as Johanek.
Regarding claims 7 and 15, Starkebaum as modified teaches the system/method of claim 6/14.
Starkebaum as modified does not teach wherein the device is configured such that the plateau amplitude value of the specific therapeutic electric pulse of each electrode of the group is automatically adjusted using ECAP waveform measurement.
Attention is brought to the Johanek reference, which a device configured such that a plateau amplitude value of a specific therapeutic electric pulse of each electrode of a group of electrodes is automatically adjusted using ECAP waveform measurement (¶[0048]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the adjustment of Starkebaum as modified to use ECAP feedback, as taught by Johanek, because the sensing an ECAP provides feedback to assist in identifying parameter values for pulse pairs that results in effective stimulation therapy (Johanek ¶[0024]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMANDA L STEINBERG whose telephone number is (303)297-4783. The examiner can normally be reached Mon-Fri 8-4.
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/AMANDA L STEINBERG/Examiner, Art Unit 3792