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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 8/5/2026 has been entered.
Response to Arguments
Applicant’s amendments to the claims merit new citations to the same prior art references of record and may therefore be considered new grounds for rejection. In the interest of moving forward prosecution, additional grounds for rejection under 35 U.S.C. § 103 are presented further in view of Hogg et al. (U.S. Patent Application Publication No. 2022/0062621) hereinafter referred to as Hogg.
Applicant’s amendments overcome the rejections under 35 U.S.C. § 112 for improper dependency and the rejections are withdrawn.
Applicant's arguments filed 8/5/2026 have been fully considered but they are not persuasive. With respect to the rejections under 35 U.S.C. § 103, on p. 5, Applicant alleges that the pulses of Starkebaum and Corndorf do not teach a plateau having a periodically changing or constant amplitude that extends over a pre-defined plateau time period. Applicant goes on to state that the monotonic decay of Corndorf is neither constant nor periodically changing.
This is not persuasive because the stimulation pulses of Corndorf are delivered at a defined frequency and therefore with a defined period, and the examiner considers the claimed periodically changing amplitude to be met by the changing amplitude per period of the stimulation. It’s noted that Applicant does not claim that the plateau amplitude change is based on the plateau time period specifically, and would not have proper antecedent basis to do so as the plateau time period is claimed after “the plateau has a periodically changing or constant amplitude”. Lastly, Starkebaum further teaches wherein the plateau has the periodically 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).
Applicant further alleges that Corndorf does not have a pre-defined plateau time period, stating that the claimed pulse encompasses all of a leading edge, plateau, and trailing edge and therefore one interval spanning an entirety of a pulse cannot simultaneously serve as all three portions. Applicant’s point appears to be that a leading edge and trailing edge necessarily comprise a time period that would have to be subtracted from the pulse width to yield the plateau time period.
This is not found persuasive because in Corndorf, the pulse width is the width of the plateau due to the fact that the leading and trailing edges of the pulses are substantially vertical, comprising no specific time width. Therefore, Corndorf teaches a configurable pre-defined plateau time period described by element 312 in Fig. 8. Furthermore, Corndorf also teaches terminating pulses specifically after a predetermined period of decay, referred to as pulse tilt (¶[0073]). Therefore, terminating at a specific percentage decay, known to comprise a particular period of time due to the capacitor discharge rate, specifically refers to the time width of the decay (the decreasing pulse amplitude across the identified plateau) itself.
Therefore, it is the examiner’s position that a pulse with a plateau as claimed is known in the art as stated in the rejection below and therefore the rejection is maintained.
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, 3-4, 6, 8-9, 11-12, and 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) having a leading edge, a trailing edge, and wherein the leading edge has a fast edge shape, an exponential shape, or a linear slope, and the trailing edge has a linear slope or a section running exponentially (Figs. 8-9, charge balancing pulse has a leading fast edge and a trailing exponential section).
Starkebaum does not teach the therapeutic electric pulse having a non-rectangular shape or that the charge balancing pulse comprises a plateau between the leading edge and the trailing edge, wherein the plateau has a changing or constant amplitude.
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) and comprising a plateau that has a periodically changing amplitude (Figs. 6-8, the stimulation pulses of Corndorf are delivered at a defined frequency and therefore with a defined period, and the examiner considers the claimed periodically changing amplitude to be met by the changing amplitude per period of the stimulation) and the plateau extends over a pre-defined plateau time period (312 in Fig. 8, ¶[0060], ¶[0073], ¶[0103]).
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 shapes for both therapeutic and charge balancing pulses, as taught by Corndorf, with a plateau, 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]).
Starkebaum as modified does not teach the charge balancing pulse comprises a plateau between the leading edge and the trailing edge, wherein the plateau has a changing or constant amplitude.
However, Applicant has disclosed no criticality to the specific plateau shape when broadly considered with any of the listed leading and trailing edge combinations. The Examiner considers there may be criticality disclosed to the overall rampart shape (p. 7 of the Specification filed 5/22/2024) but Applicant has refrained from claiming the rampart shape, instead broadly claiming in terms of possible shapes that are not limited solely to a rampart shape. Therefore, in the context of the claimed pulse, the plateau lacks criticality.
Therefore the Examiner considers that pulses with a plateau are known in the art (Starkebaum, Fig. 6A-B, Corndorf Fig. 6-8) and that the results of pulses with a plateau are predictable (they are known and widely used). Furthermore, the energy delivery of the pulses are calculable and function in each part the same as a whole (Starkebaum Fig. 9 these are piecemeal pulses that have the same effect as the whole pulses in Fig. 8). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the pulses of Starkebaum as modified to include a plateau, because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. at 416, 82 USPQ2d at 1395; B/E Aerospace, Inc. v. C&D Zodiac, Inc., 962 F.3d 1373, 1379, 2020 USPQ2d 10706 (Fed. Cir. 2020); Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atl. & P. Tea Co. v. Supermarket Equip. Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950).
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 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, 11-12 and 14, the claims are directed to a method comprising substantially the same subject matter as claims 1 and 3-6, and are rejected under substantially the same sections of Starkebaum and Corndorf.
Claim(s) 1, 3-4, 6, 8-9, 11-12, and 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 Hogg et al. (U.S. Patent Application Publication No. 2022/0062621) hereinafter referred to as Hogg.
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) having a leading edge, a trailing edge, and wherein the leading edge has a fast edge shape, an exponential shape, or a linear slope, and the trailing edge has a linear slope or a section running exponentially (Figs. 8-9, charge balancing pulse has a leading fast edge and a trailing exponential section).
Attention is drawn to the Hogg reference, which teaches a therapeutic and charge-balancing pulse pair (¶[0213]), each therapeutic pulse and each charge balancing electric pulse have a non-rectangular shape (Fig. 74B, 74D), pulses are each non-rectangular) and comprising a plateau that has a periodically changing amplitude (Fig. 74B, 74D, the stimulation pulses of Hogg are delivered at a defined frequency and therefore with a defined period, and the examiner considers the claimed periodically changing amplitude to be met by the changing amplitude per period of the stimulation) and the plateau extends over a pre-defined plateau time period (¶[1274]).
Applicant has disclosed no criticality to the specific plateau shape when broadly considered with any of the listed leading and trailing edge combinations. The Examiner considers there may be criticality disclosed to the overall rampart shape (p. 7 of the Specification filed 5/22/2024) but Applicant has refrained from claiming the rampart shape, instead broadly claiming in terms of possible shapes that are not limited solely to a rampart shape. Therefore, in the context of the claimed pulse, the plateau lacks criticality.
Therefore the Examiner considers that pulses with a plateau are known in the art (Starkebaum, Fig. 6A-B, Hogg Fig. 74B, 74D) and that the results of pulses with a plateau are predictable (they are known and widely used). Furthermore, the energy delivery of the pulses are calculable and function in each part the same as a whole (Starkebaum Fig. 9 these are piecemeal pulses that have the same effect as the whole pulses in Fig. 8). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the pulses of Starkebaum as modified to include a plateau, because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. at 416, 82 USPQ2d at 1395; B/E Aerospace, Inc. v. C&D Zodiac, Inc., 962 F.3d 1373, 1379, 2020 USPQ2d 10706 (Fed. Cir. 2020); Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atl. & P. Tea Co. v. Supermarket Equip. Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950).
Regarding claim 3, Starkebaum as modified teaches the system of claim 2.
Starkebaum further teaches wherein the plateau has the periodically changing amplitude, and the periodically 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.
Hogg 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 (Fig. 74B, 74D, the pulse amplitude does not reach zero between first and second amplitudes of the Hogg 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 Hogg, because Hogg teaches pulse parameters for effective stimulation (Hogg ¶[01391]).
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 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, 11-12 and 14, the claims are directed to a method comprising substantially the same subject matter as claims 1 and 3-6, and are rejected under substantially the same sections of Starkebaum and Hogg.
Claim(s) 7 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Starkebaum and Corndorf or Hogg 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
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