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, see Applicant Arguments/Remarks Made in an Amendment, filed 11 February 2026, with respect to the rejection(s) of claim(s) 50 – 73 under 35 U.S.C. § 102(a)(1) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Mishra et al. (US PGPUB 2019/0001139 – previously cited) in view of Panken et al. (US PGPUB 2009/0082829 – in IDS).
Applicant's submission of an information disclosure statement under 37 CFR 1.97(c) with the timing fee set forth in 37 CFR 1.17(p) on 11 February 2026 prompted the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 609.04(b). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
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 (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 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) 50 – 73 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mishra et al. (US PGPUB 2019/0001139 – previously cited) in view of Panken et al. (US PGPUB 2009/0082829 – in IDS).
Regarding claim 50, Mishra discloses a method for providing stimulation to a patient, the method comprising: configuring a first pulse rate of stimulation pulses of a first stimulation waveform independently from a second pulse rate of stimulation pulses of a second stimulation waveform (e.g. ¶ 175 – 176), wherein the first and second pulse rates are different (e.g. ¶ 444); wherein the first stimulation waveform is delivered via at least a first delivery element of an implantable device and the second stimulation waveform is delivered via at least a second delivery element of the implantable device (e.g. ¶ 23), but fails to teach delivering the first and second stimulation waveforms simultaneously to the patient over a periodic time interval such that the stimulation pulses of the first and second stimulation waveforms do not overlap over the periodic time interval.
Panken teaches it is known to deliver first and second stimulation waveforms simultaneously to the patient over a periodic time interval such that the stimulation pulses of the first and second stimulation waveforms do not overlap over the periodic time interval (e.g. ¶ 250-251; blanking circuitry). It would have been obvious to one having ordinary skill in the art to modify the invention as taught by Mishra with the blanking circuitry as taught by Panken since such a modification would provide the predictable results of delivering the stimulation waveforms offset and non-overlapping.
Regarding claim 51, Mishra discloses each of the first and second pulse rates comprise a number of stimulation pulses delivered over the periodic time interval, and wherein the periodic time interval is one second (e.g. ¶ 55).
Regarding claim 52, Mishra discloses the stimulation pulses of the first and second stimulation waveforms are separated to maintain a constant average load condition for the implantable device (e.g. e.g. ¶ 162 and 368).
Regarding claims 53 and 54, Mishra discloses configuring one or both of an on time and an off time for a first dose of the first stimulation waveform independently from one or both of an on time and an off time for a second dose of the second stimulation waveform, wherein the first and second doses are time-shifted and non- overlapping over the periodic time interval (e.g. ¶ 55 and 450).
Regarding claim 55, Mishra discloses the first stimulation waveform is delivered to a first anatomical location of the patient and the second stimulation waveform is delivered to a second, different anatomical location of the patient (e.g. ¶ 98).
Regarding claim 56, Mishra discloses each of the first and second stimulation waveforms is delivered from an independent current source (e.g. ¶ 48).
Regarding claim 57, Mishra discloses the first pulse rate is higher than the second pulse rate, and wherein delivering the first and second stimulation waveforms comprises: delivering the stimulation pulses of the first stimulation waveform with the first pulse rate over each of a plurality of periodic time intervals; and delivering a subset of stimulation pulses of the second stimulation waveform with the first pulse rate over each of the plurality of periodic time intervals such that the second pulse rate is achieved over the plurality of time intervals (e.g. ¶ 444).
Regarding claim 58, Mishra discloses the stimulation pulses of the first stimulation waveform are evenly spaced within each of the plurality of periodic time intervals (e.g. at least Figs 22, 24, 30A).
Regarding claims 59 – 61¸ Mishra discloses configuring a first form of charge recovery of the first stimulation waveform independently from a second form of charge recovery of the second stimulation waveform, wherein each of the first and second forms of charge recovery comprises a combination of active and passive charge recovery and wherein each of the first and second forms of charge recovery comprises normalized charge recovery based on one or more time periods each comprising a predetermined number of stimulation pulses (e.g. ¶ 16 and 100).
Regarding claim 62, Mishra discloses each of the first and second stimulation waveforms are configured to treat pain of the patient (e.g. ¶ 3).
Regarding claim 63, Mishra discloses a method for providing stimulation to a patient, the method comprising: configuring a first stimulation waveform for a first anatomical location of the patient independently from a second stimulation waveform configured for a second anatomical location of the patient (e.g. ¶ 175 – 176); wherein the first stimulation waveform is delivered via at least a first delivery element of an implantable device to a first anatomical location of the patient and the second stimulation waveform is delivered via at least a second delivery element of the implantable device to a second anatomical location of the patient (e.g. ¶ 98), wherein the implantable device is configured to balance charge delivered and charge recovered from each of the independent current sources over a time period comprising a predetermined number of stimulation pulses (e.g. ¶ 16 and 100), but fails to teach delivering the first and second stimulation waveforms simultaneously from independent current sources of an implantable device over a periodic time interval.
Panken teaches it is known to deliver first and second stimulation waveforms simultaneously to the patient over a periodic time interval such that the stimulation pulses of the first and second stimulation waveforms do not overlap over the periodic time interval (e.g. ¶ 250-251; blanking circuitry). It would have been obvious to one having ordinary skill in the art to modify the invention as taught by Mishra with the blanking circuitry as taught by Panken since such a modification would provide the predictable results of delivering the stimulation waveforms offset and non-overlapping.
Regarding claim 64, Mishra discloses delivering the first and second stimulation waveforms comprises passively recovering charge during periods between stimulation pulses of each of the first and second stimulation waveforms (e.g. ¶ 16 and 100).
Regarding claim 65, Mishra discloses delivering the first and second stimulation waveforms comprises performing a combination of active and passive charge recovery for one or both of the first and second stimulation waveforms (e.g. ¶ 68).
Regarding claim 66, Mishra discloses the implantable device is configured to achieve a net zero charge over each of the first and second anatomical locations of the patient (e.g. ¶ 249).
Regarding claim 67, Mishra discloses configuring the first and second waveforms comprises configuring, for each of the first and second stimulation waveforms, one or more of a number of anatomical locations for stimulating, a pulse width of stimulation pulses, an amplitude of stimulation pulses, a pulse rate of stimulation pulses, a form of charge recovery, a stimulation dose on time, and a stimulation dose off time (e.g. ¶ 98 – 100).
Regarding claim 68, Mishra discloses the first and second stimulation waveforms are delivered in time-shifted doses that are non-overlapping over the periodic time interval (e.g. ¶ 55 and 450).
Regarding claims 69 and 70, Mishra discloses one or both of the first and second stimulation waveforms are delivered at a sub-threshold level and/or a supra threshold level (e.g. ¶ 60).
Regarding claim 71, Mishra discloses transferring power from an external system to the implantable device during the time period (e.g. ¶ 13).
Regarding claim 72, Mishra discloses the first and second anatomical locations are overlapping (e.g. 445).
Regarding claim 73, Mishra discloses the first and second stimulation waveforms are configured to treat pain of the patient (e.g. ¶ 3).
Conclusion
Applicant's submission of an information disclosure statement under 37 CFR 1.97(c) with the timing fee set forth in 37 CFR 1.17(p) on 11 February 2026 prompted the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 609.04(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.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Cholette et al. (US PGPUB 2018/0369573) discloses a method for treating pain by applying a plurality of stimulation waveforms.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH M DIETRICH whose telephone number is (571)270-1895. The examiner can normally be reached Mon - Fri 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached at 571-270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSEPH M DIETRICH/Primary Examiner, Art Unit 3796
