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 .
Response to Amendment
The amendment filed July 22, 2026 has been entered. Claims 16, 18, 20-21, 23, 26-29, 31, 33-34 have been amended. Claims 1-15, 22, 24-25, 35-37 are canceled. Currently, claims 16-21, 23, 26-34 are pending for examination.
Response to Arguments
Applicant’s arguments with respect to claim(s) 16-21, 23, 26-34 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Objections
Claim 33 is objected to because of the following informalities: line 12 recites, “the third and fourt” and should recite, “the third and fourth”. Appropriate correction is required.
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.
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.
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) 16-19, 23, 26-27, 29-32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hou et al. (US 2018/0126169) in view of Wu et al. (US 2012/0271375).
Regarding claims 16, 29, Hou et al. discloses a computer readable storage medium storing instructions executable by a processor to control a neurostimulation system to, and a neurostimulation system, comprising: at least one electrode array 3111a-h adapted for implantation in or near a target neural structure, the electrode array comprising a plurality of electrodes; a signal generator 152 ([0039]) selectively coupled to each of the plurality of electrodes and configured to apply at least a first electrical stimulus having a first stimulus amplitude at a firs electrode in the array (“a series of SCS pulses 406 delivered by the IPG 308 and emitted by one… of the lead electrodes 3111a-h” [0048]) and then apply a second electrical stimulus having a second stimulus amplitude at the first electrode (“emitted by one… of the lead electrodes 3111a-h” [0048]), wherein the first and second stimulus amplitudes are different (“an Increased amplitude 610 and 616 over the amplitudes 414 and 416 of the SCS pulses 406” [0051-0052]) wherein the first electrode is at a first position of the patient (fig. 3); a measurement device 158 selectively coupled to each of the plurality of electrodes ([0049]) and configured to detect a first response evoked in the target neural structure by the first electrical stimulus and a second response evoked in the target neural structure by the second electrical stimulus (“the method 200 determines an ECAP amplitude 510 based on an ECAP waveform 502 resulting from the ECAP therapy” [0049]); and a processing unit 151 ([0030]) coupled to the measurement device and configured to: determine a first change in one or more common waveform characteristics between the first and second resonant responses (“trend divergence” [0055]); determine an effectiveness of delivering therapeutic stimulation at the first position based on the change ([0057-0058]); and deliver therapeutic stimulation at the first position or another position based on the determined effectiveness of delivering therapeutic stimulation at the first position (“method 200 returns to 204 to deliver the SCS pulses (e.g., the SCS pulses 606a-c) from the IPG 308 to the same stimulation location” [0059]).
Hou et al. discloses stimulating target neural structures of the spinal cord ([0005]) and does not expressly disclose this neurostimulation system is for implantation in or near a target neural structure in the brain. However Hou et al. teaches that a neurostimulation system for use with the spinal cord may be adapted to also stimulate deep brain tissue ([0029]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the neurostimulation system would also be capable of being used for implantation in or near a target neural structure of the brain.
Hou et al. does not expressly disclose the responses evoked by the electrical stimuli are specifically resonant responses. Wu et al. teaches a neurostimulation system for stimulating target neural structures in the brain, where the responses evoked by electrical stimuli are specifically resonant responses (([0049]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hou et al. to detect resonant responses evoked from the electrical stimuli delivered to target neural structures in the brain as Wu et al. teaches these are the types of responses detected when stimulating the area of the brain ([0028]), such types of measurements known in the art and would have been reasonably predictable.
Regarding claims 17 and 30, Hou et al. discloses wherein the one or more common waveform characteristics comprises an amplitude of the resonant response ([0058]).
Regarding claims 18 and 31, Hou et al. discloses wherein the processing unit is further configured to select an amplitude for therapeutic stimulation of the target neural structure based on the change ([0063]).
Regarding claims 19 and 32, Hou et al. discloses wherein the processing unit is further configured to: select the first position for therapeutic stimulation of the target neural structure based on the change ([0059]).
Regarding claim 23, Hou et al. discloses wherein determining the change in the one or more common waveform characteristics comprises determining a rate of change in the one or more of the common waveform characteristics (“slope” [0057]).
Regarding claim 26, Hou et al. discloses wherein the resonant response is detected at two or more of the plurality of electrodes ([0049]).
Regarding claim 27, the limitation "wherein the signal generator is configured to apply the plurality of electrical stimuli to the brain of patient while the patient is under general anaesthetic" is not given patentable weight as it does not invoke structural limitations on the invention and is beyond the scope of the invention. "[A]pparatus claims cover what a device is, not what a device does." Hewlett Packard Co.v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Citation of Pertinent Art
Claims 20, 28 and 33 recite limitations where third and fourth electrical stimuli are applied to a second electrode at a second position in the brain of the patient, and detecting third and fourth resonant responses evoked by the third and fourth electrical stimuli, respectively, determining a second change in common waveform characteristics between the third and fourth resonant responses, and comparing the first change (recited in the independent claims 16 and 29) to the second change. Hou et al. does not disclose these specific limitations.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERICA S LEE whose telephone number is (571)270-1480. The examiner can normally be reached M-F 8-7pm, flex.
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/ERICA S LEE/Primary Examiner, Art Unit 3796
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