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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 8/6/2026 was filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
Applicant's election with traverse of Group I in the reply filed on 8/3/2026 is acknowledged. The traversal is on the ground(s) that the Groups are not mutually exclusive. This is not found persuasive because even though claims 2 and 6 disclose changing a location, the changing of location is claimed and disclosed for different modes of operation, function or effect, and thus do not overlap in scope. Specifically, claims 1 and 5 compare a sensed ESAP to a stored best ESAP signal, and then a therapy parameter (including neurostimulation location) can be determined based on the comparison. However, in claim 15, the neurostimulation location is recurrently changed in order to identify and store a best sensed ESAP. Claims 1 and 5 do not require changing neurostimulation locations in order to identify and store a best sensed ESAP and claim 15 does not require changing neurostimulation parameters based on comparison to a stored ESAP.
Claims 15-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 8/3/2026. The requirement is still deemed proper and is therefore made FINAL.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 9-14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 9 recites the limitation "the trial neurostimulation" in the claim. There is insufficient antecedent basis for this limitation in the claim as claims 5 and 9 do not previously recite trial neurostimulation.
Claims 10-14 are rejected based on their dependence to claim 9.
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 (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 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.
Claims 1-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sinclair et al. (US 2021/0236821, hereinafter Sinclair)
Regarding claims 1 and 5, Sinclair discloses a neurostimulation device 90 (fig. 10, par. 0001-0003, 0034, 0200), the device comprising: a stimulation circuit 94 (fig. 10, par. 0200) configured to deliver electrical neurostimulation energy to a subject when coupled to an implantable lead 70 (fig. 10, par. 0200)/ Sinclair disclose a sensing circuit 96 configured to sense evoked synaptic activity potential (ESAP) signals when coupled to the implantable lead (fig. 10, par. 0001-0003, 0034, 0200-0202, such that although Sinclair does not mention ESAP signals using the same terminology, Examiner considers the sensed ERNA to be equivalent to ESAP, as currently claimed; additionally, the implantation and the use (Deep Brain Stimulation) of the system described in Sinclair make it suitable for sensing evoked synaptic activity potential (ESAP) in the brain of a patient). Sinclair discloses a control circuit 92 operatively coupled to the stimulation circuit and the sensing circuit (fig. 10, par. 0200) configured to initiate delivery of neurostimulation energy by the stimulation circuit (par. 0203.]), initiate sensing by the sensing circuit of ESAP signals produced by the delivery of neurostimulation energy (par. 0202), change at least one parameter of the neurostimulation energy and continue the sensing of the ESAP signals (fig. 11, 12, par. 0206-0214), compare the sensed ESAP signals to a stored best sensed ESAP signal (par.. 0213), wherein the best sensed ESAP signal was previously sensed at a recorded anatomical location (par. 0213-0214), and determine neurostimulation therapy parameters including a neurostimulation location to produce a best match ESAP signal at the recorded anatomical location that is a closest match to the stored best sensed ESAP signal (fig. 11, 12, par. 0206-0214).
Regarding claims 2 and 6, Sinclair discloses that the control circuit is configured to recurrently change the neurostimulation location for multiple prospective lead placements of the implantable lead (fig. 11, 12, par. 0211-0214), compare the sensed ESAP signals to the stored best sensed ESAP signal (fig. 11, 12, par. 0213-0214), and determine, for each prospective lead placement, a neurostimulation location that produces the best match ESAP signal at the recorded anatomical location that is a closest match to the stored best sensed ESAP signal (fig. 11, 12, par. 0206-0214).
Regarding claims 3 and 7, Sinclair discloses that the control circuit is configured to calculate a correlation of matching of the best match ESAP signal determined for each prospective lead placement to the stored best sensed ESAP signal (fig. 11, 12, par. 0013, 0045, 0206-0214).
Regarding claims 4 and 8, Sinclair discloses that the control circuit is configured to change the neurostimulation location by changing combinations of electrodes of the implantable lead used to deliver the neurostimulation energy (fig. 11, 12, par. 0211-0214) and change the combinations of electrodes of the implantable lead used to sense the ESAP signals in accordance with a change in the electrodes used to deliver the neurostimulation energy (fig. 12, par. 0212).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See attached PTO-892, especially US 2024/0238591, US 2024/0033525 and US 2018/0221644, all of which disclose adjusting neurostimulation based on detected evoked potentials.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eric D Bertram whose telephone number is (571)272-3446. The examiner can normally be reached Monday-Friday 8am-6pm Central Time.
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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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/Eric D. Bertram/Primary Examiner, Art Unit 3796
