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
This Office Action is responsive to the amendment filed on 02 Jul 2026. As directed by the amendment: claims 1, 4-10, 12, 14, 16, and 18 have been amended, no claims have been canceled, and claim 20 has been added. Thus, claims 1-20 are presently pending in this application.
Response to Arguments
CLAIM OBJECTIONS
Applicant’s arguments, see Remarks, filed 02 Jul 2026, with respect to the objections to the claims have been fully considered and are persuasive in light of the claim amendments. The objections to the claims have been withdrawn.
CLAIM REJECTIONS UNDER 35 U.S.C. § 112
Applicant’s arguments, see Remarks, filed 02 Jul 2026, with respect to the rejections of the claims under 35 U.S.C. 112 have been fully considered and are persuasive in light of the claim amendments. The rejections of the claims under 35 U.S.C. 112 have been withdrawn.
However, new rejections are made below as necessitated by the claim amendments.
CLAIM REJECTIONS UNDER 35 U.S.C. § 103
Applicant’s arguments, see Remarks, filed 02 Jul 2026, with respect to the rejections of the claims under 35 U.S.C. 103 have been fully considered and are persuasive in light of the claim amendments. The rejections of the claims under 35 U.S.C. 103 have been withdrawn for reasons explained in further detail below.
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 1-20 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 1 recites “stimulation of a nerve”, “identifying that a patient has a decreased level of OPCs”, and “applying electrical stimulation to the nerve from an implanted neurostimulator”. Claim 1 does not explicitly state that the nerve is in the identified patient, nor that the implanted neurostimulator is implanted in the identified patient. For the purposes of examination, “stimulation of a nerve” will be interpreted as “stimulation of a nerve of a patient”, “identifying that a patient” will be interpreted as “identifying that the patient”, and “an implanted neurostimulator” will be interpreted as “a neurostimulator implanted in the patient”.
Claim 1 recites “a reference level”, which is unclear as to what the reference level is, or what the reference level is based on.
Claims 2-8 and 20 are also rejected because they are dependent on claim 1.
Claim 9 recites “applying electrical stimulation to the nerve of the patient from an implanted neurostimulator”. Claim 1 does not explicitly state that the implanted neurostimulator is implanted in the identified patient. For the purposes of examination, “an implanted neurostimulator” will be interpreted as “a neurostimulator implanted in the patient”.
Claim 10 recites “stimulation of a nerve”, “a nerve stimulator configured to be implanted”, and “a measured or derived level of OPCs within the patient”. There is insufficient antecedent basis for “the patient” in line 10. Claim 10 does not explicitly state that the nerve is in the patient, nor that the nerve stimulator is implanted in the patient. For the purposes of examination, “stimulation of a nerve” will be interpreted as “stimulation of a nerve of a patient”, and “a nerve stimulator configured to be implanted” will be interpreted as “a nerve stimulator configured to be implanted in the patient”.
Claims 11-19 are also rejected because they are dependent on claim 10.
Claim 20 recites “a level of OPCs associated with a healthy subject”. It is unclear as to what a healthy subject comprises and what level of OPCs would be associated with a healthy subject.
Claims Free of the Art
Claim 1 is free of the art, but it not allowable due to the outstanding rejections under 35 USC 112. Claims 2-8 and 20 are dependent on claim 1, and are therefore also free of the art. Claims 9-10 recite similar subject matter to that of claim 1, and are therefore also free of the art for similar reasons. Claims 11-19 are dependent on claim 10, and are therefore also free of the art.
Applicant’s arguments and amendments as made in the Amendment filed 02 Jul 2026 overcome the previous 35 U.S.C. 103 rejection of claim 1 made in the Non-Final Rejection Office Action mailed 05 Jan 2026. Applicant argues that none of the previously cited prior art references “teach or suggest first identifying a patient as having decreased OPC levels and using OPC level itself as a direct therapeutic protocol/target. Nor do they contemplate timing of nerve stimulation and dosing being tailored to increase OPCs. These references alone or in combination provide no motivation to consider treatment based on OPC depletion. Cui leaves the relationship between BDNF and OPCs unclear and provides no teaching that OPC is a useful clinical indicator or tailoring closed-loop electrical stimulation based OPC levels” (Remarks, page 7). Examiner agrees with these arguments.
The prior art does not disclose or teach a method for increasing oligodendrocyte progenitor cells (OPCs) by stimulation of a nerve, the method comprising: identifying that a patient has a decreased level of OPCs relative to a reference level; applying electrical stimulation to the nerve from an implanted neurostimulator, wherein the applied electrical stimulation to the nerve is delivered as a charge per day of between 2.5 nC and 7.5 mC to increase the level of OPCs.
The prior art does not disclose or teach the method and system recited in claims 9-10 for similar reasons as claim 1. Therefore, claims 9-10 are free of the art.
Claims 2-8 and 20 are dependent on claim 1, and thus further limit claim 1, and are also free of the prior art of record. Claims 11-19 are dependent on claim 10, and thus further limit claim 10, and are also free of the prior art of record.
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 CHRISTINE SISON whose telephone number is (703)756-4661. The examiner can normally be reached 8 am - 5 pm PT, Mon - Fri.
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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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/CHRISTINE SISON/Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796
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