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 .
Status of Claims and Response to Amendments
The amendments filed September 10, 2026 have been acknowledged and entered. Claims 1-6, 9 and 11-17 are pending.
Election/Restriction
The present examination is based on Applicant’s election of chlorzoxazone during the interview on June 10, 2026. Applicant remarks filed September 10, 2026 did not overcome the art rejection set forth in the previous office action. The search has thus been limited to chlorzoxazone.
Claims 9 and 13 (in full) and claims 1-6, 11-12 and 14-17 (all in part, other than wherein the SK ion channel activator is chlorzoxazone) are additionally withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species
Withdrawn Rejections
Applicant is notified that any outstanding rejection or objection that is not expressly maintained in this Office Action has been withdrawn or rendered moot in view of Applicant’s amendments and/or
remarks.
Maintained Rejections
Claim Rejections - 35 USC § 103
Claims 1-5, 11-12 and 14-17 are rejected under 35 U.S.C. 103 as being unpatentable over Aumann et al. (WO2010/015037)(hereinafter “Aumann”).
Claim(s) 1 and 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Aumann et al. (WO2010/015037)(hereinafter “Aumann”) in view of Alqahtani et al. (Frontiers in Pharmacology Feb 2021, Vol. 12, Article 618411) (hereinafter “Alqahtani”).
The reasons for these rejections were set forth in the previous Office Action mailed June 10, 2026 and are incorporated herein by reference.
Response to Arguments
Applicant’s arguments filed September 10, 2026 have been fully considered but they are not persuasive.
Applicant states that they have amended claim 1 to recite a method of treating a cognitive impairment in a subject in need thereof, the method comprising administering to the subject a therapeutically effective amount of a SK ion channel activator, wherein the SK ion channel activator comprises chlorzoxazone. This amendment is not found persuasive because of the reasons set forth in the rejection. Aumann teaches a method of treating a cognitive impairment in a subject comprising administration of an SK ion channel activator to the subject wherein the SK ion channel activator is chlorzoxazone (see claims 1-3, condition is….memory deficit, attention deficit; see claims 6-7, agonist specific for SK channel is…chlorzoxazone). The instant specification teaches cognitive impairments include working memory (see paragraph [00036]). Impairments in working memory would include memory deficiency. The only difference between Aumann and the claimed invention is that the invention explicitly recites a method of treating a cognitive impairment comprising administration of chlorzoxazone as well as specific doses. The claims would have been prima facie obvious for the reasons set forth in the rejection.
In response to Applicant’s statement that the presently claimed invention teaches an unexpected
result of improving attention and memory in ketamine-treated animals exhibiting schizophrenia like
cognitive defects, Examiner notes that unexpected results must be commensurate in scope with the claimed invention. See MPEP 716.02(d). In the present case the claims are very broadly drawn to treatment in any subject whereas the unexpected result is only demonstrated in a model of schizophrenia. There is no evidence of record to suggest that cognitive impairments associated with schizophrenia represent cognitive impairments in a subject generally. Applicant’s unexpected results are not commensurate with the scope of the claimed invention. Applicant’s argument and unexpected result would be found persuasive if the claims where amended to require, for instance, wherein the symptoms of the cognitive impairment originate from schizophrenia (limitations of instant claim 2).
The rejection is still deemed proper and thus maintained.
Rejections Necessitated by Applicant Amendment
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 1-6, 11-12 and 14-17 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.
Claims 1 has been amended to recite the phrase “SK ion channel activator comprises”. In this context “ comprises” renders the scope of the claims indefinite because it is not clear what other elements are intended to be included in SK ion channel activator other than chlorzoxazone. The transitional term "comprising", which is synonymous with "including," "containing," or "characterized by," is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. See MPEP 2111.03. It appears from the specification that the SK ion channel activator intended to be a compound (see e.g. [00015] to [00018]). It is suggested Applicant amend the claim to recite “SK ion channel activator is chlorzoxazone”.
Claims 2-6, 11-12 and 14-17 depend from claim 1, do not cure all of the abovementioned deficiencies, and therefore are also indefinite.
Conclusion
THIS ACTION IS MADE FINAL. 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 KEVIN MARTIN whose telephone number is (571)270-0917. The examiner can normally be reached Monday - Friday 8 am - 5 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached on (571) 272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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October 1, 2026
/K.S.M./Examiner, Art Unit 1624
/BRUCK KIFLE/Primary Examiner, Art Unit 1624
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