DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission, filed 01/02/2026, has been entered.
Status of Application
Receipt of the amendments to the claims and applicant arguments/remarks, filed 01/02/2026, is acknowledged.
Applicant has previously elected without traverse the invention of Group I, claims 1-9, drawn to a composition comprising an aqueous solution comprising 4-((L-valyl)oxy)butanoic acid and a pH adjusting agent
Claims 1, 4-13 are pending in this action. Claim 3 has been cancelled. Claim 2 has been cancelled previously. Claims 1, 6, 8, 11 have been amended. Claims 10-13 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species and inventions, there being no allowable generic or linking claim. Claims 1, 4-9 are currently under consideration.
Any rejection or objection not reiterated in this action is withdrawn. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
This application is a continuation of U.S. Patent Application No. 17/383,253, filed July 22, 2021 and now issued as U.S. Patent No. 11,896,573, which claims benefit of provisional U.S. Application No. 63/056,141, filed July 24, 2020, and U.S. Application No. 63/059,514, filed July 31, 2020.
Terminal Disclaimer
The terminal disclaimers, filed 05/15/2025 and 01/02/2026, disclaiming the terminal portion of any patent granted on this application, which would extend beyond the expiration date of the prior Patent Nos. 11,896,573, 11,510,892, 11,304,906, 11,395,801, 11,925,710; and any patent granted on pending reference application Nos. 17/687,160, 17/737,700, 18/421,426, 18/422,456, 18/239,265, 18/789,932, have been reviewed and are accepted. The terminal disclaimers have been recorded.
Claim Rejections - 35 USC § 112(b)
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.
Claim 8 is 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 pre-AIA the applicant regards as the invention.
Claim 8 is not reasonably clear, because the total amounts of recited compounds in the compositions comprising 90 wt% of 4-((L-valyl)oxy)butanoic acid is more than 100 wt%. Clarification is required.
Rejoinder
Claims 1, 4-7, 9 are directed to an allowable product. Pursuant to the procedures set forth in MPEP § 821.04(B), claims 10-13, directed to the process of using an allowable product, previously withdrawn from consideration as a result of a restriction requirement, are hereby rejoined and fully examined for patentability under 37 CFR 1.104.
Because all claims previously withdrawn from consideration under 37 CFR 1.142 have been rejoined, the restriction requirement as set forth in the Office action mailed on 08/12/2024 is hereby withdrawn. In view of the withdrawal of the restriction requirement as to the rejoined inventions, applicant(s) are advised that if any claim presented in a continuation or divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971); and/or MPEP § 804.01.
Claim Objections
Claims 10, 12 are objected to because of the following informalities:
In claim 10 the limitation “patient comprising orally administering” should be corrected to “patient, the method comprising orally administering” for clarity.
In claim 12 the limitation “patient in need thereof comprising orally administering” should be corrected to “patient in need thereof, the method comprising orally administering” for clarity.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter: The prior art teaches a large variety of pharmaceutical compositions comprising [Symbol font/0x67]-hydroxybutyrate and/or derivatives thereof as an active agent and their use for treating narcolepsy, excessive daytime sleepiness associated with various neurodegenerative disorders, fibromyalgia, chronic fatigue, etc.
The prior art does not teach pharmaceutical compositions comprising claimed compounds in claimed amounts, i.e., pharmaceutical compositions in a form of aqueous solution comprising 4-(L-valyl)oxy)butanoic acid (i.e., a prodrug of [Symbol font/0x67]-hydroxy butyric acid) as an active agent in combination with malic acid. Applicant teaches that said compositions comprising said active/prodrug allow increasing the amount of active agent/prodrug, decreasing amounts of pharmaceutical excipients, providing thereby high dose pharmaceutical compositions with improved palatability and stability.
Response to Arguments
Applicant's arguments, filed 01/02/2026, have been fully considered, and they were found to be persuasive. Any rejection or objection not reiterated in this action is withdrawn.
Claims 1, 4-7, 9 are allowed.
Claim 8 is rejected, but would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claims 10, 12 are objected, but would be allowable if rewritten to clarify the claim language. Claims 11, 13 are objected as being dependent on objected claims 10, 12.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLGA V. TCHERKASSKAYA whose telephone number is (571)270-3672. The examiner can normally be reached 9 am - 6 pm, Monday - Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A. Wax can be reached at (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/OLGA V. TCHERKASSKAYA/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615