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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 on 08/07/2026 has been entered.
Response to Amendment
The amendments received 08/25/2025 have been entered. Claims 26 and 51-55 are examined herein. Claims 1 and 10-20 remain withdrawn. Applicant’s amendments have overcome each and every rejection previously set forth in the Office Action mailed 07/11/2025. Applicant’s arguments set forth in the remarks received 08/25/2025 are therefore moot. New grounds of rejection are set forth as necessitated by amendment.
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.
Claims 26 and 51-55 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 26 recites “wherein the pharmaceutical formulation comprises: a) a therapeutically effective amount of free amino acids… wherein the therapeutically effective amount of free amino acids does not comprise any one of alanine, arginine, asparagine, leucine, lysine…”. Given that the components of the pharmaceutical formulation are set forth using open language (“wherein the pharmaceutical formulation comprises”), it is unclear whether “wherein the therapeutically effective amount of free amino acids does not comprise” excludes the recited amino acids from the pharmaceutical formulation as a whole, or only excludes the amino acids from the “therapeutically effective amount of amino acids”. If the former is true, Examiner suggests amending the claims to exclude the amino acids (“alanine, arginine, asparagine, leucine, lysine…”) from the pharmaceutical formulation rather than the therapeutically effective amount of amino acids. Clarification is requested. Claims 51-55 do not clarify the limitations at issue and are also rejected.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MADELINE E BRAUN whose telephone number is (703)756-4533. The examiner can normally be reached M-F 8:30am-5:00pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached at (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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/MADELINE E BRAUN/Examiner, Art Unit 1624 08/27/2026
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