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 .
Status of the Claims
This Office Action is in response to Applicant's Restriction Requirement remarks filed on January 28, 2026. Claim(s) 1-25 are pending. Claim(s) 1-14 and 23-25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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's election of Group III drawn to a method of inhibiting the progression of a urea cycle disorder and election of species of Ornithine transcarbamoylase (OTC) without traverse of the restriction requirement in the reply is acknowledged. The requirement is deemed proper and is therefore made FINAL. Claim(s) 15-22 are examined herein insofar as they read on the elected invention and species.
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 15-22 are rejected under 35 U.S.C. 103 as being unpatentable over Pahan (WO 2015/109215) and Marini (US 2020/170984) of record.
Pahan teaches a method for inhibiting the progression of a urea cycle disorder comprising administering to a patient in need thereof an effective amount of a pharmaceutical composition comprising glyceryl tribenzoate and/or glyceryl dibenzoate (claim 1).
Pahan teaches the pharmaceutical composition is administered to the patient one time per day (claim 2).
Pahan teaches the effective amount is from about 3 grams to about 10 grams per day, based on a 50 kg patient (claim 3).
Pahan teaches the pharmaceutical composition is formulated together with a pharmaceutically acceptable carrier or excipient (claim 4).
Pahan teaches the pharmaceutical composition is administered orally (claim 5).
Pahan teaches the urea cycle disorder is selected from the group consisting of N-acetylglutamate synthase, Carbamoyl Phosphate Synthetase 1, Ornithine transcarbamoylase, Argininosuccinate synthase, argininosuccinate lyase, Arginase 1, and any combination thereof (claim 6).
Pahan does not teach glycerol phenylbutyrate in combination with glycerol tribenzoate.
Marini teaches a method of treating an individual for one or more urea cycle disorders administering a therapeutically effective amount of sodium benzoate and sodium phenylbutyrate or glycerol phenylbutyrate, wherein, the sodium benzoate and sodium phenylbutyrate or glycerol phenylbutyrate are each administered at no more than 200mg/kg/day (claim 1).
Marini teaches the urea cycle disorder encompasses one or more of the following diseases: N-acetylglutamate synthase deficiency (NAGS deficiency), Carbamoyl-phosphate synthase 1 deficiency (CPS1 deficiency), Ornithine transcarbamylase deficiency (OTC deficiency), Ornithine translocase (ORNT1) deficiency, Citrullinemia type I (ASS1 deficiency), Argininosuccinic aciduria (AS L deficiency), Arginase deficiency (hyperargininemia, ARG1 deficiency), and/or Citrin deficiency (claim 2).
Marini teaches the glycerol phenylbutyrate is administered to the individual orally (claim 3) as well as intranasally [0040].
Marini teaches glycerol phenylbutyrate are administered to the individual daily, weekly, multiple times in a week, bi-weekly, or monthly (claim 4).
Marini teaches the active compound may comprise between about 2% to about 75% of the weight of the unit [0042].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have employed the use of glyceryl tribenzoate for the use of treating urea disorders as taught by Pahan and combined said agent with glycerol phenylbutyrate for the treatment of the same disorders as taught b Marini. The examiner respectfully points out the following from MPEP 2144.06: "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose ....[T]he idea of combining them flows logically from their having been individually taught in the prior art.', In re Kerkhoven, 626 F.2d 846, 850,205 USPQ 1069, 1072 (CCPA 1980).
Thus, based on the foregoing reasons, the instant claims are deemed unpatentable over the cited reference.
Conclusion
Claims 15-22 are not allowed.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sahar Javanmard whose telephone number is (571)270-3280. The examiner can normally be reached on Monday-Friday, 9:00-5:00 EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Alstrum-Acevedo can be reached on 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
/SAHAR JAVANMARD/Primary Examiner, Art Unit 1622
