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 .
Election/Restrictions
Applicant's election with traverse of Group I (claims 14-24) in the reply filed on 5 January 2026 is acknowledged. The traversal is on the ground(s) that by enhancing phosphoenolpyruvate carboxykinase (pck), formation of acetyl Co-A from PEP is decreased. Applicant’s arguments have been fully considered and are persuasive. Thus, the restriction requirement as set forth in the Office action mailed on 3 November 2025 is hereby withdrawn.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 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 Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable.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). See also MPEP § 804.01.
Claims 14-27 will be examined on the merits herein.
Priority
The instant application is a 371 of application PCT/JP2021/041257 (filed 10 November 2021) and claims priority to foreign application JP 2020-187848 (filed 11 November 2020). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. However, because no certified translation of the foreign priority document was provided, the foreign priority claim has not been perfected. Therefore, for the purposes of searching the prior art, the effective filing date of instant claims 14-24 is 10 November 2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 27 April 2023, 25 July 2024, and 15 September 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, each information disclosure statement is being considered by the examiner.
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 14-15, 21-22, and 25-27 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 14 recites the limitations “the reaction to generate acetyl-CoA” and “the productivity of 3-hydroxyadipic acid and/or α-hydromuconic acid”. There is insufficient antecedent basis for this limitation in the claim.
Claim 15 recites the limitations “the reaction catalyzed by pyruvate dehydrogenase complex” and “the reaction catalyzed by pyruvate formate-lyase”. There is insufficient antecedent basis for this limitation in the claim or the claim upon which it depends, claim 14.
Claim 25 recites the limitations “the reaction to generate acetyl-CoA” and “the enzyme function of pyruvate kinase and/or phosphotransferase system.” There is insufficient antecedent basis for this limitation in the claim.
Claim 26 recites the limitation “the reaction that reduces 3-oxoadipyl-CoA to generate 3-hydroxyadipyl-CoA.” There is insufficient antecedent basis for this limitation in claim 26 or the claim from which it depends.
Claim 26 depends upon claim 24; however, because claim 24 does not recite a step (a) or step (b), it is unclear how many steps are required to be performed. In the interest of compact prosecution, claim 26 has been interpreted as being dependent upon claim 25, which recites a step (a) and step (b), instead of claim 24.
Claim 27 recites the limitation “the phosphoenolpyruvate carboxykinase reaction.” There is insufficient antecedent basis for this limitation in claim 27 or the claim from which it depends.
Regarding claim 14, the claim recites the phrases, “the reaction to generate acetyl-CoA from pyruvic acid is enhanced and function of pyruvate kinase and/or phosphotransferase system is reduced….” Regarding claim 15, the claim recites the phrases, “enhancement of the reaction.” Regarding claim 21, the claim recites the phrase, “the reaction that reduces 3-oxoadipyl-CoA to generate 3-hydroxyadipyl-CoA is further enhanced.” Regarding claim 22, the claim recites the phrase, “phosphoenolpyruvate carboxykinase reaction is further enhanced.” Regarding claim 25, the claim recites, “a step of enhancing or reducing a function”, “a step (a) of enhancing the reaction to generate acetyl-CoA”, and “a step (b) of reducing the enzyme function”. Regarding claim 26, the claim recites, “enhancing the reaction that reduces 3-oxoadipyl-CoA”. Regarding claim 27, the claim recites, “enhancing the phosphoenolpyruvate carboxykinase reaction.” The specification does not provide a definition of “enhanced”, “reduced”, or “enhancement”, generically or with respect to the recited reactions. “Enhanced” and “reduced” are also relative terms of which the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Thus, the scope of the limitations is unclear because one of ordinary skill in the art cannot determine the scope of modifications to the microorganism that would result in “enhanced” reactions or from what standard level of activity the reactions/functions are “enhanced” or “reduced”. In the interest of compact prosecution, in this action the claims will be interpreted so that the full scope of “enhanced” reactions/functions encompasses any level of reaction activity or functional activity greater than zero and the full scope of “reduced” reactions/functions encompasses any level of reaction activity or functional activity.
Clarification is requested.
Additional Pertinent Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Isobe et al. (WO 2020/230719 A1; effectively filed 8 May 2020; not eligible as prior art under 35 U.S.C. 102(a)(2) because the publication does not name another inventor or inventive entity than that of the instant application): Isobe et al. teaches a genetically modified microorganism capable of producing 3-hydroxyadipic acid and/or α-hydromuconic acid in a higher yield than a parent strain without genetic modification (para. 15) and is deficient in pyruvate kinase function and/or phosphotransferase function (para. 15 and 109). Isobe et al. also teaches that a decrease in the amount of acetyl-CoA was previously predicted to result in a decrease in the amount of 3-hydroxyadipic acid and/or α-hydromuconic acid produced, but their genetically modified microorganism is able to increase production of 3-hydroxyadipic acid and/or α-hydromuconic acid because of the increase in activity of phosphoenolpyruvate carboxykinase and the enzyme that catalyzes the reduction of 3-oxoadipyl-CoA to 3-hydroxyadipyl-CoA and deletion of pyruvate kinase and phosphotransferase enzymes (para. 123). Isobe et al. teaches that the genetically modified microorganism is able to produce 3-oxoadipyl-CoA and coenzyme A from acetyl-CoA and succinyl-CoA (para. 27), i.e., the microorganism is able to produce some amount of acetyl-CoA to be converted into 3-oxoadipyl-CoA (Fig. 2) (i.e., the amount produced is enhanced relative to a strain with no ability to generate acetyl-CoA from pyruvic acid).
Allowable Subject Matter
Claims 16-20 and 23-24 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BAILEY M MORGAN whose telephone number is (703)756-5388. The examiner can normally be reached M-F 9-5 ET.
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/BAILEY M MORGAN/Examiner, Art Unit 1645
/BAO-THUY L NGUYEN/Supervisory Patent Examiner, Art Unit 1677 April 28, 2026
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