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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 3/9/2026 has been entered.
Applicant’s amendment of claims 1, 2 and 4, in the paper of 3/9/2026, is acknowledged.
Applicants filing of a new sequence listing, on 3/18/2026, to correct the error in the sequence listing submitted on 3/9/2026 is acknowledged. It is noted that the sequence listing submitted on 3/18/2026 has been added to the file and overcame the issues with the previous sequence listing submission.
Applicants' arguments filed on 3/9/2026 have been fully considered and are deemed to be persuasive to overcome some of the rejections previously applied. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. Claims 1-13 are still at issue and are present for examination.
Election/Restrictions
Applicant's election without traverse of the species of the transaminase of SEQ ID NO:1 and the fluorine-containing dihydroxy ketal
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, in the paper of 6/24/2025, is acknowledged.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim(s) 1-13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim(s) 1-13 are directed to all possible methods for synthesizing a fluorine-containing chiral amine compound, wherein the method comprises:
reacting an amino donor with a fluorine-containing dihydroxy ketal compound under a catalysis of a transaminase to generate the fluorine-containing chiral amine compound;
wherein the transaminase is derived from: the transaminase has the amino acid sequence of SEQ ID NO:1, SEQ ID NO:2,SEQ ID NO:3, SEQ ID NO:4, SEQ ID NO: 5, SEQ ID NO: 6, SEQ ID NO: 7, SEQ ID NO: 8, SEQ ID NO: 9, SEQ ID NO: 10, SEQ ID NO: 11, SEQ ID NO: 12, SEQ ID NO:13, SEQ ID NO: 14, SEQ ID NO: 15, SEQ ID NO: 16, SEQ ID NO: 17, SEQ ID NO: 18,SEQ ID NO: 19, SEQ ID NO: 20, SEQ ID NO: 21, SEQ ID NO: 22, SEQ ID NO: 23, SEQ ID NO: 24, SEQ ID NO: 25, SEQ ID NO:26, or SEQ ID NO: 27; the fluorine-containing dihydroxy ketal compound is selected from any one of the group consisting of:
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The specification, however, only provides the representative species of those methods for synthesizing a fluorine-containing chiral amine compound, wherein the method comprises: reacting an amino donor with a fluorine-containing dihydroxy ketal compound under a catalysis of a transaminase to generate the fluorine-containing chiral amine compound; wherein the transaminase has the amino acid sequence of SEQ ID NO:1, SEQ ID NO:2,SEQ ID NO:3, SEQ ID NO:4, SEQ ID NO: 5, SEQ ID NO: 6, SEQ ID NO: 7, SEQ ID NO: 8, SEQ ID NO: 9, SEQ ID NO: 10, SEQ ID NO: 11, SEQ ID NO: 12, SEQ ID NO:13, SEQ ID NO: 14, SEQ ID NO: 15, SEQ ID NO: 16, SEQ ID NO: 17, SEQ ID NO: 18,SEQ ID NO: 19, SEQ ID NO: 20, SEQ ID NO: 21, SEQ ID NO: 22, SEQ ID NO: 23, SEQ ID NO: 24, SEQ ID NO: 25, SEQ ID NO:26, or SEQ ID NO: 27; the fluorine-containing dihydroxy ketal compound is selected from any one of the group consisting of:
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encompassed by these claims. There is insufficient disclosure of a particular structure to function/activity relationship in the disclosed species of transaminases and methods of use as it relates to the broader genus of “derived transaminases” and claimed methods of use. The molecular mechanism of the catalytic reaction as it relates to the transaminases and fluorine-containing compounds remains somewhat elusive (Xie et al., Organic and Biomolecular Chemistry, Vol 12 p 7836-7843, 2019; cited in the IDS of 8/26/2022). The specification also fails to describe additional representative species of these derived transaminases having the required catalytic properties by any identifying structural characteristics or properties, for which no predictability of structure is apparent.
Regarding the level of skill and knowledge in the art of amino acid substitutions, mutations or derivations, the reference of Singh et al. (Curr. Protein Pept. Sci. 18:1-11, 2014; cited in the IDS of 8/26/2022) reviews various protein engineering methods and discloses that despite the availability of an ever-growing database of protein structures and highly sophisticated computational algorithms, protein engineering is still limited by the incomplete understanding of protein functions, folding, flexibility, and conformational changes (see p. 7, column 1, top). Also, the unpredictability associated with amino acid substitutions, mutations or derivations is exemplified by the reference of Zhang et al. (Structure 26:1474-1485, 2018; cited on the attached Form PTO-892), which discloses that even a mutation of a surface residue that was predicted to be benign caused significant structural changes and unexpected effects on the function of a polypeptide (p. 1475, column 1).
Given this lack of additional representative species as encompassed by the claims, Applicants have failed to sufficiently describe the claimed invention, in such full, clear, concise, and exact terms that a skilled artisan would recognize Applicants were in possession of the claimed invention.
Applicant is referred to the revised guidelines concerning compliance with the written description requirement of U.S.C. 112, first paragraph, published in the Official Gazette and also available at www.uspto.gov.
Closest Prior Art:
CN 110592042 discloses preparation of a fluorine-containing chiral amine compound (description, paragraphs 8-80): transaminase catalyzes transamination reaction of a ketone compound and an amino donor; the transaminase is derived from a Chromobacterium violaceum mutant and has the amino acid sequence of SEQ ID NO: 1. CN 110592042 differs from the claimed methods because it discloses a different fluorine containing dihydroxy ketal compound, and a different resulting product.
Remarks
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RICHARD G HUTSON whose telephone number is (571)272-0930. The examiner can normally be reached on 6-3 EST Mon-Fri.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Mondesi can be reached on (571) 272-0956. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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rgh
3/19/2026
/RICHARD G HUTSON/Primary Examiner, Art Unit 1652
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