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 .
Applicant’s amendment of claims 26, in the paper of 5/27/2026, is acknowledged. Applicants' arguments filed on 5/27/2026, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 26-28 are pending and at issue.
Election/Restrictions
Applicant's election with traverse of Group 1, Claims 1-5, 6-8, 15-19, drawn to a ketose 3-epimerase, in the paper of 5/28/2024, is acknowledged. Applicants election of the species of S218, in the paper of 5/28/2024, is acknowledged.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 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.
Claims 26-28 are rejected under 35 U.S.C. 112, first paragraph, as containing 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(s), at the time the application was filed, had possession of the claimed invention.
This rejection was stated in the previous office action as it applied to previous claims 26-28. In response applicants have amended claims 26-28 and traverse the rejection as it applies to the newly added claims.
Newly amended claims 26-28 are drawn to any mutated protein comprising an amino acid sequence which is 75% or more identical to the amino acid sequence of SEQ ID NO: 1 and is not identical to the amino acid sequence of SEQ ID NO: 1, wherein the mutated protein has the following ketose 3-epimerase activities (A) and (B) and has a higher ketose 3-epimerase activity ratio (T70/T50) at a reaction temperature of 70°C to 50oC or has a higher residual activity after incubation at 60°C for one hour than the protein having the amino acid sequence of SEQ ID NO: 1, wherein the ketose 3-epimerase activity ratio (T70/T50) is 1.55 or more: (A) having an activity of epimerizing position 3 of a D- or L-ketose; and (B) having the highest epimerization activity on position 3 of D-allulose among D- or L- ketohexoses, the mutated protein does not have any amino acid substitution of H6, S63, M110, E146, E152, D179, H182, H205, R211, and E240 in the amino acid sequence represented by SEQ ID NO: 1 such that the mutated protein retains a three-dimensional structure of the protein having the amino acid sequence of SEQ ID NO: 1, and the mutated protein has amino acid substitution of at least one selected from H56Y, L94V, L97M, D101E, A109S, A128V, V129IV132IS144A, S167Q, P172G, E199D, A200V, S218N, T59SA60VD101EV1291A200VS218N, A200VS218N, D101EV129IA200V, T59SA60VA200VS218N, T59SA60VV129IA200V, T59SA60VA200V, V129IA200VS218N, T59SA60V, T59SA60VS218N, V129IS218N, V129IA200V, T59SA60VD101EA200V, T59SA60VD101EV129I, D101EA200V, T59SA60VV129IA200VS218N, T59SA60VV129I, T59SA60VD101E, T59SA60VP77SL94VD101EA109SV129IS144AS167QA200VS218N, D101EV129I, D101EV129IA200VS218N, and T59SA60VD101EA200VS218N in the amino acid sequence of SEQ ID NO: 1.
Applicants continue to traverse the rejection on the basis that applicants submit that since claim 26 recites a mutated protein comprising an amino acid sequence which is 75% or more identical to the amino acid sequence of SEQ ID NO: 1 and is not identical to the amino acid sequence of SEQ ID NO: 1, where the mutated protein has amino acid substitutions recited in the claim, they are adequately supported by a representative number of the mutants disclosed in the present specification.
Applicants submit that the specification provides adequate written-description support for that claimed genus at Paragraph [0041] of the present specification as originally filed which explains the structural basis for the claimed exclusion of substitutions at critical residues: "the active site residues of the present enzyme are amino acids at position 6, position 63, position 110, position 152, position 179, position 182, position 205, position 211, and position 240," and "residues at a presumed metal ion binding site are amino acids at position 146, position 177, position 205, and position 240." Paragraph [0041] further states that "[a]mino acid substitution in the vicinity of these amino acids is therefore not performed and a mutant is prepared by amino acid substitution at the other sites." Applicants submit that thus, the specification does identify the relevant structural regions to be preserved and explains where substitutions are made to maintain the enzyme's three-dimensional structure and activity.
Applicants submit that the specification also provides representative experimental support across the claimed identity range, referencing paragraph [0083] and Table 8 that even a mutant enzyme having about 78% or 77% amino acid identity has rather a high T70/T50 ratio, which is an index of heat resistance as a useful property, while maintaining its enzyme activity and has no change in properties as an enzyme, insofar as amino acid substitution is conducted at a site except for the vicinity of the active site, the presumed metal ion binding site.
Applicants submit that this disclosure directly supports the claimed lower identity boundary and the claim requirement that the mutant retain the recited ketose 3-epimerase activities while prescribing the critical active-site and metal-binding residues.
Applicants’ amendment of the claims and applicant’s complete traversal is acknowledged and has been carefully considered, however, is not found persuasive for the reasons previously made of record and for those reasons repeated herein.
Applicants continue to traverse the rejection on the basis that applicants submit that since claim 26 recites a mutated protein comprising an amino acid sequence which is 75% or more identical to the amino acid sequence of SEQ ID NO: 1 and is not identical to the amino acid sequence of SEQ ID NO: 1, where the mutated protein has amino acid substitutions recited in the claim, they are adequately supported by a representative number of the mutants disclosed in the present specification. This is not found persuasive on the basis that applicants submission of two mutant enzymes is insufficient to adequately describe the breadth of applicants claimed genus for the reasons previously stated and for those reasons repeated herein.
In response to applicants submission that the specification provides adequate written-description support for that claimed genus at Paragraph [0041] of the present specification as originally filed which explains the structural basis for the claimed exclusion of substitutions at critical residues: "the active site residues of the present enzyme are amino acids at position 6, position 63, position 110, position 152, position 179, position 182, position 205, position 211, and position 240," and "residues at a presumed metal ion binding site are amino acids at position 146, position 177, position 205, and position 240." and applicants submission that the specification thus identifies the relevant structural regions to be preserved and explains where substitutions are made to maintain the enzyme's three-dimensional structure and activity, this is insufficient to adequately describe the required structure to function correlation for the breadth of the claimed ketose 3-epimerase mutants having the required functional limitations.
It continues that the specification continues to only provide the representative species of those ketose 3-epimerase having the amino acid sequence of SEQ ID NO:1, 3 and 4 and those limited mutants thereof encompassed by these claims. There is insufficient disclosure of any particular structure to function/activity relationship in the disclosed species. The specification fails to describe sufficient representative species of these mutant epimerases by sufficient identifying structural characteristics or properties, for which no predictability of the structure associated with the claimed functions is apparent. Given this lack of additional representative species as encompassed by the claims, and applicant’s lack of defining structural limitations of 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.
The rejection of claims 6, 7, 19, 24 are rejected under 35 U.S.C. 112, first paragraph, as containing 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(s), at the time the application was filed, had possession of the claimed invention based upon new matter is found persuasive. Based upon applicants’ arguments presented in the paper of 2/10/2025
Deposit Requirement
The rejection of claim 5 under 35 U.S.C. 112, first paragraph, as containing subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention based upon the deposit requirement is withdrawn based upon applicants attorney of records statement over his or her signature and registration number, in the paper of 9/30/2024, stating that the specific strain has been deposited under the Budapest Treaty and that the strain will be irrevocably and without restriction or condition released to the public upon the issuance of the patent, would satisfy the deposit requirement made herein
Claim Rejections - 35 USC § 102
The rejection of claims 26-28 under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Izumori et al. (WO 2014/109254 and US Patent No. 9,932,617) is withdrawn based upon applicants arguments and amendment of the claims in the paper of 5/27/2026.
Remarks
No claim is allowed.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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 6-3 EST Mon-Fri.
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rgh
7/21/2026
/RICHARD G HUTSON/Primary Examiner, Art Unit 1652
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