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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/24/2025 has been entered.
Applicant’s cancellation of all previous claims )claims 1, 6-14, 16-17,19-22,24-25) and the addition of new claims 26-28, in the paper of 12/24/2025, is acknowledged. Applicants' arguments filed on 12/24/2025, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 6-8, 19, 24 and 25. In response applicants have cancelled claims 6-8, 19, 24 and 25 and added new claims 26-28. Applicants traverse the rejection as it applies to the newly added claims.
Newly added 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, K202R,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 traverse the rejection on the basis that applicants submit that since new 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’ 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.
In response to applicants newly added claims and applicants traversal, applicants have not adequately described the breadth of the claimed mutant proteins for the reasons stated previously with regard to previous claim 6 and 8 and for those reasons repeated herein.
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 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 also fails to describe additional representative species of these mutant epimerase s by any identifying structural characteristics or properties, for which no predictability of structure 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
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 26-28 is/are rejected 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).
A similar rejection was stated in the previous office action as it applied to previous claim 8. In response applicants have cancelled claim 8 and added new claims 26-28 and traverse the rejection as it applies to the newly amended claim.
As previously stated, Izumori et al. (WO 2014/109254 and US Patent No. 9,932,617) teach the identification, production, isolation and characterization of a ketose 3-epimerase from Arthobacter globiformis. Izumori et al. teach the ketose 3-epimerase comprising the 289 amino acid sequence of SEQ ID NO:1 which has at least 94% sequence identity to instant SEQ ID NO: 1 and can epimerize position 3 in a D- or L-ketose to produce a corresponding D- or L-ketose (see example 3 and supporting text). Further the ketose 3-epimerase comprising the 289 amino acid sequence of SEQ ID NO:1 taught by Izumori et al. comprises a substitution at position T59, position S167 and position K202 (see below alignment). Further the ketose 3-epimerase comprising the 289 amino acid sequence of SEQ ID NO:1 taught by Izumori et al. 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. Izumori et al. teach that the ketose 3-epimerase from Arthobacter globiformis has an optimum reaction pH of from 6 to 8 and has an optimum reaction temperature of 60oC. Izumori et al. teach that the ketose 3-epimerase from Arthobacter globiformis. immobilized on a ion exchange resin as a carrier (Figure 8 and supporting text).
The substrate specificity of the ketose 3-epimerase taught by Izumori et al. is considered inherent to the enzyme taught by Izumori et al. and based on the high degree of sequence identity to instant SEQ ID NO:1 is considered to be similar to the substrate specificity in the order of D-allulose, D-tagatose, L-tagatose, D-fructose, and L-allulose, under certain conditions. While Izumori et al. disclose a slightly different substrate specificity, this is considered to be a result of the specific reaction conditions used by Izumori et al.. Further while Izumori et al. teach that the ketose 3-epimerase from Arthobacter globiformis has an optimum reaction temperature of 60oC, they do not disclose that it has a higher residual activity after incubation at 60°C for one hour to the protein having the amino acid sequence of instant SEQ ID NO: 1, although this is considered inherent to the ketose 3-epimerase taught by Izumori et al.
Sequence comparison of instant SEQ ID NO:1 and Izumori et al. (WO 2014/109254 and US Patent No. 9,932,617) SEQ ID NO:1:
ORGANISM: Arthrobacter globiformis
Query Match 94.1%; Score 1391; Length 289;
Best Local Similarity 91.7%;
Matches 265; Conservative 14; Mismatches 10; Indels 0; Gaps 0;
Inst.SEQ1: 1 MKIGCHGLVWTGRFDAEGIRYSVQKTKEAGFDLIEFPLMDPFSFDVATAKSALAEHGLTA 60
|||||||||||| |||||||||||||:||||||:|||||||||||| ||||||||||| |
Izumori 1 MKIGCHGLVWTGHFDAEGIRYSVQKTREAGFDLVEFPLMDPFSFDVQTAKSALAEHGLAA 60
Inst.SEQ1: 61 SASLGLSEATDVSSEDPAIVKAGEELLNRALDVLAELGATDFCGVIYSAMKKYMEPATEQ 120
|||||||:||||||||||:|||||||||||:|||||||||||||||||||||||||||
Izumori 61 SASLGLSDATDVSSEDPAVVKAGEELLNRAVDVLAELGATDFCGVIYSAMKKYMEPATAA 120
Inst.SEQ1 121 GLSNSKAAVGRVVDRAAGLGINVSLEVVNRYETNVLNTGRQALSYLSDVKRPNLGVHLDT 180
||:||||||||| |||: |||||||||||||||||||||||||:|| :: |||||:||||
Izumori 121 GLANSKAAVGRVADRASDLGINVSLEVVNRYETNVLNTGRQALAYLEELNRPNLGIHLDT 180
K202R
Inst.SEQ1:181 YHMNIEESDMFSPVLDTAEALKYVHIGESHRGYLGTGSVDFDNFFKALGRIGYDGPVVFE 240
|||||||||||||:|||||||:|||||||||||||||||||| |||||||||||||||||
Izumori 181 YHMNIEESDMFSPILDTAEALRYVHIGESHRGYLGTGSVDFDTFFKALGRIGYDGPVVFE 240
Inst.SEQ1 241 SFSSAVVAPDLSRMLGIWRNLWADNEELGAHANAFIRDKLTAIKTIELH 289
||||:||||||||||||||||||||||||||||||||||||||||||||
Izumori 241 SFSSSVVAPDLSRMLGIWRNLWADNEELGAHANAFIRDKLTAIKTIELH 289
Thus, claim(s) 26-28 is/are rejected 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).
Remarks
No claim is allowed.
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rgh
2/27/2026
/RICHARD G HUTSON/Primary Examiner, Art Unit 1652