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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 May 12, 2026 has been entered.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.
Claim 2 is canceled. Claims 6-9, 11-13 are withdrawn. Claims 1, 3-5, 10, 14-15, to amino acid substitutions (1) to (4) recited in claim 1, are under consideration.
Priority: This application is a 371 of PCT/JP2021/007453, filed February 26, 2021, which claims priority to JP 2020-035920, filed March 3, 2020. A copy of the foreign priority document has been received in the instant application on September 1, 2022, and is not in the English language.
Objections and Rejections
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 4-5 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 4 recites the amino acid substitutions described in (1)-(5). Claim 4 is dependent on claim 1, which has been amended to recite amino acid substitutions (1) to (4). Further clarification and/or correction is requested.
Claim 5 recites the modified transglutaminase according to claim 1, consisting of an amino acid sequence of any of SEQ ID NOS: 14-18 and 22. The instant specification discloses that instant SEQ ID NO: 14 is the amino acid sequence consisting the R5H substitution (application publication paragraph 0175). However, claim 1 has been amended and does not recite an amino acid substitution selected from R5H. Further clarification and/or correction is requested.
Reply: In view of Applicants’ amendments/remarks, claims 4-5 are rejected under 35 U.S.C. 112(b) for the reasons noted above.
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.
Claims 1, 3-5, 10, 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Suzuki et al. (US 20120021458; IDS 09.01.22). Suzuki et al. disclose transglutaminase (MTG) are utilized for production of gelled foods such as jellies, yogurt, cheese, etc. (at least paragraph 0006). Suzuki et al. disclose that regarding enzymatic reaction conditions, a gelled food, for example, does not set if the enzymatic reaction is short, and conversely, if the reaction time is too long, the gelled food becomes too hard to be a commercial product (at least paragraph 0006). Suzuki et al. disclose that as foods, reagents and the like, which can be produced by utilizing MTG have become increasingly diverse, in some instances, the desired product cannot be prepared solely by adjusting concentrations, temperature, time, and the like; therefore, there is a need to modify the enzymatic activity of MTG (at least paragraph 0006).
Suzuki et al. disclose the amino acid sequence of Streptomyces mobaraensis (Table 1). It is noted that instant SEQ ID NO: 1 is the amino acid sequence of Streptomyces mobaraensis MTG.
Suzuki et al. disclose selecting amino acid residues for mutagenesis and screening, including MTG mutants having a W59C substitution (at least example 15, Table 7). Therefore, Suzuki et al. disclose select amino acid residues for mutagenesis, including the recited W59 position.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to arrive at a mutant MTG comprising an amino acid substitution at position W59, where the amino acid substitution is similar to the amino acid substitutions disclosed in Suzuki et al. (instant claims 1, 3-5, 10, 14-15). For instance, one of ordinary skill would have reasonable motivation to perform mutagenesis at position W59 in the MTG disclosed in Suzuki et al. to arrive at the recited amino acid substitution T, and thereby, the claimed invention because the recited substitution is similar to the substitution disclosed in the prior art for position W59. One of ordinary skill would have a reasonable expectation of success because positions of interest to create MTG mutants having industrial utility have been identified, including the recited position W59, and methods of mutating protein variants were known at the time of the invention, as disclosed in the prior art.
Regarding the recited property of a decreased pH stability (claims 1, 15), since position W59 is recognized as a position of altered activity and mutagenesis of MTG at W59 to amino acid substitutions similar to the prior art substitution W59C would include at least the recited W59T substitution, any additional properties such as the decreased pH stability, would flow naturally from following the suggestions of the prior art.
Regarding instant claim 10, Suzuki et al. disclose a composition comprising the modified MTG and an excipient (at least example 15).
Regarding instant claim 5, the recited amino acid substitution T is similar to the C disclosed in the prior art for position W59. It would have been obvious to one of ordinary skill to arrive at the known amino acid substitution T, including W59T (i.e. instant SEQ ID NO: 16) because there are a finite number of amino acids to select from and it is routine to substitute a similar or different amino acid residue at an identified position. It would be obvious to arrive at a recited amino acid amino acid sequence of SEQ ID NO: 16 because in view of the grammatically indefinite article “an” (claim 5), the recitation of an amino acid sequence of SEQ ID NO: 16, for instance, encompasses all sequences that comprise two or more contiguous amino acid residues in the SEQ ID NO.
Regarding instant claims 3-4, 14, Suzuki et al. also disclose other positions for mutation, in addition to W59 (example 15). Therefore, it would have been obvious to incorporate an additional substitution with the MTG mutant having the W59 substitution noted above. One of ordinary skill would be motivated to do so because the prior art discloses multiple amino acid positions for mutagenesis in MTG for industrial utility. One of ordinary skill would have a reasonable expectation of success because positions of interest to create MTG mutants having industrial utility have been identified, including the recited position W59, and methods of mutating protein variants were known at the time of the invention, as disclosed in the prior art.
Reply: In view of Applicant’s amendments/remarks, the previous 103 rejection over Yokoyama et al. has been withdrawn. However, the claims are rejected under a new 103 rejection over Suzuki et al. for the reasons noted above. Suzuki et al. disclose that there is a need to modify MTG for different enzymatic reaction conditions, including for gelled foods, where the reaction times not too long, where the recited position W59 has been identified in Suzuki et al. as a position for mutagenesis to a polar amino acid.
No claim is allowed.
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/Marsha Tsay/Primary Examiner, Art Unit 1656
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