The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This office action is in response to Applicant’s amendments/remarks received October 24, 2025.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 Claims 6-9, 11-13 are withdrawn.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 (5) recited in claim 1, are under consideration.
In view of Applicant’s amendments to the claims, consideration has been extended to substitutions (1) to (5) recited in claim 1.
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 1, 3-5, 10, 14-15 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 1 recites wherein the modified transglutaminase has a decrease in pH stability in a range of weak acidity, compared to a pH stability of the wildtype transglutaminase… . It is not clear what is meant by a range of “weak acidity” or how a range has “weak acidity.” It appears that the modified transglutaminase has a decrease in pH stability in a weakly acidic pH range or in a pH range that is weakly acidic. It is suggested that Applicant clarifies that the decrease in pH stability is at a low pH range. Further clarification and/or correction is requested.
Claim 3 is dependent on claim 1 and recites that the modified transglutaminase further comprises one or more additional differences in amino acid sequence compared to SEQ ID NO: 1…and wherein the modified transglutaminase has at least 90% sequence identity to SEQ ID NO: 1. The claim is confusing because it appears to recite that the modified transglutaminase having the various amino acid substitutions and/or differences can have a sequence identity of 100% sequence identity to SEQ ID NO: 1.
Claim 4 is included in this rejection for the reasons similarly noted above for claim 3. It is not clear how the modified transglutaminase having the various amino acid substitutions and/or differences can have a sequence identity of 100% sequence identity to SEQ ID NO: 1.
Claim 14 is rejected for the same reasons similarly noted above for claim 3. It is not clear how the modified transglutaminase having the various amino acid substitutions and/or differences can have a sequence identity of 100% sequence identity to SEQ ID NO: 1.
Claim 15 is rejected for the reasons similarly noted above for claim 1. It is not clear what is meant by a range of “weak acidity” or how a range has “weak acidity.” It appears that the modified transglutaminase has a decrease in pH stability in a weakly acidic pH range or in a pH range that is weakly acidic. It is suggested that Applicant clarifies that the decrease in pH stability is at a low pH range. Further clarification and/or correction is requested.
Claim 5 is included in this rejection because it is dependent on the above claim(s) and fail to cure its defects.
Claim Rejections - 35 USC § 103
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 Yokoyama et al. (2010 Appl Microbiol Biotechnol 87: 2087-2096; IDS 09.01.22, previously cited). Yokoyama et al. disclose Streptomyces mobaraensis transglutaminase (MTG) has industrial utility (p. 2010). It is noted that instant SEQ ID NO: 1 is the amino acid sequence of MTG.
Yokoyama et al. disclose selecting amino acid residues for random mutagenesis (p. 2091). Yokoyama et al. disclose rationally designed MTG mutants, including MTG mutants having a R5K substitution, a V6T substitution, a W59F substitution (p. 2092). Therefore, Yokoyama et al. disclose select amino acid residues for mutagenesis, including the recited R5, V6, and W59 positions.
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 one of the positions R5, V6, and W59, where the amino acid substitution is similar to the amino acid substitutions disclosed in Yokoyama 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 R5 in the MTG disclosed in Yokoyama et al. to arrive at the recited amino acid substitution H, and thereby, the claimed invention because the recited substitution is similar to the substitution disclosed in the prior art for position R5. 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 R5, 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 R5 is recognized as a position of altered activity and mutagenesis of MTG at R5 to amino acid substitutions similar to the prior art substitution R5K would include at least the recited R5H 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, Yokoyama et al. disclose a composition comprising the modified MTG and an excipient (p. 2088-2092).
Regarding instant claim 5, the recited amino acid substitution H is similar to the K disclosed in the prior art for position R5. It would have been obvious to one of ordinary skill to arrive at the known amino acid substitution H, including R5H (i.e. instant SEQ ID NO: 14) 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: 14 because in view of the grammatically indefinite article “an” (claim 5), the recitation of an amino acid sequence of SEQ ID NO: 14, 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, Yokoyama et al. also disclose other positions for mutation, in addition to R5, V6, W59 (p. 2092). Therefore, it would have been obvious to incorporate an additional substitution with the MTG mutant having the R5 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 R5, 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 102(a)(1) rejections as being anticipated by Yokoyama et al. has been withdrawn. However, the claims are rejected under a new 103 rejection over Yokoyama et al. for the reasons noted above.
No claim is allowed.
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.
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/Marsha Tsay/Primary Examiner, Art Unit 1656