DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. The Amendment filed on April 28, 2026, have been received and entered.
Claim Disposition
3. Claims 14-15, 17 and 21 have been cancelled. Claims 1-13, 16, 18-20 and 22-25 are pending. Claims 13, 16,18-20 and 26-27 are under examination. Claims 1-12 and 22-25 are withdrawn from further consideration pursuant to 37 CFR 1.12(b), as being drawn to a non-elected invention, there being no allowable generic or linking claim.
Information Disclosure Statement
4. The Information Disclosure Statement filed on April 28, 2026, has been received and entered. The references cited on the PTO-1449 Form have been considered by the examiner and a copy is attached to the instant Office action. Note that a reference has been lined through based on an incomplete date.
Claim objection
5. Claims 13, 16,18-20 and 26-27 are objected to for the following informalities:
For clarity and precision of claim language it is suggested that 13 recite,
“….having a transglutaminase activity, of [[wherein the transglutaminase activity comprises]] catalyzing an acyl group transfer reaction between ….[[wherein the specific mutation is a mutation of improving thermostability and/or pH stability of the mutant compared to wild-type transglutaminase]] wherein the specific mutation comprises the mutation (A) and/or the mutation (B)……and R89C/S116C in SEQ ID NO: 2, that improves thermostability …..”. The dependent claims hereto are also included.
For clarity and precision of claim language it is suggested that claims 13 and 26 are amended to delete the phrase ‘showing”, for example, recite “amino acid sequence [[showing an identity of ]] with 90% sequence identity…..”.The dependent claims hereto are also included.
For clarity it is suggested that claim 20 is amended to recite, “….mutant transglutaminase [[TG]]…”.
For clarity it is suggested that claim 27 is amended to read, “…..claim 13, wherein the mutant transglutaminase [[that]] comprises mutations…..”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
6. Claims 13, 16,18-20 and 26-27 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 13 lacks clarity for the recitation of, “…wherein the specific mutation is a mutation of improving thermostability and/or pH stability of the mutant compared to wild-type transglutaminase….”, because this statement is not a specific mutation in the amino acid sequence of a wild-type transglutaminase as recited in the preamble of the claim. This language can be construed as a resulting effect, thus the claim language needs clarification, thus indefinite (it is also noted that the claim recites a second “specific mutation”, however, the metes and bounds of the claim language is unclear with both).
Claim Rejections - 35 USC § 102
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.
7. Claim(s) 13, 16, 18, 20 and 26-27 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by WO 2019/107288 (2019, of record in the application).
The primary reference is directed to improving Streptomyces mobaraensis derived transglutaminase by an amino acid substitution and identified a plurality of substitutions effective for changes in its properties, for example, reduction in temperature stability, improvement in heat resistance, improvement in oxidation resistance, improvement in reactivity, or conversion into deamidase [0005]-[0007]; FIG 1-1 to FIG 6-9; claims 1-13). Further the reference suggests that modified enzymes with altered temperature stability are highly useful in applications such as production of yogurt and cheese (see par. [0016]). The reference also discloses in particular the Streptomyces mobaraensis transglutaminase mutant G275A (GSP:BGK02275;FIG. 6-6). The reference discloses a structure that is 99.70% identical to the instant SEQ ID NO:2 with the mutation of G275A that accounts for the mismatch in the sequence. Therefore, the limitations of the claims are met by the reference.
Response to Arguments
8. Applicant’s arguments have been considered in full. Withdrawn objections/rejections will not be discussed herein as applicant’s comments are moot. Note that new objections have been instituted for the reasons stated above. Also note that a new 112 second paragraph has been instituted for the reasons set forth above . In addition, note the art of record remains for the reasons set forth above and herein. Applicant traverses the rejection stating that the art is not anticipatory because it does not teach the claim as amended. This argument is not persuasive because the claim language in claim 13 is broad and written with lots of alternatives, thus the art still applies.
Conclusion
9. No claims are presently allowable.
10. Applicant’s amendment necessitated the new/modified ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HOPE A ROBINSON whose telephone number is (571) 272-0957. The examiner can normally be reached 9-5pm on Monday to Friday.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Mondesi can be reached on (408) 918-7584. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/HOPE A ROBINSON/Primary Examiner, Art Unit 1652
Prosecution Insights