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 .
DETAILED ACTION
Applicant’s response filed on 03/06/2026 (along with specification amendment filed on 04/27/2026 for sequence listing in ST.25 format) is duly acknowledged and entered.
Claims 1-14 (as amended on 12/12/2023) are pending in this application.
Election/Restrictions
Applicant’s election without traverse of Group III (claim 7; directed to “A method for modifying a protein or a peptide..”) in the reply filed on 03/06/2026 (see REM, p. 1) is duly acknowledged.
Claims 1-6 and 8-14 (directed to non-elected inventions of Groups I, II and IV-X) have been withdrawn from further considerations.
Claim 7 (elected invention of Group III, without traverse; directed to “A method for modifying a protein or a peptide..”) has been examined on its merits in this action hereinafter.
Priority
This application is a 371 of PCT/JP2022/023617 (filed on 06/13/2022), which claims foreign priority from a Japanese application JP 2021-098423 (filed on 06/14/2021).
Claim Objections
Claim 7 (as presented) is objected to because of the following informalities: Claim 7 (the elected invention under examination) recites the limitations “A method for modifying a protein or a peptide, containing allowing the enzyme agent according to claim 1…”, wherein the claim 1 is drawn to a non-elected invention, and therefore applicants are suggested to incorporate all the limitations from claim 1 into instant claim 7. Appropriate correction in response to this office action is required.
For the purposes of this office action, the elected claim 7 has been taken as incorporating all the limitations of instant claim 1.
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.
Claim 7 (as presented) is 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 7 is reproduced hereinbelow:
“Claim 7 (currently amended). A method for modifying a protein or a peptide, containing allowing the enzyme agent according to claim 1 a substrate.”
It is noted that instant claim 7 is directed to a method for modifying “a protein or a peptide” by allowing the “enzyme agent” from claim 1 to act on “a substrate”, wherein it is unclear if the “substrate” is “a protein or a peptide”, or in other words it is unclear if it comprises “a protein or a peptide” per se. Transglutaminase (see instant claim 1 for the “enzyme agent” as presented) enzymes are known to act on certain specific amino acids in a protein or peptide (see instant specification disclosure, p. 1, [0002]), and do not act on ANY type of substrate. From the recitation it is also not clear if the term “a substrate” is actually referring to the same protein or peptide that is being modified, or some other compound/substrate. Thus the recitation is deemed ambiguous and confusing as the metes and bounds of the claimed process does not appear to be properly defined.
In addition, the recitation of active step of “allowing the enzyme agent according to claim 1 to act on a substrate” is ambiguous as it does not clarify if the process is being performed in vitro using “a protein or peptide” as a substrate, or in fact the “enzyme agent” (it is noted that claim 1 as presented, does not require an isolated transglutaminase enzyme per se) is acting on “a substrate” under natural conditions in live cells comprising said enzyme according to claim 1. It is also not clear as to how “allowing the enzyme agent according to claim 1 to act on a substrate” modifies the “protein or a peptide” as intended and/or required by the process as being claimed. Appropriate correction and/or explanation is required.
Claim Rejections - 35 USC § 103
NOTICE: 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 7 (as currently presented) is rejected under 35 U.S.C. 103 as being unpatentable over Chou (WO 03/074004 A2; FOR cited as ref. [N] on PTO 892 form) in view of WP_189053072 (09/19/2020; NCBI database ref. sequence; NPL cited in IDS dated 06/05/2025).
Claim 7 (and claim 1 from which claim 7 directly depends from) are as follows:
“Claim 7 (currently amended). A method for modifying a protein or a peptide, containing allowing the enzyme agent according to claim 1 a substrate.”
“Claim 1 (original). An enzyme agent containing, as an active ingredient, a transglutaminase consisting of an amino acid sequence having a sequence identity of 90% or more to the amino acid sequence of SEQ ID NO: 1.”
NOTE: Claim 7 has been interpreted to incorporate all the limitations of claim 1 from which it directly depends from. Applicants are advised to amend claim 7 accordingly in response to this office action.
Chou (2003), while teaching a method for producing antigens (see Title, Abstract, and Summary of the invention, Figures 1-2, and Claims 1, 4, 7-8, 15, for instance), disclose the method for modifying proteins or polypeptides in order to produce cross-links using the enzyme agent comprising a recombinant microbial transglutaminase (TGase), in order to improve antigenicity of protein antigens for downstream use/applications in immunotherapy and/or antibody production (see [0015], [0067], [0082], Figures 4-7); wherein the recombinant TGase enzyme is derived from an actinomycetes bacteria, Streptomyces mobaraensis ATCC 29032 (SM TGase, amino acid sequence disclosed as SEQ ID NO: 6; see [0082], Example 8, [00205]-[00207]) and the purified TGase is able to modify protein and peptide substrates (and non-substrate proteins) by cross-linking reactions in vitro, such as beta-casein, serum albumin, cellulase, beta-amyloid peptide, synthetic peptides, etc. (see Examples 8-16, for instances).
However, Chou does not disclose the enzyme agent comprising a TGase “consisting of an amino acid sequence having a sequence identity of 90% or more to the amino acid sequence of SEQ ID NO: 1” as required by instant claim 7.
WP_189053072 (2020) discloses a hypothetical protein predicted/designated as a microbial transglutaminase enzyme that comprises a sequence length of 265 amino acids, and has 100% identity to SEQ ID NO: 1 amino acid sequence starting from amino acid 37 to 265 (i.e. corresponds or identical to amino acid sequence from 1 to 229 of SEQ ID NO: 1 required by the instant claim), and in addition has been disclosed to be from the same source of microorganism, Longimycelium tulufanense, an actinomycetes bacteria (see the amino acid sequence homology reproduced below).
PNG
media_image1.png
382
702
media_image1.png
Greyscale
Thus, to an artisan of ordinary skill in the art at the time this invention was made, it would have been obvious to substitute the microbial transglutaminase as taught by Chou with the alternative microbial TGase from another actinomycetes bacteria, such as derived from Longimycelium tulufanense that has been specifically disclosed in the prior art to be a microbial TGase (i.e. an art recognized functional equivalent) with a reasonable expectation of success, unless evidence/data provided on record to the contrary (which is currently lacking on record; see applicant’s disclosure SPEC, Examples 4 and 6, for instance that shows similar enzymatic activities on given substrates for both microbial TGases such as on protein/peptide substrates, being different only in the inherent characteristics and/or properties, under certain specific conditions of temperature and pH; see Tables 1-4). Therefore, the process as generically claimed fails to distinguish itself over the combined teachings and/or suggestion from the prior art references as discussed above.
Thus the invention as a whole would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention as claimed.
As per MPEP 2111.01, during examination, the claims must be interpreted as broadly as their terms reasonably allow. In re American Academy of Science Tech Center, F.3d, 2004 WL 1067528 (Fed. Cir. May 13, 2004)(The USPTO uses a different standard for construing claims than that used by district courts; during examination the USPTO must give claims their broadest reasonable interpretation.). This means that the words of the claim must be given their plain meaning unless applicant has provided a clear definition in the specification. In re Zletz, 893 F.2d 319, 321, 13 USPQ2d 1320, 1322 (Fed. Cir. 1989).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SATYENDRA K. SINGH whose telephone number is (571)272-8790. The examiner can normally be reached M-F 8:00- 5:00.
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, LOUISE W HUMPHREY can be reached at 571-272-5543. 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.
SATYENDRA K. SINGH
Primary Examiner
Art Unit 1657
/SATYENDRA K SINGH/Primary Examiner, Art Unit 1657
Prosecution Insights