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 Amendments filed on December 5, 2025, has been received and entered.
Claim Disposition
3. Claims 1-8 and 11-13 are cancelled. Claims 9-10 and 14 are pending and are under examination.
Claim objection
4. Claims 9-10 and 14 are objected to for the following informalities:
For clarity and precision of claim language it is suggested that claim 9 is amended to read, “A method for performing an acyl transfer…. …..reacting a transglutaminase protein [[set forth in any one of (a) or (b)]] with………….an acyl transfer [[:]], and wherein
a transglutaminase protein….. [[and]] or
a transglutaminase protein……….”.
For clarity it is suggested that claim 10 is cancelled or amended because it is substantially duplicative based on amendments made to claim 9.
For clarity it is suggested that claims 10 and 14 are amended to read, “The method of claim 9, in lieu of [[The method according to claim 9]].
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.
5. Claims 9, 10 and 14 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 9 is indefinite for the recitation of “set forth in any one of (a) or (b)” and the recitation of “(a)…..and (b) (see about suggested language). The dependent claims hereto are also included.
Claim Rejections - 35 USC § 103
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.
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.
6. Claim(s) 9, 10 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO2014202616-A2, 2014 in view of A0A1S9DXU2_ASPOZ (see below alignment).
The claimed invention is directed to a method of performing an acyl transfer reaction. This reaction is established in the art wherein a transglutaminase protein performs a transamidation reaction. The claimed invention as set forth in claim 9 reads on any acyl transfer reaction using a transglutaminase protein which would necessarily have the activity as enzymes are named by their action. The WO document discloses a structure that is substantially identical to the instant SEQ ID NO: 2 thus would inherently have the claimed activity (see entire document and alignment of record). The WO document discloses a structure that is less than the recited 90% or 100%, however, the below alignment demonstrates a structure that could be used in the method that is 100% identical to SEQ ID NO: 2. The organism Aspergillus oryzae is also disclosed as a source of the protein structure (see the alignment).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to arrive at the claimed invention as a whole because the primary reference teaches the process and the secondary reference discloses the full structure of the protein and are construed as analogous art. Moreover, the Supreme Court pointed out in KSR, “a patent composed of several elements is not proved obvious merely by demonstrating that each of its elements was, independently, known in the prior art.” KSR, 127 S. Ct. at 1741. The Court thus reasoned that the analysis under 35 U.S.C. 103 "need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the “inferences and creative steps that a person of ordinary skill in the art would employ.” Id. at 1741. The Court further advised that “[a] person of ordinary skill is…a person of ordinary creativity, not an automation.” Id. at 1742. Therefore, the claimed invention was obvious to make and use at the time the invention was made and was prima facie obvious.
ALIGNMENT
RESULT 1
A0A1S9DXU2_ASPOZ
(NOTE: this sequence has 2 duplicates in the database searched.
See complete list at the end of this report)
ID A0A1S9DXU2_ASPOZ
697 AA.
AC A0A1S9DXU2;
DT 10-MAY-2017, integrated into UniProtKB/TrEMBL.
DT 10-MAY-2017, sequence version 1.
DT 08-OCT-2025, entry version 29.
DE SubName: Full=Transglutaminase domain-containing protein {ECO:0000313|EMBL:OOO13878.1};
DE SubName: Full=Unnamed protein product {ECO:0000313|EMBL:GMG36009.1};
GN ORFNames=Aory04_001112700 {ECO:0000313|EMBL:GMG36009.1},
GN OAory_01024730 {ECO:0000313|EMBL:OOO13878.1};
OS Aspergillus oryzae (Yellow koji mold).
OC Eukaryota; Fungi; Dikarya; Ascomycota; Pezizomycotina; Eurotiomycetes;
OC Eurotiomycetidae; Eurotiales; Aspergillaceae; Aspergillus;
OC Aspergillus subgen. Circumdati.
OX NCBI_TaxID=5062 {ECO:0000313|EMBL:OOO13878.1, ECO:0000313|Proteomes:UP000190312};
RN [1] {ECO:0000313|EMBL:OOO13878.1, ECO:0000313|Proteomes:UP000190312}
RP NUCLEOTIDE SEQUENCE [LARGE SCALE GENOMIC DNA].
RC STRAIN=BCC7051 {ECO:0000313|EMBL:OOO13878.1,
RC ECO:0000313|Proteomes:UP000190312};
RA Thammarongtham C., Vorapreeda T., Nookaew I., Srisuk T., Land M.,
RA Jeennor S., Laoteng K.;
RT "Genome sequencing of Aspergillus oryzae BCC7051.";
RL Submitted (OCT-2016) to the EMBL/GenBank/DDBJ databases.
RN [2] {ECO:0000313|EMBL:GMG36009.1}
RP NUCLEOTIDE SEQUENCE.
RC STRAIN=NBRC 4228 {ECO:0000313|EMBL:GMG36009.1};
RA Ichikawa N., Sato H., Tonouchi N.;
RT "Aspergillus oryzae NBRC 4228.";
RL Submitted (APR-2023) to the EMBL/GenBank/DDBJ databases.
CC -!- CAUTION: The sequence shown here is derived from an EMBL/GenBank/DDBJ
CC whole genome shotgun (WGS) entry which is preliminary data.
CC {ECO:0000313|EMBL:OOO13878.1}.
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DR EMBL; BSYA01000186; GMG36009.1; -; Genomic_DNA.
DR EMBL; MKZY01000001; OOO13878.1; -; Genomic_DNA.
DR AlphaFoldDB; A0A1S9DXU2; -.
DR VEuPathDB; FungiDB:AO090023000250; -.
DR eggNOG; KOG4575; Eukaryota.
DR OMA; HGKGFGH; -.
DR OrthoDB; 6129702at2759; -.
DR Proteomes; UP000190312; Unassembled WGS sequence.
DR Proteomes; UP001165205; Unassembled WGS sequence.
DR GO; GO:0005737; C:cytoplasm; IEA:TreeGrafter.
DR Gene3D; 3.10.620.30; -; 1.
DR InterPro; IPR052557; CAP/Cytokinesis_protein.
DR InterPro; IPR038765; Papain-like_cys_pep_sf.
DR InterPro; IPR002931; Transglutaminase-like.
DR PANTHER; PTHR46333; CYTOKINESIS PROTEIN 3; 1.
DR PANTHER; PTHR46333:SF5; TRANSGLUTAMINASE-LIKE DOMAIN-CONTAINING PROTEIN; 1.
DR Pfam; PF01841; Transglut_core; 1.
DR SMART; SM00460; TGc; 1.
DR SUPFAM; SSF54001; Cysteine proteinases; 1.
PE 4: Predicted;
FT DOMAIN 409..483
FT /note="Transglutaminase-like"
FT /evidence="ECO:0000259|SMART:SM00460"
FT REGION 19..305
FT /note="Disordered"
FT /evidence="ECO:0000256|SAM:MobiDB-lite"
FT COMPBIAS 19..28
FT /note="Polar residues"
FT /evidence="ECO:0000256|SAM:MobiDB-lite"
FT COMPBIAS 48..62
FT /note="Polar residues"
FT /evidence="ECO:0000256|SAM:MobiDB-lite"
FT COMPBIAS 76..96
FT /note="Pro residues"
FT /evidence="ECO:0000256|SAM:MobiDB-lite"
FT COMPBIAS 127..153
FT /note="Polar residues"
FT /evidence="ECO:0000256|SAM:MobiDB-lite"
FT COMPBIAS 209..221
FT /note="Low complexity"
FT /evidence="ECO:0000256|SAM:MobiDB-lite"
FT COMPBIAS 265..287
FT /note="Polar residues"
FT /evidence="ECO:0000256|SAM:MobiDB-lite"
SQ SEQUENCE 697 AA; 74867 MW; 7DCDF97609C53A76 CRC64;
Query Match 100.0%; Score 3730; Length 697;
Best Local Similarity 100.0%;
Matches 697; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MAEETQVLSIQQRIAALNQAQVGQSPQAAASPLLGAQPTPFASRPAPSRQQTINNPPVNS 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MAEETQVLSIQQRIAALNQAQVGQSPQAAASPLLGAQPTPFASRPAPSRQQTINNPPVNS 60
Qy 61 HDSLGDRNEPTGAQPKPVPRPPPIPVQKPRAPPPLPARKASTESAPALPPRRPSGFSRKE 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 HDSLGDRNEPTGAQPKPVPRPPPIPVQKPRAPPPLPARKASTESAPALPPRRPSGFSRKE 120
Qy 121 SRESLGSDVSHSTSTSAGRATIASTTSNNSDTIRSVRAPAWGAKLPPLPPKRQDTKTVQP 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 SRESLGSDVSHSTSTSAGRATIASTTSNNSDTIRSVRAPAWGAKLPPLPPKRQDTKTVQP 180
Qy 181 PPRPRPSPANSSRSLSQGRPSLPPRRESTNSTSTNGNRSTSRPPPPLPSRINSDKSPGPS 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 PPRPRPSPANSSRSLSQGRPSLPPRRESTNSTSTNGNRSTSRPPPPLPSRINSDKSPGPS 240
Qy 241 ADTNGKQSTRKLPPPPPSSAALEKIQSSGLAGINRNTENSGKGTNGSVQEPQPNGVPPPV 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 ADTNGKQSTRKLPPPPPSSAALEKIQSSGLAGINRNTENSGKGTNGSVQEPQPNGVPPPV 300
Qy 301 PRATRPDVDLAKLQATKPRLCKTTHSATAPSTMCLKCRDFSAPDAHAAQYPRESLPSYDL 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 PRATRPDVDLAKLQATKPRLCKTTHSATAPSTMCLKCRDFSAPDAHAAQYPRESLPSYDL 360
Qy 361 AWLARELTAPFPSPTDKARALFTWFHHNIEYDVHSFFNKCVKPSTPAGTLASGLAVCEGY 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 AWLARELTAPFPSPTDKARALFTWFHHNIEYDVHSFFNKCVKPSTPAGTLASGLAVCEGY 420
Qy 421 ASLFATLATHAGLEAVVVAGHGKGYGYDAPAPGSPIPPVSATGHAWSAVRIDNGQWKLLD 480
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 421 ASLFATLATHAGLEAVVVAGHGKGYGYDAPAPGSPIPPVSATGHAWSAVRIDNGQWKLLD 480
Qy 481 ACWGAGVVQGPGLPYKKQFNPAMFTDSNDEFGLRHFPSNRSHFFRDDGRPEITWEEYILG 540
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 481 ACWGAGVVQGPGLPYKKQFNPAMFTDSNDEFGLRHFPSNRSHFFRDDGRPEITWEEYILG 540
Qy 541 NPNSPLSAEQPTIFGDAQNHSIGERSFRPAAKQISIHDPSPLRFQFNLICEHWTLEHHTR 600
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 541 NPNSPLSAEQPTIFGDAQNHSIGERSFRPAAKQISIHDPSPLRFQFNLICEHWTLEHHTR 600
Qy 601 AKPGLFLLMVHGLDGRQDDRLPFTHVRGSGPGGGGDFWYVDVPNAKILGAPGQKLAIA VL 660
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 601 AKPGLFLLMVHGLDGRQDDRLPFTHVRGSGPGGGGDFWYVDVPNAKILGAPGQKLAIA VL 660
Qy 661 TSFGDRKDARGVTAEEYRQQVGRVGMAWAYIAEWQLV 697
|||||||||||||||||||||||||||||||||||||
Db 661 TSFGDRKDARGVTAEEYRQQVGRVGMAWAYIAEWQLV 697
Response to Arguments
7. Applicant’s comments have been considered. Withdrawn objections/rejections will not be discussed herein as applicant’s comments are moot. The IDS filed has been considered, however, note that a reference is lined through because it has an improper citation of the date.
Regarding the amendment filed, based on amendments made to the claims, note that a new rejection has been applied under art. Applicant states that the suggestions by the examiner has been adopted, however, note that some objections remain over claims 10 and 14 for example; and new ones have been instituted based on amendments to the claims. Applicant points out that the structure in the WO document is only 72.6% identical to SEQ ID NO:2, however, the art was applied to a broad recitation in the claim and based on the amended language a secondary reference is provided which meets the recited 90% or 100% sequence identity. Therefore, the arguments presented are persuasive and the rejection is made final.
Conclusion
8. No claims are presently allowable.
9. 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.
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/HOPE A ROBINSON/Primary Examiner, Art Unit 1652