Prosecution Insights
Last updated: October 25, 2026
Application No. 18/418,226

T7 DNA Ligase Variants Having Increased Ligation Efficiency

Non-Final OA §101§112§DOUBLEPATENT
Filed
Jan 20, 2024
Priority
Jan 24, 2023 — provisional 63/481,194 +1 more
Examiner
HASAN, KHALEDA B
Art Unit
1636
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Abclonal Science Inc.
OA Round
1 (Non-Final)
59%
Grant Probability
Moderate
1-2
OA Rounds
8m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 59% of resolved cases
59%
Career Allowance Rate
80 granted / 135 resolved
-0.7% vs TC avg
Strong +49% interview lift
Without
With
+49.0%
Interview Lift
resolved cases with interview
Typical timeline
3y 5m
Avg Prosecution
26 currently pending
Career history
163
Total Applications
across all art units

Statute-Specific Performance

§101
6.6%
-33.4% vs TC avg
§103
33.5%
-6.5% vs TC avg
§102
14.6%
-25.4% vs TC avg
§112
26.9%
-13.1% vs TC avg
Black line = Tech Center average estimate • Based on career data from 135 resolved cases

Office Action

§101 §112 §DOUBLEPATENT
DETAILED ACTION 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 . Application Status This action is written in response to applicant’s correspondence received 7/9/2026. Claims 1-14 are currently pending and examined herein. The restriction requirement mailed 7/7/2026 is still deemed proper. Applicant's elected SEQ ID NO: 6 for Group A and SEQ ID NO: 5 for Group B without traverse in the reply filed 7/9/2026. Species of claim 1 of E63K (SEQ ID NO:4), E243K (SEQ ID NO: 8), D245R (SEQ ID NO: 10), E272K (SEQ ID NO: 12), D288R (SEQ ID NO:14), E289K (SEQ ID NO: 16), and E292K (SEQ ID NO:18) and species of claim 6 of E63K (SEQ ID NO:3), E243K (SEQ ID NO:7), D245R (SEQ ID NO:9), E272K (SEQ ID NO:11), D288R (SEQ ID NO:13), E289K (SEQ ID NO:15), and E292K (SEQ ID NO:17) are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Specification The use of the terms CELLYTIC™ B (p. 15), GELRED® (pp. 16-17), NEBNEXT® (p. 17), QUICK LIGATION™ (p. 17), and HELISCOPE™ (pp.19 and 21), which are trade names or marks used in commerce, have been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the terms. Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks. Claim Objections Claim 1 is objected to because of the following informalities: claim 1, line 2, appears to have a typo or grammatical error in “the following the amino acid mutations”. Removing “the” between “following” and “amino” would be remedial. Appropriate correction is required. Claim Rejections - 35 USC § 101 35 U.S.C. 101 reads as follows: Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title. Section 33(a) of the America Invents Act reads as follows: Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism. Claims 11 and 12 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claim 11 recites “A cell transformed with and expression a polynucleotide of claim 5.” Claim 12 recites “A cell transformed with and expressing a vector of claim 9.” The specification states “The mutant T7 DNA ligase of the invention can be expressed in any suitable host system, including a bacterial, yeast, fungal, baculovirus, plant or mammalian host cell” (p. 8, para 1). Accordingly, the broadest reasonable interpretation of the term “a host cell” embraces a human host cell and wherein the host cell resides in a human organism and therefore is otherwise inseparable from the human. In view of BRI, a human comprising the host cell would be encompassed by the claimed product. Claim Rejections - 35 USC § 112(b) 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 1-14 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 1 recites the phrase “comprising: one or more of the following the amino acid mutations preceding a comma, wherein the mutation is the substitution at the positions indicated in each amino acid sequence and wherein the entire amino acid sequence is represented in the adjacent even numbered sequence identification number: E63K (SEQ ID NO:4), D132R (SEQ ID NO:6), E243K (SEQ ID NO: 8), D245R (SEQ ID NO: 10), E272K (SEQ ID NO: 12), D288R (SEQ ID NO:14), E289K (SEQ ID NO: 16), and E292K (SEQ ID NO:18)”. The phrase renders the claim indefinite because the claim does not further recite a reference sequence pointing to where the D132R mutation lies. Claims 2-14 depend from claim 1 and are therefore included in the rejection. Claim 1 recites the phrase a “biologically active fragment thereof”, thereby encompassing an N-terminal deletion fragments, in which case, it is unclear which of the amino acids would require substitution without a reference sequence. There are examples of such fragments in the specification such that one would be able to determine the metes and bounds of the term. Claims 2-14 depend from claim 1 and are therefore included in the rejection. Claim 9 recites the limitation "a polynucleotide of claim 5" in line 1. It is unclear whether this is the same or a different polynucleotide of claim 5. Amending “a” to “the” would be sufficient to overcome this rejection. Claim 10 recites the limitation "a polynucleotide of claim 8" in line 1. It is unclear whether this is the same or a different polynucleotide of claim 8. Amending “a” to “the” would be sufficient to overcome this rejection. Claim 11 recites the limitation "a polynucleotide of claim 5" in line 1. It is unclear whether this is the same or a different polynucleotide of claim 5. Amending “a” to “the” would be sufficient to overcome this rejection. Claim 12 recites the limitation "a vector of claim 9" in line 1. It is unclear whether this is the same or a different vector of claim 9. Amending “a” to “the” would be sufficient to overcome this rejection. Claim 13 recites the limitation “a mutant T7 DNA ligase or a biologically active fragment of claim 1”. It is unclear whether this is the same or different mutant T7 DNA ligase or a biologically active fragment of claim 1. Amending “a” to “the” would be sufficient to overcome this rejection. Claim Rejections - 35 USC § 112 – Written Description The following is a quotation of the first paragraph of 35 U.S.C. 112(a): (a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention. The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112: The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention. Claims 1-14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The claimed invention embraces a mutant T7 DNA ligase or a biologically active fragment thereof, comprising: one or more of the following the amino acid mutations preceding a comma, wherein the mutation is the substitution at the positions indicated in each amino acid sequence and wherein the entire amino acid sequence is represented in the adjacent even numbered sequence identification number: E63K (SEQ ID NO:4), D132R (SEQ ID NO:6), E243K (SEQ ID NO: 8), D245R (SEQ ID NO: 10), E272K (SEQ ID NO: 12), D288R (SEQ ID NO:14), E289K (SEQ ID NO: 16), and E292K (SEQ ID NO:18), polynucleotides encoding the mutant T7 ligases or biologically active fragments of claim 1, vectors incorporating the polynucleotides encoding the mutant T7 ligases or biologically active fragments of claim 1, a cell transformed with and expressing the polynucleotides and vectors encoding the mutant T7 ligases or biologically active fragment of claim 1 and a method of using mutant a T7 DNA ligase or biologically active fragment of claim 1 for polynucleotide ligation to generate circular polynucleotides. The claimed invention, in claim 6, encompasses the polynucleotide of claim 5 which is one of the following sequences: E63K (SEQ ID NO:3), D132R (SEQ ID NO:5), E243K (SEQ ID NO:7), D245R (SEQ ID NO:9), E272K (SEQ ID NO:11), D288R (SEQ ID NO:13), E289K (SEQ ID NO:15), and E292K (SEQ ID NO:17). The claimed invention, in claim 7, encompasses the mutant T7 DNA ligase or a biologically active fragment thereof of claim 1 wherein one or more of said even-numbered amino acid sequence has conservative substitutions for certain of its amino acids but only to the extent that there remains at least 80%, 90%, 95%, 96%, 97%, 98% or 99% sequence identity to the sequence represented in the adjacent sequence identification number. *Note: Elected species are in bold. In University of California v. Eli Lilly & Co., 43 USPQ2d 1938, the Court of Appeals for the Federal Circuit has held that “A written description of an invention involving a chemical genus, like a description of a chemical species, ‘requires a precise definition, such as by structure, formula, [or] chemical name,’ of the claimed subject matter sufficient to distinguish it from other materials”. As indicated in MPEP § 2163, the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show that Applicant was in possession of the claimed genus. In addition, MPEP § 2163 states that a representative number of species means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. The specification, however, only describes a single species of the D132R mutant T7 DNA ligase of SEQ ID NO: 6 and the polynucleotide encoding the mutant T7 DNA ligase having the nucleotide sequence of SEQ ID NO: 5. The specification only describes mutants having single substitutions (Fig. 1). The ligases disclosed comprise 358 aa, whereby a single amino acid substitution would represent an amino acid having 99.7% of the disclosed sequences. The specification does not contain any disclosure or description of the structure and function of all amino acid sequences that are at least 80-99% identical to SEQ ID NO: 6, or biologically active fragment thereof of any size, or a derivative derived from such a sequence by insertion, deletion or substitution, and result in a protein that has T7 DNA ligase activity. The single mutant or species disclosed from Teseptimavirus is not representative of the genus claimed. According to MPEP 2163, to satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v.Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed.Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116. The scope of each genus includes many members of T7 DNA ligase enzymes with widely differing structural, chemical, and physical characteristics. Furthermore, each genus is highly variable because a significant number of structural differences between genus members exit. The specification does not describe and define any structural features and amino acid sequences commonly possessed by each genus. There is no art-recognized correlation between any structure of a T7 DNA ligase protein/enzyme and sequences having varying sequence homology, i.e., 80%-99% of SEQ ID NO: 6. Those of ordinary skill in the art would not be able to identify without further testing what specific protein sequences would have T7 DNA ligase activity. The genus of T7 DNA ligase that comprise these protein molecules may be obtained with the aid of a computer by a skilled artisan. However, there is no teaching regarding which 1%-20% of the sequence that can be varied and still result in a protein having T7 DNA ligase activity. An important consideration is that structure is not necessarily a reliable indicator of function. The instant specification provides no disclosure relating similarity or identity of structure to conservation of function. General knowledge in the art provides guidance to modification of some amino acids that are tolerated without losing a protein’s tertiary structure. An important consideration is that structure is not necessarily a reliable indicator of function. In this example, there is no disclosure relating similarity of structure to conservation of function. General knowledge in the art included the knowledge that some amino acid variations are tolerated without losing a protein’s tertiary structure. The results of amino acid substitutions have been studied so extensively that amino acids are grouped in so-called “exchange groups” of similar properties because substituting within the exchange group is expected to conserve the overall structure. For example, the expectation from replacing leucine with isoleucine would be that the protein would likely retain its tertiary structure. On the other hand, when non-exchange group members are substituted, e.g., proline for tryptophan, the expectation would be that the substitution would not likely conserve the protein’s tertiary structure. Given what is known in the art about the likely outcome of substitutions on structure, those in the art would have likely expected the applicant to have been in possession of a genus of proteins having a tertiary structure similar to SEQ ID NO: 6 although the claim is not so limited. However, conservation of structure is not necessarily a surrogate for conservation of function. In this case, there is no disclosed correlation between structure and function. There is no disclosure of the active site amino acid residues responsible for the catalytic activity. While general knowledge in the art may have allowed one of skill in the art to identify other proteins expected to have the same or similar tertiary structure, in this case there is no general knowledge in the art about similar proteins to SEQ ID NO: 6 (D132R) to suggest that general similarity of structure confers the activity. Accordingly, one of skill in the art would not accept the disclosure of SEQ ID NO: 6 (with the nucleotide sequence of SEQ ID NO: 5) and a single mutant as representative of other proteins having T7 DNA ligase activity. The specification, taken with the pre-existing knowledge in the art of amino acid substitution and the genetic code, fails to satisfy the written description requirement of 35 U.S.C. 112, first paragraph. Double Patenting The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969). A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b). The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13. The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer. Claims 1 and 7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 12644112. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-4 of the ‘112 patent encompasses a mutant T7 DNA ligase or a biologically active fragment thereof, comprising the mutation E63K (SEQ ID NO:4) and the mutant T7 DNA ligase or a biologically active fragment thereof of claim 1, wherein one or more of said even-numbered amino acid sequence has conservative substitutions for certain of its amino acids but only to the extent that there remains at least 90%, 95%, or 99% sequence identity to the sequence represented in the adjacent sequence identification number. Allowable Subject Matter SEQ ID NO: 6 comprising the D132R substitution in a mutant T7 DNA ligase appears to be free of the prior art. The mutant T7 DNA ligase having SEQ ID NO: 6 is not found in nature. The closest prior art in Dunn and Studier ("Complete nucleotide sequence of bacteriophage T7 DNA and the locations of T7 genetic elements." J. Mol. Biol. 1983) discloses E. coli T7 DNA ligase with 99.6% identity to Applicant’s SEQ ID NO: 6, differing in the one amino acid substitution of D132R (see below). (Qy: Applicant’s SEQ ID NO: 6) Qy 1 MNIKTNPFKAVSFVESAIKKALDNAGYLIAEIKYDGVRGNICVDNTANSYWLSRVSKTIP 60 |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| Db 2 MNIKTNPFKAVSFVESAIKKALDNAGYLIAEIKYDGVRGNICVDNTANSYWLSRVSKTIP 61 Qy 61 ALEHLNGFDVRWKRLLNDDRCFYKDGFMLDGELMVKGVDFNTGSGLLRTKWTDTKNQEFH 120 |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| Db 62 ALEHLNGFDVRWKRLLNDDRCFYKDGFMLDGELMVKGVDFNTGSGLLRTKWTDTKNQEFH 121 Qy 121 EELFVEPIRKKRKVPFKLHTGHLHIKLYAILPLHIVESGEDCDVMTLLMQEHVKNMLPLL 180 ||||||||||| |||||||||||||||||||||||||||||||||||||||||||||||| Db 122 EELFVEPIRKKDKVPFKLHTGHLHIKLYAILPLHIVESGEDCDVMTLLMQEHVKNMLPLL 181 Qy 181 QEYFPEIEWQAAESYEVYDMVELQQLYEQKRAEGHEGLIVKDPMCIYKRGKKSGWWKMKP 240 |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| Db 182 QEYFPEIEWQAAESYEVYDMVELQQLYEQKRAEGHEGLIVKDPMCIYKRGKKSGWWKMKP 241 Qy 241 ENEADGIIQGLVWGTKGLANEGKVIGFEVLLESGRLVNATNISRALMDEFTETVKEATLS 300 |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| Db 242 ENEADGIIQGLVWGTKGLANEGKVIGFEVLLESGRLVNATNISRALMDEFTETVKEATLS 301 Qy 301 QWGFFSPYGIGDNDACTINPYDGWACQISYMEETPDGSLRHPSFVMFRGTEDNPQEKM 358 |||||||||||||||||||||||||||||||||||||||||||||||||||||||||| Db 302 QWGFFSPYGIGDNDACTINPYDGWACQISYMEETPDGSLRHPSFVMFRGTEDNPQEKM 359 (DB: Dunn and Studier’s 1983 sequence for T7 DNA ligase) SEQ ID NO: 5 representing a polynucleotide sequence encoding the mutant T7 DNA ligase comprising the D132R substitution appears to be free of the prior art. The mutant T7 DNA ligase having the nucleotide sequence of SEQ ID NO: 5 is not found in nature. The closest prior art in Dunn and Studier (Nucleotide sequence from the genetic left end of bacteriophage T7 DNA to the beginning of gene 4. Journal of Molecular Biology. 1981) discloses nucleotide sequence encoding E. coli T7 DNA ligase having 62.6% sequence identity to Applicant’s SEQ ID NO: 5 (see below). (Qy: Applicant’s SEQ ID NO: 5) Qy 1 ATGAATATCAAGACTAATCCGTTTAAAGCAGTATCGTTCGTGGAAAGCGCGATCAAAAAA 60 ||||| || |||||||| ||||||||||| || || ||||| || || || || || Db 6478 ATGAACATTAAGACTAACCCGTTTAAAGCCGTGTCTTTCGTAGAGTCTGCCATTAAGAAG 6537 Qy 61 GCCTTGGACAACGCTGGTTATTTAATCGCAGAAATTAAATATGATGGTGTCAGAGGGAAC 120 || |||| |||||||| ||| | ||||| ||||| || || |||||||| | |||||| Db 6538 GCTCTGGATAACGCTGGGTATCTTATCGCTGAAATCAAGTACGATGGTGTACGCGGGAAC 6597 Qy 121 ATCTGCGTCGATAATACGGCCAATTCGTATTGGCTGAGCCGTGTGTCTAAAACTATTCCG 180 |||||||| || ||||| || || || ||||| ||||| |||||||| |||||| Db 6598 ATCTGCGTAGACAATACTGCTAACAGTTACTGGCTCTCTCGTGTATCTAAAACGATTCCG 6657 Qy 181 GCACTCGAACACCTGAATGGTTTTGATGTTAGATGGAAACGCCTTTTAAATGACGATCGG 240 ||||| || ||| | || || ||||||||| | ||||| || || | || || || || Db 6658 GCACTGGAGCACTTAAACGGGTTTGATGTTCGCTGGAAGCGTCTACTGAACGATGACCGT 6717 Qy 241 TGTTTTTACAAAGATGGCTTTATGCTGGATGGGGAACTGATGGTTAAAGGCGTCGATTTC 300 || || |||||||||||||||||||| ||||||||||| ||||| || ||||| || || Db 6718 TGCTTCTACAAAGATGGCTTTATGCTTGATGGGGAACTCATGGTCAAGGGCGTAGACTTT 6777 Qy 301 AATACCGGATCTGGGTTATTACGTACGAAATGGACTGACACAAAAAATCAAGAATTTCAC 360 || || || || || || | ||||| |||||||||||||| || || ||||| || || Db 6778 AACACAGGGTCCGGCCTACTGCGTACCAAATGGACTGACACGAAGAACCAAGAGTTCCAT 6837 Qy 361 GAAGAATTATTTGTAGAACCAATTCGAAAAAAGCGTAAAGTGCCTTTTAAGTTACATACA 420 ||||| ||||| || |||||||| || || || |||||| || |||||| | || || Db 6838 GAAGAGTTATTCGTTGAACCAATCCGTAAGAAAGATAAAGTTCCCTTTAAGCTGCACACT 6897 Qy 421 GGCCATCTGCATATAAAGCTCTATGCGATACTGCCCCTTCACATTGTGGAAAGCGGTGAG 480 || || || || ||||| || || || || || || || ||||| ||||| || || Db 6898 GGACACCTTCACATAAAACTGTACGCTATCCTCCCGCTGCACATCGTGGAGTCTGGAGAA 6957 Qy 481 GATTGTGACGTCATGACGCTGCTGATGCAGGAACATGTGAAAAACATGTTACCTCTGTTA 540 || ||||| ||||||||| |||| ||||||||||| || || |||||| | |||||| || Db 6958 GACTGTGATGTCATGACGTTGCTCATGCAGGAACACGTTAAGAACATGCTGCCTCTGCTA 7017 Qy 541 CAAGAATATTTTCCAGAGATTGAGTGGCAGGCCGCGGAATCCTATGAAGTTTATGACATG 600 || ||||| || || || || || ||||| || || ||||| || || || || || ||| Db 7018 CAGGAATACTTCCCTGAAATCGAATGGCAAGCGGCTGAATCTTACGAGGTCTACGATATG 7077 Qy 601 GTAGAACTCCAGCAGTTGTATGAACAAAAACGCGCCGAAGGGCACGAAGGATTGATCGTC 660 |||||||| ||||| |||| || || || || || ||||| || || || | || || Db 7078 GTAGAACTACAGCAACTGTACGAGCAGAAGCGAGCAGAAGGCCATGAGGGTCTCATTGTG 7137 Qy 661 AAAGATCCCATGTGTATCTATAAACGGGGTAAAAAATCCGGTTGGTGGAAAATGAAACCG 720 ||||| || |||||||||||||| || ||||| ||||| || ||||||||||||||||| Db 7138 AAAGACCCGATGTGTATCTATAAGCGCGGTAAGAAATCTGGCTGGTGGAAAATGAAACCT 7197 Qy 721 GAAAACGAAGCGGATGGTATAATTCAGGGACTGGTGTGGGGTACGAAAGGATTAGCGAAT 780 || |||||||| || ||||| |||||||| ||||| |||||||| ||||| | || ||| Db 7198 GAGAACGAAGCTGACGGTATCATTCAGGGTCTGGTATGGGGTACAAAAGGTCTGGCTAAT 7257 Qy 781 GAAGGCAAAGTCATCGGTTTTGAAGTTTTGCTGGAAAGCGGTCGCCTCGTCAATGCGACA 840 ||||| ||||| || |||||||| || | || || || ||||| | || || || || Db 7258 GAAGGTAAAGTGATTGGTTTTGAGGTGCTTCTTGAGAGTGGTCGTTTAGTTAACGCCACG 7317 Qy 841 AACATCAGTCGGGCACTGATGGATGAGTTCACAGAGACCGTGAAAGAAGCGACCTTGTCT 900 || ||| ||| || | |||||||||||||| ||||| || ||||| || ||| | | Db 7318 AATATCTCTCGCGCCTTAATGGATGAGTTCACTGAGACAGTAAAAGAGGCCACCCTAAGT 7377 Qy 901 CAGTGGGGCTTCTTTTCTCCTTACGGTATAGGAGATAATGATGCTTGTACTATTAATCCG 960 || ||||| |||||| || |||||||| || || || ||||||||||||||||| || Db 7378 CAATGGGGATTCTTTAGCCCATACGGTATTGGCGACAACGATGCTTGTACTATTAACCCT 7437 Qy 961 TATGACGGATGGGCATGTCAGATCAGTTACATGGAAGAAACTCCTGACGGTTCACTGCGC 1020 || || || ||||| ||||| || || |||||||| ||||| ||||| || || |||| Db 7438 TACGATGGCTGGGCGTGTCAAATTAGCTACATGGAGGAAACACCTGATGGCTCTTTGCGG 7497 Qy 1021 CATCCCAGCTTCGTGATGTTCCGGGGTACTGAAGATAATCCCCAAGAGAAAATGTAA 1077 || || ||||| |||||||| || || || || || || ||||||||||||||| Db 7498 CACCCATCGTTCGTAATGTTCCGTGGCACCGAGGACAACCCTCAAGAGAAAATGTAA 7554 (DB: Dunn and Studier’s 1981 nucleotide sequence for T7 DNA ligase) Conclusion No claim is allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to KHALEDA B HASAN whose telephone number is (571)272-0239. The examiner can normally be reached IFP, Monday - Friday 7:30am-5pm. 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, Neil Hammell can be reached at (571) 270-5919. 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. /KHALEDA B HASAN/Examiner, Art Unit 1636 /BRIAN WHITEMAN/Primary Examiner, Art Unit 1636
Read full office action

Prosecution Timeline

Jan 20, 2024
Application Filed
Oct 15, 2026
Non-Final Rejection mailed — §101, §112, §DOUBLEPATENT (current)

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4y 7m to grant Granted Oct 13, 2026
Patent 12747441
RIBOSWITCH MODULATED GENE THERAPY FOR RETINAL DISEASES
3y 2m to grant Granted Sep 29, 2026
Patent 12742172
ENGINEERED DNA MOLECULE FOR CODING RNA
1y 6m to grant Granted Sep 22, 2026
Patent 12697400
GENE EDITING METHODS FOR TREATING ALPHA-1 ANTITRYPSIN (AAT) DEFICIENCY
2y 3m to grant Granted Aug 04, 2026
Patent 12692494
SERPIN FAMILY F MEMBER 2 (SERPINF2) iRNA COMPOSITIONS AND METHODS OF USE THEREOF
4y 5m to grant Granted Jul 28, 2026
Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

1-2
Expected OA Rounds
59%
Grant Probability
99%
With Interview (+49.0%)
3y 5m (~8m remaining)
Median Time to Grant
Low
PTA Risk
Based on 135 resolved cases by this examiner. Grant probability derived from career allowance rate.

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