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 .
Election/Restrictions
Applicant’s election without traverse of Invention I, claims 1-5,7-8,14,20-23,26,28-30,32,34-36,41,45 and 63 in the reply filed on 05/11/2026 is acknowledged.
Claims 49,53-54,57,60,65 and 82-83 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Applicant's election with traverse of species SEQ ID NO: 14 with the substitution position set of 95/177 and the substitution set 95V/177P in the reply filed on 05/11/2026 is acknowledged. The traversal is on the ground(s) that the variants do not present an undue search burden. This is not found persuasive because examination encompassing all of sequence variants, substitution positions, and substitution residues would be a serious search burden.
Regarding the species election (I)(i) of a single SEQ ID in claim 1, applicants elected SEQ ID NO: 14.
Claims 4, 5, 20-23, 26, 28-30, 32, 34-36, and 41 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Regarding species elections (I)(ii)(a)-(d), the election requirement (I)(ii)(d) for claim 26 is withdrawn because the elected species SEQ ID NO:14 is not present in the claim and the claim includes only unelected species.
Applicant’s response did not indicate which specific claims the further species elections (I)(ii)(a)-(c) of substitution positions and residues were directed to. For purposes of examination, it is interpreted that the following elections were made:
For claim 7: the substitution position set of 95/177.
For claim 8: the substitution set 95V/177P.
For claim 14: the substitution position set of 95/177.
Amendments to claims 1-4, 7, 8, 14, 20-23, 26, 28-30, 32, 34-36, 45, and 63 are acknowledged.
Claims 1-5, 7, 8, 14, 20-23, 26, 28-30, 32, 34-36, 41, 45, 49, 53, 54, 57, 57, 60, 63, 65, 82, and 83 are pending.
Claims 1-3, 7, 8, 14, 45, and 63 are under examination on the merits.
The requirement is still deemed proper and is therefore made FINAL.
Priority
This application 18/395,294 filed on 12/22/2023 claims the benefit of provisional U.S. Patent Application No. 63/476,912, filed on 12/22/2022.
The priority date of claim 1 and its dependent claims is determined to be 12/22/2022, the filing date of provisional U.S. Patent Application No. 63/476,912.
Specification
The use of terms which are trade names or marks used in commerce (including Amberlite, Sephadex, among others), has been noted in this application. The term should be accompanied by the generic terminology; furthermore, the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM, or ® following the term.
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 Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by QPB08846.1 (Genbank Accession QPB08846.1, RnlB-like RNA ligase, submitted 07/01/2020).
Regarding claims 1-3, QPB08846.1 teaches the sequence of an RNA ligase
which has 86.5% sequence identity to residues 12-346 of SEQ ID NO:14, with one or more substitutions as shown below:
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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 1,7-8,14,45 and 63 are rejected under 35 U.S.C. 103 as being unpatentable over QPB08846.1 (Genbank Accession QPB08846.1, RnlB-like RNA ligase, submitted 07/01/2020) in view of Konishi et al. (US 20210301280, on IDS dated 12/09/2025).
The teachings of QPB08846.1 as they relate to claim 1 are stated in the 102 rejection above in this office action.
Regarding claims 7, 8, and 14, QPB08846.1 teaches a sequence with a substitution at amino acid position 177, wherein the amino acid positions are relative to the reference sequence corresponding to SEQ ID NO: 14, as shown below (amino acid position 177 indicated by box). The substitution is 177P as required by claim 8:
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QPB08846.1 does not teach a second substitution at amino acid position 95 (claims 7 and 14), or that the substitution is 95V (claim 8).
Konishi teaches RNA ligase mutants (engineered RNA ligases) that have more excellent properties than those of the non-mutant (para 19). Konishi teaches that the ligase mutants have nucleic acid-linking activity (para 51). Konishi teaches a sequence (SEQ ID NO: 2) that has substitutions at amino acid positions 95 and 177 relative to the reference sequence corresponding to SEQ ID NO: 14 (amino acid positions 95 and 177 indicated by boxes), as shown below:
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Konishi teaches a ligase mutant may have mutation at one or more amino acid residues as long as desired percent identity and linking activity are maintained and, further, that a position of an amino acid residue to which the mutation may be introduced is evident to a person skilled in the art (para 54).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of QPB08846.1and Konishi to arrive at the instantly claimed invention. The modification would have entailed incorporating the substitution at amino acid position 95 (relative to the reference sequence of SEQ ID NO:14). The sequence of Konishi shows that the combination of substitutions at positions 95 and 177 retains function, i.e. comprises a functional fragment. One would have been motivated to make mutations and substitutions to improve RNA ligase activity. One of skill in the art , as taught by Konishi, would have known which mutation positions maintained activity. There would have been a reasonable expectation of success given the underlying materials and methods are widely known, successfully demonstrated, and commonly used as evidenced by the prior art.
Regarding claim 45, QPB08846.1 teaches the sequence of an RNA ligase. And Konishi teaches a ligase mutant may have mutation at one or more amino acid residues that maintains linking activity (has RNA ligase activity) and, further, that a position of an amino acid residue to which the mutation may be introduced is evident to a person skilled in the art (para 54).
Konishi teaches the RNA ligase mutants have excellent temperature stability (para 53).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of QPB08846.1and Konishi to arrive at the instantly claimed invention. The modification would have entailed incorporating the substitution at amino acid position 95 (relative to the reference sequence of SEQ ID NO:14). The sequence of Konishi shows that the combination of substitutions at positions 95 and 177 retains function, i.e. comprises a functional fragment. One would have been motivated to make mutations and substitutions to improve RNA ligase activity and, further, as taught by Konishi to make substitutions that retain ligase activity and improve thermostability. One of skill in the art, as taught by Konishi, would have known which mutation positions maintained activity. There would have been a reasonable expectation of success given the underlying materials and methods are widely known, successfully demonstrated, and commonly used as evidenced by the prior art.
Regarding claim 63, Konish teaches a composition of a reaction solution comprising ligase mutants (para 53).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of QPB08846.1and Konishi to arrive at the instantly claimed invention. The modification would have entailed incorporating the substitution at amino acid position 95 (relative to the reference sequence of SEQ ID NO:14). The sequence of Konishi shows that the combination of substitutions at positions 95 and 177 retains function, i.e. comprises a functional fragment. One would have been motivated to make mutations and substitutions to improve RNA ligase activity. One of skill in the art, as taught by Konishi, would have known which mutation positions with maintained activity. The modification would further have entailed using the ligase mutant in a composition such as a reaction. On would have been motivated to add the ligase mutant to a reaction in order to use the enzymatic activity of the ligase. There would have been a reasonable expectation of success given the underlying materials and methods are widely known, successfully demonstrated, and commonly used as evidenced by the prior art.
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.
(I). Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 19/009,695 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims substantially anticipate the identified claims of this application. The additional limitations of the ‘965 claims are encompassed by the open claim language "comprising" found in the instant claims.
Regarding instant claim 1, copending claim 1 requires an engineered RNA ligase, or a functional fragment thereof, comprising an amino acid sequence having at least 70% --- or more sequence identity to a reference sequence corresponding to a reference sequence corresponding to SEQ ID NO: 2, which has 96.3% sequence identity to SEQ ID NO: 14 with one or more substitutions as shown below:
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This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
(II). Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/955,904 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims substantially anticipate the identified claims of this application. The additional limitations of the ‘904 claims are encompassed by the open claim language "comprising" found in the instant claims.
Regarding instant claim 1, copending claim 1 encompasses a functional fragment of an engineered RNA ligase and requires an engineered RNA ligase, or a functional fragment thereof, comprising an amino acid sequence having at least 70% --- or more sequence identity to a reference sequence corresponding to a reference sequence corresponding to an even numbered SEQ ID NO. of SEQ ID NOs: 2-220, 224-252, and 270- 958. SEQ ID NO. 2 of the copending application has 54.6% sequence identity to SEQ ID NO: 14 with one or more substitutions as shown below:
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The claims of the copending application encompass a functional fragment of an engineered RNA ligase
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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/JESSICA GRAY/Examiner, Art Unit 1682
/WU CHENG W SHEN/Supervisory Patent Examiner, Art Unit 1682
Prosecution Insights