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 .
Applicants’ amendment to the claims filed on 03/06/2026 is acknowledged. This listing of claims replaces all prior listings of claims in the application.
Claims 39-51, 60-62 are pending.
Claims 1-38, 52-59 are canceled.
Election/Restrictions
Applicant’s election with traverse of Group I (claims 39-51, 60-62) in the reply filed on 3/6/2026 is acknowledged.
Upon further consideration, the restriction requirement between Groups I, II, III has been reconsidered in view of Applicant’s cancellation of claims 53-57. As such, the restriction requirement between Groups I, II, III, as set forth in the Office action mailed on 11/7/2025 has been reconsidered and is hereby withdrawn.
Priority
Acknowledgement is made of this U.S. Non-provisional Application No. 18/296,798, filed on 10/28/2021, which is a divisional application of 17/594,761, which claims priority to PCT/US2020/030782 filed on 3/18/2020, which claims priority to provisional application 62/991,285, filed on 3/18/2020, provisional application 62/959,672 filed on 1/10/2020, provisional application 62/931,630, filed on 11/6/2019, provisional application 62/897,806, filed on 9/9/2019, provisional application 62/841,046, filed on 4/30/2019.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 4/6/2023, 5/26/2023, 9/8/2023, 9/11/2023, 9/26/2023, 4/29, 2023 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Drawings
The Drawings filed on 4/6/2023, 6/7/2023 are acknowledged and accepted by the examiner.
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 39-51, 60-62 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 68, 87, 90 of U.S. Patent No. US 11,666,641 B2 which are commonly owned and have common inventors and filed after the instant application on 10/28/2021. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are drawn to a non-naturally occurring composition comprising a CRISPR nuclease of SEQ ID NO: 3.
The instant application claims 39-51 are not patentably distinct from claims 1, 90 of ‘641 because claims 1, 90 of ‘641 recites ‘a non-naturally occurring composition comprising a Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR) nuclease comprising a sequence having at least 95% identity to the amino acid sequence of SEQ ID NO: 3,’ which is not patentably distinct from the instant application claims 1, 90.
The instant application claim 60 is not patentably distinct from claim 2 of ‘641 because claim 2 of ‘641 recites ‘the composition of claim 1, further comprising a a) a CRISPR RNA (crRNA) molecule and a transactivating CRISPR RNA (tracrRNA) molecule, wherein the crRNA molecule, tracrRNA molecule, and the CRISPR nuclease do not naturally occur together; orb) a single-guide RNA (sgRNA) molecule, wherein the crRNA molecule or sgRNA molecule comprises a guide sequence portion that is complementary to a sequence in a target region,’ which is not patentably distinct from the instant application claim 60.
The instant application claim 61 is not patentably distinct from claim 68 of ‘641 because claim 68 of ‘641 recites ‘the composition of claim 1, wherein the CRISPR nuclease further comprises a nuclear localization sequence (NLS),’ which is not patentably distinct from the instant application claim 61.
The instant application claim 62 is not patentably distinct from claim 87 of ‘641 because claim 87 of ‘641 recites ‘the composition of claim 39, further comprising a donor template molecule,’ which is not patentably distinct from the instant application claim 62.
Conclusion
Status of the claims
Claims 39-51, 60-62 are pending.
Claims 1-38, 52-59 are canceled.
Claims 39-51, 60-62 are rejected.
No claims are in condition for allowance.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERICA NICOLE JONES-FOSTER whose telephone number is (571)270-0360. The examiner can normally be reached mf 7:30a - 4:30p.
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, Manjunath Rao can be reached at 571-272-0939. 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.
/ERICA NICOLE JONES-FOSTER/Examiner, Art Unit 1656
/MANJUNATH N RAO/Supervisory Patent Examiner, Art Unit 1656
Appendix A
Instant Application SEQ ID NO: 3 vs U.S. Patent No. US 11,666,641 B2 SEQ ID NO: 3
Query Match 100.0%; Score 7072; DB 1; Length 1370;
Best Local Similarity 100.0%;
Matches 1370; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MTKVKDYYIGLDIGTSSVGWAVTDEAYNVLKFNSKKMWGVRLFDDAKTAEERRGQRGARR 60
Db 1 MTKVKDYYIGLDIGTSSVGWAVTDEAYNVLKFNSKKMWGVRLFDDAKTAEERRGQRGARR 60
Qy 61 RLDRKKERLSLLQDFFAEEVAKVDPNFFLRLDNSDLYMEDKDQKLKSKYTLFNDKDFKDK 120
Db 61 RLDRKKERLSLLQDFFAEEVAKVDPNFFLRLDNSDLYMEDKDQKLKSKYTLFNDKDFKDK 120
Qy 121 NFHKKYPTIHHLLMDLIEDDSKKDIRLVYLACHYLLKNRGHFIFEGQKFDTKSSFENSLN 180
Db 121 NFHKKYPTIHHLLMDLIEDDSKKDIRLVYLACHYLLKNRGHFIFEGQKFDTKSSFENSLN 180
Qy 181 ELKVHLNDEYGLDLEFDNENLINILTDPKLNKTAKKKELKSVIGDTKFLKAVSAIMIGSS 240
Db 181 ELKVHLNDEYGLDLEFDNENLINILTDPKLNKTAKKKELKSVIGDTKFLKAVSAIMIGSS 240
Qy 241 QKLVDLFENPEDFDDSAIKSVDFSTTSFDDKYSDYELALGDKIALVNILKEIYDSSILEN 300
Db 241 QKLVDLFENPEDFDDSAIKSVDFSTTSFDDKYSDYELALGDKIALVNILKEIYDSSILEN 300
Qy 301 LLKEADKSKDGNKYISNAFVKKYNKHGQDLKEFKRLVRQYHKSAYFDIFRSEKVNDNYVS 360
Db 301 LLKEADKSKDGNKYISNAFVKKYNKHGQDLKEFKRLVRQYHKSAYFDIFRSEKVNDNYVS 360
Qy 361 YTKSSISNNKRVKANKFTDQEAFYKFAKKHLETIKYKINKVNGSKADLELIDGMLRDMEF 420
Db 361 YTKSSISNNKRVKANKFTDQEAFYKFAKKHLETIKYKINKVNGSKADLELIDGMLRDMEF 420
Qy 421 KNFMPKIKSSDNGVIPYQLKLMELNKILENQSKHHEFLNVSDEYGSVCDKIASIMEFRIP 480
Db 421 KNFMPKIKSSDNGVIPYQLKLMELNKILENQSKHHEFLNVSDEYGSVCDKIASIMEFRIP 480
Qy 481 YYVGPLNPNSKYAWIKKQKDSEITPWNFKDVVDLDSSREEFIDSLIGRCTYLKDEKVLPK 540
Db 481 YYVGPLNPNSKYAWIKKQKDSEITPWNFKDVVDLDSSREEFIDSLIGRCTYLKDEKVLPK 540
Qy 541 ASLLYNEYMVLNELNNLKLNDLPITEEMKKKIFDQLFKTRKKVTLKAVANLLKKEFNING 600
Db 541 ASLLYNEYMVLNELNNLKLNDLPITEEMKKKIFDQLFKTRKKVTLKAVANLLKKEFNING 600
Qy 601 EILLSGTDGDFKQGLNSYNDFKAIVGDKVDSDDYRDKIEEIIKLIVLYGDDKSYLQKKIK 660
Db 601 EILLSGTDGDFKQGLNSYNDFKAIVGDKVDSDDYRDKIEEIIKLIVLYGDDKSYLQKKIK 660
Qy 661 AGYGKYFTDSEIKKMAGLNYKDWGRLSKKLLTGLEGANKITGERGSIIHFMREYNLNLME 720
Db 661 AGYGKYFTDSEIKKMAGLNYKDWGRLSKKLLTGLEGANKITGERGSIIHFMREYNLNLME 720
Qy 721 LMSASFTFTEEIQKLNPVDDRKLSYEMVDELYLSPSVKRMLWQSLRIVDEIKNIMGTDSK 780
Db 721 LMSASFTFTEEIQKLNPVDDRKLSYEMVDELYLSPSVKRMLWQSLRIVDEIKNIMGTDSK 780
Qy 781 KIFIEMARGKEEVKARKESRKNQLLKFYKDGKKAFISEIGEERYSYLLSEIEGEEENKFR 840
Db 781 KIFIEMARGKEEVKARKESRKNQLLKFYKDGKKAFISEIGEERYSYLLSEIEGEEENKFR 840
Qy 841 WDNLYLYYTQLGRCMYSLEPIDISELSSKNIYDQDHIYPKSKIYDDSIENRVLVKKDLNS 900
Db 841 WDNLYLYYTQLGRCMYSLEPIDISELSSKNIYDQDHIYPKSKIYDDSIENRVLVKKDLNS 900
Qy 901 KKGNSYPIPDEILNKNCYAYWKILYDKGLIGQKKYTRLTRRTGFTDDELVQFISRQIVET 960
Db 901 KKGNSYPIPDEILNKNCYAYWKILYDKGLIGQKKYTRLTRRTGFTDDELVQFISRQIVET 960
Qy 961 RQATKETANLLKTICKNSEIVYSKAENASRFRQEFDIVKCRAVNDLHHMHDAYINIIVGN 1020
Db 961 RQATKETANLLKTICKNSEIVYSKAENASRFRQEFDIVKCRAVNDLHHMHDAYINIIVGN 1020
Qy 1021 VYNTKFTKDPMNFVKKQEKARSYNLENMFKYDVKRGGYTAWIADDEKGTVKNASIKRIRK 1080
Db 1021 VYNTKFTKDPMNFVKKQEKARSYNLENMFKYDVKRGGYTAWIADDEKGTVKNASIKRIRK 1080
Qy 1081 ELEGTNYRFTRMNYIESGALFNATLQRKNKGSRPLKDKGPKSSIEKYGGYTNINKACFAV 1140
Db 1081 ELEGTNYRFTRMNYIESGALFNATLQRKNKGSRPLKDKGPKSSIEKYGGYTNINKACFAV 1140
Qy 1141 LDIKSKNKIERKLMPVEREIYAKQKNDKKLSDEIFSKYLKDRFGIEDYRVVYPVVKMRTL 1200
Db 1141 LDIKSKNKIERKLMPVEREIYAKQKNDKKLSDEIFSKYLKDRFGIEDYRVVYPVVKMRTL 1200
Qy 1201 LKIDGSYYFITGGSDKTLELRSALQLILPKKNEWAIKQIDKSSENDYLTIERIQDLTEEL 1260
Db 1201 LKIDGSYYFITGGSDKTLELRSALQLILPKKNEWAIKQIDKSSENDYLTIERIQDLTEEL 1260
Qy 1261 VYNTFDIIVNKFKTSVFKKSFLNLFQDDKIENIDFKFKSMDFKEKCKTLLMLVKAIRASG 1320
Db 1261 VYNTFDIIVNKFKTSVFKKSFLNLFQDDKIENIDFKFKSMDFKEKCKTLLMLVKAIRASG 1320
Qy 1321 VRQDLKSIDLKSDYGRLSSKTNNIGNYQEFKIINQSITGLFENEVDLLKL 1370
Db 1321 VRQDLKSIDLKSDYGRLSSKTNNIGNYQEFKIINQSITGLFENEVDLLKL 1370
Prosecution Insights