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 .
Applicant’s response filed 12/22/2025 has been received and considered entered. This is a response to amendments and arguments filed 12/22/2025.
Claims Status
Claims 2, 6-7, 10, 12, 15, 19-34, 36-163, 165-232, 234, 239-408 is/are cancelled and claims 417-418 is/are newly added. Claims 1, 3-5, 8-9, 11, 13-14, 16-18, 35, 164, 233, 235-238, 409-418 is/are currently pending. Claims 1, 3-5, 8-9, 11, 13-14, 16-18, 35, 164, 233, 235-238, 409-418 is/are under examination.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
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.
US 11821012 B2:
Claims 1, 3-5, 8-9, 13, 16-17, 35, 164, 409-418 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. US 11821012 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the scope of the claims of ~012 encompasses and anticipates the instant claims. ~012 claims a variant Cas12i2 polypeptide at least 95% identical to SEQ ID NO:922 and comprising amino acid residue substitutions D581R, I926R, and V1030G (claims 1-2) (SEQ ID NO:922 is 100% identical to instant SEQ ID NO:2 and 99.6% identical to instant SEQ ID NO:4, see below). ~012 claims that the variant further comprises a G624R, F626R, P868T, E1035R, or S1046G substitution (claims 4-5). ~012 further claims that the variant Cas12i2 polypeptide has the sequence of SEQ ID NO:924 (100% identical to instant SEQ ID NO:4) or SEQ ID NO:927 (100% identical to instant SEQ ID NO:496) (see alignments below) (claim 6).
Alignment of instant SEQ ID NO:4 and ~012 SEQ ID NO:922:
PNG
media_image1.png
102
523
media_image1.png
Greyscale
Alignment of instant SEQ ID NO:4 and ~012 SEQ ID NO:924:
PNG
media_image2.png
104
528
media_image2.png
Greyscale
Alignment of instant SEQ ID NO:496 and ~012 SEQ ID NO:927:
PNG
media_image3.png
104
524
media_image3.png
Greyscale
~012 claims a direct repeat sequence of SEQ ID NO:10 (SEQ ID NO:10 is 100% identical to instant SEQ ID NO:492, see alignment below) (claim 12).
PNG
media_image4.png
100
532
media_image4.png
Greyscale
Regarding claims 13 and 414, ~012 recites a PAM sequence of 5’-TTN-3’ (claim 1). Instant claim 13 requires a PAM sequence of 5’-NTTN-3’. However, since, N can be any nucleotide, a Cas12i2 protein that recognizes target nucleic acids comprising the 5’-TTN-3’ PAM sequence would inherently also be able to recognize target nucleic acids comprising the 5’-NTTN-3’ PAM sequence, as it contains the 5’-TTN-3’ PAM sequence and is taught in the specification of ~012 to be equivalent to the 5’-TTN-3’ PAM sequence (see col. 12 lines 5-8).
US 11939607 B2:
Claims 1, 3-5, 8-9, 13, 16-18, 35, 164, 409-418 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. US 11939607 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the scope of the claims of ~607 encompasses and anticipates the instant claims. ~607 claims a variant Cas12i2 polypeptide at least 95% identical to SEQ ID NO:1166 and comprising amino acid residue substitutions D581R, I926R, and V1030G (claims 1-2). ~607 claims that the variant further comprises a G624R, F626R, P868T, E1035R, or S1046G substitution (claim 2). ~607 further claims that the variant Cas12i2 polypeptide has the sequence of SEQ ID NO:1168 (100% identical to instant SEQ ID NO:4) or SEQ ID NO:1171 (100% identical to instant SEQ ID NO:496) (see alignments below) (claim 6).
Alignment of instant SEQ ID NO:4 and ~607 SEQ ID NO:1168:
PNG
media_image5.png
103
524
media_image5.png
Greyscale
Alignment of instant SEQ ID NO:496 and ~607 SEQ ID NO:1171:
PNG
media_image6.png
101
525
media_image6.png
Greyscale
~607 further claims a direct repeat sequence of SEQ ID NO:10 (SEQ ID NO:10 is 100% identical to instant SEQ ID NO:492, see alignment below) (claim 9).
PNG
media_image4.png
100
532
media_image4.png
Greyscale
Regarding claims 13 and 414, ~607 recites a PAM sequence of 5’-TTN-3’ (claim 1). Instant claim 13 requires a PAM sequence of 5’-NTTN-3’. However, since, N can be any nucleotide, a Cas12i2 protein that recognizes target nucleic acids comprising the 5’-TTN-3’ PAM sequence would inherently also be able to recognize target nucleic acids comprising the 5’-NTTN-3’ PAM sequence, as it contains the 5’-TTN-3’ PAM sequence and is taught in the specification of ~607 to be equivalent to the 5’-TTN-3’ PAM sequence (see col. 11 lines 40-42).
18/000218:
Claim 1, 3-5, 8-9, 11, 13-14, 16-18, 35, 164, 233, 235-238, 409-418 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 5, 9, 12, 23, 26-29, 34, 36-37, 44, 47 of copending Application No. 18/000218 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the scope of the instant claims fully encompasses the scope of the reference claims (instant SEQ ID NO:4 is 100% identical to copending SEQ ID NO:4, see alignment below; the copending application claims a variant Cas12i2 polypeptide of SEQ ID NO:4) (claim 23). The reference claims recite all the required limitations of the above instant claims.
PNG
media_image7.png
126
527
media_image7.png
Greyscale
The copending application claims a variant Cas12i2 polypeptide of SEQ ID NO:7 (SEQ ID NO:7 is 100% identical to instant SEQ ID NO:496, see alignment below) (claim 23).
PNG
media_image8.png
103
527
media_image8.png
Greyscale
The copending application further claims a direct repeat sequence of SEQ ID NO:10 (SEQ ID NO:10 comprises a sequence 100% identical to instant SEQ ID NO:492, see alignment below) (claim 12).
PNG
media_image9.png
98
529
media_image9.png
Greyscale
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
18/251183:
Claims 1, 3-5, 8-9, 11, 13, 16-18, 35, 164, 233, 235-239, 409-418 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1,4-6, 8, 10, 12, 14, 17-18, 20-21, 42-45, 47-48 of copending Application No. 18/251183 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the scope of the reference claims is narrower (the reference application specifies specific spacer sequences and target nucleic acids); however, the scope of the instant claims fully encompasses the scope of the reference claims. The copending application claims a variant Cas12i2 polypeptide of SEQ ID NO:2642 (copending SEQ ID NO:2642 is 100% identical to instant SEQ ID NO:4, see alignment below) (claim 18).
PNG
media_image10.png
98
526
media_image10.png
Greyscale
The copending application further claims a variant Cas12i2 polypeptide of SEQ ID NO:2645 (SEQ ID NO:2645 is 100% identical to instant SEQ ID NO:496, see alignment below) (claim 18).
PNG
media_image11.png
101
527
media_image11.png
Greyscale
The copending application further claims a direct repeat sequence of SEQ ID NO:10 (SEQ ID NO:10 is 100% identical to instant SEQ ID NO:492, see alignment below) (claim 6).
PNG
media_image12.png
105
524
media_image12.png
Greyscale
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
18/262086:
Claims 1, 3-5, 8, 14, 16-18, 35, 164, 233, 235-239, 409-411, 414-418 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 14, 39, 45, 50-54, 56-65 of copending Application No. 18/262086 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the recited changes in protein activity of instant claim 35 is interpreted to be inherent qualities of the variant Cas12i2 polypeptides recited by both the instant and reference applications. The copending application claims a Cas12i2 of SEQ ID NO:40 (copending SEQ ID NO:40 is 100% identical to instant SEQ ID NO:4, see alignment below) (claims 14, 51-52).
PNG
media_image13.png
98
530
media_image13.png
Greyscale
The copending application further claims a variant Cas12i2 of SEQ ID NO:42 (SEQ ID NO:42 is 100% identical to instant SEQ ID NO:495, see alignment below) (claims 14, 53).
PNG
media_image14.png
103
529
media_image14.png
Greyscale
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
18/565575:
Claims 1, 3-5, 8-9, 11, 13-14, 16-18, 35, 164, 233, 235-239, 409-418 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9, 12-27, 47-49, 52, 56 of copending Application No. 18/565575 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the recited changes in protein activity of instant claim 35 is interpreted to be inherent qualities of the variant Cas12i2 polypeptides recited by both the instant and reference applications. Furthermore, the scope of the reference claims is narrower than the scope of the instant claims, while still being encompassed by the scope of the instant claims, or having such overlap that they are patentably indistinct. The copending application claims a variant Cas12i2 polypeptide of SEQ ID NO:924 (claim 5) (SEQ ID NO:924 is 100% identical to instant SEQ ID NO:4, see alignment below).
PNG
media_image15.png
103
522
media_image15.png
Greyscale
The copending application further claims a variant Cas12i2 polypeptide of SEQ ID NO:927 (SEQ ID NO:927 is 100% identical to instant SEQ ID NO:496, see alignment below) (claim 5).
PNG
media_image16.png
100
531
media_image16.png
Greyscale
The copending application further claims a direct repeat sequence of SEQ ID NO:10 (SEQ ID NO:10 is 100% identical to instant SEQ ID NO:492, see alignment below).
PNG
media_image17.png
98
525
media_image17.png
Greyscale
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
18/565148:
Claims 1, 3-5, 8-9, 11, 13-14, 16-18, 35, 164, 233, 235-239, 409-418 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13, 21, 23-30, 49, 58, 62-64, 66, 70, 72, 83-88 of copending Application No. 18/565148 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the recited changes in protein activity of instant claim 35 is interpreted to be inherent qualities of the variant Cas12i2 polypeptides recited by both the instant and reference applications. Furthermore, the scope of the reference claims is narrower than the scope of the instant claims, while still being encompassed by the scope of the instant claims, or having such overlap that they are patentably indistinct. The copending application claims a variant Cas12i2 polypeptide of SEQ ID NO:4 (claim 8) (SEQ ID NO:4 is 100% identical to instant SEQ ID NO:4, see alignment below).
PNG
media_image18.png
98
522
media_image18.png
Greyscale
The copending application claims a variant Cas12i2 polypeptide of SEQ ID NO:7 (claim 8) (SEQ ID NO:7 is 100% identical to instant SEQ ID NO:496, see alignment below).
PNG
media_image19.png
98
530
media_image19.png
Greyscale
The copending application further claims a direct repeat sequence of SEQ ID NO:15 (SEQ ID NO:15 is 100% identical to instant SEQ ID NO:492, see alignment below) (claim 27).
PNG
media_image20.png
103
524
media_image20.png
Greyscale
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
18/565567:
Claims 1, 3-5, 8-9, 11, 13, 16-18, 35, 164, 233, 235-239, 409-418 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 13-15, 17-18, 30, 33, 60, 62-64, 72 of copending Application No. 18/565567 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the recited changes in protein activity of instant claim 35 is interpreted to be inherent qualities of the variant Cas12i2 polypeptides recited by both the instant and reference applications. Furthermore, the scope of the reference claims is narrower than the scope of the instant claims, while still being encompassed by the scope of the instant claims, or having such overlap that they are patentably indistinct. The copending application claims a Cas12i2 variant polypeptide of SEQ ID NO:224 (SEQ ID NO:224 is 100% identical to instant SEQ ID NO:4, see alignment below) (claim 5).
PNG
media_image21.png
99
528
media_image21.png
Greyscale
The copending application further claims a variant Cas12i2 polypeptide of SEQ ID NO:227 (SEQ ID NO:227 is 100% identical to instant SEQ ID NO:496, see alignment below) (claim 5).
PNG
media_image22.png
107
526
media_image22.png
Greyscale
The copending application further claims a direct repeat sequence of SEQ ID NO:10 (SEQ ID NO:10 is 100% identical to instant SEQ ID NO:492, see alignment below).
PNG
media_image23.png
99
526
media_image23.png
Greyscale
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
18/688176:
Claims 1, 3-5, 17-18, 233, 235-238, 411, 414-415, 418 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 7, 24, 32, 57 of copending Application No. 18/688176 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the scope of the reference claims is narrower than that of the instant claims (the reference claims recite specific types of cells and methods of using the variant Cas12i2 polypeptides to make these specific modified cells). However, the recited limitations of the reference claims are fully encompassed by the recited limitations of the instant claims. The copending application claims a variant Cas12i2 polypeptide of SEQ ID NO:224 (claim 5) (SEQ ID NO:224 is 100% identical to instant SEQ ID NO:4, see alignment below). The copending application further claims that the variant Cas12i2 polypeptide comprises one or more amino acid residue substitutions selected from D581R, G624R, F626R, P868T, I926R, V1030G, E1035R, and S1046G (claims 3-4).
PNG
media_image24.png
99
524
media_image24.png
Greyscale
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
18/442529:
Claims 1, 3-5, 8, 11, 17-18, 35, 164, 233, 235-239, 409-411, 413-418 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12, 15, 28-33, 36 of copending Application No. 18/442529 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the recited changes in protein activity of instant claim 35 is interpreted to be inherent qualities of the variant Cas12i2 polypeptides recited by both the instant and reference applications. Furthermore, the scope of the reference claims is narrower than the scope of the instant claims, while still being encompassed by the scope of the instant claims, or having such overlap that they are patentably indistinct. The copending application claims a variant Cas12i2 polypeptide of SEQ ID NO:3 (SEQ ID NO:3 is 100% identical to instant SEQ ID NO:4, see alignment below).
PNG
media_image25.png
99
528
media_image25.png
Greyscale
The copending application further claims a variant Cas12i2 polypeptide of SEQ ID NO:266 (SEQ ID NO:266 is 100% identical to instant SEQ ID NO:496, see alignment below).
PNG
media_image26.png
104
529
media_image26.png
Greyscale
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
18/682643:
Claims 1, 3-5, 8-9, 11, 13, 16-18, 35, 164, 233, 235-239, 409-418 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 11-18, 20-21, 23, 26, 45-47, 54 of copending Application No. 18/682643 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the recited changes in protein activity of instant claim 35 is interpreted to be inherent qualities of the variant Cas12i2 polypeptides recited by both the instant and reference applications. Furthermore, the scope of the reference claims is narrower than the scope of the instant claims (the reference claims recite specific target sequences and a more limited set of variant Cas12i2 polypeptides), while still being encompassed by the scope of the instant claims, or having such overlap that they are patentably indistinct. The copending application claims a variant Cas12i2 polypeptide of SEQ ID NO:452 (SEQ ID NO:452 is 99.5% identical to instant SEQ ID NO:4 and comprises the amino acid residue substitutions D581R, I926R, and V1030G, see alignment below) (claim 5).
PNG
media_image27.png
101
531
media_image27.png
Greyscale
The copending application further claims a variant Cas12i2 polypeptide of SEQ ID NO:453 (SEQ ID NO:453 is 100% identical to instant SEQ ID NO:496, see alignment below).
PNG
media_image28.png
99
529
media_image28.png
Greyscale
The copending application further claims a direct repeat sequence of SEQ ID NO:10 (SEQ ID NO:10, as described in copending claim 17, is 100% identical to instant SEQ ID NO:492, see alignment below).
PNG
media_image29.png
99
527
media_image29.png
Greyscale
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
17/832038:
Claims 1, 3-5, 8-9, 11, 13, 16-18, 35, 164, 233, 235-239, 409-418 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 13, 17-19, 22, 25, 27, 47-49, 56 of copending Application No. 17/832038 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the recited changes in protein activity of instant claim 35 is interpreted to be inherent qualities of the variant Cas12i2 polypeptides recited by both the instant and reference applications. Furthermore, the scope of the reference claims is narrower than that of the instant claims (the reference recites specific target sequences), while still being fully encompassed by the scope of the instant claims. The copending application claims a variant Cas12i2 polypeptide of SEQ ID NO:924 (SEQ ID NO:924 is 100% identical to instant SEQ ID NO:4, see alignment below) (claim 5).
PNG
media_image30.png
100
526
media_image30.png
Greyscale
The copending application further claims a variant Cas12i2 polypeptide of SEQ ID NO:927 (SEQ ID NO:927 is 100% identical to instant SEQ ID NO:496, see alignment below).
PNG
media_image31.png
98
528
media_image31.png
Greyscale
The copending application further claims a direct repeat sequence of SEQ ID NO:10 (SEQ ID NO:10 is 100% identical to SEQ ID NO:492, see alignment below).
PNG
media_image32.png
109
528
media_image32.png
Greyscale
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
17/832114:
Claims 1, 3-5, 8-9, 11, 13, 16-18, 35, 164, 233, 235-239, 409-418 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 13, 17-18, 21-22, 25, 27, 47-49, 56 of copending Application No. 17/832114 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the recited changes in protein activity of instant claim 35 is interpreted to be inherent qualities of the variant Cas12i2 polypeptides recited by both the instant and reference applications. Furthermore, the scope of the reference claims is narrower than that of the instant claims (the reference recites specific target sequences), while still being fully encompassed by the scope of the instant claims. The copending application claims a variant Cas12i2 polypeptide of SEQ ID NO:1168 (SEQ ID NO:1168 is 100% identical to instant SEQ ID NO:4, see alignment below) (claim 5).
PNG
media_image30.png
100
526
media_image30.png
Greyscale
The copending application further claims a variant Cas12i2 polypeptide of SEQ ID NO:1171 (SEQ ID NO:1171 is 100% identical to instant SEQ ID NO:496, see alignment below) (claim 5).
PNG
media_image33.png
101
527
media_image33.png
Greyscale
The copending application further claims a direct repeat sequence of SEQ ID NO:10 (SEQ ID NO:10 is 100% identical to instant SEQ ID NO:492, see alignment below).
PNG
media_image34.png
98
530
media_image34.png
Greyscale
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
17/830212:
Claims 1, 3-5, 8-9, 11, 13-14, 16-18, 35, 164, 233, 235-239, 409-418 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7, 13, 21, 25, 28, 33-35, 46, 49, 57, 62-64, 67, 70, 89-90 of copending Application No. 17/830212 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the recited changes in protein activity of instant claim 35 is interpreted to be inherent qualities of the variant Cas12i2 polypeptides recited by both the instant and reference applications. Furthermore, the scope of the reference claims is narrower than that of the instant claims (the reference recites specific target sequences), while still being fully encompassed by the scope of the instant claims. The copending application claims a variant Cas12i2 polypeptide of SEQ ID NO:4 (SEQ ID NO:4 is 100% identical to instant SEQ ID NO:4, see alignment below) (claim 89).
PNG
media_image35.png
107
526
media_image35.png
Greyscale
The copending application further claims a variant Cas12i2 polypeptide of SEQ ID NO:7 (SEQ ID NO:7 is 100% identical to instant SEQ ID NO:496, see alignment below) (claim 89).
PNG
media_image36.png
103
527
media_image36.png
Greyscale
The copending application further claims a direct repeat sequence of SEQ ID NO:15 (SEQ ID NO:15 is 100% identical to instant SEQ ID NO:492, see alignment below) (claim 28).
PNG
media_image37.png
103
528
media_image37.png
Greyscale
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
17/931027:
Claims 1, 3-5, 8, 11, 13-14, 17-18, 35, 164, 235-239, 409-418 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 118, 20, 30-35, 47-49, 51-58 of copending Application No. 17/931027 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the recited changes in protein activity of instant claim 35 is interpreted to be inherent qualities of the variant Cas12i2 polypeptides recited by both the instant and reference applications. Furthermore, the scope of the reference claims, while having sufficient overlap with the scope of the instant claims to not be patentably distinct, differs from that of the instant claims. In particular, the reference application recites variant Cas12i2 fusion proteins that are nuclease-dead or nuclease-deficient, while the instant claims do not require this limitation. The copending application claims a variant Cas12i2 comprising amino acid alterations relative to SEQ ID NO:2 (SEQ ID NO:2 is 99.6% identical to instant SEQ ID NO:4, see below), the alterations comprising D581R, I926R, V1030G, S1046G, G624R, F626R, E1035R, or P868T (claims 1, 10-14, 59).
PNG
media_image38.png
106
529
media_image38.png
Greyscale
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed 12/22/2025 have been fully considered but they are not persuasive.
Applicant has also argued that the provisional double patenting rejections over copending applications with later filing dates should be withdrawn if these provisional rejections are the only rejections remaining in the application. As the application is not in condition for allowance due to the pending nonstatutory double patenting rejections above, these provisional rejections are maintained.
Limitations Not Found in the Prior Art
Amino acid residue substitutions of D581, I926, or V1030 in the polypeptide sequence of Cas12i2, relative to SEQ ID NO:2, are not found in the art published or effectively filed prior to the effective filing date of the pending claims (03/31/2020).
Conclusion
THIS ACTION IS MADE FINAL. 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AFRICA M MCLEOD whose telephone number is (703)756-1907. The examiner can normally be reached Mon-Fri 9:00AM-6:00PM EST.
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, Ram Shukla can be reached on (571) 272-0735. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
For those applications where applicant wishes to communicate with the examiner via Internet communications, e.g., email or video conferencing tools, the following is a sample authorization form which may be used by applicant:
"Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file."
To facilitate processing of the internet communication authorization or withdraw of authorization, the Office strongly encourages use of Form PTO/SB/439, available at www.uspto.gov/patent/patents-forms. The form may be filed via EFS-Web using the document description Internet Communications Authorized or Internet Communications Authorization Withdrawn to facilitate processing. See MPEP 502.03(II).
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.
/AFRICA M MCLEOD/ Examiner, Art Unit 1635
/KIMBERLY CHONG/ Primary Examiner, Art Unit 1636
Prosecution Insights