CTNF 18/269,813 CTNF 80605 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia 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 08-25 AIA Applicant's election with traverse of Group I, claims 1, 2, 5-7, 10, 13-15, 19, 21, 25 and 29 in the reply filed on 3/13/2026 is acknowledged. The traversal is on the ground(s) that the cited references do not support the Examiner's position that the claimed combination lacks a special technical feature. Petassi et al. discusses Type I-F3 Tn7-CRISPR-Cas systems, not Type I-B systems. The abstract explicitly states that Tn7-like elements "adapted a specific subtype of CRISPR-Cas systems in the type I-F group for guide RNA- directed transposition," and the entire paper focuses on Type I-F3a and I-F3b systems with their associated cascade proteins (Cas8, Cas5, Cas7, Cas6 of the I-F type). Liu et al. mentions Type I-B systems only in passing, noting: "Type I CRISPR/Cas systems include seven subtypes, I-A to I-F and I-U. Cas8a, Cas8b, and Cas8c are signature proteins of the I-A, I-B, and I-C systems, respectively" (page 9). Liu provides no teaching or suggestion of combining Type I-B Cas proteins with Tn7-CRISPR-Cas elements. Applicant's claimed invention-comprising one or more Tn7 transposase polypeptides and one or more Type I-B Cas proteins-represents a novel combination that constitutes a special technical feature distinguishing all claim groups from the prior art . This is not found persuasive because the claimed invention only requires a Tn7 transposase, a Type I-B Cas protein and a guide molecule. The Cas5, Cas6 and Cas7 taught by Petassie are all Type I-B Cas proteins (see instant claim 13) and can be combined with a Tn7 transposase and thus is a sufficient teaching, in combination with Liu, to break unity of invention . The requirement is still deemed proper and is therefore made FINAL. 08-05 AIA Claim s 34-36, 41, 42, 45, 48, 50, 51, 54-58, 62, 66-69, 71, 74, 77 and 83-85 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention , there being no allowable generic or linking claim.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 timely traversed the restriction (election) requirement in the reply filed on 3/13/2026 . Claim Objections 07-29-01 AIA Claim 1 is objected to because of the following informalities: claim 1 recites for example steps “a.” and “b.”. However, as set forth in MPEP 608.01(m), periods may not be used elsewhere in the claims except for abbreviations. It is suggested that “a.” be replaced with “(a)”, for example . Appropriate correction is required. 07-29-01 AIA Claim 10 is objected to because of the following informalities: claim 10 recites for example steps “a.” and “b.”. However, as set forth in MPEP 608.01(m), periods may not be used elsewhere in the claims except for abbreviations. It is suggested that “a.” be replaced with “(a)”, for example . Appropriate correction is required. 07-29-01 AIA Claim 19 is objected to because of the following informalities: claim 19 recites for example steps “a.” and “b.”. However, as set forth in MPEP 608.01(m), periods may not be used elsewhere in the claims except for abbreviations. It is suggested that “a.” be replaced with “(a)”, for example . Appropriate correction is required. Double Patenting 08-33 AIA 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. 08-35 Claim s 1, 2, 5-7, 10, 13-15, 19, 21, 25 and 29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1, 2, 7, 13, 14, 16-18, 24, 28, 29, 31-33 of copending Application No. 17/773,104 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the engineered system of ‘104 encompasses the same structural and functional limitations, Tn7 transposase, Type I-B Cas and species A. variabilis as the instantly claimed engineered system . This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. 08-35 Claim s 1, 2, 5-7, 10, 13-15, 19, 21, 25 and 29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1, 2, 4, 6, 8, 19, 22, 26, 27, 30 and 31 of copending Application No. 19/043,619 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the engineered system of ‘618 encompasses the same structural and functional limitations, Tn7 transposase, Type I-B Cas and donor polynucleotide as the instantly claimed engineered system . This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Claim Rejections - 35 USC § 102 07-06 AIA 15-10-15 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. 07-07-aia AIA 07-07 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 – 07-12-aia AIA (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. 07-15-03-aia AIA Claim(s) 1, 2, 5-7, 10, 13, 14, 19, 21, 25 and 29 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Zhang et al. (WO 2020/131862 A1, filed 12/17/2019) . 07-15-02-aia The applied reference has a common applicant with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. Regarding claims 1, 13 and 14, Zhang et al. teach an engineered system comprising: one or more CRISPR-associated Tn7 transposase polypeptides, one or more Type I-B Cas proteins (such as Cas5, Cas6, Cas7 or Cas8) a guide molecule capable of complexing with one or more Type I-B Cas protein and directing binding to a target polynucleotide (see parags. 4, 9, 158, 160 and 310). Regarding claims 2 and 7, Zhang teaches that Tn7 transposase polypeptides TnsA, TsnB and TsnC. Additionally, Zhang teaches that that there can be multiple combinations of transposase polypeptides and that TniQ is also known as TnsD (parags. 132 and 1066). Regarding claims 5, 6 and 10, Zhang teaches that the TniQ comprises a DNA-binding domain at the C-terminus of TniQ (paras. 20-22, 127 and 258). Regarding claim 19, Zhang teaches that the donor polynucleotides comprising a polynucleotide insert, a left element sequence and a right element sequence (parag. 1076). Regarding claim 21, Zhang teaches that the one or more mutations comprises substitutions, deletions, insertions, or a combination thereof (parag. 1078). Regarding claim 25, Zhang teaches that the PAM is AT or ATG (Fig. 49A). Regarding claim 29, Zhang teaches that the Tn7 transposase polypeptides can be derived from one species and the Type I-B Cas proteins is derived from a second different species (Table 1 and parag. 1203). Thus the teachings of Zhang clearly anticipate the invention of claims 1, 2, 5-7, 10, 13, 14, 19, 21, 25 and 29. Claim Rejections - 35 USC § 103 07-06 AIA 15-10-15 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. 07-20-aia AIA 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. 07-21-02-aia AIA Claim s 1, 14 and 15 is/are rejected under 35 U.S.C. 103 as being obvious over Zhang et al. (WO 2020/131862 A1, filed 12/17/2019) in view of Makarova et al. (2015, Nat. Rev. Microbiol., Vol. 13(11), pgs. 722-736) . The applied reference has a common applicant with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02. Regarding claims 1 and 14, Zhang et al. teach an engineered system comprising: one or more CRISPR-associated Tn7 transposase polypeptides, one or more Type I-B Cas proteins (such as Cas5, Cas6, Cas7 or Cas8b) a guide molecule capable of complexing with one or more Type I-B Cas protein and directing binding to a target polynucleotide (see parags. 4, 9, 158, 160 and 310). Zhang does not teach: Cas8b3. Regarding Cas8b3, Makarova et al. teach that Cas8b3 is one of the subtypes of Type I-B (pg. 8 last parag. bridge pg. 9 lines 1-4). Thus at the time of filing that ordinary artisan would have found it prima facie obvious to modify the teachings of Zhang regarding Cas8b with the teaching so Makarova regarding Cas8b3 to arrive at the claimed invention. One of ordinary skill in the art would have been motivated to make such a combination since Zhang teaches that a variety of Cas’s can be used in their system including Cas8b. The ordinary artisan would find the routine substation of a Cas8b subtype such as Cas8b3 obvious since different targets require different Cas proteins. There would have been a reasonable expectation of success that the Cas8b3 of Makarova could be substituted for the Cas8b of Zhang since Makarova teaches that Cas8b3 is a subspecies of Cas8b. Thus the cited art provides the requisite teachings and motivations to make and use the invention as claimed. Conclusion No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID A MONTANARI whose telephone number is (571)272-3108. The examiner can normally be reached M-Tr 8-6. 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, Peter Paras can be reached at 571-272-4517. 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. /DAVID A MONTANARI/Examiner, Art Unit 1632 Application/Control Number: 18/269,813 Page 2 Art Unit: 1632 Application/Control Number: 18/269,813 Page 3 Art Unit: 1632 Application/Control Number: 18/269,813 Page 4 Art Unit: 1632 Application/Control Number: 18/269,813 Page 5 Art Unit: 1632 Application/Control Number: 18/269,813 Page 6 Art Unit: 1632 Application/Control Number: 18/269,813 Page 7 Art Unit: 1632 Application/Control Number: 18/269,813 Page 8 Art Unit: 1632 Application/Control Number: 18/269,813 Page 9 Art Unit: 1632 Application/Control Number: 18/269,813 Page 10 Art Unit: 1632
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