DETAILED ACTION
Status of Application
The amendments and response filed 16 December 2026 are acknowledged and have been considered in their entireties. Claims 1-2, 7, 13-14, 16-18, 24, 28-29, 31-35, 37-42, 49-50, 54, 57, 61, 67-68, 71-73, 75-76, 79-80 and 82-83 remain pending; Claims 34-35, 37-42, 49-50, 54, 57, 61, 67-68, 71-73, 75-76, 79-80 and 82-83 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected subject matter, there being no allowable generic or linking claim. Thus, claims 1-2, 7, 13-14, 16-18, 24, 28-29 and 31-33 remain subject to examination on the merits.
Information Disclosure Statement
The information disclosure statement (IDS) submitted 26 September 2026 has considered by the examiner. See initialed and signed PTO/SB/08.
Withdrawal of Previous Objections/Rejections
The objection to claims 1 and 18 for having extraneous periods is withdrawn in view of the amendments to remove them.
The objection to the specification or drawings for lack of sequence identifiers for Figure 6 is withdrawn in view of the submission of the new sequence listing and updated Figure 6 with appropriate sequence identifiers.
The rejection of claims 1-2, 7, 13-14, 16-18, 24, 28 and 31-33 under 35 U.S.C. 101 is with withdrawn in view of the amendments to claims 1 and 14 requiring heterologous guide molecules.
The rejection of claims 1-2, 7, 13, 17-18, 28, 31-33 under 35 U.S.C. 102(a)(2) as being anticipated by Sternberg & Klompe (US 20200283769, with an effectively filed date of 07 March 2019 – cited previously) is withdrawn in view of the amendments which stipulate the Tn7 transposases and/or Type I-B CRISPR Cas proteins are from, or originated from, Anabaena variabilis.
The rejection of claim(s) 1-2, 7, 13-14, 17-18, 28-29, 31-32 under 35 U.S.C. 102(a)(2) as being anticipated by Zhang et al. (US20200190487 – cited previously) is withdrawn in view of the 35 U.S.C. 102(b)(2)(C) statement made on p. 18.
The provisional rejection of claim 1 under 35 U.S.C. 101, statutory double patenting, for claiming the same invention as that of claim 1 of copending Application No. 18269813 (reference application) is withdrawn in view of the amendments made to the instant claims.
Maintained Rejections
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.
Claim(s) 14 is rejected under 35 U.S.C. 102(a)(2) as being anticipated by Sternberg & Klompe (US 20200283769, with an effectively filed date of 07 March 2019 – cited herein).
Sternberg & Klompe teach:
Regarding claims 14 an engineered system comprising one or more Tn7 transposase selected from TnsA, TnsB, TnsC, and, TnsD and/or TniQ; and comprising one or more Type I-B Cas proteins comprising at least one of Cas5, Cas6, Cas7, Cas8, in a RNA guided system including a heterologous gRNA (See paragraph 0025, 0027-0028; 0035, 0037-0038, 0065, 0080); and said system comprises a donor polynucleotide (DNA) to be integrated (See paragraph 0030-0031, 0035; 0147-0156). With regard to the term “engineered”, as noted in the instant specification this is to mean that the polypeptide is at least substantially free from at least one other component to which they are naturally associated with in nature (paragraph 0362 of instant PG-Pub). The Cas proteins as described Sternberg & Klompe minimally meet this definition.
Applicant’s Response and Examiner’s Rebuttal:
Applicant’s contend the rejection of record is overcome because the CAST system comprises a Cas8b protein selected from Cas8b1, Cas8b2 and Cas8b3 – See Remarks, p. 17.
The Examiner acknowledges this argument but does not find it convincing given a Cas8b is not required because the claim stipulates “a Type I-B CRISPR Cas Cascade complex comprising one or more engineered Type I-B CRISPR Cas5, Cas6, Cas7 and Cas8b, wherein the Cas8b protein is selected from the group consisting of Cas8b1, Cas8b2 and Cas8b3”. As such, given the claim construction, a Cas8b protein is not required to be present in the system. Minimally, one or Cas5, Cas6, Cas7 OR Cas8b is required. As such, Sternberg & Klompe still anticipate claim 14.
Non-Statutory 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 1-2, 7, 13-14, 16-18, 24, 28-29 and 31-33 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2, 5-7, 10, 13-15, 19, 25, 29, 34-36, 41-42, 45, 48, 50-51, 67-69, 71, 74, 77, 83-85 of copending Application No. 18269813 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘812 application anticipate and/or render obvious the instant claims.
The instant claims in their broadest are noted above, e.g. An engineered system, the system comprising: a. one or more CRISPR-associated Tn7 transposases; b. one or more Type I-B Cas proteins; and c. a guide molecule capable of complexing with the Type I-B Cas protein and directing binding of the guide-Cas protein complex to a target polynucleotide. Dependent claim 2 recites wherein the one or more Tn7 transposases comprise TnsA, TnsB, TnsC and/or TnsQ, with optional combinations thereof; dependent claim 7 recites wherein the one or more Tn7 transposases is TnsA, TnsB, TnsC and/or TnsD, with optional combinations thereof. Dependent claims 13-14 recite the Tupe I-B Cas protein is Cas5, Cas6, Cas7 and/or Cas8; and wherein the Type I-B Cas protein comprises Cas8b, optionally Cas8b3.
The claims to the ‘813 application in their broadest are noted above, e.g. An engineered system, the system comprising: a. one or more CRISPR-associated Tn7 transposases; b. one or more Type I-B Cas proteins; and c. a guide molecule capable of complexing with the one or more Type I-B Cas protein and directing binding of the guide-Cas protein complex to a target polynucleotide. Dependent claim 2 recites wherein the one or more Tn7 transposases comprise The system of claim 1, wherein the one or more CRiISPR- associated Tn7 transposase polypeptides comprise TnsA, TnsB, and TnsC, TnsA, TnsB, TnsC, and a TniQ; or TnsA, TnsB, TnsC, a first TniQ and a second TniQ, wherein the first and second TniQ are different; dependent claim 7 recites wherein the one or more Tn7 transposases is TnsA, TnsB, TnsC; TnsA, TnsB, TnsC and a TnsD; or TnsA, TnsB, TnsC, a first TnsD and a second TnsD wherein the first and second TnsD are different. Dependent claims 13-14 recite the Tupe I-B Cas protein is Cas5, Cas6, Cas7 and/or Cas8; and wherein the Type I-B Cas protein comprises Cas8b, optionally Cas8b3. Additional claims are drawn to polynucleotides encoding the same, vectors comprising the same, cells comprising the same and methods for inserting a donor polynucleotide using the system.
Thus, the claims of the ‘813 application overlap in scope to such an extent to anticipate the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1-2, 7, 13-14, 16-18, 24, 28-29 and 31-33 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-2, 4, 8, 19, 22, 26-27, 30-33, 37, 39, 41-42, 44-45 of copending Application No. 19043619 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘619 application anticipate the instant claims.
The instant claims in their broadest are noted above, e.g. An engineered system, the system comprising: a. one or more CRISPR-associated Tn7 transposases; b. one or more Type I-B Cas proteins; and c. a guide molecule capable of complexing with the Type I-B Cas protein and directing binding of the guide-Cas protein complex to a target polynucleotide. Dependent claim 2 recites wherein the one or more Tn7 transposases comprise TnsA, TnsB, TnsC and/or TnsQ, with optional combinations thereof; dependent claim 7 recites wherein the one or more Tn7 transposases is TnsA, TnsB, TnsC and/or TnsD, with optional combinations thereof. Dependent claims 13-14 recite the Type I-B Cas protein is Cas5, Cas6, Cas7 and/or Cas8; and wherein the Type I-B Cas protein comprises Cas8b, optionally Cas8b3.
The claims to the ‘619 application in their broadest are drawn to: An engineered system, the system comprising: a. one or more CRISPR-associated Tn7 transposases or functional fragments thereof; b. one or more Type I-B Cas proteins or functional fragments thereof; and c. a guide molecule capable of forming a complex with the Type I-B Cas protein and directing binding of the guide molecule-Cas protein complex to a target polynucleotide, wherein the system is capable of reproducible insertions. Dependent claim 8 recites wherein the Type I-B cas protein is IB-43, and/or the Tn7 transposase polypeptides comprise TnsA, TnsB, TnsC and/or TnsQ; and or the Type I-B Cas protein is Cas5, Cas6, Cas7, Cas8, Cas11 and/or combinations thereof, and/or additional elements.
Thus, the scope of the ‘619 claims and their combination necessarily anticipate the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Applicant’s Response and Examiner’s Rebuttal:
Applicant’s acknowledge the instant rejection and ask that they ultimately be held in abeyance until such time that that allowable subject matter is identified.
This is acknowledged, however, given at least one rejection remains for at least one claim then rejections are maintained.
Conclusion
No claim is allowed.
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 SUZANNE M NOAKES whose telephone number is (571)272-2924. The examiner can normally be reached M-F (7-4).
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/SUZANNE M NOAKES/Primary Examiner, Art Unit 1656 06 April 2026