DETAILED CORRESPONDENCE
Application Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Applicants’ amendment to the claims filed on 03/19/2026 is acknowledged. This listing of claims replaces all prior listings of claims in the application.
3. Claims 1-5, 7-30, and 34-41 are pending.
Election/Restrictions
4. Applicant’s election of Group I, claims 1-5 and 7-23 in the reply filed on 03/19/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
5. Claims 24-30 and 34-41 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/19/2026.
Claims 1-5 and 7-23 are pending and examined on the merits.
Priority
6. Acknowledgement is made of applicants’ claimed domestic priority to U.S. Provisional Application No. 63/134,857, filed on 01/07/2021.
Information Disclosure Statement
7. The IDSs filed on 07/04/2023, 01/19/2024, and 10/21/2024 have been considered by the examiner and copies of the Form PTO/SB/08 are attached to the office action.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency – Nucleotide and/or amino acid sequences appearing in the drawings are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). Sequence identifiers for nucleotide and/or amino acid sequences must appear either in the drawings or in the Brief Description of the Drawings. See Figure 1.
Required response – Applicant must provide:
Replacement and annotated drawings in accordance with 37 CFR 1.121(d) inserting the required sequence identifiers;
AND/OR
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers into the Brief Description of the Drawings, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Specification
8. The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
In the instant case, paragraphs 0387, 0534 and 0574 contain embedded hyperlinks.
Claim Rejections - 35 USC § 112(b)
9. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
10. Claims 5 and 7 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 5, there is insufficient antecedent basis for the limitations “DNA-binding polypeptide”.
Regarding claim 7, the reference to Tables 1-6 is indefinite. MPEP 2173.05(s) states that “[w]here possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicants’ convenience. Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993)”.
Claim Rejections - 35 USC § 101
11. 35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
12. Claims 1-5 and 7-23 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. The claim(s) recite(s) an engineered composition comprising: a programmable DNA-binding protein and two or more Tn7-like transposition proteins, wherein at least one of the Tn7-like transposition proteins is connected to the DNA-binding protein or otherwise capable of forming a complex with the DNA-binding protein. This judicial exception is not integrated into a practical application because the claims are drawn to what already exists in nature. Saito et al. (Cell, 2021; cited on IDS filed on 01/19/2024) teach that cyanbacteria, such as Anabaena variabilis possess naturally occurring systems comprising one or more CRISPR TN7 transposases (TnsA, TnsB, TnsC, TniQ, and TnsD), along with Type I-B Cas proteins (Cas6, Cas8, Cas7, Cas5) [see Figure 3], wherein said transposon system is directed to targets via gRNA/crRNA [see p. 2444, column 2 to p. 2445, column 1], wherein the gRNA targeting can be in the donor cell and is directed by crRNA [see Figure 7]. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the recitation of the term “engineered” cannot distinguish that which is naturally occurring from one that is synthetically engineered. As such, the claims are not patent eligible under 35 U.S.C. 101.
Claim Rejections - 35 USC § 102
13. 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.
14. Claim(s) 1-5 and 7-23 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Zhang et al. (US Patent Application Publication 2020/0190487 A1; cited on IDS filed on 07/04/2023).
The applied reference has a common inventor 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.
15. Claims 1-5 and 7-23 are drawn to an engineered composition comprising: a programmable DNA-binding protein and two or more Tn7-like transposition proteins, wherein at least one of the Tn7-like transposition proteins is connected to the DNA-binding protein or otherwise capable of forming a complex with the DNA-binding protein.
16. With respect to claim 1, Zhang et al. teach an engineered composition comprising a programmable DNA-binding protein (CRISPR) and two or more Tn7-like transposition proteins, wherein at least one of the Tn7-like transposition proteins is connected to the DNA-binding protein or otherwise capable of forming a complex with the DNA-binding protein [see Abstract; Figure 18 and 46; paragraphs 0008-0009].
With respect to claim 2, Zhang et al. teach the composition wherein at least one of the Tn7-like transposition proteins is connected to an N-terminus or C-terminus of the DNA binding protein [see paragraph 0332].
With respect to claim 3, Zhang et al. teach the composition wherein the two or more Tn7-like transposition proteins are derived from CRISPR-associated Tn7-like transposition proteins [see paragraph 0009].
With respect to claim 4, Zhang et al. teach the composition wherein the CRISPR-associated Tn7-like transpositions comprises at least a Cas-12k associated transposase [see paragraph 0011].
With respect to claim 5, Zhang et al. teach the composition wherein the two or more Tn7-like transposition proteins consist of TnsB, TnsC, and TniQ, wherein TniQ is connected to the DNA-binding polypeptide and TnsC is connected to the DNA-binding polypeptide [see paragraphs 0009; 0013-0021].
With respect to claim 7, Zhang et al. teach the composition wherein the TnsB, TnsC, and TniQ are proteins that fall in Tables 1-6 [see paragraph 0009; Tables 28 and 29].
With respect to claim 8, Zhang et al. teach the composition wherein the programmable DNA-binding protein is a Zinc finger protein, meganuclease, a Cas protein, or a complex of Cas proteins [see paragraphs 0126 and 0528].
With respect to claim 9, Zhang et al. teach the composition wherein the DNA-binding protein is a Cas protein other than a Cas12k protein and the composition further comprises a guide molecule capable of forming a complex with the Cas protein and directing site specific binding of the complex to a target sequence in a target polypeptide [see paragraphs 0008-0011].
With respect to claim 10, Zhang et al. teach the composition wherein the Cas protein is a Type II or Type V Cas protein or a complex of Cas protein complexes [see paragraphs 0011-0020].
With respect to claim 11, Zhang et al. teach the composition wherein the Cas protein is a catalytically inactive Cas9 or a nickase [see paragraphs 0012 and 0158].
With respect to claim 12, Zhang et al. teach the composition wherein the dCas9 is fused to one, two or three or more TniQ [see paragraphs 0009 and 0332].
With respect to claim 13, Zhang et al. teach the composition wherein the Cas protein is a catalytically inactive Cas12, dCas12 [see paragraph 0012].
With respect to claim 14, Zhang et al. teach the composition wherein the dCas12 is a dCas12b or dCas12a [see paragraph 0012].
With respect to claim 15, Zhang et al. teach the composition wherein the Tn7-like transposition proteins consist of TnsC or TniQ [see paragraphs 0009-0020].
With respect to claim 16, Zhang et al. teach the composition further comprising a donor polynucleotide comprising a donor sequence for insertion into a target polynucleotide [see paragraphs 0008-0020].
With respect to claim 17, Zhang et al. teach the composition wherein the DNA-binding protein is a Cas protein and the donor sequence is to be inserted at a position 3’ or 5’ of a PAM sequence of the Cas protein in the target polynucleotide [see paragraphs 0008-0020].
With respect to claim 18, Zhang et al. teach the composition wherein the donor sequence is flanked by a right end sequence and a left end sequence [see paragraphs 0008-0020].
With respect to claim 19, Zhang et al. teach the composition wherein the donor sequence introduces one or more mutations to the target polynucleotide, corrects or introduces a premature stop codon in the target polynucleotide, disrupts a splicing site, restores or introduces a splicing site, inserts a gene or gene fragment at one or both alleles of a target polynucleotide or a combination thereof [see paragraph 0018].
With respect to claim 20, Zhang et al. teach the composition wherein the one or more mutations introduced by the donor polynucleotide comprises substitutions, deletions, insertions, or a combination thereof [see paragraph 0019].
With respect to claim 21, Zhang et al. teach the composition wherein the one or more mutations causes a shift in an open reading frame on the target polynucleotide [see paragraph 0019].
With respect to claim 22, Zhang et al. teach the composition wherein the donor sequence is up to 30 kb in length [see paragraph 0019].
With respect to claim 23, Zhang et al. teach the composition wherein the donor polynucleotide is linear [see paragraph 0069].
16. Claims 1-5, 7-12, and 16-23 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Sternberg et al. (US Patent Application Publication 2020/0283769 A1; cited on IDS filed on 07/04/2023).
17. With respect to claim 1, Sternberg et al. teach an engineered composition comprising a programmable DNA-binding protein and two or more Tn7-like transposition proteins, wherein at least one of the Tn7-like transposition protein is connected to the DNA binding protein or otherwise capable of forming a complex with the DNA binding protein [see Abstract; Figure 1; paragraphs 0007-0023].
With respect to claim 2, Sternberg et al. teach the composition wherein at least one of the Tn7-like transposition proteins is connected to an N-terminus or C-terminus of the DNA binding protein [see Abstract; Figure 1; paragraphs 0007-0023].
With respect to claim 3, Sternberg et al. teach the composition wherein the two or more Tn7-like transposition proteins are derived from CRISPR-associated Tn7-like transposition proteins [see paragraphs 0007-0023].
With respect to claim 4, Sternberg et al. teach the composition wherein the CRISPR-associated Tn7-like transpositions comprises at least a Cas-12k associated transposase [see paragraph 0122].
With respect to claim 5, Sternberg et al. teach the composition wherein the two or more Tn7-like transposition proteins consist of TnsB, TnsC, and TniQ, wherein TniQ is connected to the DNA-binding polypeptide and TnsC is connected to the DNA-binding polypeptide [see Abstract; Figure 1; paragraphs 0007-0023].
With respect to claim 7, Sternberg et al. teach the composition wherein the TnsB, TnsC, and TniQ are proteins that fall in Tables 1-6 [see Abstract; Figure 1; paragraphs 0007-0023].
With respect to claim 8, Sternberg et al. teach the composition wherein the programmable DNA-binding protein is a Cas protein or a complex of Cas proteins [see see Abstract; Figure 1; paragraphs 0007-0023].
With respect to claim 9, Sternberg et al. teach the composition wherein the DNA-binding protein is a Cas protein other than a Cas12k protein and the composition further comprises a guide molecule capable of forming a complex with the Cas protein and directing site specific binding of the complex to a target sequence in a target polypeptide [see Abstract; Figure 1; paragraphs 0007-0023; 0096; 0122].
With respect to claim 10, Sternberg et al. teach the composition wherein the Cas protein is a Type II or Type V Cas protein or a complex of Cas protein complexes [see Abstract; Figure 1; paragraphs 0007-0023; 0096; 0122; 0297].
With respect to claim 11, Sternberg et al. teach the composition wherein the Cas protein is a catalytically inactive Cas9 [see Abstract; Figure 1; paragraphs 0007-0023; 0106].
With respect to claim 12, Sternberg et al. teach the composition wherein the dCas9 is fused to one, two or three or more TniQ [see Abstract; Figure 1; paragraphs 0007-0023; 0106].
With respect to claim 16, Sternberg et al. teach the composition further comprising a donor polynucleotide comprising a donor sequence for insertion into a target polynucleotide [see Abstract; Figure 1; paragraphs 0007-0023].
With respect to claim 17, Sternberg et al. teach the composition wherein the DNA-binding protein is a Cas protein and the donor sequence is to be inserted at a position 3’ or 5’ of a PAM sequence of the Cas protein in the target polynucleotide [see Abstract; Figure 1; paragraphs 0007-0023].
With respect to claim 18, Sternberg et al. teach the composition wherein the donor sequence is flanked by a right end sequence and a left end sequence [see Abstract; Figure 1; paragraphs 0007-0023].
With respect to claim 19, Sternberg et al. teach the composition wherein the donor sequence introduces one or more mutations to the target polynucleotide and correct a premature stop codon [see paragraphs 0421 and 0863].
With respect to claim 20, Sternberg et al. teach the composition wherein the one or more mutations introduced by the donor polynucleotide comprises substitutions, deletions, insertions, or a combination thereof [see paragraphs 0434-0438].
With respect to claim 21, Sternberg et al. teach the composition wherein the one or more mutations causes a shift in an open reading frame on the target polynucleotide [see Abstract; Figures 1 and 103; paragraphs 0007-0023].
With respect to claim 22, Sternberg et al. teach the composition wherein the donor sequence is up to 30 kb in length [see paragraph 0029].
With respect to claim 23, Sternberg et al. teach the composition wherein the donor polynucleotide is linear [see paragraph 0619].
Claim Rejections - 35 USC § 103
18. 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.
19. Claim(s) 13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sternberg et al. (US Patent Application Publication 2020/0283769 A1; cited on IDS filed on 07/04/2023) in view of Bryson et al. (WO 2019/217944 A1; examiner cited).
20. The relevant teachings of Sternberg et al. as applied to claims 1-5, 7-12, and 16-23 are set forth above.
With respect to claims 13-15, Sternberg et al. teach the composition wherein the CRISPR-associated Tn7-like transpositions comprises at least a Cas-12k associated transposase [see paragraph 0122] and the Tn7-like transposition proteins consist of TnsC or TniQ [see Abstract; Figure 1; paragraphs 0007-0023]. Sternberg et al. also teach wherein the Cas protein is a catalytically inactive Cas protein [see Abstract; Figure 1; paragraphs 0007-0023; 0106].
However, Sternberg et al. does not teach the composition of claim 13, wherein the Cas protein is a catalytically inactive Cas12 and the composition of claim 14, wherein the dCas12 is a dCas12 or dCas12a.
Bryson et al. teach compositions for base editing comprising catalytically inactive Cpf1 (Cas12a) proteins for targeted nucleotide sequences for modification [see Abstract; paragraph 0151].
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to combine the teachings of Sternberg et al. and Bryson et al. to use the catalytically inactive Cpf1 of Bryson et al. in the compositions of Sternberg et al. because Sternberg et al. teach compositions comprising transposases fused or associated with catalytically inactive Cas proteins for targeted modification of genes. Bryson et al. teach catalytically inactive Cpf1 proteins that can fused with DNA modification enzymes for the targeted modification of nucleotide sequences. One of ordinary skill in the art would have had a reasonable expectation of success and a reasonable level of predictability to combine the teachings of Sternberg et al. and Bryson et al. because Bryson et al. acknowledges that catalytically inactive Cpf1 can be used in targeted modification of nucleotide sequences. Therefore, the above invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Double Patenting
21. 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.
22. Claims 1-5 and 7-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 and 21 of U.S. Patent No. 11,384,344. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-19 and 21 of the ‘344 patent recite an engineered nucleic acid targeting system for insertion of donor polynucleotides, the system comprising: one or more CRISPR-associated Tn7 transposase or Tn7-like transposase proteins that form a transposase; a catalytically inactive Type V Cas protein capable of forming a complex with the transposase; a guide molecule capable of forming a complex with the Type V Cas protein and directing sequence-specific binding of a guide-Cas protein complex to a target sequence of a target polynucleotide; and a donor construct, comprising a heterologous donor polynucleotide sequence flanked by a first and second binding sequence capable of complexing the donor construct with one or more Tn7 or Tn7-like transposase proteins. The dependent claims are further drawn to transposase proteins, TnsA, TnsB, TnsC and TniQ.
23. Claims 1-5 and 7-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7, 13-14, 16-18, 24, 28-29, and 31-33 of copending Application No. 17/773104. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1, 7, 13-14, 16-18, 24, 28-29, and 31-33 of the ‘104 application recite an engineered system for RNA guided DNA transposition, the system comprising a CRISPR-Cas Transposon complex, comprising a Type I-B CRISPR Cas cascade complex comprising one or more engineered Type I-B CRISPR Cas protein selected from the group consisting of Type I-B CRISPR Cas5, Cas6, Cas7 and Cas8 proteins, one or more engineered CRISPR-associated Tn7 transposases, and a heterologous guide molecule designed to base pair with a complementary target nucleotide sequence of a target polynucleotide, wherein the binding of the guide molecule to the Type I-B CRISPR Cas Cascade complex directs the sequence specific binding of the CAST complex to the target polynucleotide, wherein the system further comprises a donor polynucleotide, and wherein one or more of the engineered CRISPR-associated Tn7 transposases and/or Type I-B CRISPR Cas proteins are from, or originated from, Anabaena variabilis.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
24. Claims 1-5 and 7-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 5-7, 10, 13-15, 19, 21, 25, 29, and 34-36 of co-pending Application No. 18/269813. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1, 7, 13-14, 16-18, 24, 28-29, and 31-33 of the ‘813 application recite an engineered system, the system comprising: one or more CRISPR-associated Tn7 transposase polypeptides; one or more Type I-B Cas protein; and a guide molecule capable of complexing with the one or more Type I-B Cas protein and directing binding of the guide-Cas protein complext to a target polynucleotide.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
25. Claims 1-5 and 7-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4, 6, 8, 19, 22, 26-27, 30-31, and 33 of co-pending Application No. 19/043619. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-2, 4, 6, 8, 19, 22, 26-27, 30-31, and 33 of the ‘619 application recite an engineered system, the system comprising: one or more CRISPR-associated Tn7 or Tn7-like transposase polypeptides or functional fragments thereof; and a guide molecule capable of forming a complex with the one or more Type I-B Cas proteins and directing binding of the guide molecule-Cas protein complex to a target polynucleotide, wherein the system is capable of reproducible insertions.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
26. Status of the claims:
Claims 1-5, 7-30, and 34-41 are pending.
Claims 24-30 and 34-41 stand withdrawn pursuant to 37 CFR 1.142(b).
Claims 1-5 and 7-23 are rejected.
No claims are in condition for an allowance.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL J HOLLAND whose telephone number is (571)270-3537. The examiner can normally be reached Monday to Friday from 8AM to 5PM.
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/PAUL J HOLLAND/Primary Examiner, Art Unit 1656