Notice of Pre-AIA or AIA Status
The present application, 17907510, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1,4-5,10, 16-21,25-28,30-31,34 and 39 are pending.
Priority
The filing receipt, mailed 5/30/2023, states that this application, 17907510, filed 9/27/2022, states that this application is a 371 of PCT/US21/24422, filed 03/26/2021 which claims benefit of 63/001,008, filed 03/27/2020 and claims priority benefit of 63/053,460, filed 07/17/2020 and claims benefit of 63/081,677, filed 9/33/2020.
Response to Arguments
Applicant’s arguments and claim amendments, see Reply at pp. 6-8, filed 11/18/2025, with respect to the rejection(s) of claim(s) 1,4-5,10-11, 13, 16-21, 25-28, 30-31, 34 and 39 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejections have been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the amendments to claim 1, filed 11/18/2025, this argument is found persuasive, and the rejections are withdrawn, in favor of the new rejections necessitated by these amendments.
1. Claim(s) 1, 4, 5, 10, 16, 18-21, 25-28, 30-31, 34 and 39 is/are rejected under 35 U.S.C. 1. 103 as being unpatentable over Zhang, WO 2019/126774 A1, published 27 June 2019, of record IDS, Serial No: 16773000.
2. Claim(s) 4, 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang, WO 2019/126774 A1, published 27 June 2019, of record IDS, Serial No: 16773000, as above in claims 1, 5, 10, 16, 18-21, 25-28, 30-31, 34 and 39 and further in view of Tsai, US 2017/0362611 A1, Serial No. 15/533,164.
3. Claim(s) 11, 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang, WO 2019/126774 A1, published 27 June 2019, of record IDS, as above in claims 1, 5, 10, 16, 18- 21, 25-28, 30-31, 34 and 39 and further in view of Strecker, Science, (2019), vol. 365, pp.48-53, of record IDS.
In the Reply to the non-final Office action, it is noted that with the current amendments, claim 1 recites that at least one Cas protein comprises Cas4, Cas6, Cas7, Cas8, or a combination thereof. The Reply states the prior art reference of Strecker does not teach or suggest Cas4, Cas6, Cas7, Cas8. Given the amendment to at least claim 1, this argument is found persuasive, and the rejection is withdrawn, in favor of the new rejections necessitated by amendment.
It is noted that the cancelation of claims 11 and 13 render that particular rejection mute.
4. Claim(s) 39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Clube, US- 4. 9701964-B2, published 2017-07-11, in view of Baltes, US 20200061211, published 2020-02-27.
5. The provisional rejection of Claims 1,4-5,10-11,16-21,25-28,30-31,34 and 39 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 5, 8, 11, 12, 15, 18-22, 25-27, 29, 32, 65, 68 of copending Application No. 17634759 (reference application) has been traversed but applicant requests that these rejections be held in abeyance until allowable subject matter has been obtained by applicant. Therefore this provisional nonstatutory double patenting rejection is maintained.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
1. Claim(s) 1, 4, 5, 10, 16, 18-21, 25-28, 30-31, 34 and 39 is/are rejected under 35 U.S.C. 1. 103 as being unpatentable over Zhang, WO 2019/126774 A1, published 27 June 2019, of record IDS, Serial No: 16773000, and Sternberg, 20200283769.
Regarding claim 1, Zhang teaches a system for targeted nucleic acid deletions throughout the publication and at para [1079] - "In certain embodiments, the locus of interest is first modified by the CRISPR-C2cl system at the distal end of the PAM sequence, and further modified by the CRISPR-C2cl system near the PAM sequence and repaired via HDR. In certain embodiments, the locus of interest is modified by the CRISPR-C2c1 system by introducing a mutation, deletion"), comprising: an engineered Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR)-CRISPR. associated (Cas) (CRISPR-Cas) system (Abstract - "Embodiments herein include engineered CRISPR-Cas effector proteins").
Zhang teaches one or more vectors encoding the engineered CRISPR-Cas system, wherein the engineered CRISPR-Cas system comprises: (a) at least one Cas protein (Abstract - "In certain embodiments, the CRISPR-Cas effector protein Is a Type V-B effector protein, e.g., C2c1."), and (b) a pair of guide RNAs (gRNAs) (para [0195] - "As is known in the art, a single gene, locus, or other genomic site may be targeted more than once, such as by use of multiple gRNAs."), wherein the pair of gRNAs is configured to hybridize to target sites flanking a nucleic acid sequence for deletion (para [0397] - "The Cas12b enzyme may form part of a CRISPR system or complex, which further teaches tandemly arranged guide RNAs (QRNAS) comprising a series of 2, ...30, or more than 30 guide sequences, each capable of specifically hybridizing to a target sequence in a genomic locus of interest in a cell." Zhang, at para [0413], teaches "Preferred locations for engineered guide molecule modifications, including but are not limited to insertions, deletion").
Zhang, at para [1390], teaches an engineered transposon system, and/or one or more vectors encoding the engineered transposon system (para [1390] - "Alternative techniques may be used to transform target immunoresponsive cells, such as protoplast fusion, lipofection, transfection or electroporation. A wide variety of vectors may be used, such as plasmids or transposons, such as a Sleeping Beauty transposon"); a recombinase, or catalytic domain thereof, and/or one or more vectors encoding a recombinase, or catalytic domain thereof. Zhang, at para [0245], teaches "Suitable heterologous domains include without limitation a nuclease, a ligase, a repair protein, a methyltransferase, (viral) integrase, a recombinase, a transposase". Zhang, at para [1076], teaches at donor nucleic acid to be integrated, stating "The CRISPR system of the present invention for use in P. falciparum by disrupting chromosomal loci. the donor DNA template for homologous recombination repair on the same plasmid, pL7.").
Zhang teaches, at para [0390], CRE and Lox, as in claims 4 and 5; at para [0011], [0143], Type V systems, as in claim 10; at para [0026], [0219], target deletion sites, as in claims 18, 25, 26, 28, 30; at para [0332], non-naturally occurring gRNA, as in claim 19; at para [0474], cell free system, as in claim 20; at [0090]-[0091], detecting the presence of a nucleic acid target sequence in an in vitro sample, as in claim 25; at para [0012], introducing the effector protein complex into any desired cell type, prokaryotic or eukaryotic cell, as in claim 21, 26, 31.
However, Zhang does not specifically teach wherein the donor nucleic acid comprises a recognition site for the recombinase flanked by at least one transposon end sequence. Zhang does not teach Cas5, Cas6, Cas7, Cas8. Zhang does not teach TnsA, TnsB, TnsC, or TniQ.
Sternberg, 20200283769, throughout the publication and abstract and the claims, as in claim 1, which states:
1. A system for RNA-guided DNA integration, the system comprising one or more vectors encoding: a) an engineered Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR)-CRISPR associated (Cas) (CRISPR-Cas) system, the engineered CRISPR-Cas system comprising: Cas5, Cas6, Cas7 and Cas8; and b) an engineered Tn7-like transposon system, the engineered Tn7-like transposon system comprising: i) TnsA, ii) TnsB, iii) TnsC, and iv) TniQ, wherein the engineered Tn7-like transposon system is derived from Vibrio cholerae Tn6677.
Sternberg, 20200283769, at claim 1, (emphasis added).
Sternberg, at para [0005]-[0009], teaches RNA-guided DNA integration that uses an engineered transposon system derived from a Tn7-like transposon and comprising TnsA, TnsB, TnsC, or TniQ that obviates the need to introduce double-stand breaks (DSBs) thereby reducing the need to rely on homology-directed repair (HDR). Sternberg teaches, at para [0012], an engineered CRISPR-Cas system comprising Cas5, Cas6, Cas7 and Cas8.
It would have been prima facie obvious before the effective filing date of the instant invention for one of ordinary skill in the art to have combined Cas5, Cas6, Cas7, Cas8 into an engineered CRISPR-Cas9 system. It would have been prima facie obvious before the effective filing date of the instant invention for one of ordinary skill in the art to have combined TnsA, TnsB, TnsC, or TniQ into an engineered CRISPR-Cas9 system.
One with ordinary skill in the art would have motivated to combine a CRISPR system comprising a recombinase that can be engineered, and a donor nucleic acid for target modification, which is further designed to include a recognition site for the recombinase domain, and flanked by a transposon element for desired functionality (as taught by Zhang) for target-specific deletion.
One with ordinary skill in the art would have motivated to combine a CRISPR system comprising a recombinase that can be engineered, and a donor nucleic acid for target modification, which is further designed to include a recognition site for the recombinase domain, and flanked by a transposon element for desired functionality (as taught by Zhang) for target-specific deletion. One of ordinary skill in the art would have been motivated to combine recombinase and transposon systems with Crispr systems as Zhang teaches and suggests their use together.
It would have been routine optimization to have introduced one or more vectors encoding a recombinase, or catalytic domain to the cell after the introduction of the engineered CRISPR-Cas system, the engineered transposon system, and the at least one donor nucleic acid, as in Claim 27. The instant Specification, at p. 26, para [0132], indicate similar results, notwithstanding the relative timing of the introduction of the transposon system:
[0132] In some embodiments, the methods may comprise introducing the disclosed systems into a cell. In some embodiments, the recombinase, or catalytic domain thereof, and/or one or more vectors encoding a recombinase, or catalytic domain thereof is introduced to the cell after the introduction of the engineered CRISPR-Cas system, the engineered transposon system, and the at least one donor nucleic acid. For example, all four components may be introduced simultaneous or nearly simultaneously. In some embodiments, all four components may be introduced, in any order, with a time period separating each introduction. In alternative embodiments, the introduction of the recombinase to the cell is after the introduction the CRISPR-Cas system, the transposon system, and the donor nucleic acid, such that RNA-guided nucleic acid integration has already occurred.
The instant Specification, at p. 26, para [0132]. As there is a limited number of possibilities regarding that relative timing, whether the recombinase is added after the other components, is not considered a result effective variable.
2. Claim(s) 4, 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang, WO 2019/126774 A1, published 27 June 2019, of record IDS, Serial No: 16773000, and Sternberg, 20200283769, as above in claims 1, 4, 5, 10, 16, 18-21, 25-28, 30-31, 34 and 39 and further in view of Tsai, US 2017/0362611 A1, Serial No. 15/533,164, of record.
The publications of Zhang and Sternberg, are relied upon as above. Zhang and Sternberg do not describe Crispr-Cas systems that can be tyrosine recombinase or can be serine recombinase, such as Gin invertase or Hin invertase.
Tsai, throughout the publication and at para [0004]-[0006], teaches polypeptides that include a CRISPR-Cas domain and tyrosine or serine recombinase domain. Tsai, at para [0013]- [0014], Fig.s 1 and 2A, teaches a tetramer of recombinase or recombinase domain is formed at the target sequence and activated by binding to its cognate sites, and mediates the recombination between the donor DNA and the target DNA. The cognate sites are either located on a helper DNA or on a donor vector, which reads on a recognition site for the recombinase comprised within the cargo nucleic acid of claim 17.
It would have been prima facie obvious before the effective filing date of the claimed invention for one of ordinary skill in the art to have used tyrosine and serine recombinases, as taught by Tsai, with the claimed CRISPR-Cas system, as taught by Zhang, Strecker and Tsai, in order to have mediated the recombination between donor DNA and target DNA through cognate sites located on a donor vector, reading on a recognition site for the recombinase comprised within the cargo nucleic acid of claim 17.
One of ordinary skill in the art would have been motivated to use, as Sternberg and Zhang teaches recombinases, Zhang teaches tyrosine recombinases, and as Tsai teaches, serine recombinases, because Tsai indicates that both tyrosine and serine recombinases are compatible within their CRISPR-Cas system.
4. Claim(s) 39 is/are rejected under 35 U.S.C. 103 as being unpatentable over is/are rejected under 35 U.S.C. 103, as being unpatentable over Zhang, WO 2019/126774 A1, published 27 June 2019, of record IDS, Serial No: 16773000, and Sternberg, 20200283769, as in Claim(s) 1, 4, 5, 10, 16, 18-21, 25-28, 30-31, 34 and 39 above, and further in view of Clube, US 9701964-B2, published 2017-07-11, of record.
The publications of Zhang and Sternberg, are relied upon as above.
Clube teaches, throughout the patent and at, e.g., the abstract, col. 4, line 11-col. 5, line 11; col. 5, line 62-col. 6, line 59; col. 8, line 54-col 9, line 3; col. 113-col. 118, line 56, teaches methods, uses, systems, arrays, engineered nucleotide sequences and vectors for inhibiting bacterial population growth or for altering the relative ratio of Sub-populations of first and second bacteria in a mixed population of bacteria. The invention is particularly useful, for example, for treatment of microbes such as for environ mental, medical, food and beverage use. Clube teaches the use of transposons for transfer of nucleotide sequences.
Clube does not teach wherein the engineered CRISPR, Cas system comprises recombinase.
The publication of Zhang, is relied upon as above. Zhang describes the use of recombinase in CAST (CRISPR-associated transposase systems).
Given that Clube teaches the method of modifying bacterial populations with CRISPR comprising transposon sequences to modify target genes, and using a donor nucleic acid to be integrated comprising transposon end sequence and given that Zhang and Sternberg specifically teach the method of editing genes using a recombinase for target DNA integration, one of ordinary skill in the art before the effective date of the claimed invention would have combined the method of Clube for effective transposition in bacterial communities in order to genetically modify diverse bacterial communities. Therefore, claim 39 is rejected as prima facie obvious over the cited prior art references of Clube and Zhang and Sternberg.
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.
1. Claims 1, 4, 5, 10, 16, 18-21, 25-28, 30-31, 34 and 39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 3, 4, 5, 9 of Sternberg, U.S. Patent No. 10,947,534 (“Patent 534”) in view of Zhang, WO 2019/126774 A1, (Serial No: 16773000, US 20200392473).
Sternberg, “Patent 534”, throughout the publication and abstract and the claims, as in claim 1, which states:
1. A system for RNA-guided DNA integration, the system comprising one or more vectors encoding: a) an engineered Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR)-CRISPR associated (Cas) (CRISPR-Cas) system, the engineered CRISPR-Cas system comprising: Cas5, Cas6, Cas7 and Cas8; and b) an engineered Tn7-like transposon system, the engineered Tn7-like transposon system comprising: i) TnsA, ii) TnsB, iii) TnsC, and iv) TniQ, wherein the engineered Tn7-like transposon system is derived from Vibrio cholerae Tn6677.
Claim 4 of the Patent ‘534 is drawn to guide RNA (gRNA) specific for a target site.
Sternberg does not appear to claim a recombinase.
Zhang teaches a system for targeted nucleic acid deletions throughout the publication and at para [1079] - "In certain embodiments, the locus of interest is first modified by the CRISPR-C2cl system at the distal end of the PAM sequence, and further modified by the CRISPR-C2cl system near the PAM sequence and repaired via HDR. In certain embodiments, the locus of interest is modified by the CRISPR-C2c! system by introducing a mutation, deletion"), comprising: an engineered Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR)-CRISPR. associated (Cas) (CRISPR-Cas) system (Abstract - "Embodiments herein include engineered CRISPR-Cas effector proteins").
Zhang teaches one or more vectors encoding the engineered CRISPR-Cas system, wherein the engineered CRISPR-Cas system comprises: (a) at least one Cas protein (Abstract - "In certain embodiments, the CRISPR-Cas effector protein Is a Type V-B effector protein, e.g., C2c1."), and (b) a pair of guide RNAs (gRNAs) (para [0195] - "As is known in the art, a single gene, locus, or other genomic site may be targeted more than once, such as by use of multiple gRNAs."), wherein the pair of gRNAs is configured to hybridize to target sites flanking a nucleic acid sequence for deletion (para [0397] - "The Cas12b enzyme may form part of a CRISPR system or complex, which further teaches tandemly arranged guide RNAs (QRNAS) comprising a series of 2, ...30, or more than 30 guide sequences, each capable of specifically hybridizing to a target sequence in a genomic locus of interest in a cell." Zhang, at para [0413], teaches "Preferred locations for engineered guide molecule modifications, including but are not limited to insertions, deletion").
Zhang, at para [1390], teaches an engineered transposon system, and/or one or more vectors encoding the engineered transposon system (para [1390] - "Alternative techniques may be used to transform target immunoresponsive cells, such as protoplast fusion, lipofection, transfection or electroporation. A wide variety of vectors may be used, such as plasmids or transposons, such as a Sleeping Beauty transposon"); a recombinase, or catalytic domain thereof, and/or one or more vectors encoding a recombinase, or catalytic domain thereof. Zhang, at para [0245], teaches "Suitable heterologous domains include without limitation a nuclease, a ligase, a repair protein, a methyltransferase, (viral) integrase, a recombinase, a transposase". Zhang, at para [1076], teaches at donor nucleic acid to be integrated, stating "The CRISPR system of the present invention for use in P. falciparum by disrupting chromosomal loci. the donor DNA template for homologous recombination repair on the same plasmid, pL7.").
Zhang teaches, at para [0390], CRE and Lox, as in claims 4 and 5; at para [0011], [0143], Type V systems, as in claim 10; at para [0026], [0219], target deletion sites, as in claims 18, 25, 26, 28, 30; at para [0332], non-naturally occurring gRNA, as in claim 19; at para [0474], cell free system, as in claim 20; at [0090]-[0091], detecting the presence of a nucleic acid target sequence in an in vitro sample, as in claim 25; at para [0012], introducing the effector protein complex into any desired cell type, prokaryotic or eukaryotic cell, as in claim 21, 26, 31.
It would have been prima facie obvious before the effective filing date of the instant invention for one of ordinary skill in the art to have combined a recombinase in the CRISPR-cas system as claimed in Sternberg.
One with ordinary skill in the art would have motivated to combine a CRISPR system comprising a recombinase that can be engineered, and a donor nucleic acid for target modification, which is further designed to include a recognition site for the recombinase domain, and flanked by a transposon element for desired functionality as taught by Zhang.
One with ordinary skill in the art would have motivated to combine a CRISPR system comprising a recombinase that can be engineered, and a donor nucleic acid for target modification, which is further designed to include a recognition site for the recombinase domain, and flanked by a transposon element for desired functionality (as taught by Zhang) for target-specific deletion. One of ordinary skill in the art would have been motivated to combine recombinase and transposon systems with Crispr systems as Zhang teaches and suggests their use together.
It would have been routine optimization to have introduced one or more vectors encoding a recombinase, or catalytic domain to the cell after the introduction of the engineered CRISPR-Cas system, the engineered transposon system, and the at least one donor nucleic acid, as in Claim 27. The instant Specification, at p. 26, para [0132], indicate similar results, notwithstanding the relative timing of the introduction of the transposon system:
[0132] In some embodiments, the methods may comprise introducing the disclosed systems into a cell. In some embodiments, the recombinase, or catalytic domain thereof, and/or one or more vectors encoding a recombinase, or catalytic domain thereof is introduced to the cell after the introduction of the engineered CRISPR-Cas system, the engineered transposon system, and the at least one donor nucleic acid. For example, all four components may be introduced simultaneous or nearly simultaneously. In some embodiments, all four components may be introduced, in any order, with a time period separating each introduction. In alternative embodiments, the introduction of the recombinase to the cell is after the introduction the CRISPR-Cas system, the transposon system, and the donor nucleic acid, such that RNA-guided nucleic acid integration has already occurred.
The instant Specification, at p. 26, para [0132]. As there is a limited number of possibilities regarding that relative timing, whether the recombinase is added after the other components, is not considered a result effective variable.
2. Claims 1,4-5,10-11,16-22,25-28,30-31,34 and 39 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 5, 8, 11, 12, 15, 18-22, 25-27, 29, 32, 65, 68 of copending Application No. 17634759 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant invention of claim 1 and the invention of reference claim 1 appear to 17634759.
Claims 1,4-5,10-11,16-21,25-28,30-31,34 and 39 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 5, 8, 11, 12, 15, 18-22, 25-27, 29, 32, 65, 68 of copending Application No. 17634759 (reference application). Claim 1 of the instant application, Serial No. 17907510, recites:
1. (Currently Amended) A system for targeted nucleic acid deletions comprising: an engineered Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR)- CRISPR associated (Cas) (CRISPR-Cas) system, and/or one or more vectors encoding the engineered CRISPR-Cas system, wherein the engineered CRISPR-Cas system comprises: (a) at least one Cas protein, wherein the at least one Cas protein comprises Cas5, Cas6, Cas7, Cas8, or a combination thereof, and (b) a pair of guide RNAs (gRNAs), wherein the pair of gRNAs is configured to hybridize to target sites flanking a nucleic acid sequence for deletion; an engineered transposon system, and/or one or more vectors encoding the engineered transposon system, wherein the engineered transposon system comprises TnsA, TnsB, TnsC, TniQ, or a combination thereof; a recombinase, or catalytic domain thereof, and/or one or more vectors encoding a recombinase, or catalytic domain thereof; and at least one donor nucleic acid to be integrated, wherein the donor nucleic acid comprises a recognition site for the recombinase flanked by at least one transposon end sequence.
Instant application 17907510 at claim 1, (emphasis added).
In particular, Claims 1, 20 and 22, of the reference application, Serial No. 17634759, recite:
1. (Previously Presented) A system for RNA-guided DNA integration comprising: an engineered Clustered Regularly Interspaced Short Palindromic Repeats (a) (CRISPR)-CRISPR associated (Cas) (CRISPR-Cas) system, and/or one or more vectors encoding the engineered CRISPR-Cas system, wherein the engineered CRISPR-Cas system comprises: (a) at least one Cas protein, and (b) a guide RNA (gRNA); (b) an engineered transposon system, and/or one or more vectors encoding the engineered transposon system, wherein the engineered transposon system is configured for replicative transposition; a recombinase, or catalytic domain thereof, and/or one or more vectors (c) encoding a recombinase, or catalytic domain thereof; and at least one donor nucleic acid to be integrated, wherein the donor nucleic acid (d) comprises a recognition site for the recombinase and a cargo nucleic acid flanked by at least one transposon end sequence.
20. (Previously Presented) The system of claim 1, wherein the engineered CRISPR-Cas system comprises Cas5, Cas6, Cas7, Cas8, or a combination thereof.
22. (Previously Presented) The system of claim 1, wherein the engineered transposon system comprises one or more of TnsB and TnsC, inactive TnsA, and TniQ.
Reference application 17634759 at claims 1, 20 and 22.
Reference application 17634759, which claims a CRISPR-cas system comprising Cas5, Cas6, Cas7, Cas8, or a combination thereof and one or more of TnsB and TnsC, inactive TnsA, and TniQ, as currently amended in the instant application, suggests the claimed invention of the instant application because the limitations and subject matter of the claims overlap.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 Mark L Shibuya whose telephone number is (571)272-0806. The examiner can normally be reached M-F, 9AM-4:30PM.
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, James (Doug) Schultz, can be reached at (571) 272-0763. 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.
MARK L. SHIBUYA
Primary Patent Examiner
Art Unit 1631
/MARK L SHIBUYA/ Primary Patent Examiner, Art Unit 1631