DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 1-2, 7, 9, 11, 16, 20-21, 28-29, 33, 37-38, 42, 45-46, 52, 53, 59-60, 73, and 74-79 are currently pending.
Claims 1, 11, 16, 21, 28-29, 33, 38, 45, 52, 53, and 60 are amended.
Claims 46, 59-60, and 75-79 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim.
Claims 73 and 74 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Claims 3-6, 8, 10, 12-15, 17-19, 22-27, 30-32, 34-36, 39-41, 43-44, 47-51, 54-58, and 61-72 are cancelled.
Claim(s) 1-2 7, 9, 11, 16, 20-21, 28-29, 33, 37-38, 42, 45, 52, and 53 have been considered on the merits.
Withdrawn Objections/Rejections
The objections made onto the specification are withdrawn in light of the amendments made to the specification in the reply filled on 05/26/2026.
The objections made onto claims 1, 3, and 16 are withdrawn in light of the amendments made onto the claims in the reply filled on 05/26/2026.
The 112(b) rejections made onto claims 4, 21, and 45 are withdrawn in light of the amendments made onto the claims in the reply filled on 05/26/2026.
The double patenting rejection made over copending Application No. 19/016,260 has been withdrawn in light of the amendments made on 05/26/2026.
The double patenting rejection made over copending Application No. 18/270,854 has been withdrawn in light of the amendments made on 05/26/2026.
The double patenting rejection made over copending Application No. 18/248,252 has been withdrawn in light of the amendments made on 05/26/2026.
The double patenting rejection made over copending Application No. 17/638,335 has been withdrawn in light of the amendments made on 05/26/2026.
The double patenting rejection made over copending Application No. 17/612,245 has been withdrawn in light of the amendments made on 05/26/2026.
New Claim Objections Necessitated by Amendment
Claim 11 is objected to because of the following informalities: Claim 11 contains a partially deleted limitation which currently reads “wherein the donor polynucleotide” in line 7-8, which appears to be a typographical error. Appropriate correction is required.
Maintained Double Patenting Rejections Necessitated by Amendment
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, 3-4, 7, 11, 16, 20, 21, 28, 37, 38, 42, 46, and 52 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 5, 8, 11, 14-18, and 20 of U.S. Patent No. 11384344, as evidenced by Strecker et al (Science, July 5, 2019; reference of record). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of the instant application is generic to all that is recited in claim 1 of ‘344.
Claim 1 of the instant application details an engineered system for insertion of donor polynucleotides comprising one or more CRISPR-associated transposase proteins, a Cas protein, and a guide molecule which guides Cas to a target sequence, which is fully encompassed by claim 1 of ‘344. Dependent claim 3 is fully encompassed by claims 3 of ‘344. Dependent claim 4 is fully encompassed by claim 5 of ‘344. Dependent claim 7 is fully encompassed by claim 1 of ‘344. Dependent claim 11 is fully encompassed by claim 1. Dependent claim 16 is fully encompassed by claim 8 of ‘344. Dependent claim 20 is fully encompassed by claim 11 of ‘344. Dependent claim 21 is fully encompassed by claim 14 of ‘344. Dependent claim 28 is fully encompassed by claim 16 of ‘344. Dependent claim 37 is fully encompassed by claim 15 of ‘344. Dependent claim 38 is fully encompassed by claims 16 and 17 of ‘344. Dependent claim 42 is fully encompassed by claim 18 of ‘344. Dependent claims 46 and 52 are fully encompassed by claim 20 of ‘344.
Claim 1 has been amended to include the limitation of “a donor polynucleotide that is linear” which is inherent to the system of US11384344 as evidence by Strecker. Specifically, ‘344 describes the system comprising one or more Tn7 transposases (claim 1 of ‘344) and Strecker teaches “We were unable to detect rejoined pDonor backbone during transposition in E. coli (fig. S6, D and E), suggesting that a linear donor backbone is formed, not a rejoined product, consistent with the known reaction products of canonical Tn7” (pg. 3, col. 3, para 3).
Claims 1, 7, 11, and 42 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 11, and 16 of copending Application No. 19/287,917 (reference application) as evidenced by Strecker et al (Science, July 5, 2019; reference of record). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of the instant application is generic to all that is recited in claim 1 of ‘917.
That is, claim 1 of the instant application details an engineered system for insertion of donor polynucleotides comprising one or more CRISPR-associated transposase proteins, a Cas protein, and a guide molecule which guides Cas to a target sequence, which is fully encompassed by claim 1 of ‘917. Dependent claim 7 of the instant application is also fully encompassed by claim 1 of ‘917. Dependent claim 11 of the instant application limits wherein the system further comprises a donor polynucleotide, which is encompassed by claim 16 of ‘917. Dependent claim 42 of the instant application limited wherein the target nucleic acid contains a PAM, which is fully encompassed by claim 11 of ‘917.
Claim 1 has been amended to include the limitation of “a donor polynucleotide that is linear” which is inherent to the system of 19/287,917 as evidence by Strecker. Specifically, 19/287,917 describes the system comprising one or more Tn7 transposases (claim 1 of 19/287,917) and Strecker teaches “We were unable to detect rejoined pDonor backbone during transposition in E. coli (fig. S6, D and E), suggesting that a linear donor backbone is formed, not a rejoined product, consistent with the known reaction products of canonical Tn7” (pg. 3, col. 3, para 3).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 3-4, 7, 11, 16, and 53 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8, 27, and 41-42 of copending Application No. 19/043,619 (reference application) as evidenced by Strecker et al (Science, July 5, 2019; reference of record). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of the instant application is generic to all that is recited in claim 1 of ‘619.
That is, claim 1 of the instant application details an engineered system for insertion of donor polynucleotides comprising one or more CRISPR-associated transposase proteins, a Cas protein, and a guide molecule which guides Cas to a target sequence, which is fully encompassed by claim 1 of ‘619. Dependent claim 3 and 4 of the instant application are fully encompassed by claim 8 of ‘619. Dependent claim 7 is fully encompassed by claim 1 of ‘619. Dependent claim 11 is fully encompassed by claim 27 of ‘619. Claim 16 is fully encompassed by claim 41 of ‘619. Dependent claim 53 is fully encompassed by claim 42 of ‘619.
Claim 1 has been amended to include the limitation of “a donor polynucleotide that is linear” which is inherent to the system of 19/043,619 as evidence by Strecker. Specifically, 19/043,619 describes the system comprising one or more Tn7 transposases (claim 1 of 19/043,619) and Strecker teaches “We were unable to detect rejoined pDonor backbone during transposition in E. coli (fig. S6, D and E), suggesting that a linear donor backbone is formed, not a rejoined product, consistent with the known reaction products of canonical Tn7” (pg. 3, col. 3, para 3).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 7, 11, and 42 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 13, and 34-35 of copending Application No. 18/269,813 (reference application) as evidenced by Strecker et al (Science, July 5, 2019; reference of record). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of the instant application is generic to all that is recited in claim 1 of ‘813.
Claim 1 of the instant application details an engineered system for insertion of donor polynucleotides comprising one or more CRISPR-associated transposase proteins, a Cas protein, and a guide molecule which guides Cas to a target sequence, which is fully encompassed by claim 1 or 34 of ‘813. Dependent claim 7 of the instant application is fully encompassed by claim 1 or 34 of ‘813. Dependent claim 11 of the instant application is fully encompassed by claim 19 or 35 of ‘813. Dependent claim 42 is fully encompassed by claim 13 of ‘813.
Claim 1 has been amended to include the limitation of “a donor polynucleotide that is linear” which is inherent to the system of 18/269,813 as evidence by Strecker. Specifically, 18/269,813 describes the system comprising one or more Tn7 transposases (claim 1 of 18/269,813) and Strecker teaches “We were unable to detect rejoined pDonor backbone during transposition in E. coli (fig. S6, D and E), suggesting that a linear donor backbone is formed, not a rejoined product, consistent with the known reaction products of canonical Tn7” (pg. 3, col. 3, para 3).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 7, 11, 16, 37, 42, and 52-53 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 17-18, 24, 34, 41, and 46 of copending Application No. 17/773,104 (reference application) as evidenced by Strecker et al (Science, July 5, 2019; reference of record). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of the instant application is generic to all that is recited in claim 1 of ‘104.
Claim 1 of the instant application details an engineered system for insertion of donor polynucleotides comprising one or more CRISPR-associated transposase proteins, a Cas protein, and a guide molecule which guides Cas to a target sequence, which is fully encompassed by claim 1 or 34 of ‘104. Dependent claim 7 is fully encompassed by claim 1 or 34 of ‘104. Dependent claims 11 and 16 are fully encompassed by claim 18 of ‘104. Dependent claim 37 is fully encompassed by claim 17 of ‘104. Dependent claim 42 is fully encompassed by claim 24 of ‘104. Dependent claim 52 is fully encompassed by claim 41 of ‘104. Dependent claim 53 is fully encompassed by claim 46 of ‘104.
Claim 1 has been amended to include the limitation of “a donor polynucleotide that is linear” which is inherent to the system of 17/773,104 as evidence by Strecker. Specifically, 17/773,104 describes the system comprising one or more Tn7 transposases (claim 1 of 17/773,104) and Strecker teaches “We were unable to detect rejoined pDonor backbone during transposition in E. coli (fig. S6, D and E), suggesting that a linear donor backbone is formed, not a rejoined product, consistent with the known reaction products of canonical Tn7” (pg. 3, col. 3, para 3).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
New and Maintained Rejections Necessitated by Amendment
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.
Claims 1, 2, 7, 9, 11, 16, 20-21, 33, 37-38, 42, and 52 remain rejected under 35 U.S.C. 102(a)(1) as being anticipated by Strecker et al (Science, July 5, 2019).
Claim Interpretation:
Regarding claim 1, Strecker teaches an engineered nucleic acid targeting system for insertion of donor polynucleotide comprising:
a) one or more CRISPR-associated transposase proteins (Fig. 1A and 1D),
b) a Cas protein (Fig. 1A and 1D),
c) a guide molecule capable of complexing with the Cas protein and directing sequence-specific binding of the guide-Cas protein complex to a target sequence of a target polynucleotide (Fig. 5, see sgRNA), and
d) a donor polynucleotide that is linear (See pg. 3, col. 3, para 3).
Regarding claim 7, Strecker teaches that the one or more CRISPR-associated transposase proteins are TnsB, TnsC, and TniQ (Fig. 1A and 1D), which are Tn7 transposases (pg. 1, col. 2, para 2).
Regarding claim 2, Strecker teaches wherein the one or more CRISPR-associated transposase protein comprises TnsB and TnsC (Fig. 1A and 1D).
Regarding claim 9, Strecker teaches the use of the TnpA transposase in an alternatively presented embodiment wherein Strecker states “we observe targeted DNA insertions in vitro and in Escherichia coli that are dependent on TnpA transposase activity, Cas9 single guide RNA (sgRNA), and the presence of an insertion site within the ssDNA” (pg. 1, col. 2, para 1).
Regarding claim 11, Strecker teaches that the system further comprises a donor polynucleotide (pg. 2, col. 2, para 1). Strecker teaches that the donor polynucleotide is to be inserted at a position between 40-100 bases downstream of a PAM sequence in the target nucleic acid (Fig. 1F). Further, Strecker teaches wherein the donor polynucleotide is between 100 bases and 300 kb in length, in this case between 500bp and 10 kb (pg. 3, col. 3, para 3).
Regarding claim 16, Strecker teaches wherein the donor polynucleotide inserts a gene or gene fragment at one or both alleles of a target nucleic acid (Fig. 1D).
Regarding claim 20, Strecker teaches wherein the system further comprises a trans-activating CRISPR (tracr) sequence (Fig. 1D, see “tracrRNA”).
Regarding claim 21, Strecker teaches that the Cas protein is a type V Cas, more specifically a Cas12k (Fig. 1A).
Regarding claim 33, Strecker teaches the system employing a Type II Cas protein, wherein the Cas protein is a mutated Cas9, dCas9 (pg. 4, col. 1, para 2).
Regarding claim 37, Strecker teaches wherein the Cas lacks nuclease activity (pg. 4, col. 1, para 2).
Regarding claim 38, Strecker teaches wherein the CRISPR-Cas system comprises a DNA-binding domain (Fig. 1A and 1D). Streaker also teaches wherein the DNA-binding domain is a dead Cas protein, and teaches the optional limitation of dCas9 dCas12 (pg. 4, col. 1, para 2).
Regarding claim 42, Strecker teaches wherein the target nucleic acid has a PAM (Fig. 5, se “PAM”).
Regarding claim 52, Strecker teaches a vector comprising the components of claim 1 (Fig. 1D).
Therefore, Strecker anticipates the claims.
Claim Rejections - 35 USC § 103
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 28 and 53 are rejected under 35 U.S.C. 103 as being unpatentable over Strecker et al (Science, July 5, 2019), as applied to claims 1-2, 7, 9, 11, 16, 20-21, 33, 37-38, 42, and 52 in the 102 rejection above, and in view of Strecker et al (Nature Communications, January 22, 2019), referred to as “Strecker 2”.
Regarding claims 28 and 53, the limitations of the independent claim 1 are taught above.
Strecker does not teach the employment of the system of claim 1 in a eukaryotic cell, however, Strecker states “[t]his work identifies a function for CRISPR-Cas systems beyond adaptive immunity that does not require Cas nuclease activity and pro-vides a strategy for targeted insertion of DNA without engaging homologous recombination pathways, with a particularly exciting potential for genome editing in eukaryotic cells (pg. 6, col. 2, para 1).
Strecker does not teach wherein the Cas protein comprises an activation mutation as required by claim 28. Strecker does not teach wherein the cell is a eukaryotic cell, wherein the eukaryotic cell is a mammalian cell, a cell of a non-human primate or a human cell as required by claim 53.
However, Strecker 2 teaches a CRISPR-Cas system employing bhCas12b in which gain-of-function mutations allow for robust genome editing in human cell lines and in primary human T cells (abstract).
Regarding claim 28, Strecker 2 teaches a CRISPR-Cas system using bhCas12b which has gain-of-function mutations, which is being interpreted to meet the limitation of “activation mutation” because the Cas protein exhibits increased robustness in genome editing following the mutations (abstract).
Regarding claim 53, Strecker 2 teaches the use of the CRISPR-Cas system in eukaryotic cells, which are taught to be human cells (pg. 5, col. 1, para 1; abstract).
One of ordinary skill in the would find it obvious at the effective filling date of the instant invention to combine the CRISPR-Cas system of Strecker with the mutated Cas protein of Strecker 2 to arrive at the instant invention. One of ordinary skill in the art would be motivated to make this combination because Strecker teaches that their CRISPR-Cas system is “particularly exciting potential for genome editing in eukaryotic cells (pg. 6, col. 2, para 1) and Strecker 2 teaches a CRISPR-Cas system employing bhCas12b in which gain-of-function mutations allow for robust genome editing in human cell lines and in primary human T cells (abstract). One of ordinary skill in the art would have a reasonable expectation of success when combining Strecker with Strecker 2 because both teach the necessary information for employing the CRISPR-Cas systems in cells.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the effective time of filing of the invention, especially in the absence of evidence to the contrary.
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Strecker et al (Science, July 5, 2019), as applied to claims 1, 2, 7, 9, 11, 16, 20-21, 33, 37-38, 42, and 52 in the 102 rejection above, and in view of Peters et al (PNAS, 2017).
Regarding claim 29, the limitations of the independent claim 1 are taught above.
Strecker teaches wherein the Cas protein is a Type I Cas protein as required by claim 29 (pg. 1, col. 2, para 2; and col. 3, para 3).
Strecker does not teach wherein the Type I Cas protein comprises Cas8f-Cas5f, Cas6f, and Cas7f, and wherein the Type I Cas protein is a Type I-F Cas protein as required by claim 29.
However, Peters teaches about the recruitment of CRISPR-Cas systems by Tn7-like transposons (abstract).
Regarding claim 29, Peters teaches that “many Tn7-liketransposons contain minimal type I-F CRISPR-Cas systems that consist of fused cas8f and cas5f, cas7f, and cas6f genes and a short CRISPR array” (abstract). Peters also teaches “Canonical Tn7 encodes two targeting pathways that are both mediated by the same set of TnsABC proteins (Fig. 1B). The TnsABC+TnsD(TniQ) pathway appears to be broadly conserved, allowing high-frequency transposition into an attachment site recognized by a cognate TnsD (TniQ) protein (Figs. 1 and 4 and Table S1) (49). The cas1-less I-F CRISPR-Cas variant is encoded in the same location where the tnsE gene that promotes transposition into conjugal plasmids and filamentous bacteriophages is typically located (Fig. 3). Thus, it appears likely that the CRISPR-Cas system functionally re-places TnsE as a mechanism facilitating horizontal transfer of the element” (pg. E7363, col. 2, para 3).
One of ordinary skill in the would find it obvious at the effective filling date of the instant invention to combine the engineered nucleic acid targeting system employing transposase proteins of Strecker with the Type I-F CRISPER-Cas systems consisting of fused cas8f and cas5f, cas7f, and cas6f of Peters to arrive at the instant invention. One of ordinary skill in the art would be motivated to make this combination because Peters also teaches “Canonical Tn7 encodes two targeting pathways that are both mediated by the same set of TnsABC proteins (Fig. 1B). The TnsABC+TnsD(TniQ) pathway appears to be broadly conserved, allowing high-frequency transposition into an attachment site recognized by a cognate TnsD (TniQ) protein (Figs. 1 and 4 and Table S1) (49). The cas1-less I-F CRISPR-Cas variant is encoded in the same location where the tnsE gene that promotes transposition into conjugal plasmids and filamentous bacteriophages is typically located (Fig. 3). Thus, it appears likely that the CRISPR-Cas system functionally re-places TnsE as a mechanism facilitating horizontal transfer of the element” (pg. E7363, col. 2, para 3). One of ordinary skill in the art would have a reasonable expectation of success when combining Strecker with Peters because Strecker teaches the use of Tn7 transposase proteins and Peters teaches about the natural working mechanism of Tn7 transposases and Type I-F CRISPR Cas systems (abstract).
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the effective time of filing of the invention, especially in the absence of evidence to the contrary.
Subject Matter Free of Prior Art
Claim 45 has been amended to include a multitude of SEQ ID NOs which have been searched and deemed free of the prior art. The closest art, which is not available as prior art, is US11384344B2 (16/717,713) which teaches all of the claimed sequences of Claim 45. Incorporation of these claimed sequences into the independent claim would advance prosecution.
Response to Arguments
Applicant's arguments filed 05/26/2026 have been fully considered but they are not persuasive.
Applicant argues (pg. 15) regarding the rejection made under 35 U.S.C. 102 that Strecker does not teach the newly amended limitation of claim 1 requiring that the donor polynucleotide is linear.
In response, this argument is not found persuasive because Strecker does teach a linear donor polynucleotide (See pg. 3, col. 3, para 3). Therefore, the argument is not found persuasive.
Applicant argues (pg. 15-16) in reference to the rejections made under 35 U.S.C. 103 that Strecker II does not remedy the alleged deficiencies of Strecker and that there is no motivation to combine Strecker II.
In response the argument is not found persuasive. The alleged deficiencies of Strecker I are addressed at point 37 above.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, One of ordinary skill in the would find it obvious at the effective filling date of the instant invention to combine the CRISPR-Cas system of Strecker with the mutated Cas protein of Strecker 2 to arrive at the instant invention. One of ordinary skill in the art would be motivated to make this combination because Strecker teaches that their CRISPR-Cas system is “particularly exciting potential for genome editing in eukaryotic cells (pg. 6, col. 2, para 1) and Strecker 2 teaches a CRISPR-Cas system employing bhCas12b in which gain-of-function mutations allow for robust genome editing in human cell lines and in primary human T cells (abstract). One of ordinary skill in the art would have a reasonable expectation of success when combining Strecker with Strecker 2 because both teach the necessary information for employing the CRISPR-Cas systems in cells.
Conclusion
No claims are allowed.
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.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CONSTANTINA E STAVROU whose telephone number is (571)272-9899. The examiner can normally be reached M-F 8:00-5:00.
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CONSTANTINA E. STAVROU
Examiner
Art Unit 1632
/TITILAYO MOLOYE/ Primary Examiner, Art Unit 1632
Prosecution Insights