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 .
Claims 150-169, of record 1/20/2026, are pending and subject to prosecution. Claims 150, 162, and 167 are amended.
Status of Prior Rejections/Response to Arguments
RE: Rejection of claims 150-169 under 35 U.S.C. 112(a):
The applicant asserts that the specification provides the residues responsible for the gene editing capability of Cas12J, including for SEQ ID NO 120, and for the consensus identity sequence in the gRNA constant region, thereby establishing a structure-function relationship for the claimed genus (Applicant Remarks, page 7-8). The applicant points to examples 3 and 5-6 (fig. 12-13 and 16-18) as evidence of reduction to practice (Applicant Remarks, page 9). The applicant asserts that the state of the art surrounding Cas12J at the effective filing date of the claimed invention was not unpredictable given the variety of assays available to probe Cas function and that the experimental burden to one of ordinary skill in making/using the invention would not have been undue (Applicant Remarks, page 9-10).
The applicant’s arguments are found persuasive. In light of the arguments, the rejection is withdrawn.
RE: Rejection of claims 150-151, 153-155, and 166-167 on the ground of nonstatutory double patenting over claims 1, 4-6, 9-14, 16, 28, and 30-31 of U.S. Patent No. 11685909 B2:
RE: Rejection of claims 150, 153-156, 158-160, and 162 on the ground of nonstatutory double patenting over claims 1-3, 5-6, 17, 21-23, 25, and 29-31 of U.S. Patent No. 11377646 B2:
RE: Rejection of claims 150-151, 153-155, 162, and 166-167 on the ground of nonstatutory double patenting over claims 1-11, 14, 17, 19-20, and 28-29 of U.S. Patent No. 11578313 B2:
RE: Rejection of claims 150, 153, 155-156, 162, and 166-167 on the ground of nonstatutory double patenting over claims 1-8, 12-14, 22, and 25-26 of U.S. Patent No. 11530398 B2:
RE: Rejection of claims 150-152, 155-156, and 158-161 on the ground of nonstatutory double patenting over claims 15-16, 19-21, and 23 of U.S. Patent No. 12365887 B2:
RE: Provisional rejection of claims 150, 155-156, 158, and 160-162 on the ground of nonstatutory double patenting over claims 150, 152, 158-160, 162, and 166 of copending Application No. 17990074:
The applicant is reminded that 37 CFR 1.111 requires that replies by applicant or patent owner must reply to every ground of objection and rejection in the prior Office action. Only objections or requirements as to form not necessary to further consideration of the claims may be requested to be held in abeyance until allowable subject matter is indicated. Non-statutory double patenting rejections may not be held in abeyance. See MPEP 714.02. The applicant did not traverse the NSDP rejections. The rejections are maintained in modified form to address amended limitations.
Maintained Rejections
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 150-151, 153-155, and 166-167 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-6, 9-14, 16, 28, and 30-31 of U.S. Patent No. 11685909 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons.
Regarding claims 150 and 155: Patented claim 1 recites a pharmaceutical composition comprising: a) at least one expression vector encoding: i) a polypeptide comprising an amino acid sequence that is at least 95% identical to SEQ ID NO: 120 (which reads on “the amino acid sequence has a length of up to 800 amino acids”); and ii) a recombinant guide RNA comprising: 1) a constant region comprising a first nucleotide sequence that is at least 80% identical to SEQ ID NO: 181 (which reads on “a 15-50 nucleotides long constant region”); and 2) a targeting segment comprising a second nucleotide sequence complementary to a target sequence on a target strand (TS) of a double-stranded DNA molecule, wherein the double-stranded DNA molecule comprises a 5′-NTTN-3′ protospacer adjacent motif (PAM) sequence positioned immediately 5′ of the target sequence on a non-target strand (NTS) of the double stranded DNA molecule, wherein T is thymine and N is any nucleotide, and wherein a 3′ end of the first nucleotide sequence of the recombinant guide RNA is linked to a 5′ end of the second nucleotide sequence; and b) a pharmaceutically acceptable excipient. Patented claim 4 recites the pharmaceutical composition of patented claim 1, wherein the constant region is at least 90% identical to SEQ ID NO: 181. Patented claim 5 recites the pharmaceutical composition of patented claim 1, wherein the constant region is at least 95% identical to SEQ ID NO: 181. Patented claim 6 recites the pharmaceutical composition of patented claim 1, wherein the constant region has the nucleic acid sequence set forth in SEQ ID NO: 181. The combined limitations of the patented claims render obvious the instant claims.
Regarding claim 151: Following the discussion of claims 150 and 155, patented claim 28 recites the pharmaceutical composition of patented claim 1, comprising a molecule selected from a lipid and a lipid nanoparticle.
Regarding claim 153: Following the discussion of claims 150 and 155, patented claim 14 recites the pharmaceutical composition of patented claim 1, comprising a DNA donor template.
Regarding claim 154: Following the discussion of claims 150, 153, and 155, patented claim 16 recites the pharmaceutical composition of patented claim 1, wherein the expression vector is an adenoviral vector, adenoviral-associated viral (AAV) vector, a lentiviral vector, or a retroviral vector. Patented claim 30 recites the pharmaceutical composition of patented claim 1, wherein the polypeptide and the recombinant guide RNA are encoded by the expression vector. Patented claim 31 recites the pharmaceutical composition of patented claim 30, wherein the expression vector is an adenoviral-associated viral (AAV) vector. The combined limitations of the patented claims render obvious the instant claim.
Regarding claims 166-167: Following the discussion of claims 150 and 155, patented claim 9 recites the pharmaceutical composition of patented claim 1, wherein the polypeptide is fused to a nuclear localization signal (NLS). Patented claim 10 recites the pharmaceutical composition of patented claim 9, wherein the NLS is fused to the N terminus of the polypeptide, the C terminus of the polypeptide, or both termini of the polypeptide. Patented claim 11 recites the composition of patented claim 10, wherein the NLS is fused to the N terminus of the polypeptide via an amide bond, and wherein the NLS comprises the amino acid sequence set forth in SEQ ID NO: 49. Patented claim 12 recites the composition of patented claim 10, wherein the NLS is fused to the carboxyl terminus (C terminus) of the polypeptide, and wherein the NLS comprises the amino acid sequence set forth in SEQ ID NO: 50. Patented claim 13 recites the composition of patented claim 10, wherein a first NLS comprising the amino acid sequence set forth in SEQ ID NO: 49 is fused to the N terminus of the polypeptide and wherein a second NLS comprising the amino acid sequence set forth in SEQ ID NO: 50 is fused to the C terminus of the polypeptide.
Claims 150, 153-156, 158-160, and 162 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5-6, 17, 21-23, 25, and 29-31 of U.S. Patent No. 11377646 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons.
Regarding claims 150 and 155: Patented claim 1 recites an eukaryotic cell comprising: a) a nuclease comprising an amino acid sequence that is at least 98% identical to the amino acid sequence set forth in SEQ ID NO:120 (which reads on “the amino acid sequence has a length of up to 800 amino acids”); b) a target nucleic acid comprising a target strand and a non-target strand; and c) a recombinant guide nucleic acid comprising in a 5′ to 3′ orientation: i) a first region that binds to the nuclease; and ii) a second region that is complementary to a portion of the target strand of the target nucleic acid, wherein the target nucleic acid comprises a protospacer adjacent motif (PAM) of 5′-NTTN-3′, wherein T is thymine and N is any nucleotide, and wherein the PAM is on the non-target strand of the target nucleic acid. Patented claim 2 recites the eukaryotic cell of patented claim 1, wherein the nuclease comprises an amino acid sequence that is at least 99% identical to the amino acid sequence of SEQ ID NO: 120. Patented claim 3 recites the eukaryotic cell of patented claim 1, wherein the nuclease comprises an amino acid sequence that is 100% identical to the amino acid sequence of SEQ ID NO: 120. Patented claim 5 recites the eukaryotic cell of patented claim 1, wherein the first region of the recombinant guide nucleic acid comprises a nucleotide sequence that is at least 80% identical to SEQ ID NO:181 (which reads on “a 15-50 nucleotides long constant region”). Patented claim 6 recites the eukaryotic cell of patented claim 1, wherein the first region of the recombinant guide nucleic acid comprises a nucleotide sequence that is at least 95% identical to SEQ ID NO:181. The combined teachings of the patented claims render obvious the instant claims.
Regarding claim 153-154: Following the discussion of claims 150 and 155, patented claim 9 recites the eukaryotic cell of patented claim 1, wherein said eukaryotic cell comprises a DNA donor template. Patented claim 17 recites a eukaryotic cell comprising A) a target nucleic acid comprising a target strand and a non-target strand, wherein the target nucleic acid comprises a protospacer adjacent motif (PAM) of 5′-NTTN-3′, wherein T is thymine and N is any nucleotide, and wherein the PAM is on the non-target strand of the target nucleic acid; and B) at least one nucleic acid molecule encoding: a) a nuclease comprising an amino acid sequence that is at least 98% identical to the amino acid sequence set forth in SEQ ID NO:120; and b) a recombinant guide nucleic acid comprising in a 5′ to 3′ orientation: i) a first region that binds to the nuclease; and ii) a second region that is complementary to a portion of the target strand of the target nucleic acid. Patented claim 22 recites the eukaryotic cell of patented claim 21, wherein the expression vector is an adeno-associated viral vector. Patented claim 23 recites the eukaryotic cell of patented claim 17, wherein the eukaryotic cell comprises a DNA donor template.
Regarding claims 156 and 158-160: Following the discussion of claims 150 and 155, patented claim 29 recites the eukaryotic cell of patented claim 1, wherein the recombinant guide nucleic acid comprises at least one modified sugar moiety. Patented claim 30 recites the eukaryotic cell of patented claim 29, wherein the at least one modified sugar moiety is 2′-O-Methyl. Patented claim 31 recites the eukaryotic cell of patented claim 1, wherein the recombinant guide nucleic acid comprises a phosphorothioate linkage.
Regarding claim 162: Following the discussion of claims 150 and 155, patented claim 25 recites the eukaryotic cell of patented claim 17, wherein the nuclease is fused to a heterologous polypeptide (which reads on “fusion partner protein”).
Claims 150-151, 153-155, 162, and 166-167 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11, 14, 17, 19-20, and 28-29 of U.S. Patent No. 11578313 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons.
Regarding claims 150 and 155: Patented claim 1 recites a non-naturally occurring composition comprising: a) a polypeptide, or a nucleic acid comprising a nucleotide sequence encoding the polypeptide, wherein the amino acid sequence of the polypeptide is at least 95% identical to SEQ ID NO:120 (which reads on “the amino acid sequence has a length of up to 800 amino acids”); and b) a guide RNA comprising: i) a first region comprising a guide sequence that hybridizes to a target sequence; and ii) a second region that binds the polypeptide, wherein the first region is heterologous to the second region and wherein the second region is 5′ to the first region; and c) a target double-stranded DNA comprising: i) the target sequence; and ii) a protospacer adjacent motif (PAM) of 5′-NTTN-3′ wherein T is thymine and N is any nucleotide, wherein said PAM is immediately adjacent to the target sequence and wherein the PAM is on the non-target strand of the target double-stranded DNA, 5′ of the target sequence. Patented claim 2 recites the composition of patented claim 1, wherein the N terminus of the polypeptide begins with the amino acid sequence “MIK” (amino acids 1-3 of SEQ ID NO: 120). Patented claim 3 recites the composition of patented claim 1, wherein the N terminus of the polypeptide begins with the amino acid sequence “MIKP” (amino acids 1-4 of SEQ ID NO: 120). Patented claim 4 recites the composition of patented claim 1, wherein the N terminus of the polypeptide begins with the amino acid sequence “MIKPT” (amino acids 1-5 of SEQ ID NO: 120). Patented claim 5 recites the composition of patented claim 1, wherein the N terminus of the polypeptide begins with the amino acid sequence “MIKPTV” (amino acids 1-6 of SEQ ID NO: 120). Patented claim 6 recites the composition of patented claim 1, wherein the N terminus of the polypeptide begins with the amino acid sequence “MIKPTVS” (amino acids 1-7 of SEQ ID NO: 120). Patented claim 7 recites the composition of patented claim 1, wherein the N terminus of the polypeptide begins with the amino acid sequence “MIKPTVSQ” (amino acids 1-8 of SEQ ID NO: 120). Patented claim 8 recites the composition of patented claim 1, wherein the N terminus of the polypeptide begins with the amino acid sequence “MIKPTVSQF” (amino acids 1-9 of SEQ ID NO: 120). Patented claim 9 recites the composition of patented claim 1, wherein the recombinant guide RNA comprises a nucleobase sequence that is at least 80% identical to SEQ ID NO:181 (which reads on “a 15-50 nucleotides long constant region”). Patented claim 10 recites the composition of patented claim 1, wherein the recombinant guide RNA comprises a nucleobase sequence that is at least 95% identical to SEQ ID NO:181. Patented claim 17 recites the pharmaceutical composition comprising the composition of patented claim 1, and a pharmaceutically acceptable excipient. Patented claim 20 recites the composition of patented claim 1, wherein the amino acid sequence of the polypeptide is at least 98% identical to SEQ ID NO: 120. The combined limitations of the patented claims render obvious the instant claims.
Regarding claim 151: Following the discussion of claims 150 and 155, patented claim 28 recites the composition of patented claim 1, comprising a lipid nanoparticle.
Regarding claims 153-154: Following the discussion of claims 150 and 155, patented claim 14 recites the composition of patented claim 1, comprising a DNA donor template, an additional recombinant guide RNA. Patented claim 29 recites the composition of patented claim 1, comprising an adeno-associated viral (AAV) vector that comprises the nucleic acid encoding the polypeptide. Patented claim 30 recites the composition of patented claim 29, wherein the AAV vector encodes the guide RNA. The combined limitations of the patented claims render obvious the instant claims.
Regarding claim 162: Following the discussion of claims 150 and 155, patented claim 19 recited the composition of patented claim 1, comprising a heterologous polypeptide (which reads on “fusion partner protein” fused directly to the N terminus or C terminus of the polypeptide.
Regarding claims 166-167: Following the discussion of claims 150 and 155, patented claim 11 recites the composition of patented claim 1, comprising a nuclear localization signal (NLS) that is fused to the N terminus of the polypeptide, the C terminus of the polypeptide, or both termini.
Claims 150, 153, 155-156, 162, and 166-167 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8, 12-14, 22, and 25-26 of U.S. Patent No. 11530398 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons.
Regarding claims 150 and 155: Patented claim 1 recites a composition comprising: a) a polypeptide consisting of the amino acid sequence of SEQ ID NO:120 (which reads on “the amino acid sequence has a length of up to 800 amino acids”); and b) a recombinant guide RNA comprising; i. a nucleotide sequence that is complementary to a target sequence of a target nucleic acid and ii. a region that associates with the polypeptide to form a guide RNA-polypeptide complex, wherein (i) is heterologous to (ii). Patented claim 2 recites the composition of patented claim 1, wherein the recombinant guide RNA comprises a nucleotide sequence that is at least 80% identical to SEQ ID NO:181 (which reads on “a 15-50 nucleotides long constant region”). Patented claim 3 recites the composition of patented claim 1, wherein the recombinant guide RNA comprises a nucleotide sequence that is at least 95% identical to SEQ ID NO:181. Patented claim 12 recites the composition of patented claim 1, comprising the target nucleic acid, wherein the target nucleic acid comprises a protospacer adjacent motif (PAM) adjacent to said target sequence, wherein the PAM comprises the sequence 5′-NTTN-3′, wherein N is any nucleotide and T is thymine. Patented claim 14 recites the composition of patented claim 1, comprising a pharmaceutically acceptable excipient. Patented claim 25 recites the composition of patented claim 12, wherein the target nucleic acid comprises: (i) a target strand (TS) and (ii) a non-target strand (NTS) comprising the PAM wherein the PAM is 5′ to the target sequence. Patented claim 26 recites the composition of patented claim 2, wherein the nucleotide sequence that is at least 80% identical to SEQ ID NO: 181 is in a 5′ orientation with respect to the nucleotide sequence that is complementary to the target sequence. The combined limitation of the patented claims render obvious the instant claims.
Regarding claim 153: Following the discussion of claims 150 and 155, patented claim 8 recites the composition of patented claim 1, comprising a DNA donor template.
Regarding claim 156: Following the discussion of claims 150 and 155, patented claim 22 recites the composition of patented claim 1, wherein the recombinant guide RNA comprises one or more of a base modification, a sugar modification, and a backbone modification.
Regarding claim 162: Following the discussion of claims 150 and 155, patented claim 13 recites the composition of patented claim 1, comprising a heterologous polypeptide (which reads on “fusion partner protein”) that is fused to the polypeptide.
Regarding claims 166-167: Following the discussion of claims 150 and 155, patented claim 4 recites the composition of patented claim 1, comprising a nuclear localization signal (NLS) fused to the amino terminus (N terminus), the carboxyl terminus (C terminus), or both termini of the polypeptide. Patented claim 5 recites the composition of patented claim 4, wherein the NLS is fused to the N terminus of the polypeptide, and wherein the NLS comprises the amino acid sequence set forth in SEQ ID NO:49 or SEQ ID NO:50. Patented claim 6 recites composition of patented claim 4, wherein the NLS is fused to the C terminus of the polypeptide, and wherein the NLS comprises the amino acid sequence set forth in SEQ ID NO:49 or SEQ ID NO:50. Patented claim 7 recites the composition of patented claim 4, wherein a first NLS comprising the amino acid sequence set forth in SEQ ID NO: 49 is fused to the N terminus of the polypeptide and wherein a second NLS comprising the amino acid sequence set forth in SEQ ID NO: 50 is fused to the C terminus of the polypeptide.
Claims 150-152, 155-156, and 158-161 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 15-16, 19-21, and 23 of U.S. Patent No. 12365887 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons.
Regarding claims 150 and 155: Patented claim 15 recites a composition for cleaving double stranded DNA (dsDNA) in a cell, the composition comprising: a) a nucleic acid encoding a polypeptide, wherein the polypeptide comprises an amino acid sequence that is at least 95% identical to any one of SEQ ID NOs: 109-126 (which reads on “the amino acid sequence has a length of up to 800 amino acids”); and b) a guide nucleic acid, wherein the guide nucleic acid comprises: i) a repeat sequence; and ii) a spacer sequence, wherein the spacer sequence hybridizes to a target sequence on a target strand of the dsDNA, wherein: the target sequence is adjacent to a protospacer adjacent motif (PAM) of 5′-NTTN-3′ and the PAM is located 5′ of the target sequence on the non-target strand, and the polypeptide and the guide nucleic acid form a ribonucleoprotein (RNP) complex that binds the target sequence and cleaves the dsDNA. Patented claim 16 recites a pharmaceutical composition comprising the composition of patented claim 15 and a pharmaceutically acceptable excipient. Patented claim 23 recites the composition of patented claim 15, wherein the repeat sequence comprises a nucleotide sequence that is at least 80% identical to SEQ ID NO: 181 (which reads on “a 15-50 nucleotides long constant region”).
While the patented claims do not recite a nucleotide sequence that is at least 85% identical to SEQ ID NO 181, a prima facie case of obviousness exists where claimed amounts do not overlap with the prior art but are merely close. See MPEP 2144.05(I).The combined limitations of the patented claims therefore render obvious the instant claims.
Regarding claims 151-152: Following the discussion of claims 150 and 155, patented claim 19 recites the composition of patented claim 15, comprising an LNP, wherein the nucleic acid encoding the polypeptide and the guide nucleic acid are contained in the LNP.
Regarding claims 156 and 158-160: Following the discussion of claims 150 and 155, patented claim 21 recites the composition of patented claim 15, wherein the guide nucleic acid comprises a 2′-O-Methyl modified nucleotide, a phosphorothioate linkage, or a combination thereof.
Regarding claim 161: Following the discussion of claims 150 and 155, patented claim 20 recites the composition of patented claim 15, wherein the nucleic acid encoding the polypeptide comprises a messenger RNA.
Claims 150, 155-156, 158, and 160-162 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 150, 152, 158-160, 162, and 166 of copending Application No. 17990074 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons.
Regarding claims 150 and 155: Co-pending claim 150 recites a composition comprising: a. a nucleic acid sequence that encodes a protein at least 95% identical to SEQ ID NO: 120 (which reads on “the amino acid sequence has a length of up to 800 amino acids”); and b. a DNA molecule encoding a guide RNA, or a guide RNA thereof, wherein the guide RNA comprises: i. a nucleotide sequence that is complementary to a target sequence of a target nucleic acid; and ii. a region that associates with a protein to form a guide RNA-protein complex wherein (i) is heterologous to (ii). Co-pending claim 152 recites the composition of co-pending claim 150, wherein the DNA molecule encodes a sequence that transcribes into, or the guide RNA is, a sequence that is 80% similar to SEQ ID NO: 181 (which reads on “a 15-50 nucleotides long constant region”) and is in a 5′ orientation with respect to the nucleotide sequence that is complementary to the target sequence. Co-pending claim 158 recites the composition of co-pending claim 150, comprising the target nucleic acid, wherein the target nucleic acid comprises a protospacer adjacent motif (PAM) adjacent to said target sequence, wherein the PAM comprises the sequence 5′ -NTTN-3′, wherein N is any nucleotide and T is thymine. Co-pending claim 159 recites the composition of co-pending claim 158, wherein the target nucleic acid comprises: (i) a target strand (TS) and (ii) a non-target strand (NTS) comprising the PAM wherein the PAM is 5′ to the target sequence. The combined limitations of the co-pending claims render obvious the instant claims.
Regarding claims 156, 158, and 160: Following the discussion of claims 150 and 155, co-pending claim 166 recites the composition of co-pending claim 150, wherein the recombinant guide RNA comprises one or more of a base modification, a sugar modification, and a backbone modification.
Regarding claim 161: Following the discussion of claims 150 and 155, co-pending claim 162 recites composition of co-pending claim 150, wherein the nucleic acid sequence is a messenger RNA.
Regarding claim 162: Following the discussion of claims 150 and 155, co-pending claim 160 recites the composition of co-pending claim 150, wherein the nucleic acid sequence encodes a heterologous polynucleotide (which reads on “fusion partner protein”) that is fused to the protein.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Allowable Subject Matter
Claims 157, 163-165, and 168-169 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/J.S.S./Examiner, Art Unit 1633
/CHRISTOPHER M BABIC/Supervisory Patent Examiner, Art Unit 1633