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 29-48, of record 9/7/23 are pending and subject to prosecution.
PRIORITY
The instant application, filed 3/6/23, is a CONTINUATION of US Patent No. 11,634,731, filed 9/16/2019, is a CONTINUATION of US. Patent No. 10,415,059, filed 2/10/17; which is a CONTINUATION of US Patent No. 9,567,604, filed 3/14/14; which claims priority to US Provisional Application No. 61/921,007 filed 12/26/13; US Provisional Application No. 61/838, 178, filed 6/21/13; US Provisional Application No. 61/838,148 filed 6/21/13; and US Provisional Application No. 61/799,647 filed 3/15/13. Thus, the earliest possible priority for the instant application is 3/15/13.
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. However, Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 61/799,647, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
Independent claims 29, 38 and 39 are directed to compositions comprising a guide RNA and cas9 protein to modify a target genomic sequence, wherein the guide RNA comprises a "complementarity region" consisting of 17-18 nucleotides in length. Provisional Application 61/799,647, filed 3/15/13 discloses RNA guide modification of genomic or double-stranded DNA sequences using complementarity regions of 20 nucleotides in length. Nowhere does this provisional application teach or suggest truncating the complementarity region of the guide RNA.
Thus, pending claims 29-48 are afforded priority to US Provisional Application No. 61/838, 178, filed 6/21/13 and US Provisional Application No. 61/838,148 filed 6/21/13, which disclose 17-18 complementarity regions of guide RNAs.
Claims
Independent claims 29 and 38 are drawn to compositions comprising a complex comprising an S. pyogenes a cas9 protein and a gRNA that includes a complementarity region at the 5’ end of the guide RNA consisting of 17-18 nucleotides that are complementary to 17-18 consecutive nucleotides of the complementary strand of a selected target sequence present on a double-stranded DNA molecule, wherein the target sequence is immediately 5’ of a protospacer adjacent motif (PAM), and
wherein the guide RNA is a single guide RNA (claim 29) or a crRNA (claim 38) .
Independent claim 39 is drawn to a vector encoding a gRNA that includes a complementarity region at the 5’ end of the guide RNA consisting of 17-18 nucleotides that are complementary to 17-18 consecutive nucleotides of the complementary strand of a selected target sequence present on a double-stranded DNA molecule, wherein the target sequence is immediately 5’ of a protospacer adjacent motif (PAM), and
wherein the guide RNA is a single guide RNA or a crRNA .
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 29-48 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,634,731, further in view of US Patent Application Publication No. 2014/0068797 to Doudna, of record. Doudna is cited as a 102(a)(2). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are an obvious variant of the patented claims.
The instant application is a CONTINUATION of 11,634,731.
Claim 1 of the ‘731 patent is drawn to, at least, methods of using a Cas9-HFD fusion protein and a gRNA that includes a complementarity region at the 5’ end of the guide RNA consisting of 17-18 nucleotides that are complementary to 17-18 consecutive nucleotides of the complementary strand of a selected target sequence present on a double-stranded DNA molecule, wherein the target sequence is immediately 5’ of a protospacer adjacent motif (PAM), and wherein the guide RNA is a single guide RNA.
Claim 19 of the patent limits the gRNA to a crRNA .
Instant claims 29, 38 and 39 are drawn to compositions comprising a complex comprising an S. pyogenes a cas9 protein and a gRNA that includes a complementarity region at the 5’ end of the guide RNA consisting of 17-18 nucleotides that are complementary to 17-18 consecutive nucleotides of the complementary strand of a selected target sequence, or a vector encoding the gRNA.
Instant claims 29, 38 and 39 thus comprise a broader “cas9 protein” and gRNA compositions encompassed by the methods used in the patented claims. It would have been obvious to modify the claims of the patent to claim the broader compositions comprising a cas9 protein and guide RNA separately.
Instant claims 33-34 are drawn to wherein the complementarity region is 17 nucleotides or 18 nucleotides and are obvious over claims of the patent for the same reasons as stated above.
Instant claims 30-32, 35-37 and 40-48 are not disclosed in the claims of the patent.
Instant claims 30-32 are drawn to wherein the cas9 has specific cleavage.
Instant claims 35-37 are drawn to a DNA molecule, a vector and a host cell comprising or encoding the complex of claim 29.
Instant claims 40-48 are drawn to specific embodiments of the promoter, the vector type, and a host cell comprising the vector of claim 39.
Doudna is drawn to methods of using compositions comprising cas9 proteins and gRNA to cleave targeted DNA. Doudna discloses the cas9 protein is catalytically active, a nickase, or catalytically inactive (para. [0013], [0618]-[0622], [0626]). Doudna discloses the cas9 protein and the gRNA molecules are encoded on DNA nucleic acids, encoded on vectors, and host cells comprising the nucleic acids encoding them (para. [0010], [0015]). Doudna discloses the vectors encoding the gRNA comprise promoters, including constitutive, inducible, minimal, RNA, U6 and T7 proteins (para. [0103]-[0106], [0446]). Doudna discloses the vectors encoding the gRNA are bacterial or eukaryotic (para. [0139], [0220], [0220]). Doudna discloses host cells comprising the gRNA molecules (para. [0010], [0015]).
It would have been obvious to combine claims directed to a cas9 protein and gRNA further with the disclosure of Doudna. A skilled artisan would have been motivated to use known compositions of functional cas9 proteins, or compositions known for expressing nucleic acids encoding a cas9 and gRNA, such specific promoters, vectors, etc. in claims using cas9 proteins and truncated gRNA.
Claims 29-48 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-31 of U.S. Patent No. 10,415,059, further in view of US Patent Application Publication No. 2014/0068797 to Doudna, of record. Doudna is cited as a 102(a)(2). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are an obvious variant of the patented claims.
The instant application is a CONTINUATION of 11,634,731, which is a CONTINUATION of US 10,415,059.
Claim 1 of the ‘059 patent is drawn to, at least, methods of using a Cas9 protein and a gRNA that includes a complementarity region consisting of 17-18 nucleotides that are complementary to 17-18 consecutive nucleotides of the complementary strand of a selected target sequence present on a double-stranded DNA molecule.
Claim 2 of the ‘059 patent is directed to gRNA that includes a complementarity region consisting of 17-18 nucleotides that are complementary to 17-18 consecutive nucleotides of the complementary strand of a selected target sequence present on a double-stranded DNA molecule.
Claims 8 and 9 of the patent limits the gRNA to a single strand or a crRNA .
Claims 10-12, and 27-31 of the patent are directed to a DNA encoding the gRNA, a vector and a host cell.
Instant claims 29, 38 and 39 are drawn to compositions comprising a complex comprising an S. pyogenes a cas9 protein and a gRNA that includes a complementarity region at the 5’ end of the guide RNA consisting of 17-18 nucleotides that are complementary to 17-18 consecutive nucleotides of the complementary strand of a selected target sequence, or a vector encoding the gRNA.
Instant claims 29, 38 and 39 thus comprise obvious variants of the cas9 protein and gRNA compositions encompassed by the patented claims. It would have been obvious to modify the claims of the patent to claim compositions comprising a cas9 protein and guide RNA, as well as vectors and host cells separately.
Instant claims 33-34 are drawn to wherein the complementarity region is 17 nucleotides or 18 nucleotides and are obvious over claims of the patent for the same reasons as stated above.
Instant claims 30-32 are drawn to wherein the cas9 has specific cleavage. These claims are obvious over patented claims 17-18 of the patent.
Instant claims 35-37 are drawn to a DNA molecule, a vector and a host cell comprising or encoding the complex of claim 29. These claims are obvious over claims 10-12, and 27-31 of the patent.
Instant claims 40-48 are not disclosed in the claims of the patent.
Doudna is drawn to methods of using compositions comprising cas9 proteins and gRNA to cleave targeted DNA. Doudna discloses the cas9 protein and the gRNA molecules are encoded on DNA nucleic acids, encoded on vectors, and host cells comprising the nucleic acids encoding them (para. [0010], [0015]). Doudna discloses the vectors encoding the gRNA comprise promoters, including constitutive, inducible, minimal, RNA, U6 and T7 proteins (para. [0103]-[0106], [0446]). Doudna discloses the vectors encoding the gRNA are bacterial or eukaryotic (para. [0139], [0220], [0220]). Doudna discloses host cells comprising the gRNA molecules (para. [0010], [0015]).
It would have been obvious to combine claims directed to a cas9 protein and gRNA further with the disclosure of Doudna. A skilled artisan would have been motivated to use known compositions for expressing nucleic acids encoding a cas9 and gRNA, such specific promoters, vectors, etc. in claims using cas9 proteins and truncated gRNA.
Claims 29-48 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 9,567,604, further in view of US Patent Application Publication No. 2014/0068797 to Doudna, of record. Doudna is cited as a 102(a)(2). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are an obvious variant of the patented claims.
The instant application is a CONTINUATION of 11,634,731, which is a CONTINUATION of US 10,415,059, which is a CONTINUATION of US 9,567,604.
Independent claims 1, 9 and 17 of US Patent No. 9,567,604 are directed to methods of using a Cas9-HFD fusion protein and a gRNA that includes a complementarity region at the 5’ end of the guide RNA consisting of 17-18 nucleotides that are complementary to 17-18 consecutive nucleotides of the complementary strand of a selected target sequence present on a double-stranded DNA molecule, wherein the target sequence is immediately 5’ of a protospacer adjacent motif (PAM), and wherein the guide RNA is a single guide RNA or crRNA.
Instant claims 29, 38 and 39 are drawn to compositions comprising a complex comprising an S. pyogenes a cas9 protein and a gRNA that includes a complementarity region at the 5’ end of the guide RNA consisting of 17-18 nucleotides that are complementary to 17-18 consecutive nucleotides of the complementary strand of a selected target sequence, or a vector encoding the gRNA.
Instant claims 29, 38 and 39 thus comprise a broader “cas9 protein” and gRNA compositions encompassed by the methods used in the patented claims. It would have been obvious to modify the claims of the patent to claim the broader compositions comprising a cas9 protein and guide RNA separately.
Instant claims 33-34 are drawn to wherein the complementarity region is 17 nucleotides or 18 nucleotides and are obvious over claims of the patent for the same reasons as stated above.
Instant claims 30-32, 35-37 and 40-48 are not disclosed in the claims of the patent.
Instant claims 30-32 are drawn to wherein the cas9 has specific cleavage.
Instant claims 35-37 are drawn to a DNA molecule, a vector and a host cell comprising or encoding the complex of claim 29.
Instant claims 40-48 are drawn to specific embodiments of the promoter, the vector type, and a host cell comprising the vector of claim 39.
Doudna is drawn to methods of using compositions comprising cas9 proteins and gRNA to cleave targeted DNA. Doudna discloses the cas9 protein is catalytically active, a nickase, or catalytically inactive (para. [0013], [0618]-[0622], [0626]). Doudna discloses the cas9 protein and the gRNA molecules are encoded on DNA nucleic acids, encoded on vectors, and host cells comprising the nucleic acids encoding them (para. [0010], [0015]). Doudna discloses the vectors encoding the gRNA comprise promoters, including constitutive, inducible, minimal, RNA, U6 and T7 proteins (para. [0103]-[0106], [0446]). Doudna discloses the vectors encoding the gRNA are bacterial or eukaryotic (para. [0139], [0220], [0220]). Doudna discloses host cells comprising the gRNA molecules (para. [0010], [0015]).
It would have been obvious to combine claims directed to a cas9 protein and gRNA further with the disclosure of Doudna. A skilled artisan would have been motivated to use known compositions of functional cas9 proteins, or compositions known for expressing nucleic acids encoding a cas9 and gRNA, such specific promoters, vectors, etc. in claims using cas9 proteins and truncated gRNA.
Claims 29-48 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 10,119,113, further in view of US Patent Application Publication No. 2014/0068797 to Doudna, of record. Doudna is cited as a 102(a)(2). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are an obvious variant of the patented claims.
The instant application shares the same priority to US Provisional Application No. 61/921,007 filed 12/26/13; US Provisional Application No. 61/838, 178, filed 6/21/13 and US Provisional Application No. 61/838,148 filed 6/21/13, as claimed by U.S. Patent No. 10,119,113.
Independent claims 1-3 of US Patent No. 10,119,133 are directed to methods of using a guide RNA and cas9 to modify a target genomic sequence, wherein the guide RNA comprises a “complementarity region” consisting of 17-18 nucleotides in length, and encompass embodiments wherein the cas9 is catalytically active, is a nickase and/or catalytically inactive.
Instant claims 29, 38 and 39 are drawn to compositions comprising a complex comprising an S. pyogenes a cas9 protein and a gRNA that includes a complementarity region at the 5’ end of the guide RNA consisting of 17-18 nucleotides that are complementary to 17-18 consecutive nucleotides of the complementary strand of a selected target sequence, or a vector encoding the gRNA.
It would have been obvious to modify the claims of the patent to claim compositions comprising a cas9 protein and guide RNA separately.
Instant claims 30-32 are drawn to wherein the cas9 has specific cleavage. These claims are obvious over claims 1-2 of the patent.
Instant claims 33-34 are drawn to wherein the complementarity region is 17 nucleotides or 18 nucleotides and are obvious over claims of the patent for the same reasons as stated above.
Instant claims 35-37 and 40-48 are not disclosed in the claims of the patent.
Instant claims 35-37 are drawn to a DNA molecule, a vector and a host cell comprising or encoding the complex of claim 29.
Instant claims 40-48 are drawn to specific embodiments of the promoter, the vector type, and a host cell comprising the vector of claim 39.
Doudna is drawn to methods of using compositions comprising cas9 proteins and gRNA to cleave targeted DNA. Doudna discloses the cas9 protein and the gRNA molecules are encoded on DNA nucleic acids, encoded on vectors, and host cells comprising the nucleic acids encoding them (para. [0010], [0015]). Doudna discloses the vectors encoding the gRNA comprise promoters, including constitutive, inducible, minimal, RNA, U6 and T7 proteins (para. [0103]-[0106], [0446]). Doudna discloses the vectors encoding the gRNA are bacterial or eukaryotic (para. [0139], [0220], [0220]). Doudna discloses host cells comprising the gRNA molecules (para. [0010], [0015]).
It would have been obvious to combine claims directed to a cas9 protein and gRNA further with the disclosure of Doudna. A skilled artisan would have been motivated to use known compositions of functional cas9 proteins, or compositions known for expressing nucleic acids encoding a cas9 and gRNA, such specific promoters, vectors, etc. in claims using cas9 proteins and truncated gRNA.
Claims 29-48 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 10,844,403, further in view of US Patent Application Publication No. 2014/0068797 to Doudna, of record. Doudna is cited as a 102(a)(2). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are an obvious variant of the patented claims.
Claims 1, 7, and 13 of US Patent No. 10,844,403 are directed to DNA compositions comprising a guide RNA and cas9 to modify a target genomic sequence, wherein the guide RNA comprises a “complementarity region” comprising of 17-20 nucleotides in length, a host cell comprising the gRNA, or a vector encoding the gRNA.
Instant claims 29, 38 and 39 are drawn to compositions comprising a complex comprising an S. pyogenes a cas9 protein and a gRNA that includes a complementarity region at the 5’ end of the guide RNA consisting of 17-18 nucleotides that are complementary to 17-18 consecutive nucleotides of the complementary strand of a selected target sequence, or a vector encoding the gRNA.
It would have been obvious to modify the claims of the patent to claim compositions comprising a cas9 protein and guide RNA separately.
Instant claims 30-32 are drawn to wherein the cas9 has specific cleavage. These claims are obvious over claims 1, 11-12 and 14 of the patent.
Instant claims 33-34 are drawn to wherein the complementarity region is 17 nucleotides or 18 nucleotides and are obvious over claims of the patent for the same reasons as stated above.
Instant claims 35-37 are drawn to a DNA molecule, a vector and a host cell comprising or encoding the complex of claim 29. These claims are obvious over the patented claims for the reasons stated above.
Instant claims 40-48 are not disclosed in the claims of the patent.
Instant claims 40-48 are drawn to specific embodiments of the promoter, the vector type, and a host cell comprising the vector of claim 39.
Doudna is drawn to methods of using compositions comprising cas9 proteins and gRNA to cleave targeted DNA. Doudna discloses the vectors encoding the gRNA comprise promoters, including constitutive, inducible, minimal, RNA, U6 and T7 proteins (para. [0103]-[0106], [0446]). Doudna discloses the vectors encoding the gRNA are bacterial or eukaryotic (para. [0139], [0220], [0220]).
It would have been obvious to combine claims directed to a cas9 protein and gRNA further with the disclosure of Doudna. A skilled artisan would have been motivated to use compositions known for expressing nucleic acids encoding a cas9 and gRNA, such specific promoters, vectors, etc. in claims using cas9 proteins and truncated gRNA.
Claims 29-48 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 11,920,152, further in view of US Patent Application Publication No. 2014/0068797 to Doudna, of record. Doudna is cited as a 102(a)(2). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are an obvious variant of the patented claims.
The instant application shares the same priority to US Provisional Application No. 61/921,007 filed 12/26/13; US Provisional Application No. 61/838, 178, filed 6/21/13 and US Provisional Application No. 61/838,148 filed 6/21/13, as claimed by U.S. Patent No. 11,920,152.
Claims 1, and 7-8 of US Patent No. 11,920,152 are directed to DNA compositions comprising a guide RNA and cas9 to modify a target genomic sequence, wherein the guide RNA comprises a “complementarity region” comprising of 17-20 nucleotides in length in a cell.
Instant claims 29, 38 and 39 are drawn to compositions comprising a complex comprising an S. pyogenes a cas9 protein and a gRNA that includes a complementarity region at the 5’ end of the guide RNA consisting of 17-18 nucleotides that are complementary to 17-18 consecutive nucleotides of the complementary strand of a selected target sequence, or a vector encoding the gRNA.
It would have been obvious to modify the claims of the patent to claim compositions comprising a cas9 protein and guide RNA separately.
Instant claims 33-34 are drawn to wherein the complementarity region is 17 nucleotides or 18 nucleotides and are obvious over claims of the patent for the same reasons as stated above.
Instant claims 30-32, 35-37 and 40-48 are not disclosed in the claims of the patent.
Instant claims 30-32 are drawn to wherein the cas9 has specific cleavage.
Instant claims 35-37 are drawn to a DNA molecule, a vector and a host cell comprising or encoding the complex of claim 29.
Instant claims 40-48 are drawn to specific embodiments of the promoter, the vector type, and a host cell comprising the vector of claim 39.
Doudna is drawn to methods of using compositions comprising cas9 proteins and gRNA to cleave targeted DNA. Doudna discloses the cas9 protein is catalytically active, a nickase, or catalytically inactive (para. [0013], [0618]-[0622], [0626]). Doudna discloses the cas9 protein and the gRNA molecules are encoded on DNA nucleic acids, encoded on vectors, and host cells comprising the nucleic acids encoding them (para. [0010], [0015]). Doudna discloses the vectors encoding the gRNA comprise promoters, including constitutive, inducible, minimal, RNA, U6 and T7 proteins (para. [0103]-[0106], [0446]). Doudna discloses the vectors encoding the gRNA are bacterial or eukaryotic (para. [0139], [0220], [0220]). Doudna discloses host cells comprising the gRNA molecules (para. [0010], [0015]).
It would have been obvious to combine claims directed to a cas9 protein and gRNA further with the disclosure of Doudna. A skilled artisan would have been motivated to use known compositions of functional cas9 proteins, or compositions known for expressing nucleic acids encoding a cas9 and gRNA, such specific promoters, vectors, etc. in claims using cas9 proteins and truncated gRNA.
Conclusion
No claims are allowed.
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KAA
/CHRISTOPHER M BABIC/ Supervisory Patent Examiner, Art Unit 1633