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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/6/2026 has been entered.
Applicant’s amendment of claim 23 and 26, deleting “SEQ ID NO: 174”, from claim 23, in the paper of 2/6/2026, is acknowledged. Applicants' arguments filed on 2/6/2026, have been fully considered and are deemed to be persuasive to overcome some of the rejections previously applied. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. Claims 1, 2, 4, 6, 8, 10, 12-15, 21, 23, 24, 26, 30, 32, 35-37, 43-45, 48, 49, 55, 57-60, 62, 64, 66, 67-69 are still at issue and are present for examination.
Election/Restrictions
Applicant's election without traverse of Group II, claims 23-26, 28, 30, 32, 34-37, 43, 48, 49, 55 and 67, drawn to a composition comprising a Cas13c effector protein and a nucleic acid component, in the paper of 8/6/2021, is acknowledged.
Applicant's election without traverse of the Species of SEQ ID NO:171, in the paper of 11/23/2022, is acknowledged.
It is noted that with applicants response and amendment of the claims deleting “SEQ ID NO:174” from the claims, the examiner has moved on to SEQ ID NO:169.
Claims 1, 2, 4, 6, 8, 10, 12-15, 21, 44-45, 57-60, 62, 64, 66, 68, 69 are withdrawn from further consideration by the examiner, 37CFR 1.142(b), as being drawn to a non-elected invention.
Claim Objections
Claim 23 is objected to because of the following informalities:
Claim 23 recites “SEQ ID NOs: 33, 36-38 and SEQ ID NOs: 167-170, 172-173 and 175-178” which should be “SEQ ID NOs: 33, 36-38, 167-170, 172-173 and 175-178”.
Appropriate correction is required.
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).
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Claims 23-24, 26, 30, 32, 35-36, 37, 43, 48, 49, 55, 67 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 11,021,740. Although the claims at issue are not identical, they are not patentably distinct from each other because instant claims 23-24, 26, 30, 32, 35-36, 37, 43, 48, 49, 55, 67 drawn to an engineered composition comprising (a) a Cas13c effector protein, and (b) one or more engineered guide RNA(s), wherein the Casl3c effector protein is selected from the group consisting of SEQ ID NOs: 33, 36-38 and SEQ ID NOs: 167-170, 172-173 and 175-178, and, wherein the one or more engineered guide RNA(s) are capable of forming a CRISPR-Cas complex with the Casl3c effector protein and comprise a heterologous guide sequence that directs sequence-specific binding of the CRISPR-Cas complex to a target locus of interest other than a naturally occurring protospacer of the CRISPR-Cas complex and that reprograms the CRISPR-Cas complex to bind said target locus of interest, and wherein the CRISPR-Cas complex modifies the target locus of interest, and wherein the modification comprises a nucleotide strand break are anticipated/obvious by claims 1-28 of U.S. Patent No. 11,021,740 drawn to a diagnostic device comprising one or more individual discrete volumes, each individual discrete volume comprising nucleic acid amplification reagents for amplifying a target sequence, a Cas13 protein exhibiting collateral activity and one or more guide polynucleotides comprising a guide sequence capable of binding the target sequence and designed to form a complex with the Cas protein; and a masking construct.
Further, U.S. Patent No. 11,021,740 teaches that the Cas13 effector protein can be that disclosed in Table 5 WP_005959231 (SEQ. I.D. NO. 575) which is 100% identical to instantly taught SEQ ID NO:169. Thus the claims 1-28 of U.S. Patent No. 11,021,740 drawn to diagnostic device comprising one or more individual discrete volumes, each individual discrete volume comprising nucleic acid amplification reagents for amplifying a target sequence, a Cas13 protein exhibiting collateral activity and one or more guide polynucleotides comprising a guide sequence capable of binding the target sequence and designed to form a complex with the Cas protein; and a masking construct make obvious the above system comprising the Cas13 protein of SEQ. ID. NO. 571 and thus an engineered composition comprising (a) a Cas13c effector protein, and (b) one or more engineered guide RNA(s), wherein the Casl3c effector protein is selected from the group consisting of SEQ ID NOs: 33, 36-38 and SEQ ID NOs: 167-170, 172-173 and 175-178, and, wherein the one or more engineered guide RNA(s) are capable of forming a CRISPR-Cas complex with the Casl3c effector protein and comprise a heterologous guide sequence that directs sequence-specific binding of the CRISPR-Cas complex to a target locus of interest other than a naturally occurring protospacer of the CRISPR-Cas complex and that reprograms the CRISPR-Cas complex to bind said target locus of interest, and wherein the CRISPR-Cas complex modifies the target locus of interest, and wherein the modification comprises a nucleotide strand break (instant claims 23-24, 26, 30, 32, 35-36, 37, 43, 48, 49, 55, 67).
Claims 23-24, 26, 30, 32, 35-36, 37, 43, 48, 49, 55, 67 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 10,266,886. Although the claims at issue are not identical, they are not patentably distinct from each other because instant claims 23-24, 26, 30, 32, 35-36, 37, 43, 48, 49, 55, 67 drawn an engineered composition comprising (a) a Cas13c effector protein, and (b) one or more engineered guide RNA(s), wherein the Casl3c effector protein is selected from the group consisting of SEQ ID NOs: 33, 36-38 and SEQ ID NOs: 167-170, 172-173 and 175-178, and, wherein the one or more engineered guide RNA(s) are capable of forming a CRISPR-Cas complex with the Casl3c effector protein and comprise a heterologous guide sequence that directs sequence-specific binding of the CRISPR-Cas complex to a target locus of interest other than a naturally occurring protospacer of the CRISPR-Cas complex and that reprograms the CRISPR-Cas complex to bind said target locus of interest, and wherein the CRISPR-Cas complex modifies the target locus of interest, and wherein the modification comprises a nucleotide strand break are anticipated/obvious by claims 1-16 of U.S. Patent No. 10,266,886 drawn to a system for detecting the presence of a nucleic acid target sequence in an in vitro sample, comprising: reagents for amplifying the target sequence; a Cas13; at least one guide polynucleotide comprising a guide sequence that hybridizes with the target sequence, and designed to form a complex with the Cas13; and an RNA-based masking construct comprising a non-target sequence; and wherein the Cas13 exhibits collateral RNase activity and cleaves the non-target sequence of the RNA-based masking construct once activated by the target sequence.
Further, U.S. Patent No. 10,266,886 teaches that the Cas13 effector protein can be that disclosed in Table 5 WP_005959231 (SEQ. I.D. NO. 575) which is 100% identical to instantly taught SEQ ID NO:169. Thus the claims 1-16 of U.S. Patent No. 10,266,886 drawn to a system for detecting the presence of a nucleic acid target sequence in an in vitro sample, comprising: reagents for amplifying the target sequence; a Cas13; at least one guide polynucleotide comprising a guide sequence that hybridizes with the target sequence, and designed to form a complex with the Cas13; and an RNA-based masking construct comprising a non-target sequence; and wherein the Cas13 exhibits collateral RNase activity and cleaves the non-target sequence of the RNA-based masking construct once activated by the target sequence make obvious the above system comprising the Cas13 protein of SEQ. I.D. NO. 571 and thus an engineered composition comprising (a) a Cas13c effector protein, and (b) one or more engineered guide RNA(s), wherein the Casl3c effector protein is selected from the group consisting of SEQ ID NOs: 33, 36-38 and SEQ ID NOs: 167-170, 172-173 and 175-178, and, wherein the one or more engineered guide RNA(s) are capable of forming a CRISPR-Cas complex with the Casl3c effector protein and comprise a heterologous guide sequence that directs sequence-specific binding of the CRISPR-Cas complex to a target locus of interest other than a naturally occurring protospacer of the CRISPR-Cas complex and that reprograms the CRISPR-Cas complex to bind said target locus of interest, and wherein the CRISPR-Cas complex modifies the target locus of interest, and wherein the modification comprises a nucleotide strand break (instant claims 23-24, 26, 30, 32, 35-36, 37, 43, 48, 49, 55, 67).
Claims 23-24, 26, 30, 32, 35-36, 37, 43, 48, 49, 55, 67 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,104,937. Although the claims at issue are not identical, they are not patentably distinct from each other because instant claims 23-26, 28, 30, 32, 35-36, 37, 43, 48, 49, 55, 67, 70 drawn an engineered composition comprising (a) a Cas13c effector protein, and (b) one or more engineered guide RNA(s), wherein the Casl3c effector protein is selected from the group consisting of SEQ ID NOs: 33, 36-38 and SEQ ID NOs: 167-170, 172-173 and 175-178, and, wherein the one or more engineered guide RNA(s) are capable of forming a CRISPR-Cas complex with the Casl3c effector protein and comprise a heterologous guide sequence that directs sequence-specific binding of the CRISPR-Cas complex to a target locus of interest other than a naturally occurring protospacer of the CRISPR-Cas complex and that reprograms the CRISPR-Cas complex to bind said target locus of interest, and wherein the CRISPR-Cas complex modifies the target locus of interest, and wherein the modification comprises a nucleotide strand break are anticipated/obvious by claim 1 of U.S. Patent No. 11,104,937 drawn to a nucleic acid detection system comprising: a CRISPR system comprising a Cas13 protein exhibiting collateral activity and one or more guide polynucleotides each comprising a guide sequence capable of binding a target sequence and designed to form a complex with the Cas13 protein; nucleic acid amplification reagents for amplifying the target sequence, and a RNA-based masking construct; wherein the target sequence comprises one or more microbial target sequences.
Further, U.S. Patent No. 11,104,937 teaches that the Cas13 effector protein can be that disclosed in Table 5 WP_005959231 (SEQ. I.D. NO. 575) which is 100% identical to instantly taught SEQ ID NO:169. Thus claim 1 of U.S. Patent No. 11,104,937 drawn to a nucleic acid detection system comprising: a CRISPR system comprising a Cas13 protein exhibiting collateral activity and one or more guide polynucleotides each comprising a guide sequence capable of binding a target sequence and designed to form a complex with the Cas13 protein; nucleic acid amplification reagents for amplifying the target sequence, and a RNA-based masking construct; wherein the target sequence comprises one or more microbial target sequences make obvious the above system comprising the Cas13 protein of SEQ ID. NO. 571 and thus an engineered composition comprising (a) a Cas13c effector protein, and (b) one or more engineered guide RNA(s), wherein the Casl3c effector protein is selected from the group consisting of SEQ ID NOs: 33, 36-38 and SEQ ID NOs: 167-170, 172-173 and 175-178, and, wherein the one or more engineered guide RNA(s) are capable of forming a CRISPR-Cas complex with the Casl3c effector protein and comprise a heterologous guide sequence that directs sequence-specific binding of the CRISPR-Cas complex to a target locus of interest other than a naturally occurring protospacer of the CRISPR-Cas complex and that reprograms the CRISPR-Cas complex to bind said target locus of interest, and wherein the CRISPR-Cas complex modifies the target locus of interest, and wherein the modification comprises a nucleotide strand break (instant claims 23-24, 26, 30, 32, 35-36, 37, 43, 48, 49, 55, 67).
Claims 23-24, 26, 30, 32, 35-36, 37, 43, 48, 49, 55, 67 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-35 of US 11,174,515 . Although the claims at issue are not identical, they are not patentably distinct from each other because instant claims 23-26, 28, 30, 32, 35-36, 37, 43, 48, 49, 55, 67, 70 drawn an engineered composition comprising (a) a Cas13c effector protein, and (b) one or more engineered guide RNA(s), wherein the Casl3c effector protein is selected from the group consisting of SEQ ID NOs: 33, 36-38 and SEQ ID NOs: 167-170, 172-173 and 175-178, and, wherein the one or more engineered guide RNA(s) are capable of forming a CRISPR-Cas complex with the Casl3c effector protein and comprise a heterologous guide sequence that directs sequence-specific binding of the CRISPR-Cas complex to a target locus of interest other than a naturally occurring protospacer of the CRISPR-Cas complex and that reprograms the CRISPR-Cas complex to bind said target locus of interest, and wherein the CRISPR-Cas complex modifies the target locus of interest, and wherein the modification comprises a nucleotide strand break are anticipated/obvious by claims 1-35 of US 11,174,515 drawn to a nucleic acid detection system comprising: a CRISPR system comprising a Cas13 protein exhibiting collateral activity and one or more guide polynucleotides each comprising a guide sequence capable of binding a target sequence and designed to form a complex with the Cas13 protein; nucleic acid amplification reagents for amplifying the target sequence, and a RNA-based masking construct; wherein the target sequence comprises one or more microbial target sequences.
Further, US 11,174,515 teaches that the Cas13 effector protein can be that disclosed in Table 5 WP_005959231 (SEQ. I.D. NO. 575) which is 100% identical to instantly taught SEQ ID NO:169. Thus the claims 1-35 of US 11,174,515 drawn to a nucleic acid detection system comprising: a CRISPR system comprising a Cas13 protein exhibiting collateral activity and one or more guide polynucleotides each comprising a guide sequence capable of binding a target sequence and designed to form a complex with the Cas13 protein; nucleic acid amplification reagents for amplifying the target sequence, and a RNA-based masking construct; wherein the target sequence comprises one or more microbial target sequences make obvious the above system comprising the Cas13 protein of SEQ. I.D. NO. 571 and thus an engineered composition comprising (a) a Cas13c effector protein, and (b) one or more engineered guide RNA(s), wherein the Casl3c effector protein is selected from the group consisting of SEQ ID NOs: 33, 36-38 and SEQ ID NOs: 167-170, 172-173 and 175-178, and, wherein the one or more engineered guide RNA(s) are capable of forming a CRISPR-Cas complex with the Casl3c effector protein and comprise a heterologous guide sequence that directs sequence-specific binding of the CRISPR-Cas complex to a target locus of interest other than a naturally occurring protospacer of the CRISPR-Cas complex and that reprograms the CRISPR-Cas complex to bind said target locus of interest, and wherein the CRISPR-Cas complex modifies the target locus of interest, and wherein the modification comprises a nucleotide strand break (instant claims 23-24, 26, 30, 32, 35-36, 37, 43, 48, 49, 55, 67).
Claims 23-24, 26, 30, 32, 35-36, 37, 43, 48, 49, 55, 67 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of US 11,618,928. Although the claims at issue are not identical, they are not patentably distinct from each other because instant claims 23-26, 28, 30, 32, 35-36, 37, 43, 48, 49, 55, 67, 70 drawn an engineered composition comprising (a) a Cas13c effector protein, and (b) one or more engineered guide RNA(s), wherein the Casl3c effector protein is selected from the group consisting of SEQ ID NOs: 33, 36-38 and SEQ ID NOs: 167-170, 172-173 and 175-178, and, wherein the one or more engineered guide RNA(s) are capable of forming a CRISPR-Cas complex with the Casl3c effector protein and comprise a heterologous guide sequence that directs sequence-specific binding of the CRISPR-Cas complex to a target locus of interest other than a naturally occurring protospacer of the CRISPR-Cas complex and that reprograms the CRISPR-Cas complex to bind said target locus of interest, and wherein the CRISPR-Cas complex modifies the target locus of interest, and wherein the modification comprises a nucleotide strand break are anticipated/obvious by claims 1-22 of US 11,618,928 drawn to a nucleic acid detection system comprising: a CRISPR system comprising a Type VI Cas effector protein exhibiting collateral activity and one or more guide RNAs each comprising a guide sequence capable of binding a target sequence comprising one or more mosquito-borne parasite target sequences and designed to form a complex with the effector protein; and an RNA-based masking construct.
Further, US 11,618,928 teaches that the Cas13 effector protein can be that disclosed in Table 5 WP_005959231 (SEQ. I.D. NO. 575) which is 100% identical to instantly taught SEQ ID NO:169. Thus the claims 1-22 of US 11,618,928 drawn to a nucleic acid detection system comprising: a CRISPR system comprising a Type VI Cas effector protein exhibiting collateral activity and one or more guide RNAs each comprising a guide sequence capable of binding a target sequence comprising one or more mosquito-borne parasite target sequences and designed to form a complex with the effector protein; and an RNA-based masking construct make obvious the above system comprising the Cas13 protein of SEQ. I.D. NO. 571 and thus an engineered composition comprising (a) a Cas13c effector protein, and (b) one or more engineered guide RNA(s), wherein the Casl3c effector protein is selected from the group consisting of SEQ ID NOs: 33, 36-38 and SEQ ID NOs: 167-170, 172-173 and 175-178, and, wherein the one or more engineered guide RNA(s) are capable of forming a CRISPR-Cas complex with the Casl3c effector protein and comprise a heterologous guide sequence that directs sequence-specific binding of the CRISPR-Cas complex to a target locus of interest other than a naturally occurring protospacer of the CRISPR-Cas complex and that reprograms the CRISPR-Cas complex to bind said target locus of interest, and wherein the CRISPR-Cas complex modifies the target locus of interest, and wherein the modification comprises a nucleotide strand break (instant claims 23-24, 26, 30, 32, 35-36, 37, 43, 48, 49, 55, 67).
Claims 23-24, 26, 30, 32, 35-36, 37, 43, 48, 49, 55, 67 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 31-63 of copending Application No. 17/241,382 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because instant claims 23-26, 28, 30, 32, 35-36, 37, 43, 48, 49, 55, 67, 70 drawn an engineered composition comprising (a) a Cas13c effector protein, and (b) one or more engineered guide RNA(s), wherein the Casl3c effector protein is selected from the group consisting of SEQ ID NOs: 33, 36-38 and SEQ ID NOs: 167-170, 172-173 and 175-178, and, wherein the one or more engineered guide RNA(s) are capable of forming a CRISPR-Cas complex with the Casl3c effector protein and comprise a heterologous guide sequence that directs sequence-specific binding of the CRISPR-Cas complex to a target locus of interest other than a naturally occurring protospacer of the CRISPR-Cas complex and that reprograms the CRISPR-Cas complex to bind said target locus of interest, and wherein the CRISPR-Cas complex modifies the target locus of interest, and wherein the modification comprises a nucleotide strand break are anticipated/obvious claims 31-63 of copending Application No. 17/241,382 (reference application) drawn to a diagnostic device comprising one or more individual discrete volumes, each individual discrete volume comprising two or more CRISPR systems, each CRISPR system comprising a distinct Cas13 effector protein having orthogonal cleavage preferences, one or more guide RNAs designed to bind to target molecules, and a masking construct, wherein the two or more CRIPSR systems enable multiplexed detection within the discrete volume.
Further, copending Application No. 17/241,382 (reference application) teaches that the Cas13 effector protein can be that disclosed in Table 5 WP_005959231 (SEQ. I.D. NO. 575) which is 100% identical to instantly taught SEQ ID NO:169. Thus the claims 31-63 of copending Application No. 17/241,382 (reference application) drawn to a diagnostic device comprising one or more individual discrete volumes, each individual discrete volume comprising two or more CRISPR systems, each CRISPR system comprising a distinct Cas13 effector protein having orthogonal cleavage preferences, one or more guide RNAs designed to bind to target molecules, and a masking construct, wherein the two or more CRIPSR systems enable multiplexed detection within the discrete volume make obvious the above device comprising the Cas13 protein of SEQ. I.D. NO. 571 and thus an engineered composition comprising (a) a Cas13c effector protein, and (b) one or more engineered guide RNA(s), wherein the Casl3c effector protein is selected from the group consisting of SEQ ID NOs: 33, 36-38 and SEQ ID NOs: 167-170, 172-173 and 175-178, and, wherein the one or more engineered guide RNA(s) are capable of forming a CRISPR-Cas complex with the Casl3c effector protein and comprise a heterologous guide sequence that directs sequence-specific binding of the CRISPR-Cas complex to a target locus of interest other than a naturally occurring protospacer of the CRISPR-Cas complex and that reprograms the CRISPR-Cas complex to bind said target locus of interest, and wherein the CRISPR-Cas complex modifies the target locus of interest, and wherein the modification comprises a nucleotide strand break (instant claims 23-24, 26, 30, 32, 35-36, 37, 43, 48, 49, 55, 67).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Remarks
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RICHARD G HUTSON whose telephone number is (571)272-0930. The examiner can normally be reached on 6-3 EST Mon-Fri.
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rgh
4/8/2026
/RICHARD G HUTSON/Primary Examiner, Art Unit 1652
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