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 .
Application Status
This action is written in response to applicant’s correspondence received 21 November 2025. Claims 1-2 and 4-15 are currently pending. Claims 11-15 are withdrawn from prosecution as being drawn to non-elected subject matter. Accordingly, claims 1-2 and 4-10 are examined herein. The restriction requirement mailed 22 May 2025 is still deemed proper. Applicant's elected group I without traverse in the reply filed 10 June 2025.
Any rejection or objection not reiterated herein has been overcome by amendment. Applicant' s amendments and arguments have been thoroughly reviewed, but are not persuasive to place the claims in condition for allowance for the reasons that follow.
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.
Claim(s) s 1-2, 4-10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhang (US Patent No. 9,790,490 B2, published 17 October 2017).
Regarding claim 1, Zhang is drawn to an invention concerned with methods and compositions for targeting nucleic acids (Abstract). Zhang teaches the use of an inducible Cpf1 CRISPR-Cas system, termed “Split-Cpf1”, that comprises the following: a first Cpf1 fusion construct attached to a first half of an inducible dimer and a second Cpf1 fusion construct attached to a second half of the inducible dimer that, in the presence of an inducer energy, form a functional Cpf1 protein (Col. 78, lines 41-48). Zhang teaches that the first Cpf1 fusion construct that comprises FKBP fused to C terminal part of the split CPf1 (i.e., a C-terminal side fragment of a split Cpf1 protein) via a GlySer linker while the second Cpf1 fusion construct comprises FRB fused with the N terminal part of the split CPf1 (i.e., an N-terminal side fragment of a split Cpf1 protein) via a GlySer linker (Col. 95, lines 55-67).
Regarding claim 2, Zhang teaches that FKBP and FRB is a dimer that separates the split Cpf1 fusion constructs until rapamycin-induced dimerization (i.e., formation of a dimer with dependence on the presence of a drug) of the FKBP and FRB domains form a set of fused polypeptides that forms a functional full-length Cpf1 nuclease (Col. 89, lines 47-54).
Regarding claim 4, Zhang teaches that the split Cpf1 may be utilized to cleave target nucleic acid sequences (i.e., the split Cpf1 is nuclease-active) (Col. 3, lines 57-63).
Regarding claim 5, Zhang teaches that the Cpf1 may be catalytically inactive (Col. 80, lines 51-59; Col 108, lines 44-67).
Regarding claim 6, Zhang teaches that functional domains may be fused to a functional effector domain (i.e., a functional domain) in order to recruit the functional effector domain to a target region of a gene without inducing cleavage of the target region of the gene (Col. 108, lines 44-67).
Regarding claim 7, Zhang teaches that a heterologous functional domain selected from a transcriptional activator may be located at the amino- or carboxy-terminus and fused to the Cpf1 protein (i.e., a functional domain may be bound to either the N-terminal side fragment or the C-terminal side fragment) (Col. 7, lines 4-5, 33-39).
Regarding claim 8, Zhang teaches the use of an LbCpf1 protein having 100% identity to the claimed SEQ ID NO: 2 (Col. 535; see SEQ ID NO: 242 in previously attached sequence alignment). Zhang teaches that the LbCpf1 protein can be split at positions 566-571 in order to create the split CPf1 protein (Col. 93, lines 12-23).
Regarding claims 9-10, Zhang teaches the use of expression vectors comprising nucleic acids encoding the split Cpf1 protein (Col. 96, line 61 to Col. 97, line 5).
Response to Arguments
Applicant' s amendments and arguments have been thoroughly reviewed, but are not persuasive to place the claims in condition for allowance for the reasons that follow.
Applicant alleges that the newly amended claim 1 has been amended to incorporate the previously pending claim 3, which was not previously rejected under 35 USC 102; therefore, the previously pending 35 USC 102 rejection of record should be withdrawn.
This argument is not found persuasive because the previously pending claim 3 claimed “[..] wherein the N-terminal side fragment of the Cpf1 protein and the C-terminal side fragment of the Cpf1 protein spontaneously associate.” The newly amended claim 1 does not claim the spontaneous association of the C- and N-terminal sides of the Cpf1 protein. Thus, the newly amended claim 1 does not incorporate the subject matter of previously pending claim 3. Therefore, because Zhang teaches each and every limitation present in the newly amended claims 1-2 and 4-10, as described above, the 35 USC 102 rejection of claims 1-2 and 4-10 over Zhang is maintained.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE T REGA whose telephone number is (571)272-2073. The examiner can normally be reached M-R 8:30-4:30, every other F 8:30-4:30 (EDT/EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Neil Hammell can be reached at 571-270-5919. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KYLE T REGA/Examiner, Art Unit 1636
/NEIL P HAMMELL/Supervisory Patent Examiner, Art Unit 1636