DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
2. Applicant’s election of invention Group I (claims 1-8, which are drawn to a guide RNA comprising a target domain) in the reply filed on 1 Oct, 2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
3. Claim1, 3, 4, 9-22 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions Group I and III and corresponding species , there being no allowable generic or linking claim.
4. In response to the species election requirement, Applicant elected SEQ ID NO: 9 as the species of gRNA targeting domain sequence and 2’O-methyl nucleotide and phoshorothioate linkage as the species of chemical modifications. Accordingly, claims 2 and 5-8 are examined herein.
Claim Rejections - 35 USC § 102
5. 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.
6. 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)(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.
7. Claims 2 and 5-8 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Terrett et al (US 2022/0226375 A1; PCT No: PCT/IB2019/001194; Provisional Application 62/767,388, Filed Date: 14 Nov, 2018).
Regarding claim 2, Terret et al teaches [0151] "a guide RNA comprising a spacer sequence (targeting domain) of SEQ ID NO: 171”, wherein SEQ ID NO: 171 is the same as instant SEQ ID NO: 9, see ABSS sequence alignment below.
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Regarding claim 5, Terret et al teaches [0199] that a single-molecule guide RNA comprises, in the 5’ to 3’ direction, a spacer sequence (a targeting domain), a minimum CRISPR repeat sequence (a first complementarity domain), a single-molecule guide linker (a linking domain), a minimum tracrRNA sequence (a second complementarity domain), a 3’ tracrRNA sequence (proximal domain), and an optional spacer extension sequence.
Regarding claim 6, Terret et al teaches ([0197] and [0199]) the genome-targeting nucleic acid is a single molecule guide RNA (sgRNA).
Regarding claim 7 and 8, Terret et al teaches [0204] “various types of RNA modifications can be introduced during or after chemical synthesis and/or enzymatic generation of RNAs, e.g., modifications that enhance stability, reduce the likelihood or degree of innate immune response, and/or enhance other attributes”. Terret et al further discloses SEQ ID NO: 171 (the instant SEQ ID NO: 9) was “modified with 2’-Omethyl phosphorothioate” and is referred as SEQ ID NO: 149 containing additional sequences required for sgRNA (Table 10, pg. 59, sgRNA named CD33-8).
Conclusion
8. Any inquiry concerning this communication or earlier communications from the examiner should be directed to QIWEN SU-TOBON whose telephone number is (571)272-0331. The examiner can normally be reached Monday - Friday, 8:00am-4:30pm.
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QIWEN SU-TOBON
Examiner
Art Unit 1636
/NEIL P HAMMELL/Supervisory Patent Examiner, Art Unit 1636