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 .
Amendments
In the reply filed 12/23/2025, Applicant has amended Claims 6, 9 and 10.
Claims 1-5 are pending but withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected invention, there being no allowable generic or linking claim.
Claim 6-10 are under consideration.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 3/13/2026 was filed after the mailing date of the non-final Office action on 9/23/2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Withdrawn Objection to Drawings
The prior objection to the drawings Figure 3 (target sequences for FANCF and RNF2), Figure 10 (target sequences for BIRC7 and ABHD12), Figure 13 (target sequences), Figure 15 (target sequences and modified sequences for ARAP2), and Figures 16a & b of the Specification as not conforming to sequence rules is withdrawn in light of the sequence listing filed on 12/23/2025.
Withdrawn Objection to Specification
The prior objection to the specification for failing to comply with the requirements of 37 CFR 1.821 - 1.825 because it did not contain a "Sequence Listing" is withdrawn in light of the sequence listing filed on 12/23/2025.
Withdrawn Claim Objections
The prior objection to Claim 6 is withdrawn in light of Applicant’s amendments.
Withdrawn 35 USC § 112(b)
The prior rejection of Claim 9 under 35 U.S.C. § 112(b) pre-AIA 2nd paragraph as being indefinite is withdrawn in light of Applicant’s amendments of instant claim to describe the cytosine being base edited.
Withdrawn Claim Rejections - 35 USC § 102
The prior rejection of Claims 6-10 under 35 U.S.C. 102(a)(1) as being anticipated by Kim et al. (Nature Biotech, published October 2019, 37:1145-1148, see IDS filed 1/27/2022) is withdrawn in light of Applicant’s perfection of their foreign priority with a certified English translation.
Maintained Claim Rejections - 35 USC § 102
Note that the grounds of the rejection by Lee have not changed, and that the evidentiary reference of Liu has been incorporated to address Applicant’s amendment that the ABE is fusion to the N-term of a Cas9 nickase
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.
Claims 6-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lee et al. (Nature Comm, 2018, 9:4804, prior art of record), as evidenced by Liu et al. (Nature Comm, 2018, 9:2338)
With respect to claim 6, Lee teaches a method for both adenine and cytosine base-editing comprising bring a seventh generation ABE (i.e., ABE7.10) and Cas9 protein into contact with a target sequence in a mouse embryo (pgs. 3-4, Tables 1-2, p. 5, Methods, Sup Fig. 3). In regard to the ABE and Cas9 being a fusion protein, Lee teaches that the “deaminase fused-Cas9” was microinjected into the mouse embryos (Methods, 3rd para.). Furthermore, Lee teaches the ABE 7.10 were described in their previously published experiments by Liu et al. (2018) (p. 2, Results, 1st para.). Importantly, Liu evidences that the ABE 7.10 comprises TadA deaminases fused to the N-terminus of a Cas9 D10A nickase (Introduction).
In regard to claim 7, Lee teaches the C5 position in the Ar target locus is substituted to A, T or G (Sup Fig. 3 “sgRNA-1”).
In regard to claim 8, Lee teaches a window of base-editing ranging from the 4th position to the 8th position in the target (Supp Fig. 3).
In regard to claim 9, as stated supra, Lee demonstrates the substitution of C5 in the Ar target locus, which is adjacent to a 5’ T.
In regard to claim 10, as stated supra, Lee teaches the base-editing composition is ABE7.10.
Accordingly, Lee anticipates instant claims.
RESPONSE TO ARGUMENTS
Applicant's arguments filed on 12/23/2025 are acknowledged.
Applicant argues that Lee teaches the ABE 7.10 used edited adenosine (A) to guanosine (G) with remarkable fidelity, and that A to C editing was an “unexpected result”, with only 3 out of 214 alleles demonstrating cytosine editing. Applicant argues that the teaches of Lee would have discouraged one of ordinary skill in the art from use the ABE 7.10 base editor for cytosine base editing.
Applicant’s arguments have been fully considered but are not found persuasive.
In response to Applicant’s argument that Lee et al. teach away from using the ABE 7.10-nCas9 fusion for cytosine base editing, a reference is no less anticipatory if, after disclosing the invention, the reference then disparages it. The question whether a reference teaches away from the invention is inapplicable to an anticipation analysis. Thus, the fact that the ABE 7.10-nCas9 fusion are shown to be less than optimal in modifying cytosine based, does not vitiate the fact that their use in said method was disclosed (also see MPEP § 2131.05).
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 6 and 7 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 1-13 of copending Application No. 18/292,048. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented
The subject matter claimed in the instant application is disclosed in the referenced application as follows: the method for preventing or treating retinal dysfunction comprising administering a fusion protein comprising Cas9 and an adenine deaminase of cited application anticipates the composition of instant application. It is clear that elements of the cited application claims are to be found in instant claims. The difference between the cited application claims and the instant claims lies in the fact that the cited application claims are much more specific. Thus the invention of said claims of the cited application are in effect “species” of the “generic” invention of the instant claim. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
Since the instant application claims are anticipated by cited application claims, said claims are not patentably distinct.
RESPONSE TO ARGUMENTS
Applicant's arguments filed on 12/23/2025 are acknowledged and ask that the provisional rejection be held in abeyance until allowable subject matter is identified.
Conclusion
Applicant's amendment necessitated the modification of the 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 extension fee 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 date of this final action.
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARTHUR S LEONARD whose telephone number is (571)270-3073. The examiner can normally be reached on Mon-Fri 9am-5pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Doug Schultz can be reached on 571-272-0763. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ARTHUR S LEONARD/Examiner, Art Unit 1631