DETAILED ACTION
All objections and rejections stated in prior Office Actions are withdrawn unless restated below.
Claims 2, 4, 11 and 14 remain withdrawn.
It is noted that no Power of Attorney is filed in this application, which may be needed to file a Terminal Disclaimer.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 07/30/2026 has been entered.
Specification
The disclosure is objected to because of the following informalities:
There is a mis-match between SEQ ID NO: 475 as presented within the body of the Specification and SEQ ID NO: 475 as in the Sequence Listing. The two sequences must match.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 56, 64, 65, and 69 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The purpose of the written description requirement is to ensure that the inventor had possession, at the time the invention was made, of the specific subject matter claimed. For a broad generic claim, the specification must provide adequate written description to identify the genus of the claim.
“A written description of an invention involving a chemical genus, like a description of a chemical species, 'requires a precise definition, such as by structure, formula, [or] chemical name,' of the claimed subject matter sufficient to distinguish it from other materials." Fiers, 984 F.2d at 1171, 25 USPQ2d 1601; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284985 (CCPA 1973) (“In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus.”). Regents of the University of California v. Eli Lilly & Co., 119, F.3d 1559, 1568, 43 USPQ2d 1398, 1405 (Fed. Cir. 1997).
MPEP § 2163 further states that if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure of the biomolecule, it is "not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed biomolecule.”
“The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice . . ., reduction to drawings . . ., or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus.” MPEP 2163(II)(3)(a).
Furthermore, a “‘representative number of species’ means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure ‘indicates that the patentee has invented species sufficient to constitute the gen[us].’ See Enzo Biochem, 323 F.3d at 966, 63 USPQ2d at 1615; Noelle v. Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004) (Fed. Cir. 2004) (‘[A] patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated.’). ‘A patentee will not be deemed to have invented species sufficient to constitute the genus by virtue of having disclosed a single species when … the evidence indicates ordinary artisans could not predict the operability in the invention of any species other than the one disclosed.’ In re Curtis, 354 F.3d 1347, 1358, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004).” MPEP 2163(II)(3)(a).
SEQ ID NO: 475 as recited in claim 56 is as follows:
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That is, SEQ ID NO: 475 is one amino acid residue that can be any naturally-occurring amino acid. As such, claim 56 recites a base editor as defined by having any single amino acid sequence.
As such, a base editor comprising SEQ ID NO: 475 encompasses substantial structural diversity wherein a single amino acid residue does not constitute sufficient structure for activity of a base editor.
“The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice . . ., reduction to drawings . . ., or by disclosure of relevant, identifying characteristics.” Here, the specification discloses many full-length base editors, wherein, for example, SEQ ID NO: 169 has 1605 amino acid residues. However, the same is not representative for all base editors defined by having a single amino acid as set forth in SEQ ID NO: 475 of the Sequence Listing nor a sufficient disclosure of relevant, identifying characteristics shared by members of the genus of base editors comprising SEQ ID NO: 475. The claims lack adequate written description for these reasons. This rejection can be overcome by amending SEQ ID NO: 475.
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.
(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.
Claim(s) 56, 65, and 69 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Joung et al. (U.S. 2020/0308571 A1, filed 02/04/2020).
Joung et al, in the claims, states:
1. An adenine base editor (ABE) variant comprising an adenosine deaminase and a programmable DNA binding domain, the adenosine deaminase comprising one or more E. coli TadA monomers, wherein at least one of the one or more E. coli TadA monomers comprise one or more mutations that decrease RNA editing activity while preserving DNA editing activity.
2. The ABE variant of claim 1, wherein the adenosine deaminase comprises a wild type or engineered E. coli TadA monomer, or a variation of homo- or heterodimers thereof.
3. The ABE variant of claim 1, wherein the adenosine deaminase comprises ABE 0.1, ABE 0.2, ABE 1.1, ABE 1.2, ABE 2.1, ABE 2.2, ABE 2.3, ABE 2.4, ABE 2.5, ABE 2.6, ABE 2.7, ABE 2.8, ABE 2.9, ABE 2.10, ABE 2.11, ABE 2.12, ABE 3.1, ABE 3.2, ABE 3.3, ABE 3.4, ABE 3.5, ABE 3.6, ABE 3.7, ABE 3.8, ABE 4.1, ABE 4.2, ABE 4.3, ABE 5.1, ABE 5.2, ABE 5.3, ABE 5.4, ABE 5.5, ABE 5.6, ABE 5.7, ABE 5.8, ABE 5.9, ABE 5.10, ABE 5.11, ABE 5.12, ABE 5.13, ABE 5.14, ABE 6.1, ABE 6.2, ABE 6.3, ABE 6.4, ABE 6.5, ABE 6.6, ABE 7.1, ABE 7.2, ABE 7.3, ABE 7.4, ABE 7.5, ABE 7.6, ABE 7.7, ABE 7.8, ABE 7.9, ABE 7.10, or ABEmax.
4. The ABE variant of claim 1, wherein the one or more mutations comprise one or more mutations at amino acid positions that correspond to residues of wild type E. coli TadA (SEQ ID NO:1) or E. coli TadA deaminase monomer with ABE 7.10 mutations (SEQ ID: [[24]]34) as listed in Table A.
5. The ABE variant of claim 4, wherein the one or more mutations are at amino acid positions that correspond to residues Y10, W11, R13, T17, K20, R21, R23, E25, R26, A48, 149, A56, A58, Q71, N72, R74, D77, V82, V106, R107, N108, A109, K110,T111, H122, Y123, H128, R129, A138, D139, E140, A142, A143, F148, and/or R150, R153, V155 of wild type E. coli TadA (SEQ ID NO:1) or E. coli TadA deaminase monomer with ABE 7.10 mutations (SEQ ID: [[24]]34).
6. The ABE variant of claim 5, wherein the one or more mutations comprise mutations that correspond to Y10A, W11A, R13A, T17A, K20A, R21A, R23A, R23W, E25A, R26A, A48G, I49A, A56G, A58G, Q71A, N72A, R74A, D77A, V82G, V106G, V106W, R107A, N108A, A109G, A109W, K110A, T111A, H122A, Y123A, H128A, R129A, A138W, A138G, D139A, E140A, A142W, A142G, A143G, F148A, R150A, R153A, V155G, and/or V155W of wild type E. coli TadA (SEQ ID NO:1) or E. coli TadA deaminase monomer with ABE 7.10 mutations (SEQ ID: [[24]]34).
“Adenine base editors (ABEs) are fusions of programmable DNA-binding domains (e.g, catalytically impaired RNA-guided CRISPR-Cas nucleases) linked to engineered adenosine deaminases that can induce programmable adenosine (A) to inosine (I) edits in single-stranded DNA that in turn result in A-to-G transitions after DNA repair or replication.” Joung, para. [0005].
To engineer SECURE-ABE variants, we first used a protein truncation strategy to reduce the RNA recognition capability of the widely used ABEmax fusion. ABEmax harbors a single-chain heterodimer of the wild type (WT) E. coli TadA adenosine deaminase monomer (which deaminates adenines on tRNA) fused to an engineered E. coli TadA monomer that was modified by directed evolution to deaminate DNA adenines3,6,7 (FIG. 6a ). We hypothesized that the WT TadA monomer should still be capable of recognizing its tRNA substrate and therefore might recruit ABEmax to deaminate RNA adenines that lie in the same or a similar sequence motif to that present in the tRNA. Consistent with this idea, a re-analysis of our previously published RNA-seq data5 revealed that adenines that are edited at the highest efficiencies (80-100%) are embedded in a more extended CUACGAA motif, which contrasts to the shorter UA sequence observed across all edits (FIG. 6b ). Importantly, the CUACGAA motif is a perfect match to the sequence surrounding the adenine deaminated in the tRNA substrate of the WT E. coli TadA enzyme6. We reasoned that removing the WT TadA domain from ABEmax might reduce its RNA editing activity and we therefore generated a smaller ABEmax variant lacking this domain that we refer to as miniABEmax (FIG. 6a ).” Joung, para. [0169].
SEQ ID NO: 33 of Young is an embodiment miniABEmax base editor that comprises a naturally-occurring amino acid residue as to comprise SEQ ID NO: 475.
As such, the above anticipates claim 56.
Regarding claim 65, for Fig. 9, “Heat maps showing the on-target DNA editing efficiencies of nCas9 (Control), ABEmax, miniABEmax, miniABEmax-K20A/R21A, and miniABEmax-V82G each assessed with two gRNAs targeted to ABE site 16 and HEK site 2 and performed in triplicate.” Joung, para. [0045]. Fig 9 of Joung shows ABE site 16 is GAATAA and shows that embodiments of Joung have A to G editing efficiencies above 70%.
Regarding claim 69, for Fig. 14 of Joung,” Heat maps showing A-to-G DNA on-target (left) and A-to-G DNA off-target (right) editing efficiencies of nCas9 (Control), ABEmax, miniABEmax-K20A/R21A, and miniABEmax-V82G each co-expressed with HEK site 2, HEK site 3, or HEK site 4 gRNAs (n=4 independent replicates).” Joung, para. [0055]. Fig. 14 of Young indicates that off-target frequency achievable by embodiment base editors of Joung is less than 1%.
Claim(s) 56, 64, 65, and 69 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gaudelli et al. (Programmable base editing of A•T to G•C in genomic DNA without DNA cleavage, Nature 551, 2017, 464-71).
Gaudelli, abstract, state:
The spontaneous deamination of cytosine is a major source of transitions from C•G to T•A base pairs, which account for half of known pathogenic point mutations in humans. The ability to efficiently convert targeted A•T base pairs to G•C could therefore advance the study and treatment of genetic diseases. The deamination of adenine yields inosine, which is treated as guanine by polymerases, but no enzymes are known to deaminate adenine in DNA. Here we describe adenine base editors (ABEs) that mediate the conversion of A•T to G•C in genomic DNA. We evolved a transfer RNA adenosine deaminase to operate on DNA when fused to a catalytically impaired CRISPR–Cas9 mutant. Extensive directed evolution and protein engineering resulted in seventh-generation ABEs that convert targeted A•T base pairs efficiently to G•C (approximately 50% efficiency in human cells) with high product purity (typically at least 99.9%) and low rates of indels (typically no more than 0.1%). ABEs introduce point mutations more efficiently and cleanly, and with less off-target genome modification, than a current Cas9 nuclease-based method, and can install disease-correcting or disease-suppressing mutations in human cells. Together with previous base editors, ABEs enable the direct, programmable introduction of all four transition mutations without double-stranded DNA cleavage.
The adenine base editor identified as ABE7.10 (Gaudelli, Supplemental material) has a naturally-occurring amino acid residue as to comprise SEQ ID NO: 475.
It is noted that ABE7.10 and ABE7.4 as disclosed by Gaudelli are identical except for a difference a single R152P substitution site. See Gaudelli, Fig. 3C.
Claim 56 is anticipated for these reasons.
Regarding claim 64, Gaudelli states that indel rate is below 0.1% as to satisfy claim 64.
Regarding claim 65, Gaudelli, Fig. 3C, shows for ABE7.4 that conversion/efficiency is over 70% for a site containing CAC for conversion of A to G as described. Supplementary Table 2 of Gaudelli also shows efficiency/conversion values for ABE7.10 that are above 70% at site A5 (within a TAT sequence as shown in Fig. 4).
Regarding claim 69, “Next we examined off-target editing by ABE7 variants. As no method yet exists to comprehensively profile the off-target activity of ABEs, we assumed that off-target ABE editing occurred primarily at the off-target sites that are edited when Cas9 nuclease is complexed with the same guide RNA, as is the case with BE. We treated HEK293T cells with three well-characterized guide RNAs35 and either Cas9 nuclease or ABE7 variants, and sequenced the on-target loci and the 12 most active off-target human genomic loci associated with these guide RNAs as identified by the genome-wide GUIDE-Seq method35. The efficiency of on-target indels by Cas9 and the efficiency of on-target base editing by ABE7.10 both averaged 54% (Supplementary Tables 2–4). We observed detectable modification (0.2% indels or more) by Cas9 nuclease at nine of the 12 (75%) known off-target loci (Fig. 5c and Supplementary Tables 2–4). In contrast, when complexed with the same sgRNAs, ABE7.10, ABE7.9, or ABE 7.8 produced 0.2% or more off-target base editing at only four of the twelve (33%) known Cas9 off-target sites.” Gaudelli, page 469, left col. As such, off target editing frequences of embodiments of Gaudelli is understood to be at 0.2% or less for most sites.
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 1, 3, 5, 9, 10, 12, 13, 16, 56, 64, 65, 69, 76 and 189-193 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 14 of copending Application No. 17/797,700 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons.
The copending claims recite:
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The base editor ABE8e recited in copending claim 14 is understood to be the same ABE8e base editor in the specification, which is stated to be SEQ ID NO: 202 of the copending specification. SEQ ID NO: 202 of the copending application is identical to recited SEQ ID NO: 169. Further, SEQ ID NO: 202 of the copending application has substitutions T111R, D119N, F149Y, A109S, H122N, Y147D, T166I, and Y147D. As such, the copending claims anticipate at least claims 1, 3, 5, 9, 10, 12, 13 and 56.
Regarding claims 64, 65, 69, 72, and 76, these claims recite a composition of matter and do not require the active performance of any method or editing of any DNA/RNA. Rather, these claims only require a base editor to latently have the recited properties under some unrecited condition (e.g. target site, gRNA, assay system, etc.). The specification evidences that the base editor ABE8e (recited SEQ ID NO: 169) is an embodiment of all of claims 64, 65, 69, 72, and 76.
Regarding claim 16, an alignment between SEQ ID NO: 202 of Application No. 17/797,700 and recited SEQ ID NO: 324 is below wherein amino acid residues 184 of 185 of SEQ ID NO: 202 are I and N, respectively, corresponding to position T166 and D167 as recited. As such, the based edition of SEQ ID NO: 202 of the reference specification and recited in the claims thereof further meets the features of claim 16. This rejection is necessitated by applicant’s amendment wherein it was not previously apparent that number of claim 16 is in accordance with SEQ ID NO: 324.
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Regarding claim 189, SEQ ID NO: 202 of Application No. 17/797,700 (identical to recited SEQ ID NO: 169) is understood to be a fusion polypeptide containing an adenosine deaminase including the specific substitutions recited in claims 190-192, as discussed above, and a Cas9 domain as a napDNAbp domain as recited in claims 189 and 193.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 3, 5, 9, 10, 12, 13, 16, 56, 64, 65, 69, 76 and 189-193 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 40 of copending Application No. 19/288,071 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons.
Claims 1, 3, 5, 9, 10, 12, 13, 16, 56, 64, 65, 69, 76 and 189-193 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 170 of copending Application No. 18/715,569 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons.
Claims 1, 3, 5, 9, 10, 12, 13, 16, 56, 64, 65, 69, 76 and 189-193 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 58 of copending Application No. 19/170,891 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons.
Claim 40 of ‘071 recites a base editor is ABE8e, which is SEQ ID NO: 317 as set forth in that application that is identical to recited SEQ ID NO: 169.
Claim 170 of ‘569 recites a base editor is ABE8e, which is SEQ ID NO: 202 as set forth in that application that is identical to recited SEQ ID NO: 169.
Claim 58 of ‘891 recites a fusion protein of a DNA-binding protein and a deaminase (i.e. a base editor) having SEQ ID NO: 202 that is identical to recited SEQ ID NO: 169.
A base editor having recited SEQ ID NO: 169 as recited in the claims of the copending application has substitutions T111R, D119N, F149Y, A109S, H122N, Y147D, T166I, and Y147D. As such, the copending claims anticipate at least claims 1, 3, 5, 9, 10, 12, 13 and 56.
Regarding claims 64, 65, 69, 72, and 76, these claims recite a composition of matter and do not require the active performance of any method or editing of any DNA/RNA. Rather, these claims only require a base editor to latently have the recited properties under some unrecited condition (e.g. target site, gRNA, assay system, etc.). The specification evidences that the base editor ABE8e (recited SEQ ID NO: 169) is an embodiment of all of claims 64, 65, 69, 72, and 76.
Regarding claim 16, an alignment between the referenced base editor of the copending applications and recited SEQ ID NO: 324 is below wherein amino acid residues 184 of 185 of SEQ ID NO: 202 are I and N, respectively, corresponding to position T166 and D167 as recited. As such, the based edition of SEQ ID NO: 202 of the reference specification and recited in the claims thereof further meets the features of claim 16. This rejection is necessitated by applicant’s amendment wherein it was not previously apparent that number of claim 16 is in accordance with SEQ ID NO: 324.
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Regarding claim 189, the referenced based editor recited in the copending claims is understood to be a fusion polypeptide containing an adenosine deaminase including the specific substitutions recited in claims 190-192, as discussed above, and a Cas9 domain as a napDNAbp domain as recited in claims 189 and 193.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 3, 5, 9, 10, 12, 13, 16, 56, 64, 65, 69, 76 and 189-193 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 10 of copending Application No. 17/921,971 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons.
Copending claim 10 recites a method employing a base editor identified as ABE8e, which is SEQ ID NO: 379 of the copending applicant and identical to recited SEQ ID NO: 169.
This based editor has substitutions T111R, D119N, F149Y, A109S, H122N, Y147D, T166I, and Y147D. As such, the copending claims anticipate at least claims 1, 3, 5, 9, 10, 12, 13 and 56.
Regarding claims 64, 65, 69, 72, and 76, these claims recite a composition of matter and do not require the active performance of any method or editing of any DNA/RNA. Rather, these claims only require a base editor to latently have the recited properties under some unrecited condition (e.g. target site, gRNA, assay system, etc.). The specification evidences that the base editor ABE8e (recited SEQ ID NO: 167) is an embodiment of all of claims 64, 65, 69, 72, and 76.
Regarding claim 16, an alignment between SEQ ID NO: 379 of Application No. 17/921,971 and recited SEQ ID NO: 324 is below wherein amino acid residues 184 of 185 of SEQ ID NO: 379 are I and N, respectively, corresponding to position T166 and D167 as recited. As such, the based edition of SEQ ID NO: 379 of the reference specification and recited in the claims thereof further meets the features of claim 16. This rejection is necessitated by applicant’s amendment wherein it was not previously apparent that number of claim 16 is in accordance with SEQ ID NO: 324.
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Regarding claim 189, SEQ ID NO: 379 of Application No. 17/921,971 (identical to recited SEQ ID NO: 169) is understood to be a fusion polypeptide containing an adenosine deaminase including the specific substitutions recited n claims 190-192, as discussed above and a Cas9 domain as a napDNAbp domain as recited in claims 189 and 193.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 3, 5, 9, 10, 12, 13, 15, 16, 56, 64, 65, 69, 76 and 189-193 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 27 of copending Application No. 18/927,415 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons.
Copending claim 27 recites a method employing a base editor identified as ABE8e(V106W), which is inherently understood to be the same base editor identical to recited SEQ ID NO: 188 that is described as ABE8e (V106W) in the current specification. That is, the specification evidences that base editor known in the art as ABE8e(V106W) is recited SEQ ID NO: 188.
This based editor has substitutions V106W, T111R, D119N, F149Y, A109S, H122N, Y147D, T166I, and Y147D. As such, the copending claims anticipate at least claims 1, 3, 5, 9, 10, 12, 13, 15 and 56. Further, the base editor ABE8e (also recited in copending claim 27) has substitutions T111R, D119N, F149Y, A109S, H122N, Y147D, T166I, and D167N and is identical to recited SEQ ID NO: 166 as evidenced by the specification.
Regarding claims 64, 65, 69, 72, and 76, these claims recite a composition of matter and do not require the active performance of any method or editing of any DNA/RNA. Rather, these claims only require a base editor to latently have the recited properties under some unrecited condition (e.g. target site, gRNA, assay system, etc.). The specification evidences that the base editor ABE8e (recited SEQ ID NO: 167) is an embodiment of all of claims 64, 65, 69, 72, and 76.
Regarding claim 16, SEQ ID NO: 433 of the copending application has all of the substitutions recited in claim 16, wherein the rejection to claim 16 is necessitated by applicant’s amendment wherein it was not clear that numbering is in regards to SEQ ID NO: 324.
Regarding claim 189, SEQ ID NO: 379 of Application No. 18/927,415 (identical to recited SEQ ID NO: 188) is understood to be a fusion polypeptide containing an adenosine deaminase including the specific substitutions recited in claims 190-192, as discussed above and a Cas9 domain as a napDNAbp domain as recited in claims 189 and 193.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 3, and 9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9, 13 and 14 of copending Application No. 18/579,685 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons.
Copending claims recite:
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100
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746
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SEQ ID NO: 315 of the copending claims is the same as in the current claims. The copending claims suggest the possibility of making all of the indicated substitutions. As such, the copending claims anticipate or directly suggest the features of at least claims 1, 3, and 9.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to arguments
Applicant notes that a terminal disclaimer may be filed to obviate double patenting rejections. It is noted that any provisional double patenting rejection over an application having a later filing date will be withdrawn at time of allowance, but in the interim will remain of record.
Conclusion
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/TODD M EPSTEIN/Primary Examiner, Art Unit 1652
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