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 .
This office action is in response to the paper filed on 11/13/2025. Claims 1-4, 7, 11, 15, 19, 31, 42, 45, 49-50, 57-59, 61-62, 64, 66, 73, 75, 78, 82, 84, 88, 93, 113, 118-119 were previously presented and claims 125-129 are newly presented. Applicant’s election of inventions of group X claim 118-119.
Election/Restrictions
Applicant’s election of inventions of group X (Claims 118-119), in the reply filed on 11/13/2025 is acknowledged. As newly presented claims 125-129 fall within the invention of group X, they are included in group X and considered as elected. 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)).
Claims 1-4, 7, 11, 15, 19, 31, 42, 45, 49-50, 57-59, 61-62, 64, 66, 73, 75, 78, 82, 84, 88, 93, and 113 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/13/2025.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17 (i).
Application Status
The action is written in response to applicant’s correspondence received 11/13/2025. Claims 118-129 are currently pending in the instant application.
Priority
Current application is a national stage 371 application of PCT/US2021/055057. The PCT claims priority to US provisional applications 63/248,081 and 63/091,891 with their filing date 9/24/2021 and 10/14/2020.
Drawings
The drawings are objected to under 37 CFR 1.83(a) because they fail to show “target” and “bystander” in A>G base-editing percentage, the A to G conversion percentage, and the Kaplan-Meier survival estimates as described in Figures 6, 8, 11, and 12 of the specification. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency – Nucleotide and/or amino acid sequences appearing in the drawings are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). Sequence identifiers for nucleotide and/or amino acid sequences must appear either in the drawings or in the Brief Description of the Drawings. For Figure 1 of the drawings, applicant fails to provide a SEQ ID NO. for the mutated targeted G6PC nucleotide target sequence for the correction of the GSD1a R83C mutation. Though applicant provides a SEQ ID NO. for both the non-mutated target sequence and the amino acid sequence, all sequences need to have a proper SEQ ID NO. assigned.
Required response – Applicant must provide:
Replacement and annotated drawings in accordance with 37 CFR 1.121(d) inserting the required sequence identifiers;
AND/OR
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers into the Brief Description of the Drawings, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Claim Objections
Claim 119 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 118. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Both claims recite a lipid nanoparticle comprising an mRNA expressing a base editor and a gRNA, wherein the base editor comprises a Cas9 domain and at least one adenosine deaminase variant with identical mutations.
Claim Rejections - 35 USC § 112
Written Description
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 118 and 119 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.
MPEP 2163.II.A.3.(a).i) states, “Whether the specification shows that applicant was in possession of the claimed invention is not a single, simple determination, but rather is a factual determination reached by considering a number of factors. Factors to be considered in determining whether there is sufficient evidence of possession include the level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention”.
For claims drawn to a genus, MPEP § 2163 states 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. See Eli Lilly, 119 F.3d at 1568, 43 USP USPQ2d at 1406.
Claim 118 and 119 directs to a broad genus, i.e. at least one adenosine deaminase variant comprising of claimed modifications, or corresponding alterations in another adenosine deaminase. In the specification, the broadness of an adenosine deaminase is shown as in some embodiments, the adenosine deaminase or deaminase domain may be from any organism (e.g., eukaryotic, prokaryotic), including but not limited to algae, bacteria, fungi, plants, invertebrates, and vertebrates (See page 17). In other embodiments, the adenosine deaminase is a variant of a naturally occurring deaminase from an organism such as human, chimpanzee, gorilla, monkey, cow, dog, rat, or mouse (see page 18). Further on, the specification recites in some embodiments, the adenosine deaminase is a TadA deaminase, where the TadA deaminase is an E. coli TadA (ecTadA) deaminase or a fragment thereof.
Based on an article by Skaldin et al. (Secreted Bacterial Adenosine Deaminase is an Evolutionary Precursor of Adenosine Deaminase Growth Factor, Molecular Biology and Evolution, 2018, Pg. 2851-2861), there are two distinct adenosine deaminases (ADA), ADA1 and ADA2. Cytoplasmic ADA1 plays a key role in purine metabolism and is widely distributed from prokaryotes to mammals (see abstract). On the other hand, ADA2 is a cell-signaling protein that was thought only to be present in multicellular organisms (see abstract). While the article discusses a discovery of a novel ADA2, ADA2 is known to function as a growth factor in humans and other mammals, regulating inflammation, and is found in the extracellular space, unlike ADA1 (see introduction). This article highlights that ADAs across different organisms can serve different functions within organisms and not all ADAs are present in prokaryotes compared to eukaryotes. Therefore, there is insufficient discussion of representative species within the broad genus in the specification, since the composition as described administers a TadA variant adenosine deaminase, an adenosine deaminase originally extracted from E. coli.
Claims 118 and 119 are rejected for failing to remedy the lack of written description. Claims 125-129 are also rejected based off dependency on claim 118.
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.
Claims 118-119, 126-127 are rejected under 35 U.S.C. 102 (a)(1) and 35 U.S.C. 102 (a)(2) as being anticipated by the international patent publication Gaudelli et al. (WO 2020/168088 A1).
With respect claim 118-119, Gaudelli teaches an adenosine deaminase enzyme that comprises the sequence of SEQ ID NO:1 as well as variants comprising of the following combinations of alterations a) I76Y + V82G + Y147T + Q154S (see abstract; page 351, lines 1-13 – “mono-V82G, di-R20A/K21A, di-V82G, di/mono double mutant with 20nt guide showed increased on-target and decreased off-target activities.
Regarding claims 118-119, Gaudelli further teaches a formulation comprising a lipid nanoparticle (page 312, lines 1-8) comprising an mRNA expressing a base editor (page 272, lines 14-33), and a gRNA with reference to SEQ ID NO. 370 of the instant application (see page 350),
Regarding claim 126, an additional experiment showed that monomeric TadA7.10 comprising Y147T and Q154S mutations fused to SaCas9 or heterodimeric TadA(wt)-TadA7.10 comprising Y147D, Q154S, and V82G”; page 248 with reference to SEQ ID NO. 1).
Regarding claim 127, wherein the base editor comprises a Cas9 domain and at least one adenosine deaminase variant (page 3, lines 24-34 and page 4, lines 1-10).
Absent evidence to the contrary, the formulation described in Gaudelli has the same composition of the lipid nanoparticle in the instantly claimed application. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. See MPEP 211.2 and 2112. Thus, Gaudelli clearly anticipate instant claims 118-119 and 126-127.
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 118-119 are rejected under 35 U.S.C. 103 as being unpatentable over Joung (Joung, J.K. et al. US Patent 11,946,040 B2, published April 2, 2024, benefitting from priority of US Application No. 16/781,979 filed February 4, 2020 and Provisional Application Nos. 62/844,717 filed May 7, 2019 and 62/800,974 filed February 4, 2019), in view of Finn et al (Cell Reports, 2018, Pg. 2227-2235).
With regards to claim 118-119, US Patent No. 11,946,040, hereafter referred as Joung, teaches a sequence that is 100% identical to SEQ ID NO: 1 of the instant application, in the form of SEQ ID NO: 34. Joung also teaches “Adenine DNA Base Editor variants with reduced Off-target RNA editing” (see title and abstract). Joung teaches modifying/mutating the adenine DNA base editor at different positions to obtain variants with reduced off-target editing, presenting some of the variants in Figure 15A-D.
Joung further teaches variants V82G in Figures 15A-B, and 16A-B. Joung teaches that modifying residues V82, D147, Q154, I76 and substituting these residues will generate ABE variants with reduced RNA editing and therefore less off-target events (see Table A, columns 10-11). Joung teaches that the mutations can include substitutions with any other amino acid other than the WT amino acid (see column 11, line 65-66).
Joung also teaches that “In some embodiments, the base editors include programmable DNA binding domains such as engineered C2H2 zinc-fingers, transcription activator effector-like effectors (TALEs), and Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR) Cas RNA-guided nucleases (RGNs) and their variants including ssDNA nickases (nCas9) or their analogs and catalytically inactive dead Cas9 (dCas9) and its analogs (e.g., as shown in Table C), and any engineered protospacer-adjacent motif (PAM) or high-fidelity variants (e.g., as shown in Table D). A programmable DNA binding domain is one that can be engineered to bind to a selected target sequence.” (see column 13, lines 6-18).
Regarding claim 127, Joung teaches using an ABE variant, wherein the CRISPR-Cas nuclease is a Cas9 or Cas12a that has ssDNA nickase activity or is a catalytically inactive Cas9 or Cas12a (see claim 8, column 193).
Regarding claim 128, Joung also teaches the use of a Streptococcus pyogenes Cas9 (see column 8, line 65).
Joung also teaches that “ABEs have been used successfully for installation of A-to-G substitutions in multiple cell types and organisms and could potentially reverse a large number of mutations known to be associated with human disease” (see column 1, lines 65-67, and column 2, lines 1-4).
Joung does not teach a formulation of a lipid nanoparticle comprising the mRNA, expressing a base editor and a gRNA. However, Finn teaches the administration of CRISPR/Cas9 lipid nanoparticles for in vivo genome editing.
Regarding claims 118-119, Finn teaches that lipid nanoparticles is a non-viral delivery approach that can achieve high levels of durability in vivo CRISPR/Cas9-mediated gene editing (see conclusion and Figure 4).
It would have been obvious to one with ordinary skills in the at before the effective filing date of the claimed invention to have adapted the gene editing method of Joung, which used a recombinant fusion protein of modified adenosine deaminase base editors with a Cas9 domain to reduce off-target RNA editing, allowing for a higher accuracy of base editing due to the mutated adenine deaminase base editor domain of TadA comprising alterations, including V82, Y147, Q154, and I76. It would have been obvious to have tried and tested multiple types of amino acid substitutions as suggested by Joung at these positions to obtain an effective recombinant protein with high efficiency. Furthermore, it would have been obvious to use a lipid nanoparticle as taught by Finn as a method of mRNA CRISPR/Cas9 delivery that yields improved durability combined with the 2’-O-methyl phosphorothioate modifications taught by Basila that results in higher level of gene editing and potential to prevent exonuclease degradation, and the base editor taught in John, to improve the formulation of base editing claimed in the instant application.
In view of the foregoing, claims 118-119 and 126-128, taken as a whole, would have been prima facie obvious before the effective filing date.
Claim 125 is rejected under 35 U.S.C. 103 as being unpatentable over Joung et al. and Finn et al., applied to claim 118-119 above, and further in view of Basila et al.
Joung and Finn teaches the limitations of Claim 118-119, 126-128 as described above.
Joung and Finn does not teach a gRNA comprising of 3x 5’ and 3’ 2’-O-methyl phosphorothioate modifications. However, Basila the effects of 2x and 3x 5’ and 3’ 2’-O-methyl phosphorothioate modification.
Regarding claim 125, Basila teaches both 2x and 3x 2-O-methyl phosphorothioate modifications on both the 5’ and 3’ end of crRNA and tracrRNA. Basila teaches that pairing 5’ 2x or 3xMS modified crRNA with 3’ 2x or 3xMS modified tracrRNA showed the highest level of gene editing on average (see results section, paragraph 4 line 3). Furthermore, Basila teaches MS modifications on the 5’ end of the crRNA and 3’ end of the tracrRNA provides protection of the single-strand region, and Basila hypothesize these modifications may be sufficient to prevent rapid degeneration by exonuclease activity.
It would have been obvious to one with ordinary skills in the at before the effective filing date of the claimed invention to have adapted the gene editing method of Joung, which used a recombinant fusion protein of modified adenosine deaminase base editors with a Cas9 domain to reduce off-target RNA editing, allowing for a higher accuracy of base editing due to the mutated adenine deaminase base editor domain of TadA comprising alterations, including V82, Y147, Q154, and I76. It would have been obvious to have tried and tested multiple types of amino acid substitutions as suggested by Joung at these positions to obtain an effective recombinant protein with high efficiency. Furthermore, it would have been obvious to use a lipid nanoparticle as taught by Finn as a method of mRNA CRISPR/Cas9 delivery that yields improved durability combined with the 2’-O-methyl phosphorothioate modifications taught by Basila that results in higher level of gene editing and potential to prevent exonuclease degradation, and the base editor taught in John, to improve the formulation of base editing claimed in the instant application.
In view of the foregoing, claims 118-119 and 125-128, taken as a whole, would have been prima facie obvious before the effective filing date.
Claim 129 is rejected under 35 U.S.C. 103 as being unpatentable over Joung et al., Finn et al., and Basila et al. as applied to claims 118-119 and 125-128 above, and further in view of Evans et al (WO 2020/051562 A2, PCT filed 9/7/2019).
Regarding claim 129, John teaches composition and methods for improving base editing which discloses SEQ ID NOs: 138, 139, and 141 which share a 91.0%, 90.8% and 90.9% identity to SEQ ID NO: 398 in the instant application.
It would have been obvious to one with ordinary skills in the at before the effective filing date of the claimed invention to have adapted the gene editing method of Joung, which used a recombinant fusion protein of modified adenosine deaminase base editors with a Cas9 domain to reduce off-target RNA editing, allowing for a higher accuracy of base editing due to the mutated adenine deaminase base editor domain of TadA comprising alterations, including V82, Y147, Q154, and I76. It would have been obvious to have tried and tested multiple types of amino acid substitutions as suggested by Joung at these positions to obtain an effective recombinant protein with high efficiency.
Furthermore, it would have been obvious to use a lipid nanoparticle as taught by Finn as a method of mRNA CRISPR/Cas9 delivery that yields improved durability combined with the 2’-O-methyl phosphorothioate modifications taught by Basila that results in higher level of gene editing and potential to prevent exonuclease degradation, and the base editor taught in John, to improve the formulation of base editing claimed in the instant application.
In view of the foregoing, claims 118-119 and 125-129, taken as a whole, would have been prima facie obvious before the effective filing date.
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.
Claim 118-119, and claim 126 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim of copending Application No. 17/430,274 in view of Joung et al.
Regarding Claim 118-119 of the instant application, though claim 1 of Application No. 17/430,274 recites a method claim, the method claim recites a method of editing which includes a nucleic acid programmable DNA binding protein and an adenosine deaminase domain comprising an amino acid sequence having at least 85% sequence identity to SEQ ID NO: 3, wherein the adenosine deaminase domain comprises at least one alteration selected from the group consisting of I76Y, Y147T, and Q154S. With regards to the instant application, SEQ ID NO: 1 and SEQ ID NO: 3 share a 100% identity.
The modifications of the adenosine deaminase read on the modifications of instant application, specifically Y147T, Q154S, and I76Y. The method of claim 1 in Application No: 17/430,274 would require the composition of the instant application in order to practice “editing G6PC. This method would also require pharmaceutically accepted carriers (lipid nanoparticle, gRNA, and Cas9, all of which are recited in claim 118 of the instant application. Additional modifications, such as V82G in the instant application, would have been obvious as these mutations are taught in the prior art (Joung et al.) listed above.
Claim 126 of this application is patentably indistinct from claim 25 of Application No. 17/430,274. Pursuant to 37 CFR 1.78(f), when two or more applications filed by the same applicant or assignee contain patentably indistinct claims, elimination of such claims from all but one application may be required in the absence of good and sufficient reason for their retention during pendency in more than one application. Applicant is required to either cancel the patentably indistinct claims from all but one application or maintain a clear line of demarcation between the applications. See MPEP § 822.
These claims are patentably indistinct because both claim 126 and claim 25 of 17/430,274 recite where either the formulation or method require an adenosine deaminase domain which comprises of the amino acid alterations I76Y, V82G, F149Y, and Q154S referenced to SEQ ID NO: 1 and 3. Both SEQ ID NOs have 100% identity.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 118-119 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 22 and 38 of copending Application No. 18/418,751. Although the claims at issue are not identical, they are not patentably distinct from each other because both claims 118-119 and claims 22 and 38 of 18/418,751 recite a composition or formulation comprising of a lipid nanoparticle, mRNA, adenosine deaminase variant with reference to SEQ ID NO: 1 and 3, and gRNA where the adenosine deaminase variant comprises of the same positional modifications in both the instant application and application 18/418,751. Furthermore, in both the instant application and 18/418,751, SEQ ID NO: 1 and 3 have 100% identity.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID YU whose telephone number is (571)272-1118. The examiner can normally be reached Monday-Friday 7:30 am -5 pm.
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/D.T.Y./Examiner, Art Unit 1635
/RAM R SHUKLA/Supervisory Patent Examiner, Art Unit 1635