DETAILED ACTION
Receipt of Arguments/Remarks filed on June 29 2026 is acknowledged. Claims 3-4, 11-12 and 14-17 were/stand cancelled. Claims 1 and 6 were amended. Claims 1-2, 5-10 and 13 are pending.
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 .
Withdrawn Objections/Rejections
The cancellation of claims 16-17 in the response filed June 29 2026 have rendered the rejection under 35 USC 112(b) moot.
The amendments filed June 29 2026 are sufficient to overcome the rejection of claims 1-17 under 35 USC 102(a)(1) or 102(a)(2) by Zhang et al. and the rejection of claims 3 and 11 under 35 U.S.C. 103 over Zhang et al. The amendment reciting the oligonucleotide consisting of a first oligonucleotide and a second oligonucleotide wherein the first oligonucleotide consists of is interpreted as limiting the scope to the specific number of residues recited. While the second oligonucleotide utilizes the transitional phrase “has”, in light of the recitation oligonucleotide consists of, this “has” is interpreted as closed claim language. Note. MPEP 2111.03.
New Rejections Necessitated by the Amendments filed June 29 2026
Claim Rejections - 35 USC § 102
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) 1-2, 5-10 and 13 is/are rejected under 35 U.S.C. 102(a)(1) and/or 102(a)(2) as being anticipated by Turunen et al. (USPGPUB No. 20190218552).
The instant application claims an oligonucleotide that induces site-specific editing of a target RNA, comprising the oligonucleotide consisting of a first oligonucleotide that identifies the target RNA, and a second oligonucleotide linked to the 5' side of the first oligonucleotide, wherein the first oligonucleotide consists of: a target-corresponding nucleotide residue that corresponds to an adenosine residue in the target RNA, wherein the target-corresponding nucleotide residue does not form a base pair with the adenosine residue to be edited, 10 to 24 residue oligonucleotide linked to the 3' side of the target-corresponding nucleotide residue and having a base sequence complementary to the target RNA, and a 3 to 6 residue oligonucleotide linked to the 5' side of the target-corresponding nucleotide residue and having a base sequence complementary to the target RNA; and wherein the second oligonucleotide has 2 to 10 residues and forms a complementary strand with the target RNA, and the oligonucleotide lacks a nucleotide residue corresponding to a nucleotide residue between nucleotide residues corresponding to the first oligonucleotide and nucleotide residues corresponding to the second oligonucleotide in the target RNA.
The instant application claims a method for site-specific editing of a target RNA, comprising contacting an oligonucleotide with the target RNA in the presence of adenosine deaminase 1, wherein the oligonucleotide consists of a first oligonucleotide that identifies the target RNA, and a second oligonucleotide linked to the 5' side of the first oligonucleotide, wherein the first oligonucleotide consists of: a target-corresponding nucleotide residue that corresponds to an adenosine residue in the target RNA, wherein the target-corresponding nucleotide residue does not form a base pair with the adenosine residue to be edited, a 10 to 24 residue oligonucleotide linked to the 3' side of the target-corresponding nucleotide residue and having a base sequence complementary to the target RNA, and a 3 to 6 residue oligonucleotide linked to the 5' side of the target-corresponding nucleotide residue and having a base sequence complementary to the target RNA; and wherein the second oligonucleotide has 2 to 10 residues and forms a complementary strand with the target RNA, and the oligonucleotide lacks a nucleotide residue corresponding to a nucleotide residue between nucleotide residues corresponding to the first oligonucleotide and nucleotide residues corresponding to the second oligonucleotide in the target RNA.
The recitation “wherein the second oligonucleotide has 2 to 10 residues and forms a complementary strand with the target RNA” is interpreted as closed claim language limiting the length of the second oligonucleotide to 10 residues. Note. MPEP 2111.03. The instant specification provides no limiting definition of “complementary”, thus the claim is interpreted as requiring at least 2 of the residues to be complementary with the target RNA.
While the instant claims recites the oligonucleotide consists of, this is interpreted as limiting the length of the oligonucleotide. The recitation “residue oligonucleotide” is interpreted as including both natural ribonucleotides as well as a non-natural modified nucleotide residue (see paragraph 0031 of the specification as filed).
Turunen et al. is directed to chemically modified single-stranded RNA-editing oligonucleotides. Claims is an antisense oligonucleotide (AON) capable of forming a double stranded complex with a target RNA sequence in a cell, preferably a human cell, for the deamination of a target adenosine in the target RNA sequence by an ADAR enzyme present in the cell, said AON comprising a Central Triplet of 3 sequential nucleotides, wherein the nucleotide directly opposite the target adenosine is the middle nucleotide of the Central Triplet, wherein 1, 2 or 3 nucleotides in said Central Triplet comprise a sugar modification and/or a base modification to render the AON more stable and/or more effective in inducing deamination of the target adenosine; with the proviso that the middle nucleotide does not have a 2′-O-methyl modification (claim 1). In a preferred aspect, the AON comprises a mismatch at the position of the target adenosine, wherein the opposite nucleotide is a cytidine (paragraph 0031). Claimed is a method for the deamination of at least one specific target adenosine present in a target RNA sequence in a cell, the method comprising the steps of: (i) providing the cell with an AON according to any one of claims 1 to 13; (ii) allowing uptake by the cell of the AON; (iii) allowing annealing of the AON to the target RNA sequence; (iv) allowing a mammalian ADAR enzyme comprising a natural dsRNA binding domain as found in the wild type enzyme to deaminate the target adenosine in the target RNA sequence to an inosine; and (v) optionally identifying the presence of the inosine in the RNA sequence (claim 17). The AONs are complementary to a target RNA for deaminating a target adenosine present in a target RNA sequence to which the AON is complementary.
Exemplary AONs are shown in Fig. 2. Fig. 1 shows AON ADAR60-1 targeting SERPINA1. ADAR60-1 contains, from the 5’ end to the C which corresponds to the position opposite the A to be edited (see Fig. 1), 13 residues which corresponds to the second oligonucleotide and the 3 to 6 residues linked to the 5’ side of the target corresponding nucleotide residue (C), and contains 17 residues linked to the 3’-side of the target corresponding nucleotide residue. It is noted that ADAR60-1 through ADAR60-21 would contain the same residues albeit some are modified which as set forth above falls within the scope claimed. ADARs taught include hADAR1 and hADAR2.
Regarding claims 5-6 and 13, since there are only two ADARs taught, ADAR1 and ADAR2, one skilled in the art would immediately envision enzymatic reaction by adenosine deaminase 1 (aka ADAR1).
Regarding claim 7, the invention is used to make a change in target RNA sequence in a eukaryotic cell through the use of an oligonucleotide that is capable of targeting a site to be edited and recruiting RNA editing entities resident in the cell to bring about the editing reaction(s) (paragraph 0079).
Regarding claims 8-9, the AON are used in the treatment of genetic disorders which include numerous hereditary disorders such as cystic fibrosis, hereditary hemochromatosis, etc. (claims 15-16) with human subjects expressly disclosed (paragraph 0103-0104).
Claim Rejections - 35 USC § 103
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1-2, 5-10 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Boudet et al. (WO 2019158475).
Applicant Claims
The instant application claims and BRI of the claims are set forth above.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Boudet et al. is directed to antisense oligonucleotides for RNA editing. Claimed is an editing oligonucleotide capable of forming a double stranded complex with a target RNA molecule in a cell, and capable of recruiting an endogenous enzyme with ADAR activity, wherein:
the target RNA molecule comprises a target adenosine for deamination by the enzyme with ADAR activity;
the EON comprises a Central Triplet of three sequential nucleotides in which the nucleotide directly opposite the target adenosine is the middle nucleotide (position 0) of the Central Triplet and wherein the positions are positively (+) and negatively (-) incremented towards the 5’ and 3’ ends of the EON, respectively;
the EON comprises a nucleotide at position 0 that mismatches with the target adenosine; the EON comprises one or more nucleotides comprising a 2’-0-methoxyethyl (2’-MOE) ribose modification; and
the EON comprises one or more nucleotides not comprising a 2’-MOE ribose modification; characterized in that the nucleotides comprising a 2’-MOE ribose modification are at positions that do not prevent the enzyme with ADAR activity from deaminating the target adenosine (claim 1). The enzyme with ADAR activity is ADAR1 or ADAR2 (claim 2). In a preferred embodiment the EON comprises 18 to 50 nucleotides (claim 7; page 12). The invention relates to an EON for the deamination of a target adenosine in a target RNA, wherein the EON is complementary to a target RNA region comprising the target adenosine (page 11, lines 3-6).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.02)
While Boudet et al. teaches EONs which are complementary to a target RNA which are capable of recruiting an endogenous enzyme with ADAR activity which contain a mismatch at the adenosine to be edited, Boudet et al. only discloses an overlapping length to the instant claims.
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to manipulate the length of the EON. One skilled in the art would have been motivated to choose any length from 18 to 50 nucleotides as taught by Boudet et al. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Note MPEP 2144.05.
Regarding claims 5-6 and 13, since there are only two ADARs taught, ADAR1 and ADAR2, one skilled in the art would immediately envision enzymatic reaction by adenosine deaminase 1 (aka ADAR1).
Regarding claims 7-9, the target sequence is endogenous to the eukaryotic, more preferably human cell (page 22). The EONs are used in the treatment of genetic disorders which include numerous hereditary disorders such as cystic fibrosis, hereditary hemochromatosis, etc. (claims 9-10) with human subjects expressly disclosed (paragraph 0103-0104).
Modified Rejection Based on Amendments in the reply filed on June 29 2026
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 1-2 and 5 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11, 13-18, 20-32 and 48 of copending Application No. 18265756 (USPGPUB No. 20240093227). Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims overlap in scope.
This is a provisional nonstatutory double patenting rejection.
The instant application claims an oligonucleotide that induces site-specific editing of a target RNA, comprising the oligonucleotide consisting of a first oligonucleotide that identifies the target RNA, and a second oligonucleotide linked to the 5' side of the first oligonucleotide, wherein the first oligonucleotide consists of: a target-corresponding nucleotide residue that corresponds to an adenosine residue in the target RNA, wherein the target-corresponding nucleotide residue does not form a base pair with the adenosine residue to be edited, 10 to 24 residue oligonucleotide linked to the 3' side of the target-corresponding nucleotide residue and having a base sequence complementary to the target RNA, and a 3 to 6 residue oligonucleotide linked to the 5' side of the target-corresponding nucleotide residue and having a base sequence complementary to the target RNA; and wherein the second oligonucleotide has 2 to 10 residues and forms a complementary strand with the target RNA, and the oligonucleotide lacks a nucleotide residue corresponding to a nucleotide residue between nucleotide residues corresponding to the first oligonucleotide and nucleotide residues corresponding to the second oligonucleotide in the target RNA.
The recitation “wherein the second oligonucleotide has 2 to 10 residues and forms a complementary strand with the target RNA” is interpreted as closed claim language limiting the length of the second oligonucleotide to 10 residues. Note. MPEP 2111.03. The instant specification provides no limiting definition of “complementary”, thus the claim is interpreted as requiring at least 2 of the residues to be complementary with the target RNA.
While the instant claims recites the oligonucleotide consists of, this is interpreted as limiting the length of the oligonucleotide. The recitation “residue oligonucleotide” is interpreted as including both natural ribonucleotides as well as a non-natural modified nucleotide residue (see paragraph 0031 of the specification as filed).
Copending ‘756 claims an oligonucleotide, or a pharmaceutically acceptable salt thereof, comprising:
a first oligonucleotide identifying a target RNA; and a second oligonucleotide linked to the 5'-side of the first oligonucleotide,
wherein the first oligonucleotide consists of a target-corresponding nucleotide residue corresponding to an adenosine residue in the target RNA, an oligonucleotide of 10 to 24 residues, linked to the 3'-side of the target- corresponding nucleotide residue and having a base sequence complementary to the target RNA, and an oligonucleotide of 3 to 6 residues, linked to the 5'-side of the target- corresponding nucleotide residue and having a base sequence complementary to the target RNA, the second oligonucleotide has no nucleotide residue corresponding to a nucleotide residue of the target RNA or has a nucleotide residue which does not form a complementary pair with a nucleotide residue of the target RNA (i.e. it contains a mismatch) at the 3'-end thereof, a number of residues in the second oligonucleotide is 2 to 10, and at least the nucleotide residues other than at the 3'-end form a double-stranded structure complementary to the target RNA, a counter region consisting of the target-corresponding nucleotide residue and each one residue at the 3'-side and the 5'-side thereof is contained, the nucleotide residue linked to the 3'-side of the target-corresponding nucleotide residue is a 2'-deoxynucleotide residue, the third nucleotide residue counted in the 3'-direction from the target-corresponding nucleotide in the oligonucleotide linked to the 3'-side of the target-corresponding nucleotide residue is a 2'-deoxy-2'-fluoronucleotide residue, and the oligonucleotide, or a pharmaceutically acceptable salt thereof induces site-specific editing for the target RNA (claim 1). The number of residues in the second oligonucleotide is 4 to 8 (claim 2). Site-specific editing is due to adenosine deaminase 1 (claim 4).
Therefore, the scopes of the copending claims and the instant application overlap and thus they are obvious variants of one another as the instant claims allow for modified bases as well as mismatches.
Claims 6-10 and 13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11, 13-18, 20-32 and 48 of copending Application No. 18265756 (USPGPUB No. 20240093227) as applied to claims 1-2 and 5 above in view of Boudet et al. (WO2019158475). Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims overlap in scope.
This is a provisional nonstatutory double patenting rejection.
The instant application claims a method for site-specific editing of a target RNA, comprising contacting an oligonucleotide with the target RNA in the presence of adenosine deaminase 1, wherein the oligonucleotide consists of a first oligonucleotide that identifies the target RNA, and a second oligonucleotide linked to the 5' side of the first oligonucleotide, wherein the first oligonucleotide consists of: a target-corresponding nucleotide residue that corresponds to an adenosine residue in the target RNA, wherein the target-corresponding nucleotide residue does not form a base pair with the adenosine residue to be edited, a 10 to 24 residue oligonucleotide linked to the 3' side of the target-corresponding nucleotide residue and having a base sequence complementary to the target RNA, and a 3 to 6 residue oligonucleotide linked to the 5' side of the target-corresponding nucleotide residue and having a base sequence complementary to the target RNA; and wherein the second oligonucleotide has 2 to 10 residues and forms a complementary strand with the target RNA, and the oligonucleotide lacks a nucleotide residue corresponding to a nucleotide residue between nucleotide residues corresponding to the first oligonucleotide and nucleotide residues corresponding to the second oligonucleotide in the target RNA.
The claims of copending ‘756 are set forth above. While copending ‘756 claims the editing is due to an enzyme reaction by adenosine deaminase 1, copending ‘756 does not expressly claim contacting an oligonucleotide with the target RNA in the presence of adenosine deaminase 1, a eukaryotic cell or in a subject. However, these deficiencies are cured by Boudet et al.
Boudet et al. is directed to antisense oligonucleotides for RNA editing. Claimed is an editing oligonucleotide capable of forming a double stranded complex with a target RNA molecule in a cell, and capable of recruiting an endogenous enzyme with ADAR activity, wherein:
the target RNA molecule comprises a target adenosine for deamination by the enzyme with ADAR activity;
the EON comprises a Central Triplet of three sequential nucleotides in which the nucleotide directly opposite the target adenosine is the middle nucleotide (position 0) of the Central Triplet and wherein the positions are positively (+) and negatively (-) incremented towards the 5’ and 3’ ends of the EON, respectively;
the EON comprises a nucleotide at position 0 that mismatches with the target adenosine; the EON comprises one or more nucleotides comprising a 2’-0-methoxyethyl (2’-MOE) ribose modification; and
the EON comprises one or more nucleotides not comprising a 2’-MOE ribose modification; characterized in that the nucleotides comprising a 2’-MOE ribose modification are at positions that do not prevent the enzyme with ADAR activity from deaminating the target adenosine (claim 1). The enzyme with ADAR activity is ADAR1 or ADAR2 (claim 2). In a preferred embodiment the EON comprises 18 to 50 nucleotides (claim 7; page 12). The invention relates to an EON for the deamination of a target adenosine in a target RNA, wherein the EON is complementary to a target RNA region comprising the target adenosine (page 11, lines 3-6).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of copending ‘756 and Boudet et al. and contact the target RNA with the oligonucleotide of ‘756 in the presence of adenosine deaminase 1 (ADAR1). One skilled in the art would have been motivated to contact the target RNA with the oligonucleotide of ‘756 in the presence of ADAR1 in order to edit the target RNA. One skilled in the art would have a reasonable expectation of success as copending ‘756 claims the site-specific editing is due to ADAR1 and Boudet et al. suggests guide oligonucleotides like the one in copending ‘756 can be used in combination with ADAR1 to induce editing.
Regarding claims 7-9, Boudet et al. suggests the editing can be in eukaryotic cells or in subjects in need thereof and that the subject can have a hereditary disease. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of copending ‘756 and Boudet et al. and utilize the oligonucleotide anywhere editing is desired. Since Boudet et al. teaches editing in eukaryotic cells or in subjects there is a reasonable expectation of success.
Response to Arguments
Applicants’ arguments filed June 29 2026 have been fully considered but they are not persuasive.
Applicants argue that the present application has an earlier effective filing date. As set forth in the MPEP once the other objections and rejections are withdrawn and the only other remaining issue is the double patenting the ejection can be withdrawn in the earlier filed application.
Regarding Applicants arguments, the patent term filing date of the instant application is September 25 2020 and the patent term filing date of the copending application is December 8 2021. Therefore, Applicants are correct that the instant application is earlier filed. Therefore, as long as the copending application remains unpatented, once the instant claims are indicated as free of prior art, the double patenting rejection can be withdrawn as set forth in MPEP 804.
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.
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/ABIGAIL VANHORN/ Primary Examiner, Art Unit 1636
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