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 .
DETAILED ACTION
Applicant's preliminary amendment filed on September 17, 2024 is acknowledged. Claims 4, 5, 8-10, 12, 13, 16, 19, 29-33, 36-40, 42-45, 47-54, and 56-59 have been canceled. Claims 1-3, 6, 7, 11, 14, 15, 17, 18, 20-28, 34, 35, 41, 46, and 55 were amended. Claims 1-3, 6, 7, 11, 14, 15, 17, 18, 20-28, 34, 35, 41, 46, and 55 are pending.
Election/Restrictions
Applicant’s election of Group I (claims 1-3, 6, 7, 11, 14, 15, 17, 18, 20-28, 34, 35, and 41) and the following species: SERPINA1 E342K (rs2892474) in the reply filed on August 21, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 46 and 55 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 1-3, 6, 7, 11, 14, 15, 17, 18, 20-28, 34, 35, and 41 are examined on the merits herein.
Priority
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42
434
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Information Disclosure Statement
The information disclosure statement (IDS) submitted on April 5, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings were received on December 15, 2023. These drawings are found acceptable by the examiner.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because the abstract uses the phrase “The present invention” which can be implied. In addition, the abstract is less than 50 words in length. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 1, 3, 14, 21, 26, and 28 are objected to because of the following informalities:
Claim 1 recites in part
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28
140
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. It appears that the superscript is an apostrophe; however, the superscript should be the number “1”.
Claim 3 recites in part
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32
154
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. It appears that the superscript is the number “1”; however, the superscript should be an apostrophe.
Claim 14 recites in part “[BD]” but should recite “[Bn]” instead.
Claim 21 is missing the word “of” before the phrase “claim 1”.
Claim 26 is missing a period at the end of the claim.
Claim 28 recites in part
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34
160
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. It appears that the first superscript is an apostrophe; however, the superscript should be the number “1”.
Appropriate correction is required.
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 1, 2, 3, 6, 7, 11, 14, 15, 17, 18, 20, 21, 25, 26, 27, 28, 34, 35, and 41 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Monian et al. (WO 2021/071858; reference cited by Applicant).
Regarding claims 1, 2, 3, 6, 7, 11, 14, 15, 17, 18, 20, 21, 25, 26, 27, 28, and 41, Monian et al. teaches WV-27387 which is an oligonucleotide that targets ACTB
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56
936
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[page 172] wherein f is 2’-F, * is phosphorothioate, S is phosphorothioate in the Sp configuration, *S is single phosphorothioate linkage in the Sp configuration, m is 2’-OMe, and all are 2’-deoxy sugars unless otherwise indicated (e.g., with m) [page 241]. WV-27387 is 30 nucleotides in length wherein “m” is 23 and “n” is 4; at least one nucleotide of “A” is a 2’-F nucleotide; a 2’-F nucleotide is at positions -19 and -22; X1 is not a 2’-O-methyl nucleotide; X2 is not a 2’-O-methyl nucleotide; X3 is not a 2’-O-methyl nucleotide; a 2’-F nucleotide is not at positions +2, X2, and X3; and X2 comprises a cytosine nucleobase. Further, Monian et al. teaches that chirally controlled oligonucleotide compositions provide high levels of adenosine modifying (e.g., converting A to I) activities with various isoforms of an ADAR protein [0015]. It is noted that the instant specification defines the term “nuclease resistant nucleotide” as nucleotides which limit nuclease degradation of oligonucleotides and generally increase stability of oligonucleotides by being poor substrates for the nucleases. Further, nuclease resistant nucleotides are known in the art, e.g., 2'-O-methyl-nucleotides and 2'-fluoro-nucleotides [0034].
Regarding claim 34, Monian et al. teaches that oligonucleotides may contain portions that are not designed for complementarity (e.g., protein binding sequences for recruiting of proteins, e.g., ADAR) [00172].
Regarding claim 35, Monian et al. teaches that complementarity between oligonucleotides and target nucleic acids, is about 50%-100% [00172].
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, 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.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Monian et al. (WO 2021/071858; reference cited by Applicant) as applied to claims 1, 2, 3, 6, 7, 11, 14, 15, 17, 18, 20, 21, 25, 26, 27, 28, 34, 35, and 41 above.
Regarding claim 22, the teachings of Monian et al. are discussed above.
Although Monian et al. WV-27387 does not comprise a 2’-F-nucleotide at position +3 and a 2’-O-methoxyethyl-nucleotide at position +2, it would have been obvious to try because Monian et al. teaches that a 2’-F modified sugar is at position +3 wherein position 0 being the position of the nucleoside opposite to a target adenosine [00487] and also teaches that in some embodiments, a 2’-modification is 2’-MOE [00116]. Monian et al. also teaches that a 2’-MOE modification has been reported as having improved binding affinity compared to unmodified sugars and to some other modified nucleosides, such as 2’- O-methyl [00659]. Further, there are a finite number of residues in WV-27387 and thus it would have been obvious for one of ordinary skill in the art to try because Monian et al. taught that there are over 20,000 conditions, disorders or diseases associated with G to A mutation and can benefit from A to I editing [0022] and Monian et al. also taught that a 2’-MOE modification improves binding affinity.
Claims 23 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Monian et al. (WO 2021/071858; reference cited by Applicant) as applied to claims 1, 2, 3, 6, 7, 11, 14, 15, 17, 18, 20, 21, 25, 26, 27, 28, 34, 35, and 41 above.
Regarding claims 23 and 24, the teachings of Monian et al. are discussed above.
Monian et al. WV-27387 is 30 nucleotides in length wherein “m” is 23 and “n” is 4.
Regarding claim 23, WV-27387 does not have a position +8. Although WV-
27387 does not comprise a 2’-F-nucleotide at position +3, Monian et al. does teach that a 2’-F modified sugar is at position +3 wherein position 0 being the position of the nucleoside opposite to a target adenosine [00487].
Regarding claim 24, WV-27387 does not have a position -26. WV-27387 does
not comprise a 2’-F-nucleotide at position -6; however, WV-27387 comprises a 2’-F-nucleotide at positions -15, -20, -21, and -23.
It would have been obvious to try to modify the length of the oligonucleotide because Monian et al. taught that nucleosides opposite to target adenosines are located in the middle of provided oligonucleotides, e.g., with 5-50 nucleosides to 5’ side, and 1-50 nucleosides on its 3’ side [0008]. Further, there are a finite number of solutions based on the design parameter of Monian et al. Therefore, it would have been obvious for one of ordinary skill in the art to try to modify the length of the oligonucleotide and vary the positions of the 2’-F modification and arrive at the instantly claimed limitations in the process of optimizing the oligonucleotide because Monian et al. taught that there are over 20,000 conditions, disorders or diseases associated with G to A mutation and can benefit from A to I editing [0022] and Monian et al. also taught that synthetic oligonucleotides containing chemical modifications such as sugar modifications render the molecules less susceptible to degradation and improve other properties and/or activities [00154].
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINA TRAN whose telephone number is (571)270-0550. The examiner can normally be reached M-F 7:30 - 5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Dunston can be reached at (571) 272-2916. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.T./
Examiner, Art Unit 1637
/Jennifer Dunston/Supervisory Patent Examiner, Art Unit 1637
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