DETAILED ACTION
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 .
Election/Restrictions
Applicant’s election without traverse of claims 65-66 in the reply filed on July 15, 2026 is acknowledged.
Status of Claims
Claims 65-72 are currently pending in the instant application. Claims 67-72 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Accordingly, claims 65-66 are under examination on the merits in the instant application.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on April 1, 2026 has been considered by the examiner, except NPL Citation No. 15, which is illegible.
Drawings
The drawings are objected to because Figures 1B and 7 contain sequence rule non-compliant subject matter. Appropriate correction is required as instructed below.
In addition, “Figure” should be abbreviated “FIG.”. See 37 CFR 1.84.
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.
Nucleotide and/or Amino Acid Sequence Disclosures
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 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.
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.
Priority
Acknowledgment is made of applicant's claim for foreign priority based on eight different applications filed in Australia on November 19, 2023, December 4, 2023, December 5, 2023, June 6, 2024, July 17, 2024, and November 13, 2024. It is noted, however, that applicant has not filed a certified copy of the any of the foreign priority applications as required by 37 CFR 1.55.
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.
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 65-66 are rejected under 35 U.S.C. 103 as being unpatentable over Böckers et al. (WO 2021/219555 A1, applicant’s citation) in view of Swildens et al. (US 2022/0213478 A1).
Böckers discloses a 50-mer “AON34” (SEQ ID NO:44) targeting “the human 3’ end of the SHANK3 gene”, wherein 18-mer sequences within the 50-mer sequence can be synthesized as chemically modified antisense oligonucleotides (AONs), which “increase the amount of Shank3 protein present in cells transfected herewith.” See pages 32-33; Table 2.
Böckers exemplifies 18-mer, chemically modified antisense oligonucleotides (e.g., SEQ ID NOs: 81 and 90) within the 50-mer “AON4” (SEQ ID NO:6) and “AON5” (SEQ ID NO:7). See for instance “AON4” (SEQ ID NO:6) and “AON5” (SEQ ID NO:7) in Table 2 as reproduced below, wherein a box has been added for the 18-mer sequence at positions 9-26 of each of SEQ ID NO:6 and SEQ ID NO:7.
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The boxed 18-mer sequences in each of SEQ ID NO:6 and SEQ ID NO:7 are disclosed as chemically modified AONs in Table 4 as reproduced below, wherein “*” represents a PTO backbone.
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Böckers teaches making a pharmaceutical composition comprising an ASO and a pharmaceutically acceptable carrier. See pages 8-9.
Böckers teaches that the AON can be “modified to decrease its degradation rate in a cell; appropriate modifications are known in the art”. See page 7.
Böckers does not expressly disclose the 18-mer sequence of SEQ ID NO:1092 modified with a 2’-O-methoxyethyl moiety at every position.
Swildens teaches that 2’-O-methoxyethyl (MOE)-modified nucleotides can be incorporated into an antisense oligonucleotide (AON) “to increase nuclease resistance”, wherein “all nucleotides of the AON are 2’-MOE modified”, wherein the fully 2’-MOE-modified AONs provided higher levels of AON’s intended activity compared to fully 2’-O-methyl-modfiied AONs. See paragraphs 0006, 0042; Figure 6.
It would have been obvious to one of ordinary skill in the art before the effective filing date to make an 18-mer antisense oligonucleotide (ASO) of 5’-AATTGAACGGAACCAAAA by merely selecting the nucleotide positions 9-26 of the 50-mer “AON34” (SEQ ID NO:44). One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success because making an 18-mer ASO by selecting an 18-mer sequence within 50-mer AON sequences was expressly taught/suggested by Böckers, who exemplified two ASO sequences of SEQ ID NO:81 and SEQ ID NO:90 each corresponding to nucleotide positions 9-26 of the 50-mer “AON4” (SEQ ID NO:6) and “AON5” (SEQ ID NO:7), respectively. As such, one of ordinary skill in the art would have had a reasonable expectation of success in identifying, selecting, and synthesizing the 18-mer sequence (see boxed) at positions 9-26 of the 50-mer “AON34” as shown below.
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It is noted that the above boxed 18-mer sequence is 100% identical to the nucleotide sequence of SEQ ID NO:1092 claimed in the instant case.
One of ordinary skill in the art would have been motivated to incorporate 2’-MOE modified nucleotide into all positions of the above boxed 18-mer sequence so as to increase the nuclease resistance of the ASO when formulated as a pharmaceutical composition because Böckers expressly taught incorporating an art-recognized modification into the AON so as “to decrease its degradation rate in a cell”, and because 2’-MOE was an art-recognized modification that is well known to be utilized “to increase nuclease resistance” of an AON so much so that AONs fully modified with 2’-MOE at all positions were synthesized and shown to provide a higher activity level as evidenced by Swildens.
In view of the foregoing, claims 65-66 taken as a whole would have been prima facie obvious before the effective filing date.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANA H SHIN whose telephone number is (571)272-8008. The examiner can normally be reached Monday-Thursday: 8am - 6:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, RAM SHUKLA can be reached at 571-272-0735. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANA H SHIN/Primary Examiner, Art Unit 1635
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