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 .
Status of Claims
Claims 1-2, 4-5, 7-8, 10, 12, 18, 20, and 22-25 are pending.
Priority
Instant application 17/802,863, filed 08/26/2022 claims priority as follows:
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Information Disclosure Statement
All references from IDS(s) received 08/08/2025, 08/26/2022, and 12/12/2025 have been considered unless marked with a strikethrough.
Response to Amendment/Arguments
The amendment filed 12/12/2025 has been entered. Claims 1, 8, 10, 12, 13, 18, and 24 are amended. Claims 3, 13, 21, 26, and 29 have been cancelled.
In view of the amendment, applicant has overcome:
the previous objections to claims 8 and 12;
the previous 112(a) rejection of claims 26 and 29;
the previous 112(b) rejection of claim 29;
the previous 112(d) rejection of claims 12 and 24;
the previous 102(a)(1) rejection of claims 1-3, 10, 12, 18, 23, 25, 26, and 29 as anticipated by FURET;
the previous 102(a)(1) rejection of claims 1-5, 10, 12, 18, 20, 22, 25, 26, and 29 as anticipated by PANDEY; and
the previous 103 rejection of claims 1-5, 7-8, 10, 12, 18, 20, 22, 25-26, and 29 as being unpatentable over WOLL.
In view of the amendment overcoming the prior art rejections of record, the scope of the search has been expanded to encompass the full scope of the pending claims.
Additionally, the specification was previously objected to for issues related to sequence compliance. Applicant has amended the specification to introduce the missing sequence identifiers, which resolves the issue previously identified. However, the added sequence identifiers range from 1 to 5533, while the sequence listing (SEQ.TXT) for the application only contains 5527 sequences. Therefore, the specification is still objected to for issues related to sequence compliance. See the objection below.
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 - This application contains sequence disclosures in accordance with the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.821(a)(1) and (a)(2). However, this application fails to comply with the requirements of 37 CFR 1.821 - 1.825.
The sequence disclosures at issue are located on page 290 of the specification filed 12/12/2025. Specifically, the sequences labelled SEQ ID NO: 5228 through SEQ ID NO: 5533 appear to be missing in the SEQ.TXT, which only contains 5527 SEQ IDs.
Required response – Applicant must provide:
A "Sequence Listing" part of the disclosure, as described above in item 1); as well as
An amendment specifically directing entry of the "Sequence Listing" part of the disclosure into the application in accordance with 1.825(b)(2);
A statement that the "Sequence Listing" includes no new matter in accordance with 1.825(b)(5); and
A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.825(b)(4).
If the "Sequence Listing" part of the disclosure is submitted according to item 1) a) or b) above, Applicant must also provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, 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;
If the "Sequence Listing" part of the disclosure is submitted according to item 1) b), c), or d) above, Applicant must also provide:
A replacement CRF in accordance with 1.825(b)(6); and
Statement according to item 2) a) or b) above.
Claim Objections
Claim 12 is objected to because of the following informalities: There is only one “W” in the formula of claim 1, but claim 12 recites “at least one of W is N or N(R3c)”. This appears to be a typographical error. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 18 and 24 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 18 recites the limitation
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in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 1 requires that Z is N or N(R3c) and at least one of W, X, and Y is N or N(R3c). Therefore claim 18 lacks antecedent basis.
Claim 24 recites the limitations:
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and
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There is insufficient antecedent basis for these limitations in the claim. Claim 1 requires that Z is N or N(R3c) and at least one of W, X, and Y is N or N(R3c). Therefore claim 24 lacks antecedent basis.
Double Patenting - Maintained
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.
17/802,833
Claims 1-2, 4-5, 7-8, 10, 12, 18, 20, and 22-25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-5, 7-8, 10-12, 22-32, 35, 37-40, and 43-46 of copending Application No. 17/802,833 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
The reference application recites compounds of Formula (I):
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and sub-formulas thereof which encompass compounds possessing the same core, L2 linker, and A/B ring substituents required by the instant claims.
The primary difference between the compounds recited by the reference application and the compounds instantly claimed is the position of the A ring substituent.
MPEP 2144.09, second paragraph, states, “Compounds which are position isomers or homologs are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties.” In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). The homolog is expected to be preparable by the same method and to have generally the same properties. This expectation is then deemed the motivation for preparing the homolog. This circumstance has arisen many times. See In re Schechter and LaForge, 98 USPQ 144, 150, which states “a novel useful chemical compound which is homologous or isomeric with compounds of the prior art is unpatentable unless it possesses some unobvious or unexpected beneficial property not possessed by the prior art compounds.” See In re Wilder, 166 USPQ 545, 548. Note also In re Deuel 34 USPQ2d 1210, 1214 which states, “Structural relationships may provide the requisite motivation or suggestion to modify known compounds to obtain new compounds … a known compound may suggest its analogs or isomers, either geometric isomers (cis v. trans) or position isomers (e.g., ortho v. para).”
Therefore, Formula (I) of the instant claims, having similar structure and the same utility as the compounds in the reference application, would have been prima facie obvious before the effective filing date of the instant application. A skilled artisan would have been motivated to prepare a position isomer of the compounds recited in the reference application with a reasonable expectation of success in obtaining a compound with the same utility.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
18/688,088
Claims 1-2, 4-5, 7-8, 10, 12, 18, 20, and 22-25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 7, 15, 25, 32, 40-41, 44, 47, 50-51, 56-57, 61, 63, 79, 81, 102, 116-118, 121, 125, 130-131, and 137 of copending Application No. 18/688,088 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application claims subject matter overlapping with the instant claims.
The reference application recites compounds of Formula (I):
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and sub-formulas thereof which encompass compounds possessing the same core, L2 linker, and A/B ring substituents required by the instant claims. Additionally, Formula (I) of the reference application covers the elected species compound 118 which is disclosed in the specification of the reference application at page 72 and provides support for the reference claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant requests that the double patenting rejection be held in abeyance until indication of allowable claims scope is acknowledged by the Office. In response, the rejections are still deemed proper and are maintained.
PTO-892 Citation of Pertinent Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
PINARD (Journal of Medicinal Chemistry, vol. 60, no. 10, May 2017, pp. 4444–57) and BHATTACHARYYA (WO 2021007378 A1) are cited because they also disclose compounds useful for modulating nucleic acid splicing. However, the compounds differ from those instantly claimed because the “core” between rings A and B is a monocyclic aryl or heteroaryl; whereas the instant claims require a bicyclic heteroaryl comprising at least 2 nitrogen atoms.
PINARD
BHATTACHARYYA
App. No. 17/802,863
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The prior art fails to teach, suggest, or otherwise provide any motivation to modify the compounds in PINARD or BHATTACHARYYA to arrive at a compound instantly claimed.
Conclusion
Claims 1-2, 4-5, 7-8, 10, 12, 18, 20, and 22-25 are rejected.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kyle Nottingham whose telephone number is (571)270-0640. The examiner can normally be reached M-F from 10:00 am - 6:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached at (571) 270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/K.N./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621