Detailed Action
The present office action is in response to the remarks filed on 11 Aug 2025.
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
Claims 1, 3-5, 7-8, 10, 14, 16, 19, 25, 28-37, and 40 of the pending application have been examined on the merits. Claims 42-45, 48, and 54-56 are withdrawn (see “Response to Applicant Elections” below). Acknowledgement is made of the amendments filed 11 Aug 2025. Acknowledgement is made of the cancellation of claims 2, 6, 9, 11-13, 15, 17-18, 20-24, 26-27, 37-39, 41, 46-47, and 49-53.
Priority
Applicants identify the instant application, Serial #: 17/802,702 filed 26 Aug 2022, as a National Stage Entry of International Patent Application #: PCT/US2021/020173, filed 28 Feb 2021, which claims priority from U.S. Provisional Application #s: 63/126,491, filed 16 Dec 2020, 63/072,781, filed 31 Aug 2020, 63/040,474, filed 17 Jun 2020, 63/007,134, filed 08 Apr 2020, and 62/983,537, filed 28 Feb 2020.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 26 Aug 2022 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Applicant Election
Applicant’s election without traverse of Group I in the reply filed on 11 Aug 2025 is acknowledged. Applicant’s election of species without traverse of Compound 146 (below) in the reply filed on 11 Aug 2025 is acknowledged.
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The elected species was found to be free of prior art. Examiner expanded the Markush search to encompass the entire generic claim. Prior art was returned during this search.
Claims 42-45 and 48 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11 Aug 2025.
Claim Objections
Claim 35 is objected to for referencing a table in the specification which can be incorporated into the claim. See MPEP § 2173.05(s). Applicant may overcome this objection by amending the claim to include the elements of the referenced table.
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 specification are not identified by sequence identifiers in accordance with 37 CFR 1.821(d).
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers, 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.
Specific deficiency - The Incorporation by Reference paragraph required by 37 CFR 1.821(c)(1) is missing or incomplete. See item 1) a) or 1) b) above.
Required response – Applicant must 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.
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 28, 30, 34, and 40 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.
Claims 28 and 30 recites the limitation "wherein…m…[is] as described in claim 1." Claim 34 recites the limitation “m is 0 or 1.” There is insufficient antecedent basis for this limitation in the claim. Applicant may overcome this rejection by amending the claims to have proper antecedent basis.
Claim 34 contains Markush groupings which do not have the coordinating conjunctions “and” or “or” to properly limit the alternatives defined in the list. Specifically, the limitations for E and F do not include the proper coordinating conjunction. See MPEP § 2117(I). Applicant may overcome this rejection by adding the proper coordinating conjunction to each Markush group in need of one.
Claim 40 recites the limitation, “e.g., as determined by qPCR.” The person of ordinary skill in the art would be confused whether “as determined by qPCR” is a limitation or an example of a type of analysis that might be used by the artisan to determine how much of the target nucleic acid was spliced. Applicant may overcome this rejection by amending the claim to clarify if “as determined by qPCR” is a limitation or not.
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.
Claim(s) 1, 14, and 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2018/140578 (cited in the office action mailed 09 May 2025), hereinafter ‘578.
The instant application is drawn towards compounds of Formula (I-d) (claim 1):
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‘578 teaches the following compound (paragraph [0050]):
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The reference compound reads on compounds of Formula (I-d) when ring B is heteroaryl optionally substituted with one R1; R1 is heteroaryl; D and F are N; E is S; P is N; M is C(R5d); R5d is H; L is absent; and ring A is heteroaryl. Therefore ‘578 anticipates the instant claims.
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, 3-5, 7-8, 10, 14, 16, 19, 25, 28-37, 40, 42-45, 48 and 54-56 are provisionally rejected on the ground of anticipatory-type nonstatutory double patenting as being unpatentable over claims 1, 5, 7, 13, 20, 22, 28, 35, 44, 46, 51, 56, 58, 65-66, 70, 86, 100, 111, 121, 125, 140, 157, 171- 174, and 177 of copending Application No. 18/688,098, hereinafter ‘098 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
‘098 teaches compounds of Formula (I):
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Formula (I) anticipates the instant compounds of Formula (I-d). ‘098 further limits the compounds of Formula (I) to compounds which alters a target nucleic acid, binds to a target nucleic acid, or stabilizes a target nucleic acid (ref claim 174). ‘098 further limits compounds of Formula (I) to those compounds which increase splicing at a target nucleic acid site (ref claim 177). ‘098 teaches a composition of a compound of Formula (I) and a pharmaceutically acceptable excipient. Therefore, ‘098 anticipates the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan D. Mahlum whose telephone number is (703)756-4691. The examiner can normally be reached 8:30 AM - 5:00 PM ET, M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached at (571) 272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.D.M./Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625