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 30-31, 33-37, 39-47, 50-56, 59, 61-62, 64-67, 70-73 and 76-78 are pending in the instant application. Claims 30-31, 37, 54, 59 and 71 are amended and claims 1-29 are cancelled via the amendment filed February 4th, 2026.
Election/Restrictions
In view of Applicant’s amendments, the search and examination of the instant claims has been extended according to MPEP 803.02, to include the following species:
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. Claims 33-34, 39-40, 47, 53, 61-62, 64-67, 70 and 76-78 remain withdrawn without traverse, as being drawn to a nonelected invention.
Information Disclosure Statement (IDS)
The Information Disclosure Statement filed 02/04/2026 was considered by the Examiner.
Withdrawn Rejections
Applicant’s arguments and amendments, filed February 4th, 2026, with respect to 112(b) rejection of claim 54 have been fully considered and are persuasive. The 112(b) rejection of claim 54 has been withdrawn.
Applicant has overcome this rejection by amending claim 54 to recite the compound of Table 2 in the claim.
Applicant’s arguments and amendments, filed February 4th, 2026, with respect to 112(b) rejection of claim 59 have been fully considered and are persuasive. The 112(b) rejection of claim 59 has been withdrawn.
Applicant has overcome this rejection by amending claim 59 to remove the phrase “e.g.” in the claim.
Applicant’s arguments and amendments, filed February 4th, 2026, with respect to 112(b) rejection of claims 71-73 have been fully considered and are persuasive. The 112(b) rejection of claims 71-73 has been withdrawn.
Applicant has overcome this rejection by amending claim 71 to delete the phrase “administering to the subject.
Applicant’s arguments and amendments, filed February 4th, 2026, with respect to 112(d) rejection of claim 71 have been fully considered and are persuasive. The 112(d) rejection of claim 71 has been withdrawn.
Applicant has overcome this rejection by amending the claim to recite “comprising a compound of Formula (II)”.
Applicant’s arguments and amendments, filed February 4th, 2026, with respect to 102(a)(1) rejection of claims 30, 37, 43-45, 50, 52, 55-56, 59 and 71-73 over Washburn have been fully considered and are persuasive. The 102(a)(1) rejection of claims 30, 37, 43-45, 50, 52, 55-56, 59 and 71-73 has been withdrawn.
Applicant has overcome this rejection by amending claim 30 to recite “provided that one of A and B is said heterocyclyl”.
Applicant’s arguments and amendments, filed February 4th, 2026, with respect to 102(a)(1) and 102(a)(2) rejection of claims 30-31, 43-46, 50-52, 56, 59 and 71-73 over Cerezo-Galvez have been fully considered and are persuasive. The 102(a)(1) and 102(a)(2) rejection of claims 30-31, 43-46, 50-52, 56, 59 and 71-73 has been withdrawn.
Applicant has overcome this rejection by amending claim 30 to recite “provided that one of A and B is said heterocyclyl”.
Response to Remarks
Applicant’s arguments with respect to the rejections under 112(b), 112(d), 102(a)(1) and 102(a)(2) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
On pages 16-17 of the response, filed February 4th, 2026, Applicant requests that the double patenting rejection be held in abeyance. The request is considered improper, as a request to hold a matter in abeyance may only be made in response to an objection or requirements as to form (see MPEP 37 CFR 1.111(b) and 714.02). Until such time as the instant claims are allowable or the rejection is otherwise overcome, the provisional rejection below is maintained.
New Claim Rejections - 35 USC § 102 necessitated by Amendment
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) 30-31, 37, 43-45, 50, 52, 55-56, 59 and 71-73 are newly rejected under 35 U.S.C. 102(a)(1) as being anticipated by Goodfellow et al (WO 2005/047293 A1).
Goodfellow teaches the following compound (page 31, compound 9-9):
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Regarding claim 30, this compound is embraced by Formula (II), wherein L1 and L2 are absent, A is heteroaryl, B is heterocyclyl, Z is C(R6), wherein R6 hydrogen, Y is N, R2 is absent and R7 is hydrogen.
Regarding claim 31, in the compound above, A is heteroaryl.
Regarding claim 37, B is heterocyclyl.
Regarding claims 43-44, L1 and L2 are absent.
Regarding claim 45, R is N.
Regarding claim 50, the compound above is of Formula (II-a).
Regarding claim 52, the compound above is of Formula (II-c).
Regarding claim 55, Goodfellow teaches the above compound in a pharmaceutical composition also comprising a pharmaceutically acceptable carrier or diluent (claim 21).
Regarding claims 56 and 59, the prior art is silent on the properties of the cited compounds; however, MPEP 2112.01(II) states: ‘"Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id.’
Regarding claims 71-73, claim 71 recites “for use in treating a disease or disorder in a subject…” which is intended use and the claim limitation is presumed met by the compound of claim 1. Claims 72-73 further place limitations on the disease or disorder, which, again, is intended use.
Claim(s) 30, 45-46, 56, 59 and 71-73 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAS Registry No. 343375-40-6, which entered STN on June 26th, 2001.
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Regarding claim 30, this compound is embraced by instant Formula (II), wherein L1 is absent, L2 is -N(R3)-, wherein R3 is hydrogen, A is heterocylcyl, B is heteroaryl substituted with R1, wherein R1 is halo, Z is N and Y is N.
Regarding claim 45, Y is N.
Regarding claim 46, Z is N.
Regarding claims 56 and 59, the prior art is silent on the properties of the cited compounds; however, MPEP 2112.01(II) states: ‘"Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id.’
Regarding claims 71-73, claim 71 recites “for use in treating a disease or disorder in a subject…” which is an intended use and the claim limitation is presumed met by the compound of claim 1. Claims 72-73 further place limitations on the disease or disorder, which, again, are statements of intended use, which do not further limit claim scope MPEP 2103 C.
Maintained 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 30-31, 35-37, 41-46, 50-52, 54, 56, 59 and 71-73 stand provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-6, 12, 16, 19, 24, 27, 37, 42, 44, 49-50, 52-53, 55, 63, 65, 71, 75, 80-81, 84, 92, 97, 100, 10312, 130-132, 135, 137, 141-142 and 146-147 of copending Application No. 18/700, 515.
The copending application claims the following compound (claim 80):
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Regarding claim 30, This compound is embraced by formula (II-a) of the instant application, wherein Z is N, L1 is absent, A is heterocyclyl, R2 is absent, R7 is hydrogen, L2 is absent and B is heteroaryl, subituted with one R1, wherein R1 is alkyl. Regarding instant claims 71-73, these claims only appear to require an intended use that does not otherwise the cited compounds above.
Regarding claim 31, A is heterocyclyl.
Regarding claims 35-36, A is
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Regarding claim 37, B is heteroaryl.
Regarding claims 41-42, B is
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Regarding claims 43-44, L1 and L2 are absent.
Regarding claims 45-46, Y is N.
Regarding claim 50, the compound is of Formula (II-a).
Regarding claim 51, the compound is of Formula (II-b).
Regarding claim 52, the compound is of Formula (II-c).
Regarding claim 54, this compound is compound 203.
Regarding claim 56, the copending application claims that the compound binds to a target nucleic acid (claim 132).
Regarding claim 59, the copending application claims the compound increases or decreases splicing at a splice cite (claim 135).
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claims allowed.
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 Anna Grace Kuckla whose telephone number is (703)756-5610. The examiner can normally be reached Monday-Friday 7:30-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton A 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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/A.G.K./Examiner, Art Unit 1626
/FEREYDOUN G SAJJADI/Supervisory Patent Examiner, Art Unit 1699