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
Claims 73-92 are pending in the instant application.
Claims 75 and 78 are withdrawn from consideration.
Claims 90-92 are cancelled.
Claims 73 and 81 are amended.
Claims 73, 74, 76, 77, and 79-89 are examined herein.
Priority
The instant application claims benefit of foreign priority to PCTCN2020111722, filed on 27 August 2020, and the benefit of priority to PCT/CN2021/115167, filed on 27 August 2021. The claims to the benefit of priority are acknowledged. As such, the effective filing date of the claims is 27 August 2020.
Information Disclosure Statement
The information disclosure statements (IDS), submitted on 02 March 2023, 02 March 2023, and 21 October 2025, are acknowledged and considered. The submissions are in compliance with the provisions of 37 CFR 1.97.
Response to Arguments
The amendment filed on 182 June 2026 has been entered.
In view of applicant arguments, the 103 rejection of record is withdrawn. Applicant successfully argues the unpredictability in the art and the flaws of Romero, Qi, Liu, and Giles that would not motivate the skilled artisan to combine the prior art. Romero teaches small molecule inhibitors of CBP and/or EP300 and Qi teaches bifunctional compounds that target EP300. Neither Romero nor Qi teach the linker and degradation tag of the instant claims. The Applicant points out the chemical properties of the linker is crucial to the ternary complex formation, and this formation is unpredictable. Liu teaches degradation tags and linkers of the instant invention however they are taught for the degradation of TRKs. In light of the unpredictability in the formation of the ternary complex the skilled artisan would not be motivated to use the linkers designed for degradation of a different protein, nor would the skilled artisan have any reasonable expectation of success.
With respect to the double patenting rejection, Applicant has requested the rejection be held in abeyance until allowable claims are identified. As such, the rejection is maintained and amended to reflect the claim amendments of the instant and co-pending application.
All rejections and objections not found below have been withdrawn.
MAINTAINED REJECTIONS
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 73, 74, 76-78, 80, and 82 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 87 and 86 of co-pending Application No. 17434587 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding claims 73, 74, and 76-78, the co-pending application recites a bivalent compound comprising a cyclic-AMP response element binding protein (CBP) and/or adenoviral E1A binding protein of 300 kDa (P300) ligand (CBP/P300 ligand) conjugated to a degradation tag via a linker moiety, or a pharmaceutically acceptable salt thereof, wherein: (I) the CBP/P300 ligand is a moiety of Formula 3U or Formula 3W and (II) the degradation tag is a moiety selected from Formula 5E and Formula 5F and (III) the linker is selected from the group consisting of -(CO)-(CH2)3-7- and -(CH2)1-2(CONH)(CH2)3-7- (claim 86).
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These corresponds to the instant Formulas of 3A1, 3C1, 5B, and 9.
Regarding claim 80, the co-pending application recites a pharmaceutical composition comprising a bivalent compound or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable carrier or diluent. (claim 87).
Regarding claim 82, the co-pending application recites a pharmaceutical compound comprising a bivalent compound or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable carrier or diluent (claim 98).
Claim Objections
Claims 84-89 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Allowable Subject Matter
Claims 81 and 83 are allowed.
The following is a statement of reasons for the indication of allowable subject matter:
The compounds and compositions of claims 81 and 83 are novel over the prior art for the reasons expressed above.
Conclusion
Claims 73, 74, 76-78, 80, and 82 are rejected.
Claims 81 and 83 are allowed.
Claims 84-89 are objected to.
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 Jerica K Wilson whose telephone number is (703)756-4690. The examiner can normally be reached Monday-Friday 9:00-5:00.
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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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/J.K.W./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
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