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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/24/2026 has been entered.
Status of the Claims
Claims 1, 2, 11-12, and 15-16 are pending.
Claims 3-10 and 13-14 are cancelled.
Priority
Applicant’s claim for benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged. This application claims priority to provisional application 63/319,582, filed 03/14/2022.
Information Disclosure Statement
No IDS has been filed as of 3/25/2025.
Response to Arguments
Applicant's arguments filed 2/24/2026 have been fully considered but they are not persuasive.
In a final dated 3/31/2025, Claims 1, 2, 11-12, and 15-16 were examined upon their merits.
In a final dated 3/31/2025, Claims 1, 2, 11-12, and 15-16 were rejected under 35 U.S.C. 103. In response, Applicant amended claims 1, 2, 11-12, and 15-16.
With respect to the 103 rejection for claims 1-2, 11-12, and 15-16 the Examiner does not find the argument fully persuasive. The applicant argues that the prior art provided by the Examiner (“You”) does not teach the new genus structure of “Formula II” because instant R2 must always be a halogen and instant R5-6 must be an alkyl group, which is not seen in the genus structure by You. The Examiner agrees that You does not teach where instant R2 can be a halogen in that specific position, however You does teach -X where X can be a halogen in another position on the ring. Therefore, a person skilled in the art would just have to be motivated to extract You and substitute with a ring positional isomer where the instant -R2 position can be a halogen. With respect to R5-R6, You does teach that R4 of the prior art genus structure can be dimethylpiperazine (Claim 1). Therefore, the Examiner does not find this part of the argument persuasive. Further the Applicant argues that a person skilled in the art would not be motivated to make these changes through the teachings of the secondary reference provided by the Examiner (“Jin”) because Jin teaches bifunctional compounds, while the compounds taught by You are monovalent. The Applicant argues that You teaches MLL-WRD5 inhibitors while You teaches bivalent compounds meant to degrade and/or disrupt WDR5. The Applicant cites the following excerpt from Jin as part of the argument:
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The Applicant argues that because of this, Jin does not actually teach inhibitors like You and therefore a person skilled in the art would not be motivated to combine the teachings of Jin and You to arrive at the instant invention. The Examiner argues that Jin explicitly teaches that the “targeting ligand” can be WDR5 inhibitors:
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Therefore, although Jin does teach that the end goal is to take the inhibitor and use it as a ligand to target a bifunctional degrader compound, Jin still does teach that they are WDR5 inhibitors. Therefore, a person skilled in the art would be motivated to combine the teachings of You and Jin to arrive at the instant invention. Therefore, this part of the argument is not found persuasive.
However, the Applicant does provide data that shows the addition of the -F in the instant R2 position and the dimethylpiperazine does improve the inhibitory activity in comparison to the example compound taught by You.
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Since neither You or Jin teach these results or why this addition would improve the inhibitory activity, the Examiner finds this part of the argument persuasive. Therefore the 103 rejection is withdrawn.
With respect to the double patenting rejections:
The double patenting rejection over US11479545 was based on secondary reference Jin and therefore is withdrawn for the same reasons above.
The double patenting rejection over application 18/120,326 is withdrawn because the applicant argues that the ‘326 application requires X2 to be N while the ring in the instant application is set with all carbons in the genus. Therefore, this rejection is withdrawn.
For the double patenting rejections over applications 18/120,311 and 18,351,439, the Applicant does not argue against these rejections and requests that the Examiner holds them in abeyance until the rest of the material is found allowable. Therefore, the Examiner maintains these rejections, see Maintained rejections below.
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 1, 2, 11-12, and 15-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of copending Application No. 18/120,311 Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘311 application includes the same compound of the elected species. Therefore, the compound structure would not be novel.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 2, 11-12, and 15-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 49-50 of copending Application No. 18/351,439. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘439 application includes the same compound of the elected species. Therefore, the compound structure would not be novel.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1, 2, 11-12, and 15-16 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLA MARIA BAUER whose telephone number is (703)756-1269. The examiner can normally be reached Monday-Friday 7:30-5 EST.
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/N.M.B./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621