FINAL REJECTION
Receipt is acknowledged of Applicants' Amendments and Remarks, filed Dec. 12, 2025.
Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. The rejections and/or objections set forth below are either maintained or newly applied, and constitute the complete set presently applied to the instant claims.
STATUS OF THE CLAIMS
Claims 1-2 have been amended and incorporate no new matter.
No new claims have been added.
Thus, claims 1-11 and 13-22 now represent all claims currently pending and under consideration.
INFORMATION DISCLOSURE STATEMENT
The information disclosure statement (IDS) submitted on Dec. 12, 2025 was filed after the mailing date of the non-final action on Aug. 12, 2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
MAINTAINED REJECTIONS
The following rejection is maintained from the previous Office Action dated Aug. 12, 2025, on the ground that the references cited therein continue to read on the limitations of the amended claims.
Double Patenting
Claims 1-11 and 13-22 stand provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of copending Application No. 17/772,384 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because compounds recited by the reference claims would anticipate the examined claims.
For example, compound 123 recited by reference claim 23, having the structural formula,
PNG
media_image1.png
112
452
media_image1.png
Greyscale
reads on examined claim 1, wherein R1a, R1a', R1b, R1b', R2, R3, R4, R4', R5, and R5' are each hydrogen; n1 is 1; and R6 is
PNG
media_image2.png
162
128
media_image2.png
Greyscale
,
wherein all Q are carbon, Y is C=O; n3 is 1; R14 and R14' are hydrogen; and R8 is C6 aryl (phenyl).
Furthermore, examined claims 1 and 7 (below, left) and reference claim 1 (below, right) recite compounds with nearly identical core structures and substituents,
PNG
media_image3.png
198
518
media_image3.png
Greyscale
PNG
media_image4.png
190
396
media_image4.png
Greyscale
Examined Claims 1 and 7 Reference Claim 1
PNG
media_image5.png
210
532
media_image5.png
Greyscale
differing only slightly in the scope of R6/R21, which largely overlap:
Reference Claim 1
Formula (I)
Examined Claim 1
Formula (I)
Examined Claim 7
Formula (II)
R6 is optionally substituted aryl or heteroaryl,
R7-substituted aryl,
R7-substituted heteroaryl, or one of 9 substituted bicyclic heteroaryl groups
R6 is R7-substituted aryl or heteroaryl, or one of 10 substituted bicyclic heteroaryl groups
R21 is a bicyclic heteroaryl
Further, reference claims 24-26 and examined claims 17-19 are substantially identical, being directed to compounds of formula (I) in the form of a pharmaceutically acceptable salt; in a composition comprising a pharmaceutically acceptable carrier; and in the form of a co-crystal.
Finally, reference claims 27-29 and examined claims 20-22 are substantially identical, being drawn to methods of treating a disease or disorder associated with IKZF2 (Helios) and would benefit from IKZF2 degradation, by administering a compound of formula (I), wherein the disease or disorder is cancer, specifically T cell leukemia, T cell lymphoma, Hodgkin's lymphoma, non-Hodgkin's lymphoma, myeloid leukemia, non-small cell lung cancer (NSCLC), melanoma, triple-negative breast cancer, nasopharyngeal cancer, microsatellite stable colorectal cancer, thymoma, carcinoid, or gastrointestinal stromal tumor (GIST).
Thus, the examined claims would have been anticipated by and/or obvious over 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's arguments filed Dec. 12, 2025 have been fully considered but they are not persuasive.
Applicant asserts that the claim amendments overcome the non-statutory double patenting rejection over co-pending Application No. 17/772,384 ("the '384 Application").
It is acknowledged that compound 52 of reference claim 23 no longer falls within the scope of the amended claims. However, it remains that reference claim 23 recites nearly 300 compound species, many of which continue to fall within the scope of the newly amended claims, including, e.g., compound 123, as discussed supra.
CONCLUSION
No claims are allowed.
THIS ACTION IS MADE FINAL. 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.
CORRESPONDENCE
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARA E. TOWNSLEY whose telephone number is 571-270-7672. The examiner can normally be reached on Mon-Fri from 9:00 am to 6:00 pm (EST). If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Jeff S. Lundgren, can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://portal.uspto.gov/external/portal. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/SARA ELIZABETH TOWNSLEY/Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629