NON-FINAL REJECTION
Receipt is acknowledged of Applicants' Amendments and Remarks, filed Jun. 26, 2026.
No claims have been amended, and no new claims have been added.
Claims 12 and 23-32 have been canceled.
Thus, claims 1-11 and 13-22 now represent all claims currently pending and under consideration.
Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn.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.
REQUEST FOR CONTINUED EXAMINATION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 Jun. 26, 2026 has been entered.
INFORMATION DISCLOSURE STATEMENT
No new Information Disclosure Statements (IDS) have been submitted.
RESPONSE TO ARGUMENTS
Applicant’s arguments, see Remarks pp. 42-43, filed Jun. 26, 2026, with respect to the obviousness-type double patenting rejection over co-pending application 17/772,384 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn.
However, upon further consideration, new grounds of rejection are set forth below.
NEW REJECTIONS
Claim Rejections - 35 USC § 112(b) – Indefiniteness
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.
1. Claims 1-11 and 13-22 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 pre-AIA the applicant regards as the invention.
Specifically, independent claim 1 is drawn to compounds of formula (I) or a pharmaceutically acceptable salt, hydrate, solvate, prodrug, stereoisomer, or tautomer thereof.
Independent claim 7 is drawn to compounds of formula (II) or a pharmaceutically acceptable salt, hydrate, solvate, prodrug, stereoisomer, or tautomer thereof.
Independent claim 16 is drawn to compound species of formulae (I) or (II) or a pharmaceutically acceptable salt, hydrate, solvate, prodrug, stereoisomer, or tautomer thereof.
However, the term "prodrug" is not defined in the specification. While prodrugs are understood in the art as compounds which are therapeutically inactive until administered and metabolized to its active form, the term encompasses compounds of unknown structure defined in purely functional terms, which sets no limit on the moieties or functional groups which may be added to any position of the claimed compounds to yield a “prodrug” thereof.
As recognized by MPEP § 2173.05(g), a claim term is merely functional descriptive language when it recites a feature "by what it does rather than by what it is" (e.g., as evidenced by its specific structure). In re Swinehart, 439 F.2d 210, 212, 169 USPQ 226, 229 (CCPA 1971).
Here, the term "prodrug" identifies the claimed compounds by their function, rather than by structure. Thus, the scope of the compounds encompassed by the term “prodrug,” and the nature of the steps required to prepare them, have no clear boundary. What might constitute a “prodrug” of the claimed compounds is vague and open to interpretation. Therefore, one of ordinary skill in the art could not clearly distinguish compounds which are included by the claims, from compounds which are excluded.
Because a skilled artisan would not be reasonably apprised of the scope of the claimed invention, infringing compounds cannot be distinguished from non-infringing compounds, rendering the metes and bounds of the claims indefinite.
2. Claim 20 is 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.
Claim 20 is drawn to a method of treating a disease or disorder that is associated with IKZF2 (Helios) and would benefit from IKZF2 degradation, comprising administering to a subject in need thereof a therapeutically effective amount of the compound of formula (I).
However, the specification fails to provide a limiting definition of diseases or disorders "associated with IKZF2 (Helios) and would benefit from IKZF2 degradation," which has no commonly understood and accepted meaning in the art. Thus, claim 20 amounts to a method of treating unspecified diseases or conditions defined only by their molecular mechanism, leaving the patient population encompassed by the claim ambiguous.
Certain diseases or conditions associated with IKZF2 are disclosed and recited in claims 21-22, e.g., cancers, such as 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 (TNBC), nasopharyngeal cancer (NPC), microsatellite stable colorectal cancer (mssCRC), thymoma, carcinoid, or gastrointestinal stromal tumor (GIST).
However, "diseases or disorders associated with IKZF2 (Helios)" that would "benefit from IKZF2 degradation" are much broader terms, encompassing unrelated disorders with widely varying etiologies, as well as diseases and disorders not yet known to be associated with IKZF2 or that would benefit from IKZF2 degradation.
This ambiguous, open-ended terminology does not define the patient population encompassed by the claims with sufficient clarity. Because infringing activity cannot be clearly distinguished from non-infringing activity, the metes and bounds of the claims are indefinite.
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.
3. Claims 7-11 and 13-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3-5, 8, 16, 17, and 19-23 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 examined claims would have been prima facie obvious over the compounds of the reference claims.
For example, compound 287 recited by reference claim 23, having the structural formula,
Reference claim 23
Compound 287
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media_image1.png
132
526
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Greyscale
Examined claim 16
Compound 38
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150
554
media_image2.png
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Examined claim 13
Formula (IIb)
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media_image3.png
244
662
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Examined claim 7
Formula (II)
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media_image4.png
204
520
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Greyscale
reads on examined claims 7-11 and 13-16, to the extent that R1a, R1a', R1b, R1b', R2, R4, R4', R5, R5', and R16 are each hydrogen; n1 is 1; and R21 is a 6-membered heteroaryl (pyridyl) substituted with at least two R15 which form a 5-membered heteroaryl (pyrazolyl) substituted with C6-aryl (R8, phenyl).
Reference compound 287 differs from the examined claims, and compound 38 as recited by claim 16, only in that the piperidinyl ring is substituted with hydroxyl (-OH).
However, formula (II) as recited by examined claim 7 defines each R4 and R4′ as independently selected from various substituents, including hydrogen or hydroxyl (-OH). Because R4 and R4' are adjacent to the position of the hydroxyl substituent of reference compound 287, it is a positional isomer of the compounds of the examined claims.
Therefore, it would have been predictable to one of ordinary skill in the art to modify compound 287 of reference claim 23 by exchanging the positions of hydrogen and hydroxyl on the piperidinyl ring to arrive at the compounds of the examined claims with a reasonable expectation of success, because positional isomers are prima facie obvious even in the absence of a teaching to modify.
As recognized by MPEP § 2144.09, compounds which are positional isomers (i.e., having the same radicals in physically different positions on the same nucleus) are generally of sufficiently close structural similarity that there is a presumed expectation that they possess the same properties. This expectation is then deemed the motivation for preparing the position isomers. See In re Wilder, 563 F.2d 457 (CCPA 1977). Compounds that differ only in the placement of substituents in a ring system are not patentable absent a showing of unexpected properties. See In Re Papesch, 315 F.2d 381 (CCPA 1963) and MPEP § 2144.09 (I).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
CONCLUSION
No claims are allowed.
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 10:00 am - 6:00 pm (ET) M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JEFF S. LUNDGREN can be reached on 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARA E. TOWNSLEY/Examiner, Art Unit 1629
Prosecution Insights