FINAL REJECTION
Receipt is acknowledged of Applicants' Amendments and Remarks, filed Aug. 11, 2026.
Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn.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
Claim 19 is canceled.
Claims 1-5, 8, 20, and 21 have been amended and incorporate no new matter.
New claim 23 has been added.
Claims 6, 7, and 9-18 stand withdrawn as drawn to nonelected inventions and/or species. Amended claim 21 no longer reads on the elected species; and new claim 23 does not read on the elected species.
Thus, claims 1-5, 8, 20, and 22 now represent all claims currently pending and under consideration.
INFORMATION DISCLOSURE STATEMENT
The information disclosure statement (IDS) submitted on Aug. 11, 2026 was filed after the mailing date of the non-final action on Mar. 11, 2026. 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 Mar. 11, 2026, on the ground that the references cited therein continue to read on the limitations of the amended claims.
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.
Claims 1-5, 20, and 22 stand 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.
Specifically, claim 1 is drawn to a bivalent compound comprising a degrader/disruption tag EL conjugated to an eleven nineteen leukemia (ENL) ligand PI via a Linker: PI-Linker-EL;
and enantiomers, diastereoisomers and pharmaceutically acceptable salts thereof.
As recognized by MPEP § 2111.03, the term “comprising”, which is syn-onymous with “including,” “containing,” or “charac-terized by,” is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. See, e.g., Mars Inc. v. H.J. Heinz Co., 377 F.3d 1369, 1376, 71 USPQ 2d 1837, 1843 (Fed. Cir. 2004) (“like the term ‘comprising,’ the terms ‘containing’ and ‘mixture’ are open-ended.”) “Comprising” is a term of art used in claim language which means that the named elements are essential, but other ele-ments may be added and still form a construct within the scope of the claim. Moleculon Research Corp. v. CBS, Inc., 793 F.2d 1261, 229 USPQ 805 (Fed. Cir. 1986); In re Baxter, 656 F.2d 679, 686, 210 USPQ 795, 803 (CCPA 1981); Ex parte Davis, 80 USPQ 448, 450 (Bd. App. 1948) (“comprising” leaves “the claim open for the inclusion of unspecified ingredi-ents even in major amounts”).
Claims 2-5, 20, and 22 all depend from claim 1, and thus remain open to the inclusion of unrecited elements. Because the boundaries of the claimed compounds remain open-ended and undefined, the term “comprising” renders the metes and bounds of the claims indefinite.
This rejection can be overcome by amending claim 1 from:
“A bivalent compound comprising a degrader/disruption tag EL conjugated to an eleven nineteen leukemia (ENL) ligand PI via a Linker: PI-Linker-EL”
to, for example:
“A bivalent compound of formula PI-Linker-EL.”
Since a group has two or more members, it is further suggested to amend “PI is an ENL ligand selected from the group consisting of” on page 2 to “PI is an ENL ligand” of formula 2B.
Similarly, it is suggested to amend “the linker is selected from the group consisting of” on page 16 to “Linker is” formula 8C.
Finally, for clarity and consistency, it is suggested to amend “the degrader/disruption tag is selected from the group consisting of” on page 13 to “EL is a degrader/disruption tag selected from the group consisting of” formula 5A and 5D.
RESPONSE TO ARGUMENTS
Applicant's arguments filed Aug. 11, 2026 have been fully considered but they are not persuasive.
With respect to the rejection under 35 U.S.C. § 112(b) for indefiniteness, Applicant contends that claim 1 has been amended to remove the second instance of the term “comprising,” and to recite defined structures for both the Linker (Formula 8C) and the EL degrader (Formulae 5A or 5D). Thus, Applicant contends that these components are no longer open-ended and claim 1 is definite (Remarks, p. 56).
However, claim 1 continues to recite a bivalent compound comprising formula PI-Linker-EL. Although claim 1 has been amended to limit PI to formula 2B, Linker to formula 8C, and EL to formulae 5A or 5D, it remains that the structure of the claimed compounds is open-ended and does not exclude additional, unrecited elements. This leaves the claims open for the inclusion of unspecified substituents, moieties, and functional groups, even in major amounts. A claim drawn to compounds “comprising” various moieties fails to limit the compounds to the expressly recited structure(s), rendering the scope of the claimed compounds indefinite.
NEW OBJECTIONS/REJECTIONS
Claim Objections
Applicant is advised that should claim 4 be found allowable, claim 22 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
CONCLUSION
Claim 8 is 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.
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 10:00 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.
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/SARA E. TOWNSLEY/Examiner, Art Unit 1629
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