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 .
Status of Claims and Response to Amendments
The amendments filed February 24, 2026 have been acknowledged and entered. Claims 7-9, 59-62, 64-70, 72-73, 75-77 and 79-88 are pending.
Information Disclosure Statements
Acknowledgement is made of the Information Disclosure Statements filed on February 24, 2026. All references have been considered except where marked with a strikethrough.
Election/Restriction
The present examination is based on Applicant’s election without traverse of Group I (presently claims 59-62, 64-70, 72-73, 75-77 and 79-88, drawn to a compound of formula II) and the species corresponding to Molecule 17 in the reply filed on September 15, 2025. Claims 7-9 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Withdrawn Rejections
Applicant is notified that any outstanding rejection or objection that is not expressly maintained in this Office Action has been withdrawn or rendered moot in view of Applicant’s amendments and/or
remarks.
Claim Objections and Allowable Subject Matter
Claim 62 is objected to because of the following informalities:
Claim 62 has been amended to recite R3 is formula (I)
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The claim recites formula (I) twice and the amendments to R1 appear to be cut off and incomplete. The duplication of formula (I) and partial amendment of R1 appear to be typographical errors. Appropriate correction is required.
Claims 65-70 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. The following is a statement of reasons for the indication of allowable subject matter: Claims 65-70 are free of the prior art. The examiner performed a chemical structure as well as an inventor and classification search to identify any potential prior art. The Examiner was unable to identify any prior art which contained the limitations seen in the present application
Maintained Rejections
Claim Rejections - 35 USC § 112a
Claims 59-62, 64, 72-73, 75-77 and 79-88 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for formula (II) wherein R2 is an antibody or an antigen binding fragment , does not reasonably provide enablement for any other R2 group presently claimed. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make the invention commensurate in scope with these claims. The specification does not enable the full scope of claimed compounds because it fails to show how one skilled in the art would we prepare or obtain a compound of formula (II) comprising the full scope of R2. Accordingly, one skilled in the art could not practice the entire scope of the invention without undue and unreasonable experimentation.
The reasons for this rejection were set forth in the previous Office Action mailed October 24, 2025 and are incorporated herein by reference.
Response to Arguments
Applicant’s arguments filed February 24, 2026 have been fully considered but they are not persuasive.
Applicant argues the specification provides detailed description, specific embodiments, and
sufficient technical guidance to allow a person of ordinary skill in the art to practice the claimed
invention across its scope using no more than routine experimentation. Applicant thus submits that the specification provides a clear guidance to one skilled in the art, such that any adaptation of the specifically exemplified embodiments to these disclosed alternatives would require no more than routine experimentation. (page 9 of 12 of remarks).
Examiner respectfully disagrees that the claims are enabled for the full scope of R2 because claim 59 has been amended to delete any definition of R2 and the specification fails to provide any definition of R2. The scope of R2 and therefore the claimed compound of Formula (II) is thus incredibly broad. The specification fails to provide enablement for the full scope of the claims.
The rejection is still deemed proper and thus maintained.
Claim Rejections - 35 USC § 112b
Claims 72-73 and 75 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 72 recites the limitation “further comprising a linker” which renders the claim indefinite because it is unclear where this linker is attached in formula (II). Is the linker part of R2 or R3? Where is it located? A person skilled in the art cannot ascertain the metes and bound of formula (II). Claims 73 and 75 depend from claim 72 and fail to cure this deficiency.
Applicant’s arguments filed February 24, 2026 have not addressed this rejection. The claim has been amended to recite “that is linked to a target-binding moiety”; however, this amendment does not clarify the scope of the claim. The rejection is still deemed proper and maintained.
Rejections Necessitated by Applicant Amendment
Claim Rejections - 35 USC § 112b
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 59-62, 64, 72-73, 75-77 and 79-88 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. The claims are indefinite for the reasons that follow:
Applicant has amended claim 59 to delete the phrase “a moiety” from the definition of R2. In view of this amendment there is no definition of R2 in the claim. The specification does not provide any definition of R2. The scope of R2 is therefore unclear. The specification as a whole fails to convey what groups could be reasonably included in the scope of R2. A person skilled in the art therefore cannot ascertain the metes and bounds of the invention. 60-62, 64, 72-73, 75-77 and 79-88 depend directly or indirectly from claim 59, fail to cure this deficiency, and therefore are also indefinite.
Claim 62 recites Y1 is an oxycarbonyl group and X1 is a C1-6 alkyl group, a 9-fluorenylmethyl group, a benzyl group, or a tert-butyl group. There is insufficient antecedent basis for Y1 and X1 in the claim because the claim has been amended to delete “group X1-Y1”. Claims 64, 76 and 79-88 depend directly or indirectly from claim 62 and are indefinite for this reason.
Conclusion
No claim is 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.
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 KEVIN MARTIN whose telephone number is (571)270-0917. The examiner can normally be reached Monday - Friday 8 am - 5 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached on (571) 272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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March 25, 2026
/K.S.M./Examiner, Art Unit 1624
/BRUCK KIFLE/Primary Examiner, Art Unit 1624