DETAILED ACTION
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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Election/Restrictions
Applicant’s election without traverse of Group II, claims 20-39, and the species of compound 102 (structure below), in the response dated 9/15/2025, is acknowledged.
Claim 31 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
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Compound 102
Claim Status
Claims 1-19 are cancelled.
Claims 20-39 are newly added and are pending.
Claim 31 is withdrawn
Claims 20-30 and 32-39 are examined on the merits in this prosecution.
CLAIM REJECTIONS
Indefiniteness Rejection
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.
Claims 20-30 and 32-38 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.
Claim 20 recites the following limitation:
A conjugate of Formula (ID) or a pharmaceutically acceptable salt, solvate, or isomer thereof:
wherein:
FG is a reactive functional group capable of conjugation to a targeting vector;
A is a trivalent or tetravalent atom or an amino acid residue;
B is a first branch point;
T is a releasable trigger;
P is a payload;
dPEG is a linear or branched discrete polyethylene glycol-based chain;
q is 0 or 1;
X is an integer from 4 to 48;
y is 2 or 3; and
D1, D2, and D3 are each independently a spacer moiety,
wherein D’, the sum of atoms in a linear chain between B and T, is less than or equal to 22 atoms.
The claim is considered indefinite since “the language of the claim is such that a person of ordinary skill in the art could not interpret the metes and bounds of the claim so as to understand how to avoid infringement” when “he claim is read in light of the specification,” as discussed in MPEP 2173.02.
Claim 20 recites the term “isomer thereof,” but the specification does not provide a limiting definition of the term. An isomer is defined by the National Cancer Institute as “one of two or more compounds that have the same chemical formula but a different arrangements of the atoms within the molecules and that may have different physical/chemical properties” (https://www.cancer.gov/publications/dictionaries/cancer-terms/def/isomer). As such, the isomers of Formula (II) have an unlimited number of potential structures, and one of ordinary skill in the art cannot determine the metes and bounds of the structures recited in the claim, nor how to avoid infringement of the patent.
Claim 20 recites the term “B is a first branch point,” but the specification does not provide a limiting definition of the term. As such, “B” may comprise an unlimited number of potential structures, and one of ordinary skill in the art cannot determine the metes and bounds of the structures recited in the claim, nor how to avoid infringement of the patent.
Claim 20 recites the term “P is a payload”; paragraph [0136] of the specification provides a description of a “payload”:
In some embodiments, P is a payload and may include molecules intended for either therapeutic or diagnostic purposes. In certain embodiments, the payload is a therapeutic moiety designed to treat a specific condition and may be chosen from auristatins, maytansinoids, PBDs, tubulysins, amanatins, duocarmycins, or other payloads known to those in the art. In other embodiments, the payload may be a profluorophore, fluorophore, or chelator used for diagnostic and imaging purposes and may be chosen from the fluoresceins, rhodamines, cyanines, coumarins, DOTAs, NOTAs, or other functional molecules known to those in the art.
As such, “P” is defined as “molecules intended for either therapeutic or diagnostic purposes” or “functional molecules known to those in the art” and thus may comprise an unlimited number of structures currently known or which are discovered in the future, and one of ordinary skill in the art cannot determine the metes and bounds of the structures recited in the claim, nor how to avoid infringement of the patent
Claim 20 recites the term “D1, D2, and D3 are each independently a spacer moiety,” and the specification at ¶ [0159] provides examples, but does not provide a limiting definition of the terms. As such, any of D1, D2, or D3 may comprise an unlimited number of potential structures, and one of ordinary skill in the art cannot determine the metes and bounds of the structures recited in the claim, nor how to avoid infringement of the patent.
Potentially Allowable Subject Matter
Claim 39 is 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 closest prior art considered by the Examiner is that of co-inventor Davis (US 2017/0313656 A1). Davis teaches compounds such as PhthN-dPEG12-Tyr(-dPEG4-amido-dPEG12-Tris(-dPEG24-TBE)3)-dPEG12-Tris(-dPEG24-m)3 (pg 163, [0309], shown below)
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but does not teach or suggest the presence of a releasable trigger or a payload distal to D3. It is noted that Davis does teach maleimide in the position corresponding to FG1 of instant Formula (II), reading on a “reactive functional group capable of conjugation to a targeting vector (see, for example, the structure on pg 170 or the top of pg 177 of Davis).
CONCLUSION
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL P COHEN whose telephone number is (571)270-7402. The examiner can normally be reached on M-Th 8:30-5:30; F 9-4.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana S. Kaup, can be reached on (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL P COHEN/Primary Examiner, Art Unit 1612
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