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 .
Response to Arguments
Applicant’s arguments, see Page 1, filed 03/02/2026, with respect to the 112b rejection of claim 13 have been fully considered and are persuasive with the amendment to the claim. Therefore, the rejection has been withdrawn. In respect to the objection of claims 2-3, upon further consideration the prior art teaching of Sperry et al. (WO 2021003157 A1) is obvious to the reversible and irreversible covalent binding with an amino acid residue at or near an active site of eIF4E. Additionally the teaching of Sperry in view of Cawley et al. eIF4E-binding protein regulation of mRNAs with differential 5′-UTR secondary structure: a polyelectrostatic model for a component of protein–mRNA interactions, June 20th, 2012, Pages 7666-7675 and Gallagher, Modulating the eIF4E–eIF4G Protein–Protein Interaction in Human Disease, 2019, Pages 1-182 reads to the limitation of binding to an amino acid residue of lysine, arginine, cysteine and serine.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-21 are rejected under 35 U.S.C. 103 as being unpatentable over Sperry et al. (WO 2021003157 A1), published 01/07/2021, with a US priority date of 07/02/2019 in view of Wan et al. Discovery of Lysine-Targeted eIF4E Inhibitors through Covalent Docking, J Am Chem Soc., March 2020, Pages 1-10, Cawley et al. eIF4E-binding protein regulation of mRNAs with differential 5′-UTR secondary structure: a polyelectrostatic model for a component of protein–mRNA interactions, June 20th, 2012, Pages 7666-7675 and Gallagher, Modulating the eIF4E–eIF4G Protein–Protein Interaction in Human Disease, 2019, Pages 1-182.
Regarding claims 1-21, Sperry teaches compounds or stereoisomers, tautomers and pharmaceutically acceptable salts of such compounds having activity as inhibitors of eukaryotic initiation factor 4e (eIF4e), as well as to related compositions and methods for utilizing the inventive compounds as therapeutic agents for treatment of eIF4e dependent diseases (abstract), comprising administration of the eIF4e inhibitor and an acceptable carrier or excipient (relevant to claims 1, 4 and 15-16) (para. 012). Of the compounds Sperry teaches Formula I, Formula II, Formula III, Formula IV, Formula V, or Formula VI, which discloses the same limitations of claimed invention formulas I-VI (relevant to claims 11-13) (para. 012).
Of particular embodiments Sperry teaches compounds
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187
211
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(example 4),
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175
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to treat cancers of Hodgkin’s lymphoma cell, T-cell lymphoma, colon cancer, gastric cancer, thyroid cancer and lung cancer by route of oral, topical, transdermal, inhalation, parenteral, sublingual, buccal, rectal, vaginal, and intranasal (relevant to claims 17-21) (para. 016 and 0126). Sperry additionally teaches eIF4E binding for the mRNAs leads to production of malignancy-associated proteins when over-expressed (para. 002).
Sperry fails to teach the inhibitor compounds covalently binding with an amino acid residue at or near an active site of eIf4E and wherein the covalent binding is reversible and/or irreversible.
Wan teaches eIF4E inhibitors are negatively charged guanine analogues with negligible cell permeability, so to overcome that challenge a covalent docking approach focused on lysine residue (Lys162) was developed (abstract).
Crawley teaches eIF4E binding exist with certain amino acids in which there are RS (arginine–serine)-rich domains that interact with mRNAs (Pg. 7667, 1st column, 3rd para.).
Gallagher teaches Cysteine residues stabilize eIF4E-binding partners (like 4E-T), while cysteine accumulation is an established metabolic hallmark for rapid cancer cell proliferation and survival (Pg. 48).
Therefore, it would have been obvious to some one of ordinary skill in the art to have constructed the translational inhibitor compounds of claim 14 that covalently binds with an amino acid residue at or near an active site of eIf4E and wherein covalent binding is reversible and/or irreversible. One would be motivated to do so from the teachings of Sperry of formulas I-VI of claimed invention, thus including the compounds of claim 14 as a translational inhibitor of eIF4E and the teaching of Wan, Crawley and Gallagher of the amino acids of lysine, arginine, cysteine and serine binding at or near the active site of eIF4E. Thus, in inhibiting the overexpression of eIF4E one would construct the translational inhibitor compounds of claim 14 to covalently bind with an amino acid residue of lysine, arginine, cysteine and serine on or near the eIf4E protein from the teachings of Sperry, Wan, Crawley and Gallagher.
Additionally, the covalent binding would be reversible or irreversible as it is known in the art covalent binding between an amino acid and a molecule can be either reversible or irreversible depending on the mechanism of the binding. As applicants’ specification does not specify the mechanisms of the binding being reversible or irreversible the teachings of Sperry, Wan, Crawley and Gallagher would be obvious as being the same structure of claimed invention binding to the same amino acid residues thus having the same properties as per MPEP 2112.01 (II): "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
Conclusion
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MIKHAIL O'DONNEL. ROBINSON
Examiner
Art Unit 1627
/MIKHAIL O'DONNEL ROBINSON/Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627
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