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 .
DETAILED ACTION
This is a response to Applicant’s communication filed on August 25, 2026. Application No. 18/639,526, filed April 18, 2024, is a U.S. Nonprovisional application, and claims the benefit of U.S. Provisional application No. 63/496,926, filed April 18, 2023. In a preliminary amendment filed August 23, 2024, Applicant cancelled claims 4, 6, 7, 18, 20-22, 24, 25, 27-30, 32, and 33. Claims 1-3, 5, 8-17, 19, 23, 26, 31, 34, and 35 are pending.
Election/Restriction
Applicant’s election without traverse of the invention of Group I in the reply filed on August 25, 2026, is acknowledged. Claims 15-17, 19, 23, and 26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention.
Applicant's election with traverse of the species “therapeutic agent” in the reply filed on August 23, 2024, is also acknowledged. In order to advance prosecution the species election requirement is withdrawn. Please see the 35 U.S.C. 112, Written Description Rejection below.
Accordingly, the election was made without traverse in the reply filed on August 25, 2026.
Claims 1-3, 5, 8-14, 31, 34, and 35 are examined below.
Claim Rejections - 35 USC § 112, Written Description Rejection
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 1-3, 5, 8-14, 31, 34, and 35 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. Possession may be shown in a variety of ways including description of actual reduction to practice or by showing that the invention was “ready for patenting,” such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention. Claims requiring an essential or critical feature that is not adequately described in the specification and that is not conventional in the art or known to one of ordinary skill in the art suggest that the invention lacks written support. See MPEP § 2163.
Written description analysis considers (1) actual reduction to practice, (2) disclosure of drawings or structural chemical formulas, and (3) disclosure of sufficient relevant identifying characteristics by way of complete/partial structure or physical and/or chemical properties or functional characteristics coupled with known or disclosed features.
In this case, the summary states that “[t]his summary is not intended to identify key features of the claimed subject matter, nor is it intended to be used as an aid in determining the scope of the claimed subject matter.” Specification, para. [0005]. Notably, the Detailed Description fails to provide compensatory guidance. The Detailed Description states the “agents are individually a small molecule, a protein, a fusion protein, a peptide, a nucleic acid, an aptamer, an avimer, or a derivative or fragment thereof. In some embodiments, the agent is a peptide or a peptide mimetic.” (Specification, para. [0053]; see also, Id., claim 10.) This description of a therapeutic agent fails to provide chemical structures (partial structures or physical and/or chemical properties or functional characteristics coupled with known or disclosed features), or any distinguishing identifying characteristics sufficient to show that the applicants had possession of any therapeutic agent as claimed. Although, the specification identifies certain “suitable” agents (see para. [0065]) however, it is unclear how any of the listed agents fall within the description of therapeutic agents stated above. Accordingly, the present disclosure fails to show the applicant was in possession of the claimed invention.
Claim Rejections - 35 USC § 102(a)(1)
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3, 5, 8-14, 31, 34, and 35 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang et al., Eukaryotic Elongation Factor 2 Kinase Activity is Controlled by Multiple Inputs from Oncogenic Signaling, 34(22) Mol. & Cell. Biol. 4088-4103 (2014). Wang discloses a method for treating a SWI/SNF chromatin remodeling complex mutant tumor or cancer in a subject in need thereof, the method comprising: administering to the subject a therapeutically effective amount of an agent effective in preventing, inhibiting, or suppressing mRNA translation elongation; wherein the SWI/SNF chromatin remodeling complex mutant tumor or cancer comprises an ARID 1A-deficient tumor or cancer; and wherein the agent comprises an agent that (i) activates eEF2 kinase (eEF2K); (ii) inhibits a mitogenic activator of protein kinase (MAPK) pathway; or (iii) inhibits or suppresses the activity or expression of RASGRPl. See Wang et al., p. 4088, Col. 1, second para., for rapamycin inhibiting mTORC1, and AZD8055 that directly inhibits the catalytic activity of mTOR.
Similarly, Wang discloses a method for inducing a transcription-translation conflict in an ARID1A-deficient tumor cell of a subject, the method comprising contacting the ARID1A-deficient tumor cell of the subject with an agent effective in preventing, inhibiting, or suppressing mRNA translation elongation, wherein the agent comprises a therapeutic agent capable of preventing, inhibiting, or suppressing eEF2 activity or expression. (See again, Id, p. 4088, Col. 1, 1st para. – p. 4089, Col. 1, third para.
Please note that agents cited in the prior art, Wang et al., read on the therapeutic agents as construed by the present invention. See the 35 USC 112(a) Written Description Rejection above.
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.
Claims 1-3, 5, 8-14, 31, 34, and 35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim of U.S. Patent No. 12, 527,764
Claims 1-3, 5, 8-14, 31, 34, and 35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 12,527,764. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘764 patent are drawn to the same invention claimed by the present invention. The claims of the present invention are generally drawn to a method of treating cancer with an agent that modulates mRNA translation elongation. The ‘764 patent is drawn to a method of treating castration resistant prostate cancer with an agent that disrupts eIF4F translation-initiation complexes. See Hseih, ‘764 patent, claim 1. Notably, claim 1 of the ‘764 patent lists the same compounds cited in the present specification as “suitable” agents. Compare claim 1 of the ‘764 patent, and those compounds listed in para. [0065] of the present specification.
Conclusion
No claims are allowed.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIMOTHY R ROZOF whose telephone number is (571)270-5992. The examiner can normally be reached on Monday - Friday, 9:00 a.m. -5:00 p.m..
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached on (571) 272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TIMOTHY R ROZOF/
Primary Examiner, Art Unit 1625
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