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
Election/Restrictions
Applicant’s election without traverse of group 1 with further election of first and second binding domains being small molecule and ligand and the species as follows:
1) USP10, then CFTR (claim 10 and 15), 2) ZnF-UBP domain (claim 22), 3) covalently linked claim 26), and 4) claim 28(b), in the reply filed on 11/4/2025 is acknowledged;
Claims 8-9, 12, 14, 24, 32 have been cancelled.
Claims 1-7, 10-11, 13, 15-23, 25-31, and 33-35 are pending.
Claims 11, 13, 23, 27, and 29-31, and 33-35 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species, there being no allowable generic or linking claim.
Claims 1-7, 10, 15-22, 25-26, and 28, drawn to a survival-targeting chimeric (SURTAC) molecule comprising a first and second domains linked by a linker, are examined on merits.
Information Disclosure Statement
The information disclosure statement (s) (IDS) submitted on 9/15/2022 and 7/28/2021 are/is considered by the examiner and initialed copies/copy of the PTO-1449 are/is enclosed.
Priority
It is acknowledged that application is 371 national stage application of PCT/EP2020/054327 filed at 2/19/2020 that claims benefit of 62/808305 filed at 2/21/2019.
Claim Rejections - 35 USC § 112
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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Written Description:
small molecule or ligand binding to
1) a ubiquitinylated protein, and
2) a ubiquitin protease
Claims 1-7, 10, 15-22, 25-26, and 28 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, 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.
The claims are drawn to a Survival-Targeting Chimeric (SURTAC) molecule comprising the first and second domain (TEM and DEM) linked by a linker, wherein the first binding domain binding to a ubiquitinylated protein with ubiquitin molecule and second binding domain binding to a ubiquitin protease that cleaves ubiquitin to deubiquitinate ubiquitinylated protein (claim 1+, see finger 1A and 1D). The claims are then broadly drawn to the first and second domains, TEM (TAR engagement motif) and DEM (DUB engagement motif) being a peptide or small molecule (elected, claims 2 and 17) or antibody or ligand (elected, claims 4 and 19). Thus, the claims broadly encompass a chimeric protein comprising any peptides comprising an antibody or any ligand and any small molecules that could bind to any ubiquitinylated protein with ubiquitin molecule or any ubiquitin protease to perform a function of deubiquitinating any ubiquitinylated protein without structural definition of any claimed molecule.
To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof.
The specification teaches and hypnotizes the chimeric molecule having the structure as figure 1A below and more in Figure 1B-1E:
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wherein the specific DUB enzyme here is ubiquitin specific protease including USP family, USP5, 7, and 10 in the second arm with DEM that can deubiquitinate the ubiquitinylated protein of first arm interacted with TEM ([0013], 0038-39, 0078-82] and figure 4 etc). The specification lists the ubiquitinylated protein being substrates that can be deubiquitinated by the DUB enzymes, USP5, USP7 and USP10 [0083-85] and contemplates a method of using the chimeric molecule to deubiquitinate of a ubiquitinylated protein to achieve a purpose of inducing cell apoptosis and treating a disease including cancer (see schematic diagram in figures 5-6 and examples).
However, this specification is insufficient to provide any SURTAC molecule with structurally defined peptide, small molecule, or an antibody, or a ligand as a (any) DEM or TEM as claimed to perform the function as the claimed of SURTAC and as described in the specification. The specification does not reduce to practice of any SURTAC molecule as claimed.
The specification in the examples teaches deubiquitinating ubiquitinated p53 by USP11, but not any defined TEM or DEM molecule in details has been described or structurally defined in the chimeric molecule used. The specification does not teach any results of treating a cancer or any other condition by using the claimed chimeric molecule. In fact, the specification does not reduce to practice using any claimed SURTAC chimeric molecule to perform any function in any condition or disease.
MPEP § 2163.02 states, “[a]n objective standard for determining compliance with the written description requirement is, 'does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed' ”. The courts have decided:
The purpose of the “written description” requirement is broader than to merely explain how to “make and use”; the applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the “written description” inquiry, whatever is now claimed.
See Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Federal Circuit, 1991). Furthermore, the written description provision of 35 USC § 112 is severable from its enablement provision; and adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen Inc. V. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
The Guidelines for Examination of Patent Applications Under the 35 U.S.C. 112, paragraph 1, ``Written Description'' Requirement (66 FR 1099-1111, January 5, 2001) state, “[p]ossession may be shown in a variety of ways including description of an actual reduction to practice, or by showing the invention was 'ready for patenting' such as by 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” (Id. at 1104). Moreover, because the claims encompass a genus of chimeric molecule, an adequate written description of the claimed invention must include sufficient description of at least representative numbers of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics sufficient to show that Applicant was in possession of the claimed genus.
However, factual evidence of an actual reduction to practice has not been disclosed by Applicant in the specification; nor has Applicant shown the invention was “ready for patenting” by disclosure of drawings or structural chemical formulas that show that the invention was complete; nor has Applicant described distinguishing identifying characteristics sufficient to show that Applicant were in possession of the claimed invention at the time the application was filed.
The Guidelines further state, “[f]or inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus” (Id. at 1106); accordingly, it follows that an adequate written description of a genus cannot be achieved in the absence of a disclosure of at least one species within the genus.
Therefore, because the art is not disclosed and described, in accordance with the Guidelines, the description of SURTAC molecules to which the claims refer is deemed to be lacking and one of skill in the art would reasonably conclude that the inventor(s), at the time the application was filed, did not have possession of the claimed invention.
Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. §112 is severable from its enablement provision (see page 1115). Applicant may also refer to Written Description Guideline at USPTO website:
http://www.uspto.gov/web/patents/guides.htm
Conclusion
No claim is allowed.
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure.
Crew et al (US 2016/0058872) teaches PROTAC compound used for regulating protein activity comprises targeting protein and a its binding moiety (PTM) and E3 ubiquitin ligase and its binding ligand (ULM), and PTM and ULM linked by a linker shown as follows. T
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E3 ubiquitin ligase brings ubiquitin molecules to the target protein to regulate the activity of the protein. By broad definition, PROTAC has the similar concept as instantly claimed SURTAC molecule, but contain structurally and functionally different molecules as SURTAC. Crew et al do not teach that the PROTAC contains a target protein being ubiquitinated protein and the enzyme being ubiquitin protease.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Lei Yao, whose telephone number is (571) 272-3112. The examiner can normally be reached on 8:00am-6:00pm Monday-Friday.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis, can be reached on (571) 270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LEI YAO/Primary Examiner, Art Unit 1642