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 .
Election/Restrictions
Applicant’s election without traverse of Group III (claims 95-98 and 108-113) in the reply filed on 06/24/2025 is acknowledged. The mailed response, however, did not include species election. In a phone call on 10/02/2025, Applicant’s representative, Robin Teskin, elected species (i) encompassing nucleic acid encoding dominant negative Zbtb20, which includes SEQ ID NO 39 and SEQ ID NO 40. Affirmation of this election must be made by applicant in replying to this Office action.
Therefore, claims 1-2,54-55, 92-93,95-98, and 108-113 are pending.
Claims 1-2,54-55, 92-93, and 108-113 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/24/2025 and the telephone call made on 10/02/2025 .
Claims 95-98 are under examination.
Priority
Applicant’s claim for the benefit of a prior-filed application provisional application # 62943526 , filed on 12/04/2019 under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) was filed before the mailing date of the non-final first action on the merits. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
Claims 95-98 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 nucleic acid encoding a dominant negative Zbtb20 (DN Zbtb20), where the DN Zbtb20 comprises one or more Zbtb20 C-terminal zinc-finger domains but lacks at least a portion of a Zbtb20 N-terminal comprising the BTB domain. Claim 97 specifies the function of the claimed DN Zbtb20 as being capable of binding the endogenous Zbtb20 binding sites within DNA, preventing endogenous Zbtb20 form binding to said binding sites.
According to the specification, a “dominant negative “ is any variant of endogenous Zbtb20 which is capable of suppressing the activity of endogenous Zbtb20 by acting as a competitive inhibitor of Zbtb20. For example, the dominant negative would be any variant of the endogenous Zbtb20 that can bind to endogenous Zbtb20 binding sites within DNA, preventing the binding of endogenous Zbtb20 to said binding sites.(See paragraph [98]). While the specification provides the SEQ ID NOs defining the nucleic acid/ amino acid sequences of the DN Zbtb20 (e.g. SEQ ID 39/40, respectively); however, Applicants have not demonstrated a reduction in practice that the claimed DN Zbtb20 will produce a stable and functional variant that can perform the claimed function (e.g. to reduce the activity of endogenous Zbtb20 by acting as a competitive inhibitor of Zbtb20).
In the instant case, the specification defines the dominant negative Zbtb20 as the variant comprising one or more Zbtb20 C-terminal zinc-finger domains but lacking at least a portion of a Zbtb20 N-terminal comprising the BTB domain. The specification also contemplates that the said variant is capable of acting as a competitive inhibitor of Zbtb20 upon delivery to the cell, suppressing the activity of the endogenous Zbtb20.(See paragraph [98]). Prior arts by Cordeddu et al and Stellacci et al had identified dominant negative variants of Zbtb20 occurring in patients with Primrose syndrome. The identified variants comprise of full-length Zbtb20 with missense mutations affecting the C-terminal domain of Zbtb20 (i.e. the DNA binding domain), resulting in the production of stable but dysfunctional protein. ( See Fig.1A, and Fig.2B provided by Stellacci et al ). On the other hand, prior art by Sutherland et al demonstrated that removing exon 6 encoding the BTB domain from endogenous Zbtb20 resulted in a knockout rather than the production of a dominant negative mutant. (See Sutherland et al , Results section- 1st paragraph on page 2805, and Fig.1D). Therefore, one with ordinary skill in the art would expect that a nucleic acid encoding the Zbtb20 ‘s C-terminal domain but lacking the BTB domain would not produce a stable and functional protein capable of serving as a competitive inhibitor. Applicants have not reduce to practice that truncating the N-terminal domain comprising the BTB domain from the full Zbtb20 will result in a stable and functional protein that is capable of acting as a competitive inhibitor of the Zbtb20. Accordingly, Applicants have not provided sufficient description of the invention to support they were in possession of a dominant negative Zbtb20 comprising one or more Zbtb20 C-terminal zinc-finger domains but lacking at least a portion of a Zbtb20 N-terminal comprising the BTB domain.
Possession of an invention may be shown in a variety of ways including description of an 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. See, e.g., Pfaff v. Wells Elecs., Inc.,525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641, 1647 (1998).
Furthermore, claims 96 and 98 ((i),(ii) require a nucleic acid/ amnio acid sequence that is at least 75%,80%,85%,90%,95% or 99% identical to the claimed SEQ ID NO: 39/40, which encodes a dominant negative variant of Zbtb20. Therefore, claims 96 and 98 encompass a large genus of DN Zbtb20 variants with as little as 75% identity to the claimed DN variant associated with SEQ ID NO: 39/40 (elected species). To begin with, the specification does not provide a written description for obtaining stable and functional DN Zbtb20 from the claimed SEQ ID NO: 39/40, nor does it provides a written description for obtaining stable and functional DN Zbtb20 to cover all possible variants of the human DN Zbtb20 that would result in a sequence with as little as 75% identity to the claimed sequence of SEQ ID NO:39/40 and producing a stable and functional protein imparting a dominant negative human Zbtbt20 activity. Furthermore, the specification does not identify what changes, deletion, fragments, etc. could be made to SEQ ID NO: 39/40 that would still produce a stable and functional dominant negative variants of the human Zbtb20. Accordingly, Applicants have not provided sufficient description of the invention to support they were in possession of all sequences having at least 75% sequence identity to SEQ ID NO: 39/40.
Taken together, the claims are considered to lack sufficient written description and are properly rejected under 35 USC 112, first paragraph. Dependent claims are included in the basis of the rejection because they do not correct the primary deficiencies of the independent claims.
Conclusion
No Claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FATIMAH KHALAF MATALKAH whose telephone number is (703)756-5652. The examiner can normally be reached Monday-Friday,7:30 am-4:30 pm EST.
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/FATIMAH KHALAF MATALKAH/Examiner, Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638