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 action is in response to the papers filed on July 27, 2026. Claims 3-11, 13, 15-18, and 20-45 have been canceled. Claims 46-50 are newly added.
Therefore, claims 1-2, 12, 14, 19, and 46-50 are currently under examination.
Election/Restriction
Applicant's election without traverse of Group I, claims 1-2, 12, 14 and 19, directed to a method for inducing oligomerization of C terminal Binding Proteins (CtBPs), comprising treating a sample in vitro with at least one selected from the group consisting of a compound of Chemical Formula 1, a compound of Chemical Formula 2, and a compound of Chemical Formula 3, is acknowledged. Claims 20-28, 30-34 and 36 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 July 27, 2026. The withdrawn claims are presently canceled by Applicant.
Priority
The present application is a 35 U.S.C. 371 national stage filing of the International Application No. PCT/KR2022/018430, filed November 21, 2022, which claims priority to Republic of Korea Application No. KR10-2021-0161446 filed on November 22, 2021 is acknowledged. Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e). Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Thus, priority date is not yet perfected, and the earliest possible priority for the instant application is November 22, 2021.
Claim Objections
Claim 2 is objected to as being grammatically incorrect as there is incorrect punctuation with a period missing after the sentence.
Claims 12, 14, and 19 are objected to for the recitation of treatment with “the compound.” The parent claim 1 recites treatment with “at least one selected from the group consisting of” the compounds of Chemical Formula 1-3 and references one or more compounds. Applicant may obviate the objection by amending the claim to recite “the at least one compound”.
Claim 46 is objected to and should recite: “wherein the CtBPs is CtBP 1 or CtBP2.” The plural subject “CtBPs” is inconsistent with the singular verb “is” and with the identification of an individual CtBP protein.
Claim 50 is objected to and should recites “CtBP-mediated differentiation” or “through CtBP mediation.
Claim Rejections - 35 USC § 112(a)
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 1-2, 12, 14, 19, and 46-50 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for certain embodiments involving YJ102 (chemical formula 2)-induced oligomerization of CtBP1 in human mesenchymal stem cells, does not reasonably provide enablement for the full scope of the claimed methods. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
While determining whether a specification is enabling, one considers whether the claimed invention provides sufficient guidance to make or use the claimed invention, if not, whether an artisan would require undue experimentation to make and use the claimed invention and whether working examples have been provided. Factors to be considered in determining whether a disclosure meets the enablement requirement of 35 USC§ 112, first paragraph, have been described by the court in In re Wands, 8 USPQ2d 1400 (CA FC 1988).
Wands states on page 1404,
“Factors to be considered in determining whether a disclosure would require undue experimentation have been summarized by the board in Ex parte Forman. They include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, ( 4) the nature of the invention, (5) the state of the prior art, (6) the relative skills of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.”
In the instant application, claim 1 is directed broadly to a method for inducing oligomerization of C-terminal Binding Proteins (CtBPs) by treating a sample in vitro with at least one compound selected from Chemical formula 1, 2, and 3. The specification likewise states generally that the method includes treatment with any one of these three compounds, that the CtBPs may be CtBP1 or CtBP2, and that the oligomerization may include CtBP1-CtBP1 or CtBP2-CtBP2 homooligomerization (specification, pg. 28, lines 13-15). The specification further states that the sample may be an adult stem cell and identifies mesenchymal stem cells derived from umbilical cord blood, umbilical cord, adipose tissue, or bone marrow (pg. 28, lines 16-20).
However, the working oligomerization experiment and support is substantially narrower than the scope of the claims. In Example 1-2, the specification specifically identifies the experiment as a “Confirmation of regulation of CtBP1 oligomerization by YJ102” and states that the experiment was conducted in human UCB-MSCs using immunoprecipitation (pg. 48-49). The cells were treated with YJ102 at 20 µM, together with the CtBP inhibitor MTOB where applicable, and FLAG- and HA- tagged CtBP constructs were used to evaluate interaction (pg. 49).
The experimental result is specifically reported as follows: “YJ102 induced oligomerization of CtBP1,” and the oligomerization was inhibited by MTOB. The specification additionally reports that YJ102 had no effect on CtBP1-CtBP2 heteromerization (pg. 50, para. 1). Thus, the working example directly demonstrates YJ102-induced CtBP1 oligomerization, but does not provide a corresponding working example showing that the compounds of Chemical Formula 1 and Chemical Formula 3 induce CtBP oligomerization, nor does it provide a working example showing induction of CtBP2-CtBP2 homooligomerization by any of the recited compounds.
The specification does disclose DARTs binding data for the three compounds. Specifically, the specification reports that YJ101, YJ102, YJ103 protected overexpressed CtBP1 from pronase degradation, while YJ102 also protected CtBP2, and concludes that YJ101, YJ102, and YJ103 bound CtBP1 and that YJ102 bound both CtBP1 and CtBP2 in human UCB-MSCs (pg. 48, lines 9-19). These binding data do not demonstrate that each of the three compounds induces the claimed oligomerization. Binding of a compound to CtBP is does not support nor demonstrate such binding produces CtBP oligomerization.
Hence, the specification is enabling, at most, for inducing CtBP1 oligomerization with YJ102 in human UCB-MSCs under the disclosed experimental conditions. Although the specification generally states that CtBPs may be CtBP1 or CtBP2, that oligomerization may include CtBP1-CtBP1 or CtBP2-CtBP2 homooligomerization, and that Chemical Formula 1-3 may bind CtBP1, these statements are broader than the working oligomerization data (pg. 23-24 and 28).
Claims 2, 12, 14, 19, and 46-50 do not cure this deficiency. Claim 2 limits the sample to adult stem cells, and claims 12, 14, and 19 further recite changes in marker expression or secretion described in the specification. Claim 46 expressly encompasses CtBP1 and CtBP2, while the demonstrated oligomerization result is limited to CtBP1. Claims 47-49 recite residue-specific interactions derived from molecular docking, which the specification characterizes as predicted or expected interaction rather than direct experimental confirmation (pg. 50-51).
Thus, due to the lack of sufficient working examples and guidance demonstrating CtBP oligomerization across the claimed alternatives, one of ordinary skill in the art would require undue experimentation to practice the full scope of the claims. The scope of the claims exceeds the scope of enablement provided by the specification. While the specification reasonably enables YJ102-induced CtBP1 oligomerization in human UCB-MSCs under the disclosed conditions, it does not reasonably enable the broader claimed methods encompassing oligomerization induced by each Chemical Formula 1, 2, and 3 and CtBP1 or CtBP2 throughout the claimed scope.
Claim Rejections - 35 USC § 112(b)
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 50 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth the subject matter which the inventor or a joint inventor,
Claim 50 recites the limitation "wherein adult stem cells" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 2 recites “an adult stem cell,” not claim 1. Additionally, the limitation “by CtBPs-mediation” is indefinite because it is unclear what type of CtBP involvement is required to satisfy the limitation. The specification states that transdifferentiation may be induced by “CtBPs-mediation,” and more preferably through oligomerization of CtBPs, but does not provide a reasonable interpretation of what constitutes CtBP mediation. Therefore, the ordinary artisan would not be reasonably apprised of the scope of the claimed “CtBPs-mediation”.
Subject Matter Free of the Prior Art
Claims 1-2, 12, 14, 19, and 46-50 contain allowable subject matter. The closest prior art Ewha University (KR20190041897A, published April 23, 2020, see IDS) generally related to differentiation or direct conversion of stem cells into neural or neural progenitor cells. However, the prior art of record does not teach or suggest inducing oligomerization of CtBPs by treating a sample in vitro with YJ102 (Chemical Formula 2), particularly inducing CtBP1 oligomerization in human mesenchymal stem cells. The instant application demonstrates that YJ102 binds CtBP1 and CtBP2 and that YJ102 induces oligomerization of CtBP1 in human UCB-MSCs. The specification further describes differentiation of adult stem cells into neural progenitor cells through oligomerization of CtBP.
Conclusion
Claims 1-2, 12, 14, 19, and 46-50 are rejected. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOEL D LEVIN whose telephone number is (571)270-0616. The examiner be reached 8:00 am to 5:00 pm, Monday through Friday.
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/J.D.L./Examiner, Art Unit 1633
/FEREYDOUN G SAJJADI/Supervisory Patent Examiner, Art Unit 1699
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