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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Current Status of 17/904,404
This Office Action is responsive to the amended claims of 16 December 2025.
Claims 5-23 are currently pending.
Priority
Applicant’s claim for the benefit of the prior-filed applications PCT/TR2021/050147 (filed 17 February 2021) and TR2020/02326 (filed 17 February 2020) under 35 U.S.C. 119(e), 120, 121, 365(c), or 386(c) is acknowledged.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Receipt of the certified translation of the foreign priority document is acknowledged.
For the purpose of this office action, the priority date of the instant claims is determined to be 17 February 2020.
Response to Amendments
The 35 U.S.C. 112 rejections to the claims, present in the previous office action, are partially withdrawn due to Applicant’s amendments.
Response to Amendments
The Examiner has reviewed the arguments and amendments received on 16 December 2025. These arguments and amendments have not been found sufficient to remove the previously presented rejections under 35 USC 112(a).
Applicant now argues that a paper published by the instant authors, AYDIN (Cited in Applicant’s arguments received 16 December 2025), described an indole version of the indoline compound that has support within the instant priority documents. Applicant admits that the indole compound of AYDIN is not referred to as “DRG-MDM2-5”, but instead is referred to as compound E9. AYDIN was published between the filing date of the instant foreign priority document and the instant priority PCT document. Applicant points to identical IC50 values for compound E9 and the instantly claimed “DRG-MDM2-5” in AYDIN and the instant specification. Applicant also points to a cell viability plot that is identical in the instant application and in AYDIN, referring to data for compounds E9 and DRG-MDM2-5 respectively.
Unfortunately, the disclosure of AYDIN does not refer to the indole compound therein with the same compound name that is present in the instant application. These new arguments presented by the Applicant are determined to be insufficient to show that the indoline structure was clearly presented in error. The clerical error described by the Applicant is not readily apparent, as both the indoline and the indole structures are valid chemical structures.
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.
Claim 5-23 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 Applicant has replaced the indoline-bearing compound originally claimed in the instant application (top structure below) with an indole-bearing compound (bottom structure below).
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The original claims in the instant application, the specification (top of Pg. 4), and the foreign priority document (top of Pg. 4) all identify Applicant’s invention as related to the indoline compound above, also referred to as DRG-MDM2-5 in these documents. Applicant states, in their arguments/remarks of 9 June 2025, that a “clerical error” was responsible for the indoline compound being submitted instead of the indole. Unfortunately, Applicant does not or cannot point to any support for the indole structure above within: the foreign priority document, the international patent application, or the national stage application.
While there is no in haec verba requirement, newly added claims or claim limitations must be supported in the specification through express, implicit, or inherent disclosure. An amendment to correct an obvious error does not constitute new matter where the ordinary artisan would not only recognize the existence of the error in the specification, but also recognize the appropriate correction. In re Oda, 443 F.2d 1200, 170 USPQ 268 (CCPA 1971). See MPEP 2163(I)(B). There is no implicit, explicit, or inherent support found by the Examiner for Applicant’s amendment related to the indole structure above. The clerical error described by the Applicant is not readily apparent, as both the indoline and the indole structures are valid chemical structures.
If Applicant is aware of any document, being publicly available before the filing date of the foreign priority document, the international patent application, or the national stage application, that shows DRG-MDM2-5 as being synonymous with the indole structure above, it may be helpful herein.
Claim Interpretations
The Examiner is interpreting a “derivative”, as instantly claimed, to refer to only “hydrates, solvates, prodrugs, all stereoisomers, salts, esters, tautomers, isotopically labeled derivatives or forms of [a] compound of formula I that form under [the] physiological conditions of the human body”. This definition is present on page 4 of the instant specification and is a closed definition as interpreted by the Examiner.
Conclusion
No claims are currently allowable.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/JDMc/Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625