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 .
Priority
This application, filed 2 February, 2023, is a national stage application of PCT/KR2021/010298, filed 4 August, 2021, which claims foreign benefit of Application KR10-2021-0102226, filed 3 August, 2021; KR10-2020-0097553, 4 August, 2020; and KR10-2020-0097550, 4 August, 2020.
Status of the Application
Receipt is acknowledged of Applicant’s claimed invention, filed 25 February, 2026, in the matter of Application N° 18/040,323. Said documents have been entered on the record.
Claims 1, 5 and 8 are amended. Claims 2-4, 7 and 9 are canceled. No new matter was introduced.
Claims 10-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II – Method Claims, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 1 October, 2025.
Thus, Claims 1, 5-6, and 8 represent all claims currently under consideration.
Response to Amendment/Arguments
Claims 2-4, 7 and 9 have been canceled. Therefore, the rejections of these claims
under 35 U.S.C. 112(a), 102(a)(1), and provisional Double Patenting are moot.
The Amendments and Declaration under 37 CFR 1.132 filed 25 February, 2026 are sufficient to overcome the previous rejections of Claims 1, 5-6, and 8 under 35 U.S.C. 112(a) 102(a)(1), and provisional Double Patenting.
Additionally, the requirement for Species Election is also withdrawn.
The election without traverse of Group I: Complexes in the reply filed on 1 October, 2025 is maintained.
Below can be found new grounds of rejection necessitated by amendments.
Claim Rejections - 35 USC § 103
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.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 5-6, and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Vincent et al. (WO 2019/236567 A2), hereinafter Vincent.
Regarding Claims 1, 5 and 8, Vincent teaches a tumor microenvironment-activated drug-binder conjugate comprising: (i) a cell binding moiety which is an antibody (‘567, Pg. 3, Line 28), (ii) a drug moiety which is TLR7/8 (‘567, Pg. 9, Line 17), and (iii) a linker moiety which is cleaved completely so as to release the drug moiety (‘567, Pg. 4, Lines 14), wherein L2 is p-aminobenzyloxycarbonyl (PABC), a self immolative linker (‘567, Pg. 8, Lines 7-8). Furthermore, Vincent exemplifies the connection for TLR7/8 agonists at the active site (NH2) as shown below (‘567, Pg. 105.)
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Regarding Claim 6, Vincent teaches the linker L1 is a polyether such as a poly(ethylene glycol) (‘567, Pg. 8, Line 16).
Applicant asserts that the invention lies in conjugating the TLR7/8 agonist at the active amine site via a cleavable linker to achieve controlled or timed release (see Declaration, Para 8). However, Vincent expressly teaches conjugation of TLR7/8 agonists via the active site (NH2) using cleavable linkers to achieve release of the payload. Thus, the feature relied upon by Applicant as inventive was already known in the art.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of the invention to conjugate a TLR7/8 agonist via the amine active site using a cleavable linker as taught by Vincent, in order to enable controlled release of the payload. Vincent teaches that such linker systems, including peptide- and carbamate-containing linkers, are suitable for delivering functional agents and releasing them under physiological conditions. In view of these teachings, a skilled artisan would have had a reasonable expectation that modifying the agonist at an available amine site with a cleavable linker would successfully yield a conjugate capable of controlled payload release.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Donna M. Nestor whose telephone number is (703)756-5316. The examiner can normally be reached generally (w/flex): 5:30a-5p EST M-Th.
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/D.M.N./ Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627