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 7 October, 2020, is a national stage application of PCT/US2021/026691, filed 9 April, 2021, which claims the benefit of U.S. provisional application 63/007,847, filed 9 April, 2020.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 29 December, 2025 has been entered.
Status of the Application
Receipt is acknowledged of Applicant’s claimed invention, filed 16 December, 2025, in the matter of Application N° 17/995,806. Said documents have been entered on the record.
Claims 1, 11, 14, 17, and 24 are amended. Claims 4-10, and 23 are canceled. Claims 28-31 are new. No new matter was introduced.
Thus, Claims 1-3, 11, 14-22, 24 and 27-31 represent all claims currently under consideration.
Response to Amendment/Remarks
Claims 4-10, and 23 have been canceled. Therefore, the rejections of these claims under 35 U.S.C. 112(b) are moot.
Applicant’s amendments are sufficient to overcome the remaining rejections under 35 U.S.C. 112(b).
The terminal disclaimer filed on 16 December, 2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration dates of US Patent N° 11,426,472 and 11,890,357 has been reviewed and is accepted. The terminal disclaimer has been recorded and is sufficient to overcome the nonstatutory double patenting rejections of Claims 17-19.
Below can be found new grounds of rejection necessitated by amendments, as well as allowable subject matter.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 17-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhu et al. (US 2016/0168118 A1, cited in IDS), hereinafter Zhu.
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Zhu teaches compound 5 (‘118, Pg. 7, Table 1), shown right, which is fully encompassed by instant Formula I, wherein Z1 is -CRa, wherein Ra is H, R1 is an aminoalkyl, R2 is F, and R3 is F.
As such, Zhu anticipates Claims 17-19.
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 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 17-19 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Fernandez (US 2014/0256717 A1, of previous record), in view of Patani and LaVoie (Chem. Rev. 1996, 96, 3147-3176).
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Fernandez teaches compound I-07 (‘717, Pg. 35, Para 0557), shown to the right, which is significantly overlaps instant Formula I, wherein Z1 is N (as in instant Claims 17-19 and 27), R1 is aminoalkyl, and R2 is H
Fernandez fails to exemplify R3 as an acyl group as amended (i.e., a carbonyl group bonded to carbon), but instead discloses a carboxylic acid substituent (-C(O)OH).
However, Patani and LaVoie teach that hydroxyl and alkyl substituents are well-recognized bioisosteres, as evidenced by Grimm’s Hydride Displacement Law, which places -OH and -CH3 within the same bioisosteric grouping (1996, Pg. 3148, Table 1.)
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to replace the hydroxyl moiety of the carboxylic acid with a carbon-based substituent as a routine and predictable modification, with a reasonable expectation of success.
Allowable Subject Matter
Claims 1-3, 11, 14-16, 24 and 28-31 are allowed.
Claims 20-22 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The allowable claims are directed to a conjugate compound comprising a specific arrangement of functional components covalently linked in a defined structural relationship. While the prior art of record (WO 2011/082285 A1, WO 2018/111989 A1, and US 2016/0168118 A1 – Zhu, all cited in an IDS, and referenced in the ISR), generally described aspects of the relevant chemical and biological art, none of the references, alone or in combination, disclose or suggest the claimed conjugates as a whole, nor do they teach or render obvious the particular manner in which the recited components are linked together in the instant claims. The prior art instead describes the individual components or related systems in isolation or in different structural contexts. Accordingly, the claimed subject matter represents a patentably distinct conjugate over the art of record.
Communication
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