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
The species election requirement dated 11/14/2025 required a species of an alkyne-linker-payload of formula (1), which corresponded with Applicant’s election of Group 1, claims 1-14. Applicant elected the following compound, which did not satisfy formula 1:
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In the reply dated 1/14/2026, Applicant explicitly indicated that claims 1, 4, 6, 8, 13 and 14 cover the elected species. These claims define structures that are present in the elected species and are examined on the merits. Any claims reciting species that are currently withdrawn will be rejoined if falling within an allowed generic claim.
The rejections under section 103 are withdrawn since the applied references do not teach or suggest the recited reactions. The following are new grounds of rejection under this section, which are necessitated by Applicant’s amendments.
Claim Rejections - 35 USC § 103
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.
Claims 1, 4, 6, 8, 13, 14, 23, 24 are rejected under 35 U.S.C. 103 as being unpatentable over Dovgan, et al., Sci Rep 10, 7691 (2020) (Dovgan).
Dovgan teaches the following reaction:
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See Sci Rep 10, 7691 (2020), On the use of DNA as a linker in antibody-drug conjugates: synthesis, stability and in vitro potency, Supporting Information.
The polynucleotide moiety satisfies the instant payload group, given its broadest reasonable interpretation.
In this manner, the difference between Dovgan and the claimed inventions is that Dovgan does not teach the invention with particularity so as to amount to anticipation (See M.P.E.P. § 2131: "[t]he identical invention must be shown in as complete detail as is contained in the ... claim." Richardson v. Suzuki Motor Co., 868 F.2d 1226, 1236, 9 USPQ2d 1913, 1920 (Fed. Cir. 1989). The elements must be arranged as required by the claim, but this is not an ipsissimis verbis test, i.e., identity of terminology is not required. In re Bond, 910 F.2d 831, 15 USPQ2d 1566 (Fed. Cir. 1990).). However, based on the above, Dovgan teaches the elements of the instant reaction with sufficient guidance, particularity, and with a reasonable expectation of success, that the invention would be prima facie obvious to one of ordinary skill (the prior art reference teaches or suggests all the claim limitations with a reasonable expectation of success. See M.P.E.P. § 2143).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Dovgan in view of WO 2017/137456, previously cited (WO 456).
Dovgan may fail to teach the alkyne compound of formula (2) with the sulfonamide linker (L1) required by claim 8:
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However, this linker functionality was well within the purview of those of ordinary skill. It is for this proposition that the rejection joins WO 456. Specifically, WO 456 teaches that this linker is employed in a bioconjugates, such as an anti-body-drug conjugates, and is not therapeutically inert but has an effect on the therapeutic index of the bioconjugate. WO 456 teaches that these linkers increase therapeutic index of bioconjugates for use in treatment, in particular cancer, see abstract.
See also, page 4:
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In particular, WO 456 teaches that these linkages are used specifically with cyclooctyne linker payloads, such as those of instant formula (1):
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In this way, those of ordinary skill could have applied the sulfonamide linker in the manner required and in a predictable fashion for the purposes of obtaining the recited alkyne compound of formula (2) comprising these linkages. As outlined above, Dovgan teaches the recited condensation of compounds of formulas (2) and (3) to prepare linker-payload precursors for ADC’s. WO 456 is added for the proposition that alkyne compounds of formula (2), containing sulfonamide linkage in claim 8, are applicable to the process preparing these ADC linker-payload precursors. Specifically, WO 456 teaches the particular known technique of using these linkages in ADC’s to increase therapeutic index was recognized as part of the ordinary capabilities of one skilled in the art. In this regard, those of ordinary skill would have recognized that applying the known technique to preparing linker-payloads would have yielded predictable results. Accordingly, using an alkyne compound of formula (2) with the recited sulfonamide linkages for purposes of providing an ADC precursor would have been prima facie obvious.
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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARL J PUTTLITZ whose telephone number is (571)272-0645. The examiner can normally be reached on Monday to Friday from 9 a.m. to 5 p.m.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Gregory Emch, can be reached at telephone number 571-272-8149. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KARL J PUTTLITZ/ Primary Examiner, Art Unit 1646
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