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 .
The rejection under section 112(a) is withdrawn in view of the amendments limiting the recited conjugates to those with support in the specification.
The rejection under section 112(b) is withdrawn in view of the amendments in connection with this ground of rejection.
The rejection under section 103 is maintained:
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, 5, 6, 11-13, 54, 61, 64-69 remain rejected under 35 U.S.C. 103 as being unpatentable over WO 2019154315, as evidenced by counterpart U.S. Publication No. 20210032347 based on an application by Bao et al. (Bao), in view of:
Leong et al., Mol. Pharmaceutics 2015, 12, 1717−1729 (Leong); and
U.S. Publication No. 20140322129 based on an application by Leong et al. (Leong II); and
WO 2020063676 (WO 676).
Citations to Bao are made with reference to the U.S. publication.
Boa teaches the instant anti-B7-H4 antibodies and that these antibodies can be conjugated into ADC’s.
For example, Bao teaches B7-H4 antibody. In Example 2 Bao discloses antibodies with the required sequences, e.g.:
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Also, the antibodies 2F8 and 1C9 of Bao and the corresponding sequences thereof are the same as the antibodies 2F8 and 1C9 in the present application.
Bao also teaches that antibody drug conjugates (ADC’s) of B7-H4 antibodies were known:
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In this regard, the difference between Bao and the claimed inventions is that Bao 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, Bao teaches the elements of anti-B7-H4 ADC’s 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).
Nonetheless, the specific structure of the recited anti-B7-H4 ADC’s were known. It is for this proposition that the examiner joins Leong, which specifically teaches the structures of the recited linker-drugs conjugated to anti-B7-H4 antibodies:
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See also Leong II:
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Other preferred linker-drugs recited in the claims were also known. See for example WO 676, teaching the elected linker-drug:
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See page 12.
In this way, those of ordinary skill could have applied the linker-drug moieties in the manner required and a predictable fashion for the purposes of obtaining the recited ADC’s. As outlined above, Boa teaches the instant anti-B7-H4 antibodies and that these antibodies can be conjugated into ADC’s. The secondary references are added for the proposition that the recited linker-drug moieties are applicable to anti-B7-H4 ADC’s. Specifically, the secondary references teach structures of the recited linker-drugs conjugated to anti-B7-H4 antibodies, and that this particular known technique of was recognized as part of the ordinary capabilities of one skilled in the art. In this manner, those of ordinary skill would have recognized that applying the known technique to anti-B7-H4 antibodies, such as those taught by Bao, would have yielded predictable results. Accordingly, using the recited linker-drug moieties for the purposes of preparing the instant ADC’s would have been prima facie obvious.
Applicant has excepted U.S. Publication No. 20210032347 under 102(b)(2)(C), but has not excepted its issued patent US 11472882, or counterpart WO 2019154315, which also qualify as prior art under 102(b)(2). Moreover, WO 2019154315 also qualifies as prior art under section 102(b)(1) since applicant has not perfected priority to priority document CN201910498993.2.
Therefore, the rejection is maintained.
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.
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