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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 5/13/2026 has been entered.
The rejection under section 112(b) is withdrawn in view of Applicant’s amendments in connection with this ground of rejection.
The rejection under section 103 is withdrawn in favor of the following new ground of rejection under this section, which was necessitated by Applicant’s amendments: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 18, 20, 21, 23, 27-33 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2014065661, previously cited (WO 661), in view of:
Steel et al., Trends Pharmacol Sci. 2011 Oct 25;33(1):35–41 (Steel); and
U.S. Publication No. 20210107961 based on an application by Gellert et al. (Gellert).
The recited conjugates were known. For example, WO 661 teaches conjugates of antibodies and a molecule of interest (defined as “D”):
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The molecule of interest is protein, peptide or amino acid (i.e., antibody fragment).
The molecule of interest can include biological molecules (page 36), which include the recited cytokines.
See page 35.
WO 661 teaches the structure of the instant conjugates:
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Antibodies with the required specificities are taught, see page 17.
The molecule of interest can include biological molecules and peptides (page 36), which include the recited cytokines.
WO may not explicitly teach IL-15 payload-conjugates. However, Interleukin-15 (IL-15) is a powerful immunostimulatory cytokine that drives the proliferation and cytotoxic activity of Natural Killer (NK) cells and memory CD8+ T cells. It acts as a next-generation alternative to IL-2, attacking cancer without expanding immunosuppressive regulatory T cells (Tregs). For example, Steel teaches that the broad immunological activity coupled with an apparent lack of toxicity seen in preclinical studies makes IL-15 an exciting candidate for cancer therapy. The similarity it shares with IL-2 has lead to the speculation that it might be effective in cancers in which IL-2 has been effective, i.e. renal cancer and melanoma, and to date these are the cancers being examined in the first clinical trials of IL-15. Improved safety while retaining or improving efficacy, when compared to IL-2, would make IL-15 attractive for treating these cancers, see conclusion.
Moreover, Gellert teaches constructs comprising an antibody against the cancer antigen MUC1 and IL-15. In particular, the fusion protein constructs activate NK cells and T cells at the cancer site:
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In this way, those of ordinary skill could have applied IL-15 payloads in the manner required and in a predictable fashion for the purposes of obtaining the recited conjugates. As outlined above, WO 661 teaches the structure of the instant conjugates. The secondary references are added for the proposition that IL-15 payloads are to these conjugates. Specifically, the secondary references teach that the particular known technique of using IL-15 as an anti-cancer agent in antibody conjugates 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 the conjugates described by WO 661 would have yielded predictable results. Accordingly, using IL-15 as a payload for the purposes of providing an antibody conjugate for cancer therapy would have been prima facie obvious. Therefore, based on the above, the references teach the structural elements of the claimed constructs 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).
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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