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
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 allowance or after an Office action under Ex Parte Quayle, 25 USPQ 74, 453 O.G. 213 (Comm'r Pat. 1935). 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, prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant's submission filed on 11-17-2025 has been entered.
Claims 2-8 and 13-17, and 21-28 are currently pending and under consideration.
The previous objection to the drawings (Action mailed 10/02/2025, paragraph 6) is withdrawn in view of applicant’s corrected drawings.
Double Patenting
Claims 2-8, 13-17, and 21-28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 16-21, 23-29, and 31-35 of copending Application No. 18/696616 (reference application, applicant’s IDS). Although the claims at issue are not identical, they are not patentably distinct from each other because the examined claims and the reference claims are drawn to the same multispecific antigen-binding molecules. For example, compare reference claim 17 (1) to examined claims 2 (a3) and claim 3 (b2).
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The above antigen binding molecules comprise the same CDRs with the same sequences. Additionally, both sets of claims broadly encompass methods of treating cancer including cancers that express CLDN6. For example, currently examined claims 14-15, 22-25 are drawn to methods of treating cancer with the claimed antigen binding molecules. Both sets of claims also include pharmaceutical compositions comprising the multispecific antigen-binding molecules.
The difference between the pending claims and the reference claims is that the reference claims include “at least one other anticancer agent”. However, the inclusion or combination of anti-cancer agents is well-known to those of ordinary skill in the oncology arts as such combinations can provide additive or even synergetic therapeutic effects. Additionally, in terms of looking at the definition of the pending claims drawn to treatment and pharmaceutical compositions, the specification teaches [0517] and is inclusive of multispecific antigen-binding molecules administered in combination with one or more other agents in therapy. For instance, a multispecific antigen-binding molecules as described herein may be co-administered with at least one additional therapeutic agent. The term “therapeutic agent” encompasses any agent administered to treat a symptom or disease in an individual in need of such treatment. Such additional therapeutic agents may comprise any active ingredient suitable for the particular indication being treated, preferably those with complementary activities that do not adversely affect each other. In certain embodiments, an additional therapeutic agent is an immunomodulatory agent, a cytostatic agent, an inhibitor of cell adhesion, a cytotoxic agent, an activator of cell apoptosis, or an agent that increases the sensitivity of cells to apoptotic inducers. The portion of the specification of the reference that describes subject matter that falls within the scope of a reference claim may be relied upon to properly construe the scope of that claim. In particular, when ascertaining the scope of the reference’s claim(s) to a compound, the examiner should consider the reference’s specification, including all of the compound’s uses that are disclosed. See Sun Pharm. Indus., 611 F.3d at 1386-88, 95 USPQ2d at 1801-02.
As to pending claims 8 and 17, drawn to specific heavy and light chain constant regions, all of the claimed sequences are identical to the SEQ IDs disclosed in the reference application and would be referenced by one of ordinary skill in the art when combining the framework regions.
As to reference claim 21, “wherein the at least one other anticancer agent comprises a TGFβ inducing agent”, the reference teaches [1101] well known chemotherapeutic drugs such as paclitaxel, cisplatin and carboplatin and radiation each of which would be obvious as a combinatorial regimen.
Reference claims 22 and 30 were not included in this rejection because reference application 18/696616 does not define or disclose what is encompassed by the term “CLDN6 expression inducing agent”. Thus, it could not be deduced if this is an obvious variation.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GARY B NICKOL, Ph.D. whose telephone number is (571)272-0835. The examiner can normally be reached M-F 9AM-5:30PM.
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/GARY B NICKOL/Primary Examiner, Art Unit 1643