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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 5/14/26 has been entered.
Claims 16-35 are pending.
Claim 16 has been amended by Applicant.
Claims 16-35 are currently under consideration.
This Office Action contains New Rejections.
Rejections Withdrawn
The rejection of claims on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 12312403 B2 is withdrawn.
Rejections Maintained
Double Patenting
Claims 16-25 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11787859 B2. Both the instant claims and the patent claims are directed to administering the same antibodies to subjects with cancer. The difference between the patent claims and the instant claims is that the instant claims recite subjects of the claimed method that have a higher percentages of EM TILs and/or effector TILs that are positive for TIM-3 than a percentage of naïve TILs and/or CM TILs that are positive for TIM-3 are administered the antibodies. However, one performing the patented method would administer the antibodies of the patent method to subjects with cancer that have a higher percentages of EM TILs and/or effector TILs that are positive for TIM-3 than a percentage of naïve TILs and/or CM TILs that are positive for TIM-3 because the patent discloses such subjects are the ones that therapeutically benefit from being administered the antibodies (lines 10-18 of column 2 of the patent, in particular).
As stated at MPEP 804: those portions of the specification which provide support for the reference claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference patent or application (as distinguished from an obvious variation of the subject matter disclosed in the reference patent or application). In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970). The court in Vogel recognized “that it is most difficult, if not meaningless, to try to say what is or is not an obvious variation of a claim,” but that one can judge whether or not the invention claimed in an application is an obvious variation of an embodiment disclosed in the patent or application which provides support for the claim. According to the court, one must first “determine how much of the patent disclosure pertains to the invention claimed in the patent” because only “[t]his portion of the specification supports the patent claims and may be considered.” The court pointed out that “this use of the disclosure is not in contravention of the cases forbidding its use as prior art, nor is it applying the patent as a reference under 35 U.S.C. 103, since only the disclosure of the invention claimed in the patent may be examined.” In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 95 USPQ2d 1797 (Fed. Cir. 2010); Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003).
New Rejections
Double Patenting
Claim 16-35 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 6, and 8-18 of copending Application No. 19/030490 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims and the instant claims are drawn to methods of determining the same class of subjects that are responsive to the same therapeutic treatment and/or treating said class of subjects with said therapeutic treatment. Copending claims are directed to species of the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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/SEAN E AEDER/Primary Examiner, Art Unit 1642
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