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 .
Detailed Action
The Amendments and Remarks filed 12/15/25 in response to the Office Action of 8/15/25 are acknowledged and have been entered.
Claims 16-35 are pending.
Claim 16 has been amended by Applicant.
Claims 16-35 are currently under examination.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Rejections Withdrawn
The rejection under 35 U.S.C. 103(a) is withdrawn.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 happen to 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 predicted to respond to the administering. However, neither the patent claims not the instant claims require the subjects to have recited higher percentages. Therefore, both the patent claims and the instant claims encompass embodiments wherein the subjects do not have recited higher percentages. Further, subjects of the patent claims that have recited higher percentages are equivalent to subjects of the instant claims having recited higher percentages that are predicted to respond to the administering.
Response to Arguments
In the Reply of 12/15/25, applicant argues this rejection should be withdrawn because the instant application was filed as a divisional and the instant claims are encompassed by unelected Group III of the restriction requirement of Application 16/642511 (the application of the patent) and are therefore protected from NSDP rejection over claims of the patent.
The amendments to the claims and the arguments found in the Reply of 12/15/25 have been carefully considered, but are not deemed persuasive. Unlike instant claims 26-35, instant claims 16-25 are not claims of unelected Group III of the restriction requirement of Application 16/642511. Further, the instant claims are not consonant with the restriction requirement of Application 16/642511, since the claims have been changed in material respects from the claims at the time the restriction requirement was made. No claims restricted in the restriction requirement of Application 16/642511 recited administering a TIM-3 antagonist to the subject if the percentage of EM TILs and/or effector TILs that are TIM-3 positive is higher than the percentage of naïve TILs and/or CM TILs that are TIM-3 positive without a step of determining a percentage of naïve TILs, CM TILs, EM TILs, and effector TILs that are TIM-3 positive in a subject. Further, Group III of the restriction requirement of Application 16/642511 was drawn to “methods comprising determining a percentage of naïve TILs, CM TILs, EM TILs, and effector TILs that are TIM-3 positive in a subject” and (unlike instant claims 26-35) instant claims 16-25 do not require a step of determining a percentage of naïve TILs, CM TILs, EM TILs, and effector TILs that are TIM-3 positive in a subject.
Group III of 16/642511 is set-forth below:
“Group III, claim(s) 3, 8-11, and 15, drawn to methods comprising determining a percentage of naïve TILs, CM TILs, EM TILs, and effector TILs that are TIM-3 positive in a subject and: (i) determining the subject would respond to treatment with a TIM-3 antagonist if the percentage of EM TILs and/or effector TILs that are TIM-3 positive is higher than the percentage of naïve TILs and/or CM TILs that are TIM-3 positive or (ii) administering a TIM-3 antagonist to the subject if the percentage of EM TILs and/or effector TILs that are TIM-3 positive is higher than the percentage of naïve TILs and/or CM TILs that are TIM-3 positive.”
Double Patenting
Claims 16-25 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 12312403 B2. Both the instant claims and the patent claims are directed to administering the same antibodies to subjects. While the patent claims do not recite the subject have “cancer”, the patent claims recite the administered antibodies are to stimulate an immune response in the subjects (claim 1), that the subjects have a tumor and the immune response is against the tumor (claim 4), and that the subject are also administered therapeutics known to treat cancer (claim 17). Therefore, it would be obvious to perform the patent method with just any subjects that have cancer. In regards to the instant claims reciting subjects of the claimed method that happen to 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 predicted to respond to the administering, neither the patent claims not the instant claims require the subjects to have recited higher percentages. Therefore, both the patent claims and the instant claims encompass embodiments wherein the subjects do not have recited higher percentages. Further, subjects of the patent claims that have recited higher percentages are equivalent to subjects of the instant claims having recited higher percentages that are predicted to respond to the administering.
Response to Arguments
In the Reply of 12/15/25, applicant argues this rejection should be withdrawn because the predictability of a subject having recited percentages is non-obvious.
The amendments to the claims and the arguments found in the Reply of 12/15/25 have been carefully considered, but are not deemed persuasive. In regards the to argument that this rejection should be withdrawn because the predictability of a subject having recited percentages is non-obvious, the examiner disagrees. Neither the patent claims not the instant claims require the subjects to have recited higher percentages. Therefore, both the patent claims and the instant claims encompass embodiments wherein the subjects do not have recited higher percentages. Also, subjects of the patent claims that have recited higher percentages are equivalent to subjects of the instant claims having recited higher percentages that are predicted to respond to the administering.
Allowable Subject Matter
Claims 26-35 are allowed.
Conclusion
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.
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/SEAN E AEDER/Primary Examiner, Art Unit 1642
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