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
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Claims 1-3, 14-18, 44-48, 53-55, 57-58, 71-73, and 76 have an effective filing date of 04 FEB 2020.
Status of Claims
Claims 1-3, 14-18, 44-48, 53-55, 57-58, 71-73, and 76 are currently pending and presented for examination on the merits.
Claims 1, 14-17, 44-47, 73, and 76 are amended.
Claims 4-13, 19-43, 49-52, 56, 59-70, 74-75, and 77-79 are canceled.
Rejections Withdrawn
35 U.S.C. 112(a)
The rejection of the claims under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement, is withdrawn. The claims have been amended to recite 6 CDRs for the anti-PD-L1 antigen binding region and 6 CDRs for the anti-CD137 antigen-binding region.
The rejection of the claims under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement, is withdrawn in view of the amendments to the specification, dated 02/26/2026.
35 U.S.C. 112(b)
The rejection of claim 73 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention, is withdrawn in view of the amendment to the claim, dated 02/26/2026.
Rejections Maintained
35 U.S.C. 103
The rejection of the claims under 35 U.S.C. 103 as being unpatentable over Sin et al (Combined stimulation of TLR9 and 4. 1BB augments Trp2 peptide vaccine-mediated melanoma rejection by increasing Ag-specific CTL activity and infiltration into tumor sites, Cancer Letters 330 (2013) 190-199, IDS 8/1/2022), and further in view of Altintas et al (WO 2019025545 A1, IDS 8/1/2022), is maintained.
Nonstatutory Double Patenting
The nonstatutory double patenting rejections of record are maintained.
Response to Arguments
In Applicant Arguments, dated 06/26/2026, Applicant asserts that the Office has not provided reasoning to combine PD-L1 blockade with a vaccine. The Sin reference does not teach PD-L1 blockade, and the Altintas references does not teach the use of PD-L1 blockade in the context of vaccination.
This argument has been fully considered but is not deemed persuasive. At p. 12 of the Final Rejection, dated 12/29/2025, it is noted that Sin et al teaches the combined stimulation of TLR9 with CpG-ODN and 4.1BB with anti-4.1BB is essential for achieving TRP2 peptide vaccine-mediated melanoma eradication, and at p. 13 of the Final Rejection, it is noted that a PD-L1/CD137 bispecific antibody may be used to treat melanoma. Given that both references teach the treatment of melanoma, one of ordinary skill in the art would reason that combining the references, which would include the administration of TRP2 peptide vaccination (with TLR9 and CpG-ODN) in combination with a PD-L1/CD137 bispecific antibody may also be used in the treatment of melanoma.
Applicant further states that “the present specification provides data to demonstrate that the claimed combination provides unexpected benefits relative to the individual agents alone. For example, Example 3 shows that a combination treatment comprising the recited PD-L1x4-1BB bsAb and vaccination with a tumor antigen resulted in ‘further tumor growth reduction and enhanced survival compared to each individual therapy.’ Specification, pages 97- 98. The specification states that the PD-L1x4-1BB bsAb ‘synergizes with T-cell vaccination by expanding vaccine-induced T-cell responses.’ Id. (emphasis added).”
These arguments have been fully considered but are not deemed persuasive. First Applicant has not provided any evidence of the alleged synergy between a PD-L1x4-1BB bsAb and T cell vaccination. Second even if said evidence were presented, it would not be sufficient to overcome the rejection of the claims under 35 U.S.C. 103, because said evidence would not be commensurate in scope with the claims. Example 3 of the specification relates to the administration of a PD-L1 x 4-1BB bsAb in combination with TRP1 RNA-LPX; however the claims are drawn to the administration of a PD-L1 x CD137 bsAb and any peptide or protein comprising an epitope for inducing an immune response against an antigen (or a polynucleotide encoding the peptide or protein). Furthermore Example 3 of the specification relates to the treatment of melanoma, but claim 1 is drawn to the treatment of any cancer type. Therefore Applicant’s alleged evidence of unexpected results is not commensurate in scope with the claims. Accordingly the rejection of the claims under 35 U.S.C. 103 is maintained. By the same reasoning the obviousness-type nonstatutory double patenting rejections of record are also maintained.
Conclusion
No claims are allowed.
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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/DENNIS J SULLIVAN/ Examiner, Art Unit 1642
/NELSON B MOSELEY II/ Primary Examiner, Art Unit 1642