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 .
Claim Status
Claim listing filed on January 20, 2026 is pending. Claims 1-13 and 27-28 are canceled. Claims 14, 19, and 29-30 are amended. Claims 14-26 and 29-32 are examined upon their merits.
Withdrawn Objections and Rejections
Applicant’s cancelation of Claims 27-28 has rendered all previous rejections directed to these claims moot.
The amendments to the specification and the claims have overcome all objections of record, and the specification objections and the claim objections are withdrawn.
The rejection of Claims 14-26 and 29-32 under 35 U.S.C. 112(b) as being indefinite is withdrawn in view of Applicant’s amendments to Claim 14. In particular, removing “or a derivative thereof” overcomes the indefiniteness rejection of record.
The rejection of Claims 29-30 under 35 U.S.C. 112(a) as failing to comply with the enablement requirement is withdrawn in view of Applicant’s amendments to Claims 29-30. In particular, the claims are now directed to a method of treating colorectal cancer.
The provisional rejection of Claims 14, 16-18, 24-26, and 29-32 on the ground of nonstatutory double patenting as being unpatentable over claims 15, 17-18, 21, 28-29, and 31 of copending U.S. App. No. 17/620,271 is withdrawn because U.S. App. No. 17/620,271 has been abandoned.
The provisional rejection of Claims 14-18, 22-26, and 29-32 on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 31-32 and 36-39 of copending U.S. App. No. 17/435,561 in view of Fotin-Mleczek WO 2014/127917 (of record) is withdrawn because U.S. App. No. 17/435,561 has been abandoned.
Claim Rejections - 35 USC § 103 (Modified, necessitated by amendment)
The rejection of Claims 14-18, 22-26, and 29-32 under 35 U.S.C. 103 as being unpatentable over Thielemans US 2014/056939 (of record) in view of Fotin-Mleczek WO 2014/127917 (of record) is maintained.
In regard to amended Claims 29-30 now directed to a method of treating colorectal cancer, Thielemans teaches wherein treating “cancer” encompasses colon cancer (paragraph [0138]). Fotin-Mleczek teaches that the first clinical trial with an anti-PD-1 antibody was conducted in patients with treatment-refractory metastatic solid tumors and showed clinical activity in patients with colorectal cancer (page 3, lines 1-5). Fotin-Mleczek further teaches that treatment is “particularly preferred” in colon cancer which is associated with an overexpression of PD-L1 (paragraph spanning pages 89-90). From these teachings, one of ordinary skill could administer the combination of Claim 14 to treat colorectal cancer with a reasonable expectation of success, especially considering the anti-PD-1 antibody component. The motivation to combine the teachings of Thielemans and Fotin-Mleczek is on record in the non-final office action filed 09/18/2025. Thus, the claimed method of treating colorectal cancer is obvious over Thielemans in view of Fotin-Mleczek.
Applicant's arguments filed January 20, 2026 have been fully considered but they are not persuasive. Applicant argues that the results would not have been predictable to one of ordinary skill in the art, because the cited prior art documents do not teach or suggest that the combination would result in synergistic effects, especially in the context of colorectal cancer patients. As outlined above, the teachings of Thielemans in view of Fotin-Mleczek do make obvious administering the claimed combination to treat colorectal cancer, especially considering that anti-PD-1 antibodies are known to effectively treat colorectal cancer. In regard to unpredicted synergy, it is of record that combining TriMix with an antigen stimulated a greater T cell response than an antigen alone (Thielemans Fig. 17). Thielemans further teaches that the vaccine can be combined with other immunotherapy treatments to “exploit any synergy between the different treatment modalities” such as improving the immune response to the vaccine by combining with ipilimumab or tremelimumab (both of which are anti-CTLA-4 checkpoint inhibitors) (paragraph [0199]). New sections of Thielemans are cited solely in response to Applicant’s arguments and not as a new grounds of rejection. It is of record that Fotin-Mleczek teaches that combining an RNA vaccine comprising an RNA coding for a tumor antigen in combination with a PD-1 pathway inhibitor inhibited tumor growth in mice in a synergistic manner (page 59, lines 7-18; emphasis added). Based on these teachings, it is clear that a tumor antigen in combination with a PD-1 pathway inhibitor is synergistic, and TriMix enhances the immune response to antigens. All of the combination components (TriMix, tumor antigen, and anti-PD-1 antibody) are known to enhance one another’s efficacy in stimulating an anti-tumor immune response, and one of ordinary skill could have predicted the synergistic effects of the combination with a reasonable expectation of success. Applicant’s arguments have been considered but are not persuasive, and the rejection is maintained.
The rejection of Claims 19-21 under 35 U.S.C. 103 as being unpatentable over Thielemans US 2014/056939 (of record) in view of Fotin-Mleczek WO 2014/127917 (of record) as applied to Claims 14-18, 22-26, and 29-32 above, and further in view of Lostale-Seijo et al. Nat Rev Chem. Sept 2018 (of record) is maintained.
Applicant's remarks filed January 20, 2026 do not distinctly and specifically point out the supposed errors in the 35 U.S.C. 103 over Thielemans in view of Fotin-Mleczek and further in view of Lostale-Seijo as is required in a complete response (MPEP § 714.02). Therefore, the rejection is maintained.
Double Patenting (Maintained)
1. The provisional rejection of Claims 14-20, 22-26, and 29-32 on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 16, 23-26, and 27-30 of copending U.S. App. No. 17/604,559 in view of Fotin-Mleczek WO 2014/127917 (of record) is maintained.
Applicant's remarks filed January 20, 2026 do not distinctly and specifically point out the supposed errors in the provisional double patenting rejection as is required in a complete response (MPEP § 714.02). Therefore, the rejection is maintained.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH COOPER PATTERSON whose telephone number is (703)756-1991. The examiner can normally be reached Monday - Friday 8:00am - 5:00pm EST.
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/SARAH COOPER PATTERSON/Examiner, Art Unit 1675
/JEFFREY STUCKER/Supervisory Patent Examiner, Art Unit 1675
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