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 .
Applicant's response to the previous Office action, dated September 24, 2025, has been received. By way of this submission, Applicant has amended claims 1, 14, and 19.
Claims 1-9, 14, 19, 24-31 and 33-35 are pending in the application. Claims 4 and 7 remain withdrawn from consideration, pursuant to the Restriction Requirement mailed March 4, 2022.
Claims 1-3, 5-6, 8-9, 14, 19, 24-31 and 33-35 are therefore under examination before the Office.
The rejections of record can be found in the previous Office action, dated April 24, 2025.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on September 24, 2025 was filed after the mailing date of the first Office action on the merits on September 20, 2022. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3, 5, 8-9, 14, 19, 24-25, 27-31 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Escobar (Sci Transl Med. 2014 Jan 1;6(217):217ra3, cited in IDS) in view of Picarda (Clin Cancer Res. 2016 Jul 153;22(14):3425-3431).
Applicant argues that neither Escobar nor Picarda teach every aspect of the claims as amended; specifically, the references do not teach that expression of the cytokine increases the number of tumor-associated antigen (TAA)-specific T-cells.
Applicant's arguments have been considered fully but are not found to be persuasive.
Escobar teaches that it is desirable to target interferon-alpha to tumors by the above method, for example, to promote the survival, proliferation, and cytotoxicity of CD8+ T cells, as well as increasing the expression of tumor antigens on neoplastic cells to make them more immunogenic (page 1, right column, first and second paragraphs). A treatment that promotes the survival and proliferation of T cells within the tumor microenvironment would naturally increase the number of TAA-specific T-cells.
"[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). MPEP 2112(I).
The amendment to the claims adds nothing more than a natural result of performing the claimed method steps, and do not change the steps of the method in any way. While Escobar may not explicitly state that the combination results in an increase the number of TAA-specific T-cells, this result is an inherent feature of performing the claimed method steps, and as such, would naturally result from the teachings of Escobar and Picarda. Even if the property of increasing the number of TAA-specific T cells were not expected, the balance of the teachings of the prior art weigh towards obviousness. See MPEP 716.01(d). In this situation, the burden of proof is shifted to the applicant to prove that subject matter shown to be in the prior art does not possess the characteristic relied on. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977) and In re Fitzgerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980). MPEP 2112(V). Applicant's mere conclusory statement does not meet this burden. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965).
This rejection is therefore maintained.
Claims 6 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Escobar and Picarda as applied to claim 1 above, and further in view of Chen (US20180362975A1).
Applicant argues that Chen does not remedy the alleged deficiencies of Escobar and Picarda, described above. This argument is not found to be persuasive, for reasons described supra.
This rejection is therefore maintained.
Conclusion
No claim is 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER JOHANSEN whose telephone number is (571)272-0280. The examiner can normally be reached Monday-Friday, 8:00 to 4:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Daniel Kolker can be reached at (571) 272-3181. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PETER JOHANSEN/Examiner, Art Unit 1644
/DANIEL E KOLKER/Supervisory Patent Examiner, Art Unit 1644