DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/05/2026 has been entered.
Disposition of Claims
Claims 1-7, 21-22, 28, 34-35, 50, 59, 84-87, and 94 were pending. Amendments to claims 1, 3-4, 6, and 59 are acknowledged and entered. Claims 2, 5, 7-27, 29-33, 35-49, 51-58, 60-83, and 88-93 are cancelled. Claims 1, 3-4, 6, 28, 34, 50, 59, 84-87, and 94 will be examined on their merits.
Examiner’s Note
All paragraph numbers (¶) throughout this office action, unless otherwise noted, are from the US PGPub of this application US20220152168A1, Published 05/19/2022. Amendments to the specification presented on 06/23/2025 are acknowledged and entered.
Response to Arguments
Applicant's arguments filed 01/05/2026 regarding the previous Office action dated 09/15/2025 have been fully considered. If they have been found to be persuasive, the objection/rejection has been withdrawn below. Likewise, if a rejection/objection has not been recited, said rejection/objection has been withdrawn. If the arguments have not been found to be persuasive, or if there are arguments presented over art that has been utilized in withdrawn rejections but utilized in new rejections, the arguments will be addressed fully with the objection/rejection below.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/05/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
(Objection withdrawn.) The objection to Claim 35 is withdrawn in light of the cancellation of the claim.
Claim Rejections - 35 USC § 112(b); Second Paragraph
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
(Rejection withdrawn.) The rejection of Claim 59 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in light of the amendments to the claim.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
(Rejection withdrawn.) The rejection of Claims 1-2, 6-7, 21-22, 28, 34, 50, and 84-87 under 35 U.S.C. 102(a)(1) as being anticipated by Wood et. al. (WO2017044780A1, Pub. 03/16/2017; hereafter “Wood”) is withdrawn in light of the amendments to the claims.
(Rejection withdrawn.) The rejection of Claims 1-7, 21-22, 28, 34-35, 50, 59, 84-87, and 94 under 35 U.S.C. 102(a)(2) as being anticipated by Qin et. al. (CN111320677A, Priority 12/14/2018, Pub. 06/23/2020; hereafter “Qin”; NB: All citations are of the machine translation of the ‘677 patent) is withdrawn in light of the amendments to the claims.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
(Rejection withdrawn.) The rejection of Claim 94 under 35 U.S.C. 103 as being unpatentable over Wood as applied to claims 1-2, 6-7, 21-22, 28, 34, 50, and 84-87 above, and further in view of Walsh et. al. (Walsh SR, et. al. J Clin Invest. 2019 Feb 1;129(2):518-530. Epub 2018 Dec 18.; hereafter “Walsh”) is withdrawn in light of the amendments to the claims.
(Rejection withdrawn.) The rejection of Claims 2-5, 35, and 59 under 35 U.S.C. 103 as being unpatentable over Wood as applied to claims 1-2, 6-7, 21-22, 28, 34, 50, and 84-87 above, and further in view of Stojdl et. al. (US20160106820A1, Pub. 04/21/2016; CITED ART OF RECORD; hereafter “Stojdl”) and Bell et. al. (US20120275999A1, Pub. 11/01/2012; CITED ART OF RECORD; hereafter “Bell”) is withdrawn in light of the amendments to the claims.
Double Patenting
The text regarding nonstatutory double patenting was provided in a previous Office action.
(Rejection maintained in part and extended – necessitated by amendment.) Claims 1, 3-4, 6, 28, 34, 50, 59, 84-87, and 94 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 15, 27, 30, 35, 39, 41, 45, 62, 64, 69, and 72 of copending Application No. 17/440,671 (reference application) in view of Qin et. al. (supra). Note that the rejection of instant claims 2, 5, 7, 21-22, and 35 is withdrawn in light of the cancellation of said claims and the rejection of reference claims 13, 67, 130, 147, 149, 179, and 182 is withdrawn in light of the cancellation of said claims and is extended to include new reference claims 201-205.
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to methods of inducing immune responses to antigens in a subject, wherein the subject has at least one exposure to said antigen, wherein the immune response is elicited or strengthened via a heterologous prime-boost-boost vaccination regimen, wherein the boosting is done using oncolytic viruses (OVs) which are immunologically distinct from each other yet comprise the same antigen, namely a neoantigen. Both claim the same amount of time after the priming/boosting steps, both claim the same strength of immune responses are increased over baseline/primary exposure. Both claim the antigen can elicit an immune response to two or more neoantigens, both claim the OVs are selected from rhabdoviruses, vaccinia viruses, adenoviruses, measles virus, or vesicular stomatitis virus. While other limitations in the ‘671 claims are not present in the instant claims (e.g. methods of delivery via intramuscular or intravenous routes), said limitations are obvious routes of delivery of viral vaccines and would be obvious optimizations for a skilled artisan to undertake, and do not impart patentable distinction between the claims. The main difference between the instant claims and the ‘671 claims is that the instant claims require the steps of administration of a vaccinia virus comprising a tumor antigen followed by adoptive transfer of CD8+ T cells which respond to said tumor antigen to the subject prior to the oncolytic virus delivery. However, given the prior art, as evidenced by the teachings of Qin, one of skill in the art would have found this an obvious optimization step to take in order to improve the therapeutic response to malignancies or tumors. (NB: All citations of Qin are of the machine translation of the ‘677 patent provided in the previous Office action.) Qin teaches the use of adoptive immune cell therapy along with oncolytic viral vaccines, namely oncolytic rhabdoviruses, wherein tumor antigen-specific central memory CD8+ T cells are delivered to a host, followed by vaccination with the oncolytic rhabdovirus engineered to express the same antigen(s) to which the CD8+ T cells target (entire document; see abstract; reference claims 33-60; p. 22, ¶2). Qin teaches that the CD8+ T-cells are responsive against one or more neoantigens, such as CDK4, catenin, or cystatin-8, and that the oncolytic rhabdovirus can be engineered to express one or more tumor antigens (p. 11, ¶9; p. 20, ¶11). Qin teaches the oncolytic rhabdovirus may target different tumor antigens, as the cancer type may require the targeting of multiple antigens (p. 11, ¶10), and can use a variety of different rhabdovirus backgrounds (p. 36, ¶3), and that a second oncolytic virus may be used in the method that is or is not a rhabdovirus (p. 11, ¶4-5). Qin teaches the virus may be a Maraba virus (p. 12, ¶9), such as an MG1 strain of Maraba virus (p. 13, ¶4) or a Farmington virus (p. 21, ¶5). Qin teaches that oncolytic rhabdoviruses and oncolytic non-rhabdoviruses may be used, such as vaccinia virus (p. 13, ¶4). Qin teaches the adoptive T cell therapy and oncolytic rhabdovirus may be delivered anywhere from 1 to 72 hours, or that the virus may be delivered anywhere from 1-7 days after the T cell therapy, or anywhere from 8-31 days after the T cell therapy (p. 19, ¶9). Qin teaches the subject in need of treatment may be a mammal, specifically a human (p. 20, ¶6). Qin teaches antigen-specific immune responses in the host was determined by analyzing the number of interferon-gamma-positive CD8+ T cells (“Detection of antigen-specific T cell responses” starting at p. 26).
As the instant claims teach the delivery of tumor antigens via vaccinia viruses, and the reference ‘671 claims are drawn to open-ended language for the methods (“comprising”) and detail that in the method a priming composition are delivered, followed by adoptive CD8+ T cell transfer (ACT) of cells which respond to said tumor antigen delivered in said priming composition, and note the use of additional oncolytic viruses, such as vaccinia viruses, it would be routine optimization to determine the specific order of oncolytic viral antigen delivery followed by ACT followed by subsequent boosting regimens with distinct oncolytic viruses carrying the same heterologous tumor antigen, especially in light of the teachings of Qin.
For at least these reasons, the ‘671 claims and the instant claims remain patentably indistinct, especially in light of the teachings of Qin.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed 01/05/2026 have been fully considered but they are not entirely persuasive.
Applicant argues that the claims are patentable over Qin for the reasons “provided above”, and references the arguments regarding the 35 USC 102 rejections. Qin was withdrawn as an anticipatory prior art teaching, but the teachings of Qin, for the reasons detailed supra, still render obvious the minor differences between the two copending sets of claims. No arguments specifically pertaining to why the instant claims and why the reference claims are patentably distinct were presented.
For at least these reasons, the rejection is maintained.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHEL B GILL whose telephone number is (571)272-3129. The examiner can normally be reached on M to F 8:00 AM to 5:00 PM Eastern.
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/RACHEL B GILL/
Primary Examiner, Art Unit 1671