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 .
Election/Restrictions
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-9, drawn to an oncolytic virus comprising a nucleic acid molecule that encodes IRF2, classified in A61K 35/768.
II. Claims 10-18, drawn to a method of treating a subject having cancer, classified in C12N 2710/24143.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case the product of Inventive Group I can be used to perform transfect cells in vitro. Methods of transfecting cells in vitro are considered patentably distinct from methods of treating cancer, as required by the method of Inventive Group II, as the methods involve different steps and result in different outcomes. Therefore, the product of Inventive Group I can be used in materially distinct processes than that of Group II.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
the inventions have acquired a separate status in the art in view of their different classification
the inventions require a different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries)
the inventions are likely to raise non-prior art issues, such as non-prior art issues under 35 USC 101 and/or 35 USC 112(a), which issues would be relevant to one invention, but not the other(s).
During a telephone conversation with Sam Kwiatkowski on 08/05/2026 a provisional election was made without traverse to prosecute the invention of Inventive Group II, claims 10-18. Affirmation of this election must be made by applicant in replying to this Office action. Claims 1-9 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Priority
Acknowledgement is made of Applicants’ claim for benefit as a continuation of US application No. 17/869,943 (filed 07/21/2022) which is a national stage of international application No. PCT/US2021/021173 (filed 03/05/2021), which claims the benefits of US Provisional Application No. 62/985,979 (filed03/06/2020).
Claim Rejections - 35 USC § 102
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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 10-11 and 17-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McCart et al (EP1180157B1), cited in the IDS filed (03/03/2026).
McCart et al discloses vaccinia virus expression vectors comprising mutations in the thymidine kinase gene that result in a negative thymidine kinase phenotype and vaccinia virus growth factor genes (See ¶001). The negative thymidine kinase phenotype can result from a deletion, insertion, or substitution of a nucleic acid sequence in the thymidine kinase gene or deletion of the thymidine kinase gene (See claims 6 and 7). The vaccinia virus vector of McCart et al can be used in vitro and in vivo to express any gene including human IRF2 (See ¶0063 and 0064). In Example 6, McCart et al discloses the double mutant vaccinia virus (i.e. TK- and VGF- vaccinia virus) failed to replicate in brain tissues but was able to replicate in host’s tumor cells (See ¶0105 and 0108). The vaccinia virus of McCart et al can be used in a method of treatment of the human or animal body. Such treatment includes a method of treating the growth of neoplastic cells and killing cancer cells which comprises administering to a patient in need of treatment the vaccinia virus of the invention (See ¶0069 and claim 25). In Example 4, McCart et al discloses injecting mice with MC38 murine colon adenocarcinoma cells and administering the double mutant vaccinia virus to the mice (See ¶0102-0104). Additionally, McCart discloses the vaccinia virus can be used to treat breast, colorectal, pancreatic, melanoma, glioblastoma, hepatoma, small cell lung, non-small cell lung, muscle, and prostate tumors (See ¶0081).
Regarding claim 10: McCart discloses a method of treating the growth of neoplastic cells and killing cancer cells comprising administering a vaccinia virus comprising mutations in the thymidine kinase (TK) gene and a vaccinia virus growth factor gene, to a subject in need of treatment which reads on a method of treating a subject having cancer. The TK mutation in the vaccinia virus of McCart results in a negative thymidine kinase phenotype as a result of a TK deletion, insertion, or substitution (reads on lacks the expression of a function TK). The vaccinia virus of McCart et al can be used to express any gene including human IRF2 which reads on comprising a nucleic acid molecule that encodes IRF2. The vaccinia virus of McCart fails to replicate in brain tissue but is able to replicate in tumor cells which reads on the definition of oncolytic virus provided in the specification of the instant application (See Specification of instant application pg. 6 lns 22-32).
Regarding claim 11: Following the discussion of claim 10 above, McCart discloses the vaccinia virus can be used to treat a human.
Regarding claims 17-18: Following the discussion of claim 10 above, McCart discloses the vaccinia virus can be used to treat t, colorectal, pancreatic, melanoma, glioblastoma, hepatoma, small cell lung, non-small cell lung, muscle, and prostate tumors (reads on solid tumor and cancers listed in claim 18). Additionally, McCart exemplifies treatment of adenocarcinoma cells in mice.
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.
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 10-18 are rejected under 35 U.S.C. 103 as being unpatentable over McCart et al (EP1180157B1) in view of Martin and Bell (Molecular Therapy, 2018).
The teachings of McCart et al are set forth above.
McCart et al anticipates claims 10-11 and 17-18.
Regarding claims 12-16: Following the discussion of claim 10 above, McCart et al discloses a method of treating cancer comprising administering to a subject a TK deleted, oncolytic vaccinia virus, which can express IRF2.
McCart et al does not disclose a treatment method comprising administering an immunomodulatory agent to the subject.
Martin and Bell review oncolytic virus combination therapies in cancer therapeutics (See Title and Fig. 1). Martin teaches combining viruses with different immune profiles can overcome antiviral immune responses and exert synergistic effect (See pg. 1416, sec. Combinatorial application of Microbes). One such combination therapy comprises administering a virus with an anti-PD1 checkpoint blockade (See pg. 1416, sec. Combinatorial application of Microbes). Additionally, Martin and Bell teach immune checkpoint inhibitors such as antibodies blocking CTLA-4 and PD1/PD-L1 which enhance T cell responses and dismantle tumor defense respectively can be used synergistically with oncolytic viruses (See pg. 1417, sec. Strategic Combinations of Immune Modulators with Ovs).
Given that McCart et al discloses a method of treating cancer comprising administering an oncolytic virus to a subject and Martin and Bell teach combining oncolytic viruses with immune checkpoint inhibitors such as antibodies against CTLA-4, PD1, and PD-L1 can be used to overcome antiviral immune responses and to exert synergistic effects in cancer therapeutics, it would have been prima facie obvious to modify the treatment method of McCart et al by further administering a CTLA-4, PD1, or PD-L1 antibody (read on immunomodulatory agents and immune checkpoint inhibitors). One would have been motivated to modify the method of McCart et al by further administering an antibody against CTLA-4, PD1, or PD-L1 because Martin and Bell teach combination treatment methods comprising an immune checkpoint inhibitor and an oncolytic virus can be used to exert a synergistic effect and to overcome antiviral immune responses. There is a reasonable expectation of success because Martin and Bell teach immune checkpoint inhibitors such as antibodies against CTLA-4, PD1, and PD-L1 can be used in combination therapies with oncolytic viruses to exert a synergistic effect.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARISOL A O'NEILL whose telephone number is (571)272-2490. The examiner can normally be reached Monday - Friday 7:30 - 5:00 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher Babic can be reached at (571) 272-8507. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARISOL ANN O'NEILL/Examiner, Art Unit 1633
/ALLISON M FOX/Primary Examiner, Art Unit 1633
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