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 .
Claims 1-5, 7-8, 10-12, 16, and 18, of record 11/4/2025, are pending and subject to prosecution. Claims 12, 16, and 18 are amended. Claims 13-15, 17, and 19 are cancelled.
Declaration under 37 CFR 1.132
The declaration submitted on 11/4/2025 by Dr. Jaeil Shin has been considered. Dr. Shin acknowledged the pending rejections of claims 12-19 as rejected under 112a, and claims 1, 10, and 12-19 as rejected under prior art (Declaration, page 2-3). Dr. Shin makes no arguments against any pending prior art rejection. At page 3, Dr. Shin states, “for this Declaration, rechallenge tests were conducted to evaluate cancer preventative effects of the claimed recombinant virus”, thus addressing the 112a rejection of record.
The affidavit presents results from colorectal and breast cancer mouse models treated with a vaccinia virus encompassed by the pending claims, comprising transgenes for the expression of sPD-1, hyaluronidase, and IL-12 and inactivated/deleted endogenous K3L, TK, and VGF genes. The animals were inoculated with tumor cells, injected with the virus, and later rechallenged with tumor cells. In the colorectal cancer model, most of the treated animals achieved complete regression and exhibited protection against tumor growth upon rechallenge with the original cancer cell type (Declaration, page 3-5). The breast cancer model likewise demonstrated complete regression of tumor growth upon the first injection of tumor cells in the majority of animals and prevented tumor growth following a second injection of the tumor cells (Declaration, page 5-8). The declaration further shows that the virus utilized has efficacy over a broad range of solid cancer-derived cells`(Declaration, page 11-12). A theorized mechanism of action is provided (Declaration, page 9-11).
The declaration provides evidence that the virus utilized in the experiments can prevent the recurrence of same type of tumor growth in a specific mouse model system. However, this evidence does not support the full scope of instant claim 16, which recites “[a] method for preventing… a solid cancer”. The data provide support for the prevention of cancer only in a very specific situation, wherein a subject having a specific solid tumor undergoes complete regression following administration of a virus encompassed by the pending claims. It appears that a single treatment course with the virus is sufficient to prevent the regrowth of that type of tumor, at least within a particular time span. This represents a much smaller scope of activity than “prevention of solid cancer”, which would encompass, for example, prevention of a second, different cancer versus the first cancer treated, prevention of cancer in a subject that did not achieve complete regression of a first cancer, or even prevention of cancer in a subject in a subject that did not previously have cancer. At most, the declaration supports the claimed virus as preventing the recurrence, rather than any occurrence, of a specific cancer in a specific model system following a specific mode of administration.
The declaration asserts that because a virus comprising deletion/inactivation of the same three endogenous genes has been shown to induce cell death through infection and replication in various solid tumors cell lines, “it is likewise capable of eliciting a tumor-specific systemic immune response through the immune mechanism described above in a wide range of solid tumors” (Declaration, page 11-12). However, the ability to induce tumor cell death is not at issue; the recombinant vaccinia virus taught by Shin et al. in Human Gene Therapy (2021) was not assayed for any ability to prevent tumor formation and therefore cannot be used for extrapolating broad preventative activity to the claimed virus.
Status of Prior Rejections/Response to Arguments
RE: Rejection of claims 12-19 under 35 U.S.C. 112(a):
The cancellation of claims 13-15, 17, and 19 renders the rejection thereto moot.
The applicant asserts that the additional experimental data provided by Dr. Shin’s declaration provide a basis for expecting similar preventive effects for other solid cancers, due to the claimed virus’s theorized mechanism of action (Applicant Remarks, page 6-9).
As discussed above, the experimental data presented thus far provides support for the prevention of cancer recurrence, rather than the comprehensive prevention of cancer. While the virus utilized in the experiments may exert its effects as theorized, such effects cannot be extrapolated to the broad and complete scope of “prevention” of solid cancer for a couple of reasons. The virus was unable to prevent the growth of the Renca kidney cancer cell line, which indicates that the breadth of the virus’s efficacy is limited, at least in part. Further, while in vitro cytotoxicity is demonstrated against a number of different cancer cell types, it does not necessarily follow that the virus would be effective as an in vivo preventive under any or all circumstances.
The constraints and difficulties placed on the applicant in terms of experimentation are understandable; however, the full scope of the claims must be supported by sufficient disclosure, given that the scope of the claims is very broad and that the prevention of cancer is a relatively rare achievement, especially through the use of a viral vector.
The amendment of claim 12 is effective to obviate the rejection thereto. The rejection over claim 12 is withdrawn. The rejection over claims 16 and 18 is maintained in modified form for the reasons discussed above.
RE: Rejection of claims 1, 10, and 12-19 under 35 U.S.C. 103 over Thorne (US 11065286 B2) in view of Meko et al. (Cancer Research, 1995) and Bartee et al. (Cancer Research, 2017):
RE: Rejection of claims 1-2, 10, and 12-19 under 35 U.S.C. 103 over Thorne (US 11065286 B2) in view of Meko et al. (Cancer Research, 1995) and Bartee et al. (Cancer Research, 2017), further in view of Ahmed et al. (US 20100040614 A1):
RE: Rejection of claims 1, 5, 10, and 12-19 under 35 U.S.C. 103 over Thorne (US 11065286 B2) in view of Meko et al. (Cancer Research, 1995) and Bartee et al. (Cancer Research, 2017), further in view of Carrio et al. (US 20120148535 A1):
RE: Rejection of claims 1, 7, 10, and 12-19 under 35 U.S.C. 103 over Thorne (US 11065286 B2) in view of Meko et al. (Cancer Research, 1995) and Bartee et al. (Cancer Research, 2017), further in view of Hicklin et al. (US 10232053 B2):
RE: Rejection of claims 1, 8, 10, and 12-19 under 35 U.S.C. 103 over Thorne (US 11065286 B2) in view of Meko et al. (Cancer Research, 1995) and Bartee et al. (Cancer Research, 2017), further in view of Wähler et al. (US 8067227 B2):
RE: Rejection of claims 1 and 10-19 under 35 U.S.C. 103 over Thorne (US 11065286 B2) in view of Meko et al. (Cancer Research, 1995) and Bartee et al. (Cancer Research, 2017), further in view of Chen et al. (US 8052968 B2):
The cancellation of claims 13-15, 17, and 19 renders the rejections thereto moot.
The applicant asserts that the claimed virus exhibits unexpectedly superior effects compared to the closest prior art embodiment, described by Thorne (Applicant Remarks, page 11-12). The applicant also asserts that the other prior art references do not teach or suggest the superior effects observed with the claimed virus (Applicant Remarks, page 12).
These arguments are not found to be persuasive. While the applicant is correct that the closest embodiment of Thorne is to a vaccinia virus comprising deletion of VGF, TK, and K3L and encoding a hyaluronidase gene, and that the claimed virus exhibits superior effects to this embodiment, the 103 rejections of record are also over the teachings of Bartee et al. and Meko et al. Bartee et al. teach that sPD-1 can be expressed from another oncolytic virus, myxoma virus (See Abstract). In addition to teaching eradication of established tumors, Bartee et al. teach that mice whose tumors had been eliminated by treatment were rechallenged 100 days after initial tumor cell injection and displayed antitumor memory in rejecting the tumors (See page 2953, col. 2, ¶1; page 2956, col. 2, full ¶1; page 2957 col. 1, ¶1; and fig. S5). Meko et al. teach an antitumor vaccinia virus encoding IL-12, and while Meko et al. do not expressly teach any protective activity, Rodriguez-Madoz et al. teach that IL-12 expressed from the oncolytic Semliki Forest virus yields tumor regression as well as long-term tumor-free survival (See Abstract and page 161, col. 1, ¶1). Mice that had eliminated the initial tumor following treatment were fully protected against rechallenge three months later (See page 161, col. 1, ¶1).
Because the teachings of Bartee et al., Meko et al., and Rodriguez-Madoz et al. indicate that oncolytic virus-encoded sPD-1 and IL-12 each confer tumor-killing activity as well as protection against tumor rechallenge, the performance of the claimed virus is not unexpectedly superior in view of the prior art. The rejections are maintained.
Maintained Rejections
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 16 and 18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of treating cancer using the method claimed, does not reasonably provide enablement for prevention of cancer using the method claimed. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
The claimed invention is drawn to a method of preventing or treating cancer comprising administering to an individual a composition containing the recombinant vaccinia virus of claim 1.
The instant application provides support for preventing the recurrence of cancer in subjects exhibiting complete remission following administration of the claimed virus. However, the invention as claimed in fact embraces the full and complete prevention of any solid cancer in any situation using the recited steps. The full scope of the claim term "preventing" is thus not enabled as it regards prevention of cancer, since it would require, at best, extensive undue trial and error experimentation, the outcome of which is highly unpredictable. Amendment to remove this term would be remedial.
Claim Rejections - 35 USC § 103
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 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 1, 10, 12, 16, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Thorne (US 11065286 B2), of record, in view of Meko et al. (Cancer Research, 1995), of record, and Bartee et al. (Cancer Research, 2017), of record.
Regarding claims 1, 10, 12, 16, and 18: Thorne teaches oncolytic VACV encoding a variant HMGB1 protein and hyaluronidase and having a TK gene deletion (See col. 4, line 51-67). Thorne teaches the use of the Western Reserve strain having a deletion in TK and expressing the PH-20 hyaluronidase (with and without HMGB1) for treating mice in Example 2 (See col. 46, line 5-25 and fig. 8). The virus can be further modified to have deletions of virulence genes such as VGF and K3L (See col. 22, line 47-55). The virus can be used in a pharmaceutical composition and can be used for treating solid tumors or leukemia or lymphoma (which read on “blood cancer”) (See col. 6, line 27-45; col. 24, line 2-18; and col. 25, line 1-30). Specific cancers that can be treated include lung cancer, prostate cancer, colorectal cancer, breast cancer, head and neck squamous cell carcinoma (which reads on “head and neck cancer”), epithelial carcinoma (which reads on “skin cancer”), gastric cancer, hepatocellular carcinoma (which reads on “liver cancer”), ovarian cancer, bladder cancer, pancreatic cancer, and multiple myeloma (See col. 24, line 2-67 and col. 25, line 1-30). Thorne does not teach the virus as expressing IL-12 or sPD-1.
Meko et al. teach a recombinant VACV encoding IL-12 capable of reducing tumor growth in mice (See Abstract and fig. 1 and 3).
Bartee et al. teach myxoma virus expressing sPD-1 for enhancing oncolytic virotherapy (See Abstract and fig. 4-5 and 7). Bartee et al. mention that an anti-PD-1 antibody had been previously expressed from VACV and that myxoma virus-expressed sPD-1 worked better than myxoma virus in combination with anti-PD-1 antibodies (See page 2959, col. 2, full ¶1 and page 2960, col. 1, ¶1), which suggests that VACV-expressed sPD-1 may be similarly efficacious.
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the recombinant VACV of Thorne to comprise a gene encoding IL-12, as taught by Meko et al. One would be motivated to make this modification because Meko et al. teach that VACV expressing IL-2 has increased anti-tumor activity (See Abstract and fig. 3). There would be a reasonable expectation of success in making this modification because Thorne teaches that the virus can comprise one or more insertions of heterologous nucleic acids (See col. 14, line 32-36).
It also would have been obvious to modify the recombinant VACV of Thorne to comprise a sPD-1 gene, such as is taught by Bartee et al. One would be motivated to make this modification because Bartee et al. teach that sPD1 can be expressed from an oncolytic virus for improved outcomes in cancer (See Abstract and fig. 4-5 and 7). There would be a reasonable expectation of success in doing so because Thorne teaches that the virus can comprise one or more insertions of heterologous nucleic acids (See col. 14, line 32-36) and because Bartee et al. suggest that the expression of sPD-1 by other oncolytic viruses could be feasible and efficacious (See page 2959, col. 2, full ¶1 and page 2960, col. 1, ¶1).
Claims 1-2, 10, 12, 16, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Thorne (US 11065286 B2), of record, in view of Meko et al. (Cancer Research, 1995), of record, and Bartee et al. (Cancer Research, 2017), of record, further in view of Ahmed et al. (US 20100040614 A1), of record.
The teachings of Thorne, Meko et al., and Bartee et al. are set forth in the rejection above and are incorporated herein in their entirety.
Regarding claim 2: Following the discussion of claims 1, 10, 12, 16, and 18, Thorne, modified by Meko et al. and Bartee et al., render obvious a recombinant VACV encoding genes for sPD-1, hyaluronidase, and IL-12 but do not teach the sequence of sPD-1 as comprising instant SEQ ID NO 131 or 133.
Ahmed et al. teach PD-1 antagonists for enhancing specific anti-tumor immune responses that can be delivered by vectors such as vaccinia virus (See ¶0010, 0206, and 0245-0246). Ahmed et al. teach a PD-1 sequence comprising the sequence of instant SEQ ID NO 131 (See ¶0047, SEQ ID NO 2, and alignment below (first 120 aa displayed)).
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It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the recombinant vaccinia virus of Thorne, modified by Meko et al. and Bartee et al., to substitute the PD-1 sequence taught by Ahmed et al. Simple substitution of one known element for another known element is considered to be prima facie obvious, absent a showing that the result of the substitution yields more than predictable results.
Claims 1, 4, 10, 12, 16, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Thorne (US 11065286 B2), of record, in view of Meko et al. (Cancer Research, 1995), of record, and Bartee et al. (Cancer Research, 2017), of record, further in view of Frost et al. (US 20120171153 A1), of record.
The teachings of Thorne, Meko et al., and Bartee et al. are set forth in the rejection above and are incorporated herein in their entirety.
Regarding claim 4: Following the discussion of claims 1, 10, 12, 16, and 18, Thorne, modified by Meko et al. and Bartee et al., render obvious a recombinant VACV encoding genes for sPD-1, hyaluronidase, and IL-12 but do not teach the hyaluronidase as comprising the amino acid sequence of instant SEQ ID NO 135.
Frost et al. teach a hyaluronidase sequence comprising the sequence of instant SEQ ID NO 135 for administration to tumors (See table 2, SEQ ID NO 111, and alignment below (first 120 aa displayed)).
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It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the virus of Thorne, modified by Meko et al. and Bartee et al., to substitute the hyaluronidase sequence taught by Frost et al. Simple substitution of one known element for another known element is considered to be prima facie obvious, absent a showing that the result of the substitution yields more than predictable results.
Claims 1, 5, 10, 12, 16, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Thorne (US 11065286 B2), of record, in view of Meko et al. (Cancer Research, 1995), of record, and Bartee et al. (Cancer Research, 2017), of record, further in view of Carrio et al. (US 20120148535 A1), of record.
The teachings of Thorne, Meko et al., and Bartee et al. are set forth in the rejection above and are incorporated herein in their entirety.
Regarding claim 5: Following the discussion of claims 1, 10, 12, 16, and 18, Thorne, modified by Meko et al. and Bartee et al., render obvious a recombinant VACV encoding genes for sPD-1, hyaluronidase, and IL-12 but do not teach the hyaluronidase as comprising the nucleotide sequence of instant SEQ ID NO 136.
Carrio et al. teach a genetically modified oncolytic virus comprising a hyaluronidase gene for use as an anticancer agent (See Abstract). Carrio et al. teach a nucleotide sequence matching nucleotides 1-1467 of instant SEQ ID NO 136 (See ¶0059, SEQ ID NO 2, and alignment below (first 120 bp displayed)).
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Carrio et al. also teach that the sequence was appended with the stop codon TAA, yielding a sequence identical to instant SEQ ID NO 136 (See ¶0059).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the recombinant virus of Thorne, modified by Meko et al. and Bartee et al., to substitute the hyaluronidase sequence taught by Carrio et al. Simple substitution of one known element for another known element is considered to be prima facie obvious, absent a showing that the result of the substitution yields more than predictable results.
Claims 1, 7, 10, 12, 16, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Thorne (US 11065286 B2), of record, in view of Meko et al. (Cancer Research, 1995), of record, and Bartee et al. (Cancer Research, 2017), of record, further in view of Hicklin et al. (US 10232053 B2), of record.
The teachings of Thorne, Meko et al., and Bartee et al. are set forth in the rejection above and are incorporated herein in their entirety.
Regarding claim 7: Following the discussion of claims 1, 10, 12, 16, and 18, Thorne, modified by Meko et al. and Bartee et al., render obvious a recombinant VACV encoding genes for sPD-1, hyaluronidase, and IL-12 but do not teach the hyaluronidase as comprising the amino acid sequence of instant SEQ ID NO 137.
Hicklin et al. teach an immunomodulatory oncolytic virus comprising an IL-12 transgene with a polypeptide sequence identical to instant SEQ ID NO 137 (See table 1, SEQ ID NO 20, and alignment below (first 120 aa displayed)).
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It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the recombinant virus of Thorne, modified by Meko et al. and Bartee et al., to substitute the IL-12 sequence taught by Hicklin et al. Simple substitution of one known element for another known element is considered to be prima facie obvious, absent a showing that the result of the substitution yields more than predictable results.
Claims 1, 8, 10, 12, 16, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Thorne (US 11065286 B2), of record, in view of Meko et al. (Cancer Research, 1995), of record, and Bartee et al. (Cancer Research, 2017), of record, further in view of Wähler et al. (US 8067227 B2), of record.
The teachings of Thorne, Meko et al., and Bartee et al. are set forth in the rejection above and are incorporated herein in their entirety.
Regarding claim 8: Following the discussion of claims 1, 10, 12, 16, and 18, Thorne, modified by Meko et al. and Bartee et al., render obvious a recombinant VACV encoding genes for sPD-1, hyaluronidase, and IL-12 but do not teach the IL-12 gene as comprising the nucleotide sequence of any of instant SEQ ID NO 138-140.
Wähler et al. teach viral vectors comprising nucleic acid sequences coding for IL-12 for the treatment of tumors (See Abstract). Wähler et al. teach the IL-12 gene comprising a sequence identical to instant SEQ ID NO 139 (See fig. 1, SEQ ID NO 1, and alignment below (first 120 bp displayed)).
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It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the recombinant virus of Thorne, modified by Meko et al. and Bartee et al., to substitute the IL-12 sequence taught by Wähler et al. Simple substitution of one known element for another known element is considered to be prima facie obvious, absent a showing that the result of the substitution yields more than predictable results.
Claims 1, 10-12, 16, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Thorne (US 11065286 B2), of record, in view of Meko et al. (Cancer Research, 1995), of record, and Bartee et al. (Cancer Research, 2017), of record, further in view of Chen et al. (US 8052968 B2), of record.
The teachings of Thorne, Meko et al., and Bartee et al. are set forth in the rejection above and are incorporated herein in their entirety.
Regarding claim 11: Following the discussion of claims 1, 10, 12, 16, and 18, Thorne, modified by Meko et al. and Bartee et al., render obvious a recombinant VACV encoding genes for sPD-1, hyaluronidase, and IL-12 but do not teach the VACV strain as IHD-W.
Chen et al. teach genetically modified vaccinia virus comprising therapeutic heterologous genes for use as antitumor agents (See col. 3, lines 59-66 and col. 6, lines 6-12). Chen et al. teach that the IHD-W strain can be modified for therapeutic use (See col. 31, lines 18-23).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the recombinant vaccinia virus of Thorne, modified by Meko et al. and Bartee et al., to substitute the IHD-W strain, as taught by Chen et al., for use in cancer treatment. Simple substitution of one known element for another known element is considered to be prima facie obvious, absent a showing that the result of the substitution yields more than predictable results.
Allowable Subject Matter
Claim 3 is objected to as being dependent upon a rejected base claim but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. SEQ ID NOs 132 and 134 appear to be free of the prior art.
Conclusion
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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/J.S.S./Examiner, Art Unit 1633
/CHRISTOPHER M BABIC/Supervisory Patent Examiner, Art Unit 1633