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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 May 21, 2026, has been entered.
DETAILED ACTION
The amended claims filed on May 21, 2026, have been acknowledged. Claims 1-5, 7, and 12 were cancelled. Claims 6 and 11 were amended. Claims 6, 8-11, and 13 are pending and examined on the merits.
Rejections and/or objections not reiterated from the previous office action mailed February 27, 2026, are hereby withdrawn. The following rejections and/or objections are either newly applied or are reiterated and are the only rejections and/or objections presently applied to the instant application.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Priority
Acknowledgment is made of Applicant’s claim for foreign priority under 35 U.S.C. 119(a)-(d).The applicant claims foreign priority from JP2020-166661 filed on October 1, 2020. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55, received March 24, 2023, and English translations filed on December 17, 2025. Claims 6, 8-11, and 13 find support in foreign application JP2020-166661 filed on October 1, 2020.
New Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 6, 8-11, and 13 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In claim 6, there are a multitude of recited limitations (identified as limitations a-c below) that are separated but it is not clear which limitations are required and which are not. The claims lack comprising or transitional language to definitively identify which of the limitations (a-c) are required by the claim and which are in the alternative.
An oncolytic vaccinia virus,
wherein genes except for the C2L, CIL, NIL, or N2L gene or genes homologous to the genes in the following regions in the genome sequence of a vaccinia virus strain are deleted, does not grow in normal cells, grows in cancer cells and damages cancer cells:
a region in the genome sequence of a vaccinia virus which corresponds to a region consisting of nucleotides from the nucleotide at position 26240 to the nucleotide at position 34314 in the nucleotide sequence shown in SEQ ID NO: 17; or
a region in the genome sequence of a vaccinia virus which corresponds to a region consisting of nucleotides from the nucleotide at position 23767 to the nucleotide at position 32499 in the nucleotide sequence shown in SEQ ID NO: 17.
As identified above, there appears to be 3 sets of limitations that could be read as being alternative limitations as the “or” after claim limitation group c suggests that only one of these 3 limitations groupings are required. The : after claim limitation group a suggests that there could be an and so that claim limitation group a is required and one of claim limitation groups b and c. However, without explicitly stating the transitional phrase and after claim limitation group a, there is a lack of clarity regarding which limitations are required and which are meant to be considered in the alternative.
Claims 8-11 and 13 are also rejected because of their dependency on claim 6.
New Claim Rejections - 35 USC § 102
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 6, 8-11, and 13 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by World Intellectual Property Organization Patent Application No. 2020/124274 (Bell), as evidenced by Morikawa et al. (Journal of Virology 79: 11873-11891. 2005). This a new rejection made in response to Applicant’s amendments to claim 6. Applicant’s traversal has been considered but is moot in response to the new rejection.
As an initial matter, the claim limitation “wherein genes … are deleted” is broadly considered to require two or more genes are deleted from one of the regions identified in claim 1.
Furthermore, as per the 112b rejection above, only one of the claim limitation groups a-c are considered to be required.
Regarding claim 6, Bell teaches genetically modified vaccinia viruses from the LC16mO strain modified to comprise deletions of the M1L, M2L, K1L, K2L, K3L, K4L, K5L, K6L, K7R, F1L, F2L, F3L, K ORF A, and K ORF B genes and expression of at least one of three transgenes: IL-12-TM, FLT3-L and anti-CLTA4 to treat cancer. Bell teaches that genetic modification of the vaccinia viruses can enhance oncolytic activity and spread of infection (paragraphs 0006, 00210, 00281, and 00447).
Morikawa evidences that the M1L to F3L genes correspond to nucleic acid positions 254580-35545. Furthermore, the instant specification identifies that their d8k vaccinia virus corresponds to deletion of the 26240-34324 region and that the above-described deficient region comprises genes in the contiguous region from the 030L gene to the 046L gene in the LC16m0 strain or the LC16m8 strain or at least one of genes homologous to these genes. In the Copenhagen (CPN) strain, genes existing in the contiguous region from 030L gene to the 046L gene correspond to the genes existing in the contiguous region from the M1L gene to the F3L gene. Examples of genes in the contiguous region from the MIL gene to the F3L gene in the Copenhagen strain include 14 genes, that is, the M1L, M2L, K1L, K ORF A, K ORF B, K2L, K3L, K4L, K5L, K6L, K7R, F1L, F2L, and F3L genes.
Therefore, the vaccinia virus of Bell is considered to delete each of the genes within the 26240-34314 region as claimed.
Although Bell identifies that their CopMD5p3p vaccinia virus grows specifically in cancer cells and damages cancer cells, this construct comprises deletion of the C2L-N2L genes as well as the M1L-F3L genes. Bell does not specifically identify that the M1L-F3L genes are sufficient for generating this phenotype.
However, Bell’s M1L-F3L deletion vaccinia virus, as identified above, corresponds to the same gene deletions as the d8k deletion of the instant specification and would have the same properties.
As shown in Example 3 of the instant specification, vaccinia viruses with the M1L-F3L genes deleted do not grow in normal cells but do grow in cancer cells and damage the cancer cells. Example 3 discloses that they used a luciferase assay to assess their expression levels in the tumor versus normal cells with their 8k-Luc vaccinia viruses. Expression of the virus Fluc in the mouse peritoneal cavity was confirmed in all virus administration groups at three days after administration. The signal of the virus Fluc had disappeared almost completely in the peritoneal cavity region seven days later, that is, at 10 days after administration whereas this was not the case with the HA-LucGFP virus. Furthermore, Examples 3-4 discloses that the d8k-Luc virus damaged cancer cells with tumor specific growth.
Therefore, Bell’s M1L-F3L deletion vaccinia virus would also have these same properties and fall within the limitations of claim 6.
Regarding claim 8, as stated supra, Bell teaches that the genetically modified vaccinia virus can be from the LC16m0 or LC16m8 vaccinia virus strain (paragraph 0006). Bell teaches that the B5R gene is not deleted (paragraph 00535).
Regarding claim 9, Bell teaches that the virus can be included in a pharmaceutical composition for cancer treatment (paragraphs 00652-00662).
Regarding claims 10-11, Bell teaches genetically modified vaccinia viruses can comprise at least one of three transgenes: IL-12-TM, FLT3-L and anti-CLTA4 to treat cancer (paragraphs 0006, 00210, 00281, and 00447).
Regarding claim 13, Bell teaches treating a cancer patient by administering their vaccinia virus (paragraphs 0006, 00612-00631, and 00652-00680).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEENAN A BATES whose telephone number is (571)270-0727. The examiner can normally be reached M-F 7:30-5:00.
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/KEENAN A BATES/Examiner, Art Unit 1631
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