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 1-3, 6-10, and 12-15, of record 5/13/2026, are pending and subject to prosecution. Claims 1-3, 6-10, and 14-15. are amended. Claims 12-13 are amended but remain withdrawn. Claims 4-5 and 11 are cancelled.
Priority
A certified copy of German application 10 2020 130 072.7 (filed 11/13/2020) has been received. The earliest priority date to which the instant application is entitled is therefore considered to be 11/13/2020.
Status of Prior Objections/Rejections
RE: Objection to the drawings:
The submission of replacement drawings is effective to obviate the objection. The objection is withdrawn.
RE: Objection to claims 2-11 and 14-15:
The cancellation of claims 4-5 and 11 render the objection thereto moot.
The amendment to claims 2-11 and 14-15 is effective to obviate the objection. The objection is withdrawn.
RE: Rejection of claims 1-11 and 14-15 under 35 U.S.C. 112(b):
The cancellation of claims 4-5 and 11 render the rejection thereto moot.
The amendment to claims 1, 3-6, 8, and 14-15 is effective to obviate the rejection. The rejection is withdrawn.
RE: Rejection of claims 1-4, 6, and 8-11 under 35 U.S.C. 102(a)(1) over Pinkert et al. (Cardiovascular Research, 2020):
RE: Rejection of claims 1-11 under 35 U.S.C. 103 over Pinkert et al. (Cardiovascular Research, 2020) in view of Luo et al. (US 20220267799 A1):
RE: Rejection of claims 1-4, 6, 8-11, and 14-15 under 35 U.S.C. 103 over Pinkert et al. (Cardiovascular Research, 2020) in view of Pryshliak et al. (FEBS Letters, 2020):
The cancellation of claims 4-5 and 11 render the rejections thereto moot.
The amendment to claim 1 is effective to obviate the rejections. The rejections are withdrawn.
New Rejections
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 1-3, 6-10, and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Pinkert et al. (Cardiovascular Research, 2020), of record, in view of Luo et al. (US 20220267799 A1), of record, and Pryshliak et al. (FEBS Letters, 2020), of record.
Regarding claims 1-3, 6-10, and 14-15: Pinkert et al. teach cDNA plasmids for expressing the H3 strain of coxsackievirus B3 comprising the miR-375 target sequence (which reads on “complementary to one or more microRNAs”) (See page 1757, col. 2, ¶1 and fig. 2A). Three copies (which reads on “threefold… repetitions”) of the target sequence were inserted at a multiple cloning site (which reads on “one or more sequence elements… integrated into the backbone of the cDNA construct”) immediately following the 3D polymerase coding sequence and before the 3’UTR (which reads on “integrated between the stop codon of a coding sequence of a 3D polymerase and the 3’UTR of a CVB3 protein coding sequence”) (See fig. 2A). The target sequences were separated by 6-bp spacer sequences (which read on “stuffer sequence”) (See fig. 2). Infectious virions comprising the miR-375 target sequence were produced and exhibited reduced replication in pancreatic cells (See fig. 2). Pinkert et al. teach that miR-375 is selectively expressed in the pancreas (which reads on “having tissue-specific expression pattern”) (See page 1758, col. 1, full ¶3 and fig. 1A).
Pinkert et al. do not teach a target site for a second, different miRNA or use of the vector for treating cancer.
Luo et al. teach enterovirus vectors modified to comprise one or more miRNA target sequences for treating cancer (See Abstract). Cancer tissues commonly have downregulated miRNAs, which promote suppression of gene expression; the insertion of a miRNA target sequence can increase tumor specificity by limiting replication in non-cancerous tissues that normally express the miRNA (See ¶0010-0011, 0036, and 0049). The virus can be coxsackievirus B3 (See ¶0011). The miRNA target sequences can recognize miRNAs including cardiac-specific miR-1 (which reads on “specifically expressed in the human heart tissue”) and miR-375 (See ¶0012, 0050-0051, and 0076-0077).
Pryshliak et al. teach the incorporation of miR-375 target sites in cDNA for expressing coxsackievirus B3 as a possible cancer treatment that could avoid pancreatitis (See Abstract). Colorectal cell lines exhibited substantially lower miR-375 expression than pancreatic cells (See fig. 1A). Pryshliak et al. teach that, while the engineered virus showed only weak replication and cytotoxicity in colorectal carcinoma cells, the incorporation of miR-375 target sites in other CVB3 strains, such as H3, could make them candidates for colorectal cancer therapy (See page 773, col. 1, full ¶2).
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 viral construct of Pinkert et al. to comprise multiple target sequences for two different miRNAs between the end of the viral polymerase gene and 3’ UTR. One would be motivated to make this modification because Luo et al. teach that miRNA sensitivity can be used to develop oncolytic viruses with higher replication in tissues of interest that do not express the miRNAs specific for the target sites (See ¶0049-0051) and because Pinkert et al. demonstrate this region of the vector as permissive for the insertion of miRNA target sites (See fig. 2). There would be a reasonable expectation of success in making this modification because Luo et al. demonstrate the generation of coxsackievirus B3 expressing two or more different miRNA target sequences (See fig. 9). Further, as Luo et al. teach that oncolytic viruses comprising a miR-375 target site can be used for cancer treatment (See ¶0010-0012) and Pryshliak et al. suggest that such a virus could be suitable for colorectal cancer therapy (See page 773, col. 1, full ¶2), the vector of Pinkert et al. could be readily modified to further comprise a miR-1 target site for use in cancer therapy.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 JENNIFER S SPENCE, whose telephone number is 571-272-8590. The examiner can normally be reached M-F 8:30-5:30.
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/J.S.S./Examiner, Art Unit 1633
/CHRISTOPHER M BABIC/Supervisory Patent Examiner, Art Unit 1633
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