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 .
Preliminary Amendment
The preliminary amendment dated 06/26/2026 has been entered. Claims 1-19-and 22 are pending and under examination.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. The earliest possible effective filing date for the instant claims is May 27, 2021 based on the filing date of the provisional application JP2021-089309.
Election/Restriction
Applicant’s election without traverse of Group I in the reply filed on 06/26/2026 is acknowledged.
Claims 6- 18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 1-5, 19 and 22 are under examination.
Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
The requirement is still deemed proper and is therefore made FINAL
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 1-2, 19 and 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ribeiro (Rev. Soc. Bras. Med. Trop. 51 (01) • Jan-Feb 2018).
Ribeiro teaches that Yellow Fever Virus (YFV) vaccines based on recombinant technology, such as pseudo-infectious viral particles (PIVs) (non-replicating agents capable of only one infection cycle, which reads on the “single round IVP”) have been used as safe alternatives (Page 66 second column, third paragraph). Pseudo-infectious yellow fever viral particles (YFV-PIVs) were produced by transfecting HEK293 cells with YFV prM/E and C genes to generate HEK293-YFV-PrM/E-opt cell line. The cells were evaluated for their ability to package the replicon repYFV-17D-LucIRES (see figure below), which codes for the capsid protein, luciferase (that is the labeled protein) (instant claim 2. The luciferase had to be expressed so the package replicon could be identified), and YFV proteins NS1 to NS5, generating YFV-PIVs (Abstract, method). As the YFV-PIVs replicon is capable of only one infection cycle, the presence of an envelope is an inherent property of the replicon to be able to infect even if once (instant claim 1). In addition, instant claim 1 recites; “…and an outer shell protein (Envelope) of an evaluation target virus.” And the specification discloses that the evaluation target virus from which the Envelope is derived, is not particularly limited as long as it belongs to the aforementioned Flavivirus genus (page 13 lines 12-19) and the Flaviviridae family/genus, examples thereof include yellow fever virus (YFV), dengue virus (DENV), Japanese encephalitis virus (JEV), West Nile virus (WNV), and tick-borne encephalitis virus (TBEV), and YFV and DENV are preferred (page 13 lines 4-8). Thus, the envelope protein can be from YFV. Ribeiro also teaches that PIVs (and their constructs are PIVs) may be useful, (that reads on being the active ingredient), for serum neutralization assays, antibody dependent enhancement (ADE) (determining antibody function) evaluation (instant claim 19).
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Instant claim 22 recites: “a kit for determining antibody function comprising the single round infectious virus particle according to claim 1 as an active ingredient”. Since Ribeiro anticipates the IVP (as the active ingredient), which can be useful for serum neutralization assays, antibody dependent enhancement (ADE) (determining antibody function) evaluation and can be used as a vaccine, Ribeiro anticipates the kit as well.
Therefore, the reference teachings anticipate the claimed invention.
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 1-5 19 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Ribeiro in view of Azevedo (PLOS ONE March 2013, Volume 8, Issue 3, 1-10) and He (Virology, Volume 533, July 2019, Pages 86-92)
Ribeiro’s teachings have been described above and incorporated herein in their entirety.
Ribeiro does not teach the use of nanoluciferase as the labeled protein (instant claim 2), the envelope protein is from Dengue Virus (instant claim 4), gene expression is directly controlled by the CMV promoter (instant claim 5).
Azevedo teaches a Chimeric virus YF17D-D2 that can be used as a vaccine. YF17D-D2 is a chimeric yellow fever (YF)/dengue 2 virus, constructed by replacing prM and E genes of the live attenuated virus vaccine YF17D by these genes from DENV2, as required by instant claim 4 (which reads on the substitution of the envelope protein from YFV for dengue’s envelope protein).
Azevedo does not teach the use of nanoluciferase or CMV promoter
He teaches the use of a flavivirus (Duck Tembusu virus (DTMUV)) expressing NanoLuc luciferase, which was stable after 10 rounds of continuous propagation without reporter gene deletion. Moreover, gene expression was driven by the T7 promoter or CMV promoter (abstract) (instant claim 2 and 4). That is, That gene expression can be driven by the CMV promoter and that NanoLuc luciferase works as a reporter in a flavivirus context. It would be obvious that the promoters are upstream of the encoding regions as gene expression is functional as shown by the fact that DTMUV is able to replicate.
It would have been obvious to one of ordinary skill in the art to combine the teachings of Ribeiro with Azevedo and He to generate a single round chimeric infectious virus particle as claimed in the instant application. One of ordinary skill would have been motivated to do so because such type of recombinant viruses can be used in multiple situations, serum neutralization assays, antibody dependent enhancement (ADE) (determining antibody function) evaluation, vaccines etc., with a reasonable expectation of success. There would be a reasonable expectation of success because the generation of these recombinant viruses requires the use of standard molecular biology tools and both the luciferase and the nanoluciferase genes are very well established as reporter genes.
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
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/IMMA BARRERA/
Examiner, Art Unit 1671
/Michael Allen/ Supervisory Patent Examiner, Art Unit 1671
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