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
Applicant’s election without traverse of Group I and certain species in the reply filed on 12/18/2025 is acknowledged.
Claims 13-22, 27, 28 and 31 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/18/2025.
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.
Claim(s) 1-9, 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Huang et al (PLOS Neglected Trop. Dis., 2013, of record) in view of Butrapet et al (J. Virol. Met., 2006) and Adikari et al ()Nat. Res., Oct. 2020).
Huang et al teach a recombinant live-attenuated Dengue vaccine comprising several attenuating mutations. Genetic analysis of the attenuated strain was conducted to ensure the stability of the attenuating mutations. Said analysis was performed by purifying viral RNA from a sample, amplifying the nucleic acid by RT-PCR, then sequencing (p. 3 first col., p. 4 first col., third ¶ to second col., first full ¶). The three attenuation loci include 5’-NCR-57-T (¶ linking pages 1-2) and are separated by ~ 5kb of the viral genome (Butrapet et al, 2006, first page second column). The nucleotide sequence at the attenuation sites was compared after passage in Vero cells to determine reversion of the attenuations (p. 4, first col, last ¶ to second col. first full ¶, Tables 2 and 3). The revertant viruses were estimated to be present at less than 1% and comprise less than 10 nucleotide changes (Table 3). Huang et al does not teach amplification of PCR products of greater than 2Kb or SMRT sequencing.
Adikari et al teaches amplification and sequencing of full (~10kb) Dengue virus genomes using a SMRT technique in order to identify within-host (i.e. patients) variants at the single nucleotide level. The technique circumvents laborious previous techniques and problems (PCR bias, fragmenting). See the abstract and page 2, first 3 ¶’s in particular.
The claimed methods are essentially disclosed by Huang and Butrapet et al with the exception of the 2kb amplification and SMRT sequencing limitations. The ordinary skilled artisan, seeking a method to identify Dengue vaccine revertants, would have been motivated to use SMRT sequencing with the methods of Huang and Butrapet et al because Adikari et al teaches SMRT sequencing to be a well-known means for detecting the Dengue reversion mutants that are ~5kb apart in a streamlined assay with cost and time advantages. It would have been obvious for the skilled artisan to do this because of the known benefit of analyzing Dengue vaccine reversion and variants as taught by Huang and Adikari et al. Given the teachings of the cited references and the level of skill of the ordinary skilled artisan at the time of applicants’ invention, it must be considered, absent evidence to the contrary, that the ordinary skilled artisan would have had a reasonable expectation of success in practicing the claimed invention.
Allowable Subject Matter
Claims 10-12 and 24 are 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael Burkhart whose telephone number is (571)272-2915. The examiner can normally be reached M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Tracy Vivlemore can be reached at 571 272-2914. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL D BURKHART/Primary Examiner, Art Unit 1638
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