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 .
Applicant’s preliminary amendment filed on February 28, 2024 is acknowledged. Claims 1-6, 8-19 and 21-22 are pending and under examination in this Office action.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on June 10, 2024 and February 28, 2024 has been considered by the examiner.
Claim Rejections - 35 USC § 103
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-6, 8-19 and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Brewoo et al. ("lmmunogenicity and efficacy of chimeric dengue vaccine (DENVax) formulations in interferon-deficient AG129 mice", Vaccine, vol. 30, no. 8, 1 February 2012 (2012-02-01), pages 1513-1520, XP055046377 in IDS on 2/28/24) and Powell WO 2020/051328 A1 (TAKEDA VACCINES INC) 12 March 2020 (2020-03-12) in IDS on 2/28/24) in view of Baer ("Viral Concentration Determination Through Plaque Assays: Using Traditional and Novel Overlay Systems", Journal of Visualized Experiments, no. 93, 1 November 2014 (2014-11-01), pages 1-10 in IDS on 2/28/24).
Present claims. 1-6, 8-19 and 21-2. Brewoo discloses a method for determining serotype-specific titer of a dengue virus in a sample, the method comprises
(a) seeding cells from a dengue-susceptible cell line in an assay plate and culturing the cells for a culture period;
(b) preparing serial dilutions of the dengue virus-containing sample;
(c) adding the serially diluted samples to the cells seeded and cultured in step
(a) and incubating the cells over a first incubation period;
(d) providing an overlay medium comprising 0.7% high viscosity carboxymethylcellulose (CMC) for the cells incubated in step (c) and incubating the cell for a second incubation period;
(e) fixing the incubated cells;
(f) immunostaining the cells with DENV serotype-specific monoclonal antibodies (MAbs) as first antibody and a second antibody being specific for the first antibody conjugated to alkaline phosphatase;
(g) determining the titer of each dengue virus serotype by counting the number of foci in each well of the assay plate. (see page 1515, left-hand column)
Powell teaches a method for determining serotype-specific titer of a dengue virus in a sample, the method comprises
(a) seeding cells from a dengue-susceptible cell line in an assay plate and culturing the cells for a culture period;
(b) preparing serial dilutions of the dengue virus-containing sample;
(c) adding the serially diluted samples to the cells seeded and cultured in step
(a) and incubating the cells over a first incubation period;
(d) providing an overlay medium comprising 0.7% high viscosity carboxymethylcellulose (CMC) for the cells incubated in step (c) and incubating the cell for a second incubation period;
(e) fixing the incubated cells;
(f) immunostaining the cells with DENV serotype-specific monoclonal antibodies (MAbs) as first antibody and a second antibody being specific for the first antibody conjugated to alkaline phosphatase;
(g) determining the titer of each dengue virus serotype by counting the number of foci in each well of the assay plate. (see paragraphs [0017-0027], [0078-0082], Examples 1-3 and claims 1-24).
Brewoo does not teach the overlay medium additionally comprises microcrystalline cellulose (MCC).
Baer teaches that liquid overlays utilizing microcrystalline cellulose and carboxymethyl cellulose sodium (also known under the name Avicel) are used as a replacement in standard plaque assays because of its ease of application and removal due to its liquid state and additionally teaches that the overlay is superior to the CMC overlay in terms of plaque definition and sensitivity (see abstract; page 3, second to last paragraph; figure 4)
It would have been prima facie obvious to the person skilled in the art, particularly when the same result is to be achieved, to use microcrystalline cellulose and carboxymethyl cellulose of Baer as overlay medium, thereby arriving at an improved method according to claim, because Baer teaches that liquid overlays utilizing microcrystalline cellulose and carboxymethyl cellulose sodium (also known under the name Avicel) are used as a replacement in standard plaque assays because of its ease of application and removal due to its liquid state and additionally teaches that the overlay is superior to the CMC overlay in terms of plaque definition and sensitivity (see abstract; page 3, second to last paragraph; figure 4). The technical effect of the invention is a better handling because the overlay medium can be easier removed since it has a lower viscosity.
The problem to be solved by the present invention may therefore be regarded as the provision of an improved method for determining the titer of a dengue virus serotype.
Baer teaches that supplementing Avicel (blend of MCC and medium viscosity CMC) with sodium salt low viscosity CMC at 0.35% (w/v) improves the presentation of foci without leading to flocculation (see page 1 and Figures 1-4). The application teaches that overlay medium with high viscosity resulted in blurry and comet-shaped foci. Hence, supplementing Avicel with high viscosity CMC used at higher concentrations would not result in the effects claimed. Hence, the problem is not solved over the whole of the claimed scope.
Regarding present claims 4-6, 8-17. It would have been prima facie obvious at the time the invention was made to optimize the conditions of the detection method and to optimize the concentration of the detergent, the medium and the time of incubation since such an optimization would have been within the skill of the ordinary artisan.
Thus, the present invention would have been prima facie obvious at the time the invention was made.
Pertinent references
Stinchcomb et al. (US Patent US 9,890,362) teach A method for culturing viruses for production and manufacture, the method comprising: growing host cells; introducing to the host cells a composition comprising media for growing viral cultures comprising one or more ethylene oxide propylene oxide (EO-PO) block copolymers before, during, or after viral infection of the host cells; the one or more EO-PO block copolymers comprising poloxamer 407, poloxamer 403, or a combination thereof, wherein the concentration of the EO-PO block copolymer is from 0.001% to 3.0% (w/v); introducing viruses to the host cells before, during or after introduction of the composition; incubating the host cells, the viruses, and the media for a predetermined period to culture the viruses; separating the media from the host cells; and harvesting the cultured viruses from the media (see claim 1).
Stinchcomb et al. (US 2014/0302088) teach A method for manufacturing viruses, the method comprising: growing host cells; introducing to the host cells a composition comprising media for growing viral cultures comprising one or more ethylene oxide propylene oxide (EO-PO) block copolymers before, during, or after viral infection of the host cells; the one or more EO-PO block copolymers comprising poloxamer 407, poloxamer 403, or a combination thereof, wherein the concentration of the one or more EO-PO block copolymers is from 0.001% to 3.0%; introducing viruses to the host cells before, during or after introduction of the composition; incubating the host cells, the viruses, and the media for a predetermined period; separating the media from the host cells; and harvesting the viruses from the media.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AGNIESZKA BOESEN whose telephone number is (571)272-8035. The examiner can normally be reached on 8:30 - 5:00 PM.
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/AGNIESZKA BOESEN/Primary Examiner, Art Unit 1648
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