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 January 18, 2024 is acknowledged. Claims 1-12 are pending and under examination in this Office action.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on February 16, 2024 and July 11, 2025 have been considered by the examiner.
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)(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 1-7 and 11-12 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Miyazaki (WO 2021/070884 A1 15 April 2021 in IDS on 2/16/2024).
Miyazaki discloses a method for detecting a virus in a specimen, comprising: a step of bringing a test solution containing the specimen, a surfactant, and a fluorescently labeled anti-nucleocapsid protein antibody into contact with a microelectrode and applying an alternating current voltage to the microelectrode so as to concentrate a fluorescently labeled anti-nucleocapsid protein antibody which is bound to a nucleocapsid protein of the virus in the specimen near the microelectrode; and a step of detecting the presence of a virus in the specimen by fluorescence observation, wherein the nucleocapsid protein forms a complex with a nucleic acid (see paragraphs [0016] and [0072], fig. 1-11).
Miyazaki teach a virus detection apparatus, comprising: a cell having microelectrodes at its bottom; a power supply that applies an alternating-current voltage between the microelectrodes; an image sensor, means for electrically recording images; and means for electronically comparing fluorescence image changes in an aggregated state of fluorescence before and after voltage application and converting a difference image into a quantitative value or qualitative judgment result, wherein a fluorescently labeled anti-nucleocapsid protein antibody bound to a nucleocapsid protein of a virus in a specimen is concentrated near the microelectrodes so as to carry out fluorescence observation of fluorescence from an anti-nucleocapsid protein antibody (see the entire document).
Miyazaki teach a method for detecting influenza virus in a specimen by dielectrophoresis (in particular, examples 1, 2). Specifically, a monoclonal antibody (an anti-nuclcocapsid protein antibody) that recognizes a nucleoprotein (NP) of an influenza virus and saliva (specimen) including an influenza A virus are mixed in a solution containing TritonX-100 (a surfactant) and introduced into a detection cell provided with a microelectrode on the bottom, and an alternating voltage is applied to the microelectrode to concentrate the NP bound by the anti-NP antibody in the vicinity of the microclectrode (see Examples 1 and 2).
Miyazaki teach the monoclonal antibody is fluorescently labeled, and the concentrated NP is detected by irradiating the detection cell with excitation light from a light source and detecting fluorescence near the microelectrode with a light sensor. It is also indicated that TritonX-100 in the solution destroys the virus envelope and releases NP (paragraph [0074] etc.).
Miyazaki discloses a device for detecting an influenza virus as discussed above, the detection device comprising: a detection cell comprising a microelectrode on the bottom; a light sensor (image sensor) for detecting fluorescence emitted by a fluorescent label; a function generator (power supply) that applies a high frequency with an optimum voltage and frequency to the microelectrode; and an electronic means in the light sensor that performs image processing in which fluorescence is captured with an imaging element via an optical filter (color filter) that does not allow excitation light to pass through, and extracted with reference to the shape of the microelectrode, and which qualitatively or quantitatively measures a binding state between a substance to be detected (for example, NP) and a material that recognizes the substance to be detected (for example, an anti-NP antibody) by evaluating fluorescence intensity, thereby allowing measurement of a substance to be tested for in a sample (paragraphs [0053]-[0059] etc.).
Thus, by this disclosure Miyazaki anticipates the present claims.
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 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Miyazaki (WO 2021/070884 A1 15 April 2021 in IDS on 2/16/2024) in view of Wang et al. (US Patent Application Publication 2011/0294225).
Miyazaki teach the claimed invention as discussed above. They do not teach the solution stirred by the electroosmotic flow, and wherein the protrusions generating the turbulent flow.
Wang teach using electroosmotic flow as a means of stirring a solution in a microscopic space (see paragraphs [0012], [0038], and {0040].
Based on the teachings in Wang a person skilled in the art could easily conceive of using a stirring means based on electroosmotic flow in the method of Miyazaki. It is well known to a person skilled in the art that, by providing a protrusion in the cell, turbulence is generated in a solution in a cell resulting in stirring.
Thus, the present invention would have been prima facie obvious at the time the invention was made.
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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