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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Objections
Claims 1-17 are objected to because of the following informalities: The claims recite the abbreviations “dPCR” for digital polymerase chain reaction and “PCB” for printed circuit board, but the claims do not recite the full terms. Appropriate correction is required.
Inventorship
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 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.
The factual inquiries 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, 2, 10-12 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Son et al. (US 2020/0114362) in view of Hopper et al. (US 2017/0343419). Son recites a reaction vessel and method for controlling temperature in a microfluidic chip.
Regarding claims 1, 10 and 17 – As shown in the cited Figures, Son teaches a microfluidic chip (100/200) configured to amplify a nucleic acid; a heater (light absorbing layers 106-1, 106-2) located at one side of the microfluidic chip (reaction vessel 506/510) and configured to perform heating to allow a nucleic acid disposed in the microfluidic chip to be amplified; an image capturer (LED 512 and detecting sensor 15) located at the other side of the microfluidic chip (510) and configured to capture fluorescence images of the microfluidic chip (reaction vessel 506/510) to detect the amplified nucleic acid; and an analyzer (processor 910) configured to analyze the fluorescence images (See Figures 9B-10 and Paragraph 0113), wherein the heater comprises: a gold thin film layer (layers 106-1, 106-2) structure on one surface thereof; a light source (LEDs 504 transmitted by fiber optics 508) configured to allow a heating area of the gold thin film layer structure to undergo plasmonic heating; and a second PCB substrate (PCB 502) configured to control the light source. Son does not teach the gold film layer structure on a PCB substrate.
Hopper teaches a chemical sensor. The embodiment of the sensor most relevant to the instant claims is shown in Figure 11 and described in Paragraph 0077. As shown in Figure 11, Hopper teaches a device microfluidic device having a microfluidic channel. The base of the channel is heated by the IR heater (2) and plasmonic layer (11) within a dielectric layer (3) of a semiconductor substrate (13). In Paragraph 0035 and the claims, Hopper teaches that the substrate layers may be packaged on a printed circuit board. The Examiner submits it would have been obvious to one of ordinary skill in the art at the time of the effective date of the invention to combine the PCB substrates from Hopper with the system of Son. One of ordinary skill in the art at the time would add the PCB substrates to Son to provide electrical connections and have the entire device packaged on PCB technology as taught by Hopper.
Regarding claim 2 – Son shows a chip (vessel 100/150) having a fluid injection part (inlet channel 108), a channel part (reaction chamber 104) through which a fluid is movable and having
microstructures (heating elements 106-1, 106-2 and curved portions), and a discharge part (outlet channel 110).
Regarding 11 and 12 – Son discloses an LED light source (excitation LED 512), excitation filter (514), emission filter (516), and CCD or CMOS sensor (515) in Figure 5C and Paragraphs 0096. Son also teaches the light source and detector may be positioned in any suitable location on or in the device in Paragraph 0096.
Claims 3-8 are rejected under 35 U.S.C. 103 as being unpatentable over Son et al. (US 2020/0114362) in view of Hopper et al. (US 2017/0343419), as applied to claims 1, 2, 10-12 and 17 above, and further in view of Ismagilov et al. (US 2007/0172954). Son and Hopper as combined in Paragraphs 7-11 above teach every element of claims 3-8 except for the additional injection element having coated surface, partitioning channels and curved channel portions. Ismagilov teaches a microfluidic device for plug flow transport, mixing and reaction. The embodiments of the device most relevant to the instant claims are shown in Figures 2A-12B and described in Paragraphs 0127-0184. The embodiments shown in Figure 2B-6 include a plurality of different inlet schemes comprised inlet feeds that combine with a stream of carrier fluid in a channel resulting in a laminar stream of aqueous plugs of sample and reagent material for reaction. See Paragraphs 0127-0153. Ismagilov teaches channel configurations for mixing in Figures 7-12B. The configurations include curved channels for increasing mixing. See Paragraphs 0154-0184, Ismagilov further teaches use of hydrophobic and hydrophilic surfaces to enhance mixing or splitting of fluids in the channels in Paragraphs 0156 and 0180. The Examiner submits it would have been obvious to one of ordinary skill in the art at the time of the effective date of the invention to combine the additional injection feeds and also the curved and coated channels from Ismagilov with the combined device of Son and Hopper. One of ordinary skill in the art at the time would add these features to Son and Hopper to provide additional reagents or samples and also enhanced mixing features in the channels as taught by Ismagilov.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Son et al. (US 2020/0114362) in view of Hopper et al. (US 2017/0343419) as applied to claims 1, 2, 10-12 and 17 above, and further in view of Hama et al. (US 2022/0268741). Son and Hopper as combined in Paragraphs 7-11 above teach every element of claim 9 except for the material of the microfluidic chip. Hama teaches a microfluidic container having structures for performing PCR reactions and separation of a sample with magnetic particles. The embodiments of the device (container 10) most relevant to the instant claims are shown in Figures 1-7 (especially Figure 5) and described in Paragraphs 0042-0081. As shown in the cited Figures, Hama teaches a container (10) having a plurality of reaction holes (accommodation parts 21 and 22) connected by a first sub-groove (staircase part 31) , second sub-groove (flow passage 30), and third sub-groove (second staircase part 32) that form a flow channel structure between the reaction holes (21, 22). The grooves are comprised of different heights (h11, h12/22, h21) and surface properties which allows for control of the movement of fluids between the reaction holes (21, 22) while also allowing the movement of magnetic particles between the reaction holes (21, 22) to perform PCR reactions in the reaction holes. See Paragraphs 0047-0054 and 0085-0094. Hama recites use of a resin molded plastic material such as polycarbonate and PMMA for making their device in Paragraph 0055. The Examiner submits it would have been obvious to one of ordinary skill in the art at the time of the effective date of the invention to combine the polycarbonate or PMMA material from Hama with the device of Son and Hopper. One of ordinary skill in the art at the time would add the polycarbonate or PMMA material to Son and Hopper in order to use plastic materials that may be used in molding processes as taught by Hama.
Claims 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over Son et al. (US 2020/0114362) in view of Hopper et al. (US 2017/0343419) as applied to claims 1, 2, 10-12 and 17 above, and further in view of Neto et al. (US 2023/0349007). Son and Hopper as combined in Paragraphs 7-11 above teach every element of claims 13-16 except for the fluorescence wavelengths recited in the claims, an analyzer based on Raspberry pi, and a wireless communicator. Neto teaches a device for amplifying and analyzing nucleic acids. The portions of the device most relevant to the instant claims are shown in Figures 2-4 and described in Paragraphs 0042-0080. The device includes a thermoblock (8) comprising openings (80) containing microtubes for performing PCR. The device further includes a plurality of RGB LEDs next to an imaging camera (11) and adapted to excite the contents of the microtubes. Neto further teaches control and analysis by Raspberry Pi architecture analysis in Figure 4 and Paragraphs 0063-0064. Neto also teaches processing elements for communicating with a mobile user in Paragraph 0063. The Examiner submits it would have been obvious to one of ordinary skill in the art at the time of the effective date of the invention to combine the LED’s, control features and wireless communication features from Neto with the combined device of Son and Hopper. One of ordinary skill in the art at the time would add the RGB LEDs from Neto in order to provide a well-known source of multiple wavelengths of light for fluorescence analysis. One of ordinary skill in the art at the time of the invention would have added the Raspberry Pi architecture to the device of Son and Hopper to provide control and analysis with open-source technology as taught by Neto. One of ordinary skill in the art at the time of the invention would have added the wireless communication elements to the device of Son and Hopper in order to wirelessly communicate with remote users as taught by Neto.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DWAYNE K HANDY whose telephone number is (571)272-1259. The examiner can normally be reached M-F 10AM-7PM.
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/DWAYNE K HANDY/Examiner, Art Unit 1798 September 27, 2025
/JILL A WARDEN/Supervisory Patent Examiner, Art Unit 1798