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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07/01/2026 has been entered.
Response to Amendment
The Amendment filed 07/01/2026 has been entered. Claims 1, 4-5, and 11-13 remain pending in the application. Claims 1 and 4 are withdrawn. New grounds of rejections necessitated by amendments are discussed below.
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 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.
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 5 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Fuchiwaki et al. (WO 2020045551 A1; cited in the IDS filed 03/21/2023; English equivalent US20210170398A1 is used herein for citation; herein, “WO ‘551”) in view of Fuchiwaki et al. (JP 2015172492 A1; see machine translation) and Momiyama et al. (US 20150185213 A1; cited in the IDS filed 03/21/2023)
Regarding claim 5, WO ‘551 teaches an assay method for quantifying a target substance (paragraph [0080] teaches determination of each quantity of liquid for detection of a specimen; paragraph [0035] teaches detecting or measuring specimen; paragraph [0003] teaches assay devices for quantifying concentration of substances in a sample and paragraph [0005] teaches the invention is an assay device), using an assay device (Fig. 15) comprising a plurality of assay units (Fig. 15 teaches a plurality of assay devices M1-M4; Figs. 12-14 teaches the details of one assay device), each assay unit (Figs. 12-14) comprising:
a microfluidic channel (Figs. 12-14, microflow passage 41) configured to allow a liquid to flow (paragraphs [0041],[0110]);
a porous absorbing medium (Figs. 12-14, first absorbing porous medium 42) disposed at a distance from one end of the microfluidic channel (41a), the one end (41a) being located on one side in a flow direction of the liquid (Figs. 12-14; paragraphs [0042],[0111]); and
a separation space (Figs. 12-14, separating space 43) disposed between the one end of the microfluidic channel (41a) and the porous absorbing medium (42) (paragraphs [0042],[0111]),
wherein the microfluidic channel comprises, in the microfluidic channel, a detection section (Figs. 12-14, reaction porous medium 54) having immobilized thereon a substance capable of specifically reacting with a target substance (paragraphs [0050],[0114] teaches reaction porous medium 54 and 14 includes cellulose that supports the antibody and antigen), and
wherein each assay unit comprises:
two parallel ventilation passages extending along the flow direction of the microfluidic channel over an entire length in the flow direction of the microfluidic channel (Figs. 12-14 and paragraphs [0044],[0111],[0114], parallel ventilation passages 46 that extend along and over an entire length of the flow direction of microflow passage 41), and being respectively adjacent to both sides of the microfluidic channel in a width direction orthogonal to the flow direction (Figs. 12-14; paragraphs [0044],[0111]), the two parallel ventilation passages communicating with the microfluidic channel to allow for air circulation (Figs. 12-14 and paragraph [0116]);
an inlet (Figs. 12-14, inlet 45) disposed at another end of the microfluidic channel located on another side in the flow direction (41b), the inlet allowing the liquid to be supplied to the microfluidic channel (paragraph [0140],[0142]); and
a connecting ventilation passage (Figs. 12-14, connecting ventilation passage 47) connecting the two parallel ventilation passages and extending around the inlet to allow for air circulation (Figs. 12-14; paragraph [0045], [0111], [0114],[0116]),
the method comprising the following steps that are sequentially performed:
(b) applying a cleaning solution to the microfluidic channel (paragraphs [0140]-[0142] teaches cleaning solution were supplied to the inlets of the microflow paths of the assay devices);
(c) applying a liquid to the microfluidic channel, the liquid comprising a first label capable of specifically binding to a target substance (paragraph [0143] teaches supplying an HRP labeled antibody solution to the inlet of the microflow path of the assay devices); and
(d) measuring a signal of the first label in the detection section (paragraph [0144] teaches confirming darkening of the absorbing porous media).
WO ‘551 fails to teach: an internal standard section having immobilized thereon an internal standard substance that does not react with the target substance, the internal standard section is provided at a distance from the detection section on an upstream or downstream side in the flow direction with respect to the detection section, and the distance between the internal standard section and the detection section is equal to or greater than the width of the microfluidic channel; the method comprising the following steps that are sequentially performed: (a) applying a sample to the microfluidic channel; the liquid comprising a second label capable of specifically binding to the internal standard substance; and (d) quantifying a signal of the first label in the detection section for obtaining concentration of the target substance and quantifying a signal of the second label in the internal standard section for correcting the concentration of the target substance, wherein the first label and the second label are different.
WO ‘551 teaches liquid samples for the assay device allows the assay device to effectively diagnostically measure a specimen in the liquid sample for the purpose of testing for pregnancy, urine, feces, adult diseases, allergies, infectious diseases, drugs, cancer, and/or the like (paragraph [0033]). WO ‘551 teaches the flow passage configured to allow the liquid flow in the assay device in order to detect or measure the specimen using a very small quantity of liquid (paragraph [0036]).
Fuchiwaki teaches an assay device (according to claim 1) comprising a plurality of assay units (Figs. 1-2 and 10; wherein Fig. 10 shows four assay units, each assay unit are shown in detail in Figs. 1-2), each assay unit (Figs. 1-2) comprising: a microfluidic channel (Figs. 1-2, microchannel 74); a porous absorbing medium (Figs. 1-2, absorbent paper 44) disposed at a distance from one end of the microfluidic channel (Figs. 1-2, interpreted as one end of the microchannel 74, such as the end adjacent to element 42), the one end being located on one side in a flow direction of the liquid (Figs. 1-2, interpreted as one end of the microchannel 74, such as the end adjacent to element 42); and a separation space (Figs. 1-2, space 82) disposed between the one end of the microfluidic channel and the porous absorbing medium (Figs. 1-2, space 82 is between the end adjacent to element 42 and the absorbent paper 44), wherein: the microfluidic channel comprises, in the microfluidic channel, a detection section (Figs. 1-2, assay area 76) having immobilized thereon a substance capable of specifically reacting with a target substance (paragraph [0059] teaches assay reagents immobilized in assay area 76, which reacts with an analyte, i.e. target substance), and an internal standard section having immobilized thereon an internal standard substance that does not react with the target substance (paragraph [0062] teaches a control region with a control regent that does not bind to the analyte), the internal standard section is provided at a distance from the detection section on an upstream or downstream side in the flow direction with respect to the detection section (paragraph [0062] teaches the control region may be provided downstream of the microchannel), and each assay unit comprises two parallel ventilation passages (Figs. 1-2, side channels 75) that are respectively adjacent to both sides of the microfluidic channel in a width direction orthogonal to the flow direction (Figs. 1-2; paragraph [0081]), the two parallel ventilation passages communicating with the microfluidic channel to allow for air circulation (paragraph [0081]). Fuchiwaki teaches: an assay method (paragraphs [0073]-[0074]) using the assay device, comprising the following steps that are sequentially performed: (a) applying a sample to the microfluidic channel (paragraph [0073] teaches a liquid sample is applied to the inlet 66 of the microfluidic device); and (c) applying a liquid to the microfluidic channel (paragraph [0074] teaches applying a second liquid to the microchannel). Fuchiwaki teaches an embodiment (paragraphs [0106]-[0107]), wherein sections were washed with saline, reacted with antigen, washed with saline, reacted with HRP-labeled second antibody solution, washed with saline, reacted with luminescent substance, and then luminescence value was measured (paragraphs [0106]-[0107]). Fuchiwaki teaches assay reagents reacting with a sample to form a complex, and the signal of the complex is detected by well-known method (paragraph [0060]). Fuchiwaki teaches the control region is provided downstream towards the tip of the microchannel to confirm that a sufficient amount of a sample has reached the assay region (paragraph [0062]). Fuchiwaki teaches the control reagent that can bind to the second assay reagent, where an observer can confirm that the assay has been performed under reliable conditions (paragraph [0062]). Fuchiwaki teaches multi-stage antigen-antibody reactions, such as ELISA, are performed (paragraphs [0074],[0104]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the assay method and assay unit of WO ‘551 to incorporate the teachings of measuring liquid samples of WO ‘551 (paragraphs [0033],[0036]) and the teachings of an assay device with an internal standard section, antibody solutions, and control reagents for confirming an assay has been performed under reliable conditions of Fuchiwaki (Figs. 1-2; paragraphs [0062],[0106]-[0107]) to provide: an internal standard section having immobilized thereon an internal standard substance that does not react with the target substance, the internal standard section is provided at a distance from the detection section on an upstream or downstream side in the flow direction with respect to the detection section, and the distance between the internal standard section and the detection section is equal to or greater than the width of the microfluidic channel; the method comprising the following steps that are sequentially performed: (a) applying a sample to the microfluidic channel; the liquid comprising a second label capable of specifically binding to the internal standard substance; and (d) measuring a signal of the second label in the internal standard section, wherein the first label and the second label are different. Doing so would have a reasonable expectation of successfully ensuring that sufficient amount of a sample has reached the assay region by the use of an internal standard section and second label different from the first label as discussed by Fuchiwaki.
Modified WO ‘551 fails to teach: (d) quantifying a signal of the first label in the detection section for obtaining concentration of the target substance and quantifying a signal of the second label in the internal standard section for correcting the concentration of the target substance.
WO ‘551 teaches lateral flow assays are known to be employed for detecting and quantifying concentrations of antibodies or antigens in a sample (paragraph [0003]).
Fuchiwaki teaches intensity of chemiluminescence was measured, i.e. quantified (paragraph [0105]) with a measurement device (paragraph [0106]); wherein the positive control had a higher luminescence value (positive control) in the liquid sample than the comparative assay device (negative control) (paragraph [0107]). Fuchiwaki teaches measurements with general purpose reliability, high sensitivity, and high accuracy (paragraph [0108]).
Momiyama teaches a method of internal correction in one chip assay, including an assay system for measuring a test substance and measuring an internal standard substance on a single chip to thereby internally correct measurement values of a test substance; and the internal correction allows for quantification of the test substance (abstract). Momiyama teaches a method for internal correction comprising quantifying the amount of an immune complex by detecting intensity of magnetic signals of a magnetic particles for labeling capture a substance (paragraph [0010]); quantifying at least one internal standard substance on the same chip at the same time (paragraph [0011]); and correcting the measurement value of the test substance based on a correlation coefficient calculated from the measurement value of the internal standard substance (paragraphs [0012]-[0013]). Momiyama teaches the use of internal correction in an assay system for measuring a test substance to eliminate effects on the measurement values of the test substance caused by an assay-interfering factor, a difference in assay environment, and a reduction in activity of an assay reagent, or another factor that affects the assay system (paragraph [0065]). Momiyama teaches the internal standard is a substance with a prescribed concentration or capacity, and the measurement values of a test substance are corrected on the basis of the measurement values of the internal standard substance (paragraph [0065]). Momiyama teaches it is thereby possible to calculate the accurate concentration of the test substance based on the internal standard substance (paragraphs [0068],[0079]). Momiyama teaches the method makes it possible to ensure the accuracy and reliability of measurement results, and to improve measurement precision (paragraph [0093]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of modified WO ‘551 to incorporate WO ‘551’s teachings of lateral flow assays for quantifying concentrations of a target substance (paragraph [0003]), Fuchiwaki’s teachings of quantification of luminescence (paragraph [0105]) and positive and negative controls (paragraph [0107]), and Moiyama’s teachings of quantification of a test substance and internal standard substance to internally correct measurement values of the test substance (abstract; paragraph [0010]-[0013]) and calculating accurate concentration of the test substance based on the internal standard substance (paragraph [0068],[0079]) to provide: (d) quantifying a signal of the first label in the detection section for obtaining concentration of the target substance and quantifying a signal of the second label in the internal standard section for correcting the concentration of the target substance. Doing so would have a reasonable expectation of successfully improving characterization of the target substance by eliminating effects on the quantification of the concentration of the target substance through correction using the internal standard section, therefore allowing accurate, reliable, and precise calculation of the concentration of the target substance as taught by Momiyama (paragraphs [0065],[0068],[0079],[0093]).
Regarding claim 11, WO ‘551 further teaches the assay method according to claim 5, wherein each assay unit (Figs. 12-15) comprises:
a housing space (44) housing the porous absorbing medium (Figs. 12-14; paragraph [0115]);
a separation space wall (49) defining the separation space in cooperation with the porous absorbing medium (Figs. 12-14; paragraph [0112]), the separation space wall comprising a top portion (49a) and a bottom portion (49b) defining the separation space on both sides in a height direction orthogonal to the flow direction and the width direction (Figs. 12-14; paragraph [0112]); and
a guide wall (50) protruding to the one side in the flow direction from the top portion or the bottom portion of the separation space wall in the housing space (Figs. 12-14; paragraph [0115]),
wherein: the guide wall (50) abuts the porous absorbing medium (42) in the height direction (Figs. 12-14 and paragraph [0115]), and
the top portion or the bottom portion of the separation space wall (49), and the guide wall (50) are formed to be away from the microfluidic channel (41) in the height direction toward the one side from the another side in the flow direction (paragraphs [0048],[0112] teaches the separating space wall and guide wall inclines to be apart from the microflow passage in the height direction from the other side to one side in the flow direction).
Claims 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over WO ‘551 in view of Fuchiwaki and Momiyama as applied to claim 5 above, and further in view of Greef et al. (US 20180264464 A1).
Regarding claim 12, WO ‘551 fails to teach: wherein the step (d) is a step of capturing a digital color image with a smartphone.
Greef teaches methods and systems for a lateral flow test including microarrays (abstract). Greef teaches images may be captured by a smartphone (paragraphs [0188],[0218]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of modified WO ‘551 to incorporate the teachings of imaging using known devices such as a smartphone to provide: wherein the step (d) is a step of capturing a digital color image with a smartphone. Doing so would have a reasonable expectation of successfully allowing improving accessibility and convenience of imaging using for a user using known imaging devices in the art.
Regarding claim 13, WO ‘551 fails to teach: wherein the internal standard section in each assay unit is provided on an upstream side in the flow direction with respect to the detection section.
Greef teaches methods and systems for a lateral flow test including microarrays (abstract). Greef teaches analyte capture zones may include one or more control regions including positive or negative controls, which serve to ensure the integrity of the biological sample as well as correct processing of the microarray (paragraph [0111]). Greef teaches analyte capture zones may be switched such that the control region is upstream of the test region (paragraph [0122]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the internal standard section of modified WO ‘551 to incorporate the teachings of multiple control regions that can be upstream of a test region of Greef (paragraphs [0111],[0122]) to provide: wherein the internal standard section in each assay unit is provided on an upstream side in the flow direction with respect to the detection section. Doing so would have a reasonable expectation of successfully ensuring the integrity of the biological sample as well as correct processing of the microarray as taught by Greef.
Response to Arguments
Applicant’s arguments, see page 7, filed 07/01/2026, with respect to the abstract objection have been fully considered and are persuasive. The abstract objection of 04/10/2026 has been withdrawn.
Applicant’s arguments, see pages 8-10, filed 07/01/2026, with respect to the rejection(s) of claim 5 under 35 U.S.C. 103, have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Fuchiwaki et al. (WO 2020045551 A1; cited in the IDS filed 03/21/2023; English equivalent US20210170398A1 is used herein for citation; herein, “WO ‘551”) in view of Fuchiwaki et al. (JP 2015172492 A1; see machine translation) and Momiyama et al. (US 20150185213 A1; cited in the IDS filed 03/21/2023).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Chen et al. (CN 105445451A ; see machine translation filed 12/23/2025) teaches a method for fluorescence immunoassay (paragraph [0002]). Chen teaches luminescence values of measurements were calculated, i.e. quantified, and calculation of their mean and standard deviation, wherein luminescence value was obtained by adding twice the standard deviation to the mean, and luminescence value obtained by adding twice the standard deviation to the mean was substituted into the calibration curve equation of the calibrator used in the kit to calculate the corresponding concentration value (paragraph [0077]). Chen teaches use of calibrators and reference standards (paragraph [0212]). Chen teaches the method improves accuracy and reliability of experimental results (paragraph [0023]).
Armbruster et al. (US 20210172945 A1; effectively filed 05/07/2018) teaches an analyte testing system for quantifying the presence of an analyte in by lateral flow chromatography, wherein visual signals are quantified (abstract). Armbruster teaches conventional lateral flow tests use as control the binding of non-reacted analyte-specific antibodies (paragraph [0043]). Armbruster teaches obtain a control zone of predetermined intensity that is independent from the amount of analyte present in the test sample; the term “control” not only refers to the conventional control but comprises an “internal standard” for a standard intensity of the visual zone (C) for external and internal calibration (paragraph [0044]). Armbruster teaches determining the amount of analyte contained in the test sample by comparison with the values of a series of calibrated standards as determined by lateral flow immunoassays of the same lot of production (paragraph [0088]).
Fong et al. (US 20100047857 A1) teaches methods for measuring the amount of analytes, including determining a detected amount of an analyte of interest, and amount of a control (abstract). Fong teaches the amount of binding at each zone and between the zones and before the initial zone and after the control zone can be determined with enough resolution to quantitate the amount of label in each of these areas (paragraph [0052]).
Wang et al. (US 20150224499 A1) teaches an automated platform for determining the amount of analytes of interest (abstract). Wang teaches without an internal standard, it would be difficult to correlate the measured signal value with the actual biomarker concentration (paragraph [0062]). Wang teaches after automatic baseline correction, peak heights at specific timing were measured and the sample concentration could be determined by comparing to the standard solutions (paragraph [0082]).
Lee et al. (US 20120028245 A1) teaches a quantitative assay device for determination of an analyte (abstract). Lee teaches the microporous test strip membranes of the present invention contain at least two different standard bands of immobilized calibrator agents capable of binding to their own pair label reagents; the labeled reagents captured at the standard bands by the calibrator agents are used to create a template against which to measure the concentration of an analyte in a sample bound in the test band (paragraph [0007]). Lee teaches commercially available optical readers can then convert the reflected light intensity of the sample into concentration as measured on the basis of the curve derived from the reflected intensity of the standard bands of known concentrations (paragraph [0007]). Lee teaches an advantage to having calibrator binding pairs is that they act as internal standards, that is, the calibrator against which the amount of an analyte present at the capture band may be calculated (paragraph [0030]).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HENRY H NGUYEN whose telephone number is (571)272-2338. The examiner can normally be reached M-F 7:30A-5:00P.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached at (571) 270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HENRY H NGUYEN/Primary Examiner, Art Unit 1758
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