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 .
Response to Amendment
The Amendment filed 03/19/2026 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 Claims 1 and 4 are withdrawn.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.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because it includes more than 150 words in length. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
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).
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, 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.
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 (paragraph [0062] teaches a control region with a control regent), 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, 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.
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 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 6, filed 03/19/2026, with respect to the rejections under 35 U.S.C. 101 have been fully considered and are persuasive. The rejections under 35 U.S.C. 101 of 12/23/2025 have been withdrawn.
Applicant’s arguments, see pages 6-10, filed 03/19/2026, 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).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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