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 .
Response to Arguments
Applicant’s arguments, filed 01/12/2026, with respect to the rejection(s) of claims under 35 U.S.C. 103 as being unpatentable over Ly et al. (US 2006/0078986) in view of Li et al. (US 2016/0008809) have been fully considered and are persuasive. Applicant has amended claim 1 to recite “wherein each of the at least one detection branch structure further comprises a water-absorbing film, the water-absorbing film is contained in the detection groove and at least partially overlaps with the reaction reagent in a direction perpendicular to a first substrate, the water-absorbing film is disposed outside of the reaction reagent for sample quantification, and a liquid storage capacity of the water-absorbing film is 10µL-50µL” and then argued this feature is not taught or suggested by the cited prior art. See pages 7-8 of Applicant’s Remarks. The Examiner agrees; therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made below.
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 1-3, 12, 28, 29, 36, 38 and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Ly et al. (US 2006/0078986) in view of Katayama et al. (US 2021/0007720). Ly teaches an analytical device having a primary and secondary flow path. The embodiments of the device most relevant to the instant claims are shown in Figures 1A-6 and described in Paragraphs 0056-0106.
Regarding claims 1 and 2 - As shown in Figures 2A and 3A Ly teaches a detection chip, comprising: a sample adding opening (sample port in top cover); and at least one detection branch structure (channel formed in upper cut out layer), wherein each of the at least one detection branch structure comprises: a detection portion, comprising a detection groove (wider portion of channel formed in upper cut-out layer) and a reaction reagent (tag and capture material), wherein the detection groove is in connection with the sample adding opening (sample port in top cover), and the reaction reagent (tag and capture material) is contained in the detection groove (wider portion of channel formed in upper cut-out layer); and the detection portion is configured to allow optical detection to be performed on the reaction reagent in the detection groove. The detection chip further includes a guiding channel (narrow portion of channel formed in upper cut-out layer) that had a first end connected to the sample adding opening (sample port in top cover) and a second end connected to the detection groove (wider portion of channel formed in upper cut-out layer). Ly does not teach the water absorbent film disposed outside of the reaction reagent. .
Katayama teaches a trace amount liquid sample collector. The embodiments of the device most relevant to the instant claims Figures 1, 3, and 7 and described in Paragraphs 0040-0069. As shown in the cited Figures, the device includes a plurality of layers that form a channel leading to a collection reservoir in the middle layer. The middle layer includes a water absorbing sheet that extends through the channel to the reservoir where the water absorbing sheet then overlays a water absorbing sponge of different properties. In Paragraphs 0045-0047, Katayama teaches that this configuration allows for the optimization of absorption and retention of a measured amount of fluid. The Examiner submits one of ordinary skill in the art at the time of the effective date of the invention to combine the water absorbing film outside the reaction area and overlapping configuration from Katayama with the device of Ly. One of ordinary skill in the art would add the water absorbing film outside the reaction area in order to retain and provide a measured amount of fluid as taught by Katayama. .
Regarding claims 3, 36 and 38 - The Examiner considers the combination of the top cover and upper cut-out to meet the limitation of the first substrate comprising a first surface having the guiding channel and detection groove, as well as the sample adding opening. The Examiner considers the bottom support to meet the limitation of the second substrate. See Figures 1A-6 of Ly.
Regarding claim 12 - The Examiner considers the vent (Figs 2A-6 of Ly) to meet the limitation of the liquid storage through hole as recited in the claim.
Regarding claim 28 and 29 – Ly shows a detection through hole (read window) in Figures 6 and 8. Figure 8 also includes a spacer material layer which the Examiner considers to be a light shielding layer as recited in the claim.
Regarding claim 39 – The Examiner considers the section having the adsorbent pad and sideways vent shown in Figure 8 of Ly to meet the limitation of an optical calibration branch structure since the area could be used to calibrate an optical device.
Claims 7-10, 18, 19, 21, 24, 25, 36 are rejected under 35 U.S.C. 103 as being unpatentable over Ly et al. (US 2006/0078986) in view of Katayama et al. (US 2021/0007720), and further in view of Park et al. (US 2016/0047740). Ly and Katayama as combined above in Paragraphs 7-13 teach every element of claims 7-10, 18, 19, 21, 24, 25, 36 except for the guiding groove, the plurality of detection branches, and the protrusion from sample opening towards the guiding channel.
Park teaches a microfluidic device for testing a sample through optical examination. The
embodiments of the device most relevant to the instant claims are shown in Figures 3-8 and 28-33, and
described in Paragraphs 0108-0144. As shown in Figures 3, 7 and 8, the device of Park includes a first
substrate (housing 310) with a sample adding opening (inlet hole 321) connected to a platform (320)
having a having a guiding channel (322) connected to a plurality of detection chambers (200).
Regarding claims 7-10 – In Paragraphs 0262-0297, Park teaches the detection chamber (200)
may have a plurality of different steps of different height, which provides a plurality of different length
light paths during optical examination of the contents of the chamber. The plurality of light paths of
different length may then be used to improve the accuracy of measurements within the well. 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 chambers having a plurality of steps of different height from Park with the combined device of Ly and Katayama. One of ordinary skill in the art at the time would add the guiding channel having portions of different height to Ly and Katayama in order to improve the accuracy of measurements during optical examination of the detection chamber as taught by Park.
Regarding claims 18, 19, 25 and 36 – 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 plurality of
detection branch structures from Park with the modified device of Ly and Katayama. One of ordinary skill in the art at the time would add a plurality of branch structures to Ly and Katayama in order process multiple samples as taught by Park.
Regarding claim 19 - The combination of Ly and Katayama does not teach an inlet structure as recited having a first main body and a protrusion protruding from the body for connection with the guiding channel. Park teaches connecting the housing (310) having the inlet (321) to the platform (32) by
inserting a protrusion portion of the housing (310) into platform such that the platform extends in the
direction of the guiding channels (200) in Figures 3 and 31, and Paragraphs 0111-0112. 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 add the housing (310) and inlet (321) structure Park with the combined device of Ly and Katayama. One of ordinary skill in the art at the time would add the housing and inlet from Ly and Katayama in order to provide a raised housing and inlet (see Figures) that is connected to the platform by an alignment element as taught by Park.
Regarding claims 21 and 24 - Ly teaches a porous material having a block shaped reaction
reagent in the detection groove in Figures 2A-5C and 8; and also in Paragraphs 0047, 0053, and 0058-
0081.
Regarding claim 25 - Park discloses the detection grooves (chambers 200) having a circular
shape in Figures 4-8 and Paragraphs 0119-0121.
Claim 37 is rejected under 35 U.S.C. 103 as being unpatentable over Ly et al. (US 2006/0078986) in view of Katayama et al. (US 2021/0007720), and further in view of Li et al. (US 2016/0008809). Ly and Katayama as combined above in Paragraphs 7-13 do not teach the third substrate being stacked on the first substrate and sealing the sample adding opening and the guiding channel. Li teaches methods and compositions for paper-based and hybrid microfluidic devices containing paper. The embodiments most relevant to the instant claims are shown in Figures 1, 7A and 10A-11B. In Paragraph 0009-0015 and 0044-0053, Li teaches a microfluidic device that comprises a sheet of paper that is part of the channel or placed in the channel. Li teaches additional (third, etc.) layers in the device in Paragraph 0008. Li further teaches a top sealing layer of tape or other layer to prevent evaporation during processing in Paragraph 0052. 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 sealing layer from Li with the combined device of Ly and Katayama. One of ordinary skill in the art at the time would add the sealing layer to Ly in order to prevent evaporation from the device as taught by Li.
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 DWAYNE K HANDY whose telephone number is (571)272-1259. The examiner can normally be reached M-F 10AM-7PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached at 571-270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DWAYNE K HANDY/Examiner, Art Unit 1798 May 21, 2026
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798
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