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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 6/30/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment
The amendments and remarks, filed on 6/5/2026, has been entered. The claim amendments overcome the previous prior art rejection, and a new prior art rejection is applied to address the claim amendments.
Claim Status
Claims 1-8 are pending and being examined.
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 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.
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 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over Han et al (US 20210221676 A1; hereinafter “Han”; already of record) in view of Mao et al (US 20210039089 A1; hereinafter “Mao”).
Regarding claim 1, Han teaches a microchannel device in a form of a plate used for a test in which a test solution containing a sample and an agent act on each other1 (Han; Fig. 4; para [42]; Microfluidic device 50), the microchannel device comprising:
an opening that receives the test solution (Han; Fig. 4; para [43]; The microfluidic channel 52 of device 50 may generally include a first fluid inlet 60);
a single main channel that communicates with the opening (Han; upstream channel 66), the single main channel including an inlet-side end communicating with the opening (Han; Image 1; inlet-side end is interepted as the area of fluid inlet 60) and an outlet-side end located opposite to the inlet-side end (Han; Image 1; outlet-side end is interpreted as the area of fluid outlet 64);
a microchannel branch from the single main channel between the inlet-side end and the outlet-side end (Han; para [43]; second fluid inlet 62; the examiner interprets the channel that connects the second fluid inlet to the main channel as the microchannel); and
a collection portion that is provided in the single main channel at the outlet-side end (Han; Fig. 4; examiner interprets the portion between the upstream channel and the downstream channel to be the collection portion), the outlet-side end being located opposite to the inlet-side end communicating with the opening (Han; Image 1; outlet-side end is interpreted as the area of fluid outlet 64), (Han; para [47]; the fluid flow 78 enters sloped chamber 68), wherein the collection portion includes
a pool that stores the test solution discharged from the single main channel (Han; Fig. 4; para [43]; pair of parallel collection chambers 72),
a connection channel that connects the pool with the outlet-side end (Han; Fig. 4; para [43]; a sloped chamber 68), and
a protrusion that is arranged in the connection channel to generate air bubbles between the protrusion and an inner wall of the connection channel to close the connection channel, upon receiving the test solution discharged from the single main channel (Han; Fig. 6; para [46]; micropillars 80 which extend from the sloped ceiling 76 at least partially towards the floor 54 of sloped chamber 68)2.
1 The limitation “used for a test in which a test solution containing a sample and an agent act on each other” is interpreted as intended use and/or functional language. The Courts have held that the manner in which a claimed apparatus is intended to be employed does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex parte Masham, 2 USPQ2d 1647 (BPAI 1987). A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. See MPEP § 2114. The microchannel device disclosed by Han teaches all of the structural limitations of the claim and thus is configured for and capable of performing the intended use and/or function language of being used for the test.
2 The limitation “to generate air bubbles between the protrusion and an inner wall of the connection channel to close the connection channel, upon receiving the test solution discharged from the main channel” is interpreted as intended use and/or functional language. The Courts have held that the manner in which a claimed apparatus is intended to be employed does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex parte Masham, 2 USPQ2d 1647 (BPAI 1987). A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. See MPEP § 2114.
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Image 1. Annotated Figure 5 of Han.
Han does not the microchannel being a plurality of microchannels that each branch orthogonally from the single main channel.
However, Mao teaches an analogous art of separating target cells from a biological sample (Mao; Abstract) comprising an opening that receives the test solution (Mao; Fig. 1C; para [69]; a first inlet 14 at the first end, the inlet configured to flow a first fluid into the main channel 12); a single main channel that communicates with the opening, the single main channel including an inlet-side end communicating with the opening (Mao; Fig. 1C; para [69]; The main channel 12 has a first end and a second end, with a first inlet 14 at the first end, the inlet configured to flow a first fluid into the main channel 12); a plurality of microchannels that each branch orthogonally from the single main channel between the inlet-side end and the outlet-side end (Mao; Fig. 1C; para [70]; these plurality of microchannels 30 run perpendicularly between the main channel and outer channel, and any collection channels, fluidly connecting the other channels). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the microfluidic device of Han to comprise the plurality of microchannels as taught by Mao, because Mao teaches that the microchannels are perpendicular to the main channel to allow single cells to pass through from the outer channel that is connected to the second inlet (Mao; para [69, 70]). The Examiner notes that the modification would be applied to the second inlet 62.
Regarding claim 2, modified Han teaches the microchannel device according to claim 1, wherein the connection channel includes an inclined channel having an inclined surface inclined toward an outside of the connection channel, and an inclination angle of the inclined surface with respect to a channel surface extending from the inclined surface is less than 90 degrees (Han; Fig. 6; para [44]; Particularly, sloped ceiling 76 may slope vertically upwardly gradually increasing the height 59 of sloped chamber 68 moving from the inlet of chamber 68 to a location corresponding to the maximum height 63 of chamber 68).
Regarding claim 3, modified Han teaches the microchannel device according to claim 2, wherein, of wall surfaces that form the single main channel and the plurality of microchannels, a surface that faces a surface provided with the opening is flat (Han; Fig 3).
Regarding claim 4, modified Han teaches the microchannel device according to claim 2, wherein, of wall surfaces that form the connection channel, the inclined surface is provided on a wall surface on a side where the opening is provided (Han; Fig. 6).
Regarding claim 5, modified Han teaches the microchannel device according to claim 2, wherein the protrusion is provided in the inclined channel (Han; Fig. 6; para [46]; sloped chamber 68 of microfluidic channel 52 may comprise an array of spaced (generally in the “X” direction) micropillars 80).
Regarding claim 6, modified Han teaches the microchannel device according to claim 1, wherein the protrusion has a shape tapered toward the outlet-side end. It would have been an obvious matter of choice to tapered shape, since such a modification would have involved a mere change in the shape of the protrusion. A change of shape is generally recognized as being within the level of ordinary skill in the art. MPEP §2144.04 (IV)(B). Further, one would have been motivated to select the shape of tapered for the purpose of redirecting air bubbles (Han; para [6]).
Regarding claim 7, modified Han teaches the microchannel device according to claim 1, wherein the connection channel includes a tapered portion in which a channel width increases from the outlet- side end toward the pool, and a taper angle of the tapered portion is less than 180 degrees (Han; Fig. 5; side walls 56 are tapered outward prior to the protrusions and are tapered inward toward the outlet-side end).
Regarding claim 8, Han a microchannel device in a form of a plate used for a test in which a test solution containing a sample and an agent act on each other1 (Han; Fig. 4; para [42]; Microfluidic device 50), the microchannel device comprising:
an opening that receives the test solution (Han; Fig. 4; para [43]; The microfluidic channel 52 of device 50 may generally include a first fluid inlet 60);
a main channel that communicates with the opening (Han; upstream channel 66), the main channel including an inlet-side end communicating with the opening (Han; Image 1; inlet-side end is interpreted as the area of fluid inlet 60) and an outlet-side end located opposite to the inlet-side end (Han; Image 1; outlet-side end is interpreted as the area of fluid outlet 64);
a microchannel branches from the main channel between the inlet- side end and the outlet-side end (Han; para [43]; second fluid inlet 62; the examiner interprets the channel that connects the second fluid inlet to the main channel as the microchannel); and
a collection portion that is provided in the main channel at the outlet-side end (Han; Fig. 4; examiner interprets the portion between the upstream channel and the downstream channel to be the collection portion), the outlet-side end being located opposite to the inlet-side end communicating with the opening (Han; Image 1; outlet-side end is interpreted as the area of fluid outlet 64), the collection portion partly collecting the test solution (Han; para [47]; the fluid flow 78 enters sloped chamber 68), wherein the collection portion includes
a pool that stores the test solution discharged from the single main channel (Han; Fig. 4; para [43]; pair of parallel collection chambers 72),
a connection channel that connects the pool with the outlet-side end (Han; Fig. 4; para [43]; a sloped chamber 68), and
a protrusion that is arranged in the connection channel to generate air bubbles between the protrusion and an inner wall of the connection channel to close the connection channel, upon receiving the test solution discharged from the main channel (Han; Fig. 6; para [46, 47]; micropillars 80 which extend from the sloped ceiling 76 at least partially towards the floor 54 of sloped chamber 68… As the fluid flow 78 enters sloped chamber 68, the air bubbles 42, being buoyant in the fluid flow 78, travel upwards along parallel bubble flowpaths (indicated by arrows 82 in FIG. 5) that extend along sloped ceiling 76), wherein when the microchannel device is viewed in a plan view from a direction orthogonal to a surface provided with the opening, the protrusion has a size that allows a channel to be formed between the protrusion and the inner wall of the connection channel (Han; Fig. 5, 6; Examiner notes the protrusions are formed within the walls and depicted in Figure 6 and has a channel between the protrusions as depicted in Figure 5ss).
Han does not the microchannel being a plurality of microchannels that each branch orthogonally from the single main channel.
However, Mao teaches an analogous art of separating target cells from a biological sample (Mao; Abstract) comprising an opening that receives the test solution (Mao; Fig. 1C; para [69]; a first inlet 14 at the first end, the inlet configured to flow a first fluid into the main channel 12); a single main channel that communicates with the opening, the single main channel including an inlet-side end communicating with the opening (Mao; Fig. 1C; para [69]; The main channel 12 has a first end and a second end, with a first inlet 14 at the first end, the inlet configured to flow a first fluid into the main channel 12); a plurality of microchannels that each branch orthogonally from the single main channel between the inlet-side end and the outlet-side end (Mao; Fig. 1C; para [70]; these plurality of microchannels 30 run perpendicularly between the main channel and outer channel, and any collection channels, fluidly connecting the other channels). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the microfluidic device of Han to comprise the plurality of microchannels as taught by Mao, because Mao teaches that the microchannels are perpendicular to the main channel to allow single cells to pass through from the outer channel that is connected to the second inlet (Mao; para [69, 70]). The Examiner notes that the modification would be applied to the second inlet 62.
Response to Arguments
Applicant’s arguments filed, 6/5/2026, have been considered and the arguments are found to be persuasive. However, those arguments are directed towards the claim amendments. The examiner notes that the previous prior art rejection is withdrawn and a new prior art rejection is applied to address the claim amendments. The non-persuasive arguments are addressed below.
In the Applicant’s arguments, on page 6, the Applicant argues that Han fails to teach “a protrusion arranged in the connection channel to generate air bubbles between the protrusion and an inner wall of the connection channel to close the connection channel”. Specifically, the Applicant notes that the phrase “to close the connection channel” is not taught by Han, because the micropillars of Han is not capable of “closing” the channel. The Examiner respectfully disagrees. The broadest reasonable interpretation of the limitation is that the protrusions “close/prevent” flow through the connection channel, because the protrusions restrict liquid at specific points. Further, the air bubbles are not a positively recited limitation of the microfluidic device.
In the Applicant’s arguments on page 7, the Applicant argues that Han fails to teach the limitation “the protrusion has a size that allows a channel to be formed between the protrusion and the inner wall of the connection channel”. The Examiner respectfully disagrees. The Examiner interprets this channel as the space area between the plurality of micropillars as seen in the birds eye view of Figure 5.
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 Austin Q Le whose telephone number is (571)272-7556. The examiner can normally be reached Monday - Friday 9am - 5pm.
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/A.Q.L./Examiner, Art Unit 1796
/MATTHEW D KRCHA/Primary Examiner, Art Unit 1796
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