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 8/24/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Status
Claims 1-7 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 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Watanabe (JP 2017067620 A; hereinafter “Watanabe”; already of record on IDS filed on 8/24/2023; English translation attached) in view of Han et al (US 20210221676 A1; hereinafter “Han”). Regarding claim 1, Watanabe 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 (Watanabe; Abstract; page 5, para [1]), the microchannel device comprising:
an opening that receives the test solution (Watanabe; Fig. 3; page 3, para [2]; one inlet 10 a);
a main channel that communicates with the opening (Watanabe; Fig. 3, 6; page 4, para [5]; the first substrate SUB1 is poured into the mold and cured. Thereafter, the cured silicone rubber is removed from the mold, thereby having a rectangular planar shape in which the flow path 10 including the neck portion 10d and the narrowed portion 10e, the inlet port 10a, and the outlet port 10b are formed on one surface; the main channel is interpreted as the flow paths formed within the first substrate);
a plurality of microchannels that each communicate with the main channel (Watanabe; Fig. 3, 5; page 4, para [2]; the two flow paths 10 has an upstream side (inlet 10a side) adjacent to the narrowed part 10e and a downstream side adjacent to the narrowed part 10e); and
a collection portion that is provided in the main channel at an outlet-side end (Watanabe; Image 1), the outlet-side end being located opposite to an inlet-side end communicating with the opening (Watanabe; Fig. 3, 4), the collection portion partly collecting the test solution (Watanabe; page 3, para [4]; the actual reaction is caused by contact of the test solution with the medicine or the like disposed in the discharge port 10b), wherein the collection portion includes
a pool that stores the test solution discharged from the main channel (Watanabe; Image 1),
a connection channel that connects the pool with the outlet-side end (Watanabe; Image 1).
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Image 1. Annotated Figure 3 of Watanabe.
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 Watanabe 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.
Watanabe does not each the collection portion including 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.
However, Han teaches an analogous art of a microfluidic device (Han; Abstract) comprising a collection portion (Han; Fig. 5; examiner interprets the portion right of the upstream channel to be the collection portion) including 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]; micropillars 80 which extend from the sloped ceiling 76 at least partially towards the floor 54 of sloped chamber 68). 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. The microchannel device disclosed by Watanabe 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 generating air bubbles. Further, it would have been obvious to one ordinary skill in the art before the effective filing date to have modified the collection portion of Watanabe to comprise the protrusion as taught by Han, because Han teaches the protrusions redirect air bubbles (Han; para [6]).
Regarding claim 2, modified Watanabe teaches the microchannel device according to claim 1, with the connection channel.
Modified Watanabe does not teach 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.
However, Han teaches an analogous art of a microfluidic device (Han; Abstract) comprising an opening (Han; Fig. 5; para [43]; first fluid inlet 60); a main channel that communicates with the opening (Han; Fig. 5; para [43]; Upstream channel 66 may extend from the fluid inlets 60, 62); and 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). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to substitute the connection channel of Watanabe to comprise the sloped ceiling as taught by Han as this is a known and suitable substitution for microfluidic channels in the art. Further, it is a matter of engineering design to change the ----connection channel in different ways, where the change in form or shape, without any new or unexpected result, is an obvious engineering design. See In re Dailey, 149 USPQ 47 (CCPA 1966) (see MPEP § 2144.04). Finally, one would have a reasonable expectation of success by substituting the connection channel of Watanabe to comprise the sloped ceiling as taught by Han, because Han teaches this substitution is a known and suitable substitution in the art. The simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, B).
Regarding claim 3, modified Watanabe teaches the microchannel device according to claim 2 (the connection portion of modified Watanabe is modified to comprise the ramps/inclined channel as taught by Han discussed above in claim 2), wherein, of wall surfaces that form channels, a surface that faces a surface provided with the opening is flat (Watanabe; Fig. 2). Sub2 is flat as seen in Fig 2.
Regarding claim 4, modified Watanabe teaches the microchannel device according to claim 2 (the connection portion of modified Watanabe is modified to comprise the ramps/inclined channel as taught by Han discussed above in 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). The examiner notes that the modification is applied to the connection portion which comprised by sub2 seen in Fig. 2, thus the inclined surface would be on the side of the opening.
Regarding claim 5, modified Watanabe teaches the microchannel device according to claim 2 (the connection portion of modified Watanabe is modified to comprise the ramps/inclined channel as taught by Han discussed above in 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 Watanabe teaches the microchannel device according to claim 1, wherein the protrusion has a shape tapered toward the outlet-side end. Modified Watanabe discloses the claimed invention except for the tapered shape. 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 Watanabe 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 (Watanabe; Image 1). The connection channel is depicted in Image 1, and the channel is tapered towards the opening with an angle less than 180 degrees as seen above.
Conclusion
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