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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-14 and 16 in the reply filed on 07/10/2050 is acknowledged.
Claim 15 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/10/2025.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/12/2022 and 08/05/2025 is being considered by the examiner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description:
Reference character “18” in Fig. 1.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 3 and 9-12 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 3 recites the broad recitation “an outlet channel” in line 3, and the claim also recites “preferably having an elongation perpendicular to an elongation of the first capillary flow channel” in lines 3-4, which is the narrower statement of the range/limitation. Claim 3 further recites the broad recitation “an inlet channel” in line 6, and the claim also recites “preferably having an elongation perpendicular to an elongation of the second capillary flow channel” in lines 6-7, which is the narrower statement of the range/limitation. The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. For the purpose of examination, the narrower statements of the limitations are considered to be merely exemplary and therefore not required.
Claims 9-12 are indefinite because of their dependence on claim 3.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-5, 7-10, 13-14 and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schwalbe (US 6537506 B1).
Regarding claim 1, Schwalbe teaches a microfluidic arrangement (170)(Figs. 17, 18A, 18C) for capillary driven fluidic connection between capillary flow channels, the microfluidic arrangement comprising:
a first microfluidic system (plates 10, 20, 30 and 40) comprising a first surface (the bottom surface of plate 40), and a first capillary flow channel (37 in plate 30)(Fig. 3 and Fig. 18A), wherein the first capillary flow channel has an elongation in a first plane (the plane where plate 30 lies)(Fig. 3), and the first surface (the bottom surface of plate 40) comprises an outlet opening (the bottom opening of the 47 that corresponds to 57c, see annotated Fig. A)(each opening 47 is conduit that has an top opening at the top surface of plate 40 and a bottom opening at the bottom surface of plate 40. The thickness of plate 40 is the length of the conduit) in a plane (the plane where plate 40 lies) different from the first plane (Fig. 18A), the outlet opening defining an outlet area (the area of the outlet opening) in the first surface (the outlet opening is at the bottom surface of plate 40) and being adapted to allow fluidic communication with the first capillary flow channel (Fig. 18A and col. 13 lns. 47, Reactant B flows from 37 to openings 47) thereby forming a flow outlet (the outlet area as defined above) of the first capillary flow channel (Fig. 18A), and a second microfluidic system (plates of 50, 60, 70 and 80) comprising a second surface (the top surface of plate 50) and a second capillary flow channel (75 and 77 in plate 70), wherein the second capillary flow channel has an elongation ((Fig. 7) in a second plane (the plane where plate 70 lies) parallel to the first plane (the plane where layer 30 layers)(Fig. 17), and a portion of the second surface (the top surface of layer 50) comprises an inlet opening (the top opening of 57c; Figs. 5, 20 and 21)(Fig. 21, 57c is a conduit that has an top opening at the top surface of plate 50 and a bottom opening at the bottom surface of plate 50) in a plane (the plane where plate 50 lies) different from the second plane (the plane where plate 70 lies), the inlet opening defining an inlet area (the area of the inlet opening. See annotated Fig. A) in the second surface (top surface of layer 50) and being adapted to allow fluidic communication with the second capillary flow channel (Fig. 20) thereby forming a flow inlet (the inlet area as defined above) of the second capillary flow channel (Figs. 18A, 18C and 20), wherein the first microfluidic system and the second microfluidic system are arranged with the first and the second surfaces (Fig. 18A and abstract, bottom surface of 40 and top surface of 50 are in contact) in contact such that the flow outlet (the outlet area) and the flow inlet (the outlet area) are interfaced (Fig. 18A, annotated Fig. A and col. 14, lns 7-21), thereby allowing capillary driven fluidic connection between the first and the second capillary flow channels (interpreted as intended use. Fig. 18A and col. 14, lns. 7-21), wherein the outlet area (the area of the bottom opening of the 47 that corresponds to 57c) overlaps at least a portion of the inlet area (the area of the top opening of the 57c), said at least a portion of the inlet area overlapped by the outlet area being smaller than the outlet area (Figs. 4 and 5 and col. 14, lns. 9-16, see also annotated Fig. A).
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Figure A. Annotated Figs. 4 and 5 of Schwalbe.
Regarding claim 2, Schwalbe teaches all of the elements of the current invention as stated above with respect to claim 1. Schwalbe further teaches wherein the inlet area has a cross-sectional area (the cross-sectional area of the opening 57c is the same as the inlet area) being smaller than the outlet area (see annotated Fig. A).
Regarding claim 3, Schwalbe teaches all of the elements of the current invention as stated above with respect to claim 1. Schwalbe further teaches wherein the outlet opening (the bottom opening of the 47 that corresponds to 57c) is adapted to allow fluidic communication with the first capillary flow channel via an outlet channel (the 47 that corresponds to 57c, see annotated Fig. A; 47 has a thickness of the plate 40, which is the length of the channel)(Fig. 18A), preferably having an elongation perpendicular to an elongation of the first capillary flow channelpreferably having an elongation perpendicular to an elongation of the second capillary flow channel
Regarding claim 4, Schwalbe teaches all of the elements of the current invention as stated above with respect to claim 1. Schwalbe further teaches wherein the outlet opening (the bottom opening of the 47 that corresponds to 57c) has a cross-sectional area (the area of the outlet opening) corresponding to an outlet region (the portion of the 37 that interface with plate 40) of the first capillary flow channel (37)(Figs. 3, 4 18A and col. 21, lns. 7-14, reactant B flow 37 to 47. Please note that the description in col. 21, ln. 7 indicates “FIG. 18B”, which is interpreted as a typo because the description matches Fig. 18A), and the inlet opening (the top opening of 57c) has a cross-sectional area (the area of the inlet opening) corresponding to an inlet region (the opening of 75 at the top surface of plate 70) of the second capillary flow channel (75 and 77)(Figs. 20 and 21).
Regarding claim 5, Schwalbe teaches all of the elements of the current invention as stated above with respect to claim 1. Schwalbe further teaches wherein the second microfluidic system (50, 60, 70 and 80) comprises a stack of layers comprising a first layer (80) and a second layer (50), and a spacer layer (70) between the first and the second layers (Fig. 18C), wherein the second layer comprises the second surface (the top surface of 50), and a through-hole (57c)(Figs. 20 and 21) comprising the inlet opening (the top opening of 57c), and is arranged to provide fluidic communication between the inlet opening and the second capillary flow channel (75 and 77)(Figs. 20 and 21), the spacer layer has an elongated cut-out (75 and 77, the cut-out defines the channel as specifies later in the claim) extending (Fig. 20) in the second plane (layer 70) and parallel to the spacer layer (Fig. 20), which elongated cut-out together with adjacent layers of the stack of layers is arranged to define the second capillary flow channel (Fig. 20).
Regarding claim 7, Schwalbe teaches all of the elements of the current invention as stated above with respect to claim 5. Schwalbe further teaches microfluidic arrangement further comprising a third layer (60) of the stack of layers arranged between the second layer and the spacer layer (Fig. 20), wherein the third layer comprises a through-hole (65) arranged to allow fluidic communication between the second layer and the spacer layer (Fig. 20).
Regarding claim 8, Schwalbe teaches all of the elements of the current invention as stated above with respect to claim 1. Schwalbe further teaches wherein the first microfluidic system (10, 20, 30 and 40) comprises a stack of layers comprising a first layer (10 or 20) and a second layer (40), and a spacer layer between the first and the second layer, wherein the second layer (40) comprises the first surface (the bottom surface of plate 40), and a through-hole comprising the outlet opening (the opening of one of the 47 at the bottom surface of 40), and is arranged to provide fluidic communication between the outlet opening and the first capillary flow channel (37)(Figs, 3, 4 and 18A), the spacer layer has an elongated cut-out (37) extending in the first plane (plane where plate 30 lies) and parallel to the spacer layer (30)(Fig. 18A), which elongated cut-out together with adjacent layers of the stack of layers is arranged to define the first capillary flow channel (Fig. 18A).
Regarding claim 9, Schwalbe teaches all of the elements of the current invention as stated above with respect to claim 3. Schwalbe further teach wherein a wall portion of the outlet channel (the 47 that corresponds to 57c, see annotated Fig. A; 47 has a thickness of the plate 40, which is the length of the channel) and/or a wall portion of the inlet channel (57c) is provided with hydrophilic property (col. 4, lns. 38-46, the plates comprises the outlet and inlet channels are made of glass, which is provided with hydrophilic property), thereby providing an effect on wetting properties of the flow outlet and/or the flow inlet (interpreted as an intended use. The outlet and inlet channels provided with hydrophilic property meet structural limitation of the intended use).
Regarding claim 10, Schwalbe teaches all of the elements of the current invention as stated above with respect to claim 9. Schwalbe further teaches, wherein the first microfluidic system and/or the second microfluidic system is manufactured from material providing or being modifiable to provide the hydrophilic property (col. 4, lns. 38-46, the plates are made of glass, which provides hydrophilic property).
Regarding claim 13, Schwalbe teaches all of the elements of the current invention as stated above with respect to claim 1. Schwalbe teaches wherein the first and/or second microfluidic system is manufactured from silicon, glass or polymer, or combinations thereof (col. 4, lns. 38-43).
Regarding claim 14, Schwalbe teaches all of the elements of the current invention as stated above with respect to claim 5. Schwalbe, wherein at least one of the layers of the stack of layers comprises material with capillary force enhancing properties in the second capillary flow channel, in particular the material comprises 2 (col. 4, lns. 38-43, the plates are made of glass, which comprises SiO2).
Regarding claim 16, Schwalbe teaches a device comprising the microfluidic arrangement according to claim 1 (see claim 1) for medical or diagnostic use (interpreted as intended use. The microfluidic arrangement meets the structural limitation of the intended use. Moreover, col. 2, lns. 27-28, the apparatus is intended for the pharmaceutical industry).
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 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Schwalbe (US 6537506 B1) in view of Steven (“Micelle-Mediated Chemistry in Water for the Synthesis of Drug Candidates.” Synthesis 2019; 51(13): 2632-2647) further in view of Taniguchi (JP 2017094270 A)(provided in Applicant’s IDS of 08/05/2025).
Regarding claim 11, Schwalbe teaches all of the elements of the current invention as stated above with respect to claim 10.
Schwalbe teaches a stacked plate chemical microreactor. Schwalbe teaches the microreactor comprises two capillary flow channels, an outlet channel and an inlet channel. Schwalbe teaches a microreactor with application in the pharmaceutical industry for carrying out chemical processes in drug searches (col. 2, lns. 27-31). Schwalbe further teaches a material of the microreactor is selected based on the material’s compatibility with the chemical process, and some of the materials includes glass and silicon (col. 4, lns. 39-46).
Schwalbe fails to explicitly teach wherein the wall portion of the outlet channel and/or the wall portion of the inlet channel is at least partially coated with or contacted with a hydrophilicity enhancing agent.
However, Steven teaches the use of aqueous medium by synthetic chemists working in the pharmaceutical industry to discover and develop drug candidates (p. 2632, abstract). Steven further teaches the benefit of using aqueous medium includes avoiding the need for organic solvent, and thus leads to savings with the purchase and disposal cost of organic solvents and reducing environment impact that is associated with the use of organic solvents (2nd paragraph on p. 2634). In addition, Taniguchi teaches an microfluidic apparatus for processing aqueous liquid sample (para. 0017). Taniguchi discloses the apparatus is made with silicon or glass (para. 0056). Taniguchi teaches the apparatus comprises flow path 122, and the inner wall of flow path 122 can be made hydrophilic by surface coating treatment, so that flow can improve (para. 0059). Taniguchi further discloses the surface coating treatment can be done using a hydrophilic polymer including PEG (para. 0059).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the glass-made wall portion of the outlet channel and the inlet channel taught by Schwalbe to be coated with PEG taught by Taniguchi in order to improve fluid flow of aqueous medium (Taniguchi, para. 0059), which is a more cost-efficient and environmental-friendly solvent for developing drug candidates as taught by Steven (Steven, abstract on p. 2632 and 2nd paragraph on p. 2634) with a reasonable expectation of success (Taniguchi, para. 0059 and Steven, abstract on p. 2632 and 2nd paragraph on p. 2634) (MPEP 2143)(I)(G).
Regarding claim 12, modified Schwalbe teaches all of the elements of the current invention as stated above with respect to claim 11. Modified Schwalbe further teaches wherein the hydrophilicity enhancing agent is selected from a group consisting of SiO2, surfactants, PEG, and PMOXA (Taniguchi, para. 0059, PEG).
Allowable Subject Matter
Claim 6 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
The closest prior art of record is considered to be Schwalbe.
Regarding claim 6, Schwalbe teaches a teaches a microfluidic arrangement for capillary driven fluidic connection between capillary flow channels as discussed above. Schwalbe teaches the microfluidic arrangement comprises a second microfluidic system (50, 60, 70 and 80) comprising a stack of layers comprising a first layer (80) and a second layer (50), and a spacer layer (70) between the first and the second layers (Fig. 18C), wherein the second layer comprises a second surface (the top surface of 50), and a through-hole (57c)(Figs. 20 and 21) comprising the inlet opening (the top opening of 57c). Schwalbe further the second layer further comprises a hole-member (the structure that comprises openings 57 in plate 50), wherein the hole-member comprises the through-hole (57c). However, the hole-member structure does not extend beyond plate 50 or occupy space of the adjacent plates, and thus the hole-member does not extend into and occupy the outlet opening or at least a portion of the cut-out of the spacer layer.
Leblanc (US 20120244043 A1) teaches a multilayer microfluidic device with a gasket layer (8C) that has a hole member that extend into and occupy the outlet opening and extend into and occupy opening of the inlet port adjacent layers (Fig. 9). However, the gasket is purposed for providing sealing of the inlet port and receiving a pipette tip. Therefore, it would not have been obvious to modify the hole-member taught by Schwalbe with the hole-member structure taught by Leblanc to arrive at the claimed features.
Therefore, the combination of features is considered to be allowable.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAY CHIU whose telephone number is (571)272-1054. The examiner can normally be reached 9 am - 5 pm.
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/M.L.C./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758