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 .
Claim Objections
Claim 1 is objected to because of the following informalities: the term “among the first base, second base and third base” is suggested to be revised to “among the first base, the second base, and the third base” for readability and consistency in the claim. Appropriate correction is required.
Response to Amendment
The amendments filed 19 DECEMBER 2025 have been entered. Claims 1 – 3 and 5 – 16 are pending. Applicant’s amendments to the Specification have overcome each and every objection to the drawings, specification, and claims previously applied in the office action dated 01 OCTOBER 2025. Applicant’s amendments to the claims have overcome each and every rejection to the claims under 35 U.S.C. 112 previously applied in the office action dated 01 OCTOBER 2025
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.
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, 3, 5 – 7, and 10 - 16 are rejected under 35 U.S.C. 103 as being unpatentable over Park et. al., (US 2005/0230767 A1), in view of Francis et. al., (“Digital nanoliter to milliliter flow rate sensor with in vivo demonstration for continuous sweat rate measurement”), further in view of O’Connor, et. al., (US 2002/0187074 A1).
Regarding Claim 1, Park discloses A biosensor ([Abstract]) comprising:
a first specimen inlet ([0037] “inlet port 122”; Fig 1) configured to provide a space through which a specimen flows inside ([0018] “inlet port in fluid communication with the inlet reservoir”, “permitting introduction of fluid to the system”);
an electrode element ([0037] “a plurality of electrodes 104”)
a chamber ([0037] “microchannel 116 connecting reservoirs 112 and 114 to one another. Microchannel 116 is situated directly over at least one of electrodes 104”; Fig 1) configured to provide a space in which an electrochemical reaction of the flowing-in specimen occurs ([0071] “complex biological experiments and biomolecular reactions within a microchannel…microchannel 116”; [0037] “over electrodes 104”)(Examiner notes that the electrodes within the chamber formed by the microchannel over the electrodes would measure electrochemical signals related to the ”biomolecular reactions”); and
a first specimen outlet ([0037] “an outlet port 124”; Fig 1) configured to provide a space through which the flowing- in specimen flows outside (([0018] “outlet port in fluid communication with the outlet reservoir”, “removal of fluid from the system”);
the biosensor has a stacked structure (Fig 1) including:
a first base (Fig 1, “Encapsulation membrane 118”);
a second base formed on the first base (Fig 1, “Patterned structure 106” shown below “Encapsulation membrane 118”); and
a third base formed on the second base (Fig 1, “Substrate 102” shown below “Patterned structure 106”);
Park does not disclose configured to measure an electromechanical signal of the flowing-in specimen; and wherein a moisture absorber is disposed in the chamber, wherein the moisture absorber is arranged to correspond to the chamber, wherein the first specimen inlet and the first specimen outlet are disposed in different bases among the first base, second base and third base.
Francis teaches a microfluidic flow rate sensor for sweat rate measurement, including a layered structure with a electrodes placed relative to a chamber, and a wicking absorbent portion to promote fluid flow in the device. Specifically for Claim 1, Francis teaches an electrode element configured to measure an electromechanical signal of the flowing-in specimen (Fig 1, “gold electrode” at the entrance to the chamber and “mesh electrode” at the base of the chamber; [Page 179, Left Column] “The droplet grows until it eventually shorts two electrodes before breaking onto a wick…droplet volume is fixed by the chamber height (h), the droplet frequency directly measures the flow rate”); and wherein a moisture absorber is disposed in the chamber (Fig 1, “wick” layer with “mesh electrode”; [Page 180, Left Column, Top] “droplet breaking onto the mesh electrode and Rayon wick”)(Examiner notes that the “wick” in the chamber is a moisture absorber, per Merriam-Webster, wick is defined as “to absorb or drain (a fluid, moisture, etc.) like a wick”), wherein the moisture absorber is arranged to correspond to the chamber (Fig 1, “wick” layer with “mesh electrode”; [Page 180, Left Column, Top] “droplet breaking onto the mesh electrode and Rayon wick”)(Examiner notes that these elements are arranged at the top part of the chamber in Fig 1, or broadly, corresponding to the chamber.)
For the electrode measurement of an electromechanical signal, Francis provides a motivation to combine at [Page 178] “Left Column Paragraph 2] with “The sweat rate, for example, is an important parameter to measure in wearable sweat biosensing especially for the diagnosis and assessment of hyperhidrosis”. A person having ordinary skill in the art before the effective filing data of the claimed invention would recognize that being able to measure a rate of fluid from a subject would be important for diagnosis and assessment of conditions regarding the rate of loss of fluids and analytes measured by the device (for Francis, liquid and analytes associated with sweat). It would have been predictable to use the electrodes placed between layers, one at the inlet of the chamber, and one at the other side to measure fluid flow rate, as taught by Francis, in any similar layered microfluid device with an inlet, chamber, and electrodes, as it would continue to operate with the function of measuring the electromechanical signal of flow rate.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the microfluidic biomeasurement device with layered bases and a chamber with an inlet disclosed in Park with Francis’ taught electrodes around a chamber to measure fluid flow rate, creating a single microfluidic biomeasurement device that can determine fluid flow rates through the device for additional useful diagnostic information for evaluating fluid and analyte-related conditions.
For the moisture absorbed disposed in the chamber of a rayon wick and mesh electrode, Francis provides a motivation to combine at [Page 179, Left Column] with “The droplet grows until it eventually shorts two electrodes before breaking onto a wick.” and “…simplicity in fabrication, and rectifying flow rate (i.e. no backflow)”. A person having ordinary skill in the art before the effective filing data of the claimed invention would recognize that including an absorbent member in the chamber would assist in directing fluid flow one direction into the chamber as well as assist with flow rate measurement at electrodes. It would have been predictable to use absorbent wick material in the chamber as taught by Francis, in any similar layered microfluid device with an inlet and chamber as it would continue to operate with the function of absorbing and directing liquid flowing into a chamber
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the microfluidic biomeasurement device with layered bases and a chamber disclosed in Park with the absorbent wick inside a microfluidic device chamber taught by Francis, creating a microfluidic biomeasurement device that can absorb liquid across its measurement chamber with a wicking material to better direct the fluid flow through the device.
Francis does not specifically disclose wherein the first specimen inlet and the first specimen outlet are disposed in different bases among the first base, second base and third base.
O’Connor teaches wherein the first specimen inlet (Fig 5A; [0085] “Inlet port 56”) and the first specimen outlet ([0085] “via 62”) are disposed in different bases among the first base (Fig 5A; [0085] “Inlet port 56”), second base, and third base (Fig 5A, “via 62” on “third layer 53”; [0085] The channel 63 may also be enlarged at the inlet side to mate with the via 62”)(Examiner notes that the “via” is a relative outlet for the fluid from one layer to another.)
O’Connor provides a motivation to combine at [0008] – [0009] with “provide a microfluidic mixer that could rapidly mix fluid streams without moving parts, in a minimal space”. A person having ordinary skill in the art before the effective filing data of the claimed invention would recognize that having an outlet in the third base would permit fluid to exit the chamber to be used for additional mixing in another layer or for other further processing downstream.
It has been held that rearranging parts of an invention involves only routine skill in the art MPEP 2144.04 VI. (C). Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the microfluidic biomeasurement device with layered bases disclosed in Park with the outlet in the third base layer taught by O’Connor, creating a single microfluidic biomeasurement device that permits fluid flow out of the chamber through the third layer.
Regarding Claim 3, Park in view of Francis, further in view of O’Connor discloses as described above, The biosensor of claim 1. For the remainder of Claim 3, Park discloses wherein a height of the chamber is 50 to 1,000 µm ([0037] “microchannel 116; [0157] “Channel size may be controlled over a broad range, and may be maintained uniform or varied, e.g., 30 microns to 750 microns”)
Regarding Claim 5, Park in view of Francis, further in view of O’Connor discloses as described above, The biosensor of claim 1. For the remainder of Claim 5, Park discloses wherein the first specimen inlet is disposed in the first base (Fig 1 “inlet port 122” in “Encapsulation membrane 118”).
Regarding Claim 6, Park in view of Francis, further in view of O’Connor discloses as described above, The biosensor of claim 5. For the remainder of Claim 6, Park does not specifically disclose wherein a width of the first specimen inlet is 100 to 1,000 µm.
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Figure A: Examiner-annotated version of Francis Fig 1(a) showing base layers for Claim 5
Francis teaches wherein a width of the first specimen inlet is 100 to 1,000 µm (Figure 1(a) and Figure A: Examiner annotated version, gap in the “acrylic” layer that is the “inlet” from the bottom sweat collecting layer to the adhesive layer; [Page 181; “Fabrication” Section Paragraph 1] “an acrylic sheet (1.5 mm thick) laser-cut into a rectangle (25 × 29 mm) with a 0.79 mm diameter hole in the center.”)(Examiner notes from Examiner-annotated Figure A that the first base for Francis can be the “sweat collector” including the “acrylic” layer as part of this base, and the second base can be the “adhesive layer” with the chamber. Therefore, the inlet is disposed in the first base as the hole in the acrylic to the second base chamber.)
Park discloses at [0055] that “Microchannel dimensions for microfluidics are typically in the range of 10 to 500 microns in width and depth”, and the microchannel size specifically taught by Francis (790 microns) is within that range. A person having ordinary skill in the art before the effective filing data of the claimed invention would recognize that this diameter of inlet would allow for capillary flow through the device, as confirmed at [Francis: Page 179, “DVDS: design and theory” section] “2) forming a capillary bridge…”, which is useful for maintaining flow and obtaining measurements with a microfluidic device.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the microfluidic biomeasurement device with layered bases and a chamber with an inlet disclosed by Park with the specifically 790 micron diameter inlet taught by Francis, creating a single microfluidic biomeasurement device with an appropriately-sized channel to facilitate microfluidic fluid-flow.
Regarding Claim 7, Park in view of Francis, further in view of O’Connor discloses as described above, The biosensor of claim 1. For the remainder of Claim 7, Park discloses wherein the chamber is disposed in the second base (Fig 1, “microchannel 116” and “reservoirs 112 and 114” located within “Patterned structure 106” ([0037] “microchannel 116 connecting reservoirs 112 and 114 to one another.”
Regarding Claim 10, Park in view of Francis, further in view of O’Connor discloses as described above, The biosensor of claim 7. For the remainder of Claim 10, Park discloses wherein the chamber ([0037] “microchannel 116 connecting reservoirs 112 and 114 to one another.”; [0017] “complex biological experiments and biomolecular reactions within a microchannel” is directly connected to the first specimen inlet (Fig 1, [0037] “an inlet port 122 and an outlet port 124 aligned directly over first reservoir 112 and second reservoir 114”)(Examiner notes that the chamber does not have a fluid break in connection between it and the first specimen inlet.)
Regarding Claim 11, Park in view of Francis, further in view of O’Connor discloses as described above, The biosensor of claim 1. For the remainder of Claim 11, Park does not disclose wherein the electrode element is disposed between the first base and the second base.
Francis teaches wherein the electrode element is disposed between the first base and the second base (Fig. 1, “gold electrode” between the inlet layer of the “sweat collector” and the “adhesive layer” that contains the chamber)
Francis provides a motivation to combine at [Page 179, Left Column] with “…droplet forms in the chamber. The droplet grows until it eventually shorts two electrodes before breaking onto a wick. Since the droplet volume is fixed by the chamber height (h), the droplet frequency directly measures the flow rate.” A person having ordinary skill in the art before the effective filing data of the claimed invention would recognize that placing the electrodes between the first base with the inlet and the second base with the chamber would be useful for positioning the electrodes to measure flow rate across them as the fluid enters the chamber (shorting them). It would have been predictable to use the electrodes placed between layers, one at the inlet of the chamber, and one at the other side to measure fluid flow rate, as taught by Francis, in any similar layered microfluid device with an inlet, chamber, and electrodes, as it would continue to operate with the function of measuring the electromechanical signal of flow rate.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the microfluidic biomeasurement device with layered bases and a chamber with an inlet disclosed in Park with Francis’ taught electrodes between layers of an inlet and a chamber to measure fluid flow rate, creating a single microfluidic biomeasurement device that can determine fluid flow rates through the device for additional useful diagnostic information for evaluating fluid and analyte-related conditions.
Regarding Claim 12, Park in view of Francis, further in view of O’Connor discloses as described above, The biosensor of claim 1. For the remainder of Claim 12, Park discloses wherein the first base (Fig 1, “encapsulation layer 118”) each independently include one or more materials selected from a group of glass ([0064] “surface(s) of PDMS of encapsulation layer 118….SiOH groups on the PDMS surface for adding other functional groups…glass…encapsulating the channel”; Fig 1), polyethersulfone (PES), poly methyl methacrylate (PMMA), polycarbonate (PC), polyethylene (PE) ([0064] “surface(s) of PDMS of encapsulation layer 118….SiOH groups on the PDMS surface for adding other functional groups…polyethylene…encapsulating the channel”; Fig 1), polyethylene naphthalate (PEN), polyphenylene sulfide (PPS), polypropylene (PP), triacetyl cellulose (TAC), cellulose acetate propionate (CAP), polyethylene terephthalate (PET), polyimide (PI), polyetherimide (PEI), polyamide (PA), cyclo olefin polymer (COP), cyclo olefin copolymer (COC), PMMA/PC copolymer, and PMMA/PC/PMMA copolymer.
Park does not specifically disclose and the second base each independently include one or more kinds selected from a group of glass, polyethersulfone (PES), poly methyl methacrylate (PMMA), polycarbonate (PC), polyethylene (PE), polyethylene naphthalate (PEN), polyphenylene sulfide (PPS), polypropylene (PP), triacetyl cellulose (TAC), cellulose acetate propionate (CAP), polyethylene terephthalate (PET), polyimide (PI), polyetherimide (PEI), polyamide (PA), cyclo olefin polymer (COP), cyclo olefin copolymer (COC), PMMA/PC copolymer, and PMMA/PC/PMMA copolymer.
Francis teaches and the second base each independently include one or more kinds selected from a group of glass, polyethersulfone (PES), poly methyl methacrylate (PMMA), polycarbonate (PC), polyethylene (PE), polyethylene naphthalate (PEN), polyphenylene sulfide (PPS), polypropylene (PP), triacetyl cellulose (TAC), cellulose acetate propionate (CAP), polyethylene terephthalate (PET) (Figure 1 (a), “adhesive” layer; [Page 180, 1st Full Paragraph] “the chamber height (h) is made by layers of double-sided adhesive and PET films”)(Examiner notes that the second base includes the chamber, which is the case for Francis’ taught “adhesive layer”), polyimide (PI), polyetherimide (PEI), polyamide (PA), cyclo olefin polymer (COP), cyclo olefin copolymer (COC), PMMA/PC copolymer, and PMMA/PC/PMMA copolymer.
Francis provides a motivation to combine at [Page 181, Left Column, 1st Full Paragraph] with “Different height (h) could be constructed by stacking additional film/tape on top or removing layers in different configurations to get the desired thickness.” A person having ordinary skill in the art before the effective filing data of the claimed invention would recognize that using double sided adhesive that is on a PET film would allow for tunable thicknesses of the chamber in its associated base, which would be useful for design and fabrication and potentially specializing the device for particular applications and fluids. It would have been predictable to use the layered adhesive PET material taught by Francis for any similar microfluid device chamber-associated base, as it would continue to operate with the function of constructing a chamber for a microfluid device.
It has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. MPEP 2144.07. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine Park’ disclosed the layered-based microfluidic biomeasurement device with chamber in a layer, with the layered double-sided adhesive PET films to make a chamber section taught by Francis, creating a microfluidic biomeasurement device with a chamber in it, such that the chamber height can be tuned in fabrication using more or less layers of the PET film.
Regarding Claim 13, Park in view of Francis, further in view of O’Connor discloses as described above, The biosensor of claim 1. For the remainder of Claim 13, Park does not disclose wherein the second base is made of a PSA (pressure sensitive adhesive) compound or an OCA (optical clear adhesive) compound.
Francis teaches wherein the second base is made of a PSA (pressure sensitive adhesive) compound (Figure 1 (a), “adhesive” layer; [Page 180, 1st Full Paragraph] “the chamber height (h) is made by layers of
double-sided adhesive and PET films”; The chamber consists of laminated sheets of 5 mil (0.127 mm) PET, 3M 1522 adhesive”)(Examiner notes that 3M 1522 adhesive is a double-sided pressure-sensitive adhesive medical tape.) or an OCA (optical clear adhesive) compound.
The motivation for Claim 13 to combine Park and Francis is similar to that described in more detail in Claim 12. In summary, it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. MPEP 2144.07. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine Park’ disclosed the layered-based microfluidic biomeasurement device with chamber in a layer, with the layered double-sided adhesive PET films to make a chamber section taught by Francis, creating a microfluidic biomeasurement device with a chamber in it, such that the chamber height can be tuned in fabrication using more or less layers of the PET film.
Regarding Claim 14, Park in view of Francis, further in view of O’Connor discloses as described above, The biosensor of claim 1. For the remainder of Claim 14, Park does not disclose a fourth base formed under the first base , wherein the fourth base has a third specimen inlet.
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Figure B: Examiner-Annotated version of Francis Fig 1(a), showing base layers for Claim 14
Francis teaches a fourth base (Fig 1, “acrylic”, where first base: “sweat collector”, second base: “adhesive” layer, and third base: “wick” layer) formed under the first base (Fig 1, “acrylic” relative to the “sweat collector” first base)(Examiner notes that the “acrylic layer” is under the first base if the frame of reference is that the “Base 1” side (of Examiner-annotated Fig B) is the “top” that is “above” all of the other layers.), wherein the fourth base has a third specimen inlet (Fig 1, “acrylic layer” has a hole through it, creating at a third specimen inlet that is in the fourth base into the “adhesive layer” chamber of the second base).
Francis provides a motivation to combine at [Page 181, Left Column, 1st Full Paragraph] with “The DVDS fabrication starts with an acrylic sheet (1.5 mm thick) laser-cut into a rectangle”. A person having ordinary skill in the art before the effective filing data of the claimed invention would recognize that starting with the acrylic sheet as a layer gives a rigid substrate onto which the electrode can be applied on one side and the double-sided adhesive PET film layers to construct the chamber-associated base on the other side, which is useful for consistent fabrication and dimension tolerancing.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the microfluidic biomeasurement device with layered bases disclosed in Park with the fourth base with an inlet taught by Francis, creating a single four-layered microfluidic biomeasurement device of consistent fabrication quality.
Regarding Claim 15, Park in view of Francis, further in view of O’Connor discloses as described above, The biosensor of claim 1. For the remainder of Claim 15, Park does not disclose wherein the first specimen outlet is disposed in the third base.
O’Connor teaches wherein the first specimen outlet ([0085] “via 62”) is disposed in the third base (Fig 5A, “via 62” on “third layer 53”; [0085] The channel 63 may also be enlarged at the inlet side to mate with the via 62”)(Examiner notes that the “via” is an outlet for the fluid.)
The motivation to combine Park and O’Connor in Claim 15 is the same as that described in more detail in Claim 1. In summary, it has been held that rearranging parts of an invention involves only routine skill in the art MPEP 2144.04 VI. (C). Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the microfluidic biomeasurement device with layered bases disclosed in Park with the outlet in the third base layer taught by O’Connor, creating a single microfluidic biomeasurement device that permits fluid flow out of the chamber through the third layer.
Regarding Claim 16, Park in view of Francis, further in view of O’Connor discloses as described above, The biosensor of claim 15. For the remainder of Claim 16, Park does not specifically disclose wherein a width of the first specimen outlet is 100 to 1,000µm. Park does broadly disclose at [0055] that “Microchannel dimensions for microfluidics are typically in the range of 10 to 500 microns in width and depth.”
O’Connor teaches wherein a width of the first specimen outlet is 100 to 1,000µm ([0034] “term “channel” or “chamber” as used herein is to be interpreted in a broad sense…cavities or tunnels of any desired shape or configuration through which liquids may be directed.”; [0034] “’microfluidic’…structures or devices through which fluid(s) are capable of being passed or directed, wherein one or more of the dimensions is less than 500 microns.”)(Examiner notes that the via is a channel outlet for liquid to pass through.)
Park discloses at [0055] that “Microchannel dimensions for microfluidics are typically in the range of 10 to 500 microns in width and depth”, and the fluid path size specifically taught by O’Connor (500 microns) is within that range. A person having ordinary skill in the art before the effective filing data of the claimed invention would recognize that this diameter of inlet would allow for capillary flow through the device, as confirmed at [Francis: [0034] “’microfluidic’” structures…through which fluid(s) are capable of being passed or directed, wherein one of more of the dimensions is less than 500 microns”), which is useful for maintaining flow and obtaining measurements with a microfluidic device.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the microfluidic biomeasurement device with layered bases and a chamber with an inlet disclosed by Park with the specifically 500 micron diameter outlet taught by O’Connor, creating a single microfluidic biomeasurement device with an appropriately-sized channel to facilitate microfluidic fluid-flow.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Park et. al., (US 2005/0230767 A1), in view of Francis et. al., (“Digital nanoliter to milliliter flow rate sensor with in vivo demonstration for continuous sweat rate measurement”), and O’Connor, et. al., (US 2002/0187074 A1), further in view of Kalish et. al. (“Modifying Wicking Speeds in Paper-Based Microfluidic Devices by Laser-Etching,”), as evidenced by Lindsay ( “Relative Flow Porosity in Paper”).
Regarding Claim 2, Park in view of Francis, further in view of O’Connor discloses as described above, The biosensor of claim 1. For the remainder of Claim 2, Park in view of Francis discloses the moisture absorber (Francis: Fig 1, “wick” layer with “mesh electrode”; [Page 180, Left Column, Top] “droplet breaking onto the mesh electrode and Rayon wick”)(Examiner notes that rayon is a cellulose-based material)
Park in view of Francis does not specifically disclose wherein the moisture absorber has a porosity of 0.5 to 0.8 that is calculated by following Equation 1
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, in the Equation 1, ε is a porosity of the moisture absorber,
b
w
0
is basis weight (kg/in2) of the moisture,
ρ
c
e
l
is density of cellulose (kg/in3) of the moisture absorber, and
τ
p
ε
is a thickness (in) of the moisture absorber. Park in view of Francis does broadly disclose [Page 180, Left Column, Top] “Rayon wick”, where Rayon is a cellulose-based material.
Kalish teaches microfluidics devices which use paper as a wicking absorbent material to delivery liquids to reaction zones of the device. Specifically for claim 2, Kalish teaches wherein the moisture absorber ([Page 1, “1. Introduction” Section, Paragraph 1] “Paper-based microfluidic devices”; [Page 16, Paragraph under Equation A1] “cellulose paper is a fully wetting material”) has a porosity of 0.5 to 0.8 ([Page 16, Paragraph underneath equation (A1)] “the porosity,φ, is 0.706”)
Regarding the equation format by which porosity is calculated, Lindsay of the Institute of Paper Science and Technology evidentiarily teaches porosity that is calculated by following Equation 1 ([Page 950] Equation 10)
ε
=
b
w
0
ρ
c
e
l
τ
p
ε
([Page 950] Equation 10,
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)
in the Equation 1 ([Page 950] Equation 10), ε is a porosity of the moisture absorber ([Page 950, Paragraph 1] “sheet porosity”),
b
w
0
is basis weight (kg/in2) of the moisture absorber ([Page 950, Paragraph 1 below the equation] “BW is the sheet basis weight”),
ρ
c
e
l
is density of cellulose (kg/in3) of the moisture absorber ([Page 950, Paragraph 1 below the equation] “
ρ
c
is the matrix density (…the density of pure cellulose in filler-free sheets)”), and
τ
p
ε
is a thickness (in) of the moisture absorber ([Page 950, Paragraph 1 below the equation] “L is the sheet thickness”). Additionally, Lindsay teaches examples of cellulose paper moisture absorbers that have an porosity within the range of 0.5 – 0.8 at [Page 956] Fig 11, “Recycled fibers” for unbleached kraft sheets using this equation.
Kalish provides a motivation to combine at [Page 1, “1. Introduction” Section, Paragraph 1] “with “Paper is a lightweight, disposable, and widely abundant material that wicks liquid through channels without the need for external pumps.” A person having ordinary skill in the art before the effective filing data of the claimed invention would recognize that using a material with a porosity of 0.7 would allow for effective moisture absorbance in order to direct fluid flow in a particular direction toward reaction chambers/zones without needing an external pump.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the microfluidic biomeasurement device with an absorbent rayon (cellulose-based) wicking material in the chamber disclosed in Park in view of Francis with the cellulose paper absorbent material with porosity of 0.706 to direct fluid flow taught by Kalish, creating a single microfluidic biomeasurement device using cellulose paper to direct liquid flow to its reaction chamber without requiring an external pump.
Claims 8 – 9 are rejected under 35 U.S.C. 103 as being unpatentable over Park et. al., (US 2005/0230767 A1), in view of Francis et. al., (“Digital nanoliter to milliliter flow rate sensor with in vivo demonstration for continuous sweat rate measurement”), and O’Connor, et. al., (US 2002/0187074 A1), further in view of Zhang, et. al, (“Multilayer Microfluidic Electrokinetic Device with Vertical Embedded Electrodes--”).
Regarding Claim 8, Park in view of Francis, further in view of O’Connor discloses as described above, The biosensor of claim 7. For the remainder of Claim 8, Park discloses wherein the second base (Fig 1, “Patterned structure 106”) further includes:
a second specimen inlet (Fig 1, “reservoirs 112 and 114”) formed at a position corresponding to the first specimen inlet (Fig 1, [0037] “an inlet port 122 and an outlet port 124 aligned directly over first reservoir 112 and second reservoir 114”),and
Park does not specifically disclose a channel configured to guide the specimen flowing in the second specimen inlet to the chamber.
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Fig C: Examiner-Annotated Zhang Figure 1, showing channel, chamber, and inlet features
Zhang teaches a multi-layer microfluidic device that includes a microchannel in a layer to deliver fluid to a chamber with electrodes in it. Specifically for Claim 8, Zhang teaches a channel (Fig C: Examiner-annotated “Microchannel”, corresponds to [Page 3] “Figure 1: 4: cross microstructure”) configured to guide thr specimen flowing in the second specimen inlet (Fig C: Examiner-annotated “Inlet 2” in the second, lower base, aligned with the “inlet 1” in the top base) to the chamber (Fig C: Examiner-annotated “Microchannel”, corresponds to [Page 3] “Figure 1: 4: cross microstructure” provides a route to direct fluid to the area over Fig C: Examiner-annotated “Chamber”, which is the chamber over [Page 3] “Figure 1: 7: detected electrode array”).
Zhang and Park each disclose and teach microchannels for distributing fluid, as well as a chamber of fluid aligned on top of electrodes. Zhang provides a motivation to combine at [Page 3, “Experimental Section” Paragraph 1] with “The microchannel was 5 cm in length” and [Page 4, “Results and Discussion” Section Paragraph 1], “…the length of microchannel was 1 x 104 µm”. A person having ordinary skill in the art before the effective filing data of the claimed invention would recognize that adding a length of microchannel between an inlet and a desired measurement chamber would allow for enhanced and tunable distance across which fluid can be transported from inlet to chamber in a device.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the microfluidic biomeasurement device with layered bases disclosed in Park with the microchannel from inlet to chamber taught by Zhang, creating a single microfluidic biomeasurement device that permits fluid flow across a distance to reach a chamber for fluid analysis in a particular position.
Regarding Claim 9, Park in view of Francis and O’Connor, further in view of Zheng discloses as described above, The biosensor of claim 8. For the remainder of Claim 9, Park broadly discloses wherein a width of channel is 100 to 1,000 µm (([0037] “microchannel 116”; [0157] “Channel size may be controlled over a broad range, and may be maintained uniform or varied, e.g., 30 microns to 750 microns”). Park alone does not specifically disclose the microchannel that extends to the chamber.
Regarding the channel from the combination of Park and Zheng that teaches the microchannel to the chamber (as described above in Claim 8), Zheng also teaches wherein a width of the channel is 100 to 1,000 µm ([Page 3, “Experimental Section” Paragraph 1] “The microchannel was…200 µm in width and 500 µm in height.”)
Park discloses at [0055] that “Microchannel dimensions for microfluidics are typically in the range of 10 to 500 microns in width and depth”, and the microchannel size specifically taught by Zhang (200 x 500 microns) is within that range. A person having ordinary skill in the art before the effective filing data of the claimed invention would recognize that this diameter of inlet would allow for capillary flow through the device, which is useful for maintaining flow and obtaining measurements with a microfluidic device.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the microfluidic biomeasurement device with layered bases disclosed in Park with 200 µm x 500 µm dimensioned microchannel taught by Zhang creating a single microfluidic biomeasurement device with an appropriately-sized channel to facilitate microfluidic fluid-flow.
Response to Arguments
Applicant's arguments filed 19 DECEMBER 2025 have been fully considered but they are not persuasive.
Regarding 35 U.S.C. 103 Rejections:
Applicant argues at [Page 9, “103 Rejection of the Claims” Section] – [Page 11, 1st Paragraph below box] that the main technical features of the present disclosure are the moisture absorber in the chamber to suppress production of bubbles in flow passage, promote smooth movement of the specimen, and shortening the measurement time and achieving improved detection accuracy. Applicant argues that Francis teaches a wicking layer that covers the chamber but is not disposed in the chamber. A wicking layer that “covers” a chamber and faces inward is broadly disposed in the chamber, as the moisture absorber elements of (Fig 1, “wick” layer with “mesh electrode”; [Page 180, Left Column, Top] “droplet breaking onto the mesh electrode and Rayon wick”) are pointed to the inside of the “chamber” of Francis Figure 1, to absorb liquid onto the mesh electrode. There is nothing particularly recited in the claim that asserts that every part of the moisture absorber is exposed inside the chamber, that the moisture absorber is aligned in the center relative to all walls of the chamber, or that the moisture absorber is not attached to a side of the chamber. The argument is not persuasive.
Applicant argues at [Page 11, bottom] – [Page 12, Top] that Francis’ disclosed purpose of the wicking layer is not to prevent production of bubbles, which is the objective of the moisture absorber of the present disclosure. The aspect of bubble prevention is not recited in the claim. Rather, the structure itself is recited. In response to applicant's argument that Francis’ disclosed purpose of the wicking layer is not to prevent production of bubbles, a recitation of the intended use 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. If the prior art structure is capable of performing the intended use, then it meets the claim. The argument is not persuasive.
Applicant argues at [Page 12, 1st Full Paragraph] – [Page 13, Top] that Francis does not disclose the technical feature of providing the wicking layer inside the chamber because the upper portion of the chamber uses adhesive to attach the wicking layer. Francis teaches that the moisture absorber elements of (Fig 1, “wick” layer with “mesh electrode”; [Page 180, Left Column, Top] “droplet breaking onto the mesh electrode and Rayon wick”) are pointed to the inside of the “chamber” of Francis Figure 1, to absorb liquid onto the mesh electrode. It is unclear how the presence of adhesive around the chamber to hold elements together is being argued to affect this. There is nothing particularly recited in the claim that asserts that every part of the moisture absorber is exposed inside the chamber, that the moisture absorber is aligned in the center relative to all walls of the chamber, or that the moisture absorber is not attached to a side of the chamber. The means of manufacturing is not what is recited in Claim 1. The argument is not persuasive.
Applicant argues at [Page 13, 1st Full Paragraph] that the amendment further limits with “disposed feature of the moisture absorber” with the limitation “which is arranged to correspond to the chamber”. It is unclear what limiting distinction “correspond” brings, as it broadly recites that the moisture absorber is in some way associated with the chamber. Francis teaches the moisture absorber elements of (Fig 1, “wick” layer with “mesh electrode”; [Page 180, Left Column, Top] “droplet breaking onto the mesh electrode and Rayon wick”) are pointed to the inside of the “chamber” of Francis Figure 1, to absorb liquid in the chamber onto the mesh electrode. The argument is not persuasive.
Applicant argues at [Page 14, 5th Full Paragraph] – [Page 15, Bottom] that the third base in the present disclosure is a cover that blocks the chamber, and that Park provides an inlet and outlet in a single substrate layer. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). As detailed in the 35 U.S.C. 103 rejection above, Park is combined with Francis and O’Connor to teach the limitations of the claim. The argument is not persuasive.
Applicant argues at [Page 16, Paragraph 1] – [Page 19, Top] that there intermediate flow paths in O’Connor such that fluid goes through inlet port (56), passes through vias (60,62)…and finally flows through the aperture (59) of a second layer to the outlet port (57), and that via (62) of O’Connor is an intermediate portion connected to the inlet port 56. Applicant further argues that inlet port (56) and outlet port (57) of O’Connor are provided on the same first layer (51). Looking to Figure 5A of O’Connor, via 62 is a different sized aperture to inlet port 56, and “via 62” is located in the third layer, while “inlet port 56” is located in the first layer. There is nothing particular in the claims that designates that the inlet and outlet are not aligned with each other. It is merely claimed that there is an outlet in a layer different than the layer in which the inlet resides. O’Connor demonstrates this. Looking to [0085] O’Connor discloses that “a microfluidic device 50 is composed of five layers”. “Inlet port 56” and “via 62” are located in layers 51 and 53, or the first and third of these layers, and these are the cited inlet and outlet of interest for the claim combination. They are not both located in layer 51. Further, as described above, it has been held that rearranging parts of an invention involves only routine skill in the art MPEP 2144.04 VI. (C). The argument is not persuasive.
Applicant argues at [Page 13, 2nd Full Paragraph] – [Page 19, 1st Full Paragraph] that Park in view of Francis does not teach, suggest, or describe each and every element of Applicant’s independent claim 1, and the additional references of Kalish, Lindsay, Zhang, and O’Connor do not cure the deficiencies of Park in view of Francis. As described in the 35 U.S.C. 103 rejection and discussion of arguments above, Park in view of Francis, further in view of O’Connor discloses all of the elements of amended Claim 1. The argument is not persuasive.
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.
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/MELISSA JO MONTGOMERY/Examiner, Art Unit 3791
/PATRICK FERNANDES/Primary Examiner, Art Unit 3791