DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment filed on July 01, 2026 was considered by the examiner. Claims 1-15 are pending in the application.
Claim Objections
Claim 1 is objected to because of the following informalities:
in claim 1, line 1: “liquid ,” should be “liquid,”; and
in claim 1, line 5: “end ,” should be “end,”.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites “A device for analyzing an absolute concentration” in lines 1-2 and “said property being representative of the absolute concentration” in lines 13-14. The term “absolute concentration” is a specific term of art (i.e., absolute vs relative concentration, etc.). There is no disclosure in the specification of the present application for “absolute concentration”. As such, one of ordinary skill in the art would not have recognized Applicant was in possession of the claimed invention at the time the application was effectively filed.
Claims 1-11 are rejected by virtue of their dependence from claim 1.
Claim 12 recites “A method for analyzing an absolute concentration” in lines 1-2 and “said property being representative of the absolute concentration” in lines 14-15. The term “absolute concentration” is a specific term of art (i.e., absolute vs relative concentration, etc.). There is no disclosure in the specification of the present application for “absolute concentration”. As such, one of ordinary skill in the art would not have recognized Applicant was in possession of the claimed invention at the time the application was effectively filed.
Claims 13-15 are rejected by virtue of their dependence from claim 12.
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.
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 1-5, 7, 9, and 11-15 are rejected under 35 U.S.C. 103 as being unpatentable over Hefti (US Patent Application Publication 2003/0203504 – cited by Applicant), hereinafter Hefti, and in view of Elms et al. (WIPO Publication 2022/213077 – cited by Applicant), hereinafter Elms.
Regarding Claim 1, Hefti teaches a diffusion-based for detecting activity of a biological or chemical species (see abstract and Fig. 2). Hefti teaches a device for analyzing a characteristic (see abstract and Fig. 2) of an analyte in a test liquid (¶[0040]-[0042] and ¶[0077]-[0078] the source constituent 222 in the source reservoir 220 may comprise sodium ions or other substances, the source constituent is the mobile biologic or chemical structure; Fig. 2), the device comprising:
a reservoir configured to hold an analysis liquid (¶[0041]-[0042] and ¶[0077]-[0078] the sink reservoir 230 comprising the sink constituent 232; Fig. 2), of a known concentration (¶[0091]-[0094] used for directly measuring diffusion rates, the direct measurement of concentrations is performed, including known initial concentrations),
the analysis liquid comprising an analysis compound (¶[0078] the sink constituent 232 may comprise sodium ions or other substances, ¶[0081] the sink constituent may comprise cells that consume sodium, ¶[0041]-[0042] the sink constituent 232 refers to a biologic or chemical structure which takes up, metabolizes, absorbs, or otherwise reacts with the source constituent 222, the bio/chemical species or the reactive constituent may each function as the source constituent 232, the reactive constituent refers to a biologic or chemical structure which is known, or suspected of being reactive with the bio/chemical species, and may comprise ionic species, molecules within the cell which are involved with metabolic activities, such as nutrient catabolic or anabolic processes; intermediate molecular constituents in a biochemical pathway, including regulatory molecules and signaling molecules; signaling molecules, such as neurotransmitters and hormones, as well as other peptidic and non-peptidic organic compounds; small molecules intended for therapeutic purposes, such as drugs and other molecules known or suspected of being biochemically active in a given cell population, ¶[0073]-[0074] the sink constituent 232 may act as both a sink constituent 232 in the first phase via a cell, and then after the cell upon activation, emits a structure that may act as a source constituent 222 diffusing out into the diffusion channel 240 during a second phase, Fig. 2; see also ¶[0142]-[0147] the reaction between the subject bio/chemical species and the reactive constituent within the diffusion channel, that are supplied fluidly to the channel, such as from reservoirs, and that either of the subject bio/chemical species and the reactive constituent may operate as the mobile constituent, indicating the diffusion of both in the embodiment of both being mobile, Figs. 13A-13B);
a microfluidic channel having a first end and a second end (¶[0077] the diffusion channel 240; Fig. 2),
wherein the first end is arranged in fluid communication with the reservoir, wherein the second end is configured to be in fluid communication with the test liquid (¶[0077]-[0078] the diffusion channel 240 has a first end (not labeled) in fluid communication with the sink reservoir 230 containing the sink constituent 232, and a second end (not labeled) in fluid communication with the source reservoir 220 containing the source constituent 222; Fig. 2);
wherein the microfluidic channel is configured to allow mixing, by diffusion, of the analysis compound entering the first end with the analyte entering the microfluidic channel from the second end (see generally ¶[0040]-[0042], ¶[0073]-[0074], and ¶[0081], the sink constituent 232 may comprise a molecule/cell/protein/etc. known to react with the source constituent 222 (i.e., sodium) that are in fluid communication with each other (with their respective reservoirs) via the diffusion channel, such that as the system is described as reaching equilibrium (see for example ¶[0082]), in the case of a molecule sink constituent 232 (see ¶[0040]-[0042] the sink constituent may be the reactive constituent, such as a molecule which is known or suspect of having a binding affinity thereto), the molecule sink constituent 232 would necessarily diffuse into the diffusion channel 240 just as the source constituent 222 does, such that, at least some of the resultant reactions would necessarily occur within the diffusion channel 240, which would be monitored by the measurement probes 244 positioned along the diffusion channel 240, Fig. 2; see also ¶[0142]-[0147] the reaction between the subject bio/chemical species and the reactive constituent within the diffusion channel, that are supplied fluidly to the channel, such as from reservoirs, and that either of the subject bio/chemical species and the reactive constituent may operate as the mobile constituent, indicating the diffusion of both in the embodiment of both being mobile, Figs. 13A-13B); and
a detector arranged in relation to the microfluidic channel (¶[0080] the measurement probes 244 positioned along the diffusion channel 240, and optionally within the source reservoir 220 and/or the sink reservoir 230; Fig. 2),
wherein the detector is configured to detect a property dependent on the mixing of the analysis compound and the analyte (see generally ¶[0040]-[0042], ¶[0073]-[0074], ¶[0081], and above interpretation, the mixing of the source and sink constituents 222/232 within the diffusion channel 240, in which the resultant reactions that occur within the diffusion channel 240 would be monitored by the measurement probes 244 positioned along the diffusion channel 240, Fig. 2; see also see also ¶[0142]-[0147] the detected diffusion response within the diffusion channel, Figs. 13A-13B),
said property being representative of the characteristic of the analyte in the test liquid (¶[0081] the measurement probes 42 may monitor electrical properties, such as AC/DC, conductance, resistance, voltage, current, capacitance, inductance, and the like, or other properties such as optical, radiometric, biochemical, at different points along the diffusion channel 240, ¶[0046] other parameters may also be measured along the diffusion channel 240 including temperature, pressure, pH, chemical potential, charge, viscosity, density, color, absorption or emission spectra, polarization, biochemical, radiometric quantities, enzymatic activity, nucleic acid hybridization, molecular binding rates or affinities, and the like).
Hefti teaches that concentrations may be directly measured (see ¶[0091]-[0094]), but not specifically that an absolute concentration is determined.
Elms teaches methods for identifying biomolecules within a microfluidic device (see abstract and Fig. 1A), in which the microfluidic device comprises a chamber and a flow region allowing diffusion of the reporter molecules (see ¶[0003]), in which a microfluidic channel may connect the chamber and the flow region, and may lie along the axis of diffusion (see ¶[0005] and Fig. 7), measuring via optical sensing (see ¶[0154]-[0156]), capable to determine an absolute concentration of the analyte in the test liquid from a known concentration of an analysis compound (see ¶[0203]-[0205] a standard curve from known concentrations of the reported molecule may be utilized and intensity measured, so that intensity of the secreted biomolecule (i.e., protein, analyte, etc.) and thus absolute concentration determined). Here, the known concentrations in the standard curve fall under the BRI of known concentration because the claim as amended does not exclude prior calibration curves.
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the absolute concentration measured via optical sensing of Elms with the optical sensing and the analyte in Hefti because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results; and/or (2) Hefti teaches determining various analyte parameters (see ¶[0046]), and Elms teaches one such parameter (i.e., absolute concentration); the absolute concentration would help a medical professional in providing care for the patient.
Regarding Claim 2, Hefti in view of Elms teaches the device of claim 1 as stated above. Hefti further teaches the first end and the second end are arranged on opposite sides of the microfluidic channel (see Fig. 2, the ends of the diffusion channel 240 fluidly connected to the source reservoir 220 and the sink reservoir 230 are on opposite sides).
Regarding Claim 3, Hefti in view of Elms teaches the device of claim 1 as stated above. Hefti further teaches the microfluidic channel is configured to provide a first diffusion direction for the analysis compound starting from the first end and diffusing towards the second end (see generally ¶[0040]-[0042], ¶[0073]-[0074], ¶[0081], and above interpretation, in the case of a molecule sink constituent 232, the molecule sink constituent 232 would necessarily diffuse into the diffusion channel 240 just as the source constituent 222 does to reach equilibrium, which would be the first diffusion direction, ¶[0073]-[0074] the sink constituent 232 may act as both a sink constituent 232 in the first phase via a cell, and then after the cell upon activation, emits a structure that may act as a source constituent 222 diffusing out into the diffusion channel 240 during a second phase, Fig. 2; see also ¶[0142]-[0147] the reaction between the subject bio/chemical species and the reactive constituent within the diffusion channel, that are supplied fluidly to the channel, such as from reservoirs, and that either of the subject bio/chemical species and the reactive constituent may operate as the mobile constituent, indicating the diffusion of both in the embodiment of both being mobile, Figs. 13A-13B), and
wherein the microfluidic channel is configured to provide a second diffusion direction for the analyte starting from the second end and diffusing towards the first end (¶[0040]-[0042], ¶[0077]-[0078], and ¶[0081] the source constituent 222 that diffuses into the diffusion channel 240, which would be the second diffusion direction; Fig. 2).
Regarding Claim 4, Hefti in view of Elms teaches the device of claim 1 as stated above. The modified Hefti does not specifically teach the dimensions of the diffusion channel 240 analysis system, including that the reservoir has a volume of 1 µL to 1 L.
Elms further teaches that the chamber may comprise a reservoir (see ¶[00390]), in which the volume of the chamber may be less than about 1 mL (see ¶[00100]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize volume of the chamber of Elms with the volume of the reservoirs in the modified Hefti because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results and/or (2) Hefti requires a volume for the reservoirs and Elms teaches such a volume.
The less than 1 mL range of the modified Hefti suggests the range of the present claim because 1 µL to 1 L overlaps with the range of less than 1 mL. See MPEP 2144.05: “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)”.
Regarding Claim 5, Hefti in view of Elms teaches the device of claim 1 as stated above. The modified Hefti does not specifically teach the dimensions of the diffusion channel 240 analysis system, including that a cross-section of the microfluidic channel is 100 nm2 to 1 mm2.
Elms further teaches that the cross-section of the fluidic channel may have various values ranging from about 500 square microns to 20,000 square microns (see ¶[00344]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the cross-section size of the fluidic channel as within the ranges of the modified Elms with the cross-section size of the diffusion channel in Hefti because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results and/or (2) Hefti requires a cross-section size for the diffusion channel and Elms teaches such cross-section sizes.
The general 500-20,000 square micron range of the modified Hefti suggests the range of the present claim because 100 nm2 to 1 mm2 overlaps with the range of 500-20,000 square microns. See MPEP 2144.05: “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)”.
Regarding Claim 7, Hefti in view of Elms teaches the device of claim 1 as stated above. Hefti does not specifically teach that a cross-section of the microfluidic channel is varied along a length of the channel (such as depicted in Fig. 2).
Hefti further teaches another embodiment which utilizes a funnel-shaped diffusion channel 240, in which the narrowed width and extra length increases the diffusion equilibrium, so that a desired diffusion equilibrium time appropriate for the specific bio/chemical species measurement is obtained (see ¶[0135]-[0137]; Figs. 11A-11B).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the funnel-shaped variable width (and thus variable cross-section area) diffusion channel 240 as the diffusion channel 240 in the embodiment of Fig. 2 because (1) it is the simple substitution of one known element for another to yield predictable results and/or (2) adjusting the geometries of the diffusion channel 240, such as with the funnel-shaped diffusion channel 240 to achieve a longer diffusion equilibrium time, is useful to capture the particular diffusion response sought for the subject bio/chemical species (see ¶[0137]).
Regarding Claim 9, Hefti in view of Elms teaches the device of claim 1 as stated above. Hefti further teaches the detector is a chemical sensor, an ion-selective electrode sensor, a chemical field effect transistor, an ion-sensitive field effect transistor, a pH sensor, a pH sensitive dye, a photodiode, a camera, a CMOS sensor, a CCD sensors, a fluorescence sensors, a spectroscope, a colorimetric sensor, or a temperature sensor (¶[0081] the measurement probes 42 may monitor electrical properties, such as AC/DC, conductance, resistance, voltage, current, capacitance, inductance, and the like, or other properties such as optical, radiometric, biochemical, at different points along the diffusion channel 240, ¶[0046] other parameters may also be measured along the diffusion channel 240 including temperature, pressure, pH, chemical potential, charge, viscosity, density, color, absorption or emission spectra, polarization, biochemical, radiometric quantities, enzymatic activity, nucleic acid hybridization, molecular binding rates or affinities, and the like).
Regarding Claim 11, Hefti in view of Elms teaches the device of claim 1 as stated above. Hefti further teaches an analysis device for monitoring a biological or chemical process, the analysis device comprising the device according to claim 1 (see above claim 1 mapping), wherein the analysis device is arranged in-line, at-line or on-line of the biological or chemical process (see generally ¶[0040]-[0042], ¶[0073]-[0074], and ¶[0077]-[0078], as the subject bio/chemical species is analyzed, the diffusion channel analysis system would necessarily have to include one of in-line, at-line or on-line arrangements, as otherwise the subject bio/chemical species would not be present within the analysis system).
Regarding Claim 12, Hefti teaches a diffusion-based for detecting activity of a biological or chemical species (see abstract and Fig. 2). Hefti teaches a method for analyzing a characteristic (see abstract and Fig. 2) of an analyte in a test liquid (¶[0040]-[0042] and ¶[0077]-[0078] the source constituent 222 in the source reservoir 220 may comprise sodium ions or other substances, the source constituent is the mobile biologic or chemical structure; Fig. 2), the method comprises:
arranging a reservoir holding an analysis liquid in relation to the test liquid (¶[0041]-[0042] and ¶[0077]-[0078] the sink reservoir 230 comprising the sink constituent 232; Fig. 2), of a known concentration (¶[0091]-[0094] used for directly measuring diffusion rates, the direct measurement of concentrations is performed, including known initial concentrations),
the analysis liquid comprising an analysis compound (¶[0078] the sink constituent 232 may comprise sodium ions or other substances, ¶[0081] the sink constituent may comprise cells that consume sodium, ¶[0041]-[0042] the sink constituent 232 refers to a biologic or chemical structure which takes up, metabolizes, absorbs, or otherwise reacts with the source constituent 222, the bio/chemical species or the reactive constituent may each function as the source constituent 232, the reactive constituent refers to a biologic or chemical structure which is known, or suspected of being reactive with the bio/chemical species, and may comprise ionic species, molecules within the cell which are involved with metabolic activities, such as nutrient catabolic or anabolic processes; intermediate molecular constituents in a biochemical pathway, including regulatory molecules and signaling molecules; signaling molecules, such as neurotransmitters and hormones, as well as other peptidic and non-peptidic organic compounds; small molecules intended for therapeutic purposes, such as drugs and other molecules known or suspected of being biochemically active in a given cell population, ¶[0073]-[0074] the sink constituent 232 may act as both a sink constituent 232 in the first phase via a cell, and then after the cell upon activation, emits a structure that may act as a source constituent 222 diffusing out into the diffusion channel 240 during a second phase, Fig. 2; see also ¶[0142]-[0147] the reaction between the subject bio/chemical species and the reactive constituent within the diffusion channel, that are supplied fluidly to the channel, such as from reservoirs, and that either of the subject bio/chemical species and the reactive constituent may operate as the mobile constituent, indicating the diffusion of both in the embodiment of both being mobile, Figs. 13A-13B);
wherein the reservoir is connected to a microfluidic channel having a first end and a second end (¶[0077] the diffusion channel 240; Fig. 2),
wherein the first end is arranged in fluid communication with the reservoir, wherein the second end is configured to be in fluid communication with the test liquid (¶[0077]-[0078] the diffusion channel 240 has a first end (not labeled) in fluid communication with the sink reservoir 230 containing the sink constituent 232, and a second end (not labeled) in fluid communication with the source reservoir 220 containing the source constituent 222; Fig. 2);
such that the analysis compound is diffused, through the first end of a microfluidic channel, into the microfluidic channel; and the analyte is diffused, through the second end of the microfluidic channel, into the microfluidic channel; mixing the analysis compound with the analyte by the diffusion of the analysis compound and the analyte into the microfluidic channel (see generally ¶[0040]-[0042], ¶[0073]-[0074], and ¶[0081], the sink constituent 232 may comprise a molecule/cell/protein/etc. known to react with the source constituent 222 (i.e., sodium) that are in fluid communication with each other (with their respective reservoirs) via the diffusion channel, such that as the system is described as reaching equilibrium (see for example ¶[0082]), in the case of a molecule sink constituent 232 (see ¶[0040]-[0042] the sink constituent may be the reactive constituent, such as a molecule which is known or suspect of having a binding affinity thereto), the molecule sink constituent 232 would necessarily diffuse into the diffusion channel 240 just as the source constituent 222 does, such that, at least some of the resultant reactions would necessarily occur within the diffusion channel 240, which would be monitored by the measurement probes 244 positioned along the diffusion channel 240, Fig. 2; see also ¶[0142]-[0147] the reaction between the subject bio/chemical species and the reactive constituent within the diffusion channel, that are supplied fluidly to the channel, such as from reservoirs, and that either of the subject bio/chemical species and the reactive constituent may operate as the mobile constituent, indicating the diffusion of both in the embodiment of both being mobile, Figs. 13A-13B); and
detecting, by a detector (¶[0080] the measurement probes 244 positioned along the diffusion channel 240, and optionally within the source reservoir 220 and/or the sink reservoir 230; Fig. 2),
a property dependent on the mixing of the analysis compound and the analyte (see generally ¶[0040]-[0042], ¶[0073]-[0074], ¶[0081], and above interpretation, the mixing of the source and sink constituents 222/232 within the diffusion channel 240, in which the resultant reactions that occur within the diffusion channel 240 would be monitored by the measurement probes 244 positioned along the diffusion channel 240, Fig. 2; see also see also ¶[0142]-[0147] the detected diffusion response within the diffusion channel, Figs. 13A-13B),
said property being representative of the characteristic of the analyte in the test liquid (¶[0081] the measurement probes 42 may monitor electrical properties, such as AC/DC, conductance, resistance, voltage, current, capacitance, inductance, and the like, or other properties such as optical, radiometric, biochemical, at different points along the diffusion channel 240, ¶[0046] other parameters may also be measured along the diffusion channel 240 including temperature, pressure, pH, chemical potential, charge, viscosity, density, color, absorption or emission spectra, polarization, biochemical, radiometric quantities, enzymatic activity, nucleic acid hybridization, molecular binding rates or affinities, and the like).
Hefti teaches that concentrations may be directly measured (see ¶[0091]-[0094]), but not specifically that an absolute concentration is determined.
Elms teaches methods for identifying biomolecules within a microfluidic device (see abstract and Fig. 1A), in which the microfluidic device comprises a chamber and a flow region allowing diffusion of the reporter molecules (see ¶[0003]), in which a microfluidic channel may connect the chamber and the flow region, and may lie along the axis of diffusion (see ¶[0005] and Fig. 7), measuring via optical sensing (see ¶[0154]-[0156]), capable to determine an absolute concentration of the analyte in the test liquid from a known concentration of an analysis compound (see ¶[0203]-[0205] a standard curve from known concentrations of the reported molecule may be utilized and intensity measured, so that intensity of the secreted biomolecule (i.e., protein, analyte, etc.) and thus absolute concentration determined). Here, the known concentrations in the standard curve fall under the BRI of known concentration because the claim as amended does not exclude prior calibration curves.
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the absolute concentration measured via optical sensing of Elms with the optical sensing and the analyte in Hefti because (1) it is the application of a known technique to a known method ready for improvement to yield predictable results; and/or (2) Hefti teaches determining various analyte parameters (see ¶[0046]), and Elms teaches one such parameter (i.e., absolute concentration); the absolute concentration would help a medical professional in providing care for the patient.
Regarding Claim 13, Hefti in view of Elms teaches the method of claim 12 as stated above. The modified Hefti further teaches wherein the analysis compound has a known concentration in the analysis liquid for determining the absolute concentration of the analyte in the test liquid (see Hefti ¶[0091]-[0094] used for directly measuring diffusion rates, the direct measurement of concentrations is performed, including known initial concentrations; see Elms ¶[0203]-[0205] a standard curve from known concentrations of the reported molecule may be utilized and intensity measured, so that intensity of the secreted biomolecule (i.e., protein, analyte, etc.) and thus absolute concentration determined). Here, the known concentrations in the standard curve fall under the BRI of known concentration because the claim as amended does not exclude prior calibration curves.
Regarding Claim 14, Hefti in view of Elms teaches the method of claim 12 as stated above. Hefti further teaches the detecting of the property detects a gradient or profile of the property along a length of the microfluidic channel (see generally ¶[0040]-[0042], ¶[0073]-[0074], ¶[0081], and above interpretation, the mixing of the source and sink constituents 222/232 within the diffusion channel 240, in which the resultant reactions that occur within the diffusion channel 240 would be monitored by the measurement probes 244 positioned along the diffusion channel 240, Fig. 2; see also see also ¶[0142]-[0147] the detected diffusion response within the diffusion channel, Figs. 13A-13B).
Regarding Claim 15, Hefti teaches the method of claim 12 as stated above. Hefti further teaches the method provides continuous detection of the property (¶[0145] the monitoring, such as the diffusion response, may be monitored/measured over a continuous time period or over discrete time points).
Claims 6 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Hefti in view of Elms as applied to claim 1 above, and in view of McAlpine et al. (US Patent Application Publication 2022/0072753 – cited in prior action), hereinafter McAlpine.
Regarding Claim 6, Hefti in view of Elms teaches the device of claim 1 as stated above. The modified Hefti does not specifically teach the dimensions of the diffusion channel 240 analysis system, including that the microfluidic channel has a length of 10 µm to 10 cm.
McAlpine teaches a printed microfluidic polymeric filament structure mixing device (see abstract and Fig. 2), such as for analyte/chemical testing/assays (see ¶[0100]-[0101]), in which the mixing device 200 may have inlets 272/274 at a T-shaped inlet portion 270 for mixing of the first/second fluids 280/282 through the microfluidic passage 232 to exit via the outlet portion 278 (see ¶[0090]-[0095]; Fig. 2), in which the inlets 272/274 are separated at the T-shaped inlet portion by a length of 300 µm and/or the T-shaped inlet portion 270 and the outlet portion 278 are separated by a length of 13 mm (see Fig. 2).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the length between the inlets and/or the length between the inlet portion and the outlet portion of McAlpine with the length of the diffusion channel in the modified Hefti because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results and/or (2) Hefti requires a length for the diffusion channel and McAlpine teaches such length.
Regarding Claim 8, Hefti in view of Elms teaches the device of claim 1 as stated above. The modified Hefti is silent regarding a removable cover arranged to avoid diffusion through the microfluidic channel, wherein the cover is configured such that the cover opens the microfluidic channel for diffusion to initiate analysis.
McAlpine teaches a printed microfluidic polymeric filament structure mixing device (see abstract and Figs. 2-3), such as for analyte/chemical testing/assays (see ¶[0100]-[0101]), in which microfluidic printed valves may be utilized to selectively control, such as in a pre-determined and changeable order, the fluid flow through the microfluidic device, including the channels (see ¶[0100]-[0102]; Figs. 2-3).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the microfluidic valves of McAlpine with for the fluid control of the diffusion channel in the modified Hefti because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results and/or (2) this would provide the user and/or medical professional with precise start timing for the commencement of the diffusion and thus the associated measurements.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Hefti in view of Elms as applied to claim 1 above, and in view of Prins et al. (US Patent Application Publication 2021/0290110 – cited in prior action), hereinafter Prins.
Regarding Claim 10, Hefti in view of Elms teaches the device of claim 1 as stated above. Hefti generally teaches that the diffusion channel analysis system is a micro-miniature structure (see generally ¶[0142]-[0147]; Figs. 13A-13B) that may be utilized to monitor biological, including cellular, activity (see ¶[0159]); however, Hefti does not specifically teach that such a system is ingestible.
Prins teaches a biosensing device for continuous monitoring of an analyte in a fluid matrix (see abstract and Fig. 1), in which a target analyte is diffused 424/426 into the gap region 408 to be detected at the biosensing surface 406 from a reaction with biosensing particles and light (see ¶[0068]-[0069]; Fig. 4), in which the analyte sensing may be utilized in various in-vitro and in-vivo biosensing, such as a catheter, a patch, a tube, a tube, a needle, a fiber, a clip, a wire, a watch, an implanted probe, a pill, a subcutaneous strip, etc. (see ¶[0003]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to implement the diffusion channel analysis system of the modified Hefti as described in the various embodiments in Prins because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results; and/or (2) the diffusion channel analysis system of Hefti would necessarily be utilized in real-world device and Prins teaches one such real-world device, such as an ingestible pill; and/or (3) ingestible sensors may provide precise diagnosis on digestive disorders along the digestive tract (see for example “Ingestible sensors”, imec, accessed on the wayback machine at https://web.archive.org/web/20230202173810/https://www.imec-int.com/en/expertise/health-technologies/ingestibles, accessed on 04/04/2026, captured on 02/02/2023, pg. 6-8).
Response to Arguments
Applicant’s arguments, objections to the claims
Applicant’s arguments, see pg. 5, filed July 01, 2026, with respect to the objections of claim 1, which have not been addressed by argument or amendment are not persuasive. Applicant’s arguments, see pg. 5, filed July 01, 2026, with respect to the objection of claim 11 have been fully considered and are persuasive; therefore, that objection has been withdrawn.
Applicant’s arguments, 35 U.S.C. § 112(b)
Applicant’s arguments, see pg. 6, filed July 01, 2026, with respect to the rejections of claims 5, 7-9, and 12-15 under 35 U.S.C. § 112(b) have been fully considered and are persuasive. Therefore, the rejections have been withdrawn. However, upon further consideration, a new grounds of rejection under 35 U.S.C. § 112 are made that were necessitated by Applicant’s amendment on July 01, 2026.
Applicant’s arguments, prior art
Applicant’s arguments, see pg. 6-10, filed July 01, 2026, with respect to the rejections of claims 1-15 under 35 U.S.C. § 102(a)(1) and § 103 have been fully considered and are persuasive. Therefore, the rejections have been withdrawn. However, upon further consideration, a new grounds of rejection are made in view of Elms et al. (WIPO Publication 2022/213077 – cited by Applicant).
Applicant argues that Elms does not teach the absolute concentration as presently claimed because “in the present claims, no prior measurement is needed to derive the absolute concentration of the analyte” (see arguments pg. 8-9). The examiner respectfully disagrees. The claims as amended to not prohibit any prior measurement, so there is nothing presently claimed that would prevent usage of Elms. Therefore, Applicant’s arguments against Elms are 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN D. MORONESO whose telephone number is (571)272-8055. The examiner can normally be reached M-F: 8:30AM - 6:00 PM, MST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JENNIFER M. ROBERTSON can be reached at (571)272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/J.D.M./Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791
