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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 3/13/2026 has been entered.
Response to Arguments
Applicant's arguments filed 3/12/2026 have been fully considered but they are not persuasive.
On Pages 9-14 of Applicant’s Remarks, the Applicant states that the prior art reference of DiMagno et al. does not teach the feature of the hydrophobic structure comprising a wax penetrating into a thickness of the distribution substrate. The Examiner agrees that the limitation is not taught by DiMagno et al., however, the limitation is taught by Whitesides et al. (US 20090298191), cited in the previous rounds of prosecution. Whitesides et al. teaches a device where wax is used to form a hydrophobic channel on a chromatographic paper, where the wax melts through the thickness of the paper substrate, see [0177]. Accordingly, the prior art references teach that it is known that wax is a functional equivalent for providing a flow path bounded by hydrophobic material.
Response to Amendment
This is an office action in response to applicant's arguments and remarks filed on 3/12/2026. Claims 1-7 and 13-30 are pending in the application.
Status of Objections and Rejections
All rejections from the previous office action are withdrawn.
New grounds for rejection are necessitated by Applicant’s amendment.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-2, 4, 7, 13-16, 19-20, 22, and 26-30 are rejected under 35 U.S.C. 103 as being unpatentable over DiMagno et al. (US 2016/0025715), and further in view of Whitesides et al. (US 20090298191).
Regarding claim 1, DiMagno et al. teaches an apparatus (assay device 100, see Fig. 1 and [0061]) comprising:
a sample receiving region (sample addition area 140, see [0065]);
a first diagnostic element that includes one or more colorimetric analysis regions (test element 121 is a colorimetric test paper with a color changing region, see [0063], and Claims 8-9);
a second diagnostic element that includes one or more lateral flow assay analysis regions (second test element 122 comprising a lateral flow assay device, see, [0088], [0095], and Claims 8-9); a distribution assembly comprising a hydrophobic structure deposited on a distribution substrate (diverter 130/630 comprising fluid impermeable (hydrophobic) material, see Fig. 1 and 6 and [0076], that allows for different volumes of sample to contact the testing elements, see [0077], and [0087]), wherein the hydrophobic structure defines
a first flow path that allows a first portion of the liquid deposited at the sample receiving region to flow to the first diagnostic element (first face 131 that allows fluid to contact the first test element 121, see Figs. 1 and 6 and [0065]), and
a second flow path that allows a second portion of the liquid deposited at the sample receiving region to flow to the second diagnostic element (second face 132 that allows fluid to contact the second test element 122, see Figs. 1 and 6 and [0065]).
However, the current embodiment does not teach that the device comprises an asymmetric fluid distribution where the second portion has a volume different from the first portion. A later embodiment of the prior art teaches a porous member with blocking material laid over the top to allow more fluid to enter the first test element than the second test element (see [0074]).
Because the difference between the prior art and the claim invention was a known variation of the diverter, the use of a diverter to asymmetrically distribute the sample to different test elements would have been recognized as predictable to one of ordinary skill in the art before the effective filing date of the instant invention. This is because there are design incentives for implementing the claimed variation. Specifically, asymmetrically dividing the sample would allow for the combining of test elements that require different volumes of fluid in a singular device i.e., colorimetric and lateral flow tests, see [0074]. Ultimately, modifying the diverter to asymmetrically divide the sample would have the reasonable expectation of successfully facilitating the flow of fluid to a respective test element.
Further, the current embodiment does not teach that the liquid flows to the first diagnostic element via a plurality of sub- channels designed to originate from a common point in the first flow path and cause an increase in a speed of the flow to the first diagnostic element. A later embodiment teaches the first flow path (808) leading to a test element wherein the path contains a plurality of microposts 707 that create a plurality of microfluidic channels that induce flow across a test strip, see [0088] – [0089].
Because the difference between the prior art and the claimed invention was a known variation of the fluid flow path, the use of microposts within the fluid flow path so as to increase the speed of fluid flow would have been recognized as predictable to one of ordinary skill in the art before the effective filing date of the instant invention. This is because there are design incentives for implementing the claimed variation. Specifically, providing a plurality fa channels with varied dimensions within a device would induce capillary flow of the received fluidic sample once the fluidic sample is introduced to the fluid flow path, see [0089]. Ultimately, modifying the flow path to include microposts to create a plurality of sub-channels within a main fluid flow path would have the reasonable expectation of successfully facilitating the flow of fluid to a respective test element.
Further, DiMagno et al. does not teach that the hydrophobic structure comprises a wax penetrating into a thickness of the distribution substrate.
However, in the analogous art of multiplexed lateral flow assays, Whitesides teaches a device where wax is used to form a hydrophobic channel on a chromatographic paper, where the wax melts through the thickness of the paper substrate, see [0177]. Accordingly, the prior art references teach that it is known that wax is a functional equivalent for providing a flow path bounded by hydrophobic material.
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have substituted the deposited hydrophobic plastic of DiMagno et al. for the wax of Whitesides et al. because both elements were known equivalents for fluid impermeable dividing material that provide fluid communication in the microfluidic device art. The substitution of the plastic of DiMagno et al. would have had the reasonable expectation of providing fluid communication from the inlet to the diagnostic elements of the microfluidic device.
Regarding claim 2, modified DiMagno et al. teaches the apparatus of claim 1, further comprising an impermeable housing (cover 150 constructed of plastic where plastic is impermeable, see Figs. 1 and 6, [0066], and [0070]), wherein the sample receiving region comprises an opening defined by the housing (sample addition region 140 is a hole defined by cover 150, see Figs. 1 and 6, [0065]).
Regarding claim 4, modified DiMagno et al. teaches the apparatus of claim 1, wherein the first diagnostic element comprises a sample conveying portion that guides the first portion of the liquid to a colorimetric reacting region (the dry slide test comprises a spreading layer, or sample layer, that guides the sample to reagent, see US 3,992,158, incorporated by reference by DiMagno et al., see [0063]).
Regarding claim 7, modified DiMagno et al. teaches a system (apparatus 1100, see Fig. 11 and [0106]) comprising:
a first device (assay device 100, see Fig. 1 and 11 and [0106]), comprising:
a sample receiving region (sample addition area 140, see [0065]);
a first diagnostic element that includes one or more colorimetric analysis regions (test element 121 is a colorimetric test paper with a color changing region, see [0063], and Claims 8-9);
a second diagnostic element that includes one or more lateral flow assay analysis regions (second test element 122 comprising a lateral flow assay device, see, [0088], [0095], and Claims 8-9)
a first flow path that allows a first portion of the liquid deposited at the sample receiving region to flow to the first diagnostic element (first face 131 that allows fluid to contact the first test element 121, see Figs. 1 and 6 and [0065]), and
a second flow path that allows a second portion of the liquid deposited at the sample receiving region to flow to the second diagnostic element (second face 132 that allows fluid to contact the second test element 122, see Figs. 1 and 6 and [0065])
an imaging device oriented to capture a visual image of an output produced by the first device (imager 1144 used to capture an image of test elements 121, 122, see Fig. 11 and [0114] – [0115]);
and a processor and one or more computer readable storage media, and program instructions collectively stored on the one or more computer readable storage media, the program instructions executable by the processor to cause the processor to perform the capture operation using the imaging device (computer readable storage medium 1640 contains instructions for processor 1686 to execute image capture and storage, see [0144] – [0147]).
However, the current embodiment does not teach that the device comprises an asymmetric fluid distribution assembly comprising a hydrophobic structure deposited on a distribution substrate, wherein the second portion has a volume different from the first portion.
A later embodiment of the prior art teaches a porous member with blocking material laid over the top to allow more fluid to enter the first test element than the second test element (see [0074]).
Because the difference between the prior art and the claim invention was a known variation of the diverter, the use of a diverter to asymmetrically distribute the sample to different test elements would have been recognized as predictable to one of ordinary skill in the art before the effective filing date of the instant invention. This is because there are design incentives for implementing the claimed variation. Specifically, asymmetrically dividing the sample would allow for the combining of test elements that require different volumes of fluid in a singular device i.e., colorimetric and lateral flow tests, see [0074]. Ultimately, modifying the diverter to asymmetrically divide the sample would have the reasonable expectation of successfully facilitating the flow of fluid to a respective test element.
Further, the current embodiment does not teach that the liquid flows to the first diagnostic element via a plurality of sub- channels designed to originate from a common point in the first flow path and cause an increase in a speed of the flow to the first diagnostic element. A later embodiment teaches the first flow path (808) leading to a test element wherein the path contains a plurality of microposts 707 that create a plurality of microfluidic channels that induce flow across a test strip, see [0088] – [0089].
Because the difference between the prior art and the claimed invention was a known variation of the fluid flow path, the use of microposts within the fluid flow path so as to increase the speed of fluid flow would have been recognized as predictable to one of ordinary skill in the art before the effective filing date of the instant invention. This is because there are design incentives for implementing the claimed variation. Specifically, providing a plurality fa channels with varied dimensions within a device would induce capillary flow of the received fluidic sample once the fluidic sample is introduced to the fluid flow path, see [0089]. Ultimately, modifying the flow path to include microposts to create a plurality of sub-channels within a main fluid flow path would have the reasonable expectation of successfully facilitating the flow of fluid to a respective test element.
Further, DiMagno et al. does not teach that the hydrophobic structure comprises a wax penetrating into a thickness of the distribution substrate.
However, in the analogous art of multiplexed lateral flow assays, Whitesides teaches a device where wax is used to form a hydrophobic channel on a chromatographic paper, where the wax melts through the thickness of the paper substrate, see [0177]. Accordingly, the prior art references teach that it is known that wax is a functional equivalent for providing a flow path bounded by hydrophobic material.
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have substituted the deposited hydrophobic plastic of DiMagno et al. for the wax of Whitesides et al. because both elements were known equivalents for fluid impermeable dividing material that provide fluid communication in the microfluidic device art. The substitution of the plastic of DiMagno et al. would have had the reasonable expectation of providing fluid communication from the inlet to the diagnostic elements of the microfluidic device.
Regarding claim 13, DiMagno et al. teaches an apparatus (assay device 100, see Fig. 1 and [0061]) comprising:
a sample receiving region (sample addition area 140, see [0065]);
a first diagnostic element that includes one or more colorimetric analysis regions (test element 121 is a colorimetric test paper with a color changing region, see [0063], and Claims 8-9);
a second diagnostic element that includes one or more lateral flow assay analysis regions (second test element 122 comprising a lateral flow assay device, see, [0088], [0095], and Claims 8-9)
a first flow passageway comprising hydrophilic material between the sample receiving region and the first diagnostic element (porous material 230 leading to test element 121, see Fig. 2);
a second flow passageway comprising hydrophilic material between the sample receiving region and the second diagnostic element (porous material 230 leading to test element 121, see Fig. 2);
an asymmetric fluid distribution assembly comprising a hydrophobic structure deposited on a distribution substrate (blocking material dispensed over porous material, see [0074]), wherein the hydrophobic structure asymmetrically defines the first flow passageway and the second flow passageway causing a liquid deposited at the sample receiving region between a first portion to flow down the first flow passageway and a second portion to flow down the second passageway (porous member with blocking material laid over the top allows more fluid to enter the first test element than the second test element (see [0074]), and a flow barrier that repels liquid between a portion of the first flow passageway and the second flow passageway (parts of cover 150 disposed over porous member that repels liquid between test elements, see Fig. 2 and [0072]), but does not teach that the hydrophobic structure comprises a wax penetrating into a thickness of the distribution substrate.
However, in the analogous art of multiplexed lateral flow assays, Whitesides teaches a device where wax is used to form a hydrophobic channel on a chromatographic paper, where the wax melts through the thickness of the paper substrate, see [0177]. Accordingly, the prior art references teach that it is known that wax is a functional equivalent for providing a flow path bounded by hydrophobic material.
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have substituted the deposited hydrophobic plastic of DiMagno et al. for the wax of Whitesides et al. because both elements were known equivalents for fluid impermeable dividing material that provide fluid communication in the microfluidic device art. The substitution of the plastic of DiMagno et al. would have had the reasonable expectation of providing fluid communication from the inlet to the diagnostic elements of the microfluidic device.
Regarding claim 14, DiMagno et al. teaches the apparatus of claim 13, further comprising an impermeable housing (cover 150 constructed of plastic where plastic is impermeable, see Figs. 1 and 6, [0066], and [0070]), wherein the sample receiving region comprises an opening defined by the housing (sample addition region 140 is a hole defined by cover 150, see Figs. 1 and 6, [0065]).
Regarding claim 16, DiMagno et al. teaches the apparatus of claim 13, wherein the first diagnostic element comprises a sample conveying portion that guides liquid from the first flow passageway to the one or more colorimetric analysis regions (the dry slide test comprises a spreading layer, or sample layer, that guides the sample to reagent, see US 3,992,158, incorporated by reference by DiMagno et al., see [0063]).
Regarding claim 19, DiMagno et al. teaches an apparatus (assay device 100, see Fig. 1 and [0061]) comprising:
a sample receiving region (sample addition area 140, see [0065]);
a first diagnostic element that includes one or more colorimetric analysis regions (test element 121 is a colorimetric test paper with a color changing region, see [0063], and Claims 8-9);
a second diagnostic element that includes one or more lateral flow assay analysis regions (second test element 122 comprising a lateral flow assay device, see, [0088], [0095], and Claims 8-9); wherein the hydrophobic structure defines a first flow path for a first portion of a liquid deposited at the sample receiving region, to the first diagnostic element, and a second flow path for a second portion of the liquid to flow to the second diagnostic element (diverter 130/630 comprising fluid impermeable (hydrophobic) material, see Fig. 1 and 6 and [0076], that allows for different volumes of sample to contact the testing elements, see [0077], and [0087]),
but the current embodiment does not teach an asymmetric multiplex flow path assembly comprising a hydrophobic structure deposited on a distribution substrate, the second portion having a smaller volume than the first portion.
A later embodiment of the prior art teaches a porous member with blocking material laid over the top to allow more fluid to enter the first test element than the second test element (10 µL and 5 µL, respectively, see [0074]).
Because the difference between the prior art and the claim invention was a known variation of the diverter, the use of a diverter to asymmetrically distribute the sample to different test elements would have been recognized as predictable to one of ordinary skill in the art before the effective filing date of the instant invention. This is because there are design incentives for implementing the claimed variation. Specifically, asymmetrically dividing the sample would allow for the combining of test elements that require different volumes of fluid in a singular device i.e., colorimetric and lateral flow tests, see [0074]. Ultimately, modifying the diverter to asymmetrically divide the sample would have the reasonable expectation of successfully facilitating the flow of fluid to a respective test element.
Further, the current embodiment does not teach that the liquid flows to the first diagnostic element via a plurality of sub- channels designed to originate from a common point in the first flow path and cause an increase in a speed of the flow to the first diagnostic element. A later embodiment teaches the first flow path (808) leading to a test element wherein the path contains a plurality of microposts 707 that create a plurality of microfluidic channels that induce flow across a test strip, see [0088] – [0089].
Because the difference between the prior art and the claimed invention was a known variation of the fluid flow path, the use of microposts within the fluid flow path so as to increase the speed of fluid flow would have been recognized as predictable to one of ordinary skill in the art before the effective filing date of the instant invention. This is because there are design incentives for implementing the claimed variation. Specifically, providing a plurality fa channels with varied dimensions within a device would induce capillary flow of the received fluidic sample once the fluidic sample is introduced to the fluid flow path, see [0089]. Ultimately, modifying the flow path to include microposts to create a plurality of sub-channels within a main fluid flow path would have the reasonable expectation of successfully facilitating the flow of fluid to a respective test element.
Further, DiMagno et al. does not teach that the hydrophobic structure comprises a wax penetrating into a thickness of the distribution substrate.
However, in the analogous art of multiplexed lateral flow assays, Whitesides teaches a device where wax is used to form a hydrophobic channel on a chromatographic paper, where the wax melts through the thickness of the paper substrate, see [0177]. Accordingly, the prior art references teach that it is known that wax is a functional equivalent for providing a flow path bounded by hydrophobic material.
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have substituted the deposited hydrophobic plastic of DiMagno et al. for the wax of Whitesides et al. because both elements were known equivalents for fluid impermeable dividing material that provide fluid communication in the microfluidic device art. The substitution of the plastic of DiMagno et al. would have had the reasonable expectation of providing fluid communication from the inlet to the diagnostic elements of the microfluidic device.
Regarding claim 20, DiMagno et al. teaches the apparatus of claim 19, further comprising an impermeable housing (cover 150 constructed of plastic where plastic is impermeable, see Figs. 1 and 6, [0066], and [0070]), wherein the sample receiving region comprises an opening defined by the housing (sample addition region 140 is a hole defined by cover 150, see Figs. 1 and 6, [0065]).
Regarding claim 22, modified DiMagno et al. teaches the apparatus of claim 19, wherein the first diagnostic element comprises a sample conveying portion that guides the first portion of the liquid to a colorimetric reacting region (the dry slide test comprises a spreading layer, or sample layer, that guides the sample to reagent, see US 3,992,158, incorporated by reference by DiMagno et al., see [0063]).
Regarding claim 26, DiMagno et al. teaches the apparatus of claim 1, further comprising:
a first size of the first flow path, the first size being controlled by a first pattern; and
a second size of a second flow path, the second size being controlled by a second pattern deposited on the distribution substrate (first and second faces 131 and 132 define first and second flow paths on the diverter 130, see [0117], where the diverter is made of an impermeable, or hydrophobic material, see [0076]).
However, DiMagno et al. does not teach that the flow path is specifically constructed of a first wax pattern and a second wax pattern.
In the analogous art of microfluidic devices using flow splitting, Whitesides et al. teaches a device comprising a sample path defined by a fluid impermeable barrier material constructed of wax, see Fig. 4, [0009], [0087], [0172], and [0177]. Accordingly, the prior art references teach that it is known that wax is a functional equivalent for providing a flow path bounded by hydrophobic material.
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have substituted the deposited hydrophobic plastic of DiMagno et al. for the wax of Whitesides et al. because both elements were known equivalents for fluid impermeable dividing material that provide fluid communication in the microfluidic device art. The substitution of the plastic of DiMagno et al. would have had the reasonable expectation of providing fluid communication from the inlet to the diagnostic elements of the microfluidic device.
Regarding claim 27, DiMagno et al. teaches the apparatus of claim 1, further comprising:
a first pattern controlling the first flow path; and
a second pattern controlling the second flow path, wherein the first and the second flow paths are deposited on a bottom surface of the distribution substrate (first and second faces 131 and 132 define first and second flow paths on the diverter 130 where the diverter extends to the lower test elements, see [0117], where the diverter is made of an impermeable, or hydrophobic material, see [0076]).
However, DiMagno et al. does not teach that the flow path is specifically constructed of a first wax pattern and a second wax pattern.
In the analogous art of microfluidic devices using flow splitting, Whitesides et al. teaches a device comprising a sample path defined by a fluid impermeable barrier material constructed of wax, see Fig. 4, [0009], [0087], [0172], and [0177]. Accordingly, the prior art references teach that it is known that wax is a functional equivalent for providing a flow path bounded by hydrophobic material.
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have substituted the deposited hydrophobic plastic of DiMagno et al. for the wax of Whitesides et al. because both elements were known equivalents for fluid impermeable dividing material that provide fluid communication in the microfluidic device art. The substitution of the plastic of DiMagno et al. would have had the reasonable expectation of providing fluid communication from the inlet to the diagnostic elements of the microfluidic device.
Regarding claim 28, DiMagno et al. teaches the apparatus of claim 1, further comprising:
a first pattern controlling the first flow path; and
a second pattern controlling the second flow path, wherein the first and the second flow paths are deposited on a top surface and a bottom surface of the distribution substrate (first and second faces 131 and 132 define first and second flow paths on the diverter 130 where the diverter extends from the upper addition area (top) to the lower test elements (bottom), see [0117], where the diverter is made of an impermeable, or hydrophobic material, see [0076]).
However, DiMagno et al. does not teach that the flow path is specifically constructed of a first wax pattern and a second wax pattern.
In the analogous art of microfluidic devices using flow splitting, Whitesides et al. teaches a device comprising a sample path defined by a fluid impermeable barrier material constructed of wax, see Fig. 4, [0009], [0087], [0172], and [0177]. Accordingly, the prior art references teach that it is known that wax is a functional equivalent for providing a flow path bounded by hydrophobic material.
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have substituted the deposited hydrophobic plastic of DiMagno et al. for the wax of Whitesides et al. because both elements were known equivalents for fluid impermeable dividing material that provide fluid communication in the microfluidic device art. The substitution of the plastic of DiMagno et al. would have had the reasonable expectation of providing fluid communication from the inlet to the diagnostic elements of the microfluidic device.
Regarding claim 29, DiMagno et al. teaches the apparatus of claim 1, further comprising:
a first pattern controlling the first flow path (the diverter consists of a fluid impermeable material; the material therefore impregnates a thickness of the diverter, see [0076]).
However, DiMagno et al. does not teach that the first pattern is specifically constructed of wax.
In the analogous art of microfluidic devices using flow splitting, Whitesides et al. teaches a device comprising a sample path defined by a fluid impermeable barrier material constructed of wax, see Fig. 4, [0009], [0087], [0172], and [0177]. Accordingly, the prior art references teach that it is known that wax is a functional equivalent for providing a flow path bounded by hydrophobic material.
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have substituted the deposited hydrophobic plastic of DiMagno et al. for the wax of Whitesides et al. because both elements were known equivalents for fluid impermeable dividing material that provide fluid communication in the microfluidic device art. The substitution of the plastic of DiMagno et al. would have had the reasonable expectation of providing fluid communication from the inlet to the diagnostic elements of the microfluidic device.
Regarding claim 30, modified DiMagno teaches the apparatus of claim 29, wherein the wax material of the first pattern only partially impregnates the thickness of the distribution substrate and creates a three-dimensional hydrophobic barrier through the thickness of the distribution substrate (the diverter comprises a porous member coated with a blocking material that creates a barrier for flow passage and therefore only partially impregnates the full thickness of the substrate, see [0073] – [0074] in DiMagno).
However, DiMagno et al. does not teach that the first pattern is specifically constructed of wax.
In the analogous art of microfluidic devices using flow splitting, Whitesides et al. teaches a device comprising a sample path defined by a fluid impermeable barrier material constructed of wax, see Fig. 4, [0009], [0087], [0172], and [0177]. Accordingly, the prior art references teach that it is known that wax is a functional equivalent for providing a flow path bounded by hydrophobic material.
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have substituted the deposited hydrophobic plastic of DiMagno et al. for the wax of Whitesides et al. because both elements were known equivalents for fluid impermeable dividing material that provide fluid communication in the microfluidic device art. The substitution of the plastic of DiMagno et al. would have had the reasonable expectation of providing fluid communication from the inlet to the diagnostic elements of the microfluidic device.
Claims 3 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over DiMagno et al. (US 2016/0025715) in view of Whitesides et al. (US 20090298191) as applied to claim 1 above, and further in view of Ramel et al. (US 2005/0227370).
Regarding claim 3, DiMagno et al. teaches the apparatus of claim 2, but does not teach a graphical element on the impermeable housing, wherein the graphical element is encoded with information associated with the first diagnostic element and the second diagnostic element
However, in the analogous art of analyte meters using immunoassay elements, Ramel et al. teaches a housing having a graphical element on the impermeable housing, wherein the graphical element is encoded with information associated with the first diagnostic element and the second diagnostic element (referred to as the machine readable code on the exterior of the cartridge that encodes identification information about the tests, see [0166] - [0167]).
The modification of the test cartridge of DiMagno et al. to include the graphical element of Ramel et al. was a known modification in the art of analyte meters to encode information regarding a test used within said meter (see [0166] – [0167]). Therefore, a person possessing ordinary skill in the art before the effective filing date of the instant application would have been motivated to add the graphical element of Ramel et al. to the outer surface of the apparatus of DiMagno et al. for the benefit of encoding test cartridge information for a cartridge reader, see [0167] in Ramel. Additionally, the modification of the apparatus of DiMagno et al. to include the graphical element of Ramel would have had the reasonable expectation of successfully facilitating the transferring of information from a cartridge to the reader for analysis.
Regarding claim 6, DiMagno et al. teaches the apparatus of claim 1, but does not teach that the device further comprises a pressure point element facilitating fluid communication along the first and second flow passageways.
However, in the analogous art of analyte detecting meters, Ramel et al. teaches a device further comprising a pressure point element (support ribs 454 and 464, see Fig. 5B-C and [0158]) facilitating fluid communication along the first and second flow paths (support ribs apply pressure to move sample across each test strip, see [0158]).
The modification of the device of Ramel to include the pressure point element of Ramel et al. was a known modification in the art of analyte testing meters to position the test strips within the device to ensure a full fluid transfer O(See [0158] in Ramel). Therefore, it would have been obvious to a person possessing ordinary skill in the art before the effective filing date of the instant application to have modified the bottom substrate of DiMagno et al. to include the supporting ribs of Ramel to arrive the pressure point element of the claimed invention for the benefit of transferring fluid from one portion of the test strip to the next, see [0158] in Ramel. Furthermore, the modification of the testing device of DiMagno et al. to include the supporting ribs of Ramel et al. would have led to the predictable result of propelling fluid down a porous membrane by squeezing the fibers of the test strip.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over DiMagno et al. (US 2016/0025715) in view of Whitesides et al. (US 20090298191).as applied to claims 1 and 13 above, respectively, and further in view of Yu (US 2003/0104510).
Regarding claim 5, DiMagno et al. teaches the apparatus of claim 4, wherein each of the one or more colorimetric analysis regions comprises a first colorimetric reaction area, but does not teach that colorimetric region comprises a second colorimetric reaction area, and a hydrophobic area that are at least partially disposed between the first colorimetric reaction area and the second colorimetric reaction area.
However, in the analogous art of colorimetric tests for analytes comprising reagent layers, Yu teaches a colorimetric test comprising reaction zones 20-24, surrounded by a hydrophobic barrier, see Fig. 1, [0051], where the hydrophobic matrix creates multiple reaction zones for different reagents).
The modification of a colorimetric test to incorporate hydrophobic barriers that separate different colorimetric reagents was known in the art before the effective filing date as evidenced by Yu. Therefore, it would have been obvious to a person possessing ordinary skill in the art before the effective filing date to substitute the colorimetric test pad of DiMagno et al. for the colorimetric test strip with the hydrophobic barrier between reagent areas for the benefit of directly moving a sample from the entrance to separated reaction areas for the detection of the concentration of multiple analytes of interest using a colorimetric indicator (see [0051] in Yu). Further, the modification of the colorimetric test pad of DiMagno et al. would have had the reasonable expectation of successfully facilitating the flow of a sample liquid down a path to react with a reagent a provide a colorimetric response to be detected by a reader.
Regarding claim 17, DiMagno et al. teaches the apparatus of claim 16, wherein each of the one or more colorimetric analysis regions comprises a first colorimetric reaction area, but does not teach that colorimetric region comprises a second colorimetric reaction area, and a hydrophobic area that are at least partially disposed between the first colorimetric reaction area and the second colorimetric reaction area.
However, in the analogous art of colorimetric tests for analytes comprising reagent layers, Yu teaches a colorimetric test comprising reaction zones 20-24, surrounded by a hydrophobic barrier, see Fig. 1, [0051], where the hydrophobic matrix creates multiple reaction zones for different reagents).
The modification of a colorimetric test to incorporate hydrophobic barriers that separate different colorimetric reagents was known in the art before the effective filing date as evidenced by Yu. Therefore, it would have been obvious to a person possessing ordinary skill in the art before the effective filing date to substitute the colorimetric test pad of DiMagno et al. for the colorimetric test strip with the hydrophobic barrier between reagent areas for the benefit of directly moving a sample from the entrance to separated reaction areas for the detection of the concentration of multiple analytes of interest using a colorimetric indicator (see [0051] in Yu). Further, the modification of the colorimetric test pad of DiMagno et al. would have had the reasonable expectation of successfully facilitating the flow of a sample liquid down a path to react with a reagent a provide a colorimetric response to be detected by a reader.
Claims 15, 18, 23-27 are rejected under 35 U.S.C. 103 as being unpatentable over DiMagno et al. (US 2016/0025715) in view of Whitesides et al. (US 20090298191) as applied to claim 13 above, and further in view of Ramel et al. (US 2005/0227370).
Regarding claim 15, DiMagno et al. teaches the apparatus of claim 14, but does not teach a graphical element on the housing, wherein the graphical element is encoded with information associated with the first diagnostic element and the second diagnostic element.
However, in the analogous art of analyte meters using immunoassay elements, Ramel et al. teaches a housing having a machine-readable identifier visible thereon where the machine-readable identifier is encoded with information associated with a type of apparatus (referred to as the machine readable code on the exterior of the cartridge that encodes identification information about the tests, see [0166] - [0167], where the code is detected by an optical reader, or imager).
The modification of the test cartridge of DiMagno et al. to include the graphical element of Ramel et al. was a known modification in the art of analyte meters to encode information regarding a test used within said meter (see [0166] – [0167]). Therefore, a person possessing ordinary skill in the art before the effective filing date of the instant application would have been motivated to add the graphical element of Ramel et al. to the outer surface of the apparatus of DiMagno et al. for the benefit of encoding test cartridge information for a cartridge reader, see [0167] in Ramel. Additionally, the modification of the apparatus of DiMagno et al. to include the graphical element of Ramel would have had the reasonable expectation of successfully facilitating the transferring of information from a cartridge to the reader for analysis.
Regarding claim 18, DiMagno et al. teaches the apparatus of claim 13, but does not teach that the device further comprises a pressure point element facilitating fluid communication along the first and second flow passageways.
However, in the analogous art of analyte detecting meters, Ramel et al. teaches a device further comprising a pressure point element (support ribs 454 and 464, see Fig. 5B-C and [0158]) facilitating fluid communication along the first and second flow paths (support ribs apply pressure to move sample across each test strip, see [0158]).
The modification of the device of Ramel to include the pressure point element of Ramel et al. was a known modification in the art of analyte testing meters to position the test strips within the device to ensure a full fluid transfer O(See [0158] in Ramel). Therefore, it would have been obvious to a person possessing ordinary skill in the art before the effective filing date of the instant application to have modified the bottom substrate of DiMagno et al. to include the supporting ribs of Ramel to arrive the pressure point element of the claimed invention for the benefit of transferring fluid from one portion of the test strip to the next, see [0158] in Ramel. Furthermore, the modification of the testing device of DiMagno et al. to include the supporting ribs of Ramel et al. would have led to the predictable result of propelling fluid down a porous membrane by squeezing the fibers of the test strip.
Regarding claim 21, DiMagno et al. teaches the apparatus of claim 20, but does not teach that the apparatus comprises a machine-readable identifier on the housing, wherein the machine-readable identifier is encoded with information associated with a type of apparatus.
However, in the analogous art of analyte meters using immunoassay elements, Ramel et al. teaches a housing having a machine-readable identifier visible thereon where the machine-readable identifier is encoded with information associated with a type of apparatus (referred to as the machine readable code on the exterior of the cartridge that encodes identification information about the tests, see [0166] - [0167], where the code is detected by an optical reader, or imager).
The modification of the test cartridge of DiMagno et al. to include the graphical element of Ramel et al. was a known modification in the art of analyte meters to encode information regarding a test used within said meter (see [0166] – [0167]). Therefore, a person possessing ordinary skill in the art before the effective filing date of the instant application would have been motivated to add the graphical element of Ramel et al. to the outer surface of the apparatus of DiMagno et al. for the benefit of encoding test cartridge information for a cartridge reader, see [0167] in Ramel. Additionally, the modification of the apparatus of DiMagno et al. to include the graphical element of Ramel would have had the reasonable expectation of successfully facilitating the transferring of information from a cartridge to the reader for analysis.
Regarding claim 23, DiMagno et al. teaches a system comprising:
a rapid test device (assay device 100, see Fig. 1 and [0061]) comprising:
a sample receiving region (sample addition area 140, see [0065]);
first and second diagnostic elements supported by the housing (test elements 121/122, see [0087] – [0088]);
wherein the first diagnostic element and the second diagnostic element perform mutually different analyses requiring different volumes of liquid, and wherein at least one of the first diagnostic element and the second diagnostic element includes a colorimetric analysis region requiring a first volume of liquid (test element 121 is a colorimetric test paper with a color changing region, see [0063], and Claims 8-9, second test element 122 is a lateral flow assay device, see, [0088], [0095], and Claims 8-9, where colorimetric tests and lateral flow assays use different volumes of fluid, see [0003] of the Instant Specification);
and a processor and one or more computer readable storage media, and program instructions collectively stored on the one or more computer readable storage media, the program instructions executable by the processor to cause the processor to perform operations (computer readable storage medium 1640 contains instructions for processor 1686 to execute image capture and storage, see [0144] – [0147]) comprising:
capturing an image of the housing and executing at least one data processing function on the captured image, wherein the data processing function comprises comparing a color attribute at a readout region in the captured image to color references in the captured image to determine at least one chemical attribute of a test sample (the imager is used to capture an image of the test elements, see [0115], where the imager is used to determine the presence of an analyte based on the detectable response, see [0121]).
However, DiMagno et al. does not teach a hydrophobic structure deposited on a distribution substrate, wherein the hydrophobic structure asymmetrically defines a first flow path from the sample receiving region to the first diagnostic element and defines a second flow path from the sample receiving region to the second diagnostic element, such that the different required volumes of liquid flow from the sample receiving region to the first and second diagnostic elements. A later embodiment of the prior art teaches a porous member (distribution substrate) with blocking material (hydrophobic structure) laid over the top to allow more fluid to enter the first test element (first flow path) than the second test element (second flow path) (see [0074]).
Because the difference between the prior art and the claim invention was a known variation of the diverter, the use of a diverter to asymmetrically distribute the sample to different test elements would have been recognized as predictable to one of ordinary skill in the art before the effective filing date of the instant invention. This is because there are design incentives for implementing the claimed variation. Specifically, asymmetrically dividing the sample would allow for the combining of test elements that require different volumes of fluid in a singular device i.e., colorimetric and lateral flow tests, see [0074]. Ultimately, modifying the diverter to asymmetrically divide the sample would have the reasonable expectation of successfully facilitating the flow of fluid to a respective test element.
In addition, the current embodiment does not teach that the liquid flows to the first diagnostic element via a plurality of sub- channels designed to originate from a common point in the first flow path and cause an increase in a speed of the flow to the first diagnostic element. A later embodiment teaches the first flow path (808) leading to a test element wherein the path contains a plurality of microposts 707 that create a plurality of microfluidic channels that induce flow across a test strip, see [0088] – [0089].
Because the difference between the prior art and the claimed invention was a known variation of the fluid flow path, the use of microposts within the fluid flow path so as to increase the speed of fluid flow would have been recognized as predictable to one of ordinary skill in the art before the effective filing date of the instant invention. This is because there are design incentives for implementing the claimed variation. Specifically, providing a plurality fa channels with varied dimensions within a device would induce capillary flow of the received fluidic sample once the fluidic sample is introduced to the fluid flow path, see [0089]. Ultimately, modifying the flow path to include microposts to create a plurality of sub-channels within a main fluid flow path would have the reasonable expectation of successfully facilitating the flow of fluid to a respective test element.
Further, DiMagno et al. does not teach a housing having a graphical element visible thereon and subsequently does not teach capturing an image of the housing including the graphical element.
However, in the analogous art of analyte meters using immunoassay elements, Ramel et al. teaches a housing having a graphical element visible thereon and capturing an image of the housing including the graphical element (referred to as the machine readable code on the exterior of the cartridge that encodes identification information about the tests, see [0166] - [0167], where the code is detected by an optical reader, or imager).
The modification of the test cartridge of DiMagno et al. to include the graphical element of Ramel et al. was a known modification in the art of analyte meters to encode information regarding a test used within said meter (see [0166] – [0167]). Therefore, a person possessing ordinary skill in the art before the effective filing date of the instant application would have been motivated to add the graphical element of Ramel et al. to the outer surface of the apparatus of DiMagno et al. for the benefit of encoding test cartridge information for a cartridge reader, see [0167] in Ramel. Additionally, the modification of the apparatus of DiMagno et al. to include the graphical element of Ramel would have had the reasonable expectation of successfully facilitating the transferring of information from a cartridge to the reader for analysis.
Regarding claim 24, modified DiMagno et al. teaches the system of claim 23, wherein the test sample is selected from the group consisting of blood, plasma, serum, lymph, urine, saliva, semen, amniotic fluid, gastric fluid, phlegm, sputum, mucus, tears, stool, and water (sample comprises blood, see [0003], [0024], [0050], and [0139] in DiMagno).
Regarding claim 25, modified DiMagno et al. teaches the system of claim 24, further comprising the program instructions executable by the processor to cause the processor to perform operations further comprising:
decoding at least a portion of the graphical element to obtain a remote data storage location; and transmitting data regarding the at least one chemical attribute of the test sample to the remote data storage location (the computer readable storage device causes the processor to analyze image to store data in a memory device, see [0144] – [0146] in DiMagno).
Conclusion
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/A.N.M./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758