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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 February 03, 2026 has been entered.
Response to Amendment
The Amendment filed February 03, 2026 has been entered. Claims 70-96 remain pending in the application.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 70-83 and 86-96 are rejected under 35 U.S.C. 103 as being unpatentable over Phan et al. (US 2005/0106713 A1) (hereinafter – Phan) in view of Schoendorfer (US 5438984 A) ("Schoendorfer") in further view of Irina et al. (US 2012/0165626 A1) (hereinafter – Irina) in further view of Rogers et al. (US 2013/0041235 A1) (hereinafter – Rogers).
Regarding claim 70, Phan discloses An epidermal microfluidic sweat patch comprising (Abstract and entire document):
a flexible and stretchable substrate having a net bending stiffness and an elastic modulus similar to human skin, such that the epidermal microfluidic sweat patch is capable of establishing a conformal contact with a human skin surface by direct adhesion to the human skin surface by an adhesive or an intermediate bonding structure between the flexible and stretchable substrate and the human skin surface, wherein during use the conformal contact remains for various epidermal mechanical stresses comprising tension forces and/or compression forces (See at least FIG. 7A and Para. [0019], “The bio-patch is implemented in a number of integrated flexible layers to form a light weight adhesively applied interactive dermal patch.” And para. [0084], “he spacing layer 162 may be formed from any suitable flexible plastic material such as polymethylmethacrylate (PMMA), polycarbonate, polytetrafluoroethylene (TEFLON.TM.), polyvinylchloride (PVC), polydimethylsiloxane (PDMS), polysulfone, and the like.” And para. [0251], “For example, the bio-patch implementation may be made to conform to any particular surface area of the body and is not intended to necessarily be limited to a rectangular shape for use on the wrist areas. Any number of different size and shape configurations would be applicable. The bio-patch may also have pre-defined contours to promote adhesion with the body surface for use, for example, on the lower back, lower neck, shoulder, chest area, or skull.” Patch is made of a flexible material that adheres to the skin and conforms to the shape and motion of the skin);
a microfluidic channel disposed in said flexible and stretchable substrate, the microfluidic channel having an inlet, formed from the flexible and stretchable substrate, on a bottom surface of the flexible and stretchable substrate to non-invasively receive sweat released by skin sweat glands without any epidermal penetration, wherein the inlet is a hole or pore of the flexible and stretchable substrate and is coincident with the bottom surface of the flexible and stretchable substrate (FIG. 7A and para. [0083], “Alternatively, the tubules, lancets, or micro-probes 159 may be non-invasive and then implemented to acquire sweat or perspiration form the skin surface of a user.” And para. [0084], “As illustrated in FIG. 7A, the spacing layer 162 is provided with reservoir openings 164. The reservoir openings 164 are cutouts in the layer 162 which are positioned to be in register with corresponding inlet formations 166 integrally formed in the sample acquisition layer 116.” Inlet is 166/160/159 channel is 166/164. As shown in FIG. 7A, without the 159/160, for non-invasive sweat monitoring as in para. [0083], the inlet thus becomes a hole or a pore on the bottom of the substrate, formed of the substrate, to allow sweat to flow into the device, non-invasively.);
a cavity disposed in said flexible and stretchable substrate, wherein the cavity is fluidically connected to the inlet or the microfluidic channel for receiving sweat released by skin sweat glands (Para. [0084], “Thus in this manner when the microprobes 159 penetrate the users skin, blood begins to flow by capillary action and then fills the sample collection chamber 224 (FIGS. 9 and 10) formed by a respective reservoir opening 164 and its corresponding inlet formation 166.” Sample collection chamber 224 is a cavity that receives the sweat.),
wherein the conformal contact is configured to provide sweat flow through the microfluidic channel to the cavity under a pressure generated by the skin sweat glands at the hole or pore (Para. [0084], “Thus in this manner when the microprobes 159 penetrate the users skin, blood begins to flow by capillary action and then fills the sample collection chamber 224 (FIGS. 9 and 10) formed by a respective reservoir opening 164 and its corresponding inlet formation 166.” And para. [0083], “Alternatively, the tubules, lancets, or micro-probes 159 may be non-invasive and then implemented to acquire sweat or perspiration form the skin surface of a user.”); and
Phan fails to explicitly disclose that the bottom surface of the flexible and stretchable substrate is configured to contact the human surface and non-invasively receive sweat released by skin sweat glands without any epidermal penetration;
a plurality of colorimetric indicators disposed in the microfluidic channel and/or in the cavity for multiparametric detection of a plurality of sweat parameters.
wherein the net bending stiffness is less than or equal to 1mN m and the elastic modulus is selected over the range of 0.5 kPa to 100 MPA
However, in the same field of endeavor, Schoendorfer teaches the bottom surface of the flexible and stretchable substrate is configured to contact the human surface and non-invasively receive sweat released by skin sweat glands without any epidermal penetration (See at least FIG. 1 and associated paragraphs, “Moisture expressed from the skin 12 within the perimeter of the test patch 10 first accumulates in a concentration zone 14 beneath the first side of a gas permeable filter or layer 16 which is in fluid communication with the skin 12. The concentration zone 14 preferably contains an absorbent material, such as a fluid permeable medium 20 which may be cotton gauze or other commonly available fluid permeable material.”);
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the epidermal microfluidic sweat patch as taught by Phan to include the bottom surface of the flexible and stretchable substrate is configured to contact the human surface and non-invasively receive sweat released by skin sweat glands without any epidermal penetration as taught by Schoendorfer to assist in concentrating the materials (FIG. 1 and associated paragraphs, “Preferably, such a material is also able to concentrate such analytes on the patch.”).
Phan as modified fails to disclose a plurality of colorimetric indicators disposed in the microfluidic channel and/or in the cavity for multiparametric detection of a plurality of sweat parameters.
wherein the net bending stiffness is less than or equal to 1mN m and the elastic modulus is selected over the range of 0.5 kPa to 100 MPA
However, in the same field of endeavor, Irina teaches a plurality of colorimetric indicators disposed in the microfluidic channel and/or in the cavity for multiparametric detection of a plurality of sweat parameters (Para. [0091], “In other variations, the light emitted and/or reflected from the colorimetric membrane may be recorded over a period of time, in preprogrammed intervals (e.g., using a video camera). The color of the test strip can be measured while the colorimetric membrane is reacting with the sample and changing color (on-meter dosing), or after the colorimetric membrane has completed the color change (off-meter dosing).” Time-lapsed image recording may provide additional data that may be used to evaluate the fluid sample, for example, to estimate the sweat rate by monitoring the appearance of colored spots, and may be used to signal whether sufficient sample has been collected (e.g., to signal insufficient or excessive sample volume).”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the epidermal microfluidic sweat patch as taught by Phan as modified to include a colorimetric sensors as taught by Irina in order to have non-invasive and quick measurements (Para. [0007], “It would also be desirable for such devices, methods, and kits to be non-invasive and easy to use. It would further be desirable to provide methods for measuring or otherwise evaluating the concentration of one or more analytes in a body fluid in a relatively short period of time.”).
Phan as modified fails to disclose wherein the net bending stiffness is less than or equal to 1mN m and the elastic modulus is selected over the range of 0.5 kPa to 100 MPA
However, in the same field of endeavor, Rogers teaches wherein the net bending stiffness is less than or equal to 1mN m and the elastic modulus is selected over the range of 0.5 kPa to 100 MPA (Para. [0013], “In an embodiment, the device has a net bending stiffness less than or equal to 1 nN m, optionally less than or equal to 0.5 nN m. In an aspect, the device has a net bending stiffness selected over the range of 0.1 to 1 nN m, optionally 0.1 to 0.5 nN m, optionally 0.2 nN m to 1 nNm.” And para. [0011], “In an aspect, the device has an average modulus less than or equal to 100 kPa. In an aspect, the device has an average modulus less than or equal to 50 kPa. In another aspect, the device has an average modulus selected over the range of 0.5 kPa to 100 kPa,).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the epidermal microfluidic sweat patch as taught by Phan as modified to include wherein the net bending stiffness is less than or equal to 1mN m and the elastic modulus is selected over the range of 0.5 kPa to 100 MPA as taught by Rogers in order to maintain conformal contact (Para. [0009], “wherein the flexible or stretchable substrate, barrier layer and the electronic circuit provide a net bending stiffness, thickness, effective elastic modulus, and areal mass density of the device such that the device establishes conformal contact with the skin of the subject.”).
Regarding claim 71, Phan as modified teaches The epidermal microfluidic sweat patch of claim 70, Phan fails to disclose wherein said plurality of sweat parameters are two or more sweat parameters selected from the group consisting of: sweat volume and/or sweat rate; sweat pH; glucose concentration; lactate concentration; chloride concentration; creatinine concentration; copper ion concentration; iron ion concentration and ethanol concentration.
However, in the same field of endeavor, Irina teaches wherein said plurality of sweat parameters are two or more sweat parameters selected from the group consisting of: sweat volume and/or sweat rate; sweat pH; glucose concentration; lactate concentration; chloride concentration; creatinine concentration; copper ion concentration; iron ion concentration and ethanol concentration (Para. [0091], “In other variations, the light emitted and/or reflected from the colorimetric membrane may be recorded over a period of time, in preprogrammed intervals (e.g., using a video camera). The color of the test strip can be measured while the colorimetric membrane is reacting with the sample and changing color (on-meter dosing), or after the colorimetric membrane has completed the color change (off-meter dosing).” Time-lapsed image recording may provide additional data that may be used to evaluate the fluid sample, for example, to estimate the sweat rate by monitoring the appearance of colored spots, and may be used to signal whether sufficient sample has been collected (e.g., to signal insufficient or excessive sample volume).” Includes sweat rate and volume.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the epidermal microfluidic sweat patch as taught by Phan to include a colorimetric sensors as taught by Irina in order to have non-invasive and quick measurements (Para. [0007], “It would also be desirable for such devices, methods, and kits to be non-invasive and easy to use. It would further be desirable to provide methods for measuring or otherwise evaluating the concentration of one or more analytes in a body fluid in a relatively short period of time.”).
Regarding claim 72, Phan discloses An epidermal microfluidic sweat patch comprising:
a flexible and stretchable substrate having a net bending stiffness and an elastic modulus similar to skin, such that during use the epidermal microfluidic sweat patch maintains conformal contact with an epidermal layer for various epidermal mechanical stresses comprising tension, compression and twist stresses (See at least FIG. 7A and Para. [0019], “The bio-patch is implemented in a number of integrated flexible layers to form a light weight adhesively applied interactive dermal patch.” And para. [0084], “he spacing layer 162 may be formed from any suitable flexible plastic material such as polymethylmethacrylate (PMMA), polycarbonate, polytetrafluoroethylene (TEFLON.TM.), polyvinylchloride (PVC), polydimethylsiloxane (PDMS), polysulfone, and the like.” And para. [0251], “For example, the bio-patch implementation may be made to conform to any particular surface area of the body and is not intended to necessarily be limited to a rectangular shape for use on the wrist areas. Any number of different size and shape configurations would be applicable. The bio-patch may also have pre-defined contours to promote adhesion with the body surface for use, for example, on the lower back, lower neck, shoulder, chest area, or skull.” Patch is made of a flexible material that adheres to the skin and conforms to the shape and motion of the skin);
a microfluidic channel disposed in said flexible and stretchable substrate, the microfluidic channel having an inlet, formed from the flexible and stretchable substrate, on a bottom surface of the flexible and stretchable substrate configured to non-invasively receive sweat released by skin sweat glands without any epidermal penetration, wherein the inlet is a hole or pore of the flexible and stretchable substrate and is coincident with the bottom surface of the flexible and stretchable substrate (FIG. 7A and para. [0083], “Alternatively, the tubules, lancets, or micro-probes 159 may be non-invasive and then implemented to acquire sweat or perspiration form the skin surface of a user.” And para. [0084], “As illustrated in FIG. 7A, the spacing layer 162 is provided with reservoir openings 164. The reservoir openings 164 are cutouts in the layer 162 which are positioned to be in register with corresponding inlet formations 166 integrally formed in the sample acquisition layer 116.” Inlet is 166/160/159 channel is 166/164. As shown in FIG. 7A, without the 159/160, for non-invasive sweat monitoring as in para. [0083], the inlet thus becomes a hole or a pore on the bottom of the substrate, formed of the substrate, to allow sweat to flow into the device, non-invasively.);
a cavity disposed in said flexible and stretchable substrate, wherein the cavity is fluidically connected to the inlet or the microfluidic channel for receiving sweat released by skin sweat glands (Para. [0084], “Thus in this manner when the microprobes 159 penetrate the users skin, blood begins to flow by capillary action and then fills the sample collection chamber 224 (FIGS. 9 and 10) formed by a respective reservoir opening 164 and its corresponding inlet formation 166.” Sample collection chamber 224 is a cavity that receives the sweat.); and
Phan fails to explicitly disclose that the bottom surface of the flexible and stretchable substrate is configured to contact the human surface and non-invasively receive sweat released by skin sweat glands without any epidermal penetration;
a plurality of colorimetric indicators disposed in the microfluidic channel and/or in the cavity for multiparametric detection of a plurality of sweat parameters;
wherein at least one of the colorimetric indicators is configured to determine a sweat parameter as a function of time by providing an optically detectable photonic response in the microfluidic channel and/or the cavity that is time-varying in the microfluidic channel and/or the cavity.
However, in the same field of endeavor, Schoendorfer teaches the bottom surface of the flexible and stretchable substrate is configured to contact the human surface and non-invasively receive sweat released by skin sweat glands without any epidermal penetration (See at least FIG. 1 and associated paragraphs, “Moisture expressed from the skin 12 within the perimeter of the test patch 10 first accumulates in a concentration zone 14 beneath the first side of a gas permeable filter or layer 16 which is in fluid communication with the skin 12. The concentration zone 14 preferably contains an absorbent material, such as a fluid permeable medium 20 which may be cotton gauze or other commonly available fluid permeable material.”);
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the epidermal microfluidic sweat patch as taught by Phan to include the bottom surface of the flexible and stretchable substrate is configured to contact the human surface and non-invasively receive sweat released by skin sweat glands without any epidermal penetration as taught by Schoendorfer to assist in concentrating the materials (FIG. 1 and associated paragraphs, “Preferably, such a material is also able to concentrate such analytes on the patch.”).
Phan as modified fails to disclose a plurality of colorimetric indicators disposed in the microfluidic channel and/or in the cavity for multiparametric detection of a plurality of sweat parameters;
wherein at least one of the colorimetric indicators is configured to determine a sweat parameter as a function of time by providing an optically detectable photonic response in the microfluidic channel and/or the cavity that is time-varying in the microfluidic channel and/or the cavity.
However, in the same field of endeavor, Irina teaches a plurality of colorimetric indicators disposed in the microfluidic channel and/or in the cavity for multiparametric detection of a plurality of sweat parameters (Para. [0091], “In other variations, the light emitted and/or reflected from the colorimetric membrane may be recorded over a period of time, in preprogrammed intervals (e.g., using a video camera). The color of the test strip can be measured while the colorimetric membrane is reacting with the sample and changing color (on-meter dosing), or after the colorimetric membrane has completed the color change (off-meter dosing).” Time-lapsed image recording may provide additional data that may be used to evaluate the fluid sample, for example, to estimate the sweat rate by monitoring the appearance of colored spots, and may be used to signal whether sufficient sample has been collected (e.g., to signal insufficient or excessive sample volume).”);
wherein at least one of the colorimetric indicators is configured to determine a sweat parameter as a function of time by providing an optically detectable photonic response in the microfluidic channel and/or the cavity that is time-varying in the microfluidic channel and/or the cavity (Para. [0091], “In other variations, the light emitted and/or reflected from the colorimetric membrane may be recorded over a period of time, in preprogrammed intervals (e.g., using a video camera). The color of the test strip can be measured while the colorimetric membrane is reacting with the sample and changing color (on-meter dosing), or after the colorimetric membrane has completed the color change (off-meter dosing).” Time-lapsed image recording may provide additional data that may be used to evaluate the fluid sample, for example, to estimate the sweat rate by monitoring the appearance of colored spots, and may be used to signal whether sufficient sample has been collected (e.g., to signal insufficient or excessive sample volume).”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the epidermal microfluidic sweat patch as taught by Phan as modified to include a colorimetric sensors as taught by Irina in order to have non-invasive and quick measurements (Para. [0007], “It would also be desirable for such devices, methods, and kits to be non-invasive and easy to use. It would further be desirable to provide methods for measuring or otherwise evaluating the concentration of one or more analytes in a body fluid in a relatively short period of time.”).
Phan as modified fails to disclose wherein the net bending stiffness is less than or equal to 1mN m and the elastic modulus is selected over the range of 0.5 kPa to 100 MPA
However, in the same field of endeavor, Rogers teaches wherein the net bending stiffness is less than or equal to 1mN m and the elastic modulus is selected over the range of 0.5 kPa to 100 MPA (Para. [0013], “In an embodiment, the device has a net bending stiffness less than or equal to 1 nN m, optionally less than or equal to 0.5 nN m. In an aspect, the device has a net bending stiffness selected over the range of 0.1 to 1 nN m, optionally 0.1 to 0.5 nN m, optionally 0.2 nN m to 1 nNm.” And para. [0011], “In an aspect, the device has an average modulus less than or equal to 100 kPa. In an aspect, the device has an average modulus less than or equal to 50 kPa. In another aspect, the device has an average modulus selected over the range of 0.5 kPa to 100 kPa,).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the epidermal microfluidic sweat patch as taught by Phan as modified to include wherein the net bending stiffness is less than or equal to 1mN m and the elastic modulus is selected over the range of 0.5 kPa to 100 MPA as taught by Rogers in order to maintain conformal contact (Para. [0009], “wherein the flexible or stretchable substrate, barrier layer and the electronic circuit provide a net bending stiffness, thickness, effective elastic modulus, and areal mass density of the device such that the device establishes conformal contact with the skin of the subject.”).
Regarding claim 73, Phan as modified teaches The epidermal microfluidic sweat patch of claim 72, Phan fails to disclose wherein the at least one sweat parameter as a function of time comprises sweat volume or sweat rate.
However, in the same field of endeavor, Irina teaches wherein the at least one sweat parameter as a function of time comprises sweat volume or sweat rate (Para. [0091], “In other variations, the light emitted and/or reflected from the colorimetric membrane may be recorded over a period of time, in preprogrammed intervals (e.g., using a video camera). The color of the test strip can be measured while the colorimetric membrane is reacting with the sample and changing color (on-meter dosing), or after the colorimetric membrane has completed the color change (off-meter dosing).” Time-lapsed image recording may provide additional data that may be used to evaluate the fluid sample, for example, to estimate the sweat rate by monitoring the appearance of colored spots, and may be used to signal whether sufficient sample has been collected (e.g., to signal insufficient or excessive sample volume).” Includes sweat rate and volume.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the epidermal microfluidic sweat patch as taught by Phan to include a colorimetric sensors as taught by Irina in order to have non-invasive and quick measurements (Para. [0007], “It would also be desirable for such devices, methods, and kits to be non-invasive and easy to use. It would further be desirable to provide methods for measuring or otherwise evaluating the concentration of one or more analytes in a body fluid in a relatively short period of time.”).
Regarding claim 74, Phan as modified teaches The epidermal microfluidic sweat patch of claim 73, Phan fails to disclose wherein the at least one colorimetric indicator that determines the sweat volume or sweat rate as a function of time is disposed in the microfluidic channel to provide an optically detectable sweat fluid leading edge in the microfluidic channel whose position can vary as a function of time.
However, in the same field of endeavor, Irina teaches wherein the at least one colorimetric indicator that determines the sweat volume or sweat rate as a function of time is disposed in the microfluidic channel to provide an optically detectable sweat fluid leading edge in the microfluidic channel whose position can vary as a function of time (Para. [0091], “In other variations, the light emitted and/or reflected from the colorimetric membrane may be recorded over a period of time, in preprogrammed intervals (e.g., using a video camera). The color of the test strip can be measured while the colorimetric membrane is reacting with the sample and changing color (on-meter dosing), or after the colorimetric membrane has completed the color change (off-meter dosing).” Time-lapsed image recording may provide additional data that may be used to evaluate the fluid sample, for example, to estimate the sweat rate by monitoring the appearance of colored spots, and may be used to signal whether sufficient sample has been collected (e.g., to signal insufficient or excessive sample volume).”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the epidermal microfluidic sweat patch as taught by Phan to include a colorimetric sensors as taught by Irina in order to have non-invasive and quick measurements (Para. [0007], “It would also be desirable for such devices, methods, and kits to be non-invasive and easy to use. It would further be desirable to provide methods for measuring or otherwise evaluating the concentration of one or more analytes in a body fluid in a relatively short period of time.”).
Regarding claim 75, Phan as modified teaches The epidermal microfluidic sweat patch of claim 70, Phan further discloses comprising a plurality of detection reservoirs each fluidically connected to the microfluidic channel (FIG. 7A, shows 8 different channels 166/164 and detectors 180 see at least para. [0083] – [0088]),
Phan fails to disclose wherein each detection reservoir contains a unique colorimetric indicator.
However, in the same field of endeavor, Irina teaches wherein each detection reservoir contains a unique colorimetric indicator (Para. [0091], “In other variations, the light emitted and/or reflected from the colorimetric membrane may be recorded over a period of time, in preprogrammed intervals (e.g., using a video camera). The color of the test strip can be measured while the colorimetric membrane is reacting with the sample and changing color (on-meter dosing), or after the colorimetric membrane has completed the color change (off-meter dosing).” Time-lapsed image recording may provide additional data that may be used to evaluate the fluid sample, for example, to estimate the sweat rate by monitoring the appearance of colored spots, and may be used to signal whether sufficient sample has been collected (e.g., to signal insufficient or excessive sample volume).”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the epidermal microfluidic sweat patch as taught by Phan to include a colorimetric sensors as taught by Irina in order to have non-invasive and quick measurements (Para. [0007], “It would also be desirable for such devices, methods, and kits to be non-invasive and easy to use. It would further be desirable to provide methods for measuring or otherwise evaluating the concentration of one or more analytes in a body fluid in a relatively short period of time.”).
Regarding claim 76, Phan as modified teaches The epidermal microfluidic sweat patch of claim 75, Phan further discloses comprising four detection reservoirs for detecting four unique sweat parameters (FIG. 7A, shows 8 different channels 166/164 and detectors 180 see at least para. [0083] – [0088]).
Regarding claim 77, Phan as modified teaches The epidermal microfluidic sweat patch of claim 70, Phan further discloses wherein the flexible and stretchable substrate comprises polydimethysiloxane (PDMS) having the net bending stiffness selected such that the epidermal microfluidic sweat patch is capable of establishing the conformal contact with an epidermal surface (See at least FIG. 7A and Para. [0019], “The bio-patch is implemented in a number of integrated flexible layers to form a light weight adhesively applied interactive dermal patch.” And para. [0084], “he spacing layer 162 may be formed from any suitable flexible plastic material such as polymethylmethacrylate (PMMA), polycarbonate, polytetrafluoroethylene (TEFLON.TM.), polyvinylchloride (PVC), polydimethylsiloxane (PDMS), polysulfone, and the like.” And para. [0251], “For example, the bio-patch implementation may be made to conform to any particular surface area of the body and is not intended to necessarily be limited to a rectangular shape for use on the wrist areas. Any number of different size and shape configurations would be applicable. The bio-patch may also have pre-defined contours to promote adhesion with the body surface for use, for example, on the lower back, lower neck, shoulder, chest area, or skull.” Patch is made of a flexible material that adheres to the skin and conforms to the shape and motion of the skin).
Regarding claim 78, Phan as modified teaches The epidermal microfluidic sweat patch of claim 70, Phan further discloses wherein the flexible and stretchable substrate is to provide a non-invasive daily-wear patch for personal healthcare monitoring (Para. [0083], “Alternatively, the tubules, lancets, or micro-probes 159 may be non-invasive and then implemented to acquire sweat or perspiration form the skin surface of a user.”).
Regarding claim 79, Phan as modified teaches The epidermal microfluidic sweat patch of claim 70, Phan further discloses wherein the microfluidic channel is part of a two-dimensional channel system within a PDMS substrate that directs a flow of sweat released from skin without pumps, valves or fluid detectors (FIG. 7A and para. [0084], “Thus in this manner when the microprobes 159 penetrate the users skin, blood begins to flow by capillary action and then fills the sample collection chamber 224 (FIGS. 9 and 10) formed by a respective reservoir opening 164 and its corresponding inlet formation 166.” And Para. [0083], “Alternatively, the tubules, lancets, or micro-probes 159 may be non-invasive and then implemented to acquire sweat or perspiration form the skin surface of a user.”).
Regarding claim 80, Phan as modified teaches The epidermal microfluidic sweat patch of claim 79, Phan further discloses further comprising a plurality of detection reservoirs connected to the two-dimensional channel system (FIG. 7A, shows 8 different channels 166/164 and detectors 180 see at least para. [0083] – [0088]).
Regarding claim 81, Phan discloses An epidermal microfluidic sweat patch configured to contact a skin surface comprising:
a flexible and stretchable substrate (See at least FIG. 7A and Para. [0019], “The bio-patch is implemented in a number of integrated flexible layers to form a light weight adhesively applied interactive dermal patch.” And para. [0084], “he spacing layer 162 may be formed from any suitable flexible plastic material such as polymethylmethacrylate (PMMA), polycarbonate, polytetrafluoroethylene (TEFLON.TM.), polyvinylchloride (PVC), polydimethylsiloxane (PDMS), polysulfone, and the like.” And para. [0251], “For example, the bio-patch implementation may be made to conform to any particular surface area of the body and is not intended to necessarily be limited to a rectangular shape for use on the wrist areas. Any number of different size and shape configurations would be applicable. The bio-patch may also have pre-defined contours to promote adhesion with the body surface for use, for example, on the lower back, lower neck, shoulder, chest area, or skull.” Patch is made of a flexible material that adheres to the skin and conforms to the shape and motion of the skin);
a microfluidic channel disposed in said flexible and stretchable substrate, the microfluidic channel having an inlet, formed from the flexible and stretchable substrate, on a bottom surface of the flexible and stretchable substrate configured to non-invasively receive sweat released by skin sweat glands without any epidermal penetration, wherein the inlet is a hole or pore of the flexible and stretchable substrate and is coincident with the bottom surface of the flexible and stretchable substrate (FIG. 7A and para. [0083], “Alternatively, the tubules, lancets, or micro-probes 159 may be non-invasive and then implemented to acquire sweat or perspiration form the skin surface of a user.” And para. [0084], “As illustrated in FIG. 7A, the spacing layer 162 is provided with reservoir openings 164. The reservoir openings 164 are cutouts in the layer 162 which are positioned to be in register with corresponding inlet formations 166 integrally formed in the sample acquisition layer 116.” Inlet is 166/160/159 channel is 166/164. As shown in FIG. 7A, without the 159/160, for non-invasive sweat monitoring as in para. [0083], the inlet thus becomes a hole or a pore on the bottom of the substrate, formed of the substrate, to allow sweat to flow into the device, non-invasively.);
a cavity disposed in said flexible and stretchable substrate, wherein the cavity is fluidically connected to the inlet or the microfluidic channel for receiving sweat released by skin sweat glands by direct adhesion of the flexible and stretchable substrate to the skin surface by an adhesive or an intermediate bonding structure between the flexible and stretchable substrate and the skin surface (Para. [0084], “Thus in this manner when the microprobes 159 penetrate the users skin, blood begins to flow by capillary action and then fills the sample collection chamber 224 (FIGS. 9 and 10) formed by a respective reservoir opening 164 and its corresponding inlet formation 166.” Sample collection chamber 224 is a cavity that receives the sweat. And para. [0083], “Alternatively, the tubules, lancets, or micro-probes 159 may be non-invasive and then implemented to acquire sweat or perspiration form the skin surface of a user.”); and
wherein the microfluidic channel and cavity together have a total volume selected to accommodate a volume of sweat released from skin for a time period of up to 6 hours (FIG. 7A and para. [0088], “The thickness of the fluid processing layer 118 relative to the thickness of the spacing layer 162 may be varied to achieve any desired volumetric relationship between the sample collection chamber 224, FIGS. 9 and 10, and the various components of the fluidic circuit represented in the fluid processing layer 118. For example, in a specific assay implementation it may be desired to have a relatively large sample volume collected in the chamber 224 while having the fluidic circuit of relatively smaller dimensions. In this case, for example, the spacing layer may be 500 microns thick while the fluid processing layer is, for example, 25 microns thick”); and
wherein the flexible and stretchable substrate have a net bending stiffness and an elastic modulus similar to skin such that during use the conformal contact remains for epidermal mechanical stresses comprising tension and/or compression forces (See at least FIG. 7A and Para. [0019], “The bio-patch is implemented in a number of integrated flexible layers to form a light weight adhesively applied interactive dermal patch.” And para. [0084], “he spacing layer 162 may be formed from any suitable flexible plastic material such as polymethylmethacrylate (PMMA), polycarbonate, polytetrafluoroethylene (TEFLON.TM.), polyvinylchloride (PVC), polydimethylsiloxane (PDMS), polysulfone, and the like.” And para. [0251], “For example, the bio-patch implementation may be made to conform to any particular surface area of the body and is not intended to necessarily be limited to a rectangular shape for use on the wrist areas. Any number of different size and shape configurations would be applicable. The bio-patch may also have pre-defined contours to promote adhesion with the body surface for use, for example, on the lower back, lower neck, shoulder, chest area, or skull.” Patch is made of a flexible material that adheres to the skin and conforms to the shape and motion of the skin).
Phan fails to explicitly disclose that the bottom surface of the flexible and stretchable substrate is configured to contact the human surface and non-invasively receive sweat released by skin sweat glands without any epidermal penetration;
a plurality of colorimetric indicators disposed in the microfluidic channel and/or in the cavity for multiparametric detection of a plurality of sweat parameters;
However, in the same field of endeavor, Schoendorfer teaches the bottom surface of the flexible and stretchable substrate is configured to contact the human surface and non-invasively receive sweat released by skin sweat glands without any epidermal penetration (See at least FIG. 1 and associated paragraphs, “Moisture expressed from the skin 12 within the perimeter of the test patch 10 first accumulates in a concentration zone 14 beneath the first side of a gas permeable filter or layer 16 which is in fluid communication with the skin 12. The concentration zone 14 preferably contains an absorbent material, such as a fluid permeable medium 20 which may be cotton gauze or other commonly available fluid permeable material.”);
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the epidermal microfluidic sweat patch as taught by Phan to include the bottom surface of the flexible and stretchable substrate is configured to contact the human surface and non-invasively receive sweat released by skin sweat glands without any epidermal penetration as taught by Schoendorfer to assist in concentrating the materials (FIG. 1 and associated paragraphs, “Preferably, such a material is also able to concentrate such analytes on the patch.”).
Phan as modified fails to disclose a plurality of colorimetric indicators disposed in the microfluidic channel and/or in the cavity for multiparametric detection of a plurality of sweat parameters;
However, in the same field of endeavor, Irina teaches a plurality of colorimetric indicators disposed in the microfluidic channel and/or in the cavity for multiparametric detection of a plurality of sweat parameters (Para. [0091], “In other variations, the light emitted and/or reflected from the colorimetric membrane may be recorded over a period of time, in preprogrammed intervals (e.g., using a video camera). The color of the test strip can be measured while the colorimetric membrane is reacting with the sample and changing color (on-meter dosing), or after the colorimetric membrane has completed the color change (off-meter dosing).” Time-lapsed image recording may provide additional data that may be used to evaluate the fluid sample, for example, to estimate the sweat rate by monitoring the appearance of colored spots, and may be used to signal whether sufficient sample has been collected (e.g., to signal insufficient or excessive sample volume).”);
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the epidermal microfluidic sweat patch as taught by Phan as modified to include a colorimetric sensors as taught by Irina in order to have non-invasive and quick measurements (Para. [0007], “It would also be desirable for such devices, methods, and kits to be non-invasive and easy to use. It would further be desirable to provide methods for measuring or otherwise evaluating the concentration of one or more analytes in a body fluid in a relatively short period of time.”).
Phan as modified fails to disclose wherein the net bending stiffness is less than or equal to 1mN m and the elastic modulus is selected over the range of 0.5 kPa to 100 MPA
However, in the same field of endeavor, Rogers teaches wherein the net bending stiffness is less than or equal to 1mN m and the elastic modulus is selected over the range of 0.5 kPa to 100 MPA (Para. [0013], “In an embodiment, the device has a net bending stiffness less than or equal to 1 nN m, optionally less than or equal to 0.5 nN m. In an aspect, the device has a net bending stiffness selected over the range of 0.1 to 1 nN m, optionally 0.1 to 0.5 nN m, optionally 0.2 nN m to 1 nNm.” And para. [0011], “In an aspect, the device has an average modulus less than or equal to 100 kPa. In an aspect, the device has an average modulus less than or equal to 50 kPa. In another aspect, the device has an average modulus selected over the range of 0.5 kPa to 100 kPa,).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the epidermal microfluidic sweat patch as taught by Phan as modified to include wherein the net bending stiffness is less than or equal to 1mN m and the elastic modulus is selected over the range of 0.5 kPa to 100 MPA as taught by Rogers in order to maintain conformal contact (Para. [0009], “wherein the flexible or stretchable substrate, barrier layer and the electronic circuit provide a net bending stiffness, thickness, effective elastic modulus, and areal mass density of the device such that the device establishes conformal contact with the skin of the subject.”).
Regarding claim 82, Phan as modified teaches The epidermal microfluidic sweat patch of claim 81, Phan further discloses wherein the microfluidic channel comprises an orbicular outer circular or serpentine fluidic channel (FIG. 7A shows shaped channels).
Regarding claim 83, Phan as modified teaches The epidermal microfluidic sweat patch of claim 70, Phan further discloses wherein the flexible and stretchable substrate comprises PDMS and has a total water loss that is less than 3% of sweat introduced to the microfluidic channel (See at least FIG. 7A and Para. [0019], “The bio-patch is implemented in a number of integrated flexible layers to form a light weight adhesively applied interactive dermal patch.” And para. [0084], “he spacing layer 162 may be formed from any suitable flexible plastic material such as polymethylmethacrylate (PMMA), polycarbonate, polytetrafluoroethylene (TEFLON.TM.), polyvinylchloride (PVC), polydimethylsiloxane (PDMS), polysulfone, and the like.” Same PDMS would also for the same water loss characteristics).
Regarding claim 86, Phan as modified teaches The epidermal microfluidic sweat patch of claim 70, Phan further discloses further comprising near field communication electronics supported by or embedded in the flexible and stretchable substrate for wireless communication with an external reader, including an external reader that is a smartphone, for quantitative determination of the plurality of sweat parameters (Para. [0030], “transmitting the information to a receiving device; and displaying output results associated with the medical information. This may include the further step of storing the information in the personal diagnostic device before the transmitting step is performed. The receiving device may be in the personal diagnostic device or it may be a personal computer, or linked to a communications network.”).
Regarding claim 87, Phan as modified teaches The epidermal microfluidic sweat patch of claim 70, Phan further discloses further comprising an image process marker laminated on or disposed in the flexible and stretchable substrate for white balance and color calibration under various light conditions (Para. [0094], “The optical emitter 228 and optical detector 230 may be embodied in a variety of different optical devices or formats including for example, but not limited to, charged coupled devices (CCD), fiber optics, nano-wires, micro-wires, semi-conductor light emitting and/or detecting materials, or other suitable light emitting and detecting materials or devices.”).
Regarding claim 88, Phan as modified teaches The epidermal microfluidic sweat patch of claim 70, Phan as modified fails to disclose further comprising an adhesive positioned on the bottom surface of the flexible or stretchable substrate to adhere the epidermal microfluidic sweat patch to skin at an adhesion force between 1 N to 10 N.
However, in the same field of endeavor, Rogers teaches further comprising an adhesive positioned on the bottom surface of the flexible and stretchable substrate to adhere the epidermal microfluidic sweat patch to skin at an adhesion force between 1 N to 10 N (Para. [0659] discussing adhesion forces of skin-like membranes).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the epidermal microfluidic sweat patch as taught by Phan as modified to include adhesion as taught by Rogers in order to maintain conformal contact (Para. [0009], “wherein the flexible or stretchable substrate, barrier layer and the electronic circuit provide a net bending stiffness, thickness, effective elastic modulus, and areal mass density of the device such that the device establishes conformal contact with the skin of the subject.”).
Regarding claim 89, Phan as modified teaches A method of measuring a plurality of sweat parameters, the method comprising the steps of (See rejections for claims 70 and 72 the same rejections can be applied as nothing different is claimed):
Regarding claim 90, Phan as modified teaches The method of claim 89, further comprising the step of monitoring at least one colorimetric change over time to determine a time course of at least one sweat parameter of the plurality of sweat parameters (See rejections for claims 70 and 72 the same rejections can be applied as nothing different is claimed).
Regarding claim 91, Phan as modified teaches The epidermal microfluidic sweat patch of claim 70, Phan further discloses wherein no sweat-absorbent material is positioned between the epidermal microfluidic sweat patch and the skin surface (Phan discloses direct adhesion and no sweat-absorbent material is needed).
Regarding claim 92, Phan as modified teaches The epidermal microfluidic sweat patch of claim 70, Phan as modified fails to disclose wherein the net bending stiffness is between 0.1 nN m to 1 nN m and the elastic modulus is less than or equal to 80 kPa.
However, in the same field of endeavor, Rogers teaches wherein the net bending stiffness is between 0.1 nN m to 1 nN m and the elastic modulus is less than or equal to 80 kPa (Para. [0013], “In an embodiment, the device has a net bending stiffness less than or equal to 1 nN m, optionally less than or equal to 0.5 nN m. In an aspect, the device has a net bending stiffness selected over the range of 0.1 to 1 nN m, optionally 0.1 to 0.5 nN m, optionally 0.2 nN m to 1 nNm.” And para. [0011], “In an aspect, the device has an average modulus less than or equal to 100 kPa. In an aspect, the device has an average modulus less than or equal to 50 kPa. In another aspect, the device has an average modulus selected over the range of 0.5 kPa to 100 kPa, “).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the epidermal microfluidic sweat patch as taught by Phan as modified to include stiffness and elastic modulus as taught by Rogers in order to maintain conformal contact (Para. [0009], “wherein the flexible or stretchable substrate, barrier layer and the electronic circuit provide a net bending stiffness, thickness, effective elastic modulus, and areal mass density of the device such that the device establishes conformal contact with the skin of the subject.”).
Regarding claim 93, Phan as modified teaches The epidermal microfluidic sweat patch of claim 70, Phan further discloses wherein the conformal contact is characterized by adaptation of the flexible and stretchable substrate to the skin surface such that at least 95% of the bottom surface of the flexible and stretchable substrate being in direct physical contact with the skin surface (Para. [0251], “For example, the bio-patch implementation may be made to conform to any particular surface area of the body and is not intended to necessarily be limited to a rectangular shape for use on the wrist areas. Any number of different size and shape configurations would be applicable. The bio-patch may also have pre-defined contours to promote adhesion with the body surface for use, for example, on the lower back, lower neck, shoulder, chest area, or skull.” Phan discloses direct adhesion and conformability and flexibility with the substrate which theoretically discloses 100 percent direct contact.).
Regarding claim 94, Phan as modified teaches The epidermal microfluidic sweat patch of claim 70, Phan further discloses wherein the microfluidic channel comprises one or more outlet channels configured to allow vapor to escape the microfluidic channel to the surrounding environment thereby facilitating the microfluidic channel receiving the sweat (Para. [0107], “Each of the chambers in the fluidic circuit may include a vent port 340 that allows air within the chamber to escape thereby preventing air blockages within the fluidic circuit. Vent port 340 may include a filter 342 that prevents contamination of the sample while allowing air to pass through.”).
Regarding claim 95, Phan as modified teaches The epidermal microfluidic sweat patch of claim 70, Phan further discloses comprising one or more detection reservoirs each fluidically connected to the microfluidic channel, wherein each detection reservoir comprises a sensor (Para. [0086], “The last principal layer illustrated in FIG. 7A is an assay results detection layer 178 which includes results detectors 180 each having an input 182 and output 184. The detector 180 may be embodied in any number of suitable types of detection formats including by way of example and not limitation, CCD imaging devices, electrical sensing or detecting electrodes, optical fibers, silicon-based sensors and bio-sensors,”); and
wherein each detection reservoir is directly or indirectly connected to an outlet channel configured to allow vapor to escape the detection reservoirs to the surrounding environment (Para. [0107], “Each of the chambers in the fluidic circuit may include a vent port 340 that allows air within the chamber to escape thereby preventing air blockages within the fluidic circuit. Vent port 340 may include a filter 342 that prevents contamination of the sample while allowing air to pass through.”).
Phan fails to disclose wherein a sensor is a colorimetric indicator
However, in the same field of endeavor, Irina teaches wherein a sensor is a colorimetric indicator (Para. [0091], “In other variations, the light emitted and/or reflected from the colorimetric membrane may be recorded over a period of time, in preprogrammed intervals (e.g., using a video camera). The color of the test strip can be measured while the colorimetric membrane is reacting with the sample and changing color (on-meter dosing), or after the colorimetric membrane has completed the color change (off-meter dosing).” Time-lapsed image recording may provide additional data that may be used to evaluate the fluid sample, for example, to estimate the sweat rate by monitoring the appearance of colored spots, and may be used to signal whether sufficient sample has been collected (e.g., to signal insufficient or excessive sample volume).”);
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the epidermal microfluidic sweat patch as taught by Phan to include a colorimetric sensors as taught by Irina in order to have non-invasive and quick measurements (Para. [0007], “It would also be desirable for such devices, methods, and kits to be non-invasive and easy to use. It would further be desirable to provide methods for measuring or otherwise evaluating the concentration of one or more analytes in a body fluid in a relatively short period of time.”).
Regarding claim 96, Phan as modified teaches The epidermal microfluidic sweat patch of claim 70, Phan further discloses wherein the flexible and stretchable substrate comprises greater than or equal to 50 pores/cm2 and less than or equal to 300 pores/cm2 (See at least FIG. 7A and Para. [0019], “The bio-patch is implemented in a number of integrated flexible layers to form a light weight adhesively applied interactive dermal patch.” And para. [0084], “he spacing layer 162 may be formed from any suitable flexible plastic material such as polymethylmethacrylate (PMMA), polycarbonate, polytetrafluoroethylene (TEFLON.TM.), polyvinylchloride (PVC), polydimethylsiloxane (PDMS), polysulfone, and the like.” And para. [0251], “For example, the bio-patch implementation may be made to conform to any particular surface area of the body and is not intended to necessarily be limited to a rectangular shape for use on the wrist areas. Any number of different size and shape configurations would be applicable. The bio-patch may also have pre-defined contours to promote adhesion with the body surface for use, for example, on the lower back, lower neck, shoulder, chest area, or skull.” Patch is made of a flexible material that adheres to the skin and conforms to the shape and motion of the skin. The claim is interpreted to read that the flexible and stretchable substrate covers an area of skin that comprises pore density as such which is covered by the patch of Phan, the recited pore density is a typical pore density of skin).
It would have been an obvious matter of design choice to modify Phan as modified to include a pore density of 50 pores/cm2 to 300 pores/cm2 since applicant has not disclosed that this limitation solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Absent a teaching as to criticality that the pore density of 50 pores/cm2 to 300 pores/cm2 this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement.
Claims 84-85 are rejected under 35 U.S.C. 103 as being unpatentable over Phan in view of Schoendorfer in further view of Irina in further view of Rogers as applied to claim 70, further in view of Davis (US 2580737) (hereinafter – Davis).
Regarding claim 84, Phan as modified teaches The epidermal microfluidic sweat patch of claim 70, Phan as modified fails to disclose wherein one colorimetric indicator comprises cobalt (II) chloride in a hydrogel matrix coated on at least a portion of a surface of the microfluidic channel for determining sweat volume and sweat rate by optical detection of a color change in the microfluidic channel.
David teaches the use of cobalt chloride wherein examiner notes that hydrogels are known to contain cobalt chloride because upon water being received cobalt chloride will change in color (col. 1, lines 15-40, col 3, lines 24-46). It would have been obvious to one skilled in the art at the filing date of the invention to modify Phan as modified by including the use of cobalt (II) chloride as taught by David, since it has been held to be within the general skill of a worker in the art to select a known component or material on the basis of suitability for the intended use as a matter of obvious mechanical design expediency. In re Leshin, 125 USPQ 416. Also see MPEP 2144.07. Sinclair & Carroll Co. v. Interchemical Corp. states "Reading a list and selecting a known compound to meet known requirements is no more ingenious than selecting the last piece to put in the last opening in a jig-saw puzzle.” 325 U.S. at 335, 65 USPQ at 301.). Since hydrogels are known to cobalt chloride to shown a change in color when exposed to water, the designation of a specific dye such as cobalt chloride does nothing to enhance the patentability of a design.
Regarding claim 85, Phan as modified teaches The epidermal microfluidic sweat patch of claim 84, Phan as modified fails to disclose further comprising an additional colorimetric indicator disposed in the cavity for detection of a sweat biomarker, wherein the sweat biomarker is selected from the group consisting of: pH; glucose; lactate; chloride; copper ion; iron ion; and ethanol.
However, in the same field of endeavor, Irina teaches further comprising an additional colorimetric indicator disposed in the cavity for detection of a sweat biomarker, wherein the sweat biomarker is selected from the group consisting of: pH; glucose; lactate; chloride; copper ion; iron ion; and ethanol (Para. [0091], “In other variations, the light emitted and/or reflected from the colorimetric membrane may be recorded over a period of time, in preprogrammed intervals (e.g., using a video camera). The color of the test strip can be measured while the colorimetric membrane is reacting with the sample and changing color (on-meter dosing), or after the colorimetric membrane has completed the color change (off-meter dosing).” Time-lapsed image recording may provide additional data that may be used to evaluate the fluid sample, for example, to estimate the sweat rate by monitoring the appearance of colored spots, and may be used to signal whether sufficient sample has been collected (e.g., to signal insufficient or excessive sample volume).”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the epidermal microfluidic sweat patch as taught by Phan as modified to include a colorimetric sensors as taught by Irina in order to have non-invasive and quick measurements (Para. [0007], “It would also be desirable for such devices, methods, and kits to be non-invasive and easy to use. It would further be desirable to provide methods for measuring or otherwise evaluating the concentration of one or more analytes in a body fluid in a relatively short period of time.”).
Response to Arguments
Applicant’s arguments with respect to claim 70-83 and 86-96 have been considered but are moot because the new ground of rejection does not solely rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH A TOMBERS whose telephone number is (571)272-6851. The examiner can normally be reached on M-TH 7:00-16:00, F 7:00-11:00(Eastern).
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/JOSEPH A TOMBERS/Examiner, Art Unit 3791