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 .
Status of the Claims
The amendment filed 10/24/2025 has been entered. Claims 1, 10, 16, and 19 have been amended and claim 23 is new. Claims 1-23 are currently pending, and claims 1-9 and 16-23 are examined herein.
Status of the Rejection
All 35 U.S.C. § 103 rejections from the previous office action are maintained and modified only in response to the amendments to the claims.
Claim Objections
Claim 22 is objected to because of the following informalities:
In claim 22 line 3, “a mesh-folding” should be amended to --a mesh-molding --.
Appropriate correction is required.
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, 3, 6, 8-9, 16, 18-19, and 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Lin et al. (“Triboelectric Active Sensor Array for Self-Powered Static and Dynamic Pressure Detection and Tactile Imaging,” 2013, ACS Nano, vol. 7, pgs. 8266-8274 and Supplementary Information) in view of Chen et al. (“Skin-Inspired Gels with Toughness, Antifreezing, Conductivity, and Remoldability,” 2019, ACS Appl. Mater. Interfaces, vol. 11, pgs. 28336-28344). Quispe et al. (“Glycerol: Production, consumption, prices, characterization and new trends in combustion,” 2013, Renewable and Sustainable Energy Reviews, vol. 27, pgs. 475-493) is applied as evidence for claim 9.
Regarding claim 1, Lin teaches a potentiometric sensor (triboelectric active sensor [TEAS] for measuring mechanical stimuli in Fig. 1a that statically detects pressure via open circuit voltage [pg. 8266, Abstract; pg. 8267, col. 1, para. 2]), comprising:
a first electrode (Al film with Ag nanowires in Fig. 1a [pg. 8268, col. 1, para. 3]);
a second electrode (Au electrode in Fig. 1a [pg. 8268, col. 1, para. 3]); and
a microstructured gel in contact with the first electrode and the second electrode (PDMS with pyramid microstructures in Fig. 1a contacts the Al film with Ag nanowires and the Au electrode [pg. 8267, col. 1, para. 3]).
The limitation “wherein the potentiometric sensor is configured so that there is no current passing from the first electrode to the second electrode and there is no current passing from the second electrode to the first electrode” is a functional recitation. Apparatus claims cover what a device is, not what a device does (MPEP 2114(II)). A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2114. In the instant case, Lin teaches a potentiometric sensor that is configured to perform the functional limitations above (the sensor performs static pressure sensing by measuring an open-circuit voltage, such that no current flows between the electrodes, see Fig. 3 [pg. 8266, Abstract; pg. 8267, col. 1, para. 2]).
Lin is silent to the limitation wherein the microstructured gel is an ionic hydrogel composite electrolyte.
Chen teaches a skin-inspired gel comprising polyvinyl alcohol (PVA), gelatin, glycerin, and sodium chloride (NaCl) [pg. 28337, col. 2, para. 7], such that the gel is an ionic hydrogel composite electrolyte. Chen further teaches that this gel material provides excellent mechanical properties, including good flexibility, antifreezing, and reusability, especially when applied as a sensor for mechanical stimulus in the various examples of Fig. 7 [pg. 28340, col. 2, para. 3; pg. 28343, col. 1, para. 1].
Lin and Chen are both considered analogous to the claimed invention because they are in the same field of gel-based mechanical stimulus sensors. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the PDMS gel material in Lin with an ionic hydrogel composite electrolyte material (PVA/gelatin/glycerin/NaCl gel), as taught in Chen, because the substitution would provide excellent mechanical properties for a mechanical stimulus sensor [pg. 28340, col. 2, para. 3; pg. 28343, col. 1, para. 1 in Chen]. Furthermore, the claimed device differs from Lin by the substitution of some components (the gel material in Lin) with other components (the gel material in Chen) whose functions were known in the prior art. One of ordinary skill in the art could substitute one known element for another to yield predictable results (MPEP 2143(I)(B)).
Furthermore, the selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art (MPEP 2144.07).
Regarding claim 3, modified Lin teaches the potentiometric sensor of claim 1, and further teaches wherein the microstructured ionic hydrogel composite electrolyte is sandwiched between the first electrode and the second electrode (as shown in Fig. 1(a) of Lin, the gel is between the Au and Ag nanowire electrodes, such that the substituted microstructured ionic hydrogel composite electrolyte is sandwiched between the first electrode and the second electrode).
Regarding claim 6, modified Lin teaches the potentiometric sensor of claim 1, and Lin teaches the sensor further comprising a flexible substrate supporting one or both of the first electrode and the second electrode (the TEAS matrix can be integrated onto a fully flexible substrate [e.g., by supporting the first electrode with the flexible substrate] to enable shape-adaptive pressure imaging [pg. 8272, col. 2, para. 1]).
Regarding claim 8, modified Lin teaches the potentiometric sensor of claim 1, and further teaches wherein the microstructured ionic hydrogel composite electrolyte comprises polyvinyl alcohol (PVA), sodium chloride, and glycerol (Gly) (as stated in the rejection of claim 1, the PDMS gel in Lin is substituted with a PVA/gelatin/Gly/NaCl gel, wherein glycerin and glycerol are both names for the same compound).
Regarding claim 9, modified Lin teaches the potentiometric sensor of claim 8, and further teaches wherein a weight ratio of PVA to Gly in the microstructured ionic hydrogel composite electrolyte is between about 0% to about 64% (as evidenced by Quispe, the density of glycerol is 1.26 g/mL [pg. 477, Table 1 in Quispe]. The hydrogel in Chen contains 5.4 g PVA and 8.5 mL glycerol [pg. 28337, Table 1 in Chen], such that the weight ratio of PVA to Gly in the hydrogel material is 100*5.4/(1.26*8.5) = 50.4%, which is within the claimed range).
Regarding claim 16, Lin teaches a flexible potentiometric sensor array (the array of flexible triboelectric active sensor [TEAS] devices for measuring mechanical stimuli in Fig. 5a, wherein the TEAS in Fig. 1a is adapted into pixel units with a common Al electrode [pg. 8267, col. 1, para. 2; pg. 8271, col. 2, para. 2]), comprising:
a flexible substrate (the TEAS matrix can be integrated onto a fully flexible substrate to enable shape-adaptive pressure imaging [pg. 8272, col. 2, para. 1]);
a first electrode on the flexible substrate (the common Al electrode in Fig. 5a [pg. 8271, col. 2, para. 2] would be disposed directly on the flexible substrate);
a second electrode on the flexible substrate (the Au electrodes in Fig. 5a [pg. 8268, col. 1, para. 3] would be supported by the flexible substrate through the stacked layers); and
a microstructured gel layer in contact with the first electrode and the second electrode (each PDMS gel layer with pyramid microstructures in the array of Fig. 5a contacts the common Al film with Ag nanowires and the individual Au electrodes [pg. 8267, col. 1, para. 3]),
wherein the microstructured gel layer has a uniform periodic mesh microstructure (the pyramid microstructures in the array of Fig. 5a are formed via a uniform periodic grid template shown in Fig. S1 [pg. 2 of Supplementary Information]).
Lin is silent to the limitation wherein the gel layer is an ionic hydrogel composite electrolyte layer.
Chen teaches a skin-inspired gel comprising polyvinyl alcohol (PVA), gelatin, glycerin, and sodium chloride (NaCl) [pg. 28337, col. 2, para. 7], such that the gel is an ionic hydrogel composite electrolyte. Chen further teaches that this gel material provides excellent mechanical properties, including good flexibility, antifreezing, and reusability, especially when applied as a sensor for mechanical stimulus in the various examples of Fig. 7 [pg. 28340, col. 2, para. 3; pg. 28343, col. 1, para. 1].
Lin and Chen are both considered analogous to the claimed invention because they are in the same field of gel-based mechanical stimulus sensors. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the PDMS gel material in Lin with an ionic hydrogel composite electrolyte material (PVA/gelatin/glycerin/NaCl gel), as taught in Chen, because the substitution would provide excellent mechanical properties for a mechanical stimulus sensor [pg. 28340, col. 2, para. 3; pg. 28343, col. 1, para. 1 in Chen]. Furthermore, the claimed device differs from Lin by the substitution of some components (the gel material in Lin) with other components (the gel material in Chen) whose functions were known in the prior art. One of ordinary skill in the art could substitute one known element for another to yield predictable results (MPEP 2143(I)(B)).
Furthermore, the selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art (MPEP 2144.07).
Regarding claim 18, modified Lin teaches the flexible potentiometric sensor array of claim 16, and further teaches the sensor including control circuitry (input and output data is controlled via a computer [pg. 8269, col. 1, para. 2; pg. 8274, col. 1, para. 2]) and leads connecting the control circuitry to the first and second electrodes (the two electrodes are connected to respective electrical leads to generate output data [pg. 8267, col. 1, para. 3; pg. 8274, col. 1, para. 2]).
Regarding claim 19, modified Lin teaches a flexible potentiometric sensor (flexible triboelectric active sensor [TEAS] for measuring mechanical stimuli in Fig. 1a [pg. 8267, col. 1, para. 2]), comprising:
a flexible substrate (the TEAS matrix can be integrated onto a fully flexible substrate to enable shape-adaptive pressure imaging [pg. 8272, col. 2, para. 1]);
a first electrode on the flexible substrate (the Al film with Ag nanowires in Fig. 1a [pg. 8268, col. 1, para. 3] would be disposed directly on the flexible substrate);
a second electrode on the flexible substrate (the Au electrode in Fig. 1a [pg. 8268, col. 1, para. 3] would be supported by the flexible substrate through the stacked layers); and
a microstructured gel layer in contact with the first electrode and the second electrode (the PDMS gel layer with pyramid microstructures in Fig. 1a contacts the Al film with Ag nanowires and the Au electrode [pg. 8267, col. 1, para. 3]),
wherein the potentiometric sensor is configured so that there is no current passing from the first electrode to the second electrode and there is no current passing from the second electrode to the first electrode (the sensor performs static pressure sensing by measuring an open-circuit voltage, such that no current flows between the electrodes, see Fig. 3 [pg. 8266, Abstract; pg. 8267, col. 1, para. 2]).
Lin is silent to the following limitations: (1) the sensor array comprises a plurality of first electrodes, (2) the sensor array comprises a plurality of second electrodes, (3) the gel layer is in contact with the plurality of first electrodes and the plurality of second electrodes, and (4) the gel layer is an ionic hydrogel composite electrolyte layer.
Modifying the sensor in Lin by including a plurality of first and second electrodes rather than a single first and second electrode would constitute a duplication of parts. It has been held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced. See MPEP 2144.04(VI)(B). Additionally, with this duplication of parts, a sensor array would be formed wherein each sensor includes an individual first and second electrode, and the gel layer remains in contact with the plurality of first electrodes and the plurality of second electrodes.
Chen teaches a skin-inspired gel comprising polyvinyl alcohol (PVA), gelatin, glycerin, and sodium chloride (NaCl) [pg. 28337, col. 2, para. 7], such that the gel is an ionic hydrogel composite electrolyte. Chen further teaches that this gel material provides excellent mechanical properties, including good flexibility, antifreezing, and reusability, especially when applied as a sensor for mechanical stimulus in the various examples of Fig. 7 [pg. 28340, col. 2, para. 3; pg. 28343, col. 1, para. 1].
Modified Lin and Chen are both considered analogous to the claimed invention because they are in the same field of gel-based mechanical stimulus sensors. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the PDMS gel material in modified Lin with an ionic hydrogel composite electrolyte material (PVA/gelatin/glycerin/NaCl gel), as taught in Chen, because the substitution would provide excellent mechanical properties for a mechanical stimulus sensor [pg. 28340, col. 2, para. 3; pg. 28343, col. 1, para. 1 in Chen]. Furthermore, the claimed device differs from modified Lin by the substitution of some components (the gel material in modified Lin) with other components (the gel material in Chen) whose functions were known in the prior art. One of ordinary skill in the art could substitute one known element for another to yield predictable results (MPEP 2143(I)(B)).
Furthermore, the selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art (MPEP 2144.07).
The limitation “wherein the potentiometric sensor array is configured so that there is no current passing from the plurality of first electrodes to the plurality of second electrodes and there is no current passing from the plurality of second electrodes to the plurality of first electrodes” is a functional recitation. Apparatus claims cover what a device is, not what a device does (MPEP 2114(II)). A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2114. In the instant case, modified Lin teaches a sensor array that is configured to perform the functional limitations above (the sensor performs static pressure sensing by measuring an open-circuit voltage, such that no current flows between the electrodes even when arranged in an array (see Fig. 3 [pg. 8266, Abstract; pg. 8267, col. 1, para. 2 in Lin])).
Regarding claim 21, modified Lin teaches the flexible potentiometric sensor array of claim 19, and further teaches the sensor including control circuitry (input and output data is controlled via a computer [pg. 8269, col. 1, para. 2; pg. 8274, col. 1, para. 2 in Lin]) and leads connecting the control circuitry to the plurality of first electrodes and the plurality of second electrodes (the two electrodes in the base sensor of Lin are connected to respective electrical leads to generate output data, such that a lead is connected to each duplicated electrode in the plurality of first and second electrodes [pg. 8267, col. 1, para. 3; pg. 8274, col. 1, para. 2 in Lin]).
Regarding claim 22, modified Lin teaches the potentiometric sensor of claim 1.
“Wherein the microstructure of the microstructured ionic hydrogel composite electrolyte is created on the surface of the microstructured ionic hydrogel composite electrolyte via a mesh-molding strategy” is a product by process limitation. The determination of patentability is based upon the product or apparatus structure itself. Patentability does not depend on its method of production or formation. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. See In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (see MPEP § 2113). The periodic patterning of the microstructure resulting from the claimed mesh-molding strategy (see Fig. 6H in the instant application) is considered obvious over the spaced pyramidal microstructure of the gel layer in Fig. 1(b) of Lin.
Regarding claim 23, Lin teaches a potentiometric sensor (the array of flexible triboelectric active sensor [TEAS] devices for measuring mechanical stimuli in Fig. 5a, wherein the TEAS in Fig. 1a is adapted into pixel units with a common Al electrode [pg. 8267, col. 1, para. 2; pg. 8271, col. 2, para. 2]. The TEAS statically detects pressure via open circuit voltage [pg. 8266, Abstract; pg. 8267, col. 1, para. 2]), comprising:
a flexible substrate (the TEAS matrix can be integrated onto a fully flexible substrate to enable shape-adaptive pressure imaging [pg. 8272, col. 2, para. 1]);
a first electrode on the flexible substrate (the common Al electrode in Fig. 5a [pg. 8271, col. 2, para. 2] would be disposed directly on the flexible substrate);
an array of second electrodes on the flexible substrate (the array of Au electrodes in Fig. 5a [pg. 8268, col. 1, para. 3] would be supported by the flexible substrate through the stacked layers);
a microstructured gel layer in contact with the first electrode and the array of second electrodes (each PDMS gel layer with pyramid microstructures in the array of Fig. 5a contacts the common Al film with Ag nanowires and the individual Au electrodes [pg. 8267, col. 1, para. 3]),
The limitation “wherein the potentiometric sensor is configured so that there is no current passing from the first electrode to the array of second electrodes or from the array of second electrodes to the first electrode” is a functional recitation. Apparatus claims cover what a device is, not what a device does (MPEP 2114(II)). A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2114. In the instant case, Lin teaches a potentiometric sensor that is configured to perform the functional limitations above (the sensor performs static pressure sensing by measuring an open-circuit voltage, such that no current flows between the electrodes, see Fig. 3 [pg. 8266, Abstract; pg. 8267, col. 1, para. 2]).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Lin in view of Chen, as applied to claim 1 above, and further in view of Perez et al. (US 20190175081 A1) and Lucarelli et al. (“Carbon and gold electrodes as electrochemical transducers for DNA hybridisation sensors,” 2004, Biosensor and Bioelectronics, vol. 19, pgs. 515-530).
Regarding claim 2, modified Lin teaches the potentiometric sensor of claim 1, and Lin further teaches wherein the first electrode comprises Ag (the first electrode is an Al film with Ag nanowires in Fig. 1a [pg. 8268, col. 1, para. 3]).
Modified Lin is silent to the limitation wherein the second electrode comprises a graphite carbon material.
Perez teaches a skin-compatible electrode system [Abstract] wherein the electrodes are comprised of graphite [0052].
Lucarelli teaches that graphite is a useful electrode material for biosensors as it offers low costs while maintaining a wide useful potential window [pg. 527, col. 1, para. 6-pg. 527, col. 2, para. 1].
Modified Lin, Perez, and Lucarelli are considered analogous to the claimed invention because they are in the same field of biosensors. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the second electrode material of gold in modified Lin with a graphite material compatible for a skin sensor, as taught in Perez, because the substitution would offer low costs while maintaining a wide useful potential window [pg. 527, col. 1, para. 6-pg. 527, col. 2, para. 1 in Lucarelli]. Furthermore, the claimed device differs from modified Lin by the substitution of some components (the second electrode material of gold in modified Lin) with other components (the graphite carbon electrode material in Perez) whose functions were known in the prior art. One of ordinary skill in the art could substitute one known element for another to yield predictable results (MPEP 2143(I)(B)).
Furthermore, the selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art (MPEP 2144.07).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Lin in view of Chen, as applied to claim 1 above, and further in view of Wang (US 20170325724 A1).
Regarding claim 4, modified Lin teaches the potentiometric sensor of claim 1, but is silent to the limitation wherein the first electrode and the second electrode are arranged in a side-by-side manner, and wherein the microstructured ionic hydrogel composite electrolyte overlays both the first electrode and the second electrode.
Wang teaches a potentiometric sensor (sensor platform 100 in Figs. 1A-1D [0111]), comprising: a first electrode (anodic compartment working electrode in Fig. 1A); a second electrode (cathodic compartment working electrode in Fig. 1A); and a hydrogel composite in contact with the first electrode and the second electrode (a hydrogel layer 109 in Fig. 1A is formed over the iontophoretic electrodes of the anode and cathode electrode assemblies to provide an electrically conductive medium between the iontophoretic electrodes and the skin [0010, 0111]). Wang further teaches wherein the first electrode and the second electrode are arranged in a side-by-side manner (see Fig. 1A), and wherein the hydrogel composite overlays both the first electrode and the second electrode (hydrogel layer 109 in Fig. 1A is formed over the electrodes of the anode and cathode electrode assemblies [0010, 0111]).
Modified Lin and Wang are both considered analogous to the claimed invention because they are in the same field of skin-mimicking potentiometric sensors. 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 sensor in modified Lin by rearranging the first and second electrode in a side-by-side manner wherein the microstructured ionic hydrogel composite electrolyte overlays both the first electrode and the second electrode, as taught in Wang, since Wang teaches this arrangement as a suitable alternative configuration for a potentiometric sensor. Furthermore, the rearrangement of parts, where both arrangements are known equivalents, is a design choice that gives predicable results. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) (Claims to a hydraulic power press which read on the prior art except with regard to the position of the starting switch were held unpatentable because shifting the position of the starting switch would not have modified the operation of the device.); In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice) [see MPEP 2144.04 (VI)].
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Lin in view of Chen and Wang, as applied to claim 4 above, and further in view of Liu et al. (“Skin-Integrated Graphene-Embedded Lead Zirconate Titanate Rubber for Energy Harvesting and Mechanical Sensing,” 2019, Adv. Mater. Technol., vol. 4, pgs. 1-9) and Etzkorn (US 20140296674 A1)
Regarding claim 5, modified Lin teaches the potentiometric sensor of claim 4, but is silent to the sensor further including an encapsulation layer overlaying the microstructured ionic hydrogel composite electrolyte.
Liu teaches a skin-integrated mechanical sensor (the piezoelectric-based electronic device in Fig. 1a [pg. 1, Abstract; pg. 2, col. 1, para. 3]), wherein the sensor includes an overall encapsulation layer (the top PDMS layer in Fig. 1a acts as an overall encapsulation layer for the sensor [pg. 2, col. 1, para. 3]).
Etzkorn teaches that encapsulating a skin-mounted sensor with a bio-compatible material such as PDMS protects the electronics of the sensor from current-carrying particles/fluids (see Figs. 3A-3K [0056, 0075, 0078]).
Modified Lin, Liu, and Etzkorn are considered analogous to the claimed invention because they are in the same field of skin-compatible biosensors. 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 sensor in modified Lin by adding an encapsulation layer of PDMS on top of the sensor, as taught in Liu, such that the encapsulation layer overlays the microstructured ionic hydrogel composite electrolyte, since this would protect the electronics of the sensor from external current-carrying particles/fluids [0056, 0075, 0078 in Etzkorn]. Furthermore, Liu teaches the claimed improvement as a known technique that is applicable to the base device in modified Lin. One skilled in the art could have applied the encapsulation layer in Liu in the same way to the base device in modified Lin, yielding predictable results (MPEP 2143(I)(D)).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Lin in view of Chen, as applied to claim 6 above, and further in view of Wang et al. (“A thin film polyethylene terephthalate (PET) electrochemical sensor for detection of glucose in sweat,” 2019, Talanta, vol. 198, pgs. 86-92), referred to as Wang2019 to differentiate from previously cited references.
Regarding claim 7, modified Lin teaches the potentiometric sensor of claim 6, but is silent to the limitation wherein the flexible substrate comprises polyethylene terephthalate (PET).
Wang2019 teaches a skin-compatible sensor (glucose sensor in Scheme 1) with a flexible substrate comprising PET [pg. 91, col. 2, para. 3]. Wang2019 further teaches that PET is a material that provides good flexibility, low cost, and easy preparation for wearable devices [pg. 87, col. 1, para. 3; pg. 91, col. 2, para. 3].
Modified Lin and Wang2019 are both considered analogous to the claimed invention because they are in the same field of flexible skin-compatible sensors. 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 flexible substrate in modified Lin by using PET as the substrate material, as taught in Wang2019, since this would provide good flexibility, low cost, and easy preparation for wearable devices [pg. 87, col. 1, para. 3; pg. 91, col. 2, para. 3 in Wang2019]. Furthermore, Wang2019 teaches the claimed improvement as a known technique that is applicable to the base device in modified Lin. One skilled in the art could have applied the flexible substrate of PET in Wang2019 in the same way to the base device in modified Lin, yielding predictable results (MPEP 2143(I)(D)).
Claims 17 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Lin in view of Chen, as applied to claim 6 above, and further in view of Liu and Etzkorn.
Regarding claim 17, modified Lin teaches the flexible potentiometric sensor array of claim 16, but is silent to the sensor further including an encapsulation layer encapsulating the first electrode, the second electrode, and the microstructured ionic hydrogel composite electrolyte layer.
Liu teaches a skin-integrated mechanical sensor (the piezoelectric-based electronic device in Fig. 1a [pg. 1, Abstract; pg. 2, col. 1, para. 3]), wherein the sensor includes an overall encapsulation layer (the top PDMS layer in Fig. 1a acts as an overall encapsulation layer for the sensor [pg. 2, col. 1, para. 3]).
Etzkorn teaches that encapsulating a skin-mounted sensor with a bio-compatible material such as PDMS protects the electronics of the sensor from current-carrying particles/fluids (see Figs. 3A-3K [0056, 0075, 0078]).
Modified Lin, Liu, and Etzkorn are considered analogous to the claimed invention because they are in the same field of skin-compatible biosensors. 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 sensor in modified Lin by adding an encapsulation layer of PDMS on top of the sensor, as taught in Liu, such that the encapsulation layer encapsulates the first electrode, the second electrode, and the microstructured ionic hydrogel composite electrolyte layer, since this would protect the electronics of the sensor from external current-carrying particles/fluids [0056, 0075, 0078 in Etzkorn]. Furthermore, Liu teaches the claimed improvement as a known technique that is applicable to the base device in modified Lin. One skilled in the art could have applied the encapsulation layer in Liu in the same way to the base device in modified Lin, yielding predictable results (MPEP 2143(I)(D)).
Regarding claim 20, modified Lin teaches the flexible potentiometric sensor array of claim 19, but is silent to the sensor further including an encapsulation layer encapsulating the plurality of first electrodes, the plurality of second electrodes, and the microstructured ionic hydrogel composite electrolyte layer.
Liu teaches a skin-integrated mechanical sensor (the piezoelectric-based electronic device in Fig. 1a [pg. 1, Abstract; pg. 2, col. 1, para. 3]), wherein the sensor includes an overall encapsulation layer (the top PDMS layer in Fig. 1a acts as an overall encapsulation layer for the sensor [pg. 2, col. 1, para. 3]).
Etzkorn teaches that encapsulating a skin-mounted sensor with a bio-compatible material such as PDMS protects the electronics of the sensor from current-carrying particles/fluids (see Figs. 3A-3K [0056, 0075, 0078]).
Modified Lin, Liu, and Etzkorn are considered analogous to the claimed invention because they are in the same field of skin-compatible biosensors. 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 sensor in modified Lin by adding an encapsulation layer of PDMS on top of the sensor, as taught in Liu, such that the encapsulation layer encapsulates the plurality of first electrodes, the plurality of second electrodes, and the microstructured ionic hydrogel composite electrolyte layer, since this would protect the electronics of the sensor from external current-carrying particles/fluids [0056, 0075, 0078 in Etzkorn]. Furthermore, Liu teaches the claimed improvement as a known technique that is applicable to the base device in modified Lin. One skilled in the art could have applied the encapsulation layer in Liu in the same way to the base device in modified Lin, yielding predictable results (MPEP 2143(I)(D)).
Response to Arguments
Applicant's arguments, see Remarks pgs. 8-12, filed 10/24/2025, with respect to the 35 U.S.C. § 103 rejections have been fully considered and are not persuasive.
Applicant’s Argument #1:
Applicant argues on pgs. 9-11 that Lin in view of Chen does not teach all of the claimed limitations of amended claims 1 and 19, particularly the limitation wherein no current passes between the electrodes, because the sensor in Lin creates a current between the electrodes (“pulse-like short-circuit current peak” [pg. 8267, col. 1, para. 2 in Lin]).
Examiner’s Response #1:
Applicant’s arguments have been fully considered, but are not persuasive. As stated in the rejections of claims 1 and 19 above, the limitation regarding the potentiometric sensor configured so that there is no current passing between the first and second electrodes is considered a functional limitation. The pulse-like short-circuit current peak is applied for dynamic pressure sensing using the TEAS. However, the TEAS also has a static pressure sensing function wherein an open-circuit voltage is measured, such that no current passes between the first and second electrodes [pg. 8266, Abstract; pg. 8267, col. 1, para. 2 in Lin].
Applicant’s Argument #2:
Applicant argues on pg. 10 that Lin in view of Chen does not teach all of the claimed limitations of amended claim 16, particularly the limitation wherein the microstructured ionic hydrogel composite electrolyte layer has a uniform periodic mesh microstructure, as the sensor in Lin teaches pyramid microstructures.
Examiner’s Response #2:
Applicant’s arguments have been fully considered, but are not persuasive. Lin teaches that the sensor’s microstructured gel layer has a uniform periodic mesh microstructure (the pyramid microstructures in the array of Fig. 5a are formed via a uniform periodic grid template shown in Fig. S1 [pg. 2 of Supplementary Information]). Based on a broadest reasonable interpretation of the limitation “uniform periodic mesh microstructure,” the pyramid grid pattern in Lin is not excluded from the interpretation of the claimed microstructure shape. Thus, the amendments to claim 16 do not overcome the previous 35 U.S.C. 103 rejection recited in the Non-Final Rejection mailed 7/24/2025.
Applicant’s Argument #3:
Applicant argues on pg. 11 that if independent claims 1, 10, 16, and 19 are allowable, the corresponding dependent claims are likewise allowable.
Examiner’s Response #3:
Based on the above responses #1-#2, applicant’s arguments regarding the amended independent claims are moot in view of the new grounds of rejection.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Zawko et al. (“Simple benchtop patterning of hydrogel grids for living cell microarrays,” 2009, Lab Chip, vol. 10, pgs. 379-383) teaches a method of hydrogel patterning using mesh-molding (see Fig. 1 [pg. 381]).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAYLEE Y TSENG whose telephone number is (703)756-5542. The examiner can normally be reached Mon - Fri 9-6 PT.
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/K.T./Examiner, Art Unit 1795
/LUAN V VAN/Supervisory Patent Examiner, Art Unit 1795