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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 07/16/2026 has been entered.
Claims Accounting
Applicant's arguments, filed 07/16/2026, have been fully considered.
The following rejections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 07/16/2026, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 1, 15, and 17 have been amended.
Claims 12-14 have been cancelled.
Claims 1-11 and 15-20 are the current claims hereby under examination.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2, 6, and 7 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 2, the claim recites the limitation “wherein the iontophoresis electrodes are loaded with carbachol.” Claim 1, from which claim 2 depends, recites the limitations “wherein the iontophoresis electrodes comprise an anode and a cathode… and a carbachol-loaded hydrogel patch disposed on the cathode” in lines 6-9. Therefore, claim 1 sets forth that at least one of the iontophoresis electrodes are loaded with carbachol. It is therefore unclear if the anode and cathode are the same cathode as the anode and cathode of claim 1. If they are the same anode and cathode, it is unclear how the limitations of claim 2 further limits the SEMS of claim 1. Clarification is requested.
For the purposes of examination, any reference, or combination of references that read on the claim limitations of claim 1, will also read on the claim limitations of claim 2.
Regarding claims 6-7, claim 6 recites the “SEMS of claim 5, further comprising a hydrogel patch disposed on the iontophoresis electrodes such that the hydrogel patch operatively contacts the human skin”. Claim 1, from which claim 5 depends recites “a sodium chloride (NaCl)-loaded hydrogel patch disposed on the anode, and a carbachol-loaded hydrogel patch disposed on the cathode” in lines 7-9. Therefore, claim 1 sets forth that the SEMS comprises at least two hydrogel patches. It is then unclear whether the hydrogel patch recited in claim 6 refers to the same hydrogel patch as recited in claim 1, or a different hydrogel patch. Claim 7 further recites “wherein the hydrogel patch comprises a first hydrogel patch and a second hydrogel patch, and wherein the iontophoresis electrodes comprise an anode and a cathode, the first hydrogel patch being loaded with sodium chloride (NaCI) and disposed on the anode, the second hydrogel patch being loaded with carbachol and disposed on the cathode.” These limitations are very similar to the limitations in lines 7-9 of claim 1, and therefore it is believed that the hydrogel patches recited in claims 6 and 7 are the same hydrogel patches in claim 1. Clarification is requested.
For the purposes of examination, the hydrogel patches of claim 1, are interpreted as the same hydrogel patches of claims 6-7.
Claim Rejections - 35 USC § 103
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.
Claims 1-2, 5-8, 11, 15, and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Publication 2024/0023880 by Gao et al. – previously cited, hereinafter “Gao” in view of Self-Powered Iontophoretic Transdermal… (2019) by Wu et al. – previously cited, hereinafter “Wu ‘19” in view of Bio-inspired ultra-thin microfluidics for soft… (2022) by Wu et al. – previously cited, hereinafter “Wu ‘22” in view of US Patent Publication 2018/0199866 by Heikenfeld – previously cited, hereinafter “Heikenfeld”.
Regarding claim 1, Figs. 1-4 of Gao teaches a sweat extraction and monitoring system (SEMS) (biosensor device 300), comprising: iontophoresis electrodes configured to be operably electrically contacting the human skin (Gao, Fig. 1B, [0087]; Hydrogel agent 140 is disposed on electrodes 129 and contacting the skin 10), wherein the iontophoresis electrodes comprise an anode and a cathode (Gao, Fig. 1B depicts a cathode (+) and anode (-)) a carbachol-loaded hydrogel patch disposed on the cathode (Gao, Fig. 1B; 140 comprises carbachol and is disposed on the cathode); at least one microfluidic channel for receiving the sweat ([0096]; Inlet layer 220 can include one or more inlets and/or channels via which the sweat flows through), wherein the at least one microfluidic channel is configured to isolate sweat sampling areas from iontophoresis gels (Gao, [0096]; Fig 3 depicts the inlet layer 220 formed of cutouts in the layers. If the cutouts comprise the inlets, reservoirs, and mixing channels, they must be capable of isolating the fluid from other parts of the layers, as the device relies on the movement of sweat from the inlets to the reagent reservoir, mixing channel, reagent reservoir, etc. Because Fig. 3 shows the cutouts for the hydrogel agents being separate from the microfluidic module, the inlets are isolated from the iontophoresis gels.); at least one biosensor for sensing the sweat received in the at least one microfluidic channel ([0092, 0101] Sensor assembly 120 receives sweat from an inlet and can include a plurality of biosensors (pH sensor 123 and ionic strength sensor 124)).
Gao does not teach that the at least one microfluidic channel comprises seven inlets for receiving the sweat. Gao does teach that the microfluidic sweat patch may be optimized to achieve the most rapid refreshing time between samples. Parameters that can be optimized in order to achieve this include the number and placement of inlets ([0116]). Where the general conditions of a claim are disclosed in the prior art ([0116] of Gao discloses a number of inlets may be selected to optimize sample collection), it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Furthermore, as Applicant has failed to provide details of criticality or unexpected results with regard to the claimed number of inlets. Therefore, it would have been obvious to a person of ordinary skill in the art, through routine optimization, to determine an optimum number of inlets taught by Gao.
Modified Gao does not teach a triboelectric nanogenerator (TENG) operable by localized manual biomechanical motion to generate TENG-induced localized sweating for a human skin to generate sweat or the iontophoresis electrodes being electrically connected to the TENG and a rectifier, the rectifier electrically between the TENG and the iontophoresis electrodes, the rectifier being configured to convert alternating current (AC) generated by the TENG to direct current (DC).
Wu ’19 teaches the use of a TENG to power iontophoresis electrodes to deliver a compound through the skin (See Fig. 2a and Fig. 4). Wu ’19 teaches that biomechanical motion can be used in order to power the TENG (the biomechanical motion occurs based on movement of the body (i.e., manual biomechanical motion) at the TENG (localized) to drive transdermal drug delivery (2. Results and Discussion, Pg. 5, par. 3). Wu ’19 teaches that the TENG is connected to the electrodes through a rectifier (which is between the TENG and electrodes), which converts the alternating current output of the TENG into direct-current output (Fig. 2a; 2. Results and Discussion, Pg. 2, par. 4). Using a TENG to power a wearable device is beneficial as TENGs are low cost, have broad material availability, are lightweight, and have high efficiency at low operation frequency (Introduction, pages 1-2, par. 3).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the SEMS of Gao to include a TENG operable by localized manual biomechanical motion to generate TENG-induced localized sweating for a human skin to generate sweat and such that the iontophoresis electrodes are electrically connected to the TENG and a rectifier, the rectifier electrically between the TENG and the iontophoresis electrodes, the rectifier being configured to convert alternating current (AC) generated by the TENG to direct current (DC), because a TENG is a power source that is low cost, has broad material availability, is lightweight, and has high efficiency at low operation frequency, as taught by Wu ‘19 (Introduction, pages 1-2, par. 3). It is noted that Wu ’19 teaches the TENG adapted for the delivery of drugs (such as carbachol) via iontophoresis, and therefore would be compatible with the invention of Gao, which relies on iontophoresis.
Gao in view of Wu ’19 does not teach at least one sweat-activated battery (SAB) comprising a cathode and an anode, the cathode comprising a layer of silver oxide (Ag2O)-coated carbon cloth, the anode comprising a magnesium foil, and a thin layer of cotton that contains potassium chloride (KCl) powders attached to the cathode and the anode, configured to be actuatable by the sweat generated via the TENG-induced localized sweating for powering the at least one biosensor.
Wu ’22 teaches an ultra-thin, soft and biocompatible sweat-activated battery that can provide sufficient power to drive the state-of-the-art wearable electronics for real-time monitoring physiological signals and wireless transmission to smartphones via Bluetooth (Abstract). The SAB comprises a cathode and an anode (Fabrication of the SAB, page 9, “a polished Mg anode… and cathode”), the cathode comprising a layer of silver oxide (Ag2O)-coated carbon cloth (Fabrication of the SAB, page 9, The cathode is conductive carbon cloth that is coated with a mixture of Ag2O and a graphene) and the anode comprising a magnesium foil (Fabrication of the SAB, page 9, “a polished Mg anode… Mg foil”. The anode is comprised of Mg foil). The SAB comprises a salt bridge comprising a thin layer of cotton between each anode and cathode containing KCl microparticles (i.e., powder) for electronically connecting the circuit (Fig. 1a: Salt bridge; Overview of the epidermal-integrated SAB platform; page 2, par. 1). The SAB taught by Wu ’22 is skin-safe, cost-effective and easy to process for flexible and wearable electronics applications (Introduction, page 3, par. 3).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the SEMS of Gao in view of Wu ’19 to include at least one sweat-activated battery (SAB) configured to be actuatable by the sweat for powering the at least one biosensor, comprising a cathode and an anode, the cathode comprising a layer of silver oxide (Ag2O)-coated carbon cloth, the anode comprising a magnesium foil, and a thin layer of cotton that contains potassium chloride (KCl) powders attached to the cathode and the anode, as SABs can be skin-safe, cost-effective and easy to process for flexible and wearable electronics applications, as taught by Wu ‘22 (Introduction, page 3, par. 3). It is noted that Gao teaches that the device comprises a battery 251, but can be powered by other or additional means such as by human motion, by a small solar panel, and/or by a biofluid powering system that powers the device using collected sweat flow ([0095]). The modifications to Gao in view of Wu ’19 and Wu ’22 comprise powering the system by additional means of human motion (TENG) and a biofluid powering system (SAB). It is further noted that the SAB is configured to be actuated by sweat, and any sweat, either generated naturally or by the TENG-induced localized sweating would activate the SAB.
It is further noted that SEMS as taught by the combination of Gao, Wu ’19, and Wu ’22 is configured such that the localized manual biomechanical motion powers the TENG to drive iontophoresis for initial sweat induction, and the TENG-induced localized sweating (or any sweating) subsequently actuates the at least one SAB in a stepwise manner for sustained powering of the at least one biosensor. To substitute the low-cost TENG of Wu ’19 and the cost-effective SAB as the power source for Gao, the TENG must be activated first, then the SAB can be activated subsequently in order to power the device.
The combination of Gao, Wu ,19, and Wu ‘22 does not teach wherein a sodium chloride (NaCl)-loaded hydrogel patch disposed on the anode.
Heikenfeld teaches a method of iontophoresis wherein electrodes are lined with porous materials. The porous material of the positive pole (i.e., cathode) may be dampened (i.e., loaded) with carbachol and the negative pole (i.e., anode) is dampened with NaCl solution ([0036]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the SEMS taught by the combination of Gao, Wu ’19, and Wu ’22 such that the first hydrogel patch being loaded with sodium chloride (NaCl) and disposed on the anode, as taught by Heikenfeld ([0036]). This modification merely comprises a simple substitution of one known element (configuration using NaCl on the anode and carbachol on the cathode) for another (configuration using carbachol on the anode and on the cathode) to obtain predictable results. See MPEP 2143.I.A.
Regarding claim 2, the combination of Gao, Wu ’19, Wu ’22, and Heikenfeld teaches the SEMS of claim 1, wherein the iontophoresis electrodes are loaded with carbachol (See the rejection of claim 1).
Regarding claim 5, the combination of Gao, Wu ’19, Wu ’22, and Heikenfeld teaches the SEMS of claim 1, further comprising a flexible polyimide substrate, the iontophoresis electrodes being formed on the flexible polyimide substrate (Gao, Fig. 1B, [0090]; Electrodes are disposed on a polyimide backing layer 110).
Regarding claim 6, the combination of Gao, Wu ’19, Wu ’22, and Heikenfeld teaches the SEMS of claim 5, further comprising a hydrogel patch disposed on the iontophoresis electrodes such that the hydrogel patch operatively contacts the human skin (Gao, Fig. 1B, [0087]; Hydrogel agent 140 is disposed on electrodes 129 and contacting the skin 10.).
Regarding claim 7, the combination of Gao, Wu ’19, Wu ’22, and Heikenfeld teaches the SEMS of claim 6, wherein the hydrogel patch comprises a first hydrogel patch and a second hydrogel patch (Gao, Fig. 1B depicts a first and second hydrogel patch), and wherein the iontophoresis electrodes comprise an anode and a cathode (See the rejection of claim 1), the first hydrogel patch being loaded with sodium chloride (NaCl) and disposed on the anode (See the rejection of claim 1), the second hydrogel patch being loaded with carbachol and disposed on the cathode (See the rejection of claim 1)
Regarding claim 8, the combination of Gao, Wu ’19, Wu ’22, and Heikenfeld teaches the SEMS of claim 1, wherein the at least one biosensor comprises one or more sensors selected from a group consisting of a sodium ion (Na+) sensor, a potassium ion (K+) sensor, and a pH sensor (Gao, [0092-0093]; Sensor assembly 120 comprises a pH sensor 123).
Regarding claim 11, the combination of Gao, Wu ’19, Wu ’22, and Heikenfeld teaches the SEMS of claim 1, wherein the at least one biosensor comprises a pH sensor (Gao, [0092-0093]; Sensor assembly 120 comprises a pH sensor 123) comprising polyaniline (Gao, [0121]; the pH sensing membrane comprises polyaniline).
Regarding claim 15, the combination of Gao, Wu ’19, Wu ’22, and Heikenfeld teaches a sweat extraction and monitoring system (SEMS), comprising: a triboelectric nanogenerator (TENG) operable by localized manual biomechanical motion to generate TENG-induced localized sweating for a human skin to generate sweat (See the rejection of claim 1); iontophoresis electrodes electrically connected to the TENG and a rectifier and configured to be operably electrically contacting the human skin, wherein the iontophoresis electrodes comprise an anode and a cathode, a sodium chloride (NaCI)-loaded hydrogel patch disposed on the anode, and a carbachol-loaded hydrogel patch disposed on the cathode (See the rejection of claim 1); the rectifier electrically between the TENG and the iontophoresis electrodes, the rectifier being configured to convert alternating current (AC) generated by the TENG to direct current (DC) (See the rejection of claim 1); at least one microfluidic channel for receiving the sweat, wherein the at least one microfluidic channel comprises seven inlets for receiving the sweat and is configured to isolate sweat sampling areas from iontophoresis gels (See the rejection of claim 1); a flexible electronic device comprising a flexible printed circuit board (FPCB) (Gao, [0093]; polyimide backing substrate 110 can be considered a flexible printed circuit board as it is CO2 laser engraved [0090] and can be formed as a LEG sensor assembly wherein it can be printed), at least one biosensor disposed on the FPCB for sensing the sweat received in the at least one microfluidic channel to generate sensed data (See the rejection of claim 1, the biosensors are disposed on the backing substrate 110), and a microcontroller, the microcontroller being configured to transmit the sensed data to an external computer system (Gao, Fig. 9, [0112]; depicts electronics of biosensor device 300, including programmable system on a chip (PSoC) BLE module 920 for wireless communication to an external device such as device 50); and at least one sweat-activated battery (SAB) comprising a cathode and an anode, the cathode comprising a layer of silver oxide (Ag2O)-coated carbon cloth, the anode comprising a magnesium foil, and a thin layer of cotton that contains potassium chloride (KCl) powders attached to the cathode and the anode, the at least one SAB configured to be actuatable by the sweat received in the at least one microfluidic channel for powering the at least one biosensor and the microcontroller (See the rejection of claim 1 above; In the combination as applied above, the TENG/SAB replaces the battery, and therefore also powers the microcontroller), wherein the SEMS is configured such that the localized manual biomechanical motion powers the TENG to drive iontophoresis for initial sweat induction, and the TENG-induced localized sweating subsequently actuates the at least one SAB in a stepwise manner for sustained powering of the at least one biosensor (See the rejection of claim 1) and the microcontroller (The microcontroller is also powered by the TENG/SAB as noted above).
Regarding claim 17, the combination of Gao, Wu ’19, Wu ’22, and Heikenfeld teaches a self-powered wearable system, comprising: a wearable sweat apparatus comprising (Gao, Fig. 1A): a triboelectric nanogenerator (TENG) operable by localized manual biomechanical motion to generate TENG-induced localized sweating for a human skin to generate sweat (See the rejection of claims 1 and 15 above); iontophoresis electrodes electrically connected to the TENG and a rectifier and configured to be operably electrically contacting the human skin, wherein the iontophoresis electrodes comprise an anode and a cathode, a sodium chloride (NaCI)-loaded hydrogel patch disposed on the anode, and a carbachol-loaded hydrogel patch disposed on the cathode (See the rejection of claims 1 and 15 above); the rectifier electrically between the TENG and the iontophoresis electrodes, the rectifier being configured to convert alternating current (AC) generated by the TENG to direct current (DC) (See the rejection of claims 1 and 15 above); at least one microfluidic channel for receiving the sweat, wherein the at least one microfluidic channel comprises seven inlets for receiving the sweat and is configured to isolate sweat sampling areas from iontophoresis gels (See the rejection of claims 1 and 15 above); a flexible electronic device comprising a flexible printed circuit board (FPCB), at least one biosensor disposed on the FPCB for sensing the sweat received in the at least one microfluidic channel to obtain sensed data, and a microcontroller electrically communicating with the at least one biosensor (See the rejection of claims 1 and 15 above); and at least one sweat-activated battery (SAB) comprising a cathode and an anode, the cathode comprising a layer of silver oxide (Ag2O)-coated carbon cloth, the anode comprising a magnesium foil, and a thin layer of cotton that contains potassium chloride (KCl) powders attached to the cathode and the anode, the at least one SAB configured to be actuatable by the sweat received in the at least one microfluidic channel for powering the at least one biosensor and the microcontroller (See the rejection of claims 1 and 15 above); and a computer system for electrically communicating with the microcontroller for receiving the sensed data (See the rejection of claim 15 above), wherein the wearable sweat apparatus is configured such that the localized manual biomechanical motion powers the TENG to drive iontophoresis for initial sweat induction, and the TENG-induced localized sweating subsequently actuates the at least one SAB in a stepwise manner for sustained powering of the at least one biosensor and the microcontroller (See the rejection of claims 1 and 15 above).
Regarding claim 18, the combination of Gao, Wu ’19, Wu ’22, and Heikenfeld teaches the self-powered wearable system of claim 17, wherein the sensed data comprises one or more of data selected from a group consisting of sodium ion (Na+) concentration, potassium ion (K+) concentration, and pH values of the sweat (Gao, Fig. 10, [0113]; Sensed data that is sent to the external device includes pH values).
Regarding claim 19, the combination of Gao, Wu ’19, Wu ’22, and Heikenfeld teaches the self-powered wearable system of claim 17, wherein the microcontroller communicates with the computer system via a protocol selected from a group consisting of near field communication (NFC), Bluetooth, ultra-wide band (UWB), Zigbee, and WiFi (Gao, [0088]; “The wireless communication link 20 can be a radio frequency link such as a Bluetooth® or Bluetooth® low energy (LE) link, a Wi-Fi® link, a ZigBee link, or some other suitable wireless communication link”).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Gao in view of Wu ‘19 in view of Wu ’22 in view of Heikenfeld, as applied to claim 1, in view of Structure and Dimension Effects on the Performance.. (2019) of by Yin et al. – previously cited, hereinafter “Yin”, in view of Origami-inspired electret-based triboelectric generator… (2020) by Tao et al. – previously cited, hereinafter “Tao”.
The combination of Gao, Wu ’19, Wu ’22 and Heikenfeld teaches the SEMS of claim 1, but does not teach wherein the TENG has a stacked layer structure comprising: a plurality of polyimide layers folded from a polyimide film; copper electrodes formed on each of the plurality of polyimide layers; and fluorinated ethylene propylene (FEP) configured to be alternatively attached onto the copper electrodes to form FEP-attached copper electrodes, wherein the copper electrodes that are not attached with FEP and the FEP-attached copper electrodes constitute output terminals of the TENG.
Fig. 1a of Yin teaches a TENG with a stacked structure (i.e., alternate structure) comprising a plurality of polyimide layers folded from a Kapton (i.e., polyimide) film, and copper electrodes formed on each of the plurality of layers. This alternate structure further teaches a dielectric material (PTFE) alternatively disposed on each copper electrode, and the pairs of copper and dielectric-attached electrodes form output terminals (where the current flows) of the TENG. The alternate TENG achieves greater transferred charge and short-circuit current (Figure 2-3).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the TENG taught by the combination of Gao, Wu ’19, Wu ’22, and Heikenfeld such that the TENG has a stacked layer structure comprising: a plurality of polyimide layers folded from a polyimide film; copper electrodes formed on each of the plurality of polyimide layers; and a dielectric material configured to be alternatively attached onto the copper electrodes to form dielectric-attached copper electrodes, wherein the copper electrodes that are not attached with dielectric and the dielectric-attached copper electrodes constitute output terminals of the TENG. This configuration results in greater transferred charge and short-circuit current (Figure 2-3).
The combination of Gao, Wu ’19, Wu ’22, Heikenfeld, and Yin does not teach wherein the dielectric material is FEP.
Fig. 1 of Tao teaches a stacked TENG using copper and FEP. Tao further teaches that electret materials such as Teflon (i.e., PTFE) and FEP are dielectric materials widely used and are advantageous in energy harvesting applications due to their relatively high surface charge density (Experimental methods, page 3, par. 2).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the TENG taught by the combination of Gao, Wu ’19, Wu ’22, Heikenfeld, and Yin such that the dielectric material is FEP. This modification merely comprises a simple substitution of one known element (dielectric material FEP) for another (dielectric material PTFE) to obtain predictable results. See MPEP 2143.I.A.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Gao in view of Wu ‘19 in view of Wu ’22 in view of Heikenfeld in view of Yin in view of Tao, as applied to claim 3, in view of US Patent Publication 2011/0027986 by Vecchione – previously cited, hereinafter “Vecchione”.
The combination of Gao, Wu ’19, Wu ’22, Heikenfeld, Yin, and Tao teaches the SEMS of claim 3, but does not teach wherein the stacked layer structure further comprises a gold film formed onto the plurality of polyimide layers.
Vecchione teaches a method of coating a substrate of a TENG with gold film and gold nanoparticles on the contact surface. This configuration can offer a five-fold increase on the current output compared to a device without modification ([0037]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the TENG taught by the combination of Gao, Wu ’19, Wu ’22, Heikenfeld, Yin, and Tao such that the stacked layer structure further comprises a gold film formed onto the plurality of polyimide layers, in order to increase the current output, as taught by Vecchione ([0037]).
Claims 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Gao in view of Wu ‘19 in view of Wu ’22 in view of Heikenfeld, as applied to claim 1, in view of US Patent Publication 2020/0337605 by Cheng – previously cited, hereinafter “Cheng”.
The combination of Gao, Wu ’19, Wu ’22, and Heikenfeld teaches the SEMS of claim 1, but does not teach wherein the at least one biosensor comprises a sodium ion (Na+) sensor, the Na+ sensor comprising a layer of poly(3,4-ethylenedioxythiophene:poly(sodium 4-styrenesulfonate) (PEDOT:PSS) and a layer of ionophore disposed onto the layer of PEDOT:PSS and serving as a sensing area for sensing sodium ions or the at least one biosensor comprises a potassium ion (K+) sensor, the potassium ion (K+) sensor comprising a layer of PEDOT: PSS and a layer of ionophore disposed onto the layer of PEDOT: PSS and serving as a sensing area for sensing potassium ions.
Cheng teaches a probe equipped with at least one of a temperature sensor, pH sensor, and an ionic sensor ([0011]). The ionic sensor may be a sodium ionic sensor and/or a potassium ionic sensor ([0039]), comprising a sodium ionic electrode NAE and a potassium ionic electrode KE ([0051]). The NAE and KE are formed by printing a layer of PEDOT:PSS and a layer of their respective ionophore (See Table 1). The printed NAE and KE demonstrate excellent stability and less noisy performance with respect to the commercial reference electrode ([0054]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the SEMS taught by the combination of Gao, Wu ’19, Wu ’22, and Heikenfeld such that wherein the at least one biosensor comprises a sodium ion (Na+) sensor, the Na+ sensor comprising a layer of poly(3,4-ethylenedioxythiophene:poly(sodium 4-styrenesulfonate) (PEDOT:PSS) and a layer of ionophore disposed onto the layer of PEDOT:PSS and serving as a sensing area for sensing sodium ions and the at least one biosensor comprises a potassium ion (K+) sensor, the potassium ion (K+) sensor comprising a layer of PEDOT: PSS and a layer of ionophore disposed onto the layer of PEDOT: PSS and serving as a sensing area for sensing potassium ions. These types of printed ionic sensors demonstrate excellent stability and less noisy performance with respect to the commercial reference electrode, as taught by Cheng ([0054]). It is noted that this modification can be achieved by substituting the ionic sensor of Gao with the ionic sensor of Cheng.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Gao in view of Wu ‘19 in view of Wu ’22 in view of Heikenfeld, as applied to claim 15, in view of US Patent Publication 2019/0365263 by Raj et al. – previously cited, hereinafter “Raj”.
The combination of Gao, Wu ’19, Wu ’22, and Heikenfeld teaches the SEMS of claim 15, but does not teach wherein the SEMS is encapsulated with polydimethylsiloxane (PDMS).
Raj teaches a wearable sensor 110 comprising electrodes configured to be coupled to the skin of a subject. An encapsulation material 470 encapsulates the sensor and may be an elastomer such as PDMS. The encapsulation layer protects the sensor and provides for tight mechanical coupling between the integrated circuits and the skin of the user ([0058, 0063]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the SEMS taught by the combination of Gao, Wu ’19, Wu ’22, and Heikenfeld such that it is encapsulated with polydimethylsiloxane (PDMS), in order to protect the sensor and provide for tight mechanical coupling between the integrated circuits and the skin of the user, as taught by Raj ([0058, 0063]).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Gao in view of Wu ‘19 in view of Wu ’22 in view of Heikenfeld, as applied to claim 15, in view of US Patent Publication 2023/0277762 by Duhamel et al. – previously cited, hereinafter “Duhamel”.
The combination of Gao, Wu ’19, Wu ’22, and Heikenfeld teaches the self-powered wearable system of claim 17, but does not teach wherein the computer system comprises a user interface configured to allow a user to remotely operate the wearable sweat apparatus.
Duhamel teaches a wearable device configured to be attached to the skin, deliver substances to the body via iontophoresis, detect analytes in body fluids, and communicate the concentrations of the analytes to an external user device. The user device comprises a user application 160 to manage the readings from the device and control the operation of the device. The user device and application allows the user to program, adjust, control, and manage readings from the device ([0086]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the self-powered wearable system taught by the combination of Gao, Wu ’19, Wu ’22, and Heikenfeld such that the computer system comprises a user interface configured to allow a user to remotely operate the wearable sweat apparatus and manage the readings, as taught by Duhamel ([0086]). The inclusion of the user interface allows the user to more conveniently manage the wearable sweat apparatus, improving the ease of use.
Response to Arguments
Applicant’s arguments, filed 07/16/2026 have been fully considered.
The amendments to the claims overcome the rejections of record under 35 U.S.C. 112(a) and 112(b). The amendments to the claims necessitate new rejections of claims 2, 6 and 7 under 35 U.S.C. 112(b).
Applicant’s assertion regarding the rejection of the independent claims under 35 U.S.C. 103 is acknowledged. This assertion is moot as it is based on amendments to the claims not entered at the time of the previous Office action. The newly presented limitations are rejected on new grounds above.
Applicant’s arguments regarding an appearance on reliance on impermissible hindsight reconstruction are acknowledged. This argument is not found persuasive. Applicant identifies Gao’s statement that other power sources including human motion or a biofluid powering system, and argues that this statement does not instruct a skilled artisan to incorporate Wu ‘19’s TENG-powered drug delivery system or Wu ’22’s passive SAB platform in a way that preserves iontophoresis. In the rejection of the independent claims, the statement of Gao is used to explain why the invention of Gao would be compatible with other power sources. The motivation to include the TENG of Wu ’19 is that Wu ’19 teaches that using a TENG to power a wearable device is beneficial as TENGs are low cost, have broad material availability, are lightweight, and have high efficiency at low operation frequency (Introduction, pages 1-2, par. 3). As the device of Gao is a lightweight wearable device, it would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified Gao in view of Wu ’19. The motivation to include the SAB of Wu ’22 is that Wu ’22 teaches that the SAB is skin-safe, cost-effective and easy to process for flexible and wearable electronics applications and provides sufficient power to drive the wearable electronics for real-time monitoring physiological signals and wireless transmission to smartphones via Bluetooth. As the device of Gao is a flexible wearable device configured for real-time monitoring physiological signals and wireless transmission, it would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified Gao in view of Wu ’22.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
A Self-Charging Power Unit by Integration… by Pu et al. (2015) teaches a method of integrating a triboelectric nanogenerator with a battery for wearable electronics.
Energy Autonomous Sweat-Based Wearable Systems by Manjakkal et al. (2021) teaches solution of energy harvesting systems, including using a TENG along with a sweat-based fuel cell to provide energy to wearable devices with biomechanical motions.
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/NELSON ALEXANDER GLOVER/Examiner, Art Unit 3791
/ADAM J EISEMAN/Primary Examiner, Art Unit 3791
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