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 .
Claims Accounting
Applicant's arguments, filed 02/23/2026, 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 02/23/2026, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 1, 15, and 17 have been amended.
Claims 1-20 are the current claims hereby under examination.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claims 1, 15, and 17, the claims recite the limitation “at least one sweat-activated battery (SAB) configured to be actuatable only by the sweat generated via the TENG-induced localized sweating”. There is insufficient support for these limitations in the original disclosure. In order for the at least one sweat-activated battery (SAB) to be configured to be actuatable only by the sweat generated via the TENG-induced localized sweating, the SAB would have to contain some structure that limits the sweat collected to only be the sweat generated via the TENG-induced localized sweating. Otherwise, any sweat present would be capable of actuating the SAB. There is no disclosure of such a structure in the written description that discriminates naturally occurring sweat from sweat generated via the TENG. The closest identified disclosure is pars. [0057-0060] of the published written description. These paragraphs state the disadvantages of existing systems, where their applications may be limited because the analysis of sweat can only occur when the person is doing sufficient exercise or movement to generate sweat, and they are not applicable to sedentary humans. Pars. [0057-0062] go on to explain how the example embodiments solve these problems through the use of a TENG, iontophoresis, and a SAB. While these improvements are cited as being capable of extracting sweat from persons who are not naturally sweating due to being sedentary or not doing sufficient exercise or movement to generate sweat, the improvements do not recite that only this extracted sweat can be used. In other words, there is no structure recited to isolate a single type of sweat (generated from the TENG) from another (i.e., naturally occurring sweat from doing sufficient exercise or movement to generate sweat) such that the “at least one sweat-activated battery (SAB) configured to be actuatable only by the sweat generated via the TENG-induced localized sweating”.
All claims not explicitly addressed above are rejected under 35 U.S.C. 112(a) are rejected by virtue of their dependency on a rejected base claim.
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 1-20 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 claims 1, 15, and 17, the claims recite the limitation “at least one sweat-activated battery (SAB) configured to be actuatable only by the sweat generated via the TENG-induced localized sweating”. It is unclear how what structure is imparted on the invention to achieve this limitation, as noted in the rejection under 35 U.S.C. 112(a) above. Due to the lack of clarity regarding what structure is imparted to achieve this limitation, the claim is rendered indefinite as it is unclear how the invention isolates a single type of sweat (generated from the TENG) from another (i.e., naturally occurring sweat from doing sufficient exercise or movement to generate sweat) for use in the SAB. Clarification is requested.
For the purposes of examination, the claim is interpreted as “at least one sweat-activated battery (SAB) configured to be actuatable by the sweat generated via the TENG-induced localized sweating”.
All claims not explicitly addressed above are rejected under 35 U.S.C. 112(b) are rejected by virtue of their dependency on a rejected base claim.
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, 5-6, 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”.
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 ([0087]; Electrodes 129 can interface the skin 100); 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); 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 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.
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). 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, 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) 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 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, 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.
Regarding claim 2, the combination of Gao, Wu ’19, and Wu ’22 teaches the SEMS of claim 1, wherein the iontophoresis electrodes are loaded with carbachol (Gao, [0087]; “Iontophoresis electrodes 129 can interface the skin 100 with a layer of hydrogel agent 140 applied in between to stimulate the production of sweat 30. The hydrogel agent 140, which can be a component of sensor patch 100, can be an agarose gel containing carbachol (carbagel)”).
Regarding claim 5, the combination of Gao, Wu ’19, and Wu ’22 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, and Wu ’22 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 8, the combination of Gao, Wu ’19, and Wu ’22 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, and Wu ’22 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 12, the combination of Gao, Wu ’19, and Wu ’22 teaches the SEMS of claim 1, wherein the at least one SAB comprises a cathode and an anode (Wu ’22, Fabrication of the SAB, page 9, “a polished Mg anode… and cathode”), the cathode comprising a layer of silver oxide (Ag2O)-coated carbon cloth (Wu ’22, Fabrication of the SAB, page 9, The cathode is conductive carbon cloth that is coated with a mixture of Ag2O and a graphene).
Regarding claim 13, the combination of Gao, Wu ’19, and Wu ’22 teaches the SEMS of claim 1, wherein the at least one SAB comprises a cathode and an anode (See the rejection of claim 12 above), the anode comprising a magnesium foil (Wu ’22, Fabrication of the SAB, page 9, “a polished Mg anode… Mg foil”. The anode is comprised of Mg foil).
Regarding claim 14, the combination of Gao, Wu ’19, and Wu ’22 teaches the SEMS of claim 1, wherein the at least one microfluidic channel comprises a plurality of inlets for receiving the sweat (Gao, [0096]; “The inlet layer 220 can include one or more inlets and/or channels via which the sweat flows through”).
Regarding claim 15, the combination of Gao, Wu ’19, and Wu ’22 teaches a sweat extraction and monitoring system (SEMS) (See the rejection of claim 1 above), 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 above); iontophoresis electrodes electrically connected to the TENG and configured to be operably electrically contacting the human skin (See the rejection of claim 1 above); at least one microfluidic channel for receiving the sweat (See the rejection of claim 1 above); a flexible electronic device comprising a flexible printed circuit board (FPCB) (Gao, 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 [0093]), 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) configured to be actuatable by the sweat generated via the TENG-induced localized sweating 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 above) and the microcontroller (The microcontroller is also powered by the TENG/SAB as noted above).
Regarding claim 17, the combination of Gao, Wu ’19, and Wu ’22 teaches a self-powered wearable system, comprising: a wearable sweat apparatus (Gao, Fig. 1A) 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 15 above); iontophoresis electrodes electrically connected to the TENG and configured to be operably electrically contacting the human skin (See the rejection of claim 15 above); at least one microfluidic channel for receiving the sweat (See the rejection of claim 15 above); a flexible electronic device comprising a flexible printed circuit board (FPCB) (See the rejection of claim 15 above), 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 claim 15 above) and at least one sweat-activated battery (SAB) configured to be actuatable by the sweat generated via the TENG-induced localized sweating for powering the at least one biosensor and the microcontroller (See the rejection of claim 15 above); and a computer system for electrically communicating with the microcontroller for receiving the sensed data (Gao, Fig. 1A shows device 50, a mobile computer system communicating via wireless communication link 20), 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 (See the rejection of claim 1 above) and the microcontroller (The microcontroller is also powered by the TENG/SAB as noted above).
Regarding claim 18, the combination of Gao, Wu ’19, and Wu ’22 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, and Wu ’22 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, as applied to claim 6, 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, and Wu ’22 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, and Wu ’22 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, 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, 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 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, 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 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, 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]).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Gao in view of Wu ‘19 in view of Wu ’22, as applied to claim 6, in view of US Patent Publication 2018/0199866 by Heikenfeld, hereinafter “Heikenfeld”.
The combination of Gao, Wu ’19, and Wu ’22 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 (Gao, Fig. 1B depicts a cathode (+) and anode (-)), wherein the second hydrogel patch being loaded with carbachol and disposed on the cathode (Gao, Fig. 1B; 140 comprises carbachol and is disposed on the cathode), but does not teach wherein the first hydrogel patch being loaded with sodium chloride (NaCl) and 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.
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, as applied to claim 6, in view of US Patent Publication 2020/0337605 by Cheng – previously cited, hereinafter “Cheng”.
The combination of Gao, Wu ’19, and Wu ’22 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, and Wu ’22 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, as applied to claim 15, in view of US Patent Publication 2019/0365263 by Raj et al., hereinafter “Raj”.
The combination of Gao, Wu ’19, and Wu ’22 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, and Wu ’22 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, as applied to claim 15, in view of US Patent Publication 2023/0277762 by Duhamel et al., hereinafter “Duhamel”.
The combination of Gao, Wu ’19, and Wu ’22 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, and Wu ’22 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 02/23/2026 have been fully considered.
Applicant’s arguments regarding the rejection of claim 1 under 35 U.S.C. 103 are acknowledged.
Applicant’s arguments regarding Wu ’19 being entirely silent on sweat generation, collection, or actuating SAB and Wu ’22 being silent on active sweat induction mechanisms are not found persuasive. Further, Applicant’s arguments that the SEMS as defined in instant claim 1 is in stark contrast with the prior art devices is not found persuasive. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The combination of Gao, Wu ’19, and Wu ’22 is used in the rejection of claim 1. The benefits of using a TENG as disclosed by Wu’ 19 and the benefits of using an SAB as taught by Wu ’22 are used as motivations to combine the three prior art references, and the combination uses a TENG to generate sweat via iontophoresis, and then uses a sweat activated battery to power the biosensor/microcontroller.
Applicant’s arguments that Gao is a passive sweat collection system and there is no motivation to integrate a TENG is not found persuasive. The motivation to integrate a TENG is provided by Wu ’19, wherein a TENG is a power source that is low cost, has broad material availability, is lightweight, and has high efficiency at low operation frequency (Introduction, pages 1-2, par. 3). It is noted in this Office action and the prior Office action 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]). Therefore, although Gao discloses a device powered by a battery, Gao teaches that the device can be powered by other means. A TENG comprises another powering source (via human motion) for the iontophoresis, and the SAB comprises another powering source (via a biofluid powering system) for the sensor and electronics.
Applicant’s arguments regarding claim 7 are acknowledged, and are not found persuasive. Applicant’s arguments that Heikenfeld iontophoresis relies on conventional power sources such as low-voltage/constant-current electric fields and in contrast, the iontophoresis of claim 7 is driven by the high-voltage pulsed electric field of a TENG is not found persuasive. Heikenfeld is relied upon to teach an alternat configuration of the chemical composition of the electrodes for iontophoresis. There is no teaching in Heikenfeld that the electrode configuration is viable only for low-voltage/constant-current electric fields. Further, there is no recitation of a high-voltage pulsed electric field of the invention of claim 7.
Applicant’s arguments regarding claims 9 and 10 that Gao’s SEMS and Cheng’s probe have different core requirements are acknowledged, and are not found persuasive. Both Gao and Cheng are directed towards having ionic sensor for sensing ions in bodily fluids. Therefore, the teachings of Cheng can be incorporated in Gao as the relied upon teaching is drawn to the composition of the ion sensor for sensing ions in bodily fluids.
Applicant’s arguments regarding claim 16 directed towards the PDMS encapsulation are acknowledged, and are not found persuasive. Applicant argues that the adoption of the PDMS would directly impede the effective contact between the SAB and the sweat while severely restricting the TENG’s motion freedom. Fig. 4C of Raj shows an embodiment of the PDMS encapsulation where the encapsulation does not encapsulate the components configured to contact the skin ([0058]). This configuration of PDMS encapsulation taught by Raj does not teach encapsulating components configured to interact with the skin. Further, the PDMS is an elastomer with sufficient flexibility to allow for stretching and bending, which would not impede biomechanical motion, and therefore, the motion of the TENG would not be severely restricted. Applicant argues that no prior art has disclosed a PDMS encapsulation design adapted to the dual-functional requirements of TENG motion-induced sweating and SAB sweat-contact power supply, and that the PDMS encapsulation of claim 16 is a customized design deeply synergized with the entire workflow. These arguments are not commensurate in scope with the claims. Claim 16 does not contain any recitation of a customized design deeply synergized with the entire workflow. Examiner invites Applicant to define the limitations of the PDMS encapsulation that distinguishes it from the prior art and defines the customized design deeply synergized with the entire workflow.
Applicant’s arguments regarding claim 20 directed towards the obviousness rejection lacking basis is acknowledged, and is not found persuasive. Applicant argues that Duhamel’s remote interface is designed for externally powered devices, while the user interface of the claimed invention is adapted to a self-powered architecture. Duhamel is relied upon to teach an external computer system comprising a user interface configured to allow a user to remotely operate the wearable sweat apparatus. The system of Duhamel is capable of managing and analyzing readings from the sensor. It is noted that the combination of Gao, Wu ’19, and Wu ’22 is capable of transmitting data from the device to an external computer system. Therefore, the transmitting of data from the wearable device to the external computer system is an operation of the wearable sweat apparatus, and the system of Duhamel need not recite details of the cross-stage collaborative design. The transmission and reception of the transmitted data can be considered operation of the wearable device.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/NELSON ALEXANDER GLOVER/ Examiner, Art Unit 3791
/ADAM J EISEMAN/ Primary Examiner, Art Unit 3791
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