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 .
Election/Restrictions
Claims 47-72 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on November 11, 2025.
Applicant's election with traverse of the restriction of claims 47-72 in the reply filed on November 11, 2025 is acknowledged. The traversal is on the ground(s) that the search and examination of all currently pending claims would not pose an undue burden on the Examiner. This is not found persuasive because claims 47-57 are drawn to a method for fabricating a hydrations sensor by forming a flexible printed circuit board and an enclosed sensing module, and claims 58-72 are drawn to a method for monitoring and/or diagnosing a condition of skin using a hydration sensor attached to a target area of the skin, which require extensive searching for features not described in claims 1-46.
The requirement is still deemed proper and is therefore made FINAL.
During a telephone conversation with Peng Zhou on January 14, 2026, a provisional election was made without traverse to prosecute the invention of the species described in claim 37. Affirmation of this election must be made by applicant in replying to this Office action. Claims 38-44 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-37 and 45-46 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 1 recites “a sensing module operably disposed on a target area of interest of skin of a living subject”, which encompasses a portion of a living organism as part of the claimed invention. In order to overcome this rejection, the claim could be amended to recite “a sensing module configured to be operably disposed on a target area of interest of skin of a living subject”. Claims 2-37 and 45-46 are rejected based on their dependence on claim 1.
Claim 28 recites “the bottom layer comprises a flexible adhesive for attaching the hydration sensor to the skin”, which encompasses a portion of a living organism as part of the claimed invention. In order to overcome this rejection, the claim could be amended to recite “the bottom layer comprises a flexible adhesive configured for attaching the hydration sensor to the skin.”. Claims 29-31 are rejected based on their dependence on claim 28.
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 5, 11, 22-31, 37, and 45 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.
Claim 5 recites “the thermal actuator comprises two or more of surface-mount thin film resistors, thick film resistors, through-hole resistors, and ultrathin-film metal resistors, coupled to each other in series” in lines 1-3. It is unclear if this claim is intended to mean that the thermal actuator comprises two or more of surface-mount thin film resistors, two or more thick film resistors, two or more through-hole resistors, and two or more ultrathin-film metal resistors, or if the thermal actuator comprises two or more resistors from a group comprising surface-mount thin film resistors, thick film resistors, through-hole resistors, and ultrathin-film metal resistors. For the purpose of examination, the claim is interpreted to mean that two or more resistors are required and they may be surface-mount thin film resistors, thick film resistors, through-hole resistors, and/or ultrathin-film metal resistors.
Claim 11 recites “the design requirement of depth sensitivity into the skin” in line 2. There is insufficient antecedent basis for these limitations in the claim.
Claim 22 recites the limitations “the NTCs” in line 3 and “the BLE SoC" in line 4. There is insufficient antecedent basis for these limitations in the claim. Claims 23-31 are rejected based on their dependence on claim 22.
Claim 24 recites the limitation “the battery” in line 2. There is insufficient antecedent basis for these limitations in the claim. Claims 25-31 are rejected based on their dependence on claim 24.
Claim 25 recites the limitation “the environment” in line 4. There is insufficient antecedent basis for these limitations in the claim. Claims 26-31 are rejected based on their dependence on claim 25.
Claim 26 recites the limitation “the critical sensing components” in line 3. There is insufficient antecedent basis for these limitations in the claim. Claim 27 is rejection based on its dependence on claim 26.
The term “various” in claim 27 is a relative term which renders the claim indefinite. The term “various” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The term “various other flexible polymers” is rendered indefinite because it is unclear how many other flexible polymers are required and what those polymers are. Additionally, the claim recites “the top layer is formed of a flexible material”, indicating that there is a single flexible material comprising the top layer. It is unclear if this top layer is meant to be formed of a single material or multiple materials. For the purpose of examination, the top layer may be formed of a single material of silicone or silicone gel, low/high density polyethylene (LDPE/HDPE), polystyrene, Teflon®, and various other flexible polymers, or may be formed of multiple of these components.
Claim 29 recites “an ultrathin fabric of fiberglass/reinforcement material” in line 2. It is unclear if the ultrathin fabric is required to be fiberglass serving as a reinforcement material, or if the fabric can be any type of reinforcement material. For the purpose of examination, the ultrathin fabric may be fiberglass or any type of reinforcement material.
Claim 29 recites “the mechanical robustness” in line 3. There is insufficient antecedent basis for these limitations in the claim. Claim 30 is rejected based on its dependence on claim 29.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 31 recites the broad recitation “the flexible adhesive layer is formed of silicone or silicone gel, or double-sided skin-safe adhesives”, and the claim also recites “the ratio of silicone and silicone gel being adjusted to co-optimize mechanical integrity and tackiness of the adhesive”, which is the narrower statement of the range/limitation. The broader limitation requires only that silicone, silicone gel, or double-sided skin safe adhesives are part of the flexible adhesive layer, however, the claim then narrows by requiring silicone and silicone gel. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 37 recites “the skin condition” in line 2. There is insufficient antecedent basis for these limitations in the claim.
Claim 45 recites “the hydration sensor adhesive” in lines 3-4. There is insufficient antecedent basis for these limitations in the claim.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-6, 12, and 32-37 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2016/025438 (Rogers et al.).
Regarding claim 1, Rogers teaches a hydration sensor, comprising:
a sensing module operably disposed on a target area of interest of skin of a living subject for detecting data associated with thermal properties of the skin ([00105]; [00114] “ultrathin, flexible, stretchable mechanics of the device components, in which precision thermal detectors conform intimately to the surface of the skin”); and
a wireless platform coupled with the sensing module for wireless data transmission between the sensing module and an external device ([0026] “wireless communication component”).
Regarding claim 2, Rogers teaches the hydration sensor of claim 1, wherein the sensing module comprises:
a thermal actuator operably disposed on the target area of interest of the skin for heating the target area of interest thereof ([0015] “one or more thermal actuators”); and
a sensing circuit for simultaneously detecting a transient temperature change (ΔT) thereof to determine the thermal properties of the skin ([0020] “the thermal actuators and thermal sensors are capable of mechanical deformation in response to a stimulus, such as a change in temperature”).
Regarding claim 3, Rogers teaches the hydration sensor of claim 2, wherein the thermal actuator and the sensing circuit are interconnected by serpentine traces to form a flexible structure that facilitates soft, intimate contact to the skin with robust mechanical and thermal coupling ([0027] “the flexible or stretchable electronic circuit comprises one or more electronic devices or device components having a curved, serpentine, bent, wavy or buckled geometry”; [00117] “The construction uses narrow, filamentary serpentine traces and thin, low modulus silicon substrates, using concepts in ultrathin, stretchable electronic sensor design [26-33], to yield a device platform that naturally conforms to the surface of the skin”).
Regarding claim 4, Rogers teaches the hydration sensor of claim 2, wherein the thermal actuator comprises at least one resistor ([0026] “resistors”).
Regarding claim 5, Rogers teaches the hydration sensor of claim 4, wherein the thermal actuator comprises two or more of surface-mount thin film resistors, thick film resistors, through-hole resistors, and ultrathin-film metal resistors, coupled to each other in series ([0019] “the thermal actuators and thermal sensors comprise thin film structures. In an embodiment, for example, the thermal actuators and thermal sensors comprise filamentary metal structures”; [0026]).
Regarding claim 6, Rogers teaches the hydration sensor of claim 2, wherein the sensing circuit comprises one or more of negative temperature coefficient thermistors, positive temperature coefficient thermistors, resistance temperature detectors (RTD), and thermocouples ([0026] “thermistors”; [00223] “thermocouples”; [0184] “To map temperature, the resistance of each sensor element can be sampled sequentially by DMM1, via opening and closing of relevant relays”).
Regarding claim 12, Rogers teaches the hydration sensor of claim 1, wherein the wireless platform comprises at least one of Wi-Fi, BLE, and NFC communication protocols ([0026] “the device further comprises one or more wireless communication antenna structures or near-field communication coil”).
Regarding claim 32, Rogers teaches the hydration sensor of claim 1, wherein the external device is a smartphone, a tablet, a computer, or any electronic device with data reading/processing capability ([00225] “smartphone”).
Regarding claim 33, Rogers teaches the hydration sensor of claim 2, wherein the thermal properties of the skin comprise thermal conductivity and thermal diffusivity of the skin that are related to water content of the skin, wherein the water content is a function of a skin depth ([00300] “The thermal mass of skin depends on the water content where thermal mass increases with skin hydration and water content”; [00120] “The temperature ΔT normalized by its steady-state value ΔT.sub.steady is independent of the radius of the blood vessel R and the blood flow velocity v (FIGS. 11 and 12); and its dependence on the normalized material properties λ.sub.s/λ.sub.f and ρ.sub.fc/ρ.sub.sc.sub.s and actuator radius B/L on the transient scaling law appears in FIG. 13. The only unknown parameter is the depth h. As a result, a comparison of experimental results of ΔT/ΔT.sub.steady versus time, t, to FEA results that employ different vessel depths, using the tissue thermal properties measured in the first step, can yield accurate estimates for h”).
Regarding claim 34, Rogers teaches the hydration sensor of claim 33, wherein the water content is determined from the measured temperature change ΔT vs. time t ([0073] “FIG. 33G provides plots of temperature versus time”; [00120] “comparison of experimental results of ΔT/ΔT.sub.steady versus time, t”).
Regarding claim 35, Rogers teaches the hydration sensor of claim 33, wherein the water content and skin surface temperature are used to determine a normal state or a disease state of the skin ([0016] “the thermal sensors are for characterizing a spatio temporal distribution of temperature resulting from heating provided by the one or more thermal actuators, for example, and in connection with physiological function, overall health of the tissue, and/diagnostic evaluation of the tissue.”; [00134] “Applications of interest include monitoring of near-surface blood flow as indicators of vascular health, particularly in diseases with vascular-associated pathologies”).
Regarding claim 36, Rogers teaches the hydration sensor of claim 33, wherein the water content and skin surface temperature serve as quantitative metrics of an efficacy of a treatment of a skin disease, or other health and wellness products including skin moisturizers, lotions, and/or creams ([0030] “The tissue may be of a subject that is undergoing treatment or diagnosis.”; [00230] “The same experiment was performed on a volunteer's forearm skin. Here, different hydration levels were achieved by applying various amounts of lotion to the measurement location, prior to application of the active e-TLC device. Immediately after image capture, the e-TLC device was removed and a hydration meter was used to determine the actual moisture level (averaged from 5 readings).”).
Regarding claim 37, Rogers teaches the hydration sensor of claim 1, being usable for monitoring the skin condition in a clinical setting and/or an at-home setting ([00134] “This class of devices is amenable to low cost, high volume production using established microfabrication procedures, thereby suggesting a potential for widespread use, both in the clinic and in the home setting.”).
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 7-11 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2016/025438 (Rogers et al.) in view of US 20190117155 A1 (Cross et al.).
Regarding claim 7, Rogers teaches the hydration sensor of claim 2,
Rogers does not teach wherein the sensing circuit comprises a first pair of negative temperature coefficient thermistors (NTCs) arranged in a first Wheatstone bridge circuit.
However,
Cross teaches wherein the sensing circuit comprises a first pair of negative temperature coefficient thermistors (NTCs) arranged in a first Wheatstone bridge circuit ([0101] “In combination with the reference resistor, there are many ways (Wheatstone bridge, voltage divider, etc.) to measure the resistance of the NTC thermistor”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the sensor taught by Rogers to include NTCs in a Wheatstone bridge circuit. Rogers teaches incorporating thermistors in the device [0026]. One would have been motivated to make this modification to use NTCs because they are preferred for measuring skin temperature [0065] and are typical for measuring human body temperatures and taking into account environmental noise, as suggested by Cross [0100-0101].
Regarding claim 8, Rogers teaches the hydration sensor of claim 7,
wherein the first pair of thermal sensors is disposed on a layer different from the thermal actuator, and the first pair of thermal sensors is directly on the top of the thermal actuator; or
wherein the first pair of thermal sensors is disposed on a layer same as the thermal actuator, and each first thermal sensor has a first distance from the thermal actuator ([0035] ‘thermally actuating the tissue with the one or more thermal actuators while simultaneously recording a nonequilibrium temperature of the thermal actuator and the plurality of thermal sensors; and identifying pairs of symmetrically disposed thermal sensors on opposing sides of the thermal actuator.”).
Roger does not explicitly teach NTCs.
However,
Cross teaches NTCs ([0100-0101]).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the sensor taught by Rogers to include NTCs. Rogers teaches incorporating thermistors in the device [0026] and using multiple pairs of thermal sensors [0035]. One would have been motivated to make this modification to use NTCs because they are preferred for measuring skin temperature [0065] and are typical for measuring human body temperatures and taking into account environmental noise, as suggested by Cross [0100-0101].
Regarding claim 9, Rogers teaches the hydration sensor of claim 8.
Rogers does not teach wherein the sensing circuit further comprises a second pair of NTCs arranged in a second Wheatstone bridge circuit serving to compensate for changes in an ambient temperature.
However,
Cross teaches wherein the sensing circuit further comprises a second pair of NTCs arranged in a second Wheatstone bridge circuit serving to compensate for changes in an ambient temperature ([0101] “In combination with the reference resistor, there are many ways (Wheatstone bridge, voltage divider, etc.) to measure the resistance of the NTC thermistor”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the sensor taught by Rogers to include NTCs in a Wheatstone bridge circuit. Rogers teaches incorporating thermistors in the device [0026]. One would have been motivated to make this modification to use NTCs because they are preferred for measuring skin temperature [0065] and are typical for measuring human body temperatures and taking into account environmental noise, as suggested by Cross [0100-0101].
Regarding claim 10, Rogers teaches the hydration sensor of claim 9, wherein the second pair of thermal sensors is disposed on the same layer as the first pair of thermal sensors, and each second thermal sensor is spatially apart from the first pair of thermal sensors and has a second distance from the thermal actuator ([0035] ‘thermally actuating the tissue with the one or more thermal actuators while simultaneously recording a nonequilibrium temperature of the thermal actuator and the plurality of thermal sensors; and identifying pairs of symmetrically disposed thermal sensors on opposing sides of the thermal actuator.”).
Roger does not explicitly teach NTCs.
However,
Cross teaches NTCs ([0100-0101]).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the sensor taught by Rogers to include NTCs. Rogers teaches incorporating thermistors in the device [0026] and using multiple pairs thermal sensors [0035]. One would have been motivated to make this modification to use NTCs because they are preferred for measuring skin temperature [0065] and are typical for measuring human body temperatures and taking into account environmental noise, as suggested by Cross [0100-0101].
Regarding claim 11, Rogers teaches the hydration sensor of claim 10, wherein the first and second distances are determined by the design requirement of depth sensitivity into the skin, and ranges from 10s of μm to a few mm ([0019] “In an embodiment, for example, the thermal sensors provide a spatial resolution greater than or equal to 10 μm.”; [00114] “When combined with thermal analysis techniques, these platforms provide routes for quantitative monitoring of both the speed and direction of near surface blood flow, up to 1.5 mm in depth”).
Claims 13-21 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2016/025438 (Rogers et al.) in view of US 20140273858 A1 (Panther et al.)
Regarding claim 13, Rogers teaches the hydration sensor of claim 12.
Rogers does not explicitly teach wherein the wireless platform comprises a Bluetooth low energy system on a chip (BLE SoC).
However,
Panther teaches wherein the wireless platform comprises a Bluetooth low energy system on a chip (BLE SoC) ([0006] “Bluetooth communications via the Bluetooth Low-Energy (BLE) protocol”; [0411] “Bluetooth chipset”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the sensor taught by Rogers to include a BLE SoC. One would have been motivated to make this modification because the BLE SoC can establish communications with external devices to communicate biometric information for a portable device, as suggested by Panther [0032, 0108].
Regarding claim 14, Rogers teaches the hydration sensor of claim 1.
Rogers does not teach wherein the BLE SoC comprises
a general-purpose input/output (GPIO) electrically coupled to the thermal actuator for providing a periodic current to activate the thermal actuator ([0039] “sequentially supplying a current to each thermal sensor and measuring a voltage from each thermal sensor”);
a differential amplifier (AMP) electrically coupled to the sensing circuit for amplifying a difference of bridge voltages;
an analog-to-digital converter (ADC) electrically coupled to the AMP to digitize output voltages of the AMP; and
a BLE radio configured to wirelessly transmit output signals of the ADC to the external device for processing to determine the hydration status of the skin, and receive data from the external device to activate a GPIO pin to provide the periodic current to the thermal actuator.
However,
Panther teaches wherein the BLE SoC comprises
a general-purpose input/output (GPIO) electrically coupled to the thermal actuator for providing a periodic current to activate the thermal actuator ([0057]);
a differential amplifier (AMP) electrically coupled to the sensing circuit for amplifying a difference of bridge voltages ([0062] “differential amplifier”; [0170-0171]);
an analog-to-digital converter (ADC) electrically coupled to the AMP to digitize output voltages of the AMP ([0057]; [0167]; [0170] “This modified signal may then be amplified before it is digitized by the ADC.”); and
a BLE radio configured to wirelessly transmit output signals of the ADC to the external device for processing to determine the hydration status of the skin, and receive data from the external device to activate a GPIO pin to provide the periodic current to the thermal actuator ([0108] “hydration levels”; [0163]; [0216] “the biometric monitoring device may also include a near-field communication (NFC) receiver/transmitter to detect proximity to another device, such as a mobile phone. When the biometric monitoring device is brought into close or detectable proximity to the second device, it may trigger the start of new functionality on the second device (e.g., the launching of an "app" on the mobile phone and radio syncing of physiological data from the device to the second device).”; [0176]; [0233]).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the sensor taught by Rogers to include an AMP and ADC to transmit output signals via BLE. One would have been motivated to make this modification because this allows physiologic parameters of interest to be measured and enhanced before being transmitted and this monitoring can modify further data collection, as suggested by Panther [0169-0170, [0176].
Regarding claim 15, Rogers teaches the hydration sensor of claim 14.
Rogers does not teach wherein a digital on/off switch controlled through a custom application on the external device is adapted to enable BLE-connection and activation of the GPIO pin to source the periodic current into the thermal actuator.
However,
Panther teaches wherein a digital on/off switch controlled through a custom application on the external device is adapted to enable BLE-connection and activation of the GPIO pin to source the periodic current into the thermal actuator ([0134] “disabling" or adjusting the operating conditions of the stress and/or heart rate detection sensors and/or circuitry in addition to other device circuitry or displays (for example, by reducing the duty cycle of or disabling the light source(s) and/or detector(s), turning off the device display, and/or disabling or attenuating associated circuitry or portions thereof). In addition, the biometric monitoring device may periodically determine (e.g., once per second) if the operating conditions of the stress and/or heart rate detection sensors and/or associated circuitry should be restored to a normal operating condition (for example, light source(s), detector(s) and/or associated circuitry should return to a normal operating mode for heart rate detection)”; [0421]).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the sensor taught by Rogers to include a digital on/off switch to enable BLE connection. One would have been motivated to make this modification because the on/off switch allows the apparatus to determine which communication protocol is being used to transmit data, as suggested by Panther [0421].
Regarding claim 16, Rogers teaches the hydration sensor of claim 14, wherein the BLE SoC further comprises a microcontroller (μC) configured to activate the GPIO pin to source the periodic current into the thermal actuator ([0039]; [00184] “controlled by a microcontroller”).
Regarding claim 17, Rogers teaches the hydration sensor of claim 14, further comprising a power module for providing power to the sensing circuit and the wireless platform ([00214] “wireless operation also demands data transmission components and power sources”).
Regarding claim 18, Rogers teaches the hydration sensor of claim 17.
Rogers does not explicitly teach wherein the power module comprises a battery.
However,
Panther teaches wherein the power module comprises a battery ([0163] “the biometric monitoring device (where it includes a rechargeable energy source (for example, rechargeable battery)) may interconnect with a charger”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the sensor taught by Rogers to include a battery. One would have been motivated to make this modification because Rogers describes that power is needed to operate the sensing circuit and wireless platform [00214], and a rechargeable battery may be used to power a biometric monitoring device, as suggested by Panther [0163, 0402].
Regarding claim 19, Rogers teaches the hydration sensor of claim 18.
Rogers does not explicitly teach wherein the battery is a rechargeable battery operably rechargeable with wireless recharging.
However,
Panther teaches wherein the battery is a rechargeable battery operably rechargeable with wireless recharging ([0163] “the biometric monitoring device (where it includes a rechargeable energy source (for example, rechargeable battery)) may interconnect with a charger via a connector that secures itself to the biometric monitoring device using magnets that couple to the ferrous material. In addition, biometric monitoring device may also engage a dock or dock station, using such magnetic properties”; [0305] “the biometric monitoring device may detect proximity to the charger by measuring the Received Signal Strength Indication (RSSI) of a wireless signal from the charger or dock, or, in some embodiments, by recognizing an NFC or RFID tag associated with the charger or dock”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the sensor taught by Rogers to include a rechargeable battery. One would have been motivated to make this modification because Rogers describes that power is needed to operate the sensing circuit and wireless platform [00214], and a rechargeable battery may be used to power a biometric monitoring device using magnetic connection, as suggested by Panther [0163, 0402].
Regarding claim 20, Rogers teaches the hydration sensor of claim 19.
Rogers does not explicitly teach wherein the power module further comprises a wireless charging module for wirelessly charging the rechargeable battery.
However,
Panther teaches wherein the power module further comprises a wireless charging module for wirelessly charging the rechargeable battery ([0163] “the biometric monitoring device (where it includes a rechargeable energy source (for example, rechargeable battery)) may interconnect with a charger via a connector that secures itself to the biometric monitoring device using magnets that couple to the ferrous material. In addition, biometric monitoring device may also engage a dock or dock station, using such magnetic properties”; [0305] “the biometric monitoring device may detect proximity to the charger by measuring the Received Signal Strength Indication (RSSI) of a wireless signal from the charger or dock, or, in some embodiments, by recognizing an NFC or RFID tag associated with the charger or dock”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the sensor taught by Rogers to include a wireless charging module. One would have been motivated to make this modification because Rogers describes that power is needed to operate the sensing circuit and wireless platform [00214], and a rechargeable battery may be used to power a biometric monitoring device using magnetic connection, as suggested by Panther [0163, 0402].
Regarding claim 21, Rogers teaches the hydration sensor of claim 18.
Rogers does not explicitly teach wherein the power module further comprises a failure prevention element including a short-circuit protection component or a circuit to avoid battery malfunction.
However,
Panther teaches wherein the power module further comprises a failure prevention element including a short-circuit protection component or a circuit to avoid battery malfunction ([0147] “An epoxy with a high thermal conductivity may be used to help prevent the light source(s) (e.g., LED's) from overheating”; [0157] “, a liquid gasket and/or a pressure sensitive adhesive are used to prevent liquid from entering the biometric monitoring device body.”; [0304] “The magnetic field of magnets in the dock or cable and the magnets in the device itself may be strategically oriented so as to force the biometric monitoring device to self-align with the dock or cable (or, more specifically, a connector on the cable) and so as to provide a force that holds the biometric monitoring device in the dock or to the cable.”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the sensor taught by Rogers to include a component for preventing battery malfunction. One would have been motivated to make this modification because liquid could enter the device or the device could overheat, causing malfunction, so materials are needed to prevent this, and additionally, a force is needed to securely hold the device to the battery dock to ensure proper contact and charging, as suggested by Panther [0163, 0402].
Claims 22-31 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2016/025438 (Rogers et al.) in view of US 20190117155 A1 (Cross et al.), further in view of US 20140273858 A1 (Panther et al.).
Regarding claim 22, Rogers teaches the hydration sensor of claim 1, further comprising a flexible substrate in the form of a flexible printed circuit board (fPCB) ([0026] “the device further comprises one or more additional device components supported by the flexible or stretchable substrate”) with circuit traces that interconnect the thermal actuator on a skin side ([0027] “the one or more actuators and/or the plurality of sensors are connected by an electronic circuit. In an embodiment, for example, the electronic circuit is flexible or stretchable. In an embodiment, for example, the flexible or stretchable electronic circuit comprises one or more electronic devices or device components having a curved, serpentine, bent, wavy or buckled geometry.”).
Rogers does not teach the NTCs on an air side.
However,
Cross teaches the NTCs on an air side ([0100-0101]).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the sensor taught by Rogers to include NTCs. Rogers teaches incorporating thermistors in the device [0026] and using multiple pairs thermal sensors [0035]. One would have been motivated to make this modification to use NTCs because they are preferred for measuring skin temperature [0065] and are typical for measuring human body temperatures and taking into account environmental noise, as suggested by Cross [0100-0101].
Rogers in view of Cross does not teach the BLE SoC.
However,
Panther teaches the BLE SoC ([0006] “Bluetooth communications via the Bluetooth Low-Energy (BLE) protocol”; [0411] “Bluetooth chipset”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the sensor taught by Rogers in view of Cross to include a BLE SoC. One would have been motivated to make this modification because the BLE SoC can establish communications with external devices to communicate biometric information for a portable device, as suggested by Panther [0032, 0108].
Regarding claim 23, Rogers teaches the hydration sensor of claim 22, wherein the flexible substrate is formed of a flexible material comprising polyimide (PI) ([0179] “polyimide”; [0262] “polyimide”), or polyethylene terephthalate (PET) ([0262] “a substrate of poly(ethyleneterephthalate) (PET)”).
Regarding claim 24, Rogers teaches the hydration sensor of claim 22, further comprising an encapsulating enclosure enclosing the thermal actuator, the wireless platform, and the fPCB ([0028] “Devices of the invention include multilayer devices, for example, including one or more additional layer such as encapsulating layers at least partially encapsulating the thermal actuators and thermal sensors, and/or intermediate layers provided between the one or more thermal actuators and thermal sensors and the substrate.”).
Rogers in view of Cross does not teach the battery.
However,
Panther teaches the battery ([0163] “the biometric monitoring device (where it includes a rechargeable energy source (for example, rechargeable battery)) may interconnect with a charger”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the sensor taught by Rogers in view of Cross to include a battery. One would have been motivated to make this modification because Rogers describes that power is needed to operate the sensing circuit and wireless platform [00214], and a rechargeable battery may be used to power a biometric monitoring device, as suggested by Panther [0163, 0402].
Regarding claim 25, Rogers teaches the hydration sensor of claim 24, wherein the encapsulating enclosure comprises
a top layer for thermal, chemical and mechanical isolation of the hydration sensor from the environment ([0031] “barrier layer”); and
a bottom layer for providing a direct interface between the thermal actuator at the skin side of the fPCB and the skin ([0249] “elastic properties of the substrate, encapsulation layer and electronics, yield soft, compliant mechanics in the overall e-TLC system. These properties yield devices that are well suited for mounting on the skin.”).
Regarding claim 26, Rogers teaches the hydration sensor of claim 25, wherein the top layer is a shell-like top encapsulation layer including small air gaps for thermally, mechanically, and chemically insulating the critical sensing components ([00215] “second layer of polyimide (1.5 μm) places the sensing/heating elements in the neutral mechanical plane and provides electrical insulation and mechanical strain isolation. Reactive ion etching of the polyimide defines the mesh layout of the array and exposes the bonding locations.”).
Regarding claim 27, Rogers teaches the hydration sensor of claim 26, wherein the top layer is formed of a flexible material including silicone or silicone gel, low/high density polyethylene (LDPE/HDPE), polystyrene, Teflon®, and various other flexible polymers ([0098]; [00182] “A final layer of silicone”; [0031] “polyethylene”).
Regarding claim 28, Rogers teaches the hydration sensor of claim 25, wherein the bottom layer comprises a flexible adhesive for attaching the hydration sensor to the skin ([0096] “adhesive layer”).
Regarding claim 29, Rogers teaches the hydration sensor of claim 28, wherein the bottom layer further comprises an ultrathin fabric of fiberglass/reinforcement material embedded in the flexible adhesive layer for enhancing the mechanical robustness of the hydration sensor ([00213] “an ultrathin, compliant skin-like, or ‘epidermal’, photonic device that combines colorimetric temperature indicators with wireless stretchable electronics for precision thermal measurements when softly laminated on the surface of the skin”; [00214] “The epidermal format induces minimal perturbations on the natural mechanical and thermal properties of the skin”; [00215] “thin (20 μm) black elastomeric membrane as a mechanical support”; [00182]).
Regarding claim 30, Rogers teaches the hydration sensor of claim 29, wherein the reinforcement material is flexible and has varying mesh density and thickness to lend tear resistance to the bottom layer ([00182] “Reactive ion etching of the polyimide defines the mesh layout of the array and exposes the bonding locations. A water-soluble tape (3M, USA) enables removal of the mesh layout from the Si wafer, to expose its back surface for deposition of Ti (3 nm)/SiO.sub.2 (30 nm) by electron beam evaporation” … “A final layer of silicone (˜40 μm) in combination with a frame of medical tape (3M, USA) provides sufficient mechanical support to allow repeated (hundreds of times) use of a single device.”; [0029] “the device has an areal mass density selected over the range of 0.1 mg cm.sup.−2 to 100 mg cm.sup.−2. In an embodiment, for example, the device exhibits a stretchability without failure of greater than 5%. In an embodiment, for example, the device exhibits a stretchability without failure selected over the range of 5% to 200%”).
Regarding claim 31, Rogers teaches the hydration sensor of claim 28, wherein the flexible adhesive layer is formed of silicone or silicone gel, or double-sided skin-safe adhesives, with the ratio of silicone and silicone gel being adjusted to co-optimize mechanical integrity and tackiness of the adhesive ([00182] “A final layer of silicone (˜40 μm) in combination with a frame of medical tape (3M, USA) provides sufficient mechanical support to allow repeated (hundreds of times) use of a single device.”).
Claims 45-46 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2016/025438 (Rogers et al.) in view of US 20170156623 A1 (Chu et al.).
Regarding claim 45, Rogers teaches the hydration sensor of claim 1.
Rogers does not explicitly teach being compatible with alcohol-based cleaning wipes allowing for re-use across different users, without any damage to the hydration sensor or loss in efficacy of the hydration sensor adhesive.
However,
Chu teaches being compatible with alcohol-based cleaning wipes allowing for re-use across different users, without any damage to the hydration sensor or loss in efficacy of the hydration sensor adhesive ([0123] “To determine reusability, three separate burst pressure measurements were taken for the same set of adhesive polymer devices bonded to the glass. After each test, the adhesive polymer was removed from the glass slide, washed with isopropyl alcohol”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the sensor taught by Rogers to include using alcohol wipes to clean and reuse the sensor. One would have been motivated to make this modification because washing the adhesive with alcohol does not have significant loss in adhesion of the device, as suggested by Chu [0125], [0129].
Regarding claim 46, Rogers teaches the hydration sensor of claim 1.
Rogers does not explicitly teach being sterilizable using alcohol, autoclave steam sterilization, and gas phase sterilization.
However,
Chu teaches being sterilizable using alcohol, autoclave steam sterilization, and gas phase sterilization ([0123] “To determine reusability, three separate burst pressure measurements were taken for the same set of adhesive polymer devices bonded to the glass. After each test, the adhesive polymer was removed from the glass slide, washed with isopropyl alcohol”; [0127] “The construct was then sterilized via autoclave”; [0093; 0125]).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the sensor taught by Rogers to include sterilizing the sensor. One would have been motivated to make this modification because exposing the adhesive to alcohol, autoclave, and gas does not have significant loss in adhesion of the device and enables to it be reused, as suggested by Chu [0125-0129].
Conclusion
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/EVELYN GRACE PARK/Examiner, Art Unit 3791 /TSE W CHEN/Supervisory Patent Examiner, Art Unit 3791