DETAILED ACTION
In furtherance to the Notice of Panel Decision from Pre-Appeal Brief Review mailed on 11/25/2025, the previous rejections as presented in the Office Action mailed on 7/29/2025 are withdrawn. This action is pursuant to claims filed on 06/05/2025. Claims 1-17 are pending. A Non-Final Action on the merits of claims 1-17 is as follows.
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 .
Claim Objections
Claims 12 and 14 are objected to because of the following informalities:
In claim 12, line 2, a period should be added after “comprises a biomarker sensor”
In claim 14, line 11 , “each the sweat droplet” should read “each of the sweat droplets”
In claim 14, line 12 , “each sweat droplet” should read “each of the sweat droplets”
Appropriate correction is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 9-12, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Begtrup (US 20180020966) in view of Gomez (WO 2019060689).
Regarding independent claim 1, Begtrup teaches a system ([0003]: “A primary goal of the disclosed invention is to provide decision support to a sweat sensor system user that is informative at the level of the individual patient”), comprising:
a sensor for sensing sweat ([0039]: “The sweat sensing device may include a plurality of sensors to detect and improve detection of sweat analytes”);
an apparatus for receiving sweat from one or more sweat glands and transporting the sweat to the sensor (Claim 9: “A sweat sensing device configured to be worn on a wearer's skin, comprising: … a microfluidic channel for receiving and transporting a sweat sample”; Fig. 8).
However, Begtrup does not teach transporting the sweat as discrete sweat droplets.
Gomez discloses a discrete volume sweat sensor. Specifically, Gomez teaches transporting the sweat to the sensor as discrete sweat droplets ([0062]: “the electrodes 110, 112 are in the path of the droplet formation and, as each discrete sample moves through the opening 102a, the circuit between the electrodes 110, 112 cycles from an open circuit, to a short circuit, and back to an open circuit, which creates discrete spikes in the current. By measuring the current during the repeated short-circuiting, the frequency of dispensing can be monitored and recorded”). Begtrup and Gomez are analogous arts as they are both related to devices that transport and measure sweat.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the sweat transportation channel that transports sweat as discrete droplets from Gomez into the system from Begtrup as it allows the device to transport individual droplets instead of a flow, which can allow for clearer measurements of individual droplets of sweat, and is a known transportation method of the sweat droplets, therefore it would be a simple substitution.
The Begtrup/Gomez combination teaches a processor (Begtrup, [0040]: “The device may have varying degrees of onboard computing capability (i.e., processing and data storage capacity)”) configured to:
record the sweat droplets sensed by the sensor during a time period; determine time intervals between consecutive sensed sweat droplets during the time period (Begtrup, [0041]: “The sweat sensing device's data aggregation capability may include collecting all of the sweat sensor data generated by sweat sensing devices and communicated to the device”; [0075]: “The volumetric sweat rate sensor includes a plurality of electrodes 1454 which are also carried on the substrate and arranged across the channel 1430. As described for FIG. 3, the electrodes are spaced at intervals with known intervening channel volumes. During device operation, when the wearer begins to sweat, a sweat sample 16 will enter the device at the inlet 1432 and move through the channel 1430. As sweat flows through and contacts the conductivity electrode 1420, the device measures the conductivity of the sweat sample. Similarly, as sweat moves further into the channel, it flows through and contacts the volumetric sweat rate electrodes 1426 in succession, which the device interprets as sweat being present at the contacted electrode. The device uses sweat's presence at each electrode, along with the intervening filled channel volume and the time of contact to determine volumetric sweat rate”); and
identify, using the time intervals, at least one active period of each of the one or more sweat glands during which the respective sweat gland is excreting sweat, and at least one rest period of each of the one or more sweat glands during which the respective sweat gland is not excreting sweat, the at least one active period and the at least one rest period being assigned to said the one or more sweat glands (Begtrup, Abstract: “The disclosure further includes methods for using a device configured to perform periodic sweat conductivity measurements, galvanic skin response measurements, and volumetric sweat rate measurements so that each sensor modality informs composite estimates of sweat onset, sweat cessation, sweat ion concentration, and sweat rate”; [0058]: “when the device wearer is actively sweating, positive pressure from the sweat gland will tend to move the sweat sample forward in the direction of the arrow 16 despite resistance from the channel. However, as depicted in FIG. 7B, when active sweating stops, or if there is any other flow interruption, the channel coating's resistance to movement in either direction will tend to keep the sweat sample stationary”. Since the device is placed over only one sweat gland as indicated in Figure 8, it is implicit, inherent, or obvious that the active and rest periods will be assigned to the one sweat gland.).
Regarding claim 9, the Begtrup/Gomez combination teaches the system according to claim 1.
However, the Begtrup/Gomez combination is silent on the volume of the droplets.
Gomez teaches wherein the apparatus is arranged to transport sweat droplets having a predetermined volume to the sensor ([0040]: “a discrete volume dosing system comprises a biofluid sensing device 10, which is a closed or sealed system in which discrete, quantized samples of fluid are delivered, analyzed, and calibrated independent of flow rate. The discrete, quantized samples have a fixed volume of fluid. The discrete, quantized samples are dispensed at an interval based at least in part on the rate at which the amount of fluid in the channel 14 meets or exceeds a threshold volume”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the predetermined volume from Gomez into the Begtrup/Gomez combination as the combination is silent on the volume of the droplets, and Gomez discloses a suitable volume in an analogous device.
Regarding claim 10, the Begtrup/Gomez combination teaches the system according to claim 1, wherein the sensor comprises a sensing device for detecting a parameter relating to a concentration of an analyte whose concentration varies as a function of sweat rate (Begtrup, [0013]: “‘Sweat conductivity’ means measurements of the electrical conductivity of sweat. Sweat conductivity serves as a means of estimating Na.sup.+ and Cl.sup.− content, since Cl.sup.− represents the dominant anion in sweat, and is usually paired with Na.sup.+ as salt. However, conductivity does not precisely correlate to Cl.sup.− levels, because lactate and bicarbonate also make significant contributions to sweat conductivity. The sweat sensing device measures sweat conductivity by means of an electrode”), wherein the processor is configured to use the parameter in assigning the at least one active period and the at least one rest period to the one or more sweat glands (Begtrup, [0014]: “‘Galvanic skin response’ (“GSR”) means measurements of the electrical conductivity of the skin. GSR serves as a means of determining sweat onset and cessation, and can be used to estimate sweat rate, since skin conductivity is dominated by the contribution of sweat”).
Regarding claim 11, the Begtrup/Gomez combination teaches the system according to claim 10, wherein the sensing device is a conductivity sensor and the parameter is conductivity (Begtrup, [0013]: ““Sweat conductivity” means measurements of the electrical conductivity of sweat. Sweat conductivity serves as a means of estimating Na.sup.+ and Cl.sup.− content, since Cl.sup.− represents the dominant anion in sweat, and is usually paired with Na.sup.+ as salt. However, conductivity does not precisely correlate to Cl.sup.− levels, because lactate and bicarbonate also make significant contributions to sweat conductivity. The sweat sensing device measures sweat conductivity by means of an electrode”; [0014]: ““Galvanic skin response” (“GSR”) means measurements of the electrical conductivity of the skin. GSR serves as a means of determining sweat onset and cessation, and can be used to estimate sweat rate, since skin conductivity is dominated by the contribution of sweat”).
Regarding claim 12, the Begtrup/Gomez combination teaches the system according to claim 1, wherein the sensor comprises a biomarker sensor (Begtrup, [0039]: “The sweat sensing device may include a plurality of sensors to detect and improve detection of sweat analytes”; [0043]: “sweat concentrations of analytes relative to blood or plasma concentrations are known to vary depending on sweat rate”).
Regarding independent claim 15, Begtrup teaches a method ([0037]: “The detailed description of the present invention will be primarily, but not entirely, limited to devices, methods and sub-methods using wearable sweat sensing devices.”) comprising:
receiving sweat from one or more sweat glands; and transporting the sweat to a sensor (Claim 9: “A sweat sensing device configured to be worn on a wearer's skin, comprising: … a microfluidic channel for receiving and transporting a sweat sample”; Fig. 8).
However, Begtrup does not teach transporting the sweat as discrete sweat droplets.
Gomez discloses a discrete volume sweat sensor. Specifically, Gomez teaches transporting the sweat to the sensor as discrete sweat droplets ([0062]: “the electrodes 110, 112 are in the path of the droplet formation and, as each discrete sample moves through the opening 102a, the circuit between the electrodes 110, 112 cycles from an open circuit, to a short circuit, and back to an open circuit, which creates discrete spikes in the current. By measuring the current during the repeated short-circuiting, the frequency of dispensing can be monitored and recorded”). Begtrup and Gomez are analogous arts as they are both related to devices that transport and measure sweat.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the sweat transportation channel that transports sweat as discrete droplets from Gomez into the method from Begtrup as it allows the device to transport individual droplets instead of a flow, which can allow for clearer measurements of individual droplets of sweat, and is a known transportation method of the sweat droplets, therefore it would be a simple substitution.
The Begtrup/Gomez combination teaches sensing the sweat droplets using the sensor during a time period; recording the sweat droplets sensed during the time period; determining time intervals between consecutive sensed sweat droplets during the time period (Begtrup, [0041]: “The sweat sensing device's data aggregation capability may include collecting all of the sweat sensor data generated by sweat sensing devices and communicated to the device”; [0075]: “The volumetric sweat rate sensor includes a plurality of electrodes 1454 which are also carried on the substrate and arranged across the channel 1430. As described for FIG. 3, the electrodes are spaced at intervals with known intervening channel volumes. During device operation, when the wearer begins to sweat, a sweat sample 16 will enter the device at the inlet 1432 and move through the channel 1430. As sweat flows through and contacts the conductivity electrode 1420, the device measures the conductivity of the sweat sample. Similarly, as sweat moves further into the channel, it flows through and contacts the volumetric sweat rate electrodes 1426 in succession, which the device interprets as sweat being present at the contacted electrode. The device uses sweat's presence at each electrode, along with the intervening filled channel volume and the time of contact to determine volumetric sweat rate”); and
using a processor (Begtrup, [0040]: “The device may have varying degrees of onboard computing capability (i.e., processing and data storage capacity)”) to identify, using the time intervals, at least one active period of each of the one or more sweat glands during which the respective sweat gland is excreting sweat, and at least one rest period of each of the one or more sweat glands during which the respective sweat gland is not excreting sweat, the at least one active period and the at least one rest period being assigned to the one or more sweat glands (Begtrup, Abstract: “The disclosure further includes methods for using a device configured to perform periodic sweat conductivity measurements, galvanic skin response measurements, and volumetric sweat rate measurements so that each sensor modality informs composite estimates of sweat onset, sweat cessation, sweat ion concentration, and sweat rate”; [0058]: “when the device wearer is actively sweating, positive pressure from the sweat gland will tend to move the sweat sample forward in the direction of the arrow 16 despite resistance from the channel. However, as depicted in FIG. 7B, when active sweating stops, or if there is any other flow interruption, the channel coating's resistance to movement in either direction will tend to keep the sweat sample stationary”. Since the device is placed over only one sweat gland as indicated in Figure 8, it is implicit, inherent, or obvious that the active and rest periods will be assigned to the one sweat gland.).
Claims 2-4, 13-14, and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over the Begtrup/Gomez combination as applied to claim 1 above, and further in view of Hoffman (WO 2019183529).
Regarding claim 2, the Begtrup/Gomez combination teaches the system according to claim 1, wherein the processor is further configured to determine at least one active period and the at least one rest period (Begtrup, Abstract: “The disclosure further includes methods for using a device configured to perform periodic sweat conductivity measurements, galvanic skin response measurements, and volumetric sweat rate measurements so that each sensor modality informs composite estimates of sweat onset, sweat cessation, sweat ion concentration, and sweat rate”; [0058]: “when the device wearer is actively sweating, positive pressure from the sweat gland will tend to move the sweat sample forward in the direction of the arrow 16 despite resistance from the channel. However, as depicted in FIG. 7B, when active sweating stops, or if there is any other flow interruption, the channel coating's resistance to movement in either direction will tend to keep the sweat sample stationary”. If the device is placed over only one sweat gland as indicated in Figure 8, it is implicit, inherent, or obvious that the active and rest periods will be assigned to the one sweat gland, and it is clear that the number of sweat glands that are active or resting are determined by each individual gland).
However, the Begtrup/Gomez combination does not teach wherein the processor is further configured to determine a number of sweat glands to which the at least one active period and the at least one rest period are assigned.
Hoffman discloses a device used to measure sweat rate. Specifically, Hoffman teaches wherein the processor is further configured to determine a number of sweat glands to which the at least one active period and the at least one rest period are assigned ([0019]: “’Sweat generation rate’ or ‘sweat rate’ means the rate at which sweat is generated by the sweat glands themselves. Sweat generation rate is typically measured by the flow rate from each gland in nL/min/gland. In some cases, the measurement is then multiplied by the number of sweat glands from which the sweat is being sampled”; [0037]: “Total body sweat rates and per-gland sweat rates can be determined or refined in a number of ways, including accounting for generalized characteristics, such as average sweat gland density of the device mounting location, the individual’s body mass index, the individual’s gender, or other factors”). Begtrup, Gomez, and Hoffman are analogous arts as they are all related to devices that transport and measure sweat.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the determination of the number of glands from Hoffman into the Begtrup/Gomez combination as it allows the combination to determine how many of the user’s glands are in each period, which can allow for information about the user’s whole body and their sweat status.
Regarding claim 3, the Begtrup/Gomez/Hoffman combination teaches the system according to claim 2, wherein the processor is further configured to: receive a measure of a volume of the sweat (Begtrup, [0045]: “The disclosed sweat sensing device will therefore include a volumetric sweat rate sensor) and determine a sweat rate per gland from the determined number of sweat glands (Hoffmann, [0019]: “’Sweat generation rate’ or ‘sweat rate’ means the rate at which sweat is generated by the sweat glands themselves. Sweat generation rate is typically measured by the flow rate from each gland in nL/min/gland. In some cases, the measurement is then multiplied by the number of sweat glands from which the sweat is being sampled”; [0037]: “Total body sweat rates and per-gland sweat rates can be determined or refined in a number of ways, including accounting for generalized characteristics, such as average sweat gland density of the device mounting location, the individual’s body mass index, the individual’s gender, or other factors”).
However, the Begtrup/Gomez combination does not teach receiving a measure of the volume of each of the recorded sweat droplets; and determine a sweat rate per gland from the number of recorded sweat droplets, the measure of the volume of each of the recorded sweat droplets, and the determined number of sweat glands.
Gomez teaches a measure of the volume of each of the recorded sweat droplets; and determine a sweat rate per gland from the number of recorded sweat droplets, the measure of the volume of each of the recorded sweat droplets ([0040]: “a discrete volume dosing system comprises a biofluid sensing device 10, which is a closed or sealed system in which discrete, quantized samples of fluid are delivered, analyzed, and calibrated independent of flow rate. The discrete, quantized samples have a fixed volume of fluid. The discrete, quantized samples are dispensed at an interval based at least in part on the rate at which the amount of fluid in the channel 14 meets or exceeds a threshold volume,”; [0041]: “the flow rate of the sample over the sensor 18 is calculated by measuring the periodicity of each sample.”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the evaluation of individual sweat droplets from Gomez into the system from the Begtrup/Gomez combination as the combination is transporting individual droplets, therefore it would be obvious to use the measurements of the individual droplets for analysis.
Regarding claim 4, the Begtrup/Gomez/Hoffmann combination teaches the system according to claim 3.
However, the Begtrup/Gomez/Hoffmann combination does not teach wherein the sensor is configured to sense an indicator of the volume of the sweat droplets.
Gomez teaches wherein the sensor is configured to sense an indicator of the volume of the sweat droplets (Gomez, [0040]: “a discrete volume dosing system comprises a biofluid sensing device 10, which is a closed or sealed system in which discrete, quantized samples of fluid are delivered, analyzed, and calibrated independent of flow rate. The discrete, quantized samples have a fixed volume of fluid. The discrete, quantized samples are dispensed at an interval based at least in part on the rate at which the amount of fluid in the channel 14 meets or exceeds a threshold volume”. The rate of which the amount of fluid in the channel meets or exceeds a threshold volume is the indicator of the volume, as this is what determines the volume.).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the indicator of the volume of the sweat droplets from Gomez into the Begtrup/Gomez/Hoffmann combination as it allows the system to determine the volume of the sweat droplets, which can be an important measurement used to determine the sweat rate.
The Begtrup/Gomez/Hoffmann combination teaches the processor is configured to receive the sensed indicator (Begtrup, [0040]: “The device may have varying degrees of onboard computing capability (i.e., processing and data storage capacity)”).
Regarding claim 13, the Begtrup/Gomez combination teaches the system according to claim 1, wherein the apparatus comprises a chamber (Fig. 8 and 8A, reference character 938)..
The Begtrup/Gomez combination does not teach a plurality of chambers, however it would be a simple duplication of parts to include a plurality of chambers, and it provides an obvious advantage of being able to measure multiple areas.
The Begtrup/Gomez combination teaches each of the chambers having an inlet for receiving sweat from skin, and an outlet arranged such that a sweat droplet forms and protrudes therefrom following filling of the chamber with sweat (Begtrup, Fig. 8A); and a fluid transport assembly arranged to release each sweat droplet protruding from the outlets and transport each released sweat droplet to the sensor (Begtrup, Fig. 8A, channel 832).
However, the Begtrup/Gomez combination is silent on the protrusion and removal of the droplet from the chamber.
Hoffman teaches the respective outlet being thereby made available for a subsequent sweat droplet to form and protrude therefrom upon further filling of a respective chamber, wherein the fluid transport assembly is arranged to transport each released sweat droplet at least as fast as the subsequent sweat droplet protrudes from the respective outlet such that the sweat droplets from a same chamber do not contact each other (Abstract: “A sensing chamber is continuously filled with a sweat sample, which forms a droplet and alters the humidity measured within the chamber. Once the sweat sample droplet expands to the edge of the chamber, the droplet contacts a wick and is drawn away, so the chamber can fill with a subsequent droplet.”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the transfer process from Hoffman into the Begtrup/Gomez combination as the combination is silent on the process, and Hoffman discloses a suitable process in an analogous device.
Regarding claim 14, the Begtrup/Gomez/Hoffman combination teaches the system according to claim 13.
However, the Begtrup/Gomez/Hoffman combination is silent on the transport of the drop to the sensor.
Gomez teaches wherein the apparatus comprises: at least one first track in which the chambers are defined (Fig. 4a, element 14); and a second track (Fig. 4a, element 16), each of the at least one first track being fluidly coupled to the second track (Fig. 4a), wherein the second track is arranged to transport sweat droplets received from the at least one first track towards the sensor ([0040]: “The wicking component 16 transports fluid from the channel 14 to the enzymatic-based, analyte biosensor 18.”), and wherein the fluid transport assembly comprises: a series of tiles, wherein the tiles are provided along the at least one first track and along the second track ([0071]: “A first electrode e1 is positioned within the fluid channel 164 and is adjacent the opening 162a. The sample fluid travels through the channel 164 towards the opening 162a. The device 160 further includes a substrate 166 at least a portion of which is adjacent to the opening 162a of the chamber 162. The substrate 166 includes an electrode array 168. The electrode array 168 includes two electrodes e2, e3 that are positioned opposite the opening 162a.”); and an electric field generator for charging and discharging each of the tiles of the series in sequence ([0071]: “a discrete volume dosing system that is capable of using active droplet formation and dispensing to monitor the flow rate of the fluid in real time using electrowetting is shown”), such as to release each the sweat droplet from the respective outlet and to transport each sweat droplet towards the sensor ([0071]: “The discrete volume dosing system comprises a fluid sensing device 160, which is a closed or sealed system in which discrete, quantized samples of fluid are delivered.”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the transportation of the droplet to the sensor from Gomez into the Begtrup/Gomez/Hoffman combination as the combination is silent on the transportation process, and Gomez discloses a suitable process and structure in an analogous device.
Regarding claim 16, the Begtrup/Gomez combination teaches the method according to claim 15, further comprising:
determining the at least one active period and the at least one rest period (Begtrup, Abstract: “The disclosure further includes methods for using a device configured to perform periodic sweat conductivity measurements, galvanic skin response measurements, and volumetric sweat rate measurements so that each sensor modality informs composite estimates of sweat onset, sweat cessation, sweat ion concentration, and sweat rate”; [0058]: “when the device wearer is actively sweating, positive pressure from the sweat gland will tend to move the sweat sample forward in the direction of the arrow 16 despite resistance from the channel. However, as depicted in FIG. 7B, when active sweating stops, or if there is any other flow interruption, the channel coating's resistance to movement in either direction will tend to keep the sweat sample stationary”. If the device is placed over only one sweat gland as indicated in Figure 8, it is implicit, inherent, or obvious that the active and rest periods will be assigned to the one sweat gland, and it is clear that the number of sweat glands that are active or resting are determined by each individual gland).
However, the Begtrup/Gomez combination does not teach wherein the processor is further configured to determine a number of sweat glands to which the at least one active period and the at least one rest period are assigned.
Hoffman discloses a device used to measure sweat rate. Specifically, Hoffman teaches determining a number of sweat glands to which the at least one active period and the at least one rest period are assigned ([0019]: “’Sweat generation rate’ or ‘sweat rate’ means the rate at which sweat is generated by the sweat glands themselves. Sweat generation rate is typically measured by the flow rate from each gland in nL/min/gland. In some cases, the measurement is then multiplied by the number of sweat glands from which the sweat is being sampled”; [0037]: “Total body sweat rates and per-gland sweat rates can be determined or refined in a number of ways, including accounting for generalized characteristics, such as average sweat gland density of the device mounting location, the individual’s body mass index, the individual’s gender, or other factors”). Begtrup, Gomez, and Hoffman are analogous arts as they are all related to devices that transport and measure sweat.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the determination of the number of glands from Hoffman into the Begtrup/Gomez combination as it allows the combination to determine how many of the user’s glands are in each period, which can allow for information about the user’s whole body and their sweat status.
Regarding claim 17, the Begtrup/Gomez/Hoffman combination teaches the method according to claim 16, further comprising: receiving a measure of a volume of the sweat (Begtrup, [0045]: “The disclosed sweat sensing device will therefore include a volumetric sweat rate sensor) and determine a sweat rate per gland from the determined number of sweat glands (Hoffmann, [0019]: “’Sweat generation rate’ or ‘sweat rate’ means the rate at which sweat is generated by the sweat glands themselves. Sweat generation rate is typically measured by the flow rate from each gland in nL/min/gland. In some cases, the measurement is then multiplied by the number of sweat glands from which the sweat is being sampled”; [0037]: “Total body sweat rates and per-gland sweat rates can be determined or refined in a number of ways, including accounting for generalized characteristics, such as average sweat gland density of the device mounting location, the individual’s body mass index, the individual’s gender, or other factors”).
However, the Begtrup/Gomez combination does not teach receiving a measure of the volume of each of the recorded sweat droplets; and determine a sweat rate per gland from the number of recorded sweat droplets, the measure of the volume of each of the recorded sweat droplets, and the determined number of sweat glands.
Gomez teaches receiving a measure of a volume of each of the recorded sweat droplets; and determining a sweat rate per gland from the number of recorded sweat droplets, the measure of the volume of each of the recorded sweat droplets ([0040]: “a discrete volume dosing system comprises a biofluid sensing device 10, which is a closed or sealed system in which discrete, quantized samples of fluid are delivered, analyzed, and calibrated independent of flow rate. The discrete, quantized samples have a fixed volume of fluid. The discrete, quantized samples are dispensed at an interval based at least in part on the rate at which the amount of fluid in the channel 14 meets or exceeds a threshold volume,”; [0041]: “the flow rate of the sample over the sensor 18 is calculated by measuring the periodicity of each sample.”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the evaluation of individual sweat droplets from Gomez into the system from the Begtrup/Gomez combination as the combination is transporting individual droplets, therefore it would be obvious to use the measurements of the individual droplets for analysis.
Claims 5-6 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over the Begtrup/Gomez/Hoffmann combination as applied to claim 3 above, and further in view of Adachi (WO 2017208650). Citations to WO 2017208650 will refer to the English Machine Translation that accompanies this Office Action.
Regarding claim 5, the Begtrup/Gomez/Hoffmann combination teaches the system according to claim 3.
However, the Begtrup/Gomez/Hoffmann combination is silent on the analysis steps used to identify active and rest periods.
Adachi discloses a perspiration state estimation device. Specifically, Adachi teaches wherein the processor is configured to fit data received from the sensor to a first template model (Page 25: “multiple pieces of local sweat data acquired by the sweat sensor 30 at multiple times (in the example of Figure 5, multiple times between time T and the time T-x on the horizontal axis of the graph showing the sweat pattern, including the time T and the time before that) are temporarily stored in the memory unit 12. The collation unit 112 calculates an approximation curve (a time-dependent characteristic obtained from the multiple pieces of local sweating data) for the multiple pieces of local sweating data acquired by the sweating sensor 30 at the multiple times, using, for example, the least squares method. Then, the matching unit 112 matches (fits) the calculated approximation curve with the first sweat pattern identified by the sweat pattern identifying unit 111”). Begtrup, Gomez, and Adachi are analogous arts as they are all related to systems used to measure sweat and the properties associated with it.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the template model from Adachi into the Begtrup/Gomez/Hoffmann combination as the combination is silent on the analysis steps, and Adachi discloses a suitable analysis step in an analogous device.
The Begtrup/Gomez/Hoffmann/Adachi combination teaches using a template model thereby to identify the at least one active period and the at least one rest period of each of the one or more sweat glands the data comprising at least the time intervals, and the measure of the volume of each of the recorded sweat droplets (Begtrup, Abstract: “The disclosure further includes methods for using a device configured to perform periodic sweat conductivity measurements, galvanic skin response measurements, and volumetric sweat rate measurements so that each sensor modality informs composite estimates of sweat onset, sweat cessation, sweat ion concentration, and sweat rate”; [0058]: “when the device wearer is actively sweating, positive pressure from the sweat gland will tend to move the sweat sample forward in the direction of the arrow 16 despite resistance from the channel. However, as depicted in FIG. 7B, when active sweating stops, or if there is any other flow interruption, the channel coating's resistance to movement in either direction will tend to keep the sweat sample stationary”. since the device is placed over only one sweat gland as indicated in Figure 8, it is implicit, inherent, or obvious that the active and rest periods will be assigned to the one sweat gland; Gomez, [0040]: “a discrete volume dosing system comprises a biofluid sensing device 10, which is a closed or sealed system in which discrete, quantized samples of fluid are delivered, analyzed, and calibrated independent of flow rate. The discrete, quantized samples have a fixed volume of fluid. The discrete, quantized samples are dispensed at an interval based at least in part on the rate at which the amount of fluid in the channel 14 meets or exceeds a threshold volume”. Adachi discloses using a template model to determine sweat pattern, which can includes the sweat rate (Page 11: “The first sweating pattern in this embodiment indicates the change over time in the amount of sweating”), Begtrup discloses that the sweat rate is used to determine the active and rest periods, and Gomez discloses determining the volume for the individual droplets.).
Regarding claim 6, the Begtrup/Gomez/Hoffmann/Adachi teaches the system according to claim 5, wherein fitting data to the first template model additionally uses at least one of: a number of sweat droplets in the at least one active period, a duration of the at least one active period, or a duration of the at least one rest period (Adachi, Page 25: “multiple pieces of local sweat data acquired by the sweat sensor 30 at multiple times (in the example of Figure 5, multiple times between time T and the time T-x on the horizontal axis of the graph showing the sweat pattern, including the time T and the time before that) are temporarily stored in the memory unit 12. The collation unit 112 calculates an approximation curve (a time-dependent characteristic obtained from the multiple pieces of local sweating data) for the multiple pieces of local sweating data acquired by the sweating sensor 30 at the multiple times, using, for example, the least squares method. Then, the matching unit 112 matches (fits) the calculated approximation curve with the first sweat pattern identified by the sweat pattern identifying unit 111”; Gomez, [0040]: “a discrete volume dosing system comprises a biofluid sensing device 10, which is a closed or sealed system in which discrete, quantized samples of fluid are delivered, analyzed, and calibrated independent of flow rate. The discrete, quantized samples have a fixed volume of fluid. The discrete, quantized samples are dispensed at an interval based at least in part on the rate at which the amount of fluid in the channel 14 meets or exceeds a threshold volume”).
Regarding claim 8, the Begtrup/Gomez/Hoffmann/Adachi teaches the system according to claim 5.
However, the Begtrup/Gomez/Hoffman/Adachi combination does not teach wherein the processor is configured to, following fitting the data to the first template model, fit at least a portion of the data to a second template model, wherein the first template model is based on at least some of the sweat droplets deriving from a sweat sample constituted by sweat excreted from a single sweat gland, and the second template model is based on at least some of the sweat droplets deriving from a further sweat sample constituted by sweat excreted from two or more sweat glands.
Adachi teaches wherein the processor is configured to, following fitting the data to the first template model, fit at least a portion of the data to a second template model, wherein the first template model is based on at least some of the sweat droplets deriving from a sweat sample constituted by sweat excreted from a single sweat gland, and the second template model is based on at least some of the sweat droplets deriving from a further sweat sample constituted by sweat excreted from two or more sweat glands (Page 26-27: “In the perspiration data estimation device 10A, in S4 of FIG. 3, the perspiration sensor 30 acquires local perspiration data over a plurality of time periods. The sweating data estimation device 10A stores the plurality of local sweating data in the storage unit 12. The collation unit 112 acquires a plurality of pieces of local sweating data stored in the storage unit 12 and calculates, for example, an approximation curve. Then, in S5, the matching unit 112 fits the calculated approximation curve to the first sweating pattern identified by the sweating pattern identification unit 111, and identifies the time To, which is the time on the first sweating pattern at which the local sweating data was acquired (i.e., the time on the first sweating pattern corresponding to the local sweating data). This is followed by estimating whole body sweat rate, predicting whole body sweat rate over time, and generating assistance data.” Page 17: “the memory unit 12 may store a transition-related pattern that corresponds to the first sweat pattern and indicates the relationship between the first sweat pattern and the second sweat pattern instead of the second sweat pattern as a transition-related pattern related to the change in the amount of sweat over time in the user's entire body”. The first template model is the approximation curve, and the second template model is the transition-related pattern.).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the second template model from Adachi into the Begtrup/Gomez/Adachi combination as it allows the combination to further compute parameters relative to more sweat glands, which can allow for a more comprehensive analysis of the user’s body and their sweat patterns.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over the Begtrup/Gomez/Hoffman/Adachi combination as applied to claim 5 above, and further in view of Kenton (“Goodness-of-Fit”).
Regarding claim 7, the Begtrup/Gomez/Hoffman/Adachi combination teaches the system according to claim 5.
However, the Begtrup/Gomez/Hoffman/Adachi combination does not teach wherein the processor is configured to assess a goodness of fit of the data to the first template model.
Kenton discloses a goodness-of-fit analysis. Specifically, Kenton teaches assessing a goodness of fit of the data to a model (Pages 1-4). Adachi and Kenton are analogous arts as they are both related to mathematical analysis.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the goodness of fit analysis from Kenton into the Begtrup/Gomez/Hoffman/Adachi combination as it allows the system to determine how well the model fits the data, which can inform the device and the user of the fit and accuracy of the model, which can allow for a more accurate analysis.
Response to Arguments
Applicant’s arguments with respect to claims 1-17 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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/E.K.M./Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791