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 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.
Claim 14 is 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. Applicant appears to be claiming the use of a specific relationship for how sweat electrolyte concentration is determined. However, because of the grammar and typos (possibly caused during translation to English) it is not exactly clear what the overall relationship is being used here. It appears like applicant is trying to define the program as estimating sweat amount and the electrolyte concentration based on some type of functional relationship using time, osmotic pressure, intracellular fluid and extracellular fluid. However, it is not clear what variables depend on what. For this examination, the interpretation taken is that the sweat amount and the sweat electrolyte concentration measurements are dependent on osmotic pressure, intracellular fluid and extracellular fluid. Regardless if this is applicant’s intended interpretation or not, applicant should clarify what is being claimed here.
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.
Claim(s) 9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Newberry et al (US 20170014035) hereafter known as Newberry.
Independent claim:
Regarding claim 9:
Newberry discloses:
A dehydration estimation device [see Fig. 2 and para 52… “FIG. 2 illustrates a perspective view of an embodiment of a health care band 50.” And para 75… “The biosensor 100 may even be configured to detect proteins or other elements or compounds associated with cancer. The biosensor 100 may also detect various electrolytes and many common blood analytic levels, such as bilirubin amount and sodium and potassium. For example, the biosensor 100 may detect sodium NACL concentration levels in the arterial blood flow to determine dehydration.”]
comprising:
one or more processors [see Fig. 3 element 102 and para 56… “the processing circuit 102”]; and
a storage device storing a program to be executed by the one or more processors [see Fig. 3 element 104 and para 56… “the memory device 104 may include one or more non-transitory processor readable memories that store instructions which when executed by the processing circuit 102, causes the processing circuit 102 to perform one or more functions described herein.”], the program including instructions for:
estimating a blood electrolyte concentration of a measurement subject [see para 187… “the biosensor 100 may detect sodium chloride NACL (using L.sub.450 nm) concentration levels in the arterial blood flow and determine dehydration level. The biosensor 100 may then output a determination of level of dehydration based on the detected NACL concentration levels.”]; and
determining presence or absence of dehydration of the measurement subject on a basis of the blood electrolyte concentration [see para 187… “the biosensor 100 may detect sodium chloride NACL (using L.sub.450 nm) concentration levels in the arterial blood flow and determine dehydration level. The biosensor 100 may then output a determination of level of dehydration based on the detected NACL concentration levels.”].
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 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.
Claim(s) 10-11 and 15-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Newberry in view of Hano et al (JP 2017198577 cited as reference 3 under foreign patent documents on IDS received on 3/13/2024 with English translation provided by applicant) hereafter known as Hano.
Regarding claims 10-11
Newberry discloses the invention substantially as claimed including all the limitations of claim 9 including a program that determines presence or absence of dehydration.
However, Newberry appears to analyze the blood directly [see para 75… “For example, the biosensor 100 may detect sodium NACL concentration levels in the arterial blood flow to determine dehydration. The biosensor 100 may also detect blood alcohol levels in vivo in the arterial blood flow.”] and fails to analyze the blood using sweat. Thus, Newberry fails to disclose: “measuring a sweat amount of the measurement subject” as recited by claims 10-11, “measuring a sweat electrolyte concentration of the measurement subject, wherein the blood electrolyte concentration is estimated on a basis of the sweat amount and the sweat electrolyte concentration” as recited by claim 10, or “estimating a sweat electrolyte concentration of the measurement subject on a basis of the sweat amount, wherein the blood electrolyte concentration is estimated on a basis of the sweat amount and the sweat electrolyte concentration” as recited by claim 11.
Hano discloses in the analogous art of physiological diagnostics [see abstract of provided English translation… “To provide a biological information measurement device that can be mounted on a body and can certainly and continuously measure a perspiration speed and specific component concentration in sweat without being affected by a perspiration state”] that another independent non-invasive known way to determine the electrolyte concentration in the blood is to measure the sweat amount and sweat concentration and then use this information to determine the electrolyte concentration in blood [see pg. 37 of translation…”In each of the above embodiments, the component concentration detector 50 detects the concentration and secretion rate of lactic acid as a specific component in sweat. However, the concentration and secretion rate of sodium as a specific component may be detected. Thereby, the secretion rate (secretion amount) of sodium as a specific component can be known. For example, by knowing the amount of sodium secreted in sweat during exercise, it is possible to know the lack of salt concentration in the blood, so it is possible to maintain proper exercise intensity by encouraging the supply of salt.”]
Since Newberry discloses one independent way of measuring the concentration of electrolyte of blood (i.e. via direct non-invasive measurement of the blood) and Hano discloses another independent way of measuring the concentration of electrolyte in blood (i.e. via measuring/estimating the amount and concentration of electrolyte in sweat), it would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Newberry’s method to include measuring the amount and concentration of electrolyte in the sweat and then using these measurements to determine the concentration of electrolyte in the blood similarly to that disclosed by Hano, because one of ordinary skill would expect that the combination of two independent measurements of concentration of electrolyte in the blood would provide a more accurate measurement (and if not the same level of accuracy) than either measurement individually, thereby leading to an expectation of improved accuracy in determining dehydration.
Independent claim:
Regarding claim 15:
Newberry discloses:
A method [see para 75…. “the biosensor 100 may detect sodium NACL concentration levels in the arterial blood flow to determine dehydration.”] comprising:
determining presence or absence of dehydration of the measurement subject on a basis of the blood electrolyte concentration [see para 187… “the biosensor 100 may detect sodium chloride NACL (using L.sub.450 nm) concentration levels in the arterial blood flow and determine dehydration level. The biosensor 100 may then output a determination of level of dehydration based on the detected NACL concentration levels.”].
However, Newberry appears to analyze the blood directly [see para 75… “For example, the biosensor 100 may detect sodium NACL concentration levels in the arterial blood flow to determine dehydration. The biosensor 100 may also detect blood alcohol levels in vivo in the arterial blood flow.”] and fails to analyze the blood using sweat. Thus, Newberry fails to disclose:
“measuring or estimating a sweat amount of a measurement subject;
measuring or estimating a sweat electrolyte concentration of the measurement subject;
estimating a blood electrolyte concentration of the measurement subject on a basis of the sweat amount and the sweat electrolyte concentration”.
Hano discloses in the analogous art of physiological diagnostics [see abstract of provided English translation of Hano… “To provide a biological information measurement device that can be mounted on a body and can certainly and continuously measure a perspiration speed and specific component concentration in sweat without being affected by a perspiration state”] that another independent non-invasive known way to determine the electrolyte concentration in the blood is to measure the sweat electrolyte amount and sweat electrolyte concentration and then use this information to determine the blood electrolyte concentration [see pg. 37 in provided English translation of Hano…”In each of the above embodiments, the component concentration detector 50 detects the concentration and secretion rate of lactic acid as a specific component in sweat. However, the concentration and secretion rate of sodium as a specific component may be detected. Thereby, the secretion rate (secretion amount) of sodium as a specific component can be known. For example, by knowing the amount of sodium secreted in sweat during exercise, it is possible to know the lack of salt concentration in the blood, so it is possible to maintain proper exercise intensity by encouraging the supply of salt.”]
Since Newberry discloses one independent way of measuring the concentration of electrolyte of blood (i.e. via direct non-invasive measurement) and Hano discloses another independent way of measuring the concentration of electrolyte in blood (i.e via the amount and concentration of electrolyte in sweat), it would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Newberry’s method to include measuring the amount and concentration of electrolyte in the sweat and then using these measurements to determine the electrolyte in the blood similarly to that disclosed by Hano, because one of ordinary skill would expect that the combination of two independent measurement/estimates of concentration of electrolyte in the blood would provide a more accurate measurement (and if not the same level of accuracy) than either measurement/estimate individually, thereby leading to an expectation of improved accuracy in determining dehydration.
Independent claim:
Regarding claim 16:
Newberry discloses:
A method for estimating dehydration [see para 75…. “the biosensor 100 may detect sodium NACL concentration levels in the arterial blood flow to determine dehydration.”], comprising:
determining a dehydration state of the measurement subject based on a basis of the blood electrolyte concentration [see para 187… “the biosensor 100 may detect sodium chloride NACL (using L.sub.450 nm) concentration levels in the arterial blood flow and determine dehydration level. The biosensor 100 may then output a determination of level of dehydration based on the detected NACL concentration levels.”].
However, Newberry appears to analyze the blood directly in a non-invasive manner [see para 75… “For example, the biosensor 100 may detect sodium NACL concentration levels in the arterial blood flow to determine dehydration. The biosensor 100 may also detect blood alcohol levels in vivo in the arterial blood flow.”] and fails to analyze the blood electrolyte concentration using sweat. Thus, Newberry fails to disclose the steps of:
“measuring, by a sensor attached to a measurement subject, a sweat amount of the measurement subject;
measuring, by the sensor, an electrolyte concentration in sweat of the measurement subject;
storing time-series data of the sweat amount and the sweat electrolyte concentration;
estimating a blood electrolyte concentration of the measurement subject based on the time-series data of the sweat amount and the sweat electrolyte concentration”. Also Newberry fails to fully disclose the step of determining a dehydration state of the measurement subject based on the estimated blood electrolyte concentration”
Hano discloses in the analogous art of physiological diagnostics [see abstract of provided English translation of Hano… “To provide a biological information measurement device that can be mounted on a body and can certainly and continuously measure a perspiration speed and specific component concentration in sweat without being affected by a perspiration state”] that another independent non-invasive known way to determine the electrolyte concentration in the blood is to measure the sweat electrolyte amount and sweat electrolyte concentration and then use this information to determine electrolyte concentration using a detector (i.e. a sensor) [see pg. 37…”In each of the above embodiments, the component concentration detector 50 detects the concentration and secretion rate of lactic acid as a specific component in sweat. However, the concentration and secretion rate of sodium as a specific component may be detected. Thereby, the secretion rate (secretion amount) of sodium as a specific component can be known. For example, by knowing the amount of sodium secreted in sweat during exercise, it is possible to know the lack of salt concentration in the blood, so it is possible to maintain proper exercise intensity by encouraging the supply of salt.”]. Hano further discloses that these measurements are done continuously by measuring the sweating at predetermined times (i.e. time-series data) [see pg. 9 of English translation of Hano… “Therefore, it is possible to realize a biological information measuring device capable of continuously measuring the sweating rate by determining the sweating position based on the presence or absence of sweating and calculating the sweating rate every predetermined time. “] and operating the device via a processor with storage unit (i.e. storing data) [see Fig. 3 and pg. 18 of English translation of Hano… “FIG. 3 is a block diagram showing a schematic circuit configuration of the biological information measuring apparatus 1. As shown in FIG. 3, the biological information measuring apparatus 1 includes a control unit 70 (so-called CPU (Central Processing Unit)) that performs overall control of the entire operation of the biological information measuring apparatus 1 and a storage unit 80 that stores various types of information.”]
Since Newberry discloses one independent way of measuring the concentration of electrolyte of blood (i.e. via direct non-invasive measurement) and Hano discloses another independent way of measuring the concentration of electrolyte in blood (i.e via the amount and concentration of electrolyte in sweat), it would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Newberry’s method to include using a measuring system with processor, storage and sensor to measure the sweat amount, measure the electrolyte concentrate, store the data, estimate the blood electrolyte concentration similarly to that disclosed by Hano and then use this estimated blood electrolyte concentration in combination with Newberry’s measured blood electrolyte concentration to determine, because one of ordinary skill would expect that the combination of two independent measurements/estimates of concentration of electrolyte in the blood would provide a more accurate measurement (and if not the same level of accuracy) than either measurement/estimate individually, thereby leading to an expectation of improved accuracy in determining dehydration.
Regarding claims 17-18:
Newberry in view of Hano discloses the invention substantially as claimed including all the limitations of claim 16.
However, Newberry in view of Hano is silent as to the sensors used to measure the sweat electrolyte, therefore Newberry in view of Hano fails to disclose “wherein the sensor calculates the sweat amount of the measurement subject based on the characteristic of current application between electrodes of the sensor” as recited by claim 17 or “wherein the wearable sensor calculates the electrolyte concentration in sweat of the measurement subject based on light receiving characteristics of a light receiving element of the sensor” as recited by claim 18.
Hano (the reference relied on to disclose the sweat electrolyte sensors) further discloses the sensor(s) used to analyze electrolytes in sweat specifically include the use of electrodes and the measurements of the current flow between the electrodes which is then used to determine the characteristic of concentration of the electrolyte in sweat [see pg. 31 of English translation of Hano… “The control unit 70 drives the conductivity measuring unit 96 to apply a voltage to the pair of electrodes 52 installed in the stimulus-responsive gel 51 and detect a current value flowing between the electrodes 52. The conductivity detected by the conductivity measuring unit 96 is converted into a digital signal by the A / D conversion unit 97 and sent to the control unit 70. Next, the process proceeds to step S210, and the concentration of lactic acid is
calculated. The component concentration processing unit 72 calculates the lactic acid
concentration based on the conductivity correlation table 84 and the conductivity input
from the A/ D conversion unit 97.”] and using the change in reflectance of light (i.e. light receiving characteristics) to determine if sweat is present or not [see pgs. 26-27 of English translation of Hano… “In step S203, the amount of received light is detected. As in step S104, the control unit 70 drives the light source driving unit 93 to cause all the light source elements 31 to emit light, and irradiates the near-infrared light to the flow path 20 (20A). Then, the control unit 70 drives the received light amount measurement unit 94. The received light amount measuring unit 94 receives near infrared light transmitted through the flow path 20 by the light receiving element 41. The data received by the light receiving element 41 is converted into a digital signal by the A/ D conversion unit 95 and sent to the control unit 70, and then the process proceeds to step S204. In step S204, the position corresponding to the tip of sweat 8 (position of sweat 8) is determined. The sweat position determination unit 71 A determines positions at predetermined intervals where it is determined that there is sweat 8 as a position corresponding to the tip of the sweat 8.”]
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to further modify Newberry in view of Hanno’s sensor configuration to achieve the claimed limitation of “wherein the sensor calculates the sweat amount of the measurement subject based on the characteristic of current application between electrodes of the sensor” as recited by claim 17 and “wherein the wearable sensor calculates the electrolyte concentration in sweat of the measurement subject based on light receiving characteristics of a light receiving element of the sensor” as recited by claim 18 because as discussed previously Hanno discloses the use of a sensing device that uses electrodes and current application and the use of a sensing device that uses light receiving characteristics and light receiving elements as known ways to measure electrolyte characteristics in sweat; therefore, absent unpredictable results one ordinary skill would expect to achieve the claimed sensing configurations via routine experimentation through the application of known systems to achieve a known result when optimizing the measurements/estimates of the characteristics of electrolyte in sweat and blood.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Newberry and further in view of Hano in view of Gong et al (Paper entitled “Sweat monitoring system” cited as reference 9 under Non patent literature on IDS received on 3/13/2024 with English translation provided by applicant)
Newberry discloses the invention substantially as claimed including all the limitations of claim 9 which includes a program with instructions for estimating a blood electrolyte concentration.
However, while Newberry discloses estimating the blood electrolyte concentration, Newberry collects this estimation via a non-invasive measurement of blood, failing employee any analysis of sweat. Thus, Newberry fails to disclose the program with instructions for: “measuring a heart rate of the measurement subject”, “measuring a temperature in a vicinity of the measurement subject”, “measuring a humidity in a vicinity of the measurement subject”, “estimating a sweat amount of the measurement subject on a basis of measurement results of the heart rate, the temperature and the humidity”, “estimating a sweat electrolyte concentration of the measurement subject on a basis of the sweat amount, wherein the blood electrolyte concentration is estimated on a basis of the sweat amount and the sweat electrolyte concentration” as recited by claim 12.
Hano discloses in the analogous art of physiological diagnostics [see abstract of English translation of Hano… “To provide a biological information measurement device that can be mounted on a body and can certainly and continuously measure a perspiration speed and specific component concentration in sweat without being affected by a perspiration state”] that another independent non-invasive known way to determine the electrolyte concentration in the blood is to measure the electrolyte sweat amount and electrolyte sweat concentration and then use this information to determine the blood electrolyte concentration [see pg. 37 of English translation of Hano…”In each of the above embodiments, the component concentration detector 50 detects the concentration and secretion rate of lactic acid as a specific component in sweat. However, the concentration and secretion rate of sodium as a specific component may be detected. Thereby, the secretion rate (secretion amount) of sodium as a specific component can be known. For example, by knowing the amount of sodium secreted in sweat during exercise, it is possible to know the lack of salt concentration in the blood, so it is possible to maintain proper exercise intensity by encouraging the supply of salt.”]
Gong discloses in the analogous art of physiological diagnostics of dehydration [see under Introduction of English translation of Gong…. “The phenomenon of dehydration of the body is mainly caused by excessive thermal sweating in the body, which knocks the bow. In this study, we propose a system to monitor the amount of sweating and to advise on appropriate water supply.”] measuring a pulse (i.e. measuring a heart rate of the measurement subject), measuring a temperature (i.e. measuring a temperature in a vicinity of the measurement subject), measuring relative humidity (i.e. measuring a humidity in a vicinity of the measurement subject) and then estimating the sweat rate (i.e. estimating sweat amount) based on these measurements [see under Introduction of English translation of Gong… “In this paper, we report the estimation method of sweat rate, which is the key of this system, and the verification experiment.” And under “Activity Contents” of Gong…. “In this system, surface temperature, relative humidity, heart rate, and core temperature of a subject are obtained using a temperature and humidity sensor, a pulse sensor, and an infrared temperature sensor. First, volumetric absolute humidity is calculated from the surface temperature and relative humidity. The change in volumetric absolute humidity over a certain period is the unit area sweat rate.”]
Since Newberry discloses one independent way of measuring/estimating the concentration of electrolyte of blood (i.e. via direct non-invasive measurement) and Hano discloses another independent way of measuring/estimating the concentration of electrolyte in blood (i.e via the amount and concentration of electrolyte in sweat), it would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Newberry’s method to include measuring/estimating the amount and concentration of electrolyte in the sweat and then using these measurements/estimates to determine the concentration of electrolyte in the blood similarly to that disclosed by Hano, because one of ordinary skill would expect that the combination of two independent measurements of concentration of electrolyte in the blood would provide a more accurate measurement/estimate (and if not the same level of accuracy) than either measurement/estimate individually, thereby leading to an expectation of improved accuracy in determining dehydration.
Since Newberry in view of Hano is directed to estimating the sweat amount in order to overall determine the blood electrolyte concentration and Gong discloses measuring the heart rate, temperature and humidity can provide the sweat amount, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Newberry in view of Hano program to obtain these additional parameters and then use these parameters to determine the sweat amount as this will provide additional information on the sweat amount thereby leading to an expectation of improved accuracy in the overall estimated results.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Newberry in view of Hano in view of Gong as applied to claims 9 and 12 above, and further in view of Abreu et al (US 20040242976) hereafter known as Abreu.
Newberry in view of Hano in view of Gong discloses the invention substantially as claimed including all the limitations of claims 9 and 12 as outlined above.
However, Newberry in view of Hano in view of Gong fails to disclose
“wherein the program further includes instructions for:
calculating an upper limit value of a normal range of water intake of the measurement subject on a basis of the sweat amount, the sweat electrolyte concentration, and the blood electrolyte concentration; and
predicting a transition of a future blood electrolyte concentration on a basis of the sweat amount, the sweat electrolyte concentration, and the blood electrolyte concentration, and estimate a time until the blood electrolyte concentration reaches the upper limit value of the normal range.” as recited by claim 13
Abreu discloses optimizing fluid intake by ingesting only a set number of ounces of water per hour (i.e. calculating an upper limit value of a normal range of water intake, predicting a transition of a future blood electrolyte concentration, and estimating a time until blood electrolyte concentration reaches upper limit value) for the purpose of preventing dehydration and overhydration using temperature and sodium (i.e. electrolyte) in sweat or blood [see para 510… “The present invention provides a method for optimizing fluid intake to achieve euhydration and avoid dehydration and overhydration.” And “The invention showed that ingestion of 4 ounces of water every hour after body temperature reaches 100.4 degrees F will lower the body temperature to 98.6 degrees F and will keep the body temperature at lower than 99.5 degrees F thus preventing the dangers of heat stroke. In case of athletes in athletic activities such as cycling” and “A variety of algorithms for use in the situation of athletes at risk of overheating, can be created based on the principle of the invention. Special size containers for fluid or water can be used by an athlete who is aware of the fluid intake needed during a competition” And para 90… “It is understood that the method of the present invention can combine measurement of temperature associated with measurement of sodium in sweat or blood, in accordance with the principles of the invention.”].
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Newberry in view of Hano in view of Gong’s program to optimize fluid intake similarly to that disclosed by Abreu (i.e. thereby reciting claim 13) so that the program also helps a user have the appropriate level of hydration in addition to determining the presence or absence of dehydration.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Newberry in view of Hano in view of Gong in view of Abreu as applied to claims 9 and 12-13 above, and further in view of Seyama et al (WO 2019176484 with English translation provided by office) hereafter known as Seyama
Newberry in view of Hano in view of Gong in view of Abreu discloses the invention substantially as claimed including all the limitations of claims 9 and 12-13 as outlined above.
However, Newberry in view of Hano in view of Gong in view of Abreu fails to disclose “wherein when the sweat amount is SW[t] and the sweat electrolyte concentration is Csw[t], intracellular fluid water amount Vrc[t + Δt] is estimated at time t + Δt after Δt on a basis of an intracellular fluid water amount Vrc[t] estimated immediately before for the measurement subject, estimates an extracellular fluid water mount VEc[t + Δt] at time t + Δt on a basis of an extracellular fluid water mount VEc[t] estimated immediately before for the measurement subject, the sweat amount SW[t], and a body surface area of the measurement subject, estimates an osmotic pressure Crc[t + Δt] of an intracellular fluid at time t + Δt on a basis of the intracellular fluid water amount Vrc[t], an osmotic pressure Crc[t] of an intracellular fluid estimated immediately before for the measurement subject, and the intracellular fluid water amount Vrc[t + Δt], and estimates a blood electrolyte concentration CEc[t + Δt] at time t + Δt on a basis of a blood electrolyte concentration CEc[t] estimated immediately before for the measurement subject, the extracellular fluid water mount VEc[t], the sweat electrolyte concentration Csw[t], the sweat amount SW[t], the body surface area, and the extracellular fluid water mount VEc[t + Δt].” as recited by claim 14.
Seyama discloses in the analogous art of diagnostics related to dehydration [see pg. 6 of English translation of Seyama…. “The present invention relates to a wearable detection device that detects ions contained in sweat. Dehydration is a symptom that often occurs in hyperthermia disorders commonly referred to as heat stroke.”] that it is known that osmotic pressure caused by sodium ion and potassium ion concentrations (i.e. electrolytes) in the intracellular fluid and extracellular fluid affect whether or not a user is dehydrated or not [see pg. 6 of English translation of Seyama… “In dehydration, the concentration of sodium ions and potassium ions is as important as the amount of sweat. Potassium is present as ions in human intracellular fluid, and sodium is present as ions in extracellular fluid. In accordance with the osmotic pressure generated by these ion concentration differences, the amount of blood in the cell moves to the extracellular fluid, so that the human blood volume is generally maintained at about 1/13 of the body weight. When dehydration begins to occur, if 10% of the blood volume is lost, it is considered mild dehydration, and a 30% loss is said to represent potentially dehydration. When a large amount of sweat comes out in a high temperature environment, it becomes difficult for moisture to come out from the intracellular fluid to the extracellular fluid, so that the sodium concentration increases while the potassium concentration does not change. In this case, since the salt concentration of the extracellular fluid increases, the difference in osmotic pressure does not occur, the amount of extracellular fluid does not increase, and the blood volume does not increase. Blood has a radiator function that lowers the body temperature by circulating it, but the effect of lowering the body temperature cannot be obtained because the blood volume does not increase.”]
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Hano in view of Gong in view of Abreu’s program to consider osmotic forces, intracellular fluid water amount and extracellular fluid water amount in addition to electrolyte concentration similarly to that described by Seyama (i.e. thereby reciting claim 14 as the claim has been interpreted as discussed under the 112 rejection) because these parameters are known to affect dehydration, therefore when considering if a user is dehydrated or not, the inclusion of these parameters would be expected to improve the accuracy of whether or not a user is dehydrated.
Conclusion
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SEBASTIAN X LUKJAN
/SXL/Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792