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 .
Response to Amendment
This office action is in response to the amendment filed on 5/5/2026. Currently claims 9-22 are pending.
Response to Arguments
Applicant’s arguments, see pg. 8, filed 5/5/2026, with respect to the previous rejection of claims 14 under 35 USC 112(b) have been fully considered and are persuasive. The previous rejection of claim 14 under 35 USC 112(b) has been withdrawn.
Applicant’s arguments, see pgs. 8-13, filed 5/5/2026, with respect to the rejection(s) of:
claim(s) 9 rejected under 35 USC 102(a)(1) as being anticipated by Newberry
claim(s) 10-11 and 16-18 rejected under 35 USC 103 as being unpatentable over Newberry in view of Hano
claim(s) 12 rejected under 35 USC 103 as being unpatentable over Newberry in view of Hano in view of Gong
claim(s) 13 rejected under 35 USC 103 as being unpatentable over Newberry in view of Hano in view of Gong in view of Abreu
claim(s) 14 as being unpatentable over Newberry in view of Hano in view of Gong in view of Abreu in view of Seyama
claim(s) 15 rejected under 35 USC 103 as being unpatentable over Newberry in view of Hano
have been fully considered and are persuasive based on the amendments to independent claims 9 and 15-16. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Seyama et al (WO 2019176484 with English translation provided by office with previous non-final mailed on 2/26/2026) as and/or Heikenfeld et al (US 20180153451) outlined in the new rejection below.
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 15 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. Claim 15 recites the limitation “determining presence or absence of dehydration of the measurement subject on a basis of the blood electrolyte concentration”. It is not clear which measurement “the blood electrolyte concentration refers to in this limitation. It could refer to the “the estimated blood electrolyte concertation”, “the previously-estimated blood electrolyte concentration” or “either the estimated blood electrolyte concentration or the previously-estimated blood electrolyte concentration”. For this examination, the interpretation taken is that it refers to the estimated blood electrolyte concentration as this appears to be applicant’s intended interpretation. Regardless, applicant should clarify what is being claimed here.
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.
Claims 9-14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract idea (i.e. specifically mathematical calculations) without significantly more.
Regarding independent claim 9:
The claim(s) recite(s) “estimating a blood electrolyte concentration of the measurement subject based on the sweat amount, the sweat electrolyte concentration, and an extracellular fluid water amount of the measurement subject” which is an abstract idea in the form of mathematical calculations. This judicial exception is not integrated into a practical application because the additional limitations of “measuring or estimating a sweat amount of a measurement subject”, “measuring or estimating a sweat electrolyte concentration of the measurement subject” are is merely gathering information and therefore is insignificant pre-solution activity and the limitation “determining presence or absence of dehydration of the measurement subject on a basis of the blood electrolyte concentration which is merely data outputting a result which is insignificant post solution activity. As ruled by Parker v. Flook, 437 U.S. 584, 588-89, 198 USPQ 193, 196 (1978) in MPEP 2106.05(g) such insignificant extra-solution activity does not integrate the judicial exception into a practical application. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims merely recite a generic one or more processors and a generic storage device. These elements are well known and conventional in the field of sweat and/or hydration diagnostics as evidenced by disclosure Newberry et al (US 20170014035) [see Fig. 3 element 102 and para 56 for processor(s) and see Fig. 3 element 104 and para 56 for storage device] and Miller et al (US 10307101) [see Fig. 8 element 804 (i.e. processor(s)) and Fig. 8 element 810 (i.e. data storage) and Col. 15 lines 55-62]
Thus, because these additional elements are well known and conventional these structures don’t amount to significantly more than the judicial exception Therefore, as the mathematical calculations (i.e. the judicial exception) is not integrated into a practical application and the additional structures do not amount to significantly more than the judicial exception. Thus, claim 9 is rejected under 101.
Regarding dependent claims 10-14, these claims only further describe the mathematical calculation (i.e. abstract idea) and do not further integrate the judicial exception into a practical application or amount to significantly more than the judicial exception. Thus, claims 10-14 are rejected under 35 USC 101 for similar reasons as claim 9.
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.
Claim(s) 9-11 and 16-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Newberry et al (US 20170014035) hereafter known as 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 in view of Seyama et al (WO 2019176484 with English translation provided by office) hereafter known as Seyama.
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.”].
However, 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 the program including instructions for:
“measuring or estimating a sweat amount of a measurement subject” or “measuring or estimating a sweat electrolyte concentration of the measurement subject” and fails to disclose instructions to fully recite “estimating a blood electrolyte concentration of the measurement subject based on the sweat amount, the sweat electrolyte concentration, and an extracellular fluid water amount of the measurement subject”.
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.”]
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 and fluid volumes 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.”]
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.
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’s program to consider osmotic forces, intracellular fluid volume (i.e. amount) and extracellular fluid volume (i.e. amount) in addition to electrolyte concentration similarly to that described by Seyama (estimating a blood electrolyte concentration of the measurement subject based on the sweat amount, the sweat electrolyte concentration, and an extracellular fluid water amount of the measurement subject) 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.
Independent claim:
Claim 16:
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 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., the sweat electrolyte concentration, and based on an extracellular fluid water amount of the measurement subject; and
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.”]
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 and fluid volumes 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.”]
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.
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 Newberry’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 (estimating a blood electrolyte concentration of the measurement subject based on the sweat amount, the sweat electrolyte concentration, and an extracellular fluid water amount of the measurement subject) 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.
Dependent claims:
Regarding claims 10-11, see rejection to claim 9 above which disclose measuring and estimating as claimed.
Regarding claims 17-18:
Newberry in view of Hano in view of Seyama discloses the invention substantially as claimed including all the limitations of claim 16.
However, Newberry in view of Hano in view of Seyama is silent as to the sensors used to measure the sweat electrolyte, therefore Newberry in view of Hano in view of Seyama 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 Hano in view of Seyama’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) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Newberry in view of Hano in view of Seyama in view of Heikenfeld et al (US 20180153451) hereafter known as Heikenfeld.
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 based on the sweat amount, the sweat electrolyte concentration. a previously-estimated
blood electrolyte concentration of the measurement subject. an extracellular fluid water amount of the measurement subject. and a body surface area of the measurement subject”
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.”]
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 and fluid volumes 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.”]
Heikenfeld in the analogous art of sweat and hydration diagnostics [see abstract… “The disclosed invention includes: a device and method of performing physiological sweat sensing device calibration; a device and method of indicating an individual's dehydration state”] discloses determining the body surface area and using this area to determine cumulative loss with a user’s intake to determine a user’s dehydration status [see para 89… “The device will also need information about the physical characteristics of the wearer, such as Body Mass Index, height, or weight, in order to calculate a body surface area for the wearer. With the foregoing information, the device can calculate a fluid loss rate for the wearer. This fluid loss rate may also account for total evaporative water loss, sweat reduction caused by the patch itself, or other factors relevant to improve the calculated value. Integrating the fluid loss rate calculations over the course of device operation provides a calculated cumulative fluid loss. Combined with the wearer's water intake during device operation., the device may then determine water loss as a function of body mass. This calculated body water volume loss percentage (between 0% and 15%) represents the wearer's dehydration status.”] and using previous data about a user to account for individual, environmental and other factors [see para 65… “This data may consist of sweat sensor data, or laboratory data collected previously on the individual, data collected on individuals performing similar activities, data on individuals in similar weather conditions, data on individuals with similar phenotypical profiles, etc. In other embodiments, the device may determine sweat rate from a function or formula based on empirical correlations between Na+ concentration and sweat rate, and may account for individual, environmental, application-specific and other relevant factors.”]
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.
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 Newberry to include the consideration of osmotic forces, intracellular fluid water amount and extracellular fluid water amount in addition to electrolyte concentration similarly to that described by Seyama 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.
Finally, since the knowing and using the surface area and a user’s intake, can help further aid in a user’s dehydration status and knowing previous data can help further aid in accounting of individual, environmental and other relevant factors as discussed by Heikenfeld, it would have been obvious to modify Hano in view of Newberry in view of Seyama to collect and use this additional information similarly to that disclosed by Heikenfeld (i.e. thereby reciting estimating a blood electrolyte concentration of the measurement subject based on the sweat amount, the sweat electrolyte concentration, a previously-estimated blood electrolyte concentration of the measurement subject, an extracellular fluid water amount of the measurement subject, and a body surface area of the measurement subject”) because these parameters will help further determine dehydration, thereby improving the accuracy of the estimation.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Newberry in view of Hano in view of Seyama further 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 in view of Hano in view of Seyama 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.
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 in view of Hano in view of Seyama 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 in view of Seyama 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 measured/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 Seyama 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 Seyama 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 Seyama 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 Seyama 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) 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Newberry in view of Hano in view of Seyama as applied to claim 9 above, and further in view of Heikenfeld et al (US 20180153451) hereafter known as Heikenfeld.
Newberry in view of Hano in view of Seyama discloses the invention substantially as claimed including all the limitations of claim 9 as outlined above.
However, Newberry in view of Hano in view of Seyama fails to disclose “wherein the program further includes instructions for measuring or estimating the sweat amount and the sweat electrolyte concentration at each of a plurality of points of a body of the measurement subject, and wherein the blood electrolyte concentration is estimated based on the sweat amount and the sweat electrolyte concentration at each of the plurality of points and a body surface area associated with each of the plurality of points” as recited by claim 19 or “wherein the program further includes instructions for receiving an input indicative of a volume and an electrolyte concentration of water consumed by the measurement subject, and wherein the blood electrolyte concentration is estimated further based on the volume and the electrolyte concentration of the water consumed” as recited by claim 20.
Heikenfeld in the analogous art of sweat and hydration diagnostics [see abstract… “The disclosed invention includes: a device and method of performing physiological sweat sensing device calibration; a device and method of indicating an individual's dehydration state”] discloses determining the body surface area (an area is understood to include a plurality of points) and using this area to determine cumulative loss with a user’s intake to determine a user’s dehydration status [see para 89… “The device will also need information about the physical characteristics of the wearer, such as Body Mass Index, height, or weight, in order to calculate a body surface area for the wearer. With the foregoing information, the device can calculate a fluid loss rate for the wearer. This fluid loss rate may also account for total evaporative water loss, sweat reduction caused by the patch itself, or other factors relevant to improve the calculated value. Integrating the fluid loss rate calculations over the course of device operation provides a calculated cumulative fluid loss. Combined with the wearer's water intake during device operation., the device may then determine water loss as a function of body mass. This calculated body water volume loss percentage (between 0% and 15%) represents the wearer's dehydration status.”] and using previous data about a user to account for individual, environmental and other factors [see para 65… “This data may consist of sweat sensor data, or laboratory data collected previously on the individual, data collected on individuals performing similar activities, data on individuals in similar weather conditions, data on individuals with similar phenotypical profiles, etc. In other embodiments, the device may determine sweat rate from a function or formula based on empirical correlations between Na+ concentration and sweat rate, and may account for individual, environmental, application-specific and other relevant factors.”]
Since the knowing and using the surface area and a user’s intake, can help further aid in a user’s dehydration status can help further aid in accounting of individual, environmental and other relevant factors as discussed by Heikenfeld, 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 Seyama to collect and use this additional information similarly to that described by Heikenfeld (i.e. thereby reciting claims 19-20) because these parameters will help further determine dehydration, thereby improving the accuracy of the measurement/estimation.
Examiner’s Note
No prior art was found to reject claim 14 and claim 14 is only rejected under 101 as outlined above.
Allowable Subject Matter
Claims 21-22 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 21:
Claim 21 is the broadest claim of this group of claims. Claim 21 recites a dehydration estimation device. The closest prior art is Newberry in view of Hano in view of Seyama. Newberry in view of Hano in view of Seyama discloses the invention substantially as claimed as outlined above (including all the limitations of claims 9, 12 on which claim 21 is dependent on) However, Newberry in view of Hano in view of Seyama fails to disclose “wherein estimating the sweat amount based on the heart rate, the temperature, and the humidity comprises: calculating heat quantities flowing into and out of a deep layer and a skin layer of each of a first site and a second site of a body of the measurement subject; calculating skin temperatures and deep part temperatures of the first site and the second site based on the heat quantities; and calculating the sweat amount based on the skin temperatures and the deep part temperatures.” It is important to note that the allowable feature is not missing limitation alone, but rather the combination of the missing limitation with all the other limitations of claim 21 (including those recited through dependency) together. Therefore, the combination of claim limitations recited by claim 21 (including those recited through dependency) is neither anticipated, nor obviated in view of the prior art.
Regarding claim 22:
Claim 22 is the broadest claim out of this group of claims. Claim 22 recites a dehydration estimation device. The closest prior art is Newberry in view of Hano in view of Seyama in view of Gong in view of Abreu. Newberry in view of Hano in view of Seyama in view of Gong in view of Abreu discloses the invention substantially as claimed as outlined above (including all the limitations of claims 9, 12 and 13 on which claim 22 is dependent on.) However, Newberry in view of Hano in view of Seyama in view of Gong in view of Abreu fails to fully disclose:
“the program further includes instructions for, wherein, when the sweat amount is SW[t] and the sweat electrolyte concentration is Csw[t]:
estimating an intracellular fluid water amount VIc[t + At] at a time t + At based on an intracellular fluid water amount VIc[t] estimated immediately before for the measurement subject;
estimating an extracellular fluid water amount VEcIt + At at the time t + At based on an extracellular fluid water amount VEc[t] estimated immediately before for the measurement subject, the sweat amount SW[t], and a body surface area of the measurement subject;
estimating an osmotic pressure CIc[t + At] of an intracellular fluid at the time t + At based on the intracellular fluid water amount VIc[t], an osmotic pressure CIc[t] of an intracellular fluid estimated immediately before for the measurement subject, and the intracellular fluid water amount VIc[t + At]; and
estimating a blood electrolyte concentration CEc[t + At] at the time t + At based on a blood electrolyte concentration CEc[t] estimated immediately before for the measurement subject, the extracellular fluid water amount VEc[t], the sweat electrolyte concentration Csw[t], the sweat amount SW[t], the body surface area, and the extracellular fluid water amount VEc[t + t]” as recited in claim 14 on which claim 22 is dependent on. Additionally, Newberry in view of Hano in view of Seyama in view of Gong in view of Abreu fails to fully disclose “wherein the program further includes instructions for calculating an initial value of the extracellular fluid water amount based on a lean body mass of the measurement subject, a density of water, a variable corresponding to a sex and an age of the measurement subject, and a ratio of a total amount of extracellular fluid to a total amount of water in a body of the measurement subject”
Furthermore, nothing in the prior art when viewed with Newberry in view of Hano in view of Seyama in view of Gong in view of Abreu obviates these deficiencies. While references such as Seyama discuss how osmosis, intracellular fluid and extracellular fluid impact dehydration [see pg. 6 of English translation of Seyama], the specific details of how these values are estimated as claimed are not recited. Nor do they take into account lean body mass of the measurement subject, a density of water, a variable corresponding to a sex and an age of the measurement subject, and a ratio of a total amount of extracellular fluid to a total amount of water in a body. Additionally, it is important to note that the allowability feature is not the missing limitations alone, but rather the missing limitations in combination with all the limitations of claim 22 (including those recited through dependency) together. Therefore, the combination of claim limitations recited by claim 22 is neither anticipated, nor obviated by the prior art.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEBASTIAN X LUKJAN whose telephone number is (571)270-7305. The examiner can normally be reached Monday - Friday 9:30AM-6PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, NIKETA PATEL can be reached at 571-272-4156. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
SEBASTIAN X LUKJAN
/SXL/Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792
Prosecution Insights