DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
This Office Action is responsive to the amendment filed 11 March 2026. As directed by the amendment: Claims 1, 5, 21, and 25-26 have been amended and no claims have been cancelled or added. Thus, claims 1-11, 13, and 21-27 are presently pending and under examination.
Response to Arguments
Response to Arguments Regarding 35 USC § 112
Applicant’s amendments to the claims have overcome the 112(a) rejection previously set forth in the Non-Final Rejection mailed 11 December 2025. Therefore, the 112(a) rejection of claims 1-11, 13, and 21-27 has been withdrawn.
Response to Arguments Regarding 35 USC § 102/103
Applicant's arguments filed 11 March 2026 have been fully considered but they are not persuasive.
Applicant has amended claims 1, 21, and 25 substantially. Specifically with regard to claim 1, the applicant has amended claim 1 to recite “filtering the physiological data to remove one or more reading from the plurality of sensors that are non-contributing factors to the hot flash, wherein the one or more readings are associated with at least one of a non-physiological change, an exercise -induced skin temperature decrease, or a sleep-induced skin temperature increase ” (emphasis added). Claims 21 and 25 have been amended to recite similar features. Applicant further argues that Wood, Wasson, and Pardey, either individually or in combination, fail to disclose or suggest each and every feature of the amended independent claims 1, 21, and 25. Specifically, that Pardey fails to teach or suggest that the excluded faulty or irrelevant data comprises reading that are non-contributing factors to a hot flash. Examiner respectfully disagrees. Pardey teaches “a processor arranged to filter the plurality of readings of the temperature of the user” ([0108]), wherein the “filtering comprises removing faulty or irrelevant measurements” ([0185]), irrelevant data is defined to be “genuine data because it genuinely reflects the body temperature of the female. However, it is caused by factors that are irrelevant to the matter of ovulation.” and “faulty data is data that does not genuinely correspond to the body temperature of the female. It may be produced, for example, by a faulty temperature measuring device or, more likely, by an intrinsic limitation of the temperature measuring device (for example a time-lag in the response of the device to being placed in a body cavity)…omit readings taken before (for example for a period of 10 mins) and after (for example for a period of 20 mins) any temperature dip (this may occur due the device having been taken out and reinserted)… remove any data that shows too high a rate of change of temperature.” ([0474]-[0503]).
It would be obvious to one skilled in the art that when modifying Wood and Wasson with the teachings of Pardey, one would clearly understand that when analyzing hot flash temperature data (Wood: [0021]-[0022], [0041], [0062]), it would be desirable to perform the same exclusion/filtering of irrelevant data (i.e. diurnal temperature fluctuations, or by changes in the ambient temperature to which the woman is exposed, Examiner interprets these temperatures to read on “one or more readings associated with at least one of a non-physiological change”) because it would provide the exact same benefit regardless of whether one is determining ovulation or hot flash.
In other words, one would be motivated to do this for a better analysis of the relevant and valid data that is necessary for diagnosis and prediction while ignoring physiological data that is caused by external/irrelevant factors, as recognized by Pardey ([0504], [0509]-[0510]).
Therefore, claims 1, 8, 11, 13, 21, and 25-26 are rejected under 35 USC 103.
No additional specific arguments were presented with previous 35 USC 103 rejections of dependent claims 2-11, 13, 22-24, and 26-27, nor specifically with respect to the previously cited de Zambotti, Stivoric, de Zambotti’106, von Badinski, and McKlarney references.
Therefore, claims 2-11, 13, 22-24, and 26 remain rejected under 35 USC 103.
Claim Objections
Claim 21 objected to because of the following informalities:
Lines 22-23 currently read “filtering the physiological data to one or more readings…” should read “filtering the physiological data to remove one or more readings…”. It appears that the applicant may have accidentally removed the word during making amendments.
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.
Claim(s) 1, 8, 11, 13, and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wood (US 2019/0133496 A1, previously cited), hereinafter Wood in view of Wasson et al. (US 2021/0169345 A1, previously cited), hereinafter Wasson, further in view of Pardey et al. (US 2019/0110692 A1), hereinafter Pardey.
Regarding claim 1, Wood discloses a method for detecting hot flashes ([0021] “the invention is described in the context of predicting an onset of an adverse health condition of the subject… the invention is described in the context of predicting an onset of a panic attack of the subject”, [0062] “The most common symptoms of panic attacks include…hot flashes… any physiological sensor capable of measuring a physiological parameter associated with any of these symptoms can be used for the sensors 102, 104, 105 in the assembly 100.”), comprising:
Receiving, via the transceiver of a user device (Figure 2: mobile phone 601) the physiological data associated with the user ([0022] “The assembly 100 includes one or more physiological sensors to measure data that indicates a change in a value of a physiological parameter of a subject over a time period”, [0032] “In an embodiment, the assembly 100 and the mobile phone 601 are in wireless communication (e.g. Bluetooth®). In an example embodiment, updates to the module 109 are communicated from the mobile phone 601 to the processor 108 of the assembly 100 using the wireless communication.”)
Identifying, via one or more processors, a first drop in the physiological data within a first time interval that is greater than a physiological data change threshold ([0041] “the processor 108 determines whether the value of the change in the physiological parameter (based on the received data in step 309) is greater than a change threshold.); Identifying, via the one or more processors, one or more physiological indication of hot flash experienced by the user based at least in part on the first drop ([0041] discusses how when the value of change of a variety of physiological parameters (such as heart rate, temperature, CO2) is greater than its respective parameter change threshold it is “indicative of the adverse health condition (e.g. panic attack, heart attack, fast breathing, etc.)”, [0043] “the determination in step 311 is used as a prediction of a health condition (e.g. panic attack, heart attack, fast breathing, etc.) of the subject”)
Causing a graphical user interface of the user device to display information associated with the hot flash ([0042]-[0043] “A positive determination in step 311 moves the method to step 313…in steps 313a, 313b, the action is performed to alert the subject (or others) of the determination in step 311. In an embodiment, in step 313c, the action is performed to provide treatment (e.g. therapy, visual symbol) to the subject in response to the determination in step 311.”)
Wood fails to disclose acquiring, via a plurality of sensors arranged on an inner surface of wearable ring device, physiological data from an underside of a finger of a user, wherein the wearable ring device is configured to be worn on the finger of the user, and wherein the plurality of sensors comprise one or more light-emitting components and one or more photodetectors arranged on the inner surface of the wearable ring device and configured to acquire the physiological data from the underside of the finger of the user and a wearable ring device.
However, Wasson teaches a wearable ring device (Abstract :”ring-shaped wearable device for detecting biometrics”) wherein the device comprises: acquiring, via a plurality of sensors (photodetector 202) arranged on an inner surface of wearable ring device (ring 104, view Figure 2A-2E), physiological data from an underside of a finger of a user ([0013] "The combination of the light source(s) and the photodetector(s) can be used to detect absorption of light at, for example, one wavelength in comparison to light at another wavelength. The different rates of absorption can be used to calculate biometric data, such as the oxygen saturation. Such a ring-shaped device can monitor other biometric information", view Figure 2A-2E: the sensors are also located at the underside of the finger, [0024] "the ring 104 to monitor the oxygen saturation (SpO2), pulse, blood pressure, glucose levels, lipid concentration, carboxyhemoglobin levels, hemoglobin concentration (hematocrit levels), etc. In some embodiments, the ring 104 can monitor pulsatile (arterial) blood oxygenation (“SpO2”) or non-pulsatile (arterial and venous blood, usually called tissue oxygenation or “StO2”)") , wherein the wearable ring device is configured to be worn on the finger of the user([0019] "The ring 104 can be worn on a wearer's finger.") , and wherein the plurality of sensors comprise one or more light-emitting components and one or more photodetectors arranged on the inner surface of the wearable ring device ([0023] "FIGS. 2A-2E illustrate example configurations of a ring 104 according to various embodiments. The ring 104 can include a light source 204 and a photodetector 202. For the purposes of these illustrations, the photodetector 202 is illustrated using an empty rectangle whereas the light source 204 104 is illustrated using a rectangle with a dark rectangle inside.") and configured to acquire the physiological data from the underside of the finger of the user ([0058] A combination can include elements opposite of each other. For example, a photodetector on one side of the ring and a light source on the other side of the ring. This can enable transmissive measurements of light passing through the finger. In this design, red and infrared light sources can be incident on the palmar (ventral) side of the finger, just below the first knuckle (where a ring is worn), and a detector can receive the transmitted light on the opposite, dorsal side of the finger. Thus the optical path from light source to detector extends through the finger from the palm side to the back side. This can provide a more accurate reading in comparison to reflective readings. In some embodiments, the photodetector and light source can be positioned close to each other to facilitate reflective measurements. Other combinations are contemplated such as a 90 degree offset such that the light source is placed at the top of the finger and the photodetector is placed on the right side of the finger. Other configurations are contemplated.", view Figures 2A-2E: where the photodetectors are positioned around the circumference of the ring and therefore would also be on the underside of the finger to detect physiological data")
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wood to incorporate the teachings of Wasson have a wearable ring device and for acquiring, via a plurality of sensors arranged on an inner surface of wearable ring device, physiological data from an underside of a finger of a user, wherein the wearable ring device is configured to be worn on the finger of the user, and wherein the plurality of sensors comprise one or more light-emitting components and one or more photodetectors arranged on the inner surface of the wearable ring device and configured to acquire the physiological data from the underside of the finger of the user, as these prior art references are directed to wearable devices that measure physiological signals. One would be motivated to do this as the ring can provide more accurate biometric information that a smart watch or similar device because the ring 1 abuts the users skin more completely and reliably, as recognized by Wasson ([0022]).
Although Wood acknowledges that “conventional systems are not capable of ruling out alternative reasons other than an adverse health condition (e.g. subject is exercising) for elevated physiological parameter values” ([0002]), Wood and Wasson, alone or in combination fail to teach filtering the physiological data to remove one or more readings from the plurality of sensors that are non-contributing to the hot flash, wherein the one or more readings are associated with at least one of a non-physiological change, an exercise-induced skin temperature decrease, or a sleep-induced skin temperature increase.
However, Pardey teaches a method and apparatus for processing a physical signal to obtain and provide health information in relation to the user, in particular in relation to the user’s fertility or state of ovulation (Abstract) and for monitoring the onset of the menopause ([0146]) wherein the method further comprises: identifying, via one or more processors, a first drop in the physiological data within a first time interval ([0404] “In particular, the parameters may include information relating to whether the temperature data exhibits a dip in temperature prior to a temperature rise and details of how quickly and how far the temperature rises during and immediately following the temperature change event.”, [0097]-[0098] temperature sensors) and filtering the physiological data to remove one or more readings from the plurality of sensors that are non-contributing to the hot flash, wherein the one or more readings are associated with at least one of a non-physiological change ([0108] “a processor arranged to filter the plurality of readings of the temperature of the user”, [0185] “the method may further include filtering the temperature measurements prior to calculating the representative temperature values, wherein filtering comprises removing faulty or irrelevant measurements, preferably wherein filtering further comprises removing the maximum…temperature measurements from the measurements obtained during the extended period”, [0474]-[0503]“Irrelevant data is genuine data because it genuinely reflects the body temperature of the female. However, it is caused by factors that are irrelevant to the matter of ovulation. It may be produced, for example, by diurnal temperature fluctuations, or by changes in the ambient temperature to which the woman is exposed. Faulty data is data that does not genuinely correspond to the body temperature of the female. It may be produced, for example, by a faulty temperature measuring device or, more likely, by an intrinsic limitation of the temperature measuring device (for example a time-lag in the response of the device to being placed in a body cavity)…omit readings taken before (for example for a period of 10 mins) and after (for example for a period of 20 mins) any temperature dip (this may occur due the device having been taken out and reinserted)… remove any data that shows too high a rate of change of temperature.”, Examiner would like to note that a “temperature dip” would require a drop followed by a rise, which is filtered out (Figure 6).).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wood and Wasson to incorporate the teachings of Pardey to filter the physiological data to remove one or more readings from the plurality of sensors that are non-contributing to the hot flash, wherein the one or more readings are associated with at least one of a non-physiological change, an exercise-induced skin temperature decrease, or a sleep-induced skin temperature increase, as these prior art references are directed to measuring physiological signals to predict/determine onset of women’s health disorders. One would be motivated to do this for a better analysis of the relevant and valid data that is necessary for diagnosis and prediction while ignoring physiological data that is caused by external/irrelevant factors, as recognized by Pardey ([0504], [0509]-[0510]).
Regarding claim 8, Wood in view of Wasson further in view of Pardey teaches the method of claim 1 (as shown above). Wood further discloses wherein the physiological data comprises at least temperature data ([0052]” the second physiological sensor is the temperature sensor 104 that measures data that indicates a change in a value of the body temperature of the subject over the time period”) and heart rate data ([0051] “the first physiological sensor is the heart rate sensor 102 that measures data that indicates a change in a value of the heart rate of the subject over the time period”), wherein identifying the one or more physiological indications of the hot flash([0041] “In step 311, the processor 108 determines whether the value of the change in the physiological parameter (based on the received data in step 309) is greater than a change threshold. In one embodiment, the change threshold is a minimum value of the change in the physiological parameter over the time period that is indicative of an adverse health condition”) comprises:
identifying the first drop in the temperature data within the first time interval is greater than a temperature change threshold; and identifying a second change in the heart rate data within the first time interval is greater than a heart rate change threshold ([0041] “the data received in step 309 indicates a change in the value of the heart rate and the change in the value of the body temperature over the time period, in step 311 the processor 108 determines whether the value of the change in the heart rate exceeds the heart rate change threshold and whether the value of the change in the value of the body temperature exceeds the body temperature change threshold.”)
Regarding claim 11, Wood in view of Wasson further in view of Pardey teaches the method of claim 1(as shown above).
Wood further discloses wherein the physiological data comprises temperature data, heart rate data, respiratory rate data, or any combination thereof ([0023]-[0026] heart rate, temperature, oxygen saturation, and CO2).
Regarding claim 13, Wood in view of Wasson further in view of Pardey teaches the method of claim 1 (as shown above).
Wood teaches wherein the wearable device collects the physiological data from the user based on arterial blood flow ([0023] “the heart rate sensor 102 and includes small light emitting diodes (LEDs) on an underside of the sensor 102 that shines green light onto the skin of the wrist of the subject. The different wavelengths of light from these optical emitters interact differently with the blood flowing through the wrist of the subject. When that light refracts (or reflects) off the flowing blood of the subject, the heart rate sensor 102 captures that information.”)
Wasson further teaches wherein the wearable ring device collects the physiological data from the user based on arterial blood flow ([0024] “A system can utilize the ring 104 to monitor the oxygen saturation (SpO2), pulse, blood pressure, glucose levels, lipid concentration, carboxyhemoglobin levels, hemoglobin concentration (hematocrit levels), etc. In some embodiments, the ring 104 can monitor pulsatile (arterial) blood oxygenation (“SpO2”) or non-pulsatile (arterial and venous blood, usually called tissue oxygenation or “StO2”). These measurements can largely be taken by measuring the transmission and/or reflection of light through a user's finger.”)
Regarding claim 21, Wood teaches a system for detecting hot flashes ([0021] “the invention is described in the context of predicting an onset of an adverse health condition of the subject… the invention is described in the context of predicting an onset of a panic attack of the subject”, [0062] “The most common symptoms of panic attacks include…hot flashes… any physiological sensor capable of measuring a physiological parameter associated with any of these symptoms can be used for the sensors 102, 104, 105 in the assembly 100.”), comprising:
One or more processors (processor 108) communicatively coupled with the plurality of sensors (view Figure 1, [0028]) wherein the one or more processors are configured to:
Receive, via the transceiver of a user device (Figure 2: mobile phone 601), the physiological data associated with the user ([0022] “The assembly 100 includes one or more physiological sensors to measure data that indicates a change in a value of a physiological parameter of a subject over a time period”, [0032] “In an embodiment, the assembly 100 and the mobile phone 601 are in wireless communication (e.g. Bluetooth®). In an example embodiment, updates to the module 109 are communicated from the mobile phone 601 to the processor 108 of the assembly 100 using the wireless communication.”)
Identify, via one or more processors, a first drop in the physiological data within a first time interval that is greater than a physiological data change threshold ([0041] “the processor 108 determines whether the value of the change in the physiological parameter (based on the received data in step 309) is greater than a change threshold.)
Identify, via the one or more processors, one or more physiological indication of hot flash experienced by the user based at least in part on the first drop ([0041] discusses how when the value of change of a variety of physiological parameters (such as heart rate, temperature, CO2) is greater than its respective parameter change threshold it is “indicative of the adverse health condition (e.g. panic attack, heart attack, fast breathing, etc.)”, [0043] “the determination in step 311 is used as a prediction of a health condition (e.g. panic attack, heart attack, fast breathing, etc.) of the subject”)
Causing a graphical user interface of the user device to display information associated with the hot flash ([0042]-[0043] “A positive determination in step 311 moves the method to step 313…in steps 313a, 313b, the action is performed to alert the subject (or others) of the determination in step 311. In an embodiment, in step 313c, the action is performed to provide treatment (e.g. therapy, visual symbol) to the subject in response to the determination in step 311.”)
Wood fails to disclose a wearable ring device configured to be worn on a finger of a user and comprising a plurality of sensors arranged on an inner surface of the wearable ring device and configured to acquire physiological data from the finger of the user, the plurality of sensors comprising one or more light-emitting components and one or more photodetectors arranged on the inner surface of the wearable ring device and configured to acquire the physiological data from an underside of the finger of the user and a processor configured to acquire, via the plurality of sensors arranged on the inner surface of the wearable ring device, the physiological data from the underside of the finger of the user.
However, Wasson teaches a ring-shaped wearable device for detecting biometrics wherein a wearable ring device (ring 104) configured to be worn on a finger of a user ([0018] “a user can wear a ring 104 on a finger of the user’s hand 106”, Figure 1) and comprising a plurality of sensors arranged on an inner surface of the wearable ring device (view Figures 2A-2E: the photodetectors 202 are arranged on the inner surface, [0023]) and configured to acquire physiological data from the finger of the user ([0013] "The combination of the light source(s) and the photodetector(s) can be used to detect absorption of light at, for example, one wavelength in comparison to light at another wavelength. The different rates of absorption can be used to calculate biometric data, such as the oxygen saturation. Such a ring-shaped device can monitor other biometric information", view Figure 2A-2E: the sensors are also located at the underside of the finger, [0024] "the ring 104 to monitor the oxygen saturation (SpO2), pulse, blood pressure, glucose levels, lipid concentration, carboxyhemoglobin levels, hemoglobin concentration (hematocrit levels), etc. In some embodiments, the ring 104 can monitor pulsatile (arterial) blood oxygenation (“SpO2”) or non-pulsatile (arterial and venous blood, usually called tissue oxygenation or “StO2”)"), the plurality of sensors comprising one or more light-emitting components and one or more photodetectors arranged on the inner surface of the wearable ring device ([0023] "FIGS. 2A-2E illustrate example configurations of a ring 104 according to various embodiments. The ring 104 can include a light source 204 and a photodetector 202. For the purposes of these illustrations, the photodetector 202 is illustrated using an empty rectangle whereas the light source 204 104 is illustrated using a rectangle with a dark rectangle inside.") and configured to acquire the physiological data from an underside of the finger of the user ([0013] "The combination of the light source(s) and the photodetector(s) can be used to detect absorption of light at, for example, one wavelength in comparison to light at another wavelength. The different rates of absorption can be used to calculate biometric data, such as the oxygen saturation. Such a ring-shaped device can monitor other biometric information", view Figure 2A-2E: the sensors are also located at the underside of the finger, [0024] "the ring 104 to monitor the oxygen saturation (SpO2), pulse, blood pressure, glucose levels, lipid concentration, carboxyhemoglobin levels, hemoglobin concentration (hematocrit levels), etc. In some embodiments, the ring 104 can monitor pulsatile (arterial) blood oxygenation (“SpO2”) or non-pulsatile (arterial and venous blood, usually called tissue oxygenation or “StO2”)") and a processor ([0042] “The ring 104 can include a processor 502 for analyzing data and preprocessing data before transmitting it to a portable electronic device.”) configured to acquire, via the plurality of sensors arranged on the inner surface of the wearable ring device, the physiological data from the underside of the finger of the user (citations above: [0013],[0024], Figures 2A-2E).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wood to incorporate the teachings of Wasson to have a wearable ring device configured to be worn on a finger of a user and comprising a plurality of sensors arranged on an inner surface of the wearable ring device and configured to acquire physiological data from the finger of the user, the plurality of sensors comprising one or more light-emitting components and one or more photodetectors arranged on the inner surface of the wearable ring device and configured to acquire the physiological data from an underside of the finger of the user and a processor configured to acquire, via the plurality of sensors arranged on the inner surface of the wearable ring device, the physiological data from the underside of the finger of the user, as these prior art references are directed to wearable devices that measure physiological signals. One would be motivated to do this as the ring can provide more accurate biometric information that a smart watch or similar device because the ring 1 abuts the users skin more completely and reliably, as recognized by Wasson ([0022]).
Although Wood acknowledges that “conventional systems are not capable of ruling out alternative reasons other than an adverse health condition (e.g. subject is exercising) for elevated physiological parameter values” ([0002]), Wood and Wasson, alone or in combination fail to teach wherein the one or more processors are configured to: filtering the physiological data to remove one or more readings from the plurality of sensors that are non-contributing factors to the hot flash, wherein the one or more readings are associated with at least one of a non-physiological change, an exercise-induced skin temperature decrease, or a sleep-induced skin temperature increase.
However, Pardey teaches a method and apparatus for processing a physical signal to obtain and provide health information in relation to the user, in particular in relation to the user’s fertility or state of ovulation (Abstract) and for monitoring the onset of the menopause ([0146]) wherein one or more processors are configured to: identify, via one or more processors, a first drop in the physiological data within a first time interval ([0404] “In particular, the parameters may include information relating to whether the temperature data exhibits a dip in temperature prior to a temperature rise and details of how quickly and how far the temperature rises during and immediately following the temperature change event.”, [0097]-[0098] temperature sensors) and filtering the physiological data to remove one or more readings from the plurality of sensors that are non-contributing factors to the hot flash, wherein the one or more readings are associated with at least one of a non-physiological change, an exercise-induced skin temperature decrease, or a sleep-induced skin temperature increase ([0108] “a processor arranged to filter the plurality of readings of the temperature of the user”, [0185] “the method may further include filtering the temperature measurements prior to calculating the representative temperature values, wherein filtering comprises removing faulty or irrelevant measurements, preferably wherein filtering further comprises removing the maximum…temperature measurements from the measurements obtained during the extended period”, [0474]-[0503]“Irrelevant data is genuine data because it genuinely reflects the body temperature of the female. However, it is caused by factors that are irrelevant to the matter of ovulation. It may be produced, for example, by diurnal temperature fluctuations, or by changes in the ambient temperature to which the woman is exposed. Faulty data is data that does not genuinely correspond to the body temperature of the female. It may be produced, for example, by a faulty temperature measuring device or, more likely, by an intrinsic limitation of the temperature measuring device (for example a time-lag in the response of the device to being placed in a body cavity)…omit readings taken before (for example for a period of 10 mins) and after (for example for a period of 20 mins) any temperature dip (this may occur due the device having been taken out and reinserted)… remove any data that shows too high a rate of change of temperature.”, Examiner would like to note that a “temperature dip” would require a drop followed by a rise, which is filtered out (Figure 6).).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wood and Wasson to incorporate the teachings of Pardey for filtering the physiological data to remove one or more readings from the plurality of sensors that are non-contributing factors to the hot flash, wherein the one or more readings are associated with at least one of a non-physiological change, an exercise-induced skin temperature decrease, or a sleep-induced skin temperature increase, as these prior art references are directed to measuring physiological signals to predict/determine onset of women’s health disorders. One would be motivated to do this for a better analysis of the relevant and valid data that is necessary for diagnosis and prediction while ignoring physiological data that is caused by external/irrelevant factors, as recognized by Pardey ([0504], [0509]-[0510]).
Claim(s) 3, 5-6, 9-11, 13, and 23is/are rejected under 35 U.S.C. 103 as being unpatentable over Wood in view of Wasson in view of Pardey as applied to claims 1 and 21 above, further in view of de Zambotti et al. (US Patent 11804301 B2, previously cited), hereinafter de Zambotti.
Regarding claim 3, Wood in view of Wasson further in view of Pardey teaches the method of claim 1 (as shown above).
Wood, Wasson, and Pardey, alone or in combination, fail to teach the method further comprising: receiving, via the user device, supplemental data associated with the physiological data, the supplemental data comprising indications of events, subjective attributes, or both; and identifying the one or more physiological indications of the hot flash based at least in part on the supplemental data.
However, de Zambotti teaches methods of managing hot flashes (Abstract) wherein the method further comprises: receiving, via the user device, supplemental data associated with the physiological data (Column 13, lines 3-8: “The user interface module 431 can also be used to self-report hot flashes. The self-report can be compared with any sensed values and the results can be used to predict onset of future hot flashes or the information can be presented to the user. In general, the user interface module 431 can be used to obtain data from the user.”, Column 15, lines 27-30: “emotional state data can be collected through user input of their mood or may be assessed based on a combination of physiological parameters that are detected or entered”), the supplemental data comprising indications of events, subjective attributes, or both; and identifying the one or more physiological indications of the hot flash based at least in part on the supplemental data (Column 13, line 61-Column 14, line 6: “analyzes the impact of factors implicated in the severity and manifestation of hot flashes, including but not limited to environmental circumstances (e.g., ambient temperature, humidity, season, time of day, meal composition, caffeine and/or alcohol consumption, use of medications), individual circumstances (e.g., mood, stress, anxiety, time of day, exercise, menstrual cycle patterns, calendar events), users' location from GPS and/or user inputs (e.g., supermarket, home, work), and physiological state (e.g., skin temperature, thermosensitivity, heart rate, cardiac autonomic state, such as heart rate variability, skin blood flow, such as peripheral vasoconstriction/vasodilation) to assess the severity and manifestation of hot flashes”) .
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wood, Wasson, and Pardey to incorporate the teaching of de Zambotti to have the method further comprising: receiving, via the user device, supplemental data associated with the physiological data, the supplemental data comprising indications of events, subjective attributes, or both; and identifying the one or more physiological indications of the hot flash based at least in part on the supplemental data, as these prior art references are directed to wearable devices for monitoring physiological parameters. One would be motivated to do this as this supplemental data can help analyze the severity and manifestation of the hot flash, as recognized by de Zambotti (Column 14, lines 5-6).
Regarding claim 5, Wood in view of Wasson in view of Pardey further in view of de Zambotti teaches the method of claim 3 (as shown above).
Wood, Wasson, Pardey, alone or in combination fail to teach identifying one or more hot flash triggers for the user based at least in part on identifying the hot flash, the supplemental data, or both; and causing the graphical user interface of the user device to display an indication of the one or more hot flash triggers.
However, de Zambotti further teaches the method further comprising: identifying one or more hot flash triggers for the user based at least in part on identifying the one or more physiological indications of the hot flash, the supplemental data, or both (Column 15, lines 61-65: “analyzing what conditions are most likely to trigger hot flashes for each user (based on analysis of data gathered by the system), which is sometimes herein referred to as the “predictive model””); and causing the graphical user interface of the user device to display an indication of the one or more hot flash triggers (Column 16, lines 33-37: “examining the conditions that are prevalent when hot flashes occur, one hypothesis that may be reached is that condition 1 has a high likelihood of triggering a hot flash. Thus this hypothesis may be displayed or conveyed to the user”, Column 2, lines 4-15: For each specific user and/or users in general, there are specific biopsychosocial factors (e.g., stress, drinking hot beverages, eating spicy food, hot environments), physiological state, demography and behaviors that are associated with a greater probability of having a hot flash. The system can learn over time what biological, individual, and environmental factors trigger hot flashes and/or increase a probability of an occurrence of a hot flash and/or a severity of the hot flash, putting users in control of the management of their symptoms and optionally enabling the provision of cooling relief or other therapeutics in advance of, or coincident with, a suspected hot flash.).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wood, Wasson, and Pardey to incorporate the teaching of de Zambotti to have the method further comprising: identifying one or more hot flash triggers for the user based at least in part on identifying the one or more physiological indications of the hot flash, the supplemental data, or both; and causing the graphical user interface of the user device to display an indication of the one or more hot flash triggers, as these prior art references and the instant application are directed to wearable devices for monitoring physiological parameters. One would be motivated to do this as to put users in control of the management of their symptoms and optionally enable the provision of cooling relief or other therapeutics in advance of, or coincident with, a suspected hot flash, as recognized by de Zambotti (Column 2, lines 12-15).
Regarding claim 6, Wood in view of Wasson in view of Pardey teaches the method of claim 1 (as shown above).
Wood, Wasson, and Pardey, alone or in combination, fail to teach the method further comprising: receiving, via the transceiver of the user device, additional physiological data associated with the user; determining a hot flash risk metric for the user based at least in part on the additional physiological data, the hot flash risk metric associated with a relative probability that the user will experience a potential hot flash; and causing the graphical user interface of the user device to display an indication of the potential hot flash based at least in part on the hot flash risk metric satisfying a hot flash prediction threshold.
However, de Zambotti teaches the method further comprising: receiving, via the transceiver of the user device, additional physiological data associated with the user (Column 6, lines 41-49: “dynamically update the predictive model for a particular user over time based on additional input parameters and feedback data indicative of experienced (e.g., past) hot flashes. Such feedback data can include verification of an occurrence of a hot flash at a particular date and time, body location of the hot flash, and/or an indication of a severity or impact on the user. The feedback data can be input by the user and/or inferred using data obtained by the sensor circuitry”); determining a hot flash risk metric for the user based at least in part on the additional physiological data, the hot flash risk metric associated with a relative probability that the user will experience a potential hot flash (Column 6, lines 53-59: “Based on the dynamic predictive model, the system is used to predict occurrence of a hot flash and to anticipate an imminent hot flash. As used herein, a predicted hot flash includes a hot flash that is suspected to occur at a particular time and date based on identified hot flash patterns of the user and the input parameters. The predicted hot flash is probability driven”); and causing the graphical user interface of the user device to display an indication of the potential hot flash based at least in part on the hot flash risk metric satisfying a hot flash prediction threshold (Column 9, lines 29-34: “a user device to provide a notification to the user, such as a smart watch beeping to notify the user of a likely or imminent hot flash, and/or a display on an application executed by a smartphone which instructs the user on a particular action to take, among other specific actions”, Column 9, lines 56-61: “the revised probability being outside the threshold indicates that a hot flash is imminent for the user, e.g., to occur within 30 seconds. In other embodiments, the revised probability being outside the threshold indicates that the hot flash is occurring or is predicted to occur at the date and time”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wood, Wasson, and Pardey n to incorporate the teaching of de Zambotti to have the method further comprising: receiving, via the transceiver of the user device additional physiological data associated with the user from the wearable device; determining a hot flash risk metric for the user based at least in part on the additional physiological data, the hot flash risk metric associated with a relative probability that the user will experience a potential hot flash; and causing the graphical user interface of the user device to display an indication of the potential hot flash based at least in part on the hot flash risk metric satisfying a hot flash prediction threshold, as these prior art references and the instant application are directed to wearable devices for monitoring physiological parameters. One would be motivated to do this to be able to proactively mitigate or prevent the hot flash, as recognized by de Zambotti (Column 6, lines 64-67).
Regarding claim 9, Wood in view of Wasson in view of Pardey teaches the method of claim 1 (as shown above).
Wood, Wasson, and Pardey alone or in combination, fail to teach wherein the method further comprising: inputting the received physiological data into a classifier, wherein the classifier is configured to identify the one or more physiological indications of the hot flash based at least in part on the received physiological data.
However, de Zambotti teaches the method further comprising: inputting the physiological data into a classifier, wherein the classifier is configured to identify the one or more physiological indications of the hot flash based at least in part on the physiological data (Claim 19: “train a predictive model using machine learning and training data including a plurality of input parameters…wherein: the trained predictive model is indicative of a probability of the user having a hot flash at a date and time based on the plurality of input parameters and weights associated with the plurality of input parameters, the plurality of input parameters includes calendar or schedule data, lifestyle data, environmental data, and health information including a plurality of physical measurements including heart rate, skin conductance, and blood pressure; and the plurality of patterns includes different patterns having different weights and being associated with the reported hot flashes and respectively with input parameters of physiological signals, calendar or schedule data, and environmental data…the sensor circuitry using the trained predictive model; in response to the revised probability being outside at least one threshold that is indicative of a hot flash that is predicted to occur or to imminently occur for the user”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wood, Wasson, and Pardey to incorporate the teaching of de Zambotti to have the method further comprising: inputting the physiological data into a classifier, wherein the classifier is configured to identify the one or more physiological indications of the hot flash based at least in part on the physiological data, as these prior art references and the instant application are directed to wearable devices for monitoring physiological parameters. One would be motivated to do this as classifiers can help identify pattern at lower dimension which can be more precise and efficient which can help improve the learning and generalization capability of the system, as recognized by de Zambotti (Column 13, lines 41-48).
Regarding claim 10, Wood in view of Wasson in view of Pardey further in view of de Zambotti teaches the method of claim 9 (as shown above).
Wood, Wasson, and Pardey, alone or in combination, fail to teach the method further comprising: receiving, via the user device, a user input that confirms or denies the hot flash; and inputting the user input into the classifier to train the classifier for hot flash detection.
However, de Zambotti further discloses the method further comprising: receiving, via the user device, a user input that confirms or denies the hot flash (Claim 8: “confirmation of occurrence of the experienced hot flashes based on at least the physical measurement from the sensor circuitry and user input”, Column 13, lines 3-7: “The user interface module 431 can also be used to self-report hot flashes. The self-report can be compared with any sensed values and the results can be used to predict onset of future hot flashes or the information can be presented to the user.”), inputting the user input into the classifier to train the classifier for hot flash detection (Column 19, lines 26-41: “each machine learning process is used to build a sub-model…between the inputs and the outputs which are current and/or future probabilities of hot flash occurrence. Based on the “gold standard” measure of hot flashes (e.g., skin conductance signal) and user self-report inputs about hot flash occurrence and severity, the parameters of the predictive model 544 are optimized by minimizing a cost function of each of the sub-models 543-1, 543-2, 543-3, 543-4.”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wood, Wasson, and Pardey to incorporate the teaching of de Zambotti to have the method further comprising: receiving, via the user device, a user input that confirms or denies the hot flash; and inputting the user input into the classifier to train the classifier for hot flash detection, as these prior art references and the instant application are directed to wearable devices for monitoring physiological parameters. One would be motivated to do this as classifiers can help identify pattern at lower dimension which can be more precise and efficient which can help improve the learning and generalization capability of the system and to minimize cost function, as recognized by de Zambotti (Column 13, lines 41-48 and Column 19, lines 40-41).
Alternatively, regarding claim 11, Wood in view of Wasson in view of Pardey teaches the method of claim 1 (as shown above).
Wood, Wasson, and Pardey, alone or in combination, fail to explicitly teach wherein the physiological data comprises temperature data, heart rate data, respiratory rate data, galvanic skin response data, or any combination thereof.
However, de Zambotti teaches wherein the physiological data comprises temperature data, heart rate data, respiratory rate data, galvanic skin response data, or any combination thereof (Column 7, lines 30-32: “Example physiological signals include parameters such as blood pressure, heart rate, skin conductance, body temperature, etc.”, Column 17, lines 61-63: “The monitoring garments may include sensors that detect other physiological parameters in addition to respiration and heart beat and rhythms”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wood, Wasson, and Pardey to incorporate the teaching of de Zambotti to have the physiological data comprises temperature data, heart rate data, respiratory rate data, galvanic skin response data, or any combination thereof, as these prior art references and the instant application are directed to wearable devices for monitoring physiological parameters. One would be motivated to do this these physiological parameters can help better predict hot flash occurrences, as recognized by de Zambotti (Column 17, lines 61-63).
Alternatively, regarding claim 13, Wood in view of Wasson in view of Pardey teaches the method of claim 1 (as shown above).
Wood, Wasson, and Pardey, alone or in combination, fail to explicitly teach wherein the wearable device collects the physiological data from the user based on arterial blood flow.
However, de Zambotti further discloses wherein the wearable ring device collects the physiological data from the user based on arterial blood flow (“analyzes the impact of factors implicated in the severity and manifestation of hot flashes, including but not limited to…skin blood flow, such as peripheral vasoconstriction/vasodilation) to assess the severity and manifestation of hot flashes.”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wood, Wasson, and Pardey to incorporate the teaching of de Zambotti to have the wearable ring device collects the physiological data from the user based on arterial blood flow, as these prior art references and the instant application are directed to wearable devices for monitoring physiological parameters. One would be motivated to do this these physiological parameters can help better predict hot flash occurrences.
Regarding claim 23, Wood in view of Wasson in view of Pardey teaches the system of claim 21 (as shown above).
Wood, Wasson, and Pardey, alone or in combination, fail to teach wherein the one or more processors are configured to receive, via the user device, supplemental data associated with the physiological data, the supplemental data comprising indications of events, subjective attributes, or both; and identify the one or more physiological indications of the hot flash based at least in part on the supplemental data.
de Zambotti teaches methods of managing hot flashes (Abstract) wherein the one or more processors are configured to receive, via the user device, supplemental data associated with the physiological data (Column 13, lines 3-8: “The user interface module 431 can also be used to self-report hot flashes. The self-report can be compared with any sensed values and the results can be used to predict onset of future hot flashes or the information can be presented to the user. In general, the user interface module 431 can be used to obtain data from the user.”, Column 15, lines 27-30: “emotional state data can be collected through user input of their mood or may be assessed based on a combination of physiological parameters that are detected or entered”), the supplemental data comprising indications of events, subjective attributes, or both; and identify the one or more physiological indications of the hot flash based at least in part on the supplemental data (Column 13, line 61-Column 14, line 6: “analyzes the impact of factors implicated in the severity and manifestation of hot flashes, including but not limited to environmental circumstances (e.g., ambient temperature, humidity, season, time of day, meal composition, caffeine and/or alcohol consumption, use of medications), individual circumstances (e.g., mood, stress, anxiety, time of day, exercise, menstrual cycle patterns, calendar events), users' location from GPS and/or user inputs (e.g., supermarket, home, work), and physiological state (e.g., skin temperature, thermosensitivity, heart rate, cardiac autonomic state, such as heart rate variability, skin blood flow, such as peripheral vasoconstriction/vasodilation) to assess the severity and manifestation of hot flashes”) .
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wood, Wasson, and Pardey to incorporate the teaching of de Zambotti to have the method further comprising: receiving, via the user device, supplemental data associated with the physiological data, the supplemental data comprising indications of events, subjective attributes, or both; and identifying the one or more physiological indications of the hot flash based at least in part on the supplemental data, as these prior art references are directed to wearable devices for monitoring physiological parameters. One would be motivated to do this as this supplemental data can help analyze the severity and manifestation of the hot flash, as recognized by de Zambotti (Column 14, lines 5-6).
Claim(s) 2 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wood in view of Wasson in view of Pardey as applied to claims 1 and 21 above, and further in view of Stivoric et al. (US 2007/0100666 A1, previously cited), hereinafter Stivoric.
Regarding claim 2 and 22, Wood in view of Wasson in view of Pardey teaches the method of claim 1 and the system of claim 21 (as shown above). Wood further teaches a normal value stored in a memory ([0049]).
Wood, Wasson, and Pardey, alone or in combination, fail to explicitly teach receiving, via the transceiver of the user device, additional physiological data associated with the user; and determining baseline physiological data for the user based at least in part on the additional physiological data, wherein the physiological data change threshold is based on the baseline physiological data for the user.
However, Stivoric teaches a monitoring system with a sensor to predict the occurrence of a number of physiological states (Abstract), such as hot flashes ([0212]) wherein the system receiving, via the transceiver of the user device, additional physiological data associated with the user ([0234] “Skin temperature sensor initially detects skin temperature 700… method of calibration includes the temperature measurement of the wearer with a digital temperature measurement device which is automatically transferred to the module. Once the initial temperature of the wearer is received by the module, the unit is set to the wearer's initial starting temperature”); and determining baseline physiological data for the user based at least in part on the additional physiological data, wherein the physiological data change threshold is based on the baseline physiological data for the user ([0234] “the unit is set to the wearer's initial starting temperature and uses this temperature as a basis for the relative changes that occur while the temperature module is in contact with the wearer.”, [0236] “sensor calibration and personalization of the system to the particular wearer. In sensor calibration, the individual sensors are calibrated against one another based on laboratory adjustments or first readings from the device before each is applied to the skin. The appropriate offset and, optionally, a slope or linear (or non-linear) function are chosen for each sensor. In personalization, a secondary reading of core temperature is taken and utilized for the purposes of calibrating the device to the individual. For example, a parent may take their child's temperature through another means before placing the module on the child. This value can be utilized to personalize the algorithm for that child by correlating the detected measurements of the module with the actual temperature recorded by other means.”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wood, Wasson, and Pardey to incorporate the teachings of Stivoric to receive, via the transceiver of the user device and from the wearable ring device, additional physiological data associated with the user; and determine baseline physiological data for the user based at least in part on the additional physiological data, wherein the physiological data change threshold is based on the baseline physiological data for the user, as these prior art references and the instant application are directed to monitoring physiological data to detect hot flashes. One would be motivated to do this as the temperature calibration aids in the accuracy of the detection of data and determine changes and to allow the system to categorize the user according to particular parameters and characteristics to increase the specificity of the application , as recognized by Stivoric ([0029], [0213]).
Claim(s) 4 and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wood in view of Wasson in view of Pardey in view of de Zambotti as applied to claim 3 and 23 above, and further in view of de Zambotti (US 2023/0277106 A1, previously cited), hereinafter de Zambotti'106.
Regarding claim 4 and 24, Wood in view of Wasson in view of Pardey further in view of de Zambotti teaches the method of claim 3 and the system of claim 23 (as shown above).
Wood, Wasson, Pardey, and de Zambotti, alone or in combination, fail to teach wherein the supplemental data comprises an indication of one or more hot flashes, one or more tags associated with the physiological data, or both.
However, de Zambotti’106 teaches systems, devices and methods involving hot flash (HF) multi-sensor circuits to determine the probability of an HF event wherein the supplemental data comprises an indication of one or more hot flashes ([0113] “the system includes… event marker 562 (e.g., a button the user can press to indicate a HF onset)”), one or more tags associated with the physiological data ([0119] “if the temperature rises and SC rises or if temperature drops and skin conductance rises very rapidly and mark the signal region as HFs.”), or both.
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wood in view of Wasson in view of Pardey further in view of de Zambotti to incorporate the teachings of de Zambotti’106 to have the supplemental data comprises an indication of one or more hot flashes, one or more tags associated with the physiological data, or both, as these prior art references and the instant application are directed to analyzing physiological data and other data to detect hot flashes. One would be motivated to do this to reliably and accurately predict the onset of a hot flash, as recognized by de Zambotti’106 ([0061]).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wood in view of Wasson in view of Pardey as applied to claim 1 above, and further in view of de Zambotti (US 2023/0277106 A1, previously cited), hereinafter de Zambotti'106.
Regarding claim 7, Wood in view of Wasson in view of Pardey teaches the method of claim 1 (as shown above). Wood, Wasson and Pardey, alone or in combination fail to teach the method further comprising adjusting one or more scores for the user based at least in part on the hot flash, wherein the one or more scores comprise a Sleep Score, a Readiness Score, or both.
However, de Zambotti’106 teaches adjusting one or more scores for the user based at least in part on the hot flash ([0021] “the tracked psychophysiological state is associated with a sleep state or an awake state of the user, and the processor circuitry is configured to calculate an amount of awake time associated with at least one of the plurality of HF events based on the tracked psychophysiological state.”), wherein the one or more scores comprises a Sleep Score ([0055] “the processor circuitry 104 evaluates the user psychophysiological state, and the real-time multi-sensor based HF classification triggers the evaluation of the immediate impact of the HF event (e.g., HF sleep impact)”, [0136] “sleep was scored according to the American Academy of Sleep (AASM) guidelines.” ) .
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wood in view of Wasson in view of Pardey to incorporate the teachings of de Zambotti’106 to adjust one or more scored for the user based at least in part on the hot flash, wherein the one or more scores comprises a Sleep Score, a Readiness Score, or both, as these prior art references and the instant application are directed to analyzing physiological data and other data to detect hot flashes. One would be motivated to do this as hot flashes disrupt sleep and HFs and sleep disturbances are the most common menopausal symptoms for which women seek care therefore by adjusting the sleep score one can track the effects of HFs and minimize the risk of higher health care costs, as recognized by de Zambotti’106 ([0045]).
Claim(s) 25-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wood in view of Wasson in view of von Badinski et al. (US 2020/0401183 A1, previously cited), hereinafter von Badinski further in view of Pardey.
Regarding claim 25, Wood teaches a system for detecting hot flashes ([0021] “the invention is described in the context of predicting an onset of an adverse health condition of the subject… the invention is described in the context of predicting an onset of a panic attack of the subject”, [0062] “The most common symptoms of panic attacks include…hot flashes… any physiological sensor capable of measuring a physiological parameter associated with any of these symptoms can be used for the sensors 102, 104, 105 in the assembly 100.”), comprising:
One or more processors (processor 108) communicatively coupled with the plurality of sensors (view Figure 1, [0028]) wherein the one or more processors are configured to:
Receive, via the transceiver of a user device (Figure 2: mobile phone 601), the temperature data associated with the user ([0022] “The assembly 100 includes one or more physiological sensors to measure data that indicates a change in a value of a physiological parameter of a subject over a time period”, [0024] “The physiological sensor is a temperature sensor 104 to measure a change in a body temperature of the subject over the time period”, [0032] “In an embodiment, the assembly 100 and the mobile phone 601 are in wireless communication (e.g. Bluetooth®). In an example embodiment, updates to the module 109 are communicated from the mobile phone 601 to the processor 108 of the assembly 100 using the wireless communication.”)
Identify, via one or more processors, a first drop in the temperature data within a first time interval that is greater than a temperature change threshold ([0041] “the processor 108 determines whether the value of the change in the physiological parameter (based on the received data in step 309) is greater than a change threshold… where the data received in step 309 indicates a change in a value of the body temperature of the subject, in step 311 the processor 308 determines whether the value of the change of the body temperature exceeds a temperature change threshold”)
Identify, via the one or more processors, one or more physiological indication of hot flash experienced by the user based at least in part on the first drop ([0041] discusses how when the value of change of a variety of physiological parameters (such as heart rate, temperature, CO2) is greater than its respective parameter change threshold it is “indicative of the adverse health condition (e.g. panic attack, heart attack, fast breathing, etc.)”, [0043] “the determination in step 311 is used as a prediction of a health condition (e.g. panic attack, heart attack, fast breathing, etc.) of the subject”)
Transmit to the user device associated with the user, a signal configured to cause a graphical user interface of the user device to display a hot flash notification based at least in part on identifying the one or more physiological indications of the hot flash and an instruction for the user to perform one or more actions to modify the one or more physiological indications of hot flash ([0042]-[0043] “A positive determination in step 311 moves the method to step 313…in steps 313a, 313b, the action is performed to alert the subject (or others) of the determination in step 311. In an embodiment, in step 313c, the action is performed to provide treatment (e.g. therapy, visual symbol) to the subject in response to the determination in step 311.”, [0045] “the processor 108 outputs one or more characters on a display device based on the determination in step 311… In yet another embodiment, the characters indicate a suggested treatment for the possible adverse health condition (e.g. visualize their symbol, activate their anchor, recite their mission statement, taking medication, psychological stress therapy, contact emergency medical services, etc.).”)
Wood fails to disclose a wearable ring device configured to be worn on a finger of a user and comprising a plurality of sensors arranged on an inner surface of the wearable ring device and configured to acquire physiological data from the finger of the user, the plurality of sensors comprising one or more light-emitting components and one or more photodetectors arranged on the inner surface of the wearable ring device and configured to acquire the physiological data from an underside of the finger of the user and a processor configured to acquire, via the plurality of sensors arranged on the inner surface of the wearable ring device, the physiological data from the underside of the finger of the user, wherein the physiological data comprises temperature data that is continuously acquired via the wearable ring device.
However, Wasson teaches a ring-shaped wearable device for detecting biometrics wherein a wearable ring device (ring 104) configured to be worn on a finger of a user ([0018] “a user can wear a ring 104 on a finger of the user’s hand 106”, Figure 1) and comprising a plurality of sensors arranged on an inner surface of the wearable ring device (view Figures 2A-2E: the photodetectors 202 are arranged on the inner surface, [0023]) and configured to acquire physiological data from the finger of the user ([0013] "The combination of the light source(s) and the photodetector(s) can be used to detect absorption of light at, for example, one wavelength in comparison to light at another wavelength. The different rates of absorption can be used to calculate biometric data, such as the oxygen saturation. Such a ring-shaped device can monitor other biometric information", view Figure 2A-2E: the sensors are also located at the underside of the finger, [0024] "the ring 104 to monitor the oxygen saturation (SpO2), pulse, blood pressure, glucose levels, lipid concentration, carboxyhemoglobin levels, hemoglobin concentration (hematocrit levels), etc. In some embodiments, the ring 104 can monitor pulsatile (arterial) blood oxygenation (“SpO2”) or non-pulsatile (arterial and venous blood, usually called tissue oxygenation or “StO2”)"), the plurality of sensors comprising one or more light-emitting components and one or more photodetectors arranged on the inner surface of the wearable ring device ([0023] "FIGS. 2A-2E illustrate example configurations of a ring 104 according to various embodiments. The ring 104 can include a light source 204 and a photodetector 202. For the purposes of these illustrations, the photodetector 202 is illustrated using an empty rectangle whereas the light source 204 104 is illustrated using a rectangle with a dark rectangle inside.") and configured to acquire the physiological data from an underside of the finger of the user ([0013] "The combination of the light source(s) and the photodetector(s) can be used to detect absorption of light at, for example, one wavelength in comparison to light at another wavelength. The different rates of absorption can be used to calculate biometric data, such as the oxygen saturation. Such a ring-shaped device can monitor other biometric information", view Figure 2A-2E: the sensors are also located at the underside of the finger, [0024] "the ring 104 to monitor the oxygen saturation (SpO2), pulse, blood pressure, glucose levels, lipid concentration, carboxyhemoglobin levels, hemoglobin concentration (hematocrit levels), etc. In some embodiments, the ring 104 can monitor pulsatile (arterial) blood oxygenation (“SpO2”) or non-pulsatile (arterial and venous blood, usually called tissue oxygenation or “StO2”)") and a processor ([0042] “The ring 104 can include a processor 502 for analyzing data and preprocessing data before transmitting it to a portable electronic device.”) configured to acquire, via the plurality of sensors arranged on the inner surface of the wearable ring device, the physiological data from the underside of the finger of the user (citations above: [0013],[0024], Figures 2A-2E).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wood to incorporate the teachings of Wasson to have a wearable ring device configured to be worn on a finger of a user and comprising a plurality of sensors arranged on an inner surface of the wearable ring device and configured to acquire physiological data from the finger of the user, the plurality of sensors comprising one or more light-emitting components and one or more photodetectors arranged on the inner surface of the wearable ring device and configured to acquire the physiological data from an underside of the finger of the user and a processor configured to acquire, via the plurality of sensors arranged on the inner surface of the wearable ring device, the physiological data from the underside of the finger of the user, as these prior art references are directed to wearable devices that measure physiological signals. One would be motivated to do this as the ring can provide more accurate biometric information that a smart watch or similar device because the ring 1 abuts the users skin more completely and reliably, as recognized by Wasson ([0022]).
Wood and Wasson, alone or in combination, fail to teach wherein the physiological data comprises temperature data that is continuously acquired via the wearable ring device.
However, von Badinski teaches wearable electronic device wherein the device is a wearable ring device (ring 610) configured to be worn on a finger of a user ([0091] “The WCD can be in the form of a ring that can be worn on the finger of a human (or animal) user. “) and comprising a plurality of sensors arranged on an inner surface of the wearable ring device (Figure 3B: shows a wearable ring device with multiple sensors) and configured to acquire physiological data from the finger of the user ([0103] “the sensor modules 220 can include a temperature sensor 320a, a red light emitting diode (LED) 320b, a light sensor 320c, and an infra-red LED 320d. Among the sensors in the sensor modules 220, those sensors (e.g., sensors 320a-320d) which are directly related to biological sign monitoring can be configured and positioned in a way that is close to the skin (e.g., facing the interior window 130 of the WCD 110)”), wherein the physiological data comprises temperature data that is continuously acquired via the wearable ring device ([0104] “The temperature sensor can be any type of sensor that detects temperature, [0045] “measuring the skin temperature comprises measuring the skin temperature via a first temperature sensor disposed at an inward facing surface of a wearable computing device.”, [0096] “WCD 110 allows it to be worn for prolonged hours with constant and consistent contact with the skin area, thereby creating a more reliable and extended recording…of the user’s…health information, such as…body temperature”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wood and Wasson to incorporate the teachings of von Badinski have the physiological data comprise temperature data that is continuously acquired via the wearable ring device, as these prior art references are directed to wearable devices that measure physiological parameters. One would be motivated to do this as body temperature is part of the indicators that can detect adverse health events, and can be a good indicator for hot flash detection.
Although Wood acknowledges that “conventional systems are not capable of ruling out alternative reasons other than an adverse health condition (e.g. subject is exercising) for elevated physiological parameter values” ([0002]), Wood, Wasson, and von Badinski, alone or in combination fail to teach wherein the one or more processors are configured to: filtering the temperature data to remove one or more readings from the plurality of sensors that are non-contributing factors to the hot flash, wherein the one or more readings are associated with at least one of a non-physiological change, an exercise-induced skin temperature decrease, or a sleep-induced skin temperature increase.
However, Pardey teaches a method and apparatus for processing a physical signal to obtain and provide health information in relation to the user, in particular in relation to the user’s fertility or state of ovulation (Abstract) and for monitoring the onset of the menopause ([0146]) wherein one or more processors are configured to: identify, via one or more processors, a first drop in the temperature data within a first time interval ([0404] “In particular, the parameters may include information relating to whether the temperature data exhibits a dip in temperature prior to a temperature rise and details of how quickly and how far the temperature rises during and immediately following the temperature change event.”, [0097]-[0098] temperature sensors) and filtering the temperature data to remove one or more readings from the plurality of sensors that are non-contributing factors to the hot flash, wherein the one or more readings are associated with at least one of a non-physiological change ([0108] “a processor arranged to filter the plurality of readings of the temperature of the user”, [0185] “the method may further include filtering the temperature measurements prior to calculating the representative temperature values, wherein filtering comprises removing faulty or irrelevant measurements, preferably wherein filtering further comprises removing the maximum…temperature measurements from the measurements obtained during the extended period”, [0474]-[0503]“Irrelevant data is genuine data because it genuinely reflects the body temperature of the female. However, it is caused by factors that are irrelevant to the matter of ovulation. It may be produced, for example, by diurnal temperature fluctuations, or by changes in the ambient temperature to which the woman is exposed. Faulty data is data that does not genuinely correspond to the body temperature of the female. It may be produced, for example, by a faulty temperature measuring device or, more likely, by an intrinsic limitation of the temperature measuring device (for example a time-lag in the response of the device to being placed in a body cavity)…omit readings taken before (for example for a period of 10 mins) and after (for example for a period of 20 mins) any temperature dip (this may occur due the device having been taken out and reinserted)… remove any data that shows too high a rate of change of temperature.”, Examiner would like to note that a “temperature dip” would require a drop followed by a rise, which is filtered out (Figure 6).).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wood, Wasson, and von Badinski to incorporate the teachings of Pardey for filtering the temperature data to remove one or more readings from the plurality of sensors that are non-contributing factors to the hot flash, wherein the one or more readings are associated with at least one of a non-physiological change, an exercise-induced skin temperature decrease, or a sleep-induced skin temperature increase, as these prior art references are directed to measuring physiological signals to predict/determine onset of women’s health disorders. One would be motivated to do this for a better analysis of the relevant and valid data that is necessary for diagnosis and prediction while ignoring physiological data that is caused by external/irrelevant factors, as recognized by Pardey ([0504], [0509]-[0510]).
Regarding claim 26, Wood in view of Wasson in view of von Badinski in view of Pardey teaches the system of claim 25 (as shown above). Wood further discloses wherein the one or more processors are further configured to: receive heart rate data associated with the user from the wearable device ([0022], “The assembly 100 includes one or more physiological sensors”, [0051] “the first physiological sensor is the heart rate sensor 102 that measures data that indicates a change in a value of the heart rate of the subject over the time period”); identify a second change in the heart rate data within the first time interval that is greater than a heart rate change threshold, wherein identifying the first drop in the temperature data within the first time interval that is greater than a temperature change threshold; and identifying the second change in the heart rate data within the first time interval that is greater than the heart rate change threshold ([0041] “the data received in step 309 indicates a change in the value of the heart rate and the change in the value of the body temperature over the time period, in step 311 the processor 108 determines whether the value of the change in the heart rate exceeds the heart rate change threshold and whether the value of the change in the value of the body temperature exceeds the body temperature change threshold.”)
Wood fails to explicitly disclose wherein the receive heart rate data associated with the user from the wearable ring device.
However, Wasson teaches wherein the receive heart rate data associated with the user from the wearable ring device ([0060] “The system can gather data and analyze it to determine various characteristics of a user's finger. For example, the system can measure the blood oxygenation (e.g., SpO2) of a user, the heartbeat of a user, and other characteristics.”, the system is the ring 104.)
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wood to incorporate the teachings of Wasson to receive heart rate data associated with the user from the wearable ring device, as these prior art references are directed to wearable devices that measure physiological signals. One would be motivated to do this as the ring can provide more accurate biometric information that a smart watch or similar device because the ring 1 abuts the users skin more completely and reliably, as recognized by Wasson ([0022]).
Claim(s) 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wood in view of Wasson in view of von Badinski in view of Pardey as applied to claim 26 above, and further in view of McKlarney (US 2013/0036549 A1, previously cited), hereinafter McKlarney.
Regarding claim 27, Wood in view of Wasson in view of von Badinski further in view of Pardey teaches the system of claim 26 (as shown above). Wood, Wasson, von Badinski, and Pardey, alone or in combination, fail to teach wherein the first drop in the temperature data comprises a decrease in the temperature data within the first time interval, wherein the second change in the heart rate data comprises an increase in heart rate data within the first time interval.
McKlarney teaches a system for treating effects of menopause and more specifically, methods for automatically detecting an imminent hot flash wherein “in response to a hot flash, a woman's heart rate and skin blood flow increase, but the internal body temperature may drop by as much as three or four degrees as the body struggles to correct the imbalance” ([0005]).
Although, McKlarney doesn’t explicitly sate that the first drop or increase in the temperature data measured would be a decrease in the temperature data along with an increase in the heart rate, it would have been obvious to one skilled in the art that this is what the data measured would indicate as a dramatic temperature drop along with an increase in rate is indicative and characteristic of a hot flash.
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to have modified Wood, Wasson, von Badinski, and Pardey to incorporate the teachings of McKlarney to have the first drop or decrease in the temperature data comprises a decrease in the temperature data within the first time interval, wherein the second change in the heart rate data comprises an increase in heart rate data within the first time interval, as these prior art references are directed to monitoring hot flashes. One would be motivated to do this as to detect the onset of a hot flash.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Lafon et al. (US 2020/0000441 A1) teaches removing any temperature variations that are due to external factors ([0055]).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/ATTIYA SAYYADA HUSSAINI/Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792
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