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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/27/2026 has been entered.
Response to Arguments
Rejection Under 101
Applicant's arguments filed 02/27/2026 have been fully considered.
Applicant argues that the recited amended claims cannot be performed mentally due to the technological architecture recited. Thus, the claim is not directed to a mental process.
In response to Applicant’s argument, the abstract idea was categorized as organizing human activity, not mental process. Therefore, the argument is moot. Additionally, the technical components, such as, the sensor, processor, etc. are considered additional elements that are merely invoked as tools to carry out the abstract idea. See the updated rejection in light of the amendments.
Applicant argues that the amended claims recite significantly more than the judicial exception. The sensor that continuously measures heat flux is an additional element being used for more than mere data gathering. The sensor is used to determine a health capacity, which is used to detect a pre-symptomatic disease state. Such operations cannot be mere data gathering.
In response to Applicant’s argument, the recited sensor is being invoked to “continuously measure” data. This data is then processed to determine the health capacity and in turn the pre-symptomatic disease state. (See amended claim 1). Therefore, the sensor’s role is to gather the measured data and is considered merely invoking a tool (sensor) to carry out the abstract idea. See the updated rejection in light of the amendments.
The claims integrate the judicial exception into a practical application by reciting an improvement.
In response to Applicant’s arguments, the additional elements recited do not amount to a practical application since, the additional elements merely invokes use of computer and other machinery, such as a sensor, as a tool. See MPEP 2106.05(f).
Rejection Under 103
Applicant's arguments filed 02/27/2026 have been fully considered.
Applicant argues that prior art does not teach the amended claims especially regarding the amended claim language directed to the pre-symptomatic disease state.
In response to Applicant’s arguments, the argument is directed toward the amendment and is therefore moot in light of the new grounds of rejection. See the updated rejection for further clarification.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-2, 7-9, 11-12, 19-26, 30-34, 37, 40-42, 62-69, 74-75, 77, 84-85 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. The dependent claims are also rejected for inheriting the issues of the independent claim.
Regarding claim 1, the claim is a system claim but then goes on to recite “a processing system comprising a processor and an interface, wherein the processor is configured to perform a method according to machine readable instruction, the method including:” in the second paragraph of the claim. It is unclear if Applicant is reciting a system and merely made an error by reciting method language or was attempting to amend this system claim to a method claim. Appropriate correction is required. For examination purposes, the claim is interpreted as a system claim and the second paragraph is construed as a processor configured to execute machine readable instructions.
Regarding claim 23, the claim is a system claim but then goes on to recite “a processor, wherein the processor is configured perform a method according to machine readable instructions, the method including:” in the third paragraph of the claim. It is unclear if Applicant is reciting a system and merely made an error by reciting method language or was attempting to amend this system claim to a method claim. Appropriate correction is required. For examination purposes, the claim is interpreted as a system claim and the third paragraph is construed as a processor configured to execute machine readable instructions.
Regarding claim 25, the claim originally recited “sensing at least one emergent factors of the biological system, generating measured data relating to the at least one emergent factor, and determining, based on the measured data, one or more stimuli that influence the health capacity of the biological system.” (See claims filed 11/20/2025). However, the recently amended claims filed 02/27/2026 only cancels out the first “sensing” limitation and does not account for the rest of the claim limitations that are missing from the now amended claim. It is unclear if this is a typo or Applicant intends for the rest of the 11/20/2025 claim to be canceled and amended with only the newly amended limitations provided or if they intended to keep the rest of the missing limitations while adding the amendment. Appropriate correction or clarification is required. For examination purposes, the claim is construed to only comprise the newly amended limitations without the missing limitations, which are construed to be canceled.
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 1-2, 7-9, 11-12, 19-26, 30-34, 37, 40-42, 62-69, 74-75, 77-78, 81, 83-87 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., an abstract idea) without significantly more.
Step 1 of the Alice/Mayo Test
Claims 1-2, 7-9, 11-12, 19-24, 74-75, 77-78, 81, 83-87 are drawn to a system, which is within the four statutory categories (i.e. apparatus). Claims 25-26, 30-34, 37, 40-42, 62-69 are drawn to a method, which is within the four statutory categories (i.e. process).
Step 2A of the Alice/Mayo Test - Prong One
The independent claims recite an abstract idea. For example, independent claim 78 (and substantially similar with independent claim 1, 23, 25) recites:
A system for quantifying and improving a metabolic status of a human, comprising:
at least one wearable thermodynamic sensor configured to:
continuously measure an emergent factor of the human, wherein the emergent factor is a temporal alignment of heat production and heat elimination of the human, the temporal alignment relating to a circadian rhythm of the human, and
based on the emergent factor, continuously generate data comprising heat flux data of the human over a period of time; and
a processing system comprising a processor and an interface, the processing system configured to:
continuously receive the data from the at least one wearable thermodynamic sensor,
based on the received data, quantify a metabolic status of the human relating to the heat production and heat elimination,
based on the received data, determine one or more stimuli that influence the metabolic status of the human,
compute a solution for maximizing the metabolic status of the human,
generate and output at least one indicator for improving the metabolic status of the human by modulating the heat production and heat elimination of the human,
based on the basal metabolic status of the human, determine a health capacity of the human; and
detect a pre-symptomatic disease state of the human based on the health capacity of the human.
These underlined elements recite an abstract idea that can be categorized, under its broadest reasonable interpretation, to cover the management of personal behavior or interactions (i.e., following rules or instructions), but for the recitation of generic computer components. For example, but for the processing system, a processor, an interface, and thermodynamic sensor, the limitations in the context of this claim encompass following rules or instructions to organize patient information in order to determine the patient’s metabolic status and health capacity, which helps to detect pre-symptomatic disease states. If a claim limitation, under its broadest reasonable interpretation, covers management of personal behavior or interactions but for the recitation of generic computer components, then the limitations fall within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. See MPEP § 2106.04(a).
Dependent claims recite additional subject matter which further narrows or defines the abstract idea embodied in the claims (such as claims 2, 7-9, 11-12, 19-22, 24, 26, 30-34, 37, 40-42, 62-69, 74-75, 77, 81, 83-87 reciting particular aspects of the abstract idea).
Step 2A of the Alice/Mayo Test - Prong Two
For example, independent claim 78 (and substantially similar with independent claim 1, 23, 25) recites:
A system for quantifying and improving a metabolic status of a human, comprising:
at least one wearable thermodynamic sensor configured to: (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f))
continuously measure an emergent factor of the human, wherein the emergent factor is a temporal alignment of heat production and heat elimination of the human, the temporal alignment relating to a circadian rhythm of the human, and
based on the emergent factor, continuously generate data comprising heat flux data of the human over a period of time; and
a processing system comprising a processor and an interface, the processing system configured to: (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f))
continuously receive the data from the at least one wearable thermodynamic sensor, (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f))
based on the received data, quantify a metabolic status of the human relating to the heat production and heat elimination,
based on the received data, determine one or more stimuli that influence the metabolic status of the human,
compute a solution for maximizing the metabolic status of the human,
generate and output at least one indicator for improving the metabolic status of the human by modulating the heat production and heat elimination of the human,
based on the basal metabolic status of the human, determine a health capacity of the human; and
detect a pre-symptomatic disease state of the human based on the health capacity of the human.
The judicial exception is not integrated into a practical application. In particular, the additional elements do not integrate the abstract idea into a practical application, other than the abstract idea per se, because the additional elements amount to no more than limitations, which:
amount to mere instructions to apply an exception (such as recitations of the processing system, a processor, an interface, and thermodynamic sensor, thereby invoking computers as a tool to perform the abstract idea, see applicant’s specification 11, 26-27, 69, 81, see MPEP 2106.05(f))
Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims (such as claims 2, 7-9, 11-12, 19-22, 24, 26, 30-34, 37, 40-42, 62-69, 74-75, 77, 81, 83-87 recite additional limitations which further narrow the abstract idea, claims 2, 7-9, 11-12, 19-22, 24, 26, 30-34, 37, 40-42, 62-69, 74-75, 77, 81, 83-87 additional limitations which generally link the abstract idea to a particular technological environment or field of use). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation and do not impose a meaningful limit to integrate the abstract idea into a practical application.
Step 2B of the Alice/Mayo Test for Claims
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to discussion of integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply an exception, add insignificant extra-solution activity to the abstract idea, and generally link the abstract idea to a particular technological environment or field of use. Additionally, the additional elements, other than the abstract idea per se, amount to no more than elements which:
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields (such as using the processing system, a processor, an interface, and thermodynamic sensor, e.g., Applicant’s spec describes the computer system with it being well-understood, routine, and conventional because it describes in a manner that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such elements to satisfy 112a. (See Applicant’s Spec. pg. 11, 26-27, 69, 81; See also Teller et al. (US 2014/0221769) and Chung et al. (US 2015/0106020)); using a processing system, processor, interface, sensors, e.g., merely adding a generic computer, generic computer components, or a programmed computer to perform generic computer functions, Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 134 S. Ct. 2347, 2358-59, 110 USPQ2d 1976, 1983-84 (2014).
Dependent claims recite additional subject matter which, as discussed above with respect to integration of the abstract idea into a practical application, amount to further narrowing the abstract idea and generally linking the abstract idea to a particular field of environment. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation. Therefore, the claims are not patent eligible, and are rejected under 35 U.S.C. § 101.
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 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.
Claims 1-2, 7-9, 11-12, 19, 21-23, 25-26, 30-34, 37, 40-42, 62-69, 74-75, 77-78, 81, 83-87 are rejected under 35 U.S.C. 103 as being unpatentable over Teller et al. (US 2014/0221769) in view of Chung et al. (US 2015/0106020).
Regarding claim 1, Teller discloses a system for quantifying a health capacity of a biological system, comprising: (Teller [0001], [0101], [0112], [0115]: calculating health indicators and health indices {a parameter relating to the health of a subject is construed as the health capacity})
at least one sensor configured to continuously measure a heat flux of the biological system and continuously generate measured data based on the heat flux; and (Teller [0012]-[0014]: sensors for measuring energy expenditure of an individual including a body motion sensor, a heat flux sensory, and a skin temperature sensor, etc. [0013] The software includes instructions for collecting a plurality of sensor signals from the at least two of a body motion sensor, a heat flux sensor, a skin conductance sensor, and a skin temperature sensor, and utilizing a first set of signals based on one or more of the plurality of sensor signals in one or more functions to predict the energy expenditure of the individual. [0016] The present invention also relates to a method of automatically measuring a first state parameter of an individual, including collecting for a period of time [0079] sensor device 10 may continuously upload data in real time.)
a processing system comprising a processor and an interface, wherein the processor is configured to perform a method according to machine readable instruction, the method including: ([0078] A digital signal or signals representing certain physiological and/or contextual characteristics of the individual user may be used by microprocessor 20 to calculate or generate data indicative of physiological and/or contextual parameters of the individual user. Microprocessor 20 is programmed to derive information relating to at least one aspect of the individual's physiological state. It should be understood that microprocessor 20 may also comprise other forms of processors or processing devices, such as a microcontroller, or any other device that can be programmed to perform the functionality described herein)
receiving the measured data from the at least one sensor; ([0101] Analytical status data is characterized by the application of certain utilities or algorithms to convert one or more of the data indicative of various physiological parameters generated by sensor device 10, the data derived from the data indicative of various physiological parameters, the data indicative of various contextual parameters generated by sensor device 10, and the data input by the user into calculated health, wellness and lifestyle indicators [0107] The Activity Level category of Health Index 155 is designed to help users monitor how and when they move around during the day and utilizes both data input by the user and data sensed by sensor device 10)
determining, based on the measured data, one or more factors that quantify the health capacity of the biological system; and ([0243] Referring to FIG. 48, an example algorithm for measuring energy expenditure of an individual is shown conceptually. This example algorithm may be run on sensor device 1201 having at least an accelerometer, a heat flux sensor and a GSR sensor, or I/O 1200 that receives data from such a sensor device [0244] This algorithm development process may be used to create algorithms to enable sensor device 1201 to detect and measure various parameters, including, without limitation, the following: (i) when an individual is suffering from duress, including states of unconsciousness, fatigue, shock, drowsiness, heat stress and dehydration; and (ii) an individual's state of readiness, health and/or metabolic status, such as in a military environment, including states of dehydration, under-nourishment and lack of sleep)
Teller does not appear to explicitly disclose the following, however, Chung teaches it is old and well known in the art of healthcare data processing wherein:
detecting a pre-symptomatic disease state of the biological system based on the health capacity of the biological system. (Chung [0044] As in FIG. 1, a remote server contains a database 112 that is updated by sensing devices. These data are used to monitor an individual's health and disease state by providing visualization of historical trending 120, classifying disease state 130, and predicting emergent conditions 132. The outputs from this algorithm may issue an alert or update to a healthcare provider 122, such as a physician or emergency medical services, depending on the health state and desired alerting level. [0053] With a model or group of models identified, a decision boundary may be constructed by various classification methods to classify health state with respect to a particular pathology or groups of pathologies. For example, in classifying an emergent condition [0066] A similar example is of the correlation between activity or movement and temperature changes. Increased activity is known to cause an increase in temperature due to metabolic demand whose magnitude of change may or may not be pathological. The degree of change in temperature relative to change in activity level may be learned for a specific individual as data collection progresses, and significant variations from the adjusted, personalized values may be indicative of emergent conditions).
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare data processing, before the effective filing date of the claimed invention, to modify Teller, to incorporate detecting a pre-symptomatic disease state of the biological system based on the health capacity of the biological system, as taught by Chung, in order to accurately monitor and predict changes in the patient’s health. See Chung [0001]-[0002].
Regarding claim 2, Teller-Chung teaches the system of Claim 1, and further discloses wherein the processor computes a solution for maximizing the health capacity of the biological system according to the machine readable instructions. (Teller [0103] discloses using stimuli for creating healthy plans and routines for the patient, where the stimuli can be nutrition, exercise, sleep, etc. [0013] discloses using software including instructions for collecting data in order to analyze the data and make health determinations).
Regarding claim 7, Teller-Chung teaches the system of Claim 1, and further discloses further comprising a storage component in communication with the processing system and for storing the measured data. (Teller [0089] discloses storing all data gathered for each user in a database which is connected to a multiprocessor server).
Regarding claim 8, Teller-Chung teaches the system of Claim 1, and further discloses wherein the measured data is an energy budget of the biological system. (Teller 204-207 caloric expenditure of a subject).
Regarding claim 9, Teller-Chung teaches the system of Claim 1, and further discloses wherein processing system comprises a plurality of transmitters configured to transmit the measured data as data streams optimized with respect to properties of the at least one sensor and the emergent factors to be reported. (Teller [0150] disclose the gathered sensor data can be transmitted and output).
Regarding claim 11, Teller-Chung teaches the system of Claim 1, and Burton further teaches wherein the processor detects the pre-symptomatic disease state of the biological system using a supervised learning algorithm according to the machine readable instructions with a collection of health metrics reported from a plurality of other objects. (Chung [0131] Supervised FIG. 4 or unsupervised learning methods may be used to identify individual patterns or classify states as normal or abnormal with personalized thresholds to provide correction factors to attributes for the health and disease state model). The motivations to combine the references is discussed above and incorporated herein.
Regarding claim 12, Teller-Chung teaches the system of Claim 11, and Chung further teaches wherein the disease state is selected from aging, sepsis, cardiovascular disease, and infectious disease. (Chung [0147] Respiratory function is an important parameter in monitoring health and disease, especially for pathologies with cardiopulmonary consequences such as heart failure or sleep apnea).
Regarding claim 19, Teller-Chung teaches the system of Claim 1, and further discloses wherein the at least one sensor comprises a plurality of wearable devices for sensing data comprising at least one of heat flux data, calorimetry data, osmometry data, and physiometry data. (Teller [0012]-[0014]: sensors for measuring energy expenditure of an individual including a body motion sensor, a heat flux sensory, and a skin temperature sensor, etc.).
Regarding claim 21, Teller-Chung teaches the system of Claim 1, and further discloses wherein the interface transmits the measured data via wireless communication. (Teller [0150] disclose the gathered sensor data can be transmitted and output using a wireless communication).
Regarding claim 22, Teller-Chung teaches the system of Claim 1, and further discloses wherein the processing system further comprises: an application program interface that controls storage of the measured data, access to the measured data, security configurations, user inputs, and output of any results. (Teller [0089] discloses storing all data gathered for each user in a database which is connected to a multiprocessor server; [0150] disclose the gathered sensor data can be transmitted and output using a wireless communication).
Regarding claim 23, the claim recites substantially similar limitations as those already addressed in the rejection of claim 1, and, as such, is rejected for similar reasons as given above. Additionally, Teller further discloses
a plurality of measuring devices, wherein at least one measuring device measures a skin temperature of the biological system, and wherein at least one other measuring device continuously measures an ambient temperature; receiving continuously measured skin temperature and the continuously measured ambient temperature (Teller [0012]-[0014]: sensors for measuring energy expenditure of an individual including a body motion sensor, a heat flux sensory, and a skin temperature sensor, etc. [0076] Additionally, sensor device 10 may also generate data indicative of various contextual parameters relating to the environment surrounding the individual. For example, sensor device 10 can generate data indicative of the air quality, sound level/quality, light quality or ambient temperature near the individual [0079] sensor device 10 may continuously upload data in real time)
determining, based on continuously measured skin temperature and the continuously measured ambient temperature, one or more factors that quantify the health capacity of the biological system; and ([0243] Referring to FIG. 48, an example algorithm for measuring energy expenditure of an individual is shown conceptually. This example algorithm may be run on sensor device 1201 having at least an accelerometer, a heat flux sensor and a GSR sensor, or I/O 1200 that receives data from such a sensor device [0244] This algorithm development process may be used to create algorithms to enable sensor device 1201 to detect and measure various parameters, including, without limitation, the following: (i) when an individual is suffering from duress, including states of unconsciousness, fatigue, shock, drowsiness, heat stress and dehydration; and (ii) an individual's state of readiness, health and/or metabolic status, such as in a military environment, including states of dehydration, under-nourishment and lack of sleep).
Regarding claim 25, the claim recites substantially similar limitations as those already addressed in the rejection of claim 1, and, as such, is rejected for similar reasons as given above. Additionally, Teller further discloses:
continuously estimating heat elimination of the biological system based on surface temperature of the biological system; continuously estimating heat production of the biological system based on a physical activity of the biological system; continuously estimating a basal metabolic status of the biological system based on temporal alignment of the estimated heat elimination and estimated heat production (Teller [0012]-[0014]: sensors for measuring energy expenditure of an individual including a body motion sensor, a heat flux sensory, and a skin temperature sensor, etc.; [0175] detect real time energy expenditure of the wearer as well as the type of activity in which the wearer is engaging, such as running or riding a bike [0234] Such variables may include, without limitation, energy expenditure, including resting, active and total values, daily caloric intake, sleep states, including in bed, sleep onset, sleep interruptions, wake, and out of bed, and activity states, including exercising, sitting, traveling in a motor vehicle, and lying down, and the algorithms for generating values for such variables may be based on data from, for example, the 2-axis accelerometer, the heat flux sensor, the GSR sensor, the skin temperature sensor, the near-body ambient temperature sensor, and the heart rate sensor in the embodiment described above. {variable for activity states construed looking at expenditure based on exercise} [0243] Referring to FIG. 48, an example algorithm for measuring energy expenditure of an individual is shown conceptually. This example algorithm may be run on sensor device 1201 having at least an accelerometer, a heat flux sensor… {heat flux sensor measures heat elimination and accelerometer measures heat production} the energy expenditure is limited for that time period to a value equal to some factor (e.g. 1.3) times their minute by minute basal metabolic rate).
Regarding claim 26, Teller-Chung teaches the method of claim 25, and Teller further discloses further comprising generating a solution for maximizing the health capacity by modifying one or more stimuli that influence the health capacity of the biological system, wherein the one or more stimuli are selected from sleep patterns, sleep durations, nutritional intakes, and exercise regimens. (Teller [0103] teaches using stimuli that would impact a user’s health for creating healthy plans and routines for the patient, where the stimuli can be nutrition, exercise, sleep, etc. [0105]-[0106] teaches nutritional intakes [0107]-[0108] teaches exercise regimens [0113] teaches sleep patterns [0114] teaches sleep amount or duration).
Regarding claim 30, Teller-Chung teaches the method of Claim 25, and Teller further discloses further comprising measuring a surface temperature and physical activity of the biological system over time. (Teller [0012]-[0014]: sensors for measuring energy expenditure of an individual including a body motion sensor, a heat flux sensory, and a skin temperature sensor, etc. [0107] discloses measuring movement data over a time period as well as other relevant sensed data in connection to their movement [0111] The Mind Centering Health Index piston level is preferably calculated with respect to a suggested healthy daily routine that includes participating each day in an activity that allows the body to achieve profound relaxation while the mind stays highly focused for at least fifteen minutes. Parameters utilized in the calculation of the relevant piston level include the amount of time spent in a mind centering activity, and the percent change in skin temperature, heart rate, respiration rate, heat flow or GSR as sensed by sensor device 10 compared to a baseline which is an indication of the depth or quality of the mind centering activity).
Regarding claim 31, Teller-Chung teaches the method of claim 30, and Teller further discloses further comprising: estimating heat elimination of the biological system over time based on differential surface temperature; estimating heat production of the biological system over time based on physical activity; and estimating a basal metabolic status of the biological system based on temporal alignment of heat elimination and heat production. (Teller [0012]-[0014]: sensors for measuring energy expenditure of an individual including a body motion sensor, a heat flux sensory, and a skin temperature sensor, etc.; [0175] detect real time energy expenditure of the wearer as well as the type of activity in which the wearer is engaging, such as running or riding a bike [0234] Such variables may include, without limitation, energy expenditure, including resting, active and total values, daily caloric intake, sleep states, including in bed, sleep onset, sleep interruptions, wake, and out of bed, and activity states, including exercising, sitting, traveling in a motor vehicle, and lying down, and the algorithms for generating values for such variables may be based on data from, for example, the 2-axis accelerometer, the heat flux sensor, the GSR sensor, the skin temperature sensor, the near-body ambient temperature sensor, and the heart rate sensor in the embodiment described above. {variable for activity states construed looking at expenditure based on exercise} [0243] Referring to FIG. 48, an example algorithm for measuring energy expenditure of an individual is shown conceptually. This example algorithm may be run on sensor device 1201 having at least an accelerometer, a heat flux sensor… {heat flux sensor measures heat elimination and accelerometer measures heat production} the energy expenditure is limited for that time period to a value equal to some factor (e.g. 1.3) times their minute by minute basal metabolic rate).
Regarding claim 32, Teller-Chung teaches the method of claim 30, and Teller further discloses further comprising: obtaining a quasiperiodic rhythm of the biological system based on the measured data, wherein the quasiperiodic rhythm is of seconds-timescale, of minutes-timescale, ultradian, circadian, circalunar, or of yearly timescale. (Teller [0113] The Sleep category of Health Index 155 is designed to help users monitor their sleep patterns and the quality of their sleep. It is intended to help users learn about the importance of sleep in their healthy lifestyle and the relationship of sleep to circadian rhythms, being the normal daily variations in body functions [0079] detection by sensor device 10 of a heart rate below a certain level, or can be initiated by the individual user or some third party authorized by the user, preferably according to some periodic schedule, such as every day at 10:00 p.m.).
Regarding claim 33, Teller-Chung teaches the method of claim 32, and Teller further discloses further comprising: obtaining a variability of the quasiperiodic rhythm across a predetermined amount of time; and determining the health capacity based on the variability of the quasiperiodic rhythm. (Teller [0113] The Sleep category of Health Index 155 is designed to help users monitor their sleep patterns and the quality of their sleep. It is intended to help users learn about the importance of sleep in their healthy lifestyle and the relationship of sleep to circadian rhythms, being the normal daily variations in body functions [0079] detection by sensor device 10 of a heart rate below a certain level, or can be initiated by the individual user or some third party authorized by the user, preferably according to some periodic schedule, such as every day at 10:00 p.m.).
Regarding claim 34, Teller-Chung teaches the method of claim 32, recites substantially similar limitations as those recited in the rejection of claim 31, and, as such, is rejected for similar reasons as given above. Additionally, Teller further discloses determining the health capacity by applying a time-dependent function to the estimated basal metabolic status, wherein the time-dependent function is derived from the quasiperiodic rhythm of the biological system. (Teller [0113] The Sleep category of Health Index 155 is designed to help users monitor their sleep patterns and the quality of their sleep. It is intended to help users learn about the importance of sleep in their healthy lifestyle and the relationship of sleep to circadian rhythms, being the normal daily variations in body functions [0079] detection by sensor device 10 of a heart rate below a certain level, or can be initiated by the individual user or some third party authorized by the user, preferably according to some periodic schedule, such as every day at 10:00 p.m.).
Regarding claim 37, Teller-Chung teaches the method of claim 25, and Teller further discloses further comprising measuring exhaust streams of the biological system. (Teller [0012]-[0014]: sensors for measuring energy expenditure of an individual including a body motion sensor, a heat flux sensory, and a skin temperature sensor, etc.)
Regarding claim 40, Teller-Chung teaches the method of claim 37, and Teller further discloses further comprising: analyzing functional aspects of thermoregulation in the biological system based on the measured data. (Teller [0012] discloses predicting energy expenditure of the individual where considerations are heat flux and basal metabolic rate for the individual).
Regarding claim 41, Teller-Chung teaches the method of claim 40, and Teller further discloses further comprising: generating and outputting indicators for understanding, improving, modulating, repurposing, or any combination thereof, one or more functions of the biological system. (Teller [0103] When each member user completes the initial survey described above, a profile is generated that provides the user with a summary of his or her relevant characteristics and life circumstances. A plan and/or set of goals is provided in the form of a suggested healthy daily routine. The suggested healthy daily routine may include any combination of specific suggestions for incorporating proper nutrition, exercise, mind centering, sleep, and selected activities of daily living in the user's life.)
Regarding claim 42, Teller-Chung teaches the method of claim 41, and Teller further discloses wherein the indicators are used to manage weight, blood pressure, circadian rhythm, sleep quality, sleep duration, or any combination thereof, of the biological system. (Teller [0103] When each member user completes the initial survey described above, a profile is generated that provides the user with a summary of his or her relevant characteristics and life circumstances. A plan and/or set of goals is provided in the form of a suggested healthy daily routine. The suggested healthy daily routine may include any combination of specific suggestions for incorporating proper nutrition, exercise, mind centering, sleep, and selected activities of daily living in the user's life.)
Regarding claim 62, Teller-Chung teaches the method of claim 25, and Teller further discloses further comprising measuring heat flux data. (Teller [0012]-[0014]: sensors for measuring energy expenditure of an individual including a body motion sensor, a heat flux sensory, and a skin temperature sensor, etc.)
Regarding claim 63, Teller-Chung teaches the method of claim 62, and Teller further discloses wherein: at least one health capacity is a basal metabolic status, and at least one emergent factor is the temporal alignment of heat production and heat elimination. (Teller [0012] discloses predicting energy expenditure of the individual where considerations are heat flux and basal metabolic rate for the individual).
Regarding claim 64, Teller-Chung teaches the method of claim 63, and Teller further discloses wherein the temporal alignment is related to at least one quasiperiodic rhythm of the biological system. (Teller [0113] The Sleep category of Health Index 155 is designed to help users monitor their sleep patterns and the quality of their sleep. It is intended to help users learn about the importance of sleep in their healthy lifestyle and the relationship of sleep to circadian rhythms, being the normal daily variations in body functions).
Regarding claim 65, Teller-Chung teaches the method of Claim 64, and Teller further discloses wherein the at least one quasiperiodic rhythm is a circadian rhythm. (Teller [0113] The Sleep category of Health Index 155 is designed to help users monitor their sleep patterns and the quality of their sleep. It is intended to help users learn about the importance of sleep in their healthy lifestyle and the relationship of sleep to circadian rhythms, being the normal daily variations in body functions).
Regarding claim 66, Teller-Chung teaches the method of Claim 25, and Teller further discloses further comprising: generating and outputting at least one indicator for improving or modulating the temporal alignment of heat production and heat elimination of the biological system. (Teller [0115] selectable sleep graph 315 which calculates and displays one sleep related parameter over a pre-selected time interval. For illustrative purposes, FIG. 9 shows heat flow over a one-day period, which tends to be lower during sleeping hours [0122] Opening Health Manager web page 150 also may include a Problem Solver section 158 that actively evaluates the user's performance in each of the categories of Health Index 155 and presents suggestions for improvement. For example, if the system detects that a user's Sleep levels have been low, which suggest that the user has been having trouble sleeping, Problem Solver 158 can provide suggestions for way to improve sleep. Problem Solver 158 also may include the capability of user questions regarding improvements in performance).
Regarding claim 67, Teller-Chung teaches the method of Claim 66, and Teller further discloses wherein the at least one indicator suggests to the biological system to perform to at least one predefined action selected from a group of actions comprising: change clothes, go inside, go outside, eat a specific food, drink a specified beverage, perform certain exercises, go to sleep, or any combination thereof. (Teller [0105] The Nutrition Health Index piston level is preferably determined with respect to the following suggested healthy daily routine: eat at least three meals; eat a varied diet consisting of 6-11 servings of bread, pasta, cereal, and rice, 2-4 servings fruit, 3-5 servings of vegetables, 2-3 servings of fish, meat, poultry, dry beans, eggs, and nuts, and 2-3 servings of milk, yogurt and cheese; and drink 8 or more 8 ounce glasses of water. This routine may be adjusted based on information about the user, such as sex, age, height and/or weight. Certain nutritional targets may also be set by the user or for the user, relating to daily calories, protein, fiber, fat, carbohydrates, and/or water consumption and percentages of total consumption. Parameters utilized in the calculation of the relevant piston level include the number of meals per day, the number of glasses of water, and the types and amounts of food eaten each day as input by the user).
Regarding claim 68, Teller-Chung teaches the method of Claims 64, and Teller further discloses further comprising a step of recommending at least one predetermined action to improve or modulate the temporal alignment of heat production and heat elimination of the biological system. (Teller [0115] selectable sleep graph 315 which calculates and displays one sleep related parameter over a pre-selected time interval. For illustrative purposes, FIG. 9 shows heat flow over a one-day period, which tends to be lower during sleeping hours [0122] Opening Health Manager web page 150 also may include a Problem Solver section 158 that actively evaluates the user's performance in each of the categories of Health Index 155 and presents suggestions for improvement. For example, if the system detects that a user's Sleep levels have been low, which suggest that the user has been having trouble sleeping, Problem Solver 158 can provide suggestions for way to improve sleep. Problem Solver 158 also may include the capability of user questions regarding improvements in performance).
Regarding claim 69, Teller-Chung teaches the method of Claim 68, and Teller further discloses wherein the at least one predetermined action manages circadian rhythm. (Teller [0113] The Sleep category of Health Index 155 is designed to help users monitor their sleep patterns and the quality of their sleep. It is intended to help users learn about the importance of sleep in their healthy lifestyle and the relationship of sleep to circadian rhythms, being the normal daily variations in body functions).
Regarding claim 74, Teller-Chung teaches the system of Claim 23, and Teller further discloses wherein the processor is further configured to generate and output at least one indicator for improving or modulating a temporal alignment of heat production and heat elimination of the biological system. (Teller [0115] selectable sleep graph 315 which calculates and displays one sleep related parameter over a pre-selected time interval. For illustrative purposes, FIG. 9 shows heat flow over a one-day period, which tends to be lower during sleeping hours [0122] Opening Health Manager web page 150 also may include a Problem Solver section 158 that actively evaluates the user's performance in each of the categories of Health Index 155 and presents suggestions for improvement. For example, if the system detects that a user's Sleep levels have been low, which suggest that the user has been having trouble sleeping, Problem Solver 158 can provide suggestions for way to improve sleep. Problem Solver 158 also may include the capability of user questions regarding improvements in performance).
Regarding claim 75, Teller-Chung teaches the system of Claim 74, and Teller further discloses wherein the at least one indicator suggests to the biological system to perform to at least one predefined action selected from a group of actions comprises: change clothes, go inside, go outside, eat a specific food, drink a specified beverage, perform certain exercises, go to sleep, or any combination thereof. (Teller [0105] The Nutrition Health Index piston level is preferably determined with respect to the following suggested healthy daily routine: eat at least three meals; eat a varied diet consisting of 6-11 servings of bread, pasta, cereal, and rice, 2-4 servings fruit, 3-5 servings of vegetables, 2-3 servings of fish, meat, poultry, dry beans, eggs, and nuts, and 2-3 servings of milk, yogurt and cheese; and drink 8 or more 8 ounce glasses of water. This routine may be adjusted based on information about the user, such as sex, age, height and/or weight. Certain nutritional targets may also be set by the user or for the user, relating to daily calories, protein, fiber, fat, carbohydrates, and/or water consumption and percentages of total consumption. Parameters utilized in the calculation of the relevant piston level include the number of meals per day, the number of glasses of water, and the types and amounts of food eaten each day as input by the user).
Regarding claim 77, Teller-Chung teaches the system of Claim 74, and Teller further discloses wherein the at least one indicator is used to manage circadian rhythm. (Teller [0113] The Sleep category of Health Index 155 is designed to help users monitor their sleep patterns and the quality of their sleep. It is intended to help users learn about the importance of sleep in their healthy lifestyle and the relationship of sleep to circadian rhythms, being the normal daily variations in body functions).
Regarding claim 78, the claim recites substantially similar limitations as those already addressed in the rejections above (see claims 1, 19, 25, 26, 34, 62-63, 65, 74), and, as such, is rejected for similar reasons as given above.
Regarding claim 81, Teller-Chung teaches the system of Claim 78, and Teller further discloses wherein quantifying a metabolic status of the human is based on determining an inter-day stability and/or an intraday variability of the heat production and/or heat elimination over at least one circadian cycle. (Teller [0012]-[0014]: sensors for measuring energy expenditure of an individual including a body motion sensor, a heat flux sensory, and a skin temperature sensor, etc.; [0113] The Sleep category of Health Index 155 is designed to help users monitor their sleep patterns and the quality of their sleep. It is intended to help users learn about the importance of sleep in their healthy lifestyle and the relationship of sleep to circadian rhythms, being the normal daily variations in body functions; [0175] detect real time energy expenditure of the wearer as well as the type of activity in which the wearer is engaging, such as running or riding a bike [0234] Such variables may include, without limitation, energy expenditure, including resting, active and total values, daily caloric intake, sleep states, including in bed, sleep onset, sleep interruptions, wake, and out of bed, and activity states, including exercising, sitting, traveling in a motor vehicle, and lying down, and the algorithms for generating values for such variables may be based on data from, for example, the 2-axis accelerometer, the heat flux sensor, the GSR sensor, the skin temperature sensor, the near-body ambient temperature sensor, and the heart rate sensor in the embodiment described above. {variable for activity states construed looking at expenditure based on exercise} [0243] Referring to FIG. 48, an example algorithm for measuring energy expenditure of an individual is shown conceptually. This example algorithm may be run on sensor device 1201 having at least an accelerometer, a heat flux sensor… {heat flux sensor measures heat elimination and accelerometer measures heat production} the energy expenditure is limited for that time period to a value equal to some factor (e.g. 1.3) times their minute by minute basal metabolic rate).
Regarding claim 83, Teller-Chung teaches the system of Claim 78, and Teller further discloses wherein quantifying a metabolic status of the human is based on comparing the inter-day stability and/or intraday variability of the heat production and/or heat elimination over a particular circadian cycle to the historical value for the human. (Teller [0209] discloses the algorithm may consider may factors such as a time of day/week and the user’s past habits, and trends in the user’s reporting data {construed as comparing particular circadian and historical data for the user}).
Regarding claim 84, Teller-Chung teaches the system of Claim 1, and Teller further comprising a wearable device, wherein the wearable device includes a case, wherein the at least one sensor is disposed within the case. (Teller Figs. 12-18 and corresponding text; [0010] In one embodiment of the apparatus, the processor and the memory are included in a wearable sensor device. In another embodiment, the apparatus includes a wearable sensor device [0224] device 1200 may take the form of a watch-like device that is worn by the user on his or her wrist).
Regarding claim 85, Teller-Chung teaches the system of Claim 84, and Teller further discloses wherein the at least one sensor includes a first sensor and a second sensor, wherein the first sensor is disposed on a first side of the case, and the second sensor is positioned offset from the first sensor. (Teller Figs. 12-18 and corresponding text; [0129] As can be seen in FIG. 13, bottom portion 440 includes, on a bottom side thereof, a raised platform 430. Affixed to raised platform 430 is heat flow or flux sensor 460, a suitable example of which is the micro-foil heat flux sensor sold by RdF Corporation of Hudson, N.H. Heat flux sensor 460 functions as a self-generating thermopile transducer, and preferably includes a carrier made of a polyamide film. Bottom portion 440 may include on a top side thereof, that is on a side opposite the side to which heat flux sensor 460 is affixed, a heat sink, not shown, made of a suitable metallic material such as aluminum. Also affixed to raised platform 430 are GSR sensors 465, preferably comprising electrodes formed of a material such as conductive carbonized rubber, gold or stainless steel. Although two GSR sensors 465 are shown in FIG. 13, it will be appreciated by one of skill in the art that the number of GSR sensors 465 and the placement thereof on raised platform 430 can vary as long as the individual GSR sensors 465, i.e., the electrodes, are electrically isolated from one another. By being affixed to raised platform 430, heat flux sensor 460 and GSR sensors 465 are adapted to be in contact with the wearer's skin when armband sensor device 400 is worn. Bottom portion 440 of computer housing 405 may also be provided with a removable and replaceable soft foam fabric pad, not shown, on a portion of the surface thereof that does not include raised platform 430 and screw holes 438a. The soft foam fabric is intended to contact the wearer's skin and make armband sensor device 400 more comfortable to wear).
Regarding claim 86, Teller-Chung teaches the system of Claim 78, and Teller further discloses further comprising a wearable device, wherein the wearable device includes a case, and wherein the at least one wearable thermodynamic sensor is disposed within the case. (Teller [0010] In one embodiment of the apparatus, the processor and the memory are included in a wearable sensor device. In another embodiment, the apparatus includes a wearable sensor device [0129] As can be seen in FIG. 13, bottom portion 440 includes, on a bottom side thereof, a raised platform 430. Affixed to raised platform 430 is heat flow or flux sensor 460 [0224] device 1200 may take the form of a watch-like device that is worn by the user on his or her wrist [0243] sensor device 1201 having at least an accelerometer, a heat flux sensor and a GSR sensor).
Regarding claim 87, Teller-Chung teaches the system of Claim 86, and Teller further discloses wherein the at least one wearable thermodynamic sensor includes a first wearable thermodynamic sensor and a second wearable thermodynamic sensor, wherein the first wearable thermodynamic sensor is disposed on a first side of the case, wherein the second wearable thermodynamic sensor is disposed on a second side of the case, and wherein a space is defined between the first wearable thermodynamic sensor and the second wearable thermodynamic sensor. (Teller Fig. 26 and corresponding text; [0160] GSR Sensors 825, heat flux, skin interface component 835, skin temperature skin interface component 840 [0161] Affixed to a bottom side of PCB 860 and electronically coupled to GSR sensors 825 are contacts 865, which preferably comprise gold plated contact pins such as the Pogo.RTM. contacts available from Everett Charles Technologies in Pomona, Calif. Also affixed to the bottom side of PCB 860 is skin temperature thermistor 870, a suitable example of which is the model 100K6D280 thermistor manufactured by BetaTherm Corporation in Shrewsbury, Mass. Skin temperature thermistor 870 is, according to a preferred embodiment, thermally coupled to skin temperature skin interface component 840 by a thermally conductive interface material 875. Thermally conductive interface material 875 may be any type of thermally conductive interface known in the art, including, for example, thermally conductive gap fillers… [0162] Specifically, heat conduit 885 is provided within housing 805. As used herein, the term heat conduit refers to one or more heat conductors which are adapted to singly or jointly transfer heat from one location to another, such as a conductor made of stainless steel. Heat conduit 885 is thermally coupled to heat flux skin interface component 835 by thermally conductive interface material 875).
Claims 20, 24 are rejected under 35 U.S.C. 103 as being unpatentable over Teller-Chung in view of Burton (JP 2018/505759).
Regarding claim 20, Teller-Chung teaches the system of Claim 1, but does not appear to explicitly teach the following, however, Burton teaches it is old and well known in the art of healthcare data processing wherein the at least one sensor is an implanted device. (Burton pg. 73 teaches any combination of monitoring one or more sleep parameters, can be done for example by an implant or attachment sensor or a wireless connection-associated sensor).
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare data processing, before the effective filing date of the claimed invention, to modify , as modified above, to incorporate wherein the at least one sensor is an implanted device, as taught by Burton, in order to extract applicable data to allow for accurate predictive monitoring to detect onset of events and health conditions. See Burton [abstract].
Regarding claim 24, Teller-Chung teaches the system of claim 22, but does not appear to explicitly teach the following, however, Burton teaches it is old and well known in the art of healthcare data processing wherein the output includes a solution for intercepting a disease state. (Burton pg. 2 teaches based on detection results, suggesting a physician visit in order to prevent the onset of the health condition). The motivations to combine the references was discussed above and is incorporated herein.
Conclusion
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/AMANDA R. COVINGTON/Examiner, Art Unit 3686
/RACHELLE L REICHERT/Primary Examiner, Art Unit 3686
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