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 .
Status of Claims
Applicant's arguments, filed 12/11/2025, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claims 17-20 continue to be withdrawn per applicant's election of restriction requirement filed on 08/11/2025.
Applicants have amended their claims, filed 12/11/2025, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Applicant canceled claims 3-4 and 11-12 in the response filed on 12/11/2025.
Claims 1-2, 5-10, and 13-16 are the current claims hereby under examination.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, “a first sensor and a second sensor” of claim 9 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The use of the terms BLE, Wi-Fi, and DVD, which are trade names or marks used in commerce, have been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the terms.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-2, 5-10, and 13-16 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding Claims 1 and 9, the claims recite determining “based at least in part on the first temperature data and the second temperature data, a proxy temperature by correlating the first temperature data and the second temperature data to estimate a core body temperature of the user”. Paragraph [0052] of the specification as filed states “The proxy temperature may be determined using one or more data analysis techniques that may correlate at least one of the first temperature data or the second temperature data to a body temperature.”. However, the specification fails to disclose any data analysis techniques that are used to determine the proxy temperature. The claims also recite “a preliminary assessment of the medical condition for the user based on the temperature change exceeding the temperature threshold”. Paragraph [0053] of the specification as filed states “If the change exceeds the temperature threshold, then the change in temperature may be indicative of a physiological change, such as a fever, ovulation, or the like”. Paragraph [0029] of the specification as filed states “Changes above the threshold can thus be used to determine a preliminary assessment of the medical condition for the user based on the temperature change”. While the specification discloses how respiration rate, heart rate, and heart rate variability change with the onset on of illness, it fails to disclose how the temperature change is used to determine a preliminary assessment of the medical condition. Furthermore, the specification discloses how a logistic regression model is trained to predict the likelihood or severity of an illness using health metrics such as “respiration rate, heart rate, heart rate variability, blood pressure, baroreflex sensitivity and oxygen saturation values”, but temperature is not used [0071]. Claims 1 and 9 fail to comply with the written description requirement because an indefinite, unbounded functional limitation would cover all ways of performing a function, and therefore are rejected under 35 U.S.C 112(a). Claims 2, 5-8, 10, 13-16 are rejected due their dependence on claims 1 and 9.
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 5-6 and 13-14 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.
Regarding Claims 5 and 13, the claims recite “at least one of a baseline temperature”. It is unclear if “at least one of a baseline temperature” refers to the “a baseline temperature” recited in claims 1 and 9, from which claims 5 and 13 are dependent. For the purposes of examination, “at least one of a baseline temperature” is herein interpreted to be the same temperature or a different temperature than “a baseline temperature” recited in claims 1 and 9. Therefore, claims 5 and 13 are rendered indefinite.
Regarding Claims 6 and 14, the claims recite “a baseline temperature”. It is unclear if “a baseline temperature” in claims 6 and 14 refers to the “a baseline temperature” recited in claims 1 and 9, from which claims 6 and 14 are dependent. For the purposes of examination, “a baseline temperature” is herein interpreted to be the same temperature or a different temperature than “a baseline temperature” recited in claims 1 and 9. Therefore, claims 6 and 14 are rendered indefinite.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-2, 5-10, and 13-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pho et al. (US Patent Pub. No. 20210401378 – previously cited) hereinafter Pho in view of Stivoric et al. (US Patent Pub. No. 20050245839) hereinafter Stivoric, and further in view of Sobol et al. (US Patent Pub. No 20190209022 – previously cited) hereinafter Sobol.
Regarding Claim 1, Pho discloses a method for assessing the presence of or likelihood of developing a medical condition of a user of a wearable computing device (a method 1600 that supports a health monitoring platform for illness detection [0328]; the use of the term “ring 104” is not to be regarded as limiting, as it is contemplated herein that aspects of the present disclosure may be performed using other wearable devices (e.g., watch wearable devices…) [0035]; Examiner notes that the term “ring” is herein interpreted to be a watch wearable device), the method comprising:
receiving, from a first sensor on the wearable computing device, first temperature data relating to a first temperature measurement of the user (temperature data generated by the temperature sensor 240 may indicate a temperature of a user at the user's finger (e.g., skin temperature) [0076]; fig 2);
receiving, from a second sensor on the wearable computing device, second temperature data relating to a second temperature measurement of the user (the ring 104 may include multiple temperature sensors 240 in one or more locations [0082]; processing module 230-a may acquire and process data from multiple temperature sensors 240 in a similar manner described with respect to a single temperature sensor 240 [0083]; fig 2), the second sensor being in a different location from the first sensor (multiple temperature sensors 240 in one or more locations [0082]);
determining, based at least in part on the first temperature data and the second temperature data, a proxy temperature by correlating the first temperature data and the second temperature data to estimate a body temperature of the user (the processing module 230-a may be configured to determine a single temperature based on the average of two or more temperatures determined by two or more temperature sensors 240 in different locations on the finger [0083]);
determining a temperature change, based at least in part on the proxy temperature relative to a baseline temperature (the term “baseline temperature data” may refer to raw/processed temperature readings collected from a user, as well as frequency content of the temperature data [0145]; the user device 106 and/or server 110 may determine whether one or more parameters of the user's recent (e.g., current) physiological data deviates from one or more of the corresponding healthy baseline values/ranges (e.g., identify a satisfaction of one or more deviation criteria) [0147]; fig 6; fig 7);
comparing the temperature change to a temperature threshold (the classifier may compare temperature data to baseline temperature data to determine whether a deviation or change between the temperature data and the baseline temperature data satisfies (e.g., is greater than or equal to) some temperature change threshold [0158]);
determining a preliminary assessment of the medical condition for the user based on the temperature change exceeding the temperature threshold (a change between a user's typical high daytime temperature readings between the baseline temperature data and the additional temperature data which satisfies a temperature change threshold (e.g., change greater than or equal to some threshold) may be indicative of illness... a change between a user's typical low daytime temperature readings between the baseline temperature data and the additional temperature data which satisfies a temperature change threshold (e.g., change greater than or equal to some threshold) may be indicative of illness [0160]; the user device 106 and/or server may then determine whether the output from one or more models (e.g., machine learning classifiers) indicates that the user is transitioning from a healthy state to an unhealthy state based on the frequency domain features of the temperature data [0165]);
and generating and displaying a recommendation for the user based on the preliminary assessment (the user device 106 may display, via the GUI 275, one or more parameters of collected physiological data which are key contributors to the generated illness assessment score. For instance, if a high illness assessment score was determined primarily due to high temperature readings, the GUI 275 may indicate that a change in temperature is the primary reason for the high illness assessment score [0152]).
Pho fails to disclose receiving, from a second sensor on the wearable computing device, second temperature data relating to a second temperature measurement associated with the wearable computing device, wherein the second temperature data is an internal temperature of the wearable computing device; determining, based at least in part on the first temperature data and the second temperature data, a proxy temperature by correlating the first temperature data and the second temperature data to estimate a core body temperature of the user; determining, via the wearable computing device, a preliminary assessment of the medical condition for the user based on the temperature change exceeding the temperature threshold; and generating and displaying, via a display of the wearable computing device, a recommendation for the user based on the preliminary assessment.
However, Stivoric teaches a wearable core body temperature device (Module 55 may further be integrated into an item of clothing or a diaper, subject to the requirements, as more fully described herein, that sufficient pressure is exerted on the module in order to achieve proper interface with the skin. [0105]; temperature module 55 is provided with display 86A for output of temperature and other data [0097]; visual presentation on display 86A of module 55 or on a receiver display 86B The visual presentation of information may include current skin and/or ambient temperature, current derived core body temperature [0104]; fig 1; Examiner notes the integrated item of the diaper and the module, as a whole, is the wearable core body temperature device) in which first temperature data relating to a first temperature measurement of a user is collected (a skin temperature sensor 125 [0124]; Skin temperature sensor initially detects skin temperature 700 [0185]; figs 1 & 22) and second temperature data relating to a second temperature measurement associated with the wearable body temperature device, wherein the second temperature data is an internal temperature of the wearable body temperature device is collected (It is to be specifically noted, however, that to the extent that module 55 is located within a diaper or article of clothing, ambient temperature sensor 120 is not detecting ambient temperature of the room or even the environment near the body. It is detecting the ambient temperature of the area enclosed within the article of clothing or the diaper... This enclosed ambient temperature which is actually sensed by ambient temperature sensor 120 in most uses and embodiments is particularly useful in both derivation of the core temperature as well as the context of the user or any events occurring to the user [0128]; fig 4). Stivoric teaches determining a proxy temperature by correlating the first temperature data and the second temperature to estimate a core body temperature of the user (Regressions 1200 are the equations that compute the estimated core temperature for a given context. These equations can be very complex. One rather simple embodiment is the following: EstimatedCoreTemp=A*SkinSideTemp+B*(SkinSideTemp-AmbientSideTemp)2 +C [0197]; fig 22) because core body temperature is more reliable than skin temperature when determining potential illnesses (Core body temperature is the temperature of the vital organs of an individual. An abnormally elevated body temperature occurs when an individual is in a febrile state and can result in denaturation which is a process that causes irreversible loss of protein function, ultimately leading to cell death. An abnormally low body temperature causes an individual to be in a hypothermic state which can affect and impair the rate at which chemical reactions in the body take place and possible lead to respiratory or circulatory failure… Skin temperature is generally recognized as being 2-3 °C. cooler than core [0003]; the body will decrease peripheral blood flow to the extremities in order to maintain the homeostasis and associated core body temperature of the vital organs. The decreased peripheral blood flow is directly correlated to decreased perfusion, which leads to a lower skin temperature. [0007]).
Stivoric is considered analogous art to the present invention because it is directed towards the same field of endeavor.
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have modified the method of Pho such that the second temperature data relates to a second temperature measurement associated with the wearable computing device, wherein the second temperature data is an internal temperature of the wearable computing device and a proxy temperature is determined by correlating the first temperature data and the second temperature data to estimate a body temperature of the user, as taught by Stivoric, because core body temperature is more reliable than skin temperature when determining potential illnesses. Applying a known technique to a known device (method or product) ready for improvement to yield predictable results is likely to be obvious. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, D.).
Pho in view of Stivoric fails to teach determining, via the wearable computing device, a preliminary assessment of the medical condition for the user based on the temperature change exceeding the temperature threshold; and generating and displaying, via a display of the wearable computing device, a recommendation for the user based on the preliminary assessment.
However, Sobol teaches analyzing, via a wearable computing device, data collected by the wearable computing device (at least some of the data acquired by the wearable electronic device 100 may be operated upon locally by the wearable electronic device 100 itself [0120]).
Sobol is considered analogous art to the present invention because it is directed towards the same field of endeavor.
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have modified the method of Pho in view of Stivoric such that a preliminary assessment of the medical condition for the user based on the temperature change is determined via the wearable computing device, as taught by Sobol. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, A.).
Pho in view Stivoric and further in view of Sobol fails to teach generating and displaying, via a display of the wearable computing device, a recommendation for the user based on the preliminary assessment.
However, Sobol teaches generating a recommendation for a user (an analysis may include a clinical decision support (CDS) model that helps a caregiver use the data being acquired by the wearable electronic device 100 in order to determine, among other things, adverse changes in the health of a person being monitored [0157]; may be used to provide CDS that in turn may correlate to an action plan or related therapy recommendation [0358]), and displaying, via a display of a wearable computing device, the generated recommendation for the user (the wearable electronic device 100 may include a screen formed in the top plate 130 such that the screen is capable of displaying information collected by wearable electronic device 100, including any alerts generated [0189]; Examiner notes CDS is information collected by the wearable electronic device and thus can be displayed via a screen of the wearable electronic device).
It would have also been obvious to one having ordinary skill in the art at the time of the effective filing date to have further modified the method of Pho in view of Stivoric and further in view of Sobol such that a recommendation for the user is generated and displayed via a display of the wearable computing device, as taught by Sobol, because the wearable computing device of Pho is a watch which has the capability to display information. Furthermore, doing so would improve the wearable computing device of Pho by integrating the data gathered/processed into a practical application that a user can act upon. The use of a known technique to improve similar devices (methods or products) in the same way is likely to be obvious. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, C.).
Regarding Claim 2, Pho in view of Stivoric and further in view of Sobol teaches the invention as discussed above in claim 1. Pho further discloses the first temperature data is a skin temperature of the user of the wearable computing device (temperature sensor 240 may indicate a temperature of a user at the user's finger (e.g., skin temperature) [0076]).
Regarding Claim 5, Pho in view of Stivoric and further in view of Sobol teaches the invention as discussed above in claim 1. Pho further discloses the temperature threshold is a standard deviation away from at least one of a baseline temperature or a specified temperature (The deviation criteria may be satisfied when a user's frequency domain temperature data deviates outside of a healthy range of low frequency signal strength (e.g., based on baseline temperature data)… For example, a healthy range may be defined as approximately one standard deviation about the center of the range, as determined based on the baseline temperature data. As another example, the healthy range may be defined as approximately two standard deviations about the center of the range. [0170]).
Regarding Claim 6, Pho in view of Stivoric and further in view of Sobol teaches the invention as discussed above in claim 1. Pho further discloses further comprising: receiving third temperature data, comprising the proxy temperature over a period of time (the ring 104 may acquire physiological data (e.g., temperature data) from a user over a first time interval (e.g., reference window) [0155]);
and determining, based at least in part on the third temperature data, a baseline temperature (the user device 106 and/or the servers 110 may determine baseline temperature data associated with the user based on the temperature data collected throughout the first time interval [0157]).
Regarding Claim 7, Pho in view of Stivoric and further in view of Sobol teaches the invention as discussed above in claim 1. Pho further discloses further comprising determining the preliminary assessment of the medical condition for the user based on the temperature change using at least one machine learning algorithm (the user device 106 and/or server may then determine whether the output from one or more models (e.g., machine learning classifiers) indicates that the user is transitioning from a healthy state to an unhealthy state based on the frequency domain features of the temperature data [0165]).
Regarding Claim 8, Pho in view of Stivoric and further in view of Sobol teaches the invention as discussed above in claim 1. Pho further discloses the medical condition comprises at least one of a fever, an ovulation event, or circadian rhythm fluctuations (a change between a user's typical high daytime temperature readings between the baseline temperature data and the additional temperature data which satisfies a temperature change threshold (e.g., change greater than or equal to some threshold) may be indicative of illness... a change between a user's typical low daytime temperature readings between the baseline temperature data and the additional temperature data which satisfies a temperature change threshold (e.g., change greater than or equal to some threshold) may be indicative of illness [0160]; the system 200 may be configured to utilize acquired physiological data, user inputs, or both, to determine characteristics of the user's menstrual cycle (e.g., start/end of menstrual periods, start/end of ovulation periods, start/end of follicular phases, start/end of luteal phases, temperature readings throughout the menstrual cycle, etc.). [0272]; based on the menstrual cycle model, a classifier may be configured to identify that the user generally exhibits heightened temperatures toward the end of each menstrual period. [0274]).
Regarding Claim 9, Pho discloses a wearable computing device (a ring 104-b, a watch wearable device 104-c [0039]; fig 1; the use of the term “ring 104” is not to be regarded as limiting, as it is contemplated herein that aspects of the present disclosure may be performed using other wearable devices (e.g., watch wearable devices…) [0035]; Examiner notes that the term “ring” is herein interpreted to be a watch wearable device), comprising:
a first sensor and a second sensor (sensors may include one or more temperature sensors 240; fig 2);
at least one processor (a processing module 230-a [0060]; fig 2);
and at least one memory device comprising instructions that, when executed by the at least one processor, cause the wearable computing device to (memory 215 may include instructions that, when executed by one or more processing circuits, cause the modules to perform various functions attributed to the modules herein [0069]; fig 2):
receive, from the first sensor on the wearable computing device, first temperature data relating to a first temperature measurement of a user (temperature data generated by the temperature sensor 240 may indicate a temperature of a user at the user's finger (e.g., skin temperature) [0076]; fig 2);
receive, from the second sensor on the wearable computing device, second temperature data relating to a second temperature measurement of the user (the ring 104 may include multiple temperature sensors 240 in one or more locations [0082]; processing module 230-a may acquire and process data from multiple temperature sensors 240 in a similar manner described with respect to a single temperature sensor 240 [0083]; fig 2), the second sensor being in a different location from the first sensor (multiple temperature sensors 240 in one or more locations [0082]);
determine, based at least in part on the first temperature data and the second temperature data, a proxy temperature by correlating the first temperature data and the second temperature data to estimate a body temperature (the processing module 230-a may be configured to determine a single temperature based on the average of two or more temperatures determined by two or more temperature sensors 240 in different locations on the finger [0083]);
determine a temperature change, based at least in part on the proxy temperature relative to a baseline temperature (the term “baseline temperature data” may refer to raw/processed temperature readings collected from a user, as well as frequency content of the temperature data [0145]; the user device 106 and/or server 110 may determine whether one or more parameters of the user's recent (e.g., current) physiological data deviates from one or more of the corresponding healthy baseline values/ranges (e.g., identify a satisfaction of one or more deviation criteria) [0147]; fig 6; fig 7);
compare the temperature change to a temperature threshold (the classifier may compare temperature data to baseline temperature data to determine whether a deviation or change between the temperature data and the baseline temperature data satisfies (e.g., is greater than or equal to) some temperature change threshold [0158]).
Pho also discloses a device configured to determine a preliminary assessment of a medical condition for the user based on the temperature change exceeding the temperature threshold (a change between a user's typical high daytime temperature readings between the baseline temperature data and the additional temperature data which satisfies a temperature change threshold (e.g., change greater than or equal to some threshold) may be indicative of illness... a change between a user's typical low daytime temperature readings between the baseline temperature data and the additional temperature data which satisfies a temperature change threshold (e.g., change greater than or equal to some threshold) may be indicative of illness [0160]; the user device 106 and/or server may then determine whether the output from one or more models (e.g., machine learning classifiers) indicates that the user is transitioning from a healthy state to an unhealthy state based on the frequency domain features of the temperature data [0165]);
and generate and display a recommendation for the user based on the preliminary assessment (the user device 106 may display, via the GUI 275, one or more parameters of collected physiological data which are key contributors to the generated illness assessment score. For instance, if a high illness assessment score was determined primarily due to high temperature readings, the GUI 275 may indicate that a change in temperature is the primary reason for the high illness assessment score [0152]).
Pho fails to disclose the at least one memory device comprising instructions that, when executed by the at least one processor, cause the wearable computing device to: receive, from the second sensor on the wearable computing device, second temperature data relating to a second temperature measurement associated with the wearable computing device, wherein the second temperature data is an internal temperature of the wearable computing device; determine, based at least in part on the first temperature data and the second temperature data, a proxy temperature by correlating the first temperature data and the second temperature data to estimate a core body temperature of the user; determine a preliminary assessment of a medical condition for the user based on the temperature change; and generate and display, via a display, a recommendation for the user based on the preliminary assessment.
However, Stivoric teaches a wearable core body temperature device (Module 55 may further be integrated into an item of clothing or a diaper, subject to the requirements, as more fully described herein, that sufficient pressure is exerted on the module in order to achieve proper interface with the skin. [0105]; temperature module 55 is provided with display 86A for output of temperature and other data [0097]; visual presentation on display 86A of module 55 or on a receiver display 86B The visual presentation of information may include current skin and/or ambient temperature, current derived core body temperature [0104]; fig 1; Examiner notes the integrated item of the diaper and the module, as a whole, is the wearable core body temperature device) in which first temperature data relating to a first temperature measurement of a user is collected (a skin temperature sensor 125 [0124]; Skin temperature sensor initially detects skin temperature 700 [0185]; figs 1 & 22) and second temperature data relating to a second temperature measurement associated with the wearable body temperature device, wherein the second temperature data is an internal temperature of the wearable body temperature device is collected (It is to be specifically noted, however, that to the extent that module 55 is located within a diaper or article of clothing, ambient temperature sensor 120 is not detecting ambient temperature of the room or even the environment near the body. It is detecting the ambient temperature of the area enclosed within the article of clothing or the diaper... This enclosed ambient temperature which is actually sensed by ambient temperature sensor 120 in most uses and embodiments is particularly useful in both derivation of the core temperature as well as the context of the user or any events occurring to the user [0128]; fig 4). Stivoric teaches determining a proxy temperature by correlating the first temperature data and the second temperature to estimate a core body temperature of the user (Regressions 1200 are the equations that compute the estimated core temperature for a given context. These equations can be very complex. One rather simple embodiment is the following: EstimatedCoreTemp=A*SkinSideTemp+B*(SkinSideTemp-AmbientSideTemp)2 +C [0197]; fig 22) because core body temperature is more reliable than skin temperature when determining potential illnesses (Core body temperature is the temperature of the vital organs of an individual. An abnormally elevated body temperature occurs when an individual is in a febrile state and can result in denaturation which is a process that causes irreversible loss of protein function, ultimately leading to cell death. An abnormally low body temperature causes an individual to be in a hypothermic state which can affect and impair the rate at which chemical reactions in the body take place and possible lead to respiratory or circulatory failure… Skin temperature is generally recognized as being 2-3 °C. cooler than core [0003]; the body will decrease peripheral blood flow to the extremities in order to maintain the homeostasis and associated core body temperature of the vital organs. The decreased peripheral blood flow is directly correlated to decreased perfusion, which leads to a lower skin temperature. [0007]).
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have modified the wearable computing device of Pho such that the second temperature data relates to a second temperature measurement associated with the wearable computing device, wherein the second temperature data is an internal temperature of the wearable computing device and a proxy temperature is determined by correlating the first temperature data and the second temperature data to estimate a body temperature of the user, as taught by Stivoric, because core body temperature is more reliable than skin temperature when determining potential illnesses. Applying a known technique to a known device (method or product) ready for improvement to yield predictable results is likely to be obvious. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, D.).
Pho in view of Stivoric fails to teach the at least one memory device comprising instructions that, when executed by the at least one processor, cause the wearable computing device to: determine a preliminary assessment of a medical condition for the user based on the temperature change; and generate and display, via a display, a recommendation for the user based on the preliminary assessment.
However, Sobol teaches analyzing, via a wearable computing device, data collected by the wearable computing device (at least some of the data acquired by the wearable electronic device 100 may be operated upon locally by the wearable electronic device 100 itself [0120]).
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have modified the wearable computing device of Pho in view of Stivoric such that the instructions that, when executed by the at least one processor, cause the wearable computing device to determine a preliminary assessment of a medical condition for the user based on the temperature change, as taught by Sobol. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, A.).
Pho in view Stivoric and further in view of Sobol fails to teach generating and displaying, via a display, a recommendation for the user based on the preliminary assessment.
However, Sobol teaches generating a recommendation for a user (an analysis may include a clinical decision support (CDS) model that helps a caregiver use the data being acquired by the wearable electronic device 100 in order to determine, among other things, adverse changes in the health of a person being monitored [0157]; may be used to provide CDS that in turn may correlate to an action plan or related therapy recommendation [0358]), and displaying, via a display of a wearable computing device, the generated recommendation for the user (the wearable electronic device 100 may include a screen formed in the top plate 130 such that the screen is capable of displaying information collected by wearable electronic device 100, including any alerts generated [0189]; Examiner notes CDS is information collected by the wearable electronic device and thus can be displayed via a screen of the wearable electronic device).
It would have also been obvious to one having ordinary skill in the art at the time of the effective filing date to have modified the wearable computing device of Pho in view Stivoric and further in view of Sobol such that the instructions that, when executed by the at least one processor, cause the wearable computing device to generate and display, via a display, a recommendation for the user based on the preliminary assessment, as taught by Sobol, because the wearable computing device of Pho is a watch which has the capability to display information. Furthermore, doing so would improve the wearable computing device of Pho by integrating the data gathered/processed into a practical application that a user can act upon. The use of a known technique to improve similar devices (methods or products) in the same way is likely to be obvious. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, C.).
Regarding Claim 10, Pho in view Stivoric and further in view of Sobol teaches the invention as discussed above in claim 9. Pho further discloses the first temperature data is a skin temperature of the user of the wearable computing device (temperature sensor 240 may indicate a temperature of a user at the user's finger (e.g., skin temperature) [0076]).
Regarding Claim 13, Pho in view Stivoric and further in view of Sobol teaches the invention as discussed above in claim 9. Pho further discloses the temperature threshold is a standard deviation away from at least one of a baseline temperature or a specified temperature (The deviation criteria may be satisfied when a user's frequency domain temperature data deviates outside of a healthy range of low frequency signal strength (e.g., based on baseline temperature data)… For example, a healthy range may be defined as approximately one standard deviation about the center of the range, as determined based on the baseline temperature data. As another example, the healthy range may be defined as approximately two standard deviations about the center of the range. [0170]).
Regarding Claim 14, Pho in view Stivoric and further in view of Sobol teaches the invention as discussed above in claim 9. Pho in view of Sobol further teaches the instructions further cause the wearable computing device to: receive third temperature data, corresponding to the proxy temperature over a period of time (the ring 104 may acquire physiological data (e.g., temperature data) from a user over a first time interval (e.g., reference window) [0155 of Pho]); and determine, based at least in part on the third temperature data, a baseline temperature (at least some of the data acquired by the wearable electronic device 100 may be operated upon locally by the wearable electronic device 100 itself [0120 of Sobol]; the user device 106 and/or the servers 110 may determine baseline temperature data associated with the user based on the temperature data collected throughout the first time interval [0157 of Pho]).
Regarding Claim 15, Pho in view Stivoric and further in view of Sobol teaches the invention as discussed above in claim 9. Pho in view of Sobol further teaches the instructions further cause the wearable computing device to: determine the preliminary assessment of the medical condition for the user based on the temperature change using at least one machine learning algorithm (at least some of the data acquired by the wearable electronic device 100 may be operated upon locally by the wearable electronic device 100 itself [0120 of Sobol]; the user device 106 and/or server may then determine whether the output from one or more models (e.g., machine learning classifiers) indicates that the user is transitioning from a healthy state to an unhealthy state based on the frequency domain features of the temperature data [0165]).
Regarding Claim 16, Pho in view Stivoric and further in view of Sobol teaches the invention as discussed above in claim 9. Pho further discloses the medical condition comprises at least one of a fever, an ovulation event, or circadian rhythm fluctuations (a change between a user's typical high daytime temperature readings between the baseline temperature data and the additional temperature data which satisfies a temperature change threshold (e.g., change greater than or equal to some threshold) may be indicative of illness... a change between a user's typical low daytime temperature readings between the baseline temperature data and the additional temperature data which satisfies a temperature change threshold (e.g., change greater than or equal to some threshold) may be indicative of illness [0160]; the system 200 may be configured to utilize acquired physiological data, user inputs, or both, to determine characteristics of the user's menstrual cycle (e.g., start/end of menstrual periods, start/end of ovulation periods, start/end of follicular phases, start/end of luteal phases, temperature readings throughout the menstrual cycle, etc.). [0272]; based on the menstrual cycle model, a classifier may be configured to identify that the user generally exhibits heightened temperatures toward the end of each menstrual period. [0274]).
Response to Arguments
Applicant’s arguments, see page 7 of Remarks, filed 12/11/2025, with respect to the drawing objections have been fully considered and are partially persuasive. Applicant failed to address all issues stated in the Non-Final Rejection. As such, the drawing objection has been maintained and updated as necessitated by Applicant’s amendments.
Applicant’s arguments, see page 7 of Remarks, filed 12/11/2025, with respect to the specification objections have been fully considered and are partially persuasive. Applicant failed to address all issues stated in the Non-Final Rejection. As such, the specification objection has been maintained and updated as necessitated by Applicant’s amendments.
Applicant’s arguments, see page 7 of Remarks, filed 12/11/2025, with respect to the claim objections have been fully considered and are persuasive. The claim objections have been withdrawn.
Applicant's arguments, see pages 7-8 of Remarks, filed 12/11/2025, with respect to the 112 rejections have been fully considered and are partially persuasive. Applicant failed to address all written description issues stated in the Non-Final Rejection. As such, the 112(a) rejections have been maintained and updated as necessitated by Applicant’s amendments. Applicant has addressed all indefiniteness issues stated in the Non-Final rejection. As such, the 112(b) rejections have been withdrawn. However, upon further consideration, a new grounds of rejection is made as necessitated by the indefiniteness issues due to Applicant’s amendments.
Applicant's arguments, see pages 8-10 of Remarks, filed 12/11/2025, with respect to the prior art rejections have been fully considered but they are not persuasive. Applicant argues “Pho does not properly qualify as prior art” because the features relied on by the Examiner “such as the classifier and the corresponding methods of determining a baseline temperature” were not disclosed in the provisional application U.S. 63/049,405, filed July 8, 2020. Examiner respectfully disagrees. Independent claims 1 and 9 do not recite a classifier. Therefore, the provisional application of Pho does not need to disclose classifiers. Claims 7 and 15 recite using machine learning and the provisional application of Pho discloses using machine learning. The provisional application of Pho discloses averaging two or more temperatures, which can be considered a baseline temperature, because claims 5-6 and 13-14 do not define what is meant by “a baseline temperature” or how it is calculated. Applicant’s other arguments are based on the amendments to the claims. As such, the prior art rejections have been maintained and updated as necessitated by Applicant’s amendments.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/JANKI M BAVA/Examiner, Art Unit 3791
/ETSUB D BERHANU/Primary Examiner, Art Unit 3791
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