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 .
Amendment Entered
This Office action is responsive to the Amendment filed on November 18th, 2025. The examiner acknowledges the amendments to claims 1, 3, 5, 6, 8, 9, 10, 11, 13, 14, 15, 16, 17, 19, 20, and 21. Claims 1-21 remain pending in the application.
Response to Arguments
Applicant’s arguments, filed November 18th, 2025, with respect to the claim objections have been considered. The claim objections are withdrawn.
Applicant’s arguments, filed November 18th, 2025, with respect to the rejections under 35 U.S.C. 112(b) have been considered. The rejections under 35 U.S.C. 112(b) are withdrawn.
Applicant’s arguments with respect to the rejections of under 35 U.S.C. 101 have been considered but are not persuasive.
At pages 11-12, Applicant argues that the claims integrate the abstract idea into a practical application. Examiner respectfully disagrees. The applicant has amended Claims 1, 11, and 17 to include a limitation of “activating a stimulator to provide feedback to the user” to integrate an additional element/improvement.
However, under step 2A, prong two, the addition of the “stimulator” does not add a meaningful limitation to the method as it merely adds insignificant extra-solution activity. With or without the claimed abstract idea, the stimulator provides feedback the same. Therefore, it is unclear how there can be an improvement to the technology. Under step 2B, the claim utilizes a stimulator, which is generic and well-known in the industry – as evidenced by: Boyd (US 20020080330 A1) discloses conventional acoustic/visual stimulators; Mason (US 3793471 A) discloses a conventional tactile stimulator (col. 1 lines 1-10).
“An example of post-solution activity is an element that is not integrated into the claim as a whole, e.g., a printer that is used to output a report of fraudulent transactions ….” MPEP 2106.05(g). The claimed stimulator provides feedback based on the second health metric exceeding a predetermined threshold (abstract idea). The stimulator does not integrate the abstract idea into a practical application. The claims do not apply the first and second health metrics/feedback, which are obtained via the judicial exception, to effect a particular treatment or effect a particular change based on the feedback, nor do the claims apply the first and second health metrics/feedback to a particular machine. Rather, the data is merely output in a post-solution step.
Applicant’s arguments with respect to the rejections of under 35 U.S.C. 103 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
In response to applicant's arguments against the references individually (see arguments on page 17 with respect to Georgiou), one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
At page 18, Applicant argues that a person of ordinary skill in the art would have no motivation to combine Ma, Clements, and Georgiou with Pho. Examiner respectfully disagrees. In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, the instant application, Ma, Clements, Georgiou, and Pho are all directed to devices comprising temperature sensors for detecting medical conditions from temperature data. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ma, as modified by Pan, Clements, and Georgiou (see claims 1, 8, 11, and 13 below), to further comprise instructing the user to take a COVID- 19 test if the time-point average temperatures have exceeded a fever threshold over the time period, in view of the teachings of Pho, as this would aid in determining which individuals should be tested for COVID-19 and how often the individuals should be tested for COVID-19 to prevent the spread of illness and conduct early identification in pre-symptomatic or asymptomatic individuals (Pho, para. [0150]).
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, the stimulator 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.
Claim Rejections - 35 USC § 101
Claims 1-21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claims 1, 11, and 17 follows.
STEP 1
Regarding claims 1, 11, 17, the claim recites a series of steps or acts. Thus, the claims are directed to a process which is one of the statutory categories of invention.
STEP 2A, PRONG ONE
The claims are then analyzed to determine whether it is directed to any judicial exception. The steps of:
Processing a first subset … to identify changes in a body temperature …
Identifying changes in a body temperature/time-point average temperature
Determining/identifying at least one first health metric
Processing the measurement of the first set … to compare …
Determining at least one second health metric
set forth a judicial exception. These steps describe a concept performed in the human mind (including an observation, evaluation, judgment, opinion). Thus, the claims are drawn to a Mental Process, which is an Abstract Idea.
STEP 2A, PRONG TWO
Next, the claims as a whole are analyzed to determine whether the claims recite additional elements that integrate the judicial exception into a practical application. The claims fail to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. Claims 1, 11, and 17 recite an insole having temperature sensors to obtain measurements, the insole having a pressure sensor, and a stimulator to provide feedback, which is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)). The insole having temperature sensors and a pressure sensor to obtain measurements and the stimulator to provide feedback does not provide an improvement to the technological field, the method does not effect a particular treatment or effect a particular change based on the measurements, nor does the method use a particular machine to perform the Abstract Idea.
STEP 2B
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Idea, the claim recites additional steps of:
Using a first temperature sensor … to obtain a measurement
Serially repeating … measurements
Using a second temperature sensor … to obtain a measurement
Serially repeating … measurements
Outputting an indication of the first health metric/second health metric
Activating a stimulator to provide feedback …
The using, serially repeating, and activating a stimulator to provide feedback steps are well-understood, routine and conventional activities for those in the field of medical diagnostics. Further, the using, serially repeating, and activating a stimulator to provide feedback steps are each recited at a high level of generality such that it amounts to insignificant pre-solution and extra-solution activity, e.g., mere data gathering step necessary to perform the Abstract Idea and mere data outputting. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes it from well-understood, routine, and conventional data gathering and comparing activity engaged in by medical professionals prior to Applicant's invention. Furthermore, it is well established that the mere physical or tangible nature of additional elements such as the temperature sensors, pressure sensor, stimulator, using, and serially repeating steps do not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int'l, 134 S.Ct. 2347, 2358-59 (2014)).
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
Regarding claims 1, 11, and 17 the insole recited in the claims is a generic device comprising generic components configured to perform the abstract idea. The recited insole, temperature sensors, pressure sensors, are generic sensors configured to perform pre-solutional data gathering activity and the stimulator is configured to perform insignificant extra-solution activity. According to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application. See - Subramaniam S, Majumder S, Faisal AI, Deen MJ. Insole-Based Systems for Health Monitoring: Current Solutions and Research Challenges. Sensors (Basel). 2022 Jan 7;22(2):438. doi: 10.3390/s22020438; Beach C, Cooper G, Weightman A, Hodson-Tole EF, Reeves ND, Casson AJ. Monitoring of Dynamic Plantar Foot Temperatures in Diabetes with Personalised 3D-Printed Wearables. Sensors. 2021; 21(5):1717. https://doi.org/10.3390/s21051717; Beach C, Cooper G, Weightman A, Hodson-Tole EF, Reeves ND, Casson AJ. Monitoring of Dynamic Plantar Foot Temperatures in Diabetes with Personalised 3D-Printed Wearables. Sensors. 2021; 21(5):1717.
The dependent claims also fail to add something more to the abstract independent claims. Claims 2-10, 12-16, and 18-20 are directed to more abstract ideas, which does not add anything significantly more. The steps recited in the independent claims maintain a high level of generality even when considered in combination with the dependent claims.
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.
Claims 1-2, 6, 9-11, 15-18, and 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Ma (US 20200253482 A1) in view of Pan (US 20210290161 A1), further in view of Clements (US 20220047250 A1).
Regarding claim 1, discloses A process for using temperature measurements to determine health metrics (“detecting inflammation … difference between the first and second temperatures”, Abstract), comprising: a. while an insole is worn by a user (“wear … set of socks”; “shoe or sole inserts”, para. [0016, 0031]), using a first temperature sensor of the insole to obtain a measurement (first temperature measured through a left temperature sensor … left foot, para. [0013]) at a first plantar location on the user's body (“sole of the user’s left foot”; “left sock … sole”, para. [0014, 0017]); b. serially repeating step a. to obtain a first set of measurements over a time period (“sets of temperature data generated by the left … socks throughout use are substantially matched in time”; “96, 144, or 216, temperature values over such a period of time”, para. [0029, 0110], Block S110, fig. 1); c. using a second temperature sensor of the insole to obtain a measurement (“second temperature measured through a right temperature sensor … right foot”, para. [0013]) at a second plantar location on the user's body (“sole of the user’s right foot”; “right sock … sole”, para. [0016, 0019]); d. serially repeating step c. to obtain a second set of measurements over the time period (“sets of temperature data generated by the … right socks throughout use are substantially matched in time”; “96, 144, or 216, temperature values over such a period of time”, para. [0029, 0110], Block S112, fig. 1); e. processing a first subset of the first set of measurements and a second subset of the second set of measurements to identify changes in a body temperature of the user over the time period (“processes these temperatures to calculate a baseline temperature difference”; “subsets”, para. [0037, 0050, 0062, 0065], Block S120, fig. 1 & Block S122, fig. 2), the second subset of the second set of measurements comprising measurements when the user is at rest as determined by a sensor of the insole (“motion sensors”; “scan … set of temperature sensors once per hour while the user is at rest … motion data collected locally … right sock … similar methods”, para. [0037, 0046]), determining at least one first health metric based on the changes (“inflammation … healing … healthy foot or steady-state”, para. [0110]), and outputting an indication of the first health metric (“issue a notification on a display”; “notification indicating possibility of inflammation”, para. [0024, 0115]); f. for each of a plurality of time-points within the time period, processing the measurement of the first set taken at the time-point and the measurement of the second set taken at the time-point (“processes these temperatures”, para. [0037, 0050]) to compare the body temperature at the first plantar location at the time point to the body temperature at the second plantar location at the time point (“compare sets of temperature data … at substantially similar times”, para. [0029], Block S122, fig. 2).,
Ma does not disclose that the user is determined at rest by a pressure sensor of the insole.
However, Pan directed to a foot-based wearable system discloses that the user is determined at rest (“pressure sensor signals from the sensor component 10 as analyzed and displayed to the user results from a user at rest”; “foot sensing gestures … sensor component … interpretations of activity level … rest or recline”, para. [0071, 0085, 0087], fig. 6A) by a pressure sensor of the insole (“pressure sensor 3 … sensor array 4”; “footwear 30”, para. [0046, 0049, 0085]). Pan further discloses that data processing functionality may incorporate data from non-pressure sensors, including temperature, accelerometers, gyroscopes, magnetometers, light detectors and individual and pluralities and combinations thereof (para. [0081]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ma such that the second subset of the second set of measurements comprising measurements when the user is at rest as determined by a pressure sensor of the insole, in view of the teachings of Pan, as such a modification would have been merely a substitution of the motion sensors of Ma for the pressure sensors of Pan as this would aid in determining activity levels based on specific foot gestures sensed by pressure sensors.
Ma further discloses that the application can implement and correlate any other trends or combination of trends in temperature changes across one or both of the user's feet with any other medical condition in any other way (para. [0096).
Ma, as modified by Pan hereinabove, does not disclose determining at least one second health metric based on the comparison.
However, Clements discloses the wearable device (temperature sensing device 102 … clothing … wearable, para. [0032]), the at least one first health metric (“fevers”; “estimate the ovulation day 403”, para. [0038, 0065-0067]), and determining at least one second health metric based on the comparison (“data from multiple sensors may be combined, compared, filtered, or otherwise analyzed to determine a nightly BBT measurement for the user”, para. [0023]), and determining if the second health metric exceeds a predetermined threshold indicative of a physiological condition (“nightly BBT of the user increases by a threshold amount … estimated that ovulation occurred”; “increase in temperature … fever”, para. [0020, 0065]). Clements further discloses the electronic device can track temperature information of the user 101 to identify fevers, illness, or other events associated with other cycles, conditions, ailments, or diseases (para. [0038]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ma such that the process further comprises determining at least one second health metric based on the comparison, and determining if the second health metric exceeds a predetermined threshold indicative of a physiological condition, in view of the teachings of Clements, as this would aid in tracking temperature information of the user to identify fevers, illness, or other events associated with other cycles, conditions, ailments, or diseases.
Ma, as modified by Pan and Clements hereinabove, further discloses g. if the second health metric exceeds a predetermined threshold indicative of a physiological condition (Ma, “exceeds … threshold probability ”, para. [0117] & Clements, para. [0020, 0065]), activating a stimulator (“display”, para. [0117]) to provide feedback to the user (“ the application generates a prompt … highlight, color, or otherwise visually demarcate a particular region of a particular foot predicted to exhibit inflammation … virtual representation”, para. [0117]), the stimulator configured to prompt an action by the user, the stimulator comprising at least one of a tactile stimulator, a visual stimulator, or an audible stimulator (“virtual representation … display of the computing device … visually indicate to the user”, para. [0117]).
Regarding claim 2, Ma, as modified by Pan and Clements hereinabove, discloses the process of claim 1. Ma, as modified by Pan and Clements hereinabove, does not disclose wherein the first health metric comprises a phase of a menstrual cycle of the user.
However, Clements discloses wherein the first health metric comprises a phase of a menstrual cycle of the user (“the temperatures 402 can be used to identify different phases that occur within a menstrual cycle 401”, para. [0065-0067]). Clements further discloses the electronic device can track temperature information of the user 101 to identify fevers, illness, or other events associated with other cycles, conditions, ailments, or diseases.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ma, as modified by Pan and Clements hereinabove, such that the first health metric comprises a phase of a menstrual cycle of the user, in view of the teachings of Clements, as this would aid in estimating an ovulation day by tracking temperature information of the user to identify different phases that occur within the menstrual cycle.
Regarding claim 6, Ma, as modified by Pan and Clements hereinabove, discloses the process of claim 1, wherein step e. comprises: i. for each of the plurality of time-points within the time period, determining a time-point average temperature by processing the first subset of the first set of measurements and the second subset of the second set of measurements at each of the plurality of time points (“calculate … average … temperatures … over a limited time window ”para. [0058]); and ii. identifying changes in the time-point average temperatures over the time period to identify the first health metric (“tracking changes in temperature differences … transform trends … a prediction of inflammation, para. [0088]), and outputting the indication of the first health metric (“issue a notification on a display”; “notification indicating possibility of inflammation”, para. [0024, 0115]).
Regarding claim 9, Ma, as modified by Pan and Clements hereinabove, discloses the process of claim 1, wherein the second health metric comprises a risk of tissue ulceration at the first plantar location and/or the second plantar location (“predict … foot ulcer”, para. [0035, 0095-0096]), and step f. comprises identifying whether the temperature at the first plantar location differs from the temperature at the second plantar location by a predetermined threshold (“threshold difference … to a temperature difference calculated from temperature data received from the first temperature sensors in the left and right socks”, para. [0074]).
Regarding claim 10, Ma, as modified by Pan and Clements hereinabove, discloses the process of claim 1, wherein the insole comprises one insole or a pair of insoles (“shoe or sole inserts”, para. [0034]), the first plantar location is on a first foot of the user (“sole of the user’s left foot”; “left sock … sole”, para. [0014, 0017]), and the second plantar location is on the first foot of the user or a second foot of the user (“sole of the user’s right foot”; “right sock … sole”, para. [0016, 0019]).
Regarding claim 11, Ma discloses a process for using temperature measurements to determine health metrics (“detecting inflammation … difference between the first and second temperatures”, Abstract), comprising: a. while an insole is worn by a user (“wear … set of socks”; “shoe or sole inserts”, para. [0016, 0031]), using a first temperature sensor of the insole to obtain a measurement at a first location on the user's body (first temperature measured through a left temperature sensor … left foot, para. [0013]); b. serially repeating step a. to obtain a first set of measurements over a time period (“sets of temperature data generated by the left … socks throughout use are substantially matched in time”; “96, 144, or 216, temperature values over such a period of time”, para. [0029, 0058, 0110], Block S110, fig. 1); c. using a second temperature sensor of the insole to obtain a measurement at a second location on the user's body (“second temperature measured through a right temperature sensor … right foot”, para. [0013]); d. serially repeating step c. to obtain a second set of measurements over the time period (“sets of temperature data generated by the … right socks throughout use are substantially matched in time”; “96, 144, or 216, temperature values over such a period of time”, para. [0029, 0058, 0110], Block S112, fig. 1); e. for each of a plurality of time-points within the time period (“time window”; “time”, para. [0058, 0061-0062]), determining a time-point average temperature by processing the measurement of the first set at the time-point and the measurement of the second set at the time-point (“limited time window … day”; “left average for all temperature values … at a first time … right average … the first time”, para. [0058, 0061-0062, 0087]), the second subset of the second set of measurements comprising measurements when the user is at rest as determined by a sensor of the insole (“motion sensors”; “scan … set of temperature sensors once per hour while the user is at rest … motion data collected locally … right sock … similar methods”, para. [0037, 0046]); f. identifying changes in the time-point average temperatures over the time period to identify at least one first health metric for the user (“processes these temperatures to calculate a baseline temperature difference … predict inflammation … exceed … threshold”; “calculate a difference between the left and right averages”, para. [0037, 0050, 0061-0062, 0065], Block S120, fig. 1 & Block S122, fig. 2), and outputting an indication of the first health metric (“issue a notification on a display”; “notification indicating possibility of inflammation”, para. [0024, 0115]); and g. for each of the plurality of time-points within the time period, processing the measurement of the first set taken at the time-point and the measurement of the second set taken at the time-point (“processes these temperatures”; “calculate … first time”, para. [0037, 0050, 0061-0062]) to compare the temperature at the first location at the time point to the temperature at the second location at the time point (“compare sets of temperature data … at substantially similar times”, para. [0029], Block S122, fig. 2).
Ma does not disclose that the user is determined at rest by a pressure sensor of the insole.
However, Pan directed to a foot-based wearable system discloses that the user is determined at rest (“pressure sensor signals from the sensor component 10 as analyzed and displayed to the user results from a user at rest”; “foot sensing gestures … sensor component … interpretations of activity level … rest or recline”, para. [0071, 0085, 0087], fig. 6A) by a pressure sensor of the insole (“pressure sensor 3 … sensor array 4”; “footwear 30”, para. [0046, 0049, 0085]). Pan further discloses that data processing functionality may incorporate data from non-pressure sensors, including temperature, accelerometers, gyroscopes, magnetometers, light detectors and individual and pluralities and combinations thereof (para. [0081]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ma such that the second subset of the second set of measurements comprising measurements when the user is at rest as determined by a pressure sensor of the insole, in view of the teachings of Pan, as such a modification would have been merely a substitution of the motion sensors of Ma for the pressure sensors of Pan as this would aid in determining activity levels based on specific foot gestures sensed by pressure sensors.
Ma further discloses that the application can implement and correlate any other trends or combination of trends in temperature changes across one or both of the user's feet with any other medical condition in any other way (para. [0096).
Ma, as modified by Pan hereinabove, does not disclose determining at least one second health metric based on the comparison, and outputting an indication of the second health metric.
However, Clements discloses the wearable device (temperature sensing device 102 … clothing … wearable, para. [0032]), the at least one first health metric (“fevers”; “estimate the ovulation day 403”, para. [0038, 0065-0067]), and determining at least one second health metric based on the comparison (“data from multiple sensors may be combined, compared, filtered, or otherwise analyzed to determine a nightly BBT measurement for the user”, para. [0023]), and outputting an indication of the second health metric (“displayed or otherwise reported to the user … nightly BBT”, para. [0063]); and determining if the second health metric exceeds a predetermined threshold indicative of a physiological condition (“nightly BBT of the user increases by a threshold amount … estimated that ovulation occurred”; “increase in temperature … fever”, para. [0020, 0065]). Clements further discloses the electronic device can track temperature information of the user 101 to identify fevers, illness, or other events associated with other cycles, conditions, ailments, or diseases (para. [0038]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ma such that the process further comprises determining at least one second health metric based on the comparison, and outputting an indication of the second health metric, and determining if the second health metric exceeds a predetermined threshold indicative of a physiological condition, in view of the teachings of Clements, as this would aid in tracking temperature information of the user to identify fevers, illness, or other events associated with other cycles, conditions, ailments, or diseases.
Ma, as modified by Pan and Clements hereinabove, further discloses h. if the second health metric exceeds a predetermined threshold indicative of a physiological condition (Ma, “exceeds … threshold probability ”, para. [0117] & Clements, para. [0020, 0065]), activating a stimulator (“display”, para. [0117]) to provide feedback to the user (“ the application generates a prompt … highlight, color, or otherwise visually demarcate a particular region of a particular foot predicted to exhibit inflammation … virtual representation”, para. [0117]), the stimulator configured to prompt an action by the user, the stimulator comprising at least one of a tactile stimulator, a visual stimulator, or an audible stimulator (“virtual representation … display of the computing device … visually indicate to the user”, para. [0117]).
Regarding claim 15, Ma, as modified by Pan and Clements hereinabove, discloses the process of claim 11, wherein the second health metric comprises a risk of tissue ulceration at the first location and/or the second location (“predict … foot ulcer”, para. [0035, 0095-0096]), and the predetermined threshold is a tissue ulceration threshold (“threshold difference … to a temperature difference calculated from temperature data received from the first temperature sensors in the left and right socks”; “threshold difference … probability of inflammation … ulcers”, para. [0074, 0088, 0093-0095]).
Regarding claim 16, Ma, as modified by Pan and Clements hereinabove, discloses the process of claim 11, wherein the insole comprises one insole or a pair of insoles (“shoe or sole inserts”, para. [0034]), the first location is a first plantar location on a first foot of the user (“sole of the user’s left foot”; “left sock … sole”, para. [0014, 0017]), and the second location is a second plantar location on the first foot of the user or a second foot of the user (“sole of the user’s right foot”; “right sock … sole”, para. [0016, 0019]).
Regarding claim 17, Ma discloses a process for using temperature measurements to determine health metrics (“detecting inflammation … difference between the first and second temperatures”, Abstract), comprising: a. while an insole is worn by a user (“wear … set of socks”; “shoe or sole inserts”, para. [0016, 0031]), using a first temperature sensor of the insole to obtain a measurement at a first location on the user's body (first temperature measured through a left temperature sensor … left foot, para. [0013]); b. serially repeating step a. to obtain a first set of measurements over a multi-day time period (“sets of temperature data generated by the left … socks throughout use are substantially matched in time”; “one week”; “96, 144, or 216, temperature values over such a period of time”, para. [0029, 0058, 0110], Block S110, fig. 1); c. using a second temperature sensor of the insole to obtain a measurement at a second location on the user's body (“second temperature measured through a right temperature sensor … right foot”, para. [0013]); d. serially repeating step c. to obtain a second set of measurements over the multi-day time period (“sets of temperature data generated by the … right socks throughout use are substantially matched in time”; “one week”; “96, 144, or 216, temperature values over such a period of time”, para. [0029, 0058, 0110], Block S112, fig. 1); e. for each day in the multi-day period (“time window … day”; “time”, para. [0058, 0061-0062]), determining a daily average temperature by analyzing a subset of the first set of measurements and a subset of the second set of measurements (“limited time window … day”; “left average for all temperature values … at a first time … right average … the first time”, para. [0058, 0061-0062, 0087]), wherein the subset of the first set of measurements and the subset of the second set of measurements are taken from a daily window (“limited time window … day”; “first time”, para. [0058, 0061-0062]), the second subset of the second set of measurements comprising measurements when the user is at rest as determined by a sensor of the insole (“motion sensors”; “scan … set of temperature sensors once per hour while the user is at rest … motion data collected locally … right sock … similar methods”, para. [0037, 0046]), f. identifying changes in the daily average temperatures over the multi-day period to identify at least one first health metric for the user (“processes these temperatures to calculate a baseline temperature difference … predict inflammation … exceed … threshold”; “calculate a difference between the left and right averages”, para. [0037, 0050, 0061-0062, 0065], Block S120, fig. 1 & Block S122, fig. 2), and outputting an indication of the first health metric (“issue a notification on a display”; “notification indicating possibility of inflammation”, para. [0024, 0115]); and g. for each of a plurality of time-points within the multi-day period, processing a measurement of the first set taken at the time-point to a measurement of the second set taken the time-point (“processes these temperatures”; “calculate … first time”, para. [0037, 0050, 0061-0062]) to compare the temperature at the first location at the time point to the temperature at the second location at the time point (“compare sets of temperature data … at substantially similar times”, para. [0029], Block S122, fig. 2).
Ma does not disclose that the user is determined at rest by a pressure sensor of the insole.
However, Pan directed to a foot-based wearable system discloses that the user is determined at rest (“pressure sensor signals from the sensor component 10 as analyzed and displayed to the user results from a user at rest”; “foot sensing gestures … sensor component … interpretations of activity level … rest or recline”, para. [0071, 0085, 0087], fig. 6A) by a pressure sensor of the insole (“pressure sensor 3 … sensor array 4”; “footwear 30”, para. [0046, 0049, 0085]). Pan further discloses that data processing functionality may incorporate data from non-pressure sensors, including temperature, accelerometers, gyroscopes, magnetometers, light detectors and individual and pluralities and combinations thereof (para. [0081]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ma such that the second subset of the second set of measurements comprising measurements when the user is at rest as determined by a pressure sensor of the insole, in view of the teachings of Pan, as such a modification would have been merely a substitution of the motion sensors of Ma for the pressure sensors of Pan as this would aid in determining activity levels based on specific foot gestures sensed by pressure sensors.
Ma further discloses that the application can implement and correlate any other trends or combination of trends in temperature changes across one or both of the user's feet with any other medical condition in any other way (para. [0096).
Ma, as modified by Pan hereinabove, does not disclose determining at least one second health metric based on the comparison, and outputting an indication of the second health metric.
However, Clements discloses the wearable device (temperature sensing device 102 … clothing … wearable, para. [0032]), the at least one first health metric (“fevers”; “estimate the ovulation day 403”, para. [0038, 0065-0067]), and determining at least one second health metric based on the comparison (“data from multiple sensors may be combined, compared, filtered, or otherwise analyzed to determine a nightly BBT measurement for the user”, para. [0023]), and outputting an indication of the second health metric (“displayed or otherwise reported to the user … nightly BBT”, para. [0063]); and determining if the second health metric exceeds a predetermined threshold indicative of a physiological condition (“nightly BBT of the user increases by a threshold amount … estimated that ovulation occurred”; “increase in temperature … fever”, para. [0020, 0065]). Clements further discloses the electronic device can track temperature information of the user 101 to identify fevers, illness, or other events associated with other cycles, conditions, ailments, or diseases (para. [0038]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ma such that the process further comprises determining at least one second health metric based on the comparison, and outputting an indication of the second health metric, and determining if the second health metric exceeds a predetermined threshold indicative of a physiological condition, in view of the teachings of Clements, as this would aid in tracking temperature information of the user to identify fevers, illness, or other events associated with other cycles, conditions, ailments, or diseases.
Ma, as modified by Pan and Clements hereinabove, further discloses h. if the second health metric exceeds a predetermined threshold indicative of a physiological condition (Ma, “exceeds … threshold probability ”, para. [0117] & Clements, para. [0020, 0065]), activating a stimulator (“display”, para. [0117]) to provide feedback to the user (“ the application generates a prompt … highlight, color, or otherwise visually demarcate a particular region of a particular foot predicted to exhibit inflammation … virtual representation”, para. [0117]), the stimulator configured to prompt an action by the user, the stimulator comprising at least one of a tactile stimulator, a visual stimulator, or an audible stimulator (“virtual representation … display of the computing device … visually indicate to the user”, para. [011]).
Regarding claim 18, Ma, as modified by Pan and Clements hereinabove, discloses the process of claim 17, Ma, as modified by Pan and Clements hereinabove, does not disclose wherein the first health metric comprises a phase of a menstrual cycle of the user, and step f. comprises identifying an ovulation phase and/or a menstruation phase in the menstrual cycle of the user.
However, Clements discloses wherein the first health metric comprises a phase of a menstrual cycle of the user (“phases … menstrual cycle 401”, para. [0065]), and step f. comprises identifying an ovulation phase and/or a menstruation phase in the menstrual cycle of the user (“identify … phases”; “ovulation day 403 can be estimated”, para. [0027, 0066-0068]). Clements further discloses that this data or other tracked data, such as a period start date, typical menstrual phase lengths, and so on can be used to develop a statistical model, which can be used to determine if a temperature shift corresponds to an ovulation event (para. [0027]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ma, as modified by Pan and Clements hereinabove, such that the first health metric comprises a phase of a menstrual cycle of the user, and step f. comprises identifying an ovulation phase and/or a menstruation phase in the menstrual cycle of the user, in view of the teachings of Clements, as this would aid in using temperature shifts to track a menstrual cycle and identify an ovulation day, a period start date, and typical menstrual phase lengths.
Regarding claim 20, Ma, as modified by Pan and Clements hereinabove, discloses the process of claim 17, wherein the second health metric comprises a risk of tissue ulceration at the first location and/or the second location (“predict … foot ulcer”, para. [0035, 0095-0096]), the predetermined threshold is a tissue ulceration threshold (“threshold difference … to a temperature difference calculated from temperature data received from the first temperature sensors in the left and right socks”; “threshold difference … probability of inflammation … ulcers”, para. [0074, 0088, 0093-0095]).
Regarding claim 21, Ma, as modified by Pan and Clements hereinabove, the process of claim 17, wherein the insole comprises one insole or a pair of insoles (“shoe or sole inserts”, para. [0034]), the first location is a first plantar location on a first foot of the user (“sole of the user’s left foot”; “left sock … sole”, para. [0014, 0017]), and the second location is a second plantar location on the first foot of the user or a second foot of the user (“sole of the user’s right foot”; “right sock … sole”, para. [0016, 0019]).
Claims 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Ma in view of Pan and Clements, as applied to claim 2 above, and further in view of Thigpen (US 20220287622 A1).
Regarding claim 3, Ma, as modified by Pan and Clements hereinabove, discloses the process of claim 2, wherein the time period is a multi- day period (“time window … one week”, para. [0058]).
Ma, as modified by Pan and Clements hereinabove, does not disclose step e. comprises: i. for each day in the multi-day period, determining a daily average temperature by processing the first subset of the first set of measurements and the second subset of the second set of measurements, wherein the first subset of the first set of measurements and the second subset of the second set of measurements are taken from a daily window; and ii. identifying changes in the daily average temperature over the multi- day period to identify the phase of the menstrual cycle of the user, and outputting an indication of the phase of the menstrual cycle.
However, Thigpen discloses for each day in the multi-day period (“analysis time period (e.g., a plurality of days)”, para. [0106-0107]), determining a daily average temperature (“average temperature values over a period of time”; “calculate a single temperature value for each day”, para. [0069, 0088, 0105-0107]) by processing the first subset of the first set of measurements and the second subset of the second set of measurements (“plurality of temperature values 355 during the day/night and process the acquired temperature values 355 to determine the single daily temperature value”, para. [0069, 0107]), wherein the first subset of the first set of measurements and the second subset of the second set of measurements are taken from a daily window (“period of time”; “day”, para. [0069, 0107]); and ii. identifying changes in the daily average temperature over the multi- day period to identify the phase of the menstrual cycle of the user (“process the time series 350 of daily temperature values 355 to identify changes in temperature values 355 that may indicate menstrual cycle phases 370”, para. [0108]), and outputting an indication of the phase of the menstrual cycle (“display the identified one or more menstrual cycle phases 370”, para. [0114]). Thigpen further discloses accurately determining when the user experiences a first day of menstruation, a first day of ovulation, or any day throughout menstruation, ovulation, and the uterine cycle (para. [0100]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ma, as modified by Pan and Clements hereinabove, such that the process further comprises for each day in the multi-day period, determining a daily average temperature by processing the first subset of the first set of measurements and the second subset of the second set of measurements, wherein the first subset of the first set of measurements and the second subset of the second set of measurements are taken from a daily window; and ii. identifying changes in the daily average temperature over the multi- day period to identify the phase of the menstrual cycle of the user, and outputting an indication of the phase of the menstrual cycle, in view of the teachings of Thigpen, as this would aid in tracking and determining when the user experiences a first day of menstruation, a first day of ovulation, or any day throughout menstruation, ovulation, and the uterine cycle.
Regarding claim 4, Ma, as modified by Pan, Clements, and Thigpen hereinabove, discloses the process of claim 3. Regarding claim 3, Ma, as modified by Pan, Clements, and Thigpen hereinabove, discloses wherein step ii. comprises identifying an ovulation phase and/or a menstruation phase in the menstrual cycle of the user, and the process further comprises predicting a future phase of a future menstrual cycle, and outputting an indication of the prediction.
However, Clements discloses wherein step ii. comprises identifying an ovulation phase and/or a menstruation phase in the menstrual cycle of the user, and the process further comprises predicting a future phase of a future menstrual cycle (“predict the start day of a subsequent menstrual cycle 401b and/or a subsequent ovulation day 405”, para. [0028, 0068]), and outputting an indication of the prediction (“output information to a user … predicting”, para. [0037]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ma, as modified by Pan, Clements, and Thigpen hereinabove, such that step ii. comprises identifying an ovulation phase and/or a menstruation phase in the menstrual cycle of the user, and the process further comprises predicting a future phase of a future menstrual cycle, and outputting an indication of the prediction, in view of the teachings of Clements, as this would aid in predicting a start date of a next menstrual cycle, and predicating an ovulation date in a subsequent menstrual cycle.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Ma in view of Pan, Clements, and Thigpen, as applied to claims 3 above, further in view of Pardey (US 20190110692 A1), and further in view of Song (US 20110153197 A1).
Regarding claim 5, Ma, as modified by Pan, Clements, and Thigpen hereinabove, discloses the process of claim 3. Ma, as modified by Pan, Clements, and Thigpen hereinabove, does not disclose the process further comprising: i. identifying a time period during which the user is at rest wherein the measurements when the user is at rest as determined by the pressure sensor of the insole indicate that feet of the user are bearing less than 50% of a body weight of the user; and ii. setting the daily window as the time period during which the user is at rest.
However, However, Pardey discloses i. identifying a time period during which the user is at rest (“heart rate monitor … period of rest … threshold … wear the device”, para. [0133, 0506-0508]); and ii. setting the daily window as the time period during which the user is at rest (“extended period … at least 4 hours long … extended period of rest”; “ensure that temperature readings are only used if they were taken during a period of rest”, para. [0468-0471, 0508] (see also para. [0390])). Pardey further discloses the system can disregard temperature readings that were not taken during a period of rest for the user and readings may be disregarded as part of the data filtering method and that a method which allows irrelevant data generated when the device is not in use to be disregarded may have the additional advantage of allowing automatic sensing of the start and end of the extended measuring period (para. [0479]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ma, as modified by Pan, Clements, and Thigpen hereinabove, to further comprise i. identifying a time period during which the user is at rest; and ii. setting the daily window as the time period during which the user is at rest, in view of the teachings of Pardey, for the obvious advantage of allowing automatic sensing of the start and end of the extended measuring period and filtering out irrelevant data.
Ma, as modified by Pan, Clements, Thigpen, and Pardey hereinabove, does not disclose wherein the measurements when the user is at rest as determined by the pressure sensor of the insole indicate that feet of the user are bearing less than 50% of a body weight of the user.
However, Song directed to an insole type navigation apparatus discloses determining that the user is at rest as determined by the pressure sensor of the insole (pressure sensors 230 & insole 200, fig. 2, para. [0031]) indicate that feet of the user are bearing less than 50% of a body weight of the user (“determined … user's current condition is standing, sitting, or raising a foot (S4420) … pressure values 0 to 1000 … average pressure value is 240, it is recognized as standing, if it is 450, it is recognized as sitting”, para. [0046, 0048, 0053] (Examiner note: a value of 1000 would be 100% of a body weight and value of 0 would be 0% body weight, therefore a value of 240 for standing and 450 sitting would be equivalent to 24% and 45% body weight and would be less than 50% body weight)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ma, as modified by Pan, Clements, Thigpen, and Pardey hereinabove, such that the measurements when the user is at rest as determined by the pressure sensor of the insole indicate that feet of the user are bearing less than 50% of a body weight of the user, in view of the teachings of Song, as this would aid in determining when the user is sitting or standing.
Claims 7 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Ma in view of Pan and Clements, as applied to claims 6 and 11 above, and further in view of Russell (WO 2009005373 A1).
Regarding claim 7, Ma, as modified by Pan and Clements hereinabove, discloses the process of claim 6. Ma and Clements do not expressly disclose wherein the first health metric comprises a period of physical activity for the user, and step ii. comprises identifying an increase in the time-point average temperature over the time period to identify the period of physical activity for the user.
However, Russell discloses wherein the first health metric comprises a period of physical activity for the user (“activity”, page 11 line 24-page 12 line 4 (see also page 8 lines 14-25)), and step ii. comprises identifying an increase in the time-point average temperature over the time period to identify the period of physical activity for the user (“compare … average temperature”; “increase in temperature … wave form … determine a person’s activity, page 10 lines 3-8 & page 11 line 24-page 12 line 4 (see also page 9 lines 11-27)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ma, as modified by Pan and Clements hereinabove, such that the first health metric comprises a period of physical activity for the user, and step ii. comprises identifying an increase in the time-point average temperature over the time period to identify the period of physical activity for the user, in view of the teachings of Russell, as this would aid in determining a person’s activity to assist in determining movement based changes in foot temperature and filtering the detected temperature values to remove temperature changes that are not indicative of potential inflammatory conditions to provide clean foot temperature data.
Regarding claim 12, Ma, as modified by Pan and Clements hereinabove, discloses the process of claim 11. Ma, as modified by Pan and Clements hereinabove, does not disclose wherein the first health metric comprises a period of physical activity for the user, and step f. comprises identifying an increase in the time-point average temperatures over the time period to identify the period of physical activity for the user.
However, Russell discloses wherein the first health metric comprises a period of physical activity for the user (“activity”, page 11 line 24-page 12 line 4 (see also page 8 lines 14-25)), and step f. comprises identifying an increase in the time-point average temperature over the time period to identify the period of physical activity for the user (“compare … average temperature”; “increase in temperature … wave form … determine a person’s activity, page 10 lines 3-8 & page 11 line 24-page 12 line 4 (see also page 9 lines 11-27)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ma, as modified by Pan and Clements hereinabove, such that wherein the first health metric comprises a period of physical activity for the user, and step f. comprises identifying an increase in the time-point average temperatures over the time period to identify the period of physical activity for the user, in view of the teachings of Russell, as this would aid in determining a person’s activity to assist in determining movement based changes in foot temperature and filtering the detected temperature values to remove temperature changes that are not indicative of potential inflammatory conditions to provide clean foot temperature data.
Claims 8 and 13 rejected under 35 U.S.C. 103 as being unpatentable over Ma in view of Pan and Clements, as applied to claims 6 and 11 above, and further in view of Georgiou (US 20220386959 A1).
Regarding claim 8, Ma, as modified by Pan and Clements hereinabove, discloses the process of claim 6. Ma, as modified by Pan and Clements hereinabove, does not disclose wherein the first health metric comprises a fever state of the user, and step ii. comprises identifying whether the time-point average temperature has exceeded a fever threshold over the time period to identify the fever state of the user.
However, Georgiou discloses wherein the first health metric comprises a fever state of the user (“fever”, para. [0177-0179], fig. 4), and step ii. comprises identifying whether the time-point average temperature has exceeded a fever threshold over the time period to identify the fever state of the user (“fever temperature 204 …temperature 208 used by the system … long-term temperature average … threshold level … identify a fever level”, para. [0177-0179]). Georgiou further discloses the device 102 can be configured to identify how rapidly a device wearer's core temperature rises from a baseline value (population or individual baseline) to a fever or supra-fever level temperature 404 (para. [0179]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ma, as modified by Pan and Clements hereinabove, such that the first health metric comprises a fever state of the user, and step ii. comprises identifying whether the time-point average temperature has exceeded a fever threshold over the time period to identify the fever state of the user, in view of the teachings of Georgiou, as this would aid in identifying a fever level of the patient and further identifying how rapidly a device wearer's core temperature rises from a baseline value (population or individual baseline) to a fever or supra-fever level temperature.
Regarding claim 13, Ma, as modified by Pan and Clements hereinabove, discloses the process of claim 11. Ma, as modified by Pan and Clements hereinabove, does not disclose wherein the first health metric comprises a fever state of the user, and step f. comprises identifying whether the time-point average temperatures have exceeded a fever threshold over the time period to identify the fever state of the user.
However, Georgiou discloses wherein the first health metric comprises a fever state of the user (“fever”, para. [0177-0179], fig. 4), and step f. comprises identifying whether the time-point average temperatures have exceeded a fever threshold over the time period to identify the fever state of the user (“fever temperature 204 …temperature 208 used by the system … long-term temperature average … threshold level … identify a fever level”, para. [0177-0179]). Georgiou further discloses the device 102 can be configured to identify how rapidly a device wearer's core temperature rises from a baseline value (population or individual baseline) to a fever or supra-fever level temperature 404 (para. [0179]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ma, as modified by Pan and Clements hereinabove, such that the first health metric comprises a fever state of the user, and step f. comprises identifying whether the time-point average temperatures have exceeded a fever threshold over the time period to identify the fever state of the user, in view of the teachings of Georgiou, as this would aid in identifying a fever level of the patient and further identifying how rapidly a device wearer's core temperature rises from a baseline value (population or individual baseline) to a fever or supra-fever level temperature.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Ma in view of Pan, Clements, and Georgiou, as applied to claims 13 above, and further in view of Pho (US 20210407684 A1).
Regarding claim 14, Ma, as modified by Pan, Clements, and Georgiou hereinabove, discloses the process of claim 13. Ma, as modified by Pan, Clements, and Georgiou hereinabove, does not disclose instructing the user to take a COVID- 19 test if the time-point average temperatures have exceeded a fever threshold over the time period.
However, Pho discloses instructing the user to take a COVID- 19 test (“report one or more … values … who should be tested for COVID-19 and how often”, para. [0150]) if the time-point average temperatures have exceeded a fever threshold over the time period (“temperature … change threshold … greater”, para. [0079, 0158-0160]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ma, as modified by Pan, Clements, and Georgiou hereinabove, to further comprise instructing the user to take a COVID- 19 test if the time-point average temperatures have exceeded a fever threshold over the time period, in view of the teachings of Pho, as this would aid in determining which individuals should be tested for COVID-19 and how often the individuals should be tested for COVID-19 to prevent the spread of illness and conduct early identification in pre-symptomatic or asymptomatic individuals.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Ma in view of Pan and Clements, as applied to claim 18 above, further in view of Pardey, and further in view of Song.
Regarding claim 19, Ma, as modified by Pan and Clements hereinabove, discloses the process of claim 18. Ma, as modified by Pan and Clements hereinabove, does not disclose the process further comprising: i. identifying a time period during which the user is at rest wherein the measurements when the user is at rest as determined by the pressure sensor of the insole indicate that feet of the user are bearing less than 50% of a body weight of the user; and ii. setting the daily window as the time period during which the user is at rest.
However, However, Pardey discloses i. identifying a time period during which the user is at rest (“heart rate monitor … period of rest … threshold … wear the device”, para. [0133, 0506-0508]); and ii. setting the daily window as the time period during which the user is at rest (“extended period … at least 4 hours long … extended period of rest”; “ensure that temperature readings are only used if they were taken during a period of rest”, para. [0468-0471, 0508] (see also para. [0390])). Pardey further discloses the system can disregard temperature readings that were not taken during a period of rest for the user and readings may be disregarded as part of the data filtering method and that a method which allows irrelevant data generated when the device is not in use to be disregarded may have the additional advantage of allowing automatic sensing of the start and end of the extended measuring period (para. [0479]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ma, as modified by Pan and Clements hereinabove, to further comprise i. identifying a time period during which the user is at rest; and ii. setting the daily window as the time period during which the user is at rest, in view of the teachings of Pardey, for the obvious advantage of allowing automatic sensing of the start and end of the extended measuring period and filtering out irrelevant data.
Ma, as modified by Pan, Clements, and Pardey hereinabove, does not disclose wherein the measurements when the user is at rest as determined by the pressure sensor of the insole indicate that feet of the user are bearing less than 50% of a body weight of the user.
However, Song directed to an insole type navigation apparatus discloses determining that the user is at rest as determined by the pressure sensor of the insole (pressure sensors 230 & insole 200, fig. 2, para. [0031]) indicate that feet of the user are bearing less than 50% of a body weight of the user (“determined … user's current condition is standing, sitting, or raising a foot (S4420) … pressure values 0 to 1000 … average pressure value is 240, it is recognized as standing, if it is 450, it is recognized as sitting”, para. [0046, 0048, 0053] (Examiner note: a value of 1000 would be 100% of a body weight and value of 0 would be 0% body weight, therefore a value of 240 and 450 would be equivalent to 24% and 45% body weight and would be less than 50% body weight)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ma, as modified by Pan, Clements, and Pardey hereinabove, such that the measurements when the user is at rest as determined by the pressure sensor of the insole indicate that feet of the user are bearing less than 50% of a body weight of the user, in view of the teachings of Song, as this would aid in determining when the user is sitting or standing.
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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/A.E.H./Examiner, Art Unit 3791
/AURELIE H TU/Primary Examiner, Art Unit 3791