DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Claim Rejections 35 U.S.C. § 101
Applicant’s arguments filed on 02/26/2026 have been fully considered but are not persuasive.
Applicant argues that the claimed invention is not directed to an abstract idea because the claimed invention “represents an improvement in the functioning of a wearable monitoring system that provides a more accurate, representative evaluation of stress by evaluating a calculated metric in the context of a probability distribution or expected values for that metric based on current data about a user’s activity”. Examiner respectfully disagrees.
Applicant is reminded that abstract ideas cannot provide a practical application or significantly more, as both Step 2A Prong 2 and Step 2B require an additional element (not an abstract idea) to provide a practical application or significantly more (e.g. an improvement). See MPEP 2106.05(a). Here the concepts of “evaluating a calculated metric in the context of a probability distribution”, captured by the limitations “calculating a heart rate reserve ratio” and “generating a probability distribution” (among others), are examples of abstract ideas not additional elements. Moreover, Examiner notes, that the additional elements recited in Applicant’s claims do not provide significantly more or a practical application as they are merely examples of generic computer components or significant extra solution activity (see section “Claim Rejections 35 USC § 101” below).
Claim Rejections 35 U.S.C. § 103
Applicant’s Arguments filed on 02/26/2026 have been fully considered but are moot in view of a new grounds of rejection.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-23 are rejected under 35 U.S.C 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1
Claims 1, 14 and 20 are directed to a computer program product, a method and a system. Thus, they are directed to statutory categories of invention. (Step 1: Yes).
Step 2A, Prong 1
Claims 1, 14 and 20 recite the following limitations
“calculating a heart rate reserve ratio for the user” (mathematical calculation and/or mental process)
“calculating a value for a physiological metric” (mathematical calculation and/or mental process)
“generating a probability distribution of expected heart rate reserve ratios for the user with a prediction model based on at least the motion data acquired by the physiological monitor, the prediction model including a machine learning model trained to generate a plurality of heart rate reserve ratios in a distribution expected for the user data based on features of training data for a population of users of a type of physiological monitor corresponding to the physiological monitor worn by the user.” (mathematical calculation and/or mental process)
“generating a classification for an activity” (mathematical calculation and/or mental process)
“calculating a stress score for the user by calculating an initial stress score based on a quantile of the heart rate reserve ratio calculated for the user within the probability distribution of the expected heart rate reserve ratios received from the prediction model” ” (mathematical calculation and/or mental process)
“adjusting the initial stress score based on the classification for activity from the classification model” ” (mathematical calculation and/or mental process)
The dependent claims recite the following limitations:
“creating the classification model, the classification model trained to identify an activity type based on a second set of features of the training data for the population of users of the type of physiological monitor” (mental process and/or mathematical calculation) (claim 2, claim 15)
“providing a recommendation to the user based on the refined stress score” (mental process) (claims 6, 22)
“wherein generating the probability distribution includes generating a set of heart rate reserve ratios corresponding to each of a number of quantiles for the probability distribution” (claim 7, claim 21, claim 23) (mathematical calculations and/or mental process)
“generating an intervention recommendation for the user based on the stress score” (claim 9), “wherein the intervention recommendation includes a real time recommendation based on at least one of a current stress score and a current activity” (claim 10) (mental process)
“identifying a threshold for the stress score that is indicative of acute stress” (claim 11) (mental process)
“at least one of reporting the acute stress to the user and recommending a remediation for the acute stress” (claim 12) (mental process)
“identifying a threshold for the stress score that is indicative of autonomic activation” (claim 13) (mental process)
As indicated above, the recited limitations are directed to abstract ideas, more specifically mental processes and/or mathematical calculations.
Under the broadest reasonable interpretation, a mathematical calculation is a mathematical operation or an act of calculating using mathematical methods. see MPEP 2106.04(a)(2)(I). Examiner notes, as discussed in MPEP 2106.04(a)(2)(I), the claim does not need to recite the word “calculating” in order to be considered a mathematical calculation.
Under the broadest reasonable interpretation mental processes are defined as concepts performed in the human mind including observations, evaluations, judgements and opinions. See MPEP 2106.04(a)(2)(III). Examiner notes that the courts do not distinguish between mental processes that are performed entirely in the human mind and mental processes that require a human to use a physical aid. Nor do the courts distinguish between claims that recite mental processes performed by humans and claims that recite mental processes performed on a computer (see Intellectual Ventures I LLC v. Symantec Corp., 838 F.3d 1307, 1318, 120 USPQ2d 1353, 1360 (Fed. Cir. 2016) (‘‘[W]ith the exception of generic computer-implemented steps, there is nothing in the claims themselves that foreclose them from being performed by a human, mentally or with pen and paper.’’).
Examiner notes that dependent claims 4 and 17-19 include limitations that serve to further limit the abstract ideas addressed above. For example, claims 17, 18 and 19 further limit the abstract idea of “calculating a physiological metric”, while claim 4 further limits the abstract idea of “creating a classification model trained to identify an activity type” by requiring the activity type to be one or more of active, sedentary, and sleeping.
For the reasons above, Examiner asserts that the claims recite a judicial exception, specifically an abstract idea. (Step 2a, Prong 1: Yes).
Step 2A, Prong 2
Independent claims 1, 14 and 20 recite the following additional elements
“receiving user data from a first physiological monitor the user data including at least motion data acquired by the physiological monitor and heart rate data acquired by the physiological monitor;” (insignificant pre solution activity, data gathering)
“displaying a value to the user indicative of the stress score” (insignificant extra solution activity, data output)
“a wearable physiological monitor” (generic computer component, accessory to data gathering)
“a data store” (generic computer component)
“one or more processors” (generic computer component)
“a display device in communication with the one or more processors” (generic computer component, accessory to data output)
Dependent claim 8 recites the following additional element:
“display the stress score on one or more of a wearable device or user device” (claim 8) (insignificant extra solution activity, data output)
The additional elements listed above are examples of insignificant extra solution activity or generic computer components. Specifically, the limitations “receiving used data…” is an example of insignificant extra pre solution activity, more specifically data gathering. Similarly, the limitations “displaying a value to a user” and “display the stress score” are examples of insignificant post solution activity, that is, generic data output. Examiner asserts that the remaining additional elements (“a wearable physiological monitor”, “a data store”, “one or more processors”, “a display device”) fail to provide significantly more because they amount to merely applying the abstract idea using generic computer components. (Step 2A, Prong 2: No).
Step 2B
The claims do not include any additional elements that amount to significantly more than the judicial exception. As discussed above, in Step 2a Prong 2, the additional element amount to no more than applying the abstract idea using generic computer components and insignificant extra solution activity. Moreover, reconsidering the claim limitations individually and as an ordered combination, the claims fail to meet the requirements for eligibility under 35 U.S.C. 101 (Step 2B: No)
Claim Rejections - 35 USC § 103
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.
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, 4, 6-14, and 17-23 rejected under 35 U.S.C. 103 as being unpatentable over Chan (US 2016/0338640), in view of Ahmed et al. (US 2014/0073486).
In re claim 1, Chan discloses a computer program product [0080] comprising computer executable code embodied in a non-transitory computer readable medium that, when executing on one or more computing devices [0080], performs the steps of (FIG. 3):
receiving user data (arrows coming into diamond 302) from a first physiological monitor (Fig. 1: 100) worn by a user [0055], the user data including at least
motion data acquired by the physiological monitor ([0030]: “an accelerometer to record physical activity and posture”) and
heart rate data acquired by the physiological monitor ([0030]: “…electrodes to measure physiological and cardiac activity”);
calculating a heart rate metric (306) for the user based on the heart rate data from the physiological monitor (Fig. 3; [0030]);
generating a probability distribution (318; [0044]) of expected heart rate metrics for the user with a prediction model [0044] based on at least the motion data acquired by the physiological monitor (318; [0042, 0043]: “probability mass function for a given posture”), the prediction model including a machine learning model trained to generate a plurality of heart rate metrics in a distribution expected for the user data based on features of training data for a population of users of a type of physiological monitor corresponding to the physiological monitor worn by the user [0044, 0051, 0043].
generating a classification for an activity of the user ([0039]: “active”, “sit, “stand”) with a classification model (302; [0057]) based on at least the motion data acquired by the physiological monitor [0039, 0057, 0058]; and
calculating a stress score (322) for the user by
calculating an initial stress score (312, 314) based on a quantile of the heart rate metric (314, “FIND CORRECT BIN”) calculated for the user within the probability distribution of the expected heart rate metrics received from the prediction model [0040, 0041, 0044] and
adjusting the initial stress score (320, 322) based on the classification for activity from the classification model ([0042]: stress level computation 322 includes updated PMF for given posture); and
displaying a value to the user indicative of the stress score (Fig. 3: output of 324 “DISPLAY A STRESS LEVEL TO USER”).
Chan does not disclose wherein the heart rate metric is a heart rate reserve ratio
Ahmed discloses an analogous system that receives data from a user wearing a physiological monitor (abstract; FIG. 5: 100). Ahmed additionally discloses using the data to calculate a stress score ([0140]: “intensity score”) that indicates an amount of physiological stress experienced by the user [0048, 0139]. Ahmed further discloses calculating the stress score using the users heart rate reserve ratio [0142].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the heart rate metric taught by Chan to be a heart rate reserve ratio, as taught by Ahmed. One would have been motivated to make this modification because the heart rate metric of Chan and heart rate reserve ratio of Ahmed are functionally equivalent, that is, they both are used to determine an amount of physiological stress experienced by the user. Moreover, one of ordinary skill in the art would have the ability to choose the heart rate metric that would best meet their needs.
In re claim 4, the proposed combination yields (all mapping directed to Chan) wherein the activity type incudes one or more of active (left arrow coming out of 302, “ACTIVE”), sedentary (bottom arrow coming out of 302, “SIT”), and sleeping.
In re claim 6, the proposed combination does not yield
further comprising code that performs the step of providing recommendations to the user based on the stress score.
As discussed above (see paragraph 31), Ahmed discloses an analogous system that uses physiological data to calculate a score that indicates the amount of physiological stress experienced by a user. In addition to displaying the score, Ahmed discloses providing a list of customized recommendations created for a user based on their calculated score [0179, 0180, 0183, 0187].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the proposed combination to further comprise code that performs the step of providing recommendations to the user based on the stress score, as taught by Ahmed. One would have been motivated to make this modification because doing so makes it possible for users without knowledge of stress reduction techniques to take immediate action towards managing their stress.
In re claim 7, the proposed combination yields wherein generating the probability distribution includes generating a set of heart rate reserve ratios corresponding to each of a number of quantiles for the probability distribution (apparent; Examiner notes that quantiles are inherent to a probability distribution, therefore because the proposed combination is capable if “generating” a probability distribution (see above In re claim 1) it would also be capable of “generating”, a set of heart rate reserve ratios corresponding to a number of quantiles.)
In re claim 8, the proposed combination yields (all mapping directed to Chan) further comprising code that performs the step of displaying the stress score on one or more of a wearable monitor [0076] and a user device [0032].
In re claim 9, for substantially the same reasons as described above (In re claim 6), it would have been obvious to one of ordinary skill of the art before the effective filing date of the claimed invention to modify the proposed combination to further comprising code that performs the steps of generating an intervention recommendation for the user based on the stress score, as taught by Ahmed.
In re claim 10, the proposed combination yields (all mapping directed to Chan) wherein the intervention includes a real time recommendation based on at least one of a current stress score and a current activity (see above modification (In re claim 6), Examiner asserts that any recommendation based on the stress score would also be based on a current activity, given that the stress score is calculated, in part, based on a current activity; Fig. 3: 322).
In re claim 11, the proposed combination yields (all mapping directed to Chan) further comprising code that performs the step of identifying a threshold (324, “>th”) for the stress score that is indicative of acute stress ([0043]; abstract: “determining a stress level…to determine the physiological acute stress”) .
In re claim 12, the proposed combination yields (all mapping directed to Chan) further comprising code that preforms the step of at least one of
reporting the acute stress to the user (right arrow coming out of 324 to “present alert”; [0043]: “if yes, an alert is presented to user” ) and
recommending a remediation for the acute stress.
In re claim 13, further comprising code that performs the step of identifying a threshold (324, “>th”) for the stress score that is indicative of autonomic activation ([0043]; abstract: “determining a stress level…to determine the physiological acute stress”).
In re claim 14, see above (In re claim 1).
The proposed combination also yields: a method (abstract, Fig. 3, Figure. 4, Figure. 6).
In re claim 17, the proposed combination yields (all mapping directed to Ahmed) wherein the physiological metric includes a heart rate metric ([0140-0142]: “heart rate reserve”).
In re claim 18, the proposed combination yields (all mapping directed to Ahmed) wherein the physiological metric includes a metric correlated to stress ([0140-0142]: “heart rate reserve”).
In re claim 19, the proposed combination yields (all mapping directed to Ahmed) wherein the physiological metric includes one or more of a heart rate reserve, a heart rate reserve ratio [0140-0142], a heart rate variability, an instantaneous heart rate, an aggregate heart rate, a skin temperature ([0035]: “skin temperature”), a core body temperature, a respiratory rate ([0035]: “breathing rate”), blood pressure and a skin conductance ([0035]: “galvanic skin response”).
In re claim 20, see above (In re claim 1).
The proposed combination also yields (all mapping directed to Chan)
the physiological monitor (602, shown in greater detail in FIG. 1) including
one or more sensors (102) and
a first processor (104) configured to continuously acquire user data [0029] including heart rate data (604) and motion data (606) for a user based on a signal from the one or more sensors (Figure 6);
a datastore (106)
a display device [0032] in communication with the one or more processors (apparent), the display device including a user interface configured to present a value to the user indicative of the stress score [0032].
In re claim 21, see above (In re claim 7).
In re claim 22, for substantially the same reasons as described above (In re claim 6), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the proposed combination to further comprise generating an intervention recommendation for the user based on the stress score, as taught by Ahmed.
In re claim 23, see above (In re claim 7).
Claims 2 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Chan (), in view of Ahmed (US 2014/0073486), in view of Gjoreski et al. (Gjoreski et al. “Monitoring Stress with a Wrist Device Using Context.” Journal of Biomedical Informatics, U.S. National Library of Medicine, Sept. 2017, pubmed.ncbi.nlm.nih.gov/28803947/), in view of Gjoreski II et al. (Gjoreski et al., How Accurately Can Your Wrist Device Recognize Daily Activities and Detect Falls? Sensors (Basel). 2016 Jun 1;16(6):800. doi: 10.3390/s16060800. PMID: 27258282; PMCID: PMC4934226.)
In re claim 2, the proposed combination yields (all mapping directed to Chan) further comprising code that performs the steps of creating the classification model (302) , the classification model trained to identify an activity type (302; [0057])
The proposed combination does not yield the classification model being trained based on a second set of features of the training data for the population of users of the type of physiological monitor.
Gjoreski discloses an analogous system that uses physiological data (Fig. 8: “Bio data” and “Acc. Data”) collected by a wrist worn device (Fig. 8) to detect stress. Gjoreski additionally discloses the system being comprised of several machine learning models including a first model (Fig. 2: “Lab stress detector”) used for stress detection (Fig. 1; pg. 162: “3.3 Machine-learning method for stress detection in constrained environments”) and an activity classification model (Fig. 2: “Activity recognizer”) used to identify an activity type (pg. 166: “4.2.2. Activity recognition classifier”). Gjoreski further discloses categorizing the activity type into one of five categories: lying, sitting, standing, walking, and running/cycling (pg. 166: “4.2.2. Activity recognition classifier”, ¶ 2). Creation of the activity recognition classifier is discussed in greater detail Gjroeski II et al. , a cited reference incorporated into Gjoreski’ s disclosure (pg. 166, “4.2.2. Activity recognition classifier”, ¶ 1). As discussed in Gjoreski II, the activity recognition classifier was trained based on a set of features extracted from training data (pg. 8, 3.13. Classification, ¶ 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the classification model of the proposed combination to be trained based on a second set of features of the training data for the population of users of the type of physiological monitor, as taught by Gjoreski. One would have been motivated to make this modification because doing so would eliminate the need for a user/operator to provide or set a predetermined threshold.
In re claim 15, see above (In re claim 2).
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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLIVIA WALKER whose telephone number is (571)272-7052. The examiner can normally be reached M-F: 7-4pm CT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571)-270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/OLIVIA WALKER/Examiner, Art Unit 3796
/DAVID HAMAOUI/SPE, Art Unit 3796
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