DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/3/25 has been entered.
Status of Claims
Claims 1-19 and 21 are rejected. Claim 20 is canceled.
Response to Arguments
Claim Rejections - 35 USC § 101
Applicant's arguments filed 12/3/25 have been fully considered but they are not persuasive.
Applicant asserts that the amended claims require specific physiological sensing hardware that is neither generic nor capable of being substituted with mental steps. However, the Examiner disagrees. While the specific physiological sensing hardware is not a mental step, these components are not integrated into a practical application. For the method claims, sensing step is not positively recited. Further, the inward facing sensor the wearable device amounts to pre-solution activity of data gathering. The non-transitory computer readable medium and processor are recited at a high-level of generality and amount to nothing more than parts of a generic computer.
Applicant asserts that the operations cannot be carried out mentally e.g., real-time. However, the claims do not recite these steps being performed in real-time or continuously. Even if the claims did recite this, MPEP 2106.05(f) states:
Similarly, "claiming the improved speed or efficiency inherent with applying the abstract idea on a computer" does not integrate a judicial exception into a practical application or provide an inventive concept. Intellectual Ventures I LLC v. Capital One Bank (USA), 792 F.3d 1363, 1367, 115 USPQ2d 1636, 1639 (Fed. Cir. 2015).
Applicant asserts that the steps including bathyphase detection, CR-oscillator computation, heart-rate-based sleep-state determination, sleep-recovery updating, or fatigue-value calculation cannot be performed mentally. However, the Examiner disagrees. With the current breadth of the claims, the steps amounting to the mental process can be performed using pen and paper.
Applicant asserts that the alert is not a generic notification or mental judgement. However, the Examiner disagrees. The alert is nothing more than a medical professional verbally communicating to a patient the duration of recovery based on a previously determined fatigue value and a recommendation to rest, which amounts to nothing more than organizing human activity of "managing personal behavior or relationships or interactions between people" (see MPEP 2106.04(a)(2)(II)).
Applicant further asserts that the sensor-driven determination reflects improved technical functionality of the wearable device in processing physiological signals to support real-time risk mitigation. However, the Examiner disagrees. First, as stated above, claims do not recite these steps being performed in real-time. Further, the sensor-driven determinations amount to the abstract idea and an improvement to the abstract idea is still an abstract idea. MPEP 2106.05(f) states:
Claims that amount to nothing more than an instruction to apply the abstract idea using a generic computer do not render an abstract idea eligible. Alice Corp., 573 U.S. at 223, 110 USPQ2d at 1983.
Applicant asserts that the invention improves the functionality of a wearable device. However, the Examiner disagrees. The sensor-driven determinations amount to the abstract idea and an improvement to the abstract idea is still an abstract idea.
Applicant additionally asserts that this case parallels CardioNet, LLC v. InfoBionic, Inc., 955 F.3d 1358, 1371 (Fed. Cir. 2020), where the court found the claims directed to improved cardiac monitoring using a specific algorithm for detecting atrial fibrillation were not abstract because they recited a technically improved physiological monitoring device. However, each case turns on its own facts. CardioNet is directed towards detecting atrial fibrillation, while the instant application is directed towards detecting fatigue.
Applicant asserts that the combination of features-including deriving bathyphase time from physiological sensor data, constructing an individualized circadian-rhythm oscillator, determining sleep state from heart-rate signals, updating a fatigue value based on sleep recovery, sleep inertia, and activity-based heart-rate factors, and generating an alert containing a sensor-driven recovery-duration output tied to ongoing physical activity amounts to a non-conventional arrangement of elements not previously available in wearable devices. However, the Examiner disagrees. Only the processor, non-transitory computer readable medium, and inward facing sensor of the wearable device were indicated as being additional elements. The inward facing sensor the wearable device amounts to pre-solution activity of data gathering. The non-transitory computer readable medium and processor are recited at a high-level of generality and amount to nothing more than parts of a generic computer. As stated in the rejection below, an inward facing sensor of the wearable device is well-understood, routine, and conventional activity as evidenced by US 20180206749 (¶45-a conventional wearable heart rate detector), US 20220096007 (¶115-conventional wearable PPG heart rate monitors), and US 20080132798 (¶2-conventional heart rate monitors employ sensors that are worn without a chest strap. The remaining limitations as indicated by Applicant are directed to the abstract idea and are not additional elements.
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 1-19 and 21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, specifically an abstract idea without significantly more.
Step 1
The claimed invention in claims 1-19 and 21 are directed to statutory subject matter as the claims recite a method, a device, and for fatigue evaluation based on sleep quality and physical activity.
Step 2A, Prong One
Regarding claims 1, 9, and 17, the recited steps are directed to mathematical concepts, certain methods of organizing human activity, and a mental process of performing concepts in a human mind or by a human using a pen and paper (see MPEP 2106.04(a)(2) subsections (I), (II), and (III)).
Regarding claims 1, 9, and 17, the limitations of “wherein a bathyphase time indicative of time-of-day of a minimum value of body temperature of the person is determined from the physiological data, and the physiological data comprises heart rate data of the person; determining…a circadian rhythm (CR) oscillator for a person based at least in part on a bathyphase time; and determining a fatigue value for the person based on the CR oscillator” are mathematical calculations of addition, subtraction, multiplication, and division (see Fig. 4; [0060]-[0061] and [0083]-[0084] of the instant specification) for fatigue assessment.
Regarding claims 1, 9, and 17, the limitation of “generating an alert, the alert comprising the duration of recovery determined based on the fatigue value, and a recommendation to the person to rest for the duration of recovery so as to decrease the fatigue value below the threshold prior to performing the activity or continuing with the activity” is a process, as drafted, covers performance of the limitation that are directed to organizing human activity (managing personal behavior or relationships or interactions between people including social activities, teaching, and following rules or instructions, see MPEP 2106.04(a)(2)(II)). For example, this limitation is nothing more than a medical professional verbally communicating to a patient the duration of recovery based on a previously determined fatigue value and a recommendation to rest.
Regarding claims 1, 9, and 17, the limitations of “wherein a bathyphase time indicative of time-of-day of a minimum value of body temperature of the person is determined from the physiological data, and the physiological data comprises heart rate data of the person; determining a fatigue value for the person based on the CR oscillator; determining whether the person is in sleep or not based on the physiological data, wherein whether the person is in sleep or not is determined at least in part from the heart rate data of the person; in response to determining that the person is in sleep, updating the fatigue value for the person based on a sleep recovery, wherein the sleep recovery is determined based on the CR oscillator and at least one first sleep parameter determined from the physiological data; in response to determining that the person is currently performing or about to perform an activity and that the fatigue value for the person is above a threshold, and determining, by the processor, a duration of recovery based on the fatigue value” is a process, as drafted, covers performance of the limitation that can be performed by a human mind (including an observation, evaluation, judgment, opinion) under the broadest reasonable standard. For example, these limitations are nothing more than a medical professional receiving a print out of body temperature data and getting the minimum value from that, analyzing the CR oscillator to determine a fatigue value, analyzing heart rate data to determine if a person is in sleep or not, if the person is in sleep updating a fatigue value, analyzing sleep recovery, evaluating data and a simple threshold comparison to further determine a duration of recovery.
Step 2A, Prong Two
For claims 1, 9, and 17, the judicial exception is not integrated into a practical application. In particular, claims 1, 9, and 17 recite “an inward facing sensor of the wearable device, a processor, and a non-transitory computer readable medium.” The inward facing sensor the wearable device amounts to pre-solution activity of data gathering. The non-transitory computer readable medium and processor are recited at a high-level of generality and amount to nothing more than parts of a generic computer. Merely including instructions to implement an abstract idea on a computer does not integrate a judicial exception into practical application.
Step 2B
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into
a practical application, the additional element of an inward facing sensor of the wearable device amounts to pre-solution activity of data gathering, which does not amount to an inventive concept. Moreover, an inward facing sensor of the wearable device is well-understood, routine, and conventional activity as evidenced by US 20180206749 (¶45-a conventional wearable heart rate detector), US 20220096007 (¶115-conventional wearable PPG heart rate monitors), and US 20080132798 (¶2-conventional heart rate monitors employ sensors that are worn without a chest strap. For example, some conventional heart rate monitors are incorporated into a band, watch, or other device worn on a user's wrist). Further, simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry, as discussed in Alice Corp., 573 U.S. at 225, 110 USPQ2d at 1984 (see MPEP § 2106.05(d)). In this case, elements of general computer are being used to implement the abstract idea.
Regarding dependent claims 2-8, 10-16, 18-19, and 21, the limitations of claims 1, 9, and 17 further define the limitations already indicated as being directed to the abstract idea.
Regarding claims 2, 10, and 18, the limitations of “in response to determining that the person is in sleep, accumulate, in a first time range indicative of the sleep, a total sleep inertia for the person based on at least one second sleep parameter obtained from the physiological data, and adjust the fatigue value based on the total sleep inertia; or in response to determining that the person is not in sleep, update the total sleep inertia for the person based on a second time range indicative of wakefulness” are a process, as drafted, covers performance of the limitation that can be performed by a human mind (including an observation, evaluation, judgment, opinion) under the broadest reasonable standard. For example, these limitations are nothing more than a medical professional analyzing a print out of data to determine the person is asleep or not. If the person is asleep, determining a total sleep inertia based on a second sleep parameter and adjusting the fatigue value based on the total sleep inertia. If the person is not asleep, updating the total sleep inertia based on a second time range to indicate wakefulness.
Regarding claims 3 and 11, the limitations of “determining the fatigue value for the person further comprises: in response to determining that the person is not in sleep, accumulating the fatigue value by a base physical fatigue factor, wherein the base physical fatigue factor is based on the heart rate data of the person; or in response to determining that the person is not in sleep, determining the fatigue value based on a total sleep inertia for the person determined from the physiological data” are a process, as drafted, covers performance of the limitation that can be performed by a human mind (including an observation, evaluation, judgment, opinion) under the broadest reasonable standard. For example, these limitations are nothing more than a medical professional analyzing a print out of data to determine is asleep or not. If the person is not asleep, accumulating the fatigue value by a base physical fatigue factor, wherein the base physical fatigue factor is based on the heart rate data of the person or determining the fatigue value based on a total sleep inertia for the person determined from the physiological data.
Regarding claims 4 and 12, the limitation of “determining the base physical fatigue factor based on a determination that the person is performing a physical exercise from the physiological data” is a process, as drafted, covers performance of the limitation that can be performed by a human mind (including an observation, evaluation, judgment, opinion) under the broadest reasonable standard. For example, these limitations are nothing more than a medical professional analyzing physiological data to determine the person is performing a physical exercise and determining the base physical fatigue factor from that.
Regarding claims 5, 13, and 19, the limitations of “determine a recovery debt for the person based on a previous fatigue value and a previous individual awakening period from a previous day from the physiological data, wherein the sleep recovery for the person is determined based on the recovery debt and the CR oscillator” are a process, as drafted, covers performance of the limitation that can be performed by a human mind (including an observation, evaluation, judgment, opinion) under the broadest reasonable standard. For example, these limitations are nothing more than a medical professional analyzing a print out of previous data including a previous fatigue value and a previous individual awakening period to determine a recovery debt for the person and wherein the sleep recovery for the person is determined based on the recovery debt and the CR oscillator.
Regarding claims 6 and 14, the limitations of “determining a total sleep recovery based on an accumulation of the sleep recovery during the sleep; and determining an adjusted total sleep recovery for the person based on a sleep quality of the person and the total sleep recovery, wherein the fatigue value is updated based on the adjusted total sleep recovery” are a process, as drafted, covers performance of the limitation that can be performed by a human mind (including an observation, evaluation, judgment, opinion) under the broadest reasonable standard. For example, these limitations are nothing more than a medical professional analyzing a print out of physiological data to determine a total sleep recovery and determining an adjusted total sleep recovery for the person based on a sleep quality of the person and the total sleep recovery, wherein the fatigue value is updated based on the adjusted total sleep recovery.
Regarding claims 7 and 15, the limitation of “the sleep quality is determined based on at least one of a number of awakenings during sleep or excess heart rate during the sleep from the physiological data” is a process, as drafted, covers performance of the limitation that can be performed by a human mind (including an observation, evaluation, judgment, opinion) under the broadest reasonable standard. For example, these limitations are nothing more than a medical professional analyzing a print out of physiological data and determining the sleep quality based on excess heart rate during the sleep.
Regarding claims 8 and 16, the limitations of “determining an individual sleep need for the person based on at least one of characteristics information or the physiological data of the person; and in response to a determination that a sleep time duration is greater than the individual sleep need for the person, updating the fatigue value for the person based on the sleep time duration” are a process, as drafted, covers performance of the limitation that can be performed by a human mind (including an observation, evaluation, judgment, opinion) under the broadest reasonable standard. For example, these limitations are nothing more than a medical professional analyzing a print out of physiological data of a person to determine an individual sleep need and in response to a determination that a sleep time duration is greater than the individual sleep need for the person, updating the fatigue value for the person based on the sleep time duration.
Regarding claims 10 and 18, the limitations of “in response to determining that the person is in sleep, accumulate, in a first time range indicative of the sleep, a total sleep inertia for the person based on at least one second sleep parameter obtained from the physiological data, and adjust the fatigue value based on the total sleep inertia; or in response to determining that the person is not in sleep, update the total sleep inertia for the person based on a second time range indicative of wakefulness” are a process, as drafted, covers performance of the limitation that can be performed by a human mind (including an observation, evaluation, judgment, opinion) under the broadest reasonable standard. For example, these limitations are nothing more than a medical professional analyzing a print out data to determine the person is asleep or not. If the person is asleep, determining a total sleep inertia based on a first time range of the data and adjusting the fatigue value based on the total sleep inertia. If the person is not asleep, updating the total sleep inertia based on a second time range to indicate wakefulness.
Regarding, claim 21, the limitations of “determining…an initial bathyphase time for the person; and adjusting…the initial bathyphase time based on historical heart rate data of the person to obtain adjusted bathyphase time, wherein the CR oscillator is determined based on at least one of the adjusted bathyphase time or a difference between the initial bathyphase time and the adjusted bathyphase time, and the CR oscillator for the person is determined based at least in part on the adjusted bathyphase time” are a process, as drafted, covers performance of the limitation that can be performed by a human mind (including an observation, evaluation, judgment, opinion) under the broadest reasonable standard. For example, these limitations are nothing more than a medical professional analyzing a print out of a person’s data to determine an initial bathyphase time, adjusting the time based on a print out of heart rate data, subtracting the initial bathyphase time and the adjusted bathyphase time for the CR oscillator.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA HODGE whose telephone number is (571) 272-7101. The examiner can normally be reached M-F: 8:00 am-5:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, UNSU JUNG can be reached at (571) 272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/L.N.H./Examiner, Art Unit 3792
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792