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
Applicant’s arguments, see Remarks, filed 10/22/2025, with respect to the rejection(s) of claim(s) 1-14 under 35 USC 103 have been fully considered and are persuasive. The applicant argues that Sivan as modified by Selvaraj does not disclose a first baseline HRV [] the user is awake, and a second baseline HRV value for when the user is asleep. This argument is fully considered and is persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Sivan and Selvaraj and US 20070260147 A1 to Giftakis et al. See details below.
Since the Giftakis reference was not provided, this office action is being presented as a second non-final rejection to provide the applicant sufficient time to review and respond.
Applicant’s arguments, see Remarks, filed 10/22/2025, with respect to the rejection(s) of claim(s) 1-14 under 35 USC 101 have been fully considered but they are not persuasive. The applicant argues that the claims are similar to that of CardioNet and should be sufficient to overcome the 101 rejection. This argument is fully considered but is not persuasive. CardionNet presented claim limitations including “determine a variability in the beat-to-beat timing”, which prevented the claimed limitations to be performed in mind. The currently presented claimed limitations merely requires limitations which do not require any number of data points or how fast the calculation needs to be performed, and therefore the limitations as presented could be performed in mind. The additional elements (highlighted below in detail) when considered both individually and as an ordered combination do not amount to significantly more than the abstract idea.
On page 9, the applicant argues the movements of obtaining more reliable and immediate treatment. These arguments are fully considered but are not persuasive. In order to have a technological improvement, the additional elements need to be improved. Here, the improvements are in the abstract idea.
For at least the reasons stated, the 101 rejection is maintained.
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 1-14 are rejected under 35 U.S.C. 101 because of the following analysis:
1 – statutory category: Claims 1-12 recite a series of steps and therefore, falls under the statutory category of being a process. See MPEP 2106.03. Claim 13-14 recites an apparatus and non-transitory computer-readable medium, and therefore, falls under the statutory category of being a thing or products. See MPEP 2106.03.
2A – Prong 1: The independent claims 1, 13 and 14 recite a judicial exception by reciting the limitations of “determining a first set of HRV values of the user during periods of the time interval that the user is awake, and a second set of HRV values of the user during periods of the time interval that the user is asleep”, “determining a cumulative stress level of the user throughout the time interval based at least in part on a first comparison of the first set of HRV values with the first baseline HRV value, and a second comparison of the second set of HRV values with the second baseline HRV value”, etc.. These limitations, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in mind or by a person using a pen and paper. Therefore, an abstract idea is involved.
2A – Prong 2: The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements when considered both individually and as an ordered combination do not amount to significantly more than the abstract idea. The independent claims 1, 13 and 14 recite the additional limitations of “a wearable device”, “user device”, “GUI”, etc. The mentioned limitations are recited at a high level of generality and are considered to be data gathering/processing which are mere extra-solution activity. The elements amount to mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea (see MPEP 2106.04(d) and 2106.05(f)). Accordingly, each of the additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limitations on practicing the abstract idea.
2B: The emphasized elements cited above do not amount to significantly more than the judicial exception because these limitations are simply appending well-understood, routine and conventional activities previously known in 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 in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’I, 110 USPQ2d 1976 (2014)).
In view of the above, the additional elements individually do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process. 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)).
Claims 2-12 depend on claim 1. The mentioned dependent claims recite the same abstract idea as the independent claims. Furthermore, these claims only contain recitations that further limit the abstract idea (that is, the claims only recite limitations that further limit the mental process). For example, the dependent claim recites the limitations “score”, “visual representation”, “instructions”, “wearable ring”, etc., are recited at a high level of generality and are mere extra-solution activity, and outputting the results of an abstract idea. The elements amount to mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea (see MPEP 2106.04(d) and 2106.05(f)).
The additional elements individually do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Thus, claims 1-14 are directed to an abstract idea and are therefore rejected.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claim(s) 1, 3, 8-9, 11-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Pat Pub No. 20180310867 to Sivan et al. in view of US 10582862 B1 to Selvaraj and US20070260147A1 to Giftakis et al. (“Giftakis”).
Regarding claims 1, 13 and 14. Sivan discloses a method for measuring cumulative stress of a user over time (para 0072 “stress monitoring process”), comprising: acquiring baseline physiological data from the user via a wearable device (para 0073 “obtain information [] user wearing the wireless wearable electronic device”); determining a baseline stress level associated with the user based at least in part on the baseline physiological data, one or more user inputs received via a user device, or both (para 0075 “threshold [] dynamic user-specific threshold (e.g. calculated based on previous stress scores calculated for the specific user)”) determining a cumulative stress level of the user throughout the time interval (para 0074 “calculate a stress score”) based at least in part on comparison of the HRV values with the baseline HRV value (para 0074-0075, see fig 3), wherein the cumulative stress level is based at least in part on the baseline stress level (para 0074 “calculate a stress score”), and wherein the cumulative stress level is associated with a total amount of stress the user experienced throughout the time interval, a trend in a stress level of the user throughout the time interval, or both (para 0074 “calculate a stress score” – it is understood that the stress score is the stress the user has experienced throughout the time interval being monitored); and displaying, to the user via a graphical user interface (GUI) of the user device, a visual representation of the cumulative stress level (para 0077 “present stress score”).
but fails to disclose determining, based at least in part on the physiological data, a first heart rate variability (HRV) value of the user during periods that the user is awake, and a second HRV value of the user during periods that the user is asleep; acquiring additional physiological data from the user via the wearable device throughout a time interval that spans a plurality of days and a plurality of nights; determining, based at least in part on the additional physiological data, a first set of HRV values of the user during periods of the time interval that the user is awake, and a second set of HRV values of the user during periods of the time interval that the user is asleep.
Selvaraj, from a similar field of endeavor teaches determining HRV over a 24 hour period, over night and over day to assess cardiovascular health risk and stress (Col 7, ln 15-50) to more accurately measure HRV since the magnitude and variability of the BHR is distinctively different during the day and night conditions (Col 6, lines 65-67). It would have been obvious before the filing date of the claimed invention to modify the disclosure of Siven with the teachings of Selvaraj to provide the predictable result of increasing accuracy.
Sivan as modified by Selvaraj renders obvious the limitations above obvious but fails to disclose a first baseline HRV [] the user is awake, and a second baseline HRV value for when the user is asleep.
Giftakis, from a similar filed of endeavor teaches that it is known to determine the baseline measure of HRV may be separately for different parts of a patient's circadian cycle. For example, the adjusted baseline measure of HRV could be broken out into separate measures of HRV, such as a night-time baseline HRV (e.g., using only cardiac signal information acquired during periods of known or expected sleep), or a day-time baseline HRV, and each of these could be calculated based on varying periods of time (e.g., hourly, daily, weekly, monthly, etc.) (para 0230). It would have been obvious before the filing date of the claimed invention to modify the disclosure of Siven as modified by Selvaraj with the known teachings of Giftakis to provide the predictable result of determining the baseline measure of HRV separately for different parts of a patient's circadian cycle to improve accuracy.
Regarding claim 3. Sivan as modified by Selvaraj and Giftakis renders obvious the method of claim 1, further comprising: determining the baseline stress level associated with the user based at least in part on the baseline physiological data, wherein the baseline physiological data comprises heart rate data, respiratory rate data, skin temperature data, or any combination thereof, and wherein determining the cumulative stress level is based at least in part on the baseline stress level (Sivan para 0061, 0075; Selvaraj Col 7, ln 15-50).
Regarding claim 8. Sivan as modified by Selvaraj and Giftakis renders obvious the method of claim 1, wherein the visual representation indicates a relative change between a baseline stress level associated with the user and the cumulative stress level (Sivan para 0077 “present stress score”).
Regarding claim 9. Sivan as modified by Selvaraj and Giftakis renders obvious the method of claim 1, further comprising: classifying a plurality of periods within time interval that the user is either awake or asleep as one of a stressful period, a recovery period, or a neutral period based at least in part on the comparison of the first set of HRV values with the first baseline HRV value and the comparison of the second set of HRV values with the second baseline HRV value, wherein determining the cumulative stress level is based at least in part on the classifying (see rejection of claim 1; As written, the claim does not provide any details on whether the cumulative stress level is being drawn based on the result of the classified periods. As such, under its BRI, the mentioned classification is merely labeling the periods which does not change the result of the classification).
Regarding claim 11. Sivan as modified by Selvaraj and Giftakis renders obvious the method of claim 1, wherein the baseline physiological data is acquired throughout a second time interval prior to the time interval, the second time interval comprising a second plurality of days and a second plurality of nights (Selvaraj, fig. 4).
Regarding claim 12. Sivan as modified by Selvaraj and Giftakis renders obvious the method of claim 1, wherein the wearable device comprises a wearable ring device (Sivan, para 0046 “worn on user’s finger”)
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sivan as modified by Selvaraj and Giftakis as applied to claims 1, 3, 8-9, 11-14 above, and further in view of US Pat Pub. No. 20160027324 to Wisbey et al. (hereinafter “Wisbey”).
Regarding claim 2. Sivan as modified by Selvaraj and Giftakis renders obvious the method of claim 1, further comprising: determining one or more stress scores associated with the user throughout periods of the time interval that the user is awake based at least in part on the first comparison of the first set of HRV values with the first baseline HRV value (see rejection of claim 1); and determining one or more recovery scores associated with the user throughout periods of the time interval that the user is asleep based at least in part on the second comparison of the second set of HRV values with the second baseline HRV value, wherein the cumulative stress level is based at least in part on the one or more stress scores and the one or more recovery scores.
Wisbey, from a similar field of endeavor, teaches using the HRV to calculate a recovery score which indicates the users physical condition and aptitude for further physical activity for the current day (para 0043). It would have been obvious before the filing date of the claimed invention to modify the disclosure of Sivan as modified by Selvaraj and Giftakis with the teachings of Wisbey to provide the predictable result of calculating the recovery score.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sivan as modified by Selvaraj and Giftakis as applied to claims 1, 3, 8-9, 11-14 above, and further in view of US Pat Pub. No. 20230114135 to Wiggermann et al. (hereinafter “Wiggermann”).
Regarding claim 4. Sivan as modified by Selvaraj and Giftakis renders obvious the method of claim 3, but fails to disclose further comprising: predicting a burnout condition of the user, a chronic stress condition of the user, or both, based at least in part on a comparison between the cumulative stress level and the baseline stress level associated with the user; and causing the GUI of the user device to display an alert associated with the burnout condition, the chronic stress condition, or both.
Wiggermann, from a similar field of endeavor, teaches the HRV to be used to calculate burnout (para 0090). It would have been obvious before the filing date of the claimed invention to modify the disclosure of Sivan as modified by Selvaraj and Giftakis with the teachings of Wiggermann to provide the predictable result of calculating burnout conditions using the gathered HRV.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sivan as modified by Selvaraj and Giftakis as applied to claims 1, 3, 8-9, 11-14 above, and further in view of US Pat Pub. No. 20150238140 to LaBelle et al. (hereinafter “LaBelle”)
Regarding claim 5. Sivan as modified by Selvaraj and Giftakis renders obvious the method of claim 3, but fails to disclose further comprising: receiving, from the user device, the one or more user inputs comprising one or more characteristics associated with the user, wherein determining the baseline stress level is based at least in part on the user input.
LaBelle, from a similar field of endeavor, teaches that it is known to use input from the subject regarding his or her personal statistics such as age, height, and weight to provide individualized and more accurate data analysis (para 0014). It would have been obvious before the filing date of the claimed invention to modify the disclosure of Sivan as modified by Selvaraj and Giftakis with the teachings of LaBelle to provide the predictable result of individualizing and generating more accurate data analysis.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sivan as modified by Selvaraj, Giftakis and LaBelle as applied to claims 1, 3, 8-9, 11-14 above, and further in view of US Pat Pub. No. 20150305675 to Warner et al. (hereinafter “Warner”).
Regarding claim 6. Sivan as modified by Selvaraj, Giftakis and LaBelle renders obvious the method of claim 5, but fails to disclose further comprising: acquiring additional baseline physiological data associated with a plurality of users associated with a set of characteristics that are common between the plurality of users and the user; and determining a plurality of baseline stress levels associated with the plurality of users, wherein determining the baseline stress level associated with the user is based at least in part on determining the plurality of baseline stress levels and a comparison between the baseline physiological data associated with the user and the additional baseline physiological data associated with the plurality of users.
Warner, from a similar field of endeavor, teaches wearable stress-testing device can compare measurement data of a user of the wearable stress-testing device to the control group to determine a difference between the data of the control group and the data of the individual (para 0100). It would have been obvious before the filing date of the claimed invention to modify the disclosure of Sivan as modified by Selvaraj, Giftakis and LaBelle with the teachings of Warner to provide the predictable result of comparing the results to others to ensure accuracy.
Claim(s) 7 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sivan as modified by Selvaraj and Giftakis as applied to claims 1, 3, 8-9, 11-14 above, and further in view of US Pat Pub. No. 20170132946 to Kinnunen et al. (hereinafter “Kinnunen”).
Regarding claim 7. Sivan as modified by Selvaraj and Giftakis renders obvious the method of claim 1, receiving, from the wearable device and based at least in part on providing the instructions to the user, a plurality of physiological measurements associated with the one or more behaviors; and determining the baseline stress level associated with the user based at least in part on comparing the plurality of physiological measurements with the baseline physiological data, wherein determining the cumulative stress level is based at least in part on determining the baseline stress level (see rejection of claim 1), but fails to disclose wherein acquiring the baseline physiological data further comprises: providing, to the user via the GUI of the user device, instructions for the user to modify one or more behaviors associated with a target stress level of the user.
Kinnunen, from a similar field of endeavor, teaches providing appropriate feedback and instruction (or guidance) that may help the individual to efficiently recover from physical and mental load (or stress) to improve his or her performance level (para 0004, 0006-0007, etc.). It would have been obvious before the filing date of the claimed invention to modify the disclosure of Sivan as modified by Selvaraj and Giftakis with the teachings of Kinnunen to provide the predictable result of reducing stress and improving performance level.
Regarding claim 10. Sivan as modified by Selvaraj and Giftakis renders obvious the method of claim 1, but fails to disclose further comprising: providing, via the GUI of the user device, feedback to the user comprising instructions for modifying one or more behaviors of the user, the one or more behaviors configured to modify the cumulative stress level of the user.
Kinnunen, from a similar field of endeavor, teaches providing appropriate feedback and instruction (or guidance) that may help the individual to efficiently recover from physical and mental load (or stress) to improve his or her performance level (para 0004, 0006-0007, etc.). It would have been obvious before the filing date of the claimed invention to modify the disclosure of Sivan as modified by Selvaraj and Giftakis with the teachings of Kinnunen to provide the predictable result of reducing stress and improving performance level.
Conclusion
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/SANA SAHAND/Examiner, Art Unit 3796