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
Applicant's arguments filed 09/11/2025 have been fully considered but they are not persuasive.
Regarding the rejection of Claims 1-5, 7-18, and 25-27 under 35 U.S.C. § 101, the applicant has argued “the claims recite numerous steps that either cannot be performed by a human (e.g., "continuously monitoring heart rate activity of the user with the physiological monitoring device by opto-electronically acquiring continuous physiological data for the user using photoplethysmography at a resolution sufficient to determine RR intervals and peaks within the heart rate activity"), or that are explicitly not performed by a human (e.g., "receiving geographic data including GeoPositioning System (GPS) data from a device different than the physiological monitoring device and associated with the user during the one of the cycles"), or both. The claims also recite this integration of sensor data from multiple sources (e.g., PPG signals sampled at a rate sufficient to detect heart rate intervals, and processing over long intervals to detect sleep cycles), at an operational scale well beyond human capabilities”. However, these claim limitations can be considered as part of an insignificant extra-solution activity to the judicial exception, e.g. a mere data gathering step.
The Applicant has also argued the steps of the claim are integrated into a highly specific and highly practical application, including achieving higher accuracy. The Applicant cites CardioNet, LLC v. InfoBionic, Inc., 955 F.3d 1358 (Fed. Cir. 2020) as a particularly applicable case which shows higher accuracy in a method can impart eligibility. However, in CardioNet, the written description’s evidence of higher accuracy is a quantitative study wherein the device was used to analyze the MIT-BIH arrhythmia database inCambridge, Massachusetts, and "a sensitivity to [these two arrhythmias] in excess of 90% and a positive predictivity in excess of 96% were obtained." Id. at col. 3 ll. 21-26. The written description of the instant applicant is missing such quantitative proof of higher accuracy.
The Applicant also relied on CardioNet to assert the claims do not recite pre-existing techniques and can be not considered routine nor conventional. However, “The novelty of any element or steps in a process, or even of the process itself, is of no relevance in determining whether the subject matter of a claim falls within the § 101 categories of possibly patentable subject matter.” See Diamond v. Diehr, 450 U.S. 175, 188-89, 101 S.Ct. 1048, 67 L.Ed.2d 155 (1981). The applicant has also argued “Additionally, by explicitly reciting the derivation of a physiological metric from the novel cycle mapping, the claim ties the metric itself to a concrete technical process and outcome. This follows USPTO Example 46 (Livestock Management) where claims that applied data gathering to automatically control a real-world process were found eligible in claims that recited an output device (a feed dispenser)”. However, unlike Example 46, the present claims do not recite a concrete output such as adjusting a feed dispenser—the ultimate outcome of Claim 1 is the presenting of an informational metric that solve an informational problem (the correction of misalignment of physiological data due to time zone shifts). No improved treatment regimen or optimized machine operation, such as in the USPTO’s October 2019 PEG Examples 43 and 45, are presented. The correct alignment of physiological data due to time-zone shifts to create meaningful fitness metrics is an abstract idea.
For these reasons, the rejection under 35 U.S.C. § 101 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 1-5, 7-18 and 25-27 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 claim 1 follows.
Regarding Claim 1, the claim recites a computer program product for managing physiological data comprising computer executable code embodied in a non-transitory computer readable medium. Thus, the claim is directed to an apparatus, which is one of the statutory categories of invention (Step 1).
The claim is then analyzed to determine whether it is directed to any judicial exception (Step 2A, Prong One). The following limitations set forth a judicial exception:
detecting sleep events for the user based on patterns in the continuous physiological data and the motion data acquired from the user indicative of sleep
segmenting the continuous physiological data into cycles demarcated by significant sleep events programmatically detected in the physiological data that indicate transitions between daily physiological cycles of sleep and waking
wherein detecting significant sleep events includes automatically generating, with the processor, a predicted end of one of the cycles after a first sleep event in the sleep events and automatically categorizing…a second sleep event in the sleep events as a significant sleep event if the second sleep event has an interval timewise intersecting with the predicted end of the one of the cycles…
storing the predicted end of the one of the cycles…
detecting a time zone change of a number of hours based on the geographic data
in response to detecting the time zone change, adjusting the predicted end of the one of the cycles by subtracting the number of hours when the time zone change indicates a westward movement of the physiological monitoring device and adjusting the predicted end of the one of the cycles by adding the number of hours when the time zone change indicates an eastward movement of the physiological monitoring device…
allocating the cycles to calendar days…using a function that allocates each calendar day to exactly one of the cycles containing data acquired during that calendar day without requiring that each one of the cycles be allocated to exactly one calendar day, thereby providing a cycle allocation with not more than one cycle per day
storing the cycle allocation as a day mapping data structure…
evaluating a metric related to at least one of sleep, recover, and day strain for the user for a calendar day based on the day mapping data structure and presenting, to the user, the metric related to at least one of sleep, recovery, or day strain for the calendar day
These limitations describe a mathematical calculation and/or a mental process as the skilled artisan is capable of performing the recited limitations and making a mental assessment thereafter. Examiner also notes that nothing from the claims suggest that the limitations cannot be practically performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps in real time. Examiner also notes that nothing from the claims suggests an undue level of complexity that the mathematical calculations and/or the mental process steps cannot be practically performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps.
For example:
A human is capable of manually/mentally detecting sleep events for the user based on patterns in the continuous physiological data and the motion data acquired from the user indicative of sleep.
“segmenting the continuous physiological data into cycles demarcated by significant sleep events programmatically detected in the physiological data that indicate transitions between daily physiological cycles of sleep and waking, wherein detecting significant sleep events includes automatically generating, with the processor, a predicted end of one of the cycles after a first sleep event in the sleep events and automatically categorizing…a second sleep event in the sleep events as a significant sleep event if the second sleep event has an interval timewise intersecting with the predicted end of the one of the cycles” is a mental process that can be performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps in real time.
A human is capable of manually/mentally storing the predicted end of the one of the cycles, e.g. by rote memorization or using pen and paper.
A human is capable of manually/mentally evaluating a metric related to at least one of sleep, recover, and day strain for the user for a calendar day based on the day mapping data structure and presenting, to the user, the metric related to at least one of sleep, recovery, or day strain for the calendar day, e.g. by using a generic computer as a tool to perform mathematical calculations and/or mental process steps in real time or using pen and paper.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, integrates the identified judicial exception into a practical application (Step 2A, Prong Two).
The following limitations amount to insignificant extra-solution activity to the judicial exception, e.g. mere data gathering. See MPEP 2106.05(g).
continuously monitoring a user by opto-electronically acquiring continuous physiological data for the user with a physiological monitoring device at a rate sufficient to detect beat-to-beat variations in heart rate, and by acquiring motion data from one or more accelerometers of the physiological monitoring device
storing the continuous physiological data including photoplethysmography data from one or more sensors of the physiological monitoring device and the motion data… wherein the continuous physiological data spans an interval of at least twenty-four hours, and wherein the continuous physiological data is stored with sufficient resolution to enable detection of heart beats and heart rate variability from the continuous physiological data within the interval
receiving geographic data including GeoPositioning System (GPS) data from a device different than the physiological monitoring device and associated with the user during the one of the cycles
The following limitations amount to a recitation of the words "apply it" (or an equivalent)and/or nothing more than mere instructions to implement the abstract idea on a generic computer. See MPEP 2106.05(f).
A computer program product for managing physiological data comprising computer executable code embodied in a non-transitory computer readable medium that, when executing on one or more computing devices, performs the steps of…
storing the continuous physiological data including photoplethysmography data from one or more sensors of the physiological monitoring device and the motion data in a non-transitory memory device
using a processor…
with a cycle-determining algorithm executing on the processor…
programmatically detected…
with the processor…
Therefore, these additional limitations do not integrate the judicial exception into a practical application.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, amounts to significantly more than the identified judicial exception (Step 2B):
The following limitations do not amount to significantly more than the abstract idea for substantially similar reasons applied in Step 2A, Prong Two.
continuously monitoring a user by opto-electronically acquiring continuous physiological data for the user with a physiological monitoring device at a rate sufficient to detect beat-to-beat variations in heart rate, and by acquiring motion data from one or more accelerometers of the physiological monitoring device
storing the continuous physiological data including photoplethysmography data from one or more sensors of the physiological monitoring device and the motion data… wherein the continuous physiological data spans an interval of at least twenty-four hours, and wherein the continuous physiological data is stored with sufficient resolution to enable detection of heart beats and heart rate variability from the continuous physiological data within the interval
receiving geographic data including GeoPositioning System (GPS) data from a device different than the physiological monitoring device and associated with the user during the one of the cycles
A computer program product for managing physiological data comprising computer executable code embodied in a non-transitory computer readable medium that, when executing on one or more computing devices, performs the steps of…
storing the continuous physiological data including photoplethysmography data from one or more sensors of the physiological monitoring device and the motion data in a non-transitory memory device
using a processor…
with a cycle-determining algorithm executing on the processor…
programmatically detected…
with the processor…
The following limitations is/are considered to be well-understood, routine, and conventional (WURC).
The processor, memory, physiological monitoring device, and computer program product are considered to be well-understood, routine, and conventional based on statement(s) from the applicant's specification filed 12/17/2020: See [0023], [0028]-[0029], and [00131].
The accelerometer is considered to be well-understood, routine, and conventional based on statement(s) from the applicant's specification filed 12/17/2020: See [0020] and [0026]; an accelerometer, under broadest reasonable interpretation, is a commercially available product.
Independent Claim 3 is also not patent eligible for substantially similar reasons.
Dependent Claims 2, 7-13, 17, and 25-27 also fail to add subject matter qualifying as significantly more to the abstract independent claims as they merely further limit the abstract idea.
Dependent Claims 4-5 14-16, 18, and 25-26 also fail to add subject qualifying as significantly more to the abstract independent claims as they recite limitations that do not integrate the claims into a practical application for substantially similar reasons as set forth above.
Dependent Claims 4-5 14-16, 18, and 25-26 also fail to add subject matter integrating the judicial exception or qualifying as significantly more to the abstract independent claims as they do not recite significantly more than the identified abstract idea for substantially similar reasons as set forth above.
Therefore, Claims 1-5, 7-18 and 25-27 are not patent eligible under 35 U.S.C. § 101.
Examiner’s Note
The Examiner notes that Claims 1-5, 7-18 and 25-27 are not currently rejected under prior art.
Conclusion
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN EPHRAIM COOPER whose telephone number is (571)272-2860. The examiner can normally be reached Monday-Friday 7:30AM-5:30PM EST.
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/JONATHAN E. COOPER/Examiner, Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791