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 and amendments regarding the 101 rejection filed 6/2/2026 have been fully considered but they are not persuasive. The Applicant amended the claims to recite receiving data from sensors, monitoring inputs over a period, training a model, and predicting a user suffering from problems with falling or staying asleep to overcome the 101 rejection. The Examiner respectfully disagrees. The collection of physiological data from sensors is an extrasolution activity of necessary data gathering (see MPEP 2106.05(g)). The monitoring multiple inputs are considered an analysis/determination step that can be performed by a physician. The training a predictive model as claimed merely inserts data as input in to a generic model/program (a physician can have knowledge of data interpretation and use mathematics to calculate the prediction), which amounts to merely applying an exception on a generic computer (see MPEP 2106.05(f)). The output of an indicator and recommendation is merely the extrasolution activity of displaying results and organizing human behavior. The Examiner recommends adding in claim language that improves the technology/function of the model.
Applicant’s arguments and amendments regarding the 103 rejection, see pages 8-9, filed 6/2/2026, with respect to the rejection(s) of claim(s) 1-2, 4, 6-11, and 20 under USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Whoop (US 11627946 B2) in view Stern (US 2019/0117151 A1) further in view of Philips (UIS 11197623 B2). Independent claim 15 was not amended or addressed like the other independent claims 1 and 20 and was not addressed in the remarks, so it is unclear if this was intentional or not. The old prior art rejection for claim 15 is maintained below.
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.
Claim(s) 1-2, 6, 8-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Whoop (US 11627946 B2) in view Stern (US 2019/0117151 A1).
Regarding claims 1 and 20, Whoop teaches a computer-implemented method performed by one or more processors including (eg. Col. 62, Ln. 20-45): receiving sleep related data for a user from one or more sensors, wherein the one or more sensors include at least one physiological sensor of a wearable device (eg. Col.1, Ln. 42-62, Col. 9, Ln. 50 – Col. 10, Ln. 25); receiving one or more inputs relating to the user's hormonal status, wherein the user's hormonal status includes an indicator of menstrual cycle phase (eg. Col. 59, Ln. 1 – Col. 60, Ln. 42, Col. 62, Ln. 20-45); monitoring the sleep related data, the user's hormonal status, and the user's level of tiredness, over an extended period of time including at least one menstrual cycle of the user (eg. Abstract, eg. Col. 59, Ln. 1 – Col. 60, Ln. 42, Col. 62, Ln. 20-45); training a predictive model that correlates the sleep related data, hormonal status, and user tiredness over the extended period of time (eg. Col.1, Ln. 42-62, Col. 9, Ln. 50 – Col. 10, Ln. 25, Col. 24, Ln. 28-51, Col. 51, Ln. 38-67); predicting, using the predictive model, the user suffering from problems with falling or staying asleep based on the monitoring (eg. Col. 50, Ln. 64 – Col. 51, Ln. 67); determining one or more recommendations and/or insights to help improve the user's sleep based at least in part on a current indicator of the user's menstrual cycle phase, wherein the one or more recommendations and/or insights includes at least sleeping time adjustment; and presenting the one or more recommendations and/or insights to the user (eg. Col. 66, Ln. 20-45).
Whoop does not disclose receiving one or more user inputs relating to the user's level of tiredness.
Stern teaches a sleep monitoring system that uses patient input for measure of a user’s sleepiness (eg. Para. 3. 19-29, claim 11) for monitoring and predicting treatments for sleep apnea.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the invention of Whoop with the sleepiness input as taught by Stern since both are related to sleeping disorders and would provide the predictable result of improving the prediction of the likelihood of a sleeping disorder and effectiveness of different forms of treatment (Eg. Stern, Para. 8).
Regarding claim 2, the combined invention of Whoop and Stern discloses the one or more sensors include one or more of: heart rate sensors, oxygen level sensors, ECG sensors, pulse rate sensors, accelerometers, gyroscopes, GPS receivers, sound sensor and/or microphone, non-contact sensing device, and an optical sensor of a wearable sensor device configured to measure a blood volume pulse of the user (eg. Whoop, Col. 8, Ln. 9-58).
Regarding claim 6, the combined invention of Whoop and Stern discloses one or more of the inputs relating to the user's hormonal status are determined using one or more characteristics of the user obtained using at least the at least one physiological sensor of the wearable device (eg. Col. 62, Ln. 20-45).
Regarding claim 8, the combined invention of Whoop and Stern discloses receiving one or more inputs relating to the user's exercise habits (eg. Whoop, Col 6, Ln. 38-61, Col. 11, Ln. 2-31 Col. 15, Ln. 3-26, Col. 18, Ln. 23 – Col. 19, Ln. 7, Col. 21, Ln. 47-64, Col. 22, Ln. 65 – Col. 23, Ln. 24).
Regarding claim 9, the combined invention of Whoop and Stern discloses the one or more inputs relating to the user's exercise habits may be received via one or more of: in response to the questionnaire, and one or more exercise applications (eg. Whoop, Col 6, Ln. 38-61, Col. 11, Ln. 2-31 Col. 15, Ln. 3-26, Col. 18, Ln. 23 – Col. 19, Ln. 7, Col. 21, Ln. 47-64, Col. 22, Ln. 65 – Col. 23, Ln. 24, Col. 28, Ln. 34-55, enter feedback).
Regarding claim 10, the combined invention of Whoop and Stern discloses the one or more recommendations further comprise one or more of: lifestyle changes, sleep hygiene, Auto Sleep Diary, sleep programs, relaxation exercises, educational articles, consulting a sleep consultant, consulting a medical professional, and/or screening for a sleep related disorder (Eg. Stern, Para. 66, sleep coach).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Whoop (US 11627946 B2) in view Stern (US 2019/0117151 A1) further in view of Fitbit (10765409 B2).
Regarding claim 4, the combined invention of Whoop and Stern discloses the invention of claim 1, but does not disclose instances of localised pain; period characteristics period timing characteristics of current or previous cycle, medication impacting menstrual cycle, and/or other factors including instances of hot flashes, nausea, constipation, acne, mood, and/or appetite.
Lafon teaches a menstrual cycle tracker that tracks mood logs, symptom logging, manual exclusion of a cycle log, cervical fluid logging, new medications, etc. (eg. Col. 10, Ln. 35 – Col. 11, Ln. 17).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the invention of Whoop and Stern with the cycle logging as taught by Lafon to provide the predictable result of improving cycle-phase correlation and personalization of sleep recommendation since both are wearable menstrual cycle aware platforms already collecting user input.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Whoop (US 11627946 B2) in view Stern (US 2019/0117151 A1) further in view of Eccrine (WO 2016/197085 A1).
Regarding claim 7, the combined invention of Whoop and Stern discloses the invention of claim 1, but does not disclose one or more of the inputs relating to the user's hormonal status comprise one or more of: glucagon, epinephrine (adrenaline), norepinephrine, cortisol, and growth hormone.
Eccrine teaches a sweat sensing device that measures cortisole and derives a stress profile coordinated with sleep (eg. Para. 3, 36, 39-40).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the invention of Whoop and Stern with the cortisol tracking as taught by Eccrine since cortisol is known to affect sleep and would provide the predictable result of improving assessment (eg. Eccrine, Para. 39-40 cortisol awakening response).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Whoop (US 11627946 B2) in view Stern (US 2019/0117151 A1) further in view of Fitbit (10765409 B2).
Regarding claim 11, the combined invention of Whoop and Stern discloses the invention of claim 1, but does not disclose
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Osaki (US 2021/0145415 A1).
Regarding claims 15 Osaki discloses A method including: receiving sleep related data for a user from one or more sensors (eg. Para. 19, 35-38, 50-56); receiving one or more inputs relating to the user's hormonal status (eg. Para. 41-42, 50-53, 57-61, 95); determining one or more recommendations and/or insights to help improve the user's sleep (eg. Para. 14, 51, 61, 95); and presenting the one or more recommendations and/or insights to the user (eg. Para. 21-22, 63, 69).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined various embodiments to have multiple types of sensors to predict menstrual cycle information and sleep information to provide the predictable result of utilizing more information from multiple sensors to more accurately make predictions.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL J LAU whose telephone number is (571)272-2317. The examiner can normally be reached 8-5:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Carl Layno can be reached at 571-272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL J LAU/Examiner, Art Unit 3796
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