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 .
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 1-20 are rejected under 35 U.S.C. 101 because of the following analysis:
Step 1: Do the claims recite one of the statutory categories of matter (i.e. method, apparatus, etc.)? YES, claims 1-15 recite methods, claims 16-20 recite apparatuses.
Step 2A Prong 1: Is there an abstract idea involved? YES, the claim language recites determining recommendations/insights to help improve the user’s sleep. 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.
Step 2a Prong 2: Do the claims recite additional elements that integrate the exception into a practical application? NO, the claims recite collecting sensor data and displaying results to a user which are considered insignificant extrasolution activities such as necessary data gathering and outputting (see MPEP 2106.05(g)). 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.
The 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). Therefore, they are also rejected.
Step 2B: Do the additional elements amount to “Significantly More” than the judicial exception?
NO, 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)).
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 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) 1-6, 8-15, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Osaki (US 2021/0145415 A1).
Regarding claims 1, 15, and 20, 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.
Regarding claim 2, Osaki 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. Para. 14, 19, 38, 65, 68, 91, 93).’
Regarding claim 3, Osaki discloses the one or more inputs relating to the user's hormonal status are user inputs (eg. Para. 38, 41, 50-53).
Regarding claim 4, Osaki discloses the one or more user inputs relating to the user's hormonal status include one or more of: level of tiredness/fatigue, 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 (eg. Para. 38, 42, 50-53, 60).
Regarding claim 5, Osaki discloses one or more user inputs are received in response to a questionnaire (eg. Para. 50).
Regarding claim 6, Osaki 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 one or more sensors (eg. Para. 38, 47, 56, 93).
Regarding claim 8, Osaki discloses receiving one or more inputs relating to the user's exercise habits (eg. Para. 14, 38, 51, 60).
Regarding claim 9, Osaki 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. Para. 90).
Regarding claim 10, Osaki discloses the one or more recommendations comprise one or more of: lifestyle changes, sleep hygiene, Auto Sleep Diary, ideal bed time, sleep programs, relaxation exercises, educational articles, consulting a sleep consultant, consulting a medical professional, and/or screening for a sleep related disorder (eg. Para. 14).
Regarding claim 11, Osaki discloses the one or more insights comprise: ovulation period, hormone fluctuations, effect of hormone fluctuations on sleep, correlation between a menstrual cycle phase and an indicator of sleep of the user, correlation between an indicator of sleep and user entered factors, an indicator of readiness, and/or guidance on factors which appear to be impacting the user's sleep and/or readiness (eg. Para. 14, 49, 61).
Regarding claim 12, Osaki discloses including predicting the user suffering from problems with falling or staying asleep based on monitoring of one or more factors over an extended period of time (eg. Para. 14, 42, 50, 52, 55).
Regarding claim 13, Osaki discloses the extended period of time is one of: at least seven days, and at least fourteen days (eg. Para. 14, 20, 34, 42, 50, 52, 55, 69, Fig. 7-9, tracking over the period which is between 21-35 days).
Regarding claim 14, Osaki discloses the one or more factors include one or more of: caffeine intake, sleep start time, diet, supplements, medications, symptoms, menstrual cycle phase, average cycle length, contraceptive use, pregnancy, lactation, Polycystic Ovarian Syndrome (PCOS), menstrual related disorders, perimenopause, menopause, improving sleep habits, life experiences, and stress relief activity (eg. Para. 14, 20, 34, 42, 50, 52, 55, 69).
Claim(s) 7 and 16-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Osaki (US 2021/0145415 A1) in view of Wild (WO 2016/074036 A1).
Regarding claim 7, Osaki 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.
Wild teaches using a stress monitoring system that uses blood testing apparatus for detecting chemicals such as norepinephrine, glucagon, epinephrine, cortisol, and growth hormone (eg. Pg. 20 Ln. 29 - Pg. 21 Ln. 4).
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 Osaki with the blood testing as taught by Wild to provide the predictable result of having more information to make predictions on a person’s health.
Regarding claim 16, the combined invention of Osaki and Wild discloses A virtual sleep clinic comprising one or more of: sleep assessment services; on-demand telehealth visits with a licensed practitioner who is attuned to female sleep issues and who can diagnose sleep disorders (eg. Wild, Pg. 7, Ln. 14 – Pg. 8, Ln. 2, Pg. 27 Ln. 6-10, provide behavioral therapy, and/or prescribe therapy; and provision of sleep solutions designed for female sleep needs, wherein the virtual sleep clinic is configured to facilitate performance of a method including: receiving sleep related data for a user from one or more sensors (eg. Wild, Pg. 27, Ln. 19 – Pg. 29, Ln. 20); 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. Osaki, Para. 14, 51, 61, 95); and presenting the one or more recommendations and/or insights to the user (eg. Osaki, Para. 21-22, 63, 69).
Regarding claim 17, the combined invention of Osaki and Wild discloses the virtual sleep clinic is configured to facilitate performance of a screening stage to determine a sleep assessment pathway for a user (eg. Para. 14, 19, 35-38, 50-56).
Regarding claim 18, the combined invention of Osaki and Wild discloses the screening stage identifies whether the user is likely to be impacted by male or female hormonal status, and directs the user to a sleep pathway based at least in part on this identification. (eg. Osaki, Para. 41-42, 50-53, 57-61, 95)
Regarding claim 19, the combined invention of Osaki and Wild discloses a first sleep assessment pathway is directed to sleep respiratory conditions, and a second sleep assessment pathway is directed to problems with falling or staying asleep (eg. Wild, Pg. 27, Ln. 6-10 sleep disorders, which would include respiratory disorders such as sleep apnea, and Pg. 7, Ln. 13-16, PTSD, depression, etc.).
Conclusion
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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/MICHAEL J LAU/Examiner, Art Unit 3796