DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim status
2. In response to the amendments filed 05/12/2026, claim 1 was amended and no claims were canceled and/or added. Therefore, claims 1-6 are currently pending for examination.
Claim Rejections - 35 USC § 103
3. Claims 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over Shouldice et al. (Shouldice; 2020/0009349) in view of Wright et al. (US 2020/0121248).
For claim 1, Shouldice discloses a method of awakening a user from sleep at a scheduled time [E.g. 0078, 0093-0094, 0349, 0658], comprising:
by using at least one processor [E.g. 0082], determining a sleep state of the user at the scheduled time [E.g. 0349: The system may include a smart alarm which may assist user with waking up during optimal wakeup/time state to ensure most restful sleep and waking. This seeks to sound the alarm when the user is in an awake, aroused, or light or REM sleep state. In some configurations, REM sleep stages may also be avoided by the smart alarm. The system will alarm at the end of the pre-programmed time window (e.g., sound an alarm at the optimal time within a defined wake-up window), regardless of the sleep state, in order that the user definitely is woken. The alarm can be set once, daily, or on selected days such as weekdays only. The user can also choose to set a time window before the alarm time where the sleep monitor device can decide to wake the user, along with an audio sound chosen from a list provided by the application or from a file on the SmD to set the audible alarm sound. The optimal wake time may be determined based on near real-time sleep staging analysis by the processing library, 0350: The user may select a time for the alarm to fire/trigger and an alarm window, which proceeds the alarm time. The system looks for a suitable sleep stage during the time window and wakes the user when one is detected. A user can query if an alarm is set. The user can query the current set alarm time. The user can disable the alarm, if set, 0078, 0093-0094] the sleep state being based on data collected from a plurality of data sources, the plurality of data source including one or more local sensors proximate the user that generate data of a sleep environment associated with the user [Fig. 3a: bedside unit 3000; 0234: The bedside unit 3000 is a device placed on a bedside table, bedside locker, stand, or other supporting means located near the user when they are in bed. This device contains the biomotion sensor and other environmental sensor(s), and a wired or wireless (e.g., Bluetooth) link to an app on a smart device 3002 (e.g., smartphone or tablet), 0079: the proposed technology helps the user relax by tracking user's breathing (also respiration) rate and guiding the user to reduce their breathing rate. Such an encouragement helps the user to slow their breathing, fall asleep faster and better recover from the stresses of the day. A ‘Mind Clear’ feature helps the user to clear their mind of thoughts that might otherwise keep the user awake. The system can record the user's sleep, breathing and heart rate patterns using a bio motion sensor, thus allowing a review of the user's level of physical (generally associated with the amount of deep sleep) & mental (generally associated with the amount of REM sleep) recharge. This can be then visualised by a simple number or by a chart plot on the screen of a PC or a smart device, such as a phone or a tablet. The system and method measure environmental parameters of the bedroom using sensors such as light, sound, temperature, humidity and/or air quality. The proposed system and method also deliver customized personal advice to help improve the user's sleep based on personal sleep data, trended data, de-identified population data, bedroom environment data and external environmental data, 0349-0350, 0094, 0301, 0531], the data of the sleep environment including physiological and/or biomechanical signals from the user [E.g. 0208: contactless biosensor can measure various physiological parameters of the user, such as a breathing rate and various sleep parameters. These may be processed to determine specific sleep stages of the user's sleep and the time the user spends in each of these stages. As discussed in more detail herein, the sleep staging analysis evaluates outputs of user presence/absence and multi-epoch analysis to generate a hypnogram, sleep parameters and sleep scores. A decision may be made for every epoch (e.g., 30 second interval or other suitable time period) to indicate if the user is asleep (deep, light or REM), awake or absent. Such data may be presented to a user to provide a feedback to the user regarding the user's mental and physical recovery (recharge) rate, portrayed in the sleep score as discussed later and hypnograph (hypnogram). The system is able to monitor and, in real time or otherwise, display to the user the sleep parameters by visualization on a screen of a bedside portable monitoring unit, a personal computer or a communication device, such as a smartphone. Other parameters, such as snoring or sleep disorder breathing (apnoea or apnoea-hypopnea index) may also optionally be monitored, recorded and presented to the user. (Detail on conducting such sleep and Sleep disordered breathing (SDB) measurements are disclosed in US 2009/0203972, which is incorporated here in its entirety by reference), 0206, 0383], and one or more auxiliary sensors that generate data of environmental factors from an area outside of the sleep environment but that affect the sleep environment [E.g. 0108, 0110, 0241,0531], the sleep data further comprising time-based sleep data collected from the one or more local sensors at or before the scheduled time [E.g. 0093-0095, 0114 ,0208, 0234, 0433, 0749-0752, Fig. 12]; and
automatically activating one or more selected stimuli to wake up the user in response and according to the determined sleep state of the user and according to the determined sleep state of the user and the time-based sleep data collected at or before the scheduled time [E.g. 0093: a processor configured to prompt a user to input a wake-up time and a wake-up time window, the wake-up time window ending with the wake-up time. The processor of the apparatus may be configured to receive signals from a motion sensor, the signals being indicative of motion of the user. The processor of the apparatus may be configured to detect sleep information with an analysis of the received signals indicative of motion. The processor of the apparatus may be configured to trigger activation of the alarm device as a function of the sleep information and a function of the wake-up window and the wake-up time, wherein the function of the sleep information and the function of the wake-up window and the wake-up time comprise detecting the user being in a light sleep stage during the wake-up window, 0095: The method may involve with a processor coupled, e.g., wirelessly, with a motion sensor prompting a user to input a wake-up time and a wake-up time window, the wake-up time window ending with the wake-up time. The method may involve with the processor receiving signals from a motion sensor, the signals being indicative of motion of the user. The method may involve with the processor detecting sleep information with an analysis of the signals indicative of motion. The method may involve with the processor triggering activation of an alarm device as a function of the sleep information and a function of the wake-up window and the wake-up time. The function of the sleep information and the function of the wake-up window and the wake-up time may comprise detecting the user being in a light sleep stage during the wake-up window, 0301: Real-time sleep staging: this output and a heuristic logic aim to wake the user within a user-defined time window, while not in deep sleep, 0349: The system may include a smart alarm which may assist user with waking up during optimal wakeup/time state to ensure most restful sleep and waking. This seeks to sound the alarm when the user is in an awake, aroused, or light or REM sleep state. In some configurations, REM sleep stages may also be avoided by the smart alarm. The system will alarm at the end of the pre-programmed time window (e.g., sound an alarm at the optimal time within a defined wake-up window), regardless of the sleep state, in order that the user definitely is woken. The alarm can be set once, daily, or on selected days such as weekdays only. The user can also choose to set a time window before the alarm time where the sleep monitor device can decide to wake the user, along with an audio sound chosen from a list provided by the application or from a file on the SmD to set the audible alarm sound. The optimal wake time may be determined based on near real-time sleep staging analysis by the processing library, 0350: The user may select a time for the alarm to fire/trigger and an alarm window, which proceeds the alarm time. The system looks for a suitable sleep stage during the time window and wakes the user when one is detected. A user can query if an alarm is set. The user can query the current set alarm time. The user can disable the alarm, if set].
Shouldice fails to expressly disclose that the one or more auxiliary sensors include a microphone positioned to receive sound signals originating from outside of the sleep environment at or before the scheduled time and that propagate into the sleep environment and that the sleep data further comprising time-based sleep data collected from the one or more auxiliary sensors at or before the scheduled time.
However, as shown by Wright, it was well known in the art of monitoring user sleep to include one or more auxiliary sensors include a microphone positioned to receive sound signals originating from outside of the sleep environment at or before the scheduled time and that propagate into the sleep environment and that the sleep data further comprising time-based sleep data collected from the one or more auxiliary sensors at or before the scheduled time [E.g. 0069, 0064-0066, 0020-0030, 0047; Fig. 2].
It would have been obvious to one of ordinary skill in the art of monitoring user sleep before the effective filling date of the claimed invention to modify Shouldice with the teaching of Wright in order to better anticipate disruptive noise that can affect the user sleep and thereby allow the system to adjust the wake up stimuli or the scheduled time so that the user can get better sleep, also it is merely combining prior art elements according to known method to yield predicable result.
For claim 2, Shouldice discloses wherein the stimuli comprise light, sound [E.g. 0349], or scent stimuli.
For claim 3, Shouldice discloses wherein the stimuli comprise audio [E.g. 0511, 0522] or visual instructions for the user to follow.
For claim 4, Shouldice discloses wherein determining the sleep state of the user is at least partly based on body movements of the user detected by at least one of the one or more auxiliary sensors [E.g. 0383: The biomotion sensor of the BeD discussed above is capable of detection of movement—both gross body movement and the movement of the chest (of a human or animal such as a dog, horse, cow, etc.) due to the physiological action of breathing. Alternative examples include infra-red- or accelerometer-based devices. Groups of algorithms can be used to distinguish fiducial patterns in both time and frequency domain representations of the sensor signal, and provide an output of the probability of being in a particular sleep stage (wake or absent) as previously discussed. A filter bank and associated signal processing block is used to separate higher frequency movement signals and those signals representing the motion of the chest, 0384: For (a)—sleep latency estimation (i.e., the time to sleep measure) is for example used to fade out the sound sequence, an aspect that can be implemented in the discussed ‘relax to sleep’ feature: The desired output is to detect the change from wakefulness to “stage 1” light sleep and to calculate a sleep latency (time to sleep) parameter. Stage 1 sleep can be considered to be the transition period between wakefulness and sleep. For example, time to sleep may be determined by the SmD processor as the time the user activates the “relax to sleep” feature or initiates a sleep session to the time that the system detects an initial sleep state. Some specific parameters that may be estimated and analysed relate to the frequency, amplitude, and “burstiness” (occurring in bursts) of higher frequency (faster) movements as a subject moves from wakefulness to the twilight stage of stage 1 sleep. The combined nature of movement pattern and breathing rate value and waveform shape may be used to classify sleep onset. Over time, the system may adapt to subject specific data in order to increase the accuracy of this classification (e.g., the typical baseline breathing rate and amount of movement of the subject—i.e., how much the move around in bed/fidget as they are falling asleep) may be learned and employed in the estimation process, 0108, 0110, 0241].
4. Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Shouldice in view of Wright and further in view of Boulton et al. (Boulton; US 2019/0343416).
For claim 5, Shouldice disclose wherein if the user is determined to be in deep sleep state at the scheduled time, automatically activating one or more selected stimuli [E.g. 0351, 0095, 0301, 0349].
Shouldice in view of Wright fails to expressly disclose that the stimuli comprise prompting the user to perform a certain physical exercise.
However, as shown by Boulton, it was well known in the art of providing user stimuli to include providing stimuli to the user to prompt the user to perform a certain physical exercise [E.g. 0075].
It would have been obvious to one of ordinary skill in the art of providing user stimuli before the effective filling date of the claimed invention to modify Shouldice in view of Wright with the teaching of Boulton in order to train the user to attain an ideal brain frequency variability/bfv index of 10 which correlates to a balanced homeostasis.
5. Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Shouldice in view of Wright and further in view of Heneghan et al. (Heneghan; US 2016/0270718).
For claim 6, Shouldice disclose wherein if the user is determined to be in deep sleep state at the scheduled time, automatically activating one or more selected stimuli [E.g. 0351, 0095, 0301, 0349].
Shouldice in view of Wright in fails to expressly disclose that the stimuli comprise causing the user to perform a test on his or her alertness or vigilance.
However, as shown by Heneghan, it was well known in the art of providing user stimuli to include causing the user to perform a test on his or her alertness or vigilance [E.g. 0051: The objective measurements of fatigue or sleepiness may be obtained from user tests. The objective measurements of fatigue or sleepiness may be obtained from game play “perform a test” by the user….].
It would have been obvious to one of ordinary skill in the art of providing user stimuli before the effective filling date of the claimed invention to modify Shouldice in view of Wright with the teaching of Heneghan in order to monitor, assess and manage fatigue of the user.
Response to Remarks
6. The Applicant's remarks regarding the rejection have been considered but are moot because the arguments do not apply to the new ground of rejection.
Conclusion
7. 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 extension fee 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 date of this final action.
8. Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOHAMED BARAKAT whose telephone number is (571)270-3696. The examiner can normally be reached on 9:00am-5:00PM.
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/MOHAMED BARAKAT/
Primary Examiner, Art Unit 2689
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