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 § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-2, 7, 11-12, and 18-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Berka et al. (US 2014/0303428).
Regarding claim 1, Berka et al. teaches a method for controlling a sleep environment (para. 0033; Fig. 2), the method comprising:
providing a control system (Fig. 4, data processor 440) that is communicatively coupled to one or more sleep contributors (Fig. 4, stimulus generator 426; paras. 0057 and 0060) of a sleep environment for a user (paras. 0053-0054 and 0058), the control system being configured to adjust the one or more sleep contributors (paras. 0033 and 0041);
monitoring, via one or more sensors a physical condition of the user that is indicative of a sleep state of the user (Fig. 2, step 210; para. 0036);
detecting a change in the physical condition that indicates onset of an initial sleep state of the user (Fig. 2, step 220; paras. 0006 and 0037); and
in response to the onset of the initial sleep state (para. 0037, “current sleep state of the subject”), automatically adjusting at least one of the one or more sleep contributors (Fig. 4, stimulus generator 426; paras. 0057 and 0060) to begin inducing a deeper sleep state for the user (Fig. 2, step 265; paras. 0040-0041 and 0050), the inducing guiding the user from the initial sleep state to a subsequent sleep state without user conscious effort (para. 0033, wherein the sensory stimuli guides the sleeping subject from the current sleep state to the desired sleep state), the subsequent sleep state being associated with a deeper sleep for the user than the initial sleep state (paras. 0040-0041 and 0050).
Regarding claim 2, Berka et al. teaches the method according to claim 1 as stated above wherein one or more sleep contributors (Fig. 4, stimulus generator 426) are selected from a group consisting of a video image, an outputted sound (paras. 0040, 0057, 0060), lights (paras. 0040, 0057, 0060), and a temperature controller (paras. 0040, 0057, 0060).
Regarding claim 7, Berka et al. teaches the method according to claim 1 as stated above wherein at least one of the one or more sensors are included in a wearable on the user (Figs. 7 and 11a; paras. 0092 and 0101, wherein the EEG sensors are integrated into the wearable sleep mask 700).
Regarding claim 11, Berka et al. teaches a system for controlling a sleep environment (Fig. 4, sleep guidance system 400; para. 0033), the system comprising:
one or more sensors (Fig. 6; paras. 0087-0088, “EEG sensors”) for detecting one or more physical conditions of a user that are indicative of a sleep state of the user (paras. 0036, 0044, 0059, and 0086);
a memory storing machine-readable instructions (Fig. 4, memory 450; Fig. 5, main memory 565 and secondary memory 570; paras. 0061, 0069-0073, and 0077-0079); and
a control system (Fig. 4, data processor 440) communicatively coupled to and configured to adjust one or more sleep contributors (Fig. 4, stimulus generator 426; paras. 0057 and 0060) of a sleep environment for the user (paras. 0053-0054 and 0058), the control system including one or more processors configured to execute the machine-readable instructions to (para. 0053):
monitor the one or more physical conditions of the user (Fig. 2, step 210; para. 0036);
detect a change in at least one physical condition of the one or more physical conditions, the change indicating onset of an initial sleep state of the user (Fig. 2, step 220; paras. 0006 and 0037); and
in response to the onset of the initial sleep state (para. 0037, “current sleep state of the subject”), automatically adjust at least one of the one or more sleep contributors to begin inducing a deeper sleep state for the user (Fig. 2, step 265; paras. 0040-0041 and 0050), the inducing guiding the user from the initial sleep state to a subsequent sleep state without user conscious effort (para. 0033, wherein the sensory stimuli guides the sleeping subject from the current sleep state to the desired sleep state), the subsequent sleep state being associated with a deeper sleep for the user than the initial sleep state (paras. 0040-0041 and 0050).
Regarding claim 12, Berka et al. teaches the system according to claim 11 as stated above wherein one or more sleep contributors (Fig. 4, stimulus generator 426) are selected from a group consisting of a video image, an outputted sound (paras. 0040, 0057, 0060), lights (paras. 0040, 0057, 0060), and a temperature controller (paras. 0040, 0057, 0060).
Regarding claim 18, Berka et al. teaches the system according to claim 11 as stated above wherein at least one of the one or more sensors is integrated into a wearable device worn by the user (Figs. 7 and 11a; paras. 0092 and 0101, wherein the EEG sensors are integrated into the wearable sleep mask 700).
Regarding claim 19, Berka et al. teaches the system according to claim 11 as stated above wherein the control system is wirelessly coupled to at least one of the one or more sleep contributors (Fig. 5, communication interface 590; paras. 0074; para. 0066, “For example the system 550 may be used as or in conjunction with or as components of one or more of the mechanisms, processes, or devices described elsewhere herein, including those components illustrated in FIGS. 4 and/or 6”; para. 0053, “The data processor 440 is configured, through hardware, software or both, to communicate with each of a number of associated peripherals 420”).
Regarding claim 20, Berka et al. teaches the system according to claim 11 as stated above wherein the machine-readable instructions are further executed to determine a sleep baseline for the user based on demographic information from a demographic database (paras. 0034, 0038 and 0046-0048).
Claim Rejections - 35 USC § 103
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.
Claim(s) 3 and 13-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Berka et al. in view of de Zambotti et al. (US 2014/0316192).
Regarding claim 3, Berka et al. teaches the method according to claim 2 as stated above. Berka et al. fails to teach displaying the video image on a television set; or projecting the video image on any surface of the sleep environment, the surface including the television set.
In the same field of endeavor, de Zambotti et al. teaches displaying the video image (Fig. 1, para. 0014 and 0018, wherein the visual display 118 presents visual elements against a graphical background) on a television set (paras. 0018, 0022, and 0031, wherein the visual display 118 may be displayed in the virtual reality viewing glasses 112 or a television); or projecting the video image on any surface of the sleep environment, the surface including the television set.
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the method of Berka et al. with the video image displayed on the television set of de Zambotti et al. Televisions constitute one of several standard visual display systems that may be configured to present visual stimuli to patients in order to facilitate sleep (de Zambotti et al., paras. 0018, 0022, 0048).
Regarding claim 13, Berka et al. teaches the system according to claim 11 as stated above. Berka et al. fails to teach wherein the video image is displayed on a television set or is projected on a surface of the sleep environment.
In the same field of endeavor, de Zambotti et al. teaches wherein the video image (Fig. 1, para. 0014 and 0018, wherein the visual display 118 presents visual elements against a graphical background) is displayed on a television set (paras. 0018, 0022, and 0031, wherein the visual display 118 may be displayed in the virtual reality viewing glasses 112 or a television) or is projected on a surface of the sleep environment.
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the system of Berka et al. with the video image displayed on the television set of de Zambotti et al. Televisions constitute one of several standard visual display systems that may be configured to present visual stimuli to patients in order to facilitate sleep (de Zambotti et al., paras. 0018, 0022, 0048).
Regarding claim 14, Berka et al. teaches the system according to claim 12 as stated above. Berka et al. fails to teach wherein the video image includes a first video image and a second video image.
In the same field of endeavor, de Zambotti et al. teaches wherein the video image includes a first video image (Fig. 1, background 120; paras. 0014 and 0017-0018) and a second video image (Fig. 1, graphical elements, e.g., foreground elements 122, 124, 126, and a background element 128; paras. 0014 and 0017-0018).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the system of Berka et al. with the first and second video image of de Zambotti et al. The visual elements may be tailored based on the user’s physiological parameters and desired mental state. For example, to promote sleep, the capability to alter visuals to portray an underwater scene could be advantageous (de Zambotti et al., para. 0018).
Regarding claim 15, Berka et al. in view of de Zambotti et al. teaches the system according to claim 14 as stated above. Berka et al. further teaches the inducing (Berka et al., paras. 0040-0041) includes replacing the first video image with the second video image (de Zambotti et al., Fig. 1, visual elements 120, 122, 124, 126, and 128; paras. 0014 and 0017-0018, wherein the visual elements can be added, removed, and adjusted).
Regarding claim 16, Berka et al. in view of de Zambotti et al. teaches the system according to claim 14 as stated above wherein the inducing (Berka et al., paras. 0040-0041) includes overlaying the first video image (de Zambotti et al., paras. 0017-0018, Fig. 1, background 120, e.g., water) with the second video image (de Zambotti et al., paras. 0017-0018, Fig. 1, foreground element 122, e.g., fish).
Claim(s) 4, 8-9, and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Berka et al. in view of Hanbury (WO 2018/160903).
Regarding claim 4, Berka et al. teaches the method according to claim 1 as stated above. Berka et al. fails to teach wherein the guiding includes switching between at least one to at least another one of the one or more sleep contributors.
Hanbury teaches an analogous method wherein the guiding includes switching between at least one to at least another one of the one or more sleep contributors (paras. 0011-0012; see Table 1; para. 0084,” Segments A2, B2, and C2 synchronize the left side light and auditory output, and the right side light and auditory output to be opposite to one another”).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the method of Berka et al. with the switching between stimuli sources of Hanbury. Supplying two or more auditory, visual, and/or tactile stimulus consecutively may provide improved therapeutic benefits (Hanbury, paras. 0066-0067).
Regarding claim 8, Berka et al. teaches the method according to claim 1 as stated above. Berka et al. fails to teach wherein the automatically adjusting is switching the at least one of the one or more sleep contributors between an on and an off state.
Hanbury teaches an analogous method wherein the automatically adjusting is switching the at least one of the one or more sleep contributors between an on and an off state (paras. 0010, 0038, 0069, and 0084).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the method of Berka et al. with the on/off switching of Hanbury. Turning the light sources on and off can produce an oscillating stimulation between 1-42 Hz. This range matches specific brain wave patterns associated with different sleep stages (Hanbury, paras. 0010, 0018, 0038-0040, and 0083).
Regarding claim 9, Berka et al. teaches the method according to claim 1 as stated above. Berka et al. fails to teach wherein the automatically adjusting is a gradual change in sensory output from the at least one of the one or more sleep contributors.
Hanbury teaches an analogous method wherein the automatically adjusting is a gradual change in sensory output from the at least one of the one or more sleep contributors (Claim 19; paras. 0072-0073).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the method of Berka et al. with the gradual sensory output change of Hanbury. The volume of the auditory stimulation and the brightness of the visual stimulation are adjusted based on the subject’s changing level of relaxation or arousal. Gradually modifying brightness and volume can help produce a more stable HRV (Hanbury, paras. 0009, 0072-0073, and 0098).
Regarding claim 17, Berka et al. teaches the system according to claim 11 as stated above. Berka et al. fails to teach wherein the machine-readable instructions are further executed to switch between at least one to at least another one of the one or more sleep contributors.
Hanbury teaches an analogous system wherein the machine-readable instructions (para. 0067) are further executed to switch between at least one to at least another one of the one or more sleep contributors (paras. 0011-0012; see Table 1; para. 0084,” Segments A2, B2, and C2 synchronize the left side light and auditory output, and the right side light and auditory output to be opposite to one another”).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the system of Berka et al. with the switching between stimuli sources of Hanbury. Supplying two or more auditory, visual, and/or tactile stimulus consecutively may provide improved therapeutic benefits (Hanbury, paras. 0066-0067).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Berka et al. in view of Wang et al. (CN 114767068), citing to attached translation.
Regarding claim 5, Berka et al. teaches the method according to claim 1 as stated above. Berka et al. further teaches wherein the physical condition is a heartbeat of the user (paras. 0036 and 0044). Berka et al. fails to teach the change being a slowdown in the heartbeat, the onset of the initial sleep state occurring when the heartbeat slows down to a predetermined slowdown threshold.
In the same field of endeavor, Wang et al. teaches wherein the change being a slowdown in the heartbeat (page 2, para. 5, “heartbeat fluctuation intensity is less”, i.e., the heartbeat is reducing), the onset of the initial sleep state occurring when the heartbeat slows down to a predetermined slowdown threshold (Abstract, “confirming the sleeping point according to the corresponding time point when the heartbeat fluctuation intensity value is less than the heartbeat fluctuation intensity threshold value”; page 5, para. 2, “the corresponding heartbeat fluctuation intensity value is less than heartbeat fluctuation intensity threshold value, then the time point according to the measured heartbeat fluctuation intensity value of time sequence to order, obtaining the most starting time is 16: 00. Then the sleep time point of the user is 16: 00”).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the method of Berka et al. with the heartbeat monitoring of Wang et al. Doing so creates an automated sleep monitor configured to determine whether or not the user is sleeping based on their heartbeat fluctuation intensity (Wang et al., page 3, para. 9, “confirming the sleeping point according to the corresponding time point when the heartbeat fluctuation intensity value is less than the heartbeat fluctuation intensity threshold value. so as to use the sleep monitor to automatically monitor the sleep time of the user, without manually inputting the sleep time, using the heartbeat fluctuation intensity of the monitoring user, comparing the heartbeat fluctuation intensity with the threshold value, judging whether the user is sleeping, improving the intelligent operation of the sleep monitor”).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Berka et al. in view of Wang et al., further in view of Shouldice (WO 2021/220247).
Regarding claim 6, Berka et al. in view of Wang et al. teaches the method according to claim 5 as stated above. Berka et al. in view of Wang et al. fails to teach in response to the heartbeat lowering by X beats, implementing a first automatic adjustment of at least one of the one or more sleep contributors; and in response to the heartbeat lowering by X+1 beats, implementing a second automatic adjustment of at least one of the one or more sleep contributors.
Shouldice teaches an analogous method further comprising:
in response to the heartbeat lowering by X beats (paras. 0051-0052, 0056, and 0061-0067 and 0078, wherein heart rate and heart rate variability may be used as inputs for classifying sleep stages, such that changes in heart rate variability or heart rate can be used to determine whether the subject is awake or sleep, and if asleep, their sleep stage; para. 0049, “Stage 2…heart rate, breathing, and brain activity slows down in this sleep stage”), implementing a first automatic adjustment of at least one of the one or more sleep contributors (para. 0082, “the system detects somebody falling asleep near the device, and in response to the detection may reduce playback volume (of audio content of the speaker(s), TV etc.); and
in response to the heartbeat lowering by X+1 beats (paras. 0051-0052, 0056, and 0061-0067 and 0078, wherein heart rate and heart rate variability may be used as inputs for classifying sleep stages, such that changes in heart rate variability or heart rate can be used to determine whether the subject is awake or sleep, and if asleep, their sleep stage; para. 0049, “Stage 2…heart rate, breathing, and brain activity slows down in this sleep stage”), implementing a second automatic adjustment of at least one of the one or more sleep contributors (para. 0083, “The volume and TV etc. may then be turned off after 5-10 minutes when the device detects that the person has moved into a deeper sleep phase”).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the method of Berka et al. in view of Wang et al. with the cardiac measurements and subsequent first and second automatic stimuli adjustments of Shouldice. Heart rate variations serve as immediate biometric indicators that can differentiate sleep stages; consequently, by monitoring heart rate and determining a reduction in heart rate, adjustments to the stimuli can be made to help the user stay asleep and reach deeper sleep stages (Shouldice, paras. 0011, 0051-0052, 0056, and 0061-0067).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Berka et al. in view of Kwak et al. (WO 2020/153584), citing to attached translation.
Regarding claim 10, Berka et al. teaches the method according to claim 1 as stated above. Berka et al. fails to teach wherein the guiding of the user includes audio output of a voice talking the user towards the deeper sleep.
Kwak et al. teaches an analogous method wherein the guiding of the user includes audio output of a voice talking the user towards the deeper sleep (page 3, para. 5, “voice stimulation through the speaker”; Fig. 8; page 9, para. 4, “the voice stimulus may provide an augo-suggestion voice for the user to increase the likelihood of entering lucid sleep. That is, voice stimulation may be provided as a self-hinting method for increasing the user's willingness to decorate a lucid dream”).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the method of Berka et al. with the voice stimulation of Kwak et al. By guiding the user with pre-recorded voice renderings, the user may be more receptive to listening to suggestions aimed at inducing lucid sleep (Kwak et al., the entirety of page 9).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Stroman (US 2017/0281119) discloses sleep management devices and methods of operating sleep management devices. The sleep management device captures the user’s conditions and provides visual and/or sound outputs to the user to regulate the user’s sleep. Molina et al. (US 2020/0197656) discloses a system configured to enhance REM sleep by delivering sensory stimulation to a subject during a sleep session. One or more sensors and sensory stimulators are provided to the user. Youngblood (US 20220105308) discloses a system to reduce stress and promote sleep by providing the user with an intuitive mobile application designed to guide the user to a desired mental state. Campanella et al. (WO 2021061655) discloses systems and methods for enhancing wellness in a habitable space. The habitable space comprises an array of sensors and controllable devices configured to monitor the patient and induce sleep. Garcia (WO 2021115889) discloses a system and method for delivering sensory stimulation to a subject for facilitating sleep onset. A means for determining an initial state of the subject based on output signals from physiological sensors is disclosed.
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/B.R.L./Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791
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