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 Amendment
The RCE filed June 12, 2026 has been entered. Claims 1, 3, 8-9, and 16 remain pending in the application.
Response to Arguments
35 USC § 103:
Applicant amended claims and overcomes the previous independent claim 1 rejections with respect to Su, Budidha, and Zavanelli. Examiner agrees that all of the amended limitations, specifically the time aligned condition, are not taught by the cited references. A new 35 USC 103 rejection below is being applied using Su in light of the amendments to the claims.
Examiner agrees that none of the cited references teach or suggest detecting microphone obstruction or modifying the algorithm based on it provided in new dependent claim 16. A 35 USC 103 rejection below is applied using Su in light of the new claim.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 3, 8-9, and 16 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 describes a situation in which all three PPG measurements (respiration event, pulse oximetry drop, and respiration rate change) are correlated with the snoring event in the amended limitation of “identify a snoring candidate event as an actual snoring event corresponding to the user by aligning timestamps of the snoring candidate event with timestamps of the photoplethysmography events, wherein the snoring candidate event coincides with: (i) the respiration event, (ii) in the pulse oximetry level drop, and (iii) the respiration rate change”. Applicant’s amendment filed June 12, 2026, asserts the features may be found at least in ¶[0052]-[0054], ¶[0059]-[0060], and ¶[0062]-[0063] to provide support. In ¶[0063] a pulse ox and respiration rate are correlated with snoring events and the spec discusses using inhale and exhale (respiration events) to sample the microphone, however, the spec does not describe using all three PPG data events in combination to evaluate snoring in these sections. The specification as-filed does not provide a written description or set forth the metes and bounds of the amended limitations above. The specification does not provide direction for the instant methods encompassing the above-mentioned "limitations" as they are currently recited. The instant claims now recite limitations which were not clearly disclosed in the specification as-filed, and now change the scope of the instant disclosure as-filed. Such limitations recited in the present claims, which did not appear in the specification, as-filed, introduce new concepts (See MPEP 2163.06). Applicant is required to cancel the new matter in the response to this Office action. Alternatively, applicant is invited to provide sufficient written support for the “limitations” indicated above.
Claims 3, 8-9, and 16 depend from rejected claim 1, and are therefore rejected for the same reasons as above.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 3, 8-9, and 16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “identify two or more ppg events…, wherein the ppg events include a respiration event, a respiration rate change, and a pulse oximetry level drop” and the claim further uses all three ppg events to detect the snoring event. This is unclear since it is not clearly conveying if only two of the three are needed or if all three are needed. For purposes of examination, “identify two or more ppg events” will be interpreted as “identify three or more ppg events” based on applicant’s remarks of using all three together to confirm snoring candidates.
Claim 3 is recites the limitation "the at least one respiration event" in line 1. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, “the at least one respiration event” will be interpreted as “the respiration event”.
Claims 3, 8-9, and 16 depend from claim 1 and are rejected for the same reasons as claim 1.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 3, 8, 10-11, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Su et al. (US 20200383633 A1, published December 10, 2020, hereinafter referred to as “Su”) in view of Chou (US 20240000396 A1, published Jan. 4, 2024, hereinafter referred to as “Chou”).
Regarding claim 1, Su teaches a wearable electronic device configured to be worn by a user (Fig. 1A element 104 in ¶[0034], Fig. 1C element 150 in ¶[0036], and Fig. 2A element 200 wearable device in ¶[0037]), the device comprising: a display (Fig. 1C element 156 display screen in ¶[0036]); a microphone (Fig. 2B element 238 microphone in ¶[0038]); and a processor coupled with the display, PPG sensors, and the microphone (Fig. 2B element 202 processors in communication with all of the sensors in ¶[0037]), the processor configured to (Fig. 2C “In some cases, the snore module 252, or at least a portion thereof, can be implemented, in part or in whole, as software running on the wearable device” ¶[0039]): sample the microphone on a periodic basis to acquire audio data (“the sensor data may include data captured by one or more microphones” ¶[0040]); process the audio data to identify one or more snoring candidate events and timestamps associated with the snoring candidate events (¶[0041] and Fig. 2C “the snore metrics module 258 can determine one or more durations of snoring activity for the user during the period of time” ¶[0042]); acquire the photoplethysmography signal from the at least one photodiode (“the sensor data may include data captured by … photoplethysmogram (PPG) sensors” ¶[0040]); process the photoplethysmography signal to identify photoplethysmography events and timestamps associated with the photoplethysmography events (“Each PPG sensor can apply generally known light-based technology to independently measure the rate of blood flow as controlled by the user's heart as it pumps blood, i.e., heart rate signals. These measurements can be indicative of the user snoring at various time intervals, as illustrated by the PPG data 504 in the example of FIG. 5.” ¶[0049]), wherein the photoplethysmography events include a respiration event (“Fig. 1A “the second breathing phase pattern can be determined based on sensor data captured by one or more photoplethysmogram (PPG) sensors ... Such sensor data can provide physiological information describing the user 102 of the wearable device 104, such as when the user 102 is inhaling and exhaling.” ¶[0034]); identify a snoring candidate event as an actual snoring event corresponding to the user, wherein the snoring candidate event coincides with: (i) the respiration event (Fig. 3 “an amount of correlation can be determined between the breathing phase of the user based on measurements captured by a PPG sensor and the breathing phase of the entity based on the audio data, as determined by the audio-based breathing determination module 304. If a threshold correlation exists, the user of the wearable device can be determined to be the source of the snores captured in the audio data” ¶[0046]); control the sampling rate of the microphone based on at least one of the identified photoplethysmography events (respiratory event) (“duty cycling module” being controlled by user respiration in ¶[0043]); and control the display to present data corresponding to the actual snoring events (“Such determinations can be especially useful so that the user 102 can be provided with accurate sleep-related information and recommendations without false positives” ¶[0034] and Fig.’s 6A-G).
Although Su teaches a PPG sensor (Fig. 2B elements 232, 234, and 236 in ¶[0038]) in contact with the user’s skin (Fig. 1C “The wearable device 150 may incorporate one or more functional components … designed for determining one or more physiological metrics associated with a user … disposed or associated with an underside/backside of the wearable device 150, and may be in contact (or substantially in contact) with human skin when the wearable device 150 is worn” ¶[0036], in Fig. 3 “the sensor-based breathing determination module 306 can obtain sensor data from one or more photoplethysmogram (PPG) sensors in the wearable device” in ¶[0049]), and Su’s device is able to calculate respiration rate and pulse oximetry (¶[0037]), Su does not directly teach the PPG sensor composed of at least one light emitting diode configured to emit light into the user’s body; at least one photodiode configured to detect light reflected from the user’s body and to generate a photoplethysmography signal. Su also does not disclose processing the photoplethysmography signal to identify two or more photoplethysmography events, wherein the two or more photoplethysmography events include a respiration rate change and a pulse oximetry level drop; identify a snoring candidate event as an actual snoring event corresponding to the user by aligning timestamps of the snoring candidate event with timestamps of the photoplethysmography events, wherein the snoring candidate event coincides with: (ii) the pulse oximetry level drop, and (iii) the respiration rate change.
Chou’s invention relates to a sleep system and a sleep alarm method, and more particularly, to a sleep system and a sleep alarm method capable of evaluating and improving sleep breathing disorders (¶[0002]). OSA is a sleep-related breathing disorder that involves a decrease or complete halt in airflow in the presence of breathing effort. This can lead to abrupt reductions in blood oxygen saturation (desaturation) (¶[0004]). The system may include an optical sensor, which includes at least a photo emitter, such as LED, and at least a photodetector, such as photodiode, for obtaining a photoplethysmography (PPG) signal. Light is emitting into the tissue and the light reflected by or penetrating through blood in the blood vessel is measured by the photodetector (¶[0039]).
Chou’s system also obtains SPO2 (pulse oximetry level) data as described in ¶[0041]. Respiratory behavior, is the collection of the respiration related physiological information acquired by the optical sensor, including the low frequency respiratory behavior obtained by analyzing the PPG waveform and the RSA respiratory behavior obtained by calculating the heart rate (¶[0071]). Snoring related information (sounds of snoring) and sounds of breathing can be detected by the microphone at any position even not on the body, e.g., detected by the microphone of a cell phone (¶[0073]). The same kind of physiological information can be acquired by different kinds of physiological sensors and at different body regions. During sleep, more than one kind of physiological sensors can be used, more than one kind of physiological signals can be acquired and/or more than one body positions can be used to place the sensors. In practice, it is possible to combine all possibilities for various kinds of needs (¶[0083]). Sleep physiological information at least includes … blood oxygen saturation, … respiratory frequency (respiratory rate), breathing flow variations, respiratory behaviors, variations of breathing sounds, snoring related information … (¶[0092]). Sleep respiratory events include low oxygen level event (therefore, a drop in pulse oximetry is a low oxygen level event) (¶[0094]). The snoring which can be detected by the microphone or the accelerometer is adapted as the basis since snore mostly occurs before OSA happens (¶[0119]). The variations of respiratory amplitude, the variations of respiratory frequency and the variations of heart rate obtained from ECG signals also can be employed to reveal if apnea events and/or hypopnea events happened in the sleep duration. For example, when obstructive sleep apnea/hypopnea happens, the respiratory amplitude gradually decreases due to the more and more serious blockage of the upper airway and then recovers until the next event happens; the respiratory frequency rises sharply (change in respiratory rate) when awakeness or arousal happens and then recovers until the next event happens (¶[0222]).
Further, Chao teaches that because the physiological information is acquired by two devices, for effectively utilizing the information, it is very important to align timelines between multiple information (¶[0177]). The timeline alignment between the alarms provisions and the sleep positions is the basis for confirming the effects of alarm provisions, e.g., through the comparison therebetween, it can know that if the provision of alarms changes the sleep position and how are the effects of alarming strength, frequency and/or mode on the change of sleep position. It can reveal if the sleep respiratory event happened and further confirm what kind of sleep position is when the sleep respiratory event happened. The alignment of timelines among all kinds of physiological information is the basis of analysis and operation (¶[0178]). It can select to utilize time stamps for aligning timelines so as to integrate information (¶[0179]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to include at least one light emitting diode configured to emit light into the user’s body; at least one photodiode configured to detect light reflected from the user’s body and to generate a photoplethysmography signal as taught by Chou in the wearable electronic device of Su in order to obtain PPG signals which can be translated into data such as blood oxygen levels, heart rate, and respiratory events.
It further would have been obvious to processing the photoplethysmography signal to identify two or more photoplethysmography events, wherein the two or more photoplethysmography events include a respiration rate change and a pulse oximetry level drop and identify a snoring candidate event as an actual snoring event corresponding to the user when: (ii) the pulse oximetry level drops, and (iii) the respiration rate changes as taught by Chou in the wearable electronic device of Su because the PPG sensors are capable of obtaining information related to pulse oximetry and respiration rate, snoring is often the first occurrence of sleep apnea and OSA, and the these conditions lead to a decrease in blood oxygen levels and a change in respiratory frequency. Combining data helps various kinds of needs and therefore, having more information aids in confirmation of the source of the snoring.
Even further, it would have been obvious to align timestamps of the snoring candidate event with timestamps of the photoplethysmography events as taught by Chou in the wearable electronic device of Su in order to effectively utilize the provided information and can be done among all kinds of physiological information as the basis of analysis and operation.
Regarding claim 3, Su teaches wherein the at least one respiration event includes inhalation and exhalation times of the user (“Fig. 1A “the second breathing phase pattern can be determined based on sensor data captured by one or more photoplethysmogram (PPG) sensors ... Such sensor data can provide physiological information describing the user 102 of the wearable device 104, such as when the user 102 is inhaling and exhaling.” ¶[0034]).
Regarding claim 8, Su teaches wherein the processor is further operable to alert the user upon identification of one or more actual snoring events (Fig. 2A “the wearable device 200 may obtain data from the sensors 206, and may calculate metrics derived from such data … cause the wearable device to perform one or more actions (e.g., displaying a message, generating an alert, etc.)” ¶[0037] and Fig. 6K “the interface 674 can indicate a current noise level 676 detected by the wearable device” ¶[0064]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Su and Chou (hereinafter referred to as “modified Su”) as applied to claim 1 above, and in further view of Reuveny et al. (CA 3222817 A1, published Jan. 5, 2023, hereinafter referred to as “Reuveny”).
Modified Su teaches the wearable electronic device of claim 1.
Regarding claim 9, Su also teaches wherein the processor is further configured to: determine a severity of the actual snoring events (Fig. 6A “the snore graph 606 also includes a third visual graph 612 that represents snore intensity measurements determined as the user slept over the period of time” ¶[0057] and Fig. 6F “depending on the snoring intensity, the snore level 662 can be classified as “None to Mild”, “Moderate”, or “Loud”” ¶[0061]); and control the display to indicate the severity of the actual snoring events (Fig 6A-G “snore report that can be provided for presentation through … a wearable device (e.g., the wearable device 200 of FIG. 2)”; Fig. 6A “the snore graph 606 also includes a third visual graph 612 that represents snore intensity measurements determined as the user slept over the period of time” ¶[0057] and Fig. 6F “depending on the snoring intensity, the snore level 662 can be classified as “None to Mild”, “Moderate”, or “Loud”” ¶[0061]).
Modified Su does not disclose determining the severity based at least in part on at least one of: (i) a magnitude of a drop in pulse oximetry level occurring during the actual snoring event.
Reuveny’s invention relates to systems, methods, and components thereof to detect, prevent, mitigate and/or treat sleep disorders, including, but not limited to, sleep apnea. Data may be processed and evaluated to assess sleep apnea episode risk; and, where appropriate, the individual may be provided with tactile, electrical, and/or audio stimulation to interrupt apneic, near apneic, and/or otherwise disordered sleep (¶[007]). As in step 320 (Fig. 3), wake rules and thresholds may be set with respect to a person’s 105 respiratory quality signals, cardiac quality signals, and/or SpO2 levels (pulse oximetry level) (¶[066]). Respiratory, cardiac, and/or oxygen saturation conditions may be assigned values based on the likelihood that they indicate an ongoing apneic episode, correspond to impending apneic risk, and/or indicate another ongoing or impending disorder or condition. Thresholds values may be set accordingly. Apneic condition or risk level based on respiratory, cardiac, and/or oxygen saturation condition may be described for example as "severe apnea ongoing," "moderate apnea ongoing," "mild apnea ongoing," "high apneic risk," "moderate apneic risk," "mild apneic risk," etc. It is contemplated that such descriptions may correspond to objective numerical thresholds such as, for example, a measurable decrease in oxygen saturation levels (e.g., >3%, >4%, >5%, >10%, >15%, >20%, and/or the like) (magnitude of a drop in pulse oximetry level); an independent measure of oxygen saturation levels (e.g., <95%, <90%, <85%, <80%, <75%, and/or the like); etc. and/or a combination thereof (¶[068]). As in step 330, wake rules and thresholds may be set with respect to a person's 105 snoring (¶[073]). Respiratory, cardiac, and/or oxygen saturation conditions may be assigned values based on the likelihood that they indicate another ongoing problematic sleep condition (whether in addition to or distinct from apnea) or correspond to impending risk thereof. Such problematic include sleep conditions may include excessive snoring and/or the like (¶[071]). The snoring condition may be described generally – e.g., "severe snoring," "moderate snoring," "mild snoring," "high apneic risk”, etc. (¶[074]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to measure the severity of snoring or other sleep related disorders using at least in part the magnitude of drop in pulse oximetry level as taught by Reuveny in the wearable electronic device of modified Su in order to determine at which threshold the user’s sleep should be interrupted.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over modified Su, as applied to claim 1 above, and in further view of Laput et al. (US 20210063434 A1, published Mar. 4, 2021, hereinafter referred to as “Laput”).
Regarding claim 16, Modified Su teaches the wearable electronic device of claim 1. Modified Su does not disclose wherein the processor is further configured to detect obstruction of the microphone and adjust one or more thresholds for identifying snoring candidate events based on the detected obstruction.
Laput’s invention relates to detecting individual health related events (e.g., handwashing events) based on multiple sensors including motion and audio sensors (¶[0004]). the audio data corresponding to a hand rinsing event may be different depending on whether an audio sensor (e.g., a microphone) is obstructed. Clothing (e.g., a sleeve or glove), for example, can cover and obstruct the audio sensor. In some examples, the presence (or absence) of an obstruction can be estimated, and can be used to select the audio model from multiple audio models (and/or select the accelerometer model from multiple accelerometer models) that may be customized for higher accuracy of detecting handwashing events given those conditions (e.g., a sleeve audio model may be customized for muted audio, as opposed to a sleeveless audio model) (¶[0074]). In some examples, estimation of an obstruction can be based on one or more ambient light sensors. For example, a wearable device 150 can include one or more ambient light sensors (e.g., corresponding to sensors circuitry 211). In some examples, when an object covers the ambient light sensor or when in a low-light environment, the ambient light detected by the ambient light sensor(s) can be below a threshold (¶[0075]). Estimation of an obstruction can be based on a differential between different ambient light sensors (¶[0076]). The proximity of an object (within a threshold distance) can be indicative of an object covering the wearable device and/or obstructing the audio sensor. In some examples, the acoustic profile measured by the audio sensor can be used to predict or infer that the audio sensor is covered/obstructed and/or detect the act of covering (or uncovering) of the audio sensor (¶[0077]). Therefore, the device detects the microphone is obstructed or not and then the models are customized for higher accuracy depending on the condition.
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to have the processor be further configured to detect obstruction of the microphone and adjust one or more thresholds for identifying events (such as snoring candidate events) based on the detected obstruction as taught by Laput in the wearable electronic device of modified Su in order to customize the models/algorithm for higher accuracy of measurements and detection given the conditions of the microphone.
Conclusion
The following prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Budidha et al. (Photoplethysmography, Academic Press, 2022, Pages 43-47, previously cited in office action) – LEDs in PPG
Zavanelli et al. (US 11464451 B1, published October 11, 2022, previously cited in office action) – teaches wherein the two or more photoplethysmography events include a respiration rate change and a pulse oximetry level drop
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Emily N Cirulnick whose telephone number is (571)272-9734. The examiner can normally be reached M-Th 8-5:30 and every other F 8-4:30ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Unsu Jung can be reached at (571) 272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/E.N.C./Patent Examiner, Art Unit 3792
/ALLEN PORTER/Primary Examiner, Art Unit 3796
Prosecution Insights