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 amendment filed Feb. 25, 2026 has been entered. Claims 1, 3, 8-11, and 14-15 remain pending in the application. Applicant’s amendments to the Specification, Drawings, and Claims have overcome each and every objection, and 112(b) and 101 rejections previously set forth in the Non-Final Office Action mailed Nov. 25, 2025.
Response to Arguments
Drawings:
Applicant amended drawings and addressed all previous objections and the objections have been withdrawn.
Specification:
Applicant amended specification and addressed all previous objections and the objections have been withdrawn.
35 USC § 101:
Applicant amended independent claim 1 to incorporate limitations from originally filed dependent claims 6 and 7. This successfully overcomes the previous rejection under 35 U.S.C. 101 and the rejection is withdrawn.
35 USC § 103:
Applicant’s arguments filed Feb. 25, 2026 with respect to claims 1, 3, 8-11, and 14-15 have been considered but are moot because the new ground of rejection necessitated by applicant's amendment. However below response addresses arguments still relevant to the new ground of rejection set forth below.
On page 4 of Applicant’s response, applicant argues that Su is limited to respiratory phase alone and nothing is taught to impose a second confirmation requirement. On page 4 of Applicant’s response, applicant argues that Budidha does not remedy the deficiencies of Su and does not teach or suggest the amended claim limitations. Further, on page 5 of Applicant’s response, applicant argues that Zavanelli does not teach oxygen desaturation as event as a required confirmation condition. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Further, MPEP § 2144 discusses supporting a rejection under 35 U.S.C. 103, with MPEP § 2144(I) specifically noting that the rationale to modify or combine the prior art does not have to be expressly stated in the prior art; the rationale may be expressly or impliedly contained in the prior art or it may be reasoned from knowledge generally available to one of ordinary skill in the art, established scientific principles, or legal precedent established by prior case law. The test for obviousness is what the combined teachings of the references would have suggested to a person having ordinary skill in the art. In this case, the new ground of rejection set forth below is a combined teaching of Su, Budidha, and Zavanelli. Therefore, while Su may be limited to determining respiratory condition without having the secondary confirmation, Zavanelli may not teach using oxygen desaturation event as a required condition for determining that snoring corresponds to the wearer, and Budidha may not associate PPG with snoring, Zavanelli does teach that having the pulse oximetry helps detect OSA and can be used in to detect other respiratory disturbances. Additionally, adding an extra step would permit an even stronger case of where the noise originated.
On page 5 of Applicant’s response, applicant argues that even if one were to combine Su, Budidha, and Zavanelli, the resulting system would still lack the claimed decision architecture and would require additional steps. Specifically, regarding their arguments that none of the references teach or suggest the amended limitations for identifying a snoring candidate event as an actual snoring event when both respiratory correspondence and contemporaneous physiological change is present. The arguments have been fully considered but are considered moot as set forth by the new ground of rejection below. Su’s respiratory system and method collects a variety of sensor data in order to determine various sleep related information accurately (¶[0034]). Zavanelli further teach the importance of measuring heart rate variability and blood oxygen levels to determine sleep quality. Therefore, the suggested modifications to include these additional physiological parameters of Zavanelli in the system and method of Su would have been obvious in order to more accurately assess sleep quality.
On pages 5-6 of Applicant’s response, applicant argues that Su does not teach the additional limitations of claims 9 and 15 and that Budidha and Zavanelli also do not teach determining a severity based on the magnitude of oxygen desaturation. Applicant’s arguments have been considered but are moot based on the new ground of rejection which addresses the amended claim limitation.
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 Budidha et al. (Photoplethysmography, Academic Press, 2022, Pages 43-47, cited in the previous office action, hereinafter referred to as “Budidha”) and Zavanelli et al. (US 11464451 B1, published October 11, 2022, hereinafter referred to as “Zavanelli”).
Regarding claim 1 and 10, 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 times 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 times 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 at least one 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 when: (i) a time associated with the snoring candidate event corresponds to the at least one 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 (at least one 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] and 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]), 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.
Budidha teaches photoplethysmography (PPG) is a noninvasive and affordable optical technique that uses a light source and a photon detector on the surface of the skin to continuously record variations in the light intensity scattered by the vascular tissues (page 43). The light from the light source is guided into a vascular tissue … a certain amount is absorbed by the tissue, and the scattered light is reflected or transmitted, depending on the measurement modality being used. The scattered protons are then detected by the photodetector (page 44). The most commonly used emitter in a PPG sensor is the light emitting diode (LED) and they make a great choice due to their small footprint and widespread wavelengths (page 45). The photodetector in a PPG sensor detects the back-scattered or transmitted light photons from the tissue and produces an electrical signal proportional to the number of photons detected over time. The most widely used photodetector in PPG is a silicon photodiode (page 46). One of the key reasons photodiodes are chosen over phototransistors is the linearity of the component (page 47).
Therefore, it would have been it would have been obvious to a person having ordinary skill in the art (PHOSITA) before the effective filing date of the claimed invention to use LEDs and photodiodes in the device of Su as taught by Budidha because LEDs have a small footprint and widespread wavelengths and photodiodes have better linearity than other photodetectors.
Su and Budidha do not disclose processing the photoplethysmography signal to identify two or more photoplethysmography events, wherein the two or more photoplethysmography events include at least one of heart rate variability and pulse oximetry level; identify a snoring candidate event as an actual snoring event corresponding to the user when: (ii) a physiological change event occurs within the time associated with the snoring candidate event, wherein the physiological change event comprises at least one of a drop in pulse oximetry level.
Zavanelli’s device relates to a patch device that includes sensors configured to be positioned over a chest of a patient that can include PPG sensors and that are used for monitoring of sleep apnea and other sleep-related disorders based on readings of a plurality of factors. One embodiment includes photoplethysmography-detected oxygen desaturations (drop in pulse oximetry level) via at least one light emitting diode and one photodiode (Col. 3, line 51-53). The device can obtain cardiorespiratory parameters that may include respiratory effort derived from inertial measures of heart rate variability and blood oxygen saturation (SpO2) (pulse oximetry level) derived from optical measures of blood flow via the PPG sensor 221 in Fig. 2 and heart rate and heart rate variability derived from the PPG sensor 221 (Col. 12, lines 39-51). A user with OSA (obstructive sleep apnea) may have restricted breathing during the series of respiratory disturbances, which can lead to a decrease of blood-oxygen levels (a physiological change event occurs within the time associated with the snoring candidate event) (Col. 29, lines 63-65).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to identify two PPG derived signals including pulse oximetry levels and determine a user has an actual health event during a drop in pulse oximetry level as taught by Zavanelli in the device of Su and Budidha in order to detect OSA and can be used in to detect other respiratory disturbances. Additionally, adding an extra step would permit an even stronger case of where the noise originated.
Regarding claims 3 and 11, 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 and 14, 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]).
Claims 9 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Su, Budidha, and Zavanelli (hereinafter referred to as “modified Su”) as applied to claims 1 and 10 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 claims 1 and 10.
Regarding claim 9 and 15, 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.
Conclusion
The following prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Fonseca et al. (US 20240000349 A1, published Jan. 4, 2024) – conserving power by activating and deactivating the pulse oximetry sensor based on breathing when oxygen desaturation is more likely to occur
Brumback (US 20140378787 A1) – wearable watch with PPG LED and photodiode
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 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
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792