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 Objections
Claim 6 is objected to because of the following informalities: Claim 6 recites “comprising” in line 2, but instead should be --comprises--. Appropriate correction is required.
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 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.
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.
Claims 1-4, 9, 10-13, and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Toong et al. (US 20210001122- Previously cited), hereinafter Toong, and further in view of Zhang et al. (US 20100076321), hereinafter Zhang.
Regarding claims 1, 10, and 19, Toong teaches a system, method, and non-transitory computer readable medium having instructions, comprising detecting an treating an occurrence of an apnea event during a sleep period of a user (see abstract), the system and method comprising:
affixing a patch externally on a dermis of the user, the patch comprising a flexible substrate, an adhesive on a first side adapted to adhere to the dermis of the user, a processor directly coupled to the substrate, and one or more sensors directly coupled to the substrate;
receiving biometric data corresponding to the user (¶ [0279], “The audio sensing device detects the sounds of snoring”);
determining an SpO2 level of the user using the one or more sensors (¶[0277-9,0312], “The oximeter monitors the saturation of peripheral oxygen (SpO2)”);
based at least on the determined SpO2 level, detecting the apnea event (¶0277,0279], “respiration monitoring device 3020 measures other biometric attributes of the user 3100 to determine the beginning of an apnea episode”);
in response to the detecting, treating the apnea event (¶ [0246,0276], “the patch is used to detect and then reduce/treat the number of apnea or hypopnea episodes during sleep”).
Toong fails to explicitly teach in response to the detecting and based on the biometric data, using a trained machine learning model to predict one or more comorbidities of the user.
Zhang teaches a system that is used to monitor biometric data, which is then used to detect abnormal physiological conditions (abstract and ¶[0088]). The biometric data along with physiological conditions including apnea are then analyzed, using a model, to determine one or more comorbidities (¶[0061-64,0070,0075,0087-88]).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Toong, such that in response to the detecting and based on the biometric data, using a trained machine learning model to predict one or more comorbidities of the user, as taught by Zhang, to aid in early identification of a worsening condition to reduce the frequency and length of hospitalization, improve the quality of life, or reduce health care costs (¶[0004]).
Regarding claims 2 and 11, Toong teaches treating comprising using an external hypoglossal nerve stimulator (¶ [0163,0247], “The TNSS creates an action potential through an externally applied electric field from outside the body” and “stimulating the hypoglossal nerve to relieve apnea to provide a closed-loop system”).
Regarding claims 3 and 12, Toong teaches treating comprising using an internal hypoglossal nerve stimulator system (¶ [0165,0247], “electric fields capable of causing action potentials can be generated by electronic stimulators connected to electrodes that are implanted surgically . . . . Such devices may be used instead of implants and/or with implants”, and “stimulating the hypoglossal nerve to relieve apnea to provide a closed-loop system”).
Regarding claims 4 and 13, Toong teaches treating comprising using a positive airway pressure device (¶ [0336], “Use of OSA system 3000 avoids awakening the user to administer CPAP to observe the effects of treatment”).
Regarding claims 9 and 18, Tong teaches the patch in wireless communication with a smart device (¶ [0064,0073], the patch communicates with a smart phone).
Claims 5, 14, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Toong in view of Zhang, as applied to claim 1, and further in view of Bandyopadhyay et al. (US 20170055898- Previously cited), hereinafter Band.
Regarding claims 5, 14 and 20, Toong-Zhang fail to teach the using the trained machine learning model comprising training the machine learning model using input PSG recordings.
Band teaches a system for determining sleep stages and sleep events using sensor data (abstract). The sensor data is used to detect audio signals when the user is sleeping to then determine patterns and match the patterns to a trained neural network (¶ [0153], “ The microphone audio signals, when available, can be used to detect sleep apnea event and breathing patterns and rates. This can be implemented using pattern matching methods or neural networks trained on data from patients with obstructive sleep apnea”). Band teaches determining patterns in the data comprising a machine learning model using input polysomnography (PSG) recordings (¶ [0008,0152-153], “The systems described herein can use a variety of techniques to analyze sleep-related sensor data and estimate sleep stages and sleep events from the data,” “The source of the data, for the method and system disclosed herein, can be from PSGs in a sleep laboratory or sensors worn on the body,” and “This can be implemented using pattern matching methods or neural networks trained on data from patients with obstructive sleep apnea”). Toong notes, “analysis of large amounts of data to detect patterns of sensing and stimulation, apply machine learning, and improve algorithms and functions,” thereby indicating that multiple datasets from different sensors aids in detecting abnormalities, e.g. apnea (¶ [0156-57]).
As such, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Toong-Zhang, such that the using the trained machine learning model comprising training the machine learning model using input PSG recordings, as taught by Band, to aid in detecting sleep apnea and breathing patterns and rates (¶ [0153] of Band).
Claims 6, 15, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Toong in view of Zhang, as applied to claim 1, and further in view of Apte et al. (US 20120286520), hereinafter Apte.
Regarding claims 6, 15, and 21, Toong-Zhang fail to teach wherein the biometric data comprises at least one of obesity, restless leg syndrome, periodic leg movement disorder, or bruxism.
Apte teaches a system for characterizing one or more sleep related conditions and determining one or more therapies based on the characterization (abstract). The system is configured to perform cross-condition analyses for a plurality of sleep related conditions, e.g., determining comorbidities (¶[0019]). The sleep related conditions that are obtained include apnea, bruxism, restless legs syndrome, etc. (¶[0022]). Therefore, Apte’s system requires obtaining biometrics to determine comorbidities which are then used to provide therapy (¶[0016]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Toong-Zhang, such that biometric data comprises at least one of obesity, restless leg syndrome, periodic leg movement disorder, or bruxism, as taught by Apte, to aid in characterizing one or more sleep related conditions and providing therapy based on the characterization.
Claims 8, 17, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Toong in view of Zhang, as applied to claim 1, and further in view of Danilov et al. (US 8849407), hereinafter Danilov.
Regarding claims 8, 17, and 22, Toong-Zhang fail to teach wherein the patch comprises a first portion adapted to be placed on a bridge of a nose of the user and at least one second portion adapted to be placed on a cheek of the user.
Danilov teaches an electrode patch in the form of a mask or single patch that comprises a plurality of portions (figs. 1-3, mask 12). The mask/patch comprise a plurality of electrodes that cover all of the nose and cheeks to aid in monitoring the user’s conditions without the need for intrusive measures or other burdensome or painful procedures (col. 2-3 and 4, ln. [65-67;1-11;14-25]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Toon-Zhang, such that wherein the patch comprises a first portion adapted to be placed on a bridge of a nose of the user and at least one second portion adapted to be placed on a cheek of the user, at taught by Danilov, to aid in monitoring the user’s conditions without the need for intrusive measures or other burdensome or painful procedures.
Response to Arguments
Applicant's arguments filed 02/20/2026 have been fully considered but they are not persuasive.
Applicant’s arguments with respect to 35 U.S.C. 103 rejection of amended claims have been considered but are moot because amendments require new grounds of rejection.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Manogue teaches stimulation may be performed using one or more patches configured to cover part of the body each containing one or more electrodes (an array of 2, 3, 4, 5, 10, or more electrodes) configured to cover part of the body (e.g. cheek, forehead, head, neck, nose, scalp, etc.) in a position sufficient to provide stimulation. US 20200094055
Wren teaches medical information associated with the user can include any medical condition, disease, affliction, etc. that the user might be suffering from, such as hypertension, drug-resistant hypertension, diabetes, chronic obstructive pulmonary disease (COPD), asthma, obesity, depression, gastroesophageal reflux disease (GERD), hypercholesterolemia, diabetes mellitus, strokes, heart attacks, heart failure, or any combination thereof. The medical information can be analyzed to determine various comorbidities of the user. US 20230343435
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 MARTIN NATHAN ORTEGA whose telephone number is (571)270-7801. The examiner can normally be reached M-F 7:10 am - 5:00 pm.
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/MARTIN NATHAN ORTEGA/Examiner, Art Unit 3791 /TSE CHEN/Supervisory Patent Examiner, Art Unit 3791
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