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 Arguments
Applicant’s arguments, see pg. 8-10, filed 05/12/2026, with respect to the 35 USC 112(b) rejections of claims 1-16, 5, 10 and 16, 10, 15 and 16 have been fully considered and are persuasive. The 112(b) rejections of claims 1-16 (regarding “trigger event”, “detection of light”, “non-therapy usage”, “therapy usage”, and “comparing the sleep score for the user to the user’s completion of the task”) have been withdrawn.
Applicant's arguments, see pg. 9, filed 05/12/2026, with respect to the 35 USC 112(b) rejection of claims 10 and 16 (regarding “preventing”) have been fully considered but they are not persuasive. Applicant argues that the method prevents the noise data from being stored when the trigger event is not detected to enhance privacy. The Examiner acknowledges the purpose for this limitation, but maintains the argument that the word “prevent” is indefinite. The Examiner has interpreted the claim as only storing noise data when the trigger event is detected.
Applicant's arguments, see pg. 10-13, filed 05/12/2026, with respect to the 35 USC 101 rejection of claims 1-16 have been fully considered but they are not persuasive. Applicant argues that the amendment to independent claim 1 to include the limitation: “performing machine-based acoustic pattern recognition” to detect trigger/wake events (via a control system) overcomes the rejection. The Examiner disagrees. Machine-based acoustic pattern recognition performed on a control system amounts to recitation of a generic controller. As detailed in the non-final filed 03/30/2026, when the claims, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it is still in the mental processes grouping unless the claim limitation cannot practically be performed in the mind. Likewise, performance of a claim limitation using generic computer components does not preclude the claim limitation from being in the mental processes grouping. A human could observe/hear an audio signal and recognize patterns in the signal (e.g., recognize when a person starts snoring or wakes up). Stating that the pattern recognition is machine-based does not practically integrate the limitation. Therefore, the Examiner maintains the 35 USC 101 rejection of claims 1-16.
Applicant’s arguments, see pg. 13-17, filed 05/12/2026, with respect to the 35 USC 102(a)(1) rejections of claims 1-9, 11-12 and the 35 USC 103 rejections of claims 10, 13-14, 15-16 have been fully considered. The Examiner agrees that the amendments to claim 1 to include the added limitation: calculating a sleep score based on noise data “captured between the detecting the trigger event and the detecting the wake event” overcomes the rejection detailed in the non-final filed 03/30/2026. Since claim 1 was amended to include new limitations, new grounds for rejection are warranted for independent claim 1 and dependent claims 3-13, 15-16. See prior art rejections below.
Claim Rejections - 35 USC § 112
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.
Claim 6 is 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.
Regarding claim 6, the phrase “preventing” renders the claim indefinite because it is unclear whether noise data portions are actually not stored when the trigger event is not detected, or if the method simply attempts or “prevents” them from being stored. For the purpose of continued examination, The Examiner has interpreted the claim as only storing noise data when the trigger event is detected.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 3-13, 15-16 are rejected under 35 U.S.C 101 because the claimed invention is directed to non-statutory subject matter of abstract ideas under the mental processes grouping, without significantly more.
The framework for establishing a prima facie case of lack of subject matter eligibility requires that the Examiner determine: (1) Does the claim fall within the four categories of patent eligible subject matter; (2a) Prong 1: Does the claim recite an abstract idea, law of nature, or natural phenomenon and (2a) Prong 2: Does the claim recite additional elements that integrate the judicial exception into a practical application; and (2b) Does the claim recite additional elements that amount of significantly more than the judicial exception.
Step (1)
The claimed invention in claims 1, 3-13, 15-16 is directed to statutory subject matter as the claims recite a method for gathering data and adjusting parameters to calculate a sleep score, and thus, the claims all fall under one of the four patent eligible categories.
Step (2a) Prong 1 (Judicial Exception)
Regarding claims 1, 3-13, 15-16, the recited steps are directed to mental processes of performing concepts in a human mind or by a human using a pen and paper (See MPEP 2106.04(a)(2) subsection (III)).
Independent claim 1 recites:
detecting… a trigger event, wherein the trigger event is the user snoring and the detecting the trigger event comprises performing… acoustic pattern recognition;
in response to detecting the trigger event, storing… at least a portion of the noise data;
detecting…. a wake event, wherein the detecting the wake event comprises performing… acoustic pattern recognition: and
calculating… based on the at least a portion of the noise data captured between the detecting the trigger event and the detecting the wake event, the sleep score for the user.
Under the broadest reasonable interpretation, these limitations require detecting a trigger event (snoring) based on patterns in noise data, storing a portion of the noise data, detecting a wake event based on patterns in noise data, and calculating a sleep score. These limitations are processes that, as drafted, cover that which can be wholly performed in a person’s mind via a series of mental observations and judgements. In particular, a person could observe a person sleeping and determine when they hear snoring, when they hear them wake up, and then calculate a score based on their observations. These are data gathering and processing steps (capturing, detecting, storing, calculating) that reflect mental processes (e.g., storing and calculating parameters based on the noise data).
Accordingly, claim 1 is directed to a judicial exception including one or more abstract ideas, specifically mental processes.
Independent claim 1 recites the corresponding apparatus associated with the method, including a microphone and control system. Under the broadest reasonable interpretation, the claim also recites a judicial exception including one or more abstract ideas under the mental processes bucket.
The dependent claims recite additional limitations for detecting trigger events and calculating a sleep score, including additional types of data to be collected, data storage instructions, sleep score calculations, and therapy usage recommendations. These limitations also fall within the judicial exception of mental processes.
Step (2a) Prong 2 (Integration into a Practical Application)
This part of the eligibility analysis evaluates whether the claim as a whole integrates the recited judicial exception into a practical application of the exception. This evaluation is performed by (1) identifying whether there are any additional elements recited in the claim beyond the judicial exception, and (2) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. MPEP 2106.04(d).
For claims 1, 3-13, 15-16, the judicial exception is not integrated into a practical application.
Regarding claim 1, the additional element of a microphone for capturing noise data amounts to recitation of a generic microphone. Under the broadest reasonable interpretation, this element is nothing more than the pre-solution activity of mere data gathering using generic components.
Regarding claim 1, the additional element of a control system amounts to recitation of a generic controller. This additional element merely defines the field of user of the current claim. This additional element does not practically integrate the judicial exception because this element does not provide improvements to the functioning of a computer or to any the technical field under MPEP 2106.05(a). Furthermore, when the claims, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it is still in the mental processes grouping unless the claim limitation cannot practically be performed in the mind. Likewise, performance of a claim limitation using generic computer components does not preclude the claim limitation from being in the mental processes grouping.
The additional elements in claims 3, 8, and 15 (microphone, respiratory device, movement sensor, mobile device) amounts to recitation of generic sensing components. Under the broadest reasonable interpretation, these elements are nothing more than the pre-solution activity of mere data gathering using generic components.
Step (2b) (Inventive Concept)
The claims also do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the judicial exception into a practical application, the additional elements of a microphone and control system in the field of sleep monitoring are well-understood, routine and conventional activities previously known in the industry as indicated in the following references:
Tiron et al. (US Pre-Grant Publication 2022/0007965) teaches a microphone (microphone or sound sensor 7302) and control system (central controller 4302).
Wren et al. (US Pre-Grant Publication 2022/0339380) teaches a microphone (microphone 140) and control system (control system 110).
Dependent claims 4-7, 9-13, and 16 are further directed towards insignificant extra-solution activities (MPEP 2106.05(g)) and do not introduce any additional elements which amount to significantly more under the Step 2A prong 2 and Step 2B analyses.
Dependent claims 3, 8, and 15 recite a respiratory therapy device, movement sensor, and mobile device, which are also recited at a high level of generality and are considered to be well-known, routine and conventional in the art as indicated in the following references:
Tiron et al. (US Pre-Grant Publication 2022/0007965) teaches a respiratory therapy device (RT device 4000), movement sensor (motion sensor 7010), and mobile device (mobile phone or processing device 7100, Fig. 7B-2).
Wren et al. (US Pre-Grant Publication 2022/0339380) teaches a respiratory therapy device (respiratory device 122), movement sensor (motion sensor 138), and mobile device ([0066], external device 170 can be mobile device).
Accordingly, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. Claims 1, 3-13, 15-16 are thus rejected under 35 USC 101 for reciting patent-ineligible subject matter- abstract ideas.
Claim Rejections - 35 USC § 103
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, 3-9, 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Tiron et al. (US Pre-Grant Publication 2022/0007965), hereinafter ‘Tiron’, in view of Cho (Korean Patent Publication 10-2444598), hereinafter ‘Cho’, further in view of Barker et al. (US Pre-Grant Publication 2021/0161465), hereinafter ‘Barker’. Citations from Cho are in parenthesis and directly copied from the English translation, which is attached to the office action.
Regarding claim 1, Tiron teaches a method for calculating a sleep score for a user ([0242], providing sleep score, sleep score 8926, Fig. 8B), the method comprising:
capturing, via a microphone (microphone or sound sensor 7302, Fig. 7B-2), noise data associated with the user sleeping ([0172], audio analysis);
detecting, via a control system (processing device 7100) based on the noise data, a trigger event, wherein the trigger event is the user snoring (feature extraction process/module 8914 determines outputs such as coughing, soring, wheezing, gasping, etc.) and detecting the trigger event comprises performing machine-based acoustic pattern recognition ([0295]);
in response to detecting the trigger event, storing (memory/data storage 7312, Fig. 7B-3), by the control system, at least a portion of the noise data ([0136], data storage);
detecting, via the control system based on the noise data, a wake event ([0211], sleep/wake differentiation), wherein the detecting the wake event comprises performing machine-based acoustic pattern recognition ([0295]); and
calculating, by the control system based on the at least a portion of the noise data, the sleep score for the user ([0242], system provides sleep score).
Tiron does not specifically teach calculating the sleep score based on the at least a portion of the noise data between the trigger/wake event.
Cho teaches a sleep apnea measurement system (abstract), further comprising:
calculating, by the control system based on the at least a portion of the noise data captured between the detecting the trigger event and the detecting the wake event, the sleep score for the user (“The mobile terminal 100 recognizes that the user starts snoring when a sound signal equal to or higher than the first set decibel is collected through the snoring detecting unit 130 , and from this point on, the signal collected through the snoring detecting unit 130”) (“Steps S401 to S409 are performed until the power supply of the oxygen saturation measuring device 200 is completely discharged, or until the user wakes up”).
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified Tiron to incorporate the teachings of Cho to include calculating the sleep score when snoring is detected until the wake event is detected. Doing so would address privacy concerns while still storing data that is helpful to determine the user’s physical condition, as recognized by Barker [0279].
Regarding claim 3, Tiron, Cho, and Barker teach the method according to claim 1. Tiron teaches the method further comprising:
wherein the microphone is associated with one or more of a respiratory therapy device and a mobile device ([0061], processing device can include respiratory therapy device or smart devices, and microphone can be coupled to it)
Regarding claim 4, Tiron, Cho, and Barker teach the method according to claim 1. Tiron teaches the method further comprising:
wherein the sleep score is calculated based on a number of disturbances detected in the at least a portion of the noise data ([0341], processor adjusts sleep score based on disruptions).
Regarding claim 5, Tiron, Cho, and Barker teach the method according to claim 4. Tiron teaches the method further comprising:
wherein the disturbances include one or more of detection of sound, detection of movement, a time to fall asleep, and a time asleep ([0055-0057], detecting coughing, [0481], detecting waking, Fig. 7B-2, process 7204).
Regarding claim 6, this claim is rejected under 35 USC 112(b), please refer to Examiner’s interpretation above.
Tiron, Cho, and Barker teach the method according to claim 1. Cho teaches the method further comprising:
preventing portions of the noise data from being stored when the trigger event is not detected (“When the measurement of sleep apnea starts, the mobile terminal 100 collects the surrounding sound in real time through the microphone 110 (S501)”)
Regarding claim 7, Tiron, Cho, and Barker teach the method according to claim 1. Tiron teaches the method further comprising:
detecting, based on the noise data, a wake event ([0211], sleep/wake differentiation);
wherein the sleep score is calculated based on the at least a portion of the noise data between the detecting the trigger event and the detecting the wake event ([0481], system determines detected snoring is not from user since they are awake).
Regarding claim 8, Tiron, Cho, and Barker teach the method according to claim 1. Tiron teaches the method further comprising:
detecting, via a movement sensor (motion sensor 7010, Fig. 7C-1), movement data for the user ([0142], bodily movement of patient);
wherein the calculating the sleep score for the user is further based on the movement data ([0467], movement/activity counts determined by 8912, Fig. 8B)
Regarding claim 9, Tiron, Cho, and Barker teach the method according to claim 1. Tiron teaches the method further comprising:
comparing, by the control system, the sleep score for the user with historical sleep score information ([0392], using current cough score compared to personal baseline cough score, [0460], comparisons of various aspects of sleep related parameters).
Regarding claim 11, Tiron, Cho, and Barker teach the method according to claim 9. Tiron teaches the method further comprising:
determining, by the control system based on the comparing the sleep score for the user with the historical sleep score information, a therapy usage recommendation for the user ([0058, 0228, 0366, 0501, 0747] discuss adjusting setting of a treatment device, or recommending different type of therapy based on sleep score or other sleep breathing events).
Regarding claim 12, Tiron, Cho, and Barker teach the method according to claim 11. Tiron teaches the method further comprising:
the therapy usage recommendation for the user includes one or more of a recommended number of nights for therapy usage, recommended duration of therapy usage, and recommended frequency of therapy usage ([0440], patient offered various exercise regimes, treatments, changes, etc.).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Tiron et al. (US Pre-Grant Publication 2022/0007965) in view of Cho (Korean Patent Publication 10-2444598) further in view of Barker et al. (US Pre-Grant Publication 2021/0161465), further in view of Kilroy et al. (US Pre-Grant Publication 2025/0073403), hereinafter ‘Kilroy’.
Regarding claim 10, Tiron, Cho, and Barker teach the method according to claim 9, but do not explicitly teach comparing sleep scores of when a user uses therapy to when the user does not.
Kilroy teaches calculation of a sleep performance score (abstract), further comprising:
the historical sleep score information is based on therapy usage and the sleep score for the user is based on non-therapy usage ([0018], relationship between sleep stage and use of respiratory therapy system, Fig. 6).
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified Tiron, Cho, and Barker to incorporate the teachings of Kilroy to include comparing sleep scores of when a user uses therapy to when the user does not. Doing so would encourage user compliance, as recognized by Kilroy [0049].
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Tiron et al. (US Pre-Grant Publication 2022/0007965) in view of Cho (Korean Patent Publication 10-2444598) further in view of Barker et al. (US Pre-Grant Publication 2021/0161465), further in view of Wren et al. (US Pre-Grant Publication 2022/0339380), hereinafter ‘Wren’.
Regarding claim 13, Tiron, Cho, and Barker teach the method of claim 11, but do not teach analyzing therapy usage trends.
Wren teaches a system/method for determining sleep parameter for a user, the method further comprising:
analyzing, by the control system (control system 110), therapy usage trends ([0090], system compares reports to determine trends and provide recommendations)
wherein the therapy usage recommendation for the user is further based on the therapy usage trends ([0096], recommendations regarding use of therapy device 122).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tiron, Cho and Barker to incorporate the teachings of Wren to include different types of therapy usage recommendations. Doing so would aid in improving the quality of the sleep score, as recognized by Wren [0094].
Claims 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Tiron et al. (US Pre-Grant Publication 2022/0007965) in view of Cho (Korean Patent Publication 10-2444598) further in view of Barker et al. (US Pre-Grant Publication 2021/0161465), further in view of Dothie et al. (US Pre-Grant Publication 2011/0015495), hereinafter ‘Dothie’.
Regarding claim 15, Tiron, Cho, and Barker teach the method according to claim 1, but do not teach presenting a task to the user.
Dothie teaches a system and method for managing a user’s sleep (Fig. 1), the method further comprising:
presenting, to the user via a mobile device (Fig. 2), a task to complete (Figs. 11(a), 11(b)), cognitive task);
evaluating, by the control system (processing means 16, Fig. 3), the user's completion of the task ([0176], collect data on cognitive/psychomotor performance); and
comparing the sleep score for the user to the user's completion of the task ([0141], processing unit tracks changes in sleep quality and performance metrics).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tiron, Cho, and Barker to incorporate the teachings of Dothie to include presenting the user with a task and comparing their performance to the sleep score. Doing so would allow the user to track how higher sleep quality may positively impact their cognitive performance and vice versa, as recognized by Dothie [0141].
Regarding claim 16, Tiron, Cho, Barker, and Dothie teach the method according to claim 15. Dothie teaches the method further comprising:
wherein the user's completion of the task is evaluated over a period of time ([0152], tests carried out over different time periods);
wherein the comparing the sleep score for the user to the user's completion of the task indicates correlations between therapy usage and non-therapy usage for the completion of the task ([0147], establish correlations between objective data collected while user is asleep).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tiron, Cho, and Barker to incorporate the teachings of Dothie to include presenting the user with a task and comparing their performance to the sleep score. Doing so would allow the user to track how higher sleep quality may positively impact their cognitive performance and vice versa, as recognized by Dothie [0141].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Shouldice et al. (US Pre-Grant Publication 2025/0134451) teaches methods for determining sleep-related physiological parameters to generate a sleep disorder prediction (abstract).
Tsutsumi et al. (US Pre-Grant Publication 2014/0323919) teaches a sleep evaluation device (abstract).
Kourtis et al. (US Pre-Grant Publication 2023/0274833) teaches a method for receiving physiological data and withholding an indicated set of data (abstract).
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 ELIZABETH L OKONAK whose telephone number is (571)272-1594. The examiner can normally be reached Monday-Friday 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at (571) 270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/E.L.O./Examiner, Art Unit 3792
/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796