DETAILED ACTION
This Office Action is in response to the filing of an amendment to the claims on 12/04/2025 and accompanying arguments. As per the amendment, claim 7 has been amended, and no claims have been added or cancelled. Thus, claims 1-7, 9, 11, 13-14, 16, 18-21, 25-26, 32-36, and 38-42 are pending in the application.
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
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)(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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 4-7, 9, 11, 13-14, 16, 18, 20-21, 25-26, 32-33, and 38 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by McMahon (US Pub. 2018/0256069).
The applied reference has a common assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Regarding claim 1, McMahon discloses a method comprising: receiving, from one or more sensors, data associated with a sleep session of a user (see [0047] and [0108] where a sound sensor records sleep audio), the data including (i) respiration data associated with the user during at least a portion of the sleep session (see [0120] and [0141] where the measured snore signal can be used to derive a respiration rate) and (ii) audio data reproducible as one or more sounds associated with the user during at least a portion of the sleep session (see [0152] where the audio signal is analyzed for the presence of apnea snoring, the measured audio signals capable of being listened to as seen in [0132]); determining a respiration signal associated with the user during the sleep session based, at least in part, on at least a portion of the data (see [0120] and [0141] where the respiration rate data is based at least in part on the measured audio data); identifying an event experienced by the user during the sleep session based, at least in part, on at least a portion of the data (see [0152]-[0153] where the audio signals are used for determination of an apnea event); and causing to be communicated to the user via a user device (see [0158]-[0163] where a display screen of device 20 is a user device) (i) a graphical representation of a portion of the respiration signal (see [0158]-[0163] where the display can display data, such as the measurement indices and statistics, like the AHI) and (ii) an event indication that aids in identifying the identified event within the graphical representation of the portion of the respiration signal (see [0158]-[0163] and Fig. 10 where the graph can display indicia that represent an event, such as SDB, apnea, hypopnea, snore, and CSR).
Regarding claim 2, McMahon discloses causing a portion of the audio data associated with the identified event to be communicated to the user via the user device (see [0158]-[0163] where audio data, such as the snoring time, can be communicated to the user device).
Regarding claim 4, McMahon discloses wherein the event indication is at least partially overlaid on or adjacent to the displayed graphical representation of the portion of the respiration signal (see [0158]-[0163] and Fig. 10 where the report 191 displays a plurality of outputs adjacent to one another, such that event counts such as AHI can be displayed adjacent to the respiration data).
Regarding claim 5, McMahon discloses wherein the event indication includes a graphical indication, alphanumeric text, or both (see [0158]-[0163] and Fig. 10, where an event indication, such as AHI, is shown by graphically and alphanumerically. Additionally, an indication on a display is understood to require at least one of a graphical indication and alphanumeric text).
Regarding claim 6, McMahon discloses determining one or more sleep-related parameters associated with the sleep session of the user based at least in part on the data (see [0155] where sleep parameters are determined); and causing an indication associated with the determined one or more sleep-related parameters to be communicated to the user via the user device (see [0158]-[0163] where the sleep related parameters can be communicated to a user).
Regarding claim 7, McMahon discloses wherein the one or more sleep-related parameters include an apnea-hypopnea index (AHI), a sleep score, a total sleep time, or any combination thereof (see [0155]).
Regarding claim 9, McMahon discloses wherein the identified event is, an apnea, a central apnea, or a hypopnea (see [0152]-[0153] where detected events can be apnea, CSR (central apnea), and hypopnea).
Regarding claim 11, McMahon discloses wherein the one or more sensors include a microphone, or an acoustic sensor (see [0104]).
Regarding claim 13, McMahon discloses wherein the user device is a smartphone (see [0021]).
Regarding claim 14, McMahon discloses identifying, based at least in part on the data, a second event experienced by the user during the sleep session (see [0152]-[0154] where multiple events can be identified, both different types and pluralities of the same type); and causing to be communicated to the user via the user device a second event indication that aids in identifying the identified second event within the graphical representation of the portion of the respiration signal (see [0158]-[0163] where the display is able to receive data regarding a plurality of different events to be seen by the user in graphical representation).
Regarding claim 16, McMahon discloses wherein the portion of the respiration signal is associated with one of (b) between about 20 seconds and about 10 minutes of the sleep session (see [0141] and [0143] where a time period for breathing analysis can be 10 minutes).
Regarding claim 18, McMahon discloses wherein the identifying the event includes selecting the event from a plurality of events experienced by the user during the sleep session (see [0153] where the system makes identifies the type of event that occurs).
Regarding claim 20, McMahon discloses wherein the selecting the event from the plurality of events includes analyzing the data to identify (i) one or more breathing pauses of the user during the sleep session (see [0153]), (ii) a frequency of the one or more sounds in the audio data during the sleep session (see [0153]), (iv) an amplitude of the one or more sounds in the audio data during the sleep session (see [0153]), or (vi) any combination thereof (see [0153]).
Regarding claim 21, McMahon discloses wherein the event selected from the plurality of events is associated with one selected from the group consisting of: (a) a breathing pause that is greater than a breathing pause for each of the other ones of the plurality of events (see [0153] where a breathing pause of an apnea is a larger pause than a detected CSR).
Regarding claim 25, McMahon discloses wherein the at least a portion of the data for determining the respiration signal includes at least a portion of the respiration data (see [0120] and [0141] where the measured snore signal can be used to derive a respiration rate, where snore data feeds into a respiration rate signal, snore detection being a breathing rate variable).
Regarding claim 26, McMahon discloses wherein the at least a portion of the data for determining the respiration signal also includes at least a portion of the audio data (see [0120] and [0141] where the measured snore signal can be used to derive a respiration rate, where snore data feeds into a respiration rate signal, the snore detection coming from audio data).
Regarding claim 32, McMahon discloses a system comprising: a memory storing machine-readable instructions (see [0103]); and a control system including one or more processors configured to execute the machine- readable instructions (see [0103]-[0104]) to: receive data associated with a sleep session of a user (see [0047] and [0108] where a sound sensor records sleep audio), the data including (i) respiration data associated with the user during at least a portion of the sleep session (see [0120] and [0141] where the measured snore signal can be used to derive a respiration rate) and (ii) audio data reproducible as one or more sounds associated with the user during at least a portion of the sleep session (see [0152] where the audio signal is analyzed for the presence of apnea snoring, the measured audio signals capable of being listened to as seen in [0132]); determine a respiration signal associated with the user during the sleep session based, at least in part, on at least a portion of the data (see [0120] and [0141] where the respiration rate data is based at least in part on the measured audio data); identify an event experienced by the user during the sleep session based, at least in part on, at least a portion of the data (see [0152]-[0153] where the audio signals are used for determination of an apnea event); and cause to be communicated to the user via a user device (see [0158]-[0163] where a display screen of device 20 is a user device) (i) a graphical representation of a portion of the respiration signal (see [0158]-[0163] where the display can display data, such as the measurement indices and statistics, like the AHI), and (ii) an event indication that aids in identifying the identified event within the graphical representation of the portion of the respiration signal (see [0158]-[0163] and Fig. 10 where the graph can display indicia that represent an event, such as SDB, apnea, hypopnea, snore, and CSR).
Regarding claim 33, McMahon discloses wherein the control system is further configured to cause a portion of the audio data associated with the identified event to be communicated to the user via the user device (see [0158]-[0163] where audio data, such as the snoring time, can be communicated to the user device).
Regarding claim 38, McMahon discloses wherein the identified event is snoring, a sleeping disorder, or labored breathing (see [0153]).
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 3 is rejected under 35 U.S.C. 103 as being unpatentable over McMahon as applied to claim 2 above, and further in view of Krausman et al. (US Pub. 2006/0212273).
Regarding claim 3, McMahon discloses audio data associated with the identified event to be communicated to the user via the user device (see [0158]-[0163]).
McMahon lacks a detailed description of causing a user-selectable audio element to be displayed via the user device, wherein the causing the portion of the audio data associated with the identified event to be communicated to the user via the user device is in response to a selection of the user-selectable audio element.
However, Krausman teaches a snoring assessment system, where a user-selectable audio element to be displayed via the user device (see [0063]-[0066] where the system can record the user’s snore audio data, and send both the raw and computed data to an external computer for display and analysis), wherein the causing the portion of the audio data associated with the identified event to be communicated to the user via the user device is in response to a selection of the user-selectable audio element (see [0063]-[0066] where the user can select the raw audio data to be reviewed on the computer, the audio data associated with any apnea and snoring events, and able to be review by the user should they select it on the external computer).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the external user device of McMahon to record the audio files for further playback by the user as taught by Krausman, as it would allow for a user to personally hear their own snoring, to better understand their sleep patterns and if improvement is being made over time.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over McMahon as applied to claim 18 above, and further in view of Pittman et al. (US Pub. 2009/0082639).
Regarding claim 19, McMahon discloses the selecting the event from the plurality of events.
McMahon lacks a detailed description of wherein the selecting the event from the plurality of events includes using a linear regression algorithm.
However, Pittman teaches a sleep and apnea detecting system, where a critical pressure deterministic of an apnea can be determined by a linear regression (see [0043], in light of [0041]-[0042]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the event selection of McMahon to use a linear regression as taught by Pittman, as it would be a simple substitution of one type of numerical analysis for another, to yield the predictable result of analyzing the sleep data to determine a presence of an apnea.
Claims 34-36 are rejected under 35 U.S.C. 103 as being unpatentable over McMahon as applied to claim 32 above, and further in view of Bao et al. (US Pub. 2016/0193437).
Regarding claim 34, McMahon discloses a respiratory therapy system.
McMahon lacks a detailed description of a respiratory therapy device configured to supply pressurized air; and an interface coupled to the respiratory device via a conduit, the interface being configured to engage a user and aid in directing the supplied pressurized air to an airway of the user. It is noted that respiratory therapy devices are used for sleep disorder treatment (see [0012]-[0013]).
However, Bao teaches a respiratory therapy device configured to supply pressurized air (system of Figs. 1-2; see also [0124]); and an interface coupled to the respiratory device via a conduit (see Fig. 1 interface 107 and conduit 106), the interface being configured to engage a user and aid in directing the supplied pressurized air to an airway of the user (see Fig. 1 and [0124]), and having sensors associated with the respiratory device (see [0133] and [0143]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sleep system of McMahon to be connected to respiratory therapy device as taught by Bao, as it would provide a source of air to the patient during sleep to help maintain proper oxygenation despite disordered breathing.
Regarding claim 35, the modified McMahon device has wherein a first one of the one or more sensors is coupled to or integrated in a portion of the respiratory therapy system (Bao; see [0133] and [0143]).
Regarding claim 36, the modified McMahon device has wherein a second one of the one or more sensors is coupled to or integrated in the user device (Bao; see [0133] and [0143]), wherein the first sensor is configured to generate the respiration data (Bao; see [0133] and [0136]) and the second sensor is configured to generate the audio data (Bao; see [0133] and [0139]).
Claims 39-42 are rejected under 35 U.S.C. 103 as being unpatentable over McMahon as applied to claims 1 and 32 above, respectively, and further in view of Krausman in view of Berger et al. (US Pub. 2004/0015079).
Regarding claims 39 and 41, McMahon discloses audio data.
The modified McMahon device lacks a detailed description of causing a playback bar to be displayed via the user device, the playback bar being overlaid on or adjacent to the graphical representation of the portion of the respiration signal, wherein the playback bar is configured to indicate to which portion of the graphical representation the audio data corresponds.
However, Krausman teaches a snoring assessment system, where a user-selectable audio element to be displayed via the user device (see [0063]-[0066] where the system can record the user’s snore audio data, and send both the raw and computed data to an external computer for display and analysis), wherein the causing the portion of the audio data associated with the identified event to be communicated to the user via the user device is in response to a selection of the user-selectable audio element (see [0063]-[0066] where the user can select the raw audio data to be reviewed on the computer, the audio data associated with any apnea and snoring events, and able to be review by the user should they select it on the external computer).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the external user device of McMahon to record the audio files for further playback by the user as taught by Krausman, as it would allow for a user to personally hear their own snoring, to better understand their sleep patterns and if improvement is being made over time.
The modified McMahon device lacks a detailed description of a playback bar to be displayed via the user device, the playback bar being overlaid on or adjacent to the graphical representation of the portion of the respiration signal, wherein the playback bar is configured to indicate to which portion of the graphical representation the audio data corresponds.
However, Berger teaches a medical audio device, where audio can be accessed via a playback toolbar that lets a person have control over the audio, as well as showing which audio it is. (see [0420]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the recording playback system of the modified McMahon device to have a playback bar as taught by Berger, as it would provide an interactive and intuitive system for the user to listen to the audio.
Regarding claim 40 and 42, the modified McMahon device, as modified in claims 39 and 41 respectively, has wherein the identified event is an apnea event (McMahon; see [0153]), and wherein the method further comprises: causing a playback bar to be displayed via the user device (where Krausman teaches the audio being displayed to the user, and the teaching of Berger has the audio shown as a playback bar), the playback bar displayed adjacent to the graphical representation of the portion of the respiration signal (McMahon; see [0158]-[0163] where the outputted data is shown together, including the audio data of the playback bar as taught by Berger), wherein the event indication comprises information associated with the apnea event overlaid within the graphical representation of the portion of the respiration signal (McMahon; see [0158]-[0163]); and in response to a selection of the playback bar, causing a portion of the audio data associated with the apnea event to be communicated to the user via the user device Krausman; see [0063]-[0066] where the audio regarding the apnea is outputted to the external user device, and see Berger [0420] where the audio is displayed as a playback bar).
Response to Arguments
Applicant's arguments filed 12/04/2025 have been fully considered but they are not persuasive.
Applicant argues on page 9 of the remarks that McMahon only discloses receiving audio data from the sensor, and not respiration data, and that derived respiration data is not the same as received respiration data. The argument is not well-taken. First, the claim requires that one or more sensors collects “data associated with a sleep session of a user.” It is understood that this data collection is broad, and includes aggregate forms of data, as long as they pertain to the sleep session. Then, the data includes 1) respiration data, and 2) audio data. It is understood that the initial source data can have a plurality of subsets of information within it, able to be analyzed and separated from one another to yield different variables. McMahon discloses where a sounds sensor is able to detect sounds associated with the sleep of the user, the data coming from the detected sound including data that corresponds to at least respiration epoch, audible snoring, and a respiration rate (see [0037], [0118]-[0120], and [0141]). The detected signal is understood to contain these separate and distinguishable elements (see [0118]-[0119] where the signal has components of frequency, time, and amplitude which are understood to relate to and derive a respiration rate). Furthermore, McMahon does describe the respiration rate as being “detected” by direct measurement of the signals (see [0141]). Additionally, the claim does not include any language that precludes the respiration rate from being derived from the data. Rather, the claim merely requires that the initial sleep session data includes (components of) the respiration data. As such, measured values that lead to a respiration rate are understood to be carried by and including within the sound data from the sensor.
Applicant argues on page 9 of the remarks that McMahon does not determine the respiration signal based on at least a portion of the data. As seen in the above paragraph, it is understood that McMahon does derive a respiration signal from the sound data, such as the respiration rate.
Applicant argues on pages 9-11 that McMahon does not have a graphical representation of the respiration signal, and that the shown report cannot be considered a respiration signal. The argument is not well-taken. As seen in [0119]-[0120] and [0158]-[0163], as well as Figs. 6A and 10, the listed indicia in the report are merely “example types that may be included” and additional measurement indices, data, and associated details may be shown in the report. As is clear from Figs. 3-10, a plurality of different outputted representations of the data and its derived information are considered. These includes breathing cycles over time, or even respiration rate detection (Fig. 7A). It is clear from the openness of [0158]-[0163] that any of the relevant data, such as respiration rate, can be outputted in the report in a graphical form. Fig. 10 merely stands as an example of what these outputs may look like, and it is clear from the disclosure that any of the variables/ outputs/ derived signals are able to be graphically shown on the outputted report, including respiration signal values such as the respiration rate. It is further understood that these outputted signals in the report show changes over time, such as an apnea to be determined from the data (e.g. as shown in Fig. 7A).
Thus, the rejections hold.
Conclusion
THIS ACTION IS MADE FINAL. 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 MATTHEW D ZIEGLER whose telephone number is (571)272-3349. The examiner can normally be reached Mon-Fri 10:00-6:00.
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/MATTHEW D ZIEGLER/Examiner, Art Unit 3785
/TIMOTHY A STANIS/Supervisory Patent Examiner, Art Unit 3785