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 .
Election/Restrictions
Claims 77 and 78 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/19/2025.
Applicant’s election without traverse of Group I drawn to a method for determining a mouth leak status associated with a user of a respiratory device using airflow data, specifically pressure data and/or flow rate data of claims 1 and 66-76 in the reply filed on 08/19/2025 is acknowledged.
Claim Objections
Claims 1, 66, 69, and 73-75 are objected to because of the following informalities:
Claim 1 (line 5), claim 66 (line 2), and claim 69 (line 3): “the airflow data” should read “the airflow data associated with the user” for consistency
Claim 1, line 7: “based at least in part on the analysis” should read “based at least in part on the analysis of the airflow data associated with the user” for clarity
Claims 73-75: “responsive” should read “in response” for clarity
Claim 73: “a wearable sensor couplable to a body part of the user” should read “a wearable sensor configured to couple to a body part of the user” for clarity
Claim 74: “reducing a pressure of the pressurized air to the airway of the user” should read “reducing a pressure of the pressurized air supplied to the airway of the user” for consistency and clarity
Appropriate correction is required.
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 and 66-76 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim(s) recite(s) a method of a mental process to determine a mouth leak status associated with a user of a respiratory device.
Regarding claim 1, the claim recites receiving airflow data associated with the user of the respiratory device, the respiratory device being configured to supply pressurized air to an airway of the user during a therapy session, the airflow data including pressure data and/or flow rate data; analyzing the airflow data associated with the user; and based at least in part on the analysis, determining the mouth leak status associated with the user, the mouth leak status being indicative of whether or not air is leaking from a mouth of the user.
The limitation “receiving airflow data associated with the user of the respiratory device, the respiratory device being configured to supply pressurized air to an airway of the user during a therapy session, the airflow data including pressure data and/or flow rate data”, as drafted, is a process, that under its broadest reasonable interpretation, covers performance of the limitation in the mind (i.e., a mental task in the human mind, and/or by a mathematical process). That is, other than reciting “the respiratory device being configured to supply pressurized air to an airway of the user during a therapy session” and “the airflow data including pressure data and/or flow rate data”, nothing in the claim element precludes the step from practically being performed in the mind or by a human. For example, but for the “the respiratory device being configured to supply pressurized air to an airway of the user during a therapy session” and “the airflow data including pressure data and/or flow rate data”, “receiving” in the context of this claim encompasses a human, or a human mind, receiving air flow data (i.e. flow data and/or pressure data) associated with a user of a respiratory device.
Similarly, the limitation “analyzing the airflow data associated with the user”, as drafted, is a process, that under its broadest reasonable interpretation, covers performance of the limitation in the mind (i.e., a mental task in the human mind, and/or by a mathematical process). Nothing in the claim element precludes the step from practically being performed in the mind or by a human. For example, “analyzing” in the context of this claim encompasses a human, or a human mind, analyzing air flow data (i.e. flow data and/or pressure data) associated with a user of a respiratory device.
Similarly, the limitation “based at least in part on the analysis, determining the mouth leak status associated with the user, the mouth leak status being indicative of whether or not air is leaking from a mouth of the user”, as drafted, is a process, that under its broadest reasonable interpretation, covers performance of the limitation in the mind (i.e., a mental task in the human mind, and/or by a mathematical process). That is, other than reciting “based at least in part on the analysis” and “the mouth leak status being indicative of whether or not air is leaking from a mouth of the user”, nothing in the claim element precludes the step from practically being performed in the mind or by a human. For example, but for the “based at least in part on the analysis” and “the mouth leak status being indicative of whether or not air is leaking from a mouth of the user”, “determining” in the context of this claim encompasses a human, or a human mind, determining a mouth leak status associated with a user of a respiratory device.
If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, claim 1 recites 3 additional elements — a respiratory device being configured to supply pressurized air to an airway of the user during a therapy session, airflow data including pressure data and/or flow rate data, and a mouth leak status being indicative of whether or not air is leaking from a mouth of the user. Regarding the additional element airflow data including pressure data and/or flow rate data, the additional element serves to gather information to be used by the abstract idea, while generically implementing it on a computer. Regarding the additional elements a respiratory device being configured to supply pressurized air to an airway of the user during a therapy session and a mouth leak status being indicative of whether or not air is leaking from a mouth of the user, are recited at a high-level of generality such that they amount to no more than mere insignificant extra solution activity of mere instructions to apply the exception using a generic structure or component. Accordingly, the above additional elements do not integrate the abstract idea into a practical application as they do not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
The claim does 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 abstract idea into a practical application, the additional element airflow data including pressure data and/or flow rate data amounts to no more than mere insignificant extra solution activity including the collection of data by performing the basic functions of: (1) receiving processing, and/or calculating data, and/or (11) automating mental tasks. The courts have recognized these functions to be well-understood, routine, and conventional functions when claimed in a merely generic manner. Therefore, the Office takes Official notice that the instantly claimed additional steps/elements airflow data including pressure data and/or flow rate data are well- understood, routine and convention. Merely adding hardware that performs “well understood, routine, conventional activities previously known to the industry” will not make claims patent- eligible (in re TLI Communications LLC). In other words, the above additional element amounts to no more than mere instructions to apply the exception using generic computer components. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements a respiratory device being configured to supply pressurized air to an airway of the user during a therapy session and a mouth leak status being indicative of whether or not air is leaking from a mouth of the user amount to no more than mere insignificant extra solution activity with mere instructions to apply the exception using a generic structure or component. Aylsworth et al. (US 20100186741 A1) discloses receiving airflow data associated with the user of the respiratory device ([0036], lines 1-5; Fig. 4), the respiratory device being configured to supply pressurized air to an airway of the user during a therapy session ([0036], lines 7-8), the airflow data including pressure data and/or flow rate data ([0036], lines 1-3; Fig. 4). Aylsworth et al. further discloses based at least in part on the analysis, determining the mouth leak status associated with the user ([0038], lines 1-4; [0038], lines 7-9), the mouth leak status being indicative of whether or not air is leaking from a mouth of the user ([0038], lines 9-11). Therefore, the instantly claimed additional elements a respiratory device being configured to supply pressurized air to an airway of the user during a therapy session and a mouth leak status being indicative of whether or not air is leaking from a mouth of the user are well-understood, routine, and conventional. In other words, the above additional element amounts to no more than a mere insignificant extra solution activity with mere instructions to apply the exception using a generic.
Regarding claim 66, the claim recites analyzing the airflow data associated with the user includes processing the airflow data to identify one or more normalized features that distinguish mouth leak from (i) normal respiration during therapy and/or (ii) other types of unintentional leak.
The limitation “analyzing the airflow data associated with the user includes processing the airflow data to identify one or more normalized features that distinguish mouth leak from (i) normal respiration during therapy and/or (ii) other types of unintentional leak”, as drafted, is a process, that under its broadest reasonable interpretation, covers performance of the limitation in the mind (i.e., a mental task in the human mind, and/or by a mathematical process). Nothing in the claim element precludes the step from practically being performed in the mind or by a human. For example, “analyzing” in the context of this claim encompasses a human, or a human mind, analyzing air flow data (i.e. flow data and/or pressure data) associated with a user of a respiratory device by processing the air flow data in order to identify one or more features that differentiate a mouth leak from (i) normal respiration during therapy and/or (ii) other types of unintentional leak.
If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, claim 66 does not recite any additional elements; hence, the above abstract idea is not integrated into a practical application as no meaningful limits are imposed on practicing the abstract idea. The claim is directed to an abstract idea.
The claim does not include additional elements; hence, the limitation above is not sufficient to amount to significantly more than the judicial exception.
Regarding claim 71, the claim recites calculating a therapy score or AHI score based at least in part on the determined mouth leak status.
The limitation “calculating a therapy score or AHI score based at least in part on the determined mouth leak status”, as drafted, is a process, that under its broadest reasonable interpretation, covers performance of the limitation in the mind (i.e., a mental task in the human mind, and/or by a mathematical process). That is, other than reciting “based at least in part on the determined mouth leak status”, nothing in the claim element precludes the step from practically being performed in the mind or by a human. For example, but for the “based at least in part on the determined mouth leak status”, “calculating” in the context of this claim encompasses a human, or a human mind, calculating, or determining, a therapy score or AHI score.
If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, claim 1 recites 1 additional element — based at least in part on the determined mouth leak status. Regarding the additional element based at least in part on the determined mouth leak status, is recited at a high-level of generality such that they amount to no more than mere insignificant extra solution activity of mere instructions to apply the exception using a generic structure or component. Accordingly, the above additional element does not integrate the abstract idea into a practical application as they do not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
The claim does 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 abstract idea into a practical application, the additional element based at least in part on the determined mouth leak status amounts to no more than mere insignificant extra solution activity with mere instructions to apply the exception using a generic structure or component. Ramanan & Armistead (US 20120179061 A1) discloses calculating a therapy score or AHI score based at least in part on the determined mouth leak status (Ramanan & Armistead: [0071], lines 17-21, where leak detection data is included within the data of the sleep state detection module 118, and where a leak event is a mouth leak event, see [0345], line 9). Therefore, the instantly claimed additional element based at least in part on the determined mouth leak status is well-understood, routine, and conventional. In other words, the above additional element amounts to no more than a mere insignificant extra solution activity with mere instructions to apply the exception using a generic.
Regarding claim 72, the claim recites receiving, from a sensor coupled to the respiratory device, sensor data associated with the user during the therapy session, the sensor data being indicative of a number of sleep- disordered breathing events during the therapy session; correlating the mouth leak status with the sensor data to output one or more false positive sleep- disordered breathing events; subtracting the one or more false positive sleep-disordered breathing events from the number of sleep-disordered breathing events to output a modified number of sleep-disordered breathing events; and calculating the therapy score based, at least in part, on the modified number of sleep-disordered breathing events.
The limitation “receiving, from a sensor coupled to the respiratory device, sensor data associated with the user during the therapy session, the sensor data being indicative of a number of sleep- disordered breathing events during the therapy session”, as drafted, is a process, that under its broadest reasonable interpretation, covers performance of the limitation in the mind (i.e., a mental task in the human mind, and/or by a mathematical process). That is, other than reciting “from a sensor coupled to the respiratory device” and “the sensor data being indicative of a number of sleep- disordered breathing events during the therapy session”, nothing in the claim element precludes the step from practically being performed in the mind or by a human. For example, but for the “from a sensor coupled to the respiratory device” and “the sensor data being indicative of a number of sleep- disordered breathing events during the therapy session”, “receiving” in the context of this claim encompasses a human, or a human mind, receiving information associated with a user during a therapy session.
Similarly, the limitation “correlating the mouth leak status with the sensor data to output one or more false positive sleep- disordered breathing events”, as drafted, is a process, that under its broadest reasonable interpretation, covers performance of the limitation in the mind (i.e., a mental task in the human mind, and/or by a mathematical process). Nothing in the claim element precludes the step from practically being performed in the mind or by a human. For example, “correlating” in the context of this claim encompasses a human, or a human mind, correlating a mouth leak status to information associated with a user during a therapy session to identify one or more false positive sleep- disordered breathing events.
Similarly, the limitation “subtracting the one or more false positive sleep-disordered breathing events from the number of sleep-disordered breathing events to output a modified number of sleep-disordered breathing events”, as drafted, is a process, that under its broadest reasonable interpretation, covers performance of the limitation in the mind (i.e., a mental task in the human mind, and/or by a mathematical process). Nothing in the claim element precludes the step from practically being performed in the mind or by a human. For example, “subtracting” in the context of this claim encompasses a human, or a human mind, removing identified false positive sleep-disordered breathing events from a number of sleep-disordered breathing events to output a modified number of sleep-disordered breathing events.
Similarly, the limitation “calculating the therapy score based, at least in part, on the modified number of sleep-disordered breathing events”, as drafted, is a process, that under its broadest reasonable interpretation, covers performance of the limitation in the mind (i.e., a mental task in the human mind, and/or by a mathematical process). That is, other than reciting “based, at least in part, on the modified number of sleep-disordered breathing events”, nothing in the claim element precludes the step from practically being performed in the mind or by a human. For example, but for the “based, at least in part, on the modified number of sleep-disordered breathing events”, “calculating” in the context of this claim encompasses a human, or a human mind, calculating a therapy score.
If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, claim 72 recites 3 additional elements — a sensor coupled to the respiratory device, sensor data being indicative of a number of sleep- disordered breathing events during the therapy session, and based, at least in part, on the modified number of sleep-disordered breathing events. Regarding the additional elements a sensor coupled to the respiratory device and sensor data being indicative of a number of sleep- disordered breathing events during the therapy session, the additional elements serve to gather information to be used by the abstract idea, while generically implementing it on a computer. Regarding the additional element based, at least in part, on the modified number of sleep-disordered breathing events, is recited at a high-level of generality such that they amount to no more than mere insignificant extra solution activity of mere instructions to apply the exception using a generic structure or component. Accordingly, the above additional elements do not integrate the abstract idea into a practical application as they do not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
The claim does 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 abstract idea into a practical application, the additional elements a sensor coupled to the respiratory device and sensor data being indicative of a number of sleep- disordered breathing events during the therapy session amount to no more than mere insignificant extra solution activity including the collection of data by performing the basic functions of: (1) receiving processing, and/or calculating data, and/or (11) automating mental tasks. The courts have recognized these functions to be well-understood, routine, and conventional functions when claimed in a merely generic manner. Therefore, the Office takes Official notice that the instantly claimed additional steps/elements airflow data including pressure data and/or flow rate data are well- understood, routine and convention. Merely adding hardware that performs “well understood, routine, conventional activities previously known to the industry” will not make claims patent- eligible (in re TLI Communications LLC). In other words, the above additional element amounts to no more than mere instructions to apply the exception using generic computer components. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. As discussed above with respect to integration of the abstract idea into a practical application, the additional element based, at least in part, on the modified number of sleep-disordered breathing events amounts to no more than mere insignificant extra solution activity with mere instructions to apply the exception using a generic structure or component. Ramanan & Armistead (US 20120179061 A1) discloses calculating the therapy score based, at least in part, on the modified number of sleep-disordered breathing events (Ramanan & Armistead: [0071], lines 17-21, where apnea event detection data is included within the data of the sleep stability detection module 116; [0394], last two sentences of paragraph; [0078], lines 1-5). Therefore, the instantly claimed additional element based, at least in part, on the modified number of sleep-disordered breathing events is well-understood, routine, and conventional. In other words, the above additional element amounts to no more than a mere insignificant extra solution activity with mere instructions to apply the exception using a generic.
Regarding claim 74, the claim recites analyzing the airflow data associated with the user to determine that the user is exhaling; and responsive to the determination that the user is exhaling, reducing a pressure of the pressurized air to the airway of the user during the exhaling of the user.
The limitation “analyzing the airflow data associated with the user to determine that the user is exhaling”, as drafted, is a process, that under its broadest reasonable interpretation, covers performance of the limitation in the mind (i.e., a mental task in the human mind, and/or by a mathematical process). Nothing in the claim element precludes the step from practically being performed in the mind or by a human. For example, “analyzing” in the context of this claim encompasses a human, or a human mind, analyzing airflow data (i.e. flow rate data and/or pressure data) associated with a user of a respiratory device to determine when the user is exhaling.
Similarly, the limitation “responsive to the determination that the user is exhaling, reducing a pressure of the pressurized air to the airway of the user during the exhaling of the user”, as drafted, is a process, that under its broadest reasonable interpretation, covers performance of the limitation in the mind (i.e., a mental task in the human mind, and/or by a mathematical process). Nothing in the claim element precludes the step from practically being performed in the mind or by a human. For example, “reducing” in the context of this claim encompasses a human, or a human mind, reducing, or decreasing, the pressure of the pressurized air being delivered to the airway of a user during exhalation in response to the determination of when the user is exhaling.
If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, claim 74 recites no additional elements; hence the abstract idea is not integrated into a practical application as no meaningful limits on practicing the abstract idea are imposed. The claim is directed to an abstract idea.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Regarding claim 75, the claim recites responsive to the mouth leak status, causing a notification to be provided to the user via an electronic device, such that the user is alerted of the mouth leak status.
The limitation “responsive to the mouth leak status, causing a notification to be provided to the user via an electronic device, such that the user is alerted of the mouth leak status”, as drafted, is a process, that under its broadest reasonable interpretation, covers performance of the limitation in the mind (i.e., a mental task in the human mind, and/or by a mathematical process). Nothing in the claim element precludes the step from practically being performed in the mind or by a human. For example, “causing a notification” in the context of this claim encompasses a human, or a human mind, causing an indication, alert, warning, notification, etc. to the user, in response to a mouth leak status, to alert the user of said mouth leak status.
This judicial exception is not integrated into a practical application. In particular, claim 75 recites 1 additional element — an electronic device. Regarding the additional element an electronic device, the additional element serves is recited at a high-level of generality such that they amount to no more than mere insignificant extra solution activity of mere instructions to apply the exception using a generic structure or component. Accordingly, the above additional element does not integrate the abstract idea into a practical application as they do not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
The claim does 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 abstract idea into a practical application, the additional element an electronic device amounts to no more than mere insignificant extra solution activity with mere instructions to apply the exception using a generic structure or component. Douglas et al. (US 20070215146 A1) discloses causing a notification to be provided to the user via an electronic device, such that the user is alerted of the mouth leak status, in response to a mouth leak status (Douglas et al.: ([0063], last sentence of paragraph, where it would be readily understood by one of ordinary skill in the art that the device generating the audible or visible alarm must be an electronic device). Therefore, the instantly claimed additional element an electronic device is well-understood, routine, and conventional. In other words, the above additional element amounts to no more than a mere insignificant extra solution activity with mere instructions to apply the exception using a generic.
Regarding claim 76, the claim recites receiving sleep stage data associated with the user during the therapy session; determining a sleep stage based at least in part on the sleep stage data; and associate the mouth leak status with the sleep stage.
The limitation “receiving sleep stage data associated with the user during the therapy session”, as drafted, is a process, that under its broadest reasonable interpretation, covers performance of the limitation in the mind (i.e., a mental task in the human mind, and/or by a mathematical process). Nothing in the claim element precludes the step from practically being performed in the mind or by a human. For example, “receiving” in the context of this claim encompasses a human, or a human mind, receiving sleep stage information associated with a user during a therapy session.
Similarly, the limitation “determining a sleep stage based at least in part on the sleep stage data”, as drafted, is a process, that under its broadest reasonable interpretation, covers performance of the limitation in the mind (i.e., a mental task in the human mind, and/or by a mathematical process). That is, other than reciting “based at least in part on the sleep stage data”, nothing in the claim element precludes the step from practically being performed in the mind or by a human. For example, but for the “based at least in part on the sleep stage data”, “determining” in the context of this claim encompasses a human, or a human mind, determining a sleep stage of a user.
Similarly, the limitation “associate the mouth leak status with the sleep stage”, as drafted, is a process, that under its broadest reasonable interpretation, covers performance of the limitation in the mind (i.e., a mental task in the human mind, and/or by a mathematical process). Nothing in the claim element precludes the step from practically being performed in the mind or by a human. For example, “associate” in the context of this claim encompasses a human, or a human mind, associating and/or comparing a mouth leak status with a sleep stage.
This judicial exception is not integrated into a practical application. In particular, claim 76 recites 1 additional element — based at least in part on the sleep stage data. Regarding the additional element based at least in part on the sleep stage data, is recited at a high-level of generality such that they amount to no more than mere insignificant extra solution activity of mere instructions to apply the exception using a generic structure or component. Accordingly, the above additional element does not integrate the abstract idea into a practical application as they do not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
The claim does 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 abstract idea into a practical application, the additional element based at least in part on the sleep stage data amounts to no more than mere insignificant extra solution activity with mere instructions to apply the exception using a generic structure or component. Shouldice (WO 2017032873 A2) discloses determining a sleep stage based at least in part on the sleep stage data (Shouldice: [324], lines 1-7). Therefore, the instantly claimed additional element based at least in part on the sleep stage data is well-understood, routine, and conventional. In other words, the above additional element amounts to no more than a mere insignificant extra solution activity with mere instructions to apply the exception using a generic.
In regard to claims 67-70 and 73, the claimed invention further describes the judicial exception in detail without however integrating said judicial exception into a practical application and/or providing additional elements that are sufficient to amount to significantly more than the judicial exception for reasons provided supra.
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 person shall be entitled to a patent unless –
(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, 66-70, and 73 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Aylsworth et al. (US 20100186741 A1).
Regarding claim 1, Aylsworth et al. discloses a method for determining a mouth leak status ([0032], lines 1-3) associated with a user of a respiratory device ([0033], lines 2-3), comprising:
receiving airflow data associated with the user of the respiratory device ([0036], lines 1-5; Fig. 4), the respiratory device being configured to supply pressurized air to an airway of the user during a therapy session ([0036], lines 7-8), the airflow data including pressure data and/or flow rate data ([0036], lines 1-3; Fig. 4);
analyzing the airflow data associated with the user ([0038], lines 1-4, where the waveforms are airflow and pressure voltage waveforms); and
based at least in part on the analysis, determining the mouth leak status associated with the user ([0038], lines 1-4; [0038], lines 7-9), the mouth leak status being indicative of whether or not air is leaking from a mouth of the user ([0038], lines 9-11).
Regarding claim 66, Aylsworth et al. discloses the invention as set forth in claim 1, wherein the analyzing the airflow data associated with the user ([0038], lines 1-4, where the waveforms are airflow and pressure voltage waveforms) includes processing the airflow data to identify one or more normalized features (root mean square voltage of waveform; [0038], lines 1-4) that distinguish mouth leak from (i) normal respiration during therapy and/or (ii) other types of unintentional leak ([0041], lines 6-9, where the mouth leak is distinguished from nasal mask leak by its comparably lower root mean squared voltage level of the waveforms, see Fig. 5).
Regarding claim 67, Aylsworth et al. discloses the invention as set forth in claim 66, wherein the one or more normalized features (root mean square voltage of waveform; [0038], lines 1-4) includes a covariance between leak and ventilation, a time the covariance holds above a threshold, a ventilation, an unintentional leak variability, a respiration rate, a respiration rate variability (root mean square voltage of airflow from patient waveform, where root mean square is a measure of variability and the airflow from the patient is the respiratory rate of the patient, hence root mean square voltage of airflow from patient is respiration rate variability; voltage line 52 indicates airflow from the patient, see Fig. 5; [0018], lines 4-7), or any combination thereof.
Regarding claim 68, Aylsworth et al. discloses the invention as set forth in claim 66,
wherein the one or more normalized features (root mean square voltage of waveform; [0038], lines 1-4) are computed on a user flow rate signal ([0008], lines 14-16, where root mean square voltage of airflow from the patient waveform is an attribute of patient airflow indicative of air leaks through the patient’s mouth; [0011], lines 3-9; [0036], lines 1-6), a mask pressure signal ([0008], lines 14-16, where root mean square voltage of patient breathing circuit pressure waveform is an attribute of patient breathing circuit pressure indicative of air leaks through the patient’s mouth; [0011], lines 3-6 & lines 10-11; [0036], lines 1-6), a blower flow rate signal, a blower pressure signal, or any combination thereof, wherein the one or more normalized features (root mean square voltage of waveform; [0038], lines 1-4) include, for each signal, (i) a frame area (flow rate range of patient breathing depicted by range of line 52 in Fig. 5; pressure range of patient breathing circuit pressure depicted by range of line 53 in Fig. 5), (ii) a breath area, (iii) a complement to the breath area, (iv) a ratio of the breath area over the frame area, (v) a ratio of the breath area over the complement to the breath area, (vi) a skewness of the signal, (vii) a kurtosis of the signal, (viii) a first derivative of the skewness, (ix) a first derivative of the kurtosis, (x) a second derivative of the skewness, (xi) a second derivative of the kurtosis, or (xii) any combination thereof.
Regarding claim 69, Aylsworth et al. discloses the invention as set forth in claim 66, wherein the one or more normalized features (root mean square voltage of waveform; [0038], lines 1-4) are associated with a first breath (sections 40 and 43 of Fig. 4, where the voltage waveform depicts patient breathing, where patient breathing is normal and the patient’s mouth is closed for the duration of sections 40 and 43; [0036], lines 6-8 & lines 13-14), the method further comprising identifying, within the received airflow data (patient breathing circuit pressure waveform and patient breathing waveform; [0036], lines 1-3; Fig. 4), the first breath of the user ([0036], lines 18-19, where the beginning of the first breath of section 43 is identified signifying the end a period of normal breathing with the mouth open, sections 41 and 42, and the beginning of a period of normal breathing with the mouth closed, section 43; Fig. 4), the first breath having an inhalation portion and an exhalation portion ([0036], lines 8-10; Fig. 4).
Regarding claim 70, Aylsworth et al. discloses the invention as set forth in claim 1, wherein the mouth leak status ([0032], lines 1-3) is (i) no mouth leak, (ii) valve-like mouth leak, or (iii) continuous mouth leak ([0040], lines 1-3, where a mouth in an opened position allows applied airflow and pressure to escape to atmosphere which is a mouth leak).
Regarding claim 73, Aylsworth et al. discloses the invention as set forth in claim 1, further comprising:
providing control signals (provide control signals via processor 29) to:
the respiratory device (positive airway pressure machine 28 has a processor 29) and, responsive to the mouth leak status, adjusting pressure settings of the respiratory device ([0046], lines 11-14, where the processor 29 controls pressure settings, see [0010], lines 16-18), the pressure settings being associated with the pressurized air supplied to the airway of the user ([0010], lines 14-20).
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.
Claims 71 and 72 are rejected under 35 U.S.C. 103 as being unpatentable over Aylsworth et al. (US 20100186741 A1) in view of Ramanan & Armistead (US 20120179061 A1).
Regarding claim 71, Aylsworth et al. discloses the invention as set forth in claim 1, but is silent to calculating a therapy score or AHI score based at least in part on the determined mouth leak status.
However, Ramanan & Armistead teaches the calculation of a sleep quality score based in part on a number of apnea events during a treatment session ([0071], lines 17-21, where apnea event detection data is included within the data of the sleep stability detection module 116; [0394], last two sentences of paragraph) and a determined mouth leak status ([0071], lines 17-21, where leak detection data is included within the data of the sleep state detection module 118, and where a leak event is a mouth leak event, see [0345], line 9), where the sleep quality score is an indication of the quality of therapy being provided to the user ([0388], lines 3-9). Ramanan & Armistead further teaches the option to exclude scoring events in the calculation of AHI based on the determination of a mouth leak status ([0078], lines 1-5) to improve accuracy of the sleep quality score by ensuring data used in the calculation of the sleep data score is recorded only when the mask is being worn by the patient ([0078], lines 5-10). Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the methods of Aylsworth et al. with calculation of a sleep quality score, which is an indicator of the quality of therapy, as taught by Ramanan & Armistead such that the method of Aylsworth et al. further comprises calculating a therapy score or AHI score based at least in part on the determined mouth leak status (Ramanan & Armistead: [0071], lines 17-21, where leak detection data is included within the data of the sleep state detection module 118, and where a leak event is a mouth leak event, see [0345], line 9) to indicate the success of therapy currently being provided and propose how the therapy could be changed for more successful therapy (Ramanan & Armistead: [0386], lines 1-7).
Regarding claim 72, Aylsworth et al. as modified discloses the invention as set forth in claim 71, further comprising, as best understood by the Examiner:
receiving, from a sensor coupled to the respiratory device, sensor data associated with the user during the therapy session ([0011], lines 1-11), the sensor data being indicative of a number of sleep-disordered breathing events during the therapy session ([0036], lines 1-5; [0043], lines 8-16; regions 61 and 63 of Fig. 6);
correlating the mouth leak status with the sensor data (airflow of patient breathing 65, patient breathing circuit pressure 66, where the data of 65 and 66 is sensor data, [0011], lines 1-11; [0043], lines 7-13, where sensor data of 65 and 66 is correlated to a mouth leak status, where a mouth leak occurs when a user’s mouth is open and the user’s airway is not blocked or is partially blocked causing air to escape through the user’s mouth to atmosphere) to output one or more false positive sleep- disordered breathing events ([0044], lines 9-18, where mouth leak is identified in sensor data that indicates an apnea event; see region 74 of Fig. 7);
subtracting the one or more false positive sleep-disordered breathing events from the number of sleep-disordered breathing events to output a modified number of sleep-disordered breathing events (Ramanan & Armistead: [0078], liens 1-10); and calculating the therapy score based, at least in part, on the modified number of sleep-disordered breathing events (Ramanan & Armistead: [0071], lines 17-21, where apnea event detection data is included within the data of the sleep stability detection module 116; [0394], last two sentences of paragraph; [0078], lines 1-10).
Claims 74 and 75 are rejected under 35 U.S.C. 103 as being unpatentable over Aylsworth et al. (US 20100186741 A1) in view of Douglas et al. (US 20070215146 A1).
Regarding claim 74, Aylsworth et al. discloses the invention as set forth in claim 73, further comprising:
analyzing the airflow data associated with the user ([0038], lines 1-4, where the waveforms are airflow and pressure voltage waveforms) to determine that the user is exhaling (analyze patient breathing voltage waveform to determine when patient is exhaling, [0036], lines 8-10; Fig. 4). Aylsworth et al. is silent to the method further comprising responsive to the determination that the user is exhaling, reducing a pressure of the pressurized air to the airway of the user during the exhaling of the user.
However, Douglas et al. teaches a CPAP apparatus analyzes airflow data associated with a user and identifies when the user is exhaling ([0051], lines 6-7 and line 14; [0063], lines 14-17). Douglas et al. further teaches decreasing the supplied pressure level in response to the user exhaling ([0051], lines 14-15). Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the method of Aylsworth et al. as modified with the reduction in supplied pressure to the user in response to a determination that the user is exhaling as taught by Douglas et al. such that, the method taught be Aylsworth et al. as modified teaches in response to the determination that the user is exhaling ([0038], lines 1-4, where the waveforms are airflow and pressure voltage waveforms), reducing a pressure of the pressurized air to the airway of the user during the exhaling of the user (Douglas et al.: [0051], lines 14-15) to reduce mouth leak or any other detected mask leak (Douglas et al.: [0063], line 24), and increase patient comfort when receiving therapy (Douglas et al.: [0064], lines 10-14) .
Regarding claim 75, Aylsworth et al. discloses the invention as set forth in claim 1, but fails to explicitly disclose the method further comprising responsive to the mouth leak status, causing a notification to be provided to the user via an electronic device, such that the user is alerted of the mouth leak status.
However, Douglas et al. teaches a warning, such as an audible or visible alarm, is generated when a leak flow is detected ([0063], last sentence of paragraph, where it would be readily understood by one of ordinary skill in the art that the device generating the audible or visible alarm must be an electronic device). Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the methods of Aylsworth et al. as modified with the generation of an audible or visual alarm in response to a detected mouth leak as taught by Douglas et al. such that the methods of Aylsworth et al. as modified comprises in response to the mouth leak status, causing a notification to be provided to the user via an electronic device, such that the user is alerted of the mouth leak status (Douglas et al.: ([0063], last sentence of paragraph, where it would be readily understood by one of ordinary skill in the art that the device generating the audible or visible alarm must be an electronic device) to increase the delivery of successful therapy to a user (Douglas et al.: [0063], lines 14-21).
Claim 76 is rejected under 35 U.S.C. 103 as being unpatentable over Aylsworth et al. (US 20100186741 A1) in view of Shouldice (WO 2017032873 A2).
Regarding claim 76, Aylsworth et al. discloses the invention as set forth in claim 1. Aylsworth et al. further discloses the collection of data over at least one sleep period during a therapy session ([0048], lines 1-9), the identification of a hypopnea event based on the data collected during the at least one sleep period (0045], lines 5-9), and the association of a mouth leak status with a hypopnea event ([0046], lines 8-14). But Aylsworth et al. fails to explicitly disclose the method as set forth in claim 1 further comprising:
receiving sleep stage data associated with the user during the therapy session;
determining a sleep stage based at least in part on the sleep stage data; and associate the mouth leak status with the sleep stage.
However, Shouldice teaches a system and method for monitoring and managing a chronic disease, such as Obstructive Sleep Apnea, where sleep stage data is associated with a user during the therapy session ([324], lines 1-4; [324], lines 9-10). Shouldice further teaches the determination of if the user is awake based in part on the sleep stage data ([324], lines 1-7), and associates a mouth leak status with sleep stage data ([307], lines 2-4, where the leak flow rate Ql is an indicator of a mouth leak status, and the respiratory flow rate Qr is used in the identification of periods of awake breathing, see [324], lines 9-10). Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the method of Aylsworth et al. as modified with the receipt of sleep stage data, determination of a sleep stage, and association of a mouth leak with the sleep stage as taught by Shouldice such that the method of Aylsworth et al. as modified teaches receiving sleep stage data associated with the user during the therapy session (Shouldice: [324], lines 1-4; [324], lines 9-10); determining a sleep stage based at least in part on the sleep stage data (Shouldice: [324], lines 1-7) ; and associate the mouth leak status with the sleep stage (Shouldice: [307], lines 2-4, where the leak flow rate Ql is an indicator of a mouth leak status, and the respiratory flow rate Qr is used in the identification of periods of awake breathing, see [324], lines 9-10) to teach the respiratory device the user’s behaviors, triggers, and symptoms for a more personalized and effective treatment (Shouldice: [105], lines 1-5).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Rao et al. (US 10328219 B2): Regarding the calculation of a therapy score based at least in part on a mouth leak status.
Hudson et al. (US 20200121873 A1): Regarding the detection of a leak status for a CPAP system.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ABIGAYLE DALE whose telephone number is (571)272-1080. The examiner can normally be reached Monday-Friday from 8:45am to 5:45pm ET.
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, Brandy Lee can be reached at (571) 270-7410. 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.
/ABIGAYLE DALE/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785
Prosecution Insights