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 .
Information Disclosure Statement
The information disclosure statement(s) filed on 1/24/2023, 1/14/2025 and 10/02/2025 is/are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement(s) is/are being considered by the examiner.
Claims
This office action is in response to the preliminary amendment filed on 12/06/2022. As directed by the preliminary amendments, claims 5, 8, 11, 14, 15, 19, 21, 23-25, 27-28, and 30 have been amended, claims 9-10, 13, 20, and 31-36 have been cancelled and claims 37-39 have been added. As such, claims 1-8, 11-12, 14- 19, 21-30, and 37-39 are being examined in this application.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
Claim(s) 1-4, 7-8, 11-12, 14-19, 21-22, 25, 27 and 37-38 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mulcahy (US 20090038616 A1).
Regarding claim 1, Mulcahy teaches a method for optimizing sleep for a user of a respiratory therapy system (Mulcahy teaches a ventilator device as seen in Fig. 1 comprising a servo-controlled blower 2, a flow sensor 4f, pressure sensor 4p, a mask 6, an air delivery conduit 8 and controller 15 as seen in [0050] and [0054]) (Mulcahy teaches a system and a flowchart with a method for an acclimatization therapy for new CPAP users as seen in Figs. 1-3 and [0035] and [0076]-[0077]), the method comprising:
receiving therapy instructions to be implemented using the respiratory therapy system for a sleep session, the therapy instructions including a plurality of prescribed control parameters, each of the plurality of prescribed control parameters having a value or a range of values for achieving a medically prescribed therapy ([0076] of applicant’s specification states the therapy instructions can be entered or pre-programmed into the respiratory therapy system and can include a plurality of prescribed control parameters such as prescribed pressure and pressure ranges. Mulcahy teaches the controller providing instruction to the flow generator to provide breathable gas at a first pressure and a second pressure to a patient while they are asleep, wherein the controller can adjust the first or second pressure until a target CPAP therapy for sleep-disordered breathing is provided as seen in [0020] and [0094]. Mulcahy further teaches controlled parameters including pressure ramp increment (see [0084]) and a predetermined time period for a user to fall asleep (see [0096]-[0097]);
receiving a desired sleep comfort level for the sleep session, wherein the desired sleep comfort level is indicative of a sleep comfort experience desired by the user for the sleep session (Mulcahy teaches a series of pre-programmed patient and/or bed partner feedback questions relating to treatment comfort to aid in providing treatment for the patient based on their comfort and compliance as seen in Figs. 2-3 and [0062] and [0071]. These questions are used to set a comfort level and treatment for the next session as seen in Figs. 2-3 and [0062]. Mulcahy further teaches methods to assist a patient in therapy and making therapy more comfortable for first time users as seen in [0135]); and
adjusting, based on the desired sleep comfort level, two or more of the values or the range of values of the plurality of prescribed control parameters to obtain two or more adjusted values or range of values, the two or more adjusted values or range of values departing from the medically prescribed therapy to aid the user in achieving the desired sleep comfort level (Mulcahy teaches a limited pressure treatment less than the full treatment pressure to aid in acclimatizing the patient as seen in [0088] and [0025]-[0026]. Mulcahy further teaches increasing pressure if a person’s response and recorded measurements of the treatment session indicate compliance as seen in Figs. 2-3 and [0063]. The pressure ramp increment can also be decreased or increased depending on how the patient is coping with the therapy as seen in [0084] and the predetermined time it takes for the patient to fall asleep can be increased as seen in [0097]).
Regarding claim 2, Mulcahy teaches the method of claim 1, and further teaches wherein the received therapy instructions are provided to aid the user in achieving a target therapy parameter during the sleep session (Mulcahy teaches parameters associated with sleep therapy that can be ramped up until target CPAP parameters are met as seen in [0019]-[0020]), and the adjusted two or more of the values or the range of values of the plurality of control parameters provides a therapy parameter that is different from the target therapy parameter (Mulcahy teaches a limited pressure treatment below the full treatment pressure as seen in [0025] and which is to be increased incrementally until the full treatment pressure is reached as seen in [0063]-[0064]. Mulcahy further teaches the pressure ramp increment can also be decreased or increased depending on how the patient is coping with the therapy as seen in [0084], wherein the pressure ramp affects the target pressure as seen in [0019] and [0092]).
Regarding claim 3, Mulcahy teaches the method of claim 2, and further teaches wherein the adjusted two or more of the values or the range of values of the plurality of control parameters provides a therapy parameter that is greater than the target therapy parameter (Mulcahy teaches setting a minimum pressure (seen as target therapy parameter) in which when apnea is detected, the pressure is increased to a predetermined amount to treat it before returning back to the minimum pressure as seen in [0074]-[0075]. Mulcahy further teaches a predetermined time it takes for the patient to fall asleep which is set at a certain time (taken as target therapy parameter), however, it can be increased by the patient until the patient falls asleep as seen in [0097]).
Regarding claim 4, Mulcahy teaches the method of claim 2, and further teaches wherein the adjusted two or more of the values or the range of values of the plurality of control parameters provides a therapy parameter that is less than the target therapy parameter (Mulcahy teaches a limited pressure treatment less than the full treatment pressure to aid in acclimatizing the patient as seen in [0088] and [0025]-[0026]. Therefore, the first pressure and the second pressure will be adjusted lower as seen in [0020]).
Regarding claim 7, Mulcahy teaches the method of claim 1, and further teaches wherein the plurality of control parameters includes a prescribed pressure, a range of prescribed pressures, a prescribed pressure ramp rate, a range of prescribed pressures ramp rates, a range of prescribed step pressures changes, or any combination thereof (Mulcahy teaches the controller providing instruction to the flow generator to provide breathable gas at a first pressure and a second pressure to a patient while they are asleep, wherein the controller can adjust the first or second pressure until a target CPAP therapy for sleep-disordered breathing is provided as seen in [0020] and [0094]. Mulcahy further teaches parameters including pressure ramp increment as seen in [0084])
Regarding claim 8, Mulcahy teaches the method of claim 7, and further teaches wherein the adjusting the two or more values or the range of values of the plurality of prescribed control parameters includes one of: (i) adjusting the prescribed pressure to an adjusted pressure that is less than the prescribed pressure (Mulcahy teaches a limited pressure treatment less than the full treatment pressure to aid in acclimatizing the patient as seen in [0088] and [0025]-[0026]), (ii) adjusting the range of prescribed pressures to a range of pressures with a median pressure that that is lower than a median pressure of the range of prescribed pressures, or (iii) adjusting the prescribed pressure ramp rate to an adjusted pressure ramp rate that is less than the prescribed pressure ramp rate (Mulcahy teaches decreasing the pressure ramp increment depending on how the patient is coping with the therapy as seen in [0084]).
Regarding claim 11, Mulcahy teaches the method of claim 1, and further teaches wherein the desired sleep comfort level is automatically set by respiratory therapy system for the user for the sleep session ([0089] of the specification recites “…the system 100 can automatically set a sleep comfort level for the user 210. The automatically set sleep comfort level can be based at least in part on data associated with the user 210 and or data based on the user's experience and/or length of time and/or hours using the respiratory therapy system 120 and/or sleep therapy.” Mulcahy teaches setting the pressure for the next therapy session in step 208 based on patient feedback as seen in Fig. 2 and [0064] and [0062]).
Regarding claim 12, Mulcahy teaches the method of claim 1, and further teaches wherein the desired sleep comfort level is a value selected from a series of incrementally increasing values between a first value, indicative that the comfort experience is not important to the user, and a second value, indicative that the user desires the best possible sleep comfort experience (Mulcahy teaches a series of pre-programmed patient and/or bed partner feedback questions relating to treatment comfort wherein the patient is asked to provide a rating out of 10 as seen in [0062]. As such, if the user selects a rating of 1 (taken as second value), showing the user has not been acclimating (see [0063]), it would indicate the user desires more comfort. On the other hand, if the user selects a rating of 10 (taken as first value), it would indicate the user has been acclimating (see [0063]) and/or comfort experience is not important).
Regarding claim 14, Mulcahy teaches the method of claim 12, and further teaches wherein a difference, a delta, between at least one of the prescribed control parameters and the corresponding adjusted control parameters, is minimized by selection of the first value, and the delta is maximized by selection of the second value ([0121] of applicant’s specification recites “A delta 406 between the prescribed target maximum pressure 404 and the adjusted target maximum pressure 402 is shown. Where a higher pressure causes more sleep discomfort, a larger delta 406 indicates the user 120 has selected a higher desired sleep comfort. In comparison, a smaller delta 406 would indicate a selected a lower sleep comfort” which is further shown in Fig. 4A. Mulcahy teaches a limited pressure treatment (similar to applicant’s adjusted target maximum pressure 402) and a full treatment pressure (similar to applicant’s target maximum pressure 404) as seen in [0025]. As such, a delta is minimized by the selection of the first value of rating of 10 (which indicates the user has been acclimating and pressure can be increased) and maximized by the selection of the rating of 1 (which indicates the user desires more comfort) as seen in [0063]).
Regarding claim 15, Mulcahy teaches the method of claim 12, and further teaches wherein the sleep comfort experience is determined by user reported sleep comfort data, one or more sensors, or a combination thereof (Mulcahy teaches a series of pre-programmed patient and/or bed partner feedback questions relating to treatment comfort wherein the patient is to provide a yes/no answer or a rating out of ten as seen in [0062]. Mulcahy further teaches a flow sensor 4f, a pressure sensor 4p and a hardware sensor as seen in [0050] and [0086] to help monitor at least one parameter of the patient as seen in [0026]).
Regarding claim 16, Mulcahy teaches the method of claim 15, and further teaches wherein the user reported sleep comfort data includes data associated with: discomfort due to incidents of bloating after a sleep session, discomfort due to skin irritation ascribed to a mask leak after a sleep session, discomfort due to dry mouth or dry sinuses after a sleep session, discomfort due to restlessness or arousals during therapy, discomfort due to an initial therapy pressure causing air hunger, discomfort due to rapid ramp rate, insomnia or difficulty in getting to sleep during a sleep session, a caretaker or sleep partner observation of discomfort of the user after a sleep session, incidence of increased activity in the following day after therapy, or any combination thereof (Mulcahy teaches a series of pre-programmed patient and/or bed partner feedback questions relating to treatment comfort wherein the questions include patient restless and sleep quality as seen in [0062]).
Regarding claim 17, Mulcahy teaches the method of claim 16, and further teaches wherein the user reported sleep comfort data includes values selected from a series of incrementally increasing values between a first value, indicative that the sleep comfort data does not change the sleep comfort, and a second value, indicative that the sleep comfort data has a negative effect on the sleep comfort (Mulcahy further teaches a series of pre-programmed patient and/or bed partner feedback questions relating to treatment comfort wherein the questions relate to patient restlessness and the patient is to provide a rating out of 10 as seen in [0062]. As such, a rating of 1 (taken as first value) can be taken as it does not affect/change sleep comfort and a rating of 10 (taken as second value) can be taken as it has a negative effect on the sleep comfort when asked about restlessness).
Regarding claim 18, Mulcahy teaches the method of claim 17, and Mulcahy further teaches wherein the user reported sleep comfort data includes an integer between a first value of 1 and a second value of 10 (Mulcahy teaches the patient to provide a rating out of 10 as seen in [0062]).
Regarding claim 19, Mulcahy teaches the method of claim 15, and further teaches wherein the one or more sensors include a pressure sensor, a flow rate sensor, a temperature sensor, a motion sensor, an acoustic sensor, a camera, a PPG sensor, an EEG sensor, ECG sensor, a force sensor, an EMG sensor, an analyte sensor, an infrared sensor, a capacitive sensor, a strain gauge sensor, an oxygen sensor, and a moisture sensor, or any combination thereof; and wherein the one or more sensor are (i) positioned within or coupled to the respiratory therapy system, (ii) separate and distinct from the respiratory therapy system, or (iii) both (i) and (ii) (Mulcahy teaches a flow sensor 4f and a pressure sensor 4p as seen in [0050] positioned within or coupled to the respiratory therapy system as seen in Fig. 1 and [0052]).
Regarding claim 21, Mulcahy teaches the method of claim 15, and further teaches further comprising determining, for the sleep session, an achieved sleep comfort level using the sleep comfort experience for the sleep session (Mulcahy teaches a series of pre-programmed patient and/or bed partner feedback questions relating to treatment comfort wherein the patient is to provide a yes/no answer or a rating out of ten before the start of the second CPAP session as seen in [0062]).
Regarding claim 22, Mulcahy teaches the method of claim 21, and further teaches further comprising determining a sleep architecture for the sleep session using physiological data associated with the user that is generated by the one or more sensors, and wherein the achieved sleep comfort level is determined as a function of the determined sleep architecture ([0087] of applicant’s speficiation recites “…the prescribed control parameters for a therapy is a function of the sleep stage or sleep architecture.” Mulcahy teaches a flow sensor 4f, a pressure sensor 4p and a hardware sensor to help monitor at least one parameter of the patient as seen in [0026], [0050] and [0086]. Mulcahy further teaches controller 15 adapted to derive parameters indicative of the patient's breathing and sleep pattern with indicators including flow, snore and apnea as seen in [0054] and [0086]. As such, Mulcahy teaches determining a sleep architecture for the sleep session using physiological data associated with the users generated by one or more sensors and the sleep comfort level is determined as a function of the determined sleep architecture).
Regarding claim 25, Mulcahy teaches the method of claim 1, and further teaches further comprising using a machine learning algorithm to aid the user in achieving the desired sleep comfort level (Mulcahy teaches the device to learn the patient preferences as seen in [0134], to help the user achieve a desired sleep comfort level as seen in [0097]), the machine learning algorithm using historical adjusted values or a range of values and associated historical desired sleep comfort levels as inputs, the historical adjusted values or range of values and the historical desired sleep comfort levels provided from one or more prior sleep sessions (“…the device may "learn" how long it takes a patient to fall asleep and adjust the initial predetermined time amount accordingly. Thus, in response to this "preferred settling time," the device may adjust an initial ramp up period (e.g. during the settling time) or the ramp up period during sleep accordingly. Similarly, as the patient acclimatizes to the therapy, the awake settling time may be reduced based on the recorded data.” See [0097]).
Regarding claim 27, Mulcahy teaches the method of claim 1, and further teaches wherein the receiving the desired sleep comfort level includes the user communicating the desired sleep comfort level to the respiratory therapy system or an external device communicatively connected to the respiratory therapy system (Mulcahy teaches a series of pre-programmed patient and/or bed partner feedback questions displayed on the machine display relating to treatment comfort wherein the patient is to provide a yes/no answer or a rating out of ten as seen in [0062]).
Regarding claim 37, Mulcahy teaches a system for optimizing sleep for a user of a respiratory therapy system (Mulcahy teaches a ventilator device as seen in Fig. 1 comprising a servo-controlled blower 2, a flow sensor 4f, pressure sensor 4p, a mask 6, an air delivery conduit 8 and controller 15 as seen in [0050] and [0054]) (Mulcahy teaches a system and a flowchart with a method for an acclimatization therapy for new CPAP users as seen in Figs. 1-3 and [0035] and [0076]-[0077]), the system comprising:
a memory having stored thereon machine readable instructions (“The controller or processor may include integrated chips, a memory, and/or other instruction or data storage mediums to implement the control methodology. For example, programmed instructions with the control methodology are either coded on integrated chips in the memory of the device, loaded as software, embedded as firmware, implemented as some combination thereof, etc.” see [0053]); and
a control system (controller/processor 15, see Fig .1) including one or more processors (controller/processor 15, see Fig .1) configured to execute the machine-readable instructions (see [0053]) to:
receive therapy instructions to be implemented using the respiratory therapy system for a sleep session, the therapy instructions including a plurality of prescribed control parameters, each of the plurality of prescribed control parameters having a value or a range of values for achieving a medically prescribed therapy ([0076] of applicant’s specification states the therapy instructions can be entered or pre-programmed into the respiratory therapy system and can include a plurality of prescribed control parameters such as prescribed pressure and pressure ranges. Mulcahy teaches the controller providing instruction to the flow generator to provide breathable gas at a first pressure and a second pressure to a patient while they are asleep, wherein the controller can adjust the first or second pressure until a target CPAP therapy for sleep-disordered breathing is provided as seen in [0020] and [0094]. Mulcahy further teaches controlled parameters including pressure ramp increment (see [0084]) and a predetermined time period for a user to fall asleep (see [0096]-[0097]);
receive a desired sleep comfort level for the sleep session, wherein the desired sleep comfort level is indicative of a sleep comfort experience desired by the user for the sleep session (Mulcahy teaches a series of pre-programmed patient and/or bed partner feedback questions relating to treatment comfort to aid in providing treatment for the patient based on their comfort and compliance as seen in Figs. 2-3 and [0062] and [0071]. These questions are used to set a comfort level and treatment for the next session as seen in Figs. 2-3 and [0062]. Mulcahy further teaches methods to assist a patient in therapy and making therapy more comfortable for first time users as seen in [0135]); and
adjust, based on the desired sleep comfort level, two or more of the values or the range of values of the plurality of prescribed control parameters to obtain two or more adjusted values or range of values, the two or more adjusted values or range of values departing from the medically prescribed therapy to aid the user in achieving the desired sleep comfort level (Mulcahy teaches a limited pressure treatment less than the full treatment pressure to aid in acclimatizing the patient as seen in [0088] and [0025]-[0026]. Mulcahy further teaches increasing pressure if a person’s response and recorded measurements of the treatment session indicate compliance as seen in Figs. 2-3 and [0063]. The pressure ramp increment can also be decreased or increased depending on how the patient is coping with the therapy as seen in [0084] and the predetermined time it takes for the patient to fall asleep can be increased as seen in [0097]).
Regarding claim 38, Mulcahy teaches the system of claim 37, and further teaches wherein the received therapy instructions are provided to aid the user in achieving a target therapy parameter during the sleep session (Mulcahy teaches parameters associated with sleep therapy that can be ramped up until target CPAP parameters are met as seen in [0019]-[0020]), and the adjusted two or more of the values or the range of values of the plurality of control parameters provides a therapy parameter that is different from the target therapy parameter (Mulcahy teaches a limited pressure treatment below the full treatment pressure as seen in [0025] and which is to be increased incrementally until the full treatment pressure is reached as seen in [0063]-[0064]. Mulcahy further teaches the pressure ramp increment can also be decreased or increased depending on how the patient is coping with the therapy as seen in [0084], wherein the pressure ramp affects the target pressure as seen in [0019] and [0092]).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mulcahy (US 20090038616 A1) in view of Lee (US 20050061315 A1).
Regarding claim 5, Mulcahy teaches the method of claim 2, and further teaches monitoring parameters including changes in the patient's Apnea-Hypopnea Index (AHI) as seen in [0086].
But does not teach wherein the target therapy parameter includes an Apnea Hypopnea Index (AHI), oxygen saturation level (SpO2), snoring, choking, heart rate, labored breathing, restlessness, or any combination thereof.
However, Lee teaches wherein the target therapy parameter includes an Apnea Hypopnea Index (AHI), oxygen saturation level (SpO2), snoring, choking, heart rate, labored breathing, restlessness, or any combination thereof (Lee teaches uses an apnea hypopnea index to assess the effectiveness of the sleep disordered breathing wherein a lower AHI indicates a more effective breathing treatment than a relatively high AHI as seen in Fig. 1E and [0054]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method taught by Mulcahy to use AHI as a parameter as taught by Lee to assess the effectiveness of the sleep disordered breathing (see [0054] and [0059]).
Regarding claim 6, Mulcahy in view of Lee teaches the method of claim 3, but does not teach wherein the target therapy parameter is a target Apnea Hypopnea Index (AHI) for the user during the sleep session, and the adjusted two or more of the values or range of values of the plurality of control parameters causes the user to experience an actual AHI that is greater than the target AHI.
However, Lee teaches wherein the target therapy parameter is a target Apnea Hypopnea Index (AHI) for the user during the sleep session (Lee teaches uses an apnea hypopnea index to assess the effectiveness of the sleep disordered breathing wherein a lower AHI indicates a more effective breathing treatment than a relatively high AHI as seen in Fig. 1E and [0054]). Lee further teaches adjusting the breathing therapy pressure upwards to provide a more effective therapy if the AHI is too high and adjusting the breathing therapy pressure downwards to a disordered breath therapy that is more comfortable for the user as seen in [0059].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method taught by Mulcahy to use AHI as a parameter as taught by Lee to assess the effectiveness of the sleep disordered breathing (see [0054] and [0059]). Mulcahy in view of Lee teaches the adjusted two or more of the values or range of values of the plurality of control parameters causes the user to experience an actual AHI that is greater than the target AHI (Lee teaches adjusting the pressure therapy downwards towards a more disordered breath therapy, therefore increasing AHI compared than the target AHI, for a more comfortable therapy as seen in [0059]. Mulcahy in view of Lee teaches adjusting the pressures/pressure treatments (see [0088] and [0025]-[0026] of Mulcahy) and pressure ramp increments (see [0084] of Mulcahy) by lowering the pressure to aid in making therapy more comfortable).
Claim(s) 23, 28-29 and 39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mulcahy (US 20090038616 A1) in view of Phillips (US 20140088373 A1).
Regarding claim 23, Mulcahy teaches the method of claim 21, and Mulcahy further teaches wherein the achieved sleep comfort level is a function of a sleep state (Mulcahy teaches a process for providing a set of pressures based on the patient’s sleep stage including determining whether or not a sleep state is changed and the patient is awake in Fig. 7 and [0101]. Mulcahy further teaches a series of pre-programmed patient and/or bed partner feedback questions relating to treatment comfort wherein the questions relate to patient restlessness as seen in [0062])
But does not teach one or more of motion, audible sounds, and a sleeping position, as detected by the one or more sensors.
However, Phillips teaches one or more of motion, audible sounds, and a sleeping position, as detected by the one or more sensors (Phillips teaches a motion sensor for detecting general bodily movement and respiration and a processor to derive signals related to breathing and motion, and hence to derive sleep stage as seen in Fig. 2 and [0021] and [0055]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method taught by Mulcahy to include a motion sensor and processor as taught by Phillips to aid in deriving the sleep stage of a user without contact (see [0019]-[0020]).
Regarding claim 28, Mulcahy teaches the method of claim 15, and further teaches further comprising:
receiving, from the one or more sensors, physiological data associated with the user (Mulcahy further teaches a flow sensor 4f, a pressure sensor 4p and a hardware sensor as seen in [0050] and [0086] to help monitor at least one parameter of the patient as seen in [0026] and [0086]);
determining, based at least in part on the received physiological data, an estimated current sleep comfort of the user during the current sleep state of the user (Mulcahy teaches monitoring one or more parameters associated with a patient's comfort level wherein the monitored parameters include changes in the patient's Apnea-Hypopnea Index (AHI), changes in the leak level, and the number of "mask off" events as seen in [0086], wherein a flow sensor 4f, a pressure sensor 4p and a hardware sensor is used to help monitor parameters as seen in [0026], [0050] and [0086]. As such, while monitoring the parameters associated with a patient’s comfort level, a user’s patient comfort level is determined. For example, if a user has numerous “mask off” events, they are most likely uncomfortable compared to a user who has no “mask off” events);
during the current sleep state, adjusting at least one of the one or more values or the range of values of the plurality of prescribed control parameters, to an adjusted value or an adjusted range of values based at least in part on the estimated current sleep comfort of the user and the received desired sleep comfort level (Mulcahy teaches a process for providing a set of pressures based on the patient’s sleep stage as seen in Fig. 7 and [0101]. Step S702 determines the sleep stage the patient is in and provides a set of pressures in step S704 based on the sleep state. If the patient is found awake, the pressure is adjusted to a comfortable “awake pressure” before being readjusted to an appropriate pressure if the patient is found asleep again as seen in Fig. 7 and [0101]. Furthermore, the device learns the patient preferences and therefore is providing a pressure based on the user’s sleep comfort as seen in [0134])
but does not teach determining a current sleep state of the user based on the received physiological data
However, Phillips teaches determining a current sleep state of the user based on the received physiological data (Phillips teaches a motion sensor for detecting general bodily movement and respiration and a processor to derive signals related to breathing and motion, and hence to derive sleep stage as seen in Fig. 2 and [0021] and [0055]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method taught by Mulcahy to include a motion sensor and processor as taught by Phillips to aid in deriving the sleep stage of a user without contact (see [0019]-[0020]).
Regarding claim 29, Mulcahy in view of Phillips teaches the method of claim 28, and further teaches wherein the current sleep comfort of the user is a function of motion of the user during the sleep session, audible sounds detected during the sleep session, sleeping position of the user during the sleep session, of any combination thereof (Mulcahy teaches a series of pre-programmed patient and/or bed partner feedback questions relating to treatment comfort wherein the questions relate to patient restlessness as seen in [0062]) and further teaches a process determining whether or not a sleep state is changed and the patient is awake in Fig. 7 and [0101]. As such, a user’s sleep comfort is related to their restlessness (the more restless they are, the less comfortable they are for sleep) and sleep stage (if a user is constantly waking up, they are not comfortable). Mulcahy in view of Phillips teaches a motion sensor which aids in deriving the sleep stage of a user as it detects bodily motion and respiration as seen in [0019]-[0020] of Phillips).
Regarding claim 39, Mulcahy teaches the system of claim 37, and further teaches further comprising one or more sensors (Mulcahy further teaches a flow sensor 4f, a pressure sensor 4p and a hardware sensor as seen in [0050] and [0086]), and wherein executing the machine-readable instructions further configure the control system to:
receive, from the one or more sensors, physiological data associated with the user (Mulcahy further teaches a flow sensor 4f, a pressure sensor 4p and a hardware sensor as seen in [0050] and [0086] to help monitor at least one parameter of the patient as seen in [0026] and [0086]);
determine, based at least in part on the received physiological data, an estimated current sleep comfort of the user during the current sleep state of the user (Mulcahy teaches monitoring one or more parameters associated with a patient's comfort level wherein the monitored parameters include changes in the patient's Apnea-Hypopnea Index (AHI), changes in the leak level, and the number of "mask off" events as seen in [0086], wherein a flow sensor 4f, a pressure sensor 4p and a hardware sensor is used to help monitor parameters as seen in [0026], [0050] and [0086]. As such, while monitoring the parameters associated with a patient’s comfort level, a user’s patient comfort level is determined. For example, if a user has numerous “mask off” events, they are most likely uncomfortable compared to a user who has no “mask off” events); and
during the current sleep state, adjust at least one of the one or more values or the range of values of the plurality of prescribed control parameters, to an adjusted value or an adjusted range of values based at least in part on the estimated current sleep comfort of the user and the received desired sleep comfort level (Mulcahy teaches a process for providing a set of pressures based on the patient’s sleep stage as seen in Fig. 7 and [0101]. Step S702 determines the sleep stage the patient is in and provides a set of pressures in step S704 based on the sleep state. If the patient is found awake, the pressure is adjusted to a comfortable “awake pressure” before being readjusted to an appropriate pressure if the patient is found asleep again as seen in Fig. 7 and [0101]. Furthermore, the device learns the patient preferences and therefore is providing a pressure based on the user’s sleep comfort as seen in [0134])
but does not teach determining a current sleep state of the user based on the received physiological data
However, Phillips teaches determining a current sleep state of the user based on the received physiological data (Phillips teaches a motion sensor for detecting general bodily movement and respiration and a processor to derive signals related to breathing and motion, and hence to derive sleep stage as seen in Fig. 2 and [0021] and [0055]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method taught by Mulcahy to include a motion sensor and processor as taught by Phillips to aid in deriving the sleep stage of a user without contact (see [0019]-[0020]).
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mulcahy (US 20090038616 A1) in view of Borshch (US 20190103182 A1).
Regarding claim 24, Mulcahy teaches the method of claim 1, but does not teach further comprising adjusting one or more devices in an environment of the user to modify, ambient lighting, ambient noise, a soothing sound, the ambient temperature, air flow, the position of the user by a smart pillow or mattress, or a combination thereof, to aid the user in achieving the desired sleep comfort level.
However, Borshch teaches comprising adjusting one or more devices in an environment of the user to modify, ambient lighting, ambient noise, a soothing sound, the ambient temperature, air flow, the position of the user by a smart pillow or mattress, or a combination thereof, to aid the user in achieving the desired sleep comfort level (Borshch teaches adjusting the light intensity, temperature, and turning on soothing white noise to in increase the user’s comfort level for sleep as seen in [0044]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method taught by Mulcahy to include adjusting the light intensity, temperature and noise as taught by Borshch to increase the user’s comfort level for sleep (see [0044]) to aid them in sleeping.
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mulcahy (US 20090038616 A1) in view of Stern (US 20190117151 A1).
Regarding claim 26, Mulcahy teaches the method of claim 25, but does not teach wherein the historical adjusted values or range of values and the historical desired sleep comfort levels are sourced from a plurality of users of respective respiratory therapy systems.
However, Stern teaches “Machine learning can be used with historical data of a plurality of users to improve prediction of the likelihood of a sleep disorder and effectiveness of different forms of treatment (see [0008]).”
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method taught by Mulcahy to use machine learning from a plurality of users as taught by Stern to improve the prediction of the likelihood of a sleep disorder and effectiveness of different forms of treatment (see [0008]). Mulcahy in view of Stern teaches wherein the historical adjusted values or range of values and the historical desired sleep comfort levels are sourced from a plurality of users of respective respiratory therapy systems (Mulcahy teaches the device learning patient preferences to aid in achieving a desired sleep comfort level by adjusting parameters as seen in [0097] and [0134]. Mulcahy in view of Stern teaches the device learning a user’s preference in machine learning along with data from a plurality of users as seen in [0008] of Stern).
Claim(s) 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mulcahy (US 20090038616 A1) in view of Phillips (US 20140088373 A1), as applied to claim 28, above and further in view of Borshch (US 20190103182 A1).
Regarding claim 30, Mulcahy in view of Phillips teaches the method of claim 28, but does not teach further comprising adjusting one or more external devices in an environment of the user to modify, ambient lighting, ambient noise, a soothing sound, the ambient temperature, air flow, the position of the user by a smart pillow or mattress, or a combination thereof.
However, Borshch teaches further comprising adjusting one or more external devices in an environment of the user to modify, ambient lighting, ambient noise, a soothing sound, the ambient temperature, air flow, the position of the user by a smart pillow or mattress, or a combination thereof (Borshch teaches adjusting the light intensity, temperature, and turning on soothing white noise to in increase the user’s comfort level for sleep as seen in [0044]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method taught by Mulcahy in view of Phillips to include adjusting the light intensity, temperature and noise as taught by Borshch to increase the user’s comfort level for sleep (see [0044]) to aid them in sleeping.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Coles (US 20180211723 A1) teaches a machine learning master link programmed to learn a user’s amount of sleep and interruptions in sleep.
Zigel (US 20190298271 A1) teaches a system for an estimation of AHI.
Whiting (US 20170014587 A1) teaches adjusting pressure of a PAP system for patient comfort.
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/TINA ZHANG/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785