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 statements (IDS) submitted on April 06, 2023, September 25, 2023, and December 05, 2025 have been received and considered by the Examiner.
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 1-9 and 12-20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Sanson et al. (US 20220323711 A1, hereinafter "Sanson").
Regarding Claim 1, Sanson discloses: A high-flow respiratory therapy system (Paragraph 0001, The present invention relates to apparatuses and methods for use in the delivery of a flow of gas, and particularly but not solely to apparatuses and methods for detection of a supplemental gases source, such as in a respiratory support system, such as a respiratory humidification system or a high flow support system) comprising:
a blender arranged to receive a first gas and a second gas (Paragraph 0047, The device comprises a gases mixer to mix inlet gases, and the gases mixer is positioned upstream of the gases composition sensor and downstream of the first inlet and second inlet) and to output a combination of the first gas and the second gas as a delivered gas to a patient respiratory interface (Paragraph 1000, The respiratory therapy apparatus 10 can deliver any concentration of oxygen (e.g., FdO2), up to 100%, at any flowrate between about 1 LPM and about 100 LPM);
an airflow source for providing a flow of air to the blender as the first gas (Paragraph 0093, The first inlet is an ambient air inlet, The first gases source is an ambient air source);
a valve operable to provide oxygen gas from an oxygen gas source to the blender as the second gas (Paragraph 0305, The device comprises a valve operable to control a flow of gases introduced to the device by the second inlet, and the valve is operable by the controller), (Paragraph 0993, The second inlet 220, in some embodiments an oxygen inlet, can include a valve through which a pressurized gas may enter the flow generator or blower. The valve can control a flow of oxygen into the flow generator blower);
a heater operable to heat the delivered gas at the patient respiratory interface (Paragraph 0991, The patient conduit 16 can have a heater wire 16a to heat gases flow passing through to the patient. The heater wire 16a can be under the control of the controller 13);
a pulse oximeter (Paragraph 0998, The respiratory therapy apparatus 10 can include a patient sensor 26, such as a pulse oximeter or a patient monitoring system, to measure one or more physiological parameters of the patient, such as a patient's blood oxygen saturation (SpO2), heart rate, respiratory rate, perfusion index, and provide a measure of signal quality);
and a controller configured to execute a learning procedure in response to a trigger (Paragraph 0987, The controller 13 may be implemented as a purely hardware controller, as a software regime running on controller hardware, or as software operational on other non-dedicated controller hardware of the device. Alternatively, it may be implemented as any number of combinations of the foregoing implementation examples), the learning procedure comprising varying
a first parameter of the airflow source (Paragraph 0994, The respiratory therapy apparatus 10 can measure and control the oxygen content of the gas being delivered to the patient, and therefore the oxygen content of the gas inspired by the patient),
a second parameter of the valve (Paragraph 0076, The closed loop gas control mode comprises closed loop oxygen control, the controller receives a target blood oxygen concentration and dependent on this target operates at least the second inlet valve to control the oxygen concentration of gases delivered by the device),
and a third parameter of the heater (Paragraph 0992, The controller 13 can also control a heating element in the humidifier 12 and/or the heating element 16a in the patient conduit 16 to heat the gas to a desired temperature for a desired level of therapy and/or level of comfort for the patient),
and determining a recommended parameter from among the first, second, and third parameters based on one or more measurements of the pulse oximeter (Paragraphs 0074-0075, The controller receives an input from a patient blood oxygen sensor. The controller operates the detection upon an operation of the device to a closed loop gas control mode),
the controller further configured to output a recommendation to adjust the recommended parameter (Paragraph 1035, With reference again to FIG. 1A, the controller 13 can be programmed with or configured to execute a closed loop control system for controlling the operation of the respiratory therapy apparatus. The closed loop control system can be configured to ensure the patient's SpO2 reaches a target level and consistently remains at or near this level).
Regarding Claim 2, Sanson discloses all of the limitations of Claim 1. Sanson further discloses: wherein said varying the first parameter, the second parameter, and the third parameter includes performing a series of experimental runs (Paragraph 1055, FIGS. 4 and 5 illustrate flowcharts for the control of a respiratory therapy device, and in particular the control of such a device in the detection of the connection of a supplemental gases source at the second inlet 220 at the operation of the device into a high pressure therapy mode), each of the runs including varying one or more of the first, second, and third parameters (Paragraph 0076, The closed loop gas control mode comprises closed loop oxygen control, the controller receives a target blood oxygen concentration and dependent on this target operates at least the second inlet valve to control the oxygen concentration of gases delivered by the device) and recording a resulting measurement of the pulse oximeter (Paragraph 0998, The pulse oximeter would be attached to the user, typically at their finger, although other places such as an earlobe are also an option. The pulse oximeter would be connected to a processor in the device and would constantly provide signals indicative of the patient's blood oxygen saturation).
Regarding Claim 3, Sanson discloses all of the limitations of Claim 2. Sanson further discloses: wherein said determining the recommended parameter includes comparing the recorded measurements of the pulse oximeter (Paragraph 0076, The closed loop gas control mode comprises closed loop oxygen control, the controller receives a target blood oxygen concentration and dependent on this target operates at least the second inlet valve to control the oxygen concentration of gases delivered by the device).
Regarding Claim 4, Sanson discloses all of the limitations of Claim 1. Sanson further discloses: wherein the trigger comprises a passage of a predefined length of time (Paragraph 0652, The controller triggers the first alarm dependent on the valve having been in its open condition for a first predetermined time period. The first predetermined time period is about 10 ms to about 1 min).
Regarding Claim 5, Sanson discloses all of the limitations of Claim 4. Sanson further discloses: wherein the trigger occurs periodically according to the predefined length of time (Paragraph 1101, At block 344 the controller 13 sets the blower to a predetermined flow condition such as to assist in the flushing of the supplemental gases from the device. The controller sets a timer at block 345, and may continue to operate the blower at the predetermined flow condition until the expiry of the timer at block 348. The controller 13 may then allow the operation of the device into the standby mode)
Regarding Claim 6, Sanson discloses all of the limitations of Claim 1. Sanson further discloses: wherein the trigger comprises a predefined measurement of the pulse oximeter (Paragraph 0076, The closed loop gas control mode comprises closed loop oxygen control, the controller receives a target blood oxygen concentration and dependent on this target operates at least the second inlet valve to control the oxygen concentration of gases delivered by the device), (Paragraph 0998, The pulse oximeter would be connected to a processor in the device and would constantly provide signals indicative of the patient's blood oxygen saturation).
Regarding Claim 7, Sanson discloses all of the limitations of Claim 1. Sanson further discloses: wherein the trigger comprises a predefined degree of change in a measurement of the pulse oximeter (Paragraph 1051, As previously described, in some closed loop control systems the device may measure and adjust the fraction of delivered oxygen FdO2 in order to meet the requirements of the closed loop control, such as meeting a target FiO2 or FdO2 level, or a target blood oxygen saturation SpO2), (Paragraph 0076, The closed loop gas control mode comprises closed loop oxygen control, the controller receives a target blood oxygen concentration and dependent on this target operates at least the second inlet valve to control the oxygen concentration of gases delivered by the device), (Paragraph 0165-166, Detection of the connection of a supplemental gases source at the second inlet is conducted upon receipt an input of a target oxygen concentration in excess of an ambient oxygen concentration. Detection is conducted upon the setting of the target oxygen concentration in excess of 21%).
Regarding Claim 8, Sanson discloses all of the limitations of Claim 1. Sanson further discloses: wherein the trigger comprises a manually entered command (Paragraph 1046, The configuration of the controller 13 may be such that it receives manual input from a user by a user interface 14 in or supplemental to the execution of a closed loop control system. In particular, the controller 13 may receive input from a user by an input device such as one or more buttons, a touch screen, or the like. The controller may also be pre-programmed to provide the input, or may receive an input from another internal or external system).
Regarding Claim 9, Sanson discloses all of the limitations of Claim 1. Sanson further discloses: wherein the controller is configured to output the recommendation as a visual indication on a display (Paragraph 1215, If instead the threshold is not exceeded, the control process of FIG. 11 provides for an alternative configuration to that of FIG. 10. As seen at block 412, the controller may trigger an alarm relating to the fact that the threshold has not been met. The alarm may in various preferred forms be an audible alarm and/or a visual alert, which may communicate that the threshold has not been met. As previously described, the alarm may be communicated to the user or operator by the apparatus itself, such as by a GUI of the apparatus, may be communicated to a connected device such as a smartphone of the user or operator, or may be communicated to a device at a medical monitoring station such as a nurses station).
Regarding Claim 12, Sanson discloses all of the limitations of Claim 1. Sanson further discloses: wherein the controller is configured to plot a plurality of measurements of the pulse oximeter as a function of time on a display (Figure 9, Paragraphs 1041-1042, The graphical user interface 14 (GUI) can be configured to display the range of values between which FdO2 and/or SpO2 are being controlled. The range could be displayed by having the two limits set apart from each other on the GUI, with an indicator appearing within the range to graphically represent the position of the current value with respect to the limits of the range. The GUI can display graphs of recent FdO2 and/or SpO2 data. The GUI can display the level of each parameter on the same or different graphs over a defined period of time, such as one or more hours. The length of time over which data is displayed could match the length of the time for which data is currently available).
Regarding Claim 13, Sanson discloses all of the limitations of Claim 1. Sanson further discloses:
a flow sensor arranged to measure a flow rate of the delivered gas (Paragraph 1070, The device may also comprise a flow sensor 270, to sense a flow of gases through the device. The controller may be configured to detect the connection of a supplemental gases source at the second inlet by the reading of an increased gases flow by the flow sensor 270 within a predetermined time of the pulsing of the valve. This determination may be independent of the reading of a signal from the gases composition sensor and/or the reading of any pressure sensor information);
an oxygen sensor arranged to measure a fraction of inspired oxygen (FiO2) of the delivered gas (Paragraph 0994, So long as the flow rate of delivered gas meets or exceeds peak inspiratory demand of the patient, entrainment of ambient air is prevented, and the gas delivered by the device is substantially the same as the gas the patient breathes in. As such, the oxygen concentration measured in the device, fraction of delivered oxygen, (FdO2) would be substantially the same as the oxygen concentration the user is breathing, fraction of inspired oxygen (FiO2), and as such the terms may can be seen as equivalent) ;
and a temperature sensor arranged to measure a temperature of the delivered gas at the patient respiratory interface (Paragraph 0995, Operation sensors 3a, 3b, 3c, such as flow, temperature, humidity, and/or pressure sensors can be placed in various locations in the respiratory therapy apparatus 10. Additional sensors (for example, sensors 20, 25) may be placed in various locations on the patient conduit 16 and/or cannula 17 (for example, there may be a temperature sensor 29 at or near the end of the inspiratory tube)).
Regarding Claim 14, Sanson discloses all of the limitations of Claim 1. Sanson further discloses: further comprising a humidification system for humidifying the delivered gas as it flows from the blender to the patient respiratory interface (Paragraph 0992, The controller 13 can also control a supplemental oxygen inlet to allow for delivery of supplemental oxygen, the humidifier 12 (if present) can humidify the gases flow and/or heat the gases flow to an appropriate level, and/or the like. The gases flow is directed out through the patient conduit 16 and cannula 17 to the patient. The controller 13 can also control a heating element in the humidifier 12 and/or the heating element 16a in the patient conduit 16 to heat the gas to a desired temperature for a desired level of therapy and/or level of comfort for the patient. The controller 13 can be programmed with or can determine a suitable target temperature of the gases flow).
Regarding Claim 15, Sanson discloses all of the limitations of Claim 14. Sanson further discloses: further comprising a second heater operable to heat the delivered gas upstream of the humidification system (Paragraph 0992, The controller 13 can also control a supplemental oxygen inlet to allow for delivery of supplemental oxygen, the humidifier 12 (if present) can humidify the gases flow and/or heat the gases flow to an appropriate level, and/or the like. The gases flow is directed out through the patient conduit 16 and cannula 17 to the patient. The controller 13 can also control a heating element in the humidifier 12 and/or the heating element 16a in the patient conduit 16 to heat the gas to a desired temperature for a desired level of therapy and/or level of comfort for the patient).
Regarding Claim 16, Sanson discloses all of the limitations of Claim 1. Sanson further discloses: wherein the airflow source comprises a blower (Paragraph 0191, a blower for generating a flow of gases from the inlets to an outlet of the device).
Regarding Claim 17, Sanson discloses all of the limitations of Claim 1. Sanson further discloses: wherein the airflow source comprises a compressed gas source (Paragraph 0097, The supplemental gases source is a pressurised gases source).
Regarding Claim 18, Sanson discloses: A method of controlling a high-flow respiratory therapy system (Paragraph 0001, The present invention relates to apparatuses and methods for use in the delivery of a flow of gas, and particularly but not solely to apparatuses and methods for detection of a supplemental gases source, such as in a respiratory support system, such as a respiratory humidification system or a high flow support system), the method comprising:
receiving a trigger (Paragraph 1055, FIGS. 4 and 5 illustrate flowcharts for the control of a respiratory therapy device, and in particular the control of such a device in the detection of the connection of a supplemental gases source at the second inlet 220 at the operation of the device into a high pressure therapy mode), (Paragraph 0987, The controller 13 may be implemented as a purely hardware controller, as a software regime running on controller hardware, or as software operational on other non-dedicated controller hardware of the device. Alternatively, it may be implemented as any number of combinations of the foregoing implementation examples);
and executing a learning procedure in response to the trigger, the learning procedure comprising:
varying a first parameter of an airflow source that provides a flow of air to a blender of the high-flow respiratory therapy system (Paragraph 0093, The first inlet is an ambient air inlet, The first gases source is an ambient air source), (Paragraph 0994, The respiratory therapy apparatus 10 can measure and control the oxygen content of the gas being delivered to the patient, and therefore the oxygen content of the gas inspired by the patient);
varying a second parameter of a valve operable to provide oxygen gas from an oxygen gas source to the blender (Paragraph 0993, The second inlet 220, in some embodiments an oxygen inlet, can include a valve through which a pressurized gas may enter the flow generator or blower. The valve can control a flow of oxygen into the flow generator blower), (Paragraph 0076, The closed loop gas control mode comprises closed loop oxygen control, the controller receives a target blood oxygen concentration and dependent on this target operates at least the second inlet valve to control the oxygen concentration of gases delivered by the device),
the blender being arranged to receive the flow of air from the airflow source as a first gas, receive the oxygen gas from the valve as the second gas (Paragraph 0047, The device comprises a gases mixer to mix inlet gases, and the gases mixer is positioned upstream of the gases composition sensor and downstream of the first inlet and second inlet), and output a combination of the first gas and the second gas as a delivered gas to a patient respiratory interface (Paragraph 1000, The respiratory therapy apparatus 10 can deliver any concentration of oxygen (e.g., FdO2), up to 100%, at any flowrate between about 1 LPM and about 100 LPM);
varying a third parameter of a heater operable to heat the delivered gas at the patient respiratory interface (Paragraph 0991, The patient conduit 16 can have a heater wire 16a to heat gases flow passing through to the patient. The heater wire 16a can be under the control of the controller 13), (Paragraph 0992, The controller 13 can also control a heating element in the humidifier 12 and/or the heating element 16a in the patient conduit 16 to heat the gas to a desired temperature for a desired level of therapy and/or level of comfort for the patient);
and determining a recommended parameter from among the first, second, and third parameters based on one or more measurements of a pulse oximeter (Paragraphs 0074-0075, The controller receives an input from a patient blood oxygen sensor. The controller operates the detection upon an operation of the device to a closed loop gas control mode),
wherein the method further comprises outputting a recommendation to adjust the recommended parameter (Paragraph 1035, With reference again to FIG. 1A, the controller 13 can be programmed with or configured to execute a closed loop control system for controlling the operation of the respiratory therapy apparatus. The closed loop control system can be configured to ensure the patient's SpO2 reaches a target level and consistently remains at or near this level).
Regarding Claim 19, Sanson discloses all of the limitations of Claim 18. Sanson further discloses: wherein the patient respiratory interface is connected to the patient and said outputting comprises
presenting the recommendation on a graphical user interface (Paragraph 0564, The first alarm and second alarm each provide a recommendation to a user to check a supplemental gases supply from the supplemental gases source), (Paragraph 1215, If instead the threshold is not exceeded, the control process of FIG. 11 provides for an alternative configuration to that of FIG. 10. As seen at block 412, the controller may trigger an alarm relating to the fact that the threshold has not been met. The alarm may in various preferred forms be an audible alarm and/or a visual alert, which may communicate that the threshold has not been met. As previously described, the alarm may be communicated to the user or operator by the apparatus itself, such as by a GUI of the apparatus, may be communicated to a connected device such as a smartphone of the user or operator, or may be communicated to a device at a medical monitoring station such as a nurses station);
receiving a user input to the graphical user interface (Paragraph 0849, The second alarm includes a prompt by which an operator may instruct the apparatus to be operated in a or the first mode, wherein the first mode is dependent on the supply of supplementary gases from the first inlet);
and adjusting the recommended parameter in response to the user input (Paragraph 1146, The device may be operated in a different therapy mode as a result of the connection of the gases source. It may be desirable or even necessary to notify a user or operator of a proposed, impending, or already operated change to the therapy mode. In addition, it some configurations it may also be desirable or necessary to or obtain the approval of the user or operator of a change to the therapy mode).
Regarding Claim 20, Sanson discloses: A non-transitory program storage medium on which are stored instructions executable by a processor or programmable circuit to perform operations for controlling a high-flow respiratory therapy system (Paragraph 0933, According to another aspect, the present disclosure provides a non-transitory computer-readable medium that stores therein a program causing a computer to execute a process), the operations comprising:
receiving a trigger (Paragraph 1055, FIGS. 4 and 5 illustrate flowcharts for the control of a respiratory therapy device, and in particular the control of such a device in the detection of the connection of a supplemental gases source at the second inlet 220 at the operation of the device into a high pressure therapy mode), (Paragraph 0987, The controller 13 may be implemented as a purely hardware controller, as a software regime running on controller hardware, or as software operational on other non-dedicated controller hardware of the device. Alternatively, it may be implemented as any number of combinations of the foregoing implementation examples);
and executing a learning procedure in response to the trigger, the learning procedure comprising:
varying a first parameter of an airflow source that provides a flow of air to a blender of the high-flow respiratory therapy system (Paragraph 0093, The first inlet is an ambient air inlet, The first gases source is an ambient air source), (Paragraph 0994, The respiratory therapy apparatus 10 can measure and control the oxygen content of the gas being delivered to the patient, and therefore the oxygen content of the gas inspired by the patient);
varying a second parameter of a valve operable to provide oxygen gas from an oxygen gas source to the blender (Paragraph 0993, The second inlet 220, in some embodiments an oxygen inlet, can include a valve through which a pressurized gas may enter the flow generator or blower. The valve can control a flow of oxygen into the flow generator blower), (Paragraph 0076, The closed loop gas control mode comprises closed loop oxygen control, the controller receives a target blood oxygen concentration and dependent on this target operates at least the second inlet valve to control the oxygen concentration of gases delivered by the device),
the blender being arranged to receive the flow of air from the airflow source as a first gas, receive the oxygen gas from the valve as the second gas (Paragraph 0047, The device comprises a gases mixer to mix inlet gases, and the gases mixer is positioned upstream of the gases composition sensor and downstream of the first inlet and second inlet), and output a combination of the first gas and the second gas as a delivered gas to a patient respiratory interface (Paragraph 1000, The respiratory therapy apparatus 10 can deliver any concentration of oxygen (e.g., FdO2), up to 100%, at any flowrate between about 1 LPM and about 100 LPM);
varying a third parameter of a heater operable to heat the delivered gas at the patient respiratory interface (Paragraph 0991, The patient conduit 16 can have a heater wire 16a to heat gases flow passing through to the patient. The heater wire 16a can be under the control of the controller 13), (Paragraph 0992, The controller 13 can also control a heating element in the humidifier 12 and/or the heating element 16a in the patient conduit 16 to heat the gas to a desired temperature for a desired level of therapy and/or level of comfort for the patient);
and determining a recommended parameter from among the first, second, and third parameters based on one or more measurements of a pulse oximeter (Paragraphs 0074-0075, The controller receives an input from a patient blood oxygen sensor. The controller operates the detection upon an operation of the device to a closed loop gas control mode),
wherein the operations further comprise outputting a recommendation to adjust the recommended parameter (Paragraph 1035, With reference again to FIG. 1A, the controller 13 can be programmed with or configured to execute a closed loop control system for controlling the operation of the respiratory therapy apparatus. The closed loop control system can be configured to ensure the patient's SpO2 reaches a target level and consistently remains at or near this level).
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 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Sanson (US 20220323711 A1) in view of Taube (US 20210128032 A1)
Regarding Claim 10, Sanson discloses all of the limitations of Claim 1. Sanson further discloses: wherein the recommendation comprises […] adjust[ing] the recommended parameter (Paragraph 0564, The first alarm and second alarm each provide a recommendation to a user to check a supplemental gases supply from the supplemental gases source), (Paragraph 0849, The second alarm includes a prompt by which an operator may instruct the apparatus to be operated in a or the first mode, wherein the first mode is dependent on the supply of supplementary gases from the first inlet), (Paragraph 1146, The device may be operated in a different therapy mode as a result of the connection of the gases source. It may be desirable or even necessary to notify a user or operator of a proposed, impending, or already operated change to the therapy mode. In addition, it some configurations it may also be desirable or necessary to or obtain the approval of the user or operator of a change to the therapy mode)
Taube more explicitly discloses wherein the recommendation comprises a direction in which to adjust the recommended parameter (Paragraph 0122, Additionally, in certain cases, where possible, the adaptive controller system 18 may take certain corrective actions at 156 when an alarm limit is exceeded. In one example, if the alarm limit is exceeded for the lower limit of SpO.sub.2, the adaptive controller processor 26 may, for example, cease to provide adaptive control over the gas mixture. Additionally, the control processor may set a prescribed or default oxygen mixture (e.g. 60%) or at the most recent oxygen mixture to be delivered by the blender system 34 and revert the blender system to manual control while sounding an audible alarm and providing a visual indication of the situation and actions taken. Other actions are possible without departing from the present teachings).
Taube and Sanson both disclose similar methods and systems for adjustable gas delivery. It would have been obvious to one skilled in the art before the effective filing date to incorporate the teachings of Taube’s parameter adjustment notifications with the existing alarms and user prompts disclosed by Sanson. Taube provides a clear indication of the various parameters envisioned to be manually and automatically adjustable in the overall system (Table 3), (Paragraph 0078, The system 34 may also provide for measurement of at gas flow rate and/or pressure at 80 with such measurement being provided to and controlled by the processor 60. Processor 60 can further provide the pressure and/or flow rate information as well as other operational parameters and alarms via bus 38 to processor 26 for display to medical personnel on user interface 30. Control of the flow rate and pressure of the gases can be implemented by controller 60 by use of valves at the oxygen mixer 64 (or elsewhere). Additionally, the processors 60 and 30 can compare various measured data with a set of prescribed alarm limits (either pre-configured or set by input by medical personnel) which will cause alarms to be generated (i.e., audible and visual alarms, or signals that can be monitored remotely—such as at a nurse's station), shown as 84).
Regarding Claim 11, Sanson in view of Taube discloses all of the limitations of Claim 10. Taube further discloses: wherein the recommendation comprises an amount by which to adjust the recommended parameter (Paragraph 0093, The user interface 30 can further provide display visual indicators and data that are useful to the medical personnel in treating patient 10. Such displayed information may, for example include some or all of the data of TABLE 3 as well as other data that may be deemed useful without limitation), (Paragraph 0121, Processor 26 also compares the data sent by the blender system with established default or operator set alarm limits at 142. If any alarm limits are exceeded at 146, an alarm 84 is generated at 150 to alert medical personnel that there is a potential problem. For example, if the processor detects that the patient's SpO2 level is below a threshold (e.g., 90%), an alarm may sound to alert medical personnel that there may be either a degradation of the patient's condition or there may be a malfunction. In another example, if the temperature of the inspired gas mixture is detected to be greater than an upper limit (e.g., 40° C.), then an alert may be generated to let the medical personnel know that there is a potential problem)
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
White et al. (US 20180280641 A1) discloses methods and an apparatus for a high gas flow system
Truschel et al. (US 20190201647 A1) discloses a system and method for providing high-flow nasal therapy
O’Donnell et al. (US 20200297960 A1) discloses system and methods for hypoxic gas delivery
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MISHAL ZAHRA HUSSAIN whose telephone number is (703)756-1206. The examiner can normally be reached M-F, 8:30am - 5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brandy S. 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.
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/MISHAL HUSSAIN/
Examiner
Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785