DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
This office action is responsive to the amendment filed on 10/24/2025. As directed by the
amendment: claims 1, 2, 4-8, 10, and 14 have been amended, no additional claims have been canceled, and no new claims have been added. Thus, claims 1-16 and 18 are presently pending in the application.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: The limitation “heating controller” in claims 1 and 4-5 should be defined in the specification.
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 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 1, 6, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Tatkov (US 20190151583 A1) in view of Leonard (US 20160184547 A1).
Regarding claim 1, Tatkov discloses a humidification controlling system of a ventilation-treatment apparatus (Integrated blower/humidifier breathing assistance system as set forth in the Abstract and [0023]), wherein the system comprises a ventilation-treatment-device body (FIG. 2b Blower unit 3 set forth in [0056]), a respiration humidifier (FIG. 2b Humidifier Unit referring to chamber 5, which is filled with water 20, humidifier base unit 21, and heater plate 12 as set forth in [0056]), a heating pipeline (FIG. 2b Delivery conduit 6 with a heating wire (not shown) as set forth in [0056]) and a nasal oxygen cannula (FIG. 2b Patient interface 7 which is a nasal Cannula as set forth in [0042] and [0056]);
the ventilation-treatment-device body comprises a fan (FIG. 2b Fan unit 13 set forth in [0056]) and a first controller (FIG. 2b Controller 8a, controllers 8a and 8b connect to form a controller system 8 as set forth in [0056]); the respiration humidifier comprises a water tank (FIG. 2b Chamber 5, which is filled with water 20 as set forth in [0056), a heating plate (FIG. 2b Heater plate 12 as set forth in [0056]), a gas-inlet temperature sensor of the water-tank (FIG. 2b Ambient temperature sensor 60 located as close as possible to the humidifier chamber or inlet port 23 as set forth in [0062]), and a heating-plate temperature sensor (FIG. 2b Heater plate temperature sensor 62 as set forth in [0066]) wherein a gas outlet of the fan is connected to a gas inlet of the water tank (FIG. 2b Pressurized gas flow away from the fan 13 and blower unit 3 via a connection conduit 4 to a humidifier chamber 5, so through inlet 23 enters the humidifier chamber 5 as set forth in [0056]); a gas outlet of the water tank is connected to a gas inlet of the heating pipeline (FIG. 2b As shown in the annotated figure below, FIG. 2a is a similar embodiment of the device, where the same element is referred to as chamber outlet/exit port 9 as set forth in [0056]); a gas outlet of the heating pipeline is connected to an input opening of the nasal oxygen cannula (FIG. 2b As shown in the annotated figure below); the gas-inlet temperature sensor of the water tank is configured for measuring a temperature of the gas inlet of the water tank (FIG. 2b Ambient temperature sensor 60 measures the temperature of the air from the atmosphere, which would reasonably be the temperature of the gas-inlet of the water tank);
the heating-plate temperature sensor is configured for measuring a temperature of the heating plate (FIG. 2b Heater plate temperature sensor 62 configured to measure the temperature of the heating plate set forth in [0066]); the heating pipeline comprises a gas-inlet temperature sensor of the heating pipeline (FIG. 2a Exit port temperature sensor 63 as set forth in [0063] and [0074]) and a heating controller of the heating pipeline (FIG. 2a Controller 8a and 8b, from the humidifier base unit, are connected and make up a control system 8 as set forth in [0056], where controller system 8 and can adjust the power supplied to the heating wire as set forth in in [0087]); wherein the gas-inlet temperature sensor of the heating pipeline is configured for measuring a temperature of the gas inlet of the heating pipeline (FIG. 2b Exit port temperature sensor 63 is for measuring temperature of the gas at the inlet of the heating pipe, exiting the water tank/chamber, as set forth in [0063], which would reasonably be the temperature of the gas inlet of the heating pipeline);
the first controller is configured for receiving an ambient-air temperature (The ambient temperature data is relayed to the controller 8 as set forth in [0072]) and an ambient-air humidity (FIG. 2a A humidity sensor 50 is shown located proximal to the atmospheric inlet 40 as set forth in [0088]), a water-tank gas temperature of the gas-inlet temperature sensor of the water tank (The controller 8 is adapted to receive the data relating to the temperature of the gases entering the chamber 5 as measured by ambient temperature sensor 60 as set forth in [0074]), a heating-plate temperature transmitted by the heating-plate temperature sensor (controller 8 can read large step changes in the heater plate temperature as measured by the heater plate temperature sensor 62 as set forth in [0101]), and a target humidity (System is designed to achieve a desired patient end temperature and absolute humidity at said interface as set forth in [0033]) and a target flow rate that are preset by a user (FIG. 2b The controller 8 receives the input from the user controls 11 and adjusts the fan speed to substantially match this requested flow rate as set forth in [0073]), to determine an air flow rate inputted by the fan (FIG. 2b In response to the user input from controls 11, and the signals received from the sensors, the control system 8 determines a control output which in the preferred embodiment sends signals to adjust the power to the humidifier chamber heater plate 12 and the speed of the fan 13 as set forth in [0057], [0072], [0125]. Additionally, FIG. 2a shows all of the mentioned sensors and input controls in communication with the control system 8 (8a, 8b) and the fan unit 13);
the heating controller of the heating pipeline is configured for receiving a temperature of the first mixed gas flow at the gas inlet of the heating pipeline and a temperature of a second mixed gas flow at the gas outlet, to determine a currently required heating power of the heating pipeline, to adjust the heating pipeline to the currently required heating power, to maintain a temperature of a mixed gas flow obtained by mixing the water vapor transmitted via the heating pipeline to the nasal oxygen cannula and the air at a target temperature (FIG. 2b The end temperature sensor 15 temperature readings at the outlet, and the temperature readings at the chamber outlet is fed to the controller system 8 and used to ensure the delivery of gas at the target temperature to the patient, the target temperature being the temperature at the chamber outlet, if the patient end temperature sensor 15 readings indicate the gas temperature being reduced when the air travels through the length of the delivery conduit 6, then the controller 8 can increase the supply conduit heating wire as set forth in [0087]); and
wherein the way for the heating controller of the heating pipeline to control the heating power of the heating pipeline is: by the heating controller of the heating pipeline, receiving an air flow rate that is inputted by the fan and is sent by the first controller in real time and by the heating controlling nodule of the heating pipeline, determining the heating power of the heating pipeline according to the air flow rate inputted by the fan, the temperature of the first mixed gas flow, the temperature of the second mixed gas flow and the target temperature preset by the user (FIG. 2a Controller 8a and 8b, from the humidifier base unit, are connected and make up a control system 8 as set forth in [0056], where controller system 8 and can adjust the power supplied to the heating wire: The end temperature sensor 15 temperature readings at the outlet, and the temperature readings at the chamber outlet is fed to the controller system 8 and used to ensure the delivery of gas at the target temperature to the patient, the target temperature being the temperature at the chamber outlet, if the patient end temperature sensor 15 readings indicate the gas temperature being reduced when the air travels through the length of the delivery conduit 6, then the controller 8 can increase the supply conduit heating wire as set forth in in [0087]. FIG. 5 Shows lines 70-76 which corresponds to different flow rates, the flow rate corresponding to an ideal target temperature which allows the controller to generate an output to controller the temperature of the heater wire as set forth in in [0073]-[0074], and [0087]).
Tatkov fails to explicitly disclose that the determined air flow rate inputted by the fan, is so that a current relative humidity of a first mixed gas flow obtained by mixing water vapor in the water tank and air inputted by the fan is the target humidity.
However, Leonard teaches that the determined air flow rate inputted by the fan, is so that a current relative humidity of a first mixed gas flow obtained by mixing water vapor in the water tank and air inputted by the fan is the target humidity (Leonard: Gas flow rates can become sufficiently low that the gas passing through the device spends more time in the humidification region. As a result, the humidity level of the gas flow exiting the device toward the patient can approach 100% relative humidity as set forth in [0003]. Additionally, The system and method control the humidity of a breathing gas over a range of flow rates. Excessive humidification of a breathing gas is prevented at low gas flow rates while impeding or preventing a significant drop in humidity at high flow rates. At low flow rates, gas flowing through the vapor transfer unit has more time to receive humidity than at high flow rates. Therefore, the systems and methods limit the humidity of breathing gasses at low flow rates as set forth in [0006]).
Tatkov and Leonard are both considered to be analogous to the claimed invention because they are in the same field of humidifying a breathing gas using vapor transfer. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tatkov to incorporate the teaching of Leonard and include that the determined air flow rate inputted by the fan, is so that a current relative humidity of a first mixed gas flow obtained by mixing water vapor in the water tank and air inputted by the fan is the target humidity (Leonard: Gas flow rates can become sufficiently low that the gas passing through the device spends more time in the humidification region. As a result, the humidity level of the gas flow exiting the device toward the patient can approach 100% relative humidity as set forth in [0003]. Additionally, the system and method control the humidity of a breathing gas over a range of flow rates. Excessive humidification of a breathing gas is prevented at low gas flow rates while impeding or preventing a significant drop in humidity at high flow rates. At low flow rates, gas flowing through the vapor transfer unit has more time to receive humidity than at high flow rates. Therefore, the systems and methods limit the humidity of breathing gasses at low flow rates as set forth in [0006]). Doing so would enable the controller of Tatkov to use the readings obtained by the sensors in order to determine the fan speed, and therefore air flow rate, to do so in order to achieve a target humidity (Leonard: Set forth in [0003] and [0006]).
Regarding claim 6, Tatkov as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Tatkov as modified further discloses the system, wherein the first controller (FIG. 2b Controller 8a and 8b, from the humidifier base unit, are connected and make up a control system 8 as set forth in [0056], are connected with the flow probe 61 to measure the gases flow as set forth in [0067], and use a feedback mechanism via controller 8 to adjust the flow rate to the level required or requested as set forth in [0073]) is further configured for, when the water evaporation rate in the water tank maintains stable (The evaporation rate will maintain stable when the heater plate and ambient temperature are at a constant temperature, the first determining module is capable of functioning during this time), determining whether a current air flow rate of the fan is equal to the target flow rate preset by the user; and when the current air flow rate of the fan is equal to the target flow rate, the first controller controlling the heating plate to continue operating at a current heating power, and controlling the fan to continue operating at the current air flow rate at the same time (If actual flow rate as measured matches the user set flow rate the controller 8 characterizes the flow rate as within tolerance between the actual measured flow rate and user set flow rate, where no adjustment to the flow rate is necessary as set forth in [0124]. If the controller ‘sees’ a large deviation or a step change in the flow rate, it uses coarse control parameters to restore the flow rate to the rate set by a user as set forth in [0125], the coarse control can be achieved by using heater plate temperature as set forth in [0131]. Since no adjustment is needed, the heating plate will continue operating at a current heating power).
Regarding claim 9, Tatkov as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Tatkov as modified further discloses the system, wherein the system further comprises a fan-gas-inlet temperature-and-humidity sensor (FIG. 2b Humidity sensor 50 is shown located proximal to the atmospheric inlet 40 as set forth in [0088] and Ambient temperature sensor 60 located as close as possible to the humidifier chamber or inlet port 23 as set forth in [0062]), and the fan-gas-inlet temperature-and-humidity sensor is configured for measuring a temperature and a humidity at a gas inlet of the fain, to obtain the ambient-air temperature and the ambient-air humidity.
Claims 2 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Tatkov (US 20190151583 A1) in view of Leonard (US 20160184547 A1) as applied to claim 1, in further view of McAuley (US 20130174841 A1) and Mulvaney (US 6796550 B2).
Regarding claim 2, Tatkov as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Tatkov as modified further discloses the system, wherein the first controller is configured for, according to the target flow rate, the target humidity, the ambient-air humidity and the ambient-air temperature, determining a heating power of the heating plate, and controlling the heating plate to operate at the heating power (As set forth in [0057], [0074], [0087]-[0089], [0093], [0113]-[0115]); and the first controller is further configured for adjusting the air flow rate inputted by the fan (FIG. 2b In response to the user input from controls 11, and the signals received from the sensors, the control system 8 determines a control output which in the preferred embodiment sends signals to adjust the speed of the fan 13 as set forth in [0057]), so that a relative humidity of the mixed gas flow obtained by mixing the water vapor and the air is the target humidity (Leonard: Gas flow rates can become sufficiently low that the gas passing through the device spends more time in the humidification region. As a result, the humidity level of the gas flow exiting the device toward the patient can approach 100% relative humidity as set forth in [0003]. Additionally, The system and method control the humidity of a breathing gas over a range of flow rates. Excessive humidification of a breathing gas is prevented at low gas flow rates while impeding or preventing a significant drop in humidity at high flow rates. At low flow rates, gas flowing through the vapor transfer unit has more time to receive humidity than at high flow rates. Therefore, the systems and methods limit the humidity of breathing gasses at low flow rates as set forth in [0006]).
Tatkov fails to explicitly disclose the first controller is further configured for, according to a first time interval, determining a current water evaporation rate in the water tank according to the water-tank gas temperature and the heating-plate temperature, until the water evaporation rate in the water tank maintains stable.
However, McAuley teaches a controller (McAuley: FIG. 1 Controller 11 calculates the amount of water consumption or evaporation rate in the humidifier chamber 5 as set forth in [0103]), further configured for, according to a first time interval (The time in which the controller is performing it’s function), determining a current water evaporation rate in the water tank according to the water-tank gas temperature and the heating-plate temperature (McAuley: FIG. 1 Controller 11 calculates the amount of water consumption or evaporation rate in the humidifier chamber 5 based on ambient temperature and heater plate setting as set forth in [0103]), until the water evaporation rate in the water tank maintains stable (It would be obvious that the controller function wouldn’t need to be utilized any further if the evaporation rate is at a stable value since doing so would be unnecessary given that the controller has already completed its function given that specific rate of evaporation).
Tatkov and McAuley are both considered to be analogous to the claimed invention because they are in the same field of humidifying a breathing gas using vapor transfer. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tatkov to incorporate the teaching of McAuley and include wherein the controller (McAuley: FIG. 1 Controller 11 calculates the amount of water consumption or evaporation rate in the humidifier chamber 5 as set forth in [0103]) configured for, according to a first time interval (The time in which the controller is performing it’s function), determining a current water evaporation rate in the water tank according to the water-tank gas temperature and the heating-plate temperature (McAuley: FIG. 1 Controller 11 calculates the amount of water consumption or evaporation rate in the humidifier chamber 5 based on ambient temperature and heater plate setting as set forth in [0103]), until the water evaporation rate in the water tank maintains stable (It would be obvious that the controller wouldn’t need to be utilized any further if the evaporation rate is at a stable value since doing so would be unnecessary given that the controller has already completed its function given that specific rate of evaporation). Doing so provides a known method of determining an evaporation rate in a humidification system (McAuley: As set forth in [0103]) which can be used by the control system of Tatkov to determine a desired flow rate and heater plate power.
While Tatkov as modified by Leonard does disclose the controller is configured for adjusting the air flow rate inputted by the fan (FIG. 2b In response to the user input from controls 11, and the signals received from the sensors, the control system 8 determines a control output which in the preferred embodiment sends signals to adjust the speed of the fan 13 as set forth in [0057]), so that a relative humidity of the mixed gas flow obtained by mixing the water vapor and the air is the target humidity (Leonard: Gas flow rates can become sufficiently low that the gas passing through the device spends more time in the humidification region. As a result, the humidity level of the gas flow exiting the device toward the patient can approach 100% relative humidity as set forth in [0003]. Additionally, The system and method control the humidity of a breathing gas over a range of flow rates. Excessive humidification of a breathing gas is prevented at low gas flow rates while impeding or preventing a significant drop in humidity at high flow rates. At low flow rates, gas flowing through the vapor transfer unit has more time to receive humidity than at high flow rates. Therefore, the systems and methods limit the humidity of breathing gasses at low flow rates as set forth in [0006]), it fails to explicitly disclose the controller is configured for adjusting the air flow rate inputted by the fan according to the current water evaporation rate.
However, a relative humidity of the mixed gas flow obtained by mixing the water vapor and the air is directly related to the evaporation rate.
Mulvaney teaches that the difference in the air’s humidity at the inlet and outlet of the system are due to the water being evaporated into the flow of air (Mulvaney: As set forth in column 4, lines 42-54).
Tatkov and Mulvaney are both considered to be analogous to the claimed invention because they are in the same field of humidifying a breathing gas using vapor transfer. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tatkov to adjust the air flow rate inputted by the fan according to the current water evaporation rate because Mulvaney teaches that the difference in the air’s humidity at the inlet and outlet of the system is due to the water being evaporated into the flow of air (Mulvaney: As set forth in column 4, lines 42-54). This indicates that the evaporation rate is reflected in the air’s humidity at the outlet of the system, a well-known concept in the art of the claimed invention, and as a result, the controller could be configured for adjusting the air flow rate inputted by the fan according to the current water evaporation rate in the same way that Tatkov as modified by Leonard can adjust the air flow rate inputted by the fan according to a humidity at the outlet of the system.
Regarding claim 4, Tatkov as modified discloses the claimed invention substantially as claimed as set forth for claim 2 above.
Tatkov as modified further discloses the system, wherein the way for the heating controller of the heating pipeline to control the heating power of the heating pipeline is: by the heating controller of the heating pipeline, receiving an air flow rate that is inputted by the fan and is sent by the first controller in real time (FIG. 2a Controller 8a and 8b, from the humidifier base unit, are connected and make up a control system 8 as set forth in [0056], where controller system 8 and can adjust the power supplied to the heating wire: The end temperature sensor 15 temperature readings at the outlet, and the temperature readings at the chamber outlet is fed to the controller system 8 and used to ensure the delivery of gas at the target temperature to the patient, the target temperature being the temperature at the chamber outlet, if the patient end temperature sensor 15 readings indicate the gas temperature being reduced when the air travels through the length of the delivery conduit 6, then the controller 8 can increase the supply conduit heating wire as set forth in in [0087]. FIG. 5 Shows lines 70-76 which corresponds to different flow rates, the flow rate corresponding to an ideal target temperature which allows the controller to generate an output to controller the temperature of the heater wire as set forth in in [0073]-[0074], and [0087]).
Claims 3 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Tatkov (US 20190151583 A1) in view of Leonard (US 20160184547 A1) as applied to claims 1 and 4, in further view of McAuley (US 20130174841 A1), Wruck (WO 2015192946 A1), and Lellouche (François Lellouche, et al. “Influence of Ambient and Ventilator Output Temperatures on Performance of Heated-Wire Humidifiers.” American Journal of Respiratory and Critical Care Medicine, vol. 170, no. 10, 15 Nov. 2004, pp. 1073–1079, https://doi.org/10.1164/rccm.200309-1245oc. Accessed 09 July 2025.).
Regarding claim 3, Tatkov as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Tatkov as modified further discloses the system, wherein the operation of the first controller of, according to the target flow rate, the target humidity, the ambient-air humidity and the ambient-air temperature, determines the heating power of the heating plate.
Tatkov fails to explicitly disclose the operation of the first controller determining the heating power of the heating plate particularly comprises by the first controller, determining a total water-evaporation amount according to the target flow rate, the target humidity, the ambient-air humidity and the ambient-air temperature; by the first controller, determining an initial heating power of the heating plate according to the total water-evaporation amount.
However, McAuley teaches determining a total water-evaporation amount according to the target flow rate, the target humidity, the ambient-air humidity and the ambient-air temperature (Evaporation rate is based on ambient temperature, ambient humidity level, heater plate setting, air volume flow rate as set forth in [0069], [0103], [0107], and [0110]); by the first controller, determining an initial heating power of the heating plate according to the total water-evaporation amount (Controlling the power supplied to a heater plate such that amount of water in said chamber lasts for at least a substantial part of the treatment time, which means the heating power is determined according to the total evaporation amount, while providing a minimum amount of humidification as per said patient's treatment data as set forth in [0025], [0061], and [0069]).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tatkov to incorporate the teaching of McAuley and include determining a total water-evaporation amount according to the target flow rate, the target humidity, the ambient-air humidity and the ambient-air temperature (Evaporation rate is based on ambient temperature, ambient humidity level, heater plate setting, air volume flow rate as set forth in [0069], [0103], [0107], and [0110]); by the first controller, determining an initial heating power of the heating plate according to the total water-evaporation amount (Controlling the power supplied to a heater plate such that amount of water in said chamber lasts for at least a substantial part of the treatment time, which means the heating power is determined according to the total evaporation amount, while providing a minimum amount of humidification as per said patient's treatment data as set forth in [0025], [0061], and [0069]). Doing so provides a known method of determining an evaporation rate in a humidification system (McAuley: As set forth in [0103]) which can be used by the control system modules of Tatkov to determine a desired heater plate power.
Tatkov fails to explicitly disclose the operation of the first controller determining the heating power of the heating plate particularly comprises by the first controller; determining the heating power of the heating plate according to the initial heating power of the heating plate and the heating efficiency of the heating plate.
However, Wruck teaches by the first controller, determining the heating power of the heating plate according to the initial heating power of the heating plate and the heating efficiency of the heating plate. (Wruck: FIG. 1 The efficiency of the heating element 2 is taken in account while determining the required heating power which is requested via the central control in the heating element 2 as set forth on page 8 paragraph 6 of the machine translation. Additionally, the heating power is controlled taking into account parameters of the gas flow downstream of the evaporation chamber, as set forth on page 3 paragraphs 1- 2, which indicates that an initial heating power was provided to the heating element, which resulted in a measurable parameter of the gas flow after evaporation has occurred, which is then used to control and further determine the heating power to be applied to the heating plate).
Tatkov and Wruck are both considered to be analogous to the claimed invention because they are in the same field of treating a breathing gas using vapor transfer. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tatkov to incorporate the teaching of Wruck and include by the first controller, determining the heating power of the heating plate according to the initial heating power of the heating plate and the heating efficiency of the heating plate. (Wruck: FIG. 1 The efficiency of the heating element 2 is taken in account while determining the required heating power which is requested via the central control in the heating element 2 as set forth on page 8 paragraph 6 of the machine translation. Additionally, the heating power is controlled taking into account parameters of the gas flow downstream of the evaporation chamber, as set forth on page 3 paragraphs 1- 2, which indicates that an initial heating power was provided to the heating element, which resulted in a measurable parameter of the gas flow after evaporation has occurred, which is then used to control and further determine the heating power to be applied to the heating plate). Doing so provides a well-known method of determining what heating power is required to sufficiently maintain or achieve a temperature of an airflow.
Tatkov as modified fails to explicitly disclose by the first controller; determining a heating efficiency of the heating plate according to the ambient-air temperature and a temperature of the heating plate
However, Lellouche teaches that heating efficiency is affected by the ambient-air temperature (Lellouche: A high inlet chamber temperature was associated with poor performance of the heating element as set forth on the last paragraph of page 5 and first paragraph of page 6) and a temperature of the heating plate (The temperature of the heat source is an inherent part of determining heating efficiency since heating efficiency is how effectively a system is converting the heat energy into useful work which is a well-known concept in the art).
Tatkov and Lellouche are both considered to be analogous to the claimed invention because they are in the same field of treating a breathing gas using vapor transfer. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tatkov to incorporate the teaching of Lellouche and include that heating efficiency is affected by the ambient-air temperature (Lellouche: A high inlet chamber temperature was associated with poor performance of the heating element as set forth on the last paragraph of page 5 and first paragraph of page 6) and a temperature of the heating plate (The temperature of the heat source is an inherent part of determining heating efficiency since heating efficiency is how effectively a system is converting the heat energy into useful work which is a well-known concept in the art). This would indicate that a heating efficiency of the heating plate is affected according to the ambient-air temperature and a temperature of the heating plate. Automating the manual process of determining a heating efficiency of the heating plate according to the ambient-air temperature and a temperature of the heating plate would allow the control system of Tatkov (FIG. 2b Control system 8 comprising 8a, 8b) to provide an ideal heating temperature of the heating plate given the parameter affecting the heating efficiency of the heating plate.
Regarding claim 5, Tatkov as modified discloses the claimed invention substantially as claimed as set forth for claim 4 above.
Tatkov as modified further discloses the system, wherein the operation of, by the heating controller of the heating pipeline, determining the heating power of the heating pipeline according to the air flow rate inputted by the fan, the temperature of the first mixed gas flow, the temperature of the second mixed gas flow and the target temperature preset by the user particularly comprises: by the heating controller of the heating pipeline, determining an initial heating power of the heating pipeline according to the air flow rate inputted by the fan (The initial end temperature sensor 15 temperature reading would be representative of the initial heating power of the heater wire according to the air flow rate inputted by the fan), the temperature of the first mixed gas flow, the temperature of the second mixed gas flow and the target temperature preset by the user; by the heating controller of the heating pipeline, receiving the ambient-air temperature sent by the first controller, determining the heating efficiency of the heating pipeline (Examiner’s Note: How effectively a heating element converts the power supplied into a heat output is an inherent part of how the heating power required is being determined since the level of power given to the heating pipeline, controlled by the control system 8, corresponds directly to the temperature readings at the inlet and outlet of the heating pipeline by temperature sensors 15 and 63. A high heating efficiency would mean the power supplied to the heating pipeline results in a higher temperature output by the wire to heat the airflow, then compared to a low heating efficiency); and by the heating controller of the heating pipeline, determining the heating power of the heating pipeline according to the initial heating power of the heating pipeline (FIG. 2a Controller 8a and 8b, from the humidifier base unit, are connected and make up a control system 8 as set forth in [0056], where controller system 8 and can adjust the power supplied to the heating wire. The end temperature sensor 15 temperature readings at the outlet, and the temperature readings at the chamber outlet is fed to the controller system 8 and used to ensure the delivery of gas at the target temperature to the patient, the initial end temperature sensor 15 temperature reading would be representative of the initial heating power of the heater wire, the target temperature being the temperature at the chamber outlet, if the patient end temperature sensor 15 readings indicate the gas temperature being reduced when the humidified air travels through the length of the delivery conduit 6, then the controller 8 can increase the supply conduit heating wire as set forth in in [0087]. FIG. 5 Shows lines 70-76 which corresponds to different flow rates, the flow rate corresponding to an ideal target temperature which allows the controller to generate an output to controller the temperature of the heater wire as set forth in in [0073]-[0074], and [0087]).
Tatkov as modified fails to explicitly discloses determining the heating power of the heating pipeline according to the heating efficiency of the heating pipeline
However, Wruck teaches by a controller, determining the heating power of a heating element according to the initial heating power of the heating element and the heating efficiency of the heating element. (Wruck: FIG. 1 The efficiency of the heating element 2 is taken in account while determining the required heating power which is requested via the central control in the heating element 2 as set forth on page 8 paragraph 6 of the machine translation. Additionally, the heating power is controlled taking into account parameters of the gas flow downstream of the evaporation chamber, as set forth on page 3 paragraphs 1-2, which indicates that an initial heating power was provided to the heating element, which resulted in a measurable parameter of the gas flow after evaporation has occurred, which is then used to control and further determine the heating power to be applied to the heating plate).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tatkov to incorporate the teaching of Wruck and include, determining the heating power of the heating pipeline according to the initial heating power of the heating pipeline and the heating efficiency of the heating pipeline. (Wruck: FIG. 1 The efficiency of the heating element 2 is taken in account while determining the required heating power which is requested via the central control in the heating element 2 as set forth on page 8 paragraph 6 of the machine translation. Additionally, the heating power is controlled taking into account parameters of the gas flow downstream of the evaporation chamber, as set forth on page 3 paragraphs 1- 2, which indicates that an initial heating power was provided to the heating element, which resulted in a measurable parameter of the gas flow after evaporation has occurred, which is then used to control and further determine the heating power to be applied to the heating plate). Doing so provides a well-known method of determining what heating power is required to sufficiently maintain or achieve a temperature of an airflow.
Tatkov as modified fails to explicitly discloses determining the heating efficiency of the heating pipeline according to the ambient-air temperature and the temperature of the first mixed gas flow.
However, Lellouche teaches that heating efficiency is affected by the air/gas temperature (Lellouche: A high inlet chamber temperature was associated with poor performance of the heating element as set forth on the last paragraph of page 5 and first paragraph of page 6).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tatkov to determine the heating efficiency of the heating pipeline according to the ambient-air temperature and the temperature of the first mixed gas flow because Lellouche teaches that heating efficiency is affected by the air/gas temperature (Lellouche: A high inlet chamber temperature was associated with poor performance of the heating element as set forth on the last paragraph of page 5 and first paragraph of page 6). Although the air/gas temperature referenced in Lellouche is drawn to the ambient temperature, it is obvious that the same applies for the temperature of the first mixed gas flow. This would indicate that a heating efficiency of the heating pipeline is affected according to the ambient-air temperature and temperature of the first mixed gas flow. Automating the manual process of determining a heating efficiency of the heating pipeline according to ambient-air temperature and the temperature of the first mixed gas flow would allow the control system of Tatkov (FIG. 2b Control system 8 comprising 8a, 8b) to provide an ideal heating temperature of the heating pipeline given the parameters affecting the heating efficiency of the heating pipeline.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Tatkov (US 20190151583 A1) in view of Leonard (US 20160184547 A1) as applied to claim 6, in further view of White (US 20030154977 A1).
Regarding claim 7, Tatkov as modified discloses the claimed invention substantially as claimed as set forth for claim 6 above.
Tatkov as modified further discloses the system, wherein the first controller further can determine when the current air flow rate of the fan is less than the target flow rate (FIG. 2b Controller 8a and 8b, from the humidifier base unit, are connected and make up a control system 8 as set forth in [0056], are connected with the flow probe 61 to measure the gases flow as set forth in [0067]).
Tatkov as modified fails to explicitly disclose the controller further configured for determining whether the current heating power of the heating plate is a maximum power and being maintained for a second time interval, and when the current heating power of the heating plate is the maximum power and being maintained for the second time interval, the first controller controlling the heating plate to continue operating at the current heating power.
However, White teaches a controller (White: FIG. 1 Control means 11 is connected with sensor 30 to monitor the heating element 15 as set forth in [0045]) configured for determining whether the current heating power of the heating element is a maximum power and being maintained for a second time interval, and when the current heating power of the heating plate is the maximum power and being maintained for the second tine interval, the first controller controlling the heating plate to continue operating at the current heating power (White: The controller 11 determines if the heating element 15 is at a predetermined safety limit, which is the maximum power level achieved safely buy the heating element as set forth in [0045]-[0046], the current/power applied to the heating element will not fall at any flow rate or ambient temperature unless the conduit is heating to a degree that approaches a safety hazard as set forth in [0047]).
Tatkov and White are both considered to be analogous to the claimed invention because they are in the same field of humidifying a breathing gas using vapor transfer. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tatkov to incorporate the teaching of White and include wherein, a controller (White: FIG. 1 Control means 11 is connected with sensor 30 to monitor the heating element 15 as set forth in [0045]) is configured for determining whether the current heating power of the heating plate is a maximum power and being maintained for a second time interval, and when the current heating power of the heating plate is the maximum power and being maintained for the second tine interval, the first controller controlling the heating plate to continue operating at the current heating power (White: The controller 11 determines if the heating element 15 is at a predetermined safety limit, which is the maximum power level achieved safely buy the heating element as set forth in [0045]-[0046], the current/power applied to the heating element will not fall at any flow rate or ambient temperature unless the conduit is heating to a degree that approaches a safety hazard as set forth in [0047]). Doing so would allow for the device to safely maintain a maximum power supplied to a heating element for use in a humidification system (White: As set forth in [0010]). It would also be obvious that second determining module would carry out its function when the current air flow rate of the fan is less than the target flow rate, so that a target amount of humidity is being still supplied to the patient. Tatkov already teaches wherein the first controller further can determine when the current air flow rate of the fan is less than the target flow rate (FIG. 2b Controller 8a and 8b, from the humidifier base unit, are connected and make up a control system 8 as set forth in [0056], are connected with the flow probe 61 to measure the gases flow as set forth in [0067]), so it would be obvious to that it could work in conjunction with the second determining module in order to allow the second determining module to complete its function as a result of the module of Tatkov being able to determine when the current air flow rate of the fan is less than the target flow rate.
Tatkov as modified fails to explicitly disclose that when the current heating power of the heating plate is the maximum power and being maintained for the second time interval, the first controller controlling the fan to continue operating at the current air flow rate at the same time.
However, Tatkov as modfied by Leonard further teaches a first controller controlling the fan to operating at a desired air flow rate in order to provide a target humidity to the patient (Leonard: Gas flow rates can become sufficiently low that the gas passing through the device spends more time in the humidification region. As a result, the humidity level of the gas flow exiting the device toward the patient can approach 100% relative humidity as set forth in [0003]. Additionally, The system and method control the humidity of a breathing gas over a range of flow rates. Excessive humidification of a breathing gas is prevented at low gas flow rates while impeding or preventing a significant drop in humidity at high flow rates. At low flow rates, gas flowing through the vapor transfer unit has more time to receive humidity than at high flow rates. Therefore, the systems and methods limit the humidity of breathing gasses at low flow rates as set forth in [0006]).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention that the device of Tatkov as modified would be able to control the fan to continue operating at the current air flow rate at the same time as when the current heating power of the heating plate is the maximum power and being maintained for the second time interval, since Tatkov is supplied with a target humidity and temperature (System is designed to achieve a desired patient end temperature and absolute humidity at said interface as set forth in [0033]) and would be able to maintain a specific flow rate at a given temperature of the heating plate in order to achieve that said humidity (Tatkov: Set forth in [0003] and [0006]).
Claims 8 is rejected under 35 U.S.C. 103 as being unpatentable over Tatkov (US 20190151583 A1) in view of Leonard (US 20160184547 A1) and White (US 20030154977 A1) as applied to claim 7, in further view of Mulvaney (US 6796550 B2).
Regarding claim 8, Tatkov as modified discloses the claimed invention substantially as claimed as set forth for claim 7 above.
Tatkov as modified by Leonard and White further discloses the system, wherein when the first controller determines that the current heating power of the heating plate is not the maximum power (White: FIG. 1 Control means 11 is connected with sensor 30 to monitor the heating element 15 as set forth in [0045], the controller 11 determines if the heating element 15 is at a predetermined safety limit, which is the maximum power level achieved safely buy the heating element as set forth in [0045]-[0046], the sensor 30 would be able to sense the heating plate at a power that is not the “maximum power”), the first controller re-determines the heating power of the heating plate (White: The control means 11 and sensor 30 are in a state of “monitoring” indicating that they are always in communication, the sensor inputting readings into the control means as set forth in [0045]), and at the same time, adjusts the air flow rate inputted by the fan, until the water evaporation rate maintains stable (The evaporation rate will maintain stable when the heater plate and ambient temperature are at a constant temperature, the second determining module and controller system are capable of functioning during this time, It would be obvious that the module wouldn’t need to be utilized any further once evaporation rate is at a stable value since doing so would be unnecessary given that the module has already completed its function given that specific rate of evaporation), to input the mixed gas flow obtained by mixing the water vapor and the air into the heating pipeline, wherein the relative humidity of the mixed gas flow is the target humidity (Leonard: Gas flow rates can become sufficiently low that the gas passing through the device spends more time in the humidification region. As a result, the humidity level of the gas flow exiting the device toward the patient can approach 100% relative humidity as set forth in [0003]. Additionally, The system and method control the humidity of a breathing gas over a range of flow rates. Excessive humidification of a breathing gas is prevented at low gas flow rates while impeding or preventing a significant drop in humidity at high flow rates. At low flow rates, gas flowing through the vapor transfer unit has more time to receive humidity than at high flow rates. Therefore, the systems and methods limit the humidity of breathing gasses at low flow rates as set forth in [0006]).
Tatkov as modified does not explicitly disclose that the air flow rate is adjusted according to a water evaporation rate of evaporation when the heating plate operates at the re-determined heating power of the heating plate.
However, a relative humidity of the mixed gas flow obtained by mixing the water vapor and the air is directly related to the evaporation rate.
Mulvaney teaches that the difference in the air’s humidity at the inlet and outlet of the system are due to the water being evaporated into the flow of air (Mulvaney: As set forth in column 4, lines 42-54).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tatkov to adjust the air flow rate inputted by the fan according to the current water evaporation rate because Mulvaney teaches that the difference in the air’s humidity at the inlet and outlet of the system is due to the water being evaporated into the flow of air (Mulvaney: As set forth in column 4, lines 42-54). This indicates that the evaporation rate is reflected in the air’s humidity at the outlet of the system, a well-known concept in the art of the claimed invention, and as a result, the flow-rate controlling module can be configured for adjusting the air flow rate inputted by the fan according to the current water evaporation rate in the same way that Tatkov as modified by Leonard can adjust the air flow rate inputted by the fan according to a humidity at the outlet of the system.
Claims 10-11 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Tatkov (US 20190151583 A1) in view of McAuley (US 20130174841 A1), Leonard (US 20160184547 A1), and Mulvaney (US 6796550 B2).
Regarding claim 10, Tatkov discloses a humidification controlling method of a ventilation-treatment apparatus (Abstract), wherein the method is applied to a humidification controlling system of a ventilation-treatment apparatus (Abstract), the humidification controlling system of a ventilation-treatment apparatus comprises a heating plate (FIG. 2b Heater plate 12 as set forth in [0056]), a water tank (FIG. 2b Chamber 5, which is filled with water 20 as set forth in [0056), a fan (FIG. 2b Fan unit 13 set forth in [0056]), and a heating pipeline (FIG. 2b Delivery conduit 6 with a heating wire (not shown) as set forth in [0056]), and the method comprises:
step S1 : receiving an ambient-air temperature (The ambient temperature data is relayed to the controller 8 as set forth in [0072]), an ambient-air humidity (FIG. 2a A humidity sensor 50 is shown located proximal to the atmospheric inlet 40 as set forth in [0088]) and a target temperature (System is designed to achieve a desired patient end temperature and absolute humidity at said interface as set forth in [0033]) and a target flowrate (FIG. 2b The controller 8 receives the input from the user controls 11 and adjusts the fan speed to substantially match this requested flow rate as set forth in [0073]) that are preset by a user, and according to the ambient-air temperature, the ambient-air humidity and the target temperature and the target flow rate that are preset by the user, determining a heating power of the heating plate, and controlling the heating plate to operate at the heating power (FIG. 2b In response to the user input from controls 11, and the signals received from the sensors, the control system 8 determines a control output which in the preferred embodiment sends signals to adjust the power to the humidifier chamber heater plate 12 as set forth in [0057], as well as in [0057], [0074], [0087]-[0089], [0093], [0113]-[0115]);
step S4: according to a third time interval, monitoring a temperature of the first mixed gas flow at a gas inlet of the heating pipeline and a temperature of a second mixed gas flow at a gas outlet of the heating pipeline (FIG. 2b The end temperature sensor 15 temperature readings at the conduit outlet, and the temperature readings at the chamber outlet by exit port temperature sensor 63, which is the conduit inlet, is fed to the controller system 8 as set forth in [0063] and [0087]); and
step S5: according to the temperature of the first mixed gas flow and the temperature of the second mixed gas flow, determining a currently required heating power of the heating pipeline, to adjust the heating pipeline to the currently required heating power, to maintain a temperature of a mixed gas flow obtained by mixing water vapor transmitted via the heating pipeline to the nasal oxygen cannula and air at a target temperature (FIG. 2b The end temperature sensor 15 temperature readings at the outlet, and the temperature readings at the chamber outlet is fed to the controller system 8 and used to ensure the delivery of gas at the target temperature to the patient, the target temperature being the temperature at the chamber outlet, if the patient end temperature sensor 15 readings indicate the gas temperature being reduced when the air travels through the length of the delivery conduit 6 to the patient via the nasal oxygen cannula, then the controller 8 can increase the supply conduit heating wire as set forth in [0087]);
wherein the step S5 comprises: determining the heating power of the heating pipeline according to the air flow rate inputted by the fan, the temperature of the first mixed gas flow, the temperature of the second mixed gas flow and the target temperature preset by the user (FIG. 2a Controller 8a and 8b, from the humidifier base unit, are connected and make up a control system 8 as set forth in [0056], where controller system 8 and can adjust the power supplied to the heating wire: The end temperature sensor 15 temperature readings at the outlet, and the temperature readings at the chamber outlet is fed to the controller system 8 and used to ensure the delivery of gas at the target temperature to the patient, the target temperature being the temperature at the chamber outlet, if the patient end temperature sensor 15 readings indicate the gas temperature being reduced when the air travels through the length of the delivery conduit 6, then the controller 8 can increase the supply conduit heating wire as set forth in in [0087]. FIG. 5 Shows lines 70-76 which corresponds to different flow rates, the flow rate corresponding to an ideal target temperature which allows the controller to generate an output to controller the temperature of the heater wire as set forth in in [0073]-[0074], and [0087]).
Tatkov fails to explicitly disclose that the method comprises: step S2: determining a current water evaporation rate in the water tank;
However, McAuley teaches determining a current water evaporation rate in the water tank (McAuley: FIG. 1 Controller 11 calculates the amount of water consumption or evaporation rate in the humidifier chamber 5 as set forth in [0103]).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tatkov to incorporate the teaching of McAuley and include determining a current water evaporation rate in the water tank (McAuley: FIG. 1 Controller 11 calculates the amount of water consumption or evaporation rate in the humidifier chamber 5 as set forth in [0103]). Doing so provides a known method of determining an evaporation rate in a humidification system (McAuley: As set forth in [0103]) which can be used by the control system modules of Tatkov to determine a desired flow rate and heater plate power.
Tatkov fails to explicitly disclose that the method comprises: part of step S3: determining an air flow rate inputted by the fan, so that a current relative humidity of a first mixed gas flow obtained by mixing a water vapor in the water tank and an air inputted by the fan is the target humidity;
However, Leonard teaches that the determined air flow rate inputted by the fan, is so that a current relative humidity of a first mixed gas flow obtained by mixing water vapor in the water tank and air inputted by the fan is the target humidity (Leonard: Gas flow rates can become sufficiently low that the gas passing through the device spends more time in the humidification region. As a result, the humidity level of the gas flow exiting the device toward the patient can approach 100% relative humidity as set forth in [0003]. Additionally, the system and method control the humidity of a breathing gas over a range of flow rates. Excessive humidification of a breathing gas is prevented at low gas flow rates while impeding or preventing a significant drop in humidity at high flow rates. At low flow rates, gas flowing through the vapor transfer unit has more time to receive humidity than at high flow rates. Therefore, the systems and methods limit the humidity of breathing gasses at low flow rates as set forth in [0006]).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tatkov to incorporate the teaching of Leonard and include that the determined air flow rate inputted by the fan, is so that a current relative humidity of a first mixed gas flow obtained by mixing water vapor in the water tank and air inputted by the fan is the target humidity (Leonard: Gas flow rates can become sufficiently low that the gas passing through the device spends more time in the humidification region. As a result, the humidity level of the gas flow exiting the device toward the patient can approach 100% relative humidity as set forth in [0003]. Additionally, The system and method control the humidity of a breathing gas over a range of flow rates. Excessive humidification of a breathing gas is prevented at low gas flow rates while impeding or preventing a significant drop in humidity at high flow rates. At low flow rates, gas flowing through the vapor transfer unit has more time to receive humidity than at high flow rates. Therefore, the systems and methods limit the humidity of breathing gasses at low flow rates as set forth in [0006]). Doing so would enable the controller of Tatkov to use the readings obtained by the sensors in order to determine the fan speed, and therefore air flow rate, to do so in order to achieve a target humidity (Leonard: Set forth in [0003] and [0006]).
While Tatkov as modified by Leonard does disclose the flow-rate controlling module is configured for adjusting the air flow rate inputted by the fan (FIG. 2b In response to the user input from controls 11, and the signals received from the sensors, the control system 8 determines a control output which in the preferred embodiment sends signals to adjust the speed of the fan 13 as set forth in [0057]), so that a relative humidity of the mixed gas flow obtained by mixing the water vapor and the air is the target humidity (Leonard: Gas flow rates can become sufficiently low that the gas passing through the device spends more time in the humidification region. As a result, the humidity level of the gas flow exiting the device toward the patient can approach 100% relative humidity as set forth in [0003]. Additionally, The system and method control the humidity of a breathing gas over a range of flow rates. Excessive humidification of a breathing gas is prevented at low gas flow rates while impeding or preventing a significant drop in humidity at high flow rates. At low flow rates, gas flowing through the vapor transfer unit has more time to receive humidity than at high flow rates. Therefore, the systems and methods limit the humidity of breathing gasses at low flow rates as set forth in [0006]), it fails to explicitly disclose that the method comprises: the other part of step S3: that the air flow rate inputted by the fan is determined according to the current water evaporation rate in the water tank.
However, a relative humidity of the mixed gas flow obtained by mixing the water vapor and the air is directly related to the evaporation rate.
Mulvaney teaches that the difference in the air’s humidity at the inlet and outlet of the system are due to the water being evaporated into the flow of air (Mulvaney: As set forth in column 4, lines 42-54).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tatkov to adjust the air flow rate inputted by the fan according to the current water evaporation rate because Mulvaney teaches that the difference in the air’s humidity at the inlet and outlet of the system is due to the water being evaporated into the flow of air (Mulvaney: As set forth in column 4, lines 42-54). This indicates that the evaporation rate is reflected in the air’s humidity at the outlet of the system, a well-known concept in the art of the claimed invention, and as a result, the flow-rate controlling module could be configured for adjusting the air flow rate inputted by the fan according to the current water evaporation rate in the same way that Tatkov as modified by Leonard can adjust the air flow rate inputted by the fan according to a humidity at the outlet of the system.
Tatkov as modified by McAuley, Leonard, and Mulvaney further discloses that the method comprises step S6: repeating to execute the step S2 to the step S3, until the water evaporation rate in the water tank maintains stable (The evaporation rate will maintain stable when the heater plate and ambient temperature are at a constant temperature, it would be obvious that the module wouldn’t need to be utilized any further if the evaporation rate is at a stable value since doing so would be unnecessary given that the module has already completed its function given that specific rate of evaporation)
Tatkov fails to explicitly disclose that the method comprises: step S7: repeating to execute the step S4, until the humidification controlling system of a ventilation-treatment apparatus stops operating.
However, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tatkov to include step 7: repeating to execute the step S4, until the humidification controlling system of a ventilation-treatment apparatus stops operating. While in operation, step 4 would need to be repeated in order to monitor a temperature of the first mixed gas flow at a gas inlet of the heating pipeline and a temperature of a second mixed gas flow at a gas outlet of the heating pipeline (FIG. 2b The end temperature sensor 15 temperature readings at the conduit outlet, and the temperature readings at the chamber outlet by FIG. 2a Exit port temperature sensor 63, which is the conduit inlet, is fed to the controller system 8 as set forth in [0063] and [0087]) in order to determine a currently required heating power of the pipeline (If the patient end temperature sensor 15 readings indicate the gas temperature being reduced when the air travels through the length of the delivery conduit 6 to the patient via the nasal oxygen cannula, then the controller 8 can increase the supply conduit heating wire as set forth in [0087]).
Regarding claim 11, Tatkov as modified discloses the claimed invention substantially as claimed as set forth for claim 10 above.
Tatkov as modified by McAuley further discloses the method, wherein the step S2 comprises: according to a first time interval (The time in which the evaporation-rate is being determined), monitoring a water-tank gas temperature and a heating-plate temperature at a water-tank gas inlet, and according to the water-tank gas temperature and the heating-plate temperature, determining the current water evaporation rate in the water tank (McAuley: FIG. 1 Controller 11 calculates the amount of water consumption or evaporation rate in the humidifier chamber 5 based on ambient temperature and heater plate setting as set forth in [0103]).
Regarding claim 13, Tatkov as modified discloses the claimed invention substantially as claimed as set forth for claim 10 above.
Tatkov as modified further discloses the method, wherein the step S4 comprises: according to a heat dissipation rate (The rate of heat loss, which is occurring through conduit 6 which is accounted for by the difference in the temperature sensor 15 temperature readings at the conduit outlet, and the temperature readings at the chamber outlet by exit port temperature sensor 63 fed to the controller system 8 as set forth in [0063] and [0087]) of the heating pipeline at a current ambient-air temperature and the temperature of the first mixed gas flow at the gas inlet of the heating pipeline, determining the temperature of the second mixed gas flow at the gas outlet of the heating pipeline (FIG. 2b The end temperature sensor 15 temperature readings at the conduit outlet, and the temperature readings at the chamber outlet by FIG. 2a Exit port temperature sensor 63, which is the conduit inlet, is fed to the controller system 8 as set forth in [0063] and [0087]).
Claims 12 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Tatkov (US 20190151583 A1) in view of McAuley (US 20130174841 A1), Leonard (US 20160184547 A1), and Mulvaney (US 6796550 B2) as applied to claim 10, in further view of Lellouche (François Lellouche, et al. “Influence of Ambient and Ventilator Output Temperatures on Performance of Heated-Wire Humidifiers.” American Journal of Respiratory and Critical Care Medicine, vol. 170, no. 10, 15 Nov. 2004, pp. 1073–1079, https://doi.org/10.1164/rccm.200309-1245oc. Accessed 09 July 2025.) and Wruck (WO 2015192946 A1) .
Regarding claim 12, Tatkov as modified discloses the claimed invention substantially as claimed as set forth for claim 10 above.
Tatkov as modified fails to explicitly disclose the method, wherein the step S1 comprises: determining a total water-evaporation amount according to the target flow rate, the target humidity, the ambient-air humidity and the ambient-air temperature; determining an initial heating power of the heating plate according to the total water-evaporation amount;
However, McAuley teaches determining a total water-evaporation amount according to the target flow rate, the target humidity, the ambient-air humidity and the ambient-air temperature (Evaporation rate is based on ambient temperature, ambient humidity level, heater plate setting, air volume flow rate as set forth in [0069], [0103], [0107], and [0110]); by the first controller, determining an initial heating power of the heating plate according to the total water-evaporation amount (Controlling the power supplied to a heater plate such that amount of water in said chamber lasts for at least a substantial part of the treatment time, which means the heating power is determined according to the total evaporation amount, while providing a minimum amount of humidification as per said patient's treatment data as set forth in [0025], [0061], and [0069]).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tatkov to incorporate the teaching of McAuley and include determining a total water-evaporation amount according to the target flow rate, the target humidity, the ambient-air humidity and the ambient-air temperature (Evaporation rate is based on ambient temperature, ambient humidity level, heater plate setting, air volume flow rate as set forth in [0069], [0103], [0107], and [0110]); by the first controller, determining an initial heating power of the heating plate according to the total water-evaporation amount (Controlling the power supplied to a heater plate such that amount of water in said chamber lasts for at least a substantial part of the treatment time, which means the heating power is determined according to the total evaporation amount, while providing a minimum amount of humidification as per said patient's treatment data as set forth in [0025], [0061], and [0069]). Doing so provides a known method of determining an evaporation rate in a humidification system (McAuley: As set forth in [0103]) which can be used by the control system modules of Tatkov to determine a desired heater plate power.
Tatkov as modified fails to explicitly disclose the method, wherein the step S1 comprises: determining a heating efficiency of the heating plate according to the ambient-air temperature and a temperature of the heating plate.
However, Lellouche teaches that heating efficiency is affected by the ambient-air temperature (Lellouche: A high inlet chamber temperature was associated with poor performance of the heating element as set forth on the last paragraph of page 5 and first paragraph of page 6) and a temperature of the heating plate (The temperature of the heat source is an inherent part of determining heating efficiency since heating efficiency is how effectively a system is converting the heat energy into useful work which is a well-known concept in the art).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tatkov to incorporate the teaching of Lellouche and include that heating efficiency is affected by the ambient-air temperature (Lellouche: A high inlet chamber temperature was associated with poor performance of the heating element as set forth on the last paragraph of page 5 and first paragraph of page 6) and a temperature of the heating plate (The temperature of the heat source is an inherent part of determining heating efficiency since heating efficiency is how effectively a system is converting the heat energy into useful work which is a well-known concept in the art). This would indicate that a heating efficiency of the heating plate is affect according to the ambient-air temperature and a temperature of the heating plate. Automating the manual process of determining a heating efficiency of the heating plate according to the ambient-air temperature and a temperature of the heating plate would allow the control system of Tatkov (FIG. 2b Control system 8 comprising 8a, 8b) to provide an ideal heating temperature of the heating plate given the parameter affecting the heating efficiency of the heating plate.
Tatkov as modified fails to explicitly disclose the method, wherein the step S1 comprises: determining the heating power of the heating plate according to the initial heating power of the heating plate and the heating efficiency of the heating plate.
However, Wruck teaches by the first controller, determining the heating power of the heating plate according to the initial heating power of the heating plate and the heating efficiency of the heating plate. (Wruck: FIG. 1 The efficiency of the heating element 2 is taken in account while determining the required heating power which is requested via the central control in the heating element 2 as set forth on page 8 paragraph 6 of the machine translation. Additionally, the heating power is controlled taking into account parameters of the gas flow downstream of the evaporation chamber, as set forth on page 3 paragraphs 1- 2, which indicates that an initial heating power was provided to the heating element, which resulted in a measurable parameter of the gas flow after evaporation has occurred, which is then used to control and further determine the heating power to be applied to the heating plate).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tatkov to incorporate the teaching of Wruck and include by the first controller, determining the heating power of the heating plate according to the initial heating power of the heating plate and the heating efficiency of the heating plate. (Wruck: FIG. 1 The efficiency of the heating element 2 is taken in account while determining the required heating power which is requested via the central control in the heating element 2 as set forth on page 8 paragraph 6 of the machine translation. Additionally, the heating power is controlled taking into account parameters of the gas flow downstream of the evaporation chamber, as set forth on page 3 paragraphs 1- 2, which indicates that an initial heating power was provided to the heating element, which resulted in a measurable parameter of the gas flow after evaporation has occurred, which is then used to control and further determine the heating power to be applied to the heating plate).
Regarding claim 14, Tatkov as modified discloses the claimed invention substantially as claimed as set forth for claim 10 above.
Tatkov as modified further discloses the method, wherein the step S5 furhter comprises: receiving the air flow rate inputted by the fan in real time (FIG. 2b Controller 8a and 8b, from the humidifier base unit, are connected and make up a control system 8 as set forth in [0056], are connected with the flow probe 61 to measure the gases flow as set forth in [0067]); determining an initial heating power of the heating pipeline, according to the air flow rate inputted by the fan (The initial end temperature sensor 15 temperature reading would be representative of the initial heating power of the heater wire according to the air flow rate inputted by the fan), the temperature of the first mixed gas flow, the temperature of the second mixed gas flow and the target temperature preset by the user (FIG. 2a Controller 8a and 8b, from the humidifier base unit, are connected and make up a control system 8 as set forth in [0056], where controller system 8 and can adjust the power supplied to the heating wire. The end temperature sensor 15 temperature readings at the outlet, and the temperature readings at the chamber outlet is fed to the controller system 8 and used to ensure the delivery of gas at the target temperature to the patient, the initial end temperature sensor 15 temperature reading would be representative of the initial heating power of the heater wire, the target temperature being the temperature at the chamber outlet, if the patient end temperature sensor 15 readings indicate the gas temperature being reduced when the humidified air travels through the length of the delivery conduit 6, then the controller 8 can increase the supply conduit heating wire as set forth in in [0087]. FIG. 5 Shows lines 70-76 which corresponds to different flow rates, the flow rate corresponding to an ideal target temperature which allows the controller to generate an output to controller the temperature of the heater wire as set forth in in [0073]-[0074], and [0087]); and determining the heating power of the heating pipeline according to the initial heating power of the heating pipeline (FIG. 2a Controller 8a and 8b, from the humidifier base unit, are connected and make up a control system 8 as set forth in [0056], where controller system 8 and can adjust the power supplied to the heating wire. The end temperature sensor 15 temperature readings at the outlet, and the temperature readings at the chamber outlet is fed to the controller system 8 and used to ensure the delivery of gas at the target temperature to the patient, the initial end temperature sensor 15 temperature reading would be representative of the initial heating power of the heater wire, the target temperature being the temperature at the chamber outlet, if the patient end temperature sensor 15 readings indicate the gas temperature being reduced when the humidified air travels through the length of the delivery conduit 6, then the controller 8 can increase the supply conduit heating wire as set forth in in [0087]).
Tatkov as modified fails to explicitly discloses determining the heating power of the heating pipeline according to the heating efficiency of the heating pipeline
However, Wruck teaches by a controller, determining the heating power of a heating element according to the initial heating power of the heating element and the heating efficiency of the heating element. (Wruck: FIG. 1 The efficiency of the heating element 2 is taken in account while determining the required heating power which is requested via the central control in the heating element 2 as set forth on page 8 paragraph 6 of the machine translation. Additionally, the heating power is controlled taking into account parameters of the gas flow downstream of the evaporation chamber, as set forth on page 3 paragraphs 1-2, which indicates that an initial heating power was provided to the heating element, which resulted in a measurable parameter of the gas flow after evaporation has occurred, which is then used to control and further determine the heating power to be applied to the heating plate).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tatkov to incorporate the teaching of Wruck and include, determining the heating power of the heating pipeline according to the initial heating power of the heating pipeline and the heating efficiency of the heating pipeline. (Wruck: FIG. 1 The efficiency of the heating element 2 is taken in account while determining the required heating power which is requested via the central control in the heating element 2 as set forth on page 8 paragraph 6 of the machine translation. Additionally, the heating power is controlled taking into account parameters of the gas flow downstream of the evaporation chamber, as set forth on page 3 paragraphs 1- 2, which indicates that an initial heating power was provided to the heating element, which resulted in a measurable parameter of the gas flow after evaporation has occurred, which is then used to control and further determine the heating power to be applied to the heating plate). Doing so provides a well-known method of determining what heating power is required to sufficiently maintain or achieve a temperature of an airflow.
Tatkov as modified fails to explicitly discloses determining the heating efficiency of the heating pipeline according to the ambient-air temperature and the temperature of the first mixed gas flow.
However, Lellouche teaches that heating efficiency is affected by the air/gas temperature (Lellouche: A high inlet chamber temperature was associated with poor performance of the heating element as set forth on the last paragraph of page 5 and first paragraph of page 6).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tatkov to determine the heating efficiency of the heating pipeline according to the ambient-air temperature and the temperature of the first mixed gas flow because Lellouche teaches that heating efficiency is affected by the air/gas temperature (Lellouche: A high inlet chamber temperature was associated with poor performance of the heating element as set forth on the last paragraph of page 5 and first paragraph of page 6). Although the air/gas temperature referenced in Lellouche is drawn to the ambient temperature, it would be obvious the same could be said for the temperature of the first mixed gas flow. This would indicate that a heating efficiency of the heating pipeline is affected according to the ambient-air temperature and temperature of the first mixed gas flow. Automating the manual process of determining a heating efficiency of the heating pipeline according to ambient-air temperature and the temperature of the first mixed gas flow would allow the control system of Tatkov (FIG. 2b Control system 8 comprising 8a, 8b) to provide an ideal heating temperature of the heating pipeline given the parameters affecting the heating efficiency of the heating pipeline.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Tatkov (US 20190151583 A1) in view of McAuley (US 20130174841 A1), Leonard (US 20160184547 A1), and Mulvaney (US 6796550 B2) as applied to claim 10, in further view of White (US 20030154977 A1).
Regarding claim 15, Tatkov as modified discloses the claimed invention substantially as claimed as set forth for claim 10 above.
Tatkov as modified further discloses the method, wherein after the step S6, the method further comprises: when the water evaporation rate in the water tank maintains stable (The evaporation rate will maintain stable when the heater plate and ambient temperature are at a constant temperature, step 6 capable of being executed during this time), determining whether a current air flow rate of the fan is equal to the target flow rate preset by the user (FIG. 2b Controller 8a and 8b, from the humidifier base unit, are connected and make up a control system 8 as set forth in [0056], are connected with the flow probe 61 to measure the gases flow as set forth in [0067], and use a feedback mechanism via controller 8 to adjust the flow rate to the level required or requested as set forth in [0073]) when the current air flow rate of the fan is equal to the target flow rate, controlling the heating plate to continue operating at a current heating power, and controlling the fan to continue operating at the current air flow rate at the same time (If actual flow rate as measured matches the user set flow rate the controller 8 characterizes the flow rate as within tolerance between the actual measured flow rate and user set flow rate, where no adjustment to the flow rate is necessary as set forth in [0124]. If the controller ‘sees’ a large deviation or a step change in the flow rate, it uses coarse control parameters to restore the flow rate to the rate set by a user as set forth in [0125], the coarse control can be achieved by using heater plate temperature as set forth in [0131]. Since no adjustment is needed, the heating plate will continue operating at a current heating power); and further can determine when the current air flow rate of the fan is less than the target flow rate (FIG. 2b Controller 8a and 8b, from the humidifier base unit, are connected and make up a control system 8 as set forth in [0056], are connected with the flow probe 61 to measure the gases flow as set forth in [0067]), and at the same time, adjusting the air flow rate inputted by the fan, until the water evaporation rate maintains stable (The evaporation rate will maintain stable when the heater plate and ambient temperature are at a constant temperature, the controller system are capable of executing step 6 during this time, It would be obvious that the method step wouldn’t need to be utilized any further once evaporation rate is at a stable value since doing so would be unnecessary given that the control system has already completed its function given that specific rate of evaporation), to input the mixed gas flow obtained by mixing the water vapor and the air into the heating pipeline, wherein the relative humidity of the mixed gas flow is the target humidity (Leonard: Gas flow rates can become sufficiently low that the gas passing through the device spends more time in the humidification region. As a result, the humidity level of the gas flow exiting the device toward the patient can approach 100% relative humidity as set forth in [0003]. Additionally, The system and method control the humidity of a breathing gas over a range of flow rates. Excessive humidification of a breathing gas is prevented at low gas flow rates while impeding or preventing a significant drop in humidity at high flow rates. At low flow rates, gas flowing through the vapor transfer unit has more time to receive humidity than at high flow rates. Therefore, the systems and methods limit the humidity of breathing gasses at low flow rates as set forth in [0006]).
Tatkov as modified fails to explicitly disclose the method, wherein when the current air flow rate of the fan is less than the target flow rate, determining whether the current heating power of the heating plate is a maximum power and being maintained for a second time interval, and when the current beating power of the beating plate is the maximum power and being maintained for the second time interval, controlling the heating plate to continue operating at a current heating power, and controlling the fan to continue operating at the current air flow rate at the same time; and when determining that the current heating power of the heating plate is not the maximum power, re-determining the heating power of the beating plate.
However, White teaches a method for determining whether the current heating power of the heating plate is a maximum power and being maintained for a second time interval, and when the current beating power of the beating plate is the maximum power and being maintained for the second time interval, controlling the heating plate to continue operating at a current heating power (White: The controller 11 determines if the heating element 15 is at a predetermined safety limit, which is the maximum power level achieved safely buy the heating element as set forth in [0045]-[0046], the current/power applied to the heating element will not fall at any flow rate or ambient temperature unless the conduit is heating to a degree that approaches a safety hazard as set forth in [0047]); and when determining that the current heating power of the heating plate is not the maximum power (White: FIG. 1 Control means 11 is connected with sensor 30 to monitor the heating element 15 as set forth in [0045], the controller 11 determines if the heating element 15 is at a predetermined safety limit, which is the maximum power level achieved safely buy the heating element as set forth in [0045]-[0046], the sensor 30 would be able to sense the heating plate at a power that is not the “maximum power”), re-determining the heating power of the beating plate (White: The control means 11 and sensor 30 are in a state of “monitoring” indicating that they are always in communication, the sensor inputting readings into the control means as set forth in [0045]).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tatkov to incorporate the teaching of White and include a method for determining whether the current heating power of the heating plate is a maximum power and being maintained for a second time interval, and when the current beating power of the beating plate is the maximum power and being maintained for the second time interval, controlling the heating plate to continue operating at a current heating power (White: The controller 11 determines if the heating element 15 is at a predetermined safety limit, which is the maximum power level achieved safely buy the heating element as set forth in [0045]-[0046], the current/power applied to the heating element will not fall at any flow rate or ambient temperature unless the conduit is heating to a degree that approaches a safety hazard as set forth in [0047]); and when determining that the current heating power of the heating plate is not the maximum power (White: FIG. 1 Control means 11 is connected with sensor 30 to monitor the heating element 15 as set forth in [0045], the controller 11 determines if the heating element 15 is at a predetermined safety limit, which is the maximum power level achieved safely buy the heating element as set forth in [0045]-[0046], the sensor 30 would be able to sense the heating plate at a power that is not the “maximum power”), re-determining the heating power of the beating plate (White: The control means 11 and sensor 30 are in a state of “monitoring” indicating that they are always in communication, the sensor inputting readings into the control means as set forth in [0045]). Doing so would allow for the device to safely maintain a maximum power supplied to a heating element for use in a humidification system (White: As set forth in [0010]). It would also be obvious that the above method step would be executed when the current air flow rate of the fan is less than the target flow rate, so that a target amount of humidity is being still supplied to the patient.
Tatkov as modified fails to explicitly disclose that when the current heating power of the heating plate is the maximum power and being maintained for the second time interval, the first controller controlling the fan to continue operating at the current air flow rate at the same time.
However, Tatkov as modified by Leonard further teaches a first controller controlling the fan to operating at a desired air flow rate in order to provide a target humidity to the patient (Leonard: Gas flow rates can become sufficiently low that the gas passing through the device spends more time in the humidification region. As a result, the humidity level of the gas flow exiting the device toward the patient can approach 100% relative humidity as set forth in [0003]. Additionally, the system and method control the humidity of a breathing gas over a range of flow rates. Excessive humidification of a breathing gas is prevented at low gas flow rates while impeding or preventing a significant drop in humidity at high flow rates. At low flow rates, gas flowing through the vapor transfer unit has more time to receive humidity than at high flow rates. Therefore, the systems and methods limit the humidity of breathing gasses at low flow rates as set forth in [0006]).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention that the device of Tatkov as modified would be able to control the fan to continue operating at the current air flow rate at the same time as when the current heating power of the heating plate is the maximum power and being maintained for the second time interval, since Tatkov is supplied with a target humidity and temperature (System is designed to achieve a desired patient end temperature and absolute humidity at said interface as set forth in [0033]) and would be able to maintain a specific flow rate at a given temperature of the heating plate in order to achieve that said humidity (Tatkov: Set forth in [0003] and [0006]).
Tatkov as modified does not explicitly disclose that the air flow rate inputted by the fan is adjusted according to a water evaporation rate of evaporation when the heating plate operates at the re-determined heating power of the heating plate.
However, a relative humidity of the mixed gas flow obtained by mixing the water vapor and the air is directly related to the evaporation rate.
Mulvaney teaches that the difference in the air’s humidity at the inlet and outlet of the system are due to the water being evaporated into the flow of air (Mulvaney: As set forth in column 4, lines 42-54).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tatkov to adjust the air flow rate inputted by the fan according to the current water evaporation rate because Mulvaney teaches that the difference in the air’s humidity at the inlet and outlet of the system is due to the water being evaporated into the flow of air (Mulvaney: As set forth in column 4, lines 42-54). This indicates that the evaporation rate is reflected in the air’s humidity at the outlet of the system, a well-known concept in the art of the claimed invention, and as a result, the flow-rate controlling module could be configured for adjusting the air flow rate inputted by the fan according to the current water evaporation rate in the same way that Tatkov as modified by Leonard can adjust the air flow rate inputted by the fan according to a humidity at the outlet of the system.
Claims 16 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Tatkov (US 20190151583 A1) in view of McAuley (US 20130174841 A1), Leonard (US 20160184547 A1), and Mulvaney (US 6796550 B2) as applied to claim 10, in further view of Novkov (US 20190344038 A1).
Regarding claim 16, Tatkov as modified discloses the claimed invention substantially as claimed as set forth for claim 10 above.
Tatkov as modified further discloses the method, wherein the calculating and processing device comprises: Computer programming to determine how the controller determines the control output (As set forth in [0057]).
Tatkov as modified is silent as to the calculating and processing device comprising: a memory storing a computer-readable code; and one or more processors, wherein when the computer-readable code is executed by the one or more processors, the calculating and processing device implements the humidification controlling method of a ventilation-treatment apparatus.
However, Novkov teaches the calculating and processing device comprising: a memory storing a computer-readable code; and one or more processors, wherein when the computer-readable code is executed by the one or more processors, the calculating and processing device implements the humidification controlling method of a ventilation-treatment apparatus (Novkov: A module as used herein refers to memory, one or more processors, storage, and/or other components of the type commonly found in command and control computing devices set forth in [0030] and the humidifier memory includes non-transitory, computer-readable storage media that stores and/or encodes software such as computer executable instruction as set forth in [0041]).
Tatkov and Novkov are both considered to be analogous to the claimed invention because they are in the same field of ventilation humidification. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tatkov to incorporate the teaching of Novkov and include where the calculating and processing device comprising: a memory storing a computer-readable code; and one or more processors, wherein when the computer-readable code is executed by the one or more processors, the calculating and processing device implements the humidification controlling method of a ventilation-treatment apparatus (Novkov: A module as used herein refers to memory, one or more processors, storage, and/or other components of the type commonly found in command and control computing devices set forth in [0030] and the humidifier memory includes non-transitory, computer-readable storage media that stores and/or encodes software such as computer executable instruction as set forth in [0041]). Doing so provides commonly used components in command-and-control computing devices of ventilators provided humidified air to a patient (Novkov: As set forth in [0030]).
Regarding claim 18, Tatkov as modified discloses the claimed invention substantially as claimed as set forth for claim 10 above.
Tatkov as modified further discloses A computer-readable medium (Computer programming to determine how the controller determines the control output as set forth in [0057]).
Tatkov as modified is silent as to the computer-readable medium storing a computer program code, and when the computer-readable code is executed, the humidification controlling method is performed.
However, Novkov teaches the computer-readable medium storing a computer program code, and when the computer-readable code is executed, the humidification controlling method is performed (Novkov: The humidifier memory includes non-transitory, computer-readable storage media that stores and/or encodes software such as computer executable instruction as set forth in [0041]).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tatkov to incorporate the teaching of Novkov and include the computer-readable medium storing a computer program code, and when the computer-readable code is executed, the humidification controlling method is performed (Novkov: The humidifier memory includes non-transitory, computer-readable storage media that stores and/or encodes software such as computer executable instruction as set forth in [0041]). Doing so provides commonly used components in command-and-control computing devices of ventilators provided humidified air to a patient (Novkov: As set forth in [0030]).
Response to Arguments
In response to Applicant’s amendments to claims 1, 2, and 4-8, the 35 USC § 112(f) rejection has been withdrawn.
In response to Applicant’s amendments to claims 1, 2, and 4-8, the 35 USC § 112(a) rejections have been withdrawn.
In response to Applicant’s amendments to claims 1, 2, and 4-8, the 35 USC § 112(b) rejections have been withdrawn.
New grounds of rejection have been made above to address the amendments to claims 1, 2, 4-8, 10, and 14.
Applicant's arguments filed 10/24/2025 have been fully considered but they are not persuasive.
Applicant argues that Tatkov as modified fails to explicitly disclose the feature in claim 1, “the heating controller of the heating pipeline is configured for receiving a temperature of the first mixed gas flow at the gas inlet of the heating pipeline and a temperature of a second mixed gas flow at the gas outlet, to determine a currently required heating power of the heating pipeline, to adjust the heating pipeline to the currently required heating power, to maintain a temperature of a mixed gas flow obtained by mixing the water vapor transmitted via the heating pipeline to the nasal oxygen cannula and the air at a target temperature”.
In response to Applicant’s argument, it is noted that the above limitation is addressed in the rejection for claim 1, wherein Tatkov explicitly discloses the following: FIG. 2b The end temperature sensor 15 temperature readings at the outlet, and the temperature readings at the chamber outlet is fed to the controller system 8 and used to ensure the delivery of gas at the target temperature to the patient, the target temperature being the temperature at the chamber outlet, if the patient end temperature sensor 15 readings indicate the gas temperature being reduced when the air travels through the length of the delivery conduit 6, then the controller 8 can increase the supply conduit heating wire as set forth in [0087]. The limitation not explicitly disclosed by Tatkov is wherein “the determined air flow rate inputted by the fan, is so that a current relative humidity of a first mixed gas flow obtained by mixing water vapor in the water tank and air inputted by the fan is the target humidity” which is taught by Leonard, the motivation being to enable the controller of Tatkov to use the readings obtained by the sensors in order to determine the fan speed, and therefore air flow rate, to do so in order to achieve a target humidity (Leonard: Set forth in [0003] and [0006]).
Applicant further argues that Leonard does not explicitly mention the control logic of the application wherein the controller determines the air flow rate input by the fan based on temperature parameters, so that a relative humidity of the mixed air flow obtained by mixing water vapor and the air input by the fan is taken at the target humidity.
In response to Applicant’s argument, it is noted that the claim language and specification indicate that the air flow rate input by the fan is determined according to the evaporation rate, so that a target humidity is achieved, specifically, “Step S3. According to the current water evaporation rate in the water tank, determining an air flow rate inputted by the fan, so that a current relative humidity of a first mixed gas flow obtained by mixing a water vapor in the water tank and an air inputted by the fan is the target humidity” as set forth in [0041], and claim 1 indicates that “…and a target humidity and a target flow rate that are preset by the user, to determine an air flow rate inputted by the fan…”. Neither the specification nor the claims indicate or disclose how temperature parameters would be used to determine the air flow rate input by the fan. As stated in the rejection, Leonard teaches that the determined air flow rate inputted by the fan, is so that a current relative humidity of a first mixed gas flow obtained by mixing water vapor in the water tank and air inputted by the fan is the target humidity (Leonard: Gas flow rates can become sufficiently low that the gas passing through the device spends more time in the humidification region. As a result, the humidity level of the gas flow exiting the device toward the patient can approach 100% relative humidity as set forth in [0003]. Additionally, The system and method control the humidity of a breathing gas over a range of flow rates. Excessive humidification of a breathing gas is prevented at low gas flow rates while impeding or preventing a significant drop in humidity at high flow rates. At low flow rates, gas flowing through the vapor transfer unit has more time to receive humidity than at high flow rates. Therefore, the systems and methods limit the humidity of breathing gasses at low flow rates as set forth in [0006]). The rejection for claim 10 further teaches wherein the evaporation rate plays a determining factor.
Applicant further argues that Tatkov fails to disclose the features "wherein the way for the heating controller of the heating pipeline to control the heating power of the heating pipeline is: by the heating controller of the heating pipeline, determining the heating power of the heating pipeline according to the air flow rate inputted by the fan, the temperature of the first mixed gas flow, the temperature of the second mixed gas flow and the target temperature preset by the user" since Tatkov only mentions a “predetermined data set” and not the parameter of an air flow rate.
In response to Applicants argument, it is noted that FIG. 5 Shows lines 70-76 which corresponds to different flow rates, the flow rate corresponding to an ideal target temperature which allows the controller to generate an output to controller the temperature of the heater wire as set forth in in [0073]-[0074], and [0087]. An air flow rate parameter is present according to one of the lines in FIG. 5 while the device is in operation. Additionally, Tatkov reiterates this in [0027]-[0028], “…a flow sensor adapted to measure the actual flow rate of said gases stream through said system, a controller adapted to receive data from said ambient temperature sensor relating to the measured temperature, data from said exit port temperature sensor relating to the measured temperature, and data from said flow sensor relating to said actual flow rate, said controller determining a control output in response, said control output adjusting the power to said humidifier unit to achieve a desired output at said humidifier unit exit port.” The rejection for claims 1 and 10 addresses how the heating controller of the heating pipeline controls the heating power of the heating pipeline.
New grounds of rejection have been made above to address the amendments to claims 1, 2, 4-8, 10, and 14.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/KEIRA EILEEN CALLISON/Examiner, Art Unit 3785
/VICTORIA MURPHY/Primary Patent Examiner, Art Unit 3785
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