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 .
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-5, 7, 11-14, and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McAuley et al. (US 2016/0375217 A1).
Regarding claim 1, McAuley discloses a humidifier of a heated pass-over type (humidification system 1 comprising a heat conductive base 7, Paragraphs 0082-0083, Abstract and Figure 1) for use in a sleep (system 1 used while patient is asleep, Paragraph 0111) or respiratory therapy device that includes a blower section having a blower for supplying a pressurized flow of breathable gas (respiratory therapy delivered via an integrated blower or ventilator 2, Paragraph 0082 and Figure 1), comprising: a heater plate (heater plate 9, Paragraph 0083 and Figure 1); a water reservoir structured to house a volume of water (chamber 5 configured to house a volume of water, Paragraph 0084 and Figure 1), the water reservoir having a breathable gas inlet (chamber 5 includes a breathable gas inlet 4, Paragraph 0082 and Figure 1) and a humidified breathable gas outlet (chamber 5 includes a breathable gas outlet 12, Paragraph 0084 and Figure 1), wherein the water reservoir includes at least one surface for contacting the heater plate (the heat conductive bas 7 of the chamber 5 is in contact with the heater plate 9, Paragraph 0083); one or more sensors configured to generate output signals conveying information about an operating status of the humidifier and ambient conditions (the system may measure the initial temperature of the chamber water or ambient temperate using a sensor, Paragraph 0089 and Figures 4-5); and a controller (controller 11, Paragraph 889 and Figures 4-5) configured to: (i) predict a water mass of the volume of water contained within the water reservoir at a predetermined time during a humidifier treatment session of a given treatment duration based on predetermined heat and water mass transfer functions of a given design of the humidifier (the controller 11 determines the level of water within the chamber based on the temperature response for a particular power level or change in power level; relationship between the rate of change of temperature and power level to water level can be determined from a look table or a derived equation for the system, Paragraphs 0088-0089; the controller 11 can control the heating of the heater plate such that the volume of the water within the chamber 5 lasts the entire time of the treatment session, Paragraph 0110), the output signals conveying information about the operating status of the humidifier and ambient conditions (the controller 11 runs a formula based on received sensor inputs of ambient conditions, temperature values or temperature rate of change, flow rates and time periods of heating and cooling, Paragraph 0092), and on a constant electrical input power to the heater plate (the controller 11 determines the power level delivered to the heater plate and is constantly delivering power, Paragraph 0088 and Figure 7);
(ii) determine a length of time needed to evaporate (controller 11 controls the power supplied to the heater plate such that the amount of water in said chamber 5 lasts for the treatment time, Paragraph 0025), at a desired evaporation rate, all water of the predicated water mass (see Paragraphs 0103-0106 describing the calculating of the desired evaporation rate); and (iii) at least one of (a) output a warning signal in response to the determined length of time to evaporate all water of the predicated water mass being insufficient for a remainder of the given treatment duration starting from the predetermined time (the controller can verify if the chamber has been filled or not and can activate a warning to the use of the chamber has not be filled enough to the appropriate water level, Paragraph 0117), and (b) adapt a heater plate constant electrical input power setting to change the desired evaporation rate to a new evaporation rate of a current predicated water mass to ensure that the current predicted water mass is sufficient to last for a remainder of the given treatment duration and prevent the water reservoir from running dry prior to an ending of the given treatment duration of the humidifier session (the controller may vary the power supplied to the heater plate such that the amount of water in said chamber 5 for at least a substantial part of the treatment time while providing a minimum amount of humidification as per said patient’s treatment data, Paragraph 0025, Abstract; see also Paragraph 0106 describing the determination of the appropriate evaporation rate and how it relates to the water level within the chamber 5).
Regarding claim 2, McAuley further discloses wherein the predetermined time comprises (i) an initial time period at a start of the humidifier treatment session, (water level determination is made at the start of therapy, Paragraph 0024) or (ii) an intermediate time period of the humidifier treatment session, subsequent to the initial time period (water level determination may be made during therapy/treatment, Paragraph 0024), or (iii) a combination of the initial time period and the intermediate time period (Paragraph 0024).
Regarding claim 3, McAuley further discloses wherein the initial time period comprises within a time period immediately after switching the humidifier power ON, but not yet applying the constant electrical input power to the heater plate (determination of water level at start up of the chamber, therefore prior to power being delivered to heater plate, Paragraph 0089 and Figures 4-5).
Regarding claim 4, McAuley further discloses wherein the controller is configured to predict the water mass of the volume of water further according to a power control algorithm for humidifying the flow of breathable gas received at the breathable gas inlet of the water reservoir into a flow of humidified breathable gas at the humidified breathable gas outlet of the water reservoir (the controller 11 is able to control and/or adjust various CPAP parameters by using a CPAP control algorithm, Paragraph 0121), wherein the power control algorithm includes a transfer function in which a required power input to the heater plate is a function of a desired evaporation rate based upon generated sensor output signals (said evaporation rate is calculated based on mass transfer of gases through said chamber, wet surface area, wet surface vapor pressure and vapor pressure of gases flow, Paragraph 0056; see also Paragraph 0106 describing functions used in the determination of the evaporation rate and how it relates to the power delivered to the heater plate).
Regarding claim 5, McAuley further discloses wherein determining the water mass comprises determining a value of water mass multiple times over an initial water mass determination period of time, and calculating an initial water mass by averaging the multiple determined values of water mass obtained over the water mass determination period (the level of water within the chamber during use is determined experimentally, meaning the relationship between the rate of change of temperature for cooling and the level of water is determined experimentally and stored within a further look up table; the table for water level during use is stored in the memory of the controller 11; the controller varies the power and measures the change in temperature. The controller then determines the level of water within the chamber 5 by using the look up table to determine the value of water level based on the other variables identified earlier, therefore the controller is fully capable of determining the water mass multiple times and using averaging methods, Paragraph 0098).
Regarding claim 7, McAuley further discloses wherein determining the length of time needed to evaporate all water of the predicted water mass is based on the predicted water mass and an average heater plate temperature gradient during the predetermined time (see Paragraph 0106 describing the determination of the evaporation time needed based on the change of temperature of the heater plate and the corresponding power supplied to the heater plate).
Regarding claim 11, McAuley further discloses wherein the one or more sensors comprise a temperature sensor for measuring a temperature of the heater plate (see Paragraph 0099 describing a sensor used for the measurement of the heater plate temperature), and a separate temperature sensor for the measuring a temperature of the water in the water reservoir (temperature sensor for measuring temperature of water within chamber, Paragraph 0064, 0088), and wherein the controller is configured to predict the water mass of the volume of water based on the predetermined heat and water mass transfer functions that include heat and water mass temperature relationships between (i) the heater plate temperature (the amount of water or evaporation rate is based on ambient temperature, heater plate temperature, air volume flow rate, etc., Paragraph 0103), (ii) the estimated water temperature (see Paragraphs 0038-0039 describing estimated water temperature calculations), (iii) system parameters for the given humidifier design, and (iv) known humidifier device parameters (the amount of water or evaporation rate is based on ambient temperature, heater plate temperature, air volume flow rate, and wet surface area, Paragraph 0103).
Regarding claim 12, McAuley further discloses wherein the system parameters and humidifier device parameters include water-air interface surface area (wet surface area calculation, Paragraph 0103), heater plate heat loss coefficient (see Paragraph 0095 describing the calculation of the temperate drop of the heater plate and the associated drop in water chamber temperature), water heat loss coefficient (see Paragraph 0095 describing the calculation of the temperate drop of the heater plate and the associated drop in water chamber temperature), mass transfer coefficient (mass transfer coefficient, Paragraph 0058), heater plate electrical input power (heater plate input power, Paragraph 0090), and heat transfer from blower to air (heat energy transfer, Paragraph 0118).
Regarding claim 13, McAuley discloses a gas delivery system for delivering a pressurized flow of humidified breathable gas to a patient via a patient circuit (respiratory humidification system 1 comprising a patient circuit 16, Figure 1 and Abstract), comprising: a blower assembly having a blower adapted to generate the pressurized flow of breathable gas (blower assembly 2, Figures 1-2 and Paragraph 0082), and a gas flow path including an inlet (inlet 4, Paragraph 0082 and Figure 1) and an outlet (outlet 12, Figure 1 and Paragraph 0084); and a humidifier according to claim 1 (humidification chamber 5, Paragraph 0082 and Figure 1), wherein the humidifier is fluidically coupled between the blower and the patient circuit (see humidification chamber 5 fluidically coupled between blower 2 and patient circuit, Figure 1), wherein the blower assembly further includes at least one of the sensors configured to generate output signals conveying information used in predicting the water mass (air flow rate can be determined using a flow or pressure sensor placed between the inlet 4 of the chamber 5 and the blower 2, Paragraph 0101).
Regarding claim 14, McAuley discloses a method for determining water mass in a humidifier (method of determining water level in a humidifier chamber that is a part of a humidified gases delivery apparatus and system, Abstract) of a heated pass-over type for use in humidifying a flow of breathable gas (humidification system 1 comprising a heat conductive base 7, Paragraphs 0082-0083, Abstract and Figure 1) in a sleep (system 1 used while patient is asleep, Paragraph 0111) or respiratory therapy device having a blower section that includes a blower for supplying a pressurized flow of breathable gas (respiratory therapy delivered via an integrated blower or ventilator 2, Paragraph 0082 and Figure 1), the method comprising: providing a heater plate (heater plate 9, Paragraph 0083 and Figure 1); providing a water reservoir structured to house a volume of water (chamber 5 configured to house a volume of water, Paragraph 0084 and Figure 1), the water reservoir having a breathable gas inlet (chamber 5 includes a breathable gas inlet 4, Paragraph 0082 and Figure 1) and a humidified breathable gas outlet (chamber 5 includes a breathable gas outlet 12, Paragraph 0084 and Figure 1), wherein the water reservoir includes at least one surface for contacting the heater plate (the heat conductive bas 7 of the chamber 5 is in contact with the heater plate 9, Paragraph 0083); providing one or more sensors configured to generate output signals conveying information about an operating status of the humidifier and ambient conditions (the system may measure the initial temperature of the chamber water or ambient temperate using a sensor, Paragraph 0089 and Figures 4-5); predicting, via a controller, a water mass of the volume of water contained within the water reservoir at a predetermined time during a humidifier treatment session of a given treatment duration based on predetermined heat and water mass transfer functions of a given design of the humidifier (the controller 11 determines the level of water within the chamber based on the temperature response for a particular power level or change in power level; relationship between the rate of change of temperature and power level to water level can be determined from a look table or a derived equation for the system, Paragraphs 0088-0089; the controller 11 can control the heating of the heater plate such that the volume of the water within the chamber 5 lasts the entire time of the treatment session, Paragraph 0110), the output signals conveying information about the operating status of the humidifier and ambient conditions (the controller 11 runs a formula based on received sensor inputs of ambient conditions, temperature values or temperature rate of change, flow rates and time periods of heating and cooling, Paragraph 0092), and on a constant electrical input power to the heater plate (the controller 11 determines the power level delivered to the heater plate and is constantly delivering power, Paragraph 0088 and Figure 7); determining, via the controller, a length of time needed to evaporate (controller 11 controls the power supplied to the heater plate such that the amount of water in said chamber 5 lasts for the treatment time, Paragraph 0025), at a desired evaporation rate, all water of the predicted water mass (see Paragraphs 0103-0106 describing the calculating of the desired evaporation rate); and controlling, via the controller, at least one of (a) outputting a warning signal in response to the determined length of time to evaporate all water of the predicted water mass being insufficient for a remainder of the given treatment duration starting from the predetermined time (the controller can verify if the chamber has been filled or not and can activate a warning to the use of the chamber has not be filled enough to the appropriate water level, Paragraph 0117), and (b) adapting a heater plate constant electrical input power setting to change the desired evaporation rate to a new evaporation rate of a current predicted water mass to ensure that the current predicted water mass is sufficient to last for a remainder of the given treatment duration and prevent the water reservoir from running dry prior to an ending of the given treatment duration of the humidifier treatment session (the controller may vary the power supplied to the heater plate such that the amount of water in said chamber 5 for at least a substantial part of the treatment time while providing a minimum amount of humidification as per said patient’s treatment data, Paragraph 0025, Abstract; see also Paragraph 0106 describing the determination of the appropriate evaporation rate and how it relates to the water level within the chamber 5).
Regarding claim 16, McAuley further discloses a computer program product, comprising instructions which, when executed by the controller of the humidifier of claim 1 (the controller 11 may comprise a microprocessor which holds a software program containing instructions regarding the operation and control of system 1, Paragraph 0086), cause the controller to: (i) predict a water mass of the volume of water contained within the water reservoir at a predetermined time during a humidifier treatment session of a given treatment duration based on predetermined heat and water mass transfer functions of a given design of the humidifier (the controller 11 determines the level of water within the chamber based on the temperature response for a particular power level or change in power level; relationship between the rate of change of temperature and power level to water level can be determined from a look table or a derived equation for the system, Paragraphs 0088-0089; the controller 11 can control the heating of the heater plate such that the volume of the water within the chamber 5 lasts the entire time of the treatment session, Paragraph 0110), the output signals conveying information about the operating status of the humidifier and ambient conditions (the controller 11 runs a formula based on received sensor inputs of ambient conditions, temperature values or temperature rate of change, flow rates and time periods of heating and cooling, Paragraph 0092), and on a constant electrical input power to the heater plate (the controller 11 determines the power level delivered to the heater plate and is constantly delivering power, Paragraph 0088 and Figure 7); (ii) determine a length of time needed to evaporate (controller 11 controls the power supplied to the heater plate such that the amount of water in said chamber 5 lasts for the treatment time, Paragraph 0025), at a desired evaporation rate, all water of the predicated water mass (see Paragraphs 0103-0106 describing the calculating of the desired evaporation rate); and (iii) at least one of (a) output a warning signal in response to the determined length of time to evaporate all water of the predicated water mass being insufficient for a remainder of the given treatment duration starting from the predetermined time (the controller can verify if the chamber has been filled or not and can activate a warning to the use of the chamber has not be filled enough to the appropriate water level, Paragraph 0117), and (b) adapt a heater plate constant electrical input power setting to change the desired evaporation rate to a new evaporation rate of a current predicated water mass to ensure that the current predicted water mass is sufficient to last for a remainder of the given treatment duration and prevent the water reservoir from running dry prior to an ending of the given treatment duration of the humidifier session (the controller may vary the power supplied to the heater plate such that the amount of water in said chamber 5 for at least a substantial part of the treatment time while providing a minimum amount of humidification as per said patient’s treatment data, Paragraph 0025, Abstract; see also Paragraph 0106 describing the determination of the appropriate evaporation rate and how it relates to the water level within the chamber 5).
Allowable Subject Matter
Claims 6, 8-10 and 15 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Regarding said claims, the claims recite limitation(s) involving wherein the initial water mass determination period of time comprises a period of time after constant electrical input power is applied to the heater plate up until a time ts, wherein the time ts corresponds to a time when a condition that (i) a first derivative in the heater plate temperature is less than 50% larger than a quasi-steady state first derivative of the heater plate temperature or (ii) the first derivative in the heater plate temperature is less than 10% larger than the quasi-steady state first derivative of the heater plate temperature, has been reached; (ii) the another first derivative in the heater plate temperature is less than 10% larger than the quasi-steady state first derivative of the heater plate temperature, has been reached, creating a heater plate temperature profile that includes sampled heater plate temperatures collected over a profile creation period of time (i) beginning with the application of the constant electrical input power to the heater plate and (ii) ending upon detection of a variation in first derivative of the heater plate temperature to time determined during the profile creation period becoming less than or equal to a minimum first derivative variation threshold amount, calculating a gradient in temperature of the water within the water reservoir based on the heater plate temperature profile, estimating the water temperature based on (i) the initial determined water temperature, (ii) the calculated gradient in temperature of the water, and (iii) a total duration of time that the constant power to the heater plate has been applied, adjusted by a correction factor, and predicting the initial water mass according to a water mass temperature relationship between (i) the heater plate temperature, (ii) the estimated water temperature, (iii) system parameters for the given humidifier design, and (iv) known humidifier device parameters. Although McAuley teaches the method of using sensors to measure and monitor the temperature of the heating plate, McAuley is silent as to developing a temperature gradient with specific derivative values as claimed.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Bath et al. (US 2016/0339200 A1) and Winkski (US 2015/0014874 A1).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH B LEDERER whose telephone number is 571-272-7274. The examiner can normally be reached on Monday - Friday, 7:30 AM - 4:30 PM.
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/SARAH B LEDERER/Examiner, Art Unit 3785
/MARGARET M LUARCA/Primary Examiner, Art Unit 3785
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