DETAILED ACTION
This application has been transferred to Primary Examiner Annette Dixon, AU 3785.
This Office Action is in response to the amendment, filed on June 2, 2025. Primary Examiner acknowledges Claims 1, 3, 5-7, and 9-24 are pending in this application, with Claims 1, 10-12, 19, 21, and 22 having been currently amended, and Claims 2, 4, and 8 having been cancelled.
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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 13, 14, and 21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Specifically, Claim 1, Line 9 recites “water”; however, this limitation lacks antecedent basis in the claims. Although Claim 1, Line 3 recites “liquid”, Applicant has not positively correlated the term “liquid” to be commensurate with “water”. Consequently, Primary Examiner is unsure if the “liquid” of Line 3 is the same as the “water” of Line 9 or some other limitation. Dependent Claims 3, 5-7, and 9-20 incorporate the indefinite subject matter from which they depend. Appropriate correction and clarification is required.
Specifically, Claim 1, Lines 22-24 recite “wherein the one or more hardware processors is configured to generate an alarm and reduce a heat output of the heating surface upon receiving a signal indicating an absence of liquid on the heating surface”; however, the breadth and scope of this limitation is unclear. Primary Examiner is unsure if Applicant is attempting to correlate the features of the “one or more liquid sensors configured to detect whether the heating surface is wetted in at least one region” in Claim 1, Lines 12-14 with the “a signal indicating an absence of liquid on the heating surface” in Lines 22-24. Dependent Claims 3, 5-7, and 9-20 incorporate the indefinite subject matter from which they depend. Appropriate correction and clarification is required.
Specifically, Claim 1, Line 21 recites “a known evaporative area”; however, the breadth and scope of this limitation is unclear. What is the “known evaporative area” is it a location within the heating system or some other feature. Dependent Claims 3, 5-7, and 9-20 incorporate the indefinite subject matter from which they depend. In particular, Claim 12 positively recites the term “known evaporative area”. Appropriate correction and clarification is required.
Specifically, Claim 13 recites “the one or more liquid sensors are temperature sensors”; however, the breadth and scope of this limitation is unclear. In particular, Primary Examiner is unsure how a liquid sensor which has the former operational requirements of the independent claim, Claim 1, “to detect whether the heating surface is wetted in at least one region, wherein the one or more liquid sensors are located at, on, adjacent, or proximal the heating surface” can further become a “temperature sensor” as now claimed in Claim 13. The “liquid sensor” appears to necessitate some value of liquid, vapor, moisture, humidity to be calculated; whilst, a temperature sensor does not necessarily take into account the phase of state of the fluid being monitored only the temperature. Although clearly Applicant has support for the concept of “at least two liquid sensors may be two temperature sensors” (ORG Para 0012) and “one or more liquid sensors may be temperature sensors” (ORG Para 0014), the means and methods by which the wetting of a liquid sensor can be correlated to a temperature sensor appears to be unclear. Is Applicant attempting to state a correlation between the water temperature (perhaps ambient) of the liquid remote from the respiratory humidification system is the same /similar as the water temperature within respiratory humidification system? If so, how does that work when the respiratory humidification system has a heating element which is activated. The natural state of the activation of the heater would raise the temperature of the water within the respiratory humidification system in order to provide humidification. Is wetting only determined prior to activation of the heater? If so, what activates the “signal indicating an absence of liquid on the heating surface”? Dependent claim 14 incorporate the indefinite subject matter from which it depends. Appropriate correction and clarification is required.
Specifically, Claim 13, Line 2 recites “the one or more liquid sensors are temperature sensors”; however, this limitation appears be grammatically incorrect. It appears the recitation should be “the one or more liquid sensors are one or more temperature sensors”; OR ALTERNATIVELY, “the one or more liquid sensors includes at least one temperature sensor”. The latter recitation would bring clarity to dependent claim, Claim 14 – which recites “at least one temperature sensor”. Dependent claim 14 incorporates the indefinite subject matter from which it depends. Appropriate correction and clarification is required.
Specifically, Claim 14 recites “wherein at least one temperature sensor is utilized to determine a proportion of the heating surface that is saturated with a liquid”; however, the breadth and scope of this limitation is unclear. Primary Examiner is unsure if the “at least one temperature sensor” recited in Lines 1 and 2 is meant to refer back to the “one or more temperature sensors” of Claim 1, Lines 10-11; OR ALTERNATIVELY, to refer to the “temperature sensors” of Claim 13, Line 1. Appropriate correction and clarification is required.
Specifically, Claim 15, Line 2 recites “the one or more liquid sensors are resistive or capacitive sensors”; however, this limitation appears be grammatically incorrect. It appears the recitation should be “the one or more liquid sensors are one or more resistive or capacitive sensors”. Appropriate correction and clarification is required.
Specifically, Claim 21, Line 9 recites “water”; however, this limitation lacks antecedent basis in the claims. Although Claim 21, Line 3 recites “liquid”, Applicant has not positively correlated the term “liquid” to be commensurate with “water”. Consequently, Primary Examiner is unsure if the “liquid” of Line 3 is the same as the “water” of Line 9 or some other limitation. Appropriate correction and clarification is required.
Specifically, Claim 21 recites “one or more sensors located at, on, adjacent, or proximal the heating surface and configured to detect whether the heating surface is wetted in at least one region, wherein the one or more sensors comprise at least one temperature sensor, wherein the at least one temperature sensor is utilized to determine a proportion of the heating surface that is saturated with a liquid”; however, the breadth and scope of this limitation is unclear. Primary Examiner is unsure how a sensor concerned with some value of liquid, vapor, moisture, humidity to be calculated can be correlated to now utilize a temperature sensor. Even if Applicant were to state the temperature sensor includes some mathematical manipulation including the psychrometric charts, the concept of wet bulb temperature requires both air temperature and humidity – which are separate and distinct valuations. Is Applicant attempting to state a correlation between the water temperature (perhaps ambient) of the liquid remote from the respiratory humidification system is the same /similar as the water temperature within respiratory humidification system? If so, how does that work when the respiratory humidification system has a heating element which is activated. The natural state of the activation of the heater would raise the temperature of the water within the respiratory humidification system in order to provide humidification. Is wetting only determined prior to activation of the heater? If so, what activates the “signal indicating an absence of liquid on the heating surface”? Appropriate correction and clarification is required.
Specifically, Claim 21, Lines 26-28 recite “wherein the one or more hardware processors is configured to generate an alarm and reduce a heat output of the heating surface upon receiving a signal indicating an absence of liquid on the heating surface”; however, the breadth and scope of this limitation is unclear. Primary Examiner is unsure if Applicant is attempting to correlate the features of the “one or more sensors … configured to detect whether the heating surface is wetted in at least one region” in Claim 21, Lines 18-22 with the “a signal indicating an absence of liquid on the heating surface” in Lines 26-28. Appropriate correction and clarification is required.
Specifically, Claim 21, Line 17 recites “a known evaporative area”; however, the breadth and scope of this limitation is unclear. What is the “known evaporative area” is it a location within the heating system or some other feature. Appropriate correction and clarification is required.
Specifically, Claim 22, Line 9 recites “water”; however, this limitation lacks antecedent basis in the claims. Although Claim 22, Line 3 recites “liquid”, Applicant has not positively correlated the term “liquid” to be commensurate with “water”. Consequently, Primary Examiner is unsure if the “liquid” of Line 3 is the same as the “water” of Line 9 or some other limitation. Dependent Claims 23 and 24 incorporate the indefinite subject matter from which they depend. Appropriate correction and clarification is required.
Specifically, Claim 22, Lines 27-29 recite “wherein the one or more hardware processors is configured to generate an alarm and reduce a heat output of the heating surface upon receiving a signal indicating an absence of liquid on the heating surface”; however, the breadth and scope of this limitation is unclear. Primary Examiner is unsure if Applicant is attempting to correlate the features of the “one or more sensors … configured to detect whether the heating surface is wetted in at least one region” in Claim 22, Lines 18-23 with the “a signal indicating an absence of liquid on the heating surface” in Lines 27-29. Dependent Claims 23 and 24 incorporate the indefinite subject matter from which they depend. Appropriate correction and clarification is required.
Specifically, Claim 22, Lines 17 and 22-23 recite “a known evaporative area”; however, the breadth and scope of this limitation is unclear. What is the “known evaporative area” is it a location within the heating system or some other feature. Dependent Claims 23 and 24 incorporate the indefinite subject matter from which they depend. In particular, Claim 23 positively recites the term “known evaporative area” in two instances. Appropriate correction and clarification is required.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 5, 6, and 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Miller (6,095,505) in view of Turnbull (5,769,071) and Drapeau et al. (4,682,010).
As to Claim 1, Miller discloses a respiratory humidification system (Figure 1) for providing heated and humidified respiratory gases to a patient (via 15, “Referring now to FIG. 1, the elements of a humidifier of the present invention are shown connected to a breathing gas source (such as ventilator 12), a liquid water source 14, a patient's "Y" connector 15, and an exhalation passageway 16. Patient's "Y" connector 15 provides a passageway to the mouth or airway of the patient using a suitable mask (not shown) or other adapter.” Column 2, Lines 55-70), the respiratory humidification system (Figure 1) comprising: a liquid flow controller (46, “Flow controller 20 is preferably a fixed displacement, metering pump 46 operably associated with a time-proportioning pump controller 48. … Metering pump 46 has a fixed, precise delivery rate. By incorporating a timer function, time proportioning controller 48 serves to turn metering pump 46 on for a fixed time period, and thereby control the amount of liquid water delivered to evaporation module 18. Controller 48 accepts a time proportion setpoint, which represents the fraction of a given time period (e.g. about 1 hour) that the pump is turned on.” Column 3, Lines 20-40) providing a controlled flow of liquid (14, “a liquid water source 14” Column 2, Lines 55-70); a heating system (18, “The humidifier comprises an evaporation module 18, a flow controller 20, and a temperature controller 22. Evaporation module 18 includes a contact chamber 24 defined by a rigid housing 26 and in part by a flash-resistant heat exchanger 28. A wicking layer 30 is positioned in contact with heat exchanger 28, and serves to receive and distribute liquid water entering contact chamber 24. An electric resistive heater 31 is provided for heat exchanger 28 so as to evaporate liquid water arriving in contract chamber 24 from liquid water source 14.” Column 2, Line 60 thru Column 3, Line 10) including a heating surface (28, “heat exchanger 28” Column 2, Line 60 thru Column 3, Line 10) configured to receive the controlled flow of liquid (via 36, “Rigid housing 26 also includes a water inlet 36 for receiving water from water source 14 through a liquid water flow passageway 42.” Column 3, Lines 5-20) and provide humidification gases (via 32, “Gas inlet 32 connects to ventilator 12 via a passageway 38, and breathing gas outlet 34 connects to patient's "Y" connector 15, via an inhalation passageway 40.” Column 3, Lines 5-20) passing through the respiratory humidification system (Figure 1), the heating surface (28) comprising a wicking element (30, “A wicking layer 30 is positioned in contact with heat exchanger 28, and serves to receive and distribute liquid water entering contact chamber 24.” Column 2, Line 60 thru Column 3, Line 10; also see: “Wicking layer 30 is made of an absorptive material, preferably a cotton pad. Other materials, synthetic as well as natural, that facilitate the distribution of liquid water over a surface are also appropriate. The wicking layer need not be made of just one material.” Column 5, Lines 1-10) configured to receive and distribute the liquid (via 36) in a layer on or through the wicking element (30), the heating surface (28) further comprising a heating element (31, “An electric resistive heater 31 is provided for heat exchanger 28 so as to evaporate liquid water arriving in contract chamber 24 from liquid water source 14.” Column 2, Line 60 thru Column 3, Line 10; also see: “The power level for heater 31 and the rate of liquid water flow to evaporation module 18 are set by breathing gas temperature controller 22.” Column 5, Lines 10-20) configured to provide heat to the wicking element (30) to vaporize liquid (via 36) on or in the wicking element (30); one or more temperature sensors (54, “As shown in FIG. 1, temperature controller 22 is optionally configured to accept a signal from a temperature sensor 54 in heater 31.” Column 4, Lines 5-15) measuring a surface temperature of the heating surface (28); one or more liquid sensors (50, “Temperature controller 22 is operably connected to flow controller 20, heater 31, and a temperature sensor 50, which is positioned in inhalation passageway 40. Given a user selectable setpoint for breathing gas temperature, controller 22 adjusts both the power to heater 31 and the setpoint of flow controller 20 in response to changes in breathing gas temperature at sensor 50.” Column 3, Lines 55-70; also see: “When the temperature of the breathing gas drops, as measured by sensor 50, breathing gas temperature controller 22 responds by increasing both the heating power for evaporation module 18 and the flow rate setpoint for time-proportioning controller 48.” Column 5, Lines 15-25), wherein the one or more liquid sensors (50) are located at, on, adjacent, or proximal the heating surface (28); one or more hardware processors (22, “The humidifier comprises an evaporation module 18, a flow controller 20, and a temperature controller 22.” Column 2, Line 60 thru Column 3, Line 10; also see: “Flow controller 20 is part of the control cascade that includes breathing gas temperature controller 22. Temperature controller 22 can also be characterized as a system control module. Temperature controller 22 is operably connected to flow controller 20, heater 31, and a temperature sensor 50, which is positioned in inhalation passageway 40. Given a user selectable setpoint for breathing gas temperature, controller 22 adjusts both the power to heater 31 and the setpoint of flow controller 20 in response to changes in breathing gas temperature at sensor 50.” Column 3, Lines 55-70; “As denoted in FIG. 1 by a dashed-line box 52, the controller elements of the present invention are preferably combined into a convenient single module. In this arrangement, the circuitry elements of time proportioning controller 48 and temperature controller 22 may share a power source as well as other required components. As shown in FIG. 1, temperature controller 22 is optionally configured to accept a signal from a temperature sensor 54 in heater 31. Temperature controller 22 uses the temperature of heater 31 as a safety constraint that limits heating power when the heater temperature exceeds a set high limit.” Column 4, Lines 1-15; “The power level for heater 31 and the rate of liquid water flow to evaporation module 18 are set by breathing gas temperature controller 22. When the temperature of the breathing gas drops, as measured by sensor 50, breathing gas temperature controller 22 responds by increasing both the heating power for evaporation module 18 and the flow rate setpoint for time-proportioning controller 48.” Column 5, Lines 10-25) providing deterministic control of a humidity level of gases (“A humidifier embodying the features of the present invention provides efficient, cost-effective temperature and humidity control of breathing gas for inhalation therapy.” Column 2, Lines 50-60; “These requirements include operating targets for breathing gas in the ranges of 30.degree. C. to 37.degree. C. and 65 to 95 percent relative humidity.” Column 5, Lines 20-35) passing through the respiratory humidification system (Figure 1) by instructing the liquid flow controller (46) to adjust the controlled flow of liquid (via 36) received at the heating surface (28) by controlling the heating element (31), wherein adjusting the surface temperature of the heating surface (28) based at least in part on an output of the one or more liquid sensors (50) and instructing the heating system (18) to adjust the surface temperature of the heating surface (28) by controlling the heating element (31), wherein adjusting the surface temperature of the heating surface (28) provides control to produce a known evaporative area (24, “Evaporation module 18 includes a contact chamber 24 defined by a rigid housing 26 and in part by a flash-resistant heat exchanger 28. A wicking layer 30 is positioned in contact with heat exchanger 28, and serves to receive and distribute liquid water entering contact chamber 24. An electric resistive heater 31 is provided for heat exchanger 28 so as to evaporate liquid water arriving in contract chamber 24 from liquid water source 14.” Column 2, Line 60 thru Column 3, Line 10).
Yet, Miller does not expressly disclose the construction of the “one or more liquid sensors configured to detect whether the heating surface is wetted in at least one region” nor the configuration whereby “the one or more hardware processors is configured to generate an alarm and reduce a heat output of the heating surface upon receiving a signal indicating an absence of liquid on the heating surface.”
With respect to the construction of the “one or more liquid sensors configured to detect whether the heating surface is wetted in at least one region”, Turnbull teaches a similar respiratory humidification system (Figure 1) for providing heated and humidified respiratory gases to a patient (via 1, “The system comprises a tracheal tube 1, or other breathing device, connected to humidifier apparatus 2 controlled by a humidity sensor 3. The system is connected to ventilator apparatus 4.” Column 1, Lines 55-70), the respiratory humidification system comprising: a liquid flow controller (30, “The tubing 28 passes through a peristaltic pump 30 contained within the same housing 31 as the control unit 20. The control unit 20 controls the speed of the pump 30 and also provides power output to the heater 25 via a lead 32.” Column 2, Lines 5-25; also see: “A fall in humidity causes the control unit 20 to increase the speed of the peristaltic pump 30 so as to increase the flow of water to the HME device 22; it may also increase the temperature of the heater 25 to increase the rate of evaporation from the wick 26.” Column 2, Lines 35-50), a heating system (22, “The flexible tubing 16 extends to a heat and moisture exchange (HME) device 22 forming a part of the humidifier apparatus 2.” Column 2, Lines 5-25) with a wicking element (26, “On the patient side of the exchange element 24, within the housing 23, there is an electrical heater 25 covered by an absorbent wick 26. A water inlet 27 is located close to the wick 26 and is connected via tubing 28 to a water reservoir in the form of a suspended bag 29 of sterile water. … The heat and moisture of the inhaled gas, after passing through the exchange element 24 is supplemented by heat from the heater 25 and moisture evaporated from the wick 26. … A fall in humidity causes the control unit 20 to increase the speed of the peristaltic pump 30 so as to increase the flow of water to the HME device 22; it may also increase the temperature of the heater 25 to increase the rate of evaporation from the wick 26.” Column 2, Lines 5-50) and heating element (25, “On the patient side of the exchange element 24, within the housing 23, there is an electrical heater 25 covered by an absorbent wick 26. A water inlet 27 is located close to the wick 26 and is connected via tubing 28 to a water reservoir in the form of a suspended bag 29 of sterile water. … The heat and moisture of the inhaled gas, after passing through the exchange element 24 is supplemented by heat from the heater 25 and moisture evaporated from the wick 26. … A fall in humidity causes the control unit 20 to increase the speed of the peristaltic pump 30 so as to increase the flow of water to the HME device 22; it may also increase the temperature of the heater 25 to increase the rate of evaporation from the wick 26.” Column 2, Lines 5-50); a sensor (3, “The system comprises a tracheal tube 1, or other breathing device, connected to humidifier apparatus 2 controlled by a humidity sensor 3. … The connector 15 includes a humidity sensor 3 exposed to gas flowing along the interior of the connector and hence along the tube. A wire 11 extends from the sensor 3 and is connected via a coupling 13 to a cable 14 extending to a control unit 20 of the humidifier apparatus 2. The sensor 3 could be mounted at various other locations such as, in the tube 1 itself, for example at its patient end, or in flexible tubing 16 connected to the connector 15.” Column 1, Line 55 thru Column 2, Line 10; “Any such change in humidity is sensed by the sensor 3 and signalled to the control unit 20. A fall in humidity causes the control unit 20 to increase the speed of the peristaltic pump 30 so as to increase the flow of water to the HME device 22; it may also increase the temperature of the heater 25 to increase the rate of evaporation from the wick 26.” Column 2, Lines 35-50); and one or more processors (20, “ A wire 11 extends from the sensor 3 and is connected via a coupling 13 to a cable 14 extending to a control unit 20 of the humidifier apparatus 2.” Column 1, Line 60 thru Column 2, Line 10; “The tubing 28 passes through a peristaltic pump 30 contained within the same housing 31 as the control unit 20. The control unit 20 controls the speed of the pump 30 and also provides power output to the heater 25 via a lead 32. Various displays may be provided on the housing 31, such as a display 33 of humidity, as sensed by the sensor 3.” Column 2, Lines 5-25; and “Any such change in humidity is sensed by the sensor 3 and signalled to the control unit 20. A fall in humidity causes the control unit 20 to increase the speed of the peristaltic pump 30 so as to increase the flow of water to the HME device 22; it may also increase the temperature of the heater 25 to increase the rate of evaporation from the wick 26.” Column 2, Lines 35-50) providing deterministic control of a humidity level of the gases passing through the respiratory humidification system (Figure 1) by instructing the liquid flow controller (30) to adjust the controlled flow of liquid received at the heating system (22) based on at least in part an output of the one or more sensor (3) and instructing the heating system (22) to adjust temperature by controlling the heating element (25) to produce a known evaporative area (lumen of 22).
Regarding the construction of the “one or more liquid sensors configured to detect whether the heating surface is wetted in at least one region”, Turnbull teaches the one or more liquid sensor (3, “The system comprises a tracheal tube 1, or other breathing device, connected to humidifier apparatus 2 controlled by a humidity sensor 3. … The connector 15 includes a humidity sensor 3 exposed to gas flowing along the interior of the connector and hence along the tube. A wire 11 extends from the sensor 3 and is connected via a coupling 13 to a cable 14 extending to a control unit 20 of the humidifier apparatus 2. The sensor 3 could be mounted at various other locations such as, in the tube 1 itself, for example at its patient end, or in flexible tubing 16 connected to the connector 15.” Column 1, Line 55 thru Column 2, Line 10; “Any such change in humidity is sensed by the sensor 3 and signalled to the control unit 20. A fall in humidity causes the control unit 20 to increase the speed of the peristaltic pump 30 so as to increase the flow of water to the HME device 22; it may also increase the temperature of the heater 25 to increase the rate of evaporation from the wick 26.” Column 2, Lines 35-50) is configured to detect whether the heating surface is wetted in at least one region.
The nature of the liquid sensor (3) of Turnbull being a humidity sensor enables the ability to determine whether there is wetting within the heating system, as the lack of humidity correlates to a lack of water vapor and the presence of humidity correlates to sufficient water vapor formation. Thus, the modification of the liquid sensor (50) of Miller to the liquid sensor (3) of Turnbull results in the configuration whereby the liquid sensor can “detect whether the heating surface is wetted in at least one region” through the presence or absence of sufficient water vapor formation.
With respect to the configuration whereby “the one or more hardware processors is configured to generate an alarm and reduce a heat output of the heating surface upon receiving a signal indicating an absence of liquid on the heating surface”, Drapeau teaches a respiratory humidification system (Figure 1) for providing heated and humidified respiratory gases to a patient (via 20, “The humidified gas stream is then heated as may be required in heater 10, and it then flows from exit 20 of the heater through the remainder of air line 12 to a patient.” Column 3, Lines 15-35; “The aerosol mixture then leaves the heater under low pressure at exit end 20 for delivery to the patient.” Column 5, Lines 1-15), the respiratory humidification system (Figure 1) comprising: a liquid flow controller (14a via 16, “A pressurized oxygen stream 14(a) is directed at the outlet from a water bottle 16.” Column 3, Lines 15-35) providing a controlled flow of liquid; a heating system (10, “Referring to FIG. 1, an electric heater 10 is located in and forms part of an air line 12.” Column 3, Lines 15-35), one or more temperature sensors (23/24, “Temperature sensors 23 and 24 may be, inexpensive and disposable sensors, such as thermocouples for the disposable in-line heater, as disclosed in more detail with regard to FIG. 9.” Column 3, Line 50 thru Column 4, Line 10) measuring the surface temperature of the heating system (10); one or more liquid sensors (22/25, wherein 22 – “Temperature sensor 22 senses the outlet temperature of the aerosol from bottle 16” Column 3, Lines 30-50; and wherein 25 – “ Similarly, temperature limit sensor 25 is also a safety device which will, if the temperature of bottle 16 exceeds design maximum, shut the system down.” Column 3, Line 50 thru Column 4, Line 10) located at, on, adjacent, or proximal the heating system (10); one or more hardware processors (26, “Temperature sensors 22 and 24 are connected to control unit 26 which, in response to the temperature differential between sensors 24 and 22 will control the power to vary the output of heater 10 and the ouput of heat for the water bottle to provide the proper aerosol temperature, moisture content and droplet size jointly or aerosol temperature separately.” Column 3, Lines 30-50; also see: “These temperature signals are fed to control unit 26 where they are used to control the power supplied to mesh heating element 36 to control aerosol temperature, moisture content and droplet size, as will be more fully explained hereinafter.” Column 5, Lines 1-15).
Regarding the construction of “the one or more hardware processors is configured to generate an alarm and reduce a heat output of the heating surface upon receiving a signal indicating an absence of liquid on the heating surface”, Drapeau teaches the one or more hardware processor (26) is configured to generate an alarm (“If a "low" signal is generated at water level unit 116, a shutdown signal will be delivered to system shutdown unit 106 which will, in turn, disconnect output power 128 until the water level in the bottle is returned to an acceptable level and activate the audio and visual alarm.” Column 9, Lines 10-35) and reduce a heat output (via 128, “disconnect output power 128” Column 9, Lines 10-35) of the heating surface upon receiving a signal indicating an absence of liquid on the heating surface.
The nature of the operation of the detection of the water within the humidification system and in response to the absence of water to produce an alarm and reduce heat output of the heating system as taught by Drapeau provides a failsafe to prevent failures to provide humidity by the respiratory humidification system. Thus, the modification of Miller with the teachings of Drapeau prevents in improper humidification to the patient by notification and corrective actions
Therefore, it would have been obvious to one having ordinary skill in the art to modify the one or more liquid sensor of Miller to be configured to detect whether the heating surface is wetted in at least one region, as taught by Turnbull to monitor the humidity generation of the respiratory humidification system and to modify the one or more hardware processors to include an alarm and reduce heat output, as taught by Drapeau to notify the user of improper humidification of gases to the patient.
As to Claim 5, the modified Miller, specifically Miller discloses the liquid flow controller (46) comprises a metering system.
As to Claim 6, the modified Miller, specifically Miller discloses the liquid flow controller (46) is a pump in an open loop configuration.
As to Claim 11, the modified Miller, specifically Miller discloses the one or more liquid sensors (50) are used by the one or more hardware processors (22) to adjust the deterministic control of the humidity level of gases (“A humidifier embodying the features of the present invention provides efficient, cost-effective temperature and humidity control of breathing gas for inhalation therapy.” Column 2, Lines 50-60; “These requirements include operating targets for breathing gas in the ranges of 30.degree. C. to 37.degree. C. and 65 to 95 percent relative humidity.” Column 5, Lines 20-35) passing through the respiratory humidification system (Figure 1).
As to Claim 12, the modified Miller, specifically Miller discloses the one or more liquid sensors (50) are used by the one or more hardware processors (22) to adjust the known evaporative area (24) of the heating surface (28).
As to Claim 13, the modified Miller, specifically Miller discloses the one or more liquid sensors (50) are temperature sensors.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Miller (6,095,505) in view of Turnbull (5,769,071) and Drapeau et al. (4,682,010), as applied to Claim 1, and further in view of Arcilla et al. (US PGPub 2013/0263851).
As to Claim 7, the modified Miller, specifically Miller discloses the liquid flow controller (46) is a pump; yet, does not expressly disclose the configuration of the “pump or flow actuator in series with a flow sensor in a closed loop configuration”.
Arcilla teaches an analogous respiratory humidification system (abstract) wherein the liquid flow controller (Fig. 1, 115) is a pump or flow actuator (paragraph 28, lines 1-6) in series with a flow sensor (Fig. 1, 113) in a closed loop configuration (see paragraph 35, lines 1-6 and paragraph 36, lines 1-2; data is received from sensor 113 to provide feedback to the controller to adjust the flow via valve 115).
Therefore, it would have been obvious to one skilled in the art, before the time of the effective filing date of the invention, to modify the liquid flow controller of the modified Miller to be in a closed loop configuration, as taught by Arcilla, in order to accurately measure and adjust the flow of liquid for the desired humidity.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Miller (6,095,505) in view of Turnbull (5,769,071) and Drapeau et al. (4,682,010), as applied to Claim 1, and further in view of Falb et al. (US 5,243,973).
As to Claim 15, the modified Miller, specifically Miller discloses the one or more liquid sensors (50) yet, does not expressly disclose the configuration of the “one or more liquid sensors are resistive or capacitive sensors”.
Falb teaches an analogous humidification system (abstract and Fig. 1) wherein the one or more sensors configured to detect whether the heating surface is wetted (Fig. 1, 8, 14, 15) are capacitive sensors (see col. 4, lines 25-30, the sensors capacitive signal changes when covered with liquid, indicating wetness on the surface). 37.
Therefore, it would have been obvious to one skilled in the art, before the time of the effective filing date of the invention, to modify the sensors of the modified Miller to be capacitive sensors, as taught by Falb, for the purpose of using a known type of sensor that allows determination of both water presence.
Claims 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Miller (6,095,505) in view of Turnbull (5,769,071) and Drapeau et al. (4,682,010), as applied to Claim 1, and further in view of Tang et al. (US PGPub 2014/0131904) and Rosman et al. (US 4523638)..
As to Claim 16, the modified Miller, specifically Miller discloses the heating system (18); yet, does not expressly disclose “a printed circuit board (PCB) or etched foil over-molded with a surface comprising micro-channels to form the heating surface.”
Regarding the use of “a printed circuit board (PCB) or etched foil over-molded with a surface”, Tang teaches an analogous respiratory humidification system (see abstract) wherein the heating system comprises a printed circuit board (PCB) over-molded with a surface (see paragraph 14) as known heating assembly used in humidifiers (see paragraph 9).
Regarding the use of “micro-channels to form the heating surface”, Rosman teaches a plate used for heat-exchange (see abstract) wherein the surface of the plate comprises micro-channels (see Figs. 8a,9 10b, showing plates with channels, see col. 7, lines 10-20; it is noted "micro-channel" doesn't have a specified size and the plate of Rosman is in the same scale as the plate of the instant application and thus the channels are in the same range of size) as a known method to increase the surface area for enhancement of heat transfer (see col. 2, lines 37-62 of Rosman).
Therefore, it would have been obvious to one skilled in the art, before the time of the effective filing date of the invention, to modify the surface of the heating assembly of the modified Miller to include a “a printed circuit board (PCB)” as taught by Tang to be a known heating assembly in humidifiers, and further to modify the modified Miller include “micro-channels” on the heating surface, as taught by Rosman, for the purpose of increasing the surface area for enhancement of heat transfer.
As to Claim 17, the modified Miller, specifically Rosman teaches the use of “micro-channels”. As shown in Figures Rosman Figs. 8a, 9a, 10b, each channel extends in only a single direction. Thus, meeting the claimed configuration of the surface having micro-channels that extends in only a single direction.
As to Claim 18, the modified Miller, specifically Rosman teaches the use of “micro-channels”. As shown in Figure 6c, distribution channels 83 and main channels 77, the channels being connected by intermediary surfaces (see col. 6, lines 38-45). Thus, meeting the claimed configuration of a first set of distribution channels connected to a second set of main channels.
As to Claim 19, the modified Miller, specifically Rosman teaches the use of “micro-channels”. As shown in Figures 6c and 6d, there are more main channels than distribution channels. Thus, meeting the claimed configuration of “a first set of distribution channels is less than a number of the second set of main channels.”.
As to Claim 20, the modified Miller, specifically Rosman teaches the use of “micro-channels”. As shown in Figures 9a and 10b, the micro-channels are distributed radially from a single point.
Claims 23 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Miller (6,095,505) in view of Turnbull (5,769,071) and Drapeau et al. (4,682,010), as applied to Claim 1, and further in view of Koch (US 6102037).
As to Claim 23, the modified Miller, specifically Miller discloses a size of the known evaporative area (24); yet, does not expressly disclose “a size of the known evaporative area varies in use such that the size of the known evaporative area comprises a first size at a first humidity level and a second size at a second humidity level.”
Koch teaches an analogous humidifier (abstract and fig. 1) wherein a size of the known evaporative area varies in use such that the size of the known evaporative area comprises a first size at a first humidity level and a second size at a second humidity level (see col. 7, lines 55-67, the amount of water needed for the humidification of the respiratory gas per unit of time is obtained through a thermodynamic equation. Using the equation, to achieve 100% relative humidity, 42.5 mg of water per L under normal pressure is needed. To achieve a relative humidity of 50%, 21.25 mg/L of water is needed. The evaporative area, or amount of water, varies based on the desired humidity level).
Therefore, it would have been obvious to one skilled in the art, before the time of the effective filing date of the invention, to modify the evaporative area of the modified Miller to have a first size at a first humidity level and a second size at a second humidity level, as taught by Koch because Koch teaches that thermodynamics equations teach this concept of varying the amount of water corresponds to different humidity levels.
As to Claim 24, the modified Miller, specifically Miller discloses a size of the heating surface (28); yet, does not expressly disclose “a size of the heating surface that is wetted varies in use such that the size of the heating surface that is wetted comprises a first size at a first humidity level and a second size at a second humidity level.”
Koch teaches an analogous humidifier (abstract and fig. 1) wherein a size of the known evaporative area varies in use such that the size of the known evaporative area comprises a first size at a first humidity level and a second size at a second humidity level (see col. 7, lines 55-67, the amount of water needed for the humidification of the respiratory gas per unit of time is obtained through a thermodynamic equation. Using the equation, to achieve 100% relative humidity, 42.5 mg of water per L under normal pressure is needed. To achieve a relative humidity of 50%, 21.25 mg/L of water is needed. The evaporative area, or amount of water, varies based on the desired humidity level).
Therefore, it would have been obvious to one skilled in the art, before the time of the effective filing date of the invention, to modify the evaporative area of the modified Miller to have a first size at a first humidity level and a second size at a second humidity level, as taught by Koch because Koch teaches that thermodynamics equations teach this concept of varying the amount of water corresponds to different humidity levels.
Claims 3, 10, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Miller (6,095,505) in view of Turnbull (5,769,071) and Drapeau et al. (4,682,010), as applied to Claim 1, and further in view of Korneff (US PGPub 20130081701).
As to Claim 10, the modified Miller, specifically Miller discloses the one or more liquid sensors (50); yet, does not expressly disclose the configuration of the “one or more liquid sensors to prevent overflow of liquid onto the heating surface”.
Korneff teaches an analogous respiration humidifier (see abstract) comprising one or more liquid sensors configured to detect whether the heating surface is wetted in at least one region (see paragraphs 77-78 and Fig, 4, sensors 410a and 410b; the surface of 402 becomes the heating surface as the water is within the container and the container is heated up to provide humidification, the sensors 410a and 410b determine if the surface is wetted in at least the region between them), wherein the one or more sensors are located at, on, adjacent, or proximal the heating surface (see Fig. 4 of Korneff, the sensors are located adjacent and proximal to the surface of 402. Surface 402 becomes heated during humidification [see paragraph 51]. Further, even if only bottom surface 406 is considered the heating surface, the sensors are adjacent or proximal the bottom surface. The terms "adjacent" and "proximal" mean "nextto" or "close to" and the sensors are located next to, or close to bottom surface 406. There is no degree of closeness claimed), one or more hardware processors (see Fig. 7, processors 706; see paragraph 105, the computing system shown is the same as the control module 420) providing deterministic control of a humidity level of gases passing through the respiratory humidification system (see paragraph 93 and 98-102 and fig. 5, the humidifier control module uses the water level calculations to measure the amount of humidified gas and controls the operation of the water level to achieve a desired humidification) by instructing the liquid flow controller to adjust the controlled flow of liquid received at the heating surface (see paragraphs 78-80, the water level control element 418 is a valve to control the flow of water to the heating surface, the controller adjusts the operation of the valve based on the water information) based at least in part on an output of the one or more liquidsensors (see paragraphs 78-80, control of the valve is based on information from liquid sensor 410). 8. Therefore, it would have been obvious to one skilled in the art, before the time of the effective filing date of the invention, to modify the system of Silver to have sensors to detect the presence of liquid located proximal and adjacent to the heating surface and to modify the controller of Silver to control the flow rate of the liquid based on the determined presence of liquid, as taught by Korneff, for the purpose of providing technology to automatically fill and maintain a desired water level on the heating surface to achieve humidification (see paragraphs 75-76 of Korneff).
Regarding the configuration of “one or more liquid sensors to prevent overflow of liquid onto the heating surface”, Korneff paragraph 79, the sensors are provided to prevent an excess amount of water in the system, an excess would be an overflow of liquid above the sensors, the liquid being on the heating surface.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the one or more liquid sensors of the modified Miller to include prevention of “overflow” as taught by Korneff, to be a known concern that would yield improper humidification of gases to the patient.
As to Claim 3, the modified Miller, specifically Miller discloses the one or more liquid sensors (50); yet, does not expressly disclose the configuration of the “one or more liquid sensors comprise at least two liquid sensors configured to detect whether the heating surface is wetted at two or more regions of the heating surface.”
Korneff teaches an analogous respiration humidifier (see abstract) comprising one or more liquid sensors configured to detect whether the heating surface is wetted in at least one region (see paragraphs 77-78 and Fig, 4, sensors 410a and 410b; the surface of 402 becomes the heating surface as the water is within the container and the container is heated up to provide humidification, the sensors 410a and 410b determine if the surface is wetted in at least the region between them), wherein the one or more sensors are located at, on, adjacent, or proximal the heating surface (see Fig. 4 of Korneff, the sensors are located adjacent and proximal to the surface of 402. Surface 402 becomes heated during humidification [see paragraph 51]. Further, even if only bottom surface 406 is considered the heating surface, the sensors are adjacent or proximal the bottom surface. The terms "adjacent" and "proximal" mean "nextto" or "close to" and the sensors are located next to, or close to bottom surface 406. There is no degree of closeness claimed), one or more hardware processors (see Fig. 7, processors 706; see paragraph 105, the computing system shown is the same as the control module 420) providing deterministic control of a humidity level of gases passing through the respiratory humidification system (see paragraph 93 and 98-102 and fig. 5, the humidifier control module uses the water level calculations to measure the amount of humidified gas and controls the operation of the water level to achieve a desired humidification) by instructing the liquid flow controller to adjust the controlled flow of liquid received at the heating surface (see paragraphs 78-80, the water level control element 418 is a valve to control the flow of water to the heating surface, the controller adjusts the operation of the valve based on the water information) based at least in part on an output of the one or more liquidsensors (see paragraphs 78-80, control of the valve is based on information from liquid sensor 410). 8. Therefore, it would have been obvious to one skilled in the art, before the time of the effective filing date of the invention, to modify the system of Silver to have sensors to detect the presence of liquid located proximal and adjacent to the heating surface and to modify the controller of Silver to control the flow rate of the liquid based on the determined presence of liquid, as taught by Korneff, for the purpose of providing technology to automatically fill and maintain a desired water level on the heating surface to achieve humidification (see paragraphs 75-76 of Korneff).
Regarding the configuration of the “one or more liquid sensors comprise at least two liquid sensors configured to detect whether the heating surface is wetted at two or more regions of the heating surface”, Figure 4 and Paragraph 0078 of Korneff teach the use of two sensors (410a and 410b) to detect distinct regions of the heating surface.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the one or more liquid sensors of the modified Miller to include at least two liquid sensors at distinct locations along the heated surface, as taught by Korneff, to provide in order to determine the wetness of the distinct regions of the heating surface.
As to Claim 22, Miller discloses a respiratory humidification system (Figure 1) for providing heated and humidified respiratory gases to a patient (via 15, “Referring now to FIG. 1, the elements of a humidifier of the present invention are shown connected to a breathing gas source (such as ventilator 12), a liquid water source 14, a patient's "Y" connector 15, and an exhalation passageway 16. Patient's "Y" connector 15 provides a passageway to the mouth or airway of the patient using a suitable mask (not shown) or other adapter.” Column 2, Lines 55-70), the respiratory humidification system (Figure 1) comprising: a liquid flow controller (46, “Flow controller 20 is preferably a fixed displacement, metering pump 46 operably associated with a time-proportioning pump controller 48. … Metering pump 46 has a fixed, precise delivery rate. By incorporating a timer function, time proportioning controller 48 serves to turn metering pump 46 on for a fixed time period, and thereby control the amount of liquid water delivered to evaporation module 18. Controller 48 accepts a time proportion setpoint, which represents the fraction of a given time period (e.g. about 1 hour) that the pump is turned on.” Column 3, Lines 20-40) providing a controlled flow of liquid (14, “a liquid water source 14” Column 2, Lines 55-70); a heating system (18, “The humidifier comprises an evaporation module 18, a flow controller 20, and a temperature controller 22. Evaporation module 18 includes a contact chamber 24 defined by a rigid housing 26 and in part by a flash-resistant heat exchanger 28. A wicking layer 30 is positioned in contact with heat exchanger 28, and serves to receive and distribute liquid water entering contact chamber 24. An electric resistive heater 31 is provided for heat exchanger 28 so as to evaporate liquid water arriving in contract chamber 24 from liquid water source 14.” Column 2, Line 60 thru Column 3, Line 10) including a heating surface (28, “heat exchanger 28” Column 2, Line 60 thru Column 3, Line 10) configured to receive the controlled flow of liquid (via 36, “Rigid housing 26 also includes a water inlet 36 for receiving water from water source 14 through a liquid water flow passageway 42.” Column 3, Lines 5-20) and provide humidification gases (via 32, “Gas inlet 32 connects to ventilator 12 via a passageway 38, and breathing gas outlet 34 connects to patient's "Y" connector 15, via an inhalation passageway 40.” Column 3, Lines 5-20) passing through the respiratory humidification system (Figure 1), the heating surface (28) comprising a wicking element (30, “A wicking layer 30 is positioned in contact with heat exchanger 28, and serves to receive and distribute liquid water entering contact chamber 24.” Column 2, Line 60 thru Column 3, Line 10; also see: “Wicking layer 30 is made of an absorptive material, preferably a cotton pad. Other materials, synthetic as well as natural, that facilitate the distribution of liquid water over a surface are also appropriate. The wicking layer need not be made of just one material.” Column 5, Lines 1-10) configured to receive and distribute the liquid (via 36) in a layer on or through the wicking element (30), the heating surface (28) further comprising a heating element (31, “An electric resistive heater 31 is provided for heat exchanger 28 so as to evaporate liquid water arriving in contract chamber 24 from liquid water source 14.” Column 2, Line 60 thru Column 3, Line 10; also see: “The power level for heater 31 and the rate of liquid water flow to evaporation module 18 are set by breathing gas temperature controller 22.” Column 5, Lines 10-20) configured to provide heat to the wicking element (30) to vaporize liquid (via 36) on or in the wicking element (30); one or more temperature sensors (54, “As shown in FIG. 1, temperature controller 22 is optionally configured to accept a signal from a temperature sensor 54 in heater 31.” Column 4, Lines 5-15) measuring a surface temperature of the heating surface (28); one or more hardware processors (22, “The humidifier comprises an evaporation module 18, a flow controller 20, and a temperature controller 22.” Column 2, Line 60 thru Column 3, Line 10; also see: “Flow controller 20 is part of the control cascade that includes breathing gas temperature controller 22. Temperature controller 22 can also be characterized as a system control module. Temperature controller 22 is operably connected to flow controller 20, heater 31, and a temperature sensor 50, which is positioned in inhalation passageway 40. Given a user selectable setpoint for breathing gas temperature, controller 22 adjusts both the power to heater 31 and the setpoint of flow controller 20 in response to changes in breathing gas temperature at sensor 50.” Column 3, Lines 55-70; “As denoted in FIG. 1 by a dashed-line box 52, the controller elements of the present invention are preferably combined into a convenient single module. In this arrangement, the circuitry elements of time proportioning controller 48 and temperature controller 22 may share a power source as well as other required components. As shown in FIG. 1, temperature controller 22 is optionally configured to accept a signal from a temperature sensor 54 in heater 31. Temperature controller 22 uses the temperature of heater 31 as a safety constraint that limits heating power when the heater temperature exceeds a set high limit.” Column 4, Lines 1-15; “The power level for heater 31 and the rate of liquid water flow to evaporation module 18 are set by breathing gas temperature controller 22. When the temperature of the breathing gas drops, as measured by sensor 50, breathing gas temperature controller 22 responds by increasing both the heating power for evaporation module 18 and the flow rate setpoint for time-proportioning controller 48.” Column 5, Lines 10-25) providing deterministic control of a humidity level of gases (“A humidifier embodying the features of the present invention provides efficient, cost-effective temperature and humidity control of breathing gas for inhalation therapy.” Column 2, Lines 50-60; “These requirements include operating targets for breathing gas in the ranges of 30.degree. C. to 37.degree. C. and 65 to 95 percent relative humidity.” Column 5, Lines 20-35) passing through the respiratory humidification system (Figure 1) by instructing the liquid flow controller (46) to adjust the controlled flow of liquid (via 36) received at the heating system (18) and instructing the heating system (18) to adjust the surface temperature of the heating surface (28) by controlling the heating element (31), wherein adjusting the surface temperature of the heating surface (28) provides control to produce a known evaporative area (24, “Evaporation module 18 includes a contact chamber 24 defined by a rigid housing 26 and in part by a flash-resistant heat exchanger 28. A wicking layer 30 is positioned in contact with heat exchanger 28, and serves to receive and distribute liquid water entering contact chamber 24. An electric resistive heater 31 is provided for heat exchanger 28 so as to evaporate liquid water arriving in contract chamber 24 from liquid water source 14.” Column 2, Line 60 thru Column 3, Line 10); and one or more sensors (50, “Temperature controller 22 is operably connected to flow controller 20, heater 31, and a temperature sensor 50, which is positioned in inhalation passageway 40. Given a user selectable setpoint for breathing gas temperature, controller 22 adjusts both the power to heater 31 and the setpoint of flow controller 20 in response to changes in breathing gas temperature at sensor 50.” Column 3, Lines 55-70; also see: “When the temperature of the breathing gas drops, as measured by sensor 50, breathing gas temperature controller 22 responds by increasing both the heating power for evaporation module 18 and the flow rate setpoint for time-proportioning controller 48.” Column 5, Lines 15-25) located at, on, adjacent, or proximal the heating surface (28), wherein instructing the liquid flow controller (46) to adjust the controlled flow of liquid received at the heating system (18) is based at least in part on an output of the one or more sensors (50).
Yet, Miller does not expressly disclose the construction of the “one or more sensors configured to detect whether the heating surface is wetted in at least one region”, nor the configuration whereby “the one or more hardware processors is configured to generate an alarm and reduce a heat output of the heating surface upon receiving a signal indicating an absence of liquid on the heating surface” nor the one or more sensors in the form of “at least two liquid sensors configured to detect whether the heating surface is wetted at two or more regions of the heating surface”.
With respect to the construction of the “one or more liquid sensors configured to detect whether the heating surface is wetted in at least one region”, Turnbull teaches a similar respiratory humidification system (Figure 1) for providing heated and humidified respiratory gases to a patient (via 1, “The system comprises a tracheal tube 1, or other breathing device, connected to humidifier apparatus 2 controlled by a humidity sensor 3. The system is connected to ventilator apparatus 4.” Column 1, Lines 55-70), the respiratory humidification system comprising: a liquid flow controller (30, “The tubing 28 passes through a peristaltic pump 30 contained within the same housing 31 as the control unit 20. The control unit 20 controls the speed of the pump 30 and also provides power output to the heater 25 via a lead 32.” Column 2, Lines 5-25; also see: “A fall in humidity causes the control unit 20 to increase the speed of the peristaltic pump 30 so as to increase the flow of water to the HME device 22; it may also increase the temperature of the heater 25 to increase the rate of evaporation from the wick 26.” Column 2, Lines 35-50), a heating system (22, “The flexible tubing 16 extends to a heat and moisture exchange (HME) device 22 forming a part of the humidifier apparatus 2.” Column 2, Lines 5-25) with a wicking element (26, “On the patient side of the exchange element 24, within the housing 23, there is an electrical heater 25 covered by an absorbent wick 26. A water inlet 27 is located close to the wick 26 and is connected via tubing 28 to a water reservoir in the form of a suspended bag 29 of sterile water. … The heat and moisture of the inhaled gas, after passing through the exchange element 24 is supplemented by heat from the heater 25 and moisture evaporated from the wick 26. … A fall in humidity causes the control unit 20 to increase the speed of the peristaltic pump 30 so as to increase the flow of water to the HME device 22; it may also increase the temperature of the heater 25 to increase the rate of evaporation from the wick 26.” Column 2, Lines 5-50) and heating element (25, “On the patient side of the exchange element 24, within the housing 23, there is an electrical heater 25 covered by an absorbent wick 26. A water inlet 27 is located close to the wick 26 and is connected via tubing 28 to a water reservoir in the form of a suspended bag 29 of sterile water. … The heat and moisture of the inhaled gas, after passing through the exchange element 24 is supplemented by heat from the heater 25 and moisture evaporated from the wick 26. … A fall in humidity causes the control unit 20 to increase the speed of the peristaltic pump 30 so as to increase the flow of water to the HME device 22; it may also increase the temperature of the heater 25 to increase the rate of evaporation from the wick 26.” Column 2, Lines 5-50); a sensor (3, “The system comprises a tracheal tube 1, or other breathing device, connected to humidifier apparatus 2 controlled by a humidity sensor 3. … The connector 15 includes a humidity sensor 3 exposed to gas flowing along the interior of the connector and hence along the tube. A wire 11 extends from the sensor 3 and is connected via a coupling 13 to a cable 14 extending to a control unit 20 of the humidifier apparatus 2. The sensor 3 could be mounted at various other locations such as, in the tube 1 itself, for example at its patient end, or in flexible tubing 16 connected to the connector 15.” Column 1, Line 55 thru Column 2, Line 10; “Any such change in humidity is sensed by the sensor 3 and signalled to the control unit 20. A fall in humidity causes the control unit 20 to increase the speed of the peristaltic pump 30 so as to increase the flow of water to the HME device 22; it may also increase the temperature of the heater 25 to increase the rate of evaporation from the wick 26.” Column 2, Lines 35-50); and one or more processors (20, “ A wire 11 extends from the sensor 3 and is connected via a coupling 13 to a cable 14 extending to a control unit 20 of the humidifier apparatus 2.” Column 1, Line 60 thru Column 2, Line 10; “The tubing 28 passes through a peristaltic pump 30 contained within the same housing 31 as the control unit 20. The control unit 20 controls the speed of the pump 30 and also provides power output to the heater 25 via a lead 32. Various displays may be provided on the housing 31, such as a display 33 of humidity, as sensed by the sensor 3.” Column 2, Lines 5-25; and “Any such change in humidity is sensed by the sensor 3 and signalled to the control unit 20. A fall in humidity causes the control unit 20 to increase the speed of the peristaltic pump 30 so as to increase the flow of water to the HME device 22; it may also increase the temperature of the heater 25 to increase the rate of evaporation from the wick 26.” Column 2, Lines 35-50) providing deterministic control of a humidity level of the gases passing through the respiratory humidification system (Figure 1) by instructing the liquid flow controller (30) to adjust the controlled flow of liquid received at the heating system (22) based on at least in part an output of the one or more sensor (3) and instructing the heating system (22) to adjust temperature by controlling the heating element (25) to produce a known evaporative area (lumen of 22).
Regarding the construction of the “one or more liquid sensors configured to detect whether the heating surface is wetted in at least one region”, Turnbull teaches the one or more liquid sensor (3, “The system comprises a tracheal tube 1, or other breathing device, connected to humidifier apparatus 2 controlled by a humidity sensor 3. … The connector 15 includes a humidity sensor 3 exposed to gas flowing along the interior of the connector and hence along the tube. A wire 11 extends from the sensor 3 and is connected via a coupling 13 to a cable 14 extending to a control unit 20 of the humidifier apparatus 2. The sensor 3 could be mounted at various other locations such as, in the tube 1 itself, for example at its patient end, or in flexible tubing 16 connected to the connector 15.” Column 1, Line 55 thru Column 2, Line 10; “Any such change in humidity is sensed by the sensor 3 and signalled to the control unit 20. A fall in humidity causes the control unit 20 to increase the speed of the peristaltic pump 30 so as to increase the flow of water to the HME device 22; it may also increase the temperature of the heater 25 to increase the rate of evaporation from the wick 26.” Column 2, Lines 35-50) is configured to detect whether the heating surface is wetted in at least one region.
The nature of the liquid sensor (3) of Turnbull being a humidity sensor enables the ability to determine whether there is wetting within the heating system, as the lack of humidity correlates to a lack of water vapor and the presence of humidity correlates to sufficient water vapor formation. Thus, the modification of the liquid sensor (50) of Miller to the liquid sensor (3) of Turnbull results in the configuration whereby the liquid sensor can “detect whether the heating surface is wetted in at least one region” through the presence or absence of sufficient water vapor formation.
With respect to the configuration whereby “the one or more hardware processors is configured to generate an alarm and reduce a heat output of the heating surface upon receiving a signal indicating an absence of liquid on the heating surface”, Drapeau teaches a respiratory humidification system (Figure 1) for providing heated and humidified respiratory gases to a patient (via 20, “The humidified gas stream is then heated as may be required in heater 10, and it then flows from exit 20 of the heater through the remainder of air line 12 to a patient.” Column 3, Lines 15-35; “The aerosol mixture then leaves the heater under low pressure at exit end 20 for delivery to the patient.” Column 5, Lines 1-15), the respiratory humidification system (Figure 1) comprising: a liquid flow controller (14a via 16, “A pressurized oxygen stream 14(a) is directed at the outlet from a water bottle 16.” Column 3, Lines 15-35) providing a controlled flow of liquid; a heating system (10, “Referring to FIG. 1, an electric heater 10 is located in and forms part of an air line 12.” Column 3, Lines 15-35), one or more temperature sensors (23/24, “Temperature sensors 23 and 24 may be, inexpensive and disposable sensors, such as thermocouples for the disposable in-line heater, as disclosed in more detail with regard to FIG. 9.” Column 3, Line 50 thru Column 4, Line 10) measuring the surface temperature of the heating system (10); one or more liquid sensors (22/25, wherein 22 – “Temperature sensor 22 senses the outlet temperature of the aerosol from bottle 16” Column 3, Lines 30-50; and wherein 25 – “ Similarly, temperature limit sensor 25 is also a safety device which will, if the temperature of bottle 16 exceeds design maximum, shut the system down.” Column 3, Line 50 thru Column 4, Line 10) located at, on, adjacent, or proximal the heating system (10); one or more hardware processors (26, “Temperature sensors 22 and 24 are connected to control unit 26 which, in response to the temperature differential between sensors 24 and 22 will control the power to vary the output of heater 10 and the ouput of heat for the water bottle to provide the proper aerosol temperature, moisture content and droplet size jointly or aerosol temperature separately.” Column 3, Lines 30-50; also see: “These temperature signals are fed to control unit 26 where they are used to control the power supplied to mesh heating element 36 to control aerosol temperature, moisture content and droplet size, as will be more fully explained hereinafter.” Column 5, Lines 1-15).
Regarding the construction of “the one or more hardware processors is configured to generate an alarm and reduce a heat output of the heating surface upon receiving a signal indicating an absence of liquid on the heating surface”, Drapeau teaches the one or more hardware processor (26) is configured to generate an alarm (“If a "low" signal is generated at water level unit 116, a shutdown signal will be delivered to system shutdown unit 106 which will, in turn, disconnect output power 128 until the water level in the bottle is returned to an acceptable level and activate the audio and visual alarm.” Column 9, Lines 10-35) and reduce a heat output (via 128, “disconnect output power 128” Column 9, Lines 10-35) of the heating surface upon receiving a signal indicating an absence of liquid on the heating surface.
The nature of the operation of the detection of the water within the humidification system and in response to the absence of water to produce an alarm and reduce heat output of the heating system as taught by Drapeau provides a failsafe to prevent failures to provide humidity by the respiratory humidification system. Thus, the modification of Miller with the teachings of Drapeau prevents in improper humidification to the patient by notification and corrective actions.
With respect to the one or more sensors in the form of “at least two liquid sensors configured to detect whether the heating surface is wetted at two or more regions of the heating surface”, Korneff teaches an analogous respiration humidifier (see abstract) comprising one or more liquid sensors configured to detect whether the heating surface is wetted in at least one region (see paragraphs 77-78 and Fig, 4, sensors 410a and 410b; the surface of 402 becomes the heating surface as the water is within the container and the container is heated up to provide humidification, the sensors 410a and 410b determine if the surface is wetted in at least the region between them), wherein the one or more sensors are located at, on, adjacent, or proximal the heating surface (see Fig. 4 of Korneff, the sensors are located adjacent and proximal to the surface of 402. Surface 402 becomes heated during humidification [see paragraph 51]. Further, even if only bottom surface 406 is considered the heating surface, the sensors are adjacent or proximal the bottom surface. The terms "adjacent" and "proximal" mean "nextto" or "close to" and the sensors are located next to, or close to bottom surface 406. There is no degree of closeness claimed), one or more hardware processors (see Fig. 7, processors 706; see paragraph 105, the computing system shown is the same as the control module 420) providing deterministic control of a humidity level of gases passing through the respiratory humidification system (see paragraph 93 and 98-102 and fig. 5, the humidifier control module uses the water level calculations to measure the amount of humidified gas and controls the operation of the water level to achieve a desired humidification) by instructing the liquid flow controller to adjust the controlled flow of liquid received at the heating surface (see paragraphs 78-80, the water level control element 418 is a valve to control the flow of water to the heating surface, the controller adjusts the operation of the valve based on the water information) based at least in part on an output of the one or more liquidsensors (see paragraphs 78-80, control of the valve is based on information from liquid sensor 410). 8. Therefore, it would have been obvious to one skilled in the art, before the time of the effective filing date of the invention, to modify the system of Silver to have sensors to detect the presence of liquid located proximal and adjacent to the heating surface and to modify the controller of Silver to control the flow rate of the liquid based on the determined presence of liquid, as taught by Korneff, for the purpose of providing technology to automatically fill and maintain a desired water level on the heating surface to achieve humidification (see paragraphs 75-76 of Korneff).
Regarding the configuration of the “one or more sensors comprise at least two liquid sensors configured to detect whether the heating surface is wetted at two or more regions of the heating surface”, Figure 4 and Paragraph 0078 of Korneff teach the use of two sensors (410a and 410b) to detect distinct regions of the heating surface.
The nature of at least two liquid sensors at distinct locations along the heated surface ensures uniformity in humidification formation.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the one or more liquid sensor of Miller to be configured to detect whether the heating surface is wetted in at least one region, as taught by Turnbull to monitor the humidity generation of the respiratory humidification system, to modify the one or more hardware processors to include an alarm and reduce heat output, as taught by Drapeau to notify the user of improper humidification of gases to the patient, and to modify the one or more sensors of the modified Miller to be in the form of two liquid sensors, as taught by Korneff, to provide in order to determine the wetness of the distinct regions of the heating surface – thereby imparting uniformity in the humidification formation.
Claims 9, 14, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Miller (6,095,505) in view of Turnbull (5,769,071) and Drapeau et al. (4,682,010), as applied to Claim 1, and further in view of Pujol et al. (US 8640696).
As to Claim 9, the modified Miller, specifically Miller discloses the at least one of the temperature sensors (54); yet, does not expressly disclose the configuration of the “at least one of the one or more temperature sensors is utilized to determine a proportion of the heating surface that is saturated with a liquid”.
Pujol teaches an analogous humidification system (abstract and Fig. 1) wherein the one or more sensors are used by the one or more hardware processors to adjust the evaporative area of the heating surface (Col. 7, lines 19-24, the temperature sensors are used to adjust the parameters for a desired "surface area of reservoir of fluid").
Regarding the configuration “to determine a proportion of the heating surface that is saturated with a liquid”, Pujol teaches at least one heater temperature sensor (Fig. 1, 48) that is utilized to determine a proportion of the heater that is saturated with a liquid (Col. 7, lines 16-26, Pujol discloses adjusting evaporation rate, parameters of which is the surface area of reservoir of fluid and heater temperature, calculating evaporation rate would lead to determining a proportion of the heater that is saturated with liquid).
The nature of the determination of the “proportion”, more accurately adjusting parameters based on more measured values in order to achieve a desired humidity (see col. 1, lines 35-40 and col. 2, lines 4-9,) such that more measurements improve the feedback to provide the appropriate level of humidity to the patient.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the modified Miller to include the use of at least one of the one or more temperature sensors to determine the proportion, as taught by Pujol to enhance feedback of the humidity performance of the humidified gases applied to the user.
As to Claim 14, the modified Miller, specifically Miller discloses the at least one of the temperature sensors (54); yet, does not expressly disclose the configuration of the “at least one of the one or more temperature sensors is utilized to determine a proportion of the heating surface that is saturated with a liquid”.
Pujol teaches an analogous humidification system (abstract and Fig. 1) wherein the one or more sensors are used by the one or more hardware processors to adjust the evaporative area of the heating surface (Col. 7, lines 19-24, the temperature sensors are used to adjust the parameters for a desired "surface area of reservoir of fluid").
Regarding the configuration “to determine a proportion of the heating surface that is saturated with a liquid”, Pujol teaches at least one heater temperature sensor (Fig. 1, 48) that is utilized to determine a proportion of the heater that is saturated with a liquid (Col. 7, lines 16-26, Pujol discloses adjusting evaporation rate, parameters of which is the surface area of reservoir of fluid and heater temperature, calculating evaporation rate would lead to determining a proportion of the heater that is saturated with liquid).
The nature of the determination of the “proportion”, more accurately adjusting parameters based on more measured values in order to achieve a desired humidity (see col. 1, lines 35-40 and col. 2, lines 4-9,) such that more measurements improve the feedback to provide the appropriate level of humidity to the patient.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the modified Miller to include the use of at least one of the one or more temperature sensors to determine the proportion, as taught by Pujol to enhance feedback of the humidity performance of the humidified gases applied to the user.
As to Claim 21, Miller discloses a respiratory humidification system (Figure 1) for providing heated and humidified respiratory gases to a patient (via 15, “Referring now to FIG. 1, the elements of a humidifier of the present invention are shown connected to a breathing gas source (such as ventilator 12), a liquid water source 14, a patient's "Y" connector 15, and an exhalation passageway 16. Patient's "Y" connector 15 provides a passageway to the mouth or airway of the patient using a suitable mask (not shown) or other adapter.” Column 2, Lines 55-70), the respiratory humidification system (Figure 1) comprising: a liquid flow controller (46, “Flow controller 20 is preferably a fixed displacement, metering pump 46 operably associated with a time-proportioning pump controller 48. … Metering pump 46 has a fixed, precise delivery rate. By incorporating a timer function, time proportioning controller 48 serves to turn metering pump 46 on for a fixed time period, and thereby control the amount of liquid water delivered to evaporation module 18. Controller 48 accepts a time proportion setpoint, which represents the fraction of a given time period (e.g. about 1 hour) that the pump is turned on.” Column 3, Lines 20-40) providing a controlled flow of liquid (14, “a liquid water source 14” Column 2, Lines 55-70); a heating system (18, “The humidifier comprises an evaporation module 18, a flow controller 20, and a temperature controller 22. Evaporation module 18 includes a contact chamber 24 defined by a rigid housing 26 and in part by a flash-resistant heat exchanger 28. A wicking layer 30 is positioned in contact with heat exchanger 28, and serves to receive and distribute liquid water entering contact chamber 24. An electric resistive heater 31 is provided for heat exchanger 28 so as to evaporate liquid water arriving in contract chamber 24 from liquid water source 14.” Column 2, Line 60 thru Column 3, Line 10) including a heating surface (28, “heat exchanger 28” Column 2, Line 60 thru Column 3, Line 10) configured to receive the controlled flow of liquid (via 36, “Rigid housing 26 also includes a water inlet 36 for receiving water from water source 14 through a liquid water flow passageway 42.” Column 3, Lines 5-20) and provide humidification gases (via 32, “Gas inlet 32 connects to ventilator 12 via a passageway 38, and breathing gas outlet 34 connects to patient's "Y" connector 15, via an inhalation passageway 40.” Column 3, Lines 5-20) passing through the respiratory humidification system (Figure 1), the heating surface (28) comprising a wicking element (30, “A wicking layer 30 is positioned in contact with heat exchanger 28, and serves to receive and distribute liquid water entering contact chamber 24.” Column 2, Line 60 thru Column 3, Line 10; also see: “Wicking layer 30 is made of an absorptive material, preferably a cotton pad. Other materials, synthetic as well as natural, that facilitate the distribution of liquid water over a surface are also appropriate. The wicking layer need not be made of just one material.” Column 5, Lines 1-10) configured to receive and distribute the liquid (via 36) in a layer on or through the wicking element (30), the heating surface (28) further comprising a heating element (31, “An electric resistive heater 31 is provided for heat exchanger 28 so as to evaporate liquid water arriving in contract chamber 24 from liquid water source 14.” Column 2, Line 60 thru Column 3, Line 10; also see: “The power level for heater 31 and the rate of liquid water flow to evaporation module 18 are set by breathing gas temperature controller 22.” Column 5, Lines 10-20) configured to provide heat to the wicking element (30) to vaporize liquid (via 36) on or in the wicking element (30); one or more temperature sensors (54, “As shown in FIG. 1, temperature controller 22 is optionally configured to accept a signal from a temperature sensor 54 in heater 31.” Column 4, Lines 5-15) measuring a surface temperature of the heating surface (28); one or more hardware processors (22, “The humidifier comprises an evaporation module 18, a flow controller 20, and a temperature controller 22.” Column 2, Line 60 thru Column 3, Line 10; also see: “Flow controller 20 is part of the control cascade that includes breathing gas temperature controller 22. Temperature controller 22 can also be characterized as a system control module. Temperature controller 22 is operably connected to flow controller 20, heater 31, and a temperature sensor 50, which is positioned in inhalation passageway 40. Given a user selectable setpoint for breathing gas temperature, controller 22 adjusts both the power to heater 31 and the setpoint of flow controller 20 in response to changes in breathing gas temperature at sensor 50.” Column 3, Lines 55-70; “As denoted in FIG. 1 by a dashed-line box 52, the controller elements of the present invention are preferably combined into a convenient single module. In this arrangement, the circuitry elements of time proportioning controller 48 and temperature controller 22 may share a power source as well as other required components. As shown in FIG. 1, temperature controller 22 is optionally configured to accept a signal from a temperature sensor 54 in heater 31. Temperature controller 22 uses the temperature of heater 31 as a safety constraint that limits heating power when the heater temperature exceeds a set high limit.” Column 4, Lines 1-15; “The power level for heater 31 and the rate of liquid water flow to evaporation module 18 are set by breathing gas temperature controller 22. When the temperature of the breathing gas drops, as measured by sensor 50, breathing gas temperature controller 22 responds by increasing both the heating power for evaporation module 18 and the flow rate setpoint for time-proportioning controller 48.” Column 5, Lines 10-25) providing deterministic control of a humidity level of gases (“A humidifier embodying the features of the present invention provides efficient, cost-effective temperature and humidity control of breathing gas for inhalation therapy.” Column 2, Lines 50-60; “These requirements include operating targets for breathing gas in the ranges of 30.degree. C. to 37.degree. C. and 65 to 95 percent relative humidity.” Column 5, Lines 20-35) passing through the respiratory humidification system (Figure 1) by instructing the liquid flow controller (46) to adjust the controlled flow of liquid (via 36) received at the heating system (18) and instructing the heating system (18) to adjust the surface temperature of the heating surface (28) by controlling the heating element (31), wherein adjusting the surface temperature of the heating surface (28) provides control to produce a known evaporative area (24, “Evaporation module 18 includes a contact chamber 24 defined by a rigid housing 26 and in part by a flash-resistant heat exchanger 28. A wicking layer 30 is positioned in contact with heat exchanger 28, and serves to receive and distribute liquid water entering contact chamber 24. An electric resistive heater 31 is provided for heat exchanger 28 so as to evaporate liquid water arriving in contract chamber 24 from liquid water source 14.” Column 2, Line 60 thru Column 3, Line 10); and one or more sensors (50, “Temperature controller 22 is operably connected to flow controller 20, heater 31, and a temperature sensor 50, which is positioned in inhalation passageway 40. Given a user selectable setpoint for breathing gas temperature, controller 22 adjusts both the power to heater 31 and the setpoint of flow controller 20 in response to changes in breathing gas temperature at sensor 50.” Column 3, Lines 55-70; also see: “When the temperature of the breathing gas drops, as measured by sensor 50, breathing gas temperature controller 22 responds by increasing both the heating power for evaporation module 18 and the flow rate setpoint for time-proportioning controller 48.” Column 5, Lines 15-25) located at, on, adjacent, or proximal the heating surface (28), wherein the one or more sensors (50) comprise at least one temperature sensor, wherein instructing the liquid flow controller (46) to adjust the controlled flow of liquid received at the heating system (18) is based at least in part on an output of the one or more sensors (50).
Yet, Miller does not expressly disclose the construction of the “one or more sensors configured to detect whether the heating surface is wetted in at least one region”, nor the configuration whereby “the one or more hardware processors is configured to generate an alarm and reduce a heat output of the heating surface upon receiving a signal indicating an absence of liquid on the heating surface” nor the one or more sensors in the form of “at least one temperature sensor to determine a proportion of the heating surface saturated with a liquid”.
With respect to the construction of the “one or more liquid sensors configured to detect whether the heating surface is wetted in at least one region”, Turnbull teaches a similar respiratory humidification system (Figure 1) for providing heated and humidified respiratory gases to a patient (via 1, “The system comprises a tracheal tube 1, or other breathing device, connected to humidifier apparatus 2 controlled by a humidity sensor 3. The system is connected to ventilator apparatus 4.” Column 1, Lines 55-70), the respiratory humidification system comprising: a liquid flow controller (30, “The tubing 28 passes through a peristaltic pump 30 contained within the same housing 31 as the control unit 20. The control unit 20 controls the speed of the pump 30 and also provides power output to the heater 25 via a lead 32.” Column 2, Lines 5-25; also see: “A fall in humidity causes the control unit 20 to increase the speed of the peristaltic pump 30 so as to increase the flow of water to the HME device 22; it may also increase the temperature of the heater 25 to increase the rate of evaporation from the wick 26.” Column 2, Lines 35-50), a heating system (22, “The flexible tubing 16 extends to a heat and moisture exchange (HME) device 22 forming a part of the humidifier apparatus 2.” Column 2, Lines 5-25) with a wicking element (26, “On the patient side of the exchange element 24, within the housing 23, there is an electrical heater 25 covered by an absorbent wick 26. A water inlet 27 is located close to the wick 26 and is connected via tubing 28 to a water reservoir in the form of a suspended bag 29 of sterile water. … The heat and moisture of the inhaled gas, after passing through the exchange element 24 is supplemented by heat from the heater 25 and moisture evaporated from the wick 26. … A fall in humidity causes the control unit 20 to increase the speed of the peristaltic pump 30 so as to increase the flow of water to the HME device 22; it may also increase the temperature of the heater 25 to increase the rate of evaporation from the wick 26.” Column 2, Lines 5-50) and heating element (25, “On the patient side of the exchange element 24, within the housing 23, there is an electrical heater 25 covered by an absorbent wick 26. A water inlet 27 is located close to the wick 26 and is connected via tubing 28 to a water reservoir in the form of a suspended bag 29 of sterile water. … The heat and moisture of the inhaled gas, after passing through the exchange element 24 is supplemented by heat from the heater 25 and moisture evaporated from the wick 26. … A fall in humidity causes the control unit 20 to increase the speed of the peristaltic pump 30 so as to increase the flow of water to the HME device 22; it may also increase the temperature of the heater 25 to increase the rate of evaporation from the wick 26.” Column 2, Lines 5-50); a sensor (3, “The system comprises a tracheal tube 1, or other breathing device, connected to humidifier apparatus 2 controlled by a humidity sensor 3. … The connector 15 includes a humidity sensor 3 exposed to gas flowing along the interior of the connector and hence along the tube. A wire 11 extends from the sensor 3 and is connected via a coupling 13 to a cable 14 extending to a control unit 20 of the humidifier apparatus 2. The sensor 3 could be mounted at various other locations such as, in the tube 1 itself, for example at its patient end, or in flexible tubing 16 connected to the connector 15.” Column 1, Line 55 thru Column 2, Line 10; “Any such change in humidity is sensed by the sensor 3 and signalled to the control unit 20. A fall in humidity causes the control unit 20 to increase the speed of the peristaltic pump 30 so as to increase the flow of water to the HME device 22; it may also increase the temperature of the heater 25 to increase the rate of evaporation from the wick 26.” Column 2, Lines 35-50); and one or more processors (20, “ A wire 11 extends from the sensor 3 and is connected via a coupling 13 to a cable 14 extending to a control unit 20 of the humidifier apparatus 2.” Column 1, Line 60 thru Column 2, Line 10; “The tubing 28 passes through a peristaltic pump 30 contained within the same housing 31 as the control unit 20. The control unit 20 controls the speed of the pump 30 and also provides power output to the heater 25 via a lead 32. Various displays may be provided on the housing 31, such as a display 33 of humidity, as sensed by the sensor 3.” Column 2, Lines 5-25; and “Any such change in humidity is sensed by the sensor 3 and signalled to the control unit 20. A fall in humidity causes the control unit 20 to increase the speed of the peristaltic pump 30 so as to increase the flow of water to the HME device 22; it may also increase the temperature of the heater 25 to increase the rate of evaporation from the wick 26.” Column 2, Lines 35-50) providing deterministic control of a humidity level of the gases passing through the respiratory humidification system (Figure 1) by instructing the liquid flow controller (30) to adjust the controlled flow of liquid received at the heating system (22) based on at least in part an output of the one or more sensor (3) and instructing the heating system (22) to adjust temperature by controlling the heating element (25) to produce a known evaporative area (lumen of 22).
Regarding the construction of the “one or more liquid sensors configured to detect whether the heating surface is wetted in at least one region”, Turnbull teaches the one or more liquid sensor (3, “The system comprises a tracheal tube 1, or other breathing device, connected to humidifier apparatus 2 controlled by a humidity sensor 3. … The connector 15 includes a humidity sensor 3 exposed to gas flowing along the interior of the connector and hence along the tube. A wire 11 extends from the sensor 3 and is connected via a coupling 13 to a cable 14 extending to a control unit 20 of the humidifier apparatus 2. The sensor 3 could be mounted at various other locations such as, in the tube 1 itself, for example at its patient end, or in flexible tubing 16 connected to the connector 15.” Column 1, Line 55 thru Column 2, Line 10; “Any such change in humidity is sensed by the sensor 3 and signalled to the control unit 20. A fall in humidity causes the control unit 20 to increase the speed of the peristaltic pump 30 so as to increase the flow of water to the HME device 22; it may also increase the temperature of the heater 25 to increase the rate of evaporation from the wick 26.” Column 2, Lines 35-50) is configured to detect whether the heating surface is wetted in at least one region.
The nature of the liquid sensor (3) of Turnbull being a humidity sensor enables the ability to determine whether there is wetting within the heating system, as the lack of humidity correlates to a lack of water vapor and the presence of humidity correlates to sufficient water vapor formation. Thus, the modification of the liquid sensor (50) of Miller to the liquid sensor (3) of Turnbull results in the configuration whereby the liquid sensor can “detect whether the heating surface is wetted in at least one region” through the presence or absence of sufficient water vapor formation.
With respect to the configuration whereby “the one or more hardware processors is configured to generate an alarm and reduce a heat output of the heating surface upon receiving a signal indicating an absence of liquid on the heating surface”, Drapeau teaches a respiratory humidification system (Figure 1) for providing heated and humidified respiratory gases to a patient (via 20, “The humidified gas stream is then heated as may be required in heater 10, and it then flows from exit 20 of the heater through the remainder of air line 12 to a patient.” Column 3, Lines 15-35; “The aerosol mixture then leaves the heater under low pressure at exit end 20 for delivery to the patient.” Column 5, Lines 1-15), the respiratory humidification system (Figure 1) comprising: a liquid flow controller (14a via 16, “A pressurized oxygen stream 14(a) is directed at the outlet from a water bottle 16.” Column 3, Lines 15-35) providing a controlled flow of liquid; a heating system (10, “Referring to FIG. 1, an electric heater 10 is located in and forms part of an air line 12.” Column 3, Lines 15-35), one or more temperature sensors (23/24, “Temperature sensors 23 and 24 may be, inexpensive and disposable sensors, such as thermocouples for the disposable in-line heater, as disclosed in more detail with regard to FIG. 9.” Column 3, Line 50 thru Column 4, Line 10) measuring the surface temperature of the heating system (10); one or more liquid sensors (22/25, wherein 22 – “Temperature sensor 22 senses the outlet temperature of the aerosol from bottle 16” Column 3, Lines 30-50; and wherein 25 – “ Similarly, temperature limit sensor 25 is also a safety device which will, if the temperature of bottle 16 exceeds design maximum, shut the system down.” Column 3, Line 50 thru Column 4, Line 10) located at, on, adjacent, or proximal the heating system (10); one or more hardware processors (26, “Temperature sensors 22 and 24 are connected to control unit 26 which, in response to the temperature differential between sensors 24 and 22 will control the power to vary the output of heater 10 and the ouput of heat for the water bottle to provide the proper aerosol temperature, moisture content and droplet size jointly or aerosol temperature separately.” Column 3, Lines 30-50; also see: “These temperature signals are fed to control unit 26 where they are used to control the power supplied to mesh heating element 36 to control aerosol temperature, moisture content and droplet size, as will be more fully explained hereinafter.” Column 5, Lines 1-15).
Regarding the construction of “the one or more hardware processors is configured to generate an alarm and reduce a heat output of the heating surface upon receiving a signal indicating an absence of liquid on the heating surface”, Drapeau teaches the one or more hardware processor (26) is configured to generate an alarm (“If a "low" signal is generated at water level unit 116, a shutdown signal will be delivered to system shutdown unit 106 which will, in turn, disconnect output power 128 until the water level in the bottle is returned to an acceptable level and activate the audio and visual alarm.” Column 9, Lines 10-35) and reduce a heat output (via 128, “disconnect output power 128” Column 9, Lines 10-35) of the heating surface upon receiving a signal indicating an absence of liquid on the heating surface.
The nature of the operation of the detection of the water within the humidification system and in response to the absence of water to produce an alarm and reduce heat output of the heating system as taught by Drapeau provides a failsafe to prevent failures to provide humidity by the respiratory humidification system. Thus, the modification of Miller with the teachings of Drapeau prevents in improper humidification to the patient by notification and corrective actions.
With respect to the configuration “to determine a proportion of the heating surface that is saturated with a liquid”, Pujol teaches an analogous humidification system (abstract and Fig. 1) wherein the one or more sensors are used by the one or more hardware processors to adjust the evaporative area of the heating surface (Col. 7, lines 19-24, the temperature sensors are used to adjust the parameters for a desired "surface area of reservoir of fluid").
Regarding the configuration “to determine a proportion of the heating surface that is saturated with a liquid”, Pujol teaches at least one heater temperature sensor (Fig. 1, 48) that is utilized to determine a proportion of the heater that is saturated with a liquid (Col. 7, lines 16-26, Pujol discloses adjusting evaporation rate, parameters of which is the surface area of reservoir of fluid and heater temperature, calculating evaporation rate would lead to determining a proportion of the heater that is saturated with liquid).
The nature of the determination of the “proportion”, more accurately adjusting parameters based on more measured values in order to achieve a desired humidity (see col. 1, lines 35-40 and col. 2, lines 4-9,) such that more measurements improve the feedback to provide the appropriate level of humidity to the patient.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the one or more liquid sensor of Miller to be configured to detect whether the heating surface is wetted in at least one region, as taught by Turnbull to monitor the humidity generation of the respiratory humidification system, to modify the one or more hardware processors to include an alarm and reduce heat output, as taught by Drapeau to notify the user of improper humidification of gases to the patient, and further to modify the one or more sensors to include at least one temperature sensor suitable for determining the proportion , as taught by Pujol to enhance feedback of the humidity performance of the humidified gases applied to the user.
Response to Arguments
Applicant’s arguments with respect to claim(s) have been considered but are moot because the new ground of rejection.
The combination of the newly located prior art references Miller (6,095,505) in view of Turnbull (5,769,071) and Drapeau et al. (4,682,010) appears to disclose the features of the respiratory humidification system as claimed, whereby Miller discloses the generic structure of the respiratory humidification system, Turnbull teaches the optional configuration of the “one or more liquid sensor” of Miller to be in the form of a humidity sensor that can “detect whether the heating surface is wetted in at least one region”, and Drapeau teaches the modification of a control system of Miller to include an alarm and corrective action shutdown of heating in the absence of liquid. Thus, it appears the combination of the prior art references meet the limitations of the claims.
Conclusion
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ANNETTE FREDRICKA DIXON
Primary Examiner
Art Unit 3782
/Annette Dixon/Primary Examiner, Art Unit 3785
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