DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
Examiner acknowledges the reply filed on 03/09/2026 in which claims 34-51 have been amended, claims 1 and 25 have been canceled, and claim 52 has been added. Currently, claims 34-52 are pending for examination in this application.
Response to Arguments
Applicant has resolved the objections to the claims.
Applicant's arguments, see Remarks pg. 6-7, filed 03/09/2026, with respect to independent claim 34 have been fully considered but they are not persuasive. Applicant argues that the power limiting methods of Bonilla are incompatible with Mcauley’s method of controlling power to the heating elements, specifically since the abstract of Bonilla states the power is supplied to the heater plate and to the heating element so they can operate at pre-established operating temperatures and Mcauley’s control is based on sensed measurements. Examiner disagrees because the pre-established operating temperatures described in Bonilla achieves the same goal as the target temperatures described during Mcauley’s control of conduit heater power. Ultimately, in both Bonilla and Mcauley, the control is based on achieving a target temperature in both the heater plate and heater conduit, see Mcauley, [0206] “Similarly, to control the heated breathing tube to achieve the target temperature (end of hose temperature 44a), the controller 109 uses the target temperature along with ambient temperature 19a, and average flow 42a and heater plate temperature 43a as inputs into a neural network model or equations 121 that outputs the target power 43b for the heated breathing tube 101 to achieve the target end of hose temperature 44a. It also optionally or as an alternative uses an end of hose temperature sensor 123 reading as a feedback input into the model 121. Based on the heater plate target temperature 43a and HBT target power 43b, the controller 109 generates and passes control voltages to the heater plate 108 and breathing tube heater 101a respectively to control them to attain and maintain the target heater plate temperature 43a and breathing tube power 43b to achieve the target temperature/humidity at the end of hose 44a, 44b”. Additionally, the argument that Mcauley and Bonilla are different because Mcauley of the sensed measurements is incorrect because Bonilla also teaches using sensed measurements to determine the target/operating temperature, see Bonilla [0047] To determine the operating temperatures, the device has a temperature sensor 7 of the heating plate 6 to measure its temperature and is operationally connected to the controller 50 to provide the temperature value of the heating plate 6. [0049] During the operation of the humidifier, the controller 50 receives the temperature values of plate 6, the gas in the humidification chamber 8 and the gas supplied to the patient 14 to compare them with preset values of these temperatures in the controller 50, so that if there is any difference greater than an error threshold, the power delivered to plate 6 and/or the heating element 9 is varied. In conclusion, the power control method Bonilla and Mcauley do not teach away or contradict each other because they both use sensed measurements to determine operating/target temperatures with the operating/target temperatures being used to control power to the conduit heater. The teachings of Bonilla act as a secondary power control method to ensure a safer and more stable power supply while improving the control of power allocation as taught by Bonilla [0017]. This is due to the fact that infinite power supply should not always be relied upon (see Bonilla [0013-0015]).
Claim Objections
Claims 39 are objected to because of the following informalities:
Claim 39, line 3, “the the” should be “the”.
Appropriate correction 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.
Claim(s) 34, 35, 39, and 42-48 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mcauley et al. (US 20150217079 A1) and Bonilla et al. (WO 2015082970 A1).
Regarding claim 34, Mcauley discloses a respiratory or surgical humidifier system configured to deliver a flow of gases to a user (figure 2), the system comprising:
a base unit ([0098] PAP apparatus 100; figure 2) comprising:
a heater plate including one or more heater plate heating elements (heater plate 108; figure 2. Examiner notes heater plate 108 includes at least one heating element in order to function as a heater as supported by [0101]); and
a hardware controller ([0102] controller 109; figure 2) configured to energize the one or more heating elements (see [0206]: The controller 109 then operates the humidification breathing apparatus to achieve and maintain the target humidity and temperature. In this embodiment, the controller does this by controlling the heater plate (HP) 108 to control target humidity and the heater (HBT) 101a in the breathing tube to control target temperature),
the base unit configured to receive a humidifier chamber ([0101] The PAP apparatus comprises a humidifier 115. In alternative embodiments, the humidifier 115 may be separate from the PAP apparatus and part of the PAP apparatus. Alternatively the humidifier may be a separate component within the housing of the PAP apparatus or separate from the PAP apparatus with a conduit connecting between the PAP apparatus and the humidifier. Other types of humidifiers, other than a pass over type may be used. In some forms multiple humidifiers may used; figure 2) including a thermally conductive base such that the thermally conductive base contacts the heater plate (see figure 2, one of ordinary skill in the art would recognize that humidifier 115 includes a thermally conductive base in order to allow for the water reservoir to be heated by the heater 108 as supported by [0101]), the humidifier chamber configured to hold a volume of water ([0101] The humidifier 115 as shown is a pass over type humidifier where air passing through the humidifier picks up a quantity of water vapour from a reservoir of water 107; figure 2), wherein the hardware controller is configured to be in electronic communication with a conduit heating element in an inspiratory conduit ([0102] The controller 109 is used to control the humidification breathing apparatus, including the PAP apparatus, tube heater 101a, and other peripherals; figure 2) configured to transport the gases from the humidifier chamber to a patient interface ([0101] The humidified air leaves the end of heated breathing tube 101 (later referred as end of hose, EOH), it is mixed with the patients' exhaled breathe and then flows out of the bias hole on a nasal, full face or oral mask 102; figure 2),
the system configured to determine or apply a first power limit on the conduit heating element based at least in part on one or more parameters of the heater plate ([0206] Similarly, to control the heated breathing tube to achieve the target temperature (end of hose temperature 44a), the controller 109 uses the target temperature along with ambient temperature 19a, and average flow 42a and heater plate temperature 43a as inputs into a neural network model or equations 121 that outputs the target power 43b for the heated breathing tube 101 to achieve the target end of hose temperature 44a. It also optionally or as an alternative uses an end of hose temperature sensor 123 reading as a feedback input into the model 121. Based on the heater plate target temperature 43a and HBT target power 43b, the controller 109 generates and passes control voltages to the heater plate 108 and breathing tube heater 101a respectively to control them to attain and maintain the target heater plate temperature 43a and breathing tube power 43b to achieve the target temperature/humidity at the end of hose 44a, 44b; figure 4).
Mcauley is silent as to the system configured to determine and/or apply a second power limit on the conduit heating element based at least in part on one or more parameters of the heater plate.
However, Bonilla teaches a humidifier system (figure 3-7) configured to determine and/or apply a power limit on the conduit heating element based at least in part on one or more parameters of the heater plate (see [0045-0051] and [0054-0056]; figure 3-6). Specifically, Bonilla teaches [0050] At the start of operation, the device supplies 20% to 100% of the power to the heating plate and the remainder to the tube heater. When the preset temperature has been reached in the tube heater and the heating plate, the device delivers 50 to 80% of the total power to the tube heater and 20 to 50% to the heating plate.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Mcauley to implement a switched mode power supply to determine and/or apply a power limit to the heating tube based on the power supplied to the heater plate in order to provide a safer and more stable power supply while improving the control of power allocation as taught by Bonilla [0017]. This is due to the fact that infinite power supply should not always be relied upon (see Bonilla [0013-0015]).
Regarding claim 35, modified Mcauley teaches the system of claim 34, wherein the first power limit is controlling to a power limit (Mcauley: [0206] Based on the heater plate target temperature 43a and HBT target power 43b, the controller 109 generates and passes control voltages to the heater plate 108 and breathing tube heater 101a respectively to control them to attain and maintain the target heater plate temperature 43a and breathing tube power 43b to achieve the target temperature/humidity at the end of hose 44a, 44b; figure 4).
Regarding claim 39, modified Mcauley teaches the system of claim 34, wherein determining or applying the first power limit or the second power limit on the conduit heating element comprises controlling power in the conduit heating element to the the first power limit (Mcauley: see [0206]) or the second power limit (Bonilla: see [0050]).
Regarding claim 42, modified Mcauley teaches the system of claim 34, comprising a heater plate temperature sensor configured to measure a heater plate temperature (Mcauley: [0103] heater plate temperature sensor 119; figure 2) and the one or more parameters of the heater plate (Mcauley: [0206] to control the heated breathing tube to achieve the target temperature (end of hose temperature 44a), the controller 109 uses the target temperature along with ambient temperature 19a, and average flow 42a and heater plate temperature 43a as inputs. Examiner notes: [0103] establishes a heater plate temperature sensor can be used to measure heater plate temperature), which the system is configured to determine or apply the first power limit based at least in part on, includes at least a conduit heating element power (Mcauley: [0206] Based on the heater plate target temperature 43a and HBT target power 43b, the controller 109 generates and passes control voltages to the heater plate 108 and breathing tube heater 101a respectively to control them to attain and maintain the target heater plate temperature 43a and breathing tube power 43b to achieve the target temperature/humidity at the end of hose 44a, 44b).
Regarding claim 43, modified Mcauley teaches the system of claim 34, comprising a heater plate temperature sensor configured to measure a heater plate temperature (Mcauley: [0103] heater plate temperature sensor 119; figure 2) and the one or more parameters of the heater plate (Mcauley: [0206] to control the heated breathing tube to achieve the target temperature (end of hose temperature 44a), the controller 109 uses the target temperature along with ambient temperature 19a, and average flow 42a and heater plate temperature 43a as inputs. Examiner notes: [0103] establishes a heater plate temperature sensor can be used to measure heater plate temperature), which the system is configured to determine or apply the first power limit based at least in part on, includes at least the heater plate temperature (Mcauley: [0206] to control the heated breathing tube to achieve the target temperature (end of hose temperature 44a), the controller 109 uses the target temperature along with ambient temperature 19a, and average flow 42a and heater plate temperature 43a as inputs into a neural network model or equations 121 that outputs the target power 43b for the heated breathing tube 101 to achieve the target end of hose temperature 44a).
Regarding claim 44, modified Mcauley teaches the system of claim 34, comprising an ambient temperature sensor configured to measure an ambient temperature (Mcauley: [0103] Ambient temperature and humidity sensors 201, 110 can also be used--which can be at the blower inlet, humidifier inlet or any other suitable location; figure 2) and the system is configured to determine or apply the first power limit on the conduit heating element based at least in part on the ambient temperature (Mcauley: [0206] to control the heated breathing tube to achieve the target temperature (end of hose temperature 44a), the controller 109 uses the target temperature along with ambient temperature 19a, and average flow 42a and heater plate temperature 43a as inputs into a neural network model or equations 121 that outputs the target power 43b for the heated breathing tube 101 to achieve the target end of hose temperature 44a).
Regarding claim 45, modified Mcauley teaches the system of claim 34, wherein the one or more parameters of the heater plate, which the system is configured to determine or apply the second power limit based at least in part on, includes at least a heater plate power (Bonilla: [0050] At the start of operation, the device supplies 20% to 100% of the power to the heating plate and the remainder to the tube heater).
Regarding claim 46, modified Mcauley teaches the system of claim 34, wherein the system is configured to determine or apply the first power limit based at least in part on a parameter indicative of a flow rate of the flow of gases (Mcauley: [0206] to control the heated breathing tube to achieve the target temperature (end of hose temperature 44a), the controller 109 uses the target temperature along with ambient temperature 19a, and average flow 42a and heater plate temperature 43a as inputs into a neural network model or equations 121 that outputs the target power 43b for the heated breathing tube 101 to achieve the target end of hose temperature 44a. also see [0062-0063]).
Regarding claim 47, modified Mcauley teaches the system of claim 34, wherein the system is configured to determine and/or apply the second power limit without requiring input from sensors in a gases flow pathway (Bonilla: [0050] At the start of operation, the device supplies 20% to 100% of the power to the heating plate and the remainder to the tube heater. When the preset temperature has been reached in the tube heater and the heating plate, the device delivers 50 to 80% of the total power to the tube heater and 20 to 50% to the heating plate. Examiner notes: the second power limit is based on the power of the heater plate).
Regarding claim 48, modified Mcauley teaches the system of claim 34, wherein the system is configured to determine or apply the first power limit or the second power limit without requiring input from sensors located at or near a chamber outlet or a patient end (Bonilla: [0050] At the start of operation, the device supplies 20% to 100% of the power to the heating plate and the remainder to the tube heater. When the preset temperature has been reached in the tube heater and the heating plate, the device delivers 50 to 80% of the total power to the tube heater and 20 to 50% to the heating plate. Examiner notes: the second power limit is based on the power of the heater plate).
Regarding claim 52, modified Mcauley teaches the system of claim 34, wherein the first power limit is applied by the hardware controller (Mcauley: [0206] the controller 109) and the second power limit is applied by a protection circuit (Bonilla: see [0045-0051] switched -mode power supply 30; figure 3-4 and 7. [0051] a commercial switched-mode power supply is used, well known to those skilled in the art, whose main circuits are illustrated in Figure 4 and which are an input circuit and electrical protection 33 which aims to reduce interference from the voltage line that affects the operation of the power supply, as well as prevent sending noise to the voltage line).
Claim(s) 36-38 and 40-41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mcauley et al. (US 20150217079 A1) and Bonilla et al. (WO 2015082970 A1), as applied to claim 34 above, and further in view of Vos et al. (US 20140216459 A1).
Regarding claim 36, modified Mcauley teaches the system of claim 34, but is silent as to wherein the second power limit is disabling power to the conduit heating element.
However, Bonilla teaches [0049] During the operation of the humidifier, the controller 50 receives the temperature values of plate 6, the gas in the humidification chamber 8 and the gas supplied to the patient 14 to compare them with preset values of these temperatures in the controller 50, so that if there is any difference greater than an error threshold, the power delivered to plate 6 and/or the heating element 9 is varied.
Additionally, Vos teaches [0088] The heated tube 320 may be used to deliver the comfort of warm, humidified air and minimise condensation in the tubing. Referring to FIG. 19, an algorithm for controlling a heated tube is shown. The algorithm starts at S300 and determines the temperature sensed by a temperature sensor in the heated tube (e.g. thermistor 410) in S302. The algorithm proceeds to S306 and determines if the sensed temperature is outside a predetermined range. If the temperature of the heated tube is not outside the predetermined range (S306: No), the algorithm ends in S316. Conversely, if the temperature is outside the predetermined range (S306: Yes) the algorithm proceeds to S310 and it is determined if the temperature is above the predetermined range. If the temperature is below the predetermined range (S310: No), the algorithm proceeds to S312 and power is supplied to the heated tube. If the sensed temperature is above the predetermined range (S310: Yes), the algorithm proceeds to S314 shuts off power to the heated tube. After the completion of S312 or S314 the algorithm returns to the beginning in S300, thus providing temperature control for the heated tube. [0089] The control of the heated tube may involve several considerations. Another consideration is, for safety, a failsafe mechanism may be provided to ensure the delivered air temperature does not exceed a safe temperature limit.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the switched mode power supply and controller of modified Mcauley to implement a failsafe mechanism where if the sensed temperature of gas supplied to the patient in the heated tube is above a predetermined range, the controller shuts off power to the heated tube, as taught by Vos for patient safety [0089].
Regarding claim 37, modified Mcauley teaches the system of claim 34, but is silent as to wherein a threshold to enact the first power limit (Mcauley teaches the temperature threshold to enact the first power limit is 34°C: [0110] once determined, M.sub.h, M.sub.t become known parameters that are inputs 42d, 42e into a target humidity and temperature model 50 that is based on (a "reverse") of the patient contribution model for humidity and temperature, along with other inputs to produce the end of conduit (hose) (target) humidity (EOH_AH) 44b and temperature (EOH_T) 44a. The inputs to the model 50 also optionally include patient temperature 19d and patient absolute humidity (AH) 19e--being the temperature and humidity of the air exhaled by the patient. Rather than direct inputs these can be included intrinsically in the model (as is the case in FIG. 5), but can still be considered model inputs. As an example, average values obtained from literature (e.g. 34.degree. C., 85%, 32 mg/L) could be used) is lower than a threshold to enact the second power limit.
However, Bonilla teaches [0049] During the operation of the humidifier, the controller 50 receives the temperature values of plate 6, the gas in the humidification chamber 8 and the gas supplied to the patient 14 to compare them with preset values of these temperatures in the controller 50, so that if there is any difference greater than an error threshold, the power delivered to plate 6 and/or the heating element 9 is varied.
Additionally, Vos teaches [0088] The heated tube 320 may be used to deliver the comfort of warm, humidified air and minimise condensation in the tubing. Referring to FIG. 19, an algorithm for controlling a heated tube is shown. The algorithm starts at S300 and determines the temperature sensed by a temperature sensor in the heated tube (e.g. thermistor 410) in S302. The algorithm proceeds to S306 and determines if the sensed temperature is outside a predetermined range. If the temperature of the heated tube is not outside the predetermined range (S306: No), the algorithm ends in S316. Conversely, if the temperature is outside the predetermined range (S306: Yes) the algorithm proceeds to S310 and it is determined if the temperature is above the predetermined range. If the temperature is below the predetermined range (S310: No), the algorithm proceeds to S312 and power is supplied to the heated tube. If the sensed temperature is above the predetermined range (S310: Yes), the algorithm proceeds to S314 shuts off power to the heated tube. After the completion of S312 or S314 the algorithm returns to the beginning in S300, thus providing temperature control for the heated tube. [0089] The control of the heated tube may involve several considerations. Another consideration is, for safety, a failsafe mechanism may be provided to ensure the delivered air temperature does not exceed a safe temperature limit. [0094] The predetermined temperature is set at a temperature to meet appropriate safety requirements of the heated tube, such as between 30.degree. C. and 45.degree. C., preferably 38.degree. C. to 43.degree. C.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the switched mode power supply and controller of modified Mcauley to implement a failsafe mechanism where if the sensed temperature of gas supplied to the patient in the heated tube is above a predetermined range of 30 °C and 45 °C, the controller shuts off power to the heated tube, as taught by Vos for patient safety [0089].
As modified, the temperature threshold to enact the first power limit, 34 °C, is lower than the temperature threshold to enact the second power limit, 45 °C.
Regarding claim 38, modified Mcauley teaches the system of claim 34, but is silent as to wherein the first power limit corresponds with a lower patient end enthalpy limit (Examiner notes enthalpy is directly proportional to temperature and Mcauley teaches the temperature threshold to enact the first power limit is 34°C: [0110] once determined, M.sub.h, M.sub.t become known parameters that are inputs 42d, 42e into a target humidity and temperature model 50 that is based on (a "reverse") of the patient contribution model for humidity and temperature, along with other inputs to produce the end of conduit (hose) (target) humidity (EOH_AH) 44b and temperature (EOH_T) 44a. The inputs to the model 50 also optionally include patient temperature 19d and patient absolute humidity (AH) 19e--being the temperature and humidity of the air exhaled by the patient. Rather than direct inputs these can be included intrinsically in the model (as is the case in FIG. 5), but can still be considered model inputs. As an example, average values obtained from literature (e.g. 34.degree. C., 85%, 32 mg/L) could be used) than the second power limit.
However, Bonilla teaches [0049] During the operation of the humidifier, the controller 50 receives the temperature values of plate 6, the gas in the humidification chamber 8 and the gas supplied to the patient 14 to compare them with preset values of these temperatures in the controller 50, so that if there is any difference greater than an error threshold, the power delivered to plate 6 and/or the heating element 9 is varied.
Additionally, Vos teaches [0088] The heated tube 320 may be used to deliver the comfort of warm, humidified air and minimise condensation in the tubing. Referring to FIG. 19, an algorithm for controlling a heated tube is shown. The algorithm starts at S300 and determines the temperature sensed by a temperature sensor in the heated tube (e.g. thermistor 410) in S302. The algorithm proceeds to S306 and determines if the sensed temperature is outside a predetermined range. If the temperature of the heated tube is not outside the predetermined range (S306: No), the algorithm ends in S316. Conversely, if the temperature is outside the predetermined range (S306: Yes) the algorithm proceeds to S310 and it is determined if the temperature is above the predetermined range. If the temperature is below the predetermined range (S310: No), the algorithm proceeds to S312 and power is supplied to the heated tube. If the sensed temperature is above the predetermined range (S310: Yes), the algorithm proceeds to S314 shuts off power to the heated tube. After the completion of S312 or S314 the algorithm returns to the beginning in S300, thus providing temperature control for the heated tube. [0089] The control of the heated tube may involve several considerations. Another consideration is, for safety, a failsafe mechanism may be provided to ensure the delivered air temperature does not exceed a safe temperature limit. [0094] The predetermined temperature is set at a temperature to meet appropriate safety requirements of the heated tube, such as between 30.degree. C. and 45.degree. C., preferably 38.degree. C. to 43.degree. C.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the switched mode power supply and controller of modified Mcauley to implement a failsafe mechanism where if the sensed temperature of gas supplied to the patient in the heated tube is above a predetermined range of 30 °C and 45 °C, the controller shuts off power to the heated tube, as taught by Vos for patient safety [0089].
As modified, the patient end temperature limit of the first power limit, 34 °C, is lower than the patient end temperature limit of the second power limit, 45 °C, and since enthalpy is proportional to temperature, the patient end enthalpy limit of the first power limit is lower than the patient end enthalpy limit of the second power limit.
Regarding claim 40, modified Mcauley teaches the system of claim 34, wherein determining or applying the first power limit and the second power limit on the conduit heating element comprises disabling a component of the system or the entire system if the first power limit or the second power limit on the conduit heating element is exceeded.
However, Bonilla teaches [0049] During the operation of the humidifier, the controller 50 receives the temperature values of plate 6, the gas in the humidification chamber 8 and the gas supplied to the patient 14 to compare them with preset values of these temperatures in the controller 50, so that if there is any difference greater than an error threshold, the power delivered to plate 6 and/or the heating element 9 is varied.
Additionally, Vos teaches [0088] The heated tube 320 may be used to deliver the comfort of warm, humidified air and minimise condensation in the tubing. Referring to FIG. 19, an algorithm for controlling a heated tube is shown. The algorithm starts at S300 and determines the temperature sensed by a temperature sensor in the heated tube (e.g. thermistor 410) in S302. The algorithm proceeds to S306 and determines if the sensed temperature is outside a predetermined range. If the temperature of the heated tube is not outside the predetermined range (S306: No), the algorithm ends in S316. Conversely, if the temperature is outside the predetermined range (S306: Yes) the algorithm proceeds to S310 and it is determined if the temperature is above the predetermined range. If the temperature is below the predetermined range (S310: No), the algorithm proceeds to S312 and power is supplied to the heated tube. If the sensed temperature is above the predetermined range (S310: Yes), the algorithm proceeds to S314 shuts off power to the heated tube. After the completion of S312 or S314 the algorithm returns to the beginning in S300, thus providing temperature control for the heated tube. [0089] The control of the heated tube may involve several considerations. Another consideration is, for safety, a failsafe mechanism may be provided to ensure the delivered air temperature does not exceed a safe temperature limit. [0094] The predetermined temperature is set at a temperature to meet appropriate safety requirements of the heated tube, such as between 30.degree. C. and 45.degree. C., preferably 38.degree. C. to 43.degree. C.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the switched mode power supply and controller of modified Mcauley to implement a failsafe mechanism where if the sensed temperature of gas supplied to the patient in the heated tube is above a predetermined range of 30 °C and 45 °C, the controller shuts off power to the heated tube, as taught by Vos for patient safety [0089].
Regarding claim 41, modified Mcauley teaches the system of claim 40, wherein disabling a component of the system comprises disabling the conduit heating element (Vos: [0088]).
Claim(s) 49-51 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mcauley et al. (US 20150217079 A1) and Bonilla et al. (WO 2015082970 A1), as applied to claim 34 above, and further in view of Kurja et al. (WO 2017036500 A1).
Regarding claim 49, modified Mcauley teaches the system of claim 34, wherein the first power limit is configured to keep a user end temperature of the gases under a first temperature limit (Mcauley: [0206] The controller 109 then operates the humidification breathing apparatus to achieve and maintain the target humidity and temperature. In this embodiment, the controller does this by controlling the heater plate (HP) 108 to control target humidity and the heater (HBT) 101a in the breathing tube to control target temperature…to control the heated breathing tube to achieve the target temperature (end of hose temperature 44a), the controller 109 uses the target temperature along with ambient temperature 19a, and average flow 42a and heater plate temperature 43a as inputs into a neural network model or equations 121 that outputs the target power 43b for the heated breathing tube 101 to achieve the target end of hose temperature 44a), and the second power limit is configured to keep the user end temperature of the gases under a second temperature limit (Bonilla: [0049] During the operation of the humidifier, the controller 50 receives the temperature values of plate 6, the gas in the humidification chamber 8 and the gas supplied to the patient 14 to compare them with preset values of these temperatures in the controller 50, so that if there is any difference greater than an error threshold, the power delivered to plate 6 and/or the heating element 9 is varied. [0054] Procedure 100 begins in stage 10 where operating temperatures (set point) are established for the heating plate; the heating element, the gases supplied by the humidification chamber and the gases supplied to the patient. Subsequently, a 120 start-up stage is performed in which the power is delivered in greater quantity to the heating plate with respect to the power delivered to the heating element until a maximum power supplied to the heating plate is reached. [0056] a stabilization stage 140 is performed where the temperatures in the tube heater and the heating plate are within the error range, and where the device delivers 50 to 80% of the total power to the tube heater and 20 to 50% to the heating plate), wherein the first temperature limit is from about 32°C to about 45°C (Mcauley: [0110] once determined, M.sub.h, M.sub.t become known parameters that are inputs 42d, 42e into a target humidity and temperature model 50 that is based on (a "reverse") of the patient contribution model for humidity and temperature, along with other inputs to produce the end of conduit (hose) (target) humidity (EOH_AH) 44b and temperature (EOH_T) 44a. The inputs to the model 50 also optionally include patient temperature 19d and patient absolute humidity (AH) 19e--being the temperature and humidity of the air exhaled by the patient. Rather than direct inputs these can be included intrinsically in the model (as is the case in FIG. 5), but can still be considered model inputs. As an example, average values obtained from literature (e.g. 34.degree. C., 85%, 32 mg/L) could be used), but is silent as to wherein the second temperature limit is from about 43°C to about 63°C, wherein the first enthalpy limit is from about 122 kJ/m3 to about 216 kJ.
However, Kurja teaches a humidifier system (figure 1) comprising a temperature limit from about 43°C to about 63°C (the target temperature of the breathable gas is in the range between 20.0 degrees and 45.0 degrees; pg. 13 line 4-6. Also see pg. 24 line 18-pg. 25 line 29).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the switched mode power supply of modified Mcauley to keep the target temperature of the breathable gas is in the range between 20.0 degrees and 45.0 degrees Celsius, in order to minimize condensation inside the breathing tube as taught by Kurja (pg. 4 line 12-14).
Regarding claim 50, modified Mcauley teaches the system of claim 49, but is silent as to wherein the system is configured to apply the first power limit or the second power limit to keep the user end temperature under the second temperature limit (see modification above) or the second enthalpy limit using a CPU or electronic circuitry outside of the CPU.
Additionally, Kuraj teaches the processing unit 23 may be provided with a comparator unit arranged for comparing the ambient temperature detected to at least one or more predetermined thresholds. The comparator may further take into account other information that may be stored in the processor unit memory or received by sensors in order to generate at least one control signal for at least operating the switches 29 of the switching mechanism 23. For example, the comparator may compare the ambient temperature detected to a predetermined ambient temperature threshold, so as to decide whether the temperature of the breathable gas needs to be adjusted; figure 14-15; pg. 28 line 11-20.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the controller of modified Mcauley to implement the control of the switched mode power supply via a comparator in order to facilitate the adjustment of the temperature within the temperature limit (which is done by controlling power to the heater plate and heated breathing tube-Bonilla), as taught by Kuraj pg. 28 line 11-20.
Regarding claim 51, modified Mcauley teaches the system of claim 49, wherein the first power limit or the second power limit to keep the user end temperature or enthalpy under the second temperature limit (see modification above) or the second enthalpy limit is applied by triggering a first protection circuit (switched mode power supply of Bonilla) that comprises a comparator.
Additionally, Kuraj teaches the processing unit 23 may be provided with a comparator unit arranged for comparing the ambient temperature detected to at least one or more predetermined thresholds. The comparator may further take into account other information that may be stored in the processor unit memory or received by sensors in order to generate at least one control signal for at least operating the switches 29 of the switching mechanism 23. For example, the comparator may compare the ambient temperature detected to a predetermined ambient temperature threshold, so as to decide whether the temperature of the breathable gas needs to be adjusted; pg. 28 line 11-20.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the controller of modified Mcauley to implement the control of the switched mode power supply via a comparator in order to facilitate the adjustment of the temperature within the temperature limit (which is done by controlling power to the heater.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mautin I Ashimiu whose telephone number is (571)272-0760. The examiner can normally be reached Monday - Friday, 7:30 a.m. - 4:30 p.m. ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kendra Carter can be reached at 571-272-9034. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/M.I.A./Examiner, Art Unit 3785
/VALERIE L WOODWARD/Primary Examiner, Art Unit 3785
Prosecution Insights