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 .
Drawings
The drawings are objected to because:
Reference characters “127” (Fig 1A), “223” (Fig 2), “1115” (Fig 11B), “1301” (Fig 13A), “1321” (Fig 13B), “1609” (Fig 16), “1901” (Fig 19), “2001” (Fig 20), “2101” (Fig 21) are not found in the instant specification.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
Reference character “1327” is mislabeled as “1427” in the instant specification (Fig 13B; paragraph 1199).
Reference character “53C” is mislabeled as “53B” in the instant specification (Fig 36; paragraph 1352).
Appropriate correction is required.
Claim Objections
Claims 122, 128, and 131 are objected to because of the following informalities:
The phrase “a condensate” should be changed to –the condensate—for consistency (Claim 122, Line 3).
The phrase “the determination” should be changed to –the condition—for consistency (Claim 128, Line 2).
The phrase “a water out condition” should be changed to –the water out condition—for consistency with Claim 127 (Claim 131, Line 4).
Appropriate correction is required.
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 119-135 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.
Claim 119 states “reducing power to a heater wire of a breathing tube” (Line 6). This statement is indefinite because it is unclear if the heater wire and breathing tube are positively claimed. It appears the applicant was trying to say the controller is configured to perform these steps on a heater wire of a breathing tube and the heater wire and breathing tube are not positively claimed. However, Claim 119 only positively claims a heater plate and controller without any other components involved. It is unclear how the controller would be able to perform the functions involved with the condition of the medical humidifier without the heater wire and breathing tube involved. Therefore, whether or not these components are positively claimed cannot be determined. For examination purposes, the claim limitation will be interpreted as the controller is configured to perform these functions and the heater wire and breathing tube are not positively claimed. Similar rejections are applied to Claims 120-124, 126 (“a dryline” and “a gases source”, Lines 3-4), 132, 133 (“a patient end”, “an outlet of a humidification chamber”, Lines 3-4), 134 (“patient end”, “outlet”, Lines 3-4), and 135.
Claim 131 states “a component” (Line 3). This statement is indefinite because it is unclear which component this is referring to. It appears the applicant was trying to say any component that is connected or involved with the medical humidifier. However, since the previous claims only positively claim the heater plate and controller, it is unclear what component this is referring to. Therefore, the identity of the components involved cannot be determined. For examination purposes, the claim limitation will be interpreted as any component that is connected with the medical humidifier.
Claims 120-135 are rejected for being dependent on rejected Claim 119.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 119, 121, 125, and 136 are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (US 2019/0307978 A1) alone.
Regarding Claim 119, Liu discloses medical humidifier (apparatus of Fig 1; 20 is a humidifier, Fig 1) configured to provide a flow of gases to a patient (40 provides humidified gases to patient, paragraph 0056), the medical humidifier comprising: a heater plate (20 can have a heat source such as a heater plate, paragraph 0055), and a controller (a controller can control gases source to generate gases flow at desired flow rate, temperature, and/or pressure, paragraph 0054) configured to determine a condition of the medical humidifier (output of the sensors can be received by the controller to assist the controller to operate the humidification system 1 in a manner that can provide optimal therapy, paragraph 0057); a heater wire (inspiratory conduit can have an inspiratory heat source, can include a heater wire, expiratory conduit can include an expiratory conduit heat source such as a heater wire, paragraph 0056) of a breathing tube (40 and/or 50, Fig 1).
The current embodiment of Liu fails to explicitly disclose determine a condition of the medical humidifier configured by steps of: reducing power to a heater wire of a breathing tube coupled to the medical humidifier; measuring a condensate metric; determining whether the measured condensate metric satisfies an expected condensate metric; and outputting the condition of the medical humidifier in response to the measured condensate metric not satisfying the expected condensate metric.
However, Liu teaches reducing power to a heater wire of a breathing tube coupled to the medical humidifier (inspiratory conduit heat source can be energized to the maximum duty cycle or a constant power, or at a variable power with a known pattern, which can be a pattern of pulses or a waveform or the like, paragraph 0105; a variable power would imply a reduction in power); measuring a condensate metric (system 1 can include additional sensors, for example, humidity sensors, at or near the humidifier inlet 22, humidifier outlet 24, and/or patient end of the inspiratory conduit 40, paragraph 0072); determining whether the measured condensate metric satisfies an expected condensate metric (other sensors can also be used, alternatively or additionally, for detecting reverse flow, such as inlet and/or outlet humidity sensors, paragraph 0135; incorrect connections of the components can result in the gases being delivered to the patient above or below a desired humidity and/or temperature, paragraph 0005; humidification systems of the present disclosure can detect the existence of a reverse flow condition/situation where a patient is receiving sub-optimal humidity and/or temperature, paragraph 0010; humidity sensor would be utilized to determine whether or not the desired humidity levels are being met); and outputting the condition of the medical humidifier in response to the measured condensate metric not satisfying the expected condensate metric (other sensors can also be used, alternatively or additionally, for detecting reverse flow, such as inlet and/or outlet humidity sensors, paragraph 0135; incorrect connections of the components can result in the gases being delivered to the patient above or below a desired humidity and/or temperature, paragraph 0005; humidification systems of the present disclosure can detect the existence of a reverse flow condition/situation where a patient is receiving sub-optimal humidity and/or temperature, paragraph 0010; if an indication of reverse flow and/or incorrect setup/connections, and/or circuit disconnection conditions is determined, the humidification system can alert 430 the patient/caregiver, the controller can output an error message, an audible alarm sound/buzz, flashing of an error indicator light, or other like methods of alarming the user, paragraph 0067; humidity sensors would be utilized to determine whether or not the measured humidity level matches a desired humidity level, and if the levels do not match, the system would output an alert) since humidity sensors are capable of being utilized to determine the desired humidity levels involved in the system and to determine the condition of the system (paragraphs 0005, 0010, and 0135).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add humidity sensors in the system at the humidifier inlet and outlet and at the patient end of the inspiratory conduit, as taught by Liu, since humidity sensors are capable of being utilized to determine the desired humidity levels involved in the system and to determine the condition of the system (Liu: paragraphs 0005, 0010, and 0135). Liu already teaches that the humidity sensors can be utilized to ensure the desired humidity levels in the system are achieved. This would improve on the controller’s functions by giving a more accurate picture of how the system is operating and improves error detection. Since Liu already teaches that certain conditions of the system can lead to sub-optimal humidity levels or humidity levels greater or lesser than the desired humidity level, one of ordinary skill in the art would obviously be motivated to track the humidity level through these humidity sensors to ensure an optimal humidity level is met and to correct errors in the system. It is noted that the phrase “condensate metric” is being interpreted as a measurement tied to or related to condensate. By broadest reasonable interpretation, a measurement of the humidity level would reasonably meet the claim limitation of a “condensate metric”. It is also noted that the reduction of power to the heater wire is not claimed as being tied to any response to the condition determined by the controller.
Regarding Claim 121, Liu teaches the power to the heater wire of the breathing tube is reduced for a predetermined period of time (inspiratory conduit heat source can be energized to the maximum duty cycle or a constant power, or at a variable power with a known pattern, which can be a pattern of pulses or a waveform or the like, paragraph 0105; since the variable power follows a known pattern or waveform, the reduction of power would obviously be for a predetermined period of time since the pattern or waveform is predetermined).
Regarding Claim 125, Liu teaches the condition comprises a reverse flow condition (other sensors can also be used, alternatively or additionally, for detecting reverse flow, such as inlet and/or outlet humidity sensors, paragraph 0135; humidification systems of the present disclosure can detect the existence of a reverse flow condition/situation where a patient is receiving sub-optimal humidity and/or temperature, paragraph 0010; if an indication of reverse flow and/or incorrect setup/connections, and/or circuit disconnection conditions is determined, the humidification system can alert 430 the patient/caregiver, the controller can output an error message, an audible alarm sound/buzz, flashing of an error indicator light, or other like methods of alarming the user, paragraph 0067).
Regarding Claim 136, Liu discloses a method of determining a condition (output of the sensors can be received by the controller to assist the controller to operate the humidification system 1 in a manner that can provide optimal therapy, paragraph 0057) of a medical humidifier (apparatus of Fig 1; 20 is a humidifier, Fig 1) configured to provide gases to a patient (40 provides humidified gases to patient, paragraph 0056), the method comprising: wherein the medical humidifier comprises a heater plate (20 can have a heat source such as a heater plate, paragraph 0055); a controller (a controller can control gases source to generate gases flow at desired flow rate, temperature, and/or pressure, paragraph 005).
The current embodiment of Liu fails to explicitly disclose reducing power to a heater wire of a breathing tube coupled to the medical humidifier; measuring a condensate metric; determining whether the measured condensate metric satisfies an expected condensate metric; and outputting the condition of the medical humidifier to the controller of the medical humidifier in response to the measured condensate metric not satisfying the expected condensate metric.
However, Liu teaches reducing power to a heater wire of a breathing tube coupled to the medical humidifier (inspiratory conduit heat source can be energized to the maximum duty cycle or a constant power, or at a variable power with a known pattern, which can be a pattern of pulses or a waveform or the like, paragraph 0105; a variable power would imply a reduction in power); measuring a condensate metric (system 1 can include additional sensors, for example, humidity sensors, at or near the humidifier inlet 22, humidifier outlet 24, and/or patient end of the inspiratory conduit 40, paragraph 0072); determining whether the measured condensate metric satisfies an expected condensate metric (other sensors can also be used, alternatively or additionally, for detecting reverse flow, such as inlet and/or outlet humidity sensors, paragraph 0135; incorrect connections of the components can result in the gases being delivered to the patient above or below a desired humidity and/or temperature, paragraph 0005; humidification systems of the present disclosure can detect the existence of a reverse flow condition/situation where a patient is receiving sub-optimal humidity and/or temperature, paragraph 0010; humidity sensor would be utilized to determine whether or not the desired humidity levels are being met); and outputting the condition of the medical humidifier to the controller of the medical humidifier in response to the measured condensate metric not satisfying the expected condensate metric (other sensors can also be used, alternatively or additionally, for detecting reverse flow, such as inlet and/or outlet humidity sensors, paragraph 0135; incorrect connections of the components can result in the gases being delivered to the patient above or below a desired humidity and/or temperature, paragraph 0005; humidification systems of the present disclosure can detect the existence of a reverse flow condition/situation where a patient is receiving sub-optimal humidity and/or temperature, paragraph 0010; if an indication of reverse flow and/or incorrect setup/connections, and/or circuit disconnection conditions is determined, the humidification system can alert 430 the patient/caregiver, the controller can output an error message, an audible alarm sound/buzz, flashing of an error indicator light, or other like methods of alarming the user, paragraph 0067; humidity sensors would be utilized to determine whether or not the measured humidity level matches a desired humidity level, and if the levels do not match, the system would output an alert) since humidity sensors are capable of being utilized to determine the desired humidity levels involved in the system and to determine the condition of the system (paragraphs 0005, 0010, and 0135).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add humidity sensors in the system at the humidifier inlet and outlet and at the patient end of the inspiratory conduit, as taught by Liu, since humidity sensors are capable of being utilized to determine the desired humidity levels involved in the system and to determine the condition of the system (Liu: paragraphs 0005, 0010, and 0135). Liu already teaches that the humidity sensors can be utilized to ensure the desired humidity levels in the system are achieved. This would improve on the controller’s functions by giving a more accurate picture of how the system is operating and improves error detection. Since Liu already teaches that certain conditions of the system can lead to sub-optimal humidity levels or humidity levels greater or lesser than the desired humidity level, one of ordinary skill in the art would obviously be motivated to track the humidity level through these humidity sensors to ensure an optimal humidity level is met and to correct errors in the system. It is noted that the phrase “condensate metric” is being interpreted as a measurement tied to or related to condensate. By broadest reasonable interpretation, a measurement of the humidity level would reasonably meet the claim limitation of a “condensate metric”. It is also noted that the reduction of power to the heater wire is not claimed as being tied to any response to the condition determined by the controller.
Claim 120 is rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (US 2019/0307978 A1) in view of Payton et al. (US 2008/0028850 A1).
Regarding Claim 120, Liu fails to explicitly teach reducing the power to the heater wire of the breathing tube comprises disabling the power to the heater wire.
However, Payton, of the same field of endeavor, teaches a system involving a heater wire (paragraph 0034) including reducing the power to the heater wire of the breathing tube comprises disabling the power to the heater wire (heater wire is commonly driven either with direct current (DC) or alternating current (AC) and in both cases the heating voltage is usually switched on and off to control the power applied to the heating element, paragraph 0034) since it is common for the heater wire to have its heating voltage switched on and off to control power to the heating element (paragraph 0034).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to disable or turn off the power to the heater wire, as taught by Payton, since it is common for the heater wire to have its heating voltage switched on and off to control power to the heating element (Payton: paragraph 0034).
Claims 122-124, 126, and 137 are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (US 2019/0307978 A1) in view of Newland et al. (US 2017/0035985 A1).
Regarding Claim 122, Liu teaches determining whether the measured condensate metric satisfies the expected condensate metric comprises comparing a condensate metric in the breathing tube to a predetermined threshold (Liu: other sensors can also be used, alternatively or additionally, for detecting reverse flow, such as inlet and/or outlet humidity sensors, paragraph 0135; incorrect connections of the components can result in the gases being delivered to the patient above or below a desired humidity and/or temperature, paragraph 0005; humidification systems of the present disclosure can detect the existence of a reverse flow condition/situation where a patient is receiving sub-optimal humidity and/or temperature, paragraph 0010; if an indication of reverse flow and/or incorrect setup/connections, and/or circuit disconnection conditions is determined, the humidification system can alert 430 the patient/caregiver, the controller can output an error message, an audible alarm sound/buzz, flashing of an error indicator light, or other like methods of alarming the user, paragraph 0067; a threshold must exist for the humidity sensor to determine whether or not the humidity levels are optimal). Liu does not explicitly teach the condensate metric is a condensate level.
However, Newland, of the same field of endeavor, teaches a humidification arrangement (Abstract) including the use of a condensate level via a condensate sensor to adjust the heat/moisture output of the conduit heater and humidification arrangement (condensation sensor adapted to determine the presence or degree of condensate in the conduit, may be used to adjust the heat output of the conduit heater, the moisture output of the humidification arrangement 412, the moisture and/or heat output of the compartments of the humidification arrangement 412, paragraph 0146) since this is a known sensor for adjusting the heat/moisture output of the humidification system that functions similarly to a humidity sensor.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to replace the humidity sensors with condensation sensors, as taught by Newland, since this is a known sensor for adjusting the heat/moisture output of the humidification system that functions similarly to a humidity sensor. One of ordinary skill in the art would obviously recognize that measuring the humidity of a conduit and the condensate in a conduit are obvious alternate ways to determine the status of a humidification system.
Regarding Claim 123, Liu-Newland combination teaches the measured condensate metric not satisfying the expected condensate metric comprises the condensate level in the breathing tube being greater than the predetermined threshold (Liu: other sensors can also be used, alternatively or additionally, for detecting reverse flow, such as inlet and/or outlet humidity sensors, paragraph 0135; incorrect connections of the components can result in the gases being delivered to the patient above or below a desired humidity and/or temperature, paragraph 0005; humidification systems of the present disclosure can detect the existence of a reverse flow condition/situation where a patient is receiving sub-optimal humidity and/or temperature, paragraph 0010; Boolean conditions can include, for example, whether a parameter is above or below a threshold, paragraph 0122).
Regarding Claim 124, Liu-Newland combination teaches the measured condensate metric not satisfying the expected condensate metric comprises the condensate level in the breathing tube being less than the predetermined threshold (Liu: other sensors can also be used, alternatively or additionally, for detecting reverse flow, such as inlet and/or outlet humidity sensors, paragraph 0135; incorrect connections of the components can result in the gases being delivered to the patient above or below a desired humidity and/or temperature, paragraph 0005; humidification systems of the present disclosure can detect the existence of a reverse flow condition/situation where a patient is receiving sub-optimal humidity and/or temperature, paragraph 0010; Boolean conditions can include, for example, whether a parameter is above or below a threshold, paragraph 0122).
Regarding Claim 126, Liu does not explicitly teach determining whether the measured condensate metric does not satisfy the expected condensate metric comprises determining whether a condensate level of a dryline connected to the medical humidifier and a gases source is greater than a condensate level of the breathing tube.
However, Newland, of the same field of endeavor, teaches a humidification arrangement (Abstract) including the use of a condensate level via a condensate sensor to adjust the heat/moisture output of the conduit heater and humidification arrangement (condensation sensor adapted to determine the presence or degree of condensate in the conduit, may be used to adjust the heat output of the conduit heater, the moisture output of the humidification arrangement 412, the moisture and/or heat output of the compartments of the humidification arrangement 412, paragraph 0146) since this is a known sensor for adjusting the heat/moisture output of the humidification system that functions similarly to a humidity sensor.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to replace the humidity sensors with condensation sensors, as taught by Newland, since this is a known sensor for adjusting the heat/moisture output of the humidification system that functions similarly to a humidity sensor. One of ordinary skill in the art would obviously recognize that measuring the humidity of a conduit and the condensate in a conduit are obvious alternate ways to determine the status of a humidification system.
Liu-Newland combination fails to explicitly teach determining whether the measured condensate metric does not satisfy the expected condensate metric comprises determining whether a condensate level of a dryline connected to the medical humidifier and a gases source is greater than a condensate level of the breathing tube.
However, Liu further teaches a scenario in which the condensate level of a dryline connected to the medical humidifier would obviously be greater than a condensate level of the breathing tube (Liu: Fig 2A; reverse flow condition and/or incorrect connections, paragraph 0033; expired gases from the patient 2 can become humidified through the humidifier 30 before returning to the gases source 10, paragraph 0058; since dry gases are feeding into 40 and 50, 30 would be expected to have a higher condensate level than 40 and 50) and that the sensors are capable of being placed at or near the humidifier inlet 22, humidifier outlet 24, and/or patient end of the inspiratory conduit 40 (Liu: paragraph 0072). Additionally, Liu teaches the use of temperature sensors to compare differences in temperature at various locations of the system to determine an error in the system (Liu: paragraph 0076).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the controller and utilize the condensation sensors of Newland placed at the humidifier inlet and outlet and at the patient end of the inspiratory conduit to compare and determine whether or not the system is connected correctly, as taught by Liu, since this would be expected results or readings provided by the sensors that would indicate an error in the system. One of ordinary skill in the art would obviously be capable of utilizing the sensors that measure moisture and condensate to determine whether or not the system has an error. Since Liu already teaches the use of temperature sensors to make this determination as well as the various error scenarios involved, it would be an obvious modification to utilize humidity or condensation sensors to determine similar errors or issues in the system.
Regarding Claim 137, Liu teaches determining whether the measured condensate metric satisfies the expected condensate metric comprises comparing a condensate metric in the breathing tube to a predetermined threshold (Liu: other sensors can also be used, alternatively or additionally, for detecting reverse flow, such as inlet and/or outlet humidity sensors, paragraph 0135; incorrect connections of the components can result in the gases being delivered to the patient above or below a desired humidity and/or temperature, paragraph 0005; humidification systems of the present disclosure can detect the existence of a reverse flow condition/situation where a patient is receiving sub-optimal humidity and/or temperature, paragraph 0010; if an indication of reverse flow and/or incorrect setup/connections, and/or circuit disconnection conditions is determined, the humidification system can alert 430 the patient/caregiver, the controller can output an error message, an audible alarm sound/buzz, flashing of an error indicator light, or other like methods of alarming the user, paragraph 0067; a threshold must exist for the humidity sensor to determine whether or not the humidity levels are optimal). Liu does not explicitly teach the condensate metric is a condensate level.
However, Newland, of the same field of endeavor, teaches a humidification arrangement (Abstract) including the use of a condensate level via a condensate sensor to adjust the heat/moisture output of the conduit heater and humidification arrangement (condensation sensor adapted to determine the presence or degree of condensate in the conduit, may be used to adjust the heat output of the conduit heater, the moisture output of the humidification arrangement 412, the moisture and/or heat output of the compartments of the humidification arrangement 412, paragraph 0146) since this is a known sensor for adjusting the heat/moisture output of the humidification system that functions similarly to a humidity sensor.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to replace the humidity sensors with condensation sensors, as taught by Newland, since this is a known sensor for adjusting the heat/moisture output of the humidification system that functions similarly to a humidity sensor. One of ordinary skill in the art would obviously recognize that measuring the humidity of a conduit and the condensate in a conduit are obvious alternate ways to determine the status of a humidification system.
Claims 127-130 and 138 are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (US 2019/0307978 A1) in view of Niu et al. (English Machine Translation of CN 105920715 B provided by Espacenet).
Regarding Claim 127, Liu does teach detecting a water-out condition when there is a greater temperature gradient (Liu: paragraph 0110). Liu fails to teach the condition of the medical humidifier includes no presence of flow or water out in the context of a humidity sensor.
However, Niu, of the same field of endeavor, teaches a humidifier (paragraph 0002) including the condition of the medical humidifier includes water out in the context of a humidity sensor (humidity sensor detects that the current airway humidity is too low, processor can determine that there is almost no water in the current humidification chamber, paragraph 0056) since it is known to utilize humidity sensors to determine whether or not there is water in a humidification chamber (paragraph 0056).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the controller to utilize the humidity sensors to detect a water out condition, as taught by Niu, since it is known to utilize humidity sensors to determine whether or not there is water in a humidification chamber (Niu: paragraph 0056). This usage of the humidity sensors would promote safety of the patient as it would alert the user if the system needs more water on the humidifier.
Regarding Claim 128, Liu-Niu combination teaches the controller is configured to confirm the determination by performing a water out test (Niu: humidity sensor detects that the current airway humidity is too low, processor can determine that there is almost no water in the current humidification chamber, paragraph 0056; the humidity sensor already tests the humidity of the chamber to determine whether or not there is water in the chamber). It is noted that Applicant has not further elaborated on the details and steps involved in a water out test.
Regarding Claim 129, Liu-Niu combination teaches the condensate metric comprises a moisture and/or a humidity (Liu: system 1 can include additional sensors, for example, humidity sensors, at or near the humidifier inlet 22, humidifier outlet 24, and/or patient end of the inspiratory conduit 40, paragraph 0072; moisture is obviously similar to humidity since humidity is known to be the moisture found in a gas).
Regarding Claim 130, Liu-Niu combination teaches the controller is configured to detect the condensate metric in normal use (Liu: system 1 can include additional sensors, for example, humidity sensors, at or near the humidifier inlet 22, humidifier outlet 24, and/or patient end of the inspiratory conduit 40, paragraph 0072) and determine a decrease in the condensate metric over time (Liu: other sensors can also be used, alternatively or additionally, for detecting reverse flow, such as inlet and/or outlet humidity sensors, paragraph 0135; incorrect connections of the components can result in the gases being delivered to the patient above or below a desired humidity and/or temperature, paragraph 0005; humidification systems of the present disclosure can detect the existence of a reverse flow condition/situation where a patient is receiving sub-optimal humidity and/or temperature, paragraph 0010; if an indication of reverse flow and/or incorrect setup/connections, and/or circuit disconnection conditions is determined, the humidification system can alert 430 the patient/caregiver, the controller can output an error message, an audible alarm sound/buzz, flashing of an error indicator light, or other like methods of alarming the user, paragraph 0067; Niu: humidity sensor detects that the current airway humidity is too low, processor can determine that there is almost no water in the current humidification chamber, paragraph 0056; humidity sensors are obviously measuring the humidity over time and would be capable, in connection with the controller, to determine a decrease in the humidity over time; when the water level in the chamber is too low, there would obviously be a decrease in the humidity over time).
Regarding Claim 138, Liu does teach detecting a water-out condition when there is a greater temperature gradient (Liu: paragraph 0110). Liu fails to teach the condition of the medical humidifier includes no presence of flow or water out in the context of a humidity sensor.
However, Niu, of the same field of endeavor, teaches a humidifier (paragraph 0002) including the condition of the medical humidifier includes water out in the context of a humidity sensor (humidity sensor detects that the current airway humidity is too low, processor can determine that there is almost no water in the current humidification chamber, paragraph 0056) since it is known to utilize humidity sensors to determine whether or not there is water in a humidification chamber (paragraph 0056).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the controller to utilize the humidity sensors to detect a water out condition, as taught by Niu, since it is known to utilize humidity sensors to determine whether or not there is water in a humidification chamber (Niu: paragraph 0056). This usage of the humidity sensors would promote safety of the patient as it would alert the user if the system needs more water on the humidifier.
Claim 135 is rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (US 2019/0307978 A1) in view of Smith et al. (WO 2007051230 A1).
Regarding Claim 135, Liu does not teach the controller is configured to remove condensate formed by reducing power to the heater wire.
However, Smith, of the same field of endeavor, teaches a sensing cuff (Abstract) including the controller is configured to remove condensate formed by reducing power to a heater (with the absolute humidity known close to the patient interface (or otherwise within the air delivery conduit), then the system can also reduce heater power as necessary to eliminate condensation of water in the air delivery conduit ('rain-out'), paragraph 0051) to adjust and maintain a specific humidity level (paragraph 0050).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the controller to reduce the heater power of the heater wire to eliminate condensation, as taught by Smith, to adjust and maintain a specific humidity level (Smith: paragraph 0050). Smith teaches that a reduction of heater power can be utilized to eliminate condensation of water, particularly when the humidity is excessive. Having this reduction of heater power would also save energy of the device and, with the humidity sensor, the device would be capable of maintaining a certain amount of heater power without putting in an excess or wasteful amount of heater power.
Allowable Subject Matter
Claims 131-134 would be allowable if the claims are amended to overcome the 35 USC 112(b) rejections above.
Claims 131-134 contain allowable subject matter.
The following is a statement of reasons for the indication of allowable subject matter:
Claim 131 is dependent on Claim 130 and discusses, in response to determining a decrease in a condensate metric over time, increase an operating parameter of the medical humidifier and monitor an increase in the condensate metric, then determine a water out condition if no increase is detected.
Claim 132 is dependent on Claim 119 and discusses the condition being an orientation of the breathing tube.
Prior art similar to the claimed invention are explained below.
Liu et al. (US 2019/0307978 A1) discusses a humidifier. Niu et al. (English Machine Translation of CN 105920715 B provided by Espacenet) also discusses a humidifier. Regarding Claim 131, though Liu-Niu combination is capable of tracking a decrease in the condensate metric over time, Liu-Niu combination does not teach performing a test in which an operating parameter is increased to see if the condensate metric changes. Liu teaches the detection of water-out in the context of a difference in the temperature gradient. In other words, Liu determines a water-out if the heater heats up faster due to the absence of water. Niu merely teaches that a humidity sensor can be used to determine if there’s a water-out in which the humidity sensor detects a decrease in the humidity. There is nothing in Liu or Niu that teaches utilizing the increase of a parameter to influence the sensor to detect a change. Regarding Claim 132, Liu does not mention anything about determining the orientation of a breathing tube in the context of a humidity sensor. The prior art also does not teach this concept of detecting and determining the orientation of a breathing tube in relation to a condensate metric.
Claims 133 and 134 contain allowable subject matter due to their dependencies on Claim 132.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 for art cited of interest including:
US 20090223514 A1 discusses a humidifier that uses a humidity sensor to control the device.
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/BRIAN T KHONG/ Examiner, Art Unit 3785
/PAIGE KATHLEEN BUGG/ Primary Examiner, Art Unit 3785
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