DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
This office action is in response to the amendment filed on 9/30/2025. As directed by the amendment, claim 1 has been amended, and claim 23 has been added. As such, claims 1, 6-15 and 17-23 are pending in the instant application.
Applicant has amended claim 1 to address a 112(a) rejection; the 112(a) rejection to claim 1 has been withdrawn as support is provided within [0079], [0294] and specifically [0315].
Response to Arguments
Applicant's arguments see pages 6-9 of Remarks, filed 9/30/2025, have been fully considered but they are not persuasive. Applicant argues that Du and Newlands fail to teach the deficiencies in Martin to reject the CPAP system of claim 1. The examiner respectfully disagrees. Du teaches a controllable heater 32 surrounding the larger diameter portion 28 of the HME as seen in Fig. 3 and [0026], to directly heat the HME. Newlands teaches a system controller 238 configured to control the operation of components of the humidification arrangement 212 using input signals from sensor modules 240 including an ambient humidity sensor and ambient temperature sensor as seen in [0095]. As such, modified Martin teaches a controllable heater 32 of Du surrounding and directly heating exchanger 3120 of Martin, wherein the controller 238 of Newlands controls the heating using input signals from sensor modules 240 of Newlands including an ambient humidity sensor and ambient temperature sensor to adjust direct heating of the HME to regulate a level of condensation within the patient interface and a temperature and moisture of the air inhaled by the patient.
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 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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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.
Claim (s) 1, 6-7, 9-13 and 21-22 is/are rejected under pre-AIA 35 U.S.C. 103 as being unpatentable over Martin (US 20160022948 A1) in view of Du (US 20060124127 A1) and Newland (WO 2015167347 A1).
Regarding claim 1, Martin teaches a CPAP system for providing air at positive pressure for respiratory therapy to a patient (“FIG. 1a shows a system in accordance with the present technology. A patient 1000 wearing a patient interface 3000, receives a supply of air at positive pressure from a PAP device or flow generator 4000. Air from the PAP device is humidified in a humidifier 5000, and passes along a conduit 4170 to the patient 1000.” see [0059]), the CPAP system comprising:
an RPT device (flower generator/blower 4000, see Fig. 1a) configured to supply a flow of air at a therapeutic pressure (“…FIG. 1a, may comprise a flow generator or blower 4000 for supplying pressurised respiratory gas, such as air, to the patient 1000 via an air delivery tube 4170 leading to a patient interface 3000.” See [0093]);
a patient interface forming a plenum chamber pressurizable to the therapeutic pressure (patient interface 3000 includes a plenum chamber 3118 defined by the mask 3110 in which there is an inlet limb 3104 and outlet limb 3106 disposed on opposite sides of the plenum chamber to allow pressure to the therapeutic pressure as seen in Figs. 6b-7 and [0111]), the patient interface including a seal-forming structure (seal-forming structure 3116, see Fig. 6b) configured to form a seal with a region of a patient's face surrounding an entrance to a patient's airways (patient interface 3000 includes a seal-forming structure 3116 used to contact the skin of a patient to form a seal as seen in Fig. 6b and 8 and [0125]);
an air delivery tube (conduit 4170, see Figs. 1a and 10-11) configured to pass the flow of air at the therapeutic pressure from the RPT device to the patient interface (“The conduit 4170 may be coupled with an output of a flow generator 4000, such as a respiratory treatment apparatus, so that the conduit 4170 may direct respiratory treatment to the patient.” See [0141] and Figs. 1a and 10-11);
a heat and moisture exchanger (HME) (exchanger 3120, see Figs. 10-11) configured to retain moisture from a flow of expiratory air from the patient (“…the exchanger 3120 may be implemented to transfer a moisture component of either the expiratory gas or inspiratory gas to the other.” See [0146] and Figs. 10-11; exchanger 3120 is used to retain moisture from the expiratory gas of the patient as seen in [0140] and [0146]), wherein retained moisture from the HME is returned to the flow of air for humidification (moisture from the expiratory flow can be condensed on the exchanger 3120 to be returned to the inspiratory side of the exchanger as described in [0146]);
a controllable heating element (“Wires may be provided to the conduit 4170 that heat the gas travelling to the patient in the inspiratory flow path 3105 by electrical resistance heating, for example. The heating function may be controlled by the control system of the flow generator 4000 or the humidifier 5000.” See [0163]);
a humidity sensor configured to measure humidity and produce one or more output signals (“…automated control of the adjustment mechanism may involve evaluation, such as by a processor-based controller, of signals from one or more sensors, such as a humidity and/or temperature sensor that may be located proximate to either flow path 3105, 3107 of the conduit 4170, in the setting of the portion or size of the area of the exchanger 3120 that can participate in the exchange transfer.” See [0150]);
a controller configured to control power to the controllable heating element (Martin teaches the heating function of the wires provided to conduit 4170 to be controlled by the control system of the flow generator 4000 or the humidifier 5000 as seen in [0163])
but does not teach a controllable heating element provided to the HME and configured and arranged to directly heat the HME;
an ambient humidity sensor configured to measure ambient humidity and produce one or more output signals; and
a controller configured to control power to the controllable heating element at least partially based on said one or more output signals from said ambient humidity sensor to adjust a level of condensation within the patient interface and a temperature and moisture of the air inhaled by the patient.
However, Du teaches a controllable heating element provided to the heating filter element and configured and arranged to directly heat the heating filter element (Du teaches heater 32 (taken as controllable heating element) comprising cylindrical heating element 34 and outer heat insulating cover 35 as seen in Fig. 3 and [0027], wherein cylindrical heating element 34 directly heats the larger diameter portion 28 of the HME as seen in Fig. 3 and [0026]. Furthermore, control unit 12 controls the power supply to the heater elements and monitors the temperature as seen in Fig. 1 and [0030]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the CPAP system taught by Martin to include the controllable heating element taught by Du for a heat insulating cover which will protect and surround the heating element to reduce heat loss to the surrounding room air and prevent burning of the patient and medical personnel (see [0027]).
However, Newlands teaches an ambient humidity sensor (sensor module 240, see Fig. 2; sensor module 240 includes an ambient humidity sensor as seen in [0095]) configured to measure ambient humidity and produce one or more output signals (Newlands teaches an ambient humidity sensor as part of the sensor module 240 where input signals from the sensor modules 240 is used to aid in the control of the humidification arrangement 212 as seen in [0095]); and
a controller configured to control power to the controllable heating element at least partially based on said one or more output signals from said ambient humidity sensor to adjust a level of condensation within the patient interface and a temperature and moisture of the air inhaled by the patient (Newlands teaches a tube heater adding heat to the gases as a function of an input/output signal of a controller (see [0018]) wherein the heat is to reduce the condensation of moisture along the walls of the tube section as seen in [0095]. Newlands further teaches a system controller 238 configured to control the operation of components of the humidification arrangement 212 using input signals from sensor modules 240 including an ambient humidity sensor and ambient temperature sensor as seen in [0095]. Furthermore, the sensor modules 240 can be placed in the patient interface as seen in [0095] to measure the ambient humidity and ambient temperature within the patient interface. Therefore, the ambient humidity sensor and ambient temperature sensor can both be placed within the patient interface and send signals to the controller to control the operation of the tube heater to adjust a level of condensation within the patient interface and a temperature and moisture of the air inhaled by the patient. Not to mention, Newlands teaches a user control interface 120 that a user might use to input commands into the humidification arrangement 112 to view data and/or control its operation and/or the operation of other aspects of the respiratory therapy system 100 as seen in [0080]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the CPAP system taught by Martin in view of Du to include the ambient humidity sensor, ambient temperature sensor, controller and user control interface as taught by Newlands to control the heater based on both sensor inputs/outputs to reduce the condensation of moisture along the walls of the tube section (see [0095]) and user input (see [0080]) to help modulate/control the moisture levels. Modified Martin teaches a controller configured to control power to the controllable heating element at least partially based on said one or more output signals from said ambient humidity sensor to adjust direct heating of the HME to regulate a level of condensation within the patient interface and a temperature and moisture of the air inhaled by the patient (Martin teaches an exchanger 3120 as seen in Figs. 10-11 and [0140] and [0146]. Du teaches a controllable heater 32 surrounding the larger diameter portion 28 of the HME as seen in Fig. 3 and [0026], to directly heat the HME. Newlands teaches a system controller 238 configured to control the operation of components of the humidification arrangement 212 using input signals from sensor modules 240 including an ambient humidity sensor and ambient temperature sensor as seen in [0095]. Wherein, the sensor modules 240 can be placed in the patient interface as seen in [0095] to measure the ambient humidity and ambient temperature within the patient interface. As such, modified Martin teaches a controllable heater 32 of Du surrounding and directly heating exchanger 3120 of Martin, wherein the controller 238 of Newlands controls the heating using input signals from sensor modules 240 of Newlands including an ambient humidity sensor and ambient temperature sensor to adjust direct heating of the HME to regulate a level of condensation within the patient interface and a temperature and moisture of the air inhaled by the patient).
Regarding claim 6, modified Martin teaches the CPAP system of claim 1, and Martin further teaches wherein the HME is provided within the plenum chamber of the patient interface (the exchanger can be positioned within the plenum chamber of the patient interface as seen in [0053] and [0141]).
Regarding claim 7, modified Martin teaches the CPAP system of claim 1, and Martin further teaches wherein the HME is provided upstream of the plenum chamber of the patient interface (the exchanger can be positioned upstream of the plenum chamber of the patient interface (see [0052] and [0141])).
Regarding claim 9, modified Martin teaches the CPAP system of claim 1, and Martin further teaches wherein the seal-forming structure of the patient interface comprises nasal prongs (Martin teaches the patient interface 3120 to be nasal prongs (see [0141]) in which the nasal prongs would form a seal against a user’s nose to provide therapy).
Regarding claim 10, modified Martin teaches the CPAP system of claim 1, and Martin further teaches wherein the seal-forming structure of the patient interface comprises a nasal cushion (Martin teaches the patient interface 3120 to be nasal pillows (see [0141]) in which the nasal pillows would form a seal against a user’s nose to provide therapy).
Regarding claim 11, modified Martin teaches the CPAP system of claim 1, and further teaches wherein the RPT device, the patient interface and/or the air delivery tube comprises one or more sensors (Martin teaches one or more sensors that can be located proximate to either flow path 3105, 3107 of the conduit 4170, in the setting of the portion or size of the area of the exchanger 3120 that can participate in the exchange transfer as seen in [0150] and is therefore located in the conduit 4170 as seen in Figs. 10-11. Additionally, Newlands teaches sensor module 240 comprising an ambient humidity sensor and ambient temperature sensor as seen in [0095].), each of the sensors configured to produce one or more output signals communicated to the controller and wherein adjustment of the controllable heating element is at least partially based on said one or more output signals from said one or more sensors (Newland teaches one or more of the sensor modules 240 to produce signals to controller 238 to aid in the control of the humidification arrangement 212 as seen in [0095], wherein the output signal of the ambient humidity sensor can be used to determined humidity (see [0117]). Therefore, the controller controls controllable heater 32 (taught by Du) at least partially based on the output signal of a sensor).
Regarding claim 12, modified Martin teaches the CPAP system of claim 11, and Martin further teaches wherein the air delivery tube comprises a gas temperature sensor (a temperature sensor can be in the conduit 4170 (see [0150])).
Regarding claim 13, modified Martin teaches the CPAP system of claim 11, and Martin further teaches wherein the RPT device comprises a pressure sensor, a flow sensor, a humidity sensor, and/or a temperature sensor (the flow generator 4000 or PAP device may include transducers such as pressure sensors or flow sensors (see [0178]) to provide signals a controller to provide instructions to the flow generator (see [0116]).).
Regarding claim 21, modified Martin teaches the CPAP system of claim 1, and Newlands further teaches wherein the ambient humidity sensor is provided to a downstream side of the HME (Newlands teaches the one or more sensor modules 240 to be positioned in a gases conduit, a patient interface or located in and/or outside the humidification arrangement as seen in [0095]).
Regarding claim 22, modified Martin teaches the CPAP system of claim 1, and Newland further teach wherein the level of condensation within the patient interface and the temperature and moisture of the air inhaled by the patient is controlled at least partially based on a patient input or setting provided by the patient (Newlands teaches using a tube heater adding heat to the gases as a function of an input/output signal of a controller (see [0018]) wherein the heat is to reduce the condensation of moisture along the walls of the tube section as seen in [0095]. Newlands further teaches a user control interface 120 that a user might use to input commands into the humidification arrangement 112 to view data and/or control its operation and/or the operation of other aspects of the respiratory therapy system 100 as seen in [0080]) which includes controlling the tube heater adjusting the condensation of moisture along the walls of the tube section. As such, by adjusting the condensation of moisture along the walls of the tube section, the temperature and moisture of the air inhaled by the patient and level of condensation within the patient interface will be affected).
Claim 8 is rejected under pre-AIA 35 U.S.C. 103 as being unpatentable over Martin (US 20160022948 A1) in view of Du (US 20060124127 A1) and Newland (WO 2015167347 A1), as applied to claim 7 above, and further in view of Dantanarayana (US 20180264222 A1).
Regarding claim 8, modified Martin teaches the CPAP system of claim 7, but does not teach wherein the HME is provided to an adaptor arranged between the air delivery tube and the patient interface.
However, Dantanarayana teaches wherein the HME is provided to an adaptor arranged between the air delivery tube and the patient interface (“The vent adaptor 9100 may also include an HME clip 9170 and an HME housing 9180 to retain HME material within the vent adaptor 9100…” see [0414] and Fig. 7D).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the CPAP system taught by modified Martin to include an adaptor in which the HME is positioned within as taught by Dantanarayana to have a removable HME unit that can be easily replaced since the housing of the adaptor will just need to be opened to remove the HME (see [0357]).
Claims 14 and 15 are rejected under pre-AIA 35 U.S.C. 103 as being unpatentable over Martin (US 20160022948 A1) in view of Du (US 20060124127 A1) and Newland (WO 2015167347 A1), as applied to claim 11 above, and further in view of Sears (US 20140069428 A1).
Regarding claim 14, Martin in view of Weinstein teaches the CPAP system of claim 11, and Martin further teaches the controller system to allow users to input commands to the processing system through a user input component (see [0115]) but does not teach wherein the RPT device comprises a patient input, and adjustment of the controllable heater element is at least partially based on said patient input.
However, Sears teaches wherein the RPT device comprises a patient input, and adjustment of the controllable heater element is at least partially based on said patient input (“…an OSA respiratory treatment apparatus may be configured to deliver pressure, vent flow (CO.sub.2 washout), humidity/moisture and/or heat to the tastes of the patient as set in "patient comfort" settings by a user interface of the apparatus. Any combination of parameters pressure, flow, moisture and temperature of delivered air may be profiled individually or in any combination.” See [0133]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the CPAP system taught by modified Martin to include a user interface on the respiratory apparatus and to adjust the heat/temperature of the delivered air based on a setting of the user interface as taught by Sears to allow a user to profile the device according to their tastes (see [0133]).
Regarding claim 15, modified Martin teaches the CPAP system of claim 14, and Sears further teaches wherein the patient input comprises a preferred gas temperature setting (Sears teaches allowing a user to set the heat/temperature of the delivered air based on a setting off the user interface (see [0133]). The set heat/temperature of the delivered air would be a preferred gas temperature setting for the user).
Claim 17 is rejected under pre-AIA 35 U.S.C. 103 as being unpatentable Martin (US 20160022948 A1) in view of Du (US 20060124127 A1) and Newland (WO 2015167347 A1), as applied to claim 1 above, and further in view of Pittman (US 20070221224 A1).
Regarding claim 17, modified Martin teaches the CPAP system of claim 1, and Martin further teaches a humidifier provided to the RPT device (see [0059] and [0140]) but does not teach comprising a heated passover humidifier provided to the RPT device.
However, Pittman teaches a heated passover humidifier provided to the RPT device (“Thus, the humidifier 63 may either be a passover or heated humidifier or a subsystem which controls humidity (adding or removing humidity).” see [0052]; Pittman teaches using a gas flow generator 52 with a humidifier (see [0041])).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the CPAP system taught by modified Martin to use a passover humidifier instead of a humidifier as taught by Pittman as they both perform the same function of adding or removing humidity (see [0052]).
Claim 18 is rejected under pre-AIA 35 U.S.C. 103 as being unpatentable over Martin (US 20160022948 A1) in view of Du (US 20060124127 A1) and Newland (WO 2015167347 A1), as applied to claim 1 above, and further in view of Bath (US 8733349 B2).
Regarding claim 18, modified Martin teaches the CPAP system of claim 1, and Martin further teaches further comprising a gas temperature sensor configured to measure a gas temperature of the flow of air (“…automated control of the adjustment mechanism may involve evaluation, such as by a processor-based controller, of signals from one or more sensors, such as a humidity and/or temperature sensor that may be located proximate to either flow path 3105, 3107 of the conduit 4170…” see [0150]) and further teaches sending sensor signals to the processor to make adjustments (see [0150]) but does not teach wherein the controller is configured to control power to the controllable heating element to correct any differences between the gas temperature measured by the gas temperature sensor and a target gas temperature.
However, Bath teaches a gas temperature sensor configured to measure a gas temperature of the flow of air (Bath teaches a flow generator 12 and/or humidifier 15 comprising of a control system and a plurality of sensors including an ambient humidity sensor to detect absolute ambient humidity and a temperature sensor to detect ambient temperature as seen in Col. 6, lines 44-61), wherein the controller is configured to control power to the controllable heating element to correct any differences between the gas temperature measured by the gas temperature sensor and a target gas temperature (the controller determines the temperature sensed by a temperature sensor (S302) and then determines if the temperature is within a predetermined range (S306) as seen in Fig 19 and Col. 9, lines 31-48. If the temperature is not within a predetermined range, power will either be given or removed from the heated tube as seen in Fig. 19).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the CPAP system taught by modified Martin to include the controller taught by Bath to have a failsafe mechanism to ensure the delivered air temperature does not exceed a safe temperature limit (see Col. 9, lines 49-54).
Claim 19 is rejected under pre-AIA 35 U.S.C. 103 as being unpatentable over Martin (US 20160022948 A1) in view of Du (US 20060124127 A1), Newland (WO 2015167347 A1) and Bath (US 8733349 B2), as applied to claim 18 above, and further in view of Harrington (US 10864346 B2).
Regarding claim 19, modified Martin teaches the CPAP system of claim 18, but does not teach wherein the target gas temperature is set based on the ambient humidity measured by the ambient humidity sensor.
However, Harrington teaches wherein the target gas temperature is set based on the ambient humidity measured by the ambient humidity sensor (humidification algorithm receiving inputs such as one or more ambient conditions such as ambient humidity or ambient temperature (see Col. 46, lines 43-49) to manage the humidity of the flow of air which is known in the art to have a correlation with temperature ([0299] from the original disclosure cites “For example, ambient humidity is measured by an ambient humidity sensor (e.g., provided to the RPT device), and the target gas temperature is set based on the measured ambient humidity, e.g., a higher gas temperature is set in higher humidity.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the CPAP system taught by modified Martin to include ambient humidity measured by the ambient humidity sensor as an input for the flow of air humidity as taught by Harrington to have more data and information regarding the gas flow for a more precise control.
Claim 20 is rejected under pre-AIA 35 U.S.C. 103 as being unpatentable over Martin (US 20160022948 A1) in view of Du (US 20060124127 A1), Newland (WO 2015167347 A1) and Bath (US 8733349 B2), as applied to claim 1 above, and further in view of Harrington (US 20160175552 A1)
Regarding claim 20, modified Martin teaches the CPAP system of claim 1, and Martin further teaches exchanger 3120 to promote absorption of liquid (see [0146]) but does not teach wherein the HME comprises a condensation and absorption surface, and the controllable heating element is configured to directly heat the condensation and absorption surface.
However, Harrington teaches wherein the HME comprises a condensation and absorption surface (“Heat and moisture exchangers are generally made up of foam, paper, or a substance capable of acting as a condensation and absorption surface.” See [0064]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the CPAP system taught by modified Martin to have the HME be made up of foam, paper or substance capable of acting as a condensation and absorption surface as taught by Harrington as known in the art. Modified Martin teaches the controllable heating element is configured to directly heat the condensation and absorption surface (Modified Martin teaches the controllable heating element is configured to directly heat the HME (taught by Du) which comprises of a condensation and absorption surface (taught by Harrington)).
Claim 23 is rejected under pre-AIA 35 U.S.C. 103 as being unpatentable over Martin (US 20160022948 A1) in view of Du (US 20060124127 A1) and Newland (WO 2015167347 A1), as applied to claim 1 above, and further in view of Sears (US 20140069428 A1), Harrington (US 20160175552 A1) and Bath (US 8733349 B2).
Regarding claim 23, modified Martin teaches the CPAP system of claim 1, and further teaches comprising a gas temperature sensor configured to measure a gas temperature of the flow of air at the patient interface (Martin teaches a temperature sensor that can be located proximate to either flow path 3105, 3107 of conduit 4170 as seen in Figs. 10-11 and [0150]. Newlands further teaches sensor module 240 comprising an ambient temperature sensor and/or other sensors placed within the patient interface as seen in [0095]) but does not teach further comprising a patient input including a preferred gas temperature setting of the flow of air from the patient, wherein the controller is configured to set a target gas temperature of the flow of air based on the preferred gas temperature setting from the patient and the ambient humidity measured by the ambient humidity sensor, wherein the controller is configured to control power to the controllable heating element to correct any differences between the gas temperature measured by the gas temperature sensor and the target gas temperature based on the preferred gas temperature setting from the patient and the ambient humidity measured by the ambient humidity sensor.
However, Sears teaches comprising a patient input (“…an OSA respiratory treatment apparatus may be configured to deliver pressure, vent flow (CO.sub.2 washout), humidity/moisture and/or heat to the tastes of the patient as set in "patient comfort" settings by a user interface of the apparatus. Any combination of parameters pressure, flow, moisture and temperature of delivered air may be profiled individually or in any combination.” See [0133]) including a preferred gas temperature setting of the flow of air from the patient (Sears teaches allowing a user to set the heat/temperature of the delivered air based on a setting off the user interface (see [0133]). The set heat/temperature of the delivered air would be a preferred gas temperature setting for the user).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the CPAP system taught by modified Martin to include a user interface on the respiratory apparatus and to adjust the heat/temperature of the delivered air based on a setting of the user interface as taught by Sears to allow a user to profile the device according to their tastes (see [0133]).
However, Harrington teaches wherein the target gas temperature is set based on the ambient humidity measured by the ambient humidity sensor (humidification algorithm receiving inputs such as one or more ambient conditions such as ambient humidity or ambient temperature (see Col. 46, lines 43-49) to manage the humidity of the flow of air which is known in the art to have a correlation with temperature ([0299] from the original disclosure cites “For example, ambient humidity is measured by an ambient humidity sensor (e.g., provided to the RPT device), and the target gas temperature is set based on the measured ambient humidity, e.g., a higher gas temperature is set in higher humidity.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the CPAP system taught by modified Martin to include ambient humidity measured by the ambient humidity sensor as an input for the flow of air humidity as taught by Harrington to have more data and information regarding the gas flow for a more precise control.
However, Bath teaches comprising a gas temperature sensor configured to measure a gas temperature of the flow of air (Bath teaches a flow generator 12 and/or humidifier 15 comprising of a control system and a plurality of sensors including an ambient humidity sensor to detect absolute ambient humidity and a temperature sensor to detect ambient temperature as seen in Col. 6, lines 44-61), wherein the controller is configured to control power to the controllable heating element to correct any differences between the gas temperature measured by the gas temperature sensor and a target gas temperature (the controller determines the temperature sensed by a temperature sensor (S302) and then determines if the temperature is within a predetermined range (S306) as seen in Fig 19 and Col. 9, lines 31-48. If the temperature is not within a predetermined range, power will either be given or removed from the heated tube as seen in Fig. 19).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the CPAP system taught by modified Martin to include the controller taught by Bath to have a failsafe mechanism to ensure the delivered air temperature does not exceed a safe temperature limit (see Col. 9, lines 49-54). Modified Martin teaches wherein the controller is configured to set a target gas temperature of the flow of air based on the preferred gas temperature setting from the patient and the ambient humidity measured by the ambient humidity sensor (Sears teaches setting the heat/temperature of the delivered air based on a setting off the user interface (see [0133]), wherein the set/target gas temperature is based on a preferred gas temperature setting from the patient. Harrington teaches having the humidification algorithm received inputs such as ambient humidity (see Col. 46, lines 43-49). [0299] from the original disclosure cites “For example, ambient humidity is measured by an ambient humidity sensor (e.g., provided to the RPT device), and the target gas temperature is set based on the measured ambient humidity, e.g., a higher gas temperature is set in higher humidity. Therefore, modified Martin teaches the controller to set a target gas temperature based on the preferred gas temperature setting from the patient (taught by Sears) and the ambient humidity measured by the ambient humidity sensor (taught by Harrington)), wherein the controller is configured to control power to the controllable heating element to correct any differences between the gas temperature measured by the gas temperature sensor and the target gas temperature based on the preferred gas temperature setting from the patient and the ambient humidity measured by the ambient humidity sensor (Bath teaches the controller determines the temperature sensed by a temperature sensor (S302) and then determines if the temperature is within a predetermined range (S306) as seen in Fig 19 and Col. 9, lines 31-48. If the temperature is not within a predetermined range, power will either be given or removed from the heated tube as seen in Fig. 19. Therefore, modified Martin teaches the controller configured to control power to controllable heater 32 (taught by Du) to give or remove power if the measured temperature is not within a predetermined range (taught by Bath), wherein the predetermined range is the target/preferred gas temperature (taught by Sears and Harrington above)).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Tina Zhang whose telephone number is (571)272-6956. The examiner can normally be reached Monday - Friday 9:00AM-5:00PM.
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/TINA ZHANG/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785