DETAILED ACTION
This Office Action is in response to the amendment, filed on September 3, 2026. Primary Examiner acknowledges Claim 1-11, 13-24, and 26 are pending in this application, with Claims 1-11, 13-24, and 26 having been currently amended, and claims 12, 25, and 27 having been cancelled.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-11 and 17-24 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by over Geist et al. (2012/0031405) in view of Burton et al. (6,349,724).
As to Claim 1, Geist discloses a system for regulating the temperature of the brain (“brain cooling system” Abstract) of a human subject, the system comprising: a heat transfer subsystem (10, the combination of 20 for gas delivery and 40 for cooling OR 57 for rewarming – “Brain cooling system 10 includes a gas delivery system 20 and a cooling apparatus 40.” Para 0017, wherein 40 – “The cooling apparatus 40, or the location at which the cooling apparatus 40 cools the respiratory gas to be inhaled by a subject, may even be located just upstream (e.g., within about 18 inches, within about 12 inches, etc.) from the interface element 30, or from a location at which respiratory gas enters the nasal cavity of the subject.” Para 0026, also see: “In some embodiments, the cooling apparatus 40 may utilize known convective heat transfer methods. As an example, the cooling apparatus 40 may include a radiator, heat sink-type configuration that removes heat from the respiratory gas and transfers that heat to the external environment. In some embodiments, the cooling apparatus 40 may employ a coolant (e.g., FREON, etc.). In other embodiments, the cooling apparatus 40 may use one or more thermoelectric Peltier effect devices, such as those manufactured by Tellurex Corporation of Traverse City, Mich., to draw heat directly from a radiator/heat sink.” Para 0027; and wherein 57 - “A rewarming element 57 may enable use of brain cooling system 10 to facilitate a post-cooling increasing the temperature of a subject's brain, or "rewarming." In some embodiments, the rewarming element 57 may comprise an element configured to heat respiratory gas. Such a rewarming element 57 may communicate with the gas delivery system 20, which may introduce heated respiratory gas (relative to the temperature of the previously delivered cool respiratory gas and, in some embodiments, gradually increasing over time) into the subject's nasal cavity. In some embodiments, the cooling apparatus 40 may also serve as a rewarming element 57. By way of non-limiting example, in embodiments where the cooling apparatus 40 comprises one or more thermoelectric Peltier effect devices, reversal of electrical current through the cooling apparatus heats, rather than cools, the side of the cooling apparatus 40 against which respiratory gas flows. Although the rewarming element 57 is depicted in FIG. 1 as comprising at least a part of the same element as the cooling apparatus 40, the cooling apparatus 40 and the rewarming element 57 may comprise separate elements.” Para 0044) configured to receive a breathable gas (22 via 20, “The pressurization apparatus 25 of a gas delivery system 20 of a brain cooling system 10 of the present invention may receive air, oxygen, or an oxygen-rich mixture of gases from a source 22. The source 22 may comprise a source of substantially pure oxygen (e.g., a gas tank, etc., containing the oxygen), the atmosphere, or a combination of the source of oxygen and the atmosphere. ”Para 0018), modify a temperature (via 40 for cooling and via 57 for heating) of the breathable gas (22 via 20), and discharge the breathable gas (22 via 20) to a line (29, “The pressurization apparatus 25 compresses the respiratory gas so that it may be delivered, under positive pressure, to an outlet 26 of the pressurization apparatus, and through an inspiratory breathing conduit 29 that communicates with the interface element 30. In some embodiments, the inspiratory breathing conduit 29 may be coupled directly to the outlet 26 of the pressurization apparatus 25.” Para 0019) coupled to a device (30, “nasal mask…nasal prongs, a cannula style bi-level positive airway pressure (BiPAP) mask, nasal pillows, etc.” Para 0024) adapted to deliver the breathable gas (22 via 20) to a human subject, the heat transfer subsystem (10, the combination of 20 for gas delivery and 40 for cooling OR 57 for rewarming) including a gas block (42’, best seen Figure 2, “Cooling apparatus 40' includes a conduit 41' and a cooling element 42' configured to be disposed within the conduit 41'. Cool and warm fluid transport conduits 46' and 47' enable circulation of a heat transfer fluid 48' between the cooling element 42' and the fluid refrigeration apparatus 49'.” Para 0028; and “may include a radiator, heat sink-type configuration that removes heat from the respiratory gas and transfers that heat to the external environment.” Para 0027) coupled to a thermoelectric cooler (TEC) (“a thermoelectric liquid chiller” via 49, “The fluid refrigeration apparatus 49' may comprise a thermoelectric liquid chiller, such as that available from Solid State Cooling Systems of Wappingers Falls, N.Y., as the OASIS 160, or any other refrigeration device that may cool a heat transfer fluid 48' to a desired temperature (e.g., from about 1.degree. C. to about 35.degree. C., about 10.degree. C. to about 20.degree. C., about 15.degree. C., etc.).” Para 0033) configured such that the breathing gas (22 via 20) is in thermal communication with the thermal electric cooler (“a thermoelectric liquid chiller” via 49) on a condition that the breathable gas (22 via 20) flows within the gas block (42’, best seen Figure 2); a flow control device (25, “Alternatively, or in addition, the pressurization apparatus 25 may include or have associated therewith a control system 60'. In some embodiments, the control system 60' associated with the pressurization apparatus 25 may include a processing element 62' and an input/output element 64'. The input/output element 64' may enable a user to select one or more of a desired gas mixture (e.g., a particular amount of oxygen), a desired pressure, and a desired flow rate of the respiratory gas to be delivered by the pressurization apparatus 25.” Para 0049; “Additionally, in some embodiments of a gas delivery system 20, the pressurization apparatus 25, its outlet 26, and the inspiratory breathing conduit 29 that communicates with the outlet 26 may be configured to deliver the respiratory gas at a flow rate of at least about 25 liters per minute (e.g., 30 liters per minute, 50 liters per minute, 60 liters per minute, etc.). In some embodiments, respiratory gas may be delivered at a rate of up to about 150 liters per minute.” Para 0021) coupled to the heat transfer subsystem (10, the combination of 20 for gas delivery and 40 for cooling OR 57 for rewarming) and configured to control the flow rate of the breathable gas (22 via 20) discharged to the line (29); a first temperature sensor (50, “A temperature sensor 50 associated with a feature of the brain cooling system 10 may be configured to provide a measure of the temperature of respiratory gas. Without limiting the scope of the present invention, a temperature sensor 50 may be positioned at or adjacent to a location of the interface unit 30 where respiratory gas exits the interface unit and/or enters the nasal cavity of a subject. Such an arrangement may enable monitoring of a temperature the respiratory gas at a point of contact with the subject.” Para 0035) configured to measure a temperature of the breathable gas (22 via 20); a second temperature sensor (52, “Alternatively, a temperature sensor 52 may be configured for use in directly monitoring the subject's temperature (e.g., a so-called "physiologic tunnel," such as a medial canthal area on a subject's face (i.e., near the medial corner of each of the subject's eyes), which provides a direct measure of brain temperature; eardrum, or tympanic membrane temperature; temperature within the nasal cavity, etc.).” Para 0034) configured to measure a temperature of a brain or of a brain correlative site of the human subject; and a controller (62, “Some embodiments of a brain cooling system 10 may also include a control system 60, which may comprise a processing element 62, such as a computer processor and associated memory, a microcontroller, or the like. The processing element 62 may be programmed to control operation of at least one of the pressurization apparatus 25, the cooling apparatus 40, any humidification component 55, any rewarming element 57, any body warming element 59, and one or more other elements of the brain cooling system 10.” Para 0046) in communication with the heat transfer subsystem (10, the combination of 20 for gas delivery and 40 for cooling OR 57 for rewarming), the flow control device (25), the first temperature sensor (50), and the second temperature sensor (52), the controller (62) configured to adjust (“By controlling operation of one or more of the pressurization apparatus 25, the cooling apparatus 40 and other components of the brain cooling system 10, the control system 60 may provide control (e.g., enable programming, etc.) over the rate and/or extent of cooling and/or heating.” Para 0046; “In the depicted embodiment, the control system 60 is part of the cooling apparatus 40. The input/output element 64 may enable a user to select a desired temperature to which the respiratory gas will be cooled, or even to which the brain will be cooled.” Para 0048; and “In some embodiments, the control system 60' associated with the pressurization apparatus 25 may include a processing element 62' and an input/output element 64'. The input/output element 64' may enable a user to select one or more of a desired gas mixture (e.g., a particular amount of oxygen), a desired pressure, and a desired flow rate of the respiratory gas to be delivered by the pressurization apparatus 25.” Para 0049) at least one of a cooling rate (via 40), a heating rate (via 57), the temperature of the breathable gas (via feedback control through 60/62/64) or the flow rate (via feedback control through 60/62/64) of the breathable gas (22 via 20) delivered to the human subject based on (“Signals from one or more other sensors of the brain cooling system (e.g., temperature sensor 52, etc.) may be transmitted to and/or received by a processing element 62' associated with the pressurization apparatus 25.” Para 0050 and ”Conversely, the processing element 62 may, in conjunction with one or more sensors or monitors of the brain cooling system, monitor one or more parameters (e.g., the temperature at a specific location of or adjacent to the cooling apparatus 40; the temperature monitored by a sensor 50, 52 associated with the interface element 30 or the subject; the humidity within the subject's nasal cavity; etc.) and, in some embodiments, based on the information, or feedback, provided by such monitoring, provide one or more alarms that enable an individual to manually adjust the delivery of respiratory gas or automatically control operation of one or more features of the cooling apparatus 40 in response to the monitored parameter or parameters (e.g., the temperature of respiratory gas; preventing hypothermia as brain cooling continues, etc.).” Para 0048) at least the temperature of the brain or brain correlative site (52).
In operation it appears, the breathing gas (22 via 20) of Geist is provided to the patient interface (30) along the line (29) which includes the intermediary conduit structure of 41’ as shown in Figure 4 which interacts with Geist’s TEC (49), whereby the TEC (49) of Geist, thermally interacts with the breathing gas within conduit (41’) to permit heat transfer. The TEC (49) heat transfer liquid is directed from 46/47 into the gas block (42’ as best seen in Figure 2) which then interacts thermally with its surface to modify/adjust the temperature of the gas provided to the patient at the patient interface (30). Thus, the gas block (42’ of Figure 2) is coupled to the TEC (49) such that the breathable gas is in thermal communication with the TEC (49) for conditioning the breathing gas within the gas block (42’ of Figure 2).
Yet, Geist does not expressly disclose the explicit use of a “flow rate sensor”.
Burton teaches a similar device for regulating the temperature of the brain of a human subject, comprising: a flow control device (36/46 via 20, “Alternatively the air intake can be a common air intake if the impellers 36 and 46 in FIG. 1 are turned around such that the air intake is between them and the air output would be to chambers which are separate.” Column 3, Lines 45-55; which experiences rotation via “motor 20” Column 3, Lines 30-50); one or more flow rate sensors (195, “Other means for detecting breathing are by measuring air flow movements to the mask 70 from the air supply such as sensors like 195 placed at the entrance to the mask 70. The sensors 195 may be laser sensors, radar Doppler sensors, ultrasonic sensors, ultrasound techniques, pitot tubes, or other electronic or mechanical means for measuring the air passing the sensor.” Column 6, Lines 45-60) configured to measure at least a flow rate of the breathing gas; a first temperature sensor (71, “The sensors 71 used for supplying information about the patient's breathing to the controller or microprocessor 82 may be imbedded in the perimeter of the mask 70 or on the mask surface.” Column 6, Lines 15-25; also see: “For example the sensors 71, 80 may collect data about breathing volumes, breathing rates, breathing times, blood oxygen, EEG, EKG, EOG, EMG, patient pulse, patient temperature, snoring, position of the patient, sleep stages, patient movement, mask pressures, mask leakage, and other relevant data such as would be collected for a Polysomnogram (PSG).” Column 8, Lines 25-45) configured to measure a temperature of the breathing gas; and a second temperature sensor (80, “Other sensors on the patient such as sensor 80 on the patient's chest may be used for supplying information about the patient's breathing to the controller or microprocessor 82.” Column 6, Lines 30-40; also see: “For example the sensors 71, 80 may collect data about breathing volumes, breathing rates, breathing times, blood oxygen, EEG, EKG, EOG, EMG, patient pulse, patient temperature, snoring, position of the patient, sleep stages, patient movement, mask pressures, mask leakage, and other relevant data such as would be collected for a Polysomnogram (PSG).” Column 8, Lines 25-45) configured to measure a temperature of a brain or brain correlative site of a human subject; and a controller (82, “sensors 71, 80 providing data to a controller 82 for application of the proper pressure at the proper time to treat the patient 100.” Column 8, Lines 1-15; “Such data for treating the patient may be sent by leads or by telemetry to the controller 82 for processing and storage.” Column 8, Lines 25-45) in communication with the flow control device (36/46 via 20), the one or more flow rate sensors (195), the first temperature sensor (71, “The sensors 71 can detect leaks or drops in pressure and send signals to microprocessor 82 to increase the pressure sent to the mask 70 to compensate for the leaks. … The microprocessor 82 is programmed to adjust valves in the mask or pressures to the mask to prevent rebreathing.” Column 6, Lines 15-40), the second temperature sensor (80, “Other sensors on the patient such as sensor 80 on the patient's chest may be used for supplying information about the patient's breathing to the controller or microprocessor 82.”Column 6, Lines 30-40), the controller (82) configured to adjust the flow rate (via 82 “programmed to adjust valves” Column 6, Lines 15-40) based on at least the temperature of the brain or brain correlative site (80).
Burton clearly teaches the cooperative feedback control of the sensors (195, 71, and 80) to direct the operation of the flow control device (34/46 via 20) to provide the desired treatment profile to the patient.
In light of the teachings of Burton as modifying Geist, the decision to add an explicit “flow rate sensor” distinct from the first temperature sensor (50) at the patient mask and the second temperature sensor (52) at the brain correlative site, would be obvious to try choosing from a finite number of identified predictable solutions with a reasonable expectation of success, whereby success would be defined by the ability to modify the pressurization and rate of flow of the gas being provided to the patient to ensure the desired treatment profile. Clearly the addition of the flow rate sensor of Burton with the invention of Geist provides a cooperative environment whereby the sensory data is feedback to the breathing gas system to meet the needs of the patient, whereby the breathing gas experiences heat transfer treatment through the TEC (via 49) of Geist to provide heating/cooling via thermal communication of the breathing gas contained within the gas block (42’ of Figure 2) so that the breathing gas that expelled to the patient is properly heated/cooled.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the construction of the flow control device of Geist to additionally include at least one flow rate sensor, as taught by Burton to ensure the proper flow rate of gas is being provided to the patient to support the desired treatment profile.
As to Claim 17, Geist discloses a method for cooling the brain (“brain cooling system” Abstract) of a human subject, the method comprising: receiving a breathable gas (22 via 20, “The pressurization apparatus 25 of a gas delivery system 20 of a brain cooling system 10 of the present invention may receive air, oxygen, or an oxygen-rich mixture of gases from a source 22. The source 22 may comprise a source of substantially pure oxygen (e.g., a gas tank, etc., containing the oxygen), the atmosphere, or a combination of the source of oxygen and the atmosphere. ”Para 0018); cooling (via 40, “The cooling apparatus 40, or the location at which the cooling apparatus 40 cools the respiratory gas to be inhaled by a subject, may even be located just upstream (e.g., within about 18 inches, within about 12 inches, etc.) from the interface element 30, or from a location at which respiratory gas enters the nasal cavity of the subject.” Para 0026, also see: “In some embodiments, the cooling apparatus 40 may utilize known convective heat transfer methods. As an example, the cooling apparatus 40 may include a radiator, heat sink-type configuration that removes heat from the respiratory gas and transfers that heat to the external environment. In some embodiments, the cooling apparatus 40 may employ a coolant (e.g., FREON, etc.). In other embodiments, the cooling apparatus 40 may use one or more thermoelectric Peltier effect devices, such as those manufactured by Tellurex Corporation of Traverse City, Mich., to draw heat directly from a radiator/heat sink.” Para 0027) or heating (via 57, “A rewarming element 57 may enable use of brain cooling system 10 to facilitate a post-cooling increasing the temperature of a subject's brain, or "rewarming." In some embodiments, the rewarming element 57 may comprise an element configured to heat respiratory gas. Such a rewarming element 57 may communicate with the gas delivery system 20, which may introduce heated respiratory gas (relative to the temperature of the previously delivered cool respiratory gas and, in some embodiments, gradually increasing over time) into the subject's nasal cavity. In some embodiments, the cooling apparatus 40 may also serve as a rewarming element 57. By way of non-limiting example, in embodiments where the cooling apparatus 40 comprises one or more thermoelectric Peltier effect devices, reversal of electrical current through the cooling apparatus heats, rather than cools, the side of the cooling apparatus 40 against which respiratory gas flows. Although the rewarming element 57 is depicted in FIG. 1 as comprising at least a part of the same element as the cooling apparatus 40, the cooling apparatus 40 and the rewarming element 57 may comprise separate elements.” Para 0044) the breathable gas (22 via 20) within a gas block (42’, best seen Figure 2, “Cooling apparatus 40' includes a conduit 41' and a cooling element 42' configured to be disposed within the conduit 41'. Cool and warm fluid transport conduits 46' and 47' enable circulation of a heat transfer fluid 48' between the cooling element 42' and the fluid refrigeration apparatus 49'.” Para 0028; and “may include a radiator, heat sink-type configuration that removes heat from the respiratory gas and transfers that heat to the external environment.” Para 0027), the gas block (42’ of Figure 2) including a surface (best seen Figure 2) in thermal communication with a thermoelectric cooler (TEC) (“a thermoelectric liquid chiller” via 49, “The fluid refrigeration apparatus 49' may comprise a thermoelectric liquid chiller, such as that available from Solid State Cooling Systems of Wappingers Falls, N.Y., as the OASIS 160, or any other refrigeration device that may cool a heat transfer fluid 48' to a desired temperature (e.g., from about 1.degree. C. to about 35.degree. C., about 10.degree. C. to about 20.degree. C., about 15.degree. C., etc.).” Para 0033) configured such that the breathable gas (22 via 20) contacts the gas block (42’ of Figure 2) and is in thermal communication with the TEC (a thermoelectric liquid chiller” via 49); discharging the breathable gas (22 via 20) to a line (29 proximate 30, “The pressurization apparatus 25 compresses the respiratory gas so that it may be delivered, under positive pressure, to an outlet 26 of the pressurization apparatus, and through an inspiratory breathing conduit 29 that communicates with the interface element 30. In some embodiments, the inspiratory breathing conduit 29 may be coupled directly to the outlet 26 of the pressurization apparatus 25.” Para 0019) coupled to a device (30, “nasal mask…nasal prongs, a cannula style bi-level positive airway pressure (BiPAP) mask, nasal pillows, etc.” Para 0024) adapted to deliver the breathable gas to a human subject; controlling (via 62, “Some embodiments of a brain cooling system 10 may also include a control system 60, which may comprise a processing element 62, such as a computer processor and associated memory, a microcontroller, or the like. The processing element 62 may be programmed to control operation of at least one of the pressurization apparatus 25, the cooling apparatus 40, any humidification component 55, any rewarming element 57, any body warming element 59, and one or more other elements of the brain cooling system 10.” Para 0046) a flow rate (25, Para 0019-0022; more explicitly: “Moreover, the respiratory gas may be delivered by the pressurization apparatus 25 at a substantially constant rate of flow. "Substantially constant," when used in reference to "rate of flow" or "flow rate," includes, but is not limited to, flow rates that vary by no more than about 10% from a predetermined flow rate.” Para 0023) of the breathable gas discharged to the line (29); measuring at least a temperature of a brain or brain correlative site of the human subject (via 52, “a temperature sensor 52 may be configured for use in directly monitoring the subject's temperature (e.g., a so-called "physiologic tunnel," such as a medial canthal area on a subject's face (i.e., near the medial corner of each of the subject's eyes), which provides a direct measure of brain temperature; eardrum, or tympanic membrane temperature; temperature within the nasal cavity, etc.).)” Para 0034) and a temperature (50, “A temperature sensor 50 associated with a feature of the brain cooling system 10 may be configured to provide a measure of the temperature of respiratory gas. Without limiting the scope of the present invention, a temperature sensor 50 may be positioned at or adjacent to a location of the interface unit 30 where respiratory gas exits the interface unit and/or enters the nasal cavity of a subject. Such an arrangement may enable monitoring of a temperature the respiratory gas at a point of contact with the subject.” Para 0035) of the breathable gas; and adjusting (“By controlling operation of one or more of the pressurization apparatus 25, the cooling apparatus 40 and other components of the brain cooling system 10, the control system 60 may provide control (e.g., enable programming, etc.) over the rate and/or extent of cooling and/or heating.” Para 0046; “In the depicted embodiment, the control system 60 is part of the cooling apparatus 40. The input/output element 64 may enable a user to select a desired temperature to which the respiratory gas will be cooled, or even to which the brain will be cooled.” Para 0048; and “In some embodiments, the control system 60' associated with the pressurization apparatus 25 may include a processing element 62' and an input/output element 64'. The input/output element 64' may enable a user to select one or more of a desired gas mixture (e.g., a particular amount of oxygen), a desired pressure, and a desired flow rate of the respiratory gas to be delivered by the pressurization apparatus 25.” Para 0049) at least one of a cooling rate (via 40), a heating rate (via 57), the temperature of the breathable gas (via feedback control through 60/62/64) or the flow rate (via feedback control through 60/62/64) of the breathable gas (22 via 20) delivered to the human subject based on (“Signals from one or more other sensors of the brain cooling system (e.g., temperature sensor 52, etc.) may be transmitted to and/or received by a processing element 62' associated with the pressurization apparatus 25.” Para 0050 and ”Conversely, the processing element 62 may, in conjunction with one or more sensors or monitors of the brain cooling system, monitor one or more parameters (e.g., the temperature at a specific location of or adjacent to the cooling apparatus 40; the temperature monitored by a sensor 50, 52 associated with the interface element 30 or the subject; the humidity within the subject's nasal cavity; etc.) and, in some embodiments, based on the information, or feedback, provided by such monitoring, provide one or more alarms that enable an individual to manually adjust the delivery of respiratory gas or automatically control operation of one or more features of the cooling apparatus 40 in response to the monitored parameter or parameters (e.g., the temperature of respiratory gas; preventing hypothermia as brain cooling continues, etc.).” Para 0048) at least the temperature of the brain or brain correlative site (52).
In operation it appears, the breathing gas (22 via 20) of Geist is provided to the patient interface (30) along the line (29) which includes the intermediary conduit structure of 41’ as shown in Figure 4 which interacts with Geist’s TEC (49), whereby the TEC (49) of Geist, thermally interacts with the breathing gas within conduit (41’) to permit heat transfer. The TEC (49) heat transfer liquid is directed from 46/47 into the gas block (42’ as best seen in Figure 2) which then interacts thermally with its surface to modify/adjust the temperature of the gas provided to the patient at the patient interface (30). Thus, the gas block (42’ of Figure 2) is coupled to the TEC (49) such that the breathable gas is in thermal communication with the TEC (49) for conditioning the breathing gas within the gas block (42’ of Figure 2).
Yet, Geist does not expressly disclose the explicit use of a “flow rate sensor”.
Burton teaches a similar device for regulating the temperature of the brain of a human subject, comprising: a flow control device (36/46 via 20, “Alternatively the air intake can be a common air intake if the impellers 36 and 46 in FIG. 1 are turned around such that the air intake is between them and the air output would be to chambers which are separate.” Column 3, Lines 45-55; which experiences rotation via “motor 20” Column 3, Lines 30-50); one or more flow rate sensors (195, “Other means for detecting breathing are by measuring air flow movements to the mask 70 from the air supply such as sensors like 195 placed at the entrance to the mask 70. The sensors 195 may be laser sensors, radar Doppler sensors, ultrasonic sensors, ultrasound techniques, pitot tubes, or other electronic or mechanical means for measuring the air passing the sensor.” Column 6, Lines 45-60) configured to measure at least a flow rate of the breathing gas; a first temperature sensor (71, “The sensors 71 used for supplying information about the patient's breathing to the controller or microprocessor 82 may be imbedded in the perimeter of the mask 70 or on the mask surface.” Column 6, Lines 15-25; also see: “For example the sensors 71, 80 may collect data about breathing volumes, breathing rates, breathing times, blood oxygen, EEG, EKG, EOG, EMG, patient pulse, patient temperature, snoring, position of the patient, sleep stages, patient movement, mask pressures, mask leakage, and other relevant data such as would be collected for a Polysomnogram (PSG).” Column 8, Lines 25-45) configured to measure a temperature of the breathing gas; and a second temperature sensor (80, “Other sensors on the patient such as sensor 80 on the patient's chest may be used for supplying information about the patient's breathing to the controller or microprocessor 82.” Column 6, Lines 30-40; also see: “For example the sensors 71, 80 may collect data about breathing volumes, breathing rates, breathing times, blood oxygen, EEG, EKG, EOG, EMG, patient pulse, patient temperature, snoring, position of the patient, sleep stages, patient movement, mask pressures, mask leakage, and other relevant data such as would be collected for a Polysomnogram (PSG).” Column 8, Lines 25-45) configured to measure a temperature of a brain or brain correlative site of a human subject; and a controller (82, “sensors 71, 80 providing data to a controller 82 for application of the proper pressure at the proper time to treat the patient 100.” Column 8, Lines 1-15; “Such data for treating the patient may be sent by leads or by telemetry to the controller 82 for processing and storage.” Column 8, Lines 25-45) in communication with the flow control device (36/46 via 20), the one or more flow rate sensors (195), the first temperature sensor (71, “The sensors 71 can detect leaks or drops in pressure and send signals to microprocessor 82 to increase the pressure sent to the mask 70 to compensate for the leaks. … The microprocessor 82 is programmed to adjust valves in the mask or pressures to the mask to prevent rebreathing.” Column 6, Lines 15-40), the second temperature sensor (80, “Other sensors on the patient such as sensor 80 on the patient's chest may be used for supplying information about the patient's breathing to the controller or microprocessor 82.”Column 6, Lines 30-40), the controller (82) configured to adjust the flow rate (via 82 “programmed to adjust valves” Column 6, Lines 15-40) based on at least the temperature of the brain or brain correlative site (80).
Burton clearly teaches the cooperative feedback control of the sensors (195, 71, and 80) to direct the operation of the flow control device (34/46 via 20) to provide the desired treatment profile to the patient.
In light of the teachings of Burton as modifying Geist, the decision to add an explicit “flow rate sensor” distinct from the first temperature sensor (50) at the patient mask and the second temperature sensor (52) at the brain correlative site, would be obvious to try choosing from a finite number of identified predictable solutions with a reasonable expectation of success, whereby success would be defined by the ability to modify the pressurization and rate of flow of the gas being provided to the patient to ensure the desired treatment profile. Clearly the addition of the flow rate sensor of Burton with the invention of Geist provides a cooperative environment whereby the sensory data is feedback to the breathing gas system to meet the needs of the patient, whereby the breathing gas experiences heat transfer treatment through the TEC (via 49) of Geist to provide heating/cooling via thermal communication of the breathing gas contained within the gas block (42’ of Figure 2) so that the breathing gas that expelled to the patient is properly heated/cooled.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the construction of the flow control device of Geist to additionally include at least one flow rate sensor, as taught by Burton to ensure the proper flow rate of gas is being provided to the patient to support the desired treatment profile.
As to Claims 2 and 18, the modified Geist, specifically Geist discloses the controller (62) is configured to adjusts the temperature of the breathing gas (22 via 20) and flow rate of the breathable gas delivered to the human subject to provide at least one of therapeutic hypothermic (TH) or targeted temperature management (TTM) to normothermic levels (“methods for returning the temperature of a subject's brain to a state of normal thermia (e.g., normal body temperature)” Para 0005, which includes methodologies of cooling and/or rewarming).
As to Claims 3 and 19, the modified Geist, specifically Geist discloses the controller (62) is configured to control the flow control device (25) to breathable gas at a flow rate in a range of 0 to 50 LPM. Explicitly, Geist discloses “configured to deliver the respiratory gas at a flow rate of at least about 25 liters per minute (e.g., 30 liters per minute, 50 liters per minute…).” (Para 0021) which meet the limitations of the claims.
As to Claims 4 and 20, the modified Geist, specifically Geist discloses the heat transfer subsystem (10, the combination of 20 for gas delivery and 40 for cooling OR 57 for rewarming) is configured receive the breathable gas (via 20) having a temperature in a range of about -10 to about 10 degrees C. Explicitly, Geist discloses “configured to cool the respiratory gas to a desired, or predetermined, temperature (e.g., about 1.degree. C., up to about 35.degree. C., about 10.degree. C. to about 20.degree. C., about 15.degree. C., etc.) or to a temperature within a desired range of temperatures.” (Para 0027). As the disclosure of “about 1.degree. C., … about 10.degree. C.” is within the claimed range of about -10 to about 10 degrees C, the modified Geist meets the limitation of the claims.
As to Claims 5 and 21, the modified Geist, specifically Geist discloses the controller (62) is configured to control heat transfer subsystem (10, the combination of 20 for gas delivery and 40 for cooling OR 57 for rewarming) to cool (via 40) the breathable gas and discharge the breathable gas delivered to the human subject having a temperature in the range of about -14 to about 7 degrees C. Explicitly, Geist discloses “configured to cool the respiratory gas to a desired, or predetermined, temperature (e.g., about 1.degree. C., up to about 35.degree. C., about 10.degree. C. to about 20.degree. C., about 15.degree. C., etc.) or to a temperature within a desired range of temperatures.” (Para 0027). As the disclosure of “about 1.degree. C.” is within the claimed range of -14 to 7 degrees C, Geist meets the limitation of the claims.
As to Claim 6, the modified Geist, specifically Geist discloses the second temperature sensor (52, “a temperature sensor 52 may be configured for use in directly monitoring the subject's temperature (e.g., a so-called "physiologic tunnel," such as a medial canthal area on a subject's face (i.e., near the medial corner of each of the subject's eyes), which provides a direct measure of brain temperature; eardrum, or tympanic membrane temperature; temperature within the nasal cavity, etc.).)” Para 0034) includes a tympanic sensor (“or tympanic membrane temperature” Para 0034) or a temporal artery sensor (“a medial canthal area on a subject's face (i.e., near the medial corner of each of the subject's eyes” Para 0034).
As to Claims 7 and 22, the modified Geist, specifically Geist discloses the device (30, “nasal mask…nasal prongs, a cannula style bi-level positive airway pressure (BiPAP) mask, nasal pillows, etc.” Para 0024) adapted to deliver the breathable gas to a human subject includes a nasal cannula (“nasal mask…nasal prongs, a cannula style bi-level positive airway pressure (BiPAP) mask, nasal pillows, etc.” Para 0024).
As to Claim 8, the modified Geist, specifically Geist discloses first temperature sensors (50) are adapted to be placed on an end of the nasal cannula. Explicitly, Geist discloses the orientation of temperature sensor (50) located in proximity to the device (30, “nasal mask…nasal prongs, a cannula style bi-level positive airway pressure (BiPAP) mask, nasal pillows, etc.” Para 0024), whereby the device can be a nasal cannula.
As to Claims 9 and 23, the modified Geist, specifically Geist discloses the controller (62) is configured to control the flow control device (25) to adjust the pressure of the flow of the breathable gas. Explicitly, Geist discloses “Alternatively, or in addition, the pressurization apparatus 25 may include or have associated therewith a control system 60'. In some embodiments, the control system 60' associated with the pressurization apparatus 25 may include a processing element 62' and an input/output element 64'. The input/output element 64' may enable a user to select one or more of a desired gas mixture (e.g., a particular amount of oxygen), a desired pressure, and a desired flow rate of the respiratory gas to be delivered by the pressurization apparatus 25. … A processing element 62' that receives such signals may be programmed to automatically operate one or more features of the pressurization apparatus 25 in such a way that one or more desired parameters (e.g., gas mix, pressure, flow rate, etc.) are substantially constantly maintained by the pressurization apparatus 25.” (Para 0049).
As to Claims 10 and 24, the modified Geist, specifically Geist discloses the gas block (42’ of Figure 2, “may include a radiator, heat sink-type configuration that removes heat from the respiratory gas and transfers that heat to the external environment.” Para 0027) is comprised of thermally conductive material (“One of the thin sheets or films 43b' may define the at least one channel 45'. As a non-limiting example, each channel 45' may be formed (e.g., thermally, etc.) into the thin sheet or film 43b', which may then be secured (e.g., by an adhesive, by thermal bonding, etc.) adhered to the other thin sheet or film 43a' to complete each channel 45'. Thermal conductivity of the substrate 41' may be enhanced by providing a film 43c' (e.g., laminating a preformed film 43c', forming a film 43c' by a vapor deposition process, forming a film 43c' by sputtering, etc., as known in the art) comprising a more thermally conductive material (e.g., a metal, such as aluminum, etc.) to at least one of the thin sheets or films 43a' or 43b', such as over the protruding areas of thin sheet or film 43b' that define each channel 45'.” Para 0031), the gas block (“a radiator, heat sink-type configuration”) including an inlet (via 29 proximate to 20, as shown in Figure 1, wherein 42’ is connected to 29 and 41’ – “Cooling apparatus 40' includes a conduit 41' and a cooling element 42' configured to be disposed within the conduit 41'. … The conduit 41' may comprise part of the source conduit 23 or of the inspiratory breathing conduit 29 of the gas delivery system 20 (FIG. 1). Alternatively, the conduit 41' may be configured to be coupled to the source conduit 23 or the inspiratory breathing conduit 29, either at an intermediate location or at an end of the source conduit 23 or the inspiratory breathing conduit 29.” Paras 0028-0029) configured to receive the breathable gas (via 20) and an outlet (via 29 proximate 50, as shown in Figure 1, wherein 42’ is connected to 29 and 41’ – “Cooling apparatus 40' includes a conduit 41' and a cooling element 42' configured to be disposed within the conduit 41'. … The conduit 41' may comprise part of the source conduit 23 or of the inspiratory breathing conduit 29 of the gas delivery system 20 (FIG. 1). Alternatively, the conduit 41' may be configured to be coupled to the source conduit 23 or the inspiratory breathing conduit 29, either at an intermediate location or at an end of the source conduit 23 or the inspiratory breathing conduit 29.” Paras 0028-0029) configured to output the breathable gas.
As to Claim 11, the modified Geist, specifically Geist discloses the gas block (42’ of Figure 2, “may include a radiator, heat sink-type configuration that removes heat from the respiratory gas and transfers that heat to the external environment.” Para 0027) includes a plurality of flow channels (defined by the circuitous structure of a radiator - “Cooling apparatus 40' includes a conduit 41' and a cooling element 42' configured to be disposed within the conduit 41'. Cool and warm fluid transport conduits 46' and 47' enable circulation of a heat transfer fluid 48' between the cooling element 42' and the fluid refrigeration apparatus 49'." Para 0028) comprised of thermally conductive material (“One of the thin sheets or films 43b' may define the at least one channel 45'. As a non-limiting example, each channel 45' may be formed (e.g., thermally, etc.) into the thin sheet or film 43b', which may then be secured (e.g., by an adhesive, by thermal bonding, etc.) adhered to the other thin sheet or film 43a' to complete each channel 45'. Thermal conductivity of the substrate 41' may be enhanced by providing a film 43c' (e.g., laminating a preformed film 43c', forming a film 43c' by a vapor deposition process, forming a film 43c' by sputtering, etc., as known in the art) comprising a more thermally conductive material (e.g., a metal, such as aluminum, etc.) to at least one of the thin sheets or films 43a' or 43b', such as over the protruding areas of thin sheet or film 43b' that define each channel 45'.” Para 0031) configured to cool (via 40) the breathable gas and direct the breathable gas to the outlet (via 29 proximate 50, as shown in Figure 1).
Allowable Subject Matter
Claims 13-16 and 26 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Terminal Disclaimer
The terminal disclaimer filed on September 3, 2026, disclaiming the terminal portion of any patent granted on this application has been reviewed and is accepted. The terminal disclaimer has been recorded.
Response to Arguments
Applicant’s arguments with respect to claims have been considered but are moot.
As addressed in the interview summary, mailed on September 1, 2026, Primary Examiner notified Applicant of the modification of Geist with Burton as a potential rejection in light of the teachings of Burton which disclose three sensors (195/71/80), a flow rate sensor (195), a temperature sensor for the breathing gas (71) and a temperature sensor for a brain correlative site (80) which cooperatively operate with a controller (82) to control the flow profile of gases provided to the patient.
Although Primary Examiner appreciates Applicant’s incorporation of Claim 12 and the TEC into the independent claims, with the filing of the terminal disclaimers, Applicant’s amendment does not appear to significantly distinguish the features, structures, and relationship of the TEC of the disclosed invention from that of Geist’s TEC in the instant claims.
As further clarified in this Office Action in the rejection of the claims above and repeated here below, it appears the breathing gas (22 via 20) is provided to the patient interface (30) along the line (29) which includes the intermediary conduit structure of 41’ as shown in Figure 4 which interacts with Geist’s TEC (49). In operation, it appears the TEC (49) of Geist thermally interacts with the breathing gas within conduit (41’) to permit heat transfer. The TEC (49) heat transfer liquid is directed from 46/47 into the gas block (42’ as best seen in Figure 2) which then interacts thermally with its surface to modify/adjust the temperature of the gas provided to the patient at the patient interface (30). Thus, the gas block (42’ of Figure 2) is coupled to the TEC (49) such that the breathable gas is in thermal communication with the TEC (49) for conditioning the breathing gas within the gas block (42’ of Figure 2).
Consequently, although Applicant has provided some further functional developments of Claim 12 to positively recite “thermal communication” and the flow of breathing gas “within the gas block”, whereby the “gas block is coupled to the TEC”, these limitations appear to be still met by the disclosure of Geist.
Nevertheless, reconsideration of dependent claims, Claim 13 and Claim 26, positively reciting the relationship of “a first side of the TEC” and the surface which provides “cooling temperature on a side of the TEC in contact with the gas block”, respectively, has been indicated allowable in light of the amendments to the instant independent claims, Claims 1, and 17, and the filing of the terminal disclaimers. Applicant is invited to place Claims 13 and 26 into independent form to proceed to allowance.
In light of the aforementioned reasoning, the rejection of the claims has been maintained and made FINAL.
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 ANNETTE F DIXON whose telephone number is (571)272-3392. The examiner can normally be reached M-F 9-5 EST with flexible hours.
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 D Carter can be reached on 571-272-9034. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ANNETTE FREDRICKA DIXON
Primary Examiner
Art Unit 3782
/Annette Dixon/Primary Examiner, Art Unit 3785
