DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
Examiner acknowledges the reply filed on 02/27/2026 in which claims 44-47, 49-51, 53-54, 56-57, and 60 have been amended, claims 59 and 62-63, and claims 64-68 are added. Currently, claims 44-58, 60-61, and 64-68 are pending for examination in this application.
Response to Arguments
Applicant has resolved the claim objections.
Applicant’s arguments, see Remarks pg. 5-7, filed 02/27/2026, with respect to the rejection(s) of amended independent claim 44 under 35 U.S.C. § 102(a)(2) in view of Westfall have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Westfall (US 20200368482 A1) and White et al. (US 20160193438 A1).
Claim Rejections - 35 USC § 101
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 67-68 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 67 recites "wherein the gas sampling device is positioned at the patient’s nose". This limitation should be amended to functionally recite " wherein the gas sampling device is configured to be positioned at the patient’s nose ".
Claim 68 recites "wherein the gas sampling device is positioned at the patient’s mouth". This limitation should be amended to functionally recite " wherein the gas sampling device is configured to be positioned at the patient’s mouth ".
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 44-45, 47-58, 60-61, and 64-68 is/are rejected under 35 U.S.C. 103 as being unpatentable over Westfall (US 20200368482 A1) and White et al. (US 20160193438 A1).
Regarding claim 44, Westfall discloses a respiratory system (O2 Concentrator and Control Method; title; see figure 1, 4, and 7), comprising:
a flow generator ([0056] oxygen concentrator 100/400/510/610; figure 1 and 4-7) to provide a gas flow to a patient ([0056] the ventilator 200 may instruct the oxygen concentrator 100 to produce a specific flow (e.g. volume flow) of gas having a specific oxygen concentration), the gas flow comprising a delivered gas flow oxygen fraction ([0056] specific oxygen concentration. [0081] known oxygen concentration of the gas supplied from the oxygen concentrator 100, 400, 510, 610, for example, based on the current/previous setpoint issued by the controller 30 and/or a measurement of the oxygen concentration sensor 190); and
a controller (controller 30 of ventilator 200; figure 7) configured to:
receive an input relating to a measured oxygen fraction at a patient's nose, mouth, or both (see [0039-0040] and [0075], [0075]: controller 30 receives input from “one or both of a valve pressure sensor 34 and a patient interface pressure sensor 36 to measure the pressure and may communicate with the flow sensor 43 to measure the flow” and “may calculate the total flow Q.sub.T based on the measured flow, the measured pressure, and the one or more constants stored in association with the nozzle geometry of the one or more nozzles 15. Based on the calculated total flow Q.sub.T, the controller 30 may further calculate the patient's % FiO.sub.2”; figure 7. Examiner notes % FiO2 is calculated using values measured at the patient ventilation interface, see [0073] “patient interface pressure sensor 36”. Examiner notes Applicant’s specifications pg. 34 line 1-5 indicates the oxygen fraction at a patient’s mouth and/or nose can be obtained in various ways including being determined from output from a sensor).
Westfall is silent as to the controller configured to adjust a flow rate of the gas flow based on the delivered gas flow oxygen fraction and the measured oxygen fraction at the patient's nose, mouth, or both.
Westfall teaches [0076] Based on the calculated total flow Q.sub.T and/or the patient's % FiO.sub.2, the controller 30 may instruct the oxygen concentrator 100, 400, 510, 610, for example, by causing a signal (e.g. a radio frequency wireless signal) to be transmitted from the ventilator 200 to the oxygen concentrator 100, 400, 510, 610. Upon receipt of the signal from the ventilator 200, the oxygen concentrator 100, 400, 510, 610 may adjust the pressure, flow, and/or oxygen concentration of the high oxygen content gas that it produces in order to meet the changing needs of the patient in real time).
White teaches a respiratory system ([1028] flow therapy breathing apparatus 10; figure 38) comprising a controller configured to:
adjust a flow rate of the gas flow ([1030] the controller 13: controls the flow generator 11 to generate a gas flow of the desired flow rate (generated gas flow); figure 38. see [1047-1058] PID, [1048]: when the delivered flow rate is less than PID, the delivered flow rate may be adjusted to a value that meets or exceeds PID) based on the delivered gas flow oxygen fraction ([1054] fraction of delivered oxygen (FdO2)) and the measured oxygen fraction at the patient's nose, mouth, or both ([1054] fraction of inspired oxygen (FiO2)) ([1054] Further display embodiments include displaying fraction of delivered oxygen (FdO2) and displaying the result of calculated (true) fraction of inspired oxygen (FiO2). This may be relevant in situations where PID is not met and room air is entrained. In such a situation, the FiO2 may be lower than FdO2. For example, 50% O2 may be delivered by the cannula (FdO2), however, if PID is not met or exceeded, entrained room air may dilute the FiO2 to a lower level, (e.g., 35%). For example if FdO2=50%, the delivered flow rate=20 L/min and PID is determined to equal 35 L/min, then at PID 15 L/min of room air is entrained at an oxygen concentration of 21%. Therefore at PID FiO2=38%).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Westfall to implement the controller comparing the FiO2 at the patient interface to a fraction of delivered oxygen (oxygen concentration) to determine whether to adjust the delivered gas flow to meet the patient’s inspiratory demand and displaying said values in order to ensure that no ambient air is required or entrained during high flow therapy and allow a medical professional or user to easily determine if peak inspiratory demand is being met, as taught by White [1047] and [1054].
Regarding claim 45, modified Westfall teaches the respiratory system according to claim 44, wherein the input relating to the measured oxygen fraction at the patient's nose, mouth, or both is received from a sensor (Westfall: see [0075], % FiO2 is calculated by values received from “a valve pressure sensor 34 and patient interface pressure sensor 36” and “the flow sensor 43”).
Regarding claim 47, modified Westfall teaches the respiratory system according to claim 44, but is silent as to wherein the input relating to the measured oxygen fraction at the patient's nose, mouth, or both is received via a user input.
However, White teaches [0791] In any embodiment where flow rate is measured using flow sensor, an alternative flow could be determined in another ways—such as by user input, or motor signal/power. It is not necessarily essential that a flow sensor is used to obtain the flow rate.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the Westfall device to determine the flow rate via user input, as taught by White, as it would have been obvious substitution of one known element for another, using the user input taught by White in place of the flow sensor of Westfall, and would provide predictable results, obtaining the flow rate (see White [0791]).
As such modified Westfall teaches wherein the input relating to the oxygen fraction at the patient's nose, mouth, or both is received via a user input, as the flow rate which is used to calculate the patient's % FiO.sub.2.
Regarding claim 48, modified Westfall teaches the respiratory system according to claim 44, wherein the flow generator is configured to provide a high flow gas flow (Westfall: [0060] the oxygen concentrator 100 may vary the total gas output between, for example, 2 L/min and 20 L/min).
Regarding claim 49, modified Westfall teaches the respiratory system according to claim 44, wherein the controller is configured to adjust the flow rate based on a comparison between measured the oxygen fraction at the patient's nose, mouth, or both and the delivered gas flow oxygen fraction (White: see [1048] and [1054]).
Regarding claim 50, modified Westfall teaches the respiratory system according to claim 44, but is silent as to further comprising a humidifier for humidifying the gas flow.
However, White teaches a respiratory system ([1028] flow therapy breathing apparatus 10; figure 38) comprising a humidifier for humidifying the gas flow ([1028] The controller 13 is programmed to control the components of the flow therapy apparatus 10, including: operating the humidifier 12 to humidify and/or heat the generated gas flow).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Westfall to implement a humidifier to humidify and/or heat the generated gas flow, as taught by White in order to improve the user’s comfort.
Regarding claim 51, modified Westfall teaches the respiratory system according to claim 44, wherein the controller is further configured to determine whether the gas flow meets an inspiratory demand of the patient (White: see [1047-1058] PID, [1048]: when the delivered flow rate is less than PID, the delivered flow rate may be adjusted to a value that meets or exceeds PID) based on:
the measured oxygen fraction at the patient's mouth, nose, or both (Westfall: [0075]: controller 30 receives input from “one or both of a valve pressure sensor 34 and a patient interface pressure sensor 36 to measure the pressure and may communicate with the flow sensor 43 to measure the flow” and “may calculate the total flow Q.sub.T based on the measured flow, the measured pressure, and the one or more constants stored in association with the nozzle geometry of the one or more nozzles 15. Based on the calculated total flow Q.sub.T, the controller 30 may further calculate the patient's % FiO.sub.2”; figure 7. Examiner notes % FiO2 is calculated using values measured at the patient ventilation interface, see [0073] “patient interface pressure sensor 36”. White: [1054] Further display embodiments include displaying fraction of delivered oxygen (FdO2) and displaying the result of calculated (true) fraction of inspired oxygen (FiO2). This may be relevant in situations where PID is not met and room air is entrained. In such a situation, the FiO2 may be lower than FdO2. For example, 50% O2 may be delivered by the cannula (FdO2), however, if PID is not met or exceeded, entrained room air may dilute the FiO2 to a lower level, (e.g., 35%). For example if FdO2=50%, the delivered flow rate=20 L/min and PID is determined to equal 35 L/min, then at PID 15 L/min of room air is entrained at an oxygen concentration of 21%. Therefore at PID FiO2=38%); or
a relationship between the measured oxygen fraction at the patient's mouth, nose, or both and the delivered gas flow oxygen fraction (White: [1054] Further display embodiments include displaying fraction of delivered oxygen (FdO2) and displaying the result of calculated (true) fraction of inspired oxygen (FiO2). This may be relevant in situations where PID is not met and room air is entrained. In such a situation, the FiO2 may be lower than FdO2. For example, 50% O2 may be delivered by the cannula (FdO2), however, if PID is not met or exceeded, entrained room air may dilute the FiO2 to a lower level, (e.g., 35%). For example if FdO2=50%, the delivered flow rate=20 L/min and PID is determined to equal 35 L/min, then at PID 15 L/min of room air is entrained at an oxygen concentration of 21%. Therefore at PID FiO2=38%).
Regarding claim 52, modified Westfall teaches the respiratory system according to claim 51, further comprising a user interface (Westfall: [0075] an input 69 such as a touch screen or buttons and an output 62 such as a display; figure 7) but is silent as to the user interface and the controller configured to convey to a user whether the patient is meeting or not meeting the inspiratory demand.
However, White teaches a user interface and the controller configured to convey to a user whether the patient is meeting or not meeting the inspiratory demand ([1050] Additionally, an absolute value of the difference between the delivered flow rate and PID may be displayed, and another mechanism, such as colour, may be used to indicate whether the value is positive (PID exceeded) or negative (PID not exceeded). For example, if the delivered flow rate is 20 Lpm and PID is 30 Lpm, a value of 10 Lpm may be displayed in red to indicate that the delivered flow rate does not exceed PID. If the delivered flow rate is 30 Lpm and PID is 20 Lpm, a value of 10 Lpm may be displayed in, for example, green to indicate that the delivered flow rate exceeds PID by 10 Lpm).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to further modify the device of Westfall to implement the controller displaying whether the patient is meeting or not meeting the peak inspiratory demand as taught by White in order to allow a medical professional or user to easily determine if inspiratory demand is being met.
Regarding claim 53, modified Westfall teaches the respiratory system according to claim 44, wherein the delivered oxygen fraction is 100% (Westfall: [0081] assuming the gas expelled by the one or more nozzles 15 is 100% oxygen…the oxygen concentration of the gas supplied from the expelled by the one or more nozzles 15 may be determined from the known oxygen concentration of the gas supplied from the oxygen concentrator 100, 400, 510, 610, for example, based on the current/previous setpoint issued by the controller 30 and/or a measurement of the oxygen concentration sensor 190).
Regarding claim 54, modified Westfall teaches the respiratory system according to claim 44, wherein the flow rate is about 20 liters per minute or more (Westfall: [0060] By using the bypass flow path 170, the oxygen concentrator 100 may vary the total gas output between, for example, 2 L/min and 20 L/min, with the oxygen concentration varying accordingly from around 93% to around 21%), or between about 20 liters per minute and 90 liters per minute (Westfall: [0060] By using the bypass flow path 170, the oxygen concentrator 100 may vary the total gas output between, for example, 2 L/min and 20 L/min, with the oxygen concentration varying accordingly from around 93% to around 21%),
Regarding claim 55, modified Westfall teaches the respiratory system according to claim 44, but is silent as to wherein the system further comprises or is configured for use with a non-sealing patient interface.
Westfall teaches [0069] The patient ventilation interface 12 may include such devices as a full-face mask or a nasal mask that can be placed in direct gas flow communication with the upper respiratory tract of the patient 13, i.e., the nasal cavity and/or the oral cavity; figure 1, 4, and 7.
Additionally, White teaches [0007] a flow therapy apparatus that delivers gas flow to a patient with a non-sealing patient interface. [0250] Preferably the patient interface is a non-sealing nasal cannula.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the Westfall device to include a non-sealing nasal cannula, as taught by White, as it would have been obvious substitution of one known element for another, using the non-sealing nasal cannula taught by White in place of the full-face mask or nasal mask of Westfall, and would provide predictable results, delivering gas flow to the patient (White [0007]).
Regarding claim 56, modified Westfall teaches the respiratory system according to claim 51, wherein whether the gas flow meets the inspiratory demand (White: [1047-1053] peak inspiratory demand (PID)) comprises comparing the measured oxygen fraction at the patient's mouth, nose, or both with the delivered gas flow oxygen fraction (White: [1054] Further display embodiments include displaying fraction of delivered oxygen (FdO2) and displaying the result of calculated (true) fraction of inspired oxygen (FiO2). This may be relevant in situations where PID is not met and room air is entrained. In such a situation, the FiO2 may be lower than FdO2. For example, 50% O2 may be delivered by the cannula (FdO2), however, if PID is not met or exceeded, entrained room air may dilute the FiO2 to a lower level, (e.g., 35%)).
Regarding claim 57, modified Westfall teaches the respiratory system according to claim 51, wherein the controller is configured to determine:
the gas flow does not meet the inspiratory demand in response to the measured oxygen fraction at the patient's nose, mouth, or both being less than delivered the gas flow oxygen fraction (White: [1054] This may be relevant in situations where PID is not met and room air is entrained. In such a situation, the FiO2 may be lower than FdO2. For example, 50% O2 may be delivered by the cannula (FdO2), however, if PID is not met or exceeded, entrained room air may dilute the FiO2 to a lower level, (e.g., 35%). For example if FdO2=50%, the delivered flow rate=20 L/min and PID is determined to equal 35 L/min, then at PID 15 L/min of room air is entrained at an oxygen concentration of 21%. Therefore at PID FiO2=38%); or
the gas flow meets or is close to the inspiratory demand in response to the measured oxygen fraction at the patient's nose, mouth, or both being equal to or matching delivered the gas flow oxygen fraction (Examiner notes that White [1054] establishes that the gas flow does not meet PID based on the FiO2 being lower than FdO2, thus the gas flow is determined to meet PID if FiO2 is at least higher than FdO2).
Regarding claim 58, modified Westfall teaches the respiratory system according to claim 51, wherein the controller is configured to increase the flow rate in response to determining the inspiratory demand is not being met (White: [1048] Displaying peak inspiratory demand (peak demand), as shown in third information section 1730 of FIG. 81, allows a user to set the flow rate of gas to meet the peak inspiratory demand such that no room air is entrained and the desired FiO2 may be accurately delivered. In particular, when the delivered flow rate is less than PID, the delivered flow rate may be adjusted to a value that meets or exceeds PID. [1052] For example, the entrained flow display may be coloured red until the cannula flow rate is increased to a level in which the entrained flow reaches zero or a negative value, upon which the display may include a green and/or a red/green coloured icon or symbol).
Regarding claim 60, modified Westfall teaches the respiratory system according to claim 51, wherein the controller is configured to maintain the flow rate in response to determining the inspiratory demand is being exceeded (this is a functional limitation: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). White: [1050] If the delivered flow rate is 30 Lpm and PID is 20 Lpm, a value of 10 Lpm may be displayed in, for example, green to indicate that the delivered flow rate exceeds PID by 10 Lpm. If both the delivered flow rate and PID are 25 Lpm, a value of zero (0) may be displayed in, for example, a green/red icon to indicate that the delivered flow rate meets PID. [1052] For example, the entrained flow display may be coloured red until the cannula flow rate is increased to a level in which the entrained flow reaches zero or a negative value, upon which the display may include a green and/or a red/green coloured icon or symbol), maintain the flow rate until the controller determines the inspiratory demand is not being met (this is a functional limitation: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). See White [1048-1053] flow rate is only adjusted when the PID is not being met, thus flow rate is maintained until the PID is not met).
Regarding claim 61, modified Westfall teaches the respiratory system according to claim 51, but is silent as to wherein the controller is further configured to determine the inspiratory demand by: monitoring a set number of previous patient breath cycles; determining a number of previous patient breath cycles that have entrainment of ambient air; and comparing the number of previous patient breath cycles having entrainment of ambient air against a set threshold.
However, White teaches a respiratory system (figure 1) wherein the controller ([0495-0497] controller 13; figure 1) is further configured to determine the inspiratory demand ([0509-0510] and [0522])by:
monitoring a set number of previous patient breath cycles ([0510] the temperature may be continuously monitored so that the flow rate may be adjusted with the patient's inspiratory demand. Monitoring may involve but is not limited to measuring the temperature at the interface for any amount of breaths between 3-720 breaths, or any time period between 5 seconds-1 hour. These ranges serve as examples of possible ranges that could be used to determine monitoring intervals and are in no way limiting to the scope of the patent);
determining a number of previous patient breath cycles that have entrainment of ambient air ([0509] In some embodiments temperature monitoring may be used to determine if any room air may have been entrained during inspiration. The flow delivered by the device or exhaled from the airways may be at a temperature that is different to room air. Room air as described herein, may be but is not limited to being between 20° C.-24° C. Therefore a fast response temperature sensor, such as, but not limited to a thermocouple, thermistor, or the like, may be positioned on the interface (FIG. 4), to detect if room air is passing over the interface or if it may be warmer air from the airways or interface. If inspiratory demand is not met, flow may be entrained over the interface and the temperature may approach room temperature thus may deviate from the temperature delivered by the device or exhaled from the airways. Thus, FIGS. 5-10 show in-vivo tests that were performed on a 28 year old male. The delivered gas temperature is approximately 37° C., thus, troughs represent where cooler room air may have been entrained. As the flow rate is increased, the figures show fewer troughs, until the point where the peak inspiratory flow demand may be met, which in this example may be greater than 35 L/min Here the figures show no troughs, which may indicate that no room air has been entrained. Examiner notes: number of previous breath cycles with entrainment of ambient air is determined by the temperature recorded at the patient interface being close to temperature of room air); and
comparing the number of previous patient breath cycles having entrainment of ambient air against a set threshold ([0510] An example may be if greater than a threshold value, for example, 50% of the measured inspiratory breaths showed a temperature less than the delivered temperature, the flow rate may be increased by 5 L/min. The threshold may be a percentage between 1-100% or may be an absolute number of breaths for example 1-720 breaths. When a threshold is crossed the increase in flow rate may be between 1-20 L/min. [0522] For example, if greater than a threshold value, for example 50% or more than 5, of the measured inspiratory breaths showed a temperature less than the delivered temperature (and the ambient temperature is below the delivered temperature), the flow rate may be increased by 5 L/min).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the controller of Westfall, such that, it is configured to determine the inspiratory demand by: monitoring a set number of previous patient breath cycles; determining a number of previous patient breath cycles that have entrainment of ambient air; and comparing the number of previous patient breath cycles having entrainment of ambient air against a set threshold as taught by White so that the flow rate of the apparatus can be adjusted by the controller according to the patient's inspiratory demand based on temperature monitoring (see White [0522]).
Regarding claim 64, modified Westfall teaches the respiratory system according to claim 44, wherein the measured oxygen fraction at a patient's nose, mouth, or both is determined using a gas sampling device ([0073] The patient interface pressure sensor 36 may also be physically disposed within the ventilator 200 but in direct gas flow communication with the patient ventilation interface 12 over a pressure sensor line 38 that is connected to a sensor inlet port 40 of the ventilator 200; figure 7).
Regarding claim 65, modified Westfall teaches the respiratory system according to claim 64, wherein the gas sampling device is attached to a patient interface ([0073] The patient interface pressure sensor 36 may also be physically disposed within the ventilator 200 but in direct gas flow communication with the patient ventilation interface 12 over a pressure sensor line 38 that is connected to a sensor inlet port 40 of the ventilator 200; figure 7).
Regarding claim 66, modified Westfall teaches the respiratory system according to claim 65, but is silent as to wherein the patient interface is a non-sealing nasal cannula.
Westfall teaches [0069] The patient ventilation interface 12 may include such devices as a full-face mask or a nasal mask that can be placed in direct gas flow communication with the upper respiratory tract of the patient 13, i.e., the nasal cavity and/or the oral cavity; figure 1, 4, and 7.
Additionally, White teaches [0007] a flow therapy apparatus that delivers gas flow to a patient with a non-sealing patient interface. [0250] Preferably the patient interface is a non-sealing nasal cannula.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the Westfall device to include a non-sealing nasal cannula, as taught by White, as it would have been obvious substitution of one known element for another, using the non-sealing nasal cannula taught by White in place of the full-face mask or nasal mask of Westfall, and would provide predictable results, delivering gas flow to the patient (White [0007]).
Regarding claim 67, modified Westfall teaches the respiratory system according to claim 64, wherein the gas sampling device is positioned at the patient's nose ([0073] The patient interface pressure sensor 36 may also be physically disposed within the ventilator 200 but in direct gas flow communication with the patient ventilation interface 12 over a pressure sensor line 38 that is connected to a sensor inlet port 40 of the ventilator 200; figure 7. [0069] The patient ventilation interface 12 may include such devices as a full-face mask or a nasal mask that can be placed in direct gas flow communication with the upper respiratory tract of the patient 13, i.e., the nasal cavity and/or the oral cavity; figure 1, 4, and 7. Examiner notes the pressure sensor line 38 may be connected to the patient ventilation interface 12 at a location at the patient’s nose depending on the type of interface used, i.e. if the interface is a nasal mask).
Regarding claim 68, modified Westfall teaches the respiratory system according to claim 64, wherein the gas sampling device is positioned at the patient's mouth ([0073] The patient interface pressure sensor 36 may also be physically disposed within the ventilator 200 but in direct gas flow communication with the patient ventilation interface 12 over a pressure sensor line 38 that is connected to a sensor inlet port 40 of the ventilator 200; figure 7. [0069] The patient ventilation interface 12 may include such devices as a full-face mask or a nasal mask that can be placed in direct gas flow communication with the upper respiratory tract of the patient 13, i.e., the nasal cavity and/or the oral cavity; figure 1, 4, and 7. Examiner notes the pressure sensor line 38 may be connected to the patient ventilation interface 12 at a location at the patient’s mouth depending on the type of interface used).
Claim(s) 46 is/are rejected under 35 U.S.C. 103 as being unpatentable over Westfall (US 20200368482 A1) and White et al. (US 20160193438 A1) as applied to claim 45 above, and further in view of Trumbower et al. (US 20220401672 A1).
Regarding claim 46, modified Westfall teaches the respiratory system according to claim 45, but is silent as to wherein the sensor is an oxygen fraction sensor.
However, Trumbower teaches a respiratory system (figure 1) comprising an oxygen fraction sensor ([0061] FiO.sub.2 sensor 230; figure 5).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the Westfall device to include a FiO2 sensor, as taught by Trumbower, as it would have been obvious substitution of one known element for another, using the FiO2 sensor taught by Trumbower in place of the calculation of FiO2 from sensor inputs as taught by Westfall, and would provide predictable results, providing data on fraction of inspired oxygen of gas entering the mask of the patient (Trumbower [0061]).
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 Mautin I Ashimiu whose telephone number is (571)272-0760. The examiner can normally be reached Monday - Friday, 7:30 a.m. - 4:30 p.m. ET.
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/M.I.A./Examiner, Art Unit 3785
/VALERIE L WOODWARD/Primary Examiner, Art Unit 3785
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