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 .
Claim Objections
Claim 59 is objected to because of the following informalities:
Claim 59, line 1, “A respiratory system” should be “The respiratory system”.
Claim 59, lines 2-4, “litres” should be “liters”.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 44-45, 48-51, 53-54, 58-60, and 63 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Westfall (US 20200368482 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 gas flow oxygen fraction ([0056] specific oxygen concentration); and
a controller (controller 30 of ventilator 200; figure 7) configured to:
receive an input relating to an 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), and
adjust a flow rate of the gas flow based on the oxygen fraction at the patient's nose, mouth, or both ([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).
Regarding claim 45, Westfall discloses the respiratory system according to claim 44, wherein the input relating to the oxygen fraction at the patient's nose, mouth, or both is received from a sensor (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 48, Westfall discloses the respiratory system according to claim 44, wherein the flow generator is configured to provide a high flow gas flow ([0060] the oxygen concentrator 100 may vary the total gas output between, for example, 2 L/min and 20 L/min).
Regarding claim 49, Westfall discloses the respiratory system according to claim 44, wherein the controller is configured to adjust the flow rate based on a relationship between the oxygen fraction at the patient's nose, mouth, or both and the gas flow oxygen fraction ([070] Depending on various factors including, for example, the prescription of the patient 13, the patient's activity level, user-adjustable settings, and the state of the patient's breathing at a given moment, the entrainment flow Q.sub.E (and consequently the total flow Q.sub.T) may vary, causing the patient's fraction of inspired oxygen % FiO.sub.2 to vary as a greater or lesser amount of ambient air is delivered in proportion to the high oxygen content gas expelled by the one or more nozzles 15. By measuring the flow Q.sub.N of gas expelled by the one or more nozzles 15 and the pressure in the patient ventilation interface 12, the ventilator 200 may calculate or estimate the total flow Q.sub.T. The ventilator 200 may instruct the oxygen concentrator 100, 400, 510, 610 to produce a specific flow of gas having a specific oxygen concentration according to the estimated or calculated total flow Q.sub.T. The ventilator 200 may then provide such high oxygen content gas to the patient 13 via the patient ventilation interface 12 such that, taking into account the entrainment of additional ambient air in the patient ventilation interface 12, the patient 13 is provided with a desired degree of assistance to the patient's work of breathing and a target % FiO.sub.2. Examiner notes: as supported in [0075], Q.sub.T is used to calculate FiO.sub.2 at the patient’s mouth and/or nose. [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).
Regarding claim 50, Westfall discloses the respiratory system according to claim 44, further comprising one or more of: an inspiratory tube ([0072] gas delivery conduit 32; figure 7), a conduit including a dry line ([0072] gas delivery conduit 32; figure 7. Examiner is interpreting “dry line” as a conduit that is not heated or humidified), a patient interface ([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), or a filter ([0071] inlet filter 24; figure 7).
Regarding claim 51, Westfall discloses the respiratory system according to claim 44, wherein the controller is further configured to determine whether the gas flow ([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) meets an inspiratory demand of the patient ([0056] Depending on various factors including, for example, the prescription of the patient 13, the patient's activity level, user-adjustable settings, and the state of the patient's breathing in a given moment… the patient 13 is provided with a desired degree of assistance to the patient's work of breathing and a target FiO.sub.2. Examiner notes: at least “the patient’s activity level”, “state of the patient’s breathing”, “the patient's work of breathing and a target FiO.sub.2” are measures of inspiratory demand) based on:
the oxygen fraction at the patient's mouth, nose, or both ([0070] The ventilator 200 may instruct the oxygen concentrator 100, 400, 510, 610 to produce a specific flow of gas having a specific oxygen concentration according to the estimated or calculated total flow Q.sub.T. The ventilator 200 may then provide such high oxygen content gas to the patient 13 via the patient ventilation interface 12 such that, taking into account the entrainment of additional ambient air in the patient ventilation interface 12, the patient 13 is provided with a desired degree of assistance to the patient's work of breathing and a target % FiO.sub.2. [0075] Based on the calculated total flow Q.sub.T, the controller 30 may further calculate the patient's % FiO.sub.2. The controller 30 may continually calculate the total flow Q.sub.T and/or % FiO.sub.2 of the patient 13 in real time as the user's activity level and breathing changes. [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); or
a relationship between the oxygen fraction at the patient's mouth, nose, or both and the gas flow oxygen fraction (Examiner notes: a gas flow having a specific oxygen concentration is delivered to the patient [0056], fraction of inspired oxygen %, FiO2, is calculated [0075], then based on the % FiO2, a signal to adjust the pressure, flow, and/or oxygen concentration of the high oxygen content gas in order to meet the needs of the patient in real time [0076] is sent to the oxygen concentrator to achieve a target % FiO2 [0070], as such determining the target % FiO2 is not being met and a parameter of the gas flow needs to be adjusted is done by determining the calculated % FiO2 is insufficient compared to the previously sent gas flow with a specific oxygen concertation. Additionally supported by the oxygen concentration of the high oxygen content gas being adjusted [0076]).
Regarding claim 53, Westfall discloses the respiratory system according to claim 44, wherein the oxygen fraction at the patient's nose, mouth, or both is at least more than about 21%, between about 30% and about 50%, or 100% (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). Examiner notes: the ranges claimed above are all possible measurements for the patient’s calculated % FiO.sub.2).
Regarding claim 54, Westfall discloses the respiratory system according to claim 44, wherein the flow rate is about 20 litres per minute or more ([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 litres per minute and 90 litres per minute ([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 58, Westfall discloses 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 (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). [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. Examiner notes: an increase in flow rate of the high oxygen content gas is one of the many possible solutions proposed by the controller of the ventilator to “meet the changing needs of the patient in real time”, as determined by changes in measures corresponding to inspiratory demand as noted above).
Regarding claim 59, Westfall discloses the respiratory system according to claim 58, wherein, in response to determining the inspiratory demand is not being met, the flow rate is increased to about 20 litres per minute or more, or between about 20 litres per minute and about 90 litres per minute (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). [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%. [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. Examiner notes: an increase in flow rate of the high oxygen content gas is one of the many possible solutions proposed by the controller of the ventilator to “meet the changing needs of the patient in real time”, as determined by changes in measures corresponding to inspiratory demand as noted above and the oxygen concentrator is capable of increasing the flow rate to about 20 L/min as established by [0060]).
Regarding claim 60, Westfall discloses the respiratory system according to claim 51, wherein the controller is configured to:
maintain or decrease 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). [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. Examiner notes: varying a property of the high oxygen content gas other than the flow rate or decreasing the flow rate of the high oxygen content gas is one of the many possible solutions proposed by the controller of the ventilator to “meet the changing needs of the patient in real time”, as determined by changes in measures corresponding to inspiratory demand as noted above, which includes an inspiratory demand measure being exceeded); or
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). [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. Examiner notes: Westfall only teaches a property of the high oxygen content gas being produced being adjusted when a measure of the inspiratory demand needs to be changed, as such if the measure of the inspiratory demand is as desired, “the pressure, flow, and/or oxygen concentration of the high oxygen content gas” are maintained).
Regarding claim 63, Westfall discloses the respiratory system according to claim 44, wherein the system is configured to provide the gas flow to the patient:
during a sedation procedure (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). Examiner notes: the device of Westfall can be used during a sedation procedure), wherein the gas-flow oxygen fraction is about 21% or more ([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%).
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) 46 is/are rejected under 35 U.S.C. 103 as being unpatentable over Westfall (US 20200368482 A1) as applied to claim 45 above, and further in view of Trumbower et al. (US 20220401672 A1).
Regarding claim 46, Westfall discloses the respiratory system according to claim 45, but is silent as to wherein the sensor is an oxygen fraction sensor coupled to the controller.
However, Trumbower teaches a respiratory system (figure 1) comprising an oxygen fraction sensor coupled to a controller ([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]).
Claim(s) 47, 52, 55-57, and 61-62 is/are rejected under 35 U.S.C. 103 as being unpatentable over Westfall (US 20200368482 A1) as applied to claim 44 above, and further in view of White et al. (US 20160193438 A1).
Regarding claim 47, Westfall discloses the respiratory system according to claim 44, but is silent as to wherein the input relating to the oxygen fraction at the patient's nose, mouth, or both is received via a user input.
However, White teaches a respiratory system (figure 1) wherein [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 52, Westfall discloses the respiratory system according to claim 51, further comprising a user interface ([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 respiratory system ([1030]; see figure 70A-B) wherein determining if peak inspiratory demand ([1047-1053] PID) is met based on fraction of inspired oxygen compared to fraction of delivered oxygen and displayed to a user ([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%)).
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 the delivered gas flow meets the patient’s inspiratory demand and displaying said values as taught by White in order to allow a medical professional or user to easily determine if inspiratory demand is being met.
Regarding claim 55, Westfall discloses 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, Westfall discloses the respiratory system according to claim 51, but is silent as to wherein whether the gas flow meets the inspiratory demand comprises comparing the oxygen fraction at the patient's mouth, nose, or both against the gas flow oxygen fraction.
However, White teaches a respiratory system ([1030]; see figure 70A-B) wherein whether the gas flow meets the inspiratory demand ([1047-1053] peak inspiratory demand (PID)) comprises comparing the oxygen fraction at the patient's mouth, nose, or both against the gas flow oxygen fraction ([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%)).
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 comparing the FiO2 at the patient interface to a fraction of delivered oxygen (oxygen concentration) to determine whether the delivered gas flow meets the patient’s inspiratory demand and display said values as taught by White in order to allow a medical professional to easily determine if inspiratory demand is being met.
Regarding claim 57, Westfall discloses the respiratory system according to claim 51, but is silent as to wherein the controller is configured to determine:
the gas flow does not meet the inspiratory demand in response to the oxygen fraction at the patient's nose, mouth, or both being less than the gas flow oxygen fraction; or
the gas flow meets or is close to the inspiratory demand in response to the oxygen fraction at the patient's nose, mouth, or both being equal to or matching the gas flow oxygen fraction.
However, White teaches a respiratory system ([1030]; see figure 70A-B) wherein determining if peak inspiratory demand ([1047-1053] PID) is met based on fraction of inspired oxygen compared to fraction of delivered oxygen ([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%)). Additionally, White teaches [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.
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 to implement comparing the FiO2 at the patient interface to a fraction of delivered oxygen (oxygen concentration) to determine whether the delivered gas flow meets the patient’s inspiratory demand and display said values as taught by White in order to easily determine if inspiratory demand is being met (see White [1054]) and automatically adjust the flow rate of gas in order to meet the changing needs of the patient in real time if inspiratory demand is not met (see White [1048] and Westfall [0076]).
Regarding claim 61, Westfall discloses 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 Westford, 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 based on temperature monitoring as taught by White in order to so that the flow rate of the apparatus can be adjusted by the controller according to the patient's inspiratory demand (see White [0522]).
Regarding claim 62, modified Westfall teaches the respiratory system according to claim 61, White teaches wherein the controller is configured to determine the inspiratory demand is not met in response to the number of previous patient breath cycles having entrainment of ambient air exceeding 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).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mautin I Ashimiu whose telephone number is (571)272-0760. The examiner can normally be reached Monday - Friday, 7:30 a.m. - 4:30 p.m. ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kendra Carter can be reached at 571-272-9034. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/M.I.A./Examiner, Art Unit 3785
/KENDRA D CARTER/Supervisory Patent Examiner, Art Unit 3785
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