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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/23/2026 has been entered.
Response to Amendment
This office action is in response to the amendment filed on 04/23/2026. As directed by the amendment, claims 1, 35 and 38 have been amended and claims 2 has been cancelled. As such, claims 1, 4, 8-15, 17-20, 22, 25-27, 30-32, 35-36 and 38 are pending in the instant application.
Response to Arguments
Applicant's arguments, see pages 11-15 of Remarks, filed 04/23/2026, pertaining to the
newly amended limitations have been noted. However, a new ground(s) of rejection has been
provided below to address the newly added limitations.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1, 4, 8-11, 17-18, 31 and 35 is/are rejected under pre-AIA 35 U.S.C. 103 as being unpatentable over Brunner (US 20080314385 A1) in view of Kruger (US 20210146072 A1).
Regarding claim 1, Brunner teaches a mechanical ventilator apparatus (a ventilator is represented diagrammatically in Fig. 1 and 6 comprising mechanical ventilation unit 13 as seen in [0085] and [0087]), comprising:
a gas delivery apparatus (mechanical ventilation unit 13, see Fig. 1 and 6 and [0069]), having a patient interface (mechanical ventilation unit 13 supplies ventilation air 15 to patient 11 through a patient interface as seen in Fig. 6 and [0069]), configured to deliver gas to a patient (“The oxygen is supplied to the patient 11 by way of a pressure source (ventilator) 13 with the ventilation air 15.” See [0069]);
an oximetry sensor (“…in order to achieve an adapted arterial oxygen-partial pressure in the blood of a patient mechanically ventilated with the ventilator, comprises at least one oxygen sensor, e.g. a pulsoximeter, and a programmed computer.” See [0024] and [0096]) configured to generate signals representative of an oxygen concentration of the patient's blood ("The oxygen sensor serves for the measurement of at least one reading (SaO.sub.2.sup.REP) which is representative for the success of the oxygen supply.” See [0024] and [0096]); and
a controller (Brunner teaches a programmed computer/circuit with control loops as seen in [0016]-[0019], [0025] and [0069]), comprising a processor (the computer has a controller for the control loops as seen in Figs. 1 and 6 and [0025] and [0035]. Furthermore, an interface according to block E processes values from sensor readings as seen in [0096] and Fig. 6) and a memory (characteristic lines of regions and functions are deposited in a memory as seen in [0032] and [0036]), in communication with the gas delivery apparatus and the oximetry sensor (the programmed computer is to compute PEEP and FiO2 based on sensor values and input values to regulate the ventilator 13 as seen in Fig. 6 and [0040], [0087] and [0096]), the controller being configured to:
control the gas delivery apparatus to deliver the gas to the patient according to a FiO2 setting and a PEEP setting, wherein the FiO2 setting and the PEEP setting are configured to be adjustable (the programmed computer regulates/controls the ventilation rate and pressure and oxygen supply via FiO2 and PEEP settings as seen in [0024] and [0039]. The PEEP and FiO2 are also optimized/adjusted in predefined temporal intervals depending on readings as seen in [0025]. Furthermore, Brunner teaches the computation of values for PEEP and FiO2 depends on input possibilities including the strategic goal of ventilation where the computation of the setting values are influenced by these inputs as seen in [0029] and [0090]-[0095]. As such, the FiO2 setting and PEEP setting can be adjusted base on the changes in input/strategic goal of ventilation or by the programmed computer for optimization),
control the delivery of the gas to the patient according to a first FiO2 value and a first PEEP value (the programmed computer forms the measurements for PEEP and FiO2 using supply intensity and sensor readings as seen in Figs. 2-4 and [0028] and [0081] for a first FiO2 value and a first PEEP value),
receive the signals representative of the oxygen concentration of the patient's blood from the oximetry sensor during the delivery of the gas to the patient (the oxygen sensor provides measurements of oxygen concentration during delivery of oxygen as seen in [0025], [0086] and [0096]),
determine the oxygen concentration of the patient's blood based at least in part on the received signals (“The readings SpO.sub.2 and PawO.sub.2 and PawCO.sub.2 provided by the sensors are then (e.g. whilst taking a blood gas measurement into account) summarised into the representative value SaO.sub.2.sup.REP.” see [0096] and [0025]),
based at least in part on the oxygen concentration of the patient's blood, control the gas delivery apparatus to adjust the FiO2 setting to an updated FiO2 setting (the oxygen sensor is continuously measured in temporal intervals in which PEEP and FiO2 is optimized based on the representative readings and the FiO2 is changed/adjusted on account of the current representative value due to the second control loop as seen in [0025] and [0031]), and
following the adjustment of the FiO2 setting, based at least in part on the updated FiO2 setting, control the gas delivery apparatus to adjust the PEEP setting to an updated PEEP value (Brunner teaches a first control loop to optimize PEEP and FiO2 based on representative reading and a second control loop used to change FiO2 based on the representative reading as seen in [0025]. Therefore, following when the FiO2 is adjusted/changed due to the second control loop, when the first control loop runs again for optimization, PEEP is often increased as seen in [0031])
But does not teach the first PEEP value associated with a first predetermined FiO2 range,
an updated PEEP associated with a second predetermined FiO2 range, the first and second predetermined FiO2 ranges partially overlapping with each other, wherein adjustment of the PEEP setting to the updated PEEP value occurs if the adjustment from the FiO2 setting to the updated FiO2 setting falls outside of the first predetermined FiO2 range associated with the first PEEP value and falls inside the second predetermined FiO2 range associated with the updated PEEP value.
However, Kruger the first PEEP value associated with a first predetermined FiO2 range (Kruger teaches a relation between ventilation parameters of PEEP and FiO2 as shown in Figs. 11a-11b and [0058], wherein a PEEP value of 5 (taken as first PEEP value) is associated with a FiO2 range of 0.3 to 0.4 (taken as first predetermined FiO2 range)),
updated PEEP associated with a second predetermined FiO2 range (Kruger teaches a PEEP value of 8 (taken as updated PEEP) is associated with a predetermined FiO2 range of 0.4 to 0.5 as seen in Figs. 11a-11b and [0058]), the first and second predetermined FiO2 ranges partially overlapping with each other (The first predetermined FiO2 range of 0.3-0.4 partially overlaps with the second predetermined FiO2 range of 0.4-0.5).
Brunner teaches a function for FiO2 and PEEP, where the functions allocate a value of PEEP to a value of FiO2 as seen in [0036]. Brunner further teaches patient paramters are different depending on lung condition such as ARDS as seen in [0073], [0082] and [0099]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus taught by Brunner to relate the ventilation parameters of PEEP and FiO2 as taught by Kruger as it is the recommended connection between the PEEP value and FiO2 value as published by the ARDSnet expert committee for optimal oxygenation (see [0058]). Brunner in view of Kruger teaches wherein adjustment of the PEEP setting to the updated PEEP value occurs if the adjustment from the FiO2 setting to the updated FiO2 setting falls outside of the first predetermined FiO2 range associated with the first PEEP value and falls inside the second predetermined FiO2 range associated with the updated PEEP value (Brunner teaches a first control loop to optimize PEEP and FiO2 based on representative reading and a second control loop used to change FiO2 based on the representative reading as seen in [0025] and allocating a value of PEEP to a value of FiO2 as seen in [0036]. As such, if the FiO2 was to be adjusted/updated due to the second control loop, PEEP will be adjusted based on the first control loop to an updated PEEP value. Kruger teaches relating the ventilation parameters of PEEP and FiO2 as seen in Figs. 11a-11b and [0058]. Therefore, Brunner in view of Kruger teaches if the adjustment from the FiO2 setting to the updated FiO2 (during the second control loop) falls outside of the first predetermined FiO2 range, and falls into a second predetermined FiO2 range, the PEEP setting will update to the updated PEEP value associated with the second predetermined FiO2 range when the first control loop runs again).
Regarding claim 4, Brunner in view of Kruger teaches the ventilator apparatus of claim 1, and Brunner further teaches wherein the oximetry sensor comprises a pulse oximetry sensor (“…comprises at least one oxygen sensor, e.g. a pulsoximeter, and a programmed computer.” See [0024] and [0096]) comprising an SpO2 sensor (Brunner teaches using a pulsoximeter to read SpO2 in [0096], therefore the pulxosimeter is a SpO2 sensor), wherein the oxygen concentration of the patient's blood is an oxygen saturation (“…the oxygen saturation of the blood may for example be measured simultaneously with two independent sensors, e.g. two pulsoximeters, a pulsoximeter and breathing gas sensors, etc.” see [0096]), wherein the gas is a breathing gas (“The oxygen is supplied to the patient 11 by way of a pressure source (ventilator) 13 with the ventilation air 15.” See [0069]).
Regarding claim 8, Brunner in view of Kruger teaches the ventilator apparatus of claim 1, and further teaches wherein the updated PEEP value is determined based at least in part on the updated FiO2 setting and the first PEEP value (Brunner teaches a first control loop to optimize PEEP and FiO2 based on representative reading and a second control loop used to change FiO2 based on the representative reading as seen in [0025]. Therefore, following when the FiO2 is adjusted/changed due to the second control loop, when the first control loop runs again for optimization, the adjustment to PEEP is based on the original PEEP value and the updated FiO2 setting as seen in Figs. 11a-11b and [0058] of Kruger).
Regarding claim 9, Brunner in view of Kruger teaches the ventilator apparatus of claim 1, and further teaches wherein the adjustment to the FiO2 setting comprises an adjustment to the FiO2 setting from a first FiO2 level to a second FiO2 level (the FiO2 setting is adjusted from a first FiO2 level to a second FiO2 level as the FiO2 is optimized/changed due to the representative reading as seen in [0025] of Brunner and Kruger teaches the ranges and levels of FiO2 as seen in Figs. 11a-11b and [0058]),
wherein the adjustment to the PEEP setting comprises an adjustment in the PEEP setting from a first PEEP level to a second PEEP level, and
wherein the determined PEEP update is based at least in part on:
the second FiO2 level, and the
first PEEP level (Brunner teaches a first control loop to optimize PEEP and FiO2 based on representative reading and a second control loop used to change FiO2 based on the representative reading as seen in [0025] and allocating a value of PEEP to a value of FiO2 as seen in [0036]. Kruger teaches relating the ventilation parameters of PEEP and FiO2 as seen in Figs. 11a-11b and [0058]. Therefore, Brunner in view of Kruger teaches if the adjustment from the FiO2 setting to the updated FiO2 (during the second control loop) falls outside of the first predetermined FiO2 range, and falls into a second predetermined FiO2 range, the PEEP setting will update to the updated PEEP value associated with the second predetermined FiO2 range when the first control loop runs again. Furthermore, the adjustment to PEEP is based on the original PEEP value and the updated FiO2 setting as seen in Figs. 11a-11b and [0058] of Kruger).
Regarding claim 10, Brunner in view of Kruger teaches the ventilator apparatus of claim 1, and further teaches wherein the PEEP setting is adjusted based on a selection from at least two PEEP levels comprising a first PEEP level associated with a first FiO2 range and a second PEEP level associated with a second FiO2 range, wherein the first FiO2 range overlaps with the second FiO2 range (Kruger teaches relating the ventilation parameters of PEEP and FiO2 as seen in Figs. 11a-11b and [0058], wherein a PEEP value of 5 (taken as first PEEP value) is associated with a FiO2 range of 0.3 to 0.4 (taken as first predetermined FiO2 range) and a PEEP value of 8 (taken as updated PEEP) is associated with a predetermined FiO2 range of 0.4 to 0.5. The first predetermined FiO2 range of 0.3-0.4 partially overlaps with the second predetermined FiO2 range of 0.4-0.5),
wherein the PEEP update is determined so as to differ from the PEEP setting if one or more conditions are met,
wherein the one or more conditions comprise that a level of FiO2 of the gas being delivered to the patient has changed so as to fall outside of the first FiO2 range (Brunner in view of Kruger teaches if the adjustment from the FiO2 setting to the updated FiO2 (during the second control loop) falls outside of the first predetermined FiO2 range, and falls into a second predetermined FiO2 range, the PEEP setting will update to the updated PEEP value associated with the second predetermined FiO2 range when the first control loop runs again).
Regarding claim 11, Brunner in view of Kruger teaches the ventilator apparatus of claim 10, and further teaches wherein the adjustment to the PEEP setting comprises a change in the PEEP setting from the first PEEP level to the second PEEP level (Brunner teaches a first control loop to optimize PEEP and FiO2 based on representative reading and a second control loop used to change FiO2 based on the representative reading as seen in [0025] and allocating a value of PEEP to a value of FiO2 as seen in [0036]. As such, if the FiO2 was to be adjusted/updated due to the second control loop, PEEP will be adjusted based on the first control loop to an updated PEEP value. Kruger teaches relating the ventilation parameters of PEEP and FiO2 as seen in Figs. 11a-11b and [0058]. Therefore, Brunner in view of Kruger teaches if the adjustment from the FiO2 setting to the updated FiO2 (during the second control loop) falls outside of the first predetermined FiO2 range, and falls into a second predetermined FiO2 range, the PEEP setting will update to the updated PEEP value associated with the second predetermined FiO2 range when the first control loop runs again).
Regarding claim 17, Brunner in view of Kruger teaches the ventilator apparatus of claim 1, and Brunner further teaches wherein a change the PEEP setting is based on a set of one or more PEEP change eligibility conditions being met, the set of conditions comprising that:
if the determined PEEP update comprises an increase in PEEP, one or more measures of a hemodynamic status of the patient indicate that the hemodynamic status of the patient is above a first threshold (Brunner teaches an increase in PEEP in patients that are haemodynamic stable as seen in [0081] and further teaches mainly increasing FiO2 and not PEEP in patients that are haemodynamic instable as seen in [0084]. Therefore, if there is an increase in PEEP, the hemodynamic status of the patient is stable (taken as a first threshold)).
Regarding claim 18, Brunner in view of Kruger teaches the ventilator apparatus of claim 1, and Brunner further teaches wherein adjusting the FiO2 value comprises:
determining a decrease in the oxygen concentration of the patient's blood from a previous time or time period to a current time or time period (SaO2rep is a representative of oxygen content (saturation) of the arterial blood (see [0041]). The ventilator checks within temporal intervals if SaO2rep has fallen below a limit value, wherein if SaO2rep does fall below a threshold, there is a demand to increase oxygen supply as seen in [0100]);
determining a correction value, wherein the correction value is increased based at least in part on the determined decrease in the oxygen concentration of the patient's blood (“Within these temporal intervals, i.e. between two optimisations of the first control loop, if necessary, only FiO.sub.2 is increased with a second control loop, if between optimisations by way of the first control loop, the current representative value (SaO.sub.2.sup.REP) falls below a limit value (characteristic line) which is dependent on the supply intensity and which demands an immediate increase of the oxygen supply…” see [0100]; the second control loop determines a correction value of an increased of FiO2 due to the decrease in the representative value); and
adjusting the FiO2 value by adding the correction value to the FiO2 setting (the second control loop determines a correction value of an increased of FiO2 due to the decrease in the representative value as seen in [0031], [0041], [0045], and [0100]).
Regarding claim 31, Brunner in view of Kruger teaches the ventilator apparatus of claim 1, and Kruger further teaches wherein a minimum PEEP setting of the gas delivery apparatus is between 0 cm water (H2O) and 10 cm H2O, wherein a maximum PEEP setting of the gas delivery apparatus is between 10 cmH2O and 25 cm H2O (Kruger teaches a minimum PEEP setting to be 5mbar and a maximum PEEP setting to be 18-24 mbar as seen in Figs. 2 and 11a-11b, which is equivalent to 5.09 cmH2O and 18.35-24.47 cmH2O).
However, Brunner in view of Kruger does not explicitly disclose the maximum PEEP setting of the gas delivery apparatus is between 10 cmH2O and 20 cmH2O.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the maximum PEEP setting of Brunner in view of Kruger from 18-24.47 cm H2O to 18-19 cmH2O as applicant appears to have placed no criticality on the claimed range (see [0192], indicating the maximum and minimum levels of PEEP may be different and given multiple ranges/values) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 35, Brunner teaches a method for controlling mechanical ventilation being provided to a patient (“The method according to the invention for the regulation of PEEP and FiO.sub.2 of a ventilator serves for achieving an arterial oxygen partial pressure in the blood of a patient being mechanically ventilated.” See [0041]), comprising a controller (Brunner teaches a programmed computer/circuit with control loops as seen in [0016]-[0019], [0025] and [0069]):
controlling a gas delivery system of a mechanical ventilator (mechanical ventilation unit 13, see Fig. 1 and 6 and [0069]) to deliver gas to the patient (“The oxygen is supplied to the patient 11 by way of a pressure source (ventilator) 13 with the ventilation air 15.” See [0069]) according to a FiO2 setting and a PEEP setting, wherein the FiO2 setting and the PEEP setting are adjustable (the programmed computer regulates/controls the ventilation rate and pressure and oxygen supply via FiO2 and PEEP settings as seen in [0024] and [0039]. The PEEP and FiO2 are also optimized/adjusted in predefined temporal intervals depending on readings as seen in [0025]. Furthermore, Brunner teaches the computation of values for PEEP and FiO2 depends on input possibilities including the strategic goal of ventilation where the computation of the setting values are influenced by these inputs as seen in [0029] and [0090]-[0095]. As such, the FiO2 setting and PEEP setting can be adjusted base on the changes in input/strategic goal of ventilation or by the programmed computer for optimization);
controlling the delivery of the gas to the patient according to a first FiO2 value and a first PEEP value (the programmed computer forms the measurements for PEEP and FiO2 using supply intensity and sensor readings as seen in Figs. 2-4 and [0028] and [0081] for a first FiO2 value and a first PEEP value),
receiving signals representative of an oxygen concentration of the patient's blood from an oximetry sensor (“…in order to achieve an adapted arterial oxygen-partial pressure in the blood of a patient mechanically ventilated with the ventilator, comprises at least one oxygen sensor, e.g. a pulsoximeter, and a programmed computer.” See [0024] and [0096]) of the mechanical ventilator during the delivery of the gas to the patient (the oxygen sensor provides measurements of oxygen concentration during delivery of oxygen to the patient as seen in Figs. 1 and 6 and [0025], [0086] and [0096]), the oximetry sensor being coupled with the gas delivery system (the pulsoximeter is coupled with the ventilator as seen in [0024]);
determining the oxygen concentration of the patient's blood based at least in part on the received signals (“The readings SpO.sub.2 and PawO.sub.2 and PawCO.sub.2 provided by the sensors are then (e.g. whilst taking a blood gas measurement into account) summarised into the representative value SaO.sub.2.sup.REP.” see [0096] and [0025]),
based at least in part on the determined oxygen concentration of the patient's blood, controlling the gas delivery system to adjust the FiO2 setting to an updated FiO2 setting (the oxygen sensor is continuously measured in temporal intervals in which PEEP and FiO2 is optimized based on the representative readings and the FiO2 is changed/adjusted on account of the current representative value due to the second control loop as seen in [0025] and [0031]), and
following the adjustment of the FiO2 setting, based at least in part on the updated FiO2 setting, control the gas delivery system to adjust the PEEP setting to an updated PEEP value (Brunner teaches a first control loop to optimize PEEP and FiO2 based on representative reading and a second control loop used to change FiO2 based on the representative reading as seen in [0025]. Therefore, following when the FiO2 is adjusted/changed due to the second control loop, when the first control loop runs again for optimization, PEEP is often increased as seen in [0031]).
But does not teach the first PEEP value associated with a first predetermined FiO2 range,
an updated PEEP associated with a second predetermined FiO2 range, the first and second predetermined FiO2 ranges partially overlapping with each other, wherein adjustment of the PEEP setting to the updated PEEP value occurs if the adjustment from the FiO2 setting to the updated FiO2 setting falls outside of the first predetermined FiO2 range associated with the first PEEP value and falls inside the second predetermined FiO2 range associated with the updated PEEP value.
However, Kruger the first PEEP value associated with a first predetermined FiO2 range (Kruger teaches a relation between ventilation parameters of PEEP and FiO2 as shown in Figs. 11a-11b and [0058], wherein a PEEP value of 5 (taken as first PEEP value) is associated with a FiO2 range of 0.3 to 0.4 (taken as first predetermined FiO2 range)),
updated PEEP associated with a second predetermined FiO2 range (Kruger teaches a PEEP value of 8 (taken as updated PEEP) is associated with a predetermined FiO2 range of 0.4 to 0.5 as seen in Figs. 11a-11b and [0058]), the first and second predetermined FiO2 ranges partially overlapping with each other (The first predetermined FiO2 range of 0.3-0.4 partially overlaps with the second predetermined FiO2 range of 0.4-0.5).
Brunner teaches a function for FiO2 and PEEP, where the functions allocate a value of PEEP to a value of FiO2 as seen in [0036]. Brunner further teaches patient paramters are different depending on lung condition such as ARDS as seen in [0073], [0082] and [0099]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus taught by Brunner to relate the ventilation parameters of PEEP and FiO2 as taught by Kruger as it is the recommended connection between the PEEP value and FiO2 value as published by the ARDSnet expert committee for optimal oxygenation (see [0058]). Brunner in view of Kruger teaches wherein adjustment of the PEEP setting to the updated PEEP value occurs if the adjustment from the FiO2 setting to the updated FiO2 setting falls outside of the first predetermined FiO2 range associated with the first PEEP value and falls inside the second predetermined FiO2 range associated with the updated PEEP value (Brunner teaches a first control loop to optimize PEEP and FiO2 based on representative reading and a second control loop used to change FiO2 based on the representative reading as seen in [0025] and allocating a value of PEEP to a value of FiO2 as seen in [0036]. As such, if the FiO2 was to be adjusted/updated due to the second control loop, PEEP will be adjusted based on the first control loop to an updated PEEP value. Kruger teaches relating the ventilation parameters of PEEP and FiO2 as seen in Figs. 11a-11b and [0058]. Therefore, Brunner in view of Kruger teaches if the adjustment from the FiO2 setting to the updated FiO2 (during the second control loop) falls outside of the first predetermined FiO2 range, and falls into a second predetermined FiO2 range, the PEEP setting will update to the updated PEEP value associated with the second predetermined FiO2 range when the first control loop runs again).
Claim(s) 12 and 19 is/are rejected under pre-AIA 35 U.S.C. 103 as being unpatentable over Brunner (US 20080314385 A1) in view of Kruger (US 20210146072 A1), as applied to claim 1 above, and further in view of Baker (US 20090320836 A1).
Regarding claim 12, Brunner in view of Kruger teaches the ventilator apparatus of claim 1, but does not teach wherein a change in the PEEP setting is based on a set of one or more PEEP change eligibility conditions being met, the set of conditions comprising that:
the FiO2 setting has not changed by at least a first amount in at least a first specified period of time or the level of SpO2 of the patient has been below a desaturation threshold for more than a second specified period of time.
However, Baker teaches wherein a change in the PEEP setting is based on a set of one or more PEEP change eligibility conditions being met, the set of conditions comprising that:
the FiO2 setting has not changed by at least a first amount in at least a first specified period of time or the level of SpO2 of the patient has been below a desaturation threshold for more than a second specified period of time (Baker teaches a primary controller 12 which receives input from a sensor 18 (pulse oximeter sensor) that measures a patient’s SpO2 value and based on a comparison of the measured SpO2 value with a target SpO2 value, manipulate the ventilator’s output as seen in [0015]. Baker further teaches an example of increasing FiO2 from the ventilator 16 when a measured SpO2 value is below a predefined SpO2 target as seen in [0015]. Furthermore, Baker teaches controller 112 to control PEEP based on patient oxygenation as seen in [0026]. Therefore, if the SpO2 value is below a target threshold, FiO2 will be increased and the PEEP will also be adjusted based on patient oxygenation. The first period of time is when there are no changes to FiO2 due to the measured SpO2 value being at the target SpO2 value and the second period of time is when the measured SpO2 is below the target SpO2 value (which is similar to applicant’s first and second period of time in [0100])).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus taught by Brunner in view of Kruger to change the PEEP setting if the level of SpO2 of the patient has been below a desaturation threshold for more than a second specified period of time as taught by Baker to be adjusted based on patient oxygenation as FiO2 is increased for SpO2 to reach its target value (see [0015] of Baker) to assure the patient is getting the required oxygen. Not to mention, Brunner teaches FiO2 and PEEP to be in a function (see [0028]) and the functions allocate a value of PEEP to a value of FiO2 (see [0036]). Therefore, it would be obvious that PEEP changes if FiO2 is to change.
Regarding claim 19, Brunner in view of Kruger teaches the ventilator apparatus of claim 18, but does not teach wherein adjusting the FiO2 setting comprises creating a tendency for the FiO2 to change so as to cause the SpO2 to approach a target SpO2.
However, Baker teaches wherein adjusting the FiO2 setting comprises creating a tendency for the FiO2 to change so as to cause the SpO2 to approach a target SpO2 (“…the primary controller 12 may receive input from a sensor 18 (e.g., a pulse oximeter sensor) that measures the patient's SpO.sub.2 value and, based on a comparison of the measured SpO.sub.2 value with a target SpO.sub.2 value, manipulate the ventilator's output (e.g., FiO.sub.2). For example, the FiO.sub.2 controller may output a request for increased FiO.sub.2 from the ventilator 16 when a measured SpO.sub.2 value is below a predefined SpO.sub.2 target, or output a request for decreased FiO.sub.2 from the ventilator 16 when the measured SpO.sub.2 value is above the SpO.sub.2 target.” See [0015]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus taught by Brunner in view of Kruger to adjust the FiO2 setting creating at tendency for the FiO2 to change to cause the SpO2 to approach a target SpO2 as taught by Baker to aid the patient in getting the proper amount of oxygen (see [0015]) by using an automatic controller based on measured physiological parameters to be more efficient and accurate ([0006]).
Claim(s) 13-14 is/are rejected under pre-AIA 35 U.S.C. 103 as being unpatentable over Brunner (US 20080314385 A1) in view of Kruger (US 20210146072 A1) and Baker (US 20090320836 A1), as applied to claims 12 above, and further in view of Lachmann (US 5738090 A),
Regarding claim 13, modified Brunner teaches the ventilator apparatus of claim 12, but does not teach wherein the set of conditions comprises:
if the determined PEEP update comprises an increase in PEEP, the PEEP setting has not changed over a third period of time, and
if the determined PEEP update comprises a decrease in PEEP, the PEEP setting has not changed over a fourth period of time, the third period of time being different than the fourth period of time.
However, Lachmann teaches if the determined PEEP update comprises an increase in PEEP, the PEEP setting has not changed over a third period of time (Lachmann teaches a PEEP update comprising an increase in PEEP from 1 minute to about 7 minutes as seen in Fig. 4 and Col. 6, lines 8-12, therefore the PEEP setting has not changed for about 7 minutes), and
if the determined PEEP update comprises a decrease in PEEP, the PEEP setting has not changed over a fourth period of time (Lachmann teaches a PEEP update comprising a decrease in PEEP from about 7 minutes to 15 minutes as seen in Fig. 4 and Col. 6, lines 26-30, therefore the PEEP setting has not changed for about 8 minutes), the third period of time being different than the fourth period of time (the time it takes for PEEP to increase is about 7 minutes (taken as third period of time) and the time it takes for PEEP to decrease is about 8 minutes (taken as fourth period of time) as seen in Fig. 4. Furthermore, Lachmann teaches the times given could vary by order of minutes or hours as seen in Col. 6, lines 5-7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method taught by modified Brunner to have the PEEP setting not change for a third period of time if the determined PEEP update comprises an increase in PEEP and to have the PEEP setting not change for a fourth period of time if the determined PEEP update comprises a decrease in PEEP and the third period of time being different than the fourth period of time as taught by Lachmann to have a lowered pressure to keep the lungs open before increasing PEEP again (see Fig. 4 and Col. 6, lines 24-30 and lines 33-35).
Regarding claim 14, modified Brunner teaches the ventilator apparatus of claim 13, and Lachmann further teaches wherein the fourth period of time is greater than the third period of time (the time it takes for PEEP to increase is about 7 minutes (taken as third period of time) and the time it takes for PEEP to decrease is about 8 minutes (taken as fourth period of time) as seen in Fig. 4. Furthermore, Lachmann teaches the times given could vary by order of minutes or hours as seen in Col. 6, lines 5-7).
Claim(s) 15 is/are rejected under pre-AIA 35 U.S.C. 103 as being unpatentable over Brunner (US 20080314385 A1) in view of Kruger (US 20210146072 A1), as applied to claim 1 above, and further in view of Wysocki (US 8528553 B2).
Regarding claim 15, Brunner in view of Kruger teaches the ventilator apparatus of claim 1, but does not teach wherein a change in the PEEP setting is based at least in part on a set of one or more PEEP change eligibility conditions being met, the set of conditions comprising that:
if the determined PEEP update comprises an increase in PEEP, the PEEP setting has not changed over a first period of time, and
if the determined PEEP update comprises a decrease in PEEP, the PEEP setting has not changed over a second period of time, the second period of time being different than the first period of time.
However, Wysocki teaches a time measurement device that control the increase and decrease in ventilation pressure and repeatedly trigger the determination of a new PEEP at certain time intervals (see Col. 3, lines 41-55).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus taught by Brunner in view of Kruger to include the time measurement device taught by Wysocki for automatic adjustment of the ventilation to the needs of the patient (see Col. 3, lines 49-55). Modified Brunner teaches wherein a change in the PEEP setting is based at least in part on a set of one or more PEEP change eligibility conditions being met, the set of conditions comprising that:
if the determined PEEP update comprises an increase in PEEP, the PEEP setting has not changed over a first period of time (Wysocki teaches a time measurement device to be combined with a ventilator to automatically increase ventilation pressure at a certain time interval (similar to [0271] of applicant’s specification of increasing PEEP if the PEEP has not changed for a predetermined period of time) as seen in Col. 3, lines 41-55), and
if the determined PEEP update comprises a decrease in PEEP, the PEEP setting has not changed over a second period of time (Wysocki teaches a time measurement device to be combined with a ventilator to automatically decrease ventilation pressure at a certain time interval (similar to [0272] of applicant’s specification of decreasing PEEP if the PEEP has not changed for a predetermined period of time) as seen in Col. 3, lines 41-55), the second period of time being different than the first period of time (it is inherent that the certain time intervals for increasing and decreasing ventilation pressure are different as the ventilator cannot increase and decrease ventilation pressure at the exact same time).
Claim(s) 20 is/are rejected under pre-AIA 35 U.S.C. 103 as being unpatentable over Brunner (US 20080314385 A1) in view of Kruger (US 20210146072 A1), as applied to claim 1 above, and further in view of Banner (US 20030010339 A1).
Regarding claim 20, Brunner in view of Kruger teaches the ventilator apparatus of claim 1, but does not teach wherein the controller is configured to estimate a respiratory system compliance (Crs) of the patient and update a peak inspiratory pressure (PIP) setting of the ventilator apparatus based at least in part on the estimated Crs of the patient, and wherein the controller is configured to estimate the Crs of the patient based at least in part on application of at least one data fitting algorithm to a set of waveforms associated with respiratory mechanics of one or more breaths administered to the patient.
However, Banner teaches wherein the controller is configured to estimate a respiratory system compliance (Crs) of the patient (“In step 720, if desired, a real-time calculation of Crs and Rrs may be determined.” See [0079] and Fig. 7) and update a peak inspiratory pressure (PIP) setting of the ventilator apparatus based at least in part on the estimated Crs of the patient (Banner teaches a closed-loop operation of inputting Crs (block 500), monitoring work of breath (block 520) and adjusting pressure support ventilation to support the physiological needs of the patient 10 (block 550) as seen in Fig. 5 and [0071]), and wherein the controller is configured to estimate the Crs of the patient based at least in part on application of at least one data fitting algorithm to a set of waveforms associated with respiratory mechanics of one or more breaths administered to the patient (“Basically, the least-squares method of determining Crs involves sampling pressure-volume data points over an entire breath cycle and then minimized the sum of the square measurement errors between the observed pressure-volume curve and a best fit pressure-volume curve using standard statistical analysis well known in the art.” See [0128] and [0109]-[0110]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus taught by Brunner in view of Kruger to have the controller estimate a respiratory system compliance (Crs) of the patient and update a peak inspiratory pressure (PIP) setting of the ventilator apparatus based at least in part on the estimated Crs of the patient as taught by Banner to know the physiological condition of the patient's respiratory system at the moment of calculation (see [0128]).
Claim(s) 22 is/are rejected under pre-AIA 35 U.S.C. 103 as being unpatentable over Brunner (US 20080314385 A1) in view of Kruger (US 20210146072 A1), as applied to claim 1 above, and further in view of Kimm (US 20150034082 A1) and Kimm (US 20190143058 A1; hereinafter known as “Miller”).
Regarding claim 22, Brunner in view of Kruger teaches the ventilator apparatus of claim 1, but does not teach wherein the controller is configured to, based at least in part on a determination that a driving pressure or plateau pressure being delivered to the patient is over a threshold, decrease a tidal volume (Vt) delivered to the patient, wherein the controller is configured to, based at least in part on the decreased Vt delivered to the patient, increase a respiration rate (RR) delivered to the patient, wherein the controller is configured to increase Ve by increasing at least one of Vt and RR.
However, Kimm teaches wherein the controller is configured to, based at least in part on the decreased Vt delivered to the patient, increase a respiration rate (RR) delivered to the patient (Kimm teaches the manage module 126 to decrease tidal volume for an increase in sweep flow rate, where the increase in sweep gas flow rate or minute ventilation is performed by increasing respiratory rate as seen in [0100]), wherein the controller is configured to increase Ve by increasing at least one of Vt and RR (“…increase minute ventilation (by either increasing the respiratory rate and/or the tidal volume).” See [0100]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus taught by Brunner in view of Kruger to include the manage module to increase a respiration rate when tidal volume is decreased and to increase minute ventilation by increasing one of Vt or RR as taught by Kimm to optimize CO2 removal (see [0100]).
However, Miller teaches wherein the controller is configured to, based at least in part on a determination that a driving pressure or plateau pressure being delivered to the patient is over a threshold, decrease a tidal volume (Vt) delivered to the patient (“For example, if the drive pressure exceeds a threshold, such as is greater than 15 cm of H.sub.2O, the treatment module 119 may recommend a decrease in tidal volume, a decrease in flow, a decrease in pressure, an increase in PEEP, and/or a decrease in PEEP to try and bring the drive pressure within the desired levels.” See [0097]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus taught by modified Brunner to decrease tidal volume delivered to the patient based at least in part on a determination that a driving pressure or plateau pressure being delivered to the patient is over a threshold as taught by Miller to bring the drive pressure within the desired levels (see [0097]) to give the patient the optimal patient ventilation within the thresholds given by a clinician (see [0096]).
Claim 25 is/are rejected under pre-AIA 35 U.S.C. 103 as being unpatentable over Brunner (US 20080314385 A1) in view of Kruger (US 20210146072 A1), as applied to claim 1 above, and further in view Khoury (US 20180160970 A1).
Regarding claim 25, Brunner in view of Kruger teaches the ventilator apparatus of claim 1, but does not teach wherein the controller is configured to, based at least in part on a Vt being delivered to the patient that is below a Vt threshold, trigger a low Vt alarm.
However, Khoury teaches wherein the controller is configured to, based at least in part on a Vt being delivered to the patient that is below a Vt threshold, trigger a low Vt alarm (“If the tidal volume Vt is lower than a preset minimum threshold, then, in a step 916, the “low tidal volume” or “low Vt” alarm message is displayed.” See [0102] and Fig. 7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus taught by Brunner in view of Kruger to include a low Vt alarm when the Vt is delivered below a Vt threshold as taught by Khoury to allow for the operator/responder to immediately influence the parameter to be corrected to reestablish an optimal ventilation for the patient (see [0105]).
Claim 26 is/are rejected under pre-AIA 35 U.S.C. 103 as being unpatentable over Brunner (US 20080314385 A1) in view of Kruger (US 20210146072 A1), as applied to claim 1 above, and further in view Kline (US 20070078357 A1).
Regarding claim 26, Brunner in view of Kruger teaches the ventilator apparatus of claim 1, but does not teach wherein a Ve setting is configured to be adjustable based at least in part on a determined carbon dioxide concentration or partial pressure of the expired gas of the patient.
However, Kline teaches wherein a Ve setting is configured to be adjustable based at least in part on a determined carbon dioxide concentration or partial pressure of the expired gas of the patient (“…the plotted data from sensors 36, 38, 40, and 44 could be used to assist in deciding how to properly adjust mechanical ventilators setting, such as the degree of positive end-expiratory pressure, minute ventilation, and peak inspiratory pressure settings, to optimize patient care.” See [0042]; Kline teaches three sensors that measure both oxygen and carbon dioxide as seen in [0035]. Therefore, the carbon dioxide measurements from the sensors are used to adjust the minute ventilation).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus taught by Brunner in view of Kruger to include a Ve setting, adjustable based at least in part on a determined carbon dioxide concentration, and sensors (to measure carbon dioxide) as taught by Kline for an additional ventilation setting that is known to be used in the art for mechanical ventilation (see [0042]).
Claim(s) 27 is/are rejected under pre-AIA 35 U.S.C. 103 as being unpatentable over Brunner (US 20080314385 A1) in view of Kruger (US 20210146072 A1), as applied to claim 1 above, and further in view Kimm (US 20150034082 A1).
Regarding claim 27, Brunner in view of Kruger teaches the ventilator apparatus of claim 1, but does not teach wherein the controller is configured to, based at least in part on a capnographic measure that is above a threshold, increase a Ve being delivered to the patient, wherein the capnographic measure is at least one of:an EtCO2 measure or a measure obtained using a capnography sensor.
However, Kimm teaches wherein the controller is configured to, based at least in part on a capnographic measure that is above a threshold, increase a Ve being delivered to the patient (“…if the ventilator-ECGE system during adjusting operation 516 determines that the E.sub.TCO.sub.2 and/or VCO.sub.2 need to be adjusted based on information from the comparison made by the processing operation 510, the ventilator-ECGE system adjusts the minute ventilation, peak inspiration pressure, tidal volume, and/or respiratory rate to achieve the desired E.sub.TCO.sub.2 and/or VCO.sub.2.” see [0157]; Kimm teaches the operation 510 comparing sensor outputs from a caponometer sensor to one or more thresholds), wherein the capnographic measure is at least one of: an EtCO2 measure or a measure obtained using a capnography sensor (the capnometer sensor measures a EtCO2 which is compared to a threshold as seen in [0079], [0149] and [0192]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus taught by Brunner in view of Kruger to include a capnometer sensor and controller taught by Kimm to include a different measurement source to measure another data point to detect improper treatment operation (see [0150]).
Claim(s) 30 is/are rejected under pre-AIA 35 U.S.C. 103 as being unpatentable over Brunner (US 20080314385 A1) in view of Kruger (US 20210146072 A1) and Banner (US 20030010339 A1), as applied to claim 20 above, and further in view of Vandine (US 20110138315 A1).
Regarding claim 30, modified Brunner teaches the ventilator apparatus of claim 20, but does not teach wherein the controller is configured to, based at least in part on a predicted or ideal bodyweight of the patient determined based at least in part a gender and a height of the patient, determine a set of initial ventilation parameters for the one or more breaths administered to the patient, the initial ventilation parameters including an initial Vt setting or an initial PIP setting used for the one or more breaths administered to the patient.
However, Vandine teaches wherein the controller (processor 206, see Fig. 2) is configured to, based at least in part on a predicted or ideal bodyweight of the patient determined based at least in part a gender and a height of the patient (“…initial parameter settings may be uniformly applied to new patients based on predicted body weight or gender and height. As such, appropriate parameter settings may be archived by the ventilator based on patient body weight or patient gender and height.” See [0036]), determine a set of initial ventilation parameters for the one or more breaths administered to the patient (after the clinician enters a predicted bodyweight as input, appropriate parameter settings will be presented to the clinician as default settings as seen in [0036]. The default settings are then applied and used as actual ventilatory settings as seen in [0036] for one or more breaths administered to the patient since ventilation is started), the initial ventilation parameters including an initial Vt setting or an initial PIP setting used for the one or more breaths administered to the patient (the quick-start module 228 with a predicted weight module 232 and height module 234 is in communication with the setup module 214 and pre-configuration module as seen in Fig. 2 and [0033]-[0034]. When the quick-start module 228 is used, ventilators are pre-configured with initial parameter settings according to a suitable specification as seen in [0034]. Therefore, the setup module 216-226 is populated with initial protocol-specific parameter settings, including the initial tidal volume 218 as seen in [0034] and Fig. 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus taught by modified Brunner to include the quick-start module and setup module taught by Vandine to promote efficient and prompt initiation of ventilation for new patients (see [0037]).
Claim 32 is/are rejected under pre-AIA 35 U.S.C. 103 as being unpatentable over Brunner (US 20080314385 A1) in view of Kruger (US 20210146072 A1), as applied to claim 1 above, and further in view of “Driving pressure: a marker of severity, a safety limit, or a goal for mechanical ventilation?” (hereinafter known as Bugedo).
Regarding claim 32, Brunner in view of Kruger teaches the ventilator apparatus of claim 1, and further teaches wherein a minimum PEEP setting of the gas delivery apparatus is 5 cm H2O (Kruger teaches a minimum PEEP setting to be 5mbar as seen in Figs. 2 and 11a-11b, which is equivalent to about 5 cmH2O)
But does not teach wherein a maximum PEEP setting of the gas delivery apparatus is 15 cmH2O.
However, Bugedo teaches wherein a maximum PEEP setting of the gas delivery apparatus is 15 cmH2O (Bugedo teaches PEEP levels measured at higher than 15 and 15 to be associated with dangerous level of stress as seen on page 2, first column. Bugedo further teaches using 15cm H2O as a safety limit as seen on page 4, second column).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus taught by Brunner in view of Kruger to have a maximum PEEP setting of 15 cmH2O as taught by Bugedo since having a higher maximum PEEP is associated with dangerous levels of stress (see page 2, first column).
Claim(s) 36 is/are rejected under pre-AIA 35 U.S.C. 103 as being unpatentable over Brunner (US 20080314385 A1) in view of Kruger (US 20210146072 A1), as applied to claim 1 above, and further in view Lellouche (US 20180280645 A1) and Cewers (US 20080168989 A1).
Regarding claim 36, Brunner in view of Kruger teaches the method of claim 35, and further teaches comprising, based at least in part on the updated FiO2 setting, controlling the gas delivery apparatus to adjust the PEEP setting to the updated PEEP value (Brunner teaches a first control loop to optimize PEEP and FiO2 based on representative reading and a second control loop used to change FiO2 based on the representative reading as seen in [0025] and allocating a value of PEEP to a value of FiO2 as seen in [0036]. As such, if the FiO2 was to be adjusted/updated due to the second control loop, PEEP will be adjusted based on the first control loop to an updated PEEP value. Kruger teaches relating the ventilation parameters of PEEP and FiO2 as seen in Figs. 11a-11b and [0058]. Therefore, Brunner in view of Kruger teaches if the adjustment from the FiO2 setting to the updated FiO2 (during the second control loop) falls outside of the first predetermined FiO2 range, and falls into a second predetermined FiO2 range, the PEEP setting will update to the updated PEEP value associated with the second predetermined FiO2 range when the first control loop runs again) but does not teach comprising, based at least in part on the determined oxygen concentration of the patient's blood, controlling the gas delivery system to adjust the FiO2 setting to the updated FiO2 setting at least in part by actuating an oxygen source valve, and comprising, based at least in part on the updated FiO2 setting, controlling the gas delivery apparatus to adjust the PEEP setting to the updated PEEP value at least in part by actuating an exhalation valve.
However, Lellouche teaches comprising, based at least in part on the determined oxygen concentration of the patient's blood, controlling the gas delivery system (system 10, see Fig. 1 and [0083]) to adjust the FiO2 setting to the updated FiO2 setting at least in part by actuating an oxygen source valve (Lellouche teaches a first control sub-unit 22a connected to at least one physiological parameter sensor 18 and an actuator of the supplemental gas supply 17, wherein the first control sub-unit 22a receives data from the sensor 18 and controls the actuator based on the data received as seen in [0098]. Therefore, the FiO2 is automatically controlled by the first control sub-unit 22a according to a measured SpO2 of the patient as seen in Figs. 7-8 and [0100]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method taught by Brunner in view of Kruger to include the control sub-unit, supplemental gas supply and actuator of the gas supply and to control the gas delivery system to adjust the FiO2 setting to the updated FiO2 setting at least in part by actuating an oxygen source valve based at least in part on the determined oxygen concentration of the patient's blood as taught by Lellouche for an optimized time spent in the SpO2 interval while minimizing oxygen flowrate to allow a substantial reduction in oxygen consumption (see [0125]).
However, Cewers teaches controlling the gas delivery apparatus (there is a ventilator in the inspiratory portion that has been omitted in Fig. 1 as seen in [0019]) to adjust the PEEP setting to the updated PEEP value at least in part by actuating an exhalation valve (first exhaust valve 7 and second exhaust valve 6, see Fig. 1) (“If, however, PEEP is desired, second exhaust valve 6 can be used to provide a "macro" control over the pressure in volume V.sub.C, and the first exhaust valve 7 can be used to provide "micro" control over the pressure in volume V.sub.C by means of controlling the pressure in volume V.sub.B, which is easier to control for the reasons noted above.” See [0035] and [0006]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method taught by modified Brunner to include the first and second exhaust valves and to control the gas delivery apparatus to adjust the PEEP setting to the updated PEEP value at least in part by actuating an exhalation valve as taught by Cewers as it is known in the art to regulate the actuation and/or position of the exhaust valve using a controller to maintain a certain PEEP (see [0006]).
Claim(s) 38 is/are rejected under pre-AIA 35 U.S.C. 103 as being unpatentable over Brunner (US 20080314385 A1) in view of Lellouche (US 20180280645 A1), Cewers (US 20080168989 A1), Kimm (US 20150034082 A1) and Kruger (US 20210146072 A1).
Regarding claim 38, Brunner teaches a system for providing mechanical ventilation to a patient (Figs. 1 and 6 show a system for providing mechanical ventilation to a patient as seen in [0024] and [0069]), comprising: a gas delivery system for delivering gas to a patient (“The oxygen is supplied to the patient 11 by way of a pressure source (ventilator) 13 with the ventilation air 15.” See [0069]), comprising:
an oximetry sensor (“…in order to achieve an adapted arterial oxygen-partial pressure in the blood of a patient mechanically ventilated with the ventilator, comprises at least one oxygen sensor, e.g. a pulsoximeter, and a programmed computer.” See [0024] and [0096]) for generating signals representative of an oxygen concentration of the patient's blood ("The oxygen sensor serves for the measurement of at least one reading (SaO.sub.2.sup.REP) which is representative for the success of the oxygen supply.” See [0024] and [0096]);
a mechanical gas mover (mechanical ventilation unit 13, see Fig. 1 and 6 and [0069]);
a patient interface coupled with the mechanical gas mover (mechanical ventilation unit 13 supplies ventilation air 15 to patient 11 through a patient interface as seen in Fig. 6 and [0069] and therefore, the patient interface is coupled to the mechanical ventilation unit 13); and
a controller (Brunner teaches a programmed computer/circuit with control loops as seen in [0016]-[0019], [0025] and [0069]), coupled with the oximetry sensor (Block E shows values from sensors being sent to first and second control loops as seen in Fig. 6 and [0096]), for controlling the gas delivery system to deliver gas to the patient according to a FiO2 setting and a PEEP setting, wherein the FiO2 setting and the PEEP setting are configured to be adjustable (the programmed computer regulates/controls the ventilation rate and pressure and oxygen supply via FiO2 and PEEP settings as seen in [0024] and [0039]. The PEEP and FiO2 are also optimized/adjusted in predefined temporal intervals depending on readings as seen in [0025]. Furthermore, Brunner teaches the computation of values for PEEP and FiO2 depends on input possibilities including the strategic goal of ventilation where the computation of the setting values are influenced by these inputs as seen in [0029] and [0090]-[0095]. As such, the FiO2 setting and PEEP setting can be adjusted base on the changes in input/strategic goal of ventilation or by the programmed computer for optimization), the controlling of the gas delivery system comprising:
control the delivery of the gas to the patient according to a first FiO2 value and a first PEEP value (the programmed computer forms the measurements for PEEP and FiO2 using supply intensity and sensor readings as seen in Figs. 2-4 and [0028] and [0081] for a first FiO2 value and a first PEEP value)
receiving the signals representative of the oxygen concentration of the patient's blood from the oximetry sensor during the delivery of the gas to the patient (the oxygen sensor provides measurements of oxygen concentration during delivery of oxygen as seen in [0025], [0086] and [0096]),
determining the oxygen concentration of the patient's blood based at least in part on the received signals (“The readings SpO.sub.2 and PawO.sub.2 and PawCO.sub.2 provided by the sensors are then (e.g. whilst taking a blood gas measurement into account) summarised into the representative value SaO.sub.2.sup.REP.” see [0096] and [0025]),
following the adjustment of the FiO2 setting, based at least in part on the updated FiO2 setting, controlling the gas delivery apparatus to adjust the PEEP setting to an updated PEEP value (Brunner teaches a first control loop to optimize PEEP and FiO2 based on representative reading and a second control loop used to change FiO2 based on the representative reading as seen in [0025]. Therefore, following when the FiO2 is adjusted/changed due to the second control loop, when the first control loop runs again for optimization, PEEP is often increased as seen in [0031]).
but does not teach an oxygen source;
a patient interface coupled with the mechanical gas mover and the oxygen source; and
a controller, coupled with the oximetry sensor and the mechanical gas mover;
the first PEEP value being associated with a first predetermined FiO2 range,
based at least in part on the determined oxygen concentration of the patient's blood, controlling the gas delivery system to adjust the FiO2 setting to an updated FiO2 setting, comprising actuating at least one oxygen source valve according to the updated FiO2 setting, the at least one oxygen source valve being coupled with, and for adjusting gas flow from, the oxygen source, and
an updated PEEP associated with a second predetermined FiO2 range, the first and second predetermined FiO2 ranges partially overlapping with each other, wherein adjustment of the PEEP setting to the updated PEEP value occurs if the adjustment from the FiO2 setting to the updated FiO2 setting falls outside of the first predetermined FiO2 range associated with the first PEEP value and falls inside the second predetermined FiO2 range associated with the updated PEEP value,
comprising actuating at least one exhalation valve according to the updated PEEP value, the at least one exhalation valve being coupled with the mechanical gas mover and the patient interface.
However, Lellouche teaches an oxygen source (supplemental gas supply 17, see Fig. 1; “…the supplemental gas supply includes an oxygen supply.” See [0052]);
a patient interface coupled with the mechanical gas mover (ambient air dispenser 16, ventilator 16a and turbine 16a’, see Fig. 1 and [0084]) and the oxygen source (“The ambient air dispenser 16 and the supplemental gas supply 17 can be connected to a gas administration device (not shown), such as, for example and without being limitative, a facial mask or a nasal cannula (not shown) with the necessary connecting tubes, to administer the breathing gas to the patient 12.” See [0083]); and
based at least in part on the determined oxygen concentration of the patient's blood, controlling the gas delivery system (system 10, see Fig. 1 and [0083]) to adjust the FiO2 setting to an updated FiO2 setting, comprising actuating at least one oxygen source valve according to the updated FiO2 setting, the at least one oxygen source valve being coupled with, and for adjusting gas flow from, the oxygen source (Lellouche teaches a first control sub-unit 22a connected to at least one physiological parameter sensor 18 and an actuator of the gas supply 17, wherein the first control sub-unit 22a receives data from the sensor 18 and controls the actuator based on the data received as seen in [0098]. Therefore, the FiO2 is automatically controlled by the first control sub-unit 22a according to a measured SpO2 of the patient as seen in Figs. 7-8 and [0100]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system taught by Brunner to include the control sub-unit, supplemental gas supply and actuator of the gas supply and to control the gas delivery system to adjust the FiO2 setting to the updated FiO2 setting at least in part by actuating an oxygen source valve based at least in part on the determined oxygen concentration of the patient's blood as taught by Lellouche for an optimized time spent in the SpO2 interval while minimizing oxygen flowrate to allow a substantial reduction in oxygen consumption (see [0125]).
However, Cewers teaches comprising actuating at least one exhalation valve (first exhaust valve 7 and second exhaust valve 6, see Fig. 1) according to the updated PEEP setting (“If, however, PEEP is desired, second exhaust valve 6 can be used to provide a "macro" control over the pressure in volume V.sub.C, and the first exhaust valve 7 can be used to provide "micro" control over the pressure in volume V.sub.C by means of controlling the pressure in volume V.sub.B, which is easier to control for the reasons noted above.” See [0035] and [0006]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system taught by Brunner in view of Lellouche to include the first and second exhaust valves and to control the gas delivery apparatus to adjust the PEEP setting to the updated PEEP value at least in part by actuating an exhalation valve as taught by Cewers as it is known in the art to regulate the actuation and/or position of the exhaust valve using a controller to maintain a certain PEEP (see [0006]).
However, Kimm teaches a controller (controller 110, see Fig. 1 and [0062]), coupled with the oximetry sensor (oximeter 105 and oximeter sensor 107, see Fig. 1 and [0076]) and the mechanical gas mover (ventilator 101, see Fig. 1) (controller 110 is coupled to the ventilator 101 with oximeter 105, oximeter sensor 107 and compressor 106 as seen in Fig. 1);
the at least one exhalation valve (“…expiratory module 108 is associated with and/or controls an expiratory valve for releasing gases from the patient 150.” See [0060]) being coupled with the mechanical gas mover and the patient interface (patient interface 180, see Fig. 1) (expiratory module 108 is coupled to the ventilator 101 and patient interface 180 as seen in Fig. 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system taught by modified Brunner to include a compressor and have the controlled coupled to the oximetry sensor and compressor and the exhalation valve coupled with the compressor and patient interface as taught by Kimm to have the controller control ventilation based on sensor information (see [0062]) and to have the exhalation valve release gas from the patient according to ventilator settings (see [0060]) to manage proper treatment for the patient (see [0013] and [0015]).
However, Kruger the first PEEP value associated with a first predetermined FiO2 range (Kruger teaches a relation between ventilation parameters of PEEP and FiO2 as shown in Figs. 11a-11b and [0058], wherein a PEEP value of 5 (taken as first PEEP value) is associated with a FiO2 range of 0.3 to 0.4 (taken as first predetermined FiO2 range)),
updated PEEP associated with a second predetermined FiO2 range (Kruger teaches a PEEP value of 8 (taken as updated PEEP) is associated with a predetermined FiO2 range of 0.4 to 0.5 as seen in Figs. 11a-11b and [0058]), the first and second predetermined FiO2 ranges partially overlapping with each other (The first predetermined FiO2 range of 0.3-0.4 partially overlaps with the second predetermined FiO2 range of 0.4-0.5).
Brunner teaches a function for FiO2 and PEEP, where the functions allocate a value of PEEP to a value of FiO2 as seen in [0036]. Brunner further teaches patient paramters are different depending on lung condition such as ARDS as seen in [0073], [0082] and [0099]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus taught by Brunner to relate the ventilation parameters of PEEP and FiO2 as taught by Kruger as it is the recommended connection between the PEEP value and FiO2 value as published by the ARDSnet expert committee for optimal oxygenation (see [0058]). Brunner in view of Kruger teaches wherein adjustment of the PEEP setting to the updated PEEP value occurs if the adjustment from the FiO2 setting to the updated FiO2 setting falls outside of the first predetermined FiO2 range associated with the first PEEP value and falls inside the second predetermined FiO2 range associated with the updated PEEP value (Brunner teaches a first control loop to optimize PEEP and FiO2 based on representative reading and a second control loop used to change FiO2 based on the representative reading as seen in [0025] and allocating a value of PEEP to a value of FiO2 as seen in [0036]. As such, if the FiO2 was to be adjusted/updated due to the second control loop, PEEP will be adjusted based on the first control loop to an updated PEEP value. Kruger teaches relating the ventilation parameters of PEEP and FiO2 as seen in Figs. 11a-11b and [0058]. Therefore, Brunner in view of Kruger teaches if the adjustment from the FiO2 setting to the updated FiO2 (during the second control loop) falls outside of the first predetermined FiO2 range, and falls into a second predetermined FiO2 range, the PEEP setting will update to the updated PEEP value associated with the second predetermined FiO2 range when the first control loop runs again).
Conclusion
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/TINA ZHANG/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785
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