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 .
Information Disclosure Statement
The information disclosure statement(s) filed on 7/15/2022 and 08/22/2022 is/are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement(s) is/are being considered by the examiner.
Claims
This office action is in response to the preliminary amendment filed on 03/29/2022. As directed by the preliminary amendments, claims 2, 4, 20, 22, 27, 30-32 and 36 have been amended and claims 3, 5-7, 16, 21, 23-24, 28-29, 33-34, 37 and 39-225 have been cancelled. As such, claims 1-2, 4, 8-15, 17-20, 22, 25-27, 30-32, 35-36 and 38 are being examined in this application.
Claim Objections
Claim 27 is objected to because of the following informalities:
Claim 27, lines 3-4, recites “wherein the capnographic measure is at least one of: an EtCO2 measure and a measure obtained using a capnography sensor” but should recite “wherein the capnographic measure is at least one of: an EtCO2 measure or a measure obtained using a capnography sensor” since the claim language asks for at least one of and not both.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
Claim(s) 1-2, 4, 8-9, 17-18 and 35 is/are rejected under pre-AIA 35 U.S.C. 102(a)(1) as being anticipated by Brunner (US 20080314385 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 as seen in [0025]. This can also be seen in Fig. 2 and [0081] where the values for FiO2 are updated), and
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 (As seen in Fig. 2, the values for both FiO2 and PEEP increases, which leads to an increase in only PEEP as seen at the top of the curve and [0081]. Furthermore, the FiO2 can be changed depending on the representative reading (see [0025]) and the supply intensity is a function of PEEP and FiO2 as seen in [0028]. Therefore, when FiO2 changes, the PEEP can change depending on the FiO2 as seen in [0036]).
Regarding claim 2, Brunner teaches the ventilator apparatus of claim 1, and further teaches comprising controlling the delivery of the gas to the patient according to a first FiO2 value for the FiO2 setting and comprising controlling the delivery of the gas to the patient according to a first PEEP value for the PEEP setting (the programmed computer regulates/controls the ventilation rate and pressure and oxygen supply via FiO2 and PEEP settings as seen in [0024] and [0039], where there is a first FiO2 value for the FiO2 setting and a first PEEP value for the PEEP setting).
Regarding claim 4, Brunner teaches the ventilator apparatus of claim 1, and 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 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 (As seen in Fig. 2, the values for both FiO2 and PEEP increases, which leads to an increase in only PEEP as seen at the top of the curve and [0081]. Furthermore, the FiO2 can be changed depending on the representative reading (see [0025]) and the supply intensity is a function of PEEP and FiO2 as seen in [0028]. Therefore, when FiO2 changes, the PEEP can change depending on the FiO2 as seen in [0036]).
Regarding claim 9, Brunner 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]),
wherein the adjustment to the PEEP setting comprises an adjustment in the PEEP setting from a first PEEP level to a second PEEP level (PEEP changes from a first PEEP level to a second PEEP level when the FiO2 is adjusted from a first FiO2 level to a second FiO2 level since the supply intensity is a function of PEEP and FiO2 as seen in [0028] and the PEEP can change depending on the FiO2 as seen in [0036]), and
wherein the determined PEEP update is based at least in part on:
the second FiO2 level (PEEP changes from a first PEEP level to a second PEEP level when the FiO2 is adjusted from a first FiO2 level to a second FiO2 level since the supply intensity is a function of PEEP and FiO2 as seen in [0028] and the PEEP can change depending on the FiO2 as seen in [0036]), and the
first PEEP level (“The second algorithm on account of one of these functions, determines the current values for PEEP and FiO.sub.2, or whether FiO.sub.2 and/or PEEP must be increased or reduced.” See [0036]).
Regarding claim 17, Brunner teaches the ventilator apparatus of claim 1, and 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 teaches the ventilator apparatus of claim 1, and 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 [0041], [0045], and [0100]).
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 an 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 as seen in [0025]. This can also be seen in Fig. 2 and [0081] where the values for FiO2 are updated), and
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 (As seen in Fig. 2, the values for both FiO2 and PEEP increases, which leads to an increase in only PEEP as seen at the top of the curve and [0081]. Furthermore, the FiO2 can be changed depending on the representative reading (see [0025]) and the supply intensity is a function of PEEP and FiO2 as seen in [0028]. Therefore, when FiO2 changes, the PEEP can change depending on the FiO2 as seen in [0036]).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 10-11 is/are rejected under pre-AIA 35 U.S.C. 103 as being unpatentable over Brunner (US 20080314385 A1) in view of “Positive end-expiratory pressure titration in COVID-19 acute respiratory failure: electrical impedance tomography vs. PEEP/FiO2 tables” (hereinafter, known as Sella) and Baker (US 20090241956 A1).
Regarding claim 10, Brunner teaches the ventilator apparatus of claim 1, but does not teach 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,
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.
However, Sella teaches wherein the PEEP setting is adjusted based on a selection from at least two PEEP levels (Fig. 2 teaches a high PEEP level shown by the dash line and low PEEP level shown by the continuous line) comprising a first PEEP level associated with a first FiO2 range (low PEEP level is associated with a first FiO2 range for each PEEP value as seen in Fig. 2) and a second PEEP level associated with a second FiO2 range (high PEEP level is associated with a second FiO2 range for each PEEP value as seen in Fig. 2), wherein the first FiO2 range overlaps with the second FiO2 range (the first FiO2 range overlaps with the second FiO2 range as seen in Fig. 2),
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]. 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 have 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 as taught by Sella to have multiple settings to select from to see which will better benefit the patient (see page 1, column 2, first paragraph).
However, Baker teaches 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 (Baker teaches a lung recruitment maneuver if the FiO2 level exceeds a predetermined threshold as seen in [0077]. After, performing the lung recruitment maneuver, breathing assistance system 1 may automatically adjust a PEEP setting as seen in [0079]-[0080]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus taught by Brunner in view of Sella to have the PEEP update after a lung recruitment maneuver due to FiO2 levels exceeding a predetermined threshold as taught by Baker to have an elevated PEEP level to maintain lung recruitment longer before returning to the original PEEP to reduce the risk of barotrauma (see [0079]).
Regarding claim 11, modified Brunner 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 (Sella teaches a low PEEP level (taken as first PEEP level) and a high PEEP level (taken as second PEEP level). Baker teaches automatically adjusting a PEEP setting after a lung recruitment maneuver to be higher/elevated as seen in [0079]. Therefore, modified Brunner teaches an adjustment to the PEEP setting from a first low PEEP level to a second high PEEP level).
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 Baker (US 20090320836 A1).
Regarding claim 12, Brunner 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 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 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 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 Baker (US 20090320836 A1), as applied to claims 1/12 above, and further in view of Lachmann (US 5738090 A),
Regarding claim 13, Brunner in view of Baker 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 Brunner in view of Baker 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 Wysocki (US 8528553 B2).
Regarding claim 15, Brunner 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 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). Brunner in view of Wysocki 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 Banner (US 20030010339 A1).
Regarding claim 20, Brunner 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 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 Kimm (US 20150034082 A1) and Kimm (US 20190143058 A1; hereinafter known as “Miller”).
Regarding claim 22, Brunner 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 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 Brunner in view of Kimm 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 Khoury (US 20180160970 A1).
Regarding claim 25, Brunner 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 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 Kline (US 20070078357 A1).
Regarding claim 26, Brunner 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 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 Kimm (US 20150034082 A1).
Regarding claim 27, Brunner 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 and 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 and a measure obtained using a capnography sensor (see claim objection above; 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 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 Banner (US 20030010339 A1), as applied to claim 20 above, and further in view of Vandine (US 20110138315 A1).
Regarding claim 30, 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 Brunner in view of Banner 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]).
Claims 31 and 32 is/are rejected under pre-AIA 35 U.S.C. 103 as being unpatentable over Brunner (US 20080314385 A1) in view of Cooke (US 20080168990 A1).
Regarding claim 31, Brunner teaches the ventilator apparatus of claim 1, but does not teach wherein a minimum PEEP setting of the gas delivery apparatus is between 0 cm water (H20) and 10 cm H20, wherein a maximum PEEP setting of the gas delivery apparatus is between 10 cmH20 and 20 cmH20.
However, Cooke teaches wherein a minimum PEEP setting of the gas delivery apparatus is between 0 cm water (H20) and 10 cm H20 (“…PEEP is variable from 5 cm H.sub.2O to 20 cm H.sub.2O.” see [0122]; Cooke teaches a minimum PEEP setting of 5 cm H2O), wherein the PEEP setting of the gas delivery apparatus is between 5 cmH20 and 20 cmH20 (Cooke teaches a variable PEEP setting from 5cm H2O to 20 cmH2O as seen in [0122]).
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 have a variable PEEP setting from 5 cm H2O (taken as minimum PEEP setting) to 20 cmH2O as taught by Cooke to have a range of PEEP settings that is known to be used in the art.
However, Brunner in view of Cooke does not explicitly disclose the maximum PEEP setting of the gas delivery apparatus is between 10 cmH20 and 20 cmH20.
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 Cooke from 20 cm H2O to 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 32, Brunner teaches the ventilator apparatus of claim 1, but does not teach wherein a minimum PEEP setting of the gas delivery apparatus is 5 cm H20, wherein a maximum PEEP setting of the gas delivery apparatus is 15 cmH20.
However, Cooke teaches wherein a minimum PEEP setting of the gas delivery apparatus is 5 cm H20 (“…PEEP is variable from 5 cm H.sub.2O to 20 cm H.sub.2O.” see [0122]; Cooke teaches a minimum PEEP setting of 5 cm H2O), wherein the PEEP setting of the gas delivery apparatus is between 5 cmH20 and 20 cmH20 (Cooke teaches a variable PEEP setting from 5cm H2O to 20 cmH2O as seen in [0122]).
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 have a variable PEEP setting from 5 cm H2O (taken as minimum PEEP setting) to 20 cmH2O as taught by Cooke to have a range of PEEP settings that is known to be used in the art.
However, Brunner in view of Cooke does not explicitly disclose the maximum PEEP setting of the gas delivery apparatus is 15 cm H2O.
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 Cooke from 20 cm H2O to 15 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).
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 Lellouche (US 20180280645 A1) and Cewers (US 20080168989 A1).
Regarding claim 36, Brunner teaches the method of claim 35, and Brunner 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 (As seen in Fig. 2, the values for both FiO2 and PEEP increases, which leads to an increase in only PEEP as seen at the top of the curve and [0081]. Furthermore, 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]. Therefore, if FiO2 updates, the PEEP value is updated) 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])