DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
This office action is in response to the amendment filed on 12/09/2025. As directed by the amendment, claims 1-3, 11 and 14-15 have been amended, claims 4, 9-10, 12-13 and 16 have been cancelled and claims 17-18 have been added. As such, claims 1-3, 5-8, 11, 14-15 and 17-18 are pending in the instant application.
Applicant has amended claim 11 to address a minor informality; the objection to the claim has been withdrawn.
Applicant has cancelled claims 12-13; the 112(b) rejections to claims 12-13 has been withdrawn.
Response to Arguments
Applicant's arguments, see pages 6-8 of Remarks, filed 12/09/2025, 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 Objections
Claim(s) 11 is/are objected to because of the following informalities:
Claim 11, line 21, recites “…the flow bias ration…” but should recite “…the flow bias ratio
Claim 15, line 2, recites “…a new expiator fall…” but should recite “…a new expiratory fall…”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 11, 14-15 and 17-18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 11, lines 1-2, recites “A ventilator apparatus comprising: non-invasive positive air-pressure system configured to provide positive air pressure to a user through a tube (12) to a mask…” However, it is unclear how the ventilator apparatus comprises a non-invasive positive air-pressure system as the ventilator apparatus seems to be just the apparatus itself. Paragraph [0018] of applicant’s specification recites “…a mucus clearing assistance system comprised of: a ventilator system configured to provide positive air pressure to a user; one or more sensors configured to detect flow rate associated with the ventilator…” As best understood, for examination purposes, the claim will read as “A ventilator system comprising:” due to the support shown in [0046].
Claims 14-15 and 17-18 are rejected as they depend from and therefore incorporate the claimed subject matter rejected under this statute.
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, 6 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Balko (US 20130269698 A1) in view of Acker (US 20090266360 A1) and Manfredo (US 20140130906 A1).
Regarding claim 1, Balko teaches a method of using a ventilator to aid in clearing mucus (Balko teaches removing sputum and/or debris from the airway and lungs of subject 106 using a pressure generator 140 as seen in Fig. 1 and [0034], wherein the pressure generator 140 is a ventilator or positive airway pressure device as seen in [0022]) comprising the steps of:
providing a non-invasive ventilator system (system 100, see Fig. 1; Balko teaches system 100 to include a subject interface appliance 184 which can be a nasal/oral mask as seen in [0025]) configured to provide positive air pressure to a user through a tube (conduit 182, see Fig. 1) to a mask (subject interface appliance 184, see Fig. 1 and [0025]) (Balko teaches pressure generator 140, which can be a ventilator or positive airway pressure device to provide positive air to subject 106 through conduit 182 to subject interface appliance 184 as seen in Fig. 1 and [0023]), said ventilator system including a controller (processor 110 and control module 170, see Fig. 1) and one or more sensors (sensor 142, see Fig. 1) configured to measure an expiratory flow rate (Balko teaches sensor 142 can include a flow sensor as seen in [0029] and further teaches monitoring peak flow during expiration as seen in [0021] and [0041]) and calculate an expiratory fall time, wherein the expiratory fall time is determined as a rate of depressurization during exhalation (Balko teaches control module 170 controlling pressure generator 140 to reduce the pressure of the pressurized flow of breathable gas with sufficient abruptness that expiratory flow through the airway of subject 106 is sufficient to remove sputum and/or other debris from the airway and/or lungs of subject 106 as seen in Fig. 3 and [0034]. As such, the control module 170 will need to calculate an expiratory fall time determined as a rate of depressurization during exhalation to aid in removing sputum and/or other debris from the airway or lungs);
inputting into the ventilator a target level of a flow metric, wherein the target level of the flow metric is in the direction of expiration (Balko teaches a target module 152 to obtain a target level of a flow metric that corresponds to the flow at which gas is drawn out of the lungs of subject 106 during expiration which may include an input of a specific target level from a user interface 120 as seen in Fig. 5 and [0037] and [0051]. Balko further teaches the flow metric is indicative of flow during exsufflation and can be a metric other than simple peak flow used to quantify exsufflation flow as seen in [0038]. Therefore, a level of peak expiratory flow can be inputted into pressure generator 140);
receiving from the one or more sensors, a measured flow rate in the direction of expiration (Balko teaches sensor 142 can include a flow sensor as seen in [0029] and further teaches monitoring peak flow during expiration as seen in Fig. 5 and [0021] and [0041]);
determining from the measured flow rate a flow metric (Balko teaches the value of the flow metric may be determined based on output signals generated by one or more sensors 142 as seen in Fig. 5 and [0054]. Balko further teaches the flow metric is indicative of flow during exsufflation and can be a metric other than simple peak flow used to quantify exsufflation flow as seen in [0038], and as such peak expiratory flow can be a flow metric);
comparing the target level of a flow metric to the measured flow metric (Balko teaches the value of the flow metric is compared with the target level of the flow metric in operation 507 as seen in Fig. 5 and [0055]);
determining if the measured flow metric needs to be increased (Balko teaches, in operation 508, determining if there needs to be adjustment to one or more parameters based on the comparison at operation 507 to bring the flow rate closer to the target level of the flow metric as seen in Fig. 5 and [0056]), and
controlling the ventilator system to increase the flow bias and thereby reducing the expiratory fall time while maintaining inspiratory pressure when inspiratory rise time increases (Operation 508 teaches adjusting to one or more of exsufflation pressure and/or one or more parameters of the inexsufflation transition is determined as seen in Fig. 5 and [0056], wherein the parameter can be a peak expiratory flow as seen in [0038], [0021] and [0041]. Balko teaches control module 170 controlling pressure generator 140 to reduce the pressure of the pressurized flow of breathable gas with sufficient abruptness that expiratory flow through the airway of subject 106 is sufficient to remove sputum and/or other debris from the airway and/or lungs of subject 106 as seen in [0033]-[0034]. Therefore, Balko teaches adjusting peak expiratory flow thereby reducing the expiratory flow time while maintaining inspiratory pressure).
but does not teach inputting into the ventilator a target flow bias ratio, wherein the target flow bias ratio is in the direction of expiration;
determining from the measured flow rate a flow bias ratio;
comparing the target flow bias ratio to the measured flow bias ratio;
determining if the measured flow bias ratio needs to be increased.
However, Acker teaches a method of mobilizing one or more occlusions from a breathing tube wherein the inspiratory flow and expiratory flow is regulated such that a peak expiratory flow is greater than a peak inspiratory flow to facilitate the automatic mobilization of the occlusion from the breathing tube as seen in Fig. 5 and [0033].
Balko teaches looking at parameters of both insufflation and exsufflation as seen in [0056]. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method taught by to include peak inspiratory flow as a flow metric as taught by Acker to regulate both peak inspiratory flow and peak expiratory flow to assure the peak expiratory flow is greater than a peak inspiratory flow for a less invasive, more comfortable method of mobilizing occlusions (see [0033]). Not to mention, Balko teaches removing sputum and/or other debris from the airway and/or lungs of subject 106 as seen in [0034] and therefore both prior arts teach using pressurized flow during expiration to remove sputum/occlusion.
However, Manfredo teaches an on-screen display where a user may enter a numeric value associated with a total flow rate, a percentage or ratio of fluids, a flow rate of a particular fluid, and/or other numeric value associated with the flow rate of one or more fluids as seen in [0006] and [0082].
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 Balko in view of Acker to include the display with on-screen interface as taught by Manfredo to allow the user to input a numeric value or ratio or percentage regarding the flow rate of a fluid (see [0006]) to give the user more options in inputting a value. As such, modified Balko teaches a flow bias ratio (Balko teaches the flow metric is indicative of flow during exsufflation and can be a metric other than simple peak flow used to quantify exsufflation flow as seen in [0038], as well as, looking at parameters of both insufflation and exsufflation. Acker teaches regulating both peak inspiratory flow and peak expiratory flow as seen in [0033] and Manfredo teaches inputting numerical values or ratios. As such, modified Balko teaches using both peak inspiratory flow and peak expiratory flow as a flow metric and further teaches a ratio of peak inspiratory flow and peak expiratory flow for a flow bias ratio).
Regarding claim 6, modified Balko teaches the method of claim 1, and Balko further teaches wherein the ventilator is configured to maintain a prescribed pressure treatment level (Balko teaches control module 170 to control pressure generator 140 to adjust the parameters of the pressurized flow of breathable gas in accordance with the therapy regimen as seen in [0034]).
Regarding claim 11, Balko teaches a ventilator apparatus (Balko teaches a pressure generator 140 as seen in Fig. 1 and [0034], wherein the pressure generator 140 is a ventilator or positive airway pressure device as seen in [0022]. Balko further teaches system 100 as seen in Fig. 1) comprising:
non-invasive positive air-pressure system (system 100, see Fig. 1; Balko teaches system 100 to include a subject interface appliance 184 which can be a nasal/oral mask as seen in [0025]) configured to provide positive air pressure to a user through a tube (12) (conduit 182, see Fig. 1) to a mask (subject interface appliance 184, see Fig. 1 and [0025]) (Balko teaches pressure generator 140, which can be a ventilator or positive airway pressure device to provide positive air to subject 106 through conduit 182 to subject interface appliance 184 as seen in Fig. 1 and [0023]);
one or more sensors (34) (sensor 142, see Fig. 1) configured to measure an expiratory flow rate (Balko teaches sensor 142 can include a flow sensor as seen in [0029] and further teaches monitoring peak flow during expiration as seen in [0021] and [0041]); and
a controller (processor 110, electronic storage 130 and control module 170, see Fig. 1) configured to reduce an expiratory fall time to increase user expiratory flow and assist in the clearing of mucus (see [0033]-[0034]), wherein the expiratory fall time is determined as a rate of depressurization during exhalation (Balko teaches control module 170 controlling pressure generator 140 to reduce the pressure of the pressurized flow of breathable gas with sufficient abruptness that expiratory flow through the airway of subject 106 is sufficient to remove sputum and/or other debris from the airway and/or lungs of subject 106 as seen in Fig. 3 and [0034]. As such, the control module 170 will need to calculate an expiratory fall time determined as a rate of depressurization during exhalation to aid in removing sputum and/or other debris from the airway or lungs),
wherein the controller has programmable logic or algorithms, a memory (32) and a processing unit (30) (Balko teaches electronic storage 130 (taken as memory) to comprise of electronic storage media that electronically stores information as seen in [0026]. Balko further teaches method 500 to be implemented in one or more processing devices as seen in Fig. 5 and [0050]) configured to perform the following steps:
receive a target level of a flow metric input to the controller via a user/patient input interface (36), wherein the target flow metric is in the direction of expiration (Balko teaches a target module 152 to obtain a target level of a flow metric that corresponds to the flow at which gas is drawn out of the lungs of subject 106 during expiration which may include an input of a specific target level from a user interface 120 as seen in Fig. 5 and [0037] and [0051]. Balko further teaches the flow metric is indicative of flow during exsufflation and can be a metric other than simple peak flow used to quantify exsufflation flow as seen in [0038]. Therefore, a level of peak expiratory flow can be inputted into pressure generator 140),
receive from the one or more sensors, a measured flow rate in the direction of expiration (Balko teaches sensor 142 can include a flow sensor as seen in [0029] and further teaches monitoring peak flow during expiration as seen in Fig. 5 and [0021] and [0041]),
determine from the measured flow rate a flow metric (Balko teaches the value of the flow metric may be determined based on output signals generated by one or more sensors 142 as seen in Fig. 5 and [0054]. Balko further teaches the flow metric is indicative of flow during exsufflation and can be a metric other than simple peak flow used to quantify exsufflation flow as seen in [0038], and as such peak expiratory flow can be a flow metric),
compare the measured flow metric to the target flow metric (Balko teaches the value of the flow metric is compared with the target level of the flow metric in operation 507 as seen in Fig. 5 and [0055]),
determine if the measured flow metric needs to be increased (Balko teaches, in operation 508, determining if there needs to be adjustment to one or more parameters based on the comparison at operation 507 to bring the flow rate closer to the target level of the flow metric as seen in Fig. 5 and [0056]), and controlling the air-pressure system to increase the flow bias ration and thereby reduce the expiratory fall time based on the determination to increase the measured flow bias ratio while maintaining inspiratory pressure when inspiratory rise time increases (Operation 508 teaches adjusting to one or more of exsufflation pressure and/or one or more parameters of the inexsufflation transition is determined as seen in Fig. 5 and [0056], wherein the parameter can be a peak expiratory flow as seen in [0038], [0021] and [0041]. Balko teaches control module 170 controlling pressure generator 140 to reduce the pressure of the pressurized flow of breathable gas with sufficient abruptness that expiratory flow through the airway of subject 106 is sufficient to remove sputum and/or other debris from the airway and/or lungs of subject 106 as seen in [0033]-[0034]. Therefore, Balko teaches adjusting peak expiratory flow which leads to increasing the flow bias ratio, reducing the expiratory flow time while maintaining inspiratory pressure).
But does not teach receive a target flow bias ratio input to the controller via a user/patient input interface (36), wherein the target flow bias ratio is in the direction of expiration,
determine from the measured flow rate a flow bias ratio,
compare the measured flow bias ratio to the target flow bias ratio,
determine if the measured flow bias ratio needs to be increased.
However, Acker teaches a method of mobilizing one or more occlusions from a breathing tube wherein the inspiratory flow and expiratory flow is regulated such that a peak expiratory flow is greater than a peak inspiratory flow to facilitate the automatic mobilization of the occlusion from the breathing tube as seen in Fig. 5 and [0033].
Balko teaches looking at parameters of both insufflation and exsufflation as seen in [0056]. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the ventilator apparatus taught by to include peak inspiratory flow as a flow metric as taught by Acker to regulate both peak inspiratory flow and peak expiratory flow to assure the peak expiratory flow is greater than a peak inspiratory flow for a less invasive, more comfortable method of mobilizing occlusions (see [0033]). Not to mention, Balko teaches removing sputum and/or other debris from the airway and/or lungs of subject 106 as seen in [0034] and therefore both prior arts teach using pressurized flow during expiration to remove sputum/occlusion.
However, Manfredo teaches an on-screen display where a user may enter a numeric value associated with a total flow rate, a percentage or ratio of fluids, a flow rate of a particular fluid, and/or other numeric value associated with the flow rate of one or more fluids as seen in [0006] and [0082].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the ventilator apparatus taught by Balko in view of Acker to include the display with on-screen interface as taught by Manfredo to allow the user to input a numeric value or ratio or percentage regarding the flow rate of a fluid (see [0006]) to give the user more options in inputting a value. As such, modified Balko teaches a flow bias ratio (Balko teaches the flow metric is indicative of flow during exsufflation and can be a metric other than simple peak flow used to quantify exsufflation flow as seen in [0038], as well as, looking at parameters of both insufflation and exsufflation. Acker teaches regulating both peak inspiratory flow and peak expiratory flow as seen in [0033] and Manfredo teaches inputting numerical values or ratios. As such, modified Balko teaches using both peak inspiratory flow and peak expiratory flow as a flow metric and further teaches a ratio of peak inspiratory flow and peak expiratory flow for a flow bias ratio).
Claim(s) 2-3, 5 and 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Balko (US 20130269698 A1) in view of Acker (US 20090266360 A1) and Manfredo (US 20140130906 A1), as applied to claim 1 above, and further in view of White (US 20160193438 A1).
Regarding claim 2, modified Balko teaches the method of claim 1, but does not teach further including the steps of providing a pre-determined minimum expiratory fall time and measuring the expiratory fall time of the ventilator and determining if the measured expiratory fall time of the ventilator has reached the pre-determined minimum.
However, White teaches “For each therapy mechanism and/or therapy mode, the user may set maximum or minimum limits for each parameter setting, thresholds or targets for particular operating parameter settings, they may select from or configure the setting to correspond to one of the modes described below that each have their own controls, or they may choose a combination of these options (see [0989]).”
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 Balko to set maximum or minimum limits for each parameter settings as taught by White for various possible user options for user customization (see [0989]). Modified Balko teaches including the steps of providing a pre-determined minimum expiratory fall time (Balko teaches control module 170 controlling pressure generator 140 to reduce the pressure of the pressurized flow of breathable gas with sufficient abruptness that expiratory flow through the airway of subject 106 is sufficient to remove sputum and/or other debris from the airway and/or lungs of subject 106 as seen in Fig. 3 and [0034]. As such, the control module 170 is providing an expiratory fall time when reducing the pressure of the pressurized flow with sufficient abruptness to remove sputum and/or other debris from the airway and/or lungs. Balko further teaches the flow metric is indicative of flow during exsufflation and can be a metric other than simple peak flow used to quantify exsufflation flow as seen in [0038], such as expiratory fall time. White teaches setting a maximum or minimum parameter for each parameter setting, threshold or target as seen in [0989]. As such, modified Balko teaches setting a minimum expiratory fall time as a threshold) and measuring the expiratory fall time of the ventilator and determining if the measured expiratory fall time of the ventilator has reached the pre-determined minimum (“The metric determination module is configured to determine a value of a flow metric during expiration by the subject, wherein the flow metric indicates flow out of the lungs of the subject during exsufflation. The flow analysis module is configured to compare the determined value of the flow metric with a target level of the flow metric.” See [0010] of Balko; Balko teaches a transition time in which control module 170 controls pressure generator 140 to reduce the pressure of the pressurized flow of breathable gas with sufficient abruptness that expiratory flow through the airway of subject 106 is sufficient to remove sputum and/or other debris from the airway and/or lungs of subject 106 as seen in [0034]. Therefore, modified Balko teaches measuring the expiratory fall time as Balko is determining the rate of depressurization during exhalation (see Fig. 3 and [0033]-[0034]) and comparing the measured expiratory fall time to the minimum threshold/target value (as seen in [0010] of Balko).
Regarding claim 3, modified Balko teaches the method of claim 2, and further teaches further comprising the step of generating a new expiratory fall time if the measured fall time has not reached the pre-determined minimum (MPEP 2111.04 recites "The broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met." As modified Balko teaches reaching the pre-determined minimum expiratory fall time, the claim limitation of "if the measured expiratory fall time has not reached the pre-determined minimum" has not occurred).
Regarding claim 5, modified Balko teaches the method of claim 3, and Balko further teaches wherein the ventilator is configured to maintain a prescribed pressure treatment level (Balko teaches control module 170 to control pressure generator 140 to adjust the parameters of the pressurized flow of breathable gas in accordance with the therapy regimen as seen in [0034]).
Regarding claim 14, modified Balko teaches the apparatus of claim 11, but does not teach wherein the controller is further configured to receive a pre-determined minimum expiratory fall time and determine if the expiratory fall time of the ventilator has reached the pre-determined minimum expiratory fall time.
However, White teaches “For each therapy mechanism and/or therapy mode, the user may set maximum or minimum limits for each parameter setting, thresholds or targets for particular operating parameter settings, they may select from or configure the setting to correspond to one of the modes described below that each have their own controls, or they may choose a combination of these options (see [0989]).”
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 Balko to set maximum or minimum limits for each parameter settings as taught by White for various possible user options for user customization (see [0989]). Modified Balko teaches the controller is further configured to receive a pre-determined minimum expiratory fall time (Balko teaches control module 170 controlling pressure generator 140 to reduce the pressure of the pressurized flow of breathable gas with sufficient abruptness that expiratory flow through the airway of subject 106 is sufficient to remove sputum and/or other debris from the airway and/or lungs of subject 106 as seen in Fig. 3 and [0034]. As such, the control module 170 is providing an expiratory fall time when reducing the pressure of the pressurized flow with sufficient abruptness to remove sputum and/or other debris from the airway and/or lungs. Balko further teaches the flow metric is indicative of flow during exsufflation and can be a metric other than simple peak flow used to quantify exsufflation flow as seen in [0038], such as expiratory fall time. White teaches setting a maximum or minimum parameter for each parameter setting, threshold or target as seen in [0989]. As such, modified Balko teaches setting a minimum expiratory fall time as a threshold) and determine if the expiratory fall time of the ventilator has reached the pre-determined minimum expiratory fall time (“The metric determination module is configured to determine a value of a flow metric during expiration by the subject, wherein the flow metric indicates flow out of the lungs of the subject during exsufflation. The flow analysis module is configured to compare the determined value of the flow metric with a target level of the flow metric.” See [0010] of Balko; Balko teaches a transition time in which control module 170 controls pressure generator 140 to reduce the pressure of the pressurized flow of breathable gas with sufficient abruptness that expiratory flow through the airway of subject 106 is sufficient to remove sputum and/or other debris from the airway and/or lungs of subject 106 as seen in [0034]. Therefore, modified Balko teaches measuring the expiratory fall time as Balko is determining the rate of depressurization during exhalation (see Fig. 3 and [0033]-[0034]) and comparing the measured expiratory fall time to the minimum threshold/target value (as seen in [0010] of Balko).
Regarding claim 15, modified Balko teaches the apparatus of claim 14, and further teaches wherein the controller is configured to generate a new expiator fall time if the measured fall time has not reached the pre-determined minimum expiratory fall time (MPEP 2111.04 recites “The broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met.” As modified Balko teaches reaching the pre-determined minimum fall time, the claim limitation of “if the measured fall time has not reached the pre-determined minimum” has not occurred).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable Balko (US 20130269698 A1) in view of Acker (US 20090266360 A1) and Manfredo (US 20140130906 A1), as applied to claim 1 above, and further in view of Farrugia (US 20120199126 A1).
Regarding claim 7, modified Balko teaches the method of claim 1, but does not teach wherein the modification step is configured to incrementally increase the measured flow bias ratio until it achieves the desired target flow bias ratio over a period of breaths.
However, Farrugia teaches wherein the modification step is configured to incrementally increase the current value of the ventilation until it achieves the desired ventilation over a period of breaths (Farrugia teaches controller 16 setting a new ventilation target greater than the current value of the ventilation, wherein the new ventilation target may be increased incrementally over a number of breaths as seen in [0083]).
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 Balko to have the modification step incrementally increase the current/measured value until it achieves a target/desired ventilation over a period of breaths as taught by Farrugia to prevent sudden changes in ventilation or pressure support levels (see [0083]).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Balko (US 20130269698 A1) in view of Acker (US 20090266360 A1), Manfredo (US 20140130906 A1) and Farrugia (US 20120199126 A1), as applied to claim 7 above, and further in view of Banner (US 20030010339 A1).
Regarding claim 8, modified Balko teaches the method of claim 7, but does not teach wherein the period of breaths is at least 5 breaths, at least 10 breaths, at least 15 breaths, at least 20 breaths, or at least 25 breaths.
However, Banner teaches wherein the period of breaths is at least 5 breaths, at least 10 breaths, at least 15 breaths, at least 20 breaths, or at least 25 breaths (Banner teaches the work of breathing of patient 10 to be measured over a serial 5 breath time period as seen in [0147]).
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 Balko to have a period of breath of at least 5 breaths as taught by Banner for enhanced accuracy of measuring average respiratory muscle pressure (see [0098]).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Balko (US 20130269698 A1) in view of Acker (US 20090266360 A1), Manfredo (US 20140130906 A1) and White (US 20160193438 A1) as applied to claim 14 above, and further in view of Farrugia (US 20120199126 A1).
Regarding claim 17, modified Balko teaches the apparatus of claim 14, but does not teach wherein the modification step is configured to incrementally increase the measured flow bias ratio until it achieves the desired target flow bias ratio over a period of breaths.
However, Farrugia teaches wherein the modification step is configured to incrementally increase the current value of the ventilation until it achieves the desired ventilation over a period of breaths (Farrugia teaches controller 16 setting a new ventilation target greater than the current value of the ventilation, wherein the new ventilation target may be increased incrementally over a number of breaths as seen in [0083]).
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 Balko to have the modification step incrementally increase the current/measured value until it achieves a target/desired ventilation over a period of breaths as taught by Farrugia to prevent sudden changes in ventilation or pressure support levels (see [0083]).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Balko (US 20130269698 A1) in view of Acker (US 20090266360 A1), Manfredo (US 20140130906 A1), White (US 20160193438 A1) and Farrugia (US 20120199126 A1), as applied to claim 17 above, and further in view of Banner (US 20030010339 A1).
Regarding claim 18, modified Balko teaches the apparatus of claim 17, but does not teach wherein the period of breaths is at least 5 breaths, at least 10 breaths, at least 15 breaths, at least 20 breaths, or at least 25 breaths.
However, Banner teaches wherein the period of breaths is at least 5 breaths, at least 10 breaths, at least 15 breaths, at least 20 breaths, or at least 25 breaths (Banner teaches the work of breathing of patient 10 to be measured over a serial 5 breath time period as seen in [0147]).
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 Balko to have a period of breath of at least 5 breaths as taught by Banner for enhanced accuracy of measuring average respiratory muscle pressure (see [0098]).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Tina Zhang whose telephone number is (571)272-6956. The examiner can normally be reached Monday - Friday 9:00AM-5:00PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brandy Lee can be reached at (571) 270-7410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TINA ZHANG/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785