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
The following section is in reference to the Applicant’s Amendments, filed April 20, 2026:
The Applicant’s amendments to Claim 1 have been acknowledged. See updated 102 and 103 claim rejections below.
The Applicant’s addition of Claim 2 has been acknowledged
The Applicant’s amendments to Claims 5-9, 12-14, 17, and 20 have been acknowledged
Claim Objections
A series of singular dependent claims is permissible in which a dependent claim refers to a preceding claim which, in turn, refers to another preceding claim.
A claim which depends from a dependent claim should not be separated by any claim which does not also depend from said dependent claim. It should be kept in mind that a dependent claim may refer to any preceding independent claim. In general, applicant's sequence will not be changed. See MPEP § 608.01(n).
Claims 4, 8, 10-11, 13, 15-16, and 18-20 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim should refer to other claims in the alternative only and/or cannot depend from any other multiple dependent claim. See MPEP § 608.01(n). Accordingly, the Claims 4, 8, 10-11, 13, 15-16, and 18-20 not been further treated on the merits.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2 and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lurie et al. (US 20100319691 A1, hereinafter "Lurie").
Regarding Claim 1, Lurie discloses: A method of controlling exhalation in a ventilation system for providing Positive Expiratory End Pressure, PEEP, ventilation to a lung (Paragraph 0081, [0081] Embodiments of the present invention encompass techniques for regulating intrathoracic pressure, airway pressure, or endotracheal pressure. In some cases, a positive end expiratory pressure (PEEP) can be provided prior to application of a vacuum. In some cases, a PEEP can be provided subsequent to application of a vacuum) the method comprising:
determining a lung resistance based on conditions of the system detected during an exhalation (Paragraph 0186, Embodiments of the present invention provide unique pressure sensor locations for breath control and unique blower configurations for a vacuum mode that allows control of expiratory resistance by turning a blower on for priming, optionally with the use of feedback control loops);
and causing the system to inhibit system exhalation by closing an exhalation valve, the valve being configured to be either fully open or fully closed (Paragraph 0013, A wide variety of valve systems may be used to repetitively decrease the person's intrathoracic pressure or volume of respiratory gases infused into and then extracted from the lungs. For example, valve systems that may be used include those having spring-biased devices, those having automated, electronic or mechanical systems to occlude and open a valve lumen, duck bill valves, ball valves, other pressure sensitive valve systems capable of opening a closing when subjected to low pressure differentials triggered either by spontaneous breathing and/or external systems to manipulate intrathoracic pressures (such as ventilators, phrenic nerve stimulators, iron lungs, and the like), (Paragraph 00189, As further described elsewhere herein, inspiratory and expiratory flow paths can be controlled via two solenoid valves (one for each direction of flow) mounted on a 2-plane manifold system. Through the valve, the flow path can enter by an outer ring of openings and exit the valve by a centrally located lumen. Inspiratory and expiratory pressures can be monitored through pneumatic ports located on each plane of the manifold. As further described elsewhere herein, the inspiratory plane can collect and combine fresh air from a positive pressure blower and oxygen from a separate valved manifold which controls the flow rate of oxygen. Check valves can be located at both fresh air and oxygen inlet locations to prevent flow in the reverse direction), to cause and maintain a target system pressure based on the determined lung resistance and a pressure condition in the system (Paragraph 0004, During this process the delivered tidal volume during the inspiratory phase may vary and the rate of respiratory gases removal by the method or device may vary, either directly or indirectly with the tidal volume delivered, thereby providing a means to achieve the desired target airway pressures and/or intrathoracic pressures), (Paragraph 0011, The device may further include a mechanism for varying the level of impedance or resistance of the valve system. It may include adding positive expiratory pressure when the chest is being compressed. This device may be used in combination with at least one physiological sensor that is configured to monitor at least one physiological parameter of the person. In this way, the mechanism for varying the level of intrathoracic pressure may be configured to receive signals from the sensor and to vary the level of impedance of the valve system based on the signals), (Paragraph 0099, System 300 may include a wide variety of sensors and/or measuring devices to measure any of the physiological parameters described herein. These sensors or measuring devices may be integrated within or coupled to valve system 200 or facial mask, or may be separate).
Regarding Claim 2, Lurie discloses all of the limitations of Claim 1. Lurie further discloses: wherein the exhalation valve may be located within the ventilator and separated from the patient by a breathing system apparatus (Figure 21, Paragraph 0177, Exhaust manifold 2110 is coupled with flow meter 2114, which in turn is coupled with a first inhalation check valve 2116. Oxygen input 2106 can be in fluid communication with a first voltage sensitive orifice (VSO) oxygen valve 2120 and a second VSO oxygen valve 2122. VSO valves 2120, 2122, in turn can be coupled with a flow meter 2124. Check valve 2116 and flow meter 2124 are coupled with a first control valve 2126, which in turn is coupled with a PS2, or second pressure sensor 2128 and a positive pressure delivery mechanism 2129), (Paragraph 0095, Referring also to FIGS. 3-5, valve system 200 will be described in greater detail. Valve system 200 includes a valve housing 202 with a socket 204 into which a ball 206 of a ventilation tube 208 is received. In this way, ventilation tube 208 may rotate about a horizontal axis and pivot relative to a vertical axis. A respiratory source, such as a ventilation bag, may be coupled to tube 208 to assist in ventilation).
Regarding Claim 15, Lurie discloses all of the limitations of Claim 1. Lurie further discloses: further comprising providing a pressure sensor and using said sensor to determine the conditions of the system (Paragraph 0187, As shown in FIG. 21, a first pressure sensor 2138 can operate to monitor pressure in the expiratory line 2141E, and a second pressure sensor 2128 can operate to monitor pressure in the inspiratory line 21411. In some cases, pressure sensor 2138 placed on or in communication with the expiratory limb 2141E can be used to monitor and control the active exhalation function in a circulatory assist mode or procedure. To maintain redundant safety monitoring of the patient airway at all times the pressure sensors are placed in such a way that when the breathing circuit 2141 is connected to the manifold or device, each pressure sensor or transducer is monitoring a particular side of the breathing circuit (e.g. exhalation side 2141E or inhalation side 21411) so that one transducer can be used for a feedback control loop and the other transducer can be used as a redundant safety monitoring feature)
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 3-4, 11-12, and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Lurie in view of Hansmann (US 20180110957 A1).
Regarding Claim 3, Lurie discloses all of the limitations of Claim 1. Lurie further discloses wherein the conditions of the ventilation system comprise data obtained from the system (Paragraph 0011, The device may further include a mechanism for varying the level of impedance or resistance of the valve system. It may include adding positive expiratory pressure when the chest is being compressed. This device may be used in combination with at least one physiological sensor that is configured to monitor at least one physiological parameter of the person. In this way, the mechanism for varying the level of intrathoracic pressure may be configured to receive signals from the sensor and to vary the level of impedance of the valve system based on the signals) to control system exhalations, (Paragraph 0187, With continued reference to FIG. 21, intrathoracic pressure regulation (IPR) system 2100 can include pressure sensors at various locations for use in breath control. Optionally, pressure sensors may provide a level of redundancy to the system. IPR system 2100 can be configured to provide pressure monitoring of both inspiratory and expiratory limb pressures, and active control of end exhale pressures to sub-atmospheric levels when in a circulatory assist mode).
However, Lurie does not explicitly disclose data from a first exhalation. Hansmann does disclose
wherein the conditions of the ventilation system comprise data obtained in a first exhalation (Paragraph 0041, a first expiratory gas flow 5, which designates the gas flow during the phase of exhalation, is shown by the dash-dot line. The first expiratory gas flow 5 drops to 0 L/sec at the end of the phase of exhalation from a maximum at the beginning of the phase of exhalation. The exhalation valve pressure 3 is controlled by the control unit 18. The first expiratory gas flow 5 is determined by the gas flow-measuring unit 14), and wherein the determined lung resistance from the first exhalation is used to cause the system to inhibit system exhalation in further exhalations (Paragraph 0045, The averaged exhalation resistance of the system from a plurality of breaths can be used as a basis for the calculation of the optimal pressure at the exhalation valve 11 in order to suppress dynamic changes between different breaths).
Both Lurie and Hansmann disclose PEEP ventilator systems that incorporate exhalation control mechanism based on different system and patient variables. Thus, it would have been obvious to one skilled in the art before the effective filing date to incorporate the teachings of Hansmann with Lurie, so as to provide a specific programming to better assess the data collected from the various sensors to control the overall ventilation system (Paragraph 0218, Likewise, in some embodiments module system 2400 may also include a storage subsystem 2420 that can store the basic programming and data constructs that provide the functionality of the various embodiments of the present invention. For example, software modules implementing the functionality of the methods of the present invention, as described herein, may be stored in storage subsystem 2420. These software modules are generally executed by the one or more processors 2404), (Paragraph 0115, the amount of inspiratory resistance, or the amount of negative intrathoracic pressure generation (which may be generated using a variety of techniques) can be controlled or regulated by feedback from measurement of ICP, blood pressure, respiratory rate, cardiac output, or other physiological parameters. Such a system could include a closed loop feedback system)
Regarding Claim 4, Lurie in view of Hansmann discloses all of the limitations of Claim 3. Lurie further discloses: wherein the conditions of the system comprise a system pressure condition (Paragraphs 0099-0100, The level of impedance may be varied based on measurements of physiological parameters, or using a programmed schedule of changes. System 300 may include a wide variety of sensors and/or measuring devices to measure any of the physiological parameters described herein. These sensors or measuring devices may be integrated within or coupled to valve system 200 or facial mask, or may be separate. For example, valve system 200 may include a pressure transducer for taking pressure measurements (such as intrathoracic pressures, intracranial pressures, intraocular pressures), a flow rate measuring device for measuring the flow rate of air into or out of the lungs, or a CO2 sensor for measuring expired CO2) and a system exhalation flowrate condition (Paragraph 00188, Treatment systems according to embodiments of the present invention provide for richer control of expiratory flow by use of a blower to generate a negative pressure to enhance expiratory flow, which may in some cases be related to a priming procedure. The use of a servo controlled expiratory pressure source allows a wide range of control of expiratory flow. With servo controlled expiratory pressure, the device can generate a thoracic vacuum at a variety of levels of end expiratory pressure and varying pressure profiles from end inhalation pressure to end expiratory pressure).
Regarding Claim 11, Lurie in view of Hansmann discloses all of the limitations of Claim 3. Lurie further discloses: wherein the system exhalation is inhibited by causing the closing of a valve, optionally the closing of an on- off type valve or the closing of a proportional valve configured to be in one of a fully closed position or a fixed open position (Figure 2, Column 3, lines 3-8, The interrupting valve 16 includes a lightweight non-circular elliptical plate 18 which is driven to occlude the lumen of a tube 20. Forces on the occluding plate 18 generated as a result of airflow through the interrupting valve 16 are balanced. Therefore only minimal force is required to move the plate 18), (Lurie, Paragraph 0013, A wide variety of valve systems may be used to repetitively decrease the person's intrathoracic pressure or volume of respiratory gases infused into and then extracted from the lungs. For example, valve systems that may be used include those having spring-biased devices, those having automated, electronic or mechanical systems to occlude and open a valve lumen, duck bill valves, ball valves, other pressure sensitive valve systems capable of opening a closing when subjected to low pressure differentials triggered either by spontaneous breathing and/or external systems to manipulate intrathoracic pressures (such as ventilators, phrenic nerve stimulators, iron lungs, and the like), Paragraph 00189, As further described elsewhere herein, inspiratory and expiratory flow paths can be controlled via two solenoid valves (one for each direction of flow) mounted on a 2-plane manifold system. Through the valve, the flow path can enter by an outer ring of openings and exit the valve by a centrally located lumen. Inspiratory and expiratory pressures can be monitored through pneumatic ports located on each plane of the manifold. As further described elsewhere herein, the inspiratory plane can collect and combine fresh air from a positive pressure blower and oxygen from a separate valved manifold which controls the flow rate of oxygen. Check valves can be located at both fresh air and oxygen inlet locations to prevent flow in the reverse direction).
Regarding Claim 12, Lurie in view of Hansmann discloses all of the limitations of Claim 11. Lurie further discloses: wherein the system exhalation is inhibited by causing a single closing of the valve (Paragraph 0179, According to some embodiments, it can be helpful to close off either one or the other control valve, which can facilitate the capability of the device to a) deliver a breath or b) deliver ITPR therapy. The sequence for turning off blowers may vary in some instances. Further, in some cases the inhalation configuration events may occur quite closely together, for example, within a period of less than 20 mSec), (Paragraph 0180, In an exhalation configuration according to some embodiments, second control valve 2132 is turned on or closed, and first control valve 2126 is turned off or opened), (Paragraph 0189, Expiratory gasses enter the manifold through the outer lumen of the patient circuit. A check valve is located at the entrance of the expiratory path to prevent expiratory gasses from being re-breathed by the patient. In a fashion similar to that of the inspiratory flow, a valve opens and closes to control the flow of expiratory gases).
Regarding Claim 16, Lurie in view of Hansmann discloses all of the limitations of Claim 3. Hansmann further discloses: further comprising repeating the determining and causing steps in subsequent exhalations (Paragraph 0045, The averaged exhalation resistance of the system from a plurality of breaths can be used as a basis for the calculation of the optimal pressure at the exhalation valve 11 in order to suppress dynamic changes between different breaths), (Paragraph 0020, Further, a device for controlling an expiratory gas flow in an exhalation path, which device has an exhalation valve at a user interface, which valve provides a positive end-expiratory pressure, and a control device for controlling the exhalation valve, is characterized in that the control device has a determination module for determining an exhalation parameter during a phase of exhalation and a change module for changing the positive end-expiratory pressure during the same phase of exhalation by means of the exhalation valve).
Regarding Claim 17, Lurie in view of Hansmann discloses all of the limitations of Claim 16. further discloses: comprising using in the repeated causing step(s) an averaged lung resistance as the lung resistance, said averaged lung resistance being based on an average of lung resistances determined from previous exhalations (Paragraph 0045, The averaged exhalation resistance of the system from a plurality of breaths can be used as a basis for the calculation of the optimal pressure at the exhalation valve 11 in order to suppress dynamic changes between different breaths).
Claims 5-10 and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Lurie in view of Hansmann, further in view of Chowienczyk et al. (US 5233998 A, hereinafter “Chowienczyk”).
Regarding Claim 5, Lurie in view of Hansmann discloses all of the limitations of Claim 4. Hansmann further discloses: wherein the system pressure condition is based on a pressure differential between two system pressures (Paragraph 0017, In another alternative embodiment, the PEEP may be reduced from a first initial value during a phase of exhalation at a predefined time. Further, the PEEP is increased again to the first initial value during the same phase of exhalation. The gas flow is thus determined during the exhalation and a differential exhalation resistance as well as a compliance are further determined from the determined gas flow at the time of the reduction), (Paragraph 0051, FIG. 4b shows an embodiment of the method with which the differential value can be calculated for the exhalation resistance and the compliance at the tidal volume or state of distension of the lungs that are present at this time).
Hansmann does not explicitly disclose that the two system pressures are measured before causing the system to inhibit system exhalation and measured after causing the system to inhibit system exhalation
Chowienczyk discloses the system pressure condition is based on a pressure differential between two system pressures, one measured before causing the system to inhibit system exhalation, and one measured after causing the system to inhibit system exhalation (Column 3, lines 27-57, The apparatus 2 operates as follows. With the interrupting valve 16 open, pressure and hence flow are continually monitored […] For the next 100 msec pressure values are stored in a memory part of the computer unit 8 at intervals of 1 msec […] these two average values are used to back extrapolate the pressure transient to a time (t0)+15 msec. The difference between this and the baseline pressure immediately prior to interruption is taken as the alveolar pressure at the time of interruption. The airway resistance as determined by the interrupter technique is taken as the ratio of this pressure to flow at the time of the interruption)
Chowienczyk and Lurie in view of Hansmann both disclose apparatuses that serve to measure airway resistance and pressure in patient interfaces. Thus, it would have been obvious to one skilled in the art before the effective filing date to incorporate the specific monitoring and measuring system as disclosed by Chowienczyk, as it provides clarification regarding the determination module as taught by Hansmann and the programming taught by Lurie.
Regarding Claim 6, Lurie in view of Hansmann and Chowienczyk discloses all of the limitations of Claim 5. Hansmann further discloses: wherein the system pressure before causing the system to inhibit exhalation is the system pressure measured at a system low pressure target (Paragraph 0013, The exhalation parameter is advantageously an exhalation resistance. Due to the exact knowledge of the exhalation resistance, the PEEP can be set exactly for the patient. The exhalation resistance acts in connection with the expiratory flow as a minimum pressure, which the patient or the ventilator must overcome for an exhalation. This pressure brings about a minimum PEEP, which can be added to the PEEP set on the device. The PEEP set on the device can be set at a lower value in this manner in order to set up an overall PEEP, which is the sum of the set PEEP and the minimum PEEP), and the system pressure after causing the system to inhibit system exhalation is the system pressure measured at a time when the system pressure equalises with a lung pressure as a consequence of causing the system to inhibit system exhalation (Paragraph 0039, The exhalation valve pressure 3 is not 0 mbar during the phase of exhalation, but it amounts to a few mbar, which corresponds to the PEEP. The difference between the maximum and the minimum of the exhalation valve pressure 3 is the first pressure difference 30. The minimum of the exhalation valve pressure 3 in FIG. 2a corresponds to the basic PEEP valve), (Paragraph 0015, As an alternative or in addition, the exhalation resistance can advantageously be determined from estimated values from partial exhalation resistances of components in the exhalation path. This estimation may already be carried out before the ventilator is put into operation, so that an exact adaptive regulation of the PEEP can be carried out from the very beginning)
Lurie in view of Hansmann and Chowienczyk teaches a system and apparatus that allows for setting specific target pressure values, as well as continuous, adaptive pressure regulation through a determination module and control system. It would have been obvious to one skilled in the art before the effective filing date that Lurie in view of Hansmann and Chowienczyk is capable of having different parameters and inputs for pressure differential values, including but not limited to the system low pressure target and the system pressure equalized with lung pressure.
Regarding Claim 7, Lurie in view of Hansmann and Chowienczyk discloses all of the limitations of Claim 5. Lurie further discloses: wherein the system low pressure target is a target PEEP which corresponds to the target system pressure (Paragraph 0150, The addition of PEEP either before or after this `wringing out` process provides a means to help maintain oxygenation and preserve and protect lung function. During this process the delivered tidal volume during the inspiratory phase may vary and the rate of respiratory gases removal by the method or device may vary, either directly or indirectly with the tidal volume delivered, thereby providing a means to achieve the desired target airway pressures and/or intrathoracic pressures. Methods and devices such as these that provide IPR therapy can therefore be used to enhance circulation and increase blood pressure, even when the thorax is open to atmospheric pressure such as during or after open heart surgery. It can be applied to both lungs or just one lung, as long as the method and device is allowed to move respiratory gases in and out of the lung(s)), (Hansmann, Paragraph 0013, The exhalation parameter is advantageously an exhalation resistance. Due to the exact knowledge of the exhalation resistance, the PEEP can be set exactly for the patient. The exhalation resistance acts in connection with the expiratory flow as a minimum pressure, which the patient or the ventilator must overcome for an exhalation. This pressure brings about a minimum PEEP, which can be added to the PEEP set on the device. The PEEP set on the device can be set at a lower value in this manner in order to set up an overall PEEP, which is the sum of the set PEEP and the minimum PEEP))
Regarding Claim 8, Lurie in view of Hansmann and Chowienczyk discloses all of the limitations of Claim 5. Chowienczyk further discloses: wherein the system flowrate condition is based on a flowrate differential between two system flowrates, one measured before and one measured after causing the system to inhibit system exhalation (Column 3, lines 27-57, The apparatus 2 operates as follows. With the interrupting valve 16 open, pressure and hence flow are continually monitored […] For the next 100 msec pressure values are stored in a memory part of the computer unit 8 at intervals of 1 msec […] these two average values are used to back extrapolate the pressure transient to a time (t0)+15 msec. The difference between this and the baseline pressure immediately prior to interruption is taken as the alveolar pressure at the time of interruption. The airway resistance as determined by the interrupter technique is taken as the ratio of this pressure to flow at the time of the interruption).
Regarding Claim 9, Lurie in view of Hansmann discloses all of the limitations of Claim 3. Hansmann further discloses: wherein the system flowrate before causing the system to inhibit system exhalation is the exhalation flowrate measured at the system low pressure target, and the system exhalation flowrate after causing the system to inhibit system exhalation is the exhalation flowrate measured at a time when system pressure equalises with a lung pressure as a consequence of causing the system to inhibit system exhalation (Paragraph 0015, As an alternative or in addition, the exhalation resistance can advantageously be determined from estimated values from partial exhalation resistances of components in the exhalation path. This estimation may already be carried out before the ventilator is put into operation, so that an exact adaptive regulation of the PEEP can be carried out from the very beginning), (Paragraph 0011, By changing the positive end-expiratory pressure during the exhalation, a PEEP adapted to individual conditions is provided. Depending on the demand during the exhalation, a rapid increase and/or a rapid reduction of the expiratory flow can take place due to the change in the PEEP. An adaptive change in the expiratory flow is thus brought about during the exhalation)
Lurie in view of Hansmann and Chowienczyk teaches a system and apparatus that allows for setting specific target pressure values, as well as continuous, adaptive pressure and flowrate regulation through a determination module and control system. It would have been obvious to one skilled in the art before the effective filing date that Lurie in view of Hansmann and Chowienczyk is capable of having different parameters and inputs for pressure differential values and system flowrate, including but not limited to the exhalation flowrate at system low pressure target and the exhalation flowrate when the system pressure equalizes with lung pressure.
Regarding Claim 10, Lurie in view of Hansmann discloses all of the limitations of Claim 3. Hansmann further discloses: causing the opening of a valve thereby providing substantially no resistance to system exhalation(Figure 1, exhalation valve 11), (Paragraph 0036, The control device 18 controls the exhalation valve 11 during the phase of exhalation on the basis of the data of the gas flow-measuring unit 14. Further, the control device 18 can actuate the exhalation valve 11 during a phase of exhalation with predefined maneuvers and then detect the change in the expiratory gas flow in the same phase of exhalation by means of the gas flow-measuring unit 14)
Hansmann does not explicitly state that the opening of a valve provides substantially no resistance to system exhalation prior to causing the system to inhibit system exhalation.
Chowienczyk does disclose further comprising causing the opening of a valve, thereby providing substantially no resistance to system exhalation prior to causing the system to inhibit system exhalation (Column 3, lines 27-42, With the interrupting valve 16 open, pressure and hence flow are continually monitored. When the flow reaches a pre-determined value, which is usually 0.5 l/s, the interrupting valve 16 is actuated. For the next 100 msec pressure values are stored in a memory part of the computer unit 8 at intervals of 1 msec. Approximately 5 msec after the valve is actuated, complete airway occlusion is achieved. The interrupting valve 18 is held in the closed position for a further 100 msec. This period of airway occlusion is virtually imperceptible to the patient. The interrupting valve 16 is then opened and the stored pressure transient obtained as a result of the closing and opening of the interrupting valve 18 is analysed to compute the airway resistance as determined by the interrupter technique, see FIG. 3.)
Chowienczyk and Lurie in view of Hansmann both disclose valved apparatuses that serve to measure airway resistance and pressure in patient interfaces. Thus, it would have been obvious to one skilled in the art before the effective filing date to incorporate the specific actuating and flow monitoring methods as disclosed by Chowienczyk, as it provides clarification regarding the control device’s actuation of the exhalation valve as taught by Lurie in view of Hansmann.
Regarding Claim 13, Lurie in view of Hansmann and Chowienczyk discloses all of the limitations of Claim 10. Chowienczyk further discloses: wherein the valve provided is configured to be in a fixed open position or a substantially fully closed position (Figure 2, Column 3, lines 3-8, The interrupting valve 16 includes a lightweight non-circular elliptical plate 18 which is driven to occlude the lumen of a tube 20. Forces on the occluding plate 18 generated as a result of airflow through the interrupting valve 16 are balanced. Therefore only minimal force is required to move the plate 18), said valve being in the open position during the exhalation apart from when system exhalation is inhibited and the valve is in the substantially fully closed position (Column 3, lines 27-37, With the interrupting valve 16 open, pressure and hence flow are continually monitored. When the flow reaches a pre-determined value, which is usually 0.5 l/s, the interrupting valve 16 is actuated. For the next 100 msec pressure values are stored in a memory part of the computer unit 8 at intervals of 1 msec. Approximately 5 msec after the valve is actuated, complete airway occlusion is achieved. The interrupting valve 18 is held in the closed position for a further 100 msec. This period of airway occlusion is virtually imperceptible to the patient).
Regarding Claim 14, Lurie in view of Hansmann and Chowienczyk discloses all of the limitations of Claim 13. Chowienczyk further discloses: wherein the fixed open position is substantially fully open (Figure 2, Column 3, lines 3-8, The interrupting valve 16 includes a lightweight non-circular elliptical plate 18 which is driven to occlude the lumen of a tube 20. Forces on the occluding plate 18 generated as a result of airflow through the interrupting valve 16 are balanced. Therefore only minimal force is required to move the plate 18).
Claim 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Lurie in view of Hansmann in view of O’Mahoney et al. (US 6321748 B1, hereinafter “O’Mahoney”), further in view of Chowienczyk.
Regarding Claim 18, Lurie in view of Hansmann discloses all of the limitations of Claim 3. Hansmann teaches a determination module that adaptively adjusts the pressure and flowrate of the system (Paragraph 0038, To detect the measured signals of the gas flow-measuring unit 14, the control device 18 has a determination module 180. The determination module 180 is further configured to receive pressure signals from pressure sensor 19. The determination module 180 can determine additional parameters, e.g., the exhalation resistance, from the transmitted signals), (Paragraph 0009, An object of the present invention is therefore to provide a device and a method that permits an adaptive change in the expiratory flow during exhalation)
However, Lurie in view of Hansmann does not explicitly disclose that the determination module is intended to identify an error occurring during the exhalation in reaching the target system pressure caused by a timing delay in causing the system to inhibit system exhalation, and subsequently causing a timing correction in causing the system to inhibit system exhalation to correct said error in a subsequent exhalation
O’Mahoney does disclose determining an error occurring during the exhalation in reaching the target system pressure caused by a timing delay, and subsequently causing a timing correction in causing the system to correct said error in a subsequent exhalation (Columns 4-5, lines 64-6, Step 414 calculates the error as the difference between actual pressure (Pcontrol) in the patient circuit and the current set point pressure (Control Target). After the error is calculated, the task is to change the air flow in the patient circuit by the amount necessary to correct the error so that the gas pressure in the patient circuit substantially conforms to the set point pressure. To accomplish this, steps 416, 418, and 420 calculate the individual correction terms to be used in step 422).
Lurie in view of Hansmann and O’Mahoney both disclose control devices and methods in ventilator systems. It would have been obvious to one skilled in the art before the effective filing date to incorporate the error detection method disclosed by O’Mahoney with the system and method disclosed by Hansmann, so as to provide an additional degree of accuracy in the patient interface (Column 1, lines 38-47).
Thus, it would have been obvious to one skilled in the art before the effective filing date to incorporate the specific monitoring and measuring system as disclosed by Chowienczyk, as it provides clarification regarding the determination module as taught by Hansmann (Column 1, lines 38-47, These prior art control schemes present a number of problems. For example, the torque constant varies with temperature. As a result, the error is never eliminated in a controlled fashion. The prior art uses current control which is a function of how frictionless the piston is. Moreover, the signals delivered to the piston motor do not take into account gas leaks in the system. Also, the prior art analog control schemes do not provide the desired level of precision and flexibility in operation needed for medical applications), (Column 1, lines 52-55, More particularly, the piston ventilator of the present invention uses digital processing to implement a control scheme for eliminating error between actual pressure in the patient circuit and the set point pressure)
Lurie in view of Hansmann and O’Mahoney teaches inhibit[ing] system exhalation (Paragraph 0013, The exhalation parameter is advantageously an exhalation resistance. Due to the exact knowledge of the exhalation resistance, the PEEP can be set exactly for the patient. The exhalation resistance acts in connection with the expiratory flow as a minimum pressure, which the patient or the ventilator must overcome for an exhalation. This pressure brings about a minimum PEEP, which can be added to the PEEP set on the device. The PEEP set on the device can be set at a lower value in this manner in order to set up an overall PEEP, which is the sum of the set PEEP and the minimum PEEP)
However, Chowienczyk provides further context and explanation regarding how a control system could cause the system to inhibit system exhalation, and subsequently causing a timing correction in causing the system to inhibit system exhalation to correct said error in a subsequent exhalation (Column 3, lines 27-57, The apparatus 2 operates as follows. With the interrupting valve 16 open, pressure and hence flow are continually monitored […] For the next 100 msec pressure values are stored in a memory part of the computer unit 8 at intervals of 1 msec […] these two average values are used to back extrapolate the pressure transient to a time (t0)+15 msec. The difference between this and the baseline pressure immediately prior to interruption is taken as the alveolar pressure at the time of interruption. The airway resistance as determined by the interrupter technique is taken as the ratio of this pressure to flow at the time of the interruption)
Chowienczyk and Lurie in view of Hansmann and O’Mahoney both disclose apparatuses that serve to measure airway resistance and pressure in patient interfaces. Thus, it would have been obvious to one skilled in the art before the effective filing date to incorporate the specific monitoring and measuring system as disclosed by Chowienczyk, as it provides clarification regarding the determination module as taught by Lurie in view of Hansmann.
Regarding Claim 19, Lurie in view of Hansmann, O’Mahoney, and Chowienczyk discloses all of the limitations of Claim 18. Lurie further discloses: An apparatus arranged to perform the method of any preceding claim (Paragraph 0047, Exemplary systems may include a processor, and a memory coupled with the processor. The memory may include a positive pressure ventilation code module comprising instructions for operating the positive pressure ventilation mechanism, and a respiratory extraction code module comprising instructions for operating the respiratory extraction mechanism. In some cases, a treatment system includes a circuit having two limbs, a manifold that maintains separation between inspiratory gases and expiratory gases, and a removable protective case that is resistant to impact and moisture. Treatment systems may also include a sensor assembly that facilitates breath control. What is more, treatment systems may include a blower mechanism that facilitates control of expiratory resistance. Optionally, systems can be configured so that a blower mechanism operates based on a feedback control loop.).
Regarding Claim 20, Lurie in view of Hansmann, O’Mahoney, and Chowienczyk discloses all of the limitations of Claim 19. Lurie further discloses: An apparatus of claim 19, wherein the apparatus comprises: a processor and a ventilation system configured to perform the method of any of claims 1 to 17 (Paragraph 0042, Embodiments of the present invention encompass systems and methods for providing an intrathoracic pressure regulation treatment to an individual. Exemplary systems include an adjustable negative pressure mechanism that delivers an adjustable negative pressure treatment to the patient when the system is in a circulatory assist mode, a positive pressure ventilation mechanism that delivers a positive pressure ventilation treatment to the patient when the system is in a ventilation mode […] Relatedly, systems may include a control mechanism or processor for receiving a operator selection input that designates a member selected from the group consisting of the circulatory assist mode, the ventilation mode, and the CPAP mode, and an operator confirmation input that activates the designated member associated with the operator selection input), (Paragraph 0219, processor component or module 2404 can be a microprocessor control module configured to receive physiological, device, or treatment parameter signals from sensor input device or module 2432 or user interface input device or module 2406, and to transmit treatment signals to output device or module 2436, user interface output device or module 2408, network interface device or module 2410, or any combination thereof.); and a computer-readable medium carrying computer-readable instructions which, when executed by a processor of a ventilation system, cause the system to carry out the method of any of claims 1 to 18 (Paragraph 0219, Each of the devices or modules according to embodiments of the present invention can include one or more software modules on a computer readable medium that is processed by a processor, or hardware modules, or any combination thereof), (Paragraph 0047, Exemplary systems may include a processor, and a memory coupled with the processor. The memory may include a positive pressure ventilation code module comprising instructions for operating the positive pressure ventilation mechanism, and a respiratory extraction code module comprising instructions for operating the respiratory extraction mechanism).
Response to Arguments
In response to applicant's argument that an on/off valve is not capable of being incorporated into the system disclosed by Hansmann, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Controlled valves can be constructed in various forms, wherein some are controlled proportionally and other cycle through fully opened and fully close through different pulses/timing. It would have been obvious to one of ordinary skill in the art to interchange valves as long as the valve of the secondary reference can perform the same function needed by the Hansmann.
Nevertheless, the Applicant’s arguments with respect to Independent Claim 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. See above rejection for further explanation.
Conclusion
Applicant's amendment necessitated the new grounds of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MISHAL Z HUSSAIN whose telephone number is (703)756-1206. The examiner can normally be reached M-F, 8:30am - 5:00pm.
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/MISHAL HUSSAIN/
Examiner
Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785
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