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 .
Priority
Acknowledgement is made to Applicant’s claim to priority to Provisional Application No. 63/320,453 filed March 16, 2022 and to foreign priority to Provisional Application No. 63/176,039 filed April 16, 2021.
• The new limitations in claims 16 (a position of each of valves at time periods), 19, 21-22 (connectors), 32 (a touch screen) and 43 (an upstream air tube splitter and its arrangement) have been introduced in the Provisional Application No. 63/320,453 filed March 16, 2022 in comparison with provisional application. The claims 16, 19, 21-22, 32, 43 appear to have a different effective filing date than the remainder of the claim listing, as the earlier provisional application does not include the features or mentioned previously and thus is not entitled to the earliest effective filing date. Therefore, claims 16, 19, 21-22, 32, 43 are given the earliest effective filing date as the Provisional Application No. 63/320,453 filed March 16, 2022.
Status of Claims
The present office action is in response to the Preliminary amendment filed 04/03/2026. As directed by the amendment, claims 1, 4, 7, 13, 16, 19, 21-22, 29, 31-32, 36, 38-41 have been amended, and claims 2-3, 6, 8-12, 14-15, 17-18, 20, 23-28, 30, 33,-35, 37 and 45-47 have been cancelled. Thus, claims 1, 4-5, 7, 13, 16, 19, 21-22, 29, 31-32, 36, and 38-44 are presenting pending in this application.
Claim Objections
Claim 43 is objected to because of the following informalities:
Claim 43 recites, “device each comprising” in ln 3 which Examiner suggest amending to read --device, each comprising--
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 (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 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)(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, 4-5, 13, 29, 32, 36, 40, and 44 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by McVicar et al. (WO 2021219805 A2).
Regarding claim 1, McVicar et al. discloses, a ventilator device for co-ventilation of multiple patients (a system as shown in Fig 1; PG 5, ln 6-7), “a ventilation system for a plurality of patients comprising a common ventilator”), the ventilator device comprising:
an air tube splitter (a first Y- connector 32, Fig 1) having an inlet (where an inspire line 16 is connected; see annotation below, Fig 1), a plurality of outlets (where an inspiration air lines 20, 26 are connected in Fig 1; see annotation below, Fig 1), and a plurality of branches (a diverging portion; see annotation below, Fig 1), wherein each of the branches extends to a respective one of the outlets (as the diverging portions are extended to the outlet as shown in Fig 1);
PNG
media_image1.png
436
678
media_image1.png
Greyscale
a plurality of valves (an electronic flow control EFC valve, Fig 1) coupled to the branches, wherein each of the valves is configured to be adjusted between an open position and a closed position (PG 9, ln 12 - PG 11, ln 21, implies that the EFC valves are capable of actuating from fully open to fully closed and controlling a pressure/volume/desired tidal volume by changing a position of the valves), wherein each of the valves is configured to be adjusted to regulate air flow through a respective one of the branches (PG 9, ln 12 - PG 11, ln 21);
a plurality of actuators coupled to the valves (PG 9, ln 12, “The EFC valve maybe be controlled by a solenoid or a motorized actuator”), wherein each of the actuators is configured to adjust a respective one of the valves (PG 13, ln 24-28, implies each actuator for each valve); and
a controller (46, 48, Figs 1-2) in operable communication with the actuators (PG 10, ln 8-13, “receives command control signals from the CPU 68 via the bus 66 and communicates these as analog control signals to the EFC valve… and the control signals required by the EFC valve to control the airflow through the valve”), wherein the controller is configured to:
receive a set of inspiratory pressure settings or tidal volume settings for the patients (PG 9, ln 16 - PG 14, ln 21, “The controller 46 operates as a monitor and has a touchscreen display 60 and input buttons and switches 62 to allow a user, typically a trained nurse or doctor, to control the unit and provide inputs, such as desired ventilation parameters…a desired volumetric parameter…a tidal volume…tailor the ventilation to a single patient by setting a single value (tidal volume) and the flow control valve setting will tailor airflow to obtain that tidal volume…has no effect on the air supply to the patient on the other breathing circuit””; and independently control the actuators to adjust the valves based at least in part on the set of inspiratory pressure settings or tidal volume settings (PG 9, ln 16 - PG 14, ln 21).
Regarding claim 4, McVicar et al. discloses the device of claim 1 as discussed above.
McVicar et al. further discloses, wherein the plurality of branches comprises a first branch and a second branch disposed adjacent to one another and defining an angle therebetween (Examiner notes that that the diverging portion of the Y connector as shown in Fig 1 are a first branch and a second branch which are disposed adjacent to one another and defining fixed angle).
Regarding claim 5, McVicar et al. discloses the device of claim 4 as discussed above.
McVicar et al. further discloses, wherein the angle is fixed (32, Fig 1).
Regarding claim 13, McVicar et al. discloses the device of claim 1 as discussed above.
McVicar et al. further discloses, wherein the controller is further configured to control the actuators to alternately adjust the valves between the open position and the closed position based at least in part on a predetermined inspiratory to expiratory ratio (Examiner interprets the “predetermined inspiratory to expiratory ratio” as any inspiratory flow to the patient as BRI since any inspiratory flow in view of exhalation/expiratory flow would be a value of I:E; Fig 11, indicates I:E as 1:2 which implies that the such ratio can be achieved via controlling the valves based on the ventilation parameters from the controller as described in PG 9, ln 16 - PG 14, ln 21).
Regarding claim 29, McVicar et al. discloses the device of claim 1 as discussed above.
McVicar et al. further discloses, a user interface (a touch screen 60, buttons & switches 62, Fig 2) in operable communication with the controller (PG 9, ln 16-23, “The controller 46 operates as a monitor and has a touchscreen display 60 and input buttons and switches 62 to allow a user, typically a trained nurse or doctor, to control the unit and provide inputs, such as desired ventilation parameters…”), wherein the user interface is configured to allow a user to input and adjust the set of inspiratory pressure settings or tidal volume settings for the patients (PG 9, ln 16 - PG 14, ln 21, implies that the user interface allows a user to input and adjust the ventilation parameters for the patient), wherein the user interface is further configured to allow the user to input and adjust an inspiratory to expiratory ratio for the patients (Examiner interprets the “an inspiratory to expiratory ratio” as any inspiratory flow to the patient as BRI since any inspiratory flow in view of exhalation/expiratory flow would be a value of I:E; Fig 11, indicates I:E as 1:2 which implies that the such ratio can be achieved via controlling the valves based on the ventilation parameters from the controller as described in PG 9, ln 16 - PG 14, ln 21).
Regarding claim 32, McVicar et al. discloses the device of claim 29 as discussed above.
McVicar et al. further discloses, wherein the user interface comprises a graphical user interface configured to display independent patient data for each of the patients (PG 9, ln 16 - PG 14, ln 21 implies that the independent patient data is displayed as shown in Figs 6-7, 11-14, and 16-19), wherein the user interface comprises a touchscreen display (60, Fig 2).
Regarding claim 36, McVicar et al. discloses the device of claim 1 as discussed above.
McVicar et al. further discloses, a ventilator (10, Fig 1) coupled to the inlet of the air tube splitter by a ventilation tubing line (16 as shown in Fig 1) and configured to deliver air to the inlet of the air tube splitter (PG 8, ln 20-27, implies that the ventilator provides gas to the patients through the components in between the ventilator and patient), wherein the controller is in operable communication with the ventilator and configured to control an air output of the ventilator (PG 9, ln 16 - PG 14, ln 21, implies that the ventilator are controlled via “pressure control mode”).
Regarding claim 40, McVicar et al. discloses the device of claim 1 as discussed above.
McVicar et al. further discloses, a continuous positive airway pressure device (PG 8, ln 20-27, implies that the ventilator is a continuous positive airway pressure device) coupled to the inlet of the air tube splitter by a ventilation tubing line (16 as shown in Fig 1) and configured to deliver air to the inlet of the air tube splitter (PG 8, ln 20-27, implies that the ventilator provides gas to the patients through the components in between the ventilator and patient).
Regarding claim 44, McVicar et al. discloses, a method for co-ventilation of multiple patients (PG 4-5, implies a method of using co-ventilation system), the method comprising:
delivering air from a ventilator (10, Fig 1) to a ventilator device (an assembly of components 32, 20, 26, 52 as shown in Fig 1), the ventilator device comprising:
an air tube splitter (a first Y- connector 32, Fig 1) having an inlet (where an inspire line 16 is connected; see annotation below, Fig 1), (where an inspiration air lines 20, 26 are connected in Fig 1; see annotation below, Fig 1), and a plurality of branches (a diverging portion; see annotation below, Fig 1), wherein each of the branches extends to a respective one of the outlets (as the diverging portions are extended to the outlet as shown in Fig 1);
PNG
media_image1.png
436
678
media_image1.png
Greyscale
a plurality of valves (an electronic flow control EFC valve, Fig 1) coupled to the branches, wherein each of the valves is configured to be adjusted between an open position and a closed position (PG 9, ln 12 - PG 11, ln 21, implies that the EFC valves are capable of actuating from fully open to fully closed and controlling a pressure/volume/desired tidal volume by changing a position of the valves), wherein each of the valves is configured to be adjusted to regulate air flow through a respective one of the branches (PG 9, ln 12 - PG 11, ln 21);
a plurality of actuators coupled to the valves (PG 9, ln 12, “The EFC valve maybe be controlled by a solenoid or a motorized actuator”), wherein each of the actuators is configured to adjust a respective one of the valves (PG 13, ln 24-28, implies each actuator for each valve); and
a controller (46, 48, Figs 1-2) in operable communication with the actuators (PG 10, ln 8-13, “receives command control signals from the CPU 68 via the bus 66 and communicates these as analog control signals to the EFC valve… and the control signals required by the EFC valve to control the airflow through the valve”), wherein the controller is configured to:
receive a set of inspiratory pressure settings or tidal volume settings for the patients (PG 9, ln 16 - PG 14, ln 21, “The controller 46 operates as a monitor and has a touchscreen display 60 and input buttons and switches 62 to allow a user, typically a trained nurse or doctor, to control the unit and provide inputs, such as desired ventilation parameters…a desired volumetric parameter…a tidal volume…tailor the ventilation to a single patient by setting a single value (tidal volume) and the flow control valve setting will tailor airflow to obtain that tidal volume…has no effect on the air supply to the patient on the other breathing circuit””; and independently control the actuators to adjust the valves based at least in part on the set of inspiratory pressure settings or tidal volume settings (PG 9, ln 16 - PG 14, ln 21).
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 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.
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.
Claims 19, and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over McVicar et al. (WO 2021219805 A2) as applied to claim 1above, and further in view of Kremeier (US 20210299390 A1).
Regarding claim 19, McVicar et al. discloses the device of claim 1 as discussed above.
While McVicar et al. indicates the connection between the branches of the Y-connector to the valves and ventilation tubing lines as shown in Fig 1, McVicar et al. is silent on a detail of the connection such as a plurality of first connectors coupled to the branches and the valves and a plurality of second connectors coupled to the valves, wherein each of the first connectors connects a respective one of the valves to a respective one of the branches and each of the second connectors is configured to connect a ventilation tubing line to a respective one of the valves.
However, Kremeier which is analogous to the claimed invention for a ventilation apparatus and a ventilation system for connecting at least two patients (¶0002) teaches, a plurality of first connectors (adapter I-5 connecting between a branch point I-2, Y-piece and an adjustable PEEP valve I-6 as shown in Fig 1; ¶0065, “For example…22mm hose 2x female”; ¶0094, an adapter for a valve) coupled to the branches and the valves and a plurality of second connectors(an attachment piece I-9 connecting between the valve I-6 and a patient hose as shown in Fig 1; ¶0054, “at least one attachment piece I-9 for connection to a patient interface 11. The patient interface 11 can be a Y-piece which is connected to a mask or to a tube, or the patient interface can be directly a mask or a tube”; ¶0065, “For example…connector 22_M + 15_F/22_M”; ¶0094, “such that a normal ventilation hose can be attached”) coupled to the valves, wherein each of the first connectors connects a respective one of the valves to a respective one of the branches and each of the second connectors is configured to connect a ventilation tubing line to a respective one of the valves as a design choice of the inspiratory hose arrangement with the known connection parts between components (¶0064, “a one-part or multi-part design. For example, different functional parts and hoses can be connected such that they yield the inspiratory hose portion”).
Therefore, 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 device of McVicar et al. to include a plurality of first connectors coupled to the branches and the valves and a plurality of second connectors coupled to the valves, wherein each of the first connectors connects a respective one of the valves to a respective one of the branches and each of the second connectors is configured to connect a ventilation tubing line to a respective one of the valves as taught by Kremeier as a design choice of the inspiratory hose arrangement with the known connection parts between components without unexpected results.
Regarding claim 21, McVicar et al. in view of Kremeier discloses the device of claim 19 as discussed above.
Modified McVicar et al. discloses, wherein the air tube splitter, the first connectors, the valves, and the second connectors are separately formed and connected to one another (Kremeier: “a one-part or multi-part design”).
Regarding claim 22, McVicar et al. in view of Kremeier discloses the device of claim 19 as discussed above.
Modified McVicar et al. discloses, wherein the air tube splitter, the first connectors, portions of the valves, and the second connectors are integrally formed with one another (Kremeier: “a one-part or multi-part design”).
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over McVicar et al. (WO 2021219805 A2) as applied to claim 29 above, and further in view of Servidio et al. (US Pat 5598838 A).
Regarding claim 31, McVicar et al. discloses the device of claim 29 as discussed above.
While McVicar et al. discloses the controller operates as a monitor and has a touchscreen display (a display screen) and input buttons and switches to allow a user to control the unit and provide input such as desired ventilation parameters (PG 9, ln 16-23), McVicar et al. does not specifically discloses an input method comprising a rotary encoder, and a knob coupled to the rotary encoder.
However, Servidio et al. which is analogous art to the claimed invention for a pressure support ventilator with a display (Col 4, ln 50 - Col 5, ln 4) and user interfaces (Fig 2), teaches an input method comprising a rotary encoder and a knob coupled to the rotary encoder (Col 6, ln 49-61, “58. The rotary incremental encoders actuated by the knobs 39 of the control panel 16 are mounted to the encoder board 60, and rotary shafts of the encoders are received through corresponding through-holes in the display board 28. The encoder board 60 detects the settings of the knobs 39 and transmits the information to the display board 58.”) in purpose of having a low-cost analog-like controls which are intuitive to use without having to scroll through menus (Col 7, ln 35-49).
Therefore, 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 device of McVicar et al. to have an input method comprising a rotary encoder, and a knob coupled to the rotary encoder as taught by Servidio et al. in purpose of having a low-cost analog-like controls which are intuitive to use without having to scroll through menus (Col 7, ln 35-49).
Claim 38 is rejected under 35 U.S.C. 103 as being unpatentable over McVicar et al. (WO 2021219805 A2).
Regarding claim 38, McVicar et al. discloses the device of claim 36 as discussed above.
McVicar et al. does not specifically discloses, wherein the ventilator is configured to deliver air to the inlet of the air tube splitter at a respiratory rate that is at least double a single patient respiratory rate requirement.
Examiner interprets a respiratory rate of the “single patient respiratory rate requirement” as 10-60 breaths/min as it varies by age group or medical conditions of the patient as broadest reasonable interpretation.
However, McVicar et al. discloses a shared ventilation system in which a single ventilator that is a conventional ventilator (PG 7, ln 22-23). Examiner assert that the conventional ventilator can used on neonates or older adults over 65 years which implies that the respiratory rate can be provided between 10-60 breaths/min. Thus, one of the ordinary skills in the art would have recognized that the device of McVicar et al. would be capable of providing the respiratory rate at least double the requirement when providing same ventilation requirement to both of the patients such as providing required respiratory rate based on the patient’s age group and/or the medical condition.
Therefore, 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 device of McVicar et al. to include wherein the ventilator is configured to deliver air to the inlet of the air tube splitter at a respiratory rate that is at least double a single patient respiratory rate requirement in purpose of providing required respiratory rate based on the patient’s age group and/or the medical condition without unexpected results.
Regarding claim 39, McVicar et al. discloses the device of claim 36 as discussed above.
McVicar et al. does not specifically discloses, wherein the ventilator is configured to deliver air to the inlet of the air tube splitter at a flow rate that is at least double a single patient respiratory rate requirement.
Examiner asserts that a flow rate varies by a patient’s age group and their size and weight or medical conditions such as 1 - 15 L/min or even more based on a type of patient interfaces.
However, McVicar et al. discloses a shared ventilation system in which a single ventilator that is a conventional ventilator (PG 7, ln 22-23). Thus, one of the ordinary skills in the art would have recognized that the device of McVicar et al. would be capable of providing a flow rate at least double the requirement when providing same ventilation requirement to both of the patients such as providing required respiratory rate based on the patient’s age group and/or the medical condition as it would be obvious to provide double flow at the inlet so that flow can be split to two patients equally as desired if they have same needs.
Therefore, 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 device of McVicar et al. wherein the ventilator is configured to deliver air to the inlet of the air tube splitter at a flow rate that is at least double a single patient respiratory rate requirement in purpose of providing required flow rate based on the patient’s age group and/or the medical condition without unexpected results.
Looking into other consideration, the conventional ventilator can be easily replaced with improved medical ventilators in the market if required as a simple substitution of one known element for another to obtain predictable results. See MPEP 2143.I.B.
Claims 41-42 are rejected under 35 U.S.C. 103 as being unpatentable over McVicar et al. (WO 2021219805 A2) as applied to claim 1 above, and further in view of Khwaja et al. (US 20240207560 A1).
Regarding claim 41, McVicar et al. discloses the device of claim 36 as discussed above.
While McVicar et al. discloses, the ventilator coupled to the inlet of the air tube splitter by a ventilation tubing line (16, Fig 1) as shown in Fig 1, McVicar et al. does not specifically discloses, an oxygen tank.
However, Khwaja et al. which is analogous art to the claimed invention for ventilator adaptors for enabling the connection of multiple patients to a single ventilator (¶0001), teaches conventional ventilators comprising an oxygen regulator for modulating a concentration of oxygen in the input gas (¶0003) and a ventilator system comprising a ventilator and an oxygen (Fig 7) in purpose of providing enhanced concentration of oxygen while providing mechanical breathing assistance to patient (¶0002-0003).
Therefore, 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 device of McVicar to include an oxygen tank as taught by Khwaja et al. in purpose of providing enhanced concentration of oxygen while providing mechanical breathing assistance to patient (¶0002-0003).
Regarding claim 42, McVicar et al. in view of Khwaja et al. discloses the device of claim 41 as discussed above.
Modified McVicar et al. does not specifically discloses, wherein the oxygen tank is configured to deliver air to the inlet of the air tube splitter at a flow rate that is at least double a single patient respiratory rate requirement.
Examiner asserts that a flow rate varies by a patient’s age group and their size and weight or medical conditions such as 1 - 15 L/min or even more based on a type of patient interfaces.
However, McVicar et al. discloses a shared ventilation system in which a single ventilator that is a conventional ventilator (PG 7, ln 22-23). Thus, one of the ordinary skills in the art would have recognized that the modified device of McVicar et al. would be capable of providing a flow rate at least double the requirement when providing same ventilation requirement to both of the patients such as providing required respiratory rate based on the patient’s age group and/or the medical condition as it would be obvious to provide double flow at the inlet so that flow can be split to two patients equally as desired if they have same needs.
Therefore, 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 device of McVicar et al. wherein the ventilator is configured to deliver air to the inlet of the air tube splitter at a flow rate that is at least double a single patient respiratory rate requirement in purpose of providing required flow rate based on the patient’s age group and/or the medical condition without unexpected results.
Looking into other consideration, the conventional ventilator can be easily replaced with improved medical ventilators in the market if required as a simple substitution of one known element for another to obtain predictable results. See MPEP 2143.I.B.
Claims 1, 16, and 43 is rejected under 35 U.S.C. 103 as being unpatentable over Lemer et al. (US Pat 6474334 B1) in view of McVicar et al. (WO 2021219805 A2).
Regarding claim 1, Lemer et al. discloses, a ventilator device for co-ventilation of multiple patients (a system as shown in Fig 1; Col , ln 5-10, “a device which permits simultaneous ventilation of a multiplicity of patients”), the ventilator device comprising:
an air tube splitter (a manifold 16, Fig 1) having an inlet ((a connection portion to either a valve 12 or a gas source 14 as shown in Fig 1), a plurality of outlets (a portion each branches 18, 20, 22, 24 divided into sub branches as shown in Fig 1), and a plurality of branches (a diverging portion of 16 which divided into branches 18, 20, 22, 24 as shown in Fig 1), wherein each of the branches extends to a respective one of the outlets (as the branches are extending towards the sub branches as shown in Fig 1);
While Lemer et al. discloses that each branches include a valve, preferably an electronically control valve such as a solenoid, electrically connected in wired or wireless manner, to a controller. Controller configured to operate valve in accordance with a predetermined operating cycle or a desired operating cycle and each sub branches including a regulating valve (Col 3, ln 48-54), Lemer et al. is silent on a plurality of actuators coupled to the valves, wherein each of the actuators is configured to adjust a respective one of the valves; and
a controller in operable communication with the actuators, wherein the controller is configured to:
receive a set of inspiratory pressure settings or tidal volume settings for the patients; and independently control the actuators to adjust the valves based at least in part on the set of inspiratory pressure settings or tidal volume settings.
However, McVicar et al. which is analogous art to the claimed invention for a ventilation system for a plurality of patients comprising a common ventilator (a system as shown in Fig 1; PG 5, ln 6-7), teaches a plurality of valves (an electronic flow control EFC valve, Fig 1) coupled to the branches, wherein each of the valves is configured to be adjusted between an open position and a closed position (PG 9, ln 12 - PG 11, ln 21, implies that the EFC valves are capable of actuating from fully open to fully closed and controlling a pressure/volume/desired tidal volume by changing a position of the valves), wherein each of the valves is configured to be adjusted to regulate air flow through a respective one of the branches (PG 9, ln 12 - PG 11, ln 21);
a plurality of actuators coupled to the valves (PG 9, ln 12, “The EFC valve maybe be controlled by a solenoid or a motorized actuator”), wherein each of the actuators is configured to adjust a respective one of the valves (PG 13, ln 24-28, implies each actuator for each valve); and
a controller (46, 48, Figs 1-2) in operable communication with the actuators (PG 10, ln 8-13, “receives command control signals from the CPU 68 via the bus 66 and communicates these as analog control signals to the EFC valve… and the control signals required by the EFC valve to control the airflow through the valve”), wherein the controller is configured to:
receive a set of inspiratory pressure settings or tidal volume settings for the patients (PG 9, ln 16 - PG 14, ln 21, “The controller 46 operates as a monitor and has a touchscreen display 60 and input buttons and switches 62 to allow a user, typically a trained nurse or doctor, to control the unit and provide inputs, such as desired ventilation parameters…a desired volumetric parameter…a tidal volume…tailor the ventilation to a single patient by setting a single value (tidal volume) and the flow control valve setting will tailor airflow to obtain that tidal volume…has no effect on the air supply to the patient on the other breathing circuit””; and independently control the actuators to adjust the valves based at least in part on the set of inspiratory pressure settings or tidal volume settings (PG 9, ln 16 - PG 14, ln 21) in purpose of controlling the airflow through the valve based on desirable ventilation parameters.
Therefore, 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 device of Lemer et al. to include a plurality of actuators coupled to the valves, wherein each of the actuators is configured to adjust a respective one of the valves; and a controller in operable communication with the actuators, wherein the controller is configured to: receive a set of inspiratory pressure settings or tidal volume settings for the patients; and independently control the actuators to adjust the valves based at least in part on the set of inspiratory pressure settings or tidal volume settings as taught by McVicar et al. in purpose of controlling the airflow through the valve based on desirable ventilation parameters (PG 9, ln 16 - PG 14, ln 21).
Regarding claim 16, Lemer et al. in view of McVicar et al. discloses, the device of claim 1.
Lemer et al. further discloses, wherein the controller is further configured to control the actuators to adjust the valves (Col 2, ln 10-33; Col 3, ln 48-54) such that: a first valve (a valve 20 of the branch 20, Fig 1) and a second valve (a valve 20 of the branch 22, Fig 1) of the plurality of valves are in the closed position for a first time period (a valve of the branch 18 is only open while other valves are closed off as shown in Fig 1; Col 2, ln 10-33, “a) causing a driving gas to flow through one of the ventilators while substantially preventing flow of the driving gas through the other ventilators”);
the first valve is in the open position or a partially open position while the second valve is in the closed position for a second time period (the valve of the branch 20 is only open while other valves are closed off as shown in Fig 2; Col 2, ln 10-33) following the first time period;
the second valve is in the open position or a partially open position while the first valve is in the closed position for a third time period (the valve of the branch 22 is only open while other valves are closed off as shown in Fig 3; Col 2, ln 10-33) following the second time period; and
the first valve and the second valve are in the closed position for a fourth time period following the third time period (the valve of the branch 24 is only open while other valves are closed off as shown in Fig 3; Col 2, ln 10-33).
Looking at other consideration, the first and the fourth periods can be read as when the device is off prior to the usage and after the usage so the valves would be off position as these valves are electronically-driven.
Regarding claim 43, Lemer et al. discloses, a ventilator system for co-ventilation of multiple patients (a system as shown in Fig 1; Col , ln 5-10, “a device which permits simultaneous ventilation of a multiplicity of patients”), the ventilator system comprising:
a first ventilation device (one of the branches 18, 20, 22, 24, Fig 1) and a second ventilation device (one of the branches 18, 20, 22, 24, Fig 1), each comprising:
an air tube splitter (T-fitting of the branches shown in Fig 1) having an inlet (see annotation below, Fig 1), a plurality of outlets (see annotation below, Fig 1), and a plurality of branches (a set of sub-branches 18A, 18B, 20A, 20B, 22A, 22B, 24A, 24B, Fig 1), wherein each of the branches extends to a respective one of the outlets (each sub branches are extended towards a corresponding outlet as shown in Fig 1);
a plurality of valves (a regulating valve 30, Fig 1) coupled to the branches, wherein each of the valves is configured to be adjusted to regulate air flow through a respective one of the branches (Col 2, ln 44-47, “a regulating valve is fluidly connected to each of the ventilators for regulating flow of a driving gas through the ventilator”);
PNG
media_image2.png
360
575
media_image2.png
Greyscale
an upstream air tube splitter (a manifold 16, Fig 1) having an inlet (a connection portion to either a valve 12 or a gas source 14 as shown in Fig 1) and a plurality of outlets (a portion where 16 is divided into branches 18, 20, 22, 24 as shown in Fig 1);
wherein the inlet of the air tube splitter of the first ventilation device is fluidically coupled to one of the outlets of the upstream air tube splitter (one of the branches 18, 20, 22, 24 are connected to one of the outlets of 16 as shown in Fig 1), and wherein the inlet of the air tube splitter of the second ventilation device is fluidically coupled to another of the outlets of the upstream air tube splitter (one of the branches 18, 20, 22, 24 are connected to one of the outlets of 16 as shown in Fig 1).
While Lemer et al. discloses that each branches include a valve, preferably an electronically control valve such as a solenoid, electrically connected in wired or wireless manner, to a controller. Controller configured to operate valve in accordance with a predetermined operating cycle or a desired operating cycle and each sub branches including a regulating valve (Col 3, ln 48-54), Lemer et al. is silent on a plurality of actuators coupled to the valves, wherein each of the actuators is configured to adjust a respective one of the valves; and
a controller in operable communication with the actuators, wherein the controller is configured to:
receive a set of inspiratory pressure settings or tidal volume settings for the patients; and independently control the actuators to adjust the valves based at least in part on the set of inspiratory pressure settings or tidal volume settings.
However, McVicar et al. which is analogous art to the claimed invention for a ventilation system for a plurality of patients comprising a common ventilator (a system as shown in Fig 1; PG 5, ln 6-7), teaches a plurality of valves (an electronic flow control EFC valve, Fig 1) coupled to the branches, wherein each of the valves is configured to be adjusted between an open position and a closed position (PG 9, ln 12 - PG 11, ln 21, implies that the EFC valves are capable of actuating from fully open to fully closed and controlling a pressure/volume/desired tidal volume by changing a position of the valves), wherein each of the valves is configured to be adjusted to regulate air flow through a respective one of the branches (PG 9, ln 12 - PG 11, ln 21);
a plurality of actuators coupled to the valves (PG 9, ln 12, “The EFC valve maybe be controlled by a solenoid or a motorized actuator”), wherein each of the actuators is configured to adjust a respective one of the valves (PG 13, ln 24-28, implies each actuator for each valve); and
a controller (46, 48, Figs 1-2) in operable communication with the actuators (PG 10, ln 8-13, “receives command control signals from the CPU 68 via the bus 66 and communicates these as analog control signals to the EFC valve… and the control signals required by the EFC valve to control the airflow through the valve”), wherein the controller is configured to:
receive a set of inspiratory pressure settings or tidal volume settings for the patients (PG 9, ln 16 - PG 14, ln 21, “The controller 46 operates as a monitor and has a touchscreen display 60 and input buttons and switches 62 to allow a user, typically a trained nurse or doctor, to control the unit and provide inputs, such as desired ventilation parameters…a desired volumetric parameter…a tidal volume…tailor the ventilation to a single patient by setting a single value (tidal volume) and the flow control valve setting will tailor airflow to obtain that tidal volume…has no effect on the air supply to the patient on the other breathing circuit””; and independently control the actuators to adjust the valves based at least in part on the set of inspiratory pressure settings or tidal volume settings (PG 9, ln 16 - PG 14, ln 21) in purpose of controlling the airflow through the valve based on desirable ventilation parameters.
Therefore, 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 device of Lemer et al. to include a plurality of actuators coupled to the valves, wherein each of the actuators is configured to adjust a respective one of the valves; and a controller in operable communication with the actuators, wherein the controller is configured to: receive a set of inspiratory pressure settings or tidal volume settings for the patients; and independently control the actuators to adjust the valves based at least in part on the set of inspiratory pressure settings or tidal volume settings as taught by McVicar et al. in purpose of controlling the airflow through the valve based on desirable ventilation parameters (PG 9, ln 16 - PG 14, ln 21).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Venkataraman et al. (US 20210322707 A1) is cited for a pressure control valve for each branch as shown in Fig 1C.
Habashi (US 20240198032 A1) is cited for having valves for each branch which can be controlled by timer control (¶0073).
Jacoby et al. (US 20210299395 A1) is cited for switching valve between two patients.
Nakamura (US 20110220101 A1) is cited for means to easily branch into plurality as shown in Fig 6b.
Darowski et al. (WO 2021262017 A1) is cited for a modular system for multi-station patient (abstract).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAEICK JANG whose telephone number is (703)756-4569. The examiner can normally be reached M-F 8:30 - 4:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kendra D Carter can be reached at (571) 272-9034. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/J.J./Examiner, Art Unit 3785
/JOSEPH D. BOECKER/Primary Examiner, Art Unit 3785
Prosecution Insights