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 .
Status of Claims
This Office Action is in response to the remarks and amendments filed on June 25th, 2026. Claim 19 has been canceled as such claims 1-18 and 20-30 are pending consideration in this Office Action.
Response to Amendment
The objections to the disclosure are withdrawn in light of the amendments.
The objections to the drawings are withdrawn in light of the amendments.
The objections to the claims are withdrawn in light of the amendments.
The rejections pursuant to 112(b) with respect to claims 7, 15-17, 28, and 29 are withdrawn in light of the amendments.
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.
Claims 27 and 28 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 27 recites the limitation "wherein the inflatable wall portion is attached to the wall of at least one of the second lumen and the third lumen" in lines 1-3. There is insufficient antecedent basis for this limitation in the claim. A third lumen is not recited in claim 26 or claim 24 from which is depends from. For purposes of examination, the limitation is being interpreted as “wherein the inflatable wall portion is attached to the wall of at least one of the first lumen and the second lumen”.
Claim 28 is rejected due to being dependent off of claim 27.
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 1-3, 8, 9, 12, 18, 22, 24-26, 29, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Darowski (US 20170128693) in view of Oldfield (AU 2017257442).
Regarding claim 1, Darowski discloses
a compartmentalized lung ventilation device (figs. 1-2; device using volume divider with ventilator; [0016]-[0017] and [0020]), comprising:
a first lumen having a proximal end and a distal end (see figs. 1 and 2; in fig. 1, line between IP and inspiratory lines 18,19; in fig. 2, tube junction 29 has a proximal end and a distal end; [0017], [0022], [0023]);
a second lumen (fig. 2; left rubber tube 26 with output end 25 (part of inspiratory line 18); [0017] and [0022]);
a third lumen (fig. 2; right rubber tube 26 with output end 25 (part of inspiratory line 19); [0017] and [0022]);
at least one flow regulation mechanism positioned along the length of at least one of the second lumen and the third lumen (figs. 1-2; volume valve divider 23 which is implemented as “tubes 26 deformed by means of a moveable pin 27 mounted on a slider having rolls 28 of a straight line mechanism with bearings in the housing 30”; [0020] and [0022]);
positioned along the length of at least one of the second lumen the third lumen, comprising at least one sensor (figs. 1-2; “monitoring circuit/system measuring the gas volume 9, 10 to provide a signal related to the volume of gas introduced into the patient's lungs”; [0021] and [0022]; system measuring the gas volume 9, 10 are volume meters 9, 10; fig. 1; pressure indicators 6 and 8 measures increase of pressure in the inspiratory branches 14, 16 during the inspiration phase; [0024]; in other words, sensors are positioned along the inspiratory lines),
a processor (figs. 1-2; controllers which implements signal processing techniques and monitoring circuit unit 24 (processing unit); [0006], [0021], [0022], [0027] and [0030]);
wherein the first lumen is fluidly connected to a mechanical ventilator circuit at the proximal end (see figs. 1 and 2; inspiratory canal IP of the ventilator 1 is connected to the proximal end of the tube junction 29; [0022], [0023]) and is fluidly connected to the second lumen and the third lumen at the distal end (see figs. 1 and 2; distal end of tube junction 29 is connected to rubber tubes 26 with output ends 25; [0022]); and
wherein the second lumen is distally connected to left mainstem bronchus (see figs. 1 and 2; inspiratory line 18/left rubber tube 26 with output end 25 is connected to the left lung L; [0022]), and
the third lumen is distally connected to right mainstem bronchus of a subject (see figs. 1 and 2; inspiratory line 19/right rubber tube 26 with output end 25 is connected to the right lung R; [0022]).
Darowski does not explicitly disclose at least one port positioned along the length of at least one of the second lumen the third lumen; wherein the at least one port is positioned distal to the at least one flow regulation mechanism.
Oldfield discloses a flow path with a flow restriction where
at least one port positioned along the length of the manifold (figs. 28-31 and 33-35; outlet pressure sensing ports 514, 536 may be included in the manifold block 512 which are each fluidly connected to a pressure sensing circuit and one or more pressure sensors 532, 540, 542,; [0414]-[0418] and [0422]);
wherein the at least one port is positioned distal to the at least one flow regulation mechanism (see figs. 28-31 and 33-35; at least one of the pressure sensing ports 514, 536 are located downstream of the flow constrictor 506 and at least one of the pressure sensing ports 536 is located upstream of the flow constrictor 506; [0422]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify each of the inspiratory lines of the Darowski with the multitude of sensing ports as disclosed in Oldfield such that the volume meters and pressure indicators of Darowski are connected to ports upstream and downstream of the flow constrictor; therefore, being able to determine the respective static pressure of the gases flow upstream and downstream of the flow constrictor, allow the flow rate of the gas flow to be determined, and provide redundancy in determining the static pressure of the gases flow travelling through the passageways on either side of the flow constrictor (Oldfield:[0422]-[0423]).
It directly follows that the resultant inspiratory lines of Darowski combined with the sensing ports of Oldfield would meet the claimed structural limitations since:
Darowski and Oldfield combined disclose
at least one port positioned along the length (Oldfield: figs. 28-31 and 33-35; outlet pressure sensing ports 514, 536 are positioned along the length of the passageway upstream and downstream of the flow constrictor 5-6; [0414]-[0418] and [0422]-[0423]) at least one of the second lumen the third lumen (Darowski: fig. 2; left rubber tube 26 with output end 25 (part of inspiratory line 18) and right rubber tube 26 with output end 25 (part of inspiratory line 19); [0017] and [0022]).
Regarding claim 2, Darowski further discloses
the compartmentalized lung ventilation device (device using volume divider with ventilator) of claim 1,
wherein the at least one sensor is selected from the group consisting of
a pressure sensor (fig. 1; pressure indicators 6 and 8 measures increase of pressure in the inspiratory branches 14, 16 during the inspiration phase; [0024]), an end-tidal carbon dioxide (EtCO2) sensor, an end-tidal oxygen (EtO2) sensor, a flow sensor (figs. 1-2; system measuring the gas volume 9, 10 can be used as a flow system with analog/digital integrating circuit that measures/provides a signal related to the volume of gas introduced into the patient's lungs; [0020]-[0022]), a gas concentration sensor, and combinations thereof, and
wherein the at least one sensor is configured to quantify regional variations in pathophysiology between regions of a subject's lung (figs. 1-2; system can measure/output “instantaneous value of gas volume supplied to the left L and the right R lung”, see volume meters 9 and 10 in fig. 1 and converters 30, and 40 in fig. 2 which are in separate inspiration lines/tubes; [0020]-[0022]).
Regarding claim 3, Darowski further discloses
the compartmentalized lung ventilation device (device using volume divider with ventilator) of claim 1,
wherein the at least one flow regulator modulates the flow to the left mainstem bronchus and the right mainstem bronchus via at least one mechanism (figs. 1-2; volume valve divider controls flow/volume of gas directed into the left and right lung; [0020] and [0022]) selected from the group consisting of:
an inflatable wall portion, a pinch mechanism (fig. 2; valve divider pinches the tubes 26; [0022]), and a valve mechanism (fig. 2; volume valve divider is a type of valve; [0022]) to provide a variable flow coefficient to the tube (figs. 1-2; volume valve divider increases (varies) flow of gas in one inspiratory line and decreases (varies) in the other inspiratory line simultaneously; [0022] and [0024]).
Regarding claim 8, Darowski further discloses
the compartmentalized lung ventilation device (device using volume divider with ventilator) of claim 3,
wherein the pinch mechanism (fig. 2; valve divider pinches the tubes 26; [0022]) comprises a pinch arm positioned externally around the second lumen and the third lumen (fig. 2; “tubes 26 deformed by means of a moveable pin 27 mounted on a slider 28 of a straight line mechanism with bearings in the housing 30”; [0022], pin 27 along with pointed ends of housing 30 extends around a portion of tubes 26 to cause deformation) and is configured to allow compression of each lumen to change the effective diameter and surface area of each lumen (see fig. 2; “tubes 26 are deformed by means of a moveable pin 27 which would inherently change the diameter and surface area of the pinched part of the tube, thus changing the flow of gas; [0022]).
Regarding claim 9, Darowski further discloses
the compartmentalized lung ventilation device (device using volume divider with ventilator) of claim 3,
wherein the valve mechanism (fig. 2; volume valve divider is a type of valve; [0022]) may be one selected from the group consisting of:
a pinch valve (see fig. 2; volume valve divider is a pinch type valve that deforms the tubes 26 through pinching them with a pin; [0022]), a ball valve, a butterfly valve, a needle valve, a solenoid valve, a sliding action valve, and a gate valve.
Regarding claim 12, Darowski further discloses
the compartmentalized lung ventilation device (device using volume divider with ventilator) of claim 1,
wherein the processor further comprises a software platform having a closed loop controller (figs. 1-2; controller has signal processing with a closed feedback loop which controls volume valve divider; abstract, [0008]-[0009], and claim 5),
wherein the closed loop controller is configured to use a proportional-integral-derivative controller (PID controller) (see fig. 2; controller 37 is preferably a PID controller, [0022]) for achieving a correct flow rate of gas through the second lumen and/or the third lumen (figs. 1-2; PID controller with linear converter 36 of displacement uses signals to form a circuit that controls the slider’s 28 position x; [0022]; the monitoring system measures gas in the inspiration lines, the measurements are converted into signals, the controller uses those signals to control the volume valve divider; thereby, the flow of gas in one of the inspiratory lines is decreased, and increased in the other inspiratory line simultaneously; abstract, [0008]-[0009], [0022], [0024], and claim 5).
Regarding claim 18, Darowski further discloses
the compartmentalized lung ventilation device (device using volume divider with ventilator) of claim 1,
wherein the device is used in an in-patient setting (idea of using a volume dividers for ventilation of each lungs during cardiothoracic surgery (hospital) to provide the possibility of controlled variation of ventilation of each of the lung making the surgery easier; [0002]).
Regarding claim 22, Darowski further discloses
the compartmentalized lung ventilation device (device using volume divider with ventilator) of claim 1,
wherein the at least one flow regulator is configured to regulate a flow of gas between various regions of a subject's lungs (figs. 1-2; volume valve divider controls flow/volume of gas directed into the left and right lung; [0020] and [0022]) by at least one mechanism selected from the group consisting of
equalizing the pressure or EtCO2 between the regions of the lungs, or
achieving an unequal, but different from baseline, distribution of pressure or EtCO2 between regions of the lungs (figs. 1-2; PID controller uses a closed feedback loop to modulate the volume valve divider changing the flow going into each lung, where a desired inspiratory gas volume division is set; abstract, [0022], flow in each lung may be set based on a desired flow, which does not need to be equal or the same as baseline which is shown when the pin in fig. 2 moves left or right, leaving an increased pressure in one line and a decreased pressure in the other line [0022]).
Regarding claim 24, Darowski discloses
a method of regulating gas exchange in the left and right lungs independently (figs. 1-2; using volume divider with ventilator to regulate gas to left and right lung independently; [0016]-[0017] and [0020]) comprising the steps of:
providing a compartmentalized lung ventilation device (figs. 1-2; device using volume divider with ventilator; [0016]-[0017] and [0020]) comprising at least a first lumen (fig. 2; left rubber tube 26 with output end 25 (part of inspiratory line 18); [0017] and [0022]) and a second lumen (fig. 2; right rubber tube 26 with output end 25 (part of inspiratory line 19); [0017] and [0022]),
at least one flow regulator positioned on each lumen (figs. 1-2; volume valve divider 23 which is implemented as “tubes 26 deformed by means of a moveable pin 27 mounted on a slider having rolls 28 of a straight line mechanism with bearings in the housing 30”; [0020] and [0022]),
at least one sensor, positioned along at least one of the first lumen and the second lumen (figs. 1-2; “monitoring circuit/system measuring the gas volume 9, 10 to provide a signal related to the volume of gas introduced into the patient's lungs” which can be “integrated with electrically controlled valve divider shown in FIG. 2.”; [0021] and [0022] and fig. 1; pressure indicators 6 and 8 measures increase of pressure in the inspiratory branches 14, 16 during the inspiration phase; [0024]; inspiratory lines 18, 19 comprise at least one sensor), and
a processor (figs. 1-2; controllers which implements signal processing techniques and monitoring circuit unit 24 (processing unit); [0006], [0021], [0022], [0027] and [0030]) communicatively connected to each of the at least one flow regulator and the at least one sensor (see figs. 1-2 controller communicates with monitoring circuit/system measuring gas volume 9, 10 and volume valve divider; [0022]);
fluidly connecting the first lumen with a left bronchus of a subject (see figs. 1 and 2; inspiratory line 18/left rubber tube 26 with output end 25 is connected to the left lung L; [0022]) and the second lumen with a right bronchus of a subject (see figs. 1 and 2; inspiratory line 19/left rubber tube 26 with output end 25 is connected to the right lung R; [0022]);
collecting physiological data at the at least one sensor (figs. 1-2; “monitoring circuit/system measuring the gas volume 9, 10 to provide a signal related to the volume of gas introduced into the patient's lungs”; [0021], [0022]);
receiving the physiological data obtained from the at least one sensor at the processor (figs. 1-2; controller which uses signal processing obtains signals of measured gas volume in the left and right lung; [0022]);
quantifying a variation between a left and right lung of the subject at the processor based on the received physiological data (figs. 1-2; controller and monitoring circuit 24 with measuring system 9,10 provides digital measurement signals of volume (that can be digitized) in the left and right lung which can be displayed; [0021], [0022], [0024]);
sending instructions from the processor to the at least one flow regulator (figs. 1-2; controller using signal processing sends instructions/controls the pins position which regulates the flow of the gas; [0022]),
wherein the instructions are configured to correct the variation between the left and right lungs (figs. 1-2; controller using signal processing sends instructions/controls the pin’s 26 position which regulates the flow of the gas, the instructions re-set the pin to the desired volume for each lung; abstract, [0009], [0022], claim 5); and
actuating the at least one flow regulator based on the sent instructions (figs. 1-2; controller using signal processing sends instructions/controls the pin’s 26 position through actuating slider 28 therefore regulating the flow of gas; [0022]).
Darowski does not explicitly disclose at least one port comprising at least one sensor, wherein the at least one port is positioned along at least one of the first lumen and the second lumen distal to the at least one flow regulator.
Oldfield discloses a flow path with a flow restriction where
at least one port comprising at least one sensor (figs. 28-31 and 33-35; pressure sensing ports 514, 536 which are each fluidly connected to a pressure sensing circuit and one or more pressure sensors 532, 540, 542; [0414]-[0418] and [0422]), wherein the at least one port is positioned along the manifold (figs. 28-31 and 33-35; outlet pressure sensing ports 514, 536 may be included in the manifold block 512; [0414]-[0418] and [0422]) distal to the at least one flow regulator (see figs. 28-31 and 33-35; at least one of the pressure sensing ports 514, 536 are located downstream of the flow constrictor 506 and at least one of the pressure sensing ports 536 is located upstream of the flow constrictor 506; [0422])
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify each of the inspiratory lines of the Darowski with the multitude of sensing ports as disclosed in Oldfield such that the volume meters and pressure indicators of Darowski are connected to ports upstream and downstream of the flow constrictor; therefore, being able to determine the respective static pressure of the gases flow upstream and downstream of the flow constrictor, allow the flow rate of the gas flow to be determined, and provide redundancy in determining the static pressure of the gases flow travelling through the passageways on either side of the flow constrictor (Oldfield:[0422]-[0423]).
It directly follows that the resultant inspiratory lines of Darowski combined with the sensing ports of Oldfield would meet the claimed structural limitations since:
Darowski and Oldfield combined disclose
at least one port positioned along the length at least one of the second lumen the third lumen
wherein the at least one port (Oldfield: figs. 28-31 and 33-35; outlet pressure sensing ports 514, 536 are positioned along the length of the passageway upstream and downstream of the flow constrictor 5-6; [0414]-[0418] and [0422]-[0423]) is positioned along at least one of the first lumen and the second lumen (Darowski: fig. 2; left rubber tube 26 with output end 25 (part of inspiratory line 18) and right rubber tube 26 with output end 25 (part of inspiratory line 19); [0017] and [0022]) distal to the at least one flow regulator (Oldfield: see figs. 28-31 and 33-35; at least one of the pressure sensing ports 514, 536 are located downstream of the flow constrictor 506 and at least one of the pressure sensing ports 536 is located upstream of the flow constrictor 506; [0422]; Darowski: fig. 2; tubes 26 with moveable pin 27; [0020]-[0022])
Regarding claim 25, Darowski further discloses
the method (using volume divider with ventilator to regulate gas to left and right lung independently) of claim 24,
wherein the at least one sensor is selected from the group consisting of a pressure sensor, an EtCO2 sensor, an EtO2 sensor, a flow sensor (figs. 1-2; system measuring the gas volume 9, 10 can be used as a flow system with analog/digital integrating circuit that measures/provides a signal related to the volume of gas introduced into the patient's lungs; [0020]-[0022]), a gas concentration sensor, and combinations thereof
Regarding claim 26, Darowski further discloses
the method (using volume divider with ventilator to regulate gas to left and right lung independently) of claim 24,
wherein the at least one flow regulator modulates the flow to the left mainstem bronchus and the right mainstem bronchus via at least one mechanism (figs. 1-2; volume valve divider controls flow/volume of gas directed into the left and right lung; [0020] and [0022]) selected from the group consisting of:
an inflatable wall portion, a pinch mechanism (fig. 2; valve divider pinches the tubes 26; [0022]), and a valve mechanism (fig. 2; volume valve divider is a type of valve; [0022]) to provide a variable flow coefficient to the tube (figs. 1-2; volume valve divider increases (varies) flow of gas in one inspiratory line and decreases (varies) in the other inspiratory line simultaneously; [0022] and [0024]).
Regarding claim 29, Darowski further discloses
the method (using volume divider with ventilator to regulate gas to left and right lung independently) of claim 26,
wherein the pinch mechanism (fig. 2; valve divider pinches the tubes 26; [0022]) comprises a pinch arm positioned externally around each of the first lumen and the second lumen (fig. 2; “tubes 26 deformed by means of a moveable pin 27 mounted on a slider 28 of a straight line mechanism with bearings in the housing 30”; [0022], pin 27 along with pointed ends of housing 30 extends around a portion of tubes 26 to cause deformation) and is configured to allow compression of each lumen to change the effective diameter and surface area of each lumen (see fig. 2; “tubes 26 are deformed by means of a moveable pin 27 which would inherently change the diameter and surface area of the pinched part of the tube, thus changing the flow of gas; [0022]).
Regarding claim 30, Darowski further discloses
the method (using volume divider with ventilator to regulate gas to left and right lung independently) of claim 26,
wherein the valve mechanism (fig. 2; volume valve divider is a type of valve; [0022]) may be one selected from the group consisting of:
a pinch valve (see fig. 2; volume valve divider is a pinch type valve that deforms the tubes 26 through pinching them with a pin; [0022]), a ball valve, a butterfly valve, a needle valve, a solenoid valve, a sliding action valve, and a gate valve.
Claims 4-7, 27, and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Darowski (US 20170128693) in view of Oldfield (AU 2017257442) and further in view of Kassab (US 20170333685).
Regarding claim 4, Darowski discloses
the compartmentalized lung ventilation device (Darowski: device using volume divider with ventilator; Oldfield: sensing ports positioned upstream and downstream of flow constrictor) of claim 3,
The modified device of Darowski does not disclose wherein the inflatable wall portion is attached to the wall of at least one of the second lumen and the third lumen, and comprises a channel extending through the inflatable wall portion.
Kassab discloses a flow unit for a catheter tube
wherein the inflatable wall portion (figs. 4-5; chamber 220 with interior 232 and exterior cage that is capable of being inflated and deflated through fluid source 280 and port 230 based on pressure/flow; [0096]-[0099]) is attached to the wall of the flow unit (see figs. 4-5; chamber 220 is coupled with the exterior surface/wall of body 216 of the flow unit; [0096]-[0099]) and comprises a channel extending through the inflatable wall portion (see figs. 4-5; arrow shows flow going through a channel that extends through chamber 220; [0097]-[0099]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the components of the volume valve divider of Darowski with the flow unit of Kassab such that the chamber is attached to the walls of the tubes of Darowski to yield the predictable result of inflating and/or deflating to the appropriate size based on the pressure and/or flow rate to provide/assert a compressing force on the flexible or semi-flexible walls of the portion of body 216 of the flow unit 210 that is sufficient to decrease/increase the diameter of the underlying interior 218; therefore, being able to adjust or maintain pressure and flow rate to desired parameters (Kassab: [0096]-[0100], [0106]-[0107]) in each of the separate inspiratory lines (Darowski: figs. 1-2, separate inspiratory lines 18,19).
It directly follows that the resultant volume divider of Darowski combined with the flow unit of Kassab would meet the claimed structural limitations since:
wherein the inflatable wall portion (Kassab: figs. 4-5; chamber 220 with interior 232 and exterior cage that is capable of being inflated and deflated through fluid source 280 and port 230 based on pressure/flow; [0096]-[0099]) is attached to the wall (Kassab: see figs. 4-5; chamber 220 is coupled with the exterior surface/wall of body 216 of the flow unit; [0096]-[0099]) of at least one of the second lumen and the third lumen (Darowski: fig. 2; left rubber tube 26 with output end 25 (part of inspiratory line 18) and right rubber tube 26 with output end 25 (part of inspiratory line 19); [0017] and [0022]).
Regarding claim 5, the modified device of Darowski further discloses
the compartmentalized lung ventilation device (Darowski: device using volume divider with ventilator; Oldfield: sensing ports positioned upstream and downstream of flow constrictor; Kassab: inflatable/deflatable flow constriction chamber with fluid source/module) of claim 4,
wherein the inflatable member wall portion is inflated or deflated by providing a precisely measured volume of fluid to the inflatable member wall portion (Kassab: figs. 4-5; interior 232 of the chamber 220 is in fluid communication with a fluid source 280 through port 230, where the amount of liquid/gas from fluid source 280 is controlled using remote module 270; [0098] and [0105]-[0107]),
wherein the fluid is introduced by one selected from the group consisting of manual application using a syringe,
an automated control box with software modules that control the level of inflation and deflation based on at least one sensor measurement (Kassab: figs. 4-5; module 270 analyzes the data received from the sensors 24, 224 (sensors monitor pressure and/or flow rate) to automatically adjust the volume of fluid injected into or withdrawn from the interior 232 of the chamber 220; [0095] and [0106]; Darowski: figs. 1-2; monitors gas volume using volume meters and [0021] and [0022] and; pressure indicators 6 and 8 measures increase of pressure in the inspiratory branches 14 [0024]).
Regarding claim 6, the modified device of Darowski further discloses
the compartmentalized lung ventilation device (Darowski: device using volume divider with ventilator; Oldfield: sensing ports positioned upstream and downstream of flow constrictor; Kassab: inflatable/deflatable flow constriction chamber with fluid source/module) of claim 4,
wherein the inflatable wall portion is configured to change at least one of the effective volume of gas, flow, and pressure rate (Kassab: figs. 4-5; by controlling the volume of fluid within the interior 232 of the chamber 220, the flow unit can affect the wave pressure, volume, and flow rates/parameters that are flowing through the interior 218 of the flow unit; [0101], [0106]-[0107]) in at least one of the first lumen, second lumen and the third lumen (Darowski: fig. 2; left rubber tube 26 with output end 25 (part of inspiratory line 18) and right rubber tube 26 with output end 25 (part of inspiratory line 19); [0017] and [0022]; inflatable flow constriction in each tube as modified above) by changing a diameter of the channel (Kassab: see figs. 4-6b; adjusts the volume, pressure, and flow rate through the interior 218 by adjusting the fluid injected into/withdrawn from the interior 232 of the chamber 220 and thereby changing the diameter of the interior 218 as the chamber 220 compresses the walls of the portion body 216; [0101], [0106]-[0107]).
Regarding claim 7, the modified device of Darowski further discloses
the compartmentalized lung ventilation device (Darowski: device using volume divider with ventilator; Oldfield: sensing ports positioned upstream and downstream of flow constrictor; Kassab: inflatable/deflatable flow constriction chamber with fluid source/module) of claim 3,
wherein the inflatable wall portion may be either inflated or deflated by providing a precisely measured volume of fluid to the inflatable member wall portion (Kassab: figs. 4-5; interior 232 of the chamber 220 is in fluid communication with a fluid source 280 through port 230, where the amount of liquid/gas from fluid source 280 is controlled using remote module 270; [0098] and [0105]-[0107]),
wherein the fluid is introduced by one selected from the group consisting of manually using a syringe,
an automated control box with software modules that control the level of inflation and deflation based on compartmentalized sensor measurements (Kassab: Kassab: figs. 4-5; module 270 analyzes the data received from the sensors 24, 224 (sensors monitor pressure and/or flow rate) to automatically adjust the volume of fluid injected into or withdrawn from the interior 232 of the chamber 220; [0095] and [0106]) from the at least one sensor (Darowski: figs. 1-2; monitors gas volume using volume meters and [0021] and [0022] and; pressure indicators 6 and 8 measures increase of pressure in the inspiratory branches [0024]) comprising a first sensor measuring the second lumen (Darowski: : fig. 2; left rubber tube 26 with output end 25 (part of inspiratory line 18), [0020]-[0022] as modified comprises sensing ports of Oldfield: where sensing ports are coupled to sensors measuring pressure and flow (such as volume meters of Darowski), [0414]-[0418] and [0422]) and a second sensor measuring the third lumen (Darowski: : fig. 2; right rubber tube 26 with output end 25 (part of inspiratory line 19), [0020]-[0022] as modified comprises sensing ports of Oldfield: where sensing ports are coupled to sensors measuring pressure and flow (such as volume meters of Darowski), [0414]-[0418] and [0422]).
Regarding claim 27, the method of Darowski discloses
the method (Darowski: device using volume divider with ventilator; Oldfield: sensing ports positioned upstream and downstream of flow constrictor) of claim 26,
The modified method of Darowski does not disclose wherein the inflatable wall portion is attached to the wall of at least one of the second lumen and the third lumen, and comprises a channel extending through the inflatable wall portion.
Kassab discloses a flow unit for a catheter tube
wherein the inflatable wall portion (figs. 4-5; chamber 220 with interior 232 and exterior cage that is capable of being inflated and deflated through fluid source 280 and port 230 based on pressure/flow; [0096]-[0099]) is attached to the wall of the flow unit (see figs. 4-5; chamber 220 is coupled with the exterior surface/wall of body 216 of the flow unit; [0096]-[0099]) and comprises a channel extending through the inflatable wall portion (see figs. 4-5; arrow shows flow going through a channel that extends through chamber 220; [0097]-[0099]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the components of the volume valve divider of Darowski with the flow unit of Kassab such that the chamber is attached to the walls of the tubes of Darowski to yield the predictable result of inflating and/or deflating to the appropriate size based on the pressure and/or flow rate to provide/assert a compressing force on the flexible or semi-flexible walls of the portion of body 216 of the flow unit 210 that is sufficient to decrease/increase the diameter of the underlying interior 218; therefore, being able to adjust or maintain pressure and flow rate to desired parameters (Kassab: [0096]-[0100], [0106]-[0107]) in each of the separate inspiratory lines (Darowski: figs. 1-2, separate inspiratory lines 18,19).
It directly follows that the resultant volume divider of Darowski combined with the flow unit of Kassab would meet the claimed structural limitations since:
wherein the inflatable wall portion (Kassab: figs. 4-5; chamber 220 with interior 232 and exterior cage that is capable of being inflated and deflated through fluid source 280 and port 230 based on pressure/flow; [0096]-[0099]) is attached to the wall (Kassab: see figs. 4-5; chamber 220 is coupled with the exterior surface/wall of body 216 of the flow unit; [0096]-[0099]) of at least one of the second lumen and the third lumen (Darowski: fig. 2; left rubber tube 26 with output end 25 (part of inspiratory line 18) and right rubber tube 26 with output end 25 (part of inspiratory line 19); [0017] and [0022], see 112 above, the third lumen is being interpreted as the first lumen).
Regarding claim 28, the modified device
the method (Darowski: device using volume divider with ventilator; Oldfield: sensing ports positioned upstream and downstream of flow constrictor; Kassab: inflatable/deflatable flow constriction chamber with fluid source/module) of claim 27,
wherein the inflatable wall portion is configured to change the effective volume and/or pressure rate (Kassab: figs. 4-5; by controlling the volume of fluid within the interior 232 of the chamber 220, the flow unit can affect the wave pressure, volume, and flow rates/parameters that are flowing through the interior 218 of the flow unit; [0101], [0106]-[0107]) in at least one of the first lumen and the second lumen (Darowski: fig. 2; left rubber tube 26 with output end 25 (part of inspiratory line 18) and right rubber tube 26 with output end 25 (part of inspiratory line 19); [0017] and [0022]; inflatable flow constriction in each tube as modified above) by changing a diameter of the channel (Kassab: see figs. 4-6b; adjusts the volume, pressure, and flow rate through the interior 218 by adjusting the fluid injected into/withdrawn from the interior 232 of the chamber 220 and thereby changing the diameter of the interior 218 as the chamber 220 compresses the walls of the portion body 216; [0101], [0106]-[0107]).
Claims 10 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Darowski (US 20170128693) in view of Oldfield (AU 2017257442) and further in view of Madsen (US 7556041).
Regarding claim 10, the modified device of Darowski discloses
the compartmentalized lung ventilation device (Darowski: device using volume divider with ventilator; Oldfield: sensing ports positioned upstream and downstream of flow constrictor) of claim 1,
wherein the first lumen is fluidly connected to the mechanical ventilator circuit at the proximal end (see figs. 1 and 2; inspiratory canal IP of the ventilator 1 is connected to the proximal end of the tube junction 29; [0022], [0023])
Darowski does not explicitly disclose the lumen being fluidly connected to the mechanical ventilator through a tubing adapter.
Madsen discloses a respiratory apparatus with an endotracheal tube with a
a tubing adapter (fig. 13; tapered adaptor 112; col. 12, lines 46-58).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the proximal end of the tube junction of Darowski with the tapered adaptor of Madsen to allow for a tight connection of the tubing or other components of the respiratory circuit (Madsen: col. 12, lines 46-58).
Regarding claim 21, the modified device of Darowski discloses
the compartmentalized lung ventilation device Darowski: device using volume divider with ventilator; Oldfield: sensing ports positioned upstream and downstream of flow constrictor) of claim 1,
Darowski does not explicitly disclose wherein the at least one port comprises a tubing adapter, configured to allow easy attachment to external devices.
Madsen discloses a respiratory apparatus with an endotracheal tube with a
wherein the at least one port comprises a tubing adapter (fig. 13; tapered adaptor 112 may be retained within port 90; col. 12, lines 46-58), configured to allow easy attachment to external devices (fig. 13; to allow for connection to tubing or other components of the respiratory circuit; col. 12, lines 46-58).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the volume meter ports of Darowski with the tapered adaptor of Madsen to allow for a tight connection of the tubing or other components of the respiratory circuit (Madsen: col. 12, lines 46-58).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Darowski (US 20170128693) in view of Oldfield (AU 2017257442) and further in view of Holyoake (US 20180085544).
Regarding claim 11, Darowski discloses
the compartmentalized lung ventilation device (Darowski: device using volume divider with ventilator; Oldfield: sensing ports positioned upstream and downstream of flow constrictor) of claim 1,
wherein the processor further comprises a software platform comprising a regulation control module (RCM) (figs. 1-2; controllers use signal processing and also has a microcontroller (has a processor); [0006], [0021], [0022], and [0030]; PID controller specifically uses signal processing to control the volume valve divider (flow regulator); [0022]), a clinical parameter module (CPM) (fig. 1; monitoring circuit unit 24 with a central unit and display which displays indications of pressure, volume, and relevant information (clinical parameters) to the physician; [0027]) and an alarm module (AM),
wherein at least one of the RCM, CPM and AM is configured to regulate flow through each of the first lumen, second lumen and the third lumen based on a signal received from the at least one sensor (fig. 2; PID controller regulates the valve divider (regulates flow of gas supplied to each lung) based on signals of measured instantaneous value of gas volume by the volume meters 9,10; [0022]).
Darowski does not disclose wherein the processor further comprises an alarm module (AM).
Holyoake discloses a respiratory system with a controller/processor used to adjust a flow of gas to a patient
wherein the processor further comprises an alarm module (AM) (processor may be controller 108 and controller may have an alarm; [0969] and [1019]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the signal processing units/controllers of Darowski with the alarm of Holyoake to provide an audible or visual alert the user in response to a change in pressure or change in flow (Holyoake: [1019], [1030]-[1038]).
Claims 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Darowski (US 20170128693) in view of Oldfield (AU 2017257442) and further in view of Chang (US 20160287824).
Regarding claim 13, the modified device of Darowski discloses
the compartmentalized lung ventilation device (Darowski: device using volume divider with ventilator; Oldfield: sensing ports positioned upstream and downstream of flow constrictor) of claim 12,
wherein the closed loop controller (Darowski: see fig. 2; controller 37 is preferably a PID controller, [0022]) comprises:
a clinical parameter configured to adjust peak pressure in left and right lungs in a non-pathophysiologic manner (Darowski: figs. 1-2; controller uses measured values of gas volume supplied to the left L and the right R lung to adjust the flow of the gas using the volume valve divider; [0022]; adjusting the amount of gas flow going into each independent lung would inherently adjust the peak pressure);
two pressure sensors positioned at the distal end of the second lumen and/or the third lumen (Darowski: gas volume meters 9, 10 are integrated with the electrically controlled valve divider, therefore, volume meters 9,10 are positioned on tubes 26 with output ends 25; [0022], see fig. 1 where volume meters 9, 10 are placed distally to the volume valve divider 23; Oldfield: see figs. 28-31 and 33-35; at least one of the pressure sensing ports 514, 536 connected to flow/pressure sensors are located downstream of the flow constrictor 506)
a closed-loop control module configured to modulate the at least one flow regulator to minimize an error (Darowski: figs. 1-2; PID controller uses a closed feedback loop to modulate the volume valve divider changing the flow going into each lung, where a desired inspiratory gas volume division is set, volume is measured, and re-setting the division in the feedback loop via the control input (measured volume values and desired volume), in other words minimizing an error (difference between the desired value and measured value); abstract, [0022])
The modified device of Darowski does not explicitly disclose an error term which is the difference between the measured pressure in the left and right lungs and the target differential between the lungs; and a closed-loop control module configured to modulate the at least one flow regulator to minimize the error.
Chang discloses a ventilator for gas delivery and a controller that has a similar control feedback loop using pressure where
an error term which is the difference between the measured pressure and the target differential (controller obtains/calculates one or more parameter target (pressure), obtains actual values of the gas parameter from the sensor as a feedback command, then compares the actual value to the target to produce a command error (difference between the target and actual value); [0061]-[0064]); and
a closed-loop control module configured to modulate the at least one flow regulator to minimize the error (the controller modifies a subsequent command based on the command error in real time, such as commanding a flow modulator to produce the target flow; [0061]-[0064]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the PID controller and volume/pressure sensing ports of the modified device of Darowski with the feedback control loop and command error of the controller of Chang to achieve a parameter/pressure target through commanding a flow modulator (Chang: [0061]-[0064]).
It directly follows that the resultant PID controller with the volume/pressure sensing ports would be able to minimize the command error (error term) or difference between the measured pressure in the left and right lungs and the target differential pressure by resetting the volume valve divider based on the command error and volume gas values.
Regarding claim 14, Darowski discloses
the compartmentalized lung ventilation device (Darowski: device using volume divider with ventilator; Oldfield: sensing ports positioned upstream and downstream of flow constrictor) of claim 12,
wherein the closed loop controller is configured to use inputs from the at least one sensor (fig. 2; controller 37 uses inputs from controller 38 which obtains converted measurements of the instantaneous value of gas volume from the left and right lung; [0022]) and a desired clinical parameter (physician is able to preset the desired/requested inspiratory gas volume division; abstract, [0005], [0022], [0027], and claim 5); and
and error, based on regional variations and desired clinical outcome for the subject
(figs. 1-2; PID controller uses a closed feedback loop to modulate the volume valve divider changing the flow going into each lung, where a desired inspiratory gas volume division is set (desired volume in each lung), volume is measured, and re-setting the division in the feedback loop via the control input (measured volume values in each long and desired volume), in other words minimizing an error (difference between the desired value and measured value); abstract, [0022]).
Darowski is silent as to the controller configured to calculate the error.
Chang discloses a ventilator for gas delivery and a controller that has a similar control feedback loop using pressure where
the controller is configured to calculate an error (controller obtains/calculates one or more parameter target, obtains actual values of the gas parameter from the sensor as a feedback command, then compares the actual value to the target to produce a command error (difference between the target (desired clinical outcome) and actual value (regional variations)); [0061]-[0064]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the PID controller of Darowski with the feedback control loop and command error of the controller of Chang to achieve a parameter target through commanding a flow modulator (Chang: [0061]-[0064]).
Claims 15 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Darowski (US 20170128693) in view of Oldfield (AU 2017257442) and further in view of Freeman (US 20180280646).
Regarding claim 15, the modified device of Darowski discloses
the compartmentalized lung ventilation device (Darowski: device using volume divider with ventilator; Oldfield: sensing ports positioned upstream and downstream of flow constrictor) of claim 1,
wherein the processor further comprises advanced algorithms (signal processing algorithms known in the state of the art; [0030]),
Darowski does not explicitly disclose advanced algorithms selected from the group consisting of a machine learning algorithm based on supervised learning and unsupervised learning, wherein in supervised machine learning, data from the device is compared to traditional lung performance test results and other clinical tests and wherein in unsupervised machine learning, time-based data from the device is used to develop a model based on how future lung performance is impacted by past lung performance.
Freeman discloses a respiration volume monitoring system that uses
advanced algorithms selected from the group consisting of a machine learning algorithm based on supervised learning and a machine learning algorithm based on unsupervised learning (“The system may additionally include machine intelligence in the form of supervised and unsupervised learning”; [0218]),
wherein in supervised machine learning, data from the device is compared to traditional lung performance test results and other clinical tests (respiratory volume monitoring system (RVM) uses supervised machine learning based on patient's own (volume and flow measurements) and/or population-based data (traditional performance results/database); [0218]- [0223]) and wherein in unsupervised machine learning, time-based data from the device is used to develop a model based on how future lung performance is impacted by past lung performance.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the controllers of Darowski with the algorithms and respiration volume monitoring system of Freeman to further monitor the patient’s respiratory status, detect the presence of specific respiratory patterns, and make recommendations based on trends analyzed in the data (Freeman: [0218]- [0223] and [0227]-[0228]).
Regarding claim 16, the modified device of Darowski further discloses
the compartmentalized lung ventilation device (Darowski: device using volume divider with ventilator; Oldfield: sensing ports positioned upstream and downstream of flow constrictor Freeman: machine learning algorithm) of claim 15,
wherein the advanced algorithms are used to provide data-informed care (Freeman: system uses analysis to determine need for additional treatment, intubation, extubating and provide real-time feedback to prevent damage or collapse of lungs; [0230-[0231]), predictive care (Freeman: diagnose/recognize specific patterns in RVM data associated with specific diseases, pathology, or impending respiratory failure; [0220]-[0222]), personalized medicine (Freeman: providing recommendations for additional respiratory treatment or medications; [0228] and improve the subject's outcomes (Freeman: system monitors respirator parameters to improve respiratory status; [0220]-[0222] and [0237]).
Claims 17 is rejected under 35 U.S.C. 103 as being unpatentable over Darowski (US 20170128693) in view of Oldfield (AU 2017257442) and further in view of Freeman (US 20180280646) and Kotmel (US 20030051733).
Regarding claim 17, the modified device of Darowski discloses
the compartmentalized lung ventilation device (Darowski: device using volume divider with ventilator; Oldfield: sensing ports positioned upstream and downstream of flow constrictor Freeman: machine learning algorithm) of claim 15,
The modified device of Darowski does not disclose wherein the processor is configured to use a compartmentalized inspiratory hold to measure a clinical parameter in a compartmentalized no-flow condition.
Kotmel discloses a device for assessing the level of pulmonary disease in the individual lung compartments
wherein the processor (figs. 1-3; EPD device 102 comprises mechanisms for processing the measurement data; [0058]) is configured to use a compartmentalized inspiratory hold to measure a clinical parameter in a compartmentalized no-flow condition (pressurization can be performed during an inspiratory hold during a pressure hold (pressure plateau) to provide useful information as to the pulmonary mechanics of the compartment; [0077]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the controllers of the modified device of Darowski with the inspiratory hold of the EPD device of Kotmel to truly isolate the target compartment and eliminate extraneous events which may provide useful information as to the pulmonary mechanics of the compartment (Kotmel: [0077]).
Claims 20 is rejected under 35 U.S.C. 103 as being unpatentable over Darowski (US 20170128693) in view of Oldfield (AU 2017257442) and further in view of Coleman (US 20140158130).
Regarding claim 20, Darowski discloses
the compartmentalized lung ventilation device (Darowski: device using volume divider with ventilator; Oldfield: sensing ports positioned upstream and downstream of flow constrictor) of claim 1,
Darowski does not disclose wherein the at least one port comprises a cap to prevent leakage of gas from a subject's circuit.
Coleman discloses medical tubes/circuits for transporting gases
wherein the at least one port comprises a cap to prevent leakage of gas from a subject's circuit (passageway 203 comprises cuff 204 molded over with sensor port 209 and electrical port 210, the sensor port can have a cap 212 that is used to cap or plug the sensor port; [0200], [0218]-[0219] and [0222]-[0224]; thus, the cap would be able to prevent leakage of gas).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the volume meter ports of the modified device of Darowski with the caps for the sensor ports of Coleman to sense one or more characteristics of gas flow in the passageway while also being capable of applying a cap or plug the sensor port when it is not in use (Coleman: [0200]-[0201], [0222]-[0224]).
Claims 23 is rejected under 35 U.S.C. 103 as being unpatentable over Darowski (US 20170128693) in view of Oldfield (AU 2017257442) and further in view of Kotmel (US 20030051733).
Regarding claim 23, Darowski discloses
the compartmentalized lung ventilation device (Darowski: device using volume divider with ventilator; Oldfield: sensing ports positioned upstream and downstream of flow constrictor) of claim 1, further comprising
Darowski does not disclose an imaging system selected from the group consisting of: an x-ray and a computed tomography (CT) scan configured to collect data on variations in regional pathophysiology of the lungs.
Kotmel discloses a device for assessing the level of pulmonary disease in individual lung compartments where
an imaging system (figs. 15-17; measuring component comprising an imaging unit/system 600, 700; [0061]-[0062], [0096], [0110]) selected from the group consisting of:
an x-ray and a computed tomography (CT) scan (CT imaging/scan; [0061]-[0062], [0096], [0110]) configured to collect data on variations in regional pathophysiology of the lungs (fig. 16; CT scans use to obtain images to evaluation of the overall lung performance and may be performed on specific segments of the lung for assessing particular regions of the lung; [0110]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the monitoring system of Darowski with the imaging unit/CT scanning of Kotmel to test and evaluate/assess particular regions of the lung and overall lung performance and use such results to determine the most effective course of treatment (Kotmel: [0110]).
Response to Arguments
Applicant’s arguments, see pages 10-11 of the remarks, filed 06/25/2026, with respect to objections of “selected from the group consisting of” have been fully considered and are persuasive. The objections of claims 3, 5, 7, 9, 15, 16, 22, 25, 26, and 30 have been withdrawn.
Applicant's arguments filed 06/25/2026 have been fully considered but they are not persuasive. Applicant’s amendments necessitated new grounds of rejection. Claim 1 (and similarly claim 24) amends “each lumen” to “at least one of the second lumen and the third lumen” in lines 5-6 and “the second lumen and/or the third lumen” to “at least one of the second lumen and the third lumen”, therefore, changing the scope of claim 1.
Applicant’s arguments with respect to claim 1-3, 8, 9, 12, 18, 19, 22, 24-26, 29, and 30 (see pages 11-15 of the remarks where Applicant argues that Darowski does not disclose at least one port), 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 claim 1 and 24 in view of Oldfield).
Applicant’s arguments with respect to the 103 rejections of claims 4 and 27 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Cullen (US 20140020687) – discloses a respiratory therapy system with a pinch valve embodiment and inflatable members embodiment in a tube that adjust based on pressure
Applicant's amendment necessitated the new ground(s) 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.
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/S.R.R./Examiner, Art Unit 3785
/VICTORIA MURPHY/Primary Patent Examiner, Art Unit 3785
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