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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a) because they fail to show the internal flapper configured to change the volume by changing the angle as described in the specification. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because it is longer than 150 words. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 3, 5, 7, 9, 15, 16, 22, 25, 26, and 30 are objected to because of the following informalities:
Claims 3, 5, 7, 9, 15, 22, 23, 25, 26, 30 and any other similar recitation in the claims, “selected from the group consisting of” should read “selecting from a group consisting of”
Claim 16, lines 1-2, “the advanced algorithm” should read “the advanced algorithms” or “the machine learning algorithm”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 7, 15-17, 28, and 29 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.
Regarding claim 7, the limitation recites controlling “based on compartmentalized sensor measurements”. This causes uncertainty of whether the compartmentalized sensor measurements are from the same sensors introduced in claim 1 or if they are measurements from a completely different sensor. There does not appear to be an indication in the specification or disclosure on what it is meant by compartmentalized sensor measurements. For purpose of examination, the compartmentalized sensor measurements are being interpreted as measurements from the at least one sensor in claim 1. However, it is also noted that this limitation is identical/similar to claim 5. Appropriate correction is required.
Regarding claim 15, the limitation states “advanced algorithms from the group consisting of a machine learning based on supervised learning and unsupervised learning”. It is unclear if the limitation is referring to “a machine learning based on supervised learning and unsupervised learning” as one machine learning group or two machine separate machine learning groups rendering the claim indefinite. For purposed of examination, since there does not appear to be another group listed in the limitation, the groups are being interpreted as a machine learning based on supervised learning or a machine learning based on unsupervised learning.
Claims 16 and 17 are also rejected due to being dependent on claim 15.
Claim 28 recites the limitation "the third lumen" in line 3. There is insufficient antecedent basis for this limitation in the claim. It is unclear if this addition is a type, appropriate correction is required.
Claim 29 recites the limitation the third lumen" in line 2. There is insufficient antecedent basis for this limitation in the claim. This appears to be a typo as claim 24 does not include a third lumen. For purposes of examination, this claim will be interpreted as the pinch arm positioned externally around the first lumen and second lumen similarly to how the limitation is written in claim 8.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 8, 9, 12, 18, 19, 22, 24-26, 29, and 30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Darowski (US 20170128693).
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 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 port positioned along the length of the second lumen and/or 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” which can be “integrated with electrically controlled valve divider shown in FIG. 2.”; [0021] and [0022]; system measuring the gas volume 9, 10 are volume meters 9, 10; in other words, ports are necessary to connect the volume meters to the inspiratory lines); 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]);
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/left rubber tube 26 with output end 25 is connected to the right lung R; [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 member, an internal flapper, 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 19, Darowski further discloses
the compartmentalized lung ventilation device (device using volume divider with ventilator) of claim 1,
wherein the at least one port is positioned distal to the at least one flow regulator (see fig. 1, monitoring circuit/system measuring the gas volume 9, 10 is distal to the flow regulator 23).
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 on each 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
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]).
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 member, an internal flapper, 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 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.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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 4 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Darowski (US 20170128693) in view of Weiss (EP 2801384).
Regarding claim 4, Darowski discloses
the compartmentalized lung ventilation device (device using volume divider with ventilator) of claim 3,
Darowski does not disclose wherein the inflatable member is positioned within the wall of each of the second lumen and the third lumen.
Weiss discloses an endobronchial tube for applying ventilation to a single lung
wherein the inflatable member is positioned within the wall of the lumen (Weiss: figs. 13 and 21-23; inflatable balloon 700 inside the tube; [0021]-[0022], [0072]-[0074]).
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 inflatable balloons as taught in Weiss such that the inflatable balloons are within the tubes Darowski of to yield the predictable result of modulating the airflow such as by closing or blocking the tube in an inflated state or allowing flow in a deflated state (Weiss: [0021]-[0022], [0072]-[0074]) in each of the separate inspiratory lines (Darowski: figs. 1-2, separate inspiratory lines 18,19).
Regarding claim 27, Darowski discloses
the method (using volume divider with ventilator to regulate gas to left and right lung independently) of claim 26,
Darowski does not disclose wherein the inflatable member is positioned within the wall of each of the first lumen and second lumen.
Weiss discloses an endobronchial tube for applying ventilation to a single lung
wherein the inflatable member is positioned within the wall of the lumen (Weiss: figs. 13 and 21-23; inflatable balloon 700 inside the tube; [0021]-[0022], [0072]-[0074]).
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 inflatable balloons as taught in Weiss such that the inflatable balloons are within the tubes Darowski of to yield the predictable result of modulating the airflow such as by closing or blocking the tube in an inflated state or allowing flow in a deflated state (Weiss: [0021]-[0022], [0072]-[0074]) 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 with the inflatable balloons of Weiss would meet the claimed structural limitations since:
wherein the inflatable member (Weiss: figs. 13 and 21-23; inflatable balloons 700 inside the tubes (tubes 26 of Darowski); [0021]-[0022], [0072]-[0074]) is positioned within the wall of each of the first lumen and second lumen (Darowski: fig. 2; rubber tubes 26 with output ends 25 (part of inspiratory lines 18,19); [0017] and [0022]).
Claims 5 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Darowski (US 20170128693) in view of Weiss (EP 2801384) and further in view of Higashiyama (US 20160038699).
Regarding claim 5, Darowski discloses
the compartmentalized lung ventilation device (device using volume divider with ventilator) of claim 3,
Darowski does not disclose wherein the inflatable member is inflated or deflated by providing a precisely measured volume of fluid to the inflatable member, 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 measurements.
Weiss discloses an endobronchial tube for applying ventilation to a single lung
wherein the inflatable member is inflated or deflated (Weiss: figs. 13 and 21-23; inflatable balloon 700 inside the tube that may be either inflated or deflated; [0021]-[0022], [0072]-[0074]),
wherein the fluid is introduced by one selected from the group consisting of:
manual application using a syringe (medium may be connected via a conduit 53 (inflation line) and conduits can comprise a syringe connector for connecting to a syringe (for delivering or removing said medium); [0056], col 12 and [0074]), an automated control box with software modules that control the level of inflation and deflation based on at least one sensor measurements.
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 inflatable balloons and inflation lines as taught in Weiss such that the inflatable balloons are within the tubes Darowski of to yield the predictable result of modulating the airflow such as by closing or blocking the tube in an inflated state or allowing flow in a deflated state (Weiss: [0021]-[0022], [0072]-[0074]) in each of the separate inspiratory lines (Darowski: figs. 1-2, separate inspiratory lines 18,19).
Wiess does not disclose wherein the inflatable member may be either inflated or deflated by providing a precisely measured volume of fluid to the inflatable member,
Higashiyama discloses a tracheal intubation device with an inflatable cuff
wherein the inflatable member may be either inflated (fig. 9; cuff 90 is inflated using pump 926, cuff pressure controller 900 with driver circuit, and flow volume regulator valve 923; [0015]) or deflated by providing a precisely measured volume of fluid to the inflatable member (fig. 9; cuff pressure controller finely regulates the flow volume of gas to be supplied to the cuff; [0021], [0033]).
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 controller, inflation lines, and inflatable balloons of the modified device of Darowski with the pressure controller, pump and flow volume regulator of Higashiyama to provide an automated way to inflate the ballon and finely regulate the flow volume of gas to be supplied to the balloon so as to control the pressure inside the cuff to stay within a predetermined range (Higashiyama: [0019], [0022], and [0033]).
Regarding claim 7, Darowski discloses
the compartmentalized lung ventilation device (device using volume divider with ventilator) of claim 3,
Darowski does not disclose wherein the inflatable member may be either inflated or deflated by providing a precisely measured volume of fluid to the inflatable member, 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.
Weiss discloses an endobronchial tube for applying ventilation to a single lung
wherein the inflatable member may be either inflated or deflated (Weiss: figs. 13 and 21-23; inflatable balloon 700 inside the tube that may be either inflated or deflated; [0021]-[0022], [0072]-[0074]),
wherein the fluid is introduced by one selected from the group consisting of:
manually using a syringe (medium may be connected via a conduit 53 (inflation line) and conduits can comprise a syringe connector for connecting to a syringe (for delivering or removing said medium); [0056], col 12 and [0074]), an automated control box with software modules that control the level of inflation and deflation based on compartmentalized sensor measurements.
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 inflatable balloons and inflation lines as taught in Weiss such that the inflatable balloons are within the tubes Darowski of to yield the predictable result of modulating the airflow such as by closing or blocking the tube in an inflated state or allowing flow in a deflated state (Weiss: [0021]-[0022], [0072]-[0074]) in each of the separate inspiratory lines (Darowski: figs. 1-2, separate inspiratory lines 18,19).
Wiess does not disclose wherein the inflatable member may be either inflated or deflated by providing a precisely measured volume of fluid to the inflatable member,
Higashiyama discloses a tracheal intubation device with an inflatable cuff
wherein the inflatable member may be either inflated (fig. 9; cuff 90 is inflated using pump 926, cuff pressure controller 900 with driver circuit, and flow volume regulator valve 923; [0015]) or deflated by providing a precisely measured volume of fluid to the inflatable member (fig. 9; cuff pressure controller finely regulates the flow volume of gas to be supplied to the cuff; [0021], [0033]).
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 controller, inflation lines, and inflatable balloons of the modified device of Darowski with the pressure controller, pump and flow volume regulator of Higashiyama to provide an automated way to inflate the ballon and finely regulate the flow volume of gas to be supplied to the balloon so as to control the pressure inside the cuff to stay within a predetermined range (Higashiyama: [0019], [0022], and [0033]).
Claims 6 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Darowski (US 20170128693) in view of Alizoti (CA 2937286).
Regarding claim 6, Darowski discloses
the compartmentalized lung ventilation device (device using volume divider with ventilator) of claim 3,
wherein the flow regulator is configured to change the effective volume of gas, flow, and/or pressure rate in each of the first lumen, second lumen and the third lumen (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])
Darowski does not disclose wherein the internal flapper is configured to change the effective volume of gas, flow, and/or pressure rate in each of the first lumen, second lumen and the third lumen by changing the angle of the flapper.
Alizoti discloses a respiratory treatment device with
wherein the internal flapper is configured to change the effective volume of gas, flow, and/or pressure rate by changing the angle of the flapper (figs. 5-11; restrictor member 130 with vane 132 that can selectively adjust the angle to restrict flow; [0106]-[0111], [0117]).
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 volume valve divider of Darowski with the restrictor member of Alizoti to yield the predictable result of providing different angled positions for the purpose of restricting/varying the flow (Alizoti; [0117]).
Regarding claim 28, Darowski discloses
the method (using volume divider with ventilator to regulate gas to left and right lung independently) of claim 26,
wherein the flow regulator is configured to change the effective volume of gas, flow, and/or pressure rate in each of the first lumen, second lumen and the third lumen (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]).
Darowski does not disclose wherein the internal flapper is configured to change the effective volume of gas, flow, and/or pressure rate in each of the first lumen, second lumen and the third lumen by changing the angle of the flapper.
Alizoti discloses a respiratory treatment device with
wherein the internal flapper is configured to change the effective volume of gas, flow, and/or pressure rate by changing the angle of the flapper (figs. 5-11; restrictor member 130 with vane 132 that can selectively adjust the angle to restrict flow; [0106]-[0111], [0117]).
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 volume valve divider of Darowski with the restrictor member of Alizoti to yield the predictable result of providing different angled positions for the purpose of restricting/varying the flow (Alizoti; [0117]).
Claims 10 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Darowski (US 20170128693) in view of Madsen (US 7556041).
Regarding claim 10, Darowski discloses
the compartmentalized lung ventilation device (device using volume divider with ventilator) 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, Darowski discloses
the compartmentalized lung ventilation device (device using volume divider with ventilator) 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 Holyoake (US 20180085544).
Regarding claim 11, Darowski discloses
the compartmentalized lung ventilation device (device using volume divider with ventilator) 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]).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Darowski (US 20170128693) in view of Darowski et al. (US 4598706) and further in view of Chang (US 20160287824).
Regarding claim 13, Darowski discloses
the compartmentalized lung ventilation device (device using volume divider with ventilator) of claim 12,
wherein the closed loop controller (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 (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 sensors positioned at the distal end of the second lumen and/or the third lumen (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)
a closed-loop control module configured to modulate the at least one flow regulator to minimize an error (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])
Darowski does not explicitly disclose two pressure sensors positioned at the distal end of the second lumen and/or the third lumen, an error term which is the difference between the measured pressure in the left and right lungs and the target differential between the lungs.
Darowski et al. discloses an analogous apparatus for dividing ventilation between the lungs where
two pressure sensors positioned at the distal end of the second lumen and/or the third lumen (fig. 1; pressure gauges 13 and 14 measure pressure in inspiratory branches 5 and 6; col. 2, lines 52-55).
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 distal ends of the tubes/output ends of Darowski with the pressure gauges of Darowski et al. to measure and indicate the increase of pressure in each of the inspiratory branches (each individual lung) during an inspiratory phase therefore indicating changes in the gas flow (Darowski et al: col. 2, lines 52-55 and col. 3, lines 9-39).
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 pressure gauges 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 pressure gauges 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.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Darowski (US 20170128693) in view of Chang (US 20160287824).
Regarding claim 14, Darowski discloses
the compartmentalized lung ventilation device (device using volume divider with ventilator) 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 Freeman (US 20180280646).
Regarding claim 15, Darowski discloses
the compartmentalized lung ventilation device (device using volume divider with ventilator) 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 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; Freeman: machine learning algorithm) of claim 15,
wherein the advanced algorithm is 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 Freeman (US 20180280646) and further in view of Kotmel (US 20030051733).
Regarding claim 17, the modified device of Darowski discloses
the compartmentalized lung ventilation device (Darowski: device using volume divider with ventilator; 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 Coleman (US 20140158130).
Regarding claim 20, Darowski discloses
the compartmentalized lung ventilation device (device using volume divider with ventilator) 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 Darowski with the sensor ports with caps 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 Kotmel (US 20030051733).
Regarding claim 23, Darowski discloses
the compartmentalized lung ventilation device (device using volume divider with ventilator) 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]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Hanemann (CN 211536094) – a y-shaped connector to provide ventilation to the left main bronchus and right main bronchus
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/S.R.R./Examiner, Art Unit 3785
/VICTORIA MURPHY/Primary Patent Examiner, Art Unit 3785