DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
Receipt is acknowledged of a certified copy of foreign application IN 202241002660, however the present application does not properly claim priority to the submitted foreign application. If this copy is being filed to obtain priority to the foreign filing date under 35 U.S.C. 119(a)-(d) or (f), 365(a) or (b), or 386(a), applicant must also file a claim for such priority as required by 35 U.S.C. 119(b) or 365(b), and 37 CFR 1.55. If the application was filed before September 16, 2012, the priority claim must be made in either the oath or declaration or in an application data sheet; if the application was filed on or after September 16, 2012, the claim for foreign priority must be presented in an application data sheet.
If the application being examined is an original application filed under 35 U.S.C. 111(a) (other than a design application), the claim for priority must be presented during the pendency of the application, and within the later of four months from the actual filing date of the application or sixteen months from the filing date of the prior foreign application. See 37 CFR 1.55(d)(1). If the application being examined is a national stage application under 35 U.S.C. 371, the claim for priority must be made within the time limit set forth in the PCT and Regulations under the PCT. See 37 CFR 1.55(d)(2). Any claim for priority under 35 U.S.C. 119(a)-(d) or (f), 365(a) or (b), or 386(a) not presented within the time period set forth in 37 CFR 1.55 is considered to have been waived. If a claim for foreign priority is presented after the time period set forth in 37 CFR 1.55, the claim may be accepted if the claim properly identifies the prior foreign application and is accompanied by a grantable petition under 37 CFR 1.55(e) to accept an unintentionally delayed claim for priority and the applicable petition fee under 37 CFR 1.17(m)(1) or (m)(2).
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “blender” must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 3 is 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 3 recites the limitation “wherein the inspiratory unit (50) and the expiratory unit (100) comprises three way electromechanical valves”. It is unclear whether the limitation is stating that the “first valve, second valve, third valve, and fourth valve” of claim 1 are three way electromechanical valves or if the three way electromechanical valves are separate/different valves. For purposes of examination, the limitation is being interpreted as the valves from claim 1 comprise three way electromechanical valves.
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 1, 6, and 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Meyerowitz (WO 2021188909) in view of Mondry (US 5682877) and further in view of Sardesai (US 20150059757).
Regarding claim 1, Meyerowitz discloses
An apparatus (10) (figs. 1-7; flow control system 100 that comprises a blender, inspiratory module, patient circuit, and expiratory module; [0005], [0006], and [0025]-[0028]) for providing noninvasive intermittent positive pressure ventilation (see fig. 2; flow control system 100 provides intermittent (4 states) positive pressure ventilation; [0029]-[0030]) comprising:
a blender and medical air supplied by the blender (fig. 1; Box 1 shows an oxygen blender which mixes air 104 and oxygen 102 to achieve the desired fraction of inspired oxygen (Fi02) level (in certain embodiments ranging between 21 % and 100% oxygen); [0025])
a first predefined volume of medical air supplied by the blender (figs. 1-3; breathing circuit has multiple flow paths arranged in parallel each having a valve, where each breath cycle a set volume of gas is delivered to the patient which can be selected by the user and altered with the control valves; [0005]-[0006], [0024], and [0029]-[0030]; first volume supplied during first breath cycle);
a second predefined volume of the medical air supplied by the blender (figs. 1-3; breathing circuit has multiple flow paths arranged in parallel each having a valve, where each breath cycle a set volume of gas is delivered to the patient which can be selected by the user and altered with the control valves; [0005]-[0006], [0024], and [0029]-[0030]; second volume supplied during second breath cycle);
an inspiratory unit (50) (fig. 1; Box 2 shows the inspiratory module (or inspiratory flow breathing circuit) which controls the flow of gas to the patient; [0005], [0006], and [0025]-[0027]); wherein the inspiratory unit (50) comprises:
a first valve (60) (fig. 1; a three-valve control valve arrangement is shown having a first valve V-1 , second valve V-2 and third valve V-3 configured in parallel; [0026]);
wherein the first valve (60) is adapted to provide the first predefined volume of the medical air to a patient (figs. 1-3; breathing circuit has multiple flow paths arranged in parallel each having a valve, where each breath cycle a set volume of gas is delivered to the patient which can be selected by the user and altered with the control valves; [0005]-[0006], [0024], and [0029]-[0030]; first volume supplied during first breath cycle) through a first outlet (70) (see fig. 1; valves are placed in parallel and exit into the same line to the patient) to assist an inspiration of the patient (80) (the controller selects a desired flow path based on the parameters and selected/target I:E ratio chosen by the user; [0005]-[0006], [0024], and [0029]-[0030]; a user sets a selected/target ratio I:E ratio, [0032], therefore, the being capable of setting a target ratio of 1:2 assists inspiration);
a second valve (90) (fig. 1; a three-valve control valve arrangement is shown having a first valve V-1 , second valve V-2 and third valve V-3 configured in parallel; [0026]);
wherein the second valve (90) is adapted to provide the second predefined volume of the medical air to the patient (80) (figs. 1-3; breathing circuit has multiple flow paths arranged in parallel each having a valve, where each breath cycle a set volume of gas is delivered to the patient which can be selected by the user and altered with the control valves; [0005]-[0006], [0024], and [0029]-[0030]; second volume supplied during second breath cycle) through the first outlet (70) (see fig. 1; valves are placed in parallel and exit into the same line to the patient) to assist an expiration of the patient (80) (the controller selects a desired flow path based on the parameters and selected/target I:E ratio chosen by the user; [0005]-[0006], [0024], and [0029]-[0030]; a user sets a selected/target ratio I:E ratio, [0032], therefore, the being capable of setting a target ratio of 1:3 or 1:4 which assists expiration);
an expiratory unit (100) mechanically coupled to the inspiratory unit (50) (see fig. 1; Box 2 which shows the inspiratory module (or inspiratory flow breathing circuit) is connected to the patient circuit is the expiration flow breathing circuit (Box 4) downstream; [0026]-[0028]),
wherein the expiratory unit (100) is adapted to:
a third valve (120) ; a fourth valve (140) (fig. 1; expiration flow breathing circuit (Box 4) has an expiratory valve V-4 and check valve CV-1; [0028);
generate a peak inspiratory pressure during the inspiration of the patient (80) and generate a peak expiratory pressure during the expiration of the patient (80) (see figs. 2-5; the system transitions between four states where the PEEP during expiration can be controlled to a desired setpoint 506 using the controllers and valves and maximum peak inspiratory pressure (PIP) can be controlled to a manual setpoints 510; [0005]-[0006], [0024], and [0029]-[0031], [0039]).
a control unit (150) operatively coupled to the expiratory unit (100) and the inspiratory unit (50) (figs. 1-5; a controller open one or more of the plurality of valves based on the ratio that most closely matches the selected I: E ratio and is configured to operate the ventilation system in one of four states selected from the group of: inspiratory flow breathing circuit open; inspiratory flow breathing circuit closed; expiratory flow breathing circuit open; and expiratory flow breathing circuit closed; [0005]-[0006], [0029]-[0030], and claim 2),
wherein the control unit (150) is adapted to provide one or more control signals to operate the first valve (60), the second valve (90), the third valve (120) and the fourth valve (140) (figs. 1-5; the controller opens/closes the valves based on which of the four states (inspiratory flow breathing circuit open; inspiratory flow breathing circuit closed; expiratory flow breathing circuit open; and expiratory flow breathing circuit closed) ventilation system is in; [0005]-[0006], [0024], [0029]-[0030], and claim 2) to control the peak inspiratory pressure, the peak expiratory pressure, an inspiratory time, an expiratory time, and a respiratory rate per minute (figs. 1-6; device setting parameters, see fig. 6, such as delivered tidal volume, inspiratory time, expiratory time, inspiratory to expiratory ratio, peak airway pressure, plateau pressure, and positive end-expiratory pressure (PEEP); [0005]-[0006], [0024], [0029]-[0030], and [0051]), based on a plurality of parameters (figs. 1-6; system/valves are controlled based on the I:E ratio that is closest to the target I:E selected 314 and the target inspiratory time, target expiratory time and target inspiratory flow paths are set 316; [0005]-[0006], [0024], [0029]-[0030], and [0033]).
Meyerowitz does not explicitly disclose an apparatus for providing noninvasive positive pressure ventilation comprising a flow control unit (20) mechanically coupled to a blender, wherein the flow control unit (20) comprises: a first flow meter (30) adapted to provide the first predefined volume of medical air supplied; a second flow meter (40) adapted to provide a second predefined volume of the medical air supplied; an inspiratory unit (50) mechanically coupled to the flow control unit (20), wherein the inspiratory unit (50) comprises: the first valve (60) mechanically coupled to the first flowmeter (30), the second valve (90) mechanically coupled to the second flow meter (40), the expiratory unit (100) is adapted to: generate a peak inspiratory pressure during the inspiration of the patient (80) by expelling the first predefined volume of the medical air to a liquid medium (130) at a first depth through a first inlet (110), and the third valve (120); generate a peak expiratory pressure during the expiration of the patient (80) by expelling the second predefined volume of the medical air to the liquid medium (130) at a second depth through the first inlet (110), and the fourth valve.
Mondry discloses an oxydosimeter system (see figs. 1, 9, 14, etc.) which controls oxygen concentration and flow of the ventilator based on oxygen measurements (col. 3, lines 29-55) with
a flow control unit (20) (fig. 1; flowmeters 36, 38, 40 and 42 and the adapters 28, 30, 32 and 34 could be fabricated into a single unit; col. 3, lines 52-62; where the pulse oximeter 12 and ECU 14 work with the system 10 to determine the proper amount of oxygen to deliver to the patient; col. 3, lines 29-55) coupled to (fig. 1; flowmeters 36, 38, 40 and 42 are connected to a manifold 44 which is connected to the high pressure source; col. 3, lines 60-67, wherein the flow control unit (20) comprises:
a first flow meter (30) (fig. 1, oxygen regulator-flowmeter 36; col. 3, lines 52-62)
a second flow meter (40) (fig. 1, oxygen regulator-flowmeters 38; col. 3, lines 52-62)
an inspiratory unit (50) mechanically coupled to the flow control unit (20) (fig. 1, solenoid valves 20, 22, 24 and 26 are connected to adapters 28, 30, 32 and 34; col. 3, lines 52-62), wherein the inspiratory unit (50) (fig. 2; plurality of solenoid valves 20, 22, 24 and 26 with oxygen tubing 48; col. 4, lines 1-8) comprises:
the first valve (60) mechanically coupled to the first flowmeter (30) (fig. 1; solenoid valves 20 which are connected to adapters 28 are adapted to oxygen regulator-flowmeter 36 ; col. 3, lines 52-62),
the second valve (90) mechanically coupled to the second flow meter (40) ((fig. 1; solenoid valves 22 which are connected to adapters 30, are adapted to oxygen regulator-flowmeter 38; col. 3, lines 52-62),
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 blender and inspiratory module of the flow control system of Meyerowitz with the pulse oximeter, control unit, adapters, and oxygen regulator flowmeters of the oxydosimeter system of Mondry to determine the proper amount of oxygen to deliver to the patient based on pulse rate and oxygen saturation of the patient, therefore, preventing poor weight maintenance or gain (due to negative nitrogen balance), increased frequency of apnea and poor development in neonates, increased frequency of oxygenation advancement, difficulty in weaning from a ventilator, poor mentation, and decreased survival rates (Mondry: col. 1, lines 32-47 and col. 3, lines 29-55).
It directly follows that the resultant flow control system of Meyerowitz combined with the oxydosimeter system of Mondry would meet the claimed structural limitations since:
Meyerowitz and Mondry combined discloses
a flow control unit (20) (Mondry: fig. 1; flowmeters 36, 38, 40 and 42 and the adapters 28, 30, 32 and 34 could be fabricated into a single unit; col. 3, lines 52-62; where the pulse oximeter 12 and ECU 14 work with the system 10 to determine the proper amount of oxygen to deliver to the patient; col. 3, lines 29-55) mechanically coupled to a blender (Meyerowitz: fig. 1; Box 1 shows an oxygen blender which mixes air 104 and oxygen 102 to achieve the desired fraction of inspired oxygen (Fi02) level (in certain embodiments ranging between 21 % and 100% oxygen); [0025]; Mondry: flowmeters are connected to the manifold 44 which is in fluid communication with the oxygen source; col. 3, lines 60-67),
a first flow meter (30) (Mondry: fig. 1; oxygen regulator-flowmeter 36; col. 3, lines 52-62) adapted to provide a first predefined volume of medical air supplied by the blender (Meyerowitz: figs. 1-3; breathing circuit has multiple flow paths arranged in parallel each having a valve, where each breath cycle a set volume of gas (from the blender as shown in box 2) is delivered to the patient which can be selected by the user and altered with the control valves; [0005]-[0006], [0024], and [0029]-[0030]; first volume supplied during first breath cycle);
a second flow meter (40) ((Mondry: fig. 1; oxygen regulator-flowmeter 38; col. 3, lines 52-62) adapted to provide a second predefined volume of the medical air supplied by the blender (Meyerowitz: figs. 1-3; breathing circuit has multiple flow paths arranged in parallel each having a valve, where each breath cycle a set volume of gas (from the blender as shown in box 2) is delivered to the patient which can be selected by the user and altered with the control valves; [0005]-[0006], [0024], and [0029]-[0030]; second volume supplied during second breath cycle).
The modified device of Meyerowitz does not explicitly disclose an apparatus that provides noninvasive positive pressure ventilation and comprises the expiratory unit (100) adapted to: generate a peak inspiratory pressure during the inspiration of the patient (80) by expelling the first predefined volume of the medical air to a liquid medium (130) at a first depth through a first inlet (110), and a third valve (120); and generate a peak expiratory pressure during the expiration of the patient (80) by expelling the second predefined volume of the medical air to the liquid medium (130) at a second depth through the first inlet (110), and a fourth valve (140).
Sardesai discloses an analogous ventilation system for modulating respiration rate, inspiratory time, I:E ratio, PIP, and PEEP ([0026] and [0049]) where the system
provides noninvasive positive pressure ventilation (fig. 12; ventilation system provides a patient interface 114 which can be non-invasive such as face or nasal masks, nasal prongs, and nasal cannulas with Bi-PAP ventilation or intermittent positive pressure ventilation (IPPV); [0034]) and comprises
the expiratory unit (100) adapted to:
generate a peak inspiratory pressure during the inspiration of the patient (80) by expelling the first predefined volume of the medical air to a liquid medium (130) at a first depth through a first inlet (110), and a third valve (120) (fig. 12; the distal end 112 of the duct 108 connects to at least one peak inspiratory pressure (PIP) control duct 117 which is immersed in a body of fluid 123 in the container 105 (at a greater depth than the PEEP control duct 121); [0049]; valve 109 is placed on the PIP control duct 117 to open thereby raising the pressure to peak inspiratory pressure or closing to allow the patient to exhale using controller 115; [0050]);
generate a peak expiratory pressure during the expiration of the patient (80) by expelling the second predefined volume of the medical air to the liquid medium (130) at a second depth through the first inlet (110), and a fourth valve (140) (fig. 12; the distal end 112 of the duct 108 connects to at least one positive end-expiratory pressure (PEEP) control duct 121 which is immersed in a body of fluid 123 in the container 105 (at a lesser depth than the PIP control duct 117); [0049]; valve 125 is placed on the PEEP control duct 121 to control the PEEP in the circuit; [0050]).
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 flow control system of Meyerowitz with the non-invasive patient interface of Sardesai to yield the predictable result of being able to deliver oxygen/air to a patient to receive Bi-PAP ventilation of intermittent positive pressure ventilation through a non-invasive patient interface (Sardesai: [0034]). Further, 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 exhalation valve and check valve of the expiratory module of Meyerowitz with the ducts, valves, container, and liquid medium of Sardesai to yield the predictable result of assisting the breathing of the subject through cycling the valves to be open and closed, thereby, allowing the user to receive peak inspiratory pressure and positive end expiratory pressure (Bi-PAP) or intermittent positive pressure (Sardesai: [0049]-[0051]).
Regarding claim 6, Meyerowitz further discloses
the apparatus (10) (flow control system 100) as claimed in claim 1,
wherein the first outlet (70) (see fig. 1; patient circuit (box 3) is positioned downstream of the outlet of the inspiratory flow breathing circuit (box 2); [0025]-[0028]) is associated with a humidifier (180) to humidify the medical air (fig. 1; patient circuit (box 3) contains a heater and moisture element that is utilized just upstream of delivery to the patient 110 to heat and humidify the gas prior to patient delivery; [0028]).
Regarding claim 8, Meyerowitz further discloses
the apparatus (10) (flow control system 100) as claimed in claim 1,
wherein the plurality of parameters comprises at least one of an inspiratory time, an expiratory time, a pressure of the medical air (figs. 1-6; system/valves are controlled based on the I:E ratio that is closest to the target I:E selected 314 and the target inspiratory time, target expiratory time and target inspiratory flow paths are set 316; [0005]-[0006], [0024], [0029]-[0030], and [0033]).
Regarding claim 9, Meyerowitz further discloses
the apparatus (10) (system 100) as claimed in claim 1, comprising
a pressure sensor associated with the control unit (150) (see figs. 1 and 5; pressure sensors/transducers PT-1 , PT-2 (508) is connected with controller 502; [0026]-[0030], [0036], [0039]) ,
wherein the pressure sensor is adapted to sense the pressure of the medical air (figs. 1 and 5; a pair of redundant pressure transducers PT-1 , PT-2 for monitoring pressure levels and triggering an alarm or safety feature; [0026]),
wherein the pressure sensor is adapted to provide alerts when the pressure sensed is different upon comparing with a predefined threshold (fig. 5; controller 502 receives sensor 508 input including pressure data which can trigger an alarm 512 if thresholds are exceeded; [0039]).
Regarding claim 10, Meyerowitz discloses
a method (500) (figs. 1-7; using flow control system 100 that comprises a blender, inspiratory module, patient circuit, and expiratory module; [0005], [0006], and [0025]-[0030]) comprising:
providing a first predefined volume of medical air supplied by a blender ((figs. 1-3; breathing circuit has multiple flow paths arranged in parallel each having a valve, where each breath cycle a set volume of gas is delivered to the patient which can be selected by the user and altered with the control valves; [0005]-[0006], [0024], and [0029]-[0030]; first volume supplied during first breath cycle); (510)
providing a second predefined volume of the medical air supplied by the blender (figs. 1-3; breathing circuit has multiple flow paths arranged in parallel each having a valve, where each breath cycle a set volume of gas is delivered to the patient which can be selected by the user and altered with the control valves; [0005]-[0006], [0024], and [0029]-[0030]; second volume supplied during second breath cycle); (520)
providing, by a first valve (fig. 1; a three-valve control valve arrangement is shown having a first valve V-1 , second valve V-2 and third valve V-3 configured in parallel; [0026]), the first predefined volume of the medical air provided to a patient (figs. 1-3; breathing circuit has multiple flow paths arranged in parallel each having a valve, where each breath cycle a set volume of gas is delivered to the patient which can be selected by the user and altered with the control valves; [0005]-[0006], [0024], and [0029]-[0030]; first volume supplied during first breath cycle) through a first outlet (see fig. 1; valves are placed in parallel and exit into the same line to the patient) to assist an inspiration of the patient (the controller selects a desired flow path based on the parameters and selected/target I:E ratio chosen by the user; [0005]-[0006], [0024], and [0029]-[0030]; a user sets a selected/target ratio I:E ratio, [0032], therefore, the being capable of setting a target ratio of 1:2 assists inspiration); (530)
providing, by a second valve (fig. 1; a three-valve control valve arrangement is shown having a first valve V-1 , second valve V-2 and third valve V-3 configured in parallel; [0026]), the second predefined volume of the medical air provided to the patient (figs. 1-3; breathing circuit has multiple flow paths arranged in parallel each having a valve, where each breath cycle a set volume of gas is delivered to the patient which can be selected by the user and altered with the control valves; [0005]-[0006], [0024], and [0029]-[0030]; second volume supplied during second breath cycle) through the first outlet (see fig. 1; valves are placed in parallel and exit into the same line to the patient) to assist an expiration of the patient (the controller selects a desired flow path based on the parameters and selected/target I:E ratio chosen by the user; [0005]-[0006], [0024], and [0029]-[0030]; a user sets a selected/target ratio I:E ratio, [0032], therefore, the being capable of setting a target ratio of 1:3 or 1:4 which assists expiration); (540)
generating, by an expiratory unit (see fig. 1; the expiration flow breathing circuit (Box 4); [0026]-[0028]), a peak inspiratory pressure during the inspiration of the patient through a third valve; (550) and a peak expiratory pressure during the expiration of the patient through a fourth valve; (560) (see figs. 2-5; the system transitions between four states where the PEEP during expiration can be controlled to a desired setpoint 506 using the controllers and valves and maximum peak inspiratory pressure (PIP) can be controlled to a manual setpoints 510; [0005]-[0006], [0024], and [0029]-[0031], [0039]) and
providing, by a control unit, one or more control signals to operate the first valve, the second valve, the third valve and the fourth valve (figs. 1-5; the controller opens/closes the valves based on which of the four states (inspiratory flow breathing circuit open; inspiratory flow breathing circuit closed; expiratory flow breathing circuit open; and expiratory flow breathing circuit closed) ventilation system is in; [0005]-[0006], [0024], [0029]-[0030], and claim 2) to control the peak inspiratory pressure, the peak expiratory pressure, an inspiratory time, an expiratory time, and a respiratory rate per minute (figs. 1-6; device setting parameters, see fig. 6, such as delivered tidal volume, inspiratory time, expiratory time, inspiratory to expiratory ratio, peak airway pressure, plateau pressure, and positive end-expiratory pressure (PEEP); [0005]-[0006], [0024], [0029]-[0030], and [0051]), based on a plurality of parameters (figs. 1-6; system/valves are controlled based on the I:E ratio that is closest to the target I:E selected 314 and the target inspiratory time, target expiratory time and target inspiratory flow paths are set 316; [0005]-[0006], [0024], [0029]-[0030], and [0033]) and thereby providing noninvasive intermittent positive pressure ventilation to the patient.
Meyerowitz does not explicitly disclose providing, by a first flow meter, a first predefined volume of medical air; providing, by a second flow meter, a second predefined volume of the medical air; generating, by an expiratory unit, a peak inspiratory pressure during the inspiration of the patient by expelling the first predefined volume of the medical air to a liquid medium at a first depth through a first inlet, and a third valve; generating, by the expiratory unit, a peak expiratory pressure during the expiration of the patient by expelling the second predefined volume of the medical air to the liquid medium at a second depth through the first inlet, and a fourth valve; and providing, by a control unit, one or more control signals to operate the valves thereby providing noninvasive intermittent positive pressure ventilation to the patient.
Mondry discloses an oxydosimeter system (see figs. 1, 9, 14, etc.) which controls oxygen concentration and flow of the ventilator based on oxygen measurements (col. 3, lines 29-55) which includes
a first flow meter (fig. 1;oxygen regulator-flowmeter 36; col. 3, lines 52-62; flowmeters 36, 38, 40 and 42 and the adapters 28, 30, 32 and 34 could be fabricated into a single unit; col. 3, lines 52-62; where the pulse oximeter 12 and ECU 14 work with the flowmeters and valves 20, 22, 24 and 26 to determine the proper amount of oxygen to deliver to the patient; col. 3, lines 29-55);
a second flow meter (fig. 1, oxygen regulator-flowmeters 38; col. 3, lines 52-62; flowmeters 36, 38, 40 and 42 and the adapters 28, 30, 32 and 34 could be fabricated into a single unit; col. 3, lines 52-62; where the pulse oximeter 12 and ECU 14 work with the flowmeters and valves 20, 22, 24 and 26 to determine the proper amount of oxygen to deliver to the patient; col. 3, lines 29-55).
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 blender and inspiratory module of the flow control system of Meyerowitz with the pulse oximeter, control unit, adapters, and oxygen regulator flowmeters of the oxydosimeter system of Mondry to determine the proper amount of oxygen to deliver to the patient based on pulse rate and oxygen saturation of the patient, therefore, preventing poor weight maintenance or gain (due to negative nitrogen balance), increased frequency of apnea and poor development in neonates, increased frequency of oxygenation advancement, difficulty in weaning from a ventilator, poor mentation, and decreased survival rates (Mondry: col. 1, lines 32-47 and col. 3, lines 29-55).
It directly follows that the resultant flow control system of Meyerowitz combined with the oxydosimeter system of Mondry would meet the claimed structural limitations since:
Meyerowitz and Mondry combined discloses
providing, by a first flow meter (Mondry: fig. 1; oxygen regulator-flowmeter 36; col. 3, lines 52-62), a first predefined volume of medical air supplied by the blender (Meyerowitz: figs. 1-3; breathing circuit has multiple flow paths arranged in parallel each having a valve, where each breath cycle a set volume of gas (from the blender as shown in box 2) is delivered to the patient which can be selected by the user and altered with the control valves; [0005]-[0006], [0024], and [0029]-[0030]; first volume supplied during first breath cycle);
providing, by a second flow meter (Mondry: fig. 1; oxygen regulator-flowmeter 38; col. 3, lines 52-62), a second predefined volume of the medical air supplied by the blender (Meyerowitz: figs. 1-3; breathing circuit has multiple flow paths arranged in parallel each having a valve, where each breath cycle a set volume of gas (from the blender as shown in box 2) is delivered to the patient which can be selected by the user and altered with the control valves; [0005]-[0006], [0024], and [0029]-[0030]; second volume supplied during second breath cycle).
The modified method of Meyerowitz does not explicitly disclose generating, by an expiratory unit, a peak inspiratory pressure during the inspiration of the patient by expelling the first predefined volume of the medical air to a liquid medium at a first depth through a first inlet, and a third valve; generating, by the expiratory unit, a peak expiratory pressure during the expiration of the patient by expelling the second predefined volume of the medical air to the liquid medium at a second depth through the first inlet, and a fourth valve; and providing, by a control unit, one or more control signals to operate the valves thereby providing noninvasive intermittent positive pressure ventilation to the patient.
Sardesai discloses an analogous ventilation system for modulating respiration rate, inspiratory time, I:E ratio, PIP, and PEEP ([0026] and [0049]) where the system is
generating, by an expiratory unit, a peak inspiratory pressure during the inspiration of the patient by expelling the first predefined volume of the medical air to a liquid medium at a first depth through a first inlet, and a third valve (fig. 12; the distal end 112 of the duct 108 connects to at least one peak inspiratory pressure (PIP) control duct 117 which is immersed in a body of fluid 123 in the container 105 (at a greater depth than the PEEP control duct 121); [0049]; valve 109 is placed on the PIP control duct 117 to open thereby raising the pressure to peak inspiratory pressure or closing to allow the patient to exhale using controller 115; [0050]);
generating, by the expiratory unit, a peak expiratory pressure during the expiration of the patient by expelling the second predefined volume of the medical air to the liquid medium at a second depth through the first inlet, and a fourth valve; (fig. 12; the distal end 112 of the duct 108 connects to at least one positive end-expiratory pressure (PEEP) control duct 121 which is immersed in a body of fluid 123 in the container 105 (at a lesser depth than the PIP control duct 117); [0049]; valve 125 is placed on the PEEP control duct 121 to control the PEEP in the circuit; [0050]) and
providing, by a control unit, one or more control signals to operate the valves (fig. 12; controller 115 operates valves to control PEEP and PIP; [0034], [0049], and [0050]) thereby providing noninvasive intermittent positive pressure ventilation to the patient (fig. 12; ventilation system provides a patient interface 114 which can be non-invasive such as face or nasal masks, nasal prongs, and nasal cannulas with Bi-PAP ventilation or intermittent positive pressure ventilation (IPPV); [0034]).
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 flow control system of Meyerowitz with the non-invasive patient interface of Sardesai to yield the predictable result of being able to deliver oxygen/air to a patient to receive Bi-PAP ventilation of intermittent positive pressure ventilation through a non-invasive interface (Sardesai: [0034]). Further, 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 exhalation valve and check valve of the expiratory module of Meyerowitz with the ducts, valves, container, and liquid medium of Sardesai to yield the predictable result of assisting the breathing of the subject through cycling the valves to be open and closed, thereby, allowing the user to receive peak inspiratory pressure and positive end expiratory pressure (Bi-PAP) or intermittent positive pressure (Sardesai: [0049]-[0051]).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Meyerowitz (WO 2021188909) in view of Mondry (US 5682877) and further in view of Sardesai (US 20150059757) and Rao (US 20090133695 ).
Regarding claim 2, the modified device of Meyerowitz discloses
the apparatus (10) (system 100) as claimed in claim 1,
wherein the blender is adapted to provide the medical air to the patient (80) in a concentration range of 21% to 100 % (fig. 1; Box 1 shows an oxygen blender which mixes air 104 and oxygen 102 to achieve the desired fraction of inspired oxygen (Fi02) level (in certain embodiments ranging between 21 % and 100% oxygen); [0025])
The modified device of Meyerowitz does not explicitly discloses wherein the blender comprises a motorized blender and the blender is adapted to provide the medical air through a feedback mechanism based on blood oxygen concentration of the patient.
Rao discloses a mechanical ventilator system with a blender for delivering mixed air to a patient
wherein the blender comprises a motorized blender (figs. 1-2; the system 100 comprises the conventional air-oxygen blender 24 which is coupled with a stepper motor 120; [0033]); and
the blender is adapted to provide the medical air through a feedback mechanism (figs. 1-2; the inspired oxygen (FiO.sub.2) is regulated via a closed loop to maintain adequate oxygenation; [0036]) based on blood oxygen concentration of the patient (figs. 1-2; the system 100 has a FiO.sub.2 regulator 22 with a pulse oxygen sensor 20 that communicates with pulse-ox OEM 112 to measure the oxygen saturation of the blood of the patient to drive the stepper motor 120 and regulate the blender to deliver the required oxygen and air mixture/concentration; [0026]-[0027], [0035], and [0038]).
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 blender, pulse oximeter, and ECU of the modified device of Meyerowitz with the FiO.sub.2 regulator and motorized blender of Rao to produce an FiO.sub.2 mix having the desired and necessary proportion of oxygen, depending upon pre-set parameters and deliver the required inspired oxygen (FiO.sub.2) to the patient in order to maintain the desired oxygenation in the patient's blood (Rao: [0026]-[0028] and [0035], and [0038]).
Claims 3 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Meyerowitz (WO 2021188909) in view of Mondry (US 5682877) and further in view of Sardesai (US 20150059757) and Di Capua (US 20160199253).
Regarding claim 3, the modified device of Meyerowitz discloses
the apparatus (10) (Meyerowitz: flow control system 100; Mondry: oxydosimeter system with oxygen regulator flowmeters; Sardesai: alternative exhalation valve system for controlling PIP and PEEP) as claimed in claim 1,
wherein the inspiratory unit (50) and the expiratory unit (100) comprises valves (Meyerowitz: fig. 1; a three-valve control valve arrangement is shown having a first valve V-1 , second valve V-2 and third valve V-3 configured in parallel; [0026]; Sardesai: fig. 12; valve 109 and valve 125 for controlling PIP and PEEP; [0049] and [0050])
The modified device of Meyerowitz does not disclose comprising three way electromechanical valves, wherein the three way electromechanical valves comprises at least one of a solenoid valve, a stepper motor controlled valve and a servo controlled valve.
Di Capua discloses an automated ventilation system for a patient which
comprises three way electromechanical valves, wherein the three way electromechanical valves comprises at least one of a solenoid valve (fig. 2b.; inspiration and expiration control valves 104, 108 that are three port solenoid valves; [0026], [0030], [0032]-[0033]), a stepper motor controlled valve and a servo controlled valve.
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 exhalation valves of Meyerowitz to be solenoid valves as disclosed in Di Capua to provide small and lightweight valves that have a rapid activation time and allows for venting of gas to depressurize (Di Capua: [0030], [0032]-[0033]).
Regarding claim 5, the modified device of Meyerowitz discloses
the apparatus (10) (Meyerowitz: system 100; Sardesai: alternative exhalation valve system for controlling PIP and PEEP) as claimed in claim 1,
wherein the third valve (120) and the fourth valve (140) are interfaced with the liquid medium (130) through a first tube (160) and a second tube (170) respectively (Sardesai: fig. 12; at least one peak inspiratory pressure (PIP) control duct 117 is interface with valve 109 and at least one positive end-expiratory pressure (PEEP) control duct 121 is interfaced with valve 125, where the ducts 117, 125 are immersed in a body of fluid 123 in the container 105; [0049] [0050]),
wherein the first tube (160), the second tube (170) (Sardesai: fig. 12; at least one peak inspiratory pressure (PIP) control duct 117 and at least one positive end-expiratory pressure (PEEP) control duct 121; [0049]-[0050]) , and the expiration unit (Meyerowitz: see fig. 1; the expiration flow breathing circuit (Box 4); [0026]-[0028]) are adapted to be replaced (structural components can in many instances be placed upstream or downstream of locations shown in the instant embodiment, and in certain instances can be eliminated, duplicated or replaced with a different component without altering the advantages of the invention; [0028]) by a tube comprising a plurality of valves (Meyerowitz: fig. 1; conduit of the expiration flow breathing circuit comprises an expiratory valve V-4 and a check valve CV-1 which can in many instances be placed upstream or downstream of locations shown in the instant embodiment, and in certain instances can be duplicated ; [0027]-[0028]).
Meyerowitz does not explicitly disclose the expiratory valves being a plurality of electromechanical valves.
Di Capua discloses an automated ventilation system for a patient with
a plurality of electromechanical valves (fig. 2b.; inspiration and expiration control valves 108that are solenoid valves; [0026], [0030], [0032]-[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 exhalation valves of Meyerowitz to be solenoid valves as disclosed in Di Capua to provide small and lightweight valves that have a rapid activation time and allows for venting of gas to depressurize (Di Capua: [0030], [0032]-[0033]).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Meyerowitz (WO 2021188909) in view of Mondry (US 5682877) and further in view of Sardesai (US 20150059757) and Jam (US 20140190481).
Regarding claim 4, the modified device of Meyerowitz discloses
the apparatus (10) (Meyerowitz: flow control system 100; Mondry: oxydosimeter system with oxygen regulator flowmeters) as claimed in claim 1,
wherein the first flow meter (30), the second flow meter (40) (Mondry: fig. 1, oxygen regulator-flowmeters 36, 38; col. 3, lines 52-62), and the inspiratory unit (50) (Meyerowitz: fig. 1; inspiratory module (box 2); [0005], [0006], and [0025]-[0027]) are adapted to be replaced (Meyerowitz: structural components can in many instances be placed upstream or downstream of locations shown in the instant embodiment, and in certain instances can be eliminated, duplicated or replaced with a different component without altering the advantages of the invention; [0028])
The modified device of Meyerowitz does not explicitly discloses being replaced by a motorized flow meter.
Jam discloses a ventilator using feedback control and a blender to supply an optimal supply of gas to the patient which uses a motorized flow meter (fig. 6; controls a motorized bias flow meter 40 with an automated blender 26 based on pressure flow composition controller and information from pressure sensors 49 and analyzer 53 [0110]).
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 flowmeters and inspiratory module of the modified device of Meyerowitz with the motorized bias flow meter 40 of Jam as Meyerowitz states that structural components can be replaced with a different component (Meyerowitz: [0028]) and such a substitution would yield the predictable result of being able to adjust and maintain optimal pressure and composition of gases or FiO2 (Jam: [0110]).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Meyerowitz (WO 2021188909) in view of Mondry (US 5682877) and further in view of Sardesai (US 20150059757) and Banner (US 20030010339).
Regarding claim 7, the modified device of Meyerowitz discloses
the apparatus (10) (Meyerowitz: flow control system 100; Mondry: oxydosimeter system with oxygen regulating flowmeters) as claimed in claim 1,
wherein the control unit (150) is adapted to provide the one or more control signals (Meyerowitz: controller opens/closes valves and receives target volumes to control operation of inspiratory and expiratory flow breathing circuits; [0005]-[0006], [0025]-[0030], [0036], [0039]) to the first flow meter (30) and the second flow meter (40) (Mondry: fig. 1; flowmeters 36, 38, 40 and 42 and the adapters 28, 30, 32 and 34 could be fabricated into a single unit; col. 3, lines 52-62; where the pulse oximeter 12 and ECU 14 work with the flow meters and valves 20, 22, 24 and 26 to determine the proper amount of oxygen to deliver to the patient; col. 3, lines 29-55)
The modified device of Meyerowitz does not disclose wherein the control unit (150) is adapted to provide the one or more control signals to increase flow rate of the medical air upon detecting an irregularity in the pressure of the medical air.
Banner discloses a ventilator for supply ventilation support
wherein the control unit (150) is adapted to provide the one or more control signals to increase flow rate of the medical air upon detecting an irregularity in the pressure of the medical air (figs. 10-12; the microprocessor of the ventilator 20 increases the pressure and/or flow rate upon detecting that the pressure of the breathing gas 32 deviates from a predetermined baseline; [0018], [0168]-[0170]).
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 and flowmeters of the modified device of Meyerowitz to increase the pressure and/or flow rate of the breathing gas supplied when the pressure deviates as disclosed in Banner to be able to maintain the pressure of the breathing gas near the distal end of the breathing attachment and improve patient efforts to breath by both reducing the work of breathing required to sustain a breath and for nullifying the work of breathing imposed by the ventilation breathing apparatus (Banner: [0016]-[0018] and 0168]-[0170]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Smith (US 20070125374) – A gas blender using multiple valves with an auxiliary gas outlet and a controller that modulates the gas mixing apparatus
DiBlasi (US 20110073112) – A ventilation assembly that has bubbler conduits with an electromechanical valves to received Vi-PAP ventilation; any number of valves and bubbler conduits can be used
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/S.R.R./Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785
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