Office Action Predictor
Last updated: April 17, 2026
Application No. 18/555,240

SYSTEMS AND METHODS FOR MEASURING PATIENT LUNG PRESSURE

Non-Final OA §102§103
Filed
Oct 12, 2023
Examiner
HUSSAIN, MISHAL ZAHRA
Art Unit
3785
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
ventec life systems Inc.
OA Round
1 (Non-Final)
69%
Grant Probability
Favorable
1-2
OA Rounds
3y 10m
To Grant
99%
With Interview

Examiner Intelligence

Grants 69% — above average
69%
Career Allow Rate
24 granted / 35 resolved
-1.4% vs TC avg
Strong +37% interview lift
Without
With
+36.7%
Interview Lift
resolved cases with interview
Typical timeline
3y 10m
Avg Prosecution
32 currently pending
Career history
67
Total Applications
across all art units

Statute-Specific Performance

§101
4.5%
-35.5% vs TC avg
§103
45.5%
+5.5% vs TC avg
§102
24.8%
-15.2% vs TC avg
§112
22.4%
-17.6% vs TC avg
Black line = Tech Center average estimate • Based on career data from 35 resolved cases

Office Action

§102 §103
CTNF 18/555,240 CTNF 98973 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Information Disclosure Statement The information disclosure statement (IDS) submitted on August 01, 2025 has been received and considered by the Examiner. Election/Restriction 18-18 REQUIREMENT FOR UNITY OF INVENTION As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art. The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e). When Claims Are Directed to Multiple Categories of Inventions: As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories: (1) A product and a process specially adapted for the manufacture of said product; or (2) A product and a process of use of said product; or (3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or (4) A process and an apparatus or means specifically designed for carrying out the said process; or (5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process. Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c). 18-19 AIA Restriction is required under 35 U.S.C. 121 and 372. This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1. In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted. Group I, Claim 1-9 and 18-20, drawn to a method for measuring lung pressure during use of a ventilator Group II, Claims 10-17 and 21-23, drawn to ventilator system, comprising a ventilator assembly with a blower and a control module with a processor and memory 18-07 AIA The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons: 18-07-02 AIA Groups I and II lack unity of invention because even though the inventions of these groups require the technical feature of a ventilator having a blower operable at a first and second speed , this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Tobia et al. (US 6371113 B1, hereinafter “Tobia”) Tobia discloses: A ventilator system (Column 1, lines 10-14, This invention relates to medical ventilators for providing breaths to a patient and, more particularly, to a ventilator having a system to provide a zero flow condition during a pause phase following a mechanical inspiration) comprising: a ventilator assembly (Column 3, lines 22-25, Ventilator 10 comprises a gas source 12 which typically provides gas at about 50 psi through a primary regulator 14 to source conduit 16 and which thus supplies flow control valve 18 with gas at approximately 25 psi) connected to the patient by a patient circuit and a patient connection (Column 2, lines 57-60, Patient breathing circuit 44, as shown is a circle system comprising an inhalation limb 46 and an exhalation limb 48 that delivers breathing gas to and receives exhaled gas from, respectively, patient connection 50) , and a blower configured to control the flow of gas to a patient (Column 3, lines 51-53, Ventilator connection 24 is made to a bellows assembly 38 and conduit 22 communicates with the bellows outer chamber 40 to actuate bellows 42) ; wherein said ventilator system: operates the blower at a first speed during an inspiratory phase of a breath to direct gas from the ventilator to the patient along a flow path including the patient circuit and the patient connection (Figure 2, Column 3, lines 56-65, Patient breathing circuit 44, as shown is a circle system comprising an inhalation limb 46 and an exhalation limb 48 that delivers breathing gas to and receives exhaled gas from, respectively, patient connection 50. An inspiratory flow sensor 52 is located in the inhalation limb 46 and an expiratory flow sensor 54 is located in the exhalation limb 48 to monitor the flow in the inhalation and exhalation limbs 46,48, that is the flow to and from the patient connection 50) after the inspiratory phase and before an expiratory phase of the breath, operates the blower at a second speed less than the first speed to achieve a zero-flow state in the flow path during which gas neither flows into nor out of the lungs of the patient (Column 4, lines 29-41, In order to maintain a positive pressure at ventilator connection 24 during the pause phase of the breath cycle, the flow control valve 18 is adjusted so as to maintain a small amount of flow exhausting across flow restrictor 34. Thus, pressure is generated in pressure control conduit 26 which serves to bias shut expiratory valve 28, holding pressure in expiratory conduit 32, ventilator connection 24 and concomitantly at the patient connection 50. By controlling the flow output of the flow control valve 18 in response to signals from the inspiratory flow sensor 52 and expiratory flow sensor 54, the pressure at patient connection 50 can be controlled such that a zero flow state exists at patient connection 50 at the point in time that the pause period ends) ; and measures a plateau pressure in the flow path during the zero-flow state (Column 3, lines 2-13, when the inspiratory cycle progresses, the pressure rises from the zero point at point A to the P MAX at point B which is the measured airway pressure at the end of inspiration. The value of P MAX is thus measured at the end of the inspiratory cycle and the airway flow (Q AW ) can be determined from the ventilator settings or supplied by the ventilator. The pause period takes place between the P MAX at point B and the end of the pause at point C where the airway pressure is reduced to P PLATEAU which, again, is a measured value. At this point, flow in the patient airway Q AW is considered to be zero in order to solve the equations of the resistance/compliance lung model) , wherein the measured plateau pressure is equal or approximately equal to the patient lung pressure (Column 4, lines 41-55, With the present system, the prior model assumption that the flow is zero at the end of the pause period is assured by adjusting the circuit pressure during the pause period so as to drive the end of the pause flow to converge on zero. Thus, the P AW measured at the end of the pause period is, in fact, equal to the patient lung pressure. Turning now to FIG. 3, there is shown a flow chart of the preferred method of assuring a zero flow at the end of the pause period. Taking the steps of the flow chart, there is a proximal flow sensing block 80 that receives information from a flow sensor that monitors the flow to and from the patient during the pause period. That flow can be positive indicating that there was a flow to the patient or may be negative indicating that a flow was received from the patient) 08-23 AIA During a telephone conversation with Jacob Gober on March 18, 2026 , a provisional election was made without traverse to prosecute the invention of Group II , Claim s 10-17 and 21-23 . Affirmation of this election must be made by applicant in replying to this Office action. Claim s 1-9 and 18-20 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention. Claim Rejections - 35 USC § 102 07-07-aia AIA 07-07 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 – 07-08-aia AIA (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. 07-12-aia AIA (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. 07-15 AIA Claim s 10-12, 13-14, and 22 are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by Tobia (US 6371113 B1) Regarding Claim 10, Tobia discloses: A ventilator system (Column 1, lines 10-14, This invention relates to medical ventilators for providing breaths to a patient and, more particularly, to a ventilator having a system to provide a zero flow condition during a pause phase following a mechanical inspiration) , comprising: a ventilation assembly (Column 3, lines 22-25, Ventilator 10 comprises a gas source 12 which typically provides gas at about 50 psi through a primary regulator 14 to source conduit 16 and which thus supplies flow control valve 18 with gas at approximately 25 psi) having a blower configured to control the flow of gas to a patient (Column 3, lines 51-53, Ventilator connection 24 is made to a bellows assembly 38 and conduit 22 communicates with the bellows outer chamber 40 to actuate bellows 42) ; a control module configured to control the blower, the control module including one or more processors, and a memory storing instructions for performing a hold maneuver to measure patient lung pressure (Column 4, lines 9-17, Processor 60 includes a microprocessor connected via an electronic bus to read only memory (ROM) and random access memory (RAM) in a known digital computer configuration. Waveform generator 66 provides a desired waveform to processor 60. Flow control valve 18 is controlled by the processor 60 via a control signal line 68 to track the desired pressure waveform established by the user), wherein the instructions, when executed by the one or more processors, cause the ventilator system to perform operations comprising: operating the blower (Column 3, lines 52-64, The patient's breathing circuit 44 is in communication with the interior of the bellows 42 and thus is isolated from the gas in the ventilator 10. […] An inspiratory flow sensor 52 is located in the inhalation limb 46 and an expiratory flow sensor 54 is located in the exhalation limb 48 to monitor the flow in the inhalation and exhalation limbs 46,48, that is the flow to and from the patient connection 50) at a first speed during an inspiratory phase of a breath to direct gas from the ventilator to the patient along a flow path (Columns 1-2, lines 65-5, Referring now to FIG. 1, there is shown a pressure diagram for a typical airway pressure profile during a volume inspiratory cycle including a pause period. In particular, as can be seen, when the inspiratory cycle progresses, the pressure rises from the zero point at point A to the P MAX at point B which is the measured airway pressure at the end of inspiration), including a patient circuit and a patient connection (Column 2, lines 57-60, Patient breathing circuit 44, as shown is a circle system comprising an inhalation limb 46 and an exhalation limb 48 that delivers breathing gas to and receives exhaled gas from, respectively, patient connection 50) , and after the inspiratory phase and before an expiratory phase of the breath, controlling the speed of the blower to achieve a zero-flow state in the flow path during which gas neither flows into nor out of the lungs of the patient (Figure 1, Column 4, lines 29-41, In order to maintain a positive pressure at ventilator connection 24 during the pause phase of the breath cycle, the flow control valve 18 is adjusted so as to maintain a small amount of flow exhausting across flow restrictor 34. Thus, pressure is generated in pressure control conduit 26 which serves to bias shut expiratory valve 28, holding pressure in expiratory conduit 32, ventilator connection 24 and concomitantly at the patient connection 50. By controlling the flow output of the flow control valve 18 in response to signals from the inspiratory flow sensor 52 and expiratory flow sensor 54, the pressure at patient connection 50 can be controlled such that a zero flow state exists at patient connection 50 at the point in time that the pause period ends) ; and a pressure sensor (Column 4, lines 4-9, Pressure sensor 62 communicates with the interior of conduit 20 and provides a signal indicative of the pressure within circuit 20 to processor 60 via a signal line 64. The pressure in conduit 20 will be referred to as the manifold pressure or MAN and, as can be seen, is indicative of the pressure within pressure control conduit 26) configured to measure a plateau pressure in the flow path during the zero- flow state (Column 3, lines 8-13, The pause period takes place between the P MAX at point B and the end of the pause at point C where the airway pressure is reduced to P PLATEAU which, again, is a measured value. At this point, flow in the patient airway Q AW is considered to be zero in order to solve the equations of the resistance/compliance lung model) , wherein the measured plateau pressure is equal or approximately equal to the patient lung pressure (Column 4, lines 41-55, With the present system, the prior model assumption that the flow is zero at the end of the pause period is assured by adjusting the circuit pressure during the pause period so as to drive the end of the pause flow to converge on zero. Thus, the P AW measured at the end of the pause period is, in fact, equal to the patient lung pressure. Turning now to FIG. 3, there is shown a flow chart of the preferred method of assuring a zero flow at the end of the pause period. Taking the steps of the flow chart, there is a proximal flow sensing block 80 that receives information from a flow sensor that monitors the flow to and from the patient during the pause period. That flow can be positive indicating that there was a flow to the patient or may be negative indicating that a flow was received from the patient) . Regarding Claim 11 , Tobia discloses all of the limitations of Claim 10. Tobia further discloses: a flow sensor configured to measure gas flow in the flow path (Column 3, lines 50-64, An inspiratory flow sensor 52 is located in the inhalation limb 46 and an expiratory flow sensor 54 is located in the exhalation limb 48 to monitor the flow in the inhalation and exhalation limbs 46,48, that is the flow to and from the patient connection 50) , and wherein the operation of controlling the speed of the blower to achieve a zero-flow state (Column 4, 28-41, In order to maintain a positive pressure at ventilator connection 24 during the pause phase of the breath cycle, the flow control valve 18 is adjusted so as to maintain a small amount of flow exhausting across flow restrictor 34. Thus, pressure is generated in pressure control conduit 26 which serves to bias shut expiratory valve 28, holding pressure in expiratory conduit 32, ventilator connection 24 and concomitantly at the patient connection 50. By controlling the flow output of the flow control valve 18 in response to signals from the inspiratory flow sensor 52 and expiratory flow sensor 54, the pressure at patient connection 50 can be controlled such that a zero flow state exists at patient connection 50 at the point in time that the pause period ends) further includes: receiving a signal from the flow sensor indicative of gas flow in the flow path (Column 4, lines 4-9, Pressure sensor 62 communicates with the interior of conduit 20 and provides a signal indicative of the pressure within circuit 20 to processor 60 via a signal line 64. The pressure in conduit 20 will be referred to as the manifold pressure or MAN and, as can be seen, is indicative of the pressure within pressure control conduit 26) , and based on the received signal, automatically adjusting the speed of the blower to achieve and maintain the zero-flow state (Columns 4-5, lines 63-1, That Pause Pressure Delta is added to the previous breath's P MAX that is continuously monitored in the ventilator in order to provide a target pressure (Pause Pressure) to be held by the expiratory valve (FIG. 2) during the pause period. In this way, the PI controller 92 is able to cause a pause pressure to be applied to the expiratory valve which produces a zero flow, end pause condition at the patient airway) . Regarding Claim 13 , Tobia discloses all of the limitations of Claim 10. Tobia further discloses: wherein the operations further comprise automatically calculating patient static compliance based on the measured plateau pressure (Columns 2-3, lines 66-13 Referring now to FIG. 1, there is shown a pressure diagram for a typical airway pressure profile during a volume inspiratory cycle including a pause period. In particular, as can be seen, when the inspiratory cycle progresses, the pressure rises from the zero point at point A to the P MAX at point B which is the measured airway pressure at the end of inspiration. The value of P MAX is thus measured at the end of the inspiratory cycle and the airway flow (Q AW ) can be determined from the ventilator settings or supplied by the ventilator. The pause period takes place between the P MAX at point B and the end of the pause at point C where the airway pressure is reduced to P PLATEAU which, again, is a measured value. At this point, flow in the patient airway Q AW is considered to be zero in order to solve the equations of the resistance/compliance lung model) . Regarding Claim 14 , Tobia discloses all of the limitations of Claim 10. Tobia further discloses: wherein the operations further comprise automatically calculating patient airway resistance based at least in part on the calculated patient static compliance (Columns 4-5, lines 63-1, That Pause Pressure Delta is added to the previous breath's P MAX that is continuously monitored in the ventilator in order to provide a target pressure (Pause Pressure) to be held by the expiratory valve (FIG. 2) during the pause period. In this way, the PI controller 92 is able to cause a pause pressure to be applied to the expiratory valve which produces a zero flow, end pause condition at the patient airway), (Column 2, lines 41-59, In using a flow signal, a preferred algorithm continually senses that flow and readjusts the control pressure in the patient exhalation circuit until the zero flow conditions are attained. By use of the ventilator drive pressures in this manner, the operator is assured that a zero flow condition is met at the end of the pause period. Thus, accurate determinations can be made of the airway resistance and lung compliance and a more ideal pause profile is achieved) . Regarding Claim 22 , Tobia discloses all of the limitations of Claim 10. Tobia further discloses: wherein the operation of controlling the speed of the blower to achieve the zero-flow state (Columns 2-3, lines 66-13, Referring now to FIG. 1, there is shown a pressure diagram for a typical airway pressure profile during a volume inspiratory cycle including a pause period […] The pause period takes place between the P MAX at point B and the end of the pause at point C where the airway pressure is reduced to P PLATEAU which, again, is a measured value. At this point, flow in the patient airway Q AW is considered to be zero in order to solve the equations of the resistance/compliance lung model) includes automatically tuning the speed of the blower (Column 2, lines 41-59, In using a flow signal, a preferred algorithm continually senses that flow and readjusts the control pressure in the patient exhalation circuit until the zero flow conditions are attained. By use of the ventilator drive pressures in this manner, the operator is assured that a zero flow condition is met at the end of the pause period. Thus, accurate determinations can be made of the airway resistance and lung compliance and a more ideal pause profile is achieved) during the hold maneuver to maintain the zero-flow state (Column 4, lines 29-41, In order to maintain a positive pressure at ventilator connection 24 during the pause phase of the breath cycle, the flow control valve 18 is adjusted so as to maintain a small amount of flow exhausting across flow restrictor 34. Thus, pressure is generated in pressure control conduit 26 which serves to bias shut expiratory valve 28, holding pressure in expiratory conduit 32, ventilator connection 24 and concomitantly at the patient connection 50. By controlling the flow output of the flow control valve 18 in response to signals from the inspiratory flow sensor 52 and expiratory flow sensor 54, the pressure at patient connection 50 can be controlled such that a zero flow state exists at patient connection 50 at the point in time that the pause period ends) ; Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-21-aia AIA Claim s 12, 15-17, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Tobia (US 6371113 B1) in view of DeVries et al. (US 20090084381 A1, hereinafter “DeVries”) . Regarding Claim 12 , Tobia discloses all of the limitations of Claim 10. Tobia further discloses: wherein the zero-flow state is maintained for between about 1 second and about 6 seconds (Columns 2-3, lines 66-13 Referring now to FIG. 1, there is shown a pressure diagram for a typical airway pressure profile during a volume inspiratory cycle including a pause period. In particular, as can be seen, when the inspiratory cycle progresses, the pressure rises from the zero point at point A to the P MAX at point B which is the measured airway pressure at the end of inspiration. The value of P MAX is thus measured at the end of the inspiratory cycle and the airway flow (Q AW ) can be determined from the ventilator settings or supplied by the ventilator. The pause period takes place between the P MAX at point B and the end of the pause at point C where the airway pressure is reduced to P PLATEAU which, again, is a measured value. At this point, flow in the patient airway Q AW is considered to be zero in order to solve the equations of the resistance/compliance lung model), . As demonstrated by Figure 1 of Tobia, the zero-flow state is held for approximately 1 second, and is further assured using proximal flow sensing (Column 4, lines 41-55, With the present system, the prior model assumption that the flow is zero at the end of the pause period is assured by adjusting the circuit pressure during the pause period so as to drive the end of the pause flow to converge on zero. Thus, the P AW measured at the end of the pause period is, in fact, equal to the patient lung pressure. Turning now to FIG. 3, there is shown a flow chart of the preferred method of assuring a zero flow at the end of the pause period. Taking the steps of the flow chart, there is a proximal flow sensing block 80 that receives information from a flow sensor that monitors the flow to and from the patient during the pause period. That flow can be positive indicating that there was a flow to the patient or may be negative indicating that a flow was received from the patient). However, if the Applicant is not convinced, DeVries discloses a system that enables a user to manually adjust the duration of the zero-flow state (Paragraph 0155, An inspiratory hold actuation button 370 is provided, to enable the operator to hold the patient at an elevated pressure following inspiration, so that breath mechanics can be calculated. The length of the delay period is determined by the period of time during which the inspiratory hold button 370 remains depressed, with a maximum limit applied), (Paragraphs 0140-0141, The set inspiratory time is the time period for the inspiratory phase of a pressure control breath. Thus, this inspiratory time setting is normally usable for pressure control ventilation. It is preferable that the range of settable inspiratory times being from 0.3 to 10.0 seconds). DeVries and Tobia both disclose controlled ventilator mechanisms that are capable of maintaining timed flow states. It would have been obvious to one skilled in the art before the effective filing date to incorporate the teachings of DeVries user interface and control mechanism with the ventilation system disclosed by Tobia so as to provide a means of accommodating the needs of different users. (Paragraph 0066, At the end of each inspiratory phase, the rotational velocity of the compressor is decelerated to the basal velocity, or is stopped until commencement of the next inspiratory ventilation phase. A programmable controller is preferably incorporated to control the timing and rotational velocity of the compressor. Additionally, the controller may be programmed to cause the compressor to operate in various modes of ventilation, and various breath types, as employed in modern clinical practice). Regarding Claim 15 , Tobia discloses all of the limitations of Claim 10. Tobia further discloses: wherein the operations further comprise adjusting blower after the zero-flow state is achieved and during the expiratory phase to permit patient expiration (Figure 1, Column 4, lines 19-27, During the inspiratory phase of a volume ventilation patient breath, the ventilator 10 operates in the flow delivery mode whereby flow is delivered from gas source 12 through the flow control valve 18 to conduits 20 and 22 and finally to the ventilator connection 24. During most of the expiratory phase of the patient breath, check valve 30 prevents flow from conduit 22 to conduit 20 and gas flows via conduit 32 to expiratory valve 28 where it is exhausted to the atmosphere. The ventilator thus operates in a flow exhaust mode) . Tobia does not explicitly disclose reducing the speed of the blower , but does describe communicating with and actuating the blower (Column 3, lines 51-53, Ventilator connection 24 is made to a bellows assembly 38 and conduit 22 communicates with the bellows outer chamber 40 to actuate bellows 42). DeVries explicitly discloses: further reducing the speed of the blower after the zero-flow state is achieved and during the expiratory phase to permit patient expiration (Paragraph 0047, E. Regulation/Control of Expiratory Pressure. The prior art has included separately controllable exhalation valves which may be preset to exert desired patterns or amounts of expiratory back pressure, when such back pressure is desired to prevent atelectasis or to otherwise improve the ventilation of the patient), (Paragraph 0240, It is desirable that the rotor 130 be accelerated and decelerated as rapidly as possible. Such rapid acceleration/deceleration is facilitated by a reduction in inertial effects as a result of the above-described low mass construction of the rotor 104. The speed and time of rotation of the rotor 104, during each inspiratory phase of the ventilator cycle, is controlled by the controller 12 based on the variables and/or parameters which have been selected for triggering, limiting and terminating the inspiratory phase) DeVries and Tobia both disclose controlled ventilator mechanisms that are capable of maintaining different degrees of flow and pressure through the systems. It would have been obvious to one skilled in the art before the effective filing date to incorporate the teachings of DeVries rotor control mechanism with the ventilation system disclosed by Tobia so as to provide a means of accommodating the needs of different users (Paragraph 0066, At the end of each inspiratory phase, the rotational velocity of the compressor is decelerated to the basal velocity, or is stopped until commencement of the next inspiratory ventilation phase. A programmable controller is preferably incorporated to control the timing and rotational velocity of the compressor. Additionally, the controller may be programmed to cause the compressor to operate in various modes of ventilation, and various breath types, as employed in modern clinical practice). Regarding Claim 16 , Tobia discloses all of the limitations of Claim 10. Tobia does not explicitly disclose a user display . DeVries discloses: a user display configured to display the measured plateau pressure during the zero-flow state (Paragraph 0176, Additionally, the controller 12 may be programmed to cause the monitor display 384 to display a special or different group of parameters during a specific operator-initiated maneuver. Examples of special parameter groups which may be displayed during a specific maneuver include the following: […] Plateau Pressure (Inspiratory Hold), Compliance (Inspiratory Hold)) The use of user interfaces and displays are well known in the art of medical devices. It would have been obvious to one skilled in the art before the effective filing date to incorporate the teachings of DeVries user interface and control mechanism with the ventilation system disclosed by Tobia so as to provide a means of accommodating the needs of different users. (Paragraph 0066, At the end of each inspiratory phase, the rotational velocity of the compressor is decelerated to the basal velocity, or is stopped until commencement of the next inspiratory ventilation phase. A programmable controller is preferably incorporated to control the timing and rotational velocity of the compressor. Additionally, the controller may be programmed to cause the compressor to operate in various modes of ventilation, and various breath types, as employed in modern clinical practice). Regarding Claim 17 , Tobia discloses all of the limitations of Claim 10. Tobia does not explicitly disclose a user input for selective operation DeVries discloses: a user input for selectively initiating operation of the hold maneuver (Paragraph 0155, An inspiratory hold actuation button 370 is provided, to enable the operator to hold the patient at an elevated pressure following inspiration, so that breath mechanics can be calculated. The length of the delay period is determined by the period of time during which the inspiratory hold button 370 remains depressed, with a maximum limit applied) . The use of user interfaces and displays are well known in the art of medical devices. It would have been obvious to one skilled in the art before the effective filing date to incorporate the teachings of DeVries user interface and control mechanism with the ventilation system disclosed by Tobia so as to provide a means of accommodating the needs of different users. (Paragraph 0066, At the end of each inspiratory phase, the rotational velocity of the compressor is decelerated to the basal velocity, or is stopped until commencement of the next inspiratory ventilation phase. A programmable controller is preferably incorporated to control the timing and rotational velocity of the compressor. Additionally, the controller may be programmed to cause the compressor to operate in various modes of ventilation, and various breath types, as employed in modern clinical practice). Regarding Claim 23 , Tobia discloses all of the limitations of Claim 22. Tobia further discloses: wherein the operation of tuning the speed of the blower to maintain the zero-flow state includes continuously adjusting the speed of the blower (Column 2, lines 41-59, In using a flow signal, a preferred algorithm continually senses that flow and readjusts the control pressure in the patient exhalation circuit until the zero flow conditions are attained. By use of the ventilator drive pressures in this manner, the operator is assured that a zero flow condition is met at the end of the pause period. Thus, accurate determinations can be made of the airway resistance and lung compliance and a more ideal pause profile is achieved) to maintain the zero-flow state for a duration of between 1 second and 6 seconds (Columns 2-3, lines 66-13 Referring now to FIG. 1, there is shown a pressure diagram for a typical airway pressure profile during a volume inspiratory cycle including a pause period. In particular, as can be seen, when the inspiratory cycle progresses, the pressure rises from the zero point at point A to the P MAX at point B which is the measured airway pressure at the end of inspiration. The value of P MAX is thus measured at the end of the inspiratory cycle and the airway flow (Q AW ) can be determined from the ventilator settings or supplied by the ventilator. The pause period takes place between the P MAX at point B and the end of the pause at point C where the airway pressure is reduced to P PLATEAU which, again, is a measured value. At this point, flow in the patient airway Q AW is considered to be zero in order to solve the equations of the resistance/compliance lung model) . As demonstrated by Figure 1 of Tobia, the zero-flow state is held for approximately 1 second, and is further assured using proximal flow sensing (Column 4, lines 41-55, With the present system, the prior model assumption that the flow is zero at the end of the pause period is assured by adjusting the circuit pressure during the pause period so as to drive the end of the pause flow to converge on zero. Thus, the P AW measured at the end of the pause period is, in fact, equal to the patient lung pressure. Turning now to FIG. 3, there is shown a flow chart of the preferred method of assuring a zero flow at the end of the pause period. Taking the steps of the flow chart, there is a proximal flow sensing block 80 that receives information from a flow sensor that monitors the flow to and from the patient during the pause period. That flow can be positive indicating that there was a flow to the patient or may be negative indicating that a flow was received from the patient). However, if the Applicant is not convinced, DeVries discloses a system that enables a user to manually adjust the duration of the zero-flow state (Paragraph 0155, An inspiratory hold actuation button 370 is provided, to enable the operator to hold the patient at an elevated pressure following inspiration, so that breath mechanics can be calculated. The length of the delay period is determined by the period of time during which the inspiratory hold button 370 remains depressed, with a maximum limit applied), (Paragraphs 0140-0141, The set inspiratory time is the time period for the inspiratory phase of a pressure control breath. Thus, this inspiratory time setting is normally usable for pressure control ventilation. It is preferable that the range of settable inspiratory times being from 0.3 to 10.0 seconds) DeVries and Tobia both disclose controlled ventilator mechanisms that are capable of maintaining timed flow states. It would have been obvious to one skilled in the art before the effective filing date to incorporate the teachings of DeVries user interface and control mechanism with the ventilation system disclosed by Tobia so as to provide a means of accommodating the needs of different users (Paragraph 0066, A programmable controller is preferably incorporated to control the timing and rotational velocity of the compressor. Additionally, the controller may be programmed to cause the compressor to operate in various modes of ventilation, and various breath types, as employed in modern clinical practice) . 07-21-aia AIA Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Tobia (US 6371113 B1) in view of Fishman et al. (FR 2939049 A1, hereinafter “Fishman”) . Regarding Claim 21 , Tobia discloses all of the limitations of Claim 10. Tobia further discloses: wherein the operation of controlling the speed of the blower to achieve the zero-flow state includes adjusting the speed of the blower (Figure 1, Column 4, lines 19-27, During the inspiratory phase of a volume ventilation patient breath, the ventilator 10 operates in the flow delivery mode whereby flow is delivered from gas source 12 through the flow control valve 18 to conduits 20 and 22 and finally to the ventilator connection 24. During most of the expiratory phase of the patient breath, check valve 30 prevents flow from conduit 22 to conduit 20 and gas flows via conduit 32 to expiratory valve 28 where it is exhausted to the atmosphere. The ventilator thus operates in a flow exhaust mode) . Tobia does not explicitly disclose reducing the speed of the blower , but does describe communicating with and actuating the blower (Column 3, lines 51-53, Ventilator connection 24 is made to a bellows assembly 38 and conduit 22 communicates with the bellows outer chamber 40 to actuate bellows 42). Fishman explicitly discloses: wherein the operation of controlling the speed of the blower to achieve the zero-flow state includes reducing the speed of the blower (Page 4, Paragraph 6, At that moment, the rotation speed of turbine 1 is reduced so as to cancel the flow of inspiratory gas produced. A measurement of the flow drop (∆Q, Figure 4) in the circuit (sensor 20) and a measurement of the pressure drop in the circuit (∆P, see Figure 4) then allows the calculation of the patient's resistance R according to the formula R = ∆P / ∆Q. As shown in Figure 4, the plateau pressure P resulting from the pressure equilibrium between the patient's pulmonary alveoli and the device's pneumatic circuit is called the 'plateau pressure' (or 'P plat '). It is established when the flow through the circuit becomes zero. Performing an inspiratory occlusion therefore allows us to measure the plateau pressure P plat and the resistance R of the patient) Fishman and Tobia both disclosed controlled ventilator mechanisms that are capable of maintaining different degrees of flow and pressure through the systems (Page 1, Paragraph 1, The invention relates more particularly to a device for supplying respiratory gas to a patient according to respiratory cycles, i.e. with alternating inspiratory and expiratory phases, comprising a pressurized respiratory gas source including a turbine). It would have been obvious to one skilled in the art before the effective filing date to incorporate the teachings of Fishman’s turbine control mechanism with the ventilation system disclosed by Tobia so as to provide a means of accommodating the needs of different users (Page 4, Paragraphs 1-2, These sensors determine the conditions of the gas inhaled by the patient. Preferably all or part of the sensors are connected to a computing and control unit 14, including for example a microprocessor. The calculation and control unit 14 is also connected to the turbine 1. The control unit calculates, for example, the operating parameters of pressure and/or flow of the device to control the rotation speed of the turbine 1 as a function of the inhalation and exhalation phases and as a function of pressure signals and/or inspired gas flow signals measured by at least one sensor 11, 12, 13,14, 19, 20.) Conclusion 07-96 AIA The prior art made of record and not relied upon is considered pertinent to applicant's disclosure Berthon-Jones et al. (US 20060032503 A1) discloses a dynamic airway compression device Bell (US 10980954 B1) discloses biomimetic flow based methods of ventilation Isaza (US 20200038611 A1) discloses a ventilator with pressure-controlled breaths administered over specific time intervals Ahmad et al. (US 20130228181 A1) discloses a respiratory assistance device with a variable speed blower Any inquiry concerning this communication or earlier communications from the examiner should be directed to MISHAL Z HUSSAIN whose telephone number is (703)756-1206. The examiner can normally be reached M-F, 8:30am - 5:00pm. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brandy S. Lee can be reached at (571) 270-7410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /MISHAL HUSSAIN/ Examiner Art Unit 3785 /BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785 Application/Control Number: 18/555,240 Page 2 Art Unit: 3785 Application/Control Number: 18/555,240 Page 3 Art Unit: 3785 Application/Control Number: 18/555,240 Page 5 Art Unit: 3785 Application/Control Number: 18/555,240 Page 6 Art Unit: 3785 Application/Control Number: 18/555,240 Page 7 Art Unit: 3785 Application/Control Number: 18/555,240 Page 8 Art Unit: 3785 Application/Control Number: 18/555,240 Page 9 Art Unit: 3785 Application/Control Number: 18/555,240 Page 10 Art Unit: 3785 Application/Control Number: 18/555,240 Page 11 Art Unit: 3785 Application/Control Number: 18/555,240 Page 12 Art Unit: 3785 Application/Control Number: 18/555,240 Page 13 Art Unit: 3785 Application/Control Number: 18/555,240 Page 14 Art Unit: 3785 Application/Control Number: 18/555,240 Page 15 Art Unit: 3785 Application/Control Number: 18/555,240 Page 16 Art Unit: 3785 Application/Control Number: 18/555,240 Page 17 Art Unit: 3785 Application/Control Number: 18/555,240 Page 18 Art Unit: 3785 Application/Control Number: 18/555,240 Page 20 Art Unit: 3785 Application/Control Number: 18/555,240 Page 22 Art Unit: 3785 Application/Control Number: 18/555,240 Page 23 Art Unit: 3785 Application/Control Number: 18/555,240 Page 24 Art Unit: 3785
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Prosecution Timeline

Oct 12, 2023
Application Filed
Apr 11, 2025
Response after Non-Final Action
Mar 21, 2026
Non-Final Rejection — §102, §103 (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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1-2
Expected OA Rounds
69%
Grant Probability
99%
With Interview (+36.7%)
3y 10m
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Low
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