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 .
Response to Amendment
This office action is responsive to the amendment filed on 12/03/2025. As directed by the amendment: claims 7, 10, and 12 have been amended, no claims have been canceled, and no new claims have been added. Thus, claims 1-20 are presently pending in the application.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required:
The “input/output device” of line 2 of claim 12 should be referenced in the specification.
New Matter
The amendment filed 12/03/2025 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: “wherein the degree of occlusion corresponds to a recovery status of the patient” in claim 10.
The specification states in [0006] that the degree of occlusion of a lumen of a breathing apparatus in real time is based on the determined amount of CO2 exhaled and oxygen required, which could correspond to a different physiological status of the patient, for example, one in which the patient isn’t progressively healing.
Applicant is required to cancel the new matter in the reply to this Office Action.
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 “input/output device” 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 § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over Allum (US 8677999 B2) in view of Kullik (DE 102008051515 B4).
Regarding claim 1, Allum discloses a breathing apparatus (FIG. 9 Airway tube adapter 81 set forth in column 12 line 57 – column 13 line 12) comprising: a lumen defining a flow path for air (FIG. 9 Inner space of airway tube adapter 81 where Gv ventilation from the gas delivery circuit 21 is delivered to the airway tube 60 as set forth in column 12 line 57 – column 13 line 12), wherein the flow path is configured to communicate fluidically with an airway of a patient (FIG. 9 Gv Ventilation from gas delivery circuit 21 is delivered to the airway tube 60 and into patient’s lungs as set forth in column 12 line 57 – column 13 line 12); and a valve (FIG. 9 Gas delivery nozzle 66 as set forth in column 12 line 57 – column 13 line 12) coupled to the lumen, and a way to obtain respiratory data from the patient (FIG. 9 Breath sensing line 80 measures the patient’s breathing pressure to track the respiratory parameters as set forth in column 12 line 57 – column 13 line 12).
Allum fails to explicitly disclose wherein the valve is a control valve coupled to the lumen, wherein the control valve automatically and selectively occludes the lumen to control a flowrate of the air passing through the lumen in real time based on respiratory data obtained from the patient.
However, Kullik teaches a control valve (Kullik: FIG. 3 Throttle body 23 is with an elastic membrane 27 as set forth on page 6 paragraph 4 – page 7 paragraph 1 of the machine translation) coupled to the lumen (Kullik: FIG. 3 Inner space of the Throttle Body 23 where the gas travels as shown in the annotated figure below), wherein the control valve automatically and selectively occludes the lumen to control a flowrate of the air passing through the lumen in real time (Kullik: FIG. 3 A volume 16 of the elastic membrane 27 and outside the flow cross-sectional area of the breathing gas is determined by means of a connecting tube 15 in connection with the gas line 10; when the gas conveyor 2 is controlled, the gas delivery device 2 can become operated at a high flow rate, so that in the gas line 10, and therefore the connecting tube 15, a high pressure is present and thus the throttle body 23 will have a small flow cross-sectional area and the pressure change or the pressure drop 12, and therefore the flowrate, caused by the throttle body is very high as set forth on page 6 paragraph 4 – page 7 paragraph 1) based on respiratory data obtained from the patient (Kullik: FIG. 3 Respiratory data including the pressure in the inspiratory gas line and pressure during the expiratory phase can be detected, and depending on the data obtained as a result of the patients inspiratory and expiratory phases, the flow rate of the gas delivery device can be controlled and/or regulated as set forth on page 6 paragraph 4 – page 7 paragraph 1; the flow rate of the gas delivery device automatically controlling the amount of occlusion performed by the throttle body 23 and membrane 27 as a result of the gas delivered via the connecting tube 15).
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Allum and Kullik are both considered to be analogous to the claimed invention because they are in the same field of respiratory apparatuses delivering gas to a patient. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Allum and replace the valve with the control valve configuration of Kullik, the control valve (Kullik: FIG. 3 Throttle body 23 is with an elastic membrane 27 as set forth on page 6 paragraph 4 – page 7 paragraph 1 of the machine translation) coupled to the lumen (Kullik: FIG. 3 Inner space of the Throttle Body 23 where the gas travels as shown in the annotated figure), wherein the control valve automatically and selectively occludes the lumen to control a flowrate of the air passing through the lumen in real time (Kullik: FIG. 3 A volume 16 of the elastic membrane 27 and outside the flow cross-sectional area of the breathing gas is determined by means of a connecting tube 15 in connection with the gas line 10; when the gas conveyor 2 is controlled, the gas delivery device 2 can become operated at a high flow rate, so that in the gas line 10, and therefore the connecting tube 15, a high pressure is present and thus the throttle body 23 will have a small flow cross-sectional area and the pressure change or the pressure drop 12, and therefore the flowrate, caused by the throttle body is very high as set forth on page 6 paragraph 4 – page 7 paragraph 1) based on respiratory data obtained from the patient (Kullik: FIG. 3 Respiratory data including the pressure in the inspiratory gas line and pressure during the expiratory phase can be detected, and depending on the data obtained as a result of the patients inspiratory and expiratory phases, the flow rate of the gas delivery device can be controlled and/or regulated as set forth on page 6 paragraph 4 – page 7 paragraph 1, the flow rate being controlled by a control unit as set forth on page 3 paragraphs 6-7; the flow rate of the gas delivery device automatically controlling the amount of occlusion performed by the throttle body 23 and membrane 27 as a result of the gas delivered via the connecting tube 15). Doing so would allow the breathing apparatus to alter flow/pressure of gas being delivered to the patient depending on the user’s respiratory status (Kullik: As set forth on page 6 paragraph 4 – page 7 paragraph 1).
Regarding claim 2, Allum as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Allum further discloses the breathing apparatus, wherein the breathing apparatus comprises a housing (FIG. 9 Outer surface of Airway tube adapter 81 as shown in the annotated figure below) with a first end (FIG. 9 First end of Airway tube adapter 81 as shown in the annotated figure below) configured to be removably engaged with a distal end of a tracheostomy tube (FIG. 9 Airway tube adapter 81 couples the gas delivery circuit 21 to the airway tube 60 as set forth in column 12 line 57 – column 13 line 12; Airway tube 60 is a trach tube as set forth in column 8 lines 34-35; FIG. 9 shows a gas delivery circuit connected to an airway tube with an open adaptor as set forth in column lines 32-33, the ability of the adapter to connect the airway tube and ventilator indicating that the airway adapter is removably attached to the trach) and a second end (FIG. 9 Second end of Airway tube adapter 81 as shown in the annotated figure below) configured to be engaged with an air conduit of a ventilator (FIG. 9 gas delivery circuit 21).
Allum fails to explicitly disclose in reference to the embodiment of FIG. 9, that the air conduit is removably engageable from the second end of the breathing apparatus.
However, Allum does teach in reference to FIG. 16 that the air conduit of a ventilator (FIG. 16 gas delivery circuit 21 as set forth in column 14 lines 18-25) can attach directly to the slot for the conduit (FIG. 16 Nozzle connection slot 89 as set forth in column 14 lines 18-25) with a removably attachable and secure connection (As set forth in as set forth in column 14 lines 18-25).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the embodiment of FIG. 9 with the teaching of Allum in the embodiment of the invention of FIG. 16, where the air conduit is removably engageable (As set forth in as set forth in column 14 lines 18-25). Doing so would provide the apparatus with a well-known feature of connection parts in the art of the claimed invention. The detachable nature of the invention allowing for easy replacement or cleaning of the separate parts.
Regarding claim 3, Allum as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Allum as modified by Kullik further teaches the breathing apparatus, wherein the control valve is an inflatable air bladder (Kullik: FIG. 3 Throttle body 23 is with an elastic membrane 27 as set forth on page 6 paragraph 4 – page 7 paragraph 1), and wherein the breathing apparatus further comprises: a pneumatic actuator (FIG. 3 Gas conveyor/Deliver device 2) configured to control air pressure delivered to the inflatable air bladder (Kullik: FIG. 3 The gas delivery device 2 can be operated at a high flow rate, so that in the gas line 10, and therefore the connecting tube 15, a high pressure is present and thus the throttle body 23 will have a small flow cross-sectional area, due to the membrane 27 being inflated with air, and the pressure change or the pressure drop 12, and therefore the decrease in flowrate, caused by the throttle body will be very high as set forth on page 6 paragraph 4 – page 7 paragraph 1).
Regarding claim 4, Allum as modified discloses the claimed invention substantially as claimed as set forth for claim 3 above.
Allum as modified by Kullik further teaches the breathing apparatus, wherein the pneumatic actuator (Kullik: FIG. 3 Gas conveyor/Deliver device 2 as set forth on page 6 paragraph 4 – page 7 paragraph 1) is coupled to an air conduit (Kullik: FIG. 3 Gas line 10 as set forth on page 6 paragraph 4 – page 7 paragraph 1) of an external air supply (Kullik: FIG. 3 The external air supply being the air initially supplied to the breathing circuit 37 to the expiratory gas line 8 as a result of the patient 7 exhaling during the expiratory breathing phase as set forth in the abstract), and wherein the pneumatic actuator controls an air coupler fitting (FIG. 3 Connecting tube 15 as set forth on page 6 paragraph 4 – page 7 paragraph 1) to control the air pressure delivered to the inflatable air bladder from the external air supply (Kullik: FIG. 3 The gas delivery device 2 can be operated at a high flow rate, so that in the gas line 10, and therefore the connecting tube 15, a high pressure is present and thus the throttle body 23 will have a small flow cross-sectional area, due to the membrane 27 being inflated with air, and the pressure change or the pressure drop 12, and therefore the decrease in flowrate, caused by the throttle body will be very high as set forth on page 6 paragraph 4 – page 7 paragraph 1).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Allum (US 8677999 B2) in view of Kullik (DE 102008051515 B4) as applied to claim 1, in further view of Yarnall (US 5771884 A).
Regarding claim 5, Allum as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Allum as modified fails to explicitly disclose the breathing apparatus, wherein the control valve is an electromechanical valve.
However, Yarnall teaches wherein the control valve is an electromechanical valve (Yarnall: FIG. 1 Valve 10 as set forth in column 1 lines 29 – 41 and column 4 lines 28 – 32).
Allum and Yarnall are both considered to be analogous to the claimed invention because they are in the same field of patient ventilators having a patient airway for breathing gas. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Allum to incorporate the teaching of Yarnall and make the control valve an electromechanical valve. (Yarnall: FIG. 1 Valve 10 as set forth in column 1 lines 29 – 41 and column 4 lines 28 – 32). Doing so provides a well-known type of valve in the art of the claimed invention, the valve providing control of back-pressure in a patient airway that is ideally proportional to current supplied by a control mechanism to the exhalation valve (Yarnall: As set forth in column 1 lines 29 – 41; the control of pressure inherently controlling the rate of gas flow).
Additionally, the control valve element of modified Allum and the control valve of Yarnall perform the identical function specified in the claim in substantially the same way, and produces substantially the same results as the corresponding element disclosed in the specification. See in Kemco Sales, Inc. v. Control Papers Co., 208 F.3d 1352, 1364, 54 USPQ2d 1308, 1315 (Fed. Cir. 2000) and Odetics Inc. v. Storage Tech. Corp., 185 F.3d 1259, 1267, 51 USPQ2d 1225, 1229-30 (Fed. Cir. 1999); Lockheed Aircraft Corp. v. United States, 193 USPQ 449, 461 (Ct. Cl. 1977), see also MPEP § 2183. The concepts of equivalents as set forth in Graver Tank & Mfg. Co. v. Linde Air Products, 339 U.S. 605, 85 USPQ 328 (1950) are relevant to any "equivalents" determination. The control valve element of modified Allum, the control valve of Yarnall, and the element claimed by Applicant are configured to control the rate of gas flow by occluding the lumen. Additionally, A person of ordinary skill in the art would have recognized the interchangeability of the element shown in the prior art for the corresponding element disclosed in the specification. Both would result in the same completion of the same function, Controlling the rate of gas flow. See in Caterpillar Inc. v. Deere & Co., 224 F.3d 1374, 56 USPQ2d 1305 (Fed. Cir. 2000); Al-Site Corp. v. VSI Int’ l, Inc., 174 F.3d 1308, 1316, 50 USPQ2d 1161, 1165 (Fed. Cir. 1999).
Therefore, it would have been prima facie obvious to modify Allum as modified with Yarnall to obtain the invention as specified in claim 5 because such a modification is considered to be well within the skill level of the ordinary artisan since they are equivalents and thus fails to patentably distinguish over the prior art of Allum as modified.
Claims 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Allum (US 8677999 B2) in view of Kullik (DE 102008051515 B4) as applied to claim 1, in further view of Lain (US 20120145152 A1).
Regarding claim 6, Allum as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Allum as modified further discloses the breathing apparatus, wherein the breathing apparatus further comprises: a sensor configured to capture the respiratory data from the patient, wherein the respiratory data is the patient’s breathing pressure (FIG. 9 Breath sensing line 80 measures the patient’s breathing pressure to track the respiratory parameters as set forth in column 12 line 57 – column 13 line 12).
Allum fails to explicitly disclose wherein the breathing apparatus further comprises: a set of sensors configured to capture the respiratory data from the patient, wherein the respiratory data is one of end tidal CO2 (ETC02), respiratory rate, pulse oximetry (sPO2), and heart rate.
However, Lain teaches a set of sensors (Lain: FIG. 8 Sensors 502A-D as set forth in [0102] and [0181]) configured to capture the respiratory data from the patient, wherein the respiratory data is one of end tidal CO2 (ETC02), respiratory rate, pulse oximetry (sPO2), and heart rate (Lain: Values measured are the respiratory rate, end tidal carbon dioxide (etCO2), saturation of pulse oxygen (SpO2) heart rate (HR) taken from the pulse as set forth in [0102]).
Allum and Lain are both considered to be analogous to the claimed invention because they are in the same field of systems comprising ventilators to deliver a controlled breathing gas. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Allum to incorporate the teaching of Lain and include a set of sensors (Lain: FIG. 8 Sensors 502A-D as set forth in [0102] and [0181]) configured to capture the respiratory data from the patient, wherein the respiratory data is one of end tidal CO2 (ETC02), respiratory rate, pulse oximetry (sPO2), and heart rate (Lain: Values measured are the respiratory rate, end tidal carbon dioxide (etCO2), saturation of pulse oxygen (SpO2) heart rate (HR) taken from the pulse as set forth in [0102]). Doing so would enable the apparatus to obtain a comprehensive set of data representing the respiratory condition of the user die to various sensors, allowing the device to be controlled according to the state of the patient (Lain: Measured patient parameters are used by a controller to compute an Integrated Pulmonary Index (IPI) value based on the two or more measured patient parameters and to provide a signal to the ventilation device, based on the computed IPI value, wherein said signal adjusts one or more parameters of the said ventilation device as set forth in the abstract).
Regarding claim 7, Allum as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Allum as modified fails to explicitly disclose the breathing apparatus, wherein the breathing apparatus further comprises a communications interface configured to communicate data between the breathing apparatus and an external device.
However, Lain teaches wherein the system further comprises a communications interface (Lain: FIG. 7 The connection between the processing logic and the sensors may include any type of communication route, such as, for example, use of wires, cables, wireless, and the like as set forth in [0180]) configured to communicate data between the sensors (Lain: FIG. 7 Sensors 402A-D as set forth in [0180]) and an external device (Lain: FIG. 7 Display 406 that may be used to present the data collected and determined/calculated/computed by the processing logic as set forth in [0180]).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Allum to incorporate the teaching of Lain and include a communications interface (Lain: FIG. 7 The connection between the processing logic and the sensors may include any type of communication route, such as, for example, use of wires, cables, wireless, and the like as set forth in [0180]) configured to communicate data between the sensors (Lain: FIG. 7 Sensors 402A-D as set forth in [0180]) and an external device (Lain: FIG. 7 Display 406 that may be used to present the data collected and determined/calculated/computed by the processing logic and controller as set forth in [0180] and the abstract), in the case of Allum, between the breathing apparatus (which comprises a sensor) and an external device. Doing so would allow for monitoring and presenting of the patient’s respiratory parameters collected/computed (Lain: As set forth in [0180]). The communication interface allowing for the transmittance of a control signal to adjust parameters of the device (Lain: As set forth in the abstract).
Regarding claim 8, Allum as modified discloses the claimed invention substantially as claimed as set forth for claim 7 above.
Allum as modified by Lain further teaches the breathing apparatus, wherein the communications interface is configured to transmit the respiratory data to the external device (Lain: FIG. 7 Medical monitoring system 400 may further include a processing logic 404, that may be used to receive information from at least one of the sensors and to determine a condition-index value, an IPI, that is directly related to a condition of the patient, the processing logic may include any type of hardware and/or software, such as, for example, a processor, and the connection between the processing logic and the sensor(s) may include any type of communication route, such as, for example, use of wires, cables, wireless, and the like. The medical monitoring system may further include a display 406 that may be used to present the data collected and determined/calculated/computed by the processing logic as set forth in [0180]), and wherein the communications interface is configured to receive control data from the external device (Lain: The Integrated Pulmonary Index (IPI) value based on the two or more measured patient parameters and to provide a signal to the ventilation device, based on the computed IPI value, wherein said signal adjusts the device parameters as set forth in the abstract) to override the automatic control of the breathing apparatus (The “automatic control” of the breathing apparatus being the initial ventilation being provided to the user before any adjustments are made, the adjustments set forth in the abstract and in more detail in [0009]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Allum (US 8677999 B2) in view of Kullik (DE 102008051515 B4) and Lain (US 20120145152 A1) as applied to claim 8, in further view of Falk (US 20170347917 A1).
Regarding claim 9, Allum as modified discloses the claimed invention substantially as claimed as set forth for claim 8 above.
Allum as modified fails to explicitly disclose the breathing apparatus, wherein the communications interface is configured to transmit the respiratory data to an electronic medical records database.
However, Falk teaches a communications interface is configured to transmit the respiratory data to an electronic medical records database Falk: FIG. 2 Respiratory information 96 may be transmitted to a host network 76 where the patient's medical record in database 78 can be accessed as set forth in [0034]).
Allum and Falk are both considered to be analogous to the claimed invention because they are in the same field of systems comprising ventilators to deliver a controlled breathing gas. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Allum to incorporate the teaching of Falk and include a communications interface is configured to transmit the respiratory data to an electronic medical records database (Falk: FIG. 2 Respiratory information 96 may be transmitted to a host network 76 where the patient's medical record in database 78 can be accessed as set forth in [0034]). Doing so would allow the respiratory parameters measured by the device in relation to the patient to be stored (Falk: As set forth in [0034]).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Allum (US 8677999 B2) in view of Kullik (DE 102008051515 B4) as applied to claim 1, in further view of McCormick (US 20190344032 A1).
Regarding claim 10, Allum as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
While Allum as modified by Kullik further teaches a control unit for controlling the flow rate of the pneumatic actuator, and therefore the occlusion of the lumen of the control valve to control a flowrate of the air passing through the lumen in real time based on the respiratory data (Kullik: FIG. 3 The flow rate being controlled by a control unit as set forth on page 3 paragraphs 6-7; the flow rate of the gas delivery device automatically controlling the amount of occlusion performed by the throttle body 23 and membrane 27 as a result of the gas delivered via the connecting tube 15; Respiratory data including the pressure in the inspiratory gas line and pressure during the expiratory phase can be detected, and depending on the data obtained as a result of the patients inspiratory and expiratory phases, the flow rate of the gas delivery device can be controlled and/or regulated as set forth on page 6 paragraph 4 – page 7 paragraph 1) wherein the degree of occlusion corresponds to a recovery status of the patient (Kullik: FIG. 3 Respiratory data including the pressure in the inspiratory gas line and pressure during the expiratory phase can be detected, and depending on the data obtained as a result of the patients inspiratory and expiratory phases, the flow rate of the gas delivery device can be controlled and/or regulated as set forth on page 6 paragraph 4 – page 7 paragraph 1; the flow rate of the gas delivery device automatically controlling the amount of occlusion performed by the throttle body 23 and membrane 27 as a result of the gas delivered via the connecting tube 15; wherein the respiratory data is a clear metric representing the recovery status of the patient), Allum is silent as to the presence of memory storing instructions and a microprocessor configured to execute the instructions.
However, McCormick teaches the control unit having a memory storing instructions and a microprocessor configured to execute the instructions (McCormick: FIG. 2 CPU 74 includes a microprocessor unit, input/output ports, and an electronic storage medium for executable programs and calibration values where the CPU is programmed with computer readable data representing instruction executable to perform the methods described as set forth in [0021]).
Allum and McCormick are both considered to be analogous to the claimed invention because they are in the same field of systems comprising ventilators to deliver a controlled breathing gas. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Allum to incorporate the teaching of McCormick and include a memory storing instructions and a microprocessor configured to execute the instructions (McCormick: FIG. 2 CPU 74 includes a microprocessor unit, input/output ports, and an electronic storage medium for executable programs and calibration values where the CPU is programmed with computer readable data representing instruction executable to perform the methods described as set forth in [0021]). Doing so provides well-known control unit elements in the art of the claimed invention necessary for executing a control function (McCormick: Set forth in [0021]).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Allum (US 8677999 B2) in view of Kullik (DE 102008051515 B4) as applied to claim 1, in further view of Amurthur (US 8591430 B2).
Regarding claim 11, Allum as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Allum as modified fails to explicitly disclose the breathing apparatus, further comprising: a set of alarms configured to notify a healthcare provider of emergent conditions of the patient based on the respiratory data.
However, Amurthur teaches a set of alarms configured to notify a healthcare provider of emergent conditions of the patient based on the respiratory data (Amurthur: The system can continuously monitor physiologic variables and issue patient and/or physician alerts when appropriate as set forth in column 6 lines 3-5 and line 46-49).
Allum and Amurthur are both considered to be analogous to the claimed invention because they are in the same field of respiratory monitoring systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Allum to incorporate the teaching of Amurthur and include a set of alarms configured to notify a healthcare provider of emergent conditions of the patient based on the respiratory data (Amurthur: The system can continuously monitor physiologic variables and issue patient and/or physician alerts when appropriate as set forth in column 6 lines 3-5 and line 46-49). Doing so would improve patient safety by enabling the device to alert a clinician of an emergent condition based on the collected data to ensure the user is provided proper treatment intervention when required (Amurthur: As set forth in column 6 lines 3-5 and 46-49).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Allum (US 8677999 B2) in view of Kullik (DE 102008051515 B4) as applied to claim 1, in further view of Hanson (US 4877025 A).
Regarding claim 12, Allum as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Allum as modified fails to explicitly disclose the breathing apparatus, further comprising: an input/output device that allows a clinician to manually adjust a degree of occlusion of the lumen in real time based on a patient's needs.
However, Hanson teaches an input/output device (Hanson: FIG. 2 Squeeze ball 27 as set forth in column 3 line 18) that allows a clinician to manually adjust a degree of occlusion of the lumen in real time based (Hanson: FIG. 2 and 4 Manually squeezable ball 27 is in fluid communication with the chamber for controlling the inflation and deflation of the chamber 19 as set forth in column 1 lines 40-47 and column 3 lines 14-20) on a patient's needs (Hanson: The valve capable of selectively blocking fluid flow through a tracheostomy stoma for when a person needs to speak as set forth in column 1 lines 49-52).
Allum and Hanson are both considered to be analogous to the claimed invention because they are in the same field of tracheostomy devices allow gas to be delivered to the patient. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Allum to incorporate the teaching of Hanson and include an input/output device (Hanson: FIG. 2 Squeeze ball 27 as set forth in column 3 line 18), to the control valve of Allum as modified by Kullik, that allows a clinician to manually adjust a degree of occlusion of the lumen in real time based (Hanson: FIG. 2 and 4 Manually squeezable ball 27 is in fluid communication with the chamber for controlling the inflation and deflation of the chamber 19 as set forth in column 1 lines 40-47 and column 3 lines 14-20) on a patient's needs (Hanson: The valve capable of selectively blocking fluid flow through a tracheostomy stoma for when a person needs to speak as set forth in column 1 lines 49-52). Doing so would allow for manual control of the control valve (Hanson: As set forth in column 1 lines 40-47) given the failure of automatic control of the valve to address the patient’s needs. It would allow for the manual control of the valve given a patient’s needs, for example, the ability to speak (Hanson: As set forth in column 1 lines 49-52).
Claims 13 and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Allum (US 8677999 B2) in view of Kullik (DE 102008051515 B4) and Som (US 20190131009 A1).
Regarding claim 13, Allum discloses a method for controlling breathing (Methods for providing mechanical ventilation support of a patient as set forth in the abstract), the method comprising: determining, based on respiratory data of a patient, ventilation required by the patient (The system includes sensors to measure the amount of air entrainment, and a control unit to adjust and regulating the amount of entrainment as set forth in column 5 lines 5-7; FIG. 9 Sensing line 80 is to measure the breathing pressure of the patient, to synchronize the ventilator functions to the patient's breathing and to track the respiratory parameters of the patient as set forth in column 12 line 64 – column 13 line 1); and automatically controlling the gas delivered through a lumen of a breathing apparatus (FIG. 9 Inner space of airway tube adapter 81 where Gv ventilation from the gas delivery circuit 21 is delivered to the airway tube 60 as set forth in column 12 line 57 – column 13 line 12) through a valve housed within the breathing apparatus (FIG. 9 Gas delivery nozzle 66 as set forth in column 12 line 57 – column 13 line 12) in real time based on the determined respiratory data (As set forth in column 12 line 64 – column 13 line 1).
Allum fails to explicitly disclose that the method comprises automatically controlling a degree of occlusion of a lumen of a breathing apparatus in real time by manipulating a control valve housed within the breathing apparatus based on the determined ventilation required by the patient.
However, Kullik teaches a method that comprises automatically controlling a degree of occlusion of a lumen (Kullik: FIG. 3 Inner space of the Throttle Body 23 where the gas travels as shown in the annotated figure below) of a breathing apparatus in real time (Kullik: FIG. 3 A volume 16 of the elastic membrane 27 and outside the flow cross-sectional area of the breathing gas is determined by means of a connecting tube 15 in connection with the gas line 10; when the gas conveyor 2 is controlled, the gas delivery device 2 can become operated at a high flow rate, so that in the gas line 10, and therefore the connecting tube 15, a high pressure is present and thus the throttle body 23 will have a small flow cross-sectional area and the pressure change or the pressure drop 12, and therefore the flowrate, caused by the throttle body is very high as set forth on page 6 paragraph 4 – page 7 paragraph 1) by manipulating a control valve (Kullik: FIG. 3 Throttle body 23 is with an elastic membrane 27 as set forth on page 6 paragraph 4 – page 7 paragraph 1 of the machine translation) based on the determined ventilation required by the patient (Kullik: FIG. 3 Respiratory data including the pressure in the inspiratory gas line and pressure during the expiratory phase can be detected, and depending on the data obtained as a result of the patients inspiratory and expiratory phases, the flow rate of the gas delivery device can be controlled and/or regulated as set forth on page 6 paragraph 4 – page 7 paragraph 1; the flow rate of the gas delivery device automatically controlling the amount of occlusion performed by the throttle body 23 and membrane 27 as a result of the gas delivered via the connecting tube 15).
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It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Allum and replace the valve with the control valve configuration of Kullik in order to perform the method that comprises automatically controlling a degree of occlusion of a lumen (Kullik: FIG. 3 Inner space of the Throttle Body 23 where the gas travels as shown in the annotated figure) of a breathing apparatus in real time (Kullik: FIG. 3 A volume 16 of the elastic membrane 27 and outside the flow cross-sectional area of the breathing gas is determined by means of a connecting tube 15 in connection with the gas line 10; when the gas conveyor 2 is controlled, the gas delivery device 2 can become operated at a high flow rate, so that in the gas line 10, and therefore the connecting tube 15, a high pressure is present and thus the throttle body 23 will have a small flow cross-sectional area and the pressure change or the pressure drop 12, and therefore the flowrate, caused by the throttle body is very high as set forth on page 6 paragraph 4 – page 7 paragraph 1) by manipulating a control valve (Kullik: FIG. 3 Throttle body 23 is with an elastic membrane 27 as set forth on page 6 paragraph 4 – page 7 paragraph 1 of the machine translation) based on the determined ventilation required by the patient (Kullik: FIG. 3 Respiratory data including the pressure in the inspiratory gas line and pressure during the expiratory phase can be detected, and depending on the data obtained as a result of the patients inspiratory and expiratory phases, the flow rate of the gas delivery device can be controlled and/or regulated as set forth on page 6 paragraph 4 – page 7 paragraph 1; the flow rate of the gas delivery device automatically controlling the amount of occlusion performed by the throttle body 23 and membrane 27 as a result of the gas delivered via the connecting tube 15). Doing so would allow the breathing apparatus to alter flow/pressure of gas being delivered to the patient depending on the user’s respiratory status (Kullik: As set forth on page 6 paragraph 4 – page 7 paragraph 1).
Allum as modified fails to explicitly disclose that a condition of the ventilation required by the patient is a desired amount of oxygen.
However, Som teaches a sensor able to determine oxygen levels of the patient (FIG. 3 Pulse oximeter 312 as set forth in [0052]) and where a condition of the ventilation required by the patient is a desired amount of oxygen (Som: FIG. 3 and 4 The oxygen saturation level in patient 310 measured by pulse oximeter 312 is above or below a threshold, the PID controller 316 instructs delivery module 306 to continue the oxygen supply at a determined rate; The adjustment of oxygen flow rate may be accomplished, as shown in step 430, by changing the settings or position of control valve 322 as set forth in [0052]).
Allum and Som are both considered to be analogous to the claimed invention because they are in the same field of devices controlling gas delivered to a patient. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Allum to incorporate the teaching of Som and include a sensor able to determine oxygen levels of the patient (FIG. 3 Pulse oximeter 312 as set forth in [0052]) and include wherein the respiratory data of a patient used to determine the flow rate of gas delivered via the control valve is an amount of oxygen required by the patient (Som: FIG. 3 and 4 The oxygen saturation level in patient 310 measured by pulse oximeter 312 is above or below a threshold, the PID controller 316 instructs delivery module 306 to continue the oxygen supply at a determined rate; The adjustment of oxygen flow rate may be accomplished, as shown in step 430, by changing the settings or position of control valve 322 as set forth in [0052]). Doing so provides a way to utilize a well-known respiratory parameter in the art, in order to determine a required gas flow to be delivered to the patient (Som: As set forth in [0005], [0014], and [0052]).
Regarding claim 15, Allum as modified discloses the claimed invention substantially as claimed as set forth for claim 13 above.
Allum as modified further discloses the method, wherein automatically controlling the degree of occlusion of the lumen (Kullik: FIG. 3 The flow rate being controlled by a control unit as set forth on page 3 paragraphs 6-7; the flow rate of the gas delivery device automatically controlling the amount of occlusion performed by the throttle body 23 and membrane 27 as a result of the gas delivered via the connecting tube 15; Respiratory data including the pressure in the inspiratory gas line and pressure during the expiratory phase can be detected, and depending on the data obtained as a result of the patients inspiratory and expiratory phases, the flow rate of the gas delivery device can be controlled and/or regulated as set forth on page 6 paragraph 4 – page 7 paragraph 1) further comprises: generating a control signal (The presence and generation of a control signal is an inherent and necessary part of the communication between the control unit and the gas conveyor/delivery device 2) for controlling a pneumatic actuator (FIG. 3 Gas conveyor/Deliver device 2) configured to control air pressure delivered to an inflatable air bladder of the control valve (Kullik: FIG. 3 The gas delivery device 2 can be operated at a high flow rate, so that in the gas line 10, and therefore the connecting tube 15, a high pressure is present and thus the throttle body 23 will have a small flow cross-sectional area, due to the membrane 27 being inflated with air, and the pressure change or the pressure drop 12, and therefore the decrease in flowrate, caused by the throttle body will be very high as set forth on page 6 paragraph 4 – page 7 paragraph 1).
Regarding claim 16, Allum as modified discloses the claimed invention substantially as claimed as set forth for claim 15 above.
Allum as modified further discloses the method, wherein the pneumatic actuator (Kullik: FIG. 3 Gas conveyor/Deliver device 2 as set forth on page 6 paragraph 4 – page 7 paragraph 1) controls an air coupler fitting (FIG. 3 Connecting tube 15 as set forth on page 6 paragraph 4 – page 7 paragraph 1; FIG. 3 The gas delivery device 2 can be operated at a high flow rate, so that in the gas line 10, and therefore the connecting tube 15, a high pressure is present and thus the throttle body 23 will have a small flow cross-sectional area, due to the membrane 27 being inflated with air, and the pressure change or the pressure drop 12, and therefore the decrease in flowrate, caused by the throttle body will be very high as set forth on page 6 paragraph 4 – page 7 paragraph 1) connected to an external air supply, and wherein the air pressure delivered to the inflatable air bladder originates from the external air supply (Kullik: FIG. 3 The external air supply being the air initially supplied to the breathing circuit 37 to the expiratory gas line 8 as a result of the patient 7 exhaling during the expiratory breathing phase as set forth in the abstract).
Claims 14 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Allum (US 8677999 B2) in view of Kullik (DE 102008051515 B4) and Som (US 20190131009 A1) as applied to claim 13, in further view of Lain (US 20120145152 A1).
Regarding claim 14, Allum as modified discloses the claimed invention substantially as claimed as set forth for claim 13 above.
Allum as modified by Som further teaches the method, wherein determining the amount of oxygen required by the patient further comprises receiving the respiratory data captured by a sensor (Som: FIG. 3 and 4 The oxygen saturation level in patient 310 measured by pulse oximeter 312 is above or below a threshold, the PID controller 316 instructs delivery module 306 to continue the oxygen supply at a determined rate).
Fails to explicitly disclose a set of sensors.
However, Lain teaches a set of sensors (Lain: FIG. 8 Sensors 502A-D, the values measured are the respiratory rate, end tidal carbon dioxide (etCO2), saturation of pulse oxygen (SpO2) heart rate (HR) taken from the pulse as set forth in [0102] and [0181]).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Allum to incorporate the teaching of Lain and include a set of sensors (Lain: FIG. 8 Sensors 502A-D, the values measured are the respiratory rate, end tidal carbon dioxide (etCO2), saturation of pulse oxygen (SpO2) heart rate (HR) taken from the pulse as set forth in [0102] and [0181]). Doing so would enable the apparatus to obtain a comprehensive set of data representing the respiratory condition of the user die to various sensors, allowing the device to be controlled according to the state of the patient (Lain: Measured patient parameters are used by a controller to compute an Integrated Pulmonary Index (IPI) value based on the two or more measured patient parameters and to provide a signal to the ventilation device, based on the computed IPI value, wherein said signal adjusts one or more parameters of the said ventilation device as set forth in the abstract).
Regarding claim 18, Allum as modified discloses the claimed invention substantially as claimed as set forth for claim 13 above.
Allum as modified fails to explicitly disclose the method, further comprising: receiving control data from an external device to override the automatic control of the breathing apparatus.
However, Lain teaches a method further comprising: receiving control data from an external device (Lain: FIG. 7 Display 406 that may be used to present the data collected and determined/calculated/computed by the processing logic and controller as set forth in [0180] and the abstract; The Integrated Pulmonary Index (IPI) value based on the two or more measured patient parameters and to provide a signal to the ventilation device, based on the computed IPI value, wherein said signal adjusts the device parameters as set forth in the abstract) to override the automatic control of the breathing apparatus (The “automatic control” of the breathing apparatus being the initial ventilation being provided to the user before any adjustments are made, the adjustments set forth in the abstract and in more detail in [0009]).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Allum to incorporate the teaching of Lain and include wherein the method further comprises receiving control data from an external device (Lain: FIG. 7 Display 406 that may be used to present the data collected and determined/calculated/computed by the processing logic and controller as set forth in [0180] and the abstract; The Integrated Pulmonary Index (IPI) value based on the two or more measured patient parameters and to provide a signal to the ventilation device, based on the computed IPI value, wherein said signal adjusts the device parameters as set forth in the abstract) to override the automatic control of the breathing apparatus (The “automatic control” of the breathing apparatus being the initial ventilation being provided to the user before any adjustments are made, the adjustments set forth in the abstract and in more detail in [0009]). Doing so would allow for monitoring and presenting of the patient’s respiratory parameters collected/computed (Lain: As set forth in [0180]). The communication interface allowing for the transmittance of a control signal to adjust parameters of the device (Lain: As set forth in the abstract).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Allum (US 8677999 B2) in view of Kullik (DE 102008051515 B4) and Som (US 20190131009 A1) as applied to claim 13, in further view of Yarnall (US 5771884 A).
Regarding claim 17, Allum as modified discloses the claimed invention substantially as claimed as set forth for claim 13 above.
Allum as modified fails to explicitly disclose the method, wherein the control valve is an electro-mechanical valve and wherein automatically controlling the degree of occlusion of the lumen further comprises: generating a control signal for controlling operation of the electro-mechanical valve.
However, Yarnall teaches wherein the control valve is an electro-mechanical valve (Yarnall: FIG. 1 Valve 10 as set forth in column 1 lines 29 – 41 and column 4 lines 28 – 32) and wherein automatically controlling the degree of occlusion of the lumen (FIG. 2 A valve poppet 26 is positioned adjacent to the diaphragm for physically contacting the diaphragm 44 to regulate the rate of flow through the valve as set forth in column 1 lines 64-66, column 4 lines 40-43, and column 5 lines 3-9; the space determined by the position of the valve poppet being the occlusion of the lumen) further comprises: generating a control signal for controlling operation of the electro-mechanical valve (FIG. 3 Control mechanism preferably includes a microprocessor based computer control unit 77 that receives input signals , the control mechanism adjusts the current supplied to the main electromagnetic coil of the control valve, indicating the presence and need for a control signal sent from the control mechanism as set forth in column 3).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Allum to incorporate the teaching of Yarnall wherein the control valve is an electro-mechanical valve (Yarnall: FIG. 1 Valve 10 as set forth in column 1 lines 29 – 41 and column 4 lines 28 – 32) and wherein automatically controlling the degree of occlusion of the lumen (FIG. 2 A valve poppet 26 is positioned adjacent to the diaphragm for physically contacting the diaphragm 44 to regulate the rate of flow through the valve as set forth in column 1 lines 64-66, column 4 lines 40-43, and column 5 lines 3-9; the space determined by the position of the valve poppet being the occlusion of the lumen) further comprises: generating a control signal for controlling operation of the electro-mechanical valve (FIG. 3 Control mechanism preferably includes a microprocessor based computer control unit 77 that receives input signals , the control mechanism adjusts the current supplied to the main electromagnetic coil of the control valve, indicating the presence and need for a control signal sent from the control mechanism as set forth in column 3). Doing so provides a well-known type of valve in the art of the claimed invention, the valve providing control of back-pressure in a patient airway that is ideally proportional to current supplied by a control mechanism to the exhalation valve (Yarnall: As set forth in column 1 lines 29 – 41; the control of pressure inherently controlling the rate of gas flow).
Additionally, the control valve element of modified Allum and the control valve of Yarnall perform the identical function specified in the claim in substantially the same way, and produces substantially the same results as the corresponding element disclosed in the specification. See in Kemco Sales, Inc. v. Control Papers Co., 208 F.3d 1352, 1364, 54 USPQ2d 1308, 1315 (Fed. Cir. 2000) and Odetics Inc. v. Storage Tech. Corp., 185 F.3d 1259, 1267, 51 USPQ2d 1225, 1229-30 (Fed. Cir. 1999); Lockheed Aircraft Corp. v. United States, 193 USPQ 449, 461 (Ct. Cl. 1977), see also MPEP § 2183. The concepts of equivalents as set forth in Graver Tank & Mfg. Co. v. Linde Air Products, 339 U.S. 605, 85 USPQ 328 (1950) are relevant to any "equivalents" determination. The control valve element of modified Allum, the control vale of Yarnall, and the element claimed by Applicant are configured to control the rate of gas flow by occluding the lumen. Additionally, A person of ordinary skill in the art would have recognized the interchangeability of the element shown in the prior art for the corresponding element disclosed in the specification. Both would result in the same completion of the same function, Controlling the rate of gas flow. See in Caterpillar Inc. v. Deere & Co., 224 F.3d 1374, 56 USPQ2d 1305 (Fed. Cir. 2000); Al-Site Corp. v. VSI Int’ l, Inc., 174 F.3d 1308, 1316, 50 USPQ2d 1161, 1165 (Fed. Cir. 1999).
Therefore, it would have been prima facie obvious to modify Allum as modified with Yarnall to obtain the invention as specified in claim 17 because such a modification is considered to be well within the skill level of the ordinary artisan since they are equivalents and thus fails to patentably distinguish over the prior art of Allum as modified.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Allum (US 8677999 B2) in view of Kullik (DE 102008051515 B4) and Som (US 20190131009 A1) as applied to claim 13, in further view of Amurthur (US 8591430 B2).
Regarding claim 19, Allum as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Allum as modified fails to explicitly disclose the method, further comprising: triggering an alarm to notify a healthcare provider of emergent conditions of the patient based on the respiratory data.
However, Amurthur teaches a method, further comprising: triggering an alarm to notify a healthcare provider of emergent conditions of the patient based on the respiratory data (Amurthur: The system can continuously monitor physiologic variables and issue patient and/or physician alerts when appropriate as set forth in column 6 lines 3-5 and line 46-49).
Allum and Amurthur are both considered to be analogous to the claimed invention because they are in the same field of respiratory monitoring systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Allum to incorporate the teaching of Amurthur and include wherein the method further comprises triggering an alarm to notify a healthcare provider of emergent conditions of the patient based on the respiratory data (Amurthur: The system can continuously monitor physiologic variables and issue patient and/or physician alerts when appropriate as set forth in column 6 lines 3-5 and line 46-49). Doing so would improve patient safety by enabling the device to alert a clinician of an emergent condition based on the collected data to ensure the user is provided proper treatment intervention when required (Amurthur: As set forth in column 6 lines 3-5 and 46-49).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Allum (US 8677999 B2) in view of Kullik (DE 102008051515 B4), Lain (US 20120145152 A1), and Som (US 20190131009 A1).
Regarding claim 20, Allum discloses a system comprising: a breathing apparatus (FIG. 9 Airway tube adapter 81 set forth in column 12 line 57 – column 13 line 12) including: a lumen defining a flow path for air (FIG. 9 Inner space of airway tube adapter 81 where Gv ventilation from the gas delivery circuit 21 is delivered to the airway tube 60 as set forth in column 12 line 57 – column 13 line 12), wherein the flow path is configured to communicate fluidically with an airway of a patient (FIG. 9 Gv Ventilation from gas delivery circuit 21 is delivered to the airway tube 60 and into patient’s lungs as set forth in column 12 line 57 – column 13 line 12); and a valve (FIG. 9 Gas delivery nozzle 66 as set forth in column 12 line 57 – column 13 line 12) coupled to the lumen, and a sensor configured to capture the respiratory data from the patient (FIG. 9 Breath sensing line 80 measures the patient’s breathing pressure to track the respiratory parameters as set forth in column 12 line 57 – column 13 line 12).
Allum fails to explicitly disclose wherein the valve is a control valve coupled to the lumen, wherein the control valve automatically and selectively occludes the lumen to control a flowrate of the air passing through the lumen in real time based on respiratory data obtained from the patient.
However, Kullik teaches a control valve (Kullik: FIG. 3 Throttle body 23 is with an elastic membrane 27 as set forth on page 6 paragraph 4 – page 7 paragraph 1 of the machine translation) coupled to the lumen (Kullik: FIG. 3 Inner space of the Throttle Body 23 where the gas travels as shown in the annotated figure below), wherein the control valve automatically and selectively occludes the lumen to control a flowrate of the air passing through the lumen in real time (Kullik: FIG. 3 A volume 16 of the elastic membrane 27 and outside the flow cross-sectional area of the breathing gas is determined by means of a connecting tube 15 in connection with the gas line 10; when the gas conveyor 2 is controlled, the gas delivery device 2 can become operated at a high flow rate, so that in the gas line 10, and therefore the connecting tube 15, a high pressure is present and thus the throttle body 23 will have a small flow cross-sectional area and the pressure change or the pressure drop 12, and therefore the flowrate, caused by the throttle body is very high as set forth on page 6 paragraph 4 – page 7 paragraph 1) based on respiratory data obtained from the patient (Kullik: FIG. 3 Respiratory data including the pressure in the inspiratory gas line and pressure during the expiratory phase can be detected, and depending on the data obtained as a result of the patients inspiratory and expiratory phases, the flow rate of the gas delivery device can be controlled and/or regulated as set forth on page 6 paragraph 4 – page 7 paragraph 1; the flow rate of the gas delivery device automatically controlling the amount of occlusion performed by the throttle body 23 and membrane 27 as a result of the gas delivered via the connecting tube 15).
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Allum and Kullik are both considered to be analogous to the claimed invention because they are in the same field of respiratory apparatuses delivering gas to a patient. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Allum and replace the valve with the control valve configuration of Kullik, the control valve (Kullik: FIG. 3 Throttle body 23 is with an elastic membrane 27 as set forth on page 6 paragraph 4 – page 7 paragraph 1 of the machine translation) coupled to the lumen (Kullik: FIG. 3 Inner space of the Throttle Body 23 where the gas travels as shown in the annotated figure), wherein the control valve automatically and selectively occludes the lumen to control a flowrate of the air passing through the lumen in real time (Kullik: FIG. 3 A volume 16 of the elastic membrane 27 and outside the flow cross-sectional area of the breathing gas is determined by means of a connecting tube 15 in connection with the gas line 10; when the gas conveyor 2 is controlled, the gas delivery device 2 can become operated at a high flow rate, so that in the gas line 10, and therefore the connecting tube 15, a high pressure is present and thus the throttle body 23 will have a small flow cross-sectional area and the pressure change or the pressure drop 12, and therefore the flowrate, caused by the throttle body is very high as set forth on page 6 paragraph 4 – page 7 paragraph 1) based on respiratory data obtained from the patient (Kullik: FIG. 3 Respiratory data including the pressure in the inspiratory gas line and pressure during the expiratory phase can be detected, and depending on the data obtained as a result of the patients inspiratory and expiratory phases, the flow rate of the gas delivery device can be controlled and/or regulated as set forth on page 6 paragraph 4 – page 7 paragraph 1, the flow rate being controlled by a control unit as set forth on page 3 paragraphs 6-7; the flow rate of the gas delivery device automatically controlling the amount of occlusion performed by the throttle body 23 and membrane 27 as a result of the gas delivered via the connecting tube 15). Doing so would allow the breathing apparatus to alter flow/pressure of gas being delivered to the patient depending on the user’s respiratory status (Kullik: As set forth on page 6 paragraph 4 – page 7 paragraph 1).
Allum as modified fails to explicitly disclose a set of sensors and a processor communicatively coupled to the set of sensors, wherein the processor determines an amount of oxygen received by the patient through the lumen based on the respiratory data, wherein the processor generates control signals for controlling the device.
However, Lain teaches a set of sensors (Lain: FIG. 8 Sensors 502A-D as set forth in [0102] and [0181]) and a processor (The processing logic may include any type of hardware and/or software, such as, for example, a processor) communicatively coupled to the set of sensors (Lain: FIG. 7 The connection between the processing logic and the sensors may include any type of communication route, such as, for example, use of wires, cables, wireless, and the like as set forth in [0180]), wherein the processor determines an amount of oxygen received by the patient based on the respiratory data (Lain: Values measured are the respiratory rate, end tidal carbon dioxide (etCO2), saturation of pulse oxygen (SpO2) heart rate (HR) taken from the pulse as set forth in [0102]) wherein the processor generates control signals for controlling the device (Lain: Measured patient parameters are used by a controller to compute an Integrated Pulmonary Index (IPI) value based on the two or more measured patient parameters and to provide a signal to the ventilation device, based on the computed IPI value, wherein said signal adjusts one or more parameters of the said ventilation device as set forth in the abstract).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Allum to incorporate the teaching of Lain and include a set of sensors (Lain: FIG. 8 Sensors 502A-D as set forth in [0102] and [0181]) and a processor (The processing logic may include any type of hardware and/or software, such as, for example, a processor) communicatively coupled to the set of sensors (Lain: FIG. 7 The connection between the processing logic and the sensors may include any type of communication route, such as, for example, use of wires, cables, wireless, and the like as set forth in [0180]), wherein the processor determines an amount of oxygen received by the patient through the lumen based on the respiratory data (Lain: Values measured are the respiratory rate, end tidal carbon dioxide (etCO2), saturation of pulse oxygen (SpO2) heart rate (HR) taken from the pulse as set forth in [0102]) wherein the processor generates control signals for controlling the device (Lain: Measured patient parameters are used by a controller to compute an Integrated Pulmonary Index (IPI) value based on the two or more measured patient parameters and to provide a signal to the ventilation device, based on the computed IPI value, wherein said signal adjusts one or more parameters of the said ventilation device as set forth in the abstract). Doing so would enable the apparatus to obtain a comprehensive set of data representing the respiratory condition of the user die to various sensors, allowing the device to be controlled according to the state of the patient (Lain: Measured patient parameters are used by a controller to compute an Integrated Pulmonary Index (IPI) value based on the two or more measured patient parameters and to provide a signal to the ventilation device, based on the computed IPI value, wherein said signal adjusts one or more parameters of the said ventilation device as set forth in the abstract).
Allum as modified fails to explicitly disclose wherein the control signals generated are for controlling the control valve to automatically control the flowrate of the air passing through the lumen in real time based on the determined amount of oxygen.
However, Som teaches wherein control signals generated are for controlling the control valve to automatically control the flowrate of the air in real time based on the determined amount of oxygen (Som: FIG. 3 and 4 The oxygen saturation level in patient 310 measured by pulse oximeter 312 is above or below a threshold, the PID controller 316 instructs delivery module 306 to continue the oxygen supply at a determined rate, the instruction by the controller indicates the presence and need for the generation and transmittance of control signals; The adjustment of oxygen flow rate may be accomplished, as shown in step 430, by changing the settings or position of control valve 322 as set forth in [0052]).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Allum to incorporate the teaching of Som and include control signals generated for controlling the control valve to automatically control the flowrate of the air passing through the lumen in real time based on the determined amount of oxygen (Som: FIG. 3 and 4 The oxygen saturation level in patient 310 measured by pulse oximeter 312 is above or below a threshold, the PID controller 316 instructs delivery module 306 to continue the oxygen supply at a determined rate, the instruction by the controller indicates the presence and need for the generation and transmittance of control signals; The adjustment of oxygen flow rate may be accomplished, as shown in step 430, by changing the settings or position of control valve 322 as set forth in [0052]). Doing so provides a way to utilize a well-known respiratory parameter in the art, in order to determine a required gas flow to be delivered to the patient (Som: As set forth in [0005], [0014], and [0052]).
Response to Arguments
Given the amendment to claim 7, the objection drawn to a minor informality has been withdrawn.
Given the amendment to claim 12, the rejection under 35 U.S.C. 112(f) has been withdrawn.
New grounds of rejection have been made above to address the amendments to claims 7, 10, and 12.
Applicant's arguments filed 12/03/2025 have been fully considered but they are not persuasive.
Regarding claim 1, and other independent claims 13 and 20, Applicant argues that replacing the gas delivery nozzle 66 of Allum with Kullik’s throttle body 23 would render Allum’s system unsatisfactory given the positioning of nozzle 66 within the apparatus as disclosed by Allum. Applicant also argues that instead of the relative distance between the nozzle and tube entrance being the primary contributor to the amount of air entrained, the amount is dictated by the elastic membrane.
However, Examiner would like to note that while the structure of the nozzle of Allum is being replaced by the control valve configuration of Kullik, the positioning of the valve near the tube entrance is maintained, and would still allow for a particular level of air entrainment. Additionally, Allum sets forth in reference to FIG. 8 in column 10 lines 9-42 that “The tip of the gas delivery circuit may be configured as a gas delivery nozzle 66 and a tip of the gas delivery nozzle 66 may be positioned proximal to or a distance outside of the entrance to the airway tube 60”, and that “Ideal distance between the gas delivery nozzle 66 and airway tube entrance varies depending on conditions such as type and size of the airway tithe 60, desired therapeutic effect, and ventilator drive pressures, as well as catheter and nozzle dimensions”. This further indicates that a modification to the “valve” or “nozzle” configuration of Allum would not render the system unsatisfactory.
The ability of the control valve configuration of Kullik to further alter the flow/pressure of gas being deliver to the patient would provide improved control of the system and would serve as an improvement that would be obvious to one of ordinary skill in the art given the motivation for doing so as stated in the office action.
Applicant further argues that there would be no way to change a flowarate of the airflow by implementing the valve configuration of Kullik, and therefore, one of ordinary skill in the art would not have made the modification.
However, Examiner would like to note that the entire configuration related to the throttle body 23 of Kullik is being included. Specifically, the control valve (Kullik: FIG. 3 Throttle body 23 is with an elastic membrane 27 as set forth on page 6 paragraph 4 – page 7 paragraph 1 of the machine translation) coupled to the lumen (Kullik: FIG. 3 Inner space of the Throttle Body 23 where the gas travels as shown in the annotated figure), wherein the control valve automatically and selectively occludes the lumen to control a flowrate of the air passing through the lumen in real time (Kullik: FIG. 3 A volume 16 of the elastic membrane 27 and outside the flow cross-sectional area of the breathing gas is determined by means of a connecting tube 15 in connection with the gas line 10; when the gas conveyor 2 is controlled, the gas delivery device 2 can become operated at a high flow rate, so that in the gas line 10, and therefore the connecting tube 15, a high pressure is present and thus the throttle body 23 will have a small flow cross-sectional area and the pressure change or the pressure drop 12, and therefore the flowrate, caused by the throttle body is very high as set forth on page 6 paragraph 4 – page 7 paragraph 1) based on respiratory data obtained from the patient (Kullik: FIG. 3 Respiratory data including the pressure in the inspiratory gas line and pressure during the expiratory phase can be detected, and depending on the data obtained as a result of the patients inspiratory and expiratory phases, the flow rate of the gas delivery device can be controlled and/or regulated as set forth on page 6 paragraph 4 – page 7 paragraph 1, the flow rate being controlled by a control unit as set forth on page 3 paragraphs 6-7; the flow rate of the gas delivery device automatically controlling the amount of occlusion performed by the throttle body 23 and membrane 27 as a result of the gas delivered via the connecting tube 15), wherein doing so would allow the breathing apparatus to alter flow/pressure of gas being delivered to the patient depending on the user’s respiratory status (Kullik: As set forth on page 6 paragraph 4 – page 7 paragraph 1).
Applicant also states that given the valve configuration of Kullik enabling the delivery of a variable amount of air would render the system of Allum unsatisfactory.
Examiner disagrees given that the system of Allum would still have the ability to provide ventilation mechanical support in an open airway ventilation system in a controlled manner.
For the reasons set forth above, all the claimed elements are disclosed in a manner in which the prior art is not rendered unsatisfactory and wherein the operation of the prior art is not changed. The motivation for replacing the valve of Allum being to allow for the breathing apparatus to alter flow/pressure of gas being delivered to the patient depending on the user’s respiratory status (Kullik: As set forth on page 6 paragraph 4 – page 7 paragraph 1).
Given the validity of the modification of Allum in view of Kullik, the rejections of the dependent claims still stand in terms of their dependency to claim 1.
Regarding claim 10, Applicant argues that the combination of reference, including that of McCormick, does not teach or suggest “a microprocessor configured to execute the instructions to cause the control valve to automatically and selectively occlude the lumen to control a flowrate of the air passing through the lumen in real time based on the respiratory data, wherein the degree of occlusion corresponds to a recovery status of the patient”.
However, In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., a microprocessor configured to execute the instructions to cause the control valve to automatically and selectively occlude the lumen to control a flowrate of the air passing through the lumen in real time based on the respiratory data, wherein the degree of occlusion corresponds to a recovery status of the patient) were not fully recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). New grounds of rejection have been made above to address the amendment to claim 10.
Additionally, Allum sets forth that the system can include a control unit to adjust and regulate the amount of entrainment, indicating the system of Allum can operate based on a control unit, wherein the control unit of McCormick teaches specifically, the control unit having a memory storing instructions and a microprocessor configured to execute the instructions (McCormick: FIG. 2 CPU 74 includes a microprocessor unit, input/output ports, and an electronic storage medium for executable programs and calibration values where the CPU is programmed with computer readable data representing instruction executable to perform the methods described as set forth in [0021]), wherein doing so provides well-known control unit elements in the art of the claimed invention necessary for executing a control function (McCormick: Set forth in [0021]).
In response to the Applicant’s request for evidentiary support, Examiner would like to note that Applicant has not specifically identified any particular finding that is being traversed given a lack of evidentiary support, or stated that nay noticed fact is not well known in the art. Under MPEP 2144.03, a proper traverse of Official Notice requires a specific challenge to the noticed fact. A general request for documentary evidence does not constitute a proper traverse. Accordingly, because no specific noticed fact has been traversed, the rejections are maintained.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEIRA EILEEN CALLISON whose telephone number is (571)272-0745. The examiner can normally be reached Monday-Friday 7:30-4:30.
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/KEIRA EILEEN CALLISON/ Examiner, Art Unit 3785
/KENDRA D CARTER/ Supervisory Patent Examiner, Art Unit 3785