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
The preliminary amendment filed 23 April 2025 has been entered. Claims 1-3, 6-8, 10-12, and 17-26 are pending.
Specification
The current title includes a typographical error of “CONYEVING”. The following title is suggested: FLUID CONVEYING DEVICE FOR INTRODUCING FLUID INTO AND/OR REMOVING FLUID FROM AN ESOPHAGEAL BALLOON CATHETER.
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claims 12 and 25-26 are objected to because of the following informalities:
Claim 12, line 17 includes a period after “measuring fluid port”. The limitation should be amended to use a semicolon instead.
Claim 25, line 4-5 “a fluid conveying device” should be “the fluid conveying device”.
Claim 26, line 1-2 “a device for detecting an esophageal balloon pressure” should be “the device for detecting the esophageal balloon pressure”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-26 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation “the fluid pump” in lines 16 and 19. There is insufficient antecedent basis for this limitation of the claim. The limitation is interpreted as referring to the at least one fluid pump.
Claim 2 recites the limitation “the fluid pump” in line 3. There is insufficient antecedent basis for this limitation of the claim. The limitation is interpreted as referring to the at least one fluid pump.
Claim 3 recites the limitations “the outlet” in line 8 and “the inlet” in line 10. There is insufficient antecedent basis for this limitation of the claim.
Claim 6 recites the limitations “an outlet” in lines 5 and 12 and “an inlet” in lines 7 and 10. As an outlet and inlet have been introduced in claim 3, from which claim 6 depends, it is unclear if these limitations are intended to refer to separate outlets and inlets from those previously introduced or if these limitations refer to the same elements. The limitations are interpreted as referring to the same outlet and inlet introduced in claim 3.
Claim 10 recites “the first fluid pump” in line 5. There is insufficient antecedent basis for this limitation of the claim. The limitation is interpreted as referring to the at least one fluid pump.
Claim 10 recites “the fluid pump” in line 6. There is insufficient antecedent basis for this limitation of the claim. The limitation is interpreted as referring to the at least one fluid pump.
Claim 11 recites “the fluid pump” in line 6. There is insufficient antecedent basis for this limitation of the claim. The limitation is interpreted as referring to the at least one fluid pump.
Claim 12 recites “the first fluid pump” in line 4. There is insufficient antecedent basis for this limitation of the claim. The limitation is interpreted as referring to the at least one fluid pump.
Claim 12 recites “the fluid pump” in each of line 5-6, 8, 9, 14-15, 16-17, 22-23, and 25-26. There is insufficient antecedent basis for this limitation of the claim. The limitation is interpreted as referring to the at least one fluid pump.
Claim 20 recites “the first micropump” and “the second micropump” in lines 3-4. There is insufficient antecedent basis for this limitation of the claim. The limitation is interpreted as referring to a first and second pump of the at least one fluid pump.
Claim 21 recites “the first fluid pump” in line 3. There is insufficient antecedent basis for this limitation of the claim. The limitation and subsequent references to the first fluid pump are interpreted as referring to a first pump of the at least one fluid pump.
Claim 21 recites “the second fluid pump” in lines 3-4. There is insufficient antecedent basis for this limitation of the claim. The limitation and subsequent references to the second fluid pump are interpreted as referring to a second pump of the at least one fluid pump.
Claim 22 recites “the first fluid pump” in line 4. There is insufficient antecedent basis for this limitation of the claim. The limitation and subsequent references to the first fluid pump are interpreted as referring to a first pump of the at least one fluid pump.
Claim 22 recites “the second fluid pump” in lines 8. There is insufficient antecedent basis for this limitation of the claim. The limitation and subsequent references to the second fluid pump are interpreted as referring to a second pump of the at least one fluid pump.
Claim 23 recites “the first fluid pump”. There is insufficient antecedent basis for this limitation of the claim. The limitation is interpreted as referring to a first pump of the at least one fluid pump.
Claim 23 recites “the second fluid pump”. There is insufficient antecedent basis for this limitation of the claim. The limitation is interpreted as referring to a second pump of the at least one fluid pump.
Claim 24 recites “the first fluid pump” in line 5. There is insufficient antecedent basis for this limitation of the claim. The limitation and subsequent references to the first fluid pump are interpreted as referring to a first pump of the at least one fluid pump.
Claim 24 recites “the second fluid pump” in line 6. There is insufficient antecedent basis for this limitation of the claim. The limitation and subsequent references to the second fluid pump are interpreted as referring to a second pump of the at least one fluid pump.
Claim 24 recites “the measuring fluid” in line 4. There is insufficient antecedent basis for this limitation of the claim. The limitation is interpreted as referring to the fluid as introduced in claim 1.
Claims 2-3, 6-8, 10-12, 17-26 are additionally rejected under 35 U.S.C. 112(b) as indefinite due to their dependence on claim 1 which has been rejected as indefinite.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(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.
Claim(s) 1-3, 6, 10, 19-21, 24-26 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Göbel (US 20220347413 A1).
Regarding claim 1, Göbel teaches a fluid conveying device for introducing fluid into and/or removing fluid from an esophageal catheter which is insertable into an esophagus and which has a balloon probe for determining an esophageal balloon pressure (Figs. 1 and 9: catheter 1 including cuff 3 where the cuff serves as a balloon and the tube may be placed in an esophagus; Paragraph 0057, 0062, 0094-- A pressure sensor can be arranged in the balloon-type foil body to detect the actual pressure value…The pressure fluctuations that also correspond to the independent respiration of the patient in a balloon placed in the esophagus and acts in a tamponading sealing manner are generally even more pronounced than is the case with a balloon that is placed in the trachea. They correspond in a good approximation to the respectively prevailing intrathoracic pressure …These types of dynamically pressure-regulated balloon tamponades can be used in particular on trans-esophageally placed probes), the fluid conveying device comprising:
- a measuring fluid port, which is configured to be coupled to a distal end of the esophageal catheter such that, in a coupled state, fluid is introducible into the esophageal catheter and/or removable from the esophageal catheter via the measuring fluid port (connector 6 which is connected to a distal end of the catheter filling hose, see figs. 1 and 6; paragraph 0079, 0090--reservoir or the source is attached by a connector 6 to the filling hose 4b);
- a pump device having at least one fluid pump, the pump device being designed to conduct fluid in at least one direction of conduction (Paragraph 0049-0051, 0055--The pressurizing of a reservoir component can also take place using a valve mechanism that is permanently connected to the reservoir, and driven in a pump-like manner or electromechanically, for example piezo-electrically…piezo-electrically driven pumps, which also noiselessly build up a reservoir pressure of to 100 mbar, can be connected upstream from the valves; paragraph 0060-0061, 0094--The regulator itself consists of a pump module 32 with an optionally integrated reservoir 33 and at least one regulating valve module 34 with an integrated control unit. The user can enter target values and alarm values into the controller. As a option, the regulator can also have two pump systems, with a respectively attached reservoir, wherein the one reservoir keeps an excess pressure available and the other a negative pressure); and
- a switching valve, which is assigned to the fluid pump and can be switched at least between a first position and a second position (Paragraph 0061, 0094-0096--at least one regulating valve module 34 with an integrated control unit…);
wherein the fluid pump is in the form of a micropump or a diaphragm pump (Paragraph 0049-0051, 0055, 0094--Both the pump functions and the valve functions are preferably based on piezo-electric components).
Regarding claim 2, Göbel teaches the fluid conveying device according to claim 1. Göbel additionally teaches wherein the fluid pump is a first fluid pump for conveying fluid in a first flow direction and wherein the pump device comprises a second fluid pump for conveying fluid in a second flow direction (paragraph 0060-0061, 0094--The regulator itself consists of a pump module 32 with an optionally integrated reservoir 33 and at least one regulating valve module 34 with an integrated control unit. The user can enter target values and alarm values into the controller. As a option, the regulator can also have two pump systems, with a respectively attached reservoir, wherein the one reservoir keeps an excess pressure available and the other a negative pressure).
Regarding claim 3, Göbel teaches the fluid conveying device according to claim 2. Göbel additionally teaches wherein the first fluid pump and the second fluid pump are connected in parallel to each other (Fig. 9—the pump module 32 consists of two pumps which are together connected in series to the reservoir such that the pumps must be connected to one another in parallel); and/or
wherein the switching valve is configured such that it selectively connects the measuring fluid port either to the first fluid pump or to the second fluid pump (Paragraph 0060-0061, 0094-- the regulator can also have two pump systems, with a respectively attached reservoir, wherein the one reservoir keeps an excess pressure available and the other a negative pressure. The gradients or the differential pressure from the target value kept available in the regulator in the cuff are adjusted autonomously by the regulator; NOTE: while not explicitly shown, the switching valve must be configured to selectively connect the measuring fluid port to the first or second pump in order to regulate the pressure in the system); and/or
wherein the switching valve is arranged between the outlet of the first fluid pump and the measuring fluid port and/or between the inlet of the second fluid pump and the measuring fluid port (Figs. 1, 9—valve module 34 is arranged between pumps 32 and connector 6).
Regarding claim 6, Göbel teaches the fluid conveying device according to claim 3. Göbel additionally teaches wherein the switching valve is switchable at least between a first and a second open position; wherein, in the first open position, an outlet of the first fluid pump is fluidly connected to the measuring fluid port and an inlet of the second fluid pump is fluidly disconnected from the measuring fluid port; and wherein, in the second open position, an inlet of the second fluid pump is fluidly connected to the measuring fluid port and an outlet of the first fluid pump is fluidly disconnected from the measuring fluid port (Paragraph 0060-0061, 0094-- the regulator can also have two pump systems, with a respectively attached reservoir, wherein the one reservoir keeps an excess pressure available and the other a negative pressure. The gradients or the differential pressure from the target value kept available in the regulator in the cuff are adjusted autonomously by the regulator; NOTE: while not explicitly shown, the switching valve must be configured to switch between a first position whereby the first fluid pump is fluidly connected to the measuring fluid port and a second position whereby the second fluid pump is fluidly connected to the measuring fluid port in order to allow one pump at a time to affect the measured pressure).
Regarding claim 10, Göbel teaches the fluid conveying device according to claim 1. Göbel additionally teaches wherein the switching valve is configured such that it selectively connects the measuring fluid port either to an inlet of the first fluid pump or to an outlet of the fluid pump (Paragraph 0060-0061, 0094-- the regulator can also have two pump systems, with a respectively attached reservoir, wherein the one reservoir keeps an excess pressure available and the other a negative pressure. The gradients or the differential pressure from the target value kept available in the regulator in the cuff are adjusted autonomously by the regulator; NOTE: while not explicitly shown, the switching valve must be configured to switch between a first position whereby the first fluid pump is fluidly connected to the measuring fluid port and a second position whereby the second fluid pump is fluidly connected to the measuring fluid port in order to allow one pump at a time to affect the measured pressure).
Regarding claim 19, Göbel teaches the fluid conveying device according to claim 1. Göbel additionally teaches wherein the switching valve comprises a blocking position in which the pump device is fluidly disconnected from the measuring fluid port (Paragraph 0060-0061, 0094-- closing phase can be influenced by the regulator… The gradients or the differential pressure from the target value kept available in the regulator in the cuff are adjusted autonomously by the regulator… NOTE: a closing phase, or otherwise a phase where the pressure is at a target value would correspond to a blocking position of the valve in which the pressure is unchanged by the pumps).
Regarding claim 20, Göbel teaches the fluid conveying device according to claim 1. Göbel additionally teaches wherein at least one of the first micropump and the second micropump is designed as a piezo pump (Paragraph 0049-0051, 0055, 0094--Both the pump functions and the valve functions are preferably based on piezo-electric components).
Regarding claim 21, Göbel teaches the fluid conveying device according to claim 1. Göbel additionally teaches wherein the first fluid pump and/or the second fluid pump each have an associated device for forming a flow resistance which is configured such that it reduces a measuring fluid flow which is achievable at maximum pumping capacity of the first fluid pump and/or the second fluid pump, to a predetermined value due to the flow resistance (Paragraph 0080-- the supply line 4a integrated into the shaft wall comprises a special barbell-shaped profile 13 in a transversal section, which maximizes the overall cross section of the supply line, which cross section determines the flow resistance in an optimal manner…such that every instance of narrowing in the system forms a flow resistance that reduces a measuring fluid flow which is achievable at maximum pumping capacity).
Regarding claim 24, Göbel teaches the fluid conveying device according to claim 1. Göbel additionally teaches further comprising a pressure sensor configured to measure a fluid pressure of the measuring fluid conveyed by the first fluid pump and/or by the second fluid pump in a region between the measuring fluid port and the first fluid pump and/or between the measuring fluid port and the second fluid pump (Paragraph 0094-0095-- a peripheral pressure-converting sensor 36 can be integrated into the supply line and be positioned in the immediate vicinity of the connector 6. With this design, it is possible to dispense with a sensor integrated in the cuff, wherein a certain delay in the regulating time must be accepted).
Regarding claim 25, Göbel teaches the fluid conveying device according to claim 1. Göbel additionally teaches a device for detecting an esophageal balloon pressure on the basis of an esophageal catheter with balloon probe, which is insertable into an esophagus, the device comprising a fluid conveying device according to claim 1 (Figs. 1 and 9: catheter 1 including cuff 3 where the cuff serves as a balloon and the tube may be placed in an esophagus; Paragraph 0057, 0062, 0094-- A pressure sensor can be arranged in the balloon-type foil body to detect the actual pressure value…The pressure fluctuations that also correspond to the independent respiration of the patient in a balloon placed in the esophagus and acts in a tamponading sealing manner are generally even more pronounced than is the case with a balloon that is placed in the trachea. They correspond in a good approximation to the respectively prevailing intrathoracic pressure …These types of dynamically pressure-regulated balloon tamponades can be used in particular on trans-esophageally placed probes).
Regarding claim 26, Göbel teaches the fluid conveying device according to claim 1. Göbel additionally teaches a ventilation device comprising a device for detecting an esophageal balloon pressure according to claim 25 (Abstract, paragraph 0003, 0040, 0045, 0080--dynamically adapting, aspiration-preventative secretion sealing of an intubated trachea in the case of independently breathing patients as well as in the case of patients who are being mechanically ventilated in a supporting spontaneous breathing mode…the tube lumen used for ventilating the lungs).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 7-8, 11-12, and 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Göbel in view of Higashiyama (WO 2014192606 A1).
Regarding claim 7, Göbel teaches the fluid conveying device according to claim 6. However, Göbel fails to explicitly teach wherein the switching valve comprises a first release valve associated with the first fluid pump and a second release valve associated with the second fluid pump; wherein the first release valve is switchable at least between an open position, in which the outlet of the first fluid pump is fluidly connected to the measuring fluid port, and a closed position, in which the outlet of the first fluid pump is fluidly disconnected from the measuring fluid port; and wherein the second release valve is switchable at least between an open position, in which the inlet of the second fluid pump is fluidly connected to the measuring fluid port, and a closed position, in which the inlet of the second fluid pump is fluidly disconnected from the measuring fluid port.
Higashiyama, in the same field of endeavor of a device that controls pressure in a balloon for use in a ventilated patient, teaches a switching valve comprises a first release valve associated with the first fluid pump and a second release valve associated with the second fluid pump;
wherein the first release valve is switchable at least between an open position, in which the outlet of the first fluid pump is fluidly connected to the measuring fluid port, and a closed position, in which the outlet of the first fluid pump is fluidly disconnected from the measuring fluid port; and
wherein the second release valve is switchable at least between an open position, in which the inlet of the second fluid pump is fluidly connected to the measuring fluid port, and a closed position, in which the inlet of the second fluid pump is fluidly disconnected from the measuring fluid port (Fig. 14 shows a switching valve comprises a first release valve and a second release valve each switchable between at least an open position allowing fluid connection between a pump and a port and a closed position which disconnects the pump from the port).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the device of Göbel to include the multiple release valves as disclosed by Higashiyama as a matter of simple substitution for the regulating valve module which is capable of performing the same actions, in this case, the coordinated switching between a negative and positive pressure pump.
Regarding claim 8, the combination of Göbel and Higashiyama teaches the fluid conveying device according to claim 7. However, Göbel fails to explicitly teach wherein the first release valve and the second release valve are arranged in parallel to each other; and/or wherein the first release valve and the second release valve are switchable in coordinated or synchronized manner with each other such that when the first release valve is in the open position, the second release valve is in the closed position, and when the first release valve is in the closed position, the second release valve is in the open position.
Higashiyama additionally teaches wherein the first release valve and the second release valve are arranged in parallel to each other (see Fig. 14—valves in parallel to each other); and/or
wherein the first release valve and the second release valve are switchable in coordinated or synchronized manner with each other such that when the first release valve is in the open position, the second release valve is in the closed position, and when the first release valve is in the closed position, the second release valve is in the open position (see Fig. 14—valves switchable in coordinated manner as claimed).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the device of Göbel to include the multiple release valves as disclosed by Higashiyama as a matter of simple substitution for the regulating valve module which is capable of performing the same actions, in this case, the coordinated switching between a negative and positive pressure pump.
Regarding claim 11, Göbel teaches the fluid conveying device according to claim 10. However, Göbel fails to explicitly teach wherein the switching valve comprises a first conveying direction switching valve and a second conveying direction switching valve which, with respect to the direction of flow of fluid through the fluid pump, are arranged in series with each other.
Higashiyama, in the same field of endeavor of a device that controls pressure in a balloon for use in a ventilated patient, teaches wherein the switching valve comprises a first conveying direction switching valve and a second conveying direction switching valve which, with respect to the direction of flow of fluid through the fluid pump, are arranged in series with each other (Figs. 3, 6A-6B and 7A-7B show each switching valve comprising a first and second conveying direction switching valve arranged in series; paragraphs 0076-0080--Each of the valve elements 128 and 138 corresponds to the "switching mechanism" of the present invention.).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the device of Göbel to include the multiple release valves as disclosed by Higashiyama as a matter of simple substitution for the regulating valve module which is capable of performing the same actions, in this case, the coordinated switching between a negative and positive pressure pump.
Regarding claim 12, the combination of Göbel and Higashiyama teaches the fluid conveying device according to claim 11. However, Göbel fails to explicitly teach wherein the first conveying direction switching valve is located downstream of the first fluid pump with respect to the direction of flow of fluid through the fluid pump; and wherein the second conveying direction switching valve is located upstream of the fluid pump with respect to the direction of flow of fluid through the fluid pump; and/or wherein the first conveying direction switching valve is switchable between at least a first and a second open position; wherein, in the first open position, the outlet of the fluid pump is fluidly connected to the measuring fluid port; and wherein in the second open position, the outlet of the fluid pump is fluidly disconnected from the measuring fluid port. and/or wherein the second conveying direction switching valve is switchable between at least a first and a second open position; wherein in the first open position, the inlet of the fluid pump is fluidly disconnected from the measuring fluid port; and wherein in the second open position, the inlet of the fluid pump is fluidly connected to the measuring fluid port; and/or wherein the first conveying direction switching valve and the second conveying direction switching valve are switchable in coordinated or synchronized manner with each other such that when the first conveying direction switching valve is in the first open position, the second conveying direction switching valve is also in the first open position; and/or wherein the first conveying direction switching valve and the second conveying direction switching valve are switchable in coordinated or synchronized manner with each other such that when the first conveying direction switching valve is in the second open position, the second conveying direction switching valve is also in the second open position.
Higashiyama, in the same field of endeavor of a device that controls pressure in a balloon for use in a ventilated patient, teaches wherein the first conveying direction switching valve is located downstream of the first fluid pump with respect to the direction of flow of fluid through the fluid pump (See Fig. 3—fluid pump 110 is arranged between first and second conveying direction switching valves 120 and 130); and
wherein the second conveying direction switching valve is located upstream of the fluid pump with respect to the direction of flow of fluid through the fluid pump (See Fig. 3—fluid pump 110 is arranged between first and second conveying direction switching valves 120 and 130); and/or
wherein the first conveying direction switching valve is switchable between at least a first and a second open position; wherein, in the first open position, the outlet of the fluid pump is fluidly connected to the measuring fluid port; and wherein in the second open position, the outlet of the fluid pump is fluidly disconnected from the measuring fluid port (See first open position and second open position of each of the first conveying direction switching valves 120 and 130 which serve to connect and disconnect each valve from the fluid pump, Figs. 6a-6b and 7-a-7b) and/or
wherein the second conveying direction switching valve is switchable between at least a first and a second open position; wherein in the first open position, the inlet of the fluid pump is fluidly disconnected from the measuring fluid port; and wherein in the second open position, the inlet of the fluid pump is fluidly connected to the measuring fluid port (See first open position and second open position of each of the first conveying direction switching valves 120 and 130 which serve to connect and disconnect each valve from the fluid pump, Figs. 6a-6b and 7-a-7b); and/or
wherein the first conveying direction switching valve and the second conveying direction switching valve are switchable in coordinated or synchronized manner with each other such that when the first conveying direction switching valve is in the first open position, the second conveying direction switching valve is also in the first open position (Figs. 6a-6b and 7a-7b demonstrate the coordinated switching manner of the valves; paragraph 0054, 0075, 0077--the control unit 111 switches the flow paths of the valves 120 and 130 based on the detection result of the cuff pressure detection unit 171 and the like);
and/or wherein the first conveying direction switching valve and the second conveying direction switching valve are switchable in coordinated or synchronized manner with each other such that when the first conveying direction switching valve is in the second open position, the second conveying direction switching valve is also in the second open position (Figs. 6a-6b and 7a-7b demonstrate the coordinated switching manner of the valves; paragraph 0054, 0075, 0077--the control unit 111 switches the flow paths of the valves 120 and 130 based on the detection result of the cuff pressure detection unit 171 and the like).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the device of Göbel to include the multiple release valves as disclosed by Higashiyama as a matter of simple substitution for the regulating valve module which is capable of performing the same actions, in this case, the coordinated switching between a negative and positive pressure pump.
Regarding claim 17, Göbel teaches the fluid conveying device according to claim 1. Göbel generally teaches a blocking mechanism comprising at least one blocking position in which the pump device is fluidly disconnected from the measuring fluid port (Paragraph 0079—closing mechanism 11…). However, Göbel fails to explicitly teach a blocking valve.
Higashiyama, in the same field of endeavor of a device that controls pressure in a balloon for use in a ventilated patient, teaches comprising a blocking valve comprising at least one blocking position in which the pump device is fluidly disconnected from the measuring fluid port (Exhaust valve 172; paragraph 0063-0064-- The exhaust valve 172 is connected to the cuff 10. The exhaust valve 172 is controlled by the control unit 111 to open and close…).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the device of Göbel to utilize a blocking valve as described by Higashiyama in place of the blocking mechanism as a matter of simple substitution for parts known in the art, wherein both components are capable of disconnecting the pump from the measuring fluid port in order to permit connection and disconnection of a pump from an esophageal catheter which has already been placed.
Regarding claim 18, Göbel teaches the fluid conveying device according to claim 1. Göbel generally teaches a blocking mechanism separate from the switching valve and which is arranged in series with the switching valve (Paragraph 0079—closing mechanism 11…). However, Göbel fails to explicitly teach wherein the blocking valve is configured as a valve.
Higashiyama, in the same field of endeavor of a device that controls pressure in a balloon for use in a ventilated patient, teaches wherein the blocking valve is configured as a valve which is separate from the switching valve and which is arranged in series with the switching valve (Exhaust valve 172 is separate from the switching valve (valves 120 and 130) and is arranged in series; Fig. 3).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the device of Göbel to utilize a blocking valve as described by Higashiyama in place of the blocking mechanism as a matter of simple substitution for parts known in the art, wherein both components are capable of disconnecting the pump from the measuring fluid port in order to permit connection and disconnection of a pump from an esophageal catheter which has already been placed.
Claim(s) 22-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Göbel in view of Novotni (US 20200016349 A1).
Regarding claim 22, Göbel teaches the fluid conveying device according to claim 1. However, Göbel fails to explicitly teach further comprising a flow sensor configured to detect a measuring fluid flow conveyed by the first fluid pump and/or by the second fluid pump, wherein the flow sensor is configured to detect a mass flow of the fluid or volume flow of the fluid conveyed by the first fluid pump and/or by the second fluid pump.
Novotni, in the same field of endeavor of a device for conveying fluid to a balloon probe of an esophageal catheter (Paragraph 0069), discloses the device comprising a flow sensor (Flow sensor 36) configured to detect a measuring fluid flow conveyed by the first fluid pump and/or by the second fluid pump, wherein the flow sensor is configured to detect a mass flow of the fluid or volume flow of the fluid conveyed by the first fluid pump and/or by the second fluid pump (Paragraph 0062, 0070-- provides for a determination of the breathing gas mass flow).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the device of Göbel to additionally include a flow sensor as disclosed by Novotni in order to predictably improve the device by allowing for monitoring of not just pressure of a measuring fluid but also volumetric flow which can allow for more comprehensive monitoring of ventilation of the patient.
Regarding claim 23, the combination of Göbel and Novotni teaches the fluid conveying device according to claim 1.
Novotni additionally teaches wherein the flow sensor is arranged between the measuring fluid port and the first fluid pump and/or between the measuring fluid port and the second fluid pump (Sensor 36 is positioned between a measuring fluid port (see port at tube 14) and a pump (see valves 18 and 24 to pumps for providing inspiration and expiration pressure; paragraph 0058).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the device of Göbel to additionally include a flow sensor as disclosed by Novotni in order to predictably improve the device by allowing for monitoring of not just pressure of a measuring fluid but also volumetric flow which can allow for more comprehensive monitoring of ventilation of the patient.
Conclusion
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/ANNA ROBERTS/Examiner, Art Unit 3791
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