DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. 17/917413 filed on October 06, 2022. Receipt is also acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 14-16, and 18 are rejected under 35 U.S.C. 102(a)(1) as being unanticipated by Hansmann et al. (US 20180110957 A1, hereinafter “Hansmann”).
Regarding Claim 1, Hansmann discloses A method of controlling exhalation in a ventilation system for providing Positive Expiratory End Pressure, PEEP, ventilation to a lung (Paragraph 0010, The following steps are provided according to the present invention during a phase of exhalation in a method at a user interface of a ventilator, wherein the user interface has an exhalation valve, which provides a positive end-expiratory pressure: Changing the positive end-expiratory pressure from a basic PEEP value by means of the exhalation valve; returning the positive end-expiratory pressure to the basic PEEP value by means of the exhalation valve; and determining an exhalation parameter) the method comprising:
determining a lung resistance based on conditions of the system detected during an exhalation (Paragraph 0038, To detect the measured signals of the gas flow-measuring unit 14, the control device 18 has a determination module 180. The determination module 180 is further configured to receive pressure signals from pressure sensor 19. The determination module 180 can determine additional parameters, e.g., the exhalation resistance, from the transmitted signals);
and causing the system to inhibit system exhalation to cause and maintain a target system pressure based on the determined lung resistance and a pressure condition in the system (Paragraph 0013, The exhalation parameter is advantageously an exhalation resistance. Due to the exact knowledge of the exhalation resistance, the PEEP can be set exactly for the patient. The exhalation resistance acts in connection with the expiratory flow as a minimum pressure, which the patient or the ventilator must overcome for an exhalation. This pressure brings about a minimum PEEP, which can be added to the PEEP set on the device. The PEEP set on the device can be set at a lower value in this manner in order to set up an overall PEEP, which is the sum of the set PEEP and the minimum PEEP).
Regarding Claim 2, Hansmann discloses all of the limitations of Claim 1. Hansmann further discloses: wherein the conditions of the ventilation system comprise data obtained in a first exhalation (Paragraph 0041, a first expiratory gas flow 5, which designates the gas flow during the phase of exhalation, is shown by the dash-dot line. The first expiratory gas flow 5 drops to 0 L/sec at the end of the phase of exhalation from a maximum at the beginning of the phase of exhalation. The exhalation valve pressure 3 is controlled by the control unit 18. The first expiratory gas flow 5 is determined by the gas flow-measuring unit 14), and wherein the determined lung resistance from the first exhalation is used to cause the system to inhibit system exhalation in further exhalations (Paragraph 0045, The averaged exhalation resistance of the system from a plurality of breaths can be used as a basis for the calculation of the optimal pressure at the exhalation valve 11 in order to suppress dynamic changes between different breaths).
Regarding Claim 3, Hansmann discloses all of the limitations of Claim 1. Hansmann further discloses: wherein the conditions of the system comprise a system pressure condition (Paragraph 0042, The exhalation valve pressure 3 is reduced by a PEEP pressure reduction 6 at the beginning of the phase of exaltation. As a result, the expiratory gas flow is increased, as is indicated by the broken line, which shows the second expiratory gas flow 50. The airway pressure 4 now drops more rapidly than in FIG. 2b. As soon as the control device 18 determines that the airway pressure 4 threatens to drop below the basic PEEP value 31, the exhalation valve pressure 3 is raised again to the basic PEEP valve 31) and a system exhalation flowrate condition (Paragraph 0044, Knowing the time curve of the airway pressure 4, the airway resistance of the system comprising the ventilator 1 and the patient 2 can be calculated. Further, the compliance of the system can be calculated. The PEEP can be set at the exhalation valve 11 accurately by means of the calculated values by the control device 18 during the same phase of exhalation. The pressure at the exhalation valve 11 may be lower in this case than the desired PEEP, because the PEEP is calculated from the pressure at the exhalation valve 11 in combination with the pressure that is calculated from the expiratory gas flow multiplied by the exhalation resistance).
Regarding Claim 14, Hansmann discloses all of the limitations of Claim 1. Hansmann further discloses: further comprising providing a pressure sensor and using said sensor to determine the conditions of the system (Paragraph 0038, To detect the measured signals of the gas flow-measuring unit 14, the control device 18 has a determination module 180. The determination module 180 is further configured to receive pressure signals from pressure sensor 19. The determination module 180 can determine additional parameters, e.g., the exhalation resistance, from the transmitted signals).
Regarding Claim 15, Hansmann discloses all of the limitations of Claim 1. Hansmann further discloses: further comprising repeating the determining and causing steps in subsequent exhalations (Paragraph 0014, The averaged exhalation resistance can advantageously be determined over at least two breath cycles. Fluctuations between a plurality of breath cycles can be compensated in this manner. As a result, the PEEP must be set or regulated less frequently. The influence of single-time changes and fluctuations during a breath cycle can thus be diminished).
Regarding Claim 16, Hansmann discloses all of the limitations of Claim 15. Hansmann further discloses: further comprising using in the repeated causing step(s) an averaged lung resistance as the lung resistance, said averaged lung resistance being based on an average of lung resistances determined from previous exhalations (Paragraph 0045, The averaged exhalation resistance of the system from a plurality of breaths can be used as a basis for the calculation of the optimal pressure at the exhalation valve 11 in order to suppress dynamic changes between different breaths).
Regarding Claim 18, Hansmann discloses all of the limitations of Claim 1. Hansmann further discloses: An apparatus arranged to perform the method of claim 1 (Figure 1, Paragraph 0009, An object of the present invention is therefore to provide a device and a method that permits an adaptive change in the expiratory flow during exhalation)
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.
Claims 4-13 are rejected under 35 U.S.C. 103 as being unpatentable over Hansmann (US 20180110957 A1) in view of Chowienczyk et al. (US 5233998 A, hereinafter “Chowienczyk”).
Regarding Claim 4, Hansmann discloses all of the limitations of Claim 3. Hansmann further discloses: the system pressure condition is based on a pressure differential between two system pressures (Paragraph 0017, In another alternative embodiment, the PEEP may be reduced from a first initial value during a phase of exhalation at a predefined time. Further, the PEEP is increased again to the first initial value during the same phase of exhalation. The gas flow is thus determined during the exhalation and a differential exhalation resistance as well as a compliance are further determined from the determined gas flow at the time of the reduction), (Paragraph 0051, FIG. 4b shows an embodiment of the method with which the differential value can be calculated for the exhalation resistance and the compliance at the tidal volume or state of distension of the lungs that are present at this time)
Hansmann does not explicitly disclose that the two system pressures are measured before causing the system to inhibit system exhalation and measured after causing the system to inhibit system exhalation
Chowienczyk discloses the system pressure condition is based on a pressure differential between two system pressures, one measured before causing the system to inhibit system exhalation, and one measured after causing the system to inhibit system exhalation (Column 3, lines 27-57, The apparatus 2 operates as follows. With the interrupting valve 16 open, pressure and hence flow are continually monitored […] For the next 100 msec pressure values are stored in a memory part of the computer unit 8 at intervals of 1 msec […] these two average values are used to back extrapolate the pressure transient to a time (t0)+15 msec. The difference between this and the baseline pressure immediately prior to interruption is taken as the alveolar pressure at the time of interruption. The airway resistance as determined by the interrupter technique is taken as the ratio of this pressure to flow at the time of the interruption)
Chowienczyk and Hansmann both disclose apparatuses that serve to measure airway resistance and pressure in patient interfaces. Thus, it would have been obvious to one skilled in the art before the effective filing date to incorporate the specific monitoring and measuring system as disclosed by Chowienczyk, as it provides clarification regarding the determination module as taught by Hansmann.
Regarding Claim 5, Hansmann in view of Chowienczyk discloses all of the limitations of Claim 4. Hansmann further discloses: wherein the system pressure before causing the system to inhibit exhalation is the system pressure measured at a system low pressure target (Paragraph 0013, The exhalation parameter is advantageously an exhalation resistance. Due to the exact knowledge of the exhalation resistance, the PEEP can be set exactly for the patient. The exhalation resistance acts in connection with the expiratory flow as a minimum pressure, which the patient or the ventilator must overcome for an exhalation. This pressure brings about a minimum PEEP, which can be added to the PEEP set on the device. The PEEP set on the device can be set at a lower value in this manner in order to set up an overall PEEP, which is the sum of the set PEEP and the minimum PEEP), and the system pressure after causing the system to inhibit system exhalation is the system pressure measured at a time when the system pressure equalises with a lung pressure as a consequence of causing the system to inhibit system exhalation (Paragraph 0039, The exhalation valve pressure 3 is not 0 mbar during the phase of exhalation, but it amounts to a few mbar, which corresponds to the PEEP. The difference between the maximum and the minimum of the exhalation valve pressure 3 is the first pressure difference 30. The minimum of the exhalation valve pressure 3 in FIG. 2a corresponds to the basic PEEP valve), (Paragraph 0015, As an alternative or in addition, the exhalation resistance can advantageously be determined from estimated values from partial exhalation resistances of components in the exhalation path. This estimation may already be carried out before the ventilator is put into operation, so that an exact adaptive regulation of the PEEP can be carried out from the very beginning)
Hansmann in view of Chowienczyk teaches a system and apparatus that allows for setting specific target pressure values, as well as continuous, adaptive pressure regulation through a determination module and control system. It would have been obvious to one skilled in the art before the effective filing date that Hansmann in view of Chowienczyk is capable of having different parameters and inputs for pressure differential values, including but not limited to the system low pressure target and the system pressure equalized with lung pressure.
Regarding Claim 6, Hansmann discloses all of the limitations of Claim 5. Hansmann further discloses: wherein the system low pressure target is a target PEEP which corresponds to the target system pressure (Paragraph 0013, The exhalation parameter is advantageously an exhalation resistance. Due to the exact knowledge of the exhalation resistance, the PEEP can be set exactly for the patient. The exhalation resistance acts in connection with the expiratory flow as a minimum pressure, which the patient or the ventilator must overcome for an exhalation. This pressure brings about a minimum PEEP, which can be added to the PEEP set on the device. The PEEP set on the device can be set at a lower value in this manner in order to set up an overall PEEP, which is the sum of the set PEEP and the minimum PEEP).
Regarding Claim 7, Hansmann in view of Chowienczyk discloses all of the limitations of Claim 5. Chowienczyk further discloses: wherein the system flowrate condition is based on a flowrate differential between two system flowrates, one measured before and one measured after causing the system to inhibit system exhalation (Column 3, lines 27-57, The apparatus 2 operates as follows. With the interrupting valve 16 open, pressure and hence flow are continually monitored […] For the next 100 msec pressure values are stored in a memory part of the computer unit 8 at intervals of 1 msec […] these two average values are used to back extrapolate the pressure transient to a time (t0)+15 msec. The difference between this and the baseline pressure immediately prior to interruption is taken as the alveolar pressure at the time of interruption. The airway resistance as determined by the interrupter technique is taken as the ratio of this pressure to flow at the time of the interruption)
Regarding Claim 8, Hansmann discloses all of the limitations of Claim 7. Hansmann further discloses: wherein the system flowrate before causing the system to inhibit system exhalation is the exhalation flowrate measured at the system low pressure target, and the system exhalation flowrate after causing the system to inhibit system exhalation is the exhalation flowrate measured at a time when system pressure equalises with a lung pressure as a consequence of causing the system to inhibit system exhalation (Paragraph 0015, As an alternative or in addition, the exhalation resistance can advantageously be determined from estimated values from partial exhalation resistances of components in the exhalation path. This estimation may already be carried out before the ventilator is put into operation, so that an exact adaptive regulation of the PEEP can be carried out from the very beginning), (Paragraph 0011, By changing the positive end-expiratory pressure during the exhalation, a PEEP adapted to individual conditions is provided. Depending on the demand during the exhalation, a rapid increase and/or a rapid reduction of the expiratory flow can take place due to the change in the PEEP. An adaptive change in the expiratory flow is thus brought about during the exhalation)
Hansmann in view of Chowienczyk teaches a system and apparatus that allows for setting specific target pressure values, as well as continuous, adaptive pressure and flowrate regulation through a determination module and control system. It would have been obvious to one skilled in the art before the effective filing date that Hansmann in view of Chowienczyk is capable of having different parameters and inputs for pressure differential values and system flowrate, including but not limited to the exhalation flowrate at system low pressure target and the exhalation flowrate when the system pressure equalizes with lung pressure.
Regarding Claim 9, Hansmann discloses all of the limitations of Claim 1. Hansmann further discloses: further comprising causing the opening of a valve, thereby providing substantially no resistance to system exhalation (Figure 1, exhalation valve 11), (Paragraph 0036, The control device 18 controls the exhalation valve 11 during the phase of exhalation on the basis of the data of the gas flow-measuring unit 14. Further, the control device 18 can actuate the exhalation valve 11 during a phase of exhalation with predefined maneuvers and then detect the change in the expiratory gas flow in the same phase of exhalation by means of the gas flow-measuring unit 14)
Hansmann does not explicitly state that the opening of a valve provides substantially no resistance to system exhalation prior to causing the system to inhibit system exhalation.
Chowienczyk does disclose further comprising causing the opening of a valve, thereby providing substantially no resistance to system exhalation prior to causing the system to inhibit system exhalation (Column 3, lines 27-42, With the interrupting valve 16 open, pressure and hence flow are continually monitored. When the flow reaches a pre-determined value, which is usually 0.5 l/s, the interrupting valve 16 is actuated. For the next 100 msec pressure values are stored in a memory part of the computer unit 8 at intervals of 1 msec. Approximately 5 msec after the valve is actuated, complete airway occlusion is achieved. The interrupting valve 18 is held in the closed position for a further 100 msec. This period of airway occlusion is virtually imperceptible to the patient. The interrupting valve 16 is then opened and the stored pressure transient obtained as a result of the closing and opening of the interrupting valve 18 is analysed to compute the airway resistance as determined by the interrupter technique, see FIG. 3.)
Chowienczyk and Hansmann both disclose valved apparatuses that serve to measure airway resistance and pressure in patient interfaces. Thus, it would have been obvious to one skilled in the art before the effective filing date to incorporate the specific actuating and flow monitoring methods as disclosed by Chowienczyk, as it provides clarification regarding the control device’s actuation of the exhalation valve as taught by Hansmann
Regarding Claim 10, Hansmann discloses all of the limitations of Claim 1. Hansmann further discloses: wherein the system exhalation is inhibited by causing the closing of a valve, optionally the closing of an on-off type valve or the closing of a proportional valve configured to be in one of a fully closed position or a fixed open position (Figure 2, Column 3, lines 3-8, The interrupting valve 16 includes a lightweight non-circular elliptical plate 18 which is driven to occlude the lumen of a tube 20. Forces on the occluding plate 18 generated as a result of airflow through the interrupting valve 16 are balanced. Therefore only minimal force is required to move the plate 18).
Chowienczyk and Hansmann both disclose valved apparatuses that serve to measure airway resistance and pressure in patient interfaces. Thus, it would have been obvious to one skilled in the art before the effective filing date to incorporate the specific actuating and flow monitoring methods as disclosed by Chowienczyk, as it provides clarification regarding the control device’s actuation of the exhalation valve as taught by Hansmann
Regarding Claim 11, Hansmann in view of Chowienczyk discloses all of the limitations of Claim 10. Hansmann further discloses: wherein the system exhalation is inhibited by causing a single closing of the valve (Figure 2, Column 3, lines 3-8, The interrupting valve 16 includes a lightweight non-circular elliptical plate 18 which is driven to occlude the lumen of a tube 20. Forces on the occluding plate 18 generated as a result of airflow through the interrupting valve 16 are balanced. Therefore only minimal force is required to move the plate 18), (Column 3, lines 27-37, With the interrupting valve 16 open, pressure and hence flow are continually monitored. When the flow reaches a pre-determined value, which is usually 0.5 l/s, the interrupting valve 16 is actuated. For the next 100 msec pressure values are stored in a memory part of the computer unit 8 at intervals of 1 msec. Approximately 5 msec after the valve is actuated, complete airway occlusion is achieved. The interrupting valve 18 is held in the closed position for a further 100 msec. This period of airway occlusion is virtually imperceptible to the patient)
Regarding Claim 12, Hansmann in view of Chowienczyk discloses all of the limitations of Claim 9. Hansmann further discloses: wherein the valve provided is configured to be in a fixed open position or a substantially fully closed position (Figure 2, Column 3, lines 3-8, The interrupting valve 16 includes a lightweight non-circular elliptical plate 18 which is driven to occlude the lumen of a tube 20. Forces on the occluding plate 18 generated as a result of airflow through the interrupting valve 16 are balanced. Therefore only minimal force is required to move the plate 18), said valve being in the open position during the exhalation apart from when system exhalation is inhibited and the valve is in the substantially fully closed position (Column 3, lines 27-37, With the interrupting valve 16 open, pressure and hence flow are continually monitored. When the flow reaches a pre-determined value, which is usually 0.5 l/s, the interrupting valve 16 is actuated. For the next 100 msec pressure values are stored in a memory part of the computer unit 8 at intervals of 1 msec. Approximately 5 msec after the valve is actuated, complete airway occlusion is achieved. The interrupting valve 18 is held in the closed position for a further 100 msec. This period of airway occlusion is virtually imperceptible to the patient).
Regarding Claim 13, Hansmann in view of Chowienczyk discloses all of the limitations of Claim 12. Hansmann further discloses: wherein the fixed open position is substantially fully open (Figure 2, Column 3, lines 3-8, The interrupting valve 16 includes a lightweight non-circular elliptical plate 18 which is driven to occlude the lumen of a tube 20. Forces on the occluding plate 18 generated as a result of airflow through the interrupting valve 16 are balanced. Therefore only minimal force is required to move the plate 18).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Hansmann (US 20180110957 A1) in view of O’Mahoney et al. (US 6321748 B1, hereinafter “O’Mahoney”), further in view of Chowienczyk (US 5233998 A)
Regarding Claim 17, Hansmann discloses all of the limitations of Claim 1. Hansmann teaches a determination module that adaptively adjusts the pressure and flowrate of the system (Paragraph 0038, To detect the measured signals of the gas flow-measuring unit 14, the control device 18 has a determination module 180. The determination module 180 is further configured to receive pressure signals from pressure sensor 19. The determination module 180 can determine additional parameters, e.g., the exhalation resistance, from the transmitted signals), (Paragraph 0009, An object of the present invention is therefore to provide a device and a method that permits an adaptive change in the expiratory flow during exhalation)
However, Hansmann does not explicitly disclose that the determination module is intended to identify an error occurring during the exhalation in reaching the target system pressure caused by a timing delay in causing the system to inhibit system exhalation, and subsequently causing a timing correction in causing the system to inhibit system exhalation to correct said error in a subsequent exhalation
O’Mahoney does disclose determining an error occurring during the exhalation in reaching the target system pressure caused by a timing delay, and subsequently causing a timing correction in causing the system to correct said error in a subsequent exhalation (Columns 4-5, lines 64-6, Step 414 calculates the error as the difference between actual pressure (Pcontrol) in the patient circuit and the current set point pressure (Control Target). After the error is calculated, the task is to change the air flow in the patient circuit by the amount necessary to correct the error so that the gas pressure in the patient circuit substantially conforms to the set point pressure. To accomplish this, steps 416, 418, and 420 calculate the individual correction terms to be used in step 422).
Hansmann and O’Mahoney both disclose control devices and methods in ventilator systems. It would have been obvious to one skilled in the art before the effective filing date to incorporate the error detection method disclosed by O’Mahoney with the system and method disclosed by Hansmann, so as to provide an additional degree of accuracy in the patient interface (Column 1, lines 38-47).
Thus, it would have been obvious to one skilled in the art before the effective filing date to incorporate the specific monitoring and measuring system as disclosed by Chowienczyk, as it provides clarification regarding the determination module as taught by Hansmann (Column 1, lines 38-47, These prior art control schemes present a number of problems. For example, the torque constant varies with temperature. As a result, the error is never eliminated in a controlled fashion. The prior art uses current control which is a function of how frictionless the piston is. Moreover, the signals delivered to the piston motor do not take into account gas leaks in the system. Also, the prior art analog control schemes do not provide the desired level of precision and flexibility in operation needed for medical applications), (Column 1, lines 52-55, More particularly, the piston ventilator of the present invention uses digital processing to implement a control scheme for eliminating error between actual pressure in the patient circuit and the set point pressure)
Hansmann in view of O’Mahoney teaches inhibit[ing] system exhalation (Paragraph 0013, The exhalation parameter is advantageously an exhalation resistance. Due to the exact knowledge of the exhalation resistance, the PEEP can be set exactly for the patient. The exhalation resistance acts in connection with the expiratory flow as a minimum pressure, which the patient or the ventilator must overcome for an exhalation. This pressure brings about a minimum PEEP, which can be added to the PEEP set on the device. The PEEP set on the device can be set at a lower value in this manner in order to set up an overall PEEP, which is the sum of the set PEEP and the minimum PEEP)
However, Chowienczyk provides further context and explanation regarding how a control system could cause the system to inhibit system exhalation, and subsequently causing a timing correction in causing the system to inhibit system exhalation to correct said error in a subsequent exhalation. (Column 3, lines 27-57, The apparatus 2 operates as follows. With the interrupting valve 16 open, pressure and hence flow are continually monitored […] For the next 100 msec pressure values are stored in a memory part of the computer unit 8 at intervals of 1 msec […] these two average values are used to back extrapolate the pressure transient to a time (t0)+15 msec. The difference between this and the baseline pressure immediately prior to interruption is taken as the alveolar pressure at the time of interruption. The airway resistance as determined by the interrupter technique is taken as the ratio of this pressure to flow at the time of the interruption)
Chowienczyk and Hansmann in view of O’Mahoney both disclose apparatuses that serve to measure airway resistance and pressure in patient interfaces. Thus, it would have been obvious to one skilled in the art before the effective filing date to incorporate the specific monitoring and measuring system as disclosed by Chowienczyk, as it provides clarification regarding the determination module as taught by Hansmann.
Claims 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Hansmann (US 20180110957 A1) in view of Hansmann et al. (US 20190083726 A1, hereinafter “Ulrich”).
Regarding Claim 19, Hansmann discloses all of the limitations of Claim 18. Hansmann further discloses: wherein the apparatus comprises: a control device and a ventilation system configured to perform the method of claim 1 (Paragraph 0036, The ventilator 1 further comprises a control device 18, which transmits control signals to the exhalation valve 11 and to the fan 17, as well as received measured signals from the gas flow-measuring unit 14. The control device 18 determines the expiratory gas flow on the basis of the measured data of the gas flow-measuring unit 14)
Hansmann does not explicitly disclose the apparatus comprising a processor, however, It would have been obvious to one skilled in the art before the effective filing date that a control device would entail a processor that can execute the specific methods and calculations as described in Claim 1. It is a well-known feature in the art of controlled ventilator systems.
If the Applicant is not convinced, Ulrich also discloses wherein the apparatus comprises: a processor and a ventilation system configured to perform the method of claim 1 (Paragraph 0011, This control unit comprises a processing unit comprising a microprocessor (or one or more processors) as well as a memory […] The above-mentioned object is thus also accomplished by means of a control unit for controlling a ventilator, which control unit operates according to the process as here and hereinafter described and comprises means for carrying out the process for this)
Regarding Claim 20, Hansmann discloses all of the limitations of Claim 1. Hansmann further discloses: A computer-readable medium carrying computer-readable instructions which, when executed by a processor of a ventilation system, cause the system to carry out the method of claim 1 (Paragraph 0037-0038, The control device 18 comprises for this a change module 182, which transmits change signals to the exhalation valve 11. The change signals cause the exhalation valve 11 to set a PEEP deviating from a basic PEEP value 31. To detect the measured signals of the gas flow-measuring unit 14, the control device 18 has a determination module 180. The determination module 180 is further configured to receive pressure signals from pressure sensor 19. The determination module 180 can determine additional parameters, e.g., the exhalation resistance, from the transmitted signals)
Hansmann does not explicitly disclose a computer-readable medium carrying computer-readable instructions, however, It would have been obvious to one skilled in the art before the effective filing date that a control device would entail a processor that can execute the specific methods and calculations as described in Claim 1 through computer-readable instructions. It is a well-known feature in the art of controlled ventilator systems.
If the Applicant is not convinced, Ulrich clearly discloses A computer-readable medium carrying computer-readable instructions which, when executed by a processor of a ventilation system, cause the system to carry out the method of claim 1 (Paragraph 0011, This control unit comprises a processing unit comprising a microprocessor (or one or more processors) as well as a memory. A control program executable by the processor unit, which program is executed during the operation of the ventilator by the processing unit thereof, is or can be loaded into the memory. Operating actions of the operator in connection with the process are limited, for example, to the predefining of parameters. The above-mentioned object is thus also accomplished by means of a control unit for controlling a ventilator, which control unit operates according to the process as here and hereinafter described and comprises means for carrying out the process for this)
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure
Sanchez et al. (US 20140224250 A1) discloses methods and systems for delivering ventilation when exhalation is unknown
Masic et al. (US 20170182269 A1) discloses methods and systems for controlling flow and pressure during exhalation
Li et al. (US 20130284177 A1) discloses methods and systems for controlling an exhalation valve
Tingay (WO 2012139159 A1) discloses systems and processes for determining PEEP for a ventilation system
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MISHAL ZAHRA HUSSAIN whose telephone number is (703)756-1206. The examiner can normally be reached M-F, 8:30am - 5:00pm.
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/MISHAL ZAHRA HUSSAIN/
Examiner
Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785