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 .
Status of Claims
This action is in reply to Applicant’s communication filed on March 10, 2026.
Claims 43, 66, 69, 72 and 73 have been amended and are hereby entered.
Claims 43, 45-64, 66-73, 75-87 and 89-92 are currently pending and have been examined.
Priority
Acknowledgment is made of Applicant’s claim for priority under 35 U.S.C. § 371 of International Application No. PCT/EP2020/079948, filed on October 23, 2020, which claims the benefit of Application No. DE10 2019 007 412.2, filed in the Federal Republic of Germany on October 24, 2019.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on March 10, 2026 has been entered.
Claim Rejections - 35 USC § 103
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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 43, 45-63, 66-73, 75-86 and 89-92 are rejected under 35 U.S.C. 103 as being unpatentable over Lain et al. (US 20120145152) in view of Laubscher et al. (US 20170095601).
Regarding Claim 43, Lain discloses the following limitations:
A processor for a ventilator of a patient, wherein the processor is adapted to receive at least one vital parameter of the patient (Lain discloses a system including processing logic such as a processor (A processor – para 179), and further including a controller that may be used to receive information such as patient vitals (receive at least one vital parameter of the patient) from at least one of the sensors and to compute/determine/generate a condition-index value that is directly related to a condition of the patient. – paras 8, 179, 181)
and adapted to: store the at least one vital parameter for a predetermined period of time, (Lain discloses that the controller (an evaluation unit) may compute a trend of the Integrated Pulmonary Index (“IPI” or “PI”) value based on the two or more measured patient parameters (the at least one vital parameter) and provide a signal to a ventilation device. Computing the IPI may include averaging measured patient parameters over a period of time (store…for a predetermined period of time). – abstract; paras 8, 16, 24-25, 29, 125, 178)
determine a target value of the at least one vital parameter based on a course of the at least one vital parameter and/or predetermined clinical data, (Lain discloses receiving patient parameters such as respiratory rate (the at least one vital parameter) continuously measured over the last predetermined period of time (e.g., 30 seconds). A received patient parameter may be compared to a reference value (determine a target value of the at least one vital parameter) in order to compute the IPI, wherein “reference value” may refer to e.g., a value, a range of values or may be defining a portion of a range of values representing a normal (healthy) condition (based on predetermined clinical data). – paras 11, 31, 44, 96, 143)
determine a setpoint or setpoint value of at least one operating parameter of the ventilator based on the course of the at least one vital parameter and the target value of the at least one vital parameter and depending on at least two physiological factors of the patient, (Lain discloses continuously measuring respiratory rate values (based on the course of the at least one vital parameter) so that the standard deviation of the respiratory rate values (the at least one vital parameter) may be determined and compared to a threshold value. The standard deviation determines the averaging time periods for collecting data which is used to further determine the IPI value. Further, the IPI value is computed based on assigned values to each of the measured patient parameters based on a comparison of the measured patient parameters against one or more reference values (based on the target value of the at least one vital parameter). The IPI value determines the operating parameters for the ventilator (determine a setpoint or setpoint value of at least one operating parameter of the ventilator) and is based on the two or more measured patient parameters (depending on at least two physiological factors of the patient). – abstract; paras 11, 31, 44, 96, 143)
wherein the determining the set point or setpoint value of the at least one operating parameter of the ventilator…comprises determining the respective set point or setpoint value from a physiological model stored in the processor (Lain discloses that the signal provided to the ventilation device to adjust one or more weaning related parameters (determining the set point or setpoint value of the at least one operating parameter of the ventilator) is based on the computed IPI value. Computing the integrated pulmonary index may include applying a mathematical model (a physiological model) reflecting medical expert considerations, literature, clinical data, medical experience or any combination thereof. A Bayesian network may be used where the Bayesian network nodes include various parameters and/or inputs and/or factors, that may include, for example: measured/sensed parameters (such as, for example, EtCO.sub.2, RR, SpO.sub.2, HR, blood pressure, and the like). – paras 28, 113, 169-170)
such that each of the at least two physiological factors are maintained within their respective predetermined tolerance ranges, (Lain discloses various measured patient parameters such as SpO2 and EtcO2 (the at least two physiological factors) and displaying high and low alarm levels for each patient parameter (respective predetermined tolerance ranges) as well as the number of time the measured patient parameter fell outside the alarm limits. A successful weaning process is where the MV is decreased and the etCO2 is maintained and respiratory rate is controlled (each of the at least two physiological factors are maintained within their respective predetermined tolerance ranges). – paras 113, 169-170, 178; FIG. 6D)
compare the course of the at least one vital parameter with a first tolerance range and/or a modeled course (Lain discloses that a graphical user interface may display the trend (the course of) (i.e., the change over time) of various parameters such as respiratory rate (RR) (the at least one vital parameter). Fig. 6D displays the frequency of events wherein deviations from upper and lower alarm limits have been detected over a period of time (compare with a first tolerance range). – paras 129, 178; FIG. 6B-6D)
and output a signal as an alarm once a deviation of the at least one vital parameter exceeding a predetermined threshold or limit value is detected, (The broadest reasonable interpretation includes alternative form and therefore only a citation to exceeding a predetermined threshold is provided) (Lain discloses that the graphical user interface may display the frequency of events wherein deviations from alarm limits (i.e., thresholds) have been detected (exceeding a predetermined threshold) over a period of time. Instantaneous measured values of patient parameters are displayed along with upper and lower alarm limits for each respective patient parameter. And in some cases, the PI may alert the caregiver (output a signal as an alarm once a deviation) that intervention is needed. – paras 112, 178; FIG. 6D)
wherein comparing the course of the at least one vital parameter comprises continuously receiving the at least one vital parameter over time, (Lain discloses that respiratory rate (the course of the at least one vital parameter) may be measured continuously (continuously receiving the at least one vital parameter) to obtain real time values of the patient parameters. The parameters may be measured and collected each second (continuously receiving the at least one vital parameter over time), displayed by the monitors (comparing the course of the at least one vital parameter), and averaged over a predetermined period of time (e.g., 30 seconds). – para 143)
and change the setpoints or setpoint values of the at least one operating parameter of the ventilator… in real time during a treatment of the patient based on the determined set point or set point value, (Lain discloses providing a signal to the ventilation device based on the computed IPI value (based on the determined set point or set point value). Wherein said signal adjusts one or more weaning related parameters in the ventilation device (change the setpoints or setpoint values of the at least one operating parameter of the ventilator). The controller is configured to, based on the IPI, the IPI behavior over time and/or the IPI trend, adjust one or more weaning related parameters (change the setpoints or setpoint values) in the ventilation device (of the at least one operating parameter of the ventilator) by providing signal(s) to the ventilation device to adjust one or more weaning related parameters. Where the IPI behavior over time/the IPI trend is determined by the real time values of the measured patient parameters (in real time during a treatment of the patient).– abstract; paras 8-10, 143)
wherein each of the at least two physiological factors are maintained within their respective predetermined tolerance ranges after the change of the setpoint or setpoint value of the at least one operating parameter of the ventilator... (Lain discloses that an example of a successful weaning process is where the MV(set) is decreased (after the change of the setpoint or setpoint value of the at least one operating parameter of the ventilator) and the VE is met without overburdening the respiratory system (increasing WOB (work of breathing)), and etCO2 is maintained, RR is controlled, and IPI remains in the selected range (wherein each of the at least two physiological factors are maintained within their respective predetermined tolerance ranges) appropriate for continuing the weaning process. – para 113)
Lain does not disclose the following limitations met by Laubscher:
determine a setpoint or setpoint value of at least one operating parameter of an ECLS system coupled to the patient based on the course of the at least one vital parameter and the target value of the at least one vital parameter and depending on the at least two physiological factors, (Laubscher teaches a system for supporting the blood gas exchange by means of mechanical ventilation and extracorporeal blood gas exchange comprises a ventilation device for mechanical ventilation of the lungs of a patient, and an ECLS device (an ECLS system coupled to the patient) for the extracorporeal blood gas exchange. A target value for the level of the extracorporeal blood gas exchange may be set (based on the target value of the at least one vital parameter) and, in consideration of currently detected blood gas values (based on the course of the at least one vital parameter), attempts to approach the preset target value and then maintains a target value once reached (determine a setpoint or setpoint value of at least one operating parameter). The predetermined target state for the blood gas exchange may be expressed, for example, by a parameter that is characteristic of the content of O2 in the blood circulation, e.g., SpO2 (saturation value of O2 in venous blood determined by pulse oximetry), SaO2 (saturation value of oxygen in the blood,) or PaO2 (partial pressure of O2 in the blood); as well as a parameter that defines the content of CO2 in the blood circulation, e.g., PaCO2 (partial pressure of CO2 in the blood) and PetCO2 (content of CO2 in the breathing air, measured at the end of the expiration phase) (depending on the at least two physiological factors). – abstract; paras 20, 34-35)
wherein the determining…the set point or setpoint value of the at least one operating parameter of the ECLS system comprises determining the respective set point or setpoint value from a physiological model stored in the processor such that each of the at least two physiological factors are maintained within their respective predetermined tolerance ranges, (Laubscher teaches modeling normal SpO2 and PaCO2 levels (a physiological model stored), showing levels of each parameter that may be considered too high or too low. Should the case occur that the concentration of oxygen in the blood detected in step 206 does not correspond to the desired target value, but rather is too low or too high, it is provided that the parameter % ECLS_O2 indicating the degree of extracorporeal support in oxygenation is reduced by a third amount which is greater than the first amount (step 212), or is increased by a fourth amount (step 214) (determining the respective set point or setpoint value from a physiological model such that each of the at least two physiological factors are maintained within their respective predetermined tolerance ranges). – paras 34-36, 57-58, 76-81, 83, 85-86; FIGs. 11, 12)
and change the…setpoint or setpoint value of the at least one operating parameter of the ECLS system in real time during a treatment of the patient based on the determined set point or set point value, (Laubscher teaches that the ECLS device sets a level of extracorporeal blood gas exchange (the setpoints or setpoint values of the at least one operating parameter of the ECLS system) and the level is transferred (change the setpoint or setpoint value based on the determined set point or set point value) to the device for mechanical ventilation as new specification for the automatic setting of the mechanical ventilation. The system is designed specifically for the intensive care of patients, in particular for supporting the pulmonary function and the blood gas exchange in the course of intensive treatment with mechanical ventilation of a patient (in real time during a treatment of the patient) in which mechanical ventilation alone is no longer sufficient for achieving adequate support of the pulmonary function of the patient. Further, in the course of therapy, the patient needs may change, thus changing the state of use of the ECLS device. – paras 4, 19-20, 43)
wherein each of the at least two physiological factors are maintained within their respective predetermined tolerance ranges after the change of…the setpoint or setpoint value of the at least one operating parameter of the ECLS system. (Laubscher teaches that the extracorporeal blood gas exchange tends to be decreased (after the change of the setpoint or setpoint value of the at least one operating parameter of the ECLS system) further and further as long as the mechanical ventilation—for the given level of the extracorporeal blood gas exchange—can adjust to a state at which a predetermined target state is reached. As was already explained, the predetermined target state in particular is a desired state as regards the achieved enrichment of the blood with oxygen and/or the achieved depletion of CO2 from the blood (wherein each of the at least two physiological factors are maintained within their respective predetermined tolerance ranges). For example, figure 4 determines if the oxygen concentration or saturation is within a desired range in step 206. If it is, then the parameter % ECLS_O2, expressing the degree of extracorporeal support in oxygenation, is reduced in step 210 by a predetermined first amount, which in the example illustrated is 0.05% (after the change of the setpoint or setpoint value of the at least one operating parameter of the ECLS system). Next, the process moves onto figure 5 where the carbon dioxide concentration or carbon dioxide saturation is determined to be within a desired range at step 302 (wherein each of the at least two physiological factors are maintained within their respective predetermined tolerance ranges), and thus the parameter % ECLS_CO2 is decreased at step 304. Then the process moves onto step 310 and returns to figure 4 where a new detection of the state. – paras 34-36, 76-81; FIGs. 4-5) (Examiner notes that Laubscher teaches determining if oxygen and carbon dioxide saturations are within desired ranges before and after making parameter changes to the ECLS device)
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system for ventilation and monitoring vitals of a patient as disclosed by Lain to incorporate the simultaneous application of mechanical ventilation and ECLS as taught by Laubscher in order to achieve mechanical ventilation as efficiently as possible with only minor damaging effects for the lungs (see Laubscher para 15).
Regarding Claim 45, Lain and Laubscher disclose all the limitation above and further disclose the following limitations:
The processor of claim 43, further adapted to receive actual values of the operating parameters from the ventilator and the ECLS system, the processor being adapted to determine the setpoints or setpoint values in dependence upon the actual values. (Lain discloses receiving one or more patient characteristics (actual values) and computing the PI value based on the two or more measured patient parameters and on one or more patient characteristics (determine the setpoints or setpoint values in dependence upon the actual values). The one or more patient characteristics may include…ventilation, oxygen supply (receive actual values of the operating parameters from the ventilator and the ECLS system). – paras 26, 36)
Regarding Claim 46, Lain and Laubscher disclose all the limitation above and further disclose the following limitations:
The processor according to claim 43, wherein the ventilator is configured to assist spontaneous breathing of the patient or to provide artificial respiration of the patient. (Lain discloses weaning a patient from mechanical ventilation (provide artificial respiration) which may be accomplished by reducing the support provided by a mechanical ventilator until a patient is able to spontaneously support respiration (assist spontaneous breathing). – abstract; paras 2, 8-10, 104)
Regarding Claim 47, Lain and Laubscher disclose all the limitation above and further disclose the following limitations:
The processor according to claim 46, wherein the ventilator is a mechanical ventilator. (Lain discloses a system for weaning a patient from mechanical ventilation. – abstract)
Regarding Claim 48, Lain and Laubscher disclose all the limitation above and further disclose the following limitations:
The processor according to claim 43, wherein the processor is coupled to a monitor, and wherein outputting the signal comprises a graphical representation of at least one of: the setpoints or setpoint values of the at least one operating parameter of the ventilator and the at least one operating parameter of the ECLS system, the actual value, the target value, and the course of the corresponding value. (Lain discloses the use of sensors (a monitor) and one or more displays showing the trend (change over time) of various measured patient parameters (outputting the signal comprises a graphical representation of the course of the corresponding value) – paras 84, 178, 180; FIGs. 6C, 7)
Regarding Claim 49, Lain and Laubscher disclose all the limitation above and further disclose the following limitations:
The processor according to claim 48, wherein the processor determines the setpoints or setpoint values from the physiological model stored in the processor (Lain discloses that the PI may be determined/calculated (determines the setpoints or setpoint values) by applying the mathematical model (the physiological model stored in the processor) reflecting medical expert considerations, literature, clinical data, medical experience or any combination thereof. – paras 28, 35, 81, 148, 169-170, 174; FIG. 5, item 104)
and wherein the signal further comprises a graphical representation of an impact of the setpoints or setpoint values of the at least one operating parameter of the ventilator and the at least one operating parameter of the ECLS system on the physiological factors modeled by the processor. (Lain discloses that the PI value (the controller uses the PI value to adjust parameters in the ventilation device and provide signals to the device) may be updated continuously, indicating that the PI value is calculated even after adjustments are made. Further, the PI value (the signal) may also be indicative of conditions such as hypoventilation and hyperventilation. When the PI is indicative of these conditions, an appropriate additional indicative signaling may be displayed (a graphical representation), such as, for example, an upward arrow (indicative of hyperventilation) and downward arrow (indicative of hypoventilation). The decision as to whether the patient's status is in either hypoventilation or hyperventilation may be based, for example, upon one of the measured patient parameters (the physiological factors modeled). – paras 8-9, 35, 141-142, 171, 174)
Regarding Claim 50, Lain and Laubscher disclose all the limitation above and further disclose the following limitations:
The processor according to claim 49, wherein the signal comprises, in addition to the impact of the setpoints or setpoint values of the at least one operating parameter of the ventilator and the at least one operating parameter of the ECLS system, a graphical representation of a modeled impact of the actual values on the physiological factors. (Lain discloses that a decision tree is a predictive model that may be used to map observations (a modeled impact) regarding an item to conclusions regarding the item's target value (the actual values on the physiological factors.). – paras 171, 174; FIG. 4C)
Regarding Claim 51, Lain and Laubscher disclose all the limitation above and further disclose the following limitations:
The processor according to claim 43, wherein the physiological factors are not operating parameters of the ventilator. (Lain discloses that the two or more measured patient parameters may include respiration rate, a CO2 related parameter, an O2 related parameter, heart rate, an electrocardiogram (ECG), an encephalogram (EEG), blood pressure, spirometry or any combination thereof. – paras 30, 36)
Regarding Claim 52, Lain and Laubscher disclose all the limitation above and further disclose the following limitations:
The processor according to claim 43, wherein the physiological factors represent the functionality of the patient's pulmonary or lung function. (Lain discloses that the two or more measured patient parameters may include respiration rate, a CO2 related parameter, an O2 related parameter, heart rate, an electrocardiogram (ECG), an encephalogram (EEG), blood pressure, spirometry or any combination thereof. – paras 30, 36)
Regarding Claim 53, Lain and Laubscher disclose all the limitation above and further disclose the following limitations:
The processor according to claim 43, wherein the physiological factors are indicative of over-ventilation or ventilation insufficiency. (Lain discloses that the PI value may also be indicative of conditions such as hypoventilation and hyperventilation. – para 142)
Regarding Claim 54, Lain and Laubscher disclose all the limitation above and further disclose the following limitations:
The processor according to claim 53, wherein the physiological factors comprise one or more of mechanical pulmonary trauma, atrophy, barotrauma, volutrauma, alkalosis, oxygen toxicity, absorption atelectasis, acidosis, hypoxia, stress, and hemodynamic side effects. (Lain discloses that the increased FiO2 (fraction of inspired oxygen in a gas mixture) helps prevent tissue hypoxia. The effect of FiO2 is measured with the SpO2 and is used in the IPI to determine overall fitness of the cardiopulmonary system. – para 114)
Regarding Claim 55, Lain and Laubscher disclose all the limitation above and further disclose the following limitations:
The processor according to claim 54, wherein the processor is adapted to determine the setpoints or setpoint values of the at least one operating parameter of the ventilator and the at least one operating parameter of the ECLS system in dependence on three or more physiological factors. (Lain discloses that the controller computes the IPI value based the measured patient parameters. The patient parameters may include respiration rate, a CO2 related parameter, an O2 related parameter, heart rate, an electrocardiogram (ECG), an encephalogram (EEG), blood pressure, spirometry or any combination thereof. (dependence on three or more physiological factors) and provides a signal to the ventilation device, wherein the signal adjusts one or more weaning related parameters in said ventilation device (determine the setpoints or setpoint values of the at least one operating parameter of the ventilator and the at least one operating parameter of the ECLS system). – paras 8-10, 13-16)
Regarding Claim 56, Lain and Laubscher disclose all the limitation above and further disclose the following limitations:
The processor according to claim 55, wherein the processor is adapted to determine the setpoints or setpoint values of the at least one operating parameter of the ventilator and the at least one operating parameter of the ECLS system in dependence on five or six physiological factors. (Lain discloses that the controller computes the IPI value based the measured patient parameters. The patient parameters may include respiration rate, a CO2 related parameter, an O2 related parameter, heart rate, an electrocardiogram (ECG), an encephalogram (EEG), blood pressure, spirometry or any combination thereof (dependence on three or more physiological factors) and provides a signal to the ventilation device, wherein the signal adjusts one or more weaning related parameters in said ventilation device (determine the setpoints or setpoint values of the at least one operating parameter of the ventilator and the at least one operating parameter of the ECLS system). – paras 8-10, 13-16)
Regarding Claim 57, this claim recites substantially similar limitations to those recited in claim 49 above; thus, the same rejection applies. Further, Lain discloses the following limitations:
The processor according to claim 43, …such that all physiological factors do not exceed their respective predetermined tolerance range. (Lain discloses various measured patient parameters (all physiological factors), e.g., SpO.sub.2 and EtcO.sub.2, and displaying high and low alarm levels (their respective predetermined tolerance range) for each patient parameter as well as the number of time the measured patient parameter fell outside the alarm limits. For example, in FIG. 6D element 354 illustrates a bar graph showing the number of times where the SpO2 value was above a high alarm limit (top panel, 355A) (such that all physiological factors do not exceed their respective predetermined tolerance range) or below a low alarm limit (bottom panel, 355B). – paras 169-170, 178; FIG. 6D)
Regarding Claim 58, Lain and Laubscher disclose all the limitation above and further disclose the following limitations:
The processor according to claim 43, wherein the at least one vital parameter comprises one or more of pulsoximetric oxygen saturation, expiratory oxygen fraction, expiratory carbon dioxide fraction, oxygen uptake capacity, carbon dioxide release, and blood pH. (Lain discloses that the measured patient parameters may include a CO2 related parameter such as an expired air CO2 concentration. – para 26)
Regarding Claim 59, Lain and Laubscher disclose all the limitation above and further disclose the following limitations:
The processor according to claim 43, wherein the processor is adapted to receive at least two vital parameters. (Lain discloses that the system receives two or more measured patient parameters (vital parameters). – abstract; paras 8-11)
Regarding Claim 60, Lain and Laubscher disclose all the limitation above and further disclose the following limitations:
The processor according to claim 43, wherein the processor is adapted to receive at least three or four vital parameters. (Lain discloses that the system receives two or more measured patient parameters. – paras 8-10)
Regarding Claim 61, Lain and Laubscher disclose all the limitation above and further disclose the following limitations:
The processor according to claim 43, wherein the at least one operating parameter of the ventilator includes the respiratory volume, peak inspiratory pressure, positive end expiratory pressure, respiratory frequency, inspiratory oxygen fraction, ratio between inhalation duration and exhalation duration, and/or inspiratory carbon dioxide fraction. (Lain discloses that the one or more weaning related parameters (the at least one operating parameter of the ventilator) may include: ventilation volume (respiratory volume), ventilation pressure, supplemental oxygen, positive end expiratory pressure (PEEP) (positive end expiratory pressure) or any combination thereof. – paras 8-16)
Regarding Claim 62, Lain and Laubscher disclose all the limitation above and further disclose the following limitations:
The processor according to claim 43, wherein the processor is adapted to determine the setpoint or setpoint value each of two, three, or four operating parameters of the ventilator and the setpoint or setpoint value for each of two operating parameters of the ECLS system. (Lain discloses that the signal (the setpoint or setpoint value) adjusts one or more weaning related parameters in the ventilation device (two, three, or four operating parameters of the ventilator and two operating parameters of the ECLS system). – paras 1, 8-16)
Regarding Claim 63, Lain and Laubscher disclose all the limitation above and further disclose the following limitations:
The processor according to claim 43, wherein the evaluation unit is further adapted to determine the setpoint or setpoint value for the at least one operating parameter of the ventilator and the setpoint or setpoint value the at least one operating parameter of the ECLS system in dependence on a ratio of support related to the at least one vital parameter. (Laubscher teaches that the ECLS device sets a level of the extracorporeal blood gas exchange (the setpoints or setpoint values), and the ventilation device, on the basis of the level of the extracorporeal blood gas exchange set by the ECLS device, then adjusts to a particular situation, or at least tries to adjust such that a particular state is achieved. Further, the ECLS system determines, by evaluation of a parameter (related to the at least one vital parameter – para 34), whether the intensity of the treatment by ECLS as compared to the intensity of mechanical ventilation (a ratio of support) is to be changed. – abstract; paras 5, 19, 22-23, 34, 36, 42-43, 61, 65)
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system for ventilation and monitoring vitals of a patient as disclosed by Lain to incorporate the automated adjustment features of the ventilation device to achieve a particular state between the ventilator and ECLS as taught by Laubscher in order to achieve an as efficient as possible mechanical ventilation with only minor damaging effects for the lungs (see Laubscher para 15).
Regarding Claim 66, this claim recites substantially similar limitations to those recited in claim 43 above; thus, the same rejection applies.
Regarding Claim 67, this claim depends on claim 66, which is rejected for the basis and reasons disclosed above. Additionally, it recites substantially similar limitations to those recited in claim 47 above; thus, the same rejection applies.
Regarding Claim 68, Lain and Laubscher disclose all the limitation above and further disclose the following limitations:
The ventilator according to claim 66, comprising a device for detecting the at least one vital parameter of the patient, the device for detecting the at least one vital parameter of the patient being communicatively coupled to the processor. (Lain discloses that the measured patient parameters originate from various sensors (a device). – paras 53, 98, 100, 121-122, 179)
Regarding Claim 69, this claim recites substantially similar limitations to those recited in claim 43 above; thus, the same rejection applies.
Regarding Claim 70, Lain and Laubscher disclose all the limitation above and further disclose the following limitations:
The ECLS system of claim 69, wherein the ECLS system is an ECMO system. (Laubscher teaches that the ECLS may be a device for extracorporeal membrane oxygenation ECMO (an ECMO system). – paras 12, 19, 64)
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system for mechanical ventilation and monitoring vitals of a patient as disclosed by Lain to incorporate the simultaneous application of mechanical ventilation and ECLS as taught by Laubscher in order to achieve an as efficient as possible mechanical ventilation with only minor damaging effects for the lungs (see Laubscher para 15).
Regarding Claim 71, this claim depends on claim 69, which is rejected for the basis and reasons disclosed above. Additionally, it recites substantially similar limitations to those recited in claim 68 above; thus, the same rejection applies.
Regarding Claim 72, this claim recites substantially similar limitations to those recited in claim 43 above; thus, the same rejection applies.
Regarding Claim 73, this claim recites substantially similar limitations to those recited in claim 43 above; thus, the same rejection applies.
Regarding Claim 75, Lain and Laubscher disclose all the limitation above and further disclose the following limitations:
The method according to claim 73, wherein determining the target value and/or the setpoints or setpoint values of the at least one operating parameter of the ventilator and…is continuous or periodic. (Lain discloses that the real time values of the patient parameters may be measured continuously and the PI value may therefore be updated continuously (determining the setpoints or setpoint values of the at least one operating parameter is continuous). – paras 141, 143)
wherein determining the target value and/or…and the at least one operating parameter of the ECLS system is continuous or periodic. (Laubscher teaches that the ECLS device comprises (closed-loop) control mechanisms operating with the aim that the ECLS device, in consideration of currently detected blood gas values, attempts to approach the preset target value and then maintains a target value once reached (determining the at least one operating parameter of the ECLS system is continuous). – paras 19-20, 67)
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system for mechanical ventilation and monitoring vitals of a patient as disclosed by Lain to incorporate the simultaneous application of mechanical ventilation and ECLS as taught by Laubscher in order to achieve an as efficient as possible mechanical ventilation with only minor damaging effects for the lungs (see Laubscher para 15).
Regarding Claim 76, Lain and Laubscher disclose all the limitation above and further disclose the following limitations:
The method according to claim 73, wherein the processor re-determines the target value and/or the setpoints or setpoint values of the at least one operating parameter of the ventilator and the at least one operating parameter of the ECLS system after a manual adjustment of the operating parameter values. (Lain discloses that the PI value may be updated continuously and the system adjusts one or more weaning related parameters in the ventilation device (re-determines the setpoints or setpoint values) based on the PI value. Further, the PI can be used manually inline with a mechanical ventilator for weaning in place (a manual adjustment of the operating parameter values). – paras 120, 141)
Regarding Claim 77, this claim depends on claim 73, which is rejected for the basis and reasons disclosed above. Additionally, it recites substantially similar limitations to those recited in claim 45 above; thus, the same rejection applies.
Regarding Claim 78, this claim depends on claim 73, which is rejected for the basis and reasons disclosed above. Additionally, it recites substantially similar limitations to those recited in claim 48 above; thus, the same rejection applies.
Regarding Claim 79, this claim depends on claim 78, which is rejected for the basis and reasons disclosed above. Additionally, it recites substantially similar limitations to those recited in claim 49 above; thus, the same rejection applies.
Regarding Claim 80, this claim depends on claim 79, which is rejected for the basis and reasons disclosed above. Additionally, it recites substantially similar limitations to those recited in claim 50 above; thus, the same rejection applies.
Regarding Claim 81, this claim depends on claim 73, which is rejected for the basis and reasons disclosed above. Additionally, it recites substantially similar limitations to those recited in claim 51 above; thus, the same rejection applies.
Regarding Claim 82, this claim depends on claim 73, which is rejected for the basis and reasons disclosed above. Additionally, it recites substantially similar limitations to those recited in claim 51 above; thus, the same rejection applies.
Regarding Claim 83, this claim depends on claim 73, which is rejected for the basis and reasons disclosed above. Additionally, it recites substantially similar limitations to those recited in claim 53 above; thus, the same rejection applies.
Regarding Claim 84, Lain and Laubscher disclose all the limitation above and further disclose the following limitations:
The method according to claim 73, wherein, upon determining a positive impact on at least one physiological factor, the impact on at least one other physiological factor is calculated, simulated, or modelled. (Lain discloses that the graphical display may exhibit the PI trend showing “good” improvements (determining a positive impact on at least one physiological factor). The PI calculation takes into consideration the various membership functions and synergistic effects between various parameters (impact on at least one other physiological factor is calculated). – para 157, 159)
Regarding Claim 85, Lain and Laubscher disclose all the limitation above and further disclose the following limitations:
The method according to claim 73, wherein the setpoints or setpoint values of the at least one operating parameter of the ventilator…are determined on the basis of the physiological model stored in the processor in such a way that all physiological factors do not exceed their respective predetermined tolerance range. (Lain discloses that the signal provided to the ventilation device to adjust one or more weaning related parameters (the setpoints or setpoint values of the at least one operating parameter of the ventilator are determined) is based on the computed IPI value. Computing the IPI value may include applying a mathematical model (the physiological model) reflecting medical expert considerations, literature, clinical data, medical experience or any combination thereof. A Bayesian network may be used where the Bayesian network nodes include various parameters and/or inputs and/or factors, that may include, for example: measured/sensed parameters (such as, for example, EtCO.sub.2, RR, SpO.sub.2, HR, blood pressure, and the like). The various measured patient parameters (all physiological factors), such as SpO.sub.2 and EtcO.sub.2, are displayed along with high and low alarm levels for each patient parameter (their respective predetermined tolerance range) as well as the number of times the measured patient parameter fell outside the alarm limits. For example, in FIG. 6D element 354 illustrates a bar graph showing the number of times where the SpO2 value was above a high alarm limit (top panel, 355A) or below a low alarm limit (bottom panel, 355B). – paras 28, 169-170, 178; FIG. 6D)
wherein the setpoints or setpoint values of…the at least one operating parameter of the ECLS system are determined on the basis of the physiological model stored in the expert module in such a way that all physiological factors do not exceed their respective predetermined tolerance range. (Laubscher teaches modeling normal SpO2 and PaCO2 levels (the physiological model), showing levels of each parameter that may be considered too high or too low (all physiological factors do not exceed their respective predetermined tolerance range). Should the case occur that the concentration of oxygen in the blood detected in step 206 does not correspond to the desired target value, but rather is too low or too high, it is provided that the parameter % ECLS_O2 indicating the degree of extracorporeal support in oxygenation is reduced by a third amount which is greater than the first amount (step 212), or is increased by a fourth amount (step 214) (the setpoints or setpoint values the at least one operating parameter of the ECLS system are determined). – paras 57-58, 83, 85-86; FIGs. 11, 12)
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system for ventilation and monitoring vitals of a patient as disclosed by Lain to incorporate the simultaneous application of mechanical ventilation and ECLS as taught by Laubscher in order to achieve mechanical ventilation as efficiently as possible with only minor damaging effects for the lungs (see Laubscher para 15).
Regarding Claim 86, this claim depends on claim 73, which is rejected for the basis and reasons disclosed above. Additionally, it recites substantially similar limitations to those recited in claim 63 above; thus, the same rejection applies.
Regarding Claim 89, Lain and Laubscher disclose all the limitation above and further disclose the following limitations:
The method according to claim 73, wherein the expert module delivers an alarm, once a manual setting of the operating parameter values exceeds at least one of: a predetermined threshold value or limit value of the operating parameter values, the at least one vital parameter, and the modeled impact on the physiological factors. (The broadest reasonable interpretation includes alternative form and therefore only a citation to a predetermined threshold value and the at least one vital parameter is provided) (Lain discloses that the graphical user interface may display the frequency of events wherein deviations from alarm limits (i.e., threshold) have been detected over a period of time. For example, element 352 illustrates a bar graph showing the number of times where the respiratory rate (the at least one vital parameter) was above a high alarm limit (parameter values exceeds) or below a low alarm limit (a predetermined threshold value). Further, additional parameters may be added either manually or by any route of communication. For example, with respect to a PI index that is determined by the parameters of HR, RR, EtCO.sub.2 and SpO.sub.2, additional on-line parameters may include such parameters as breathing related parameters (a manual setting of the operating parameter values). – para 178; FIG. 6D)
Regarding Claim 90, Lain and Laubscher disclose all the limitation above and further disclose the following limitations:
The processor according to claim 49, wherein the impact is separate for the ventilator and the ECLS system. (Laubscher teaches a ventilation device for mechanical ventilation of the lungs of a patient (the impact for the ventilator), and an ECLS device for the extracorporeal blood gas exchange (the impact for the ECLS system), wherein the ventilation system is designed to perform mechanical respiratory support by the ventilation device on the one hand and an extracorporeal blood gas exchange by the ECLS device on the other hand. – abstract; paras 4-5)
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system for ventilation and monitoring vitals of a patient as disclosed by Lain to incorporate the simultaneous application of mechanical ventilation and ECLS as taught by Laubscher in order to achieve mechanical ventilation as efficiently as possible with only minor damaging effects for the lungs (see Laubscher para 15).
Regarding Claim 91, Lain and Laubscher disclose all the limitation above and further disclose the following limitations:
The processor according to claim 43, wherein the at least one operating parameter of the ECLS system includes blood pump flow rate, system pressure and/or gas volume flow. (The broadest reasonable interpretation includes alternative form and therefore only a citation to blood pump flow rate and gas volume flow is provided) (Laubscher teaches that the following parameters can be influenced in ECLS: the flow of the gas supplied to the extracorporeal oxygenator (gas volume flow), the flow of blood through the extracorporeal oxygenator (blood pump flow rate). – paras 14, 22)
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system for ventilation and monitoring vitals of a patient as disclosed by Lain to incorporate the simultaneous application of mechanical ventilation and ECLS as taught by Laubscher in order to achieve mechanical ventilation as efficiently as possible with only minor damaging effects for the lungs (see Laubscher para 15).
Regarding Claim 92, this claim depends on claim 79, which is rejected for the basis and reasons disclosed above. Additionally, it recites substantially similar limitations to those recited in claim 90 above; thus, the same rejection applies.
Claims 64 and 87 are rejected under 35 U.S.C. 103 as being unpatentable over Lain et al. (US 20120145152) in view of Laubscher et al. (US 20170095601), further in view of Geva et al. (US 20100249541).
Regarding Claim 64, Lain and Laubscher disclose all the limitation above, however do not disclose the following limitations met by Geva:
The processor according to claim 43, wherein the signal further comprises a request to receive at least one further vital parameter.(Geva teaches a monitoring center that can request additional or different physiological data to refine the analysis. – abstract)
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified providing a signal to a ventilation device as disclosed by Lain to incorporate requesting additional or different physiological data as taught by Geva in order to achieve a quick and accurate medical diagnosis (see Geva abstract).
Regarding Claim 87, this claim depends on claim 73, which is rejected for the basis and reasons disclosed above. Additionally, it recites substantially similar limitations to those recited in claim 64 above; thus, the same rejection applies.
Response to Arguments
Regarding rejections under 35 USC § 103 to Claims 43, 45-64, 66-73, 75-87 and 89-92, Applicant’s arguments have been fully considered and are not persuasive. The rejection has been updated in light of latest amendments. Applicant argues:
(a) Lain does not describe that the Sp02 value remains within the high alarm limit and the low alarm limit after a change in the IPI value. Accordingly, Lain does not describe or render obvious "each of the at least two physiological factors are maintained within their respective predetermined tolerance ranges after the change of the setpoint or setpoint value of the at least one operating parameter of the ventilator and the setpoint or setpoint value of the at least one operating parameter of the ECLS system," as recited by independent claim 43. Laubscher does not cure the above-noted deficiencies of Lain. Independent claims 66, 69, 72, and 73 recite language similar to that of claim 43 and are patentable for at least the same reasons. The dependent claims are patentable for at least the same reasons that the independent claims are patentable. Claims 64 and 87 depend from claims 43 and 73, respectively, and are patentable over Lain and Laubscher for at least the same reasons that claims 43 and 73 are patentable. Geva further fails to cure the above-noted deficiencies of Lain and Laubscher. (p. 15).
Regarding (a), Examiner respectfully disagrees. The claim recites wherein each of the at least two physiological factors are maintained within their respective predetermined tolerance ranges after the change of the setpoint or setpoint value of the at least one operating parameter of the ventilator and the setpoint or setpoint value of the at least one operating parameter of the ECLS system. Lain is relied upon to disclose limitations regarding the ventilator and Laubscher is relied upon to teach limitations regarding the ECLS system.
Lain discloses that a successful weaning process is where, for example, mechanical ventilation is decreased (after the change of setpoint or setpoint value of the at least one operating parameter of the ventilator) and the etCO2 is maintained and respiratory rate is controlled (wherein each of the at least two physiological factors are maintained within their respective predetermined tolerance ranges). (see para 113).
Laubscher teaches determining if oxygen saturation and carbon dioxide saturation are within desired ranges (wherein each of the at least two physiological factors are maintained within their respective predetermined tolerance ranges) before and after making parameter changes to the ECLS device (after the change of the setpoint or setpoint value of the at least one operating parameter of the ECLS system). (see paras 76-81 and Figs. 4-5).
Based on response to arguments above, claim 43 is unpatentable and therefore similar independent claims 66, 69, 72 and 73, as well as all claims depending therefrom, are unpatentable according to the same rationale. See updated rejection above.
Conclusion
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/K.E.V./Examiner, Art Unit 3681
/PETER H CHOI/Supervisory Patent Examiner, Art Unit 3681
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