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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/11/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
Claims 1-4, 6-10, 15-17, 19, and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Simundic US 2022/0313889 A1 (hereinafter Simundic).
Regarding claim 1, Simundic discloses a blood pump system 40 (Fig. 4 – blood pump 40), comprising:
a blood pump 40 (Fig. 4) configured to provide a blood flow in an extracorporeal membrane oxygenation (ECMO) circuit 36 (Fig. 4 – extracorporeal circulatory support 36, and Par. 6 – “extracorporeal circulatory support systems are known… Such systems are also known under the term “extracorporeal membrane oxygenation” (ECMO)”) for extracorporeal physiological support for a patient 38 (Fig. 4 – patient 38, and Par. 118 – “A system for extracorporeal circulatory support 36 is shown schematically in FIG. 4. The system 36 is connected to the patient 38”);
a magnetic coupling member configured to drive the blood pump to operably provide the blood flow (Par. 69 – “the blood pump may be coupled with a pump drive via a pump head, for example by means of a magnetic coupling”);
a direct current (DC) motor configured to drive the magnetic coupling member, thereby driving the blood pump (Par. 38-39 – “the blood pump may also be controlled or regulated… a brushless DC motor, so that the motor of the pump drive may be switched in two opposite directions and a speed reduction may accordingly be actively achieved by a reversal of the current direction”); and
a controller 48 (Fig. 4 – control unit 48) configured to regulate a motor speed of the DC motor (Par 13 – “The control unit may, for example, control one or more pump drives or pump heads for non-occlusive blood pumps present in an extracorporeal circulatory or life support system”).
Regarding claim 2, Simundic discloses the invention of claim 1. Simundic further discloses wherein the blood pump 40 (Fig. 4) is a standard ECMO blood pump, or a customized blood pump (Abstract – “non-occlusive blood pump of an extracorporeal circulatory support”, and Par. 10 – “optimize the properties of a blood flow provided by a blood pump”).
Regarding claim 3, Simundic discloses the invention of claim 1. Simundic further discloses wherein the blood flow is a pulsatile blood flow (Par. 17 – “the non-occlusive blood pump has the further advantage of providing a pulsatile blood flow…”).
Regarding claim 4, Simundic discloses the invention of claim 1. Simundic further discloses wherein the magnetic coupling member is configured to rotate a pump impeller of the blood pump in a contactless manner (Par. 15 – “the non-occlusive blood pump may be magnetically coupled to the pump drive of a motor to allow torque transmission”).
Regarding claim 6, Simundic discloses the invention of claim 1. Simundic further discloses further comprising: a physiological sensor 56 (Fig. 4 – sensor 56) disposed in the ECMO circuit 36 (Fig. 4) for monitor physiological parameters of the patient (Par. 120 – “The ECG signal 54 is provided by sensors 56 attached to the patient 38”).
Regarding claim 7, Simundic discloses the invention of claim 6. Simundic further discloses wherein the controller 48 (Fig. 4) is further configured to receive a physiological input from the physiological sensor 56 (Fig. 4, and Par. 74 – “the control unit may record the received ECG signal”) in the ECMO circuit 36 (Fig. 4) and regulate the motor speed responsively, thereby adjusting the pump speed in a closed-loop feedback system (Par. 74 – “Furthermore, further settings such as the time of the outputted pulse parameter and the pulse duration may be displayed in the ECG signal, such that a user may monitor the control and regulation of the blood pump with regard to the physiological condition of the patient”).
Regarding claim 8, Simundic discloses the invention of claim 1. Simundic further discloses wherein the controller 48 (Fig. 4) is further configured to receive a signal from the patient about its vital state (Fig. 4, and Par. 74 – “the control unit may record the received ECG signal”) and regulate the motor speed responsively, thereby adjusting the pump speed (Par. 74 – “Furthermore, further settings such as the time of the outputted pulse parameter and the pulse duration may be displayed in the ECG signal, such that a user may monitor the control and regulation of the blood pump with regard to the physiological condition of the patient”).
Regarding claim 9, Simundic discloses the invention of claim 1. Simundic further discloses wherein the controller 48 (Fig. 4) is further configured to receive a user-scripted input to operate the blood pump system 40 (Fig. 4) in a pulsatile manner (Par. 45 – “the pump flow value may correspond to a specific speed, such that the inputting of the speed via a user interface of the control unit will define the pump flow value”, and Par. 19 – “The control unit actuates the motor of the pump drive and is configured to adjust the speed of the rotor blade of the blood pump in such a way that the blood pump produces a wave-like flow corresponding to a pulsatile blood flow”).
Regarding claim 10, Simundic discloses the invention of claim 1. Simundic further discloses wherein the blood pump system 40 (Fig. 4) is programed to vary the motor speed in a pulsatile manner (Par. 19 – “The control unit actuates the motor of the pump drive and is configured to adjust the speed of the rotor blade of the blood pump in such a way that the blood pump produces a wave-like flow corresponding to a pulsatile blood flow”).
Regarding claim 15, Simundic discloses the invention of claim 1. Simundic further discloses eing operable at clinically relevant levels of flow and pressure needed in extracorporeal life support applications (Par. 43 – “predefined threshold values may be stored in the control unit which correspond to essential values of vital parameters or the physiological condition of the patient. In other words, physiological limits for energy equivalent pressure and mean arterial pressure may thus be provided, which may be absolute and/or patient-specific values”, and Par. 45 – “the pump flow value may correspond to a specific speed, such that the inputting of the speed via a user interface of the control unit will define the pump flow value”; Examiner further notes that it should be understood by a skilled artisan that such a device like Simundic has to operate at clinically appropriate values to ensure patient safety).
Regarding claim 16, Simundic discloses a method of operating the blood pump system 40 (Fig. 4, and Abstract – “control units for non-occlusive blood pumps of an extracorporeal circulatory support as well as systems comprising such a control unit and corresponding methods”) of claim 1 (see rejection of claim 1 above) for extracorporeal life support applications 36 (Fig. 4), comprising:
driving the DC motor, thereby the blood pump at a target pump speed (Par. 39 – “the speed achieved”) to provide the blood flow in the ECMO circuit for extracorporeal physiological support for the patient in an automatic mode or a manual mode (Par. 38-39 – “the blood pump may also be controlled or regulated… a brushless DC motor, so that the motor of the pump drive may be switched in two opposite directions and a speed reduction may accordingly be actively achieved by a reversal of the current direction”),
wherein the target pump speed is determined based on preset operation parameters (Par. 20 – “the pulse amplitude may be defined by changing the rotary speed, which may be inputted at the control unit and is optionally added to a basic flow. For example, a basic flow may be predefined, wherein the respective pulses cause an increase in the total blood flow”).
Regarding claim 17, Simundic discloses the invention of claim 16. Simundic further discloses wherein the preset operation parameters include setpoint flow (Par. 20 – “the rotary speed, which may be inputted at the control unit… a basic flow may be predefined, wherein the respective pulses cause an increase in the total blood flow”) and/or a physiological state of the patient (Par. 43 – “predefined threshold values may be stored in the control unit which correspond to essential values of vital parameters or the physiological condition of the patient. In other words, physiological limits for energy equivalent pressure and mean arterial pressure may thus be provided, which may be absolute and/or patient-specific values).
Regarding claim 19, Simundic discloses the invention of claim 16. Simundic further discloses further comprising:
measuring 58 (Fig. 4 – flow sensor 58) the pump speed of in real time (Par. 124 – “the control unit 48 is configured to receive a flow value of extracorporeal circulatory support from a flow sensor 58”); and
regulating the motor speed responsively to adjust the pump speed when the measured pump speed is deviated from the target pump speed (Par. 124 – “To further adapt the blood flow according to the patient 38, the control unit 48 is configured to receive a flow value of extracorporeal circulatory support from a flow sensor 58” and “The flow sensor 58 thus provides feedback for the set speed at the blood pump 40”).
Regarding claim 21, Simundic discloses the invention of claim 16. Simundic further discloses further comprising: measuring the flow rate 58 (Fig. 4 – flow sensor 58) in the ECMO circuit 36 (Fig. 4); and regulating the motor speed responsively to adjust the pump speed when the measured flow rate are deviated from the setpoint flow (Par. 124 – “To further adapt the blood flow according to the patient 38, the control unit 48 is configured to receive a flow value of extracorporeal circulatory support from a flow sensor 58” and “The flow sensor 58 thus provides feedback for the set speed at the blood pump 40”).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Simundic in view of Petersen US 2020/0282121 A1 (hereinafter Petersen).
Regarding claim 5, Simundic discloses the invention of claim 1. However, Simundic does not disclose further comprising: a Hall effect sensor positioned in relation to the magnetic coupling member to measure a pump speed of the blood pump in real time, wherein the controller is further configured to receive a signal of the pump speed from the Hall effect sensor and regulate the motor speed of the DC motor responsively.
Petersen, in the same field of endeavor of a blood pump using impeller (Par. 10), teaches a Hall effect sensor (Par. 21 – “one Hall-Effect sensor”) positioned in relation to the magnetic coupling member (Par. 21 – “The motor stator”) to measure a pump speed of the blood pump in real time (Par. 21 – “The motor stator is mounted to the housing and operable to magnetically rotate the impeller” and “The at least one Hall-Effect sensor is configured to generate output indicative of a displacement of the impeller along the blood flow channel induced by the thrust load applied to the impeller”),
wherein the controller is further configured to receive a signal of the pump speed from the Hall effect sensor (Par. 21 – “the controller is configured to determine an impeller rotational speed for the impeller, process the output generated by the at least one Hall-Effect sensor“) and regulate the motor speed of the DC motor responsively (Par. 22 – “An impeller rotational speed for the impeller is determined by the controller. A flow rate of blood impelled by the impeller is estimated by the controller based on the impeller rotational speed and the displacement of the impeller”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Simundic to further include a Hall effect sensor for measuring and regulating pump speed as taught by Petersen, in order to generate output indicative of a displacement of the impeller along the blood flow (Par. 21 of Petersen). This also allows for controlling a motor stator to rotate the impeller (Par. 16 of Petersen).
Claims 11-13, 18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Simundic in view of Johns et al. US 2022/0249759 A1 (hereinafter Johns).
Regarding claim 11, Simundic discloses the invention of claim 1. Simundic further discloses
further comprising: a feedback mechanism for controlling the pump speed (Par. 46 – “wherein the control unit may be further configured to adjust the mean flow based on a received flow measurement and the mean arterial pressure by setting or adjusting the pulse parameter” and Par. 109 – “a flow value of 10 may be obtained… and provide direct feedback regarding the blood flow in the extracorporeal circulatory support for the control unit… the blood flow provided by a non-occlusive blood pump may be inputted as a rotational speed and may be adapted to the feedback value”), so as to enable automation according to metabolic need of the patient (Par. 48 – “This enables automated adjustment of the blood pump and the extracorporeal circulatory support”).
However, Simundic does not disclose using venous saturation as a surrogate measure for patient status and basis for speed adjustment.
Johns, in the same field of endeavor of extracorporeal support device (Abstract), teaches using venous saturation as a surrogate measure for patient status (Par. 5 – “Devices used with these automated systems typically measure… blood oxygen saturation in the venous or arterial blood…”) and basis for speed adjustment (Par. 6 – “Current automated control systems process the measured values as input signals and produce outputs that control blood… flow rates… For such systems, a clinician or perfusionist judges the target oxygen… concentrations (and/or… saturation levels) which are most desirable”).
Since Simundic discusses that the automated adjustment of the blood pump can be operated based on other vital parameters, such as other physiological values of the patient (Par. 48 of Simundic), it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Simundic to use venous saturation for patient status and speed pump adjustment as taught by Johns, as Johns discusses that it is well-known within the field to use oxygen saturation in the venous blood as a parameter for the controller to output according blood flow rate adjustments (Par. 5 and Par. 6 of Johns).
Regarding claim 12, Simundic in view of Johns discloses the invention of claim 11. The combination further discloses wherein the feedback mechanism (Par. 109 of Simundic) comprises an oxygen sensor (Abstract of Johns – “The control system comprises: a sensor arranged to detect and output a measurand”, and Par. 91 of Johns – “Measurands of blood gas composition might include… oxygen saturation”) coupled in the ECMO circuit 36 (Fig. 4 of Simundic) to monitor an oxygen saturation (SvO2) of the patient (Par. 5 of Johns – “Devices used with these automated systems typically measure… blood oxygen saturation in the venous or arterial blood”).
Examiner notes that once the modification is made as discussed in claim 11, venous oxygen saturation measurement of Johns is incorporated into the device of Simundic, which is understood by one of ordinary skill in the art that a sensor, in this instant case an oxygen sensor, has to be present within the extracorporeal circuit. Thus, the limitation is met.
Regarding claim 13, Simundic in view of Johns discloses the invention of claim 11. The combination further discloses wherein the blood pump system 40 (Fig. 4 of Simundic) is programmed (Par. 45 of Simundic – “the pump flow value may correspond to a specific speed, such that the inputting of the speed via a user interface of the control unit will define the pump flow value”).
However, the combination does not currently disclose such that the pump speed is automatically adjusted to maintain a setpoint flow for physiologic oxygen saturation.
Johns, in the same field of endeavor of extracorporeal support device (Abstract), teaches such that the pump speed is automatically adjusted to maintain a setpoint flow for physiologic oxygen saturation (Par. 4 of Johns – “The set points may be selected from… oxygen saturation in the arterial blood, or corresponding measures in the venous blood. The controllers typically use measurements of selected variables to provide feedback control to maintain them at their set points”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of the combination to further include setpoint flow to which the pump speed is automatically adjusted as taught by Johns, in order to provide feedback control and maintain the flow system at their set points (Par. 4 of Johns).
Regarding claim 18, Simundic discloses the invention of claim 16. However, Simundic does not disclose wherein the physiological state of the patient includes an oxygen level, an oxygen consumption and/or oxygen saturation.
Johns, in the same field of endeavor of extracorporeal support device (Abstract), teaches wherein the physiological state of the patient includes an oxygen level and/or oxygen saturation (Par. 5 – “Devices used with these automated systems typically measure oxygen and/or carbon dioxide concentration in the venous or arterial blood, and/or… blood oxygen saturation in the venous or arterial blood…”).
Since Simundic discusses that the adjustment of the pump speed can be operated based on other vital parameters, such as other physiological values of the patient (Par. 48 of Simundic), it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Simundic to use oxygen level or oxygen saturation as taught by Johns, as Johns discusses that it is well-known within the field to use oxygen saturation in the venous blood as a parameter for the controller to output according blood flow rate adjustments (Par. 5 and Par. 6 of Johns).
Regarding claim 20, Simundic discloses the invention of claim 16. However, Simundic does not disclose further comprising: measuring the SvO2; and regulating the motor speed responsively to adjust the pump speed when the measured SvO2 is deviated from a setpoint value.
Johns, in the same field of endeavor of extracorporeal support device (Abstract), teaches further comprising: measuring the SvO2 (Abstract – “The control system comprises: a sensor arranged to detect and output a measurand”, and Par. 91 – “Measurands of blood gas composition might include… oxygen saturation”); and regulating the motor speed responsively to adjust the pump speed when the measured SvO2 is deviated from a setpoint value (Par. 4 – “The set points may be selected from… oxygen saturation in the arterial blood, or corresponding measures in the venous blood. The controllers typically use measurements of selected variables to provide feedback control to maintain them at their set points”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of the combination to further include measurement of SvO2 and a setpoint flow to which the pump speed is automatically adjusted as taught by Johns, in order to provide feedback control and maintain the flow system at their set points (Par. 4 of Johns).
Claims 14 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Simundic in view of Franano US 2014/0296615 A1 (hereinafter Franano).
Regarding claim 14, Simundic discloses the invention of claim 1. However, Simundic does not disclose further comprising: a safety mechanism for ensuring the blood pump not to blindly increase speed in response to an abnormal ECMO circuit condition including circuit obstruction, low fluid volume status, clot formation, a suction event, pump thrombosis, and/or circuit thrombosis.
Franano, in the same field of endeavor of blood pump system (Title), teaches further comprising: a safety mechanism for ensuring the blood pump not to blindly increase speed in response to an abnormal extracorporeal circuit condition (Par. 164 – “The automatic control system may also include safety features to avoid hazards associated with changes in the patient's cardiovascular system or malfunctions of the pump system or pump control system” and “Pump speed is immediately decreased… and an alarm is triggered”) including circuit obstruction, low fluid volume status, clot formation, a suction event, pump thrombosis, and/or circuit thrombosis (Par. 164 – “a speed control method 670 can detect characteristic changes in the motor current waveform associated with decreased preload or increase in afterload (e.g. due to thrombosis), suction, flow limitation, and imminent collapse of the vessel”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Simundic to further include a safety mechanism as taught by Franano, in order to provide safety features to avoid hazards associated with changes in the system, such as pump system malfunction (Par. 164 of Franano).
Regarding claim 22, Simundic discloses the invention of claim 16. However, Simundic does not disclose further comprising: detecting an abnormal ECMO circuit condition including circuit obstruction, low fluid volume status, clot formation, a suction event, pump thrombosis, and/or circuit thrombosis; and regulating the motor speed responsively to ensure the blood pump not to blindly increase speed when the abnormal ECMO circuit condition is detected.
Franano, in the same field of endeavor of blood pump system (Title), teaches further comprising:
detecting an abnormal ECMO circuit condition including circuit obstruction, low fluid volume status, clot formation, a suction event, pump thrombosis, and/or circuit thrombosis (Par. 164 – “a speed control method 670 can detect characteristic changes in the motor current waveform associated with decreased preload or increase in afterload (e.g. due to thrombosis), suction, flow limitation, and imminent collapse of the vessel”); and
regulating the motor speed responsively to ensure the blood pump not to blindly increase speed when the abnormal ECMO circuit condition is detected (Par. 164 – “The automatic control system may also include safety features to avoid hazards associated with changes in the patient's cardiovascular system or malfunctions of the pump system or pump control system” and “Pump speed is immediately decreased… and an alarm is triggered”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Simundic to further include regulating the system when an abnormality is detected as taught by Franano, in order to provide safety features to avoid hazards associated with changes in the system, such as pump system malfunction (Par. 164 of Franano).
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Simundic in view of Franano as applied to claim 22 above, and further in view of Lerner WO 2022147476 A1 (hereinafter Lerner).
Regarding claim 23, Simundic in view of Franano discloses the invention of claim 22. However, the combination does not disclose wherein when the abnormal ECMO circuit condition is detected, the blood pump system exits from the automatic mode and enters the manual mode until the abnormal ECMO circuit condition is resolved.
Lerner, in the same field of endeavor of blood filtration system such as extracorporeal membrane oxygenation (ECMO) therapy (Page 8, line 3-13), teaches wherein when the abnormal ECMO circuit condition is detected (Page 5, line 1-6 – “blood may stagnate within the blood circuit in correspondence with the blood flow rate (through the blood circuit) exceeds the flow rate through the vein of the patient. In an example, pressure in the withdrawal lumen may increase as the blood flow rate approaches the flow rate through the vein of the patient. In an approach, the pressure in the withdrawal lumen may exceed a pressure threshold”), the blood pump system exits from the automatic mode and enters the manual mode (Page 5, line 6 – “the blood filtration system may stop the blood pump (and correspondingly stop flow within the blood circuit)”) until the abnormal ECMO circuit condition is resolved (Page 5, line 9-10 – “The filter may be replaced to resume operation of the blood filtration system”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of the combination to further include a switch from automatic mode to manual mode when an abnormal condition such as clot or blood loss is detected as taught by Lerner, in order to reduce stagnation within a blood circuit (Page 5, first paragraph of Lerner) via appropriate repair/replacement as taught by Lerner (Page 5, line 10 of Lerner). It also would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of the combination to have the system go into manual mode as taught by Lerner, so that clinicians can thoroughly investigate and fix the abnormality for patient safety.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Blanchard et al. US 2020/0390951 A1 teaches using physiological parameters for pump modification in a feedback loop.
Varasani US 2023/0018668 A1 teaches monitoring multiple parameters in response for different treatment modifications based on said measured parameters.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUYNH DAO LE whose telephone number is (571)272-7198. The examiner can normally be reached Monday - Friday 8:30 am - 5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/QUYNH DAO LE/Examiner, Art Unit 3781 /JESSICA ARBLE/Primary Examiner, Art Unit 3781
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