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 .
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.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moyer et al. (US 20180353667) in view of Edelman et al (US 20220167862).
Regarding claim 1, Moyer discloses a housing 100, configured to be positioned within a patient (Fig. 1, section 0029 , 0046, The intravascular heart pump system can be inserted in various ways, such as by percutaneous insertion into the heart); an impeller carried within the housing (Fig. 1, section 0041, The motor 108 also drives a rotor) which rotates to pump blood from the pump inlet 114 through the cannula 111 to the pump outlet); a motor 108 configured to rotate the impeller relative to the housing to cause blood to flow through the housing (Fig. 1, section 0041, The motor 108 also drives a rotor (not visible in figure) which rotates to pump blood from the pump inlet 114 through the cannula 111 to the pump outlet ); and a controller 300 operably coupled to the motor (section 0057, The user interface 300 may be used to control the intravascular heart pump system), the controller being configured to determine: a vascular pressure 302 within the patient (section 0057, The pressure signal waveform 302 indicates the pressure measured by the blood pump's pressure sensor (e.g., pressure sensor 112) and, when the pump is properly placed, corresponds to an aortic pressure); and a cardiac performance parameter based on the blood flow parameter (section 0063, The native cardiac output can be used to calculate additional cardiac parameters of clinical relevance. For example, the native cardiac output can be used in conjunction with information about the flow rate of the blood pump to calculate a total cardiac output of the heart itself and the blood pump).
However, Moyer does not specfically disclose a working voltage applied to the motor to cause the motor to rotate the impeller; a working speed of the motor caused by providing the working voltage to the motor; a blood flow parameter based on the vascular pressure, the working voltage, and the working speed. Edelman discloses a working voltage applied to the motor to cause the motor to rotate the impeller (section 0092, the controller may supply a varying voltage to hold a constant rotational velocity of the rotor 310 by the motor 308 independent of pre-load and/or afterload); a working speed of the motor caused by providing the working voltage to the motor (section 0092, he user may select a new set point (e.g., by setting a new desired flow rate or rotational speed) or may select a time-varying input signal (e.g., a delta, step, ramp function, or sinusoid). In some implementations, the fixed set point may be an amount of power delivered to the motor); a blood flow parameter based on the vascular pressure, the working voltage, and the working speed (section 0092, the heart parameter estimated by the heart parameter estimator 316 is displayed to a physician and the physician manually adjusts the set point of the motor at the controller). This allows for proper control and adjustment to drive the motor in the heart pump. Therefore it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify the device of Moyer by adding a working voltage applied to the motor to cause the motor to rotate the impeller; a working speed of the motor caused by providing the working voltage to the motor; a blood flow parameter based on the vascular pressure, the working voltage, and the working speed as taught by Edelman in order to facilitate proper control and adjustment to drive the motor in the heart pump.
Regarding claim 2, Moyer discloses a pressure sensor operably coupled to the controller, wherein the controller is configured to determine the vascular pressure within the patient via the pressure sensor (section 0048, The controller can then use the pressure gradient with other determined or measured values such as the aortic pressure measured at a pressure sensor (for example, pressure sensor 112 in FIG. 1) to determine various cardiac parameters such as LVEDP, LVP, aortic pulse pressure, mean aortic pressure, pump flow, pressure gradient, heart rate, cardiac output, cardiac power output, native cardiac output, native cardiac power output, cardiac contractility, cardiac relaxation, fluid responsiveness, volume status, cardiac unloading index, and cardiac recovery index).
Regarding claim 3, Moyer in view of Edelman, specifically Edelman discloses the motor comprises a plurality of motor windings, and the controller is configured to determine the working speed of the motor based on voltage fluctuations in the plurality of motor windings (Section 0047, The motor current drawn by a blood pump is proportional to the pressure gradient across the blood pump cannula at a known motor speed. The plot 200 may function as a look-up for an algorithm to determine a pressure gradient from a given motor current and motor speed at which a blood pump motor is currently operating). Edelman discloses voltage fluctuations in the plurality of motor windings (section 0092, the controller may supply a varying voltage to hold a constant rotational velocity of the rotor by the motor independent of pre-load and/or afterload. The controller may also allow a user to vary the rotational velocity of the rotor, and in some implementations, the motor. For example, the user may select a new set point e.g., by setting a new desired flow rate or rotational speed) or may select a time-varying input signal). This allows for proper control and adjustment to drive the motor in the heart pump.
Regarding claim 4, Moyer discloses the controller determines the blood flow parameter 1010 by using a mathematical function comprising the vascular pressure 1008, , and the working speed 1006 (Fig. 10, section 0120, the current delivered to the motor is measured and the motor speed is measured. In step 1008, the pressure differential across a cannula of the blood pump is determined based on the measured motor current and measured motor speed. In step 1010, a cardiac parameter is calculated based on the pressure differential across the cannula of the blood pump and the aortic pressure. The calculated cardiac parameter may be any of LVEDP, LVP, aortic pulse pressure, mean aortic pressure, pump flow, pressure gradient, or heart rate). Edelman disclose the working voltage (Section 0092, the controller may supply a varying voltage to hold a constant rotational velocity of the rotor 310 by the motor 308 independent of pre-load and/or afterload). This allows for proper control and adjustment to drive the motor in the heart pump.
Regarding claim 5, Moyer discloses the mathematical function comprises a square of the vascular pressure (section 0064, The total cardiac power output is calculated from the total cardiac output, calculated based on the native cardiac output as described above. The total cardiac power output is calculated by multiplying the cardiac output by the mean arterial pressure and dividing).
Regarding claim 6, Moyer discloses the mathematical function comprises a square of the working voltage (section 0047, the motor current drawn by a blood pump is proportional to the pressure gradient across the blood pump cannula at a known motor speed. The plot 200 may function as a look-up for an algorithm to determine a pressure gradient from a given motor current and motor speed at which a blood pump motor is currently operating).
Regarding claim 7, Moyer in view Edelman, specfically Edelman discloses the mathematical function comprises a square of the working speed (Section 0083, The load on the pump at a given rotor RPM is determined by the fluid motor torque described by the equation τ=H·d, where the torque, τ, is determined by the pressure head, H, and volumetric displacement per revolution, d. Torque is directly related to the power requirements of the pump by the equation: Pelectrical=V*I=τ*ω/η, where the electrical power requirement (Pelectrical) is a product of the voltage (V) and current (I), and is related to the pump torque (τ), rotational speed (ω), and combined electrical and mechanical efficiency (η)). This allows for proper control and adjustment to drive the motor in the heart pump.
Regarding claim 8, Moyer discloses the mathematical function comprises a product of the vascular pressure and the working voltage (Section 0083, The load on the pump at a given rotor RPM is determined by the fluid motor torque described by the equation τ=H·d, where the torque, τ, is determined by the pressure head, H, and volumetric displacement per revolution, d. Torque is directly related to the power requirements of the pump by the equation: Pelectrical=V*I=τ*ω/η, where the electrical power requirement (Pelectrical) is a product of the voltage (V) and current (I), and is related to the pump torque (τ), rotational speed (ω), and combined electrical and mechanical efficiency (η)). This allows for proper control and adjustment to drive the motor in the heart pump.
Regarding claim 9, Moyer discloses the mathematical function comprises a product of the vascular pressure and the working speed (section 0049, the pressure gradient across the blood pump cannula has been determined from the motor current and motor speed, the pressure gradient across the blood pump cannula can be used with a measured aortic pressure (such as pressure measured at the pressure sensor).
Regarding claim 10, Moyer in view of Edelman, specfically Edelman discloses the mathematical function comprises a product of the working voltage and the working speed (Section 0083, The load on the pump at a given rotor RPM is determined by the fluid motor torque described by the equation τ=H·d, where the torque, τ, is determined by the pressure head, H, and volumetric displacement per revolution, d. Torque is directly related to the power requirements of the pump by the equation: Pelectrical=V*I=τ*ω/η, where the electrical power requirement (Pelectrical) is a product of the voltage (V) and current (I), and is related to the pump torque (τ), rotational speed (ω), and combined electrical and mechanical efficiency (η)). This allows for proper control and adjustment to drive the motor in the heart pump.
Regarding claim 11, Moyer in view of Edelman, specfically Edelman discloses the mathematical function comprises a product of the vascular pressure, the working voltage, and the working speed (Section 0083, The load on the pump at a given rotor RPM is determined by the fluid motor torque described by the equation τ=H·d, where the torque, τ, is determined by the pressure head, H, and volumetric displacement per revolution, d. Torque is directly related to the power requirements of the pump by the equation: Pelectrical=V*I=τ*ω/η, where the electrical power requirement (Pelectrical) is a product of the voltage (V) and current (I), and is related to the pump torque (τ), rotational speed (ω), and combined electrical and mechanical efficiency (η)). This allows for proper control and adjustment to drive the motor in the heart pump.
Regarding claim 12, Moyer discloses an impeller (Fig. 1, section 0041, The motor 108 also drives a rotor), a motor 108 configured to rotate the impeller to cause blood flow within the patient (Fig. 1, section 0041, The motor 108 also drives a rotor (not visible in figure) which rotates to pump blood from the pump inlet 114 through the cannula 111 to the pump outlet), and a controller 300 operably coupled to the motor (section 0057, The user interface 300 may be used to control the intravascular heart pump system), the method comprising: determining, via the controller, a vascular pressure within the patient (section 0057, The pressure signal waveform 302 indicates the pressure measured by the blood pump's pressure sensor (e.g., pressure sensor 112) and, when the pump is properly placed, corresponds to an aortic pressure); determining, via the controller and determining, via the controller, a cardiac performance parameter based on the blood flow parameter (section 0063, The native cardiac output can be used to calculate additional cardiac parameters of clinical relevance. For example, the native cardiac output can be used in conjunction with information about the flow rate of the blood pump to calculate a total cardiac output of the heart itself and the blood pump).
However, Moyer does not specfically disclose a working voltage applied to the motor to cause the motor to rotate the impeller; a working speed of the motor caused by providing the working voltage to the motor; a blood flow parameter based on the vascular pressure, the working voltage, and the working speed. Edelman discloses a working voltage applied to the motor to cause the motor to rotate the impeller (section 0092, the controller may supply a varying voltage to hold a constant rotational velocity of the rotor 310 by the motor 308 independent of pre-load and/or afterload); a working speed of the motor caused by providing the working voltage to the motor (section 0092, he user may select a new set point (e.g., by setting a new desired flow rate or rotational speed) or may select a time-varying input signal (e.g., a delta, step, ramp function, or sinusoid). In some implementations, the fixed set point may be an amount of power delivered to the motor); a blood flow parameter based on the vascular pressure, the working voltage, and the working speed (section 0092, the heart parameter estimated by the heart parameter estimator 316 is displayed to a physician and the physician manually adjusts the set point of the motor at the controller). This allows for proper control and adjustment to drive the motor in the heart pump. Therefore it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify the device of Moyer by adding a working voltage applied to the motor to cause the motor to rotate the impeller; a working speed of the motor caused by providing the working voltage to the motor; a blood flow parameter based on the vascular pressure, the working voltage, and the working speed as taught by Edelman in order to facilitate proper control and adjustment to drive the motor in the heart pump.
Regarding claim 13, Moyer discloses modifying operation 918 of the percutaneous circulatory support device based on the cardiac performance parameter (Fig. 9, section 0115, change to the motor speed is determined based on the calculated cardiac parameter and heart function parameter).
Regarding claim 14, Moyer discloses determining, via the controller, contractability of cardiac function 910 of the patient by varying the working speed 906 of the motor (Fig. 9, section 0115, the current delivered to the motor is measured and the motor speed is measured. In step 908, the pressure differential across a cannula of the blood pump is determined based on the measured motor current and the measured motor speed. In step 910, a cardiac parameter is calculated based on the pressure differential across the cannula of the blood pump and the aortic pressure. In step 912, the calculated cardiac parameter is recorded in the memory. The calculated cardiac parameter may be any of LVEDP, LVP, aortic pulse pressure, mean aortic pressure, pump flow, pressure gradient, or heart rate).
Regarding claim 16, Moyer discloses a housing 100 configured to be positioned within a patient (Fig. 1, section 0029 , 0046, The intravascular heart pump system can be inserted in various ways, such as by percutaneous insertion into the heart); an impeller carried within the housing (Fig. 1, section 0041, The motor 108 also drives a rotor) a motor 108 configured to rotate the impeller relative to the housing to cause blood to flow through the housing (Fig. 1, section 0041, The motor 108 also drives a rotor (not visible in figure) which rotates to pump blood from the pump inlet 114 through the cannula 111 to the pump outlet); and a controller 300 operably coupled to the motor (section 0057, The user interface 300 may be used to control the intravascular heart pump system), and a cardiac performance parameter based on the blood flow parameter (section 0063, The native cardiac output can be used to calculate additional cardiac parameters of clinical relevance. For example, the native cardiac output can be used in conjunction with information about the flow rate of the blood pump to calculate a total cardiac output of the heart itself and the blood pump).
However, Moyer does not specfically disclose the controller being configured to determine: a working voltage applied to the motor to cause the motor to rotate the impeller; a blood flow parameter using a mathematical function comprising a square of the working voltage. Edelman discloses the controller being configured to determine: a working voltage applied to the motor to cause the motor to rotate the impeller; a blood flow parameter using a mathematical function comprising a square of the working voltage (section 0092, the controller may supply a varying voltage to hold a constant rotational velocity of the rotor 310 by the motor 308 independent of pre-load and/or afterload, the user may select a new set point (e.g., by setting a new desired flow rate or rotational speed) or may select a time-varying input signal (e.g., a delta, step, ramp function, or sinusoid; the heart parameter estimated by the heart parameter estimator 316 is displayed to a physician and the physician manually adjusts the set point of the motor at the controller). This allows for proper control and adjustment to drive the motor in the heart pump. Therefore it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify the device of Moyer by adding a working voltage applied to the motor to cause the motor to rotate the impeller; a working speed of the motor caused by providing the working voltage to the motor; a blood flow parameter based on the vascular pressure, the working voltage, and the working speed as taught by Edelman in order to facilitate proper control and adjustment to drive the motor in the heart pump.
Regarding claim 17, Moyer discloses the controller is further configured to determine a vascular pressure within the patient, and the mathematical function further comprises a square of the vascular pressure (section 0064, The total cardiac power output is calculated from the total cardiac output, calculated based on the native cardiac output as described above. The total cardiac power output is calculated by multiplying the cardiac output by the mean arterial pressure and dividing).
Regarding claim 18, Moyer in view of Edelman, specfically Edelman discloses the controller is further configured to determine a working speed of the motor caused by providing the working voltage to the motor, and the mathematical function further comprises a square of the working speed (Section 0083, The load on the pump at a given rotor RPM is determined by the fluid motor torque described by the equation τ=H·d, where the torque, τ, is determined by the pressure head, H, and volumetric displacement per revolution, d. Torque is directly related to the power requirements of the pump by the equation: Pelectrical=V*I=τ*ω/η, where the electrical power requirement (Pelectrical) is a product of the voltage (V) and current (I), and is related to the pump torque (τ), rotational speed (ω), and combined electrical and mechanical efficiency (η)). This allows for proper control and adjustment to drive the motor in the heart pump.
Regarding claim 19, Moyer in view of Edelman, specfically Edelman discloses the controller is further configured to determine a vascular pressure within the patient, and the mathematical function further comprises a product of the vascular pressure and the working voltage (Section 0083, The load on the pump at a given rotor RPM is determined by the fluid motor torque described by the equation τ=H·d, where the torque, τ, is determined by the pressure head, H, and volumetric displacement per revolution, d. Torque is directly related to the power requirements of the pump by the equation: Pelectrical=V*I=τ*ω/η, where the electrical power requirement (Pelectrical) is a product of the voltage (V) and current (I), and is related to the pump torque (τ), rotational speed (ω), and combined electrical and mechanical efficiency (η)). This allows for proper control and adjustment to drive the motor in the heart pump
Regarding claim 20, Moyer discloses the controller is further configured to determine: a vascular pressure within the patient (section 0048, The controller can then use the pressure gradient with other determined or measured values such as the aortic pressure measured at a pressure sensor (for example, pressure sensor 112 in FIG. 1) to determine various cardiac parameters such as LVEDP, LVP, aortic pulse pressure, mean aortic pressure, pump flow, pressure gradient, heart rate, cardiac output, cardiac power output, native cardiac output, native cardiac power output, cardiac contractility, cardiac relaxation, fluid responsiveness, volume status, cardiac unloading index, and cardiac recovery index);
However, Moyer does not disclose a working speed of the motor caused by providing the working voltage to the motor; and wherein the mathematical function further comprises a product of the vascular pressure, the working voltage, and the working speed. Edelman discloses a working speed of the motor caused by providing the working voltage to the motor; and wherein the mathematical function further comprises a product of the vascular pressure, the working voltage, and the working speed (Section 0083, The load on the pump at a given rotor RPM is determined by the fluid motor torque described by the equation τ=H·d, where the torque, τ, is determined by the pressure head, H, and volumetric displacement per revolution, d. Torque is directly related to the power requirements of the pump by the equation: Pelectrical=V*I=τ*ω/η, where the electrical power requirement (Pelectrical) is a product of the voltage (V) and current (I), and is related to the pump torque (τ), rotational speed (ω), and combined electrical and mechanical efficiency (η)). This allows for proper control and adjustment to drive the motor in the heart pump.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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/JON ERIC C MORALES/Primary Examiner, Art Unit 3796
/J.C.M/Primary Examiner, Art Unit 3796