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 § 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.
Claim(s) 1, 3, 23, 26, 51 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Spanier et al. (US 20150141842).
Regarding claim 1, Spanier discloses a method of controlling operation of a mechanical circulatory support (MCS) device to facilitate recovery of native heart function in a patient within which the MCS device is implanted (abstract, section 0002, Intravascular rotary blood pumps are used for temporary heart support and constitute an interesting alternative to conventional intraaortic balloon pumps (IABPs). Such blood pumps are introduced percutaneously into the femoral artery for example and guided through the body's vascular system in order to support or replace the pumping action in the heart), the method comprising: controlling a pump of the MCS device to operate in a first mode according to a first physiological need of the patient (section 0015, the primary task of measuring physiological pressures that give information about the heart's state of health, this pressure sensor thus has the further function of correctly positioning the blood pump in the patient's vascular system. In this case, it can be exactly ensured in a pressure-based manner that the inlet openings are located in the heart chamber, and the outlet openings in the aorta), wherein the pump of the MCS device includes an inlet arranged in a first chamber of a heart of the patient and an outlet arranged in a second chamber of the heart of the patient (Figs. 1, section 0015, it can be exactly ensured in a pressure-based manner that the inlet openings are located in the heart chamber), the pump configured to pump blood from the inlet 54 to the outlet 56 across at least one valve 15 in the heart of the patient (Figs. 1, 3, section 0025, 0029 the distal direction from the inflow end of the pump section 52 and having a suction inlet 54 located at its end, and the outlet openings in the aorta, blood is sucked through the blood pass-through openings 54 at the distal end of the flexible flow cannula 53 and ejected proximally of the impeller 58 through the blood flow-through openings 56); obtaining one or more first cardiac values associated with the patient during operation of the MCS device (Section 0026, The measurement of both the aortic pressure by means of the sensor head 60 and the ventricular pressure by means of the sensor head 30 makes possible); determining, based at least in part, on the obtained one or more first cardiac values, a second physiological need of the patient, wherein the second physiological need of the patient is different from the first physiological need of the patient to; and controlling the pump of the MCS device to operate in a second mode according to the second physiological need of the patient (section 0026, a contractility measurement by which the recovery of the heart is measured, as well as the establishment of the pressure difference which is used for computing the flow of the pumping device).
Regarding claim 3, Spanier discloses the first mode is a physiologic mode and the second mode is a sub-mode of the physiologic mode (The measurement of both the aortic pressure by means of the sensor head 60 and the ventricular pressure by means of the sensor head 30 makes possible, a contractility measurement by which the recovery of the heart is measured, as well as the establishment of the pressure difference which is used for computing the flow of the pumping device).
Regarding claim 23, Spanier in view of Simundie, specfically Simundie discloses the MCS device is a left ventricular assist device (LVAD) (Fig. 1, section 0020, a blood pump laid through the aorta, which extends through the aortic valve into the left ventricle and has an integrated pressure and kink sensor).
Regarding claim 26, Spanier discloses a controller for a pump of a mechanical circulatory support (MCS) device, the controller 100 comprising: at least one hardware processor configured to: control the pump of the MCS device to operate in a first mode according to a first physiological need of a patient (Fig. 1, section 0015, the primary task of measuring physiological pressures that give information about the heart's state of health, this pressure sensor thus has the further function of correctly positioning the blood pump in the patient's vascular system. In this case, it can be exactly ensured in a pressure-based manner that the inlet openings are located in the heart chamber, and the outlet openings in the aorta), wherein the pump of the MCS device includes in inlet 54 arranged in a first chamber of a heart of the patient and an outlet 56 arranged in a second chamber of the heart of the patient (Figs. 1, 3, section 0025, 0029 the distal direction from the inflow end of the pump section 52 and having a suction inlet 54 located at its end, and the outlet openings in the aorta, blood is sucked through the blood pass-through openings 54 at the distal end of the flexible flow cannula 53 and ejected proximally of the impeller 58 through the blood flow-through openings 56), the pump configured to pump blood from the inlet to the outlet across at least one valve in the heart of the patient (section 0025, 0029 the distal direction from the inflow end of the pump section 52 and having a suction inlet 54 located at its end, and the outlet openings in the aorta, blood is sucked through the blood pass-through openings 54 at the distal end of the flexible flow cannula 53 and ejected proximally of the impeller 58 through the blood flow-through openings 56); obtain one or more first cardiac values associated with the patient within which the MCS device is implanted, wherein the one or more first cardiac values are obtained during operation of the MCS device (Section 0026, The measurement of both the aortic pressure by means of the sensor head 60 and the ventricular pressure by means of the sensor head 30 makes possible); determine, based at least in part, on the obtained one or more first cardiac values, a second physiological need of the patient, wherein the second physiological need of the patient is different from the first physiological need of the patient; and control the pump of the MCS device to operate in a second mode according to the second physiological need of the patient (section 0026, a contractility measurement by which the recovery of the heart is measured, as well as the establishment of the pressure difference which is used for computing the flow of the pumping device).
Regarding claim 51, Spanier discloses A mechanical circulatory support (MCS) device, comprising: a pump 50, wherein the pump includes an inlet 54 arranged in a first chamber 16 of a heart of a patient and an outlet 56 arranged in a second chamber 12 of the heart of the patient, the pump configured to pump blood from the inlet to the outlet across at least one valve 15 in the heart of the patient (Figs. 1, 3, section 0025, 0029 the distal direction from the inflow end of the pump section 52 and having a suction inlet 54 located at its end, and the outlet openings in the aorta, blood is sucked through the blood pass-through openings 54 at the distal end of the flexible flow cannula 53 and ejected proximally of the impeller 58 through the blood flow-through openings 56); and a controller 100 coupled to the pump, the controller comprising at least one hardware processor configured to: control the pump to operate in a first mode according to a first physiological need of the patient; obtain one or more first cardiac values associated with the patient within which the MCS device is implanted, wherein the one or more first cardiac values are obtained during operation of the MCS device (Fig. 1, section 0015, 0026, the primary task of measuring physiological pressures that give information about the heart's state of health, this pressure sensor thus has the further function of correctly positioning the blood pump in the patient's vascular system. In this case, it can be exactly ensured in a pressure-based manner that the inlet openings are located in the heart chamber, and the outlet openings in the aorta. The measurement of both the aortic pressure by means of the sensor head and the ventricular pressure by means of the sensor head makes possible); determine, based at least in part, on the obtained one or more first cardiac values, a second physiological need of the patient, wherein the second physiological need of the patient is different from the first physiological need of the patient to transition operation of the MCS device to a second mode (section 0026, a contractility measurement by which the recovery of the heart is measured, as well as the establishment of the pressure difference which is used for computing the flow of the pumping device); and control the pump to operate in a second mode according to the second physiological need of the patient (section 0026, a contractility measurement by which the recovery of the heart is measured, as well as the establishment of the pressure difference which is used for computing the flow of the pumping device).
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) 6-14, 17-20, 22-23, 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Spanier et al. (US 20150141842) in view of Simundie (US 20220016410).
Regarding claim 6, Spanier discloses the invention substantially as claimed however does not show the first mode includes first operating parameters configured to operate the pump with a first flow type, and the second mode includes second operating parameters configured to operate the pump with a second flow type different from the first flow type. Simundie discloses the first mode includes first operating parameters configured to operate the pump with a first flow type (section 0081, 0087, the system comprises a control device that is configured to control the pump and the flow limiter in order to adjust the flow rate and the pressure. The control device is also configured to execute a support mode with a plurality of consecutive support flow rate pulses and support pressure pulses applied on the fluid flow), and the second mode includes second operating parameters configured to operate the pump with a second flow type different from the first flow type (section 0087, The control device 22 is configured to execute a weaning mode with a plurality of consecutive weaning flow rate pulses with and/or weaning pressure pulses applied on the fluid flow, wherein the pulses are essentially synchronized to the heart cycle of the patient 16 supported by the system). This allows for proper control of the blood flow within the heart pump device. Therefore it would have been obvious to one of ordinary skill in the art, at the time of the invention, to modify the device of Spanier by adding the first mode includes first operating parameters configured to operate the pump with a first flow type, and the second mode includes second operating parameters configured to operate the pump with a second flow type different from the first flow type as taught by Simundie in order to facilitate proper control of the blood flow within the heart pump device.
Regarding claim 7, Spanier in view of Simundie, specfically Simundie discloses the first flow type is continuous flow (section 0053, the resulting fluid flow may be continuous ) and the second flow type is a pulsatile flow (Section 0053, Pulses may be preferably applied on the flowing fluid or, less preferably, any flow of the fluid may be triggered by the application of pulses only). This facilitates proper control of the blood flow within the heart pump device.
Regarding claim 8, Spanier in view of Simundie, specfically Simundie discloses the first mode is a mode that provides optimized unloading of a left ventricle of a heart of the patient based on physiological signals (Section 0021, This decrease of pressure and increase in flow at the suction line may also be beneficial for supporting the patient's cardiac function, depending on the placement of the suction line, e.g. to reduce the afterload at the left ventricle portion of the heart). This facilitates proper control of the blood flow within the heart pump device for proper therapy to be delivered by the heart pump.
Regarding claim 9, Spanier in view of Simundie, specfically Simundie discloses the second mode is a mode that modulates a speed of the pump of the MCS device based on physiological responses of the patient (Section 0058-0059, pump speed may be increased by 2000 to 5000 revolutions per minute (rpm/min), preferably by 3000 rpm/min to 4500, more preferably by 3500 rpm/min and/or 4500 rpm/min, e.g. in case of an acute cardiac arrest for the support flow rate pulses and/or support pressure pulses. The support flow rate pulses and/or support pressure pulses may exhibit a pulse duration of about 150 ms (milliseconds) to 250 ms, preferably about 200 ms. In a preferred embodiment of the method, pump speed may be increased by 100 to 4000 revolutions per minute (rpm/min), preferably by 500 to 3499 rpm/min for the weaning flow rate pulses and/or weaning pressure pulses. The weaning flow rate pulses and/or weaning pressure pulses may exhibit a pulse duration of 50 ms to 250 ms, preferably 75 MS to 200 ms). This facilitates proper control of the blood flow within the heart pump device for proper therapy to be delivered by the heart pump.
Regarding claim 10, Spanier in view of Simundie, specfically Simundie discloses the second mode is a mode that facilitates reverse remodeling of heart function in the patient (Section 0054, Once the heart function, e.g. the stroke volume has reached physiological levels as a result of the cardiac support by the support mode, the method allows to continuously wean the patient and its heart from the support mode in order to allow the heart itself to recover in the best way possible). This facilitates proper control of the blood flow within the heart pump device for proper therapy to be delivered by the heart pump.
Regarding claim 11, Spanier in view of Simundie, specfically Simundie discloses optimized unloading of the left ventricle comprises maximum unloading of the left ventricle (Section 0021, This decrease of pressure and increase in flow at the suction line may also be beneficial for supporting the patient's cardiac function, depending on the placement of the suction line, e.g. to reduce the afterload at the left ventricle portion of the heart). This facilitates proper control of the blood flow within the heart pump device for proper therapy to be delivered by the heart pump.
Regarding claim 12, Spanier in view of Simundie, specfically Simundie discloses selecting a set of cardiac values to obtain based, at least in part, on the first mode, wherein obtaining one or more first cardiac values associated with the patient during operation of the MCS device comprises obtaining the one or more first cardiac values included in the set of cardiac values (Section 0040, the at least one sensor is configured to measure at least one of the following cardiac signals: a mean arterial pressure, systolic pressure, diastolic pressure, cardiac output, ejection fraction, heart rate, heartbeat, inotrope level, catecholamine level/dosing, and determination of the heart cycle wave, in particular the R-wave). This facilitates proper control of the blood flow within the heart pump device for proper therapy to be delivered by the heart pump.
Regarding claim 13, Spanier in view of Simundie, specfically Simundie discloses the one or more first cardiac values include one or more values obtained from the pump of the MCS device (section 0105, the mean flow rate may be measured by a flow sensor in one of the lines of the system). This facilitates proper control of the blood flow within the heart pump device for proper therapy to be delivered by the heart pump.
Regarding claim 14, Spanier in view of Simundie, specfically Simundie discloses processing, with at least one machine learning model, information obtained from one or more sensors 26 external to the MCS device to obtain the one or more first cardiac values (section 0082, 0085, To measure cardiac signals of the patient 16, the electrocardiograph 24 comprises one or more sensors 26, which are attached or adhere to the patient's skin in the present example. The control device 22 may be configured as a computer or a circuit board, for example. The control device may comprise a permanent or non-permanent memory device and may be configured to execute computer executable code, which may be a control algorithm for system). This facilitates proper control of the blood flow within the heart pump device for proper therapy to be delivered by the heart pump.
Regarding claim 17, Spanier in view of Simundie, specfically Simundie discloses the one or more first cardiac values include one or more values obtained from the pump of the MCS device (section 0105, the mean flow rate may be measured by a flow sensor in one of the lines of the system), one or more values obtained from one or more sensors external to the MCS device (section 0082, To measure cardiac signals of the patient 16, the electrocardiograph 24 comprises one or more sensors 26, which are attached or adhere to the patient's skin in the present example) and one or more values obtained indirectly from information associated with one or more sensors associated with the MCS device and/or the one or more sensors external to the MCS device (section 0082, This allows the control device to control the pump and the adjustable flow limiter based on measured and/or estimated cardiac signals recorded by the electrocardiograph. To measure cardiac signals of the patient, the electrocardiograph comprises one or more sensors, which are attached or adhere to the patient's skin in the present example). This facilitates proper control of the blood flow within the heart pump device for proper therapy to be delivered by the heart pump.
Regarding claim 18, Spanier in view of Simundie, specfically Simundie discloses determining, based at least in part, on the one or more first cardiac values to adjust a speed of the pump of the MCS device; and adjusting the speed of the pump of the MCS device when it is determined to adjust the speed of the pump and when it is not determined to transition operation of the MCS device to the second mode (Section 0058-0059, pump speed may be increased by 2000 to 5000 revolutions per minute (rpm/min), preferably by 3000 rpm/min to 4500, more preferably by 3500 rpm/min and/or 4500 rpm/min, e.g. in case of an acute cardiac arrest for the support flow rate pulses and/or support pressure pulses. The support flow rate pulses and/or support pressure pulses may exhibit a pulse duration of about 150 ms (milliseconds) to 250 ms, preferably about 200 ms. In a preferred embodiment of the method, pump speed may be increased by 100 to 4000 revolutions per minute (rpm/min), preferably by 500 to 3499 rpm/min for the weaning flow rate pulses and/or weaning pressure pulses. The weaning flow rate pulses and/or weaning pressure pulses may exhibit a pulse duration of 50 ms to 250 ms, preferably 75 MS to 200 ms). This facilitates proper control of the blood flow within the heart pump device for proper therapy to be delivered by the heart pump.
Regarding claim 19, Spanier in view of Simundie, specfically Simundie discloses obtaining one or more second cardiac values associated with the patient during operation of the MCS device in the second mode (section 0045, the weaning mode may thus comprise a first weaning mode operation mode with a plurality of first weaning flow rate pulse and/or of first weaning pressure pulses and a second weaning mode with a plurality of second weaning flow rate pulses and/or second weaning pressure pulses. The energy level of each pulse of the second weaning mode is lower than the energy level of the pulses of the first weaning mode); determining, based at least in part, on the obtained one or more second cardiac values to transition operation of the MCS device to a third mode; and controlling the pump of the MCS device to operate in the third mode when it is determined to transition operation of the MCS device to the third mode (section 0035, Thus, the control device is configured to execute an automatic or manually triggered emergency cardiac arrest operation mode. The control device can automatically switch from either the support or the weaning mode to such an emergency mode). This facilitates proper control of the blood flow within the heart pump device for proper therapy to be delivered by the heart pump.
Regarding claim 20, Spanier in view of Simundie, specfically Simundie discloses the first mode is a decompression mode (section 0032, the system, in particular the control device, is configured to increase the pump speed by 2000 to 5000 revolutions per minute (rpm/min), preferably by 3000 rpm/min to 4500, alternatively or additionally by 3500 rpm/min to 6000 rpm/min, preferably 4500 rpm/min, in case of acute cardiac arrest, when generating the support flow rate pulses and/or support pressure pulse), the second mode is a physiologic mode (section 0035, the system may include an alarm function when detecting cardiac arrest. Thus, the control device is configured to execute an automatic or manually triggered emergency cardiac arrest operation mode. The control device can automatically switch from either the support or the weaning mode to such an emergency mode) and the third mode is a weaning mode (Section 0045, the control device is configured to execute the weaning mode by continuously modifying the energy level of the weaning mode. The weaning mode may thus comprise a first weaning mode operation mode with a plurality of first weaning flow rate pulse and/or of first weaning pressure pulses and a second weaning mode with a plurality of second weaning flow rate pulses and/or second weaning pressure pulses). This facilitates proper control of the blood flow within the heart pump device for proper therapy to be delivered by the heart pump.
Regarding claim 22, Spanier in view of Simundie, specfically Simundie discloses selecting a set of cardiac values to obtain based, at least in part, on the second mode, wherein obtaining one or more second cardiac values associated with the patient during operation of the MCS device in the second mode comprises obtaining the one or more second cardiac values included in the set of cardiac values (Section 0045, the control device is configured to execute the weaning mode by continuously modifying the energy level of the weaning mode. The weaning mode may thus comprise a first weaning mode operation mode with a plurality of first weaning flow rate pulse and/or of first weaning pressure pulses and a second weaning mode with a plurality of second weaning flow rate pulses and/or second weaning pressure pulses). This facilitates proper control of the blood flow within the heart pump device for proper therapy to be delivered by the heart pump.
Regarding claim 25, Spanier in view of Simundie, specfically Simundie discloses receiving via a user interface (section 0044, the system may be linked to a mobile phone presenting an alarm function for the user), an instruction to transition operation of the MCS device to the second mode, wherein controlling the pump to operate in the second mode is performed in response to receiving the instruction (Section 0048, The control device may thus be configured to automatically switch from the support mode to the weaning mode after predetermined support mode time period. Weaning is considered as essential to counteract the heart's permanent dependency on exogenous cardiac energy supply, thereby rendering the cardiac system addicted to exogenous cardiac support). This facilitates proper control of the blood flow within the heart pump device for proper therapy to be delivered by the heart pump.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JON ERIC C MORALES whose telephone number is (571)272-3107. The examiner can normally be reached Monday-Friday 830AM-530PM CST.
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/JON ERIC C MORALES/Primary Examiner, Art Unit 3796
/J.C.M/Primary Examiner, Art Unit 3796