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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-10) in the reply filed on 06/12/2026 is acknowledged.
Claims 11-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/12/2026.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 1-9 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Moyer et al. (WO 2018227156 A1, "Moyer").
Regarding claim 1, Moyer teaches a circulatory support system (Fig. 1; intravascular blood pump system 100) comprising: a blood pump (blood pump system 100; para. [0042]: " The intravascular heart pump system 100 pumps blood from the left, ventricle into the aorta in parallel with the native cardiac output of the heart 102."; Fig. 1) comprising: a driven component ("Rotor"; para. [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 110."); and a motor (Fig. 1; motor 108) in communication with the driven component and configured to drive the driven component to pump a blood flow through the blood pump (para. [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 110."; see para. [0044] for more details about the drive components and mechanical transmission elements); one or more sensors configured to sense a value related to a speed of the motor (para. [0049]: "For example, once the pressure gradient across the blood pump cannula has been determined from the motor current and motor speed…"; Additionally, para. [0071] discloses a measured motor speed: "In step 408, the pressure differential across a cannula of the blood pump is determined based on the measured motor current and the motor speed…"); and a controller (controller; para. [0065]) in communication with the motor and the one or more sensors configured to sense the value related to the speed of the motor (para. [0065]: "In some modes of the controller, the controller will automatically adjust the motor speed in response to changes in afterload to maintain a target flow rate."), and wherein the controller is configured to: determine a command signal based on the value related to the speed of the motor (para. [0067]: "The flow control button may allow the user to access recommendations related to the current pump motor speed and various cardiac metrics calculated by the controller and may allow a user to input or accept adjustments to the pump motor speed."; the inputs/adjustments are recommendations based on the current motor speed; Additionally, at step 902 of Fig. 9, a speed would need to be set on the motor to operate the motor), provide the command signal to the motor to drive the driven component (As mentioned in para. [0041], the motor drives the rotor. The rotor would therefore be driven during operation of the motor in Fig. 9; Further, as mentioned, para. [0041] discloses the command signal as the recommendations related to pump motor speeds and motor speed adjustments.), determine one or more values of one or more parameters (aortic pressure, motor speed, and pressure differential are all used to calculate cardiac parameters) related to operation of the blood pump based on one or both of the command signal (Fig. 9; 902 implies that initial parameters are set to operate a motor of an intravascular blood pump, which are commands, such as motor speed/current) and the value related to the speed of the motor (Fig. 9; 906, 908, 910, and 912; See para. [0048] for examples of cardiac parameters; Additionally, at step 906, the motor speed and current are used as inputs into 908, which is input into 910 to calculate a cardiac parameter.), and output an indication a blood pump transition (Fig. 9; 918; determining a recommended change to the motor speed is considered a blood pump transition) is recommended based on one or more values determined of the one or more parameters related to operation of the blood pump (Fig. 9; 916, 918, 920, 922, and 924; The determination to change a motor speed is based on the previous steps in Fig. 9 where parameters are calculated based on pressure and motor speed).
Regarding claim 2, Moyer teaches the system of claim 1 (see above), wherein the controller is further configured to identify a trend (para. [0086]: "FIG. 5C shows a user interface 502 for a heart pump controller illustrating a metric trend screen. The trend screen includes a first plot 540 displaying a cardiac output trend waveform 542, a blood pump flow trend waveform 544, and a native cardiac output trend waveform 546, as well as associated values of cardiac output, blood pump flow, and native cardiac output for rapid assessment by a physician.") in two or more values (542 - cardiac output value shown as 6.2); 544 - blood pump flow waveform shown as 3.9; 546 - native cardiac output shown as 2.3) determined over time of the one or more parameters related to operation of the blood pump (para. [0087]: "The metric trend screen of the user interface 502 is accessible to a physician to further illustrate the historic data associated with various cardiac parameters over time."; see para. [0086] and [0087] for more blood pump values and parameters) and output the indication the blood pump transition is recommended when the trend reaches or exceeds a threshold level (para. [0068]: " In some implementations, the warnings or alarms are triggered by a cardiac metric calculated, measured or monitored by the controller falling below a set threshold value. In some implementations, the warnings or alarms are triggered by a cardiac metric calculated, measured or monitored by the controller exceeding a set threshold value."; Additionally, see para. [0078], [0082], [0098], [0108], [0113], [0117], and 0122] for other mentions of outputting an indication when a threshold is met).
Regarding claim 3, Moyer teaches the system of claim 1 (see above), wherein the controller includes a state observer (Fig. 5C; user interface 502 includes a metric trend screen) configured to determine two or more values of two or more parameters related to operation of the blood pump (para. [0086]: "FIG. 5C shows a user interface 502 for a heart pump controller illustrating a metric trend screen. The trend screen includes a first plot 540 displaying a cardiac output trend waveform 542, a blood pump flow trend waveform 544, and a native cardiac output trend waveform 546, as well as associated values of cardiac output, blood pump flow, and native cardiac output for rapid assessment by a physician. The user interface 502 metric trend screen also includes a second plot 548 displaying a mean aortic pressure trend waveform 550, and an LVEDP trend waveform 552, as well as associated values of mean aortic pressure 554 and LVEDP 556, The user interface 502 also includes an indication of motor speed of a blood pump 560, blood pump flow 562, cardiac output 564, and cardiac power output 558."; para. [0087]: "[0087] The metric trend screen of the user interface 502 is accessible to a physician to further illustrate the historic data associated with various cardiac parameters over time. Such historic data can help physicians to understand the progress of the patient's cardiac health as well as to identify events taking place. For example, the metric trend screen of the user interface 502 shown in FIG. 5C displays cardiac output trend waveform 542, blood pump flow trend waveform 544, native cardiac output trend waveform 546, aortic pressure trend waveform 550, and a LVEDP trend waveform 552 all of which are relatively stable over time.").
Regarding claims 4 and 5, Moyer teaches the system of claim 1 (see above), wherein the one or more values determined of one or more parameters related to operation of the blood pump include one or more values of a left ventricle pressure provided by the by pump (abstract: "The system can quantify the functioning of the native heart by measuring certain parameters/signals such as aortic pressure or motor current, then calculate and display one or more cardiac parameters and heart function parameters, such as left ventricular pressure, left ventricular end diastolic pressure…") (claim 4), and wherein the controller is configured to output the indication a blood pump transition is recommended when one or more values of the left ventricle pressure reaches or exceeds a threshold level. (para. [0082]: " The controller can issue a warning 514 based on a comparison of the minimum value of the indication of LVP 512 to a threshold value, for example, 0 mmHg, -10 mmHg, -20 mmHg, -30 mmHg, -40 mmHg, or any other suitable threshold value…The controller can further provide recommendations 516 to a physician, nurse, or technician for how to react to the warning 514 to address and correct the suction event. For example, the controller may provide a recommendation to check additional cardiac metrics to determine a cause of the suction event or check on patient health before adjusting the positioning or cardiac support level of the blood pump. The controller may also provide instructions or recommendations to check the positioning of the blood pump based on the suction event detection and further may recommend a change in the level of support provided by the blood pump by a change to the motor current 510.")(claim 5).
Regarding claims 6 and 7, Moyer teaches the system of claim 1 (see above), wherein the one or more values determined of one or more parameters related to operation of the blood pump include one or more values of a flow rate of blood through the blood pump (Abstract: "Providing cardiac parameters in real-time, along with warnings about adverse effects and recommendations to support cardiac function, such as increasing or decreasing the volumetric flow rate of blood pumped by the device"; Additionally, 5C shows blood pump flow 562 with a flow rate value displayed (in the figure, it's 3.9L/min)) (claim 6), and wherein the controller is configured to output the indication a blood pump transition is recommended when one or more values of the flow rate of blood through the blood pump reaches or exceeds a threshold level. (para. [0068] describes alerts that are triggered when cardiac metrics calculated, measured, or monitored fall below a threshold; Additionally, para. [0048] describes cardiac parameters that are determined: "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." Pump flow is one or more values of blood flow through the pump)(claim 7).
Regarding claims 8 and 9, Moyer teaches the system of claim 1 (see above), wherein the one or more values determined of one or more parameters related to operation of the blood pump include one or more values of a mechanical loss in the blood pump. (Para. [0043] and [0048] show that the motor current and speed correlate with the flow rate values and pressure gradient values for operating conditions; para. [0043]: "Detection of mass flow rate using motor current may also be facilitated by the small size and/or low torque of the motor 108. "; para. [0048]: " By accessing the plot 200, a controller determines the pressure gradient associated with a motor current and motor speed at which the blood pump is currently operating."; In para. [0117], the change in motor speed (correlates with current) is compared to a threshold value to determine if it is capable of operating at the required speed. The difference between the change in speed and required speed is considered to be difference caused by mechanical loss; para. [0117]: "In step 920, the recommended change to the motor speed is compared to a threshold value. The threshold value may be a value associated with the blood pump, indicating a maximum or minimum operational motor speed. The recommended change to the motor speed is compared to a threshold value in order to determine if the current blood pump is capable of operating at the required speed and/or whether the current blood pump is the optimal blood pump for operation at the required speed."; Additionally, para. [0060] describes a pressure differential that measures energy intake that varies with motor speed, and the pressure differential can be considered to be a mechanical loss.). (claim 8), and wherein the controller is configured to output the indication a blood pump transition is recommended when one or more values of the mechanical loss in the blood pump reaches or exceeds a threshold level. (para. [0117]: "In step 920, the recommended change to the motor speed is compared to a threshold value. The threshold value may be a value associated with the blood pump, indicating a maximum or minimum operational motor speed. The recommended change to the motor speed is compared to a threshold value in order to determine if the current blood pump is capable of operating at the required speed and/or whether the current blood pump is the optimal blood pump for operation at the required speed."; Additionally, Fig. 9 shows the display (recommendation) at 924 as a result of the threshold being reached) (claim 9).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Moyer et al. (WO 2018227156 A1, "Moyer") in view of Edelman et al. (WO 2018053504 A, "Edelman").
Regarding claim 10, Moyer teaches the system of claim 1 (see 102 rejection above). However, Moyer does not expressly disclose wherein the indication the blood pump transition is recommended includes a recommended time by which the blood pump transition is recommended to take place.
Edelman, in the same field of endeavor of heart pumps, discloses a system for determining heart parameters. Edelman discloses wherein an indication the blood pump transition is recommended includes a recommended time by which the blood pump transition is recommended to take place (para. [0014]: "The controller detects a motor parameter over time, receives the aortic pressure over time from the sensor, stores a relationship between the motor parameter and the aortic pressure in the memory, determines a time period in which an inflection point indicative of LVEDP can be found, and identifies the inflection point in the aortic pressure based on the determined time period."; para. [0015]: "In some implementations, determining a time period in which an inflection point indicative of the LVEDP can be found includes identifying a time period in which the received motor parameter changes. In some implementations, the controller also determines the LVEDP from a dynamic curve look-up table stored in the memory based on the inflection point in the aortic pressure. In some implementations, the controller receives an ECG signal, and determining a time period in which an inflection point indicative of LVEDP can be found includes identifying a time period in which the ECG signal indicates an end cycle of diastole."; The controller detects a parameter and identifies the time that parameter changes (inflection point). In para. [0015], it is disclosed that a time period when the motor parameter is identified. The motor parameter change is considered to be a transition of the blood pump.).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Moyer to include a time the blood pump transition takes place. One of ordinary skill would have recognized that in including a time in which a transition takes place would enable the system of Moyer to determine relationships between motor parameters and physiological parameters that occur at the same time. This is advantageous in that the system of Moyer would be able to store these relationships to optimize the motor output so that the parameters are adjusted to an individual patient’s needs. Therefore, it would have been obvious to combine the system of Edelman.
Conclusion
15. Any inquiry concerning this communication or earlier communications from the examiner should be directed to OWEN LEWIS MARSH whose telephone number is (571)272-8584. The examiner can normally be reached 7:30am – 5pm (M-Th), 8am – noon (F).
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/O.L.M./
Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796
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