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.
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.
Claim(s) 1-3, 5, 11, 23-25, 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fukamachi (WO 2020/081481 A1) in view of Mohl (US 2016/0000983 A1).
Regarding claim 1, Fukamachi discloses a system to treat heart failure with preserved ejection fraction (HFpEF), the system comprising: a blood pumping device configured for implantation in a left ventricle of a heart of a subject (Eg. Para. 2-9, 75), in which the blood pumping device is configured to draw blood from a left atrium into the left ventricle of the heart through a mitral valve upon activation (eg. Para. 62); an anchoring assembly (eg. Para. 66) and a controller configured to modify the output parameters of the blood pumping device so as to activate and deactivate the blood pumping device in a pattern synergistic with a cardiac cycle of the subject comprising activation during ventricular diastole and deactivation during ventricular systole (eg. Para. 79-83, claim 3) but does not specifically disclose for anchoring the blood pumping device to a wall of the left ventricle.
Mohl teaches a ventricular assist device using an anchor on the left ventricle (eg. Abstract, Para. 5, 13, 30, 76, Fig. 2a-b)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Fukamachi with the anchoring on the left ventricle as taught by Mohl since assist devices are typically implanted in the left ventricle (eg. Mohl, Para. 5).
Regarding claim 2, the combined invention of Fukamachi and Mohl discloses at least one sensor in communication with the controller to detect one or more parameters associated with the heart, wherein the controller is configured to modify the output parameters of the blood pumping device based on the one or more detected parameters received from the at least one sensor (eg. Fukamachi, Para. 14, 26-27, 32-41, 68, 78, 81).
Regarding claim 3, the combined invention of Fukamachi and Mohl discloses further comprising at least one sensor (in communication with the controller to detect one or more parameters associated with the heart, wherein the controller is configured to modify the output parameters of the blood pumping device based on the one or more detected parameters received from the at least one sensor (eg. Fukamachi, Para. 14, 26-27, 32-41, 68, 78, 81); and in which the at least one sensor is configured to detect one or more parameters selected from heart rate, closure of the aortic valve, opening of the aortic valve, closure of the mitral valve, and-or opening of the mitral valve; and the controller is configured to adjust the frequency of activation and deactivation of the blood pumping device based on the one or more parameters sensed by the sensor (eg. Fukamachi, Para. 14, 26-27, 32-41, 68, 78, 81); and in which controller is optionally configured to adjust the frequency of activation and deactivation of the blood pumping device by modulating the frequency of the voltage supply to the blood pumping device (Eg. Fukamatsu, Para. 14, 18, 26-27, 32-42 synchronizing with the heart beats and alternatively turn on and off).
Regarding claim 5, the combined invention of Fukamachi and Mohl discloses comprising at least one sensor in communication with the controller to detect one or more parameters associated with the heart, wherein the controller is configured to modify the output parameters of the blood pumping device based on the one or more detected parameters received from the at least one sensor (eg. Fukamachi, Para. 14, 26-27, 32-41, 68, 78, 81); and in which the at least one sensor is configured to detect a blood pressure parameter of the subject's heart and the controller is configured to adjust the pump flow rate of the blood pumping device to correspond to the blood pressure parameter sensed by the sensor (eg. Fukamachi, Para. 14, 26-27, 32-41, 68, 78, 81), in which controller is optionally configured to adjust the pump flow rate of the blood pumping device by modulating the amplitude of the voltage supply to the blood pumping device (Eg. Fukamatsu, Para. 14, 18, 26-27, 32-42 synchronizing with the heart beats and alternatively turn on and off).
Regarding claim 11, the combined invention of Fukamachi and Mohl discloses the blood pumping device comprises: a first cylindrical part (eg. Fig. 1-9, housing 20 comprising a motor (eg. Fig. 1-9 stator and rotor 40 and 60); a second cylindrical part comprising an impeller (eg. Fig. 1-9, 62 and pumping chamber 22), a central part connecting the first cylindrical part and second cylindrical part comprising the fluid inlet (Eg. Fig. 1-9, inlet 102); and a fluid outlet disposed in the first cylindrical part or second cylindrical part (eg. Fig. 1-9, outlet 104), wherein the rotor extends from the motor to the impeller through the central part (Eg. Fig. 1-9 central area of housing 20).
Regarding claim 23, the combined invention of Fukamachi and Mohl discloses an access sheath having a lumen configured for percutaneous delivery of the blood pumping device to the left ventricle (eg. Mohl, Para. 29, 42, 60, 78, 81, claim 10).
Regarding claim 24, the combined invention of Fukamachi and Mohl discloses an access sheath having a lumen configured for percutaneous delivery of the blood pumping device to the left ventricle and comprising a delivery shaft for the blood pumping device to advance the blood pumping device through the lumen of the access sheath (eg. Mohl, Para. 29, 42, 60, 78, 81, claim 10).
Regarding claim 25, the combined invention of Fukamachi and Mohl discloses an access sheath having a lumen configured for percutaneous delivery of the blood pumping device to the left ventricle and a delivery shaft for the blood pumping device to advance the blood pumping device through the lumen of the access sheath; and in which the delivery shaft and blood pumping device are configured for detachable coupling together (eg. Mohl, Para. 29, 42, 60, 78, 81, claim 10, detachable obvious in view of MPEP 2144.04).
Regarding claim 28, the combined invention of Fukamachi and Mohl discloses the anchoring assembly is configured to couple to the blood pumping device in-vivo (eg. Mohl, Para. 1, 5, 13, 30, 76, claim 1).
Claim(s) 8-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fukamachi (WO 2020/081481 A1) in view of Mohl (US 2016/0000983 A1), further in view of Schmulewitz (US 2001/0027287 A1).
Regarding claims 8-9, the combined invention of Fukamachi and Mohl discloses the invention of claim 1, but does not disclose blood pumping device comprises a fluidic extension conduit configured to provide fluidic communication from inside the left atrium to the blood inlet of the housing.
Schmulewitz discloses a blood pumping device with a flexible conduit providing fluidic communication from the left atrium to a left ventricle (eg. Para. 41-51, Fig. 1, 6, 11).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the invention to have a flexible conduit from the left atrium as taught by Schmulewitz since it is common in the art for delivering oxygenated blood and add other therapeutic agents (eg. Schmulewitz Para. 21-23). While the conduit doesn’t connect to a housing inlet, one of ordinary skill would have connected a detachable conduit to the pump system for delivery of blood and/or therapeutic agents since conduits are commonly used in the art. Making a conduit detachable is obvious in view of MPEP 2144.04.
Regarding claim 10, the combined invention of Fukamachi, Mohl, and Schmulewitz discloses the fluidic extension conduit is flexible (eg. Schmulewitz, Para. 46).
Claim(s) 26 and 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fukamachi (WO 2020/081481 A1) in view of Mohl (US 2016/0000983 A1), further in view of Quadri (US 2015/0032153 A1).
Regarding claim 26, the combined invention of Fukamachi and Mohl discloses the invention of claim 1, but does not disclose the anchoring assembly comprises a plurality of anchoring arms configured for adjustment from a stowed position suitable for percutaneous delivery to a deployed position in which the plurality of anchoring arms oppose the ventricular wall.
Quadri teaches an anchoring assembly for an anatomical wall with retractable features (Fig. 5-7, 14-15, Para. 51, 123-125, 132).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the invention of Fukamachi and Mohl with the anchoring mechanism as taught by Quadri to provide the predictable result of a retractable function to the implant.
Regarding claim 29, the combined invention of Fukamachi, Mohl, and Quadri discloses the anchoring assembly is configured to couple to the blood pumping device in-vivo (eg. Mohl, Para. 1, 5, 13, 30, 76, claim 1); and in which the anchoring assembly comprises an anchoring hub configured for coupling to the blood pumping device and a plurality of anchoring arms extending from the hub (eg. Quadri, Fig. 5-7, 14-15, Para. 51, 123-125, 132).
Conclusion
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/MICHAEL J LAU/Examiner, Art Unit 3796