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.
Claims 1-11, 16-21, and 46 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Application Publication No 2021/0077792 granted to Kapur et al (hereinafter “Kapur”).
In reference to claim 1, Kapur discloses a method for providing a therapeutic treatment to reduce preload [e.g. 0025], the method comprising: providing a plurality of devices, including a ventricular assist device (VAD) [e.g. 0209] and a catheter based flow restricting element (FRE) device comprising an adjustable FRE [e.g. 0030]; placing the VAD at least partially within either a left or right ventricle of a patient [e.g. 0209], and placing the catheter-based FRE device such that the FRE is disposed within a superior vena cava (SVC) of the patient [e.g. 0028]; receiving information from at least a first device of the plurality of devices [e.g. 0126]; determining a first determined value based on the information [e.g. 0126]; and controlling at least one performance parameter of at least a second device of the plurality of devices based on the first determined value [e.g. 0126].
In reference to claim 2, Kapur discloses wherein the information is from both the VAD and the catheter-based FRE device [e.g. 0223].
In reference to claim 3, Kapur discloses wherein the information is from the VAD and the at least one performance parameter that is controlled is of the catheter-based FRE device [e.g. [0223].
In reference to claim 4, Kapur discloses wherein the information is from the VAD and the at least one performance parameter that is controlled is of both the VAD and the catheter-based FRE device [e.g. 0223].
In reference to claim 5, Kapur discloses wherein the information is from the catheter- based FRE device and the at least one performance parameter that is controlled is of the VAD [e.g. 0126].
In reference to claim 6, Kapur discloses wherein the information is from the catheter- based FRE device and the at least one performance parameter that is controlled is of both the VAD and the catheter-based device [e.g. 0223].
In reference to claim 7, Kapur discloses wherein the information is received by a single controller [e.g. 0223].
In reference to claim 8, Kapur discloses wherein the single controller is configured to control both the VAD and the catheter-based FRE device [e.g. 0223].
In reference to claim 9, Kapur discloses wherein any information from the VAD is received by a first controller, any information from the catheter-based device is received by a second controller, and the first controller and second controller are operably communicating with each other [e.g. 0223].
In reference to claim 10, Kapur discloses wherein the information is from a non- catheter-based device and the at least one performance parameter that is controlled is of the VAD, the catheter-based FRE device, or both [e.g. 0140].
In reference to claim 11, Kapur discloses wherein the information includes left ventricular end diastolic pressure (LVEDP), right ventricular end diastolic pressure (RVEDP), left atrium pressure (LAP), right atrium pressure (RAP), a differential pressure, left ventricle systolic pressure, right ventricle systolic pressure, an arterial pressure, jugular vein pressure (JVP), motor current, an integrated ECG signal, or a combination thereof [e.g. 0141].
In reference to claim 16, Kapur discloses wherein the at least one performance parameter is a duty cycle of the adjustable FRE [e.g. 0126].
In reference to claim 17, Kapur discloses wherein the duty cycle is increased [e.g. 0127].
In reference to claim 18, Kapur discloses wherein the duty cycle is decreased [e.g. 0127].
In reference to claim 19, Kapur discloses wherein the duty cycle is paused [e.g. 0127].
In reference to claim 20, Kapur discloses further comprising displaying at least one right and left sided hemodynamic metric based on information from the VAD and the catheter-based FRE device [e.g. 0128].
In reference to claim 21, Kapur discloses further comprising determining an unloading status of one or more ventricles [e.g. 0223].
In reference to claim 46, Kapur discloses a system for providing a therapeutic treatment to reduce preload [e.g. 0025], comprising: a plurality of devices, including: a ventricular assist device (VAD) configured to be disposed at least partially in either left or right ventricle [e.g. 0209]; and a catheter-based device comprising a flow restricting element (FRE) (catheter- based FRE device), the FRE configured to be disposed within a superior vena cava (SVC) of a patient [e.g. 0030]; and one or more controllers, each controller comprising one or more processors and a non- transitory computer-readable storage media containing instructions that, when executed by the controller, causes the one or more controllers to, individually or in combination [e.g. 0125, 0223]: receive information from at least a first device of the plurality of devices [e.g. 0126]; determine a first determined value based on the information [e.g. 0126]; and control at least one performance parameter of at least a second device of the plurality of devices based on the first determined value [e.g. 0126].
Allowable Subject Matter
Claims 12-15 and 22 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 23 is allowed, since the claim recites “determining a first value representative of a first positioning or curvature of the interventricular septum based on the first information” and “determining a second value representative of a second positioning or curvature of the interventricular septum based on the second information.” The closest prior art, the Kapur reference, discloses determining a first value, but does not specifically describe where the value represents a first position or curvature.
Conclusion
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/NADIA A MAHMOOD/Primary Examiner, Art Unit 3796