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
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) 14-16, 22-23, 26, 29, and 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schenck et al (US 2018/0256797) (“Schenck”) as noted in Applicant IDS dated 8/13/2024 in view of Janeczek et al (US 2018/0228950) (“Janeczek”).
Regarding Claim 14, while Schenck teaches a system (Abstract, Figs. 1 and 2) comprising:
at least one impeller blade configured to be driven by a motor, wherein rotation of the at least one impeller blade draws blood into one or more inlet ports of a heart pump and expels blood through one or more outlet ports of the heart pump ([0076]-[0078] heart pump comprising impeller assembly 116A, with an inlet and outlet, [0076], [0078], [0080] “The impeller of the impeller assembly 116A may thus be rotated remotely by the motor assembly during operation of the catheter pump in various embodiments. For example, the motor assembly can be disposed outside the patient.”, [0196] wherein rotation of the at least one impeller blade draws blood from a left ventricle of the living being into the one or more inlet ports and expels blood into an ascending aorta of the living being through the one or more outlet ports);
a signal generator configured to generate a signal indicative of the intravascular environment ([0081] sensors / signal generators [0196] “Thus, the control system may also monitor flow rate based on flow rate and/or pressure measurements.”);
wherein the flow rate resulting from the pump can lead to adverse patient conditions ([0007], [0193]), Schneck fails to teach
a turbine proximate the at least one impeller blade and comprising at least one turbine blade, wherein the at least one turbine blade is configured to rotate in response to fluid flow through a blood vessel and at a rotational speed dependent at least in part on a speed of the fluid flow through the blood vessel, and wherein the turbine is disposed (a) a distance, in an upstream direction, from the one or more inlet ports or (b) between the one or more inlet ports and the one or more outlet ports; and
a signal generator mechanically coupled to the turbine and configured to generate a signal indicative of the rotational speed of the at least one turbine blade.
However Janeczek teaches a system (Abstract, Figs. 1 and 9) comprising:
A heart pump, wherein rotation of the heart pump draws blood into one or more inlet ports of a heart pump and expels blood through one or more outlet ports of the heart pump (Figs. 1 and 9, [0049] blood pump 6 can be used in a blood vessel and cavities with blood, indicating it could be used in the heart as well and could be recognized as a heart pump, [0051] heart pump 6 can be a rotary pump of radial, diagonal, or axial design, wherein rotation of the heart pump draws blood into inlet ports 8 and 9 and expels blood through outlet ports 10 and 11);
a turbine proximate the at least one heart pump and comprising at least one turbine blade (Fig. 1, [0052] turbine 19 proximate the at least one heart pump 6, [0056] the turbine comprising at least one turbine blade), wherein the at least one turbine blade is configured to rotate in response to fluid flow (Abstract) and at a rotational speed dependent at least in part on a speed of the fluid flow through the blood vessel, and wherein the turbine is disposed (a) a distance, in an upstream direction, from the one or more inlet ports or (b) between the one or more inlet ports and the one or more outlet ports (Fig. 1, turbine 19 is disposed a distance, in an upstream direction, from the one or more inlet ports 8 and 9); and
a signal generator mechanically coupled to the turbine and configured to generate a signal indicative of the rotational speed of the at least one turbine blade ([0020], [0052]-[0053] speed sensor 24 acts as signal generator coupled to the turbine 19).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to include an upstream turbine measuring rotational speed with a coupled signal generator as taught by Janeczek with the heart pump system of Schneck as a standardized way to determine a flow rate generated by the impeller motor (Schneck: [0019]) with Hall sensors as envisioned by Schneck. Further, the identification of rotational speed can inform whether the heart pump’s operation is causing flow rates that may lead to hemolysis (Schneck: [0007]). Further still, the structure of Janeczek would motivate a practitioner to place the turbine before the inlet port and heart pump components (i.e. impeller blade) of Schneck and thus have the turbine upstream from the inlet port.
Regarding Claim 15, Schneck and Janeczek teach the system according to claim 14, wherein the signal generator comprises an electrical generator (See Claim 14 Rejection, Janeczek [0020] has the sensed speed converted into electronic signals).
Regarding Claim 16, Schneck and Janeczek teach the system according to claim 14, wherein the signal generator comprises a magnet (See Claim 14 Rejection, Janeczek [0053] signal generator comprises the Hall sensor 24 with the magnet 72 arranged in turbine 19).
Regarding Claim 18, Schneck and Janeczek teach the system according to claim 16, further comprising a Hall effect sensor, wherein the magnet is configured to rotate, relative to the Hall effect sensor, in response to rotation of the at least one turbine blade (See Claim 16 Rejection).
Regarding Claim 22, Schenck and Janeczek teach the system according to claim 14, and Schenck further teaches that the blades of an impeller are radially collapsible ([0078] impeller assembly compresses and expands as it travels through the catheter, the impeller comprising blades, indicating that the blades must collapse when traveling the catheter), their combined efforts fail to teach wherein the at least one turbine blade is radially collapsible.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, for the radially collapsible characteristic of the impeller blades delivered through a catheter of Schenck to be applied to the blades of the turbine of Janeczek when added to the catheter as a means to facilitate safe delivery of hardware components to distal measuring location.
Regarding Claim 23, Schenck and Janeczek teach the system according to claim 22, and Schenck further teaches that the blades of an impeller are made of a flexible material that can be folded, shrunk, or compacted ([0078] impeller assembly compresses and expands as it travels through the catheter, the impeller comprising blades, indicating that the blades must collapse when traveling the catheter), their combined efforts fail to teach wherein the at least one turbine blade is made of a flexible material that can be folded, shrunk, or compacted to reduce an outside diameter of the at least one turbine blade while it is being inserted into the blood vessel.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, for the radially collapsible characteristic of the impeller blades delivered through a catheter of Schenck to be applied to the blades of the turbine of Janeczek when added to the catheter as a means to facilitate safe delivery of hardware components to distal measuring location.
Regarding Claim 26, Schenck and Janeczek teach the system according to claim 14, and Janeczek further teaches the system comprising a duct configured to direct at least a portion of the fluid flow toward the at least one turbine blade, wherein the at least one turbine blade is positioned inside the duct and configured to rotate at a rotational speed dependent at least in part on a shape and a size of the duct ([0015] fluid flow through the system and to different components, specifically the turbine, may be controlled by ducts) and wherein the fluid flow is through the blood vessel (See Claim 14 Rejection).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have a duct configured to direct at least a portion of the fluid flow toward the at least one turbine blade in Janeczek deliver blood flow to the turbine when incorporated into the system of Schenck as a way to provide a more independent controlled flow at the turbine ([0015]). Examiner notes that in applying a duct to Schenck and Janeczek, the blades of the turbine are inherently configured to rotate, relative to the catheter, at a rotational speed dependent at least in part on shape and size of the duct.
Regarding Claim 29, Schenck and Janeczek teach the system according to claim 14, and Schenck further teaches the system comprising the motor, wherein the motor is positioned at a location outside a living being, and wherein the motor is configured to drive the at least one impeller blade with a flexible drive shaft extending through a catheter ([0076], [0078], [0080] “The impeller of the impeller assembly 116A may thus be rotated remotely by the motor assembly during operation of the catheter pump in various embodiments. For example, the motor assembly can be disposed outside the patient.” [0080], [0158] drive shaft extending between motor and impeller assembly, flexibility in drive shaft required to travel intravascularly).
Regarding Claim 33, while Schenck teaches a method comprising:
driving, with a motor, at least one impeller blade, wherein rotation of the at least one impeller blade draws blood into one or more inlet ports of a heart pump and expels blood through one or more outlet ports of the heart pump ([0076]-[0078] heart pump comprising impeller assembly 116A, with an inlet and outlet, [0076], [0078], [0080] “The impeller of the impeller assembly 116A may thus be rotated remotely by the motor assembly during operation of the catheter pump in various embodiments. For example, the motor assembly can be disposed outside the patient.”, [0196] wherein rotation of the at least one impeller blade draws blood from a left ventricle of the living being into the one or more inlet ports and expels blood into an ascending aorta of the living being through the one or more outlet ports); and
receiving, with one or more processors, a signal from a signal generator configured to generate a signal indicative of the intravascular environment ([0081] sensors / signal generators [0017]-[0019] processors gathering the measuring data, [0196] “Thus, the control system may also monitor flow rate based on flow rate and/or pressure measurements.”);
wherein the flow rate resulting from the pump can lead to adverse patient conditions ([0007], [0193]),
Schenck fails to teach
Receiving a signal from a signal generator mechanically coupled to a turbine, wherein the turbine is proximate the at least one impeller blade and comprises at least one turbine blade, wherein the at least one turbine blade is configured to rotate in response to fluid flow through a blood vessel of a living being and at a rotational speed dependent at least in part on a speed of the fluid flow through the blood vessel, wherein the turbine is disposed (a) a distance, in an upstream direction, from the one or more inlet ports or (b) between the one or more inlet ports and the one or more outlet ports, and wherein the signal is indicative of the rotational speed of the at least one turbine blade.
However Janeczek teaches a system (Abstract, Figs. 1 and 9) comprising:
A heart pump, wherein rotation of the heart pump draws blood into one or more inlet ports of a heart pump and expels blood through one or more outlet ports of the heart pump (Figs. 1 and 9, [0049] blood pump 6 can be used in a blood vessel and cavities with blood, indicating it could be used in the heart as well and could be recognized as a heart pump, [0051] heart pump 6 can be a rotary pump of radial, diagonal, or axial design, wherein rotation of the heart pump draws blood into inlet ports 8 and 9 and expels blood through outlet ports 10 and 11);
a turbine proximate the at least one heart pump and comprising at least one turbine blade (Fig. 1, [0052] turbine 19 proximate the at least one heart pump 6, [0056] the turbine comprising at least one turbine blade), wherein the at least one turbine blade is configured to rotate in response to fluid flow (Abstract) and at a rotational speed dependent at least in part on a speed of the fluid flow through the blood vessel, and wherein the turbine is disposed (a) a distance, in an upstream direction, from the one or more inlet ports or (b) between the one or more inlet ports and the one or more outlet ports (Fig. 1, turbine 19 is disposed a distance, in an upstream direction, from the one or more inlet ports 8 and 9); and
a signal generator mechanically coupled to the turbine and configured to generate a signal indicative of the rotational speed of the at least one turbine blade ([0020], [0052]-[0053] speed sensor 24 acts as signal generator coupled to the turbine 19).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to include an upstream turbine measuring rotational speed with a coupled signal generator as taught by Janeczek with the heart pump system of Schneck as a standardized way to determine a flow rate generated by the impeller motor (Schneck: [0019]) with Hall sensors as envisioned by Schneck. Further, the identification of rotational speed can inform whether the heart pump’s operation is causing flow rates that may lead to hemolysis (Schneck: [0007]). Further still, the structure of Janeczek would motivate a practitioner to place the turbine before the inlet port and heart pump components (i.e. impeller blade) of Schneck and thus have the turbine upstream from the inlet port.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schenck in view of Janeczek and further in view of Wolfia, II (3,995,491) (“Wolfia”) as noted in Applicant IDS dated 8/13/2024.
Regarding Claim 17, while Schenck and Janeczek teach the system according to claim 16, their combined efforts fail to teach the system further comprising a coil, wherein the magnet is configured to rotate, relative to the coil, in response to rotation of the at least one turbine blade.
However Wolfia teaches a rotation sensing system (Abstract) wherein mechanical rotation may be measured by the use of magnets and coils (Abstract).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to perform the magnet-based rotation sensing of Janeczek utilizing the relationship between a magnet and coil as taught by Wolfia as a simple substitution of one means of converting mechanical rotations into electrical data (Janeczek: magnet and Hall sensor) for another (Wolfia: magnet and coil) to obtain predictable results of accurately assess flow rates.
Claim(s) 19-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schenck in view of Janeczek and further in view of Vromans et al (NL 2019028) (“Vromans”).
Regarding Claim 19, while Schenck and Janeczek teach the system according to claim 14, their combined efforts fail to teach wherein the at least one turbine blade is a helical turbine blade.
However Vromans teaches a physiological flow monitor utilizing a turbine (Fig. 3A, Abstract) comprising at least one turbine blade, wherein the at least one turbine blade is a helical turbine blade (Figs. 3a-d, p17, L. 22 – p18, L. 19, comprising a plurality of blades 308, wherein the at least one turbine blade is a curved turbine blade that overlap to make a helical shape).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to set the blade of the turbine of Schenck and Janeczek as a helical turbine blade as taught by Vromans as a simple substitution of one form of setting the turbine blade (Schenk: a propeller shape) for another (Vromans: a helical shape) to obtain predictable results of accurately assessed flow rate by turbine rotation.
Regarding Claim 20, while Schenck and Janeczek teach the system according to claim 14, their combined efforts fail to teach wherein the turbine comprises two helical turbine blades, each of which is configured to rotate in response to fluid flow through the blood vessel and at a rotational speed dependent at least in part on speed of the fluid flow through the blood vessel, and wherein the two helical turbine blades comprise the at least one turbine blade.
However Vromans teaches a physiological flow monitor utilizing a turbine (Fig. 3A, Abstract) comprising two helical turbine blades, each of which is configured to rotate in response to fluid flow through the blood vessel and at a rotational speed dependent at least in part on speed of the fluid flow through the blood vessel, and wherein the two helical turbine blades comprise the at least one turbine blade (Figs. 3a-d, p17, L. 22 – p18, L. 19, comprising a plurality of blades 308, wherein the at least one turbine blade is a curved turbine blade that overlap to make the at least one turbine blade in a helical shape, where the rotational speed of the turbine is dependent on fluid flow through the blood vessel).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to set the blade of the turbine of Schenck and Janeczek as two helical turbine blades as taught by Vromans as a simple substitution of one form of setting the turbine blade (Schenk: a propeller shape) for another (Vromans: two helical turbine blades) to obtain predictable results of accurately assessed flow rate by turbine rotation.
Regarding Claim 21, while Schenck and Janeczek teach the system according to claim 20, wherein the two helical turbine blades extend helically around a hub of the turbine, and wherein a longitudinal axis of the hub aligns with a longitudinal axis of a catheter (See Claim 20 Rejection, Janeczek’s Fig. 1, comprises a hub of the turbine, and wherein a longitudinal axis of the hub aligns with a longitudinal axis of a catheter and the adding of the helical turbine blade to Schenck and Janeczek would be applied like the blades around Vroman’s shaft).
Claim(s) 24-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schenck in view of Schenck and further in view of Toellner (US 9,067,006) as noted in Applicant IDS dated 8/13/2024.
Regarding Claim 24, while Schenck and Janeczek teach the system according to claim 22, their combined efforts fail to teach wherein the at least one turbine blade is made of a shape-memory material that rebounds to a memorized shape upon being heated to a temperature equal to, or slightly less than, a temperature of the fluid flowing through the blood vessel.
However Toellner teaches a catheter with rotating components acting in concert with blood (Abstract, Col. 2, L. 46-53) wherein blades of the rotating structure may be made out of a shape-memory material that rebounds to a memorized shape (Col. 4, L. 16-20) upon being heated to a temperature equal to, or slightly less than, a temperature of the fluid flowing through the blood vessel (Col. 1, L. 21-32).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that the collapsible turbine blades of Schenck and Janeczek are created with shape memory alloys as taught by Toellner as the application of a known technique to change a structure intravascularly (Toellner) for the intravascularly travelling collapsed structure (Schenck) ready for improvement to yield predictable results of reliably collapsed hardware inside a catheter that can be transitioned into an expanded state.
Regarding Claim 25, while Schenck and Janeczek teach the system according to claim 1, their combined efforts fail to teach wherein the at least one turbine blade comprises a plurality of struts that collapse or expand.
However Toellner teaches a catheter with rotating components acting in concert with blood (Abstract, Col. 2, L. 46-53) wherein blades of the rotating structure are radially collapsible by way of struts (Fig. 2, Col. 1, L. 9-17, Col. 7, L. 31-35, lamella are considered struts).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that the collapsible turbine blades of Schenck and Janeczek made collapsible by struts as taught by Toellner as the application of a known technique to collapse a structure intravascularly with struts (Toellner) for the intravascularly travelling collapsed structure (Schenck) ready for improvement to yield predictable results of reliably collapsed hardware inside a catheter.
Claim(s) 27-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schenck in view of Janeczek and further in view of Siess (US 8,814,933) a as noted in Applicant IDS dated 8/13/2024.
Regarding Claim 27, while Schenck and Janeczek teach the system according to claim 26, wherein the duct is both tapered (See Claim 14 Rejection, Janeczek’s Fig. 1 shows a supply duct around the turbine as tapered), their combined efforts fail to teach wherein the duct is both tapered and radially collapsible.
However Siess teaches a pump catheter (Abstract) comprising a duct configured to direct at least a portion of the fluid flow through the blood vessel toward the at least one impeller blade, wherein the at least one impeller blade is positioned inside the duct and configured to rotate, relative to the catheter (Fig. 1, Col. 4, L. 4-25, bulge 30 acts as a duct to the impeller blades) where the duct is radially collapsible (Col. 5, L. 39-63).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to for the duct configured to direct at least a portion of the fluid flow through the blood vessel as taught by Schenck and Janeczek to be radially collapsible as taught by Siess as this enable intravascular delivery of the blood pump (Siess: Col. 5, L. 39-63).
Regarding Claim 28, Schenck, Janeczek, and Siess teach the system according to claim 27, and Siess further teaches wherein the duct is attached to the catheter by one or more fins (Fig. 1, elastic bars 34 recognized as fins).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to for the duct configured to direct at least a portion of the fluid flow through the blood vessel as taught by Schenck and Janeczek to attach to the catheter by one or more fins as taught by Siess as this enables the opening of the duct shown in Fig. 1 (Siess: Col. 5, L. 39-63).
Claim(s) 30-32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schenck in view of Janeczek and further in view of Downie (US 2006/0162725).
Regarding Claim 30, while Schenck and Janeczek teach the system according to claim 14, wherein fluid flow caused by heart action and fluid flow caused by rotation of the at least one impeller blade of the heart pump both contribute to the total amount of fluid flowing through the blood vessel (See Claim 14 Rejection), their combined efforts fail to teach the system further comprising one or more processors configured to process the signal to determine a total amount of fluid flowing through the blood vessel.
However Downie teaches a physiological monitoring device (Abstract) where a magnet and Hall effect measurement of flow rate from rotation comprises measuring a pulse rate and an integrated value of flow may also be found from the measured pulse rate ([0020]) where an integrated value of flow rate would represent a total amount of fluid flowing through the blood vessel.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to for the flow rate sensing through the blood vessel of Schenck and Janeczek to include the parameter of total amount of fluid flowing as taught by Downie as this characterizes the patient health status by reflecting the total amount of work the heart performed during the monitoring period.
Regarding Claim 31, Schenck, Janeczek, and Downie teach the system according to claim 30, wherein the signal comprises electrical pulses or optical pulses (See Claim 30 Rejection, Downie: [0020]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to for the flow rate sensing through the blood vessel of Schenck and Janeczek to utilize electrical pulses to identify the flow rate as taught by Downie as to obtain the desired parameter of Schneck with the standardized method taught by Downie.
Regarding Claim 32, Schenck, Janeczek, and Downie teach the system according to claim 31, wherein the one or more processors are configured to count the electrical pulses or the optical pulses of the signal to determine the total amount of fluid flowing through the blood vessel (See Claim 31 Rejection).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAIRO H PORTILLO whose telephone number is (571)272-1073. The examiner can normally be reached M-F 9:00 am - 5:15 pm.
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/JAIRO H. PORTILLO/
Examiner
Art Unit 3791
/PUYA AGAHI/Primary Examiner, Art Unit 3791
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