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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 03/10/2025 and 05/01/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 5, 11, 15, and 16 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 5 recites the limitation "the second ultrasound sensor" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation "the second ultrasound sensor" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 15 recites the limitation "the second ultrasound sensor" in line 8. There is insufficient antecedent basis for this limitation in the claim.
Claim 16 recites the limitation "the second ultrasound sensor" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Examiner’s note: In claims 5, 11, 15, and 16, it appears that applicant has used the term transducer, and sensor interchangeably, especially in regards to the second ultrasound transducer. To maintain clarity, please maintain consistency in referring to the transducers to not lead to any confusion in the claims.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-6, 8-9, and 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over US20180326131 to Muller et al. “Muller”, in view of US5,078,148 to Nassi et al. ”Nassi”.
Regarding claim 1, Muller discloses a cardiac pump system ([0059], catheter pump 10 that can provide high performance including flow rates similar to full cardiac output, would read on a cardiac pump system), comprising:
a catheter shaft (Fig. 2, Ref. 84, and [0062], catheter body) having a distal end region (Fig. 2, Ref. 94, and [0062], distal end of elongate body 96 of catheter assembly 80), coupled to a cardiac pump (Fig. 3, shows the pump 10 inside the left ventricle, LV, [0061], which as can be seen, depicts the impeller assembly 92 attached to the distal end of the catheter assembly, when compared to Fig. 2, and therefore the impeller assembly must be part of pump 10, based on the description in [0061], and therefore would read on a catheter shaft having a distal end region coupled to a cardiac pump), wherein the cardiac pump includes an impeller housing ([0061] describes Fig. 3 as illustrating pump 10 inside the LV, wherein based on Fig. 2, the impeller assembly is clearly illustrated as what is described as pump 10, and would read on an impeller housing), a cannula and an impeller ([0063], impeller assembly includes a self-expanding material, such as an expandable cannula and a impeller; also see Fig. 4, and [0068], cannula 108, with impeller 112A),
wherein the cannula includes a distal end region and a proximal end region (See, Fig. 4, Ref, 222, represents the proximal portion of the cannula, also see [0085]; and thus the other end as show in Fig. 3 must be the distal end) wherein the distal end region of the cannula is configured to be positioned in a left ventricle of a heart (see Fig. 3, and [0061], describing the impeller assembly being in the LV, and in view of Fig. 4, would include the cannula being in the LV).
Muller additionally discloses sensors such as such as Doppler ultrasound flow sensors ([0111]), located at a proximal sensor assembly disposed near the proximal portion of the cannula, and a distal sensor assembly disposed near the distal portion of the cannula, wherein the distal sensor assembly can measure a flow rate in the left ventricle of blood moving from the left ventricle to the ascending aorta ([0113]; See also Figs. 18B and 19A, and [0124], proximal sensor assembly 521, and distal sensor assembly 524, wherein the proximal sensor assembly is located on the catheter body 504 [0127], and the distal sensor assembly is located on the distal lumen of the catheter body, [0129]).
However, Muller does not disclose wherein the sensors are a first ultrasound transducer coupled to the catheter shaft, wherein the first ultrasound transducer is configured to directly measure a velocity of blood flowing adjacent to the first ultrasound transducer; and
a second ultrasound transducer coupled to the catheter shaft, wherein the second ultrasound transducer is configured to transmit a first ultrasound signal toward a wall of a body vessel and receive a reflected portion of the first ultrasound signal reflected from the wall of the body vessel.
Nassi teaches wherein the sensors are a first ultrasound transducer coupled to the catheter shaft (See Fig. 3, Ref. T1, col. 8, lines 36-37, ultrasonic transducer T1), wherein the first ultrasound transducer is configured to directly measure a velocity of blood flowing adjacent to the first ultrasound transducer (Col. 8, lines 56-62, typically, a transducer T1 or T2 is excited with short bursts of ultrasound followed by the detection of Doppler shifted energy scattered from the particles in the moving liquid stream, as for example, moving erythrocytes in human blood. This Doppler shift is then used to calculate the velocity of blood flow within a sample volume or volumes within the vessel; col. 10, lines 48-50, T1 is used for velocity profile measurement); and
a second ultrasound transducer coupled to the catheter shaft (See Fig. 3, Ref. T2, col. 8, lines 36-37, ultrasonic transducer T2), wherein the second ultrasound transducer is configured to transmit a first ultrasound signal toward a wall of a body vessel (Fig. 3, Ref. B2 is the beam transmitted from transducer T2, which is directed toward vessel wall 151, also see col. 8, paragraphs starting at line 29, and starting at line 50) and receive a reflected portion of the first ultrasound signal reflected from the wall of the body vessel (T2 transmits an ultrasonic pulse across the vessel that is reflected by the wall and return to the same transducer, i.e. T2, Col. 8, lines 62-66).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified Muller’s invention wherein the sensors are a first ultrasound transducer coupled to the catheter shaft, wherein the first ultrasound transducer is configured to directly measure a velocity of blood flowing adjacent to the first ultrasound transducer, and a second ultrasound transducer coupled to the catheter shaft, wherein the second ultrasound transducer is configured to transmit a first ultrasound signal toward a wall of a body vessel and receive a reflected portion of the first ultrasound signal reflected from the wall of the body vessel, as taught by Nassi, in order to obtain both a blood flow velocity measurement and a diameter of the vessel measurement (Nassi, T2 would be used for diameter measurement, Col. 10, lines 50-51) to determine the volumetric flow rate in a vessel (Nassi, Col. 9, Paragraph starting at line 3, and also lines 31-33).
Regarding claim 2, the modifications of Muller and Nassi disclose all the features of claim 1 above.
Muller teaches a console ([0122], console with controller 502 and processing unit 503) coupled to the catheter shaft (See Fig. 18A, catheter assembly 500 is coupled to the controller 502; [0171], the proximal and distal sensor assembly, which is located on the catheter assembly, see Fig. 18A, is in communication with the controller via an elongate connector 541, which infers a coupling between the controller and the sensor assemblies, and therefore also a coupling between the controller and the catheter assembly), wherein the console includes a processor ([ 0122], console with controller 502 and processing unit 503), and wherein the console is configured to receive signals detected by the sensors ([0008], processor can be programmed to process a signal detected by the sensor; since the processor is part of the controller, which is part of the console, processing the signal would infer first, receiving the signal before the processing; See also [0114]).
However, Muller does not teach wherein the signal is the reflected portion of the first ultrasound signal from the second ultrasound transducer.
Nassi teaches wherein the signal is the reflected portion of the first ultrasound signal from the second ultrasound transducer (col. 4, line 67 – col. 5, line 1, catheter 12 is connected to control console 11; with at least two ultrasonic transducers carried by the catheter, col. 7, paragraph starting at line 21; col. 9, Paragraph starting at line 17, transducer T2 transmits an ultrasound beam B2 approximately perpendicular to the vessel wall, wherein the signal B2 is reflected by the wall and return to the same transducer, col. 8, lines 62-66, to provide a distance/diameter measurement, col. 8, lines 62-66 and col. 9, lines 17-22, wherein this diameter information is supplied to the console 11, col. 9, lines 27-28; the reflected B2 signal from transducer T2 would read on the reflected portion of the first ultrasound signal from the second ultrasound transducer).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Muller and Nassi, wherein the signal is the reflected portion of the first ultrasound signal from the second ultrasound transducer, as taught by Nassi, in order to obtain the diameter of the vessel measurement (Nassi, T2 would be used for diameter measurement, Col. 10, lines 50-51) to determine the volumetric flow rate in a vessel (Nassi, Col. 9, Paragraph starting at line 3, and also lines 31-33).
Regarding claim 3, the modifications of Muller and Nassi disclose all the features of claim 2 above.
As discussed in the claim 2 rejection above, Nassi teaches the processor is configured to utilize the reflected portion of the first ultrasound signal to determine a diameter of the body vessel adjacent to the second ultrasound transducer (col. 4, line 67 – col. 5, line 1, catheter 12 is connected to control console 11; with at least two ultrasonic transducers carried by the catheter, col. 7, paragraph starting at line 21; col. 9, Paragraph starting at line 17, transducer T2 transmits an ultrasound beam B2 approximately perpendicular to the vessel wall, wherein the signal B2 is reflected by the wall and return to the same transducer, col. 8, lines 62-66, to provide a distance/diameter measurement, col. 8, lines 62-66 and col. 9, lines 17-22, wherein this diameter information is supplied to the console 11, col. 9, lines 27-28).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Muller and Nassi, wherein the processor is configured to utilize the reflected portion of the first ultrasound signal to determine a diameter of the body vessel adjacent to the second ultrasound transducer, as taught by Nassi, in order to use the diameter information as part of the determination of the volumetric flow rate in a vessel (Nassi, Col. 9, Paragraph starting at line 3, and also lines 31-33).
Regarding claim 4, the modifications of Muller and Nassi disclose all the features of claim 3 above.
As described in the claims 1 and 3 rejections above, Nassi teaches wherein the processor is configured to calculate a flow rate of blood passing through the body vessel (Col. 9, Paragraph starting at line 3, “Flow rate may be calculated if the space average velocity and cross-sectional area of the vessel are known”; Also see Col. 9, lines 31-33) based on the velocity of blood measured by the first ultrasound transducer and the diameter of the body vessel determined by the processor (Col. 9, lines 31-33, The volumetric flow rate Q in a vessel (e.g. cardiac output) is calculated from the diameter and velocity measurements; wherein the velocity measurements are measured by transducer T1, col. 8, lines 56-62 and col. 10, lines 48-50; and the diameter measurements are measured by transducer T2, col. 8, lines 62-66 and col. 9, lines 17-22; and wherein this diameter information is supplied to the console 11, col. 9, lines 27-28).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Muller and Nassi, wherein the processor is configured to calculate a flow rate of blood passing through the body vessel based on the velocity of blood measured by the first ultrasound transducer and the diameter of the body vessel determined by the processor, as taught by Nassi, since determining the velocity and diameter using different transducers instead of one transducer, uncouples the diameter measurement angle from the velocity measurement angle, and the diameter measurement angle can be optimized, which reduces the error in the determination of the volumetric flow rate (Nassi, Col. 10, last two lines – Col. 11, 8).
Regarding claim 5, the modifications of Muller and Nassi disclose all the features of claim 1 above.
As disclosed in the claim 1 rejection above, Nassi teaches wherein the first ultrasound transducer is positioned adjacent to the second ultrasound sensor (Fig. 3 illustrates the position of transducer T1 and T2, which are adjacent from each other).
Regarding claim 6, the modifications of Muller and Nassi disclose all the features of claim 1 above.
Nassi teaches wherein the first ultrasound transducer and the second ultrasound transducer are attached to an outer surface of the catheter shaft (See Fig. 3, transducers T1 and T2 are attached to an outer surface of the catheter C).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Muller and Nassi, wherein the first ultrasound transducer and the second ultrasound transducer are attached to an outer surface of the catheter shaft, as taught by Nassi, in order of the ultrasound beams of the first and second transducer to not have to go through the walls of the catheter and perturb the transmission beams.
Regarding claim 8, the modifications of Muller and Nassi disclose all the features of claim 1 above.
Nassi teaches wherein the first ultrasound transducer, the second ultrasound transducer or both the first ultrasound transducer and the second ultrasound transducer extend at least partially into a wall of the catheter shaft (Col. 7, lines 23-29, “at least two ultrasonic transducers are carried by the catheter 12. Front and back transducers are provided as hereinafter described. The front transducers 25 typically are mounted within the recess provided by the lumen 16; wherein the transducers T1 and T2 are considered front transducers (based on the comparison of Fig. 5 with Fig. 3, where in Fig. 5, transducers T3 and T4 are considered back transducers, See col. 11 lines 19-20, and col. 12, lines 48-50). Therefore transducers T1 and T2 being located in the recess of lumen 16 would read on the first and second ultrasound transducer extending at least partially into a wall of the catheter shaft.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Muller and Nassi, wherein the first ultrasound transducer, the second ultrasound transducer or both the first ultrasound transducer and the second ultrasound transducer extend at least partially into a wall of the catheter shaft, as taught by Nassi, in order for each of the transducer beams of the transducers to lie substantially within a single plane, and the beam positioning is essential to obtain accurate diameter and velocity profile measurements (Nassi, Col. 7, lines 36-38 and 42-44).
Regarding claim 9, the modifications of Muller and Nassi disclose all the features of claim 1 above.
Nassi teaches wherein the first ultrasound transducer is configured to utilize doppler ultrasound to directly measure the velocity of blood flowing adjacent to the first ultrasound transducer (col. 9, paragraph starting at line 17, transducer T2 transmits an ultrasound beam at angle θ1 (e.g. 60°) with respect to the vessel wall 151 to provide Doppler shift velocity measurements, which is used to calculate the velocity of blood flow within the vessel, col. 8 lines 60-62).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Muller and Nassi, wherein the first ultrasound transducer is configured to utilize doppler ultrasound to directly measure the velocity of blood flowing adjacent to the first ultrasound transducer, as taught by Nassi, in order to utilize the measured velocity, along with a measured diameter of the vessel to obtain a more accurate value of the volumetric flow rate in a vessel (Nassi, Col. 9, Paragraph starting at line 3, and also lines 31-33).
Regarding claim 11, the modifications of Muller and Nassi disclose all the features of claim 2 above.
As disclosed in the claim 1 rejection above, Nassi teaches the second ultrasound transducer is configured to transmit a first ultrasound signal toward a wall of a body vessel (Fig. 3, Ref. B2 is the beam transmitted from transducer T2, which is directed toward vessel wall 151, also see col. 8, paragraphs starting at line 29, and starting at line 50) and receive a reflected portion of the first ultrasound signal reflected from the wall of the body vessel (T2 transmits an ultrasonic pulse across the vessel that is reflected by the wall and return to the same transducer, i.e. T2, Col. 8, lines 62-66).
Nassi further teaches wherein the reflected signal that returns to T2 is for determining the diameter (col. 8, lines 62-66), this diameter information is supplied to the console 11 (col. 9, lines 27-28). This reads on wherein the console is configured to receive the reflected portion of the first ultrasound signal from the second ultrasound transducer.
Additionally, Nassi teaches continuously determining the diameter (Fig. 8, and description found in col. 13, Paragraph starting at line 16). Nassi teaches continuously determining the distance between the wall of the vessel and transducer T2, and taking into account the thickness of the catheter in the DF+W plot of Fig. 8 to illustrate the variation in diameter between the systole and diastole (col. 13, Paragraph starting at line 16). Continuously acquiring the diameter would infer multiple rounds of transmitting a signal toward the body vessel wall by transducer T2, and receiving the reflected portion of the transmitted signal, reflected from the vessel wall, by the transducer T2, and sent to console 11, and would include the second ultrasound sensor is configured to transmit a second ultrasound signal toward the body vessel wall and receive a reflected portion of the second ultrasound signal reflected from the vessel wall, and wherein the console is configured to receive the reflected portion of the second ultrasound signal from the second ultrasound transducer.
Further, Nassi teaches taking a mean value of the measured diameter in the time series curve in determining a mean total diameter (col. 13, lines 24-28). By taking the mean of the measured diameter in the systole and diastole variation curve, this would read on utilizing the reflected portion of the first ultrasound signal and the reflected portion of the second ultrasound signal to determine a diameter of the body vessel adjacent the second ultrasound transducer.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Muller and Nassi, wherein the second ultrasound sensor is configured to transmit a second ultrasound signal toward the body vessel wall and receive a reflected portion of the second ultrasound signal reflected from the vessel wall, and wherein the console is configured to receive the reflected portion of the second ultrasound signal from the second ultrasound transducer, and wherein the processor is configured to utilize the reflected portion of the first ultrasound signal and the reflected portion of the second ultrasound signal to determine a diameter of the body vessel adjacent the second ultrasound transducer, as taught by Nassi, in order to determine a mean vessel diameter to overcome the variation in the diameter measurements due to systole and diastole (Nassi, col. 13, lines 24-28).
Regarding claim 12, the modifications of Muller and Nassi disclose all the features of claim 1 above.
Nassi discloses wherein the first ultrasound transducer includes a first transmission face (See Fig. 3, Ref. T1, the face of T1 is where beam B1 emanates from), configured to transmit a velocity ultrasound signal (transducer T1, is used to determine a Doppler shift, which is used to determine the velocity of the blood flow within a sample volume within the vessel, through excitation of short bursts of ultrasound, col. 8, lines 56-62; wherein the short bursts of ultrasound is represented by beam B1 as seen in Fig. 3, and in col. 8, lines 34-40), and wherein the first transmission face tapers away from the catheter shaft (See Fig. 3, face of T1 is slanted away from the catheter C) such that the velocity ultrasound signal transmitted by the first transmission face propagates away from the catheter shaft (See Fig. 3, B1 propagates away from catheter C) at an angle relative to a longitudinal axis of the catheter shaft (See Fig. 3, angle θ1).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Muller and Nassi, wherein the first ultrasound transducer includes a first transmission face configured to transmit a velocity ultrasound signal, and wherein the first transmission face tapers away from the catheter shaft such that the velocity ultrasound signal transmitted by the first transmission face propagates away from the catheter shaft at an angle relative to a longitudinal axis of the catheter shaft, as taught by Nassi, in order for the beam that is used for determining the velocity is at an optimal angle, since a deviation from the optimum angle can lead to errors in the volumetric flow rate (Nassi, col. 10, Paragraph starting at line 6).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Muller, in view of Nassi, as applied to claim 1 above, and further in view of US2007/0088214 to Shuros et al. “Shuros”.
Regarding claim 7, the modifications of Muller and Nassi disclose all the features of claim 1 above.
However, Muller and Nassi does not explicitly disclose wherein the first ultrasound transducer and the second ultrasound transducer are attached to an outer surface of the catheter shaft.
Shuros teaches in a similar field of endeavor of an implantable ultrasonic sensor for mounting to a vessel wall (Abstract). Shuros teaches wherein the first ultrasound transducer and the second ultrasound transducer (See Fig. 7, Ref. 316 and 318, ultrasonic elements) are coupled to a housing (Fig. 7, Refs. 320 and 324) positioned on an external surface (See Fig. 7, Ref. 310).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Muller and Nassi, wherein the first ultrasound transducer and the second ultrasound transducer are coupled to a housing positioned on the external surface, as taught by Shuros, in order to be able to configure the first and second transducers for a specific configuration such as Doppler ultrasound ([0054]).
Therefore in the combination of Muller, Nassi, and Shuros, the external surface that the housing of Shuros teaches, would be the catheter surface.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Muller, in view of Nassi, as applied to claim 1 above, and further in view of US2018/0296100 to Ruijters et al. “Ruijters”.
Regarding claim 10, the modifications of Muller and Nassi disclose all the features of claim 1 above.
Muller discloses an optical fiber sensor as the sensor in the proximal sensor assembly ([0171]), which is adjacent to the distal sensor assembly, which as disclosed in the claim 1 rejection above, can be a Doppler ultrasound sensor ([0111], [0113])
However, Muller does not teach wherein the optical fiber sensor is utilized to directly measure the velocity of blood flowing.
Ruijters teaches optical fiber sensor is utilized to directly measure the velocity of blood flowing ([0048], The pulsatile blood flow velocity is measured with an optical sensor comprising an optical fiber 523 integrated into the instrument.). Ruijters additionally teaches in a separate embodiment of using an ultrasound transducer in a similar region of the instrument to measure blood flow velocity ([0047], ultrasound transducer 522 is integrated for flow velocity measurements).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Muller and Nassi, wherein an optical fiber sensor is utilized to directly measure the velocity of blood flowing, along with the first ultrasound transducer, as taught by Ruijters, in order to utilize confirming measurements of the blood flow velocity. Further the optical fiber sensor can double as a pressure sensor (Ruijters, [0048]). Further, having the ultrasound transducer and the optical fiber sensor is merely combining prior art elements (an ultrasound transducer and an optical sensor) according to known methods to yield predictable results (both being able to measure blood flow velocity, while the optical sensor can also measure pressure) (See MPEP 2143).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Muller, in view of Nassi, as applied to claim 12 above, and further in view of US20200077985 to Hope Simpson et al. “Hope Simpson”.
Regarding claim 13, the modifications of Muller and Nassi disclose all the features of claim 12 above.
However, the modifications of Muller and Nassi do not disclose wherein the first ultrasound transducer extends circumferentially around the catheter shaft.
Hope Simpson teaches and ultrasound transducer that extends circumferentially around the catheter shaft ([0003], , transducer distributed around the circumference of IVUS catheter; Also see Fig. 1, Ref. 124.)
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Muller and Nassi, wherein the first ultrasound transducer extends circumferentially around the catheter shaft, as taught by Hope Simpson, in order synthesize the effect of a mechanically scanned ultrasound transducer without moving parts, and without a rotating mechanical element, the transducer array can be placed in direct contact with the blood and vessel tissue with minimal risk of vessel trauma (Hope Simpson, [0003]).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Muller, in view of Nassi, as applied to claim 1 above, and further in view of US20140236011 to Fan et al. “Fan”.
Regarding claim 14, the modifications of Muller and Nassi disclose all the features of claim 1 above.
However, the modifications of Muller and Nassi do not disclose wherein the second ultrasound transducer includes an array of individual ultrasound transducer elements.
Fan teaches wherein the second ultrasound transducer includes an array of individual ultrasound transducer elements (See Fig. 3, and [0021], image sensor 106 on catheter 104; [0049], wherein image sensor 106 is side-looking; [0050], wherein image sensor 106 include a multi-element array, which would read on the claimed array of individual ultrasound transducer elements).
(Examiner notes that image sensor 106 correlates to the T2 transducer of Nassi, since image 106 is a side-looking ultrasound transducer, and wherein the image sensor may be configured to generate high-frequency sound waves that reflect off tissue or vessel walls and may be used to create 2D and/or 3D cross-sectional images from within the vessel for visualizing structural information corresponding to the imaged vessel in offline and/or real-time mode, [0064], wherein the structural information may include the diameter of the blood vessel, [0065]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Muller and Nassi, wherein the second ultrasound transducer includes an array of individual ultrasound transducer elements, as taught by Fan, in order to be able to generate 2D and/or 3D cross-sectional image of the vessel wall (Fan, [0050]).
Claim(s) 15 and 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Muller, in view of Nassi, and further in view of US2016/0374710 to Sinelnikov et al. “Sinelnikov”.
Regarding claim 15, Muller discloses a cardiac pump system ([0059], catheter pump 10 that can provide high performance including flow rates similar to full cardiac output, would read on a cardiac pump system), comprising:
a catheter shaft (Fig. 2, Ref. 84, and [0062], catheter body) having a distal end region (Fig. 2, Ref. 94, and [0062], distal end of elongate body 96 of catheter assembly 80), coupled to a cardiac pump (Fig. 3, shows the pump 10 inside the left ventricle, LV, [0061], which as can be seen, depicts the impeller assembly 92 attached to the distal end of the catheter assembly, when compared to Fig. 2, and therefore the impeller assembly must be part of pump 10, based on the description in [0061], and therefore would read on a catheter shaft having a distal end region coupled to a cardiac pump), wherein the cardiac pump includes an impeller housing ([0061] describes Fig. 3 as illustrating pump 10 inside the LV, wherein based on Fig. 2, the impeller assembly is clearly illustrated as what is described as pump 10, and would read on an impeller housing), a cannula and an impeller ([0063], impeller assembly includes a self-expanding material, such as an expandable cannula and a impeller; also see Fig. 4, and [0068], cannula 108, with impeller 112A),
wherein the cannula includes a distal end region and a proximal end region (See, Fig. 4, Ref, 222, represents the proximal portion of the cannula, also see [0085]; and thus the other end as show in Fig. 3 must be the distal end) wherein the distal end region of the cannula is configured to be positioned in a left ventricle of a heart (see Fig. 3, and [0061], describing the impeller assembly being in the LV, and in view of Fig. 4, would include the cannula being in the LV).
Muller additionally discloses sensors such as such as Doppler ultrasound flow sensors ([0111]), located at a proximal sensor assembly disposed near the proximal portion of the cannula, and a distal sensor assembly disposed near the distal portion of the cannula, wherein the distal sensor assembly can measure a flow rate in the left ventricle of blood moving from the left ventricle to the ascending aorta ([0113]; See also Figs. 18B and 19A, and [0124], proximal sensor assembly 521, and distal sensor assembly 524, wherein the proximal sensor assembly is located on the catheter body 504 [0127], and the distal sensor assembly is located on the distal lumen of the catheter body, [0129] and Fig. 18B, Ref. 524B).
Muller further discloses the distal sensor assembly can be disposed at more than one location ([0129] sensor body of the distal sensor assembly can be disposed at one or more of a first distal sensor location 524A, a second distal sensor location 524B, and a third distal sensor location 524C). This would read on the distal sensor assembly having more than one sensor body, each at a different location [Examiner notes that this interpretation is in agreement with Muller since Muller stipulates that the catheter includes at least two sensors, which indicates that there can be more sensors, [0113]].
Muller discloses that the distal sensor assembly can be located on the outer surface of the cannula (Fig. 18B, location 524A; [0129], The first distal sensor location 524A can be disposed along an outer wall of the cannula 508).
However, Muller does not explicitly disclose a first ultrasound transducer coupled to the catheter shaft; a second ultrasound transducer coupled to the catheter shaft, wherein the first ultrasound transducer is positioned adjacent to the second ultrasound transducer.
Nassi teaches wherein the sensors are a first ultrasound transducer coupled to the catheter shaft (See Fig. 3, Ref. T1, col. 8, lines 36-37, ultrasonic transducer T1), a second ultrasound transducer coupled to the catheter shaft (See Fig. 3, Ref. T2, col. 8, lines 36-37, ultrasonic transducer T2), wherein the first ultrasound transducer is positioned adjacent to the second ultrasound transducer (See Fig. 3, T1 is adjacent to T2).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified Muller’s invention wherein the sensors are a first ultrasound transducer coupled to the catheter shaft, a second ultrasound transducer coupled to the catheter shaft, wherein the first ultrasound transducer is positioned adjacent to the second ultrasound transducer, as taught by Nassi, in order to obtain a blood flow velocity measurement with the first ultrasound transducer and a diameter of the vessel measurement with the second ultrasound transducer (col. 10, lines 48-50, T1 is used for velocity profile measurement), (Nassi, T2 would be used for diameter measurement, col. 10, lines 50-51) to determine the volumetric flow rate in a vessel (Nassi, col. 9, Paragraph starting at line 3, and also lines 31-33).
However, the modifications of Muller and Nassi do not explicitly disclose a third ultrasound transducer positioned on an outer surface of the cannula.
Sinelnikov teaches in a similar field of endeavor of ablation catheter (Abstract). The ablation catheter operates
Sinelnikov teaches in Fig. 34B, and [0296] wherein the ablation catheter comprises a fluid exit lumen, Ref. 488, a guidewire lumen, Ref. 489, and a fluid delivery port 487. As seen in Fig. 34C, the ablation catheter comprises a plurality of ultrasound imaging transducers 491 on the outer surface of the ablation catheter, and as illustrated in Fig. 34A, near the distal end. Any one of the ultrasound imaging transducers 491 would read on the claimed third ultrasound transducer.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Muller and Nassi, wherein the distal outer surface of Muller’s device that comprise a cannula, also have a third ultrasound transducer, as suggested by Sinelnikov, in order to provide a video of the distal portion of the device/probe (Sinelnikov, [0296]).
Regarding claim 17, Muller discloses a cardiac pump system ([0059], catheter pump 10 that can provide high performance including flow rates similar to full cardiac output, would read on a cardiac pump system), comprising:
a catheter shaft (Fig. 2, Ref. 84, and [0062], catheter body) having a distal end region (Fig. 2, Ref. 94, and [0062], distal end of elongate body 96 of catheter assembly 80), coupled to a cardiac pump (Fig. 3, shows the pump 10 inside the left ventricle, LV, [0061], which as can be seen, depicts the impeller assembly 92 attached to the distal end of the catheter assembly, when compared to Fig. 2, and therefore the impeller assembly must be part of pump 10, based on the description in [0061], and therefore would read on a catheter shaft having a distal end region coupled to a cardiac pump), wherein the cardiac pump includes an impeller housing ([0061] describes Fig. 3 as illustrating pump 10 inside the LV, wherein based on Fig. 2, the impeller assembly is clearly illustrated as what is described as pump 10, and would read on an impeller housing), a cannula and an impeller ([0063], impeller assembly includes a self-expanding material, such as an expandable cannula and a impeller; also see Fig. 4, and [0068], cannula 108, with impeller 112A),
wherein the cannula includes a distal end region and a proximal end region (See, Fig. 4, Ref, 222, represents the proximal portion of the cannula, also see [0085]; and thus the other end as show in Fig. 3 must be the distal end) wherein the distal end region of the cannula is configured to be positioned in a left ventricle of a heart (see Fig. 3, and [0061], describing the impeller assembly being in the LV, and in view of Fig. 4, would include the cannula being in the LV).
Muller additionally discloses sensors such as such as Doppler ultrasound flow sensors ([0111]), located at a proximal sensor assembly disposed near the proximal portion of the cannula, and a distal sensor assembly disposed near the distal portion of the cannula, wherein the distal sensor assembly can measure a flow rate in the left ventricle of blood moving from the left ventricle to the ascending aorta ([0113]; See also Figs. 18B and 19A, and [0124], proximal sensor assembly 521, and distal sensor assembly 524, wherein the proximal sensor assembly is located on the catheter body 504 [0127], and the distal sensor assembly is located on the distal lumen of the catheter body, [0129]).
However, Muller does not disclose wherein the sensors are a first ultrasound transducer coupled to the catheter shaft, wherein the first ultrasound transducer is configured to directly measure a velocity of blood flowing adjacent to the first ultrasound transducer; and
a second ultrasound transducer coupled to the catheter shaft, wherein the second ultrasound transducer is configured to transmit a first ultrasound signal toward a wall of a body vessel and receive a reflected portion of the first ultrasound signal reflected from the wall of the body vessel.
Nassi teaches wherein the sensors are a first ultrasound transducer coupled to the catheter shaft (See Fig. 3, Ref. T1, col. 8, lines 36-37, ultrasonic transducer T1), wherein the first ultrasound transducer is configured to directly measure a velocity of blood flowing adjacent to the first ultrasound transducer (Col. 8, lines 56-62, typically, a transducer T1 or T2 is excited with short bursts of ultrasound followed by the detection of Doppler shifted energy scattered from the particles in the moving liquid stream, as for example, moving erythrocytes in human blood. This Doppler shift is then used to calculate the velocity of blood flow within a sample volume or volumes within the vessel; Col. 10, lines 48-50, T1 is used for velocity profile measurement); and
a second ultrasound transducer coupled to the catheter shaft (See Fig. 3, Ref. T2, col. 8, lines 36-37, ultrasonic transducer T2), wherein the second ultrasound transducer is configured to transmit a first ultrasound signal toward a wall of a body vessel (Fig. 3, Ref. B2 is the beam transmitted from transducer T2, which is directed toward vessel wall 151, also see col. 8, paragraphs starting at line 29, and starting at line 50) and receive a reflected portion of the first ultrasound signal reflected from the wall of the body vessel (T2 transmits an ultrasonic pulse across the vessel that is reflected by the wall and return to the same transducer, i.e. T2, Col. 8, lines 62-66).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified Muller’s invention wherein the sensors are a first ultrasound transducer coupled to the catheter shaft, wherein the first ultrasound transducer is configured to directly measure a velocity of blood flowing adjacent to the first ultrasound transducer, and a second ultrasound transducer coupled to the catheter shaft, wherein the second ultrasound transducer is configured to transmit a first ultrasound signal toward a wall of a body vessel and receive a reflected portion of the first ultrasound signal reflected from the wall of the body vessel, as taught by Nassi, in order to obtain both a blood flow velocity measurement and a diameter of the vessel measurement (Nassi, T2 would be used for diameter measurement, Col. 10, lines 50-51) to determine the volumetric flow rate in a vessel (Nassi, Col. 9, Paragraph starting at line 3, and also lines 31-33).
However, the modifications of Muller and Nassi do not explicitly disclose a third ultrasound transducer positioned on an outer surface of the cannula.
Sinelnikov teaches in a similar field of endeavor of ablation catheter (Abstract). Sinelnikov teaches in Fig. 34B, and [0296] wherein the ablation catheter comprises a fluid exit lumen, Ref. 488, a guidewire lumen, Ref. 489, and a fluid delivery port 487. As seen in Fig. 34C, the ablation catheter comprises a plurality of ultrasound imaging transducers 491 on the outer surface of the ablation catheter, and as illustrated in Fig. 34A, near the distal end. Any one of the ultrasound imaging transducers 491 would read on the claimed third ultrasound transducer.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Muller and Nassi, wherein the distal outer surface of Muller’s device that comprise a cannula, also have a third ultrasound transducer, as suggested by Sinelnikov, in order to provide a video of the distal portion of the device/probe (Sinelnikov, [0296]).
Regarding claim 18, the modifications of Muller, Nassi, and Sinelnikov disclose all the features of claim 17 above.
As disclosed in the claim 17 rejection above, Sinelnikov teaches in Fig. 34B, and [0296], wherein the third ultrasound transducer is one of the plurality of ultrasound imaging transducers 491 on the outer surface of the ablation catheter, and as illustrated in Fig. 34A, near the distal end. The imaging transducer is transmitting and receiving waves to provide an image while the ablation is occurring, wherein the operating region is of the tissue in a carotid septum ([0295]).
Therefore It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Muller and Nassi, wherein the third ultrasound transducer is configured to transmit an imaging ultrasound signal and receive a reflected portion of the imaging ultrasound signal reflected from blood or a body tissue, as suggested by Sinelnikov, in order to provide a video of the distal portion of the device/probe during a medical procedure (Sinelnikov, [0296]).
Regarding claim 19, the modifications of Muller, Nassi, and Sinelnikov disclose all the features of claim 17 above.
Sinelnikov further teaches a fourth ultrasound transducer positioned on the outer surface, wherein the fourth ultrasound transducer is circumferentially spaced 180 degrees from the third ultrasound transducer ([0296], and Fig. 34A, the transducers 491 that lie on the axis B-B, in the embodiment described in [0296], wherein the imaging transducers are positioned around the entire circumference of the catheter; one transducer would read on the third ultrasonic transducer and the other one would read on the fourth ultrasonic transducer).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Muller and Nassi, wherein the distal outer surface of Muller’s device that comprise a cannula, also have a fourth ultrasound transducer, wherein the fourth ultrasound transducer is circumferentially spaced 180 degrees from the third ultrasound transducer, as suggested by Sinelnikov, in order to have a ultrasound transducer that is facing in an opposite direction of the direction of aim of the probe to act as a marker so that the position of the probe can be observed in the video image (Sinelnikov, [0296]).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Muller, in view of Nassi, and further in view of Sinelnikov, as applied to claim 15 above, and further in view of Shuros.
Regarding claim 16, the modification of Muller, Nassi, and Sinelnikov disclose all the features of claim 15 above.
Sinelnikov further teaches a fourth ultrasound transducer positioned on the outer surface ([0296], and Fig. 34A, any of the other imaging transducers 291, that was not chosen as the third ultrasound transducer).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Muller and Nassi, wherein the distal outer surface of Muller’s device that comprise a cannula, also have a fourth ultrasound transducer, as suggested by Sinelnikov, in order to provide a video of the distal portion of the device/probe (Sinelnikov, [0296]).
However, the modification of Muller, Nassi, and Sinelnikov do not disclose wherein the first ultrasound transducer and the second ultrasound sensor are coupled to a housing positioned on the catheter shaft.
Shuros teaches in a similar field of endeavor of an implantable ultrasonic sensor for mounting to a vessel wall (Abstract). Shuros teaches wherein the first ultrasound transducer and the second ultrasound sensor (See Fig. 7, Ref. 316 and 318, ultrasonic elements) are coupled to a housing (Fig. 7, Refs. 320 and 324) positioned on an external surface (See Fig. 7, Ref. 310).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Muller, Nassi, and Sinelnikov, wherein the first ultrasound transducer and the second ultrasound sensor are coupled to a housing positioned on the external surface, as taught by Shuros, in order to be able to configure the first and second transducers for a specific configuration such as Doppler ultrasound ([0054]).
Therefore in the combination of Muller, Nassi, Sinelnikov, and Shuros, the external surface that the housing of Shuros teaches, would be the catheter surface.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Muller, in view of Nassi, and further in view of Sinelnikov, as applied to claim 19 above, and further in view of Fan.
Regarding claim 20, the modifications of Muller, Nassi, and Sinelnikov disclose all the features of claim 19 above.
Muller teaches a console ([0122], console with controller 502 and processing unit 503) coupled to the catheter shaft (See Fig. 18A, catheter assembly 500 is coupled to the controller 502; [0171], the proximal and distal sensor assembly, which is located on the catheter assembly, see Fig. 18A, is in communication with the controller via an elongate connector 541, which infers a coupling between the controller and the sensor assemblies, and therefore also a coupling between the controller and the catheter assembly), wherein the console includes a processor ([0122], console with controller 502 and processing unit 503), and wherein the console is configured to receive signals detected by the sensors ([0008], processor can be programmed to process a signal detected by the sensor; since the processor is part of the controller, which is part of the console, processing the signal would infer first, receiving the signal before the processing; See also [0114]).
However, the modifications of Muller, Nassi, and Sinelnikov do not disclose wherein the processor is configured to generate a three-dimensional image based on the reflected portion of the imaging ultrasound signal received from the third ultrasound transducer.
Fan teaches wherein the processor is configured to generate a three-dimensional image based on the reflected portion of the imaging ultrasound signal received from the imaging ultrasound transducer ([0050], generating a 3D radial cross-sectional image of the vessel wall, using the imaging transducer 106, that is a multi-element array transducer; Fan additionally teaches a processing subsystem 110 for processing the received signals, [0024], and generating a 3D cross-sectional image, [0027]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Muller, Nassi, and Sinelnikov, wherein the processor is configured to generate a three-dimensional image based on the reflected portion of the imaging ultrasound signal received from the imaging ultrasound transducer, as taught by Fan, in order to be able to acquire 3D geometry and volumetric information corresponding toa region of interest in a vascular structure ([0017]).
Therefore in the combination of Muller, Nassi, and Sinelnikov, the third ultrasound transducer of Sinelnikov is an imaging transducer, part of a multi-element array, and therefore a generated 3D image would be based on the signals received from the “third ultrasound transducer” of Sinelnikov.
Conclusion
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/MT/Examiner, Art Unit 3798
/KEITH M RAYMOND/Supervisory Patent Examiner, Art Unit 3798
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