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 .
Response to Arguments
Applicant's arguments below filed 7/8/2026 have been fully considered but they are not persuasive | moot in view of the new grounds of rejection.
The Applicant asserts on pages 9-10 of the Remarks:
“Oishi and Cavin, alone or in combination, do not disclose or suggest "track an accumulated error, wherein the accumulated error is calculated based on combining the plurality of respective errors of the plurality of estimated displacements received after the first X-ray-based position" and "wherein the accumulated error increases as successive estimated displacements of the plurality of estimated displacements are received", as recited (emphasis added). In Cavin, drift is detected by comparing two independently-determined (from OCT and from camera) positions (see Cavin, col. 12, 11. 42-48; col. 13, 11. 18-22), not by combining per-displacement errors into an accumulated error that grows with successive displacements.
Oishi and Cavin, alone or in combination, also do not disclose or suggest "instruct, in response to the accumulated error exceeding a predetermined error threshold, the X-ray imaging system to obtain a second X-ray image for determining a second X-ray-based position of the distal portion of the intravascular imaging catheter inside the blood vessel," as recited (emphasis added). In Cavin, the camera system operates at its own independent rate (every time period 565) and is not triggered by any accumulated error. (See Cavin, col. 12, 11. 42-48; Fig. 5B.) Oishi does not cure these deficiencies. Oishi does not disclose or suggest triggering X-ray imaging based on an accumulated error that increases with successive displacements. (See Oishi,[0074].)
Oishi and Cavin, even when combined, do not disclose or suggest all of the features of amended independent claim 1. For at least these reasons, a primafacie case of obviousness has not been established with respect to claim 1. Applicant requests that the § 103 rejection of claim 1 be withdrawn.”
In response the examiner respectfully asserts that as cited below Cavin discloses in col. 11 line 65 - col. 12 line 4 – “the OCT eye tracking unit determines a current position of the user's eye based upon a previously determined position of the user's eye and a determined displacement or offset between the previous position and the current position. As such, any errors in the previously determined position are passed on to the determined current position” and in Col. 12 lines 2-4 – “any errors in the previously determined position are passed on to the determined current position”. Therefore, Cavin discloses combining per-displacement errors into an accumulated error that grows with successive displacements. Additionally, as cited below Cavin discloses in Col. 13 lines 18-22 – “the eye tracking unit may only perform drift correction when a difference between the first position determined at a given time and the second position determined at the same time exceeds a threshold value”. Therefore, Cavin discloses instructing in response to the accumulated error exceeding a predetermined error threshold, the imaging system to obtain an image for determining a second reference position. Oishi teaches X-ray imaging to determine a reference position of a distal portion of the intravascular imaging catheter and teaches that X-ray imaging may be performed when the amount of movement of the intravascular imaging catheter reaches a certain value. Therefore, Oishi teaches a second reference position determined by an x-ray image and it would be obvious for one with ordinary skill in the art to combine Oishi with Cavin to teach "instruct, in response to the accumulated error exceeding a predetermined error threshold, the X-ray imaging system to obtain a second X-ray image for determining a second X-ray-based position of the distal portion of the intravascular imaging catheter inside the blood vessel". Therefore, the arguments are found to be not persuasive by the examiner
In light of the examiner’s response above the arguments to the dependent claims are also found to be not persuasive by the examiner.
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.
Claims 1-2, 4, 5, 7, and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Oishi (JP 2011156086) machine translation and further in view of Cavin (US 10963046).
Regarding claims 1, 14, and 15, Oishi discloses a system for determining a position of a distal portion of an intravascular imaging catheter inside a blood vessel ([0058] – “As shown in FIG. 9, the medical image acquisition device 3 includes an X-ray diagnostic device 50 in addition to a three-dimensional image processing device 40”, therefore the medical image acquisition device can be considered as a system, [0062] – “identifies the three-dimensional position of the forward-viewing IVUS probe 12 at the second scanning time”, Fig. 4 shows scanning regions within a vessel), comprising: [claim 1]
a method of determining a position of a distal portion of an intravascular imaging catheter inside a blood vessel ([0062] – “identifies the three-dimensional position of the forward-viewing IVUS probe 12 at the second scanning time”, Fig. 4 shows scanning regions within a vessel), the method comprising: [claim 14]
a non-transitory computer-readable storage medium comprising computer program code which, when executed by a processor, causes the processor to perform a method ([0021] – “The system control unit 28 functions as the core of the three-dimensional image processing device 20. For example, the system control unit 28 controls each unit to perform various processes for supporting catheterization”) comprising: [claim 15]
a processor ([0058] – “three-dimensional image processing apparatus 40”) configured to:
receive a first X-ray based position of the distal portion of the intravascular imaging catheter inside the blood vessel, wherein the first X-ray based position is determined based on a first X-ray image obtained by an X-ray imaging system ([0062] – “The three-dimensional position identifying unit 41 identifies the three-dimensional position of the forward-viewing IVUS probe 12 at the first scanning time based on a plurality of X-ray images…The three-dimensional position identified based on the multiple X-ray images becomes the reference position”, [0067] – “The identified three-dimensional position P1, for example, defines the tip position of the forward-looking IVUS probe 12 on the three-dimensional coordinate system in the X-ray imaging mechanism”, it can be interpreted the IVUS probe would be positioned inside a blood vessel);
receive a plurality of estimated displacements representative of movement of the distal portion of the intravascular imaging catheter inside the blood vessel, wherein the plurality of estimated displacements are determined based on a plurality of intravascular images obtained by the intravascular imaging catheter, ([0006] – “first ultrasonic image data relating to the first time and second ultrasonic image data relating to the second time based on an output from the ultrasonic probe, and a calculating unit which calculates a movement amount and a movement direction of the ultrasonic probe from the first time to the second time”, [0023] – “the forward-looking IVUS probe 12 attached to the tip of the catheter 11 is inserted into a blood vessel”, [0027] discloses that the displacement is determined based on two ultrasound images, [0028] – “the movement amount/direction calculation unit 23 repeatedly calculates equation (1) while changing the values of Δx, Δy, Δz, Δθx, Δθy, and Δθz”);
determine a plurality of estimated positions of the distal portion of the intravascular imaging catheter inside the blood vessel based on the first X-ray-based position and the plurality of estimated displacements ([0062] – “the three-dimensional position identification unit 41 identifies the three-dimensional position of the forward-viewing IVUS probe 12 at the second scanning time based on the movement amount and movement direction calculated by the movement amount/movement direction calculation unit 23 and the reference position”, [0069] – “When data on the amount of movement and direction of movement is supplied, the 3D position identification unit 41 updates the 3D position of the forward-view IVUS probe 12”, therefore each time the movement is calculated the 3D position is identified),
a second X-ray-based position of the distal portion of the intravascular imaging catheter inside the blood vessel ([0074] – “X-ray imaging may be performed when the amount of movement of the forward-viewing IVUS probe 12 from a certain position reaches a certain value”, because the imaging is based on an amount a movement it would be obvious to one with ordinary skill in the art to use the second X-ray image to determine a second X-ray-based position).
As cited above, Oishi discloses a first X-ray based position which can be interpreted as a reference position and estimated displacements calculated from two ultrasound images. Oishi also discloses instructing the X-ray imaging system to obtain a second X-ray based position as a new reference position ([0074] – “X-ray imaging may be performed when the amount of movement of the forward-viewing IVUS probe 12 from a certain position reaches a certain value”) conversely Oishi does not teach wherein each estimated displacement comprises a respective error such that the plurality of estimated displacements comprises a plurality of respective errors,
track an accumulated error, wherein the accumulated error is calculated based on combining the plurality of respective errors of the plurality of estimated displacements received after the first […reference] position, and wherein the accumulated error increases as successive estimated displacements of the plurality of estimated displacements are received; and
instruct, in response to the accumulated error exceeding a predetermined error threshold, the […] imaging system to obtain a second […] image for determining a second […] based position […].
However, Cavin discloses wherein each estimated displacement comprises a respective error such that the plurality of estimated displacements comprises a plurality of respective errors (Fig. 5A, col. 11 line 65 - col. 12 line 4 – “the OCT eye tracking unit determines a current position of the user's eye based upon a previously determined position of the user's eye and a determined displacement or offset between the previous position and the current position. As such, any errors in the previously determined position are passed on to the determined current position”),
track an accumulated error, wherein the accumulated error is calculated based on combining the plurality of respective errors of the plurality of estimated displacements received after the first […reference] position, and wherein the accumulated error increases as successive estimated displacements of the plurality of estimated displacements are received (Figs. 5A and 5B, Col. 2 lines 17-19 – “FIG. 5A depicts a graph illustrating errors that may accumulate over time when using OCT eye tracking to determine eye position”, Col. 12 lines 2-4 – “any errors in the previously determined position are passed on to the determined current position”, as seen in Fig. 5A the errors are calculated after the first reference position at time zero); and
instruct, in response to the accumulated error exceeding a predetermined error threshold, the […] imaging system to obtain a second […] image for determining a second […] based position […] (Col. 12 lines 42-48 – “The eye tracking system (e.g., eye tracking system 300) receives the first positions determined by the OCT eye tracking unit. In addition, when second positions of the user's eye as determined using the eye tracking camera are available (e.g., every time period 565), the eye tracking system performs drift correction by updating the first positions based upon the determined second positions”, as seen in Fig. 5B the eye tracking camera performs drift correction by obtaining a new reference image [bold lines in Fig. 5B], Col. 13 lines 18-22 – “the eye tracking unit may only perform drift correction when a difference between the first position determined at a given time and the second position determined at the same time exceeds a threshold value”).
Cavin is an analogous art considering it is in the field of tracking using a first imaging system that determines position based on a displacement between two images and a second imaging system that determines a reference position.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Oishi to incorporate the imaging system obtaining a second reference image based position based on comparing the error to a threshold of Cavin to achieve the same results. One would have motivation to combine because it would provide more accurate and robust tracking while continuing to limit radiation dose by only obtaining a subsequent first estimated position from the x-ray machine when it is necessary.
Regarding claim 2, Oishi and Cavin disclose all of the elements of the claimed invention as cited above in claim 1.
Oishi further discloses further comprising the x-ray imaging system ([0058] – “As shown in FIG. 9, the medical image acquisition device 3 includes an X-ray diagnostic device 50”),
wherein the x-ray imaging system comprises an imaging processor configured to calculate the first x-ray-based position based on the first X-ray image and calculate the second x-ray-based position based on the second x-ray image ([0074] – “X-ray imaging may be performed when the amount of movement of the forward-viewing IVUS probe 12 from a certain position reaches a certain value”, it can be interpreted based on the disclosure of Oishi that a position of the catheter is determined each time a x-ray imaging is performed, [0062] – “The three-dimensional position identifying unit 41 identifies the three-dimensional position of the forward-viewing IVUS probe 12 at the first scanning time based on a plurality of X-ray images”, The three-dimensional position identifying unit 41 is part of the image processing apparatus).
Regarding claim 4, Oishi and Cavin disclose all of the elements of the claimed invention as cited above in claim 1.
Oishi further discloses further comprising an intravascular ultrasound (IVUS) system (Fig. 9 element 10 [forward view IVUS]),
wherein the intravascular imaging catheter comprises an IVUS catheter ([0011] – “an ultrasound probe 12 for forward-viewing IVUS (hereinafter referred to as a forward-viewing IVUS probe) is attached to the tip of the catheter 11”),
wherein the plurality of intravascular images comprises a plurality of IVUS images ([0013] – “reconstructs the 3D ultrasound image data by applying reconstruction processing for forward-view IVUS to the ultrasound signal related to the scanning area…The three-dimensional ultrasound image for the first scanning time and the three-dimensional ultrasound image for the second scanning time”),
wherein the IVUS catheter comprises an ultrasound transducer for obtaining the plurality of IVUS images ([0023] – “the forward-looking IVUS probe 12”, [0006] – “first ultrasonic image data relating to the first time and second ultrasonic image data relating to the second time based on an output from the ultrasonic probe”),
wherein the IVUS system comprises an ultrasound processor configured to calculate the plurality of estimated displacements based on the plurality of IVUS images ([0014] – “The three-dimensional image processing device 20 has an interface 21, a storage unit 22, a movement amount/movement direction calculation unit 23”, [0006] – “a calculating unit which calculates a movement amount and a movement direction of the ultrasonic probe from the first time to the second time based on the first ultrasonic image data and the second ultrasonic image data”, [0028] – “the movement amount/direction calculation unit 23 repeatedly calculates equation (1) while changing the values of Δx, Δy, Δz, Δθx, Δθy, and Δθz”).
Regarding claim 5, Oishi and Cavin disclose all of the elements of the claimed invention as cited above in claims 1 and 4.
Oishi further discloses wherein the ultrasound transducer is disposed on the distal portion of the IVUS catheter ([0011] – “an ultrasound probe for forward-looking IVUS (hereinafter referred to as a forward-looking IVUS probe) 12 is attached to the tip of the catheter 11.”),
wherein an imaging plane of the ultrasound transducer extends in a radial direction ([0011] – “an ultrasound probe for forward-looking IVUS (hereinafter referred to as a forward-looking IVUS probe) 12 is attached to the tip of the catheter 11.”, forward-looking IVUS would provide imaging planes extending in a radial direction), and
wherein the plurality of estimated displacements are in an elevational direction substantially perpendicular to the radial direction […](as seen in Fig. 3 the movement of the catheter is in the direction through the vessel which would be substantially perpendicular to the radial direction of the catheter).
Regarding claim 7, Oishi and Cavin disclose all the elements of the claimed invention as cited in claim 1.
Conversely Oishi does not teach wherein the plurality of estimated displacements comprises a sequence of estimated displacements, wherein the plurality of respective errors is based on an accuracy of the plurality of estimated displacements, wherein the error threshold comprises a predetermined value.
However, Cavin discloses wherein the plurality of estimated displacements comprises a sequence of estimated displacements (Col. 3 lines 5-9 – “the OCT eye tracking system determines eye position and updates the baseline model based upon the a determined offset or movement between different measurements, errors in position determination may accumulate over time”, Figs. 5A and 5B show the estimated displacement between the sensed position and the actual position over a sequence),
wherein the plurality of respective errors is based on a known accuracy of the plurality of estimated displacements (Figs. 5A and 5B show the estimated displacement between the sensed position and the actual position over a sequence, Col. 2 lines 17-18 – “FIG. 5A depicts a graph illustrating errors that may accumulate over time”, it can be interpreted the accuracy would be known for the error to be estimated), wherein the error threshold comprises a predetermined value (Col. 13 lines 18-22 – “the eye tracking unit may only perform drift correction when a difference between the first position determined at a given time and the second position determined at the same time exceeds a threshold value”, Col. 9 lines 25-27 – “some or all of the functionality described as performed by the eye tracking camera module 320 may be performed by the control module 330”, therefore because the drift correction performed by the eye tracking camera is performed by the control model it is interpreted that the threshold is a predetermined value).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Oishi to incorporate the sequence of estimated displacements to determine errors of Cavin to achieve the same results. One would have motivation to combine because it would provide more accurate and robust tracking when a position is tracked using a correlation between two images.
Claims 3 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Oishi (JP 2011156086) machine translation and Cavin (US 10963046) as applied to claims 1 and 2 above, and further in view of Eichler (US 20110230758).
Regarding claim 3, Oishi and Cavin disclose all the elements of the claimed invention as cited in claims 1 and 2.
As cited above, Oishi teaches an intravascular imaging catheter.
Conversely Oishi does not teach wherein the intravascular imaging catheter comprises one or more markings detectable by the X-ray imaging system, and
wherein the imaging processor is configured to calculate the first X-ray-based position based on a location of the one or more markings and/or a distance between the one or more markings.
However, Eichler discloses wherein the intravascular imaging catheter comprises one or more markings detectable by the X-ray imaging system ([0052] – “Radiopaque marker 214 and IVUS imager 220 are located at a distal portion 216 of medical catheter 212”, [0046] – “imager 106 is a three-dimensional image acquisition device, such as computer tomography (CT) imager”) and,
wherein the imaging processor is configured to calculate the first X-ray-based position based on a location of the one or more markings and/or a distance between the one or more markings (Fig. 2B, [0055] – “The surgeon can observe an image 252 of radiopaque marker 214 within operational image 250”, [0104] – “registering the selected portion (e.g., radiopaque marker 514) with the initial position”).
Eichler is an analogous art considering it is in the field of tracking of a catheter and determining an estimated current position.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Oishi to incorporate the one or more markings on the catheter of Eichler to achieve the same results. One would have motivation to combine because it allows for the catheter position to be easily detectable in an x-ray image.
Regarding claim 11, Oishi and Cavin disclose all the elements of the claimed invention as cited in claim 1.
Conversely Oishi does not disclose wherein the processor is further configured to determine a roadmap of the intravascular imaging catheter in the blood vessel based on the first X-ray-based position, the plurality of estimated displacements, and/or the second X-ray-based position.
However, Eichler discloses wherein the processor is further configured to determine a roadmap of the intravascular imaging catheter in the blood vessel based on the first X-ray-based position (Fig. 2B, [0070] – “Processor 204 superimposes previous position 280 of distal portion 216, on superimposed operational image 270”), the plurality of estimated displacements, and/or the second X-ray-based position.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Oishi to incorporate the roadmap of the interventional device of Eichler to achieve the same results. One would have motivation to combine because it allows one to visualize the path the catheter has traversed as it is moving, which may provide an understanding of how the catheter should be guided to reach the target.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Oishi (JP 2011156086) machine translation and Cavin (US 10963046) as applied to claim 1 above, and further in view of McGee (US 20060247520).
Regarding claim 8, Oishi and Cavin disclose all the elements of the claimed invention as cited in claim 1.
As cited above Oishi discloses the intravascular imaging catheter and instructing the X-ray imaging system to obtain a second x-ray based position conversely Oishi does not teach wherein the processor is further configured to determine whether the […] catheter is stationary relative to the blood vessel based on one or more of the plurality of estimated displacements being less than a predetermined threshold value, and wherein instructing the x-ray imaging system to obtain the second x-ray image is further based on the […] catheter not being stationary.
However McGee discloses wherein the processor is further configured to determine whether the […] catheter is stationary relative to the blood vessel based on one or more of the plurality of estimated displacements being less than a predetermined threshold value, and wherein instructing the x-ray imaging system to obtain the second x-ray image is further based on the […] catheter not being stationary (Abstract – “blood vessel) in which the medical device is disposed”, [0067] – “If the location parameter difference does not surpass the threshold value, the activation processor 152 sends a deactivation signal to the activation controller 154, which will deactivate the imaging device 122”, [0068] – “the imaging device 122 is activated as long as the catheter 110 remains moving, and is deactivated when the catheter 110 stops moving”, [0041] discloses that the imaging device transmits and receives x-rays).
McGee is an analogous art considering it is in the field of tracking a catheter.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Oishi to incorporate the instructing of the first system being based on the interventional device not being stationary of McGee to achieve the same results. One would have motivation to combine because “imaging may be performed only when needed, e.g., when the medical device is moving or becomes unstable, thereby further decreasing radiation exposure” (McGee – [0013]).
Claims 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Oishi (JP 2011156086) machine translation and Cavin (US 10963046) as applied to claim 1 above, and further in view of Bergman (US 20150005865).
Regarding claim 9, Oishi and Cavin disclose all the elements of the claimed invention as cited in claim 1.
Conversely Oishi does not teach wherein the processor is further configured determine a speed limit indication based on comparing one or more of the plurality of estimated displacements over a first time period to a predetermined threshold value, and wherein instructing the X-ray imaging system to obtain the second X-ray image is further based on the speed limit indication.
However Bergman discloses wherein the processor is further configured determine a speed limit indication based on comparing one or more of the plurality of estimated displacements over a first time period to a predetermined threshold value, and wherein instructing the X-ray imaging system to obtain the second X-ray image is further based on the speed limit indication ([0027] – “The X-ray exposure of the patient may be reduced by taking intermittent fluoroscopic images and the frame rate may be selected in accordance with the velocity of feeding of the guide wire or working catheter”, one with ordinary skill in the art would find it obvious to use a threshold of the velocity to adjust the frame rate).
Bergman is an analogous art considering it is in the field of tracking a catheter.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Oishi to incorporate the frame rate being selected based on a speed of the catheter of Bergman to achieve the same results. One would have motivation to combine because “The X-ray exposure of the patient may be reduced” (Bergman – [0027]).
Regarding claim 10, Oishi and Cavin disclose all the elements of the claimed invention as cited in claim 1.
Conversely Oishi does not teach wherein the processor is further configured to adapt parameters of the X-ray imaging system based on one or more of the plurality of estimated displacements.
However Bergman discloses wherein the processor is further configured to adapt parameters of the X-ray imaging system based on one or more of the plurality of estimated displacements ([0027] – “The X-ray exposure of the patient may be reduced by taking intermittent fluoroscopic images and the frame rate may be selected in accordance with the velocity of feeding of the guide wire or working catheter”, velocity is a displacement over a period of time therefore the frame rate would be adjusted based on a displacement).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Oishi to incorporate adapting the frame rate based on a speed of the catheter of Bergman to achieve the same results. One would have motivation to combine because “The X-ray exposure of the patient may be reduced” (Bergman – [0027]).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Oishi (JP 2011156086) machine translation and Cavin (US 10963046) as applied to claim 1 above, and further in view of Noordhoek (US 20090169080).
Regarding claim 12, Oishi and Cavin disclose all the elements of the claimed invention as cited in claim 1.
As cited above, Oishi teaches determining the second estimated position based on the first estimated position from the first system conversely Oishi does not teach wherein the processor is further configured to compensate for motion blur of the X-ray imaging system when determining one or more of the plurality of estimated positions.
However Noordhoek discloses wherein the processor is further configured to compensate for motion blur of the X-ray imaging system when determining one or more of the plurality of estimated positions ([0020] – “an exemplary embodiment of the invention provides near real time, improved fluoroscopic images over existing fluoroscopy methods and systems with compensation for motion blur”, [0021] – “Motion blur occurs when the stent moves “fast” compared to the detector resolution/x-ray pulse length and stent wire thickness” one with ordinary skill in the art would find it obvious to compensate for motion blur to determine the estimated positions of Oishi because the motion blur compensation provides enhanced images and therefore the estimated positions maybe be more accurate).
Noordhoek is an analogous art considering it is in the field of tracking of an interventional device.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Oishi to incorporate the compensation of motion blur of Noordhoek to achieve the same results. One would have motivation to combine because it “provides near real time, improved fluoroscopic images over existing fluoroscopy methods and systems” (Noordhoek – [0020]).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Oishi (JP 2011156086) machine translation and Cavin (US 10963046) as applied to claim 1 above, and further in view of Sen (US 20210290317).
Regarding claim 13, Oishi and Cavin disclose all the elements of the claimed invention as cited in claim 1.
As cited above, Oishi teaches determining the estimated positions based on the first estimated position from the X-ray system and the estimated displacement conversely Oishi does not teach wherein to determine the plurality of estimated positions, the processor is configured to:
input the first X-ray-based position and the plurality of estimated displacements into a Kalman filter based position estimator;
determine an estimated speed of the distal portion of the intravascular imaging catheter based on the plurality of estimated displacements and determine the plurality of estimated positions based on the first X-ray-based position and the estimated speed of the distal portion; and/or
input the first X-ray-based position and the plurality of estimated displacements into a machine learning algorithm trained to output the plurality of estimated positions based on the first X-ray-based position and the plurality of estimated displacements.
However Sen discloses wherein to determine the plurality of estimated positions, the processor is configured to:
input the first X-ray-based position and the plurality of estimated displacements into a Kalman filter based position estimator ([0067] – “position determination facility 606 may implement and use a non-linear estimator such as an unscented Kalman filter or other Bayesian filter to determine a physical position of a surgical instrument at a surgical area based on kinematics of the surgical instrument and an observation associated with the surgical instrument”, therefore one with ordinary skill in the art would find it obvious to input the estimated displacement of the catheter as well as the first X-ray-based position of the catheter into a Kalman filter to determine a position of the catheter);
determine an estimated speed of the distal portion of the intravascular imaging catheter based on the plurality of estimated displacements and determine the plurality of estimated positions based on the first X-ray-based position and the estimated speed of the distal portion; and/or
input the first X-ray-based position and the plurality of estimated displacements into a machine learning algorithm trained to output the plurality of estimated positions based on the first X-ray-based position and the plurality of estimated displacements.
Sen is an analogous art considering it is in the field of tracking a surgical instrument.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Oishi to incorporate the Kalman filter to determine the second estimated position of Sen to achieve the same results. One would have motivation to combine because it will allow one to “track surgical instrument position with precision, accuracy, efficiency, and/or reliability” (Sen – [0021]).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Oishi (JP 2011156086) machine translation and Cavin (US 10963046) as applied to claim 4 above, and further in view of Rodriguez (US 20210174940).
Regarding claim 16, Oishi and Cavin disclose all the elements of the claimed invention as cited in claims 1 and 4.
As cited above Oishi discloses an IVUS catheter taking multiple ultrasound images and Cavin discloses a determination of an accumulation of movement error being unacceptable conversely Oishi does not teach wherein the error threshold is based on an average error and/or an expected error […].
However, Rodriguez discloses wherein the error threshold is based on an average error and/or an expected error […] ([0220] – “The threshold may be selected, for example, based on a desired margin of safety, according to the expected errors”).
Rodriguez is an analogous art considering it is in the field of a determining positions of a catheter device.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Oishi to incorporate the error threshold based on an expected error of Rodriguez to achieve the same results. One would have motivation to combine because an expected error threshold allows for the errors that are expected or bound to happen to be ignored which would decrease the use of x-ray radiation in Oishi.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Oishi (JP 2011156086) machine translation and Cavin (US 10963046) as applied to claim 1 above, and further in view of Hossack (US 6014473).
Regarding claim 17, Oishi and Cavin disclose all the elements of the claimed invention as cited in claim 1.
Conversely Oishi does not teach wherein the processor is configured to calculate the accumulated error based on combining the plurality of respective errors using
e
a
c
c
=
∑
i
=
1
N
e
i
2
where eacc is the accumulated error and ei is the respective error in each estimated displacement of the plurality of estimated displacements.
However Hossack discloses wherein the processor is configured to calculate the accumulated error based on combining the plurality of respective errors using
e
a
c
c
=
∑
i
=
1
N
e
i
2
where eacc is the accumulated error and ei is the respective error in each estimated displacement of the plurality of estimated displacements (Col. 29 lines 54-56 – “it is possible to accumulate the detected motion errors between successive motion estimates”, Col.29 lines 61-62 – “the cumulative motion error (which may be derived from the sum of squared errors”, Col. 11 lines 1-2 – “the entire operation can be performed using a suitably programmed general purpose processor”).
Hossack is an analogous art considering it is in the field of tracking an interventional device.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Oishi to incorporate the accumulated error being based on an accuracy of the sequence of estimated displacement values of Hossack to achieve the same results. One would have motivation to combine because it provides “an improved system, method and transducer for acquiring two-dimensional image information and relative positional information regarding the image information to allow subsequent three-dimensional or extended field of view reconstruction” (Col. 1 lines 15-19 Hossack).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/R.C.L./ Examiner, Art Unit 3797
/SHAHDEEP MOHAMMED/ Primary Examiner, Art Unit 3797
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