DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1 and 2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pelissier et al. (Pub. No.: US 2011/0196237).
Consider claim 1, Pelissier discloses a method of detecting blood flow (paragraph [0057], Fig. 3A, determination of the velocity of blood flow) and generating a vessel contour trace from an intravascular ultrasound ("IVUS") image of a vessel (paragraph [0147], ultrasound transducer to obtain a B-mode image of the cross-section of a vessel to trace a contour of the cross-section), the method comprising:
receiving a plurality of frames of radiofrequency (RF) line data for the IVUS image (paragraph [0055], Fig. 3, RF data corresponding to the sample volume that is received in the left and right channels);
generating an interim vessel contour trace of the vessel based on one or more of the frames of RF line data (paragraph [0147], ultrasound transducer to obtain a B-mode image of the cross-section of a vessel containing the sample volumes to trace a contour of the cross-section);
generating one or more user-interactable key nodes along the interim vessel contour trace (paragraph [0156], Fig. 11, plane 112A intersects a blood vessel having a cross section shown by contour 114 wherein line segment 116A may correspond to a user-positioned cursor on an image of plane 112A);
generating a color mask representative of blood flow through the vessel based on one or more of the frames of RF line data (paragraph [0126], Fig. 9, different parts of cursor 96 may be shown in different colors to indicate of the variability of velocity measurements obtained for sample volumes along cursor 96); and
displaying a composite image on an output display, wherein the composite image comprises (a) the IVUS image (paragraph [0068], Fig. 4, display 40 displaying B-mode image 44 including an outline of a blood vessel 48), (b) the interim vessel trace and the user-interactable key nodes overlaid over the IVUS image (paragraph [0068], Fig. 4, cursors 46 (i.e., user-positionable cursor overlaid on a B-mode image, see paragraph [0066]) are positioned on image 44 to lie within the outline of a blood vessel 48), and (c) the color mask representative of blood flow through the vessel overlaid over the IVUS image (paragraph [0137], controller is configured to determine a display attribute for a cursor, or a portion of a cursor (i.e., a color for a portion of a cursor), overlaid on a B-mode image corresponding to an indication of a blood velocity characteristic).
Consider claim 2, Pelissier discloses modifying the interim vessel contour trace in response to user interaction with the one or more user-interactable key nodes (paragraph [0207], Fig. 13, user may use input device 150 to provide controls for manipulating the locations of user-positionable cursors displayed on display 148).
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.
Claims 3, 8, and 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Pelissier in view of Taerum (Pub. No.: US 2013/0064435).
Consider claim 3, Pelissier discloses wherein generating the interim vessel contour trace comprises: generating a segmentation of the IVUS image to identify the vessel (paragraph [0077], one or more cursors in the form of a line segment (or end-points of a line segment) are provided to lie along or across a B-mode image of a blood vessel);
generating an initial vessel contour trace from the segmentation (paragraph [0147], ultrasound transducer to obtain a B-mode image of the cross-section of a vessel containing the sample volumes to trace a contour of the cross-section).
Pelissier does not specifically disclose refining the initial vessel contour trace using an active contour model constrained with a statistical vein shape model.
Taerum discloses refining the initial vessel contour trace using an active contour model constrained with a statistical vein shape model (paragraph [0040], Fig. 6, generate a contour of the vessel using an active contour model wherein a snake (i.e., a set of points) is an energy minimizing, deformable spline influenced by constraint and image forces that pull it toward object contours).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify generating the interim vessel contour trace as disclosed by Pelissier to include using an active contour model as taught by Taetum in order to get as close as possible to the vessel contour (Taerum, paragraph [0041]).
Consider claim 8, Pelissier discloses a method of generating a vessel contour trace from an intravascular ultrasound ("IVUS") image (paragraph [0147], ultrasound transducer to obtain a B-mode image of the cross-section of a vessel to trace a contour of the cross-section), the method comprising:
receiving a first frame of RF line data for the IVUS image (paragraph [0055], Fig. 3, RF data corresponding to the sample volume that is received in the left and right channels);
converting the first frame of RF line data to Cartesian coordinates and displaying the IVUS image (paragraph [0074], Fig. 4, controller may generate graphical indications 45A and 45B for example by determining a location of the sample volume in a suitable coordinate system);
receiving a user selection for the generation of the vessel contour trace (paragraph [0049], (paragraph [0147], user orients ultrasound transducer to obtain a B-mode image of the cross-section of a vessel to trace a contour of the cross-section);
generating a segmentation of the IVUS image to identify a vessel of interest for the vessel contour trace (paragraph [0077], one or more cursors in the form of a line segment (or end-points of a line segment) are provided to lie along or across a B-mode image of a blood vessel);
generating an initial vessel contour trace from the generated segmentation (paragraph [0147], ultrasound transducer to obtain a B-mode image of the cross-section of a vessel containing the sample volumes to trace a contour of the cross-section);
displaying on an image output display, when the interim vessel contour trace meets or exceeds accuracy criteria (paragraph [0068], the true velocity vector is generated continually and display 40 is updated in real-time to show the changing magnitude and orientation of the measured blood flow), a complete vessel contour trace comprising the interim vessel contour trace (paragraph [0068], Fig. 4, display 40 displaying B-mode image 44 including an outline of a blood vessel 48) with user-interactable key nodes or control points (paragraph [0068], Fig. 4, cursors 46 (i.e., user-positionable cursor overlaid on a B-mode image, see paragraph [0066]) are positioned on image 44 to lie within the outline of a blood vessel 48).
Pelissier does not specifically disclose generating an interim vessel contour trace using an active contour model initialized with the initial vessel contour trace and constrained with a statistical vein shape model.
Taerum discloses generating an interim vessel contour trace using an active contour model initialized with the initial vessel contour trace and constrained with a statistical vein shape model (paragraph [0040], Fig. 6, generate a contour of the vessel using an active contour model wherein a snake (i.e., a set of points) is an energy minimizing, deformable spline influenced by constraint and image forces that pull it toward object contours).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify generating the interim vessel contour trace as disclosed by Pelissier to include using an active contour model as taught by Taetum in order to get as close as possible to the vessel contour (Taerum, paragraph [0041]).
Consider claim 11, the combination of Pelissier and Taerum discloses wherein receiving a user selection for the generation of the vessel contour trace further comprises: using a user-provided manual trace as the initial vessel contour trace and displaying the user- provided manual trace on the image output display when a user has selected autocompletion (paragraph [0068], Fig. 4, cursors 46 are positioned on image 44 to lie within the outline of a blood vessel 48).
Consider claim 12, the combination of Pelissier and Taerum discloses wherein receiving a user selection for the generation of the vessel contour trace further comprises: using user-provided key nodes as accurate or true key nodes in the complete vessel contour trace when a user has selected autocompletion (paragraph [0068], Fig. 4, cursors 46 are positioned on image 44 to lie within the outline of a blood vessel 48, wherein the length of arrow 42 corresponds to the magnitude of the true velocity vector).
Consider claim 13, the combination of Pelissier and Taerum discloses converting the initial vessel contour trace, from RF line data, into a Cartesian space coordinate system (paragraph [0074], Fig. 4, controller may generate graphical indications 45A and 45B for example by determining a location of the sample volume in a suitable coordinate system).
Claims 4 and 15-18 are rejected under 35 U.S.C. 103 as being unpatentable over Pelissier in view of Ellison (Pub. No.: US 2020/0253527).
Consider claim 4, Pelissier does not specifically disclose wherein generating the color mask representative of blood flow comprises: selecting a first subframe from a first frame of the plurality of frames of RF line data;
selecting a second subframe from a second frame of the plurality of frames of RF line data;
performing block matching between the first subframe and the second subframe to generate similarity scores; and
converting the similarity scores to Cartesian coordinates to provide the color mask.
Ellison discloses wherein generating the color mask representative of blood flow comprises: selecting a first subframe from a first frame of the plurality of frames of RF line data (paragraph [0449], determine different color blocks in the image);
selecting a second subframe from a second frame of the plurality of frames of RF line data (paragraphs [0449], [0450], determine different color blocks in the image);
performing block matching between the first subframe and the second subframe to generate similarity scores (paragraph [0449], determine similarities and dissimilarities within and across the image grid map where regions of color blocks (where each region is a group of adjacent blocks of the same color) may be compared according to different quadrants in the image grid); and
converting the similarity scores to Cartesian coordinates to provide the color mask (paragraph [0451], Quadrants arranged on the Cartesian coordinate system. The number of color block patterns identified by machine system 101, in each quadrant, relative to other quadrants in the image can provide a relational analysis of different color portions of the image, the distribution of the color portions, and/or the symmetry of the color portions).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to replace the generating the color mask representative of blood flow as disclosed by Pelissier with the generating the color mask representative of blood flow as taught by Ellison in order to determine the different values (Ellison, paragraph [0449]).
Consider claims 15, 16, Pelissier discloses a method of detecting blood flow from intravascular ultrasound ("IVUS") (paragraph [0057], Fig. 3A, determination of the velocity of blood flow) and generating a blood flow IVUS image (paragraph [0147], ultrasound transducer to obtain a B-mode image of the cross-section of a vessel to trace a contour of the cross-section), the method comprising:
receiving a plurality of frames of RF line data for the blood flow IVUS image, the plurality of frames of RF line data comprising a first frame of RF line data and a second frame of RF line data (paragraph [0055], Fig. 3, RF data corresponding to the sample volume that is received in the left and right channels);
displaying the blood flow IVUS image on an image output display (paragraph [0068], Fig. 4, display 40 displaying B-mode image 44 including an outline of a blood vessel 48).
Pelissier does not specifically disclose selecting a first subframe of a plurality of first subframes of the first RF line data frame;
selecting a second subframe of a plurality of second subframes of the second RF line data frame for search and comparison, the second subframe larger than the first subframe;
performing block matching for each selected first subframe, of the plurality of first subframes, with each corresponding portion of the selected second subframe, of the plurality of second subframes, and generating a similarity score for each selected comparison;
generating a third RF line data frame as a matrix of the plurality of similarity scores using a plurality of similarity scores from the block matching; converting the matrix of the plurality of similarity scores to Cartesian coordinates to provide a color image or mask to display as a visual image of the blood flow;
generating a brightness-mode IVUS image from one or more frames of RF line data of the plurality of frames of RF line data;
merging or superimposing the color image or mask on or with the brightness-mode IVUS image to generate the blood flow IVUS image.
Ellison discloses selecting a first subframe of a plurality of first subframes of the first RF line data frame (paragraph [0449], determine different color blocks in the image);
selecting a second subframe of a plurality of second subframes of the second RF line data frame for search and comparison, the second subframe larger than the first subframe (paragraph [0449], determine different color blocks in the image);
performing block matching for each selected first subframe, of the plurality of first subframes, with each corresponding portion of the selected second subframe, of the plurality of second subframes, and generating a similarity score for each selected comparison (paragraph [0449], determine similarities and dissimilarities within and across the image grid map where regions of color blocks (where each region is a group of adjacent blocks of the same color) may be compared according to different quadrants in the image grid);
generating a third RF line data frame as a matrix of the plurality of similarity scores using a plurality of similarity scores from the block matching (paragraph [0449], determine similarities and dissimilarities within and across the image grid map where regions of color blocks (where each region is a group of adjacent blocks of the same color) may be compared according to different quadrants in the image grid);
converting the matrix of the plurality of similarity scores to Cartesian coordinates to provide a color image or mask to display as a visual image of the blood flow (paragraph [0451], Quadrants arranged on the Cartesian coordinate system. The number of color block patterns identified by machine system 101, in each quadrant, relative to other quadrants in the image can provide a relational analysis of different color portions of the image, the distribution of the color portions, and/or the symmetry of the color portions);
generating a brightness-mode IVUS image from one or more frames of RF line data of the plurality of frames of RF line data (paragraph [0131], divide images into regions that have pixels with brightness values above and below a particular threshold);
merging or superimposing the color image or mask on or with the brightness-mode IVUS image to generate the blood flow IVUS image (paragraph [0443], thresholding logic 226, may be configured to apply a threshold filter function to the image, wherein the threshold may be for brightness, a particular color, and/or hue).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to replace the generating the color mask representative of blood flow as disclosed by Pelissier with the generating the color mask representative of blood flow as taught by Ellison in order to determine the different values (Ellison, paragraph [0449]).
Consider claim 17, the combination of Pelissier and Ellison discloses receiving a user selection of or determining one or more signal acquisition modes (paragraph [0049], user may use input device 24 to control aspects of the operation of controller 21).
Consider claim 18, the combination of Pelissier and Ellison discloses receiving a user selection of blood flow detection (paragraph [0137], controller is configured to determine a display attribute for a cursor, or a portion of a cursor, overlaid on a B-mode image corresponding to an indication of a blood velocity characteristic) and color parameters; and
applying the user selection of blood flow detection and color parameters (paragraph [0137], a controller may be configured to determine a color for a portion of a cursor).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Pelissier in view of Hancock et al. (Pub. No.: WO 2018/091487).
Consider claim 5, Pelissier does not specifically disclose removing a ringdown artifact from one or more of the plurality of frames of RF line data prior to generating the interim vessel contour trace or the color mask.
Hancock discloses removing a ringdown artifact from one or more of the plurality of frames of RF line data prior to generating the interim vessel contour trace or the color mask (paragraph [0042], reducing or removing ringdown artifacts is to obtain a single static reference frame and subtract the reference frame from subsequent image frames, wherein the reference frame is generated or acquired prior to starting the imaging process).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to replace the method as disclosed by Pelissier with method as taught by Hancock in order to prevent interference or hidden tissues in a region close to a catheter surface (Hancock, paragraph [0042]).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Pelissier in view of Tadross (Pub. No.: US 2021/0390685).
Consider claim 6, Pelissier does not specifically disclose applying one or more thresholds to the plurality of frames of RF line data; and performing clutter filtering on the plurality of frames of RF line data based on the one or more thresholds.
Tadross discloses applying one or more thresholds to the plurality of frames of RF line data; and performing clutter filtering on the plurality of frames of RF line data based on the one or more thresholds (paragraph [0036], Fig. 3, if the spatial correlation between the vessel lumen regions 204, 304 of the B-mode image 202 and the flow image frame 302 exceed a correlation threshold, the flow characteristics of the image pixels 308 in the vessel lumen 304 of the flow image 302 may be used to perform clutter filtering on the image pixels 208 in the vessel lumen region 204 of the B-mode image 202).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to replace the method as disclosed by Pelissier with method as taught by Tadross to provide for displaying a flow image frame, color flow image, or a frame a vector flow image frame (Tadross, paragraph [0036]).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Pelissier in view of Harada (Pub. No.: JP 2002-017728).
Consider claim 7, Pelissier does not specifically disclose generating and displaying on the output display one or more selected biometrics.
Harada discloses generating and displaying on the output display one or more selected biometrics (paragraph [0008], first biometric information and the second biometric information at the same time is displayed on the two-dimensional coordinate system).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to replace the method as disclosed by Pelissier with method as taught by Harada in representing a time change of the first biological information and the second biological information (Harada, paragraph [0008]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Pelissier and Taerum in view of Harada.
Consider claim 9, the combination of Pelissier and Taerum does not specifically disclose generating and displaying on the image output display one or more selected biometrics.
Harada discloses generating and displaying on the output display one or more selected biometrics (paragraph [0008], first biometric information and the second biometric information at the same time is displayed on the two-dimensional coordinate system).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to replace the method as disclosed by the combination of Pelissier and Taerum with method as taught by Harada in representing a time change of the first biological information and the second biological information (Harada, paragraph [0008]).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Pelissier and Taerum in view of Hancock.
Consider claim 10, the combination of Pelissier and Taerum does not specifically disclose removing any ringdown artifact from the IVUS image.
Hancock discloses removing any ringdown artifact from the IVUS image (paragraph [0042], reducing or removing ringdown artifacts is to obtain a single static reference frame and subtract the reference frame from subsequent image frames, wherein the reference frame is generated or acquired prior to starting the imaging process).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to replace the method as disclosed by the combination of Pelissier and Taerum with method as taught by Hancock in order to prevent interference or hidden tissues in a region close to a catheter surface (Hancock, paragraph [0042]).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Pelissier and Taerum in view of Min et al. (Pub. No.: US 2021/0319558).
Consider claim 14, the combination of Pelissier and Taerum does not specifically disclose modifying the vessel contour trace in a region between an IVUS catheter and a vessel wall.
Min discloses modifying the vessel contour trace in a region between an IVUS catheter and a vessel wall (paragraph [0407], Figs. 7D, 7E, modify the lumen and vessel walls (also referred to herein as contours, boundaries, or features) that were previously determined for a vessel).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to replace the method as disclosed by the combination of Pelissier and Taerum with method as taught by Min to refine the accuracy of the location of the contours (Min, paragraph [0407]).
Claims 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Pelissier and Ellison in view of Tadross.
Consider claims 19, 20, the combination of Pelissier and Ellison does not specifically disclose performing clutter filtering of the first and second RF line data frames.
Tadross discloses performing clutter filtering of the first and second RF line data frames (paragraph [0036], Fig. 3, if the spatial correlation between the vessel lumen regions 204, 304 of the B-mode image 202 and the flow image frame 302 exceed a correlation threshold, the flow characteristics of the image pixels 308 in the vessel lumen 304 of the flow image 302 may be used to perform clutter filtering on the image pixels 208 in the vessel lumen region 204 of the B-mode image 202).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to replace the method as disclosed by the combination of Pelissier and Ellison with method as taught by Tadross to provide for displaying a flow image frame, color flow image, or a frame a vector flow image frame (Tadross, paragraph [0036]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GERALD JOHNSON whose telephone number is (571)270-7685. The examiner can normally be reached Monday-Friday 8am-5pm EST.
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/Gerald Johnson/
Primary Examiner, Art Unit 3797
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