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 § 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 1-3 are 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 pre-AIA the applicant regards as the invention.
Claim 1 recites “... using the 3D coordinates of the nadir points to calculate angiographic coplanar views and an associated cusp overlap map ...”. Further, the claim recites “deriving an optimal view map from the angiographic coplanar views and an associated cusp overlap map ...”. The issue is persons of ordinary skill in the art reading the specification is not able to understand how to distinguish two of “an associated cusp overlap map”. Therefore, the examiner deems the claim indefinite as it fail to particularly point out and distinctly claim what Applicant regards as the invention. Accordingly, the claim is rejected under U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph.
Dependent claims 2-3 are rejected because they depend upon independent claim 1.
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 of this title, 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.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Chen et al (U.S. Patent Application Publication 2020/0261157 A1) in view of Lavi et al (U.S. Patent Application Publication 2020/0126229 A1) in view of BRACKEN et al (U.S. Patent Application Publication 2018/0256131 A1).
Regarding claim 1, Chen discloses a non-transitory computer readable medium having a computer program stored (Paragraphs [0090]-[0092], FIG. 6 presents a drawing of a computer system 600 that implements at least a portion of graphical system 100 (FIG. 1) ... Memory 624 may store an operating system 626 that includes procedures (or a set of instructions) for handling various basic system services for performing hardware-dependent tasks ... Memory 624 may also include program instructions (or sets of instructions), including: initialization module 630 (or a set of instructions), data module 632 (or a set of instructions) corresponding to data engine 110 (FIG. 1), graphics module 634 (or a set of instructions) corresponding to graphics engine 112 (FIG. 1), tracking module 636 (or a set of instructions) corresponding to tracking engine 118 (FIG. 1), and/or encryption module 638 (or a set of instructions) ...) thereon for performing a direct three-dimensional (3D) modeling technique for or in preparation for a transcatheter aortic valve replacement (TAVR) procedure (Paragraph [0172], embodiments of an analysis technique that determines at least an anatomic feature associated with an aortic valve is described. Notably, pre-operative 2D CT images can be used with True 3D to generate a 3D image that can be used to: predict the correct angle for visualization using a C-arm during a TAVR procedure ...), the computer program comprising instructions for causing one or more processors (Paragraph [0150], instructions in the various modules in memory 624 may be implemented in: a high-level procedural language, an object-oriented programming language, and/or in an assembly or machine language. Note that the programming language may be compiled or interpreted, e.g., configurable or configured, to be executed by the one or more processors 610) to:
receive a plurality of datasets of medical images (Paragraph [0052], during operation, data engine 110 may receive input data (such as a computed-tomography or CT scan, histology, an ultrasound image, a magnetic resonance imaging or MRI scan, or another type of 2D image slice depicting volumetric information), including dimensions and spatial resolution. In an exemplary embodiment, the input data may include representations of human anatomy) comprising coronary anatomical structures (Paragraph [0013], note that the anatomical feature may include: one or more dimensions of the 2D plane (such as an aortic annulus) defined by the bases of the left coronary cusp, the right coronary cusp ...);
segmenting the medical images to produce a set of 3D surface points (Paragraph [0053], after receiving the input data, data engine 110 may: define segments in the data ... and identify 3D objects in the data (such as the lung, liver, colon and, more generally, groups of voxels); paragraph [0107], data module 632 may perform the segmentation process (including data-structure processing and linking) to identify landmarks and region-of-interest parameters. The objective of the segmentation process is to identify functional regions of the clinical anatomy to be evaluated. This may be accomplished by an articulated model, which includes piecewise rigid parts for the anatomical segments coupled by joints, to represent the clinical anatomy. The resulting segments 642 in FIG. 6 may each include: a proximal point (5) location specified by the DICOM image-voxel index coordinate (i1, j1, k1) ...; paragraph [0059], this may allow the 3D coordinates of the reflecting surfaces to be determined ...), wherein the set of 3D surface points represents a 3D geometrical shape of the coronary anatomical structures (Paragraph [0107], the resulting segments 642 in FIG. 6 may each include: a proximal point (5) location specified by the DICOM image-voxel index coordinate (i1, j1, k1); a distal point (D) location specified by the DICOM image-voxel index coordinate (i2, j2, k2); a central point (C) location specified by the DICOM image-voxel index coordinate (i3, j3, k3), which may be the half point of the Euclidean distance between S and D; image-voxel index bounds (B) of the region of interest surrounding the central point including the proximal and distal points (imin, imax, jmin, jmax, kmin, kmax); and the corresponding world x, y, z coordinates of the central point and the region bounds locations calculated by accounting for the x, y, z voxel spacing of the source DICOM image ...);
transform the set of 3D surface points to a structure-based representation of the coronary anatomical structures (Paragraph [0118], the user can control the problem-solving virtual instrument to recall a bookmarked clinical target or a selected region of interest of a 3D object and can interact with its center point. In this case, the surface of the 3D object may be transparent (as specified by one of optional transfer functions 644 in FIG. 6));
segmenting the structure-based representation of the coronary anatomical structures into independent 3D objects (Paragraphs [0108]-[0109], the user may select or specify n voxel index locations from the clinical field, which may be used to define the central points (Cs). Then, a 3D Voronoi map (and, more generally, a Euclidean-distance map) may determine regions around each of the selected index locations. For each of the Voronoi regions and each of the n voxel indexes ... data module 632 may generate a list of 3D objects (such as anatomical segments) of the clinical anatomy based at least in part on these values ...), wherein the independent 3D objects comprise at least two coronary cusps (Paragraph [0007], this 3D image may present a view along a perpendicular direction to a 2D plane in which bases (or tips) of a right coronary cusp and a left coronary cusp ) and an extended aortic root (Paragraph [0007], information specifying a set of reference locations that are associated with an aortic-root structure), wherein the at least two coronary cusps and the extended aortic root are each represented by a dataset of structured 3D point coordinates (Paragraphs [0173]-[0176], FIG. 15 presents a flow diagram illustrating a method 1500 for determining at least an anatomic feature associated with an aortic valve, which may be performed by graphical system 100 (FIG. 1) ... during operation, the computer generates a 3D image (such as a 3D CT image) associated with an individual's heart (operation 1510). This 3D image may present a view along a perpendicular direction to a 2D plane in which bases (or tips) of a noncoronary cusp, a right coronary cusp and a left coronary cusp reside ,,, the computer may receive (or access in a computer-readable memory) information (operation 1514) specifying a set of reference locations that are associated with an aortic-root structure. For example, the set of reference locations may include: a location of the left coronary cusp, a location of the right coronary cusp);
characterizing each dataset of structured 3D point coordinates as a parametric surface function (Paragraph [0053], data engine 110 may: define segments in the data (such as labeling tissue versus air); other parameters (such as transfer functions for voxels); identify landmarks or reference objects in the data (such as anatomical features); and identify 3D objects in the data (such as the lung, liver, colon and, more generally, groups of voxels));
performing a minimization process on the structured 3D point coordinates (Paragraph [0108], for each of the Voronoi regions and each of the n voxel indexes, data module 632 may obtain: the minimum voxel index along the x axis of the DICOM image (i.sub.min) ... the minimum voxel index along the y axis of the DICOM image (j.sub.min) ... the minimum voxel index along the z axis of the DICOM image (k m m) ...).
However, Chen does not specifically disclose performing a 3D curve-based skeletonization process to transform the set of 3D surface points to a structure-based representation of the coronary anatomical structures;
the parametric surface functions to simultaneously determine 3D coordinates of nadir points associated with each of the least two coronary cusps;
using the 3D coordinates of the nadir points to calculate angiographic coplanar views and an associated cusp overlap map; and
deriving an optimal view map from the angiographic coplanar views and an associated cusp overlap map, the optimal view map comprising optimal viewing configurations for imaging equipment used during the TAVR procedure.
In additional, Lavi discloses (Abstract, automated image analysis used in vascular state modeling. Coronary vasculature in particular is modeled in some embodiments. Methods of “virtual revascularization” of a presently stenotic vasculature are described; useful, for example, as a reference in disease state determinations. Structure and uses of a model which relates records comprising acquired images or other structured data to a vascular tree representation are described) performing a 3D curve-based skeletonization process (Paragraph [0164], the vascular tree skeleton is represented as a branching set of ordered locations, for example with coordinates defined by segment, node, and or segment displacement coordinates. Additionally or alternatively, the ordered locations comprise 3-D coordinates) to transform the set of 3D surface points to a structure-based representation of the coronary anatomical structures (Paragraph [0165], 3-D coordinates are generated in the reconstruction of a vascular tree skeleton).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the transcatheter aortic-valve replacement (TAVR) procedure taught by Chen incorporate the teachings of Lavi, and applying the system for producing a vascular model taught by Lavi to provide the skeletonization process for the system to transform the 3-D coordinate points in the ordered locations associated to the coronary anatomical structures. Accordingly, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify Chen according to the relied-upon teachings of Lavi to obtain the invention as specified in claim.
However, Chen does not specifically disclose the parametric surface functions to simultaneously determine 3D coordinates of nadir points associated with each of the least two coronary cusps;
using the 3D coordinates of the nadir points to calculate angiographic coplanar views and an associated cusp overlap map; and
deriving an optimal view map from the angiographic coplanar views and an associated cusp overlap map, the optimal view map comprising optimal viewing configurations for imaging equipment used during the TAVR procedure.
In additional, BRACKEN discloses (Paragraph [0003], during transcatheter aortic valve replacement (TAVR) procedures in a catheter lab or hybrid operating room, a key required task is determining an improved imaging view to help guide the deployment of a prosthetic valve in the aortic annulus. This view depends on a number of factors including patient anatomy, the specific bioprosthetic valve being deployed, and the patient positioning ...; FIG. 1; paragraph [0027], a system 100 for finding improved views using shape sensing enabled devices with real-time imaging (e.g., ultrasound) ...) the parametric surface functions to simultaneously determine 3D coordinates of nadir points associated with each of the least two coronary cusps (Paragraphs [0037]-[0039], an automatic search program 140 conducts a search of the images 136 around a region of the native aortic annulus to locate the positions of all three cusp nadirs in three dimensional space. The cusp nadirs will then be automatically marked and labeled in the ultrasound images using the image processing module 148. Concurrently, the device 102 (e.g., bioprosthetic valve) will be optically shape sensed using system 104, so its 3D position and orientation will be tracked in real-time. The combined image guidance approach using images 134 and 136 provides both the geometric information of the cusp nadirs in the ultrasound images 136 and the geometric information/images 134 of the shaped-sensed bioprosthetic valve 102 ... The pre-determined set of parameters may include, e.g., an aortic slice plane, cusp nadir alignment and relative distance and position in the images 136, etc.);
using the 3D coordinates of the nadir points to calculate angiographic coplanar views and an associated cusp overlap map (Paragraph [0043], FIG. 2C shows a 3D echocardiography image 206 showing the marked cusps. FIG. 2C shows locations and markings of the native aortic valve cusp nadirs from 3D echocardiography image sequences; paragraph [0045], with FORS™, it is possible to generate a real-time outline in three dimensions of the device 102 (e.g., the bioprosthetic valve) and its delivery system. FORS™ is able to track the geometric position and orientation of the prosthetic valve device 102 in real-time. With image registration performed by a registration module 144, the ultrasound image sequence images 136 can be overlaid with the shape-sensed device data/images 134. Registration by the registration module 144 may be performed using known methods to align coordinate systems of the imaging modalities (e.g., for systems 104 and 110); paragraph [0048], an improved co-planar); and
deriving an optimal view map from the angiographic coplanar views and an associated cusp overlap map (Paragraph [0046], referring to FIG. 3, registered overlay images 302, 304 are illustratively shown depicting an ultrasound image 136 and an optical shape sensing image 134. A selection of an improved 2-chambered view in image 304 is based on the position of the device 102 from the volume on the image 302; paragraph [0047], once the search program 140 (FIG. 1) locates and labels the native valve cusp nadirs, this geometric information can be sent back to the processor 114, which will then calculate and optimize the ultrasound beam orientation needed to generate the improved view. The ultrasound beam configuration will be selected by the processor 114 based on a desired improved view for a specific device. For the Edwards™ SAPIEN™ valve, the ultrasound beams will be configured such that the cusp nadirs are displayed in a view that shows them on a common line with each other and equidistant from each other (e.g., the improved view parameters), as depicted in FIG. 4; paragraph [0048], referring to FIG. 4, an improved co-planar view is computed by the processor 114 to provide a perspective that shows three valve cusp nadirs (right (R), non (N) and left (L)) of the native aortic valve aligned and equidistant from each other as depicted in image 402), the optimal view map comprising optimal viewing configurations for imaging equipment used during the TAVR procedure (Paragraph [0017], the present principles, systems and methods are provided for finding improved imaging views to deploy medical devices, such as a bioprosthetic valve for a transcatheter aortic valve replacement (TAVR) procedure. In one embodiment, the improved view shows an aortic annulus in a favorable orientation to deploy the bioprosthetic valve safely and effectively; paragraph [0051], referring to FIG. 6, a block/flow diagram shows a system/method 600 for determining and implementing an improved view in TAVR using a combined FORS™/ultrasound image guidance system ...; paragraph [0054], in block 607, the processing unit 606 may output a series of visualizations, and the operator may select a preferred view. This view is then marked as the improved view and shown to the clinicians. The improved view could be patient-specific, disease specific, or clinician/site specific and be stored in a database or memory (116, FIG. 1). Examples of improved views for TAVR may include, e.g., one or more of: 2D ultrasound slice showing the coronary or non-coronary cusps and the device with respect to the cusps; a bi-plane view showing the cusps and the deployment device; a bi-plane view showing the cusps and where the device should be with respect to the cusps; 3D ultrasound showing the cusps and device; multiple views of the cusps and device in different orientations shown next to each other; etc.).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the transcatheter aortic-valve replacement (TAVR) procedure taught by Chen in view of Lavi incorporate the teachings of BRACKEN, and applying the system for finding improved views taught by BRACKEN to calculate the positions of all cusp nadirs in three dimensional space and display the cusp nadirs overlaid with the shape-sensed device images that shows them in an improved co-planar view during the transcatheter aortic valve replacement (TAVR) procedure. Accordingly, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify Chen in view of Lavi according to the relied-upon teachings of BRACKEN to obtain the invention as specified in claim.
Claims 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al (U.S. Patent Application Publication 2020/0261157 A1) in view of Lavi et al (U.S. Patent Application Publication 2020/0126229 A1) in view of BRACKEN et al (U.S. Patent Application Publication 2018/0256131 A1) in view of Harewood et al (U.S. Patent Application Publication 2022/0175524 A1).
Regarding claim 2, the combination of Chen in view of Lavi in view of BRACKEN discloses everything claimed as applied above (see claim 1).
However, Chen does not specifically disclose wherein the computer program further comprises instructions for causing one or more processors to evaluate a degree of overlap between the at least two cusps.
In additional, Harewood discloses (Abstract, methods for rotationally aligning transcatheter heart valve prosthesis within a native heart valve include percutaneously delivering the transcatheter heart valve prosthesis to the native heart valve, wherein the transcatheter heart valve prosthesis includes at least one imaging marker, receiving a cusp overlap viewing angle image and/or a coronary overlap viewing angle image of the transcatheter heart valve prosthesis within the native heart valve ...) wherein the computer program further comprises instructions for causing one or more processors to evaluate a degree of overlap between the at least two cusps (Paragraph [0142], as shown in FIGS. 8A and 8B, the native aortic valve includes three leaflets or cusps: the left coronary cusp LCC; the right coronary cusp RCC ... the location of the ostia or coronary take-off of the left and right coronary arteries may vary approximately 15-20 degrees depending on patient anatomy).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the transcatheter aortic-valve replacement (TAVR) procedure taught by Chen in view of Lavi in view of BRACKEN incorporate the teachings of Harewood, and applying the method for rotationally aligning a transcatheter heart valve prosthesis within a native heart valve taught by Harewood to provide a method for evaluating a degree of overlap between two cusps during the transcatheter aortic valve replacement (TAVR) procedure. Accordingly, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify Chen in view of Lavi in view of BRACKEN according to the relied-upon teachings of Harewood to obtain the invention as specified in claim.
Regarding claim 3, the combination of Chen in view of Lavi in view of BRACKEN in view of Harewood discloses everything claimed as applied above (see claim 2).
However, Chen does not specifically disclose wherein the computer program further comprises instructions for causing one or more processors to use the degree of overlap between the at least two cusps to calculate the angiographic coplanar views and the associated cusp overlap map.
In additional, Harewood discloses wherein the computer program further comprises instructions for causing one or more processors to use the degree of overlap between the at least two cusps (Paragraph [0142], as shown in FIGS. 8A and 8B, the native aortic valve includes three leaflets or cusps: the left coronary cusp LCC; the right coronary cusp RCC ... the location of the ostia or coronary take-off of the left and right coronary arteries may vary approximately 15-20 degrees depending on patient anatomy) to calculate the angiographic coplanar views and the associated cusp overlap map (Paragraph [0144], in the cusp overlap view, as shown in FIG. 9A, the viewing angle VA of the imaging system is such that the right coronary cusp RCC and the left coronary cusp RCC overlap each other ...; paragraphs [0146]-[0147], with the imaging system in the cusp overlap view, as shown in FIG. 10B, two of the markers 101 of the transcatheter heart valve prosthesis 100 can be seen towards the left side of the annulus and one of the markers 101 can be seen towards the right side of the annulus ... Using the cusp overlap view and the markers 101 of the transcatheter heart valve prosthesis 100, a clinician can determine the commissures 109 of the prosthetic leaflets 106 are generally aligned with the idealized native commissures when two of the markers 101 towards the left side of the annulus (i.e., towards the pigtail catheter 820) as viewed in the fluoroscopy image are substantially aligned ... for example, FIGS. 10C-10D should the left side markers 101 offset from each other by about 10° ... as shown in FIGS. 10G-10H, then the transcatheter heart valve prosthesis 100 may be rotated until there are two left side markers 101 substantially aligned with each other in the cusp overlap view ... To determine whether the center marker 101 is anterior or posterior, it may be desirable to move to the co-planar viewing, as known to those skilled in the art ...).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the transcatheter aortic-valve replacement (TAVR) procedure taught by Chen in view of Lavi in view of BRACKEN incorporate the teachings of Harewood, and applying the method for rotationally aligning a transcatheter heart valve prosthesis within a native heart valve taught by Harewood to provide a method for evaluating a degree of overlap between two cusps and determine the co-planar viewing. Accordingly, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify Chen in view of Lavi in view of BRACKEN according to the relied-upon teachings of Harewood to obtain the invention as specified in claim.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Xilin Guo whose telephone number is (571)272-5786. The examiner can normally be reached Monday - Friday 9:00 AM-5:30 PM EST.
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/XILIN GUO/Primary Examiner, Art Unit 2616