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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on June 19, 2024, September 19, 2024, October 9, 2024, and October 3, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Arguments
Applicant's arguments filed 6/11/2026 have been fully considered but they are not persuasive. Applicant argues that the prior art of record Kokubun does not teach or suggest constructing a simulated 2D angiographic image from a 3D dataset and enhancing such simulated angiographic image by mapping plaque thickness or relative lumen obstruction to contour of the coronary vessel section with a colormap as recited in f) of amended claim 1. Examiner disagrees because Kokubun explicitly discloses coronary artery CT angiography and detection of plaque or stenosis by reviewing cross sectional image of tubular argan along the luminal centerline (Kokubun Introduction), in a technique called Curved Planar Reformation (CPR). Kokubun also discloses a method called Radial Intensity Projection for lumen (RIP) to create image that includes all directional information based on luminal centerline. Kokubun also discloses constructing a simulated 2D angiographic image from a 3D dataset and enhancing such simulated angiographic image by mapping plaque thickness or relative lumen obstruction to contour of the coronary vessel section with a colormap as recited in f) of amended claim 1 in Figures 11-16, with a colored RIP image that shows plaque thickness distribution relative to the size of the coronary artery. Thus, the prior art of record still can be used to reject all of the claims as amended.
Claim Objections
Claim 3 objected to because of the following informalities:
“wherein the plurality of cross-sectional planes extend through through…” should read “wherein the plurality of cross-sectional planes extend through…” the extra word “through” should be deleted.
Appropriate correction is required.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-5, 9-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kokubun, Hiroto et al. “Radial intensity projection for lumen: application to CT angiographic imaging.” SPIE Medical Imaging (2006).
Regarding claim 1, Kokubun et. al. discloses a method of optimizing workflow for a vascular intervention based on a three-dimensional 3D) dataset of a coronary vessel section, wherein the 3D data set is acquired from a 3D imaging modality (Kokubun et. al., the abstract and section 1; note that the claimed method does not recite any step of optimizing the workflow beyond this general reference; in this regard Kokubun et. al. pertains to a visualization of CT angiography images in the context of coronary plaque treatment and this whole research field is devoted to facilitating vascular interventions), the method comprising:
a) determining a centerline of the coronary vessel section (Kokubun et. al., section 2.1, Figure 3: the step of determining is implicit because it is essential to carry out the radial intensity projection originating from the centerline);
b) performing lumen segmentation in the 3D dataset to identify a lumen of the coronary vessel section (Kokubun et. al., section 2.1, Figure 3: the step of performing the lumen segmentation is implicit because it is essential to carry out the radial intensity projection towards the vessel wall within the lumen);
c) performing plaque segmentation in the 3D dataset to identify plaque in a wall of the coronary vessel section (Kokubun et. al., section 3.1, segmentation of plaque, also section 2.2 the choice of a radial intensity projection function for each of various kinds of plaque and Figure 6);
d) defining a plaque severity parameter related to plaque severity in the wall of the coronary vessel section (Kokubun et. al. section 3.1, the severity of plaque obtained by maximum intensity projection along the ray originating at centerline and towards the vessel wall, see Figure 4, including the segmented plaque area and the processing radius);
e) creating a two-dimensional image having a first axis representing the centerline of the coronary vessel section and a second axis representing viewing angle around a centerpoint of the coronary vessel section, wherein the 2D image illustrates both the plaque severity parameter of d)and its spatial distribution in relation to circumference of the wall of the coronary vessel section using position of points along the centerline of the coronary vessel section (Kokubun et. al. Figures 3 and 4, section 2.1 radial intensity projection leading to a 2D image illustrated in Figure 8 which is the claimed created image; in Figure 8, the length of the vessel along the centerline is denoted as z-axis, which is the claimed primary axis, the spatial information in relation to the vessel wall circumference is denoted as the theta-axis, which is the secondary axis; areas A, B, and C in Figure 8 denote color-coded severity of plaque as explained in section 3.1); and
f) constructing a simulated 2D angiographic image of the coronary vessel section from the 3D dataset, and enhancing the simulated 2D angiographic image by mapping plaque thickness or relative lumen obstruction to contour of the coronary vessel section with a colormap (Kokubun et. al. Figure 7(a) illustrates such a simulated 2D image with vessel obstructions mapped).
Regarding claims 13, the analysis of claim 1 is incorporated herein, and Kokubun et. al. discloses a non-transitory computer readable medium having instructions stored thereon that, when executed by a computing device, cause the computing device to perform the method according to claim 1 (Note: the CT scanner is a computer implemented system running the RIP and PSI algorithms (i.e., instructions) discussed in the Abstract).
Regarding claim 14, the analysis of claim 1 is incorporated herein, and Kokubun et. al. discloses an apparatus for acquiring a three-dimensional image data set of a patient, the apparatus comprising: a data processing module configured to perform the method according to claim 1 to assess plaque severity in a vessel, particularly a coronary artery (Note: the CT scanner is a computer implemented system running the RIP and PSI algorithms substantiated by the claim mapping in claim 1 and discussed in the Abstract).
Regarding claim 15, which is claim 1 except for a statutory category of a system when implemented carried the method steps of claim 1. Thus, the rejection analysis of claim 1 is incorporated herein.
Regarding claim 16, Kokubun et. al. discloses the system according to claim 15, wherein: the coronary vessel section is selected from a single coronary artery, a coronary bifurcation, or the full coronary tree Kokubun et. al., the abstract and section 1; note that the claimed method does not recite any step of optimizing the workflow beyond this general reference; in this regard Kokubun et. al. pertains to a visualization of CT angiography images in the context of coronary plaque treatment and this whole research field is devoted to facilitating vascular interventions).
Regarding claim 17, Kokubun et. al. discloses the method according to claim 1, wherein: the coronary vessel section is selected from a single coronary artery, a coronary bifurcation, or the full coronary tree (Kokubun et. al., the abstract and section 1; note that the claimed method does not recite any step of optimizing the workflow beyond this general reference; in this regard Kokubun et. al. pertains to a visualization of CT angiography images in the context of coronary plaque treatment and this whole research field is devoted to facilitating vascular interventions).
Regarding claim 2, Kokubun et. al. discloses the method according to claim 1, further comprising: creating an MPR image along the centerline of the coronary vessel section using the 3D dataset and displaying the MPR image with a primary axis corresponding to the centerline of the coronary vessel section in the 2D image of e) (Kokubun et. al. discloses a side-by-side presentation of CPR (Curved Planar Reformation) and RIP (Radial Intensity Projection) images with aligned centerlines. Figure 7(b) and 8, see section 3.1 for explanation that the alignment is intentional and not merely illustrative).
Regarding claim 3, Kokubun et. al. discloses the method according to claim 1, wherein the operations of d) and e) comprise: determining a plurality of cross-sectional planes relative to the coronary vessel section, wherein the plurality of cross-sectional planes extend through a number of points of the centerline of the coronary vessel section;
for each given cross-sectional plane of the plurality of cross-section planes, identifying a vector that extends in the given cross-sectional plane and has an origin at a corresponding centerline point and a radial orientation towards the wall of the coronary vessel section at a certain angle;
calculating the plaque severity parameter of for each angle of the vector spanning from 00 to 3600 with a certain step; and presenting or displaying the plaque severity parameter of d) as a function of the angle and the position of the corresponding centerline point along the centerline of the coronary vessel section (Kokubun et. al. see Figure 3, and section 2.1, Figure 4 providing an illustration of the claimed cross-sectional plane, the same projection is disclosed).
Regarding claim 4, Kokubun et. al. discloses the method according to claim 3, further comprising: defining at least one scale of values between a minimum value and a maximum value for the plaque severity parameter of d) with the maximum value being associated with the highest plaque thickness and the minimum value being associated with the lowest plaque thickness or vice versa; and associating a value to the parameter of d) based on such scale for each angle on each cross-sectional plane to represent plaque thickness (Kokubun et. al. Figure 4, the processing range along the radius, Ra and Rb, and further the association of values related to soft plaque in Figure 6, the same determination of severity is disclosed).
Regarding claim 5, Kokubun et. al. discloses the method according to claim 4, wherein: the plaque thickness is calculated for each angular position of the vector by determining the Euclidean distance between corresponding first and last segmentation voxels intersecting the vector and/or by counting the plaque segmented voxels in a plaque segmentation mask stack obtained resampling segmented plaque along the vector and multiplying the result by the resampled stack pixel dimension (Kokubun et. al. section 2.1, 2nd paragraph, the processing of pixels in the processing range along the theta direction).
Regarding claim 9, Kokubun et. al. discloses the method according to claim 1, wherein: the plaque thickness or the relative lumen obstruction at an angle relative to a centerline point is used as a color-coded overlay on a 3D model of the coronary vessel section in f) (Kokubun et. al. Figure 7(a) illustrates such a simulated 2D image with vessel obstructions mapped).
Regarding claim 10, Kokubun et. al. discloses the method according to claim 1, further comprising: presenting or displaying a time-resolved simulated angiographic view with or without overlay of at least one plaque severity parameter to provide guidance before a percutaneous coronary intervention (Kokubun et. al. results to be achieved, applied “as is” to each frame).
Regarding claim 11, Kokubun et. al. discloses the method according to claim 1, wherein: the 3D dataset is a multiphase CCTA image dataset; and the operations of the method are performed on each phase of the multiphase CCTA image dataset to obtain a multiphase visualization parameter, including a multiphase centerline, lumen and plaque segmentation and creating a time-resolved simulated angiographic view (Kokubun et. al. results to be achieved, applied “as is” to each frame).
Regarding claim 12, Kokubun et. al. discloses the method according to claim 1, wherein: the 3D dataset is a single phase CCTA image dataset; and the method further comprises using or computing a motion model from the single phase CCTA image dataset, deforming the centerline extraction, lumen segmentation and plaque segmentation according to the motion model to create a multiphase visualization parameter (Kokubun et. al. results to be achieved, applied “as is” to each frame).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Kokubun, Hiroto et al. “Radial intensity projection for lumen: application to CT angiographic imaging.” SPIE Medical Imaging (2006) in view of Verstraeten et. al. (United States Patent US 9008386 B2).
Regarding claim 6, Kokubun et. al. discloses the method according to claim 3. However, Kokubun et. al. fails to disclose further comprising: performing a healthy vessel reconstruction to determine a healthy lumen contour of the coronary vessel section, wherein the relative lumen obstruction of f) is calculated by determining ratio or distance between a lumen contour of the coronary vessel section and the healthy lumen contour of the coronary vessel section for each angular position of the vector.
Verstraeten et. al. teaches performing a healthy vessel reconstruction to determine a healthy lumen contour of the coronary vessel section, wherein the relative lumen obstruction of f) is calculated by determining ratio or distance between a lumen contour of the coronary vessel section and the healthy lumen contour of the coronary vessel section for each angular position of the vector (Verstraeten et. al. Figure 4, col.9, lines 55ff, and Figure 6, col. 10, lines 54ff). Here, Figures 1-2 of the claimed invention are disclosed in Verstraeten as displayed together with an estimate of lumen contour, other vessel characteristic graphs and allowing user interaction to select a respective slice. This is important to the claimed invention so that visualization and vessel characteristics can be clearly seen and, in a user-friendly interface display.
Thus, it would have been obvious to one skilled in the art prior to the effective filing date of the claimed invention to have combined the teachings of Kokubun et. al. and Verstraeten et. al. so that these features are brought together.
Regarding claim 7, Kokubun et. al. discloses the method according to claim 1. However, Kokubun et. al. fails to disclose further comprising: allowing the user to select a specific centerline point and presenting or displaying, with or without overlay, a cross-sectional image of the coronary vessel section in correspondence of such centerline point together with the 2D image of e).
Verstraeten et. al. teaches allowing the user to select a specific centerline point and presenting or displaying, with or without overlay, a cross-sectional image of the coronary vessel section in correspondence of such centerline point together with the 2D image of e) (Verstraeten et. al. Figure 4, col.9, lines 55ff, and Figure 6, col. 10, lines 54ff). Figures 1-2 of the claimed invention are disclosed in Verstraeten as displayed together with an estimate of lumen contour, other vessel characteristic graphs and allowing user interaction to select a respective slice. This is important to the claimed invention so that visualization and vessel characteristics can be clearly seen and, in a user-friendly interface display.
Thus, it would have been obvious to one skilled in the art prior to the effective filing date of the claimed invention to have combined the teachings of Kokubun et. al. and Verstraeten et. al. so that these features are brought together.
Regarding claim 8, Kokubun et. al. discloses the method according to claim 1. However, Kokubun et. al. fails to disclose further comprising: creating and displaying a vessel characteristic graph that represents a vessel characteristic parameter along the centerline of the coronary vessel section, wherein the vessel characteristic is a parameter selected from the group consisting of: vessel curvature, lumen area, lumen diameter, calcified arc, calcified plaque index, calcium volume index, risk of stent under expansion such as, for example, calcium deposit in a lesion with maximum calcium arc greater than 1800, maximum plaque thickness greater than 0.5 mm, plaque length along vessel centerline greater than 5 mm.
Verstraeten et. al. teaches creating and displaying a vessel characteristic graph that represents a vessel characteristic parameter along the centerline of the coronary vessel section, wherein the vessel characteristic is a parameter selected from the group consisting of: vessel curvature, lumen area, lumen diameter, calcified arc, calcified plaque index, calcium volume index, risk of stent under expansion such as, for example, calcium deposit in a lesion with maximum calcium arc greater than 1800, maximum plaque thickness greater than 0.5 mm, plaque length along vessel centerline greater than 5 mm (Verstraeten et. al. Figure 4, col.9, lines 55ff, the MPR views in 40e and 40f, and Figure 6, col. 10, lines 54ff). Figures 1-2 of the claimed invention are disclosed in Verstraeten as displayed together with an estimate of lumen contour, other vessel characteristic graphs and allowing user interaction to select a respective slice. This is important to the claimed invention so that visualization and vessel characteristics can be clearly seen and, in a user-friendly interface display.
Thus, it would have been obvious to one skilled in the art prior to the effective filing date of the claimed invention to have combined the teachings of Kokubun et. al. and Verstraeten et. al. so that these features are brought together.
Conclusion
Response to Amendment
Examiner acknowledges the amended claims as well as the changes made to overcome the previous claim objections to claim 10. However, the prior arts of record are still effective in rejecting all of the claims as amended.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA YIFANG LIN whose telephone number is (571)272-6435. The examiner can normally be reached M-F 7:00am-6:15pm, with optional day off.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vu Le can be reached at 571-272-7332. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JESSICA YIFANG LIN/Examiner, Art Unit 2668 July 11, 2026
/VU LE/Supervisory Patent Examiner, Art Unit 2668
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