DETAILED ACTION
Allowable Subject Matter
Claim 16 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1-18 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-18 of copending Application No. 18/816,581. Although the conflicting claims are not identical, they are not patentably distinct from each other because claim in the pending application is broader than the one in co-pending application, In re Van Ornum and Stang, 214 USPQT61, broad claims in the pending application are rejected as obvious double patenting over previously patented/filed narrow claims. For example, claim 1 of the pending application is the same as claim 1 of the co-pending application except “determining the respective magnitudes of the one or more local segmentation uncertainties based on the maximum stenosis severity profile and the minimum stenosis severity profile.”.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
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 1, 2, 6-9, 17, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Compas et al. (Pub. No. US 2015/0282777) in view of Najarian et al. (Pub. No. US 2017/0148158) further in view of LAVI et al. (Pub. No. US 2015/0.342551).
Regarding claims 1, 17 and 18, Compas teaches a computer-implemented method comprising: obtaining multiple cardiac images (sequence of angiogram images), each of the multiple cardiac images depicting a portion of coronary arteries (coronary artery tree) within an anatomical region of interest (region containing the coronary artery tree) [Para. 21 “illustrated at block 102, the method 100 includes receiving a sequence of angiogram images”; Para. 22 “However, in order to find the region containing the coronary artery tree, as many pixel points on the tree as possible should to be found, to ‘fill-in’ the tree”]; determining, based on each of the multiple cardiac images (sequence of angiogram images), a respective set of lumen radius measurements (arterial width) comprising multiple lumen radius measurements respectively associated with multiple locations (point along the artery segment) of the portion of the coronary arteries [Para. 24 “Next, as shown at block 112, the method 100 includes estimating an arterial width for each of the one or more artery segments from each of the sequence of angiogram images.” and “The values in the matrix are the vessel width corresponding to that point in time and the point along the artery segment”]; Compas also teaches determining, based on the respective sets of lumen radius measurements (arterial width), a minimum stenosis (minimum Vessel width value) severity profile associated with the portion of the coronary arteries [Para. 20 “An arterial width surface is formed for each isolated artery segment by calculating the width along a segment and tracking the segment in each image frame over time”].
However, Compas doesn’t explicitly teach having a maximum stenosis severity profile.
Najarian teaches having a maximum stenosis severity profile. [Para. 53, “where h.sub.1 and h.sub.2 are the peaks on either side of the trough and d is the depth of the trough. An example algorithm, Algorithm5 describes the details of width detection”].
It would have been obvious to one of ordinary skill in the art before the effective filing data to modify Compas’s spatio-temporal coronary stenosis detection method by incorporating Najarian’s width profile peak-and-trough stenosis calculation to evaluate the arterial-width measurement using bounding maxima (peaks on either of the trough) and a narrowing minimum (trough)when determining stenosis severity. This medication improves compass by converting persistent minimum-width detection into a quantitative stenosis-severity assessment, thereby improving the stenosis characterization.
Compas also teaches determining a lumen radius profile (arterial width surface) associated with the portion of the coronary arteries [Para. 20 “An arterial width surface is formed for each isolated artery segment by calculating the width along a segment and tracking the segment in each image frame over time.”].
However, Compas doesn’t explicitly teach about that it is based on the maximum stenosis severity profile and the minimum stenosis severity profile.
Najarian teaches determining a lumen radius profile based on the maximum stenosis severity profile and the minimum stenosis severity profile (peaks on either side of the) [Para. 53, “To analyze the width profile, a Watershed segmentation was used to determine the profile associated with a blockage, and then to calculate the extent of stenosis”; “where h.sub.1 and h.sub.2 are the peaks on either side of the trough and d is the depth of the trough”].
It would have been obvious to one of ordinary skill in the art before the effective filing data to modify Compas’s arterial-width-surface generation by incorporating Najarian’s width-profile stenosis calculation so that the lumen radius profile (arterial width surface) is determined using bounding maxima (peak on either side of the trough) and a narrowing minimum (trough). This modification improves compass by tying the tracked width surface to a quantitative blockage profile, thereby improving the consistency of stenosis-severity measurement over angiographic image frames.
Compas also teaches determining, based on the lumen radius profile (arterial width surface), at a given location (point along the artery segment) of the portion of the coronary arteries [Para. 26 “By displaying the width in the Z dimension, a clear valley appears in the surface containing a stenosis.”; and “This valley corresponds to the point along the artery segment where the stenosis occurs”].
However, Compas in view of Najarian doesn’t explicitly teach determining a respective value for each of at least one hemodynamic index.
LAVI teaches determining a respective value for each of at least one hemodynamic index (FFR index) [Para. 591 “In some embodiments, an index indicative of the potential effect of revascularization, such as an FFR index (for example, FFR.sub.contrast-flow), is calculated using the data described below”].
It would have been obvious to one of ordinary skill in the art before the effective filing data to modify Compas’s spatio-temporal coronary stenosis detection method , modified by Najarian, by incorporating Lavi’s teaching of calculating a hemodynamic index (FFR index) so that Compas’s stenosis-location and arterial-width-surface output are used as image-derived geometric input for functional vascular assessment. This modification improves compass by extending anatomical stenosis detection to functional hemodynamic assessment, thereby improving clinical usefulness for revascularization decision support.
Regarding claim 2, Compas teaches aligning each of the respective sets of the lumen radius measurements with a reference set [Para. 22].
However, Compas doesn’t explicitly teach the rest of claim limitations.
Najarian teaches said determining of the maximum stenosis severity profile and the minimum stenosis severity profile comprising: determining a reference set of the lumen radius measurements [Para. 53, fig. 2 and corresponding description]; determining the maximum stenosis severity profile and the minimum stenosis severity profile (peaks, trough) based on the respective aligned sets of the lumen radius measurements [Para. 53].
It would have been obvious to one of ordinary skill in the art before the effective filing data to modify Compas’s aligned coronary artery tree width comparison by incorporating Najarian’s width profile peak and trough stenosis calculation to determine maximum and minimum stenosis severity profiles from the aligned lumen radius measurement sets. This medication improves compass by converting aligned arterial width measurement into quantitative stenosis severity profiles, thereby improving consistency of stenosis across the angiogram image sequence.
Regarding claim 6, Compas teaches determining stenosis from local narrowing in an arterial-width surface (valley) [Para. 26].
However, Compas doesn’t explicitly teach the rest of claim limitations.
Najarian teaches wherein the maximum stenosis severity profile and the minimum stenosis severity profile are respectively determined based on local concavities of multiple curves, each of the multiple curves depicting a respective relationship between a respective set of the lumen radius measurements and the multiple locations of the portion of the coronary arteries [Para. 53 “where h.sub.1 and h.sub.2 are the peaks on either side of the trough and d is the depth of the trough. An example algorithm, Algorithm5 describes the details of width detection”].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify Compas’s arterial-width surface stenosis detection by incorporating Najarian’s profile analysis using peaks and a trough to quantify local curve concavity for maximum and minimum stenosis severity profiles. This modification improves compass by converting the observed stenosis valley into a quantitative profile-shape analysis, thereby improving reproducibility of stenosis severity measurement.
Regarding claim 7, Compas teaches obtaining an angiogram acquired during an angiography exam of the anatomical region of interest [Para. 21].
However, Compas doesn’t explicitly teach the rest of claim limitations.
Najarian teaches selecting, based on at least one pre-defined criterion (selects, visible vasculature), the multiple cardiac images among frames of the angiogram [Para. 30 “The salient frame detection process 204 analyzes the received angiogram video frames and selects the preferred frames suitable for analyzing vessels” and “The salient frame selection module 204 then selects the frames containing the maximum visible vasculature, without missing important information”].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify Compas to teach the claim limitations, feature as taught by Najarian; because the modification improves reproducibility of stenosis severity measurement.
Regarding claim 8, Compas teaches determining the respective set of lumen radius measurements (arterial width) from each cardiac image [Para. 24].
However, Compas doesn’t explicitly teach the rest of claim limitations.
Najarian teaches segmenting (vessel segmentation, extraction of the vasculature) the portion of the coronary arteries from the respective cardiac image of the multiple cardiac images; and determining the respective set of the lumen radius measurements based on the respective segmented portion of the coronary arteries [Para. 10 “automatically selecting a subset of the frames of medical image data by performing on each frame of the video image data, (i) a vessel segmentation, (ii) a histogram analysis after the vessel segmentation, and (iii) determining an amount of visible vasculature for each frame, and further identifying, based on the amount of visible vasculature for each frame, frames having a desired amount of visible vasculature as the subset of frames of medical image data”].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify Compas to teach the claim limitations, feature as taught by Najarian; because the modification improves reproducibility of stenosis severity measurement.
Regarding claim 10, Compas teaches registering the multiple cardiac images aligning the sequence of angiogram image [Para. 22 “optical-flow tracking can be used to align the sequence of images”; and Para. 23].
Claims 3 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Compas et al. (Pub. No. US 2015/0282777) in view of Najarian et al. (Pub. No. US 2017/0148158) further in view of LAVI et al. (Pub. No. US 2015/0.342551) and further in view of HWANG et al. (Pub. No. US 2011/0163898).
Regarding claim 3, Compas teaches determining the respective set of lumen radius measurements (arterial width) from each cardiac image [Para. 24].
However, Compas in view of Najarian further LAVI doesn’t explicitly teach the claim limitations.
HWANG teaches said determining of the reference set of the lumen radius measurements comprising selecting the set of the lumen radius measurements having the longest length (longest reading sequence) as the reference set of the lumen radius measurements (initial template sequence) [Para. 53 “The method to select the initial template sequence from the plurality of reading sequences may comprise: (i) selecting the longest reading sequence among the plurality of reading sequences as the initial template sequence; (ii) selecting the reading sequence having a length which is closest to the average length of the plurality of reading sequences as the initial template sequence; (iii) selecting the reading sequence having a length which has the highest number of occurrence, among the plurality of reading sequences as the initial template sequence; or (iv) randomly selecting the reading sequence among the input sequences as the initial template sequence”].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify Compas’s chosen reference angiographic alignment method modified by Najarian further in view of LAVI, incorporating Hwang’s teaching of selecting the longest reading sequence as the initial template sequence, so that the longest lumen-radius measurement set is used as the reference set. This medication improves compass by using the most complete measurement set as the refence, thereby reducing loss of vessel-location coverage during alignment.
Regarding claim 4, Compas teaches aligning of each of the respective sets of the lumen radius measurements with the reference set of the lumen radius measurements [Para. 22].
However, Hwang teaches for each of the respective unaligned sets of the lumen radius measurements, iteratively performing the following: selecting the longest set of the lumen radius measurements among all the unaligned sets of the lumen radius measurements [Para. 53-55, 58, 59, and 60]; aligning the selected set of the lumen radius measurements with the reference set of the lumen radius measurements [Para. 53-55, 58, 59, and 60]; and updating the reference set of the lumen radius measurements based on all aligned sets of the lumen radius measurements [Para. 53-55, 58, 59, and 60].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify Compas’s chosen reference angiographic alignment method modified by Najarian further in view of LAVI, incorporating Hwang’s teaching of selecting the longest reading sequence as the initial template sequence, so that the longest lumen-radius measurement set is used as the reference set. This medication improves compass by using the most complete measurement set as the refence, thereby reducing loss of vessel-location coverage during alignment.
Claims 5, 11, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Compas et al. (Pub. No. US 2015/0282777) in view of Najarian et al. (Pub. No. US 2017/0148158) further in view of LAVI et al. (Pub. No. US 2015/0.342551) and further in view of LAVI et al. (Pub. No. US 2015/0335304 hereinafter LAVI2).
Regarding claim 5, Compas teaches aligning each of the respective sets of lumen radius measurement with a reference [Para. 22];
However, Compas in view of Najarian further in view of LAVI doesn’t explicitly teach the rest of claim limitations.
LAVI2 teaches wherein said aligning is based on one or more anatomical landmarks (origin, location of minima radius, bifurcation) within the anatomical region of interest [Para. 196 “corresponding image features comprise at least one of a group consisting of an origin of the tree model, a location of minimal radius in a stenosed vessel, and a bifurcation of a vessel”].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify Compas in view of Najarian further in view of LAVI to teach the claim limitations, feature as taught by LAVI2; because the modification improves the reliability of lumen-radius measurement comparisons.
Regarding 11, Compas in view Najarian further in view of LAVI doesn’t explicitly teach claim limitations.
However, LAVI2 teaches wherein said determining of the lumen radius profile associated with the portion of the coronary arteries is further based on one or more given stenosis severity values and each of the one or more stenosis severity values is associated with a respective segment of the portion of the coronary arteries [Para. 204 “the function describes radius, diameter, cross-sectional area, and/or another metric related to a degree of stenosis as a function of position along the segment”].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify Compas in view Najarian further in view of LAVI to teach the claim limitations, feature as taught by LAVI2; because the modification improves reproducibility of stenosis severity measurement.
Regarding claim 14, Compas teaches the multiple cardiac images comprise cardiac images [Para. 21 and 22]
However, Compas in view of Najarian further in view of LAVI doesn’t explicitly teach the rest of claim limitations.
LAVI teaches wherein the multiple cardiac images comprise cardiac images acquired under different acquisition angles [Para. 466 “images from orthogonal projections (and/or projections having another defined angular relationship) are selected.”].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify Compas to teach the claim limitations, feature as taught by LAVI2; because the modification improves reproducibility of stenosis severity measurement.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Compas et al. (Pub. No. US 2015/0282777) in view of Najarian et al. (Pub. No. US 2017/0148158) further in view of LAVI et al. (Pub. No. US 2015/0.342551) and further in view of Zhao et al. (Pub. No. US 2021/0022617).
Regarding claim 9, Compas teaches determining the anatomical region of interest containing the coronary artery tree [Para. 22].
However, Compas in view Najarian further in view of LAVI doesn’t explicitly teach the claim limitations.
Zhao teaches determining the anatomical region of interest based on multiple predefined seed points [Para. 49 “For example, in certain implementations processing the initial segmentation results may involve automatically setting seed points within A.sub.Coronary and A.sub.Aorra based on defined selection rules”; and “A region growing technique may then be employed with respect to the seed points to fill out and/or better define one or more of the segmented regions, resulting in the segments A.sub.PostCoronary and A.sub.PostAorta in the present context”].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify Compas in view Najarian further in view of LAVI to teach the claim limitations, feature as taught by Zhoa; because the modification improves reproducibility of stenosis severity measurement.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Compas et al. (Pub. No. US 2015/0282777) in view of Najarian et al. (Pub. No. US 2017/0148158) further in view of LAVI et al. (Pub. No. US 2015/0.342551) and further in view of LAVI et al. (Pub. No. US 2015/0265162 hereinafter LAVI3).
Regarding claim 12, Compas teaches the minimum and maximum stenosis severity values associated with the respective segment of the portion of the coronary arteries [Para. 53].
However, Compas in view of Najarian further in view of LAVI doesn’t explicitly the rest of claim limitations.
LAVI3 teaches selecting each of the one or more given stenosis severity values between the minimum and maximum stenosis severity values associated with the respective segment of the portion of the coronary arteries [Para. 237].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify Compas in view of Najarian further in view of LAVI to teach the claim limitations, feature as taught by LAVI3; because the modification improves compass by providing phase resolved coronary geometry and flow relevant information, thereby improving hemodynamic index calculation.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Compas et al. (Pub. No. US 2015/0282777) in view of Najarian et al. (Pub. No. US 2017/0148158) further in view of LAVI et al. (Pub. No. US 2015/0.342551) and further in view of PETERSEN et al. (Pub. No. US 2018/0182101)
Regarding claim 13, Compas in view Najarian further in view of LAVI doesn’t explicitly teach the claim limitations.
However, PETERSEN teaches determining one or more further lumen radius profiles associated with the portion of the coronary arteries based on the maximum stenosis severity profile and the minimum stenosis severity profile; for each of the at least one hemodynamic index: determining, based on each of the one or more further lumen radius profiles, a further respective value at the given location of the portion of the coronary arteries; and determining, based on the respective value and the further respective values, an uncertainty range associated with the respective hemodynamic index [Para. 42].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify Compas in view of Najarian further in view of LAVI to teach the claim limitations, feature as taught by LAVI2; because the modification improves Compas by quantifying how lumen profile variation affects hemodynamic index values, thereby providing an uncertainty range for the functional assessment.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Compas et al. (Pub. No. US 2015/0282777) in view of Najarian et al. (Pub. No. US 2017/0148158) further in view of LAVI et al. (Pub. No. US 2015/0.342551) and further in view of GRASS et al. (Pub. No. US 2015/0297161).
Regarding claim 15, Compas teaches the multiple cardiac images comprise cardiac images [Para. 21 and 22].
However, Compas in view of Najarian further in view of LAVI doesn’t explicitly teach the rest of claim limitations.
GRASS teaches wherein the multiple cardiac images comprise cardiac images acquired using multi-phase coronary computed tomography angiography [Para. 73 “When using a 4D cardiac CT scan (e.g. ECG gated cardiac CT scan), or at least a biphasic acquisition protocol, two cardiac images corresponding to end systole and late diastole can be reconstructed”].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify Compas in view of Najarian further in view of LAVI to teach the claim limitations, feature as taught by GRASS; because the modification improves compass by providing phase resolved coronary geometry and flow relevant information, thereby improving hemodynamic index calculation.
Conclusion
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/SOLOMON G BEZUAYEHU/ Primary Examiner, Art Unit 2666
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