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 .
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Response to Amendment
The amendment filed on May 11, 2026 has been entered.
The amendment of claims 1, 16, 17, and 19 has been acknowledged.
In view of the amendment, the objection to the title has been withdrawn.
Response to Arguments
Applicant's arguments filed on May 11, 2026, with respect to the pending claims, have been fully considered but they are not persuasive.
Applicant’s Representative submits that the prior art of record does not teach “perform[ing] an automatic anatomical shape model segmentation” because the cited paragraphs of Flohr teach vessel parameters (such as lumen diameter, wall thickness, thickening, or motion) and AHA-17 segment model. Applicant’s Representative submits that the vessel parameters do not correspond to the automatic anatomical shape model segmentation.
The examiner respectfully disagrees. As noted in the previous Office action, Flohr ¶¶0076, ¶¶0081, ¶¶0084, ¶¶0086, and Figs. 6-7 teach coronary CT angiography, 3D surface & volume rendering, and AHA-17 segment model.
Flohr’s geometrical parameters of the tissues describe the ventricle wall thickness, thickening, or wall motion, which are all parameters describing the shape (i.e., geometry).
Flohr uses the AHA-17 model. The AHA-17 segment model is a standardized model published by the American Heart Association (AHA) separating 17 regions of left ventricular myocardium. A diagram describing the AHA-17 segment model is duplicated below.
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AHA-17 segment model
Applicant’s Representative further submits that the prior art does not teach first and second layers of interest from an anatomical shape model segmentation.
The examiner respectfully disagrees. Flohr Figs. 1-5 teach using the AHA-17 model. The model comprises four locally parallel layers, i.e., 1-6, 7-12, 13-16, and 17.
Applicant’s Representative further submits that the secondary prior art does not teach the automatic anatomical shape model segmentation of volumetric medical image data because Min lists spectral CT among many possible imaging modalities.
The examiner respectfully disagrees. Volumetric imaging and anatomical shape model segmentation are already taught by Flohr. Min teaches using spectral CT to image the coronary region of the subjects. Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
Applicant’s Representative further submits that the prior art does not teach the newly added limitation “second layer of interest is locally parallel to the first layer of interest.”
The examiner respectfully disagrees. Flohr Figs. 1-5 teach using the AHA-17 model. The model comprises four locally parallel layers, i.e., 1-6, 7-12, 13-16, and 17.
In view of this reasonable interpretation of the claims and the prior art, the examiner respectfully submits that the rejections set forth below remain proper.
Claim Rejections - 35 USC § 103
Claim(s) 1-10, 12-13, and 16-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Flohr et al. (US 2020/0202522 A1), in view of Min et al. (US 2022/0392065 A1), hereinafter referred to as Flohr and Min, respectively.
Regarding claim 1, Flohr teaches a device for processing a medical image, comprising:
a memory that stores a plurality of instructions (Flohr ¶¶0056: “The computer programs include processor-executable instructions that are stored on at least one non-transitory computer-readable medium (memory)”) ; and
a processor coupled to the memory and configured to execute the plurality of instructions (Flohr ¶¶0056: “the one or more processors may be configured to execute the processor executable instructions”) to:
receive volumetric medical image data organized in voxels, wherein the volumetric medical image data is computed tomography data (Flohr ¶¶0003: “Coronary computed tomography angiography”; Flohr ¶¶0086: “The rendered image of the tissue may be obtained by rendering, particularly 3D surface rendering or 3D volume rendering, based on the imaging data of the tissue”);
perform an automatic anatomical shape model segmentation on the volumetric medical image data (Flohr ¶¶0076: “the parameter of the vessel is a geometrical parameter”; Flohr ¶¶0081: “the parameter of the tissue is a geometrical parameter, particularly a thickness, a thickening or a motion. The geometrical parameter of the tissue may be a ventricle wall thickness, a ventricle wall thickening or a ventricle wall motion”; Flohr ¶¶0084: “AHA-17 segment model”; Flohr Figs. 6-7);
determine a first layer of interest based on the anatomical shape model segmentation (Flohr ¶¶0076 & ¶¶0081discussed above; Flohr ¶¶0066: “imaging data of a tissue”, Flohr ¶¶0080: “the tissue representation comprises, for each position of a plurality of positions across the tissue, color-encoded quantitative information indicative of a value of a parameter of the tissue at that position. The plurality of positions may be distributed across the tissue, particularly distributed two-dimensionally across the tissue”; Flohr ¶¶0087: “the tissue is heart tissue, particularly tissue of the left ventricle of the heart, and/or the vessel is a coronary artery, particularly a coronary artery supplying the left ventricle of the heart. The heart tissue may be tissue of the left ventricle of the heart, tissue of the right ventricle of the heart, tissue of the left chamber of the heart, tissue of the right chamber of the heart or a combination thereof”);
determine a second layer of interest following the surface of the anatomical shape model, wherein the second layer of interest is locally parallel to the first layer of interest (Flohr ¶¶0067: “imaging data of a vessel”, Flohr ¶¶0073: “the vessel representation comprises a centerline of the vessel. In another embodiment the vessel representation comprises a representation of a wall of the vessel. In another embodiment the vessel representation comprises a representation of an inner wall of the vessel and/or a representation of an outer wall of the vessel”; Flohr Figs. 1-5: the AHA-17 model shows four locally parallel layers, i.e., 1-6, 7-12, 13-16, and 17);
project the first layer of interest yielding perfusion information data (Flohr ¶¶0080: “the tissue representation comprises, for each position of a plurality of positions across the tissue, color-encoded quantitative information indicative of a value of a parameter of the tissue at that position. The plurality of positions may be distributed across the tissue, particularly distributed two-dimensionally across the tissue”, Flohr ¶¶0082-¶¶0084: “the parameter of the tissue is a functional parameter, particularly a contrast medium concentration, a blood flow or a blood volume … The tissue representation comprising for each position of a plurality of positions across the tissue, color-encoded quantitative information indicative of a value of a parameter of the tissue at that position may be a functional image, particularly a perfusion map … the tissue representation comprises a planar polar plot of the tissue and/or the vessel representation comprises a projection of the vessel onto a reference plane. The reference plane may be in-plane with the planar polar plot of the tissue … The planar polar plot of the tissue may be obtained by projecting the tissue onto a plane based on the imaging data of the tissue and a segment model of the tissue, for example the AHA-17 segment model of the left ventricle of the heart … A planar polar plot obtained by projecting the tissue of the left ventricle onto a plane based on the imaging data of the tissue and the AHA-17 segment model will be referred to as AHA-17 plot“);
project the second layer of interest yielding vascular information data (Flohr ¶¶0082-¶¶0084 discussed above; Flohr ¶¶0085: “Coronary arteries may be projected onto a reference plane using a parameterization of the left ventricle based on a cylindrical coordinate system, using the cardiac long axis as the cylindrical axis. The reference plane is perpendicular to the cylindrical axis and in-plane with the planar polar plot”); and
graphically combine the perfusion information data and the vascular information data yielding combined information data (Flohr ¶¶0070: “generating a combined tissue-vessel representation based on the vessel representation and the tissue representation, wherein the vessel representation is overlaid over the tissue representation”, Flohr ¶¶0071: “The combined tissue-vessel representation may comprise the tissue representation as a background image and the vessel representation as a foreground image. In particular, the vessel representation may be overlaid over a portion of the tissue representation that represents the portion of the tissue that is closest to the vessel. The generating the combined tissue-vessel representation based on the vessel representation and the tissue representation may comprise registering the vessel representation with respect to the tissue representation based on the imaging data of the tissue and the imaging data of the vessel”, Flohr Fig. 7).
Flohr teaches that the CT data used is a dual-energy CT (Flohr ¶¶0004). However, Flohr does not appear to explicitly teach that the image data is spectral CT.
Pertaining to the same field of endeavor, Min teaches that the image data is spectral CT (Min ¶¶0191: “the medical image can be of the coronary region of the subject or patient … configured to take in CT data from the image domain or the projection domain as raw scanned data or any other medical data, such as but not limited to … Spectral CT”).
Flohr and Min are considered to be analogous art because they are directed to medical image processing. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method and system for generating combined tissue-vessel representation (as taught by Flohr) to use spectral CT (as taught by Min) because spectral CT allows the system to be configured to distinguish between blood and low-attenuated or non-calcified plaque directly from the image (Min ¶¶0231).
Regarding claim 2, Flohr, in view of Min, teaches the device according to claim 1, wherein the processor is further configured to perform on the volumetric medical image data:
a determination of a third layer of interest; and a third projection of the third layer of interest yielding calcification data, wherein the graphical combination further includes the calcification data (Flohr ¶¶0079: “the vessel representation comprises a local feature of the vessel, particularly color-encoded quantitative information indicative of a plaque or a plaque composition. In particular, the parameter of the vessel may be a plaque parameter, particularly a plaque density, a plaque type or a proportion of one or more plaque components in the total plaque volume. Plaque types may be, for example, calcified plaque, non-calcified plaque and mixed plaque. Plaque components may be, for example, fibrous tissue, fibro-fatty (fibro-lipid) tissue, cholesterol, necrotic core, and dense calcium”).
Regarding claim 3, Flohr, in view of Min, teaches the device according to claim 1, wherein the volumetric medical image data comprises at least a part of an organ (Flohr ¶¶0087: “the tissue is heart tissue, particularly tissue of the left ventricle of the heart, and/or the vessel is a coronary artery, particularly a coronary artery supplying the left ventricle of the heart. The heart tissue may be tissue of the left ventricle of the heart, tissue of the right ventricle of the heart, tissue of the left chamber of the heart, tissue of the right chamber of the heart or a combination thereof. The method may be applied to anatomical structures other than heart, for example to brain, liver or lung”).
Regarding claim 4, Flohr, in view of Min, teaches the device according to claim 1, wherein the automatic anatomical shape model segmentation yields a mesh model for a label volume (Min ¶¶1492: “a three-dimensional finite element mesh”; Min ¶¶1512: “a volumetric mesh such as a finite element mesh or a finite volume mesh”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method and system for generating combined tissue-vessel representation (as taught by Flohr) to generate a mesh model (as taught by Min) because the combination can solve 3D-dimensional problems using a finite element model (Min ¶¶1512).
Regarding claim 5, Flohr, in view of Min, teaches the device according to claim 3, wherein the first layer of interest is an endo-mural layer of the organ (Flohr ¶¶0073, ¶¶0082, ¶¶0087 discussed above).
Regarding claim 6, Flohr, in view of Min, teaches the device according to claim 1, wherein the first projection is an average intensity projection (Min ¶¶1167: “This can be analogous to the maximum intensity projection view, which highlights the lumen that is filled with contrast agent, but applies an intensity projection (maximum, minimum, average, ordinal) to the plaques of different distance from the field of view or of different densities”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method and system for generating combined tissue-vessel representation (as taught by Flohr) to apply an intensity projection (as taught by Min) because the combination can visualize feature differences (Min ¶¶1167).
Regarding claim 7, Flohr, in view of Min, teaches the device according to claim 1, wherein the processor is further configured to perform a dynamic auto-leveling of a perfusion scale corresponding to the perfusion information data (Flohr ¶¶0004: “dynamic myocardial perfusion technique allows calculation of functional maps of the heart (e.g. the myocardial blood flow and volume) and enables quantitative assessment of the hemodynamic relevance of intermediate stenosis of the coronaries”; Min ¶¶0459: “the normalization device is not just calibrating to a particular scanner but is also normalizing for a specific patient at a particular time in a particular environment for a particular scan, for particular scan image acquisition parameters, and/or for specific contrast protocols”; Min ¶¶1512: “The model can be dynamic, indicative of the changes in vessel shape over a cardiac cycle”).
Regarding claim 8, Flohr, in view of Min, teaches the device according to claim 1, wherein the second layer of interest is a trans-mural layer of the organ, is directly adjacent to the first layer of interest, and/or is located at a distance from the first layer of interest (Flohr ¶¶0067, ¶¶0071, ¶¶0073, ¶¶0087, & Fig. 7 discussed above).
Regarding claim 9, Flohr, in view of Min, teaches the device according to claim 1, wherein the processor is further configured to perform a restriction of the second layer of interest to avoid overlap with another anatomical entities (Flohr Figs. 5-7).
Regarding claim 10, Flohr, in view of Min, teaches the device according to claim 1, wherein the processor is further configured to perform an application of vesselness-weighting to the second layer of interest (Min ¶¶0214: “the system can be configured to generate a weighted measure of one or more vascular morphology parameters and/or quantified plaque parameters determined and/or derived from raw medical images”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method and system for generating combined tissue-vessel representation (as taught by Flohr) to apply vesselness-weighting (as taught by Min) because the combination can adjust the model based on vascular morphology (Min ¶¶0214).
Regarding claim 12, Flohr, in view of Min, teaches the device according to claim 1, wherein the second projection is a maximum intensity projection (Min ¶¶1167 discussed above).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method and system for generating combined tissue-vessel representation (as taught by Flohr) to apply an intensity projection (as taught by Min) because the combination can visualize feature differences (Min ¶¶1167).
Regarding claim 13, Flohr, in view of Min, teaches the device according to claim 1, wherein the graphical combination comprises mapping of the perfusion information data and the vascular information data to pseudo color scales and arranging the vascular information data superimposed over the perfusion information data (Flohr ¶¶0070, ¶¶0071, ¶¶0079, ¶¶0080, ¶¶0082-¶¶0084, Fig. 5 discussed above; also see Flohr ¶¶0075: “the vessel representation comprises, for each position of a plurality of positions along the vessel, color-encoded quantitative information indicative of a value of a parameter of the vessel at that position … The color-encoding of the quantitative information may be based on a color scale, particularly a multicolor scale, relating colors to values. The multicolor scale may comprise, for example, the colors red, yellow, green and blue, and/or a color continuum”).
Regarding claim 16, Flohr, in view of Min, teaches a computer-implemented method for processing a medical image (Flohr Abstract: “relates to a computer-implemented method for generating a combined tissue-vessel representation”), comprising the processes described in claim 1. Therefore claim 16 is rejected using the same rationale as applied to claim 1 discussed above.
Regarding claim 17, Flohr, in view of Min, teaches a non-transitory computer-readable medium for storing executable instructions, which cause a method to be performed to process a medical image (Flohr ¶¶0049: “software and data may be stored by one or more computer readable recording mediums, including the tangible or non-transitory computer-readable storage media discussed herein”), the method comprising the processes described in claim 1. Therefore claim 17 is rejected using the same rationale as applied to claim 1 discussed above.
Regarding claim 18, Flohr, in view of Min, teaches the device according to claim 1, wherein different spectral components and/or combinations of spectral components are used for the first and for the second layer of interest (Min ¶¶0191 discussed above; Min ¶¶0486: “spectral imaging (such as polychromatic, monochromatic and spectral imaging along with material basis decomposition and single energy imaging)”).
Allowable Subject Matter
Claims 11 and 19 are 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.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 11, the prior art teaches that it was known at the time the application was filed to use the device according to claim 10, but does not appear to teach or suggest performing a dynamic range adjustment of a vesselness scale.
Regarding claim 19, the prior art of record teaches that it was known at the time the application was filed to use the device according to claim 1, but does not appear to teach or suggest that for the first layer of interest, a spectral component or a combination of spectral component that has the highest sensitivity to the contrast agent is used, and for the second layer of interest, the spectral component or the combination of spectral components that has the least noise is used.
Conclusion
THIS ACTION IS MADE FINAL. 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 SOO J SHIN whose telephone number is (571)272-9753. The examiner can normally be reached M-F; 10-6.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Matthew Bella can be reached at (571)272-7778. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Soo Shin/Primary Examiner, Art Unit 2667 571-272-9753
soo.shin@uspto.gov
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