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 Interpretation
Claim 7 recites a limitation of the form “at least one of A and B”. Claim 16 recites a limitation of the form “at least one of A, B and C”. In accordance with the U.S. Court of Appeals for the Federal Circuit in SuperGuide Corp v. DirecTV Enterprises, Inc., these limitations are conjunctive in nature and to be construed as “at least one of A and at least one of B” or “at least one of A, at least one of B and at least one of C”. Therefore, these claims are addressed herein as requiring each of these steps rather than the alternative of A or B (or C).
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-11, 17, 19 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Trousset et al. (US 20240216063).
Regarding claim 1, Trousset et al. discloses a medical image processing apparatus comprising processing circuitry configured to:
generate a first map representing a likely location of a medical device in an anatomical region of a patient or other subject, the first map being generated based on a two-dimensional (2D) image that has been acquired by a medical imaging apparatus, the 2D image representing the medical device in the anatomical region (“Particularly, in one embodiment, the detector elements 202 may acquire electrical signals corresponding to the generated x-ray beams 112 at a variety of angular positions around the patient anatomy 104 for collecting a plurality of radiographic projection views for construction of X-ray images, such as to form fluoro image(s)” at paragraph 0030, line 1; “The representation of the 3D model 327 provides the physician with a view of the bifurcation 315 shown in the 2D image 332 in all three dimensions, such that navigation of the interventional device 319 along the predetermined path 325 through the bifurcation 315 is simplified” at paragraph 0048, line 10; a subsequent fluoroscopic image post the initial registration);
generate a second map representing an expected location of the medical device in the anatomical region, the second map being generated based on volumetric imaging data representing the anatomical region (“In the method 300, in step 310, initially a pre-op image/volume 312, such as pre-op CT image/volume, is obtained of the patient anatomy 104. The CT image/volume 312 is obtained in any suitable imaging manner using the system 102, such as by obtaining a number of projections/projection views of the patient anatomy 104 at various angles, and reconstructing the projection views into the 3D volume 312 representative of the patient anatomy 104, such as by employing the computing device 214 and/or image reconstructor 222 to perform the 3D volume reconstruction from the projection views in a known manner” at paragraph 0041) and a plurality of registration parameters, wherein the plurality of registration parameters determines a pose of the medical imaging apparatus (“In addition to presenting the information 321 on the display 218, in step 326, which can be performed concurrently or consecutively with step 324, the imaging system 200 employs the information 321 for the current itinerary step 323 to determine a 3D model 327 of the bifurcation 315 being shown on the display 218. The intra-operative 2D image 332 can be registered to the 3D volume 312, and the bifurcation 315 represented in the 2D image 332 can be recreated in the form of a 3D model 327 presented on the display 218 in conjunction with the 2D image 332’ at paragraph 0048, line 1);
compare the first and second maps with each other (“When the interventional device 319 has been moved along the bifurcation 315 to a point where the tip 331 of the interventional device 319 is positioned at a specified location, e.g., close to the edge of the 2D image 332, the computing device/AI 214 can proceed to step 328 and move to the next itinerary step 323 of the itinerary 320. In doing so, the computing device/AI 214 accesses the information 321 corresponding to the subsequent itinerary step 323 to determine the location of the bifurcation 315 associated with the next step of the itinerary 320. The computing device/AI 214 then operates the imaging system 200 to obtain a subsequent 2D intra-operative image 332 of the next bifurcation 315 for presentation on the display 218, and optionally for registration with the 3D volume 312, in order to provide the 3D model 327 for presentation in alignment and/or along with the subsequent intra-operative 2D image 332” at paragraph 0050, line 1; the movement causes an update in the registration); and
update the plurality of registration parameters based on the comparison between the first and second maps (depending on the detected movement, the registration is updated accordingly to match the subsequent 2D fluoroscopic image to the pre-operative data).
Regarding claim 20, Trousset et al. discloses a medical image processing method comprising:
generating a first map representing a likely location of a medical device in an anatomical region of a patient or other subject, the first map being generated based on a two-dimensional (2D) image that has been acquired by a medical imaging apparatus, the 2D image representing the medical device in the anatomical region (“Particularly, in one embodiment, the detector elements 202 may acquire electrical signals corresponding to the generated x-ray beams 112 at a variety of angular positions around the patient anatomy 104 for collecting a plurality of radiographic projection views for construction of X-ray images, such as to form fluoro image(s)” at paragraph 0030, line 1; “The representation of the 3D model 327 provides the physician with a view of the bifurcation 315 shown in the 2D image 332 in all three dimensions, such that navigation of the interventional device 319 along the predetermined path 325 through the bifurcation 315 is simplified” at paragraph 0048, line 10; a subsequent fluoroscopic image post the initial registration);
generating a second map representing an expected location of the medical device in the anatomical region, the second map being generated based on volumetric imaging data representing the anatomical region (“In the method 300, in step 310, initially a pre-op image/volume 312, such as pre-op CT image/volume, is obtained of the patient anatomy 104. The CT image/volume 312 is obtained in any suitable imaging manner using the system 102, such as by obtaining a number of projections/projection views of the patient anatomy 104 at various angles, and reconstructing the projection views into the 3D volume 312 representative of the patient anatomy 104, such as by employing the computing device 214 and/or image reconstructor 222 to perform the 3D volume reconstruction from the projection views in a known manner” at paragraph 0041) and a plurality of registration parameters, wherein the plurality of registration parameters determines a pose of the medical imaging apparatus (“In addition to presenting the information 321 on the display 218, in step 326, which can be performed concurrently or consecutively with step 324, the imaging system 200 employs the information 321 for the current itinerary step 323 to determine a 3D model 327 of the bifurcation 315 being shown on the display 218. The intra-operative 2D image 332 can be registered to the 3D volume 312, and the bifurcation 315 represented in the 2D image 332 can be recreated in the form of a 3D model 327 presented on the display 218 in conjunction with the 2D image 332’ at paragraph 0048, line 1);
comparing the first and second maps with each other (“When the interventional device 319 has been moved along the bifurcation 315 to a point where the tip 331 of the interventional device 319 is positioned at a specified location, e.g., close to the edge of the 2D image 332, the computing device/AI 214 can proceed to step 328 and move to the next itinerary step 323 of the itinerary 320. In doing so, the computing device/AI 214 accesses the information 321 corresponding to the subsequent itinerary step 323 to determine the location of the bifurcation 315 associated with the next step of the itinerary 320. The computing device/AI 214 then operates the imaging system 200 to obtain a subsequent 2D intra-operative image 332 of the next bifurcation 315 for presentation on the display 218, and optionally for registration with the 3D volume 312, in order to provide the 3D model 327 for presentation in alignment and/or along with the subsequent intra-operative 2D image 332” at paragraph 0050, line 1; the movement causes an update in the registration); and
updating the plurality of registration parameters based on the comparison between the first and second maps (depending on the detected movement, the registration is updated accordingly to match the subsequent 2D fluoroscopic image to the pre-operative data).
Regarding claim 2, Trousset et al. discloses an apparatus wherein the processing circuitry is configured to initialise a registration of at least one of: the medical imaging apparatus and/or a 2D image sequence with the volumetric imaging data based on a plurality of updated registration parameters, the 2D image sequence comprising at least the 2D image and/or one or more subsequent 2D images representing the medical device in the anatomical region (“When the interventional device 319 has been moved along the bifurcation 315 to a point where the tip 331 of the interventional device 319 is positioned at a specified location, e.g., close to the edge of the 2D image 332, the computing device/AI 214 can proceed to step 328 and move to the next itinerary step 323 of the itinerary 320. In doing so, the computing device/AI 214 accesses the information 321 corresponding to the subsequent itinerary step 323 to determine the location of the bifurcation 315 associated with the next step of the itinerary 320. The computing device/AI 214 then operates the imaging system 200 to obtain a subsequent 2D intra-operative image 332 of the next bifurcation 315 for presentation on the display 218, and optionally for registration with the 3D volume 312, in order to provide the 3D model 327 for presentation in alignment and/or along with the subsequent intra-operative 2D image 332” at paragraph 0050, line 1).
Regarding claim 3, Trousset et al. discloses an apparatus wherein the expected location of the medical device in the anatomical region is part of planning data and the processing circuitry is configured to generate the second map based on the planning data (“The route 330 can be planned according to the structures 313 and/or bifurcations 315 disposed along the route 330 to access the target tissue 317” at paragraph 0042, last sentence).
Regarding claim 4, Trousset et al. discloses an apparatus wherein the processing circuitry is configured to project the planning data onto one or more 2D images based on a plurality of updated registration parameters, the one or more 2D images comprising at least the 2D image and/or one or more subsequent 2D images representing the medical device in the anatomical region (“Further, as best shown in FIG. 3, an overlay 340 can be presented on the display 218 in association with the intra-operative 2D image 332. The overlay 340 can contain information relating to the direction of the path 325 for the route 330 through the structure 313 and/or bifurcation 315 represented in the intra-operative 2D image 332, as well as the position of the target tissue(s) 317 relative to the structure 313 and/or bifurcation 315” at paragraph 0049).
Regarding claim 5, Trousset et al. discloses an apparatus wherein the processing circuitry is configured to determine the planning data based on a medical procedure to be carried out (“Using the user interface/GUI 224, the physician can annotate the selected images, slices, etc., and/or the volume 312 on the display 218 to note the various features and/or structures within the images that are relevant to the interventional procedure to be performed by the physician on the patient anatomy 104, as well as to plan the route 330 (FIG. 3) to be utilized for the interventional device 319 through the patient anatomy 104 to the target tissue(s) or structure(s) 317 in the procedure. The route 330 can be planned according to the structures 313 and/or bifurcations 315 disposed along the route 330 to access the target tissue 317” at paragraph 0042, second to last sentence).
Regarding claim 6, Trousset et al. discloses an apparatus wherein the planning data is defined by a user (“Using the user interface/GUI 224, the physician can annotate the selected images, slices, etc., and/or the volume 312 on the display 218 to note the various features and/or structures within the images that are relevant to the interventional procedure to be performed by the physician on the patient anatomy 104, as well as to plan the route 330 (FIG. 3) to be utilized for the interventional device 319 through the patient anatomy 104 to the target tissue(s) or structure(s) 317 in the procedure. The route 330 can be planned according to the structures 313 and/or bifurcations 315 disposed along the route 330 to access the target tissue 317” at paragraph 0042, second to last sentence).
Regarding claim 7, Trousset et al. discloses an apparatus wherein the planning data comprises at least one of: a route of the medical device in the anatomical region and a location of an anatomical structure (“Using the user interface/GUI 224, the physician can annotate the selected images, slices, etc., and/or the volume 312 on the display 218 to note the various features and/or structures within the images that are relevant to the interventional procedure to be performed by the physician on the patient anatomy 104, as well as to plan the route 330 (FIG. 3) to be utilized for the interventional device 319 through the patient anatomy 104 to the target tissue(s) or structure(s) 317 in the procedure. The route 330 can be planned according to the structures 313 and/or bifurcations 315 disposed along the route 330 to access the target tissue 317” at paragraph 0042, second to last sentence).
Regarding claim 8, Trousset et al. discloses an apparatus wherein the medical procedure to be carried out comprises a transcatheter aortic valve implantation procedure and the anatomical region comprises an aorta of a patient or other subject (“The interventional procedures, for example, may include angioplasty, stent placement, removal of blood clots, localized thrombolytic drug administration, perfusion studies, balloon septostomy, Transcatheter Aortic-Valve Implantation (TAVI)” at paragraph 0021, line 7; it is therefore implied that the anatomy of interest is the aorta).
Regarding claim 9, Trousset et al. discloses an apparatus wherein the processing circuitry is configured to perform one or more iterations of at least one of: generating the first map, generating the second map, comparing the first and second maps with each other and updating the plurality of registration parameters based on the comparison between the first and second maps (“When the interventional device 319 has been moved along the bifurcation 315 to a point where the tip 331 of the interventional device 319 is positioned at a specified location, e.g., close to the edge of the 2D image 332, the computing device/AI 214 can proceed to step 328 and move to the next itinerary step 323 of the itinerary 320. In doing so, the computing device/AI 214 accesses the information 321 corresponding to the subsequent itinerary step 323 to determine the location of the bifurcation 315 associated with the next step of the itinerary 320. The computing device/AI 214 then operates the imaging system 200 to obtain a subsequent 2D intra-operative image 332 of the next bifurcation 315 for presentation on the display 218, and optionally for registration with the 3D volume 312, in order to provide the 3D model 327 for presentation in alignment and/or along with the subsequent intra-operative 2D image 332. The computing device/AI 214 can proceed in this manner through each step 323 of the itinerary 320 until all of the pre-determined itinerary steps 323 have been completed and the interventional device 319 has reached the target tissue 317” at paragraph 0050).
Regarding claim 10, Trousset et al. discloses an apparatus wherein in a first iteration, the plurality of registration parameters comprises a plurality of initial registration parameters, and in each subsequent iteration, the plurality of registration parameters comprises a plurality of updated registration parameters, the plurality of updated registration parameters comprising at least one registration parameter that has been updated relative to a corresponding previous registration parameter (“When the interventional device 319 has been moved along the bifurcation 315 to a point where the tip 331 of the interventional device 319 is positioned at a specified location, e.g., close to the edge of the 2D image 332, the computing device/AI 214 can proceed to step 328 and move to the next itinerary step 323 of the itinerary 320. In doing so, the computing device/AI 214 accesses the information 321 corresponding to the subsequent itinerary step 323 to determine the location of the bifurcation 315 associated with the next step of the itinerary 320. The computing device/AI 214 then operates the imaging system 200 to obtain a subsequent 2D intra-operative image 332 of the next bifurcation 315 for presentation on the display 218, and optionally for registration with the 3D volume 312, in order to provide the 3D model 327 for presentation in alignment and/or along with the subsequent intra-operative 2D image 332” at paragraph 0050, line 1; the movement causes an update in the registration due to the updated 2D image being presented).
Regarding claim 11, Trousset et al. discloses an apparatus wherein in each subsequent iteration, the processing circuitry is configured to generate the second map based on a plurality of updated registration parameters (“As such, the physician is provided with detailed information 321 on the characteristics of the structure 313 and/or bifurcation 315 constituting each step of the itinerary 320 as well as information concerning the proper direction for the interventional device 319 along the path 325 and route 330 through the structure 313 and/or bifurcation 315 to perform the interventional procedure” at paragraph 0051, last sentence; as the registered model and intraoperative image updates, the display updates the progression of the interventional device).
Regarding claim 17, Trousset et al. discloses an apparatus wherein the processing circuitry is configured to generate the second map based on one or more properties of the medical device (“In addition, the information regarding the structures 313 and bifurcations 315 detected by the computing device/AI 214 enable the computing device/AI 214 to propose alternative forms and/or sizes for the interventional device 319 to be employed in order to accommodate the features, e.g., the diameter and tortuosity, of the structures 313 and/or bifurcations 315 forming the parts or steps 323 of the route 330 for the interventional device 319 to further increase the ease in moving the interventional device 319 along the route 330” at paragraph 0045, line 1).
Regarding claim 19, Trousset et al. discloses an apparatus wherein the anatomical region comprises an artery, vein or an organ of the patient or other subject, the organ comprising a cylindrical or tubular shape (“By itself, or in conjunction with a manual, annotating review of the 3D volume by the physician, the imaging system can analyze the various anatomical structures, such as the organs and/or vascular structures within the imaged anatomy through which the interventional device can pass to reach the target tissue. In the analysis, the imaging system can determine the locations and configurations of the vascular structures/blood vessels and/or organs, including the location of angles and/or bifurcations of the passages within the organs and/or blood vessels, the diameter and tortuosity of the passages within the organs and/or blood vessels” at paragraph 0011, line 1; furthermore, as discussed in relation to claim 8 above, the anatomy of interest is the aorta).
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.
Claim(s) 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Trousset et al. and Ness et al. (US 20250366949).
Regarding claim 12, Trousset et al. discloses the elements of claim 1 as described above.
Trousset et al. does not explicitly disclose that the processing circuitry is configured to detect the medical device in the 2D image.
Ness et al. teaches an apparatus in the same field of endeavor of TAVI navigation, wherein the processing circuitry is configured to detect the medical device in the 2D image (“The catheter (e.g. pigtail catheter) and/or guidewire within the image frame 1102 may be segmented using AI. The AI may include a deep learning model, such as VNet model 1104. The VNet model 1104 may be trained to predict a plurality of classes, such as catheter, guidewire, device marker, and background. The VNet model 1104 may receive, as input, the first image frame 1102 and may output multi-label segmentation” at paragraph 0118).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to utilize the device segmentation as taught by Ness et al. in the system of Trousset et al. to be able to track and localize the device location for clearer guidance on navigation.
Regarding claim 13, Ness et al. discloses an apparatus wherein the processing circuitry is configured to use a filtering method or a machine learning method to detect the medical device in the 2D image (“The catheter (e.g. pigtail catheter) and/or guidewire within the image frame 1102 may be segmented using AI. The AI may include a deep learning model, such as VNet model 1104. The VNet model 1104 may be trained to predict a plurality of classes, such as catheter, guidewire, device marker, and background. The VNet model 1104 may receive, as input, the first image frame 1102 and may output multi-label segmentation” at paragraph 0118).
Claim(s) 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Trousset et al. and Viswanathan (US 20060269165).
Regarding claim 14, Trousset et al. discloses the elements of claim 1 as described above.
Trousset et al. does not explicitly disclose that the processing circuitry is configured to segment the anatomical region in the volumetric imaging data.
Viswanathan teaches an apparatus in the same field of endeavor of surgical navigation, wherein the processing circuitry is configured to segment the anatomical region in the volumetric imaging data (“In step three, 53, a set of cross-section planes is defined for the organ of interest within a given anterior-posterior range automatically determined from the data set by segmentation. A set of planes is selected at equal increments along the z axis. For each such plane, a plurality of lines is defined within an inferior-superior range automatically determined by the data set by segmentation. A set of lines is selected at equal increments along the y axis. On each such line, one or two contour points are automatically determined by segmentation of the three-dimensional data set” at paragraph 0031, line 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to utilize the segmentation as taught by Viswanathan in the system of Trousset et al. as it “reduces the computational effort necessary to achieve registration” (Viswanathan at paragraph 0026, line 13).
Regarding claim 15, Viswanathan discloses an apparatus wherein the processing circuitry is configured to project the segmented anatomical region onto an image plane to generate an image representing the segmented anatomical region, the segmented anatomical region being projected onto the image plane based on the plurality of registration parameters (“FIG. 4 illustrates how the matching of extreme points, for example extreme lateral points 40 and 42, can lead to the estimation of a translation vector T 44 for a convex 3D object. Accordingly, identification by the user of two extreme landmark points 46 and 48 in at least one projection of the patient's organ of interest, and consideration of the distance from projected 3D contour points to the landmark points on the projection plane(s), leads to the definition of a figure-of-merit for registration of the 3D object to the patient as positioned in the projection system. Minimization of the figure-of-merit associated with a given translation vector effectively registers the 3D data set to the patient. This approach very significantly reduces the computational effort necessary to achieve registration” at paragraph 0026, line 1).
Claim(s) 18 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Trousset et al. and Gorek et al. (US 20100312103).
Trousset et al. discloses an apparatus wherein the 2D image comprises a fluoroscopic image (“Particularly, in one embodiment, the detector elements 202 may acquire electrical signals corresponding to the generated x-ray beams 112 at a variety of angular positions around the patient anatomy 104 for collecting a plurality of radiographic projection views for construction of X-ray images, such as to form fluoro image(s)” at paragraph 0030, line 1).
Trousset et al. does not explicitly disclose that a range of a field of view of the 2D image being reduced to focus on or zoom in the anatomical region.
Gorek et al. teaches an apparatus in the same field of endeavor of surgical navigation display, wherein the 2D image comprises a fluoroscopic image, a range of a field of view of the 2D image being reduced to focus on or zoom in the anatomical region (“Selecting the option button 658 expands an option menu 659, illustrated in FIGS. 32-33, which may include but is not necessarily limited to, a show or hide angle button 660, a zoom button 662, and a hide button 664. The show or hide angle button 660 either opens or closes an instrument angle window 668 and C-arm angle window 670 (FIGS. 33 and 34). The zoom button 662 zooms in on the fluoroscopic image 630” at paragraph 0087, line 12).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to include a zoom option as taught by Gorek et al. in the display control of Trousset et al. to allow the user to enlarge the live navigation area for easier maneuvering through particular areas.
Claim(s) 16 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Trousset et al. and Viswanathan as applied to claim 15 above, and further in view of Collins et al. (US 20220079557).
The Trousset et al. and Viswanathan combination discloses an apparatus wherein the processing circuitry is configured to at least one of:
generate a binary image representing the segmented anatomical region based on the generated image (“Applying thresholding techniques to the 3D voxel gray levels generally suffices to effectively segment out the organ (vasculature and the heart in cardiac applications); prior gray-level smoothing of the voxel distribution can reduce the segmentation noise; and connectivity constraints can further reduce the likelihood of segmentation errors” Viswanathan at paragraph 0026, last sentence; while this is not explicitly a binary image in terms of black and white pixels, this thresholding is a binarization as it proves to segment out non-organ areas from organ areas); and
generate a distance map based on the generated image (“In step five, 55, the method projects every contour point on a subset of cross-section planes onto the projection image plane. The projection geometry is illustrated in FIG. 7 and further described below. The projection of these contour points establishes a set of projection points to be evaluated relative to the user-identified extreme landmark points (Xi,l) on the projection image(s). The evaluation is performed by means of a cost function, based upon the distance between the projected contour point and the user-defined landmark point associated with this projection” Viswanathan at paragraph 0034, line 1).
The Trousset et al. and Viswanathan combination does not explicitly disclose increase a size or dimension of the segmented anatomical region.
Collins et al. teaches an apparatus in the same field of surgical navigation, wherein the processing circuitry is configured to increase a size or dimension of the segmented anatomical region (“In one embodiment, the user interface allows the user turn on and off, the display of the pre-operative radiologic data. The user input interface may also be used to amend the visualization of the pre-operative radiologic data, for example switching between different visualization modes such as color maps, label maps, adjusting transparency, modify the part of the segment model that is displayed and changing the visualization viewpoint characteristics (angle, zoom etc.). The man skilled in the art will identify display modes” at paragraph 0117).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to utilize the display zooming as taught by Collins et al. in the system of the Trousset et al. and Viswanathan combination to allow the user to control the area of display focus for easier navigation.
Conclusion
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/KATRINA R FUJITA/Primary Examiner, Art Unit 2672