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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on August 10, 2026 has been entered.
Response to Amendment
The amendment filed August 10, 2026 has been entered. Claims 1, 3-4, 6-10, and 12-21 remain pending in the application. Applicant’s amendments to the Claims have overcome the objections previously set forth in the Final Office Action mailed June 11, 2026.
Response to Arguments
Applicant’s arguments, see Pages 13-16 of Remarks, filed August 10, 2026, with respect to the rejection(s) of claim(s) 1, 3-4, 6-10, and 12-21 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Kondo et al. (US 20040249270 A1).
Claim Objections
Claims 6-7, 13-14, and 19 are objected to because of the following informalities:
Claim 6 recites the limitation "the output data" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites the limitations "the output data" and “the analytic algorithms” in line 3. There is insufficient antecedent basis for these limitations in the claim.
Claims 13-14 are dependent on claim 11, but claim 11 was canceled. Perhaps claims 13-14 should be dependent on claim 1 or claim 12. For the sake of examination, the examiner interprets claims 13-14 to be dependent on claim 1.
Claim 19 recites the limitation "the metrics" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
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 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, 3-4, 6, 8-9, 12-13, and 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Weese et al. (WO 2009060355 A1) in view of Samset et al. (US 20190392944 A1) and Kondo et al. (US 20040249270 A1), hereinafter Weese, Samset, and Kondo respectively.
Regarding claim 1, Weese teaches a system for processing medical image data regarding a clinical question (Page 5 lines 26-29 – “a system 10 for facilitating diagnosis is provided. The system 10 may comprise a medical database 11 comprising pictorial and/or textual information regarding pathological or healthy states, such as sample images or guidance texts for facilitating diagnosis of a disease or disorder of a patient”; Note: diagnosis is a type of clinical question), comprising:
a processor subsystem (Page 5 line 30 – “the system comprises a first processor unit 12 configured to…”) configured to:
determine a use case regarding the clinical question for a patient based on a user input (Page 7 lines 23-30 – “The system further comprises a query unit 14 configured to prepare or retrieve a search query, such as a search mask, that may be used to search the medical database. In 25 Fig. 3e a search query is defined. The query unit may be a part of graphical user interface allowing the user to indicate or refine the search space, such as for example, search diagnosis exhibiting hypointense signals in the left cerebral hemisphere. The query may e.g. from the user's point of view, look like "search cases that contain hypointense to white matter in the left cerebral hemisphere". In an embodiment the search query may comprise textual input from the user”; Note: the user’s input and search query are the use case. The user is the patient);
retrieve patient data of the patient regarding the use case (Page 8 lines 4-5, Page 11 lines 20-21 – “The client workstation may also be configured to access a patient image e.g. from a scanner or via Picture archiving and communication system (PACS)… the user workstation may be connected to a scanner or PACS system to retrieve the acquired patient image, which is to the analyzed”; Note: patient images are a type of patient data);
retrieve image data of the patient (Page 8 lines 4-5 – “The client workstation may also be configured to access a patient image e.g. from a scanner or via Picture archiving and communication system (PACS)”);
determine an anatomical object based on the use case, the patient data (Page 10 lines 18-20 – “the graphical user interface is configured to enable the user to indicate which anatomy in the acquired patient image that is of interest, e.g. "left 20 cerebral hemisphere", "midbrain", etc. versus "cerebral hemisphere" only”; Note: the anatomical structure is determined based on patient image data and user input/selection, which is part of the use case), and medical information (Page 6 lines 2-4 – “In Fig. 3d the first processor unit has identified the left and right cerebral hemispheres as an anatomical structure. In Fig. 3e the first processor unit has identified the left cerebral hemisphere as an anatomical structure to be queried”; Note: an anatomical object is determined. It is implied that the anatomical object is determined based on medical information because it could not be identified without knowledge of what the anatomical object looks like);
select an algorithm from a repository (Page 8 lines 17-25 and 29-31 – “The system may further comprise a second processor unit 15 configured to retrieve (15a) a set of selected image-processing algorithms that are associated with the found set of diagnoses and sample cases, and optionally located on a memory 16 or a selection unit 20. A selected image-processing algorithm may be an algorithm that may be customized from a common IP algorithm and may be adapted to the modality, to the organ and so on. By customized is here meant that the algorithm may be modified particularly for being used on a certain sample image, and the acquired image resulting in parameters that may be used for facilitating diagnosis, or for discrimination between different diagnoses…The selected image-processing algorithms associated with the set of diagnoses and sample cases, which are located in the medical encyclopedia, may be stored either in the medical encyclopedia or in a memory connected to the system”; Note: an algorithm is selected from a memory that stores algorithms, which is equivalent to the repository) based on the determined anatomical object and the medical information (Page 8 lines 17-25 – “The system may further comprise a second processor unit 15 configured to retrieve (15a) a set of selected image-processing algorithms that are associated with the found set of diagnoses and sample cases, and optionally located on a memory 16 or a selection unit 20. A selected image-processing algorithm may be an algorithm that may be customized from a common IP algorithm and may be adapted to the modality, to the organ and so on. By customized is here meant that the algorithm may be modified particularly for being used on a certain sample image, and the acquired image resulting in parameters that may be used for facilitating diagnosis, or for discrimination between different diagnoses”; Note: an algorithm is selected based on a specific organ and medical information, including a set of diagnoses and sample cases).
Weese does not teach retrieving codified clinical guidelines regarding the use case; nor the “codified clinical guidelines” in the limitations: “determine an anatomical object based on the use case, the patient data, and the codified clinical guidelines” and “select an algorithm from a repository based on the determined anatomical object and the codified clinical guidelines”. However, Samset teaches retrieving codified clinical guidelines regarding the use case (Paragraph 0035 – “the clinical workflow may inform virtual diagnostic assistant 139 of the potential clinical findings to generate, and virtual diagnostic assistant 139 may identify clinical findings by comparing the clinical parameters generated by virtual parameter assistant 138 to various guidelines, which may include normal ranges of the clinical parameters obtained from published guidelines, research studies, etc. In some examples, the normal ranges for the clinical parameters may be adjusted based on patient information (e.g., patient gender, patient age). In other examples, virtual diagnostic assistant 139 may be trained to generate only specific findings for specific patients (e.g., virtual diagnostic assistant 139 may be trained to only generate clinical findings for echocardiograms of adult men)”). 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 Weese to incorporate the teachings of Samset to retrieve clinical guidelines for the use case because it can assist in quickly determining a diagnosis. “By starting with a set of automatically-generated clinical findings and working backwards to the medical images, the process of reviewing a diagnostic imaging exam may be expedited and aspects of the exam prone to error or inconsistencies (e.g., human-to-human variability in taking measurements of features of the images) may be performed in a uniform manner” (Samset: Paragraph 0004). Additionally, because Weese teaches determining said anatomical object (Page 6 lines 2-4 – “In Fig. 3d the first processor unit has identified the left and right cerebral hemispheres as an anatomical structure. In Fig. 3e the first processor unit has identified the left cerebral hemisphere as an anatomical structure to be queried”; Note: an anatomical object is determined. It is implied that the anatomical object is determined based on medical information because it could not be identified without knowledge of what the anatomical object looks like), and selecting said algorithm, also based on medical information (Page 8 lines 17-25 – “The system may further comprise a second processor unit 15 configured to retrieve (15a) a set of selected image-processing algorithms that are associated with the found set of diagnoses and sample cases, and optionally located on a memory 16 or a selection unit 20. A selected image-processing algorithm may be an algorithm that may be customized from a common IP algorithm and may be adapted to the modality, to the organ and so on. By customized is here meant that the algorithm may be modified particularly for being used on a certain sample image, and the acquired image resulting in parameters that may be used for facilitating diagnosis, or for discrimination between different diagnoses”; Note: an algorithm is selected based on medical information, including a set of possible diagnoses and sample cases), a person of ordinary skill in the art before the effective filing date of the claimed invention would have recognized that the medical information of Weese could have been substituted for the clinical guidelines of Samset because clinical guidelines are a type of medical information, and both the medical information and clinical guidelines serve the purpose of informing and contributing to medical decisions. Furthermore, a person of ordinary skill in the art would have been able to carry out the substitution. Finally, the substitution achieves the predictable result of determining an anatomical object and algorithm based on the clinical guidelines. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the medical information of Weese for the clinical guidelines of Samset according to known methods to yield the predictable result of determining an anatomical object and algorithm based on the clinical guidelines.
Furthermore, Weese modified by Samset still does not teach wherein the image data comprises three- dimensional (3D) image data; wherein the anatomical object is a 3D object in the 3D image data; wherein the selected algorithm is a slicing algorithm; determine an anatomically relevant path that is derived from the anatomical object and relevant to assess the clinical question; and compute, by execution of the slicing algorithm on the image data, slices of the 3D image data that are perpendicular to the anatomically relevant path to provide as display data for assessing the clinical question. However, Kondo teaches wherein the image data comprises three- dimensional (3D) image data (Paragraph 0077, 0083 – “Three-dimensional (solid-body) image data of a subject collected by a diagnostic imaging apparatus (medical modality), such as an X-ray CT scanner or an MRI, are sent online or offline to the memory unit 12… Image data incorporating the blood vessel to be analyzed by a diagnostic medical imaging apparatus are collected, or three-dimensional image data previously collected in this manner are read in… The image data are typically images (sliced images) of body-axis sections”; Note: the received image data is 3D); wherein the anatomical object is a 3D object in the 3D image data (Paragraph 0083 – “Image data incorporating the blood vessel to be analyzed by a diagnostic medical imaging apparatus are collected, or three-dimensional image data previously collected in this manner are read in…The image data are three-dimensional image data taken over a certain distance in the body axis direction by the use of the helical CT technique. Image data of a different kind, such as image data photographed by an MRI unit or an ultrasonic diagnosing apparatus, are acceptable as long as they are three-dimensional image data containing the vessel to be analyzed”; Note: the anatomical object, which is the blood vessel in this case, is a 3D object in the 3D image data); wherein the selected algorithm is a slicing algorithm (Paragraph 0115 – “When the vessel center line is extracted, it becomes possible to define a section perpendicular to the center line at each point on the center line. This permits display of a flat reformatted image on this surface as a perpendicular sectional image (see FIG. 10B). Particularly, the image processor 11 prepares, in a real-time manner, and displays, upon each change in section to be displayed along the center line, a corresponding perpendicular sectional image. This is useful for determining the three-dimensional structure of blood vessel such as stenosis”; Note: the process of defining perpendicular sections is equivalent to the slicing algorithm); determine an anatomically relevant path that is derived from the anatomical object and relevant to assess the clinical question (Paragraph 0087, 0115 – “the center line of the tubular area connecting the starting point S and the end point E of the vessel extraction range is extracted (step S3). Extraction of the center line can be accomplished by applying three-dimensional line-refining processing to the binarized data derived from extraction of the tubular area within the vessel… When the vessel center line is extracted, it becomes possible to define a section perpendicular to the center line at each point on the center line….the image processor 11 prepares, in a real-time manner, and displays, upon each change in section to be displayed along the center line, a corresponding perpendicular sectional image. This is useful for determining the three-dimensional structure of blood vessel such as stenosis”; Note: the center line of the vessel, which is an anatomically relevant path derived from the vessel, is determined. It is relevant to assess the clinical question related to stenosis); and compute, by execution of the slicing algorithm on the image data, slices of the 3D image data that are perpendicular to the anatomically relevant path to provide as display data for assessing the clinical question (Paragraph 0115, 0117 – “When the vessel center line is extracted, it becomes possible to define a section perpendicular to the center line at each point on the center line. This permits display of a flat reformatted image on this surface as a perpendicular sectional image (see FIG. 10B). Particularly, the image processor 11 prepares, in a real-time manner, and displays, upon each change in section to be displayed along the center line, a corresponding perpendicular sectional image. This is useful for determining the three-dimensional structure of blood vessel such as stenosis…The image processor 11 prepares the above-mentioned perpendicular sectional images at slight intervals on the center line, and a three-dimensional volume image is prepared by piling up these images”; Note: the sectional images, which are equivalent to the slices of 3D image data, are computed and are perpendicular to the center line. They are displayed for assessing stenosis. The process of defining perpendicular sections is equivalent to the slicing algorithm). Since Weese teaches using a scanner to access patient image data (Page 8 lines 4-5 – “The client workstation may also be configured to access a patient image e.g. from a scanner”) and also teaches a volumetric image (Page 7 lines 18-20 – “The mesh model may then be adapted to the volumetric image, after which the anatomical regions in the image are identified”), a person of ordinary skill in the art before the effective filing date of the claimed invention would have recognized that the image data of Weese could have been substituted for the 3D image data of Kondo because 3D image data is a type of image data, and both the image data and 3D image data serve the purpose of depicting an anatomical structure of a patient. Furthermore, a person of ordinary skill in the art would have been able to carry out the substitution. Finally, the substitution achieves the predictable result of the data being processed for assessing a clinical question. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the image data of Weese for the 3D image data of Kondo according to known methods to yield the predictable result of the data being processed for assessing a clinical question. It also would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Weese to incorporate the teachings of Kondo to have the selected algorithm be a slicing algorithm because “since a tubular structure such as a blood vessel has a complex shape because of the generally complex three-dimensional complex path, it is difficult to identify the position or the state of a disease such as stenoses and lumps even when observing a pseudo-three-dimensional displayed image (such as a volume-rendering image)” (Kondo: Paragraph 0015). In other words, when the anatomical structure is a tubular, the image alone may not be helpful in answering clinical questions, and thus, performing a slicing algorithm would help reconstruct the structure “for analyzing a tubular structure which permits three-dimensional observation, in a diagnostically useful manner, of a tubular structure (system) such as blood vessels, the intestine, the windpipe, and the esophagus on the basis of three-dimensional imaging data of a patient captured by a diagnostic medical imaging apparatus (medical modality), and quantitative analysis of indices useful for diagnosis, including the thickness (including local changes such as stenoses and lumps) or the length of a tubular structure” (Kondo: Paragraph 0002). The reconstructed structure, as a result of the slicing algorithm, would then align with Weese’s goal of “increased flexibility, cost-effectiveness, and time effectiveness” in assessing clinical questions (Weese: Page 2 lines 16-17). Additionally, 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 Weese to incorporate the teachings of Kondo to determine an anatomically relevant path and compute slices perpendicular to the path because those slices along the path results in an image that, “clearly showing changes in shape such as thickness in the axial direction of the vessel, is useful for observing the three-dimensional shape of the blood vessel from a point of view different from the perpendicular sectional image. Therefore, display of combinations of the perpendicular image and the vessel stretched image as shown in FIGS. 10A and 10B is particularly useful” (Kondo: Paragraph 0118). In other words, using the anatomically relevant path, such as a blood vessel center line, and displaying slices along the path creates a visualization that is helpful for analyzing the structure and calculating measurements, such as for measuring medical concerns like stenoses.
Regarding claim 3, Weese in view of Samset and Kondo teaches the system according to claim 1. Weese does not teach wherein the codified clinical guidelines for a use case define at least one of: anatomical object; metrics regarding relationships between anatomical objects; criteria regarding boundary values of the metrics; or guidance regarding clinical recommendations based on evaluation of the criteria. However, Samset teaches wherein the codified clinical guidelines for a use case define at least one of: anatomical object; metrics regarding relationships between anatomical objects; criteria regarding boundary values of the metrics; or guidance regarding clinical recommendations based on evaluation of the criteria (Paragraph 0035-0036 – “the clinical workflow may inform virtual diagnostic assistant 139 of the potential clinical findings to generate, and virtual diagnostic assistant 139 may identify clinical findings by comparing the clinical parameters generated by virtual parameter assistant 138 to various guidelines, which may include normal ranges of the clinical parameters obtained from published guidelines, research studies, etc… For example, referring to the left ventricle diastolic diameter, virtual diagnostic assistant 139 may compare the measurement of the left ventricle diameter during diastole generated by virtual parameter assistant 138 (e.g., 6.3 cm) to a normal range of left ventricle diastolic diameters for men (e.g., 4.2-5.9 cm) and generate a clinical finding that the left ventricle diastolic diameter is larger than normal”; Note: the clinical guidelines define an anatomical object, which in this case is the ventricle). 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 Weese to incorporate the teachings of Samset to have the clinical guidelines define an anatomical object because it can be used to identify abnormalities in the anatomical object. “By starting with a set of automatically-generated clinical findings and working backwards to the medical images, the process of reviewing a diagnostic imaging exam may be expedited and aspects of the exam prone to error or inconsistencies (e.g., human-to-human variability in taking measurements of features of the images) may be performed in a uniform manner” (Samset: Paragraph 0004).
Regarding claim 4, Weese in view of Samset and Kondo teaches the system according to claim 3. Weese further teaches wherein the processor subsystem comprises an algorithm matching lookup table for selecting the algorithm from the repository based on at least one of: the determined anatomical object; the use case; the codified clinical guidelines; the metrics; the criteria; or the guidance (Page 3 lines 1-5, page 8 lines 29-31 – “The method comprises selecting (51) an acquired image, identifying (52) an anatomical region in the acquired image, selecting (53) a record in a database corresponding to the anatomical region in the acquired image, executing (54) at least one image-processing algorithm associated with the record on the acquired image…The selected image-processing algorithms associated with the set of diagnoses and sample cases, which are located in the medical encyclopedia, may be stored either in the medical encyclopedia or in a memory connected to the system”; Note: while it is not explicitly stated that there is a lookup table, it is implied. There is a database comprising medical records, where the medical records are associated with respective algorithms. In order for the selection unit to pick an algorithm corresponding to a medical record, it is obvious there would be a table to represent the correspondence between the medical record and algorithms).
Regarding claim 6, Weese in view of Samset and Kondo teaches the system according to claim 1. Weese further teaches wherein the processor subsystem is configured to select the algorithm from the repository containing visualization algorithms for visualization of the output data (Page 7 lines 10-11 and 15-20, Page 17 lines 8-9 – “The first, second or third image-processing algorithm may be model-based image segmentation techniques…to detect anatomies in the image, a mesh based image segmentation method may be used. Each organ may be modeled by a mesh model depicting the surface model of the organ. In case of brain, such mesh model may contain parts like left/right cerebral hemispheres, cerebellum and so on. The mesh model may then be adapted to the volumetric image, after which the anatomical regions in the image are identified…a display for displaying the sample image, acquired image, or results from image processing”; Note: a mesh/model-based algorithm can be selected, which is a type of visualization algorithm since it helps show the anatomical structure and is later displayed to the user).
Regarding claim 8, Weese in view of Samset and Kondo teaches the system according to claim 1. Weese further teaches wherein the processor subsystem comprises a natural language processing subsystem for determining at least one of the anatomical object or metrics related to the object based on the use case and the patient data (Page 7 lines 23-27 and 30, Page 8 lines 8-11 – “The system further comprises a query unit 14 configured to prepare or retrieve a search query… The query unit may be a part of graphical user interface allowing the user to indicate or refine the search space, such as for example, search diagnosis exhibiting hypointense signals in the left cerebral hemisphere… the search query may comprise textual input from the user…the search query may be encoded in standard Unified Medical Language System (UMLS), Foundational Model of Anatomy (FMA), or International Classification of Diseases (ICD-10) terms and may be used in search for relevant cases in the medical encyclopedia”; Note: the query unit is a natural language processing subsystem, as it processes text in the natural language into a medical language format. The query unit is used to determine the anatomical object, which in the example is the left cerebral hemisphere), wherein the natural language processing subsystem is configured to process at least one of: clinical guidelines regarding the use case; documents regarding the use case; or documents regarding the clinical question; for identifying anatomical objects or structures, metrics, criteria or guidance relevant for the clinical question (Page 7 lines 23-24 and 30, Page 8 lines 14-15 – “The system further comprises a query unit 14 configured to prepare or retrieve a search query… the search query may comprise textual input from the user…the query unit 14 may be configured to process the search query in the medical encyclopedia, resulting in a set of possible diagnoses and sample cases”; Note: the search query is a document regarding the use case, as it contains text, and it is used to identify diagnoses or sample cases, which are guidance for the clinical question).
Regarding claim 9, Weese in view of Samset and Kondo teaches the system according to claim 1. Weese further teaches wherein the processor subsystem is configured to determine the use case; based on at least one of: detecting an anomaly in the medical image data of an area of the body of the patient; or detecting an anatomical object or structure affected by an anomaly in the medical image data of an area of the body of the patient (Page 5 lines 30-34, Page 6 lines 8-10 – “the system comprises a first processor unit 12 configured to retrieve 12a a user defined region of interest (ROI) on an image of a patient to be analyzed, as is indicated in Fig. 3b. The first processor unit 12 may also be configured to identify 12b a lesion area in the region of interest using a first image-processing algorithm… Knowing the anatomical structure and location will certainly refine the search space of DDx. In this way, the user may indicate the exact 10 15 anatomy of interest, e.g. "find diagnosis that exhibit lesions in the midbrain."”; Note: a lesion, which is an anomaly, is detected in the medical patient image data. Detecting the lesion helps with determining the use case, as it refines the search space); for enabling selecting said algorithm from the repository based on at least one of the detected anomaly or affected anatomical object or affected structure (Page 3 lines 1-5, Page 5 lines 32-33, Page 6 lines 8-10, Page 9 lines 17-19 – “The method comprises selecting (51) an acquired image, identifying (52) an anatomical region in the acquired image, selecting (53) a record in a database corresponding to the anatomical region in the acquired image, executing (54) at least one image-processing algorithm associated with the record on the acquired image… The first processor unit 12 may also be configured to identify 12b a lesion area in the region of interest using a first image-processing algorithm…Knowing the anatomical structure and location will certainly refine the search space of DDx. In this way, the user may indicate the exact 10 15 anatomy of interest… The system may further comprise a second processor unit 15 configured to retrieve (15a) a set of selected image-processing algorithms that are associated with the found set of diagnoses and sample cases”; Note: Detecting the lesion allows for finding medical records related to the lesion, and the medical records are associated with algorithms that can be selected and used on the image). Weese does not teach retrieving the codified clinical guidelines. However, Samset teaches retrieving the codified clinical guidelines (Paragraph 0035 – “the clinical workflow may inform virtual diagnostic assistant 139 of the potential clinical findings to generate, and virtual diagnostic assistant 139 may identify clinical findings by comparing the clinical parameters generated by virtual parameter assistant 138 to various guidelines, which may include normal ranges of the clinical parameters obtained from published guidelines, research studies, etc. In some examples, the normal ranges for the clinical parameters may be adjusted based on patient information (e.g., patient gender, patient age). In other examples, virtual diagnostic assistant 139 may be trained to generate only specific findings for specific patients (e.g., virtual diagnostic assistant 139 may be trained to only generate clinical findings for echocardiograms of adult men)”). 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 Weese to incorporate the teachings of Samset to retrieve clinical guidelines for the use case because it can assist in quickly determining a diagnosis. “By starting with a set of automatically-generated clinical findings and working backwards to the medical images, the process of reviewing a diagnostic imaging exam may be expedited and aspects of the exam prone to error or inconsistencies (e.g., human-to-human variability in taking measurements of features of the images) may be performed in a uniform manner” (Samset: Paragraph 0004).
Regarding claim 12, Weese in view of Samset and Kondo teaches the system according to claim 1. Weese does not teach wherein the slicing algorithm comprises the steps of: selecting a first position on the anatomically relevant path and extract first 3D coordinates of the first position; selecting a second position on the anatomically relevant path at a distance from the first position and extract second 3D coordinates of the second position; calculating a vector from the first position to the second position; computing a slice passing through the first position at an angle perpendicular to the vector. However, Kondo teaches selecting a first position on the anatomically relevant path and extract first 3D coordinates of the first position (Paragraph 0013, 0117, 0171 – “center line of a blood vessel as a sequence of points represented by three-dimensional coordinates…The image processor 11 prepares the above-mentioned perpendicular sectional images at slight intervals on the center line, and a three-dimensional volume image is prepared by piling up these images…When preparing this curved reformatted image, a straight line is first determined, as shown in FIG. 18A, which is perpendicular to the vessel center line and perpendicular to the view vector for each point obtained by dividing the vessel along the vessel center line from point S (leading end point of the extracted vessel) at intervals corresponding to single pixels of the vessel stretched image, and this is used as a first axis of the vessel stretched image”; Note: the first position, point S, on the center line, which is the anatomically relevant path, is selected. Points on the center line are represented as 3D coordinates); selecting a second position on the anatomically relevant path at a distance from the first position and extract second 3D coordinates of the second position (Paragraph 0013, 0171 – “center line of a blood vessel as a sequence of points represented by three-dimensional coordinates… When preparing this curved reformatted image, a straight line is first determined, as shown in FIG. 18A, which is perpendicular to the vessel center line and perpendicular to the view vector for each point obtained by dividing the vessel along the vessel center line from point S (leading end point of the extracted vessel) at intervals corresponding to single pixels of the vessel stretched image, and this is used as a first axis of the vessel stretched image”; Note: the following point on the interval of point S is equivalent to the second position on the center line, which is the anatomically relevant path. Points on the center line are represented as 3D coordinates); calculating a vector from the first position to the second position (Paragraph 0171 – “If the unit tangential vector (directed toward E) of the vessel center line at a point at a distance t along the vessel center line from point S is t, and the view direction vector of a unit size directed toward the depth in the primary screen is v, the vector e directed toward the first axis of the vessel stretched image is calculable as e=t.times.v.”; Note: the vector t is the vector from the first position (point S) to the second position (a following point). It is implied to have already been calculated since it is used for another calculation later on); computing a slice passing through the first position at an angle perpendicular to the vector (Paragraph 0083, 0115, 0117, 0171 – “The image data are typically images (sliced images) of body-axis sections…the image processor 11 prepares, in a real-time manner, and displays, upon each change in section to be displayed along the center line, a corresponding perpendicular sectional image…The image processor 11 prepares the above-mentioned perpendicular sectional images at slight intervals on the center line, and a three-dimensional volume image is prepared by piling up these images…When preparing this curved reformatted image, a straight line is first determined, as shown in FIG. 18A, which is perpendicular to the vessel center line and perpendicular to the view vector for each point obtained by dividing the vessel along the vessel center line from point S (leading end point of the extracted vessel) at intervals corresponding to single pixels of the vessel stretched image, and this is used as a first axis of the vessel stretched image. If the unit tangential vector (directed toward E) of the vessel center line at a point at a distance t along the vessel center line from point S is t, and the view direction vector of a unit size directed toward the depth in the primary screen is v, the vector e directed toward the first axis of the vessel stretched image is calculable as e=t.times.v. The vessel stretched image is prepared by sampling images at equal intervals along this vector, and this image is displayed on the straight view”; Note: a sectional image, which is a slice, is computed through the first position (point S) perpendicular to the vector t. It is obvious that the sectional image is computed through point S because sectional images are sampled and prepared at the intervals, which are defined by the points, starting from point S. Additionally, it is implied that the sectional image is perpendicular to vector t since the image is perpendicular to the center line, and vector t is a tangent vector of the center line). 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 Weese to incorporate the teachings of Kondo to determine an anatomically relevant path by calculating a vector between a first and second position and computing a perpendicular slice because the vector along the path determines the direction the slice should face for alignment, and when this process repeats, it would result in a volume image for better viewing of the anatomical structure: “This is useful for determining the three-dimensional structure of blood vessel such as stenosis…The image processor 11 prepares the above-mentioned perpendicular sectional images at slight intervals on the center line, and a three-dimensional volume image is prepared by piling up these images” (Kondo: Paragraph 0115, 0117). Moreover, it would help deal with anatomical structures of complex shapes: “since a tubular structure such as a blood vessel has a complex shape because of the generally complex three-dimensional complex path, it is difficult to identify the position or the state of a disease such as stenoses and lumps even when observing a pseudo-three-dimensional displayed image (such as a volume-rendering image)” (Kondo: Paragraph 0015), and further Weese’s goal of “increased flexibility, cost-effectiveness, and time effectiveness” in facilitating diagnoses (Weese: Page 2 lines 16-17).
Regarding claim 13, Weese in view of Samset and Kondo teaches the system according to claim 1. Weese futher teaches wherein the processor subsystem is configured: to select an algorithm from the repository for processing medical image data (Page 8 lines 17-25 and 29-31 – “The system may further comprise a second processor unit 15 configured to retrieve (15a) a set of selected image-processing algorithms that are associated with the found set of diagnoses and sample cases, and optionally located on a memory 16 or a selection unit 20. A selected image-processing algorithm may be an algorithm that may be customized from a common IP algorithm and may be adapted to the modality, to the organ and so on. By customized is here meant that the algorithm may be modified particularly for being used on a certain sample image, and the acquired image resulting in parameters that may be used for facilitating diagnosis, or for discrimination between different diagnoses…The selected image-processing algorithms associated with the set of diagnoses and sample cases, which are located in the medical encyclopedia, may be stored either in the medical encyclopedia or in a memory connected to the system”); to execute the algorithm to calculate clinically relevant information (Page 9 lines 6-9 and 19-21, Page 11 lines 1-2 – “the second processor 15 may further be configured to process (15b) the region of interest in the image using the retrieved selected image-processing algorithms to determine at least one diagnosis of the image…the selected image-processing algorithms is configured to calculate e.g. characteristics of lesion properties such as image appearance, or border characteristics in the image to facilitate subsequent diagnosis of the image…the graphical user interface may be visualized on a display for presenting processed information, such as determined diagnoses, etc. to a user”; Note: the selected algorithm is used on the image to output a diagnosis). Weese does not teach the “2D algorithm” and executing the “2D algorithm on a slice” from the limitations: “wherein the processor subsystem is configured: to select a 2D algorithm from the repository for processing medical image data; to execute the 2D algorithm on a slice to calculate clinically relevant information”. However, Kondo teaches a 2D algorithm for processing medical image data (Paragraph 0092-0094 – “The curved reformatted image (see FIG. 3A) is an image obtained by enlarging, over a two-dimensional plane, a grey scale image resulting from cutting of the three-dimensional image by a curved surface expressed as a collection of straight lines perpendicular to the plane of the flat reformatted image, while passing through the points on the center line (thick solid line MK) of the flat reformatted image…Information on the thickness or the like is therefore available throughout the whole range of the vessel by observing the curved reformatted image… The curved reformatted image is thus effective for observing tomographic information of the blood vessel…when the center line of the flat reformatted image is corrected, a curved reformatted image corresponding to the corrected new center line is remade and displayed”; Note: the process of correcting the center line of a flat reformatted image of a blood vessel is a 2D algorithm for processing information about the blood vessel); and executing the 2D algorithm on a slice to calculate clinically relevant information (Paragraph 0083, 0092-0094 – “The image data are typically images (sliced images) of body-axis sections…The curved reformatted image (see FIG. 3A) is an image obtained by enlarging, over a two-dimensional plane, a grey scale image resulting from cutting of the three-dimensional image by a curved surface expressed as a collection of straight lines perpendicular to the plane of the flat reformatted image, while passing through the points on the center line (thick solid line MK) of the flat reformatted image…Information on the thickness or the like is therefore available throughout the whole range of the vessel by observing the curved reformatted image… The curved reformatted image is thus effective for observing tomographic information of the blood vessel…when the center line of the flat reformatted image is corrected, a curved reformatted image corresponding to the corrected new center line is remade and displayed”; Note: the 2D algorithm of correcting the center line of a flat reformatted image of a blood vessel is executed on a flat reformatted image, which is a slice, to calculate clinically relevant information related to the blood vessel). A person of ordinary skill in the art before the effective filing date of the claimed invention would have recognized that the algorithm of Weese could have been substituted for the 2D algorithm of Kondo because both the algorithm and 2D algorithm serve the purpose of processing medical image data. Furthermore, a person of ordinary skill in the art would have been able to carry out the substitution. Finally, the substitution achieves the predictable result of providing medical information based on images. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the algorithm of Weese for the 2D algorithm of Kondo according to known methods to yield the predictable result of providing medical information based on images. Moreover, 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 Weese to incorporate the teachings of Kondo to execute a 2D algorithm on a slice because the algorithm can help improve the visualization of the image for easier medical analysis. For example, “Information on the thickness or the like is therefore available throughout the whole range of the vessel by observing the curved reformatted image. The curved reformatted image is thus effective for observing tomographic information of the blood vessel” (Kondo: Paragraph 0092-0093).
Regarding claim 20, Weese teaches a computer-implemented method for processing medical image data regarding a clinical question (Page 12 lines 29-30, Page 13 lines 8-9 – “a computer-readable medium having embodied thereon a computer program for processing by a computer is provided…method or computer-readable medium is provided for facilitating diagnosis of a region of interest in an image dataset”), the method comprising:
determining a use case regarding the clinical question for a patient based on a user input (Page 7 lines 23-30 – “The system further comprises a query unit 14 configured to prepare or retrieve a search query, such as a search mask, that may be used to search the medical database. In 25 Fig. 3e a search query is defined. The query unit may be a part of graphical user interface allowing the user to indicate or refine the search space, such as for example, search diagnosis exhibiting hypointense signals in the left cerebral hemisphere. The query may e.g. from the user's point of view, look like "search cases that contain hypointense to white matter in the left cerebral hemisphere". In an embodiment the search query may comprise textual input from the user”; Note: the user’s input and search query are the use case. The user is the patient);
retrieving patient data of the patient regarding the use case (Page 8 lines 4-5, Page 11 lines 20-21 – “The client workstation may also be configured to access a patient image e.g. from a scanner or via Picture archiving and communication system (PACS)… the user workstation may be connected to a scanner or PACS system to retrieve the acquired patient image, which is to the analyzed”; Note: patient images are a type of patient data);
retrieving image data of the patient (Page 8 lines 4-5 – “The client workstation may also be configured to access a patient image e.g. from a scanner or via Picture archiving and communication system (PACS)”);
determining an anatomical object based on the use case, the patient data (Page 10 lines 18-20 – “the graphical user interface is configured to enable the user to indicate which anatomy in the acquired patient image that is of interest, e.g. "left 20 cerebral hemisphere", "midbrain", etc. versus "cerebral hemisphere" only”; Note: the anatomical structure is determined based on patient image data and user input/selection, which is part of the use case), and medical information (Page 6 lines 2-4 – “In Fig. 3d the first processor unit has identified the left and right cerebral hemispheres as an anatomical structure. In Fig. 3e the first processor unit has identified the left cerebral hemisphere as an anatomical structure to be queried”; Note: an anatomical object is determined. It is implied that the anatomical object is determined based on medical information because it could not be identified without knowledge of what the anatomical object looks like);
selecting an algorithm from a repository (Page 8 lines 17-25 and 29-31 – “The system may further comprise a second processor unit 15 configured to retrieve (15a) a set of selected image-processing algorithms that are associated with the found set of diagnoses and sample cases, and optionally located on a memory 16 or a selection unit 20. A selected image-processing algorithm may be an algorithm that may be customized from a common IP algorithm and may be adapted to the modality, to the organ and so on. By customized is here meant that the algorithm may be modified particularly for being used on a certain sample image, and the acquired image resulting in parameters that may be used for facilitating diagnosis, or for discrimination between different diagnoses…The selected image-processing algorithms associated with the set of diagnoses and sample cases, which are located in the medical encyclopedia, may be stored either in the medical encyclopedia or in a memory connected to the system”; Note: an algorithm is selected from a memory that stores algorithms, which is equivalent to the repository) based on the determined anatomical object (Page 8 lines 17-25 – “The system may further comprise a second processor unit 15 configured to retrieve (15a) a set of selected image-processing algorithms that are associated with the found set of diagnoses and sample cases, and optionally located on a memory 16 or a selection unit 20. A selected image-processing algorithm may be an algorithm that may be customized from a common IP algorithm and may be adapted to the modality, to the organ and so on. By customized is here meant that the algorithm may be modified particularly for being used on a certain sample image, and the acquired image resulting in parameters that may be used for facilitating diagnosis, or for discrimination between different diagnoses”; Note: an algorithm is selected based on a specific organ).
Weese does not teach retrieving codified clinical guidelines regarding the use case; nor the “codified clinical guidelines” in the limitation: “determining an anatomical object based on the use case, the patient data, and the codified clinical guidelines”. However, Samset teaches retrieving codified clinical guidelines regarding the use case (Paragraph 0035 – “the clinical workflow may inform virtual diagnostic assistant 139 of the potential clinical findings to generate, and virtual diagnostic assistant 139 may identify clinical findings by comparing the clinical parameters generated by virtual parameter assistant 138 to various guidelines, which may include normal ranges of the clinical parameters obtained from published guidelines, research studies, etc. In some examples, the normal ranges for the clinical parameters may be adjusted based on patient information (e.g., patient gender, patient age). In other examples, virtual diagnostic assistant 139 may be trained to generate only specific findings for specific patients (e.g., virtual diagnostic assistant 139 may be trained to only generate clinical findings for echocardiograms of adult men)”). 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 Weese to incorporate the teachings of Samset to retrieve clinical guidelines for the use case because it can assist in quickly determining a diagnosis. “By starting with a set of automatically-generated clinical findings and working backwards to the medical images, the process of reviewing a diagnostic imaging exam may be expedited and aspects of the exam prone to error or inconsistencies (e.g., human-to-human variability in taking measurements of features of the images) may be performed in a uniform manner” (Samset: Paragraph 0004). Additionally, because Weese teaches determining said anatomical object (Page 6 lines 2-4 – “In Fig. 3d the first processor unit has identified the left and right cerebral hemispheres as an anatomical structure. In Fig. 3e the first processor unit has identified the left cerebral hemisphere as an anatomical structure to be queried”; Note: an anatomical object is determined. It is implied that the anatomical object is determined based on medical information because it could not be identified without knowledge of what the anatomical object looks like), a person of ordinary skill in the art before the effective filing date of the claimed invention would have recognized that the medical information of Weese could have been substituted for the clinical guidelines of Samset because clinical guidelines are a type of medical information, and both the medical information and clinical guidelines serve the purpose of informing and contributing to medical decisions. Furthermore, a person of ordinary skill in the art would have been able to carry out the substitution. Finally, the substitution achieves the predictable result of determining an anatomical object based on the clinical guidelines. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the medical information of Weese for the clinical guidelines of Samset according to known methods to yield the predictable result of determining an anatomical object based on the clinical guidelines.
Furthermore, Weese modified by Samset still does not teach wherein the image data comprises three- dimensional (3D) image data; wherein the anatomical object is a 3D object in the 3D image data; wherein the selected algorithm is a slicing algorithm; determining an anatomically relevant path that is derived from the anatomical object and relevant to assess the clinical question; and computing, by execution of the slicing algorithm on the image data, slices of the 3D image data that are perpendicular to the anatomically relevant path to provide as display data for assessing the clinical question. However, Kondo teaches wherein the image data comprises three- dimensional (3D) image data (Paragraph 0077, 0083 – “Three-dimensional (solid-body) image data of a subject collected by a diagnostic imaging apparatus (medical modality), such as an X-ray CT scanner or an MRI, are sent online or offline to the memory unit 12… Image data incorporating the blood vessel to be analyzed by a diagnostic medical imaging apparatus are collected, or three-dimensional image data previously collected in this manner are read in… The image data are typically images (sliced images) of body-axis sections”; Note: the received image data is 3D); wherein the anatomical object is a 3D object in the 3D image data (Paragraph 0083 – “Image data incorporating the blood vessel to be analyzed by a diagnostic medical imaging apparatus are collected, or three-dimensional image data previously collected in this manner are read in…The image data are three-dimensional image data taken over a certain distance in the body axis direction by the use of the helical CT technique. Image data of a different kind, such as image data photographed by an MRI unit or an ultrasonic diagnosing apparatus, are acceptable as long as they are three-dimensional image data containing the vessel to be analyzed”; Note: the anatomical object, which is the blood vessel in this case, is a 3D object in the 3D image data); wherein the selected algorithm is a slicing algorithm (Paragraph 0115 – “When the vessel center line is extracted, it becomes possible to define a section perpendicular to the center line at each point on the center line. This permits display of a flat reformatted image on this surface as a perpendicular sectional image (see FIG. 10B). Particularly, the image processor 11 prepares, in a real-time manner, and displays, upon each change in section to be displayed along the center line, a corresponding perpendicular sectional image. This is useful for determining the three-dimensional structure of blood vessel such as stenosis”; Note: the process of defining perpendicular sections is equivalent to the slicing algorithm); determine an anatomically relevant path that is derived from the anatomical object and relevant to assess the clinical question (Paragraph 0087, 0115 – “the center line of the tubular area connecting the starting point S and the end point E of the vessel extraction range is extracted (step S3). Extraction of the center line can be accomplished by applying three-dimensional line-refining processing to the binarized data derived from extraction of the tubular area within the vessel… When the vessel center line is extracted, it becomes possible to define a section perpendicular to the center line at each point on the center line….the image processor 11 prepares, in a real-time manner, and displays, upon each change in section to be displayed along the center line, a corresponding perpendicular sectional image. This is useful for determining the three-dimensional structure of blood vessel such as stenosis”; Note: the center line of the vessel, which is an anatomically relevant path derived from the vessel, is determined. It is relevant to assess the clinical question related to stenosis); and compute, by execution of the slicing algorithm on the image data, slices of the 3D image data that are perpendicular to the anatomically relevant path to provide as display data for assessing the clinical question (Paragraph 0115, 0117 – “When the vessel center line is extracted, it becomes possible to define a section perpendicular to the center line at each point on the center line. This permits display of a flat reformatted image on this surface as a perpendicular sectional image (see FIG. 10B). Particularly, the image processor 11 prepares, in a real-time manner, and displays, upon each change in section to be displayed along the center line, a corresponding perpendicular sectional image. This is useful for determining the three-dimensional structure of blood vessel such as stenosis…The image processor 11 prepares the above-mentioned perpendicular sectional images at slight intervals on the center line, and a three-dimensional volume image is prepared by piling up these images”; Note: the sectional images, which are equivalent to the slices of 3D image data, are computed and are perpendicular to the center line. They are displayed for assessing stenosis. The process of defining perpendicular sections is equivalent to the slicing algorithm). Since Weese teaches using a scanner to access patient image data (Page 8 lines 4-5 – “The client workstation may also be configured to access a patient image e.g. from a scanner”) and also teaches a volumetric image (Page 7 lines 18-20 – “The mesh model may then be adapted to the volumetric image, after which the anatomical regions in the image are identified”), a person of ordinary skill in the art before the effective filing date of the claimed invention would have recognized that the image data of Weese could have been substituted for the 3D image data of Kondo because 3D image data is a type of image data, and both the image data and 3D image data serve the purpose of depicting an anatomical structure of a patient. Furthermore, a person of ordinary skill in the art would have been able to carry out the substitution. Finally, the substitution achieves the predictable result of the data being processed for assessing a clinical question. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the image data of Weese for the 3D image data of Kondo according to known methods to yield the predictable result of the data being processed for assessing a clinical question. It also would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Weese to incorporate the teachings of Kondo to have the selected algorithm be a slicing algorithm because “since a tubular structure such as a blood vessel has a complex shape because of the generally complex three-dimensional complex path, it is difficult to identify the position or the state of a disease such as stenoses and lumps even when observing a pseudo-three-dimensional displayed image (such as a volume-rendering image)” (Kondo: Paragraph 0015). In other words, when the anatomical structure is a tubular, the image alone may not be helpful in answering clinical questions, and thus, performing a slicing algorithm would help reconstruct the structure “for analyzing a tubular structure which permits three-dimensional observation, in a diagnostically useful manner, of a tubular structure (system) such as blood vessels, the intestine, the windpipe, and the esophagus on the basis of three-dimensional imaging data of a patient captured by a diagnostic medical imaging apparatus (medical modality), and quantitative analysis of indices useful for diagnosis, including the thickness (including local changes such as stenoses and lumps) or the length of a tubular structure” (Kondo: Paragraph 0002). The reconstructed structure, as a result of the slicing algorithm, would then align with Weese’s goal of “increased flexibility, cost-effectiveness, and time effectiveness” in assessing clinical questions (Weese: Page 2 lines 16-17). Additionally, 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 Weese to incorporate the teachings of Kondo to determine an anatomically relevant path and compute slices perpendicular to the path because those slices along the path results in an image that, “clearly showing changes in shape such as thickness in the axial direction of the vessel, is useful for observing the three-dimensional shape of the blood vessel from a point of view different from the perpendicular sectional image. Therefore, display of combinations of the perpendicular image and the vessel stretched image as shown in FIGS. 10A and 10B is particularly useful” (Kondo: Paragraph 0118). In other words, using the anatomically relevant path, such as a blood vessel center line, and displaying slices along the path creates a visualization that is helpful for analyzing the structure and calculating measurements, such as for measuring medical concerns like stenoses.
Regarding claim 21, Weese teaches a non-transitory computer-readable medium comprising instructions which, when executed by a processor (Page 3 lines 6-7, Page 13 lines 16-17 and 24-26 – “a computer-readable medium having embodied thereon a computer program for processing by a processor is provided…The processor unit may be any unit normally used for performing the involved tasks, e.g. a hardware, such as a processor with a memory…The memory may also be a FLASH memory such as a USB, Compact Flash, SmartMedia, MMC 25 memory, MemoryStick, SD Card, MiniSD, MicroSD, xD Card, TransFlash, and MicroDrive memory etc.”; Note: flash memory is a type of non-transitory computer-readable medium), cause the processor to:
determine a use case regarding the clinical question for a patient based on a user input (Page 7 lines 23-30 – “The system further comprises a query unit 14 configured to prepare or retrieve a search query, such as a search mask, that may be used to search the medical database. In 25 Fig. 3e a search query is defined. The query unit may be a part of graphical user interface allowing the user to indicate or refine the search space, such as for example, search diagnosis exhibiting hypointense signals in the left cerebral hemisphere. The query may e.g. from the user's point of view, look like "search cases that contain hypointense to white matter in the left cerebral hemisphere". In an embodiment the search query may comprise textual input from the user”; Note: the user’s input and search query are the use case. The user is the patient);
retrieve patient data of the patient regarding the use case (Page 8 lines 4-5, Page 11 lines 20-21 – “The client workstation may also be configured to access a patient image e.g. from a scanner or via Picture archiving and communication system (PACS)… the user workstation may be connected to a scanner or PACS system to retrieve the acquired patient image, which is to the analyzed”; Note: patient images are a type of patient data);
retrieve image data of the patient (Page 8 lines 4-5 – “The client workstation may also be configured to access a patient image e.g. from a scanner or via Picture archiving and communication system (PACS)”);
determine an anatomical object based on the use case, the patient data (Page 10 lines 18-20 – “the graphical user interface is configured to enable the user to indicate which anatomy in the acquired patient image that is of interest, e.g. "left 20 cerebral hemisphere", "midbrain", etc. versus "cerebral hemisphere" only”; Note: the anatomical structure is determined based on patient image data and user input/selection, which is part of the use case), and medical information (Page 6 lines 2-4 – “In Fig. 3d the first processor unit has identified the left and right cerebral hemispheres as an anatomical structure. In Fig. 3e the first processor unit has identified the left cerebral hemisphere as an anatomical structure to be queried”; Note: an anatomical object is determined. It is implied that the anatomical object is determined based on medical information because it could not be identified without knowledge of what the anatomical object looks like);
select an algorithm from a repository (Page 8 lines 17-25 and 29-31 – “The system may further comprise a second processor unit 15 configured to retrieve (15a) a set of selected image-processing algorithms that are associated with the found set of diagnoses and sample cases, and optionally located on a memory 16 or a selection unit 20. A selected image-processing algorithm may be an algorithm that may be customized from a common IP algorithm and may be adapted to the modality, to the organ and so on. By customized is here meant that the algorithm may be modified particularly for being used on a certain sample image, and the acquired image resulting in parameters that may be used for facilitating diagnosis, or for discrimination between different diagnoses…The selected image-processing algorithms associated with the set of diagnoses and sample cases, which are located in the medical encyclopedia, may be stored either in the medical encyclopedia or in a memory connected to the system”; Note: an algorithm is selected from a memory that stores algorithms, which is equivalent to the repository) based on the determined anatomical object (Page 8 lines 17-25 – “The system may further comprise a second processor unit 15 configured to retrieve (15a) a set of selected image-processing algorithms that are associated with the found set of diagnoses and sample cases, and optionally located on a memory 16 or a selection unit 20. A selected image-processing algorithm may be an algorithm that may be customized from a common IP algorithm and may be adapted to the modality, to the organ and so on. By customized is here meant that the algorithm may be modified particularly for being used on a certain sample image, and the acquired image resulting in parameters that may be used for facilitating diagnosis, or for discrimination between different diagnoses”; Note: an algorithm is selected based on a specific organ).
Weese does not teach retrieving codified clinical guidelines regarding the use case; nor the “codified clinical guidelines” in the limitation: “determine an anatomical object based on the use case, the patient data, and the codified clinical guidelines”. However, Samset teaches retrieving codified clinical guidelines regarding the use case (Paragraph 0035 – “the clinical workflow may inform virtual diagnostic assistant 139 of the potential clinical findings to generate, and virtual diagnostic assistant 139 may identify clinical findings by comparing the clinical parameters generated by virtual parameter assistant 138 to various guidelines, which may include normal ranges of the clinical parameters obtained from published guidelines, research studies, etc. In some examples, the normal ranges for the clinical parameters may be adjusted based on patient information (e.g., patient gender, patient age). In other examples, virtual diagnostic assistant 139 may be trained to generate only specific findings for specific patients (e.g., virtual diagnostic assistant 139 may be trained to only generate clinical findings for echocardiograms of adult men)”). 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 Weese to incorporate the teachings of Samset to retrieve clinical guidelines for the use case because it can assist in quickly determining a diagnosis. “By starting with a set of automatically-generated clinical findings and working backwards to the medical images, the process of reviewing a diagnostic imaging exam may be expedited and aspects of the exam prone to error or inconsistencies (e.g., human-to-human variability in taking measurements of features of the images) may be performed in a uniform manner” (Samset: Paragraph 0004). Additionally, because Weese teaches determining said anatomical object (Page 6 lines 2-4 – “In Fig. 3d the first processor unit has identified the left and right cerebral hemispheres as an anatomical structure. In Fig. 3e the first processor unit has identified the left cerebral hemisphere as an anatomical structure to be queried”; Note: an anatomical object is determined. It is implied that the anatomical object is determined based on medical information because it could not be identified without knowledge of what the anatomical object looks like), a person of ordinary skill in the art before the effective filing date of the claimed invention would have recognized that the medical information of Weese could have been substituted for the clinical guidelines of Samset because clinical guidelines are a type of medical information, and both the medical information and clinical guidelines serve the purpose of informing and contributing to medical decisions. Furthermore, a person of ordinary skill in the art would have been able to carry out the substitution. Finally, the substitution achieves the predictable result of determining an anatomical object based on the clinical guidelines. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the medical information of Weese for the clinical guidelines of Samset according to known methods to yield the predictable result of determining an anatomical object based on the clinical guidelines.
Furthermore, Weese modified by Samset still does not teach wherein the image data comprises three- dimensional (3D) image data; wherein the anatomical object is a 3D object in the 3D image data; wherein the selected algorithm is a slicing algorithm; determine an anatomically relevant path that is derived from the anatomical object and relevant to assess the clinical question; and compute, by execution of the slicing algorithm on the image data, slices of the 3D image data that are perpendicular to the anatomically relevant path to provide as display data for assessing the clinical question. However, Kondo teaches wherein the image data comprises three- dimensional (3D) image data (Paragraph 0077, 0083 – “Three-dimensional (solid-body) image data of a subject collected by a diagnostic imaging apparatus (medical modality), such as an X-ray CT scanner or an MRI, are sent online or offline to the memory unit 12… Image data incorporating the blood vessel to be analyzed by a diagnostic medical imaging apparatus are collected, or three-dimensional image data previously collected in this manner are read in… The image data are typically images (sliced images) of body-axis sections”; Note: the received image data is 3D); wherein the anatomical object is a 3D object in the 3D image data (Paragraph 0083 – “Image data incorporating the blood vessel to be analyzed by a diagnostic medical imaging apparatus are collected, or three-dimensional image data previously collected in this manner are read in…The image data are three-dimensional image data taken over a certain distance in the body axis direction by the use of the helical CT technique. Image data of a different kind, such as image data photographed by an MRI unit or an ultrasonic diagnosing apparatus, are acceptable as long as they are three-dimensional image data containing the vessel to be analyzed”; Note: the anatomical object, which is the blood vessel in this case, is a 3D object in the 3D image data); wherein the selected algorithm is a slicing algorithm (Paragraph 0115 – “When the vessel center line is extracted, it becomes possible to define a section perpendicular to the center line at each point on the center line. This permits display of a flat reformatted image on this surface as a perpendicular sectional image (see FIG. 10B). Particularly, the image processor 11 prepares, in a real-time manner, and displays, upon each change in section to be displayed along the center line, a corresponding perpendicular sectional image. This is useful for determining the three-dimensional structure of blood vessel such as stenosis”; Note: the process of defining perpendicular sections is equivalent to the slicing algorithm); determine an anatomically relevant path that is derived from the anatomical object and relevant to assess the clinical question (Paragraph 0087, 0115 – “the center line of the tubular area connecting the starting point S and the end point E of the vessel extraction range is extracted (step S3). Extraction of the center line can be accomplished by applying three-dimensional line-refining processing to the binarized data derived from extraction of the tubular area within the vessel… When the vessel center line is extracted, it becomes possible to define a section perpendicular to the center line at each point on the center line….the image processor 11 prepares, in a real-time manner, and displays, upon each change in section to be displayed along the center line, a corresponding perpendicular sectional image. This is useful for determining the three-dimensional structure of blood vessel such as stenosis”; Note: the center line of the vessel, which is an anatomically relevant path derived from the vessel, is determined. It is relevant to assess the clinical question related to stenosis); and compute, by execution of the slicing algorithm on the image data, slices of the 3D image data that are perpendicular to the anatomically relevant path to provide as display data for assessing the clinical question (Paragraph 0115, 0117 – “When the vessel center line is extracted, it becomes possible to define a section perpendicular to the center line at each point on the center line. This permits display of a flat reformatted image on this surface as a perpendicular sectional image (see FIG. 10B). Particularly, the image processor 11 prepares, in a real-time manner, and displays, upon each change in section to be displayed along the center line, a corresponding perpendicular sectional image. This is useful for determining the three-dimensional structure of blood vessel such as stenosis…The image processor 11 prepares the above-mentioned perpendicular sectional images at slight intervals on the center line, and a three-dimensional volume image is prepared by piling up these images”; Note: the sectional images, which are equivalent to the slices of 3D image data, are computed and are perpendicular to the center line. They are displayed for assessing stenosis. The process of defining perpendicular sections is equivalent to the slicing algorithm). Since Weese teaches using a scanner to access patient image data (Page 8 lines 4-5 – “The client workstation may also be configured to access a patient image e.g. from a scanner”) and also teaches a volumetric image (Page 7 lines 18-20 – “The mesh model may then be adapted to the volumetric image, after which the anatomical regions in the image are identified”), a person of ordinary skill in the art before the effective filing date of the claimed invention would have recognized that the image data of Weese could have been substituted for the 3D image data of Kondo because 3D image data is a type of image data, and both the image data and 3D image data serve the purpose of depicting an anatomical structure of a patient. Furthermore, a person of ordinary skill in the art would have been able to carry out the substitution. Finally, the substitution achieves the predictable result of the data being processed for assessing a clinical question. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the image data of Weese for the 3D image data of Kondo according to known methods to yield the predictable result of the data being processed for assessing a clinical question. It also would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Weese to incorporate the teachings of Kondo to have the selected algorithm be a slicing algorithm because “since a tubular structure such as a blood vessel has a complex shape because of the generally complex three-dimensional complex path, it is difficult to identify the position or the state of a disease such as stenoses and lumps even when observing a pseudo-three-dimensional displayed image (such as a volume-rendering image)” (Kondo: Paragraph 0015). In other words, when the anatomical structure is a tubular, the image alone may not be helpful in answering clinical questions, and thus, performing a slicing algorithm would help reconstruct the structure “for analyzing a tubular structure which permits three-dimensional observation, in a diagnostically useful manner, of a tubular structure (system) such as blood vessels, the intestine, the windpipe, and the esophagus on the basis of three-dimensional imaging data of a patient captured by a diagnostic medical imaging apparatus (medical modality), and quantitative analysis of indices useful for diagnosis, including the thickness (including local changes such as stenoses and lumps) or the length of a tubular structure” (Kondo: Paragraph 0002). The reconstructed structure, as a result of the slicing algorithm, would then align with Weese’s goal of “increased flexibility, cost-effectiveness, and time effectiveness” in assessing clinical questions (Weese: Page 2 lines 16-17). Additionally, 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 Weese to incorporate the teachings of Kondo to determine an anatomically relevant path and compute slices perpendicular to the path because those slices along the path results in an image that, “clearly showing changes in shape such as thickness in the axial direction of the vessel, is useful for observing the three-dimensional shape of the blood vessel from a point of view different from the perpendicular sectional image. Therefore, display of combinations of the perpendicular image and the vessel stretched image as shown in FIGS. 10A and 10B is particularly useful” (Kondo: Paragraph 0118). In other words, using the anatomically relevant path, such as a blood vessel center line, and displaying slices along the path creates a visualization that is helpful for analyzing the structure and calculating measurements, such as for measuring medical concerns like stenoses.
Claims 7, 15-16, and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Weese in view of Samset, Kondo, and Shukla (US 20110161854 A1), hereinafter Shukla.
Regarding claim 7, Weese in view of Samset and Kondo teaches the system according to claim 6. Weese does not teach wherein the processor subsystem comprises a layout rendering and interaction manager for selecting a visualization algorithm matching the output data as provided by the analytic algorithms for assessing the clinical question. However, Shukla teaches a layout rendering and interaction manager for selecting a visualization algorithm matching the output data as provided by the analytic algorithms for assessing the clinical question (Paragraph 0027, 0043, 0046 – “By selecting a view and/or indicator of data within a view, a detailed view is generated to convey information regarding diagnosis, treatment, medication, physician specialist, time frame, etc…Each presentation pane can have its different context sensitive graphical user interface ("GUI") controls…Graphical and/or overlay elements of each of presentation panes can be clickable and/or otherwise selectable resulting in a certain action happening upon clicking or selecting an element, thus being a special sort of interactive controls…A user can select a tab 120 for review and access to included information via the manager interface 100.”; Note: the manager interface is equivalent to the layout rendering and interaction manager. A user can select a view/visualization, which will then render/display the corresponding layout of clinical information. The output data provided by the analytic algorithm was previously taught by Weese in the rejection of claim 1).
Regarding claim 15, Weese in view of Samset and Kondo teaches the system according to claim 1. Weese further teaches wherein the selected algorithm is an analytical algorithm arranged to analyse the image data for generating a 3D anatomical model, anatomical annotations or metrics regarding the anatomical object (Page 7 lines 15-20 – “to detect anatomies in the image, a mesh based image segmentation method may be used. Each organ may be modeled by a mesh model depicting the surface model of the organ. In case of brain, such mesh model may contain parts like left/right cerebral hemispheres, cerebellum and so on. The mesh model may then be adapted to the volumetric image, after which the anatomical regions in the image are identified”; Note: a mesh model of the organ, which is equivalent to a 3D anatomical model, is generated using a mesh-based image segmentation algorithm; the algorithm is analytical). Weese does not teach further comprising a display, wherein the display comprises a 2D view for displaying a guidance panel showing at least one of the anatomical annotations, metrics, codified clinical guidelines or a slice of the medical image data, and a 3D view for displaying the 3D anatomical model; wherein the processor subsystem is configured to synchronize the 3D view upon user input regarding the 2D view; or to synchronize the 2D view upon user input regarding the 3D view. However, Shukla teaches a display comprising a 2D view for displaying a guidance panel showing at least one of the anatomical annotations, metrics, codified clinical guidelines or a slice of the medical image data, and a 3D view for displaying the 3D anatomical model (Fig. 1, Paragraph 0047-0048, 0051 – “Views can provide 2D and/or 3D anatomical views based on actual image(s) and/or idealized anatomical representations, for example. Within each view 131-134 (and/or a composite view), one or more indicators 135-139 can be shown indicating medical data associated with the patient. For example, the anatomy representation 131-134 can include a graphical indication of findings and/or other events/conditions for the patient, areas of image data for the patient, and/or other information… The manager 100 also includes one or more additional expandable windows including, for example, one or more of allergies 160, lab results 161, radiology 162, demographics 163, medications 164, problems 165, orders 166, alert review 167, etc.”; Note: Fig. 1 shows a 3D view of a 3D anatomical model of the patient on the left side and a 2D view of textual information guiding the patient on their metrics on the right side; see modified screenshot of Fig. 1 below); wherein the processor subsystem is configured to synchronize the 3D view upon user input regarding the 2D view; or to synchronize the 2D view upon user input regarding the 3D view (Paragraph 0042, 0054 – “Content of the presentation panes can be synchronized between any two or more panes as part of a customization pattern, and/or by explicit choice of an operator, for example. For purposes of example only, selection of an anatomical region (e.g., an abdominal region) on anatomical presentation pane automatically reduces a list of historical exams to only those prior exams targeted to the selected anatomical part… the representation 131-134 can be a 3D representation of a body, certain body part”; Note: the 2D view of the historical exams are synchronized to the selection of an anatomical region on the 3D anatomical structure of the patient. The historical exams are implied to be part of the 2D view, as they are textual information). 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 Weese to incorporate the teachings of Shukla to have a 2D view, in order “to help various end users of the system to explain diagnosis and/or treatment (e.g., between a patient who is visiting a second time and a nurse, between a physician/surgeon and a patient, etc.), explore a solution for a medical procedure (e.g., between two surgeons deciding on a medical procedure), maintain a visual history of a patient's health (e.g., hospital systems), etc.” (Shukla: Paragraph 0028). In other words, a 2D view provides text information to help users understand a medical condition. It also would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Weese to incorporate the teachings of Shukla to have a 3D view because “The anatomical system views) can be used as a solution for various end users, such as between a patient and a triage nurse to understand the patient's present health condition, past health history, and pending a health condition which was diagnosed but not treated; for a surgeon to explore multiple medical procedures on a patient 3D visualization; between a surgeon and a patient to explain the related medical procedure which will be conducted on patient; etc. The views) can form a visual part of an enterprise solution system, for example” (Shukla: Paragraph 0024). In other words, a 3D view provides a clear visualization of a patient’s health. Finally, 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 Weese to incorporate the teachings of Shukla top synchronize the 2D and 3D view for the benefit of being able to use the views together, so that they can supplement each other. This would enhance the user experience and increase their understanding of the condition.
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Screenshot of Fig. 1 (taken from Shukla)
Regarding claim 16, Weese in view of Samset, Kondo, and Shukla teaches the system according to claim 15. Weese does not teach wherein the processor subsystem is configured to synchronize a 3D viewpoint with respect to the 3D model upon user interaction in the 2D view comprising one of manipulating a cursor position in a slice; selecting anatomical annotations, the metrics or the codified clinical guidelines in the guidance panel; or to synchronize the 2D view upon change of a 3D cursor position in the 3D view by displaying a slice, anatomical annotations or metrics corresponding to the 3D cursor position. However, Shukla teaches synchronizing a 3D viewpoint with respect to the 3D model upon user interaction in the 2D view comprising one of manipulating a cursor position in a slice; selecting anatomical annotations, the metrics or the codified clinical guidelines in the guidance panel (Fig. 1, Paragraph 0031, 0049 – “Information can be input to update the views and associated data. For example, 3D skeletal analysis information from a 3D digitizer can be input to display a 3D view of the patient's body with different systems identified…For example, the musculature view 131 can include a cataract indicator 135 and a shoulder muscle indicator 136. The skeletal representation 132 can include a collar bone fracture 137 and an osteoarthritis indicator 138. The circulatory view 133 can include a coronary artery blockage indicator 139, for example. By selecting a system view 131-134 and/or an indicator 135-139, a user can drill down or retrieve addition information and/or views”; Note: a user selects an indicator, which is an anatomical annotation as shown in Fig. 1, which retrieves additional 3D views; see screenshot of Fig. 1 above. In other words, the user interaction in the 2D view with the indicator causes a corresponding change in the 3D portion of the display, which is interpreted as synchronization); or synchronizing the 2D view upon change of a 3D cursor position in the 3D view by displaying a slice, anatomical annotations or metrics corresponding to the 3D cursor position (Paragraph 0042, 0054 – “Content of the presentation panes can be synchronized between any two or more panes as part of a customization pattern, and/or by explicit choice of an operator, for example. For purposes of example only, selection of an anatomical region (e.g., an abdominal region) on anatomical presentation pane automatically reduces a list of historical exams to only those prior exams targeted to the selected anatomical part… the representation 131-134 can be a 3D representation of a body, certain body part”; Note: the 2D view of the historical exams are synchronized to the selection of an anatomical region on the 3D anatomical structure of the patient. The historical exams, which are metrics, are implied to be part of the 2D view, as they are textual information). 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 Weese to incorporate the teachings of Shukla top synchronize the 2D and 3D view for the benefit of being able to use the views together, so that they can supplement each other. This would enhance the user experience and increase their understanding of the condition.
Regarding claim 18, Weese in view of Samset, Kondo, and Shukla teaches the system according to claim 15. Weese does not teach wherein the processor subsystem is configured to display the 3D anatomical model while at least one of: removing non-relevant structures from the 3D model based on the use case; making the anatomical object transparent; choosing a viewpoint that shows a suitable angle to evaluate a tumor-vessel contact; making a footprint visible to clarify the area of contact and trajectory length of a tumor-vessel contact; or adapting lighting settings for the 3D model visualization to highlight the tumor- vessel contact. However, Shukla teaches displaying the 3D anatomical model while at least one of: removing non-relevant structures from the 3D model based on the use case; making the anatomical object transparent; choosing a viewpoint that shows a suitable angle to evaluate a tumor-vessel contact; making a footprint visible to clarify the area of contact and trajectory length of a tumor-vessel contact; or adapting lighting settings for the 3D model visualization to highlight the tumor- vessel contact (Fig. 1, Paragraph 0024, 0047 – “Certain examples provide systems and methods to display a three-dimensional (3D) view of the body with different systems shadowed, emphasized, or highlighted. The view can provide a composite shadowed view of all body systems together for a patient and can be used across a treatment timeline, such as a complete duration of a patient's stay in a hospital through various stages. The composite view can be separated into its component anatomical system views (e.g., circulatory, skeletal, organ, etc.), for example. The anatomical system views) can be used as a solution for various end users, such as between a patient and a triage nurse to understand the patient's present health condition…the anatomical views 131-134 can be combined into a single composite view from which the individual body system views 131-134 can be separated or isolated for viewing, for example. The anatomical views include a musculature system view 131, a skeletal system view 132, a circulatory system view 133, and an organ system view 134, for example. Views can provide 2D and/or 3D anatomical views based on actual image(s) and/or idealized anatomical representations”; Note: a 3D anatomical model is displayed and is isolated by the anatomical system based on the patient’s health condition. In other words, only the relevant anatomical system is shown). 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 Weese to incorporate the teachings of Shukla to display the 3D anatomical model with irrelevant structures removed for the benefit of user-friendly viewing options and allowing the user to focus on a specific health problem, which may help with better understanding the condition.
Regarding claim 19, Weese in view of Samset and Kondo teaches the system according to claim 1. Weese does not teach the system comprising the display having a 2D display for displaying a guidance panel showing at least one of anatomical annotations, the metrics, the codified clinical guidelines or a slice of the medical image data, and a 3D display for displaying a 3D anatomical model of the anatomical object. However, Shukla teaches the display having a 2D display for displaying a guidance panel showing at least one of anatomical annotations, the metrics, the codified clinical guidelines or a slice of the medical image data (Fig. 1, Paragraph 0051 – “The manager 100 also includes one or more additional expandable windows including, for example, one or more of allergies 160, lab results 161, radiology 162, demographics 163, medications 164, problems 165, orders 166, alert review 167, etc.”; Note: Fig. 1 shows a 2D view, including 160-169, of textual information guiding the patient on their metrics; see modified screenshot of Fig. 1 above), and a 3D display for displaying a 3D anatomical model of the anatomical object (Fig. 1, Paragraph 0054 – “The anatomic representation(s) 131-134…can be a 3D representation of a body, certain body part, etc.”; Note: Fig. 1 shows a 3D view of a 3D anatomical model of the patient on the left side; see modified screenshot of Fig. 1 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 Weese to incorporate the teachings of Shukla to have a 2D view, in order “to help various end users of the system to explain diagnosis and/or treatment (e.g., between a patient who is visiting a second time and a nurse, between a physician/surgeon and a patient, etc.), explore a solution for a medical procedure (e.g., between two surgeons deciding on a medical procedure), maintain a visual history of a patient's health (e.g., hospital systems), etc.” (Shukla: Paragraph 0028). In other words, a 2D view provides text information to help users understand a medical condition. It also would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Weese to incorporate the teachings of Shukla to have a 3D view because “The anatomical system views) can be used as a solution for various end users, such as between a patient and a triage nurse to understand the patient's present health condition, past health history, and pending a health condition which was diagnosed but not treated; for a surgeon to explore multiple medical procedures on a patient 3D visualization; between a surgeon and a patient to explain the related medical procedure which will be conducted on patient; etc. The views) can form a visual part of an enterprise solution system, for example” (Shukla: Paragraph 0024). In other words, a 3D view provides a clear visualization of a patient’s health.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Weese in view of Samset, Kondo, and Liang et al. (US 20100316268 A1), hereinafter Liang.
Regarding claim 10, Weese in view of Samset and Kondo teaches the system according to claim 1. Weese does not teach wherein the use case is treatability based on the relation of a lesion with surrounding anatomical structures; or resectability of tumors in the vicinity of blood vessels. However, Liang teaches wherein the use case is treatability based on the relation of a lesion with surrounding anatomical structures; or resectability of tumors in the vicinity of blood vessels (Paragraph 0005-0006 – “Liver tumor resection can be an efficient treatment method for addressing liver cancer. Before surgery, physicians need to carefully evaluate a hepatic lesion or tumor to be re-sectioned, the volume of the expected remaining liver segments, how a proposed resection is going to affect nearby vascular structures and corresponding blood supply/drainage regions, and how the resection will affect biliary systems… During the planning stage, a surgeon has to understand the spatial relationships between tumors and surrounding vessel structures”). 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 Weese to incorporate the teachings of Liang to have the use case be treatability based on the relation of a lesion with surrounding anatomical structures because the relation of a lesion with surrounding anatomical structures can determine if the lesion can be removed or not (Liang: Paragraph 0005-0006), and removing lesions is one of the treatments for cancer. If the use case is related to cancer, then it is important to consider how close the lesion is with nearby structures to avoid removing or damaging healthy cells during treatment.
Claims 14 are rejected under 35 U.S.C. 103 as being unpatentable over Weese in view of Samet, Kondo, and Gindele et al. (US 20090279756 A1), hereinafter Gindele.
Regarding claim 14, Weese in view of Samset and Kondo teaches the system according to claim 1. Weese does not teach wherein the anatomically relevant path is determined along an interface of the 3D object and a further anatomical structure. However, Gindele teaches wherein the anatomically relevant path is determined along an interface of the 3D object and a further anatomical structure (Paragraph 0041 – “The image-editing algorithm constructs a cutting plane in 3-dimensional space that includes the edit point 205 shown in FIG. 2. Line 206, shown in FIG. 3, is the projection of that 3-dimensional cutting plane. The cutting plane is used to divide the lesion region 204 (shown in FIG. 2) into two parts; potential lesion region 207 and potential vessel region 208. This division of the original lesion region 204 is performed in a 3-dimensional sense, i.e. the region is divided as a 3-dimensional object”; Note: the anatomically relevant path, shown by the line 206 in Fig. 3, is determined as a cutting plane, which is an interface of the 3D object of the lesion and the 3D object of the vessel; see screenshot of Fig. 3 below).
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Screenshot of Fig. 3 (taken from Gindele)
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 Weese to incorporate the teachings of Gindele to have the path be along an interface of the 3D object and another anatomical structure. In Kondo, the path was intended for better viewing of the tubuar structure (like a blood vessel), but in cases like in Weese where there is a lesion (Page 10 lines 19-21), it would be beneficial to have the path be along the interface of the lesion and surrounding objects to have better viewing of the lesion for determining its properties and making a diagnosis.
Claims 17 are rejected under 35 U.S.C. 103 as being unpatentable over Weese in view of Samset, Kondo, Shukla, and Liang.
Regarding claim 17, Weese in view of Samset, Kondo, and Shukla teaches the system according to claim 15. Weese does not teach wherein the processor subsystem is configured: to open an interactive display panel showing involvement of a tumor with the anatomical object and metrics regarding the involvement, or metrics regarding the involvement per slice; and to synchronize the interactive display panel, the 2D view and the 3D view. However, Liang teaches opening an interactive display panel showing involvement of a tumor with the anatomical object and metrics regarding the involvement, or metrics regarding the involvement per slice (Paragraph 0040-0041 – “An exemplary embodiment for enabling a user to define a safety margin will now be described, with reference to FIG. 2a, which shows a representation of a safety margin indicator 201 surrounding a lesion or tumor 204 of an anatomical structure 205 (e.g., a liver), depicted in 3D space (i.e., in region 102 of FIG. 1). A safety margin can be useful to define an area for resection, for example, that includes both the lesion or tumor 204 and an additional buffer area around it for additional precautionary reasons…the size and shape of the safety margin indicator 201 can be specified and adjusted by the user 821 by way of a user interface”; Note: there is an interactive display (user interface) for showing a tumor, surrounding anatomical objects, and a safety indicator, which is a type of metric regarding the involvement of the tumor and the other anatomical objects); and to synchronize the interactive display panel, the 2D view and the 3D view (Fig. 1, Paragraph 0040-0041 – “An exemplary embodiment for enabling a user to define a safety margin will now be described, with reference to FIG. 2a, which shows a representation of a safety margin indicator 201 surrounding a lesion or tumor 204 of an anatomical structure 205 (e.g., a liver), depicted in 3D space (i.e., in region 102 of FIG. 1)…the size and shape of the safety margin indicator 201 can be specified and adjusted by the user 821 by way of a user interface… The safety margin indicator 201 is displayable in both 3D and 2D in the regions 102 and 103, respectively, and the size, shape, and/or location of the indicator 201, where adjusted by the user (via, e.g., the user interface 804), are updated in the display region(s) substantially instantaneously by the system 800”; Note: edits by the user are updated in the display. This means that the interactive display panel, which is the user interface, is synchronized with the 2D view and 3D view in regions 102 and 103 respectively, in Fig. 1). 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 Weese to incorporate the teachings of Liang to have an interactive display panel showing a tumor with an anatomical object and their metrics because “The foregoing capabilities for adjusting the safety margin indicator 201 can be beneficial when, for example, multiple lesions/tumors, requiring differently sized and/or shaped safety margin indicators, are to be re-sectioned in a single operative setting. Real time visual feedback provided by the system 800 is especially useful when the user interactively adjusts the size or the like of the safety margin indicator 201 as described above” (Liang: paragraph 0041). In other words, displaying a tumor in its own interactive panel provides different views and annotations of the tumor and may help the user in determining the diagnosis and treatability. It also would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Weese to incorporate the teachings of Liang to synchronize the interactive display and 2D and 3D views for the benefit of being able to use all of the views together, so that they can supplement each other. This would enhance the user experience and increase their understanding of the condition.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Vrtovec et al. (Automated curved planar reformation of 3D spine images) teaches a slicing algorithm of curved planar reformation on volumetric images. Zhang et al. (CN 106920234 B) teaches a method of generating a treatment plan for a patient based on patient image data of an anatomical structure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHELLE HAU MA whose telephone number is (571)272-2187. The examiner can normally be reached M-Th 7-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, King Poon can be reached at (571) 270-0728. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHELLE HAU MA/ Examiner, Art Unit 2617
/KING Y POON/Supervisory Patent Examiner, Art Unit 2617
