DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claims 1-2, 14, and 17-19 are objected to because of the following informalities:
In claim 1, line 1, “supports” should read –is configured to support–.
In claim 1, “the processor acquires… derives… performs… varies…” should read – the at least one processor is configured to acquire… derive… perform… vary…–.
In claim 1, lines 5-6; claim 14, line 2; and claim 19, line 5, “the medical instrument passes” should read –the medical instrument is configured to pass–.
In claim 17, “the processor acquires … a pathway through which the medical instrument passes … deforms … acquires” should read – the at least one processor is configured to acquire … the pathway through which the medical instrument is configured to pass… deform … acquire…–.
In claims 18-19, line 2, “supports” should read –is configured to support–.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-14 and 18-19 rejected under 35 U.S.C. 103 as being unpatentable over Knutson et al (US20240206981), hereinafter Knutson, in view of Reinhardt et al (US 20070092864), hereinafter Reinhardt.
Regarding claim 1, Knutson teaches a support device (80) that includes at least one processor (204) (“software and/or hardware” [0027]; “processor 204 …which controls the operation of workstation 80.” [0037]; Fig. 2) and supports insertion of a medical instrument (50) (102) into a tubular structure (“EMN system 10 generally includes an operating table 40 configured to support a patient; a bronchoscope 50 configured for insertion through the patient's mouth and/or nose into the patient's airways;… a workstation 80 including software and/or hardware used to facilitate pathway planning of this disclosure, identification of target tissue, navigation to target tissue, and digitally marking the biopsy location.” [0027]; “Also shown in FIG. 1 is a catheter biopsy tool 102 that is insertable into catheter guide assemblies 90, 100 following navigation to a target and removal of LG 92.” [0032] Fig. 1),
wherein the processor acquires a two-dimensional medical image (“the CT scans” [0034]), and a three-dimensional pathway (“the 3D model” [0034]) that is three-dimensional information on a pathway (“the patient's airways” [0027]) through which the medical instrument passes (“During procedure planning or navigation, workstation 80 may utilize computed tomographic (CT) image data for generating and viewing the 3D model of the patient's airways, which may enable the identification of target tissue on the 3D model…the CT scans may be processed and assembled into a 3D volume, which is then utilized to generate the 3D model of the patient's airways.” [0034]; Fig. 1),
derives a first feature amount (“the position of EM sensor 94” [0030]; Fig. 1) representing a relationship between a reference point (76) (a point associated with the “EM sensor 94” or a position of electromagnetic field generator 76) in a three-dimensional space and the three-dimensional pathway (“The location of EM sensor 94, and thus the distal end of EWC 96, within an electromagnetic field generated by electromagnetic field generator 76 can be derived by tracking module 72, and workstation 80.” [0028] “A six degrees-of-freedom electromagnetic tracking system 70, or any other suitable positioning measuring system, is utilized for performing navigation, although other configurations are also contemplated. Tracking system 70 is configured for use with catheter guide assemblies 90, 100 to track the position of EM sensor 94 as it moves in conjunction with EWC 96 through the airways of the patient” [0030]. “Biopsy tool 102 is further configured for use in conjunction with tracking system 70 to facilitate navigation of biopsy tool 102 to the target tissue, tracking of a location of biopsy tool 102 as it is manipulated relative to the target tissue” [0032]; “During navigation, EM sensor 94, in conjunction with tracking system 70, enables tracking of EM sensor 94 and/or biopsy tool 102 as EM sensor 94 or biopsy tool 102 is advanced through the patient's airways.” [0035]; Fig. 1), and
varies a display aspect of the three-dimensional pathway in the image (“marking the location where the tissue sample was obtained.” [0032]) according to the first feature amount (“tracking of a location of biopsy tool 102 as it is manipulated relative to the target tissue to obtain the tissue sample, and/or marking the location where the tissue sample was obtained.” [0032] “The 3D model may also show marks of the locations where previous biopsies were performed” [0034]).
Knutson does not explicitly teach performing control of displaying a composite image in which the three-dimensional pathway is superimposed on the two-dimensional medical image.
However, in the treatment planning field of endeavor, Reinhardt discloses treatment planning methods, devices and systems, which is analogous art. Reinhardt teaches performing control of displaying a composite image in which the three-dimensional pathway (“the bronchial tree” [0413]) is superimposed on the two-dimensional medical image (“a CT slice that is part of the dataset of CT images depicting a given set of lungs) may be superimposed on the relevant portion of the bronchial tree” [0413]).
Therefore, based on Reinhardt’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Knutson to perform control of displaying a composite image in which the three-dimensional pathway is superimposed on the two-dimensional medical image, as taught by Reinhardt, in order to facilitate surgical navigation thereby increasing the probability of success. In the invention of Knutson modified by Reinhardt, the display aspect of the three-dimensional pathway is varied in the composite image.
Regarding claim 2, Knutson modified by Reinhardt teaches the support device according to claim 1, wherein Knutson teaches that the processor acquires a three-dimensional position of a region of interest (305) (“a workstation 80 including software and/or hardware used to facilitate pathway planning of this disclosure, identification of target tissue, navigation to target tissue, and digitally marking the biopsy location.” [0027]; “A six degrees-of-freedom electromagnetic tracking system 70, or any other suitable positioning measuring system, is utilized for performing navigation, …Tracking system 70 is configured for use with catheter guide assemblies 90, 100 to track the position of EM sensor 94 as it moves in conjunction with EWC 96 through the airways of the patient” [0030]. Figs. 3-6),
derives a second feature amount (340) representing a relationship (“tracking of a location of biopsy tool 102 … relative to the target tissue” [0032]) between the reference point and the three-dimensional position of the region of interest (“Biopsy tool 102 is further configured for use in conjunction with tracking system 70 to facilitate navigation of biopsy tool 102 to the target tissue, tracking of a location of biopsy tool 102 as it is manipulated relative to the target tissue” [0032]; “During navigation, EM sensor 94, in conjunction with tracking system 70, enables tracking of EM sensor 94 and/or biopsy tool 102 as EM sensor 94 or biopsy tool 102 is advanced through the patient's airways.” [0035]; Fig. 1), and
varies a display aspect of the region of interest in the image according to the second feature amount (“in FIG. 3, the maximum traverse distance values 12 mm, 5 mm, and 13 mm are displayed next to the path legend boxes 332, 334, and 336, respectively, which are displayed with a color or pattern that matches the color or pattern of the corresponding possible navigation paths 312, 314, and 316. In implementations, the path legend may use other methods to help a user or clinician distinguish between possible navigation paths and to provide relevant information regarding the possible navigation paths, such as corresponding traverse or travel distances for a medical device navigating through the possible navigation paths.” [0048]; “According to possible navigation path 326, a tool has a straight approach to the target 305 once a catheter is positioned in the distal portion of the branch 316, but the tool must traverse a distance of 13 mm to reach the target 305. After an analysis of these considerations, the system may provide an indicator of the probability of success for a given navigation path 324, as illustrated in FIG. 3.” [0052]; Figs. 3-6. The information displayed, a display aspect, varies depending on the proximity of the tool to target 305).
Knutson does not explicitly teach performing control of displaying the composite image in which the three-dimensional pathway is superimposed on the two-dimensional medical image.
However, in the treatment planning field of endeavor, Reinhardt discloses treatment planning methods, devices and systems, which is analogous art. Reinhardt teaches performing control of displaying a composite image in which the three-dimensional pathway (“the bronchial tree” [0413]) is superimposed on the two-dimensional medical image (“a CT slice that is part of the dataset of CT images depicting a given set of lungs) may be superimposed on the relevant portion of the bronchial tree” [0413]).
Therefore, based on Reinhardt’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Knutson to perform control of displaying the composite image in which the three-dimensional pathway is superimposed on the two-dimensional medical image, as taught by Reinhardt, in order to facilitate surgical navigation thereby increasing the probability of success. In the invention of Knutson modified by Reinhardt, the display aspect of the three-dimensional pathway is varied in the composite image.
Regarding claim 3, Knutson modified by Reinhardt teaches the support device according to claim 1, wherein Knutson teaches that the processor acquires a visual line direction for projecting the three-dimensional pathway onto a two-dimensional plane (300), and
the first feature amount is a feature amount representing a relative positional relationship between the reference point (322, 324, 326) (“Possible navigation path 326 is associated with a small airway” [0052]) and the three-dimensional pathway (312, 314, 316) in the visual line direction (“a tool has a straight approach to the target 305 once a catheter is positioned in the distal portion of the branch 316, but the tool must traverse a distance of 13 mm to reach the target 305.” [0052]; Figs. 3-6).
Regarding claim 4, Knutson modified by Reinhardt teaches the support device according to claim 2, wherein Knutson teaches that the processor acquires a visual line direction for projecting the three-dimensional pathway onto a two-dimensional plane (300), and
the second feature amount is a feature amount representing a relative positional relationship (340) between the reference point and the three-dimensional position of the region of interest in the visual line direction (“As shown in FIG. 3, the maximum traverse distances 340 from the distal portions of the possible navigation paths 322, 324, and 326 to the target 305 are displayed. In the example shown in FIG. 3, the maximum traverse distance values 12 mm, 5 mm, and 13 mm are displayed next to the path legend boxes 332, 334, and 336, respectively, which are displayed with a color or pattern that matches the color or pattern of the corresponding possible navigation paths 312, 314, and 316.” [0048]; Figs. 3-6).
Regarding claim 5, Knutson modified by Reinhardt teaches the support device according to claim 1, wherein Knutson teaches that the reference point is a point on the three-dimensional pathway (a point on paths 322, 324, and 326, and 502, 504; Figs. 3-6).
Regarding claim 6, Knutson modified by Reinhardt teaches the support device according to claim 5, wherein Knutson teaches that the reference point is a position of the medical instrument (“a tool” [0052]) 0on the three-dimensional pathway (a position on paths 322, 324, and 326, and 502, 504; “In analyzing probabilities for successful outcomes from among the possible navigation paths, the system may analyze the following considerations. As illustrated in FIG. 3, possible navigation path 322 is associated with a large airway, which is near the target 305 and accommodates a large catheter, but a catheter must make a sweeping bend to align with the target 305, and a tool must traverse 12 mm to reach the target 305. Possible navigation path 324 is associated with an airway nearest to the target 305 and thus has the shortest traverse distance. According to possible navigation path 324, a tool must exit the catheter at a sharp acute angle to strike the target 305. Possible navigation path 326 is associated with a small airway, which aligns with the target 305. According to possible navigation path 326, a tool has a straight approach to the target 305 once a catheter is positioned in the distal portion of the branch 316, but the tool must traverse a distance of 13 mm to reach the target 305.” [0052]; Figs. 3-6).
Regarding claim 7, Knutson modified by Reinhardt teaches the support device according to claim 6, wherein Knutson teaches the medical instrument (“bronchoscope 50.” [0029]; “a catheter” [0064]) including a treatment tool (“In aspects, the input variables may include tool physical behaviors. The tool physical behaviors may include physical behaviors associated with at least one of a needle, a brush, forceps, a wire, and an ablation probe.” [0042]), and
that the reference point is a position of the treatment tool on the three-dimensional pathway (“The surgical navigation system may identify a particular tool, a particular set of tools, or an order in which a set of tools are used in a procedure. The proximal lesion mode may, for example, prioritize paths which result in greater than three points of estimated contact by a catheter with nearby airway walls, and may prioritize paths which place the catheter tip proximal to the lesion to facilitate performing a procedure on the lesion.” [0064]).
Knutson does not explicitly teach that the medical instrument is an endoscope.
However, in the treatment planning field of endeavor, Reinhardt discloses treatment planning methods, devices and systems, which is analogous art. Reinhardt teaches an endoscope (“Some embodiments include finding a feeding airway to a region t of the lung. This may be done for different reasons, including: 1) to determine which airway path is supplying air to region t; and 2) to determine which airway path is leading closest to region t such that the region can be accessed by a medical device capable of traversing the airway tree (e.g., an endoscope or a bronchoscope).” [0300]).
Therefore, based on Reinhardt’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Knutson to employ the medical instrument that is an endoscope, as taught by Reinhardt, in order to facilitate surgical navigation thereby increasing the probability of success.
Regarding claim 8, Knutson modified by Reinhardt teaches the support device according to claim 6, wherein Knutson teaches that the medical instrument (50) includes a camera (a camera for the “video images received from bronchoscope 50;” [0027]; Fig. 1), and
the reference point is a position of the camera on the three-dimensional pathway (“EMN system 10 generally includes an operating table 40 configured to support a patient; a bronchoscope 50 configured for insertion through the patient's mouth and/or nose into the patient's airways; monitoring equipment 60 coupled to bronchoscope 50 for displaying video images received from bronchoscope 50;” [0027]; “As illustrated in FIG. 1, the patient is shown lying on operating table 40 with bronchoscope 50 inserted through the patient's mouth and into the patient's airways. Bronchoscope 50 includes a source of illumination and a video imaging system (not explicitly shown) and is coupled to monitoring equipment 60, e.g., a video display, for displaying the video images received from the video imaging system of bronchoscope 50.” [0029]).
Knutson does not explicitly teach that the medical instrument is an endoscope.
However, in the treatment planning field of endeavor, Reinhardt discloses treatment planning methods, devices and systems, which is analogous art. Reinhardt teaches an endoscope (“Some embodiments include finding a feeding airway to a region t of the lung. This may be done for different reasons, including: 1) to determine which airway path is supplying air to region t; and 2) to determine which airway path is leading closest to region t such that the region can be accessed by a medical device capable of traversing the airway tree (e.g., an endoscope or a bronchoscope).” [0300]).
Therefore, based on Reinhardt’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Knutson to employ the medical instrument that is an endoscope, as taught by Reinhardt, in order to facilitate surgical navigation thereby increasing the probability of success.
Regarding claim 9, Knutson modified by Reinhardt teaches the support device according to claim 1, wherein Knutson teaches that the first feature amount is a distance (a distance that the “EM sensor 94 or biopsy tool 102 is advanced through the patient's airways.” [0035]; Fig. 1) between the reference point and the three-dimensional pathway in the three-dimensional space (“The location of EM sensor 94, and thus the distal end of EWC 96, within an electromagnetic field generated by electromagnetic field generator 76 can be derived by tracking module 72, and workstation 80.” [0028]; “A six degrees-of-freedom electromagnetic tracking system 70, or any other suitable positioning measuring system, is utilized for performing navigation... Tracking system 70 is configured for use with catheter guide assemblies 90, 100 to track the position of EM sensor 94 as it moves in conjunction with EWC 96 through the airways of the patient” [0030]. “Biopsy tool 102 is further configured for use in conjunction with tracking system 70 to facilitate navigation of biopsy tool 102 to the target tissue, tracking of a location of biopsy tool 102 as it is manipulated relative to the target tissue” [0032]; “During navigation, EM sensor 94, in conjunction with tracking system 70, enables tracking of EM sensor 94 and/or biopsy tool 102 as EM sensor 94 or biopsy tool 102 is advanced through the patient's airways.” [0035]; Fig. 1).
Regarding claim 10, Knutson modified by Reinhardt teaches the support device according to claim 2, wherein Knutson teaches that the reference point is the three-dimensional position (305) of the region of interest (“As shown in FIG. 3, the maximum traverse distances 340 from the distal portions of the possible navigation paths 322, 324, and 326 to the target 305 are displayed. In the example shown in FIG. 3, the maximum traverse distance values 12 mm, 5 mm, and 13 mm are displayed” [0048] Figs. 3-6).
Regarding claim 11, Knutson modified by Reinhardt teaches the support device according to claim 1, wherein Knutson teaches that the processor acquires a focused pathway (504) on the three-dimensional pathway, and
in the control of displaying the composite image, performs control of displaying the focused pathway in an emphasized manner (the absence of a pattern as seen in Fig. 5) as compared with a pathway (502) other than the focused pathway on the three-dimensional pathway (“as illustrated in FIG. 5, if the surgical navigation system determines that a turn 501 has not been successfully navigated by the catheter in multiple attempts based on catheter position feedback 502, the system may suggest a different path 504. The user interface 500 may display the message “Change to the different path” 514, in which case the user may select one of buttons 516 to switch to navigation path 504.” [0055]).
Regarding claim 12, Knutson modified by Reinhardt teaches the support device according to claim 11, wherein Knutson teaches that the focused pathway is a pathway (504) connecting the reference point to a point at which a distance to the region of interest on the three-dimensional pathway is equal to or less than a threshold value (The distance to the region of interest is less than a threshold value because the pathway crosses the boundary of the region of interest in Fig. 5).
Regarding claim 13, Knutson modified by Reinhardt teaches the support device according to claim 11, wherein Knutson teaches that the focused pathway is a pathway registered in advance as preoperative information (“instructions, which, when executed by the processor, cause the processor to: receive preoperative image data; determine possible navigation plans within a branched structure based on the preoperative image data, the physical parameter, the behavior parameter of the human-controlled medical device, and previous procedure information; and display the possible navigation plans and controls for clinician selection of one of the possible navigation plans.” [0011]).
Regarding claim 14, Knutson modified by Reinhardt teaches the support device according to claim 1, wherein Knutson teaches that a pathway through which the medical instrument passes is a bronchial lumen (“The disclosed technology is generally related to guiding navigation of a medical device in a body lumen” [0001]. “Current technology includes catheter systems that enable navigation of a catheter tip through a tortuous lumen of the body to a target.” [0002]; “the example implementations described below are directed to the bronchoscopy of a patient's airways,” [0024]).
Regarding claim 18, Knutson teaches a support method of processing executed by a processor (204) (“software and/or hardware” [0027]; “processor 204 …which controls the operation of workstation 80.” [0037]; Fig. 2) of a support device (80) and supports insertion of a medical instrument (50) (102) into a tubular structure (“EMN system 10 generally includes an operating table 40 configured to support a patient; a bronchoscope 50 configured for insertion through the patient's mouth and/or nose into the patient's airways;… a workstation 80 including software and/or hardware used to facilitate pathway planning of this disclosure, identification of target tissue, navigation to target tissue, and digitally marking the biopsy location.” [0027]; “Also shown in FIG. 1 is a catheter biopsy tool 102 that is insertable into catheter guide assemblies 90, 100 following navigation to a target and removal of LG 92.” [0032] Fig. 1),
the processing comprising:
acquiring a two-dimensional medical image (“the CT scans” [0034]), and a three-dimensional pathway (“the 3D model” [0034]) that is three-dimensional information on a pathway (“the patient's airways” [0027]) through which the medical instrument passes (“During procedure planning or navigation, workstation 80 may utilize computed tomographic (CT) image data for generating and viewing the 3D model of the patient's airways, which may enable the identification of target tissue on the 3D model…the CT scans may be processed and assembled into a 3D volume, which is then utilized to generate the 3D model of the patient's airways.” [0034]; Fig. 1),
deriving a first feature amount (“the position of EM sensor 94” [0030]; Fig. 1) representing a relationship between a reference point (76) (a point associated with the “EM sensor 94” or a position of electromagnetic field generator 76) in a three-dimensional space and the three-dimensional pathway (“The location of EM sensor 94, and thus the distal end of EWC 96, within an electromagnetic field generated by electromagnetic field generator 76 can be derived by tracking module 72, and workstation 80.” [0028] “A six degrees-of-freedom electromagnetic tracking system 70, or any other suitable positioning measuring system, is utilized for performing navigation, although other configurations are also contemplated. Tracking system 70 is configured for use with catheter guide assemblies 90, 100 to track the position of EM sensor 94 as it moves in conjunction with EWC 96 through the airways of the patient” [0030]. “Biopsy tool 102 is further configured for use in conjunction with tracking system 70 to facilitate navigation of biopsy tool 102 to the target tissue, tracking of a location of biopsy tool 102 as it is manipulated relative to the target tissue” [0032]; “During navigation, EM sensor 94, in conjunction with tracking system 70, enables tracking of EM sensor 94 and/or biopsy tool 102 as EM sensor 94 or biopsy tool 102 is advanced through the patient's airways.” [0035]; Fig. 1), and
varying a display aspect of the three-dimensional pathway in the image (“marking the location where the tissue sample was obtained.” [0032]) according to the first feature amount (“tracking of a location of biopsy tool 102 as it is manipulated relative to the target tissue to obtain the tissue sample, and/or marking the location where the tissue sample was obtained.” [0032] “The 3D model may also show marks of the locations where previous biopsies were performed” [0034]).
Knutson does not explicitly teach performing control of displaying a composite image in which the three-dimensional pathway is superimposed on the two-dimensional medical image.
However, in the treatment planning field of endeavor, Reinhardt discloses treatment planning methods, devices and systems, which is analogous art. Reinhardt teaches performing control of displaying a composite image in which the three-dimensional pathway (“the bronchial tree” [0413]) is superimposed on the two-dimensional medical image (“a CT slice that is part of the dataset of CT images depicting a given set of lungs) may be superimposed on the relevant portion of the bronchial tree” [0413]).
Therefore, based on Reinhardt’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Knutson to perform control of displaying a composite image in which the three-dimensional pathway is superimposed on the two-dimensional medical image, as taught by Reinhardt, in order to facilitate surgical navigation thereby increasing the probability of success. In the invention of Knutson modified by Reinhardt, the display aspect of the three-dimensional pathway is varied in the composite image.
Regarding claim 19, Knutson teaches a non-transitory computer-readable storage medium (202) (“Memory 202 includes any non-transitory computer-readable storage media for storing data and/or software that is executable by processor 204 and which controls the operation of workstation 80.” [0037]; Fig. 2) storing a support program (81) (“software” [0027] “The application 81 may include a machine learning application or system as described herein.” [0039]) for causing a processor (204) (“hardware” [0027]) of a support device (80) that includes at least one processor (204) (“hardware” [0027]; “processor 204 …which controls the operation of workstation 80.” [0037];) and supports insertion of a medical instrument (50) (102) into a tubular structure (“EMN system 10 generally includes an operating table 40 configured to support a patient; a bronchoscope 50 configured for insertion through the patient's mouth and/or nose into the patient's airways;… a workstation 80 including software and/or hardware used to facilitate pathway planning of this disclosure, identification of target tissue, navigation to target tissue, and digitally marking the biopsy location.” [0027]; “Also shown in FIG. 1 is a catheter biopsy tool 102 that is insertable into catheter guide assemblies 90, 100 following navigation to a target and removal of LG 92.” [0032] Fig. 1), to execute processing comprising:
acquiring a two-dimensional medical image (“the CT scans” [0034]), and a three-dimensional pathway (“the 3D model” [0034]) that is three-dimensional information on a pathway (“the patient's airways” [0027]) through which the medical instrument passes (“During procedure planning or navigation, workstation 80 may utilize computed tomographic (CT) image data for generating and viewing the 3D model of the patient's airways, which may enable the identification of target tissue on the 3D model…the CT scans may be processed and assembled into a 3D volume, which is then utilized to generate the 3D model of the patient's airways.” [0034]; Fig. 1),
deriving a first feature amount (“the position of EM sensor 94” [0030]; Fig. 1) representing a relationship between a reference point (76) (a point associated with the “EM sensor 94” or a position of electromagnetic field generator 76) in a three-dimensional space and the three-dimensional pathway (“The location of EM sensor 94, and thus the distal end of EWC 96, within an electromagnetic field generated by electromagnetic field generator 76 can be derived by tracking module 72, and workstation 80.” [0028] “A six degrees-of-freedom electromagnetic tracking system 70, or any other suitable positioning measuring system, is utilized for performing navigation, although other configurations are also contemplated. Tracking system 70 is configured for use with catheter guide assemblies 90, 100 to track the position of EM sensor 94 as it moves in conjunction with EWC 96 through the airways of the patient” [0030]. “Biopsy tool 102 is further configured for use in conjunction with tracking system 70 to facilitate navigation of biopsy tool 102 to the target tissue, tracking of a location of biopsy tool 102 as it is manipulated relative to the target tissue” [0032]; “During navigation, EM sensor 94, in conjunction with tracking system 70, enables tracking of EM sensor 94 and/or biopsy tool 102 as EM sensor 94 or biopsy tool 102 is advanced through the patient's airways.” [0035]; Fig. 1), and
varying a display aspect of the three-dimensional pathway in the image (“marking the location where the tissue sample was obtained.” [0032]) according to the first feature amount (“tracking of a location of biopsy tool 102 as it is manipulated relative to the target tissue to obtain the tissue sample, and/or marking the location where the tissue sample was obtained.” [0032] “The 3D model may also show marks of the locations where previous biopsies were performed” [0034]).
Knutson does not explicitly teach performing control of displaying a composite image in which the three-dimensional pathway is superimposed on the two-dimensional medical image.
However, in the treatment planning field of endeavor, Reinhardt discloses treatment planning methods, devices and systems, which is analogous art. Reinhardt teaches performing control of displaying a composite image in which the three-dimensional pathway (“the bronchial tree” [0413]) is superimposed on the two-dimensional medical image (“a CT slice that is part of the dataset of CT images depicting a given set of lungs) may be superimposed on the relevant portion of the bronchial tree” [0413]).
Therefore, based on Reinhardt’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Knutson to perform control of displaying a composite image in which the three-dimensional pathway is superimposed on the two-dimensional medical image, as taught by Reinhardt, in order to facilitate surgical navigation thereby increasing the probability of success. In the invention of Knutson modified by Reinhardt, the display aspect of the three-dimensional pathway is varied in the composite image.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Knutson and Reinhardt as applied to claim 1, and further in view of Duindam et al (US20230200790), hereinafter Duindam.
Regarding claim 15, Knutson modified by Reinhardt teaches the support device according to claim 1.
Knutson as modified by Reinhardt does not teach that the two-dimensional medical image is an image obtained by radiographic fluoroscopy.
However, in the image-guided procedures field of endeavor, Duindam discloses graphical user interface for displaying guidance information in a plurality of modes during an image-guided procedure, which is analogous art. Duindam teaches that the two-dimensional medical image is an image obtained by radiographic fluoroscopy (“display system 110 may present images of a surgical site recorded pre-operatively or intra-operatively using image data from imaging technology such as … fluoroscopy,” [0037]; “one of the perspectives may be automatically selected to match the view of a fluoroscopic imaging device used to observe the procedure.” [0074]).
Therefore, based on Duindam’ teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the combined invention of Knutson and Reinhardt to have the two-dimensional medical image that is an image obtained by radiographic fluoroscopy, as taught by Duindam, in order to facilitate image-guided surgical procedures by using intra-operatively recorded image data of a surgical site.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Knutson and Reinhardt as applied to claim 1, and further in view of Weingarten et al (EP3815613), hereinafter Weingarten.
Regarding claim 16, Knutson modified by Reinhardt teaches the support device according to claim 1, wherein Knutson teaches that the three-dimensional pathway is a bronchial lumen in a three-dimensional medical image (“a 3D volume, which is then utilized to generate the 3D model” [0034]) (“The disclosed technology is generally related to guiding navigation of a medical device in a body lumen” [0001]. “As illustrated in FIG. 1, the patient is shown lying on operating table 40 with bronchoscope 50 inserted through the patient's mouth and into the patient's airways.” [0029]; “Tracking system 70 is configured for use with catheter guide assemblies 90, 100 to track the position of EM sensor 94 as it moves in conjunction with EWC 96 through the airways of the patient, as detailed below.” [0030]; “the CT scans may be processed and assembled into a 3D volume, which is then utilized to generate the 3D model of the patient's airways. The 3D model may be presented on a display monitor associated with workstation 80,” [0034]; Fig. 1).
Knutson as modified by Reinhardt does not teach that the two-dimensional medical image is a virtual radiation image generated from the three-dimensional medical image.
However, in the three dimensional volume reconstructions field of endeavor, Weingarten discloses a system and method for local three dimensional volume reconstruction using a standard fluoroscope, which is analogous art. Weingarten teaches that the two-dimensional medical image is a virtual radiation image (“the virtual fluoroscopic image” [0019]) generated from the three-dimensional medical image (“The cropped three dimensional data may be then reprojected into two dimensional virtual fluoroscope images in which local soft-tissue features are visible, in particular.” [0016]; “the virtual fluoroscopic image, corresponding to the camera pose,” [0019]).
Therefore, based on Weingarten’ teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the combined invention of Knutson and Reinhardt to have the two-dimensional medical image that is a virtual radiation image generated from the three-dimensional medical image, as taught by Weingarten, in order to facilitate guidance, navigation planning, and for improved navigation accuracy, navigation confirmation, and treatment confirmation.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Knutson and Reinhardt as applied to claim 1, and further in view of Mansi et al (US 20230165638), hereinafter Mansi.
Regarding claim 17, Knutson modified by Reinhardt teaches the support device according to claim 1, wherein Knutson teaches that the processor acquires a three-dimensional medical image (“a 3D volume … the 3D model” [0034]) including a pathway (“the patient's airways” [0027]) through which the medical instrument passes (“During procedure planning or navigation, workstation 80 may utilize computed tomographic (CT) image data for generating and viewing the 3D model of the patient's airways, which may enable the identification of target tissue on the 3D model…the CT scans may be processed and assembled into a 3D volume, which is then utilized to generate the 3D model of the patient's airways.” [0034]; Fig. 1).
Knutson as modified by Reinhardt does not teach that that the processor deforms the three-dimensional medical image by performing registration of the three-dimensional medical image and the two-dimensional medical image, and acquires the three-dimensional pathway on the basis of the deformed three-dimensional medical image.
However, in the navigation systems field of endeavor, Mansi discloses risk management for robotic catheter navigation systems, which is analogous art. Mansi teaches that the processor deforms the three-dimensional medical image by performing registration of the three-dimensional medical image and the two-dimensional medical image (“The user thereby progressively pulls the catheter to the target position. For every selection, the path from the current position of the tip of the catheter to the selected point is computed on the overall path planned at the beginning of the procedure.” [0061]; “path planning in the vessel tree is computed from either preoperative images or multiple angio-views. If using preoperative images, 3D/2D deformable registration is performed to fuse the path plan to the patient anatomy.” [0062]);
acquires the three-dimensional pathway (“the vessel tree” [0062])) on the basis of the deformed three-dimensional medical image (“3D/2D deformable registration is performed to fuse the path plan to the patient anatomy.” [0062]).
Therefore, based on Mansi’ teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the combined invention of Knutson and Reinhardt to employ the processor that deforms the three-dimensional medical image by performing registration of the three-dimensional medical image and the two-dimensional medical image, and acquires the three-dimensional pathway on the basis of the deformed three-dimensional medical image, as taught by Mansi, in order to facilitate guidance, navigation planning, and for improved navigation accuracy, navigation confirmation, and treatment confirmation.
Conclusion
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/ALEXEI BYKHOVSKI/
Primary Examiner, Art Unit 3798