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 .
Priority
Applicant’s claim for the benefit of prior-filed application 63/610761 filed 12/15/2023 under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/24/2025 is being considered by the examiner.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 5, 6, 10, 11, 18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Pfister et al. (US 2009/0274271 A1) in view of Dougherty et al. (US 2019/0318484 A1).
Regarding Claim 1, Pfister teaches “A system, comprising: one or more processors, coupled with memory” (Pfister, [0085] discloses “The method described herein may be automated by, for example, tangibly embodying a program of instructions upon a computer readable storage media capable of being read by machine capable of executing the instructions. A general purpose computer is one example of such a machine. A non-limiting exemplary list of appropriate storage media well known in the art would include such devices as a readable or writeable CD, flash memory chips (e.g., thumb drives), various magnetic storage media, and the like”), “to:
access a 3-dimensional model of an anatomical structure generated via a scan of a subject on which a procedure is to be performed via a robotic medical system” (Pfister, [0064] discloses “Referring now to FIGS. 18A-18E, the disclosed method for selecting a guidance technique for performing a percutaneous procedure will be described in greater detail…At step 1810, a 3D patient image data set of a patient tissue region is provided”; where a 3D patient image data set is a 3-dimensional model of an anatomical structure; where a percutaneous procedure is a procedure to be performed via a robotic medical system. Pfister, [0077] also discloses “In another embodiment, a flexible mounting arm may be provided with a holder for an instrument guide (e.g., guide sleeve, instrument mounting or clamping device). The flexible mounting arm can be connected to structure such as the patient table or other adjacent equipment and may be used to hold an instrument guide during the procedure. The flexible mounting arm may be automatically robotically controllable to enable the user to determine the instrument trajectory automatically or semi-automatically, without touching the patient”);
“register the 3-dimensional model of the anatomical structure with predetermined coupling points in a digital environment established for the procedure on the subject” (Pfister, [0064] discloses “At step 1830 (FIG. 18A), the 3D patient data set is co-registered to the x-ray image acquired using the imaging system. In one embodiment (see FIG. 18C), at step 1832 the co-registering step comprises applying a transform to the 3D patient image data set such that points in a resulting overlay image align with counterpart points in the x-ray image”; where points in an x-ray image are predetermined coupling points in a digital environment);
“execute, via the digital environment, (Pfister, [0064] discloses “At step 1840 (FIG. 18A), the user plans an instrument trajectory in the 3D volume by selecting target point data representative of a target point within the patient tissue region, and skin entry point data representative of a skin entry point. The target point data and skin entry point data may be obtained from the co-registered 3D image data set. As a result of co-registration, it may also be possible to plan the instrument path immediately after step 1800”; where planning an instrument path is identifying a candidate path for a tool); “and
provide, for display via a graphical user interface, an indication of the candidate path for the tool to perform the procedure via the robotic medical system” (Pfister, [0064] discloses “At step 1824, the skin entry point, the target point and the planned instrument trajectory are graphically displayed in their respective positions on the plurality of displayed x-ray images, the three-dimensional rendering and the overlay image.”)
Although Pfizer teaches planning a path prior to further steps of a procedure, Pfizer does not explicitly teach “execute, via the digital environment, a simulation of the procedure to identify a candidate path for a tool” (emphasis added).
However, in an analogous field of endeavor, Dougherty discloses “execute, via the digital environment, a simulation of the procedure to identify a candidate path for a tool” (Dougherty, [0046] discloses “An image from the pre-procedural image data taken during the first time interval can then be selected where the distance between the pair of selected markers 22 in that image corresponds with or closely approximates the same distance determined using localization elements 24 at a given instant in time during the second time interval. This process can be done continuously during the medical procedure, producing simulated real-time, intra-procedural images illustrating the orientation and shape of the targeted anatomy as a catheter, sheath, needle, forceps, guidewire, fiducial delivery devices, therapy device, or similar medical device(s) is/are navigated to the targeted anatomy”).
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 Pfister to incorporate the teachings of Dougherty by producing simulated images of the orientation of anatomy and medical devices. The prior art Pfister contained a ‘base’ device upon which the claimed invention can be seen as an ‘improvement.’ Pfister discloses a method for selecting a guidance mode by using both 3D image data and x-ray views to generate planned trajectories in the 3D volume. The invention of Claim 1 also requires a simulation procedure to identify a candidate path. The prior art contained a ‘comparable’ device that has been improved in the same way as the claimed invention. Dougherty teaches a method of navigating a medical device in a medical image by producing simulated real-time images. One of ordinary skill in the art could have applied the known ‘improvement’ technique in the same way to the ‘base’ device and the results would have been predictable to one of ordinary skill in the art. One of ordinary skill in the art would be motivated to combine the Pfister and Dougherty references in order to improve real-time visualization during medical procedures: Dougherty, [0005] discloses “Although significant improvements have been made in these fields, a need remains for improved medical devices and procedures, including improved segmentation and image processing, for visualizing, accessing, locating, real-time confirming, sampling, and manipulating a target tissue or area.” Accordingly, the combination of Pfister and Dougherty discloses the invention of Claim 1.
Regarding Claim 5, the combination of Pfister and Dougherty teaches “The system of claim 1, wherein the one or more processors are further configured to: adjust a size of a simulated anatomy in the digital environment to register the 3-dimensional model of the anatomical structure in the digital environment” (Pfister, [0040] discloses “In the final movable arm position (again, the Bull's Eye View position), the graphical overlay may also adjust to different x-ray zoom conditions so that the user may confirm final positioning by revealing small deviations from the optimal view orientation. This resizing is automatically achieved through the use of a calculated conversion factor determined e.g., using a ‘similar triangles’ technique”; where resizing graphical overlay to x-ray zoom conditions is adjusting a size of a simulated anatomy (projected anatomical image) in a digital environment (x-ray image)).
Regarding Claim 6, the combination of Pfister and Dougherty teaches “The system of claim 1, wherein the one or more processors are further configured to: adjust an orientation of the 3-dimensional model of the anatomical structure to register the 3-dimensional model of the anatomical structure in the digital environment” (Pfister, [0040] discloses “In the final movable arm position (again, the Bull's Eye View position), the graphical overlay may also adjust to different x-ray zoom conditions so that the user may confirm final positioning by revealing small deviations from the optimal view orientation”; where revealing and adjusting for deviations from an optimal view orientation is adjusting an orientation of the 3-dimensional model for registration).
Regarding Claim 10, the combination of Pfister and Dougherty teaches “The system of claim 1, wherein the one or more processors are further configured to:
overlay, via the graphical user interface, the indication of the candidate path on the 3-dimensional model of the anatomical structure” (Pfister, [0064] discloses “At step 1824, the skin entry point, the target point and the planned instrument trajectory are graphically displayed in their respective positions on the plurality of displayed x-ray images, the three-dimensional rendering and the overlay image.”)
Regarding Claim 11, the combination of Pfister and Dougherty teaches “The system of claim 1, wherein the one or more processors are further configured to:
receive a video stream captured by a camera of the procedure performed via the robotic medical system on the subject in a medical environment” (Dougherty, [0117] discloses “Accordingly, a real-time image feed from bronchoscopic video camera 630 may be used to view the operation of the medical device”);
display the video stream via the graphical user interface” (Dougherty, [0123] discloses “In various embodiments as shown in panel 712, navigation system 70 also simulates a virtual volumetric scene within the body of patient 10, such as the airways of patient 10, from a point of view of a medical device, such as steerable catheter 600, as it is being navigated into and/or through patient 10. This virtual volumetric scene is a computer-generated visualization of a bronchoscopy procedure and simulates what would be viewed by a bronchoscopic video camera inserted into the airways”); and
overlay the indication of the candidate path for the tool through the anatomical structure on the video stream of the procedure displayed via the graphical user interface” (Dougherty, [0123] discloses “To simulate the virtual volumetric scene, navigation system 70 modifies one or more images from image dataset 400 using known image manipulation techniques” and “Navigation system 70 may also be able to display a navigation pathway 416 in the virtual volumetric scene. Accordingly, the virtual volumetric scene may allow a physician or other healthcare professional to review the navigation pathway 416 prior to inserting steerable catheter 600 and/or other medical device into patient 10.”)
Regarding Claim 18, Pfister teaches “A method, comprising:
registering, by one or more processors coupled with memory, a 3-dimensional model of an organ with predetermined coupling points in a digital environment established for a procedure to be performed via robotic medical system on a subject” (Pfister, [0064] discloses “At step 1830 (FIG. 18A), the 3D patient data set is co-registered to the x-ray image acquired using the imaging system. In one embodiment (see FIG. 18C), at step 1832 the co-registering step comprises applying a transform to the 3D patient image data set such that points in a resulting overlay image align with counterpart points in the x-ray image”; where points in an x-ray image are predetermined coupling points in a digital environment);
“with the predetermined coupling points in the digital environment” (Pfister, [0064] discloses “At step 1840 (FIG. 18A), the user plans an instrument trajectory in the 3D volume by selecting target point data representative of a target point within the patient tissue region, and skin entry point data representative of a skin entry point. The target point data and skin entry point data may be obtained from the co-registered 3D image data set. As a result of co-registration, it may also be possible to plan the instrument path immediately after step 1800”; where planning an instrument path is identifying a candidate path for a tool); “and
providing, by the one or more processors for display via a graphical user interface, an indication of the candidate path for the tool to perform the procedure via the robotic medical system” (Pfister, [0064] discloses “At step 1824, the skin entry point, the target point and the planned instrument trajectory are graphically displayed in their respective positions on the plurality of displayed x-ray images, the three-dimensional rendering and the overlay image.”)
Although Pfizer teaches planning a path prior to further steps of a procedure, Pfizer does not explicitly teach “simulating, by the one or more processors via the digital environment, the procedure.”
However, in an analogous field of endeavor, Dougherty discloses “simulating, by the one or more processors via the digital environment, the procedure” (Dougherty, [0046] discloses “An image from the pre-procedural image data taken during the first time interval can then be selected where the distance between the pair of selected markers 22 in that image corresponds with or closely approximates the same distance determined using localization elements 24 at a given instant in time during the second time interval. This process can be done continuously during the medical procedure, producing simulated real-time, intra-procedural images illustrating the orientation and shape of the targeted anatomy as a catheter, sheath, needle, forceps, guidewire, fiducial delivery devices, therapy device, or similar medical device(s) is/are navigated to the targeted anatomy”).
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 Pfister to incorporate the teachings of Dougherty by producing simulated images of the orientation of anatomy and medical devices. The prior art Pfister contained a ‘base’ device upon which the claimed invention can be seen as an ‘improvement.’ Pfister discloses a method for selecting a guidance mode by using both 3D image data and x-ray views to generate planned trajectories in the 3D volume. The invention of Claim 18 also requires a simulation procedure to identify a candidate path. The prior art contained a ‘comparable’ device that has been improved in the same way as the claimed invention. Dougherty teaches a method of navigating a medical device in a medical image by producing simulated real-time images. One of ordinary skill in the art could have applied the known ‘improvement’ technique in the same way to the ‘base’ device and the results would have been predictable to one of ordinary skill in the art. One of ordinary skill in the art would be motivated to combine the Pfister and Dougherty references in order to improve real-time visualization during medical procedures: Dougherty, [0005] discloses “Although significant improvements have been made in these fields, a need remains for improved medical devices and procedures, including improved segmentation and image processing, for visualizing, accessing, locating, real-time confirming, sampling, and manipulating a target tissue or area.” Accordingly, the combination of Pfister and Dougherty discloses the invention of Claim 18.
Regarding Claim 20, Claim 20 recites a computer-readable storage medium storing a program with instructions corresponding to the steps recited in Claim 1. Therefore, the recited programming instructions of this claim are mapped to the proposed combination in the same manner as the corresponding steps in its corresponding method claim. Additionally, the rationale and motivation to combine the Pfister and Dougherty references, presented in rejection of Claim 1, apply to this claim. Finally, the combination of Pfister and Dougherty references discloses “A non-transitory computer-readable medium storing processor-executable instructions that, when executed by one or more processors, cause the one or more processors to” (Pfister, [0085] discloses “The method described herein may be automated by, for example, tangibly embodying a program of instructions upon a computer readable storage media capable of being read by machine capable of executing the instructions. A general purpose computer is one example of such a machine. A non-limiting exemplary list of appropriate storage media well known in the art would include such devices as a readable or writeable CD, flash memory chips (e.g., thumb drives), various magnetic storage media, and the like”).
Claims 2, 19 are rejected under 35 U.S.C. 103 as being unpatentable over Pfister et al. (US 2009/0274271 A1) in view of Dougherty et al. (US 2019/0318484 A1), further in view of Finley (US 2017/0165008 A1).
Regarding Claim 2, the combination of Pfister and Dougherty does not explicitly teach the method of Claim 2.
However, in an analogous field of endeavor, Finley teaches “The system of claim 1, wherein the one or more processors are further configured to:
access a 3-dimensional model of the subject generated with a first resolution, wherein the 3-dimensional model of the anatomical structure is generated with a second resolution that is greater than the first resolution” (Finley, [0119] discloses “In each low-resolution image the reference marker 500 remains visible and may be used to scale and align the image to the registered 3D images. This allows the low-resolution image containing the surgical instrument or implant to be accurately mapped onto the high-resolution pre-operative 3D image so that it can be projected into the 3D image registered to the additional 2D images”; where a low-resolution image containing a surgical instrument is a 3-dimensional model of a subject at a first resolution; where a high-resolution pre-operative 3D image is a 3-dimensional model of the atomical structure at a second resolution)“and
register, via the predetermined coupling points, the 3-dimensional model of the anatomical structure with the 3-dimensional model of the subject in the digital environment” (Finley, [0119] discloses “In each low-resolution image the reference marker 500 remains visible and may be used to scale and align the image to the registered 3D images. This allows the low-resolution image containing the surgical instrument or implant to be accurately mapped onto the high-resolution pre-operative 3D image so that it can be projected into the 3D image registered to the additional 2D images.”)
It would have been obvious to one of ordinary skill in the art before the effective filing
date of the claimed invention to have modified the combination of Pfister and Dougherty to incorporate the teachings of Finley by registering lower and higher resolution images together. Pfister discloses obtaining 3-dimensional data using a C-arm: Pfister, [0034] “Initially, a 3-dimensional data set of a targeted region within the patient will be obtained using one of a variety of techniques, such as computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET), C-arm tomographic imaging (syngo DynaCT, Siemens AG, Forchheim, Germany) or the like.” Thus, it would be obvious to one of ordinary skill in the art to obtain 3-dimensional data at a first resolution by the teachings of both Pfister and Finley. One of ordinary skill in the art would be motivated to combine the Pfister, Dougherty, and Finley references in order to reduce radiation dose: Finley, [0119] discloses “it is possible to reduce the radiation dose for subsequent imaging by switching the C-Arm to pulse/low-dose, low-resolution mode to capture additional C-Arm images of the patient anatomy as the surgery progresses, step 435.” Accordingly, the combination of Pfister, Dougherty, and Finley discloses the invention of Claim 2.
Regarding Claim 19, Claim 19 recites a method with steps corresponding to the elements of the system recited in Claim 2. Therefore, the recited steps of this claim are mapped to the proposed combination in the same manner as the corresponding elements in its corresponding system claim. Additionally, the rationale and motivation to combine the Pfister, Dougherty, and Finley references, presented in rejection of Claim 2, apply to this claim.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Pfister et al. (US 2009/0274271 A1) in view of Dougherty et al. (US 2019/0318484 A1), further in view of Stopek (US 2014/0228858 A1).
Regarding Claim 3, the combination of Pfister and Dougherty teaches “The system of claim 1, wherein the one or more processors are further configured to:
receive an indication of one or more portions of the subject on which the procedure is to be performed” (Dougherty, [0076] discloses “Although target tissue 420 locations and navigation pathway(s) 416 may be automatically calculated by image analysis system 50 and/or navigation system 70, a physician or other healthcare professional may manually adjust target tissue 420 locations and/or navigation pathway(s) 416”; where manually adjusting target tissue location is receiving an indication of a portion of the subject);
select the 3-dimensional models having the resolution for registration in the digital environment” (Pfister, [0064] discloses “Referring now to FIGS. 18A-18E, the disclosed method for selecting a guidance technique for performing a percutaneous procedure will be described in greater detail…At step 1810, a 3D patient image data set of a patient tissue region is provided”; where a 3D patient image data set is a 3-dimensional model of an anatomical structure; where, under the broadest reasonable interpretation, selecting a 3-dimensional model having “the resolution” does not require the resolution be highest, lowest, or meet any other criteria of resolution as long as it has “the resolution.” Furthermore, a resolution of “one or more 3-dimensional models” includes a case of a singular 3-dimensional model. Thus, the disclosure of Pfister of using a 3D patient image data set teaches selecting the 3-dimensional models having the resolution). The proposed combination as well as the motivation for combining the Pfister and Dougherty references presented in the rejection of claim 1, apply to claim 3 and are incorporated herein by reference.
The combination of Pfister and Dougherty does not explicitly teach “identify a resolution of one or more 3-dimensional models for the one or more portions of the subject based on the indication that the procedure is to be performed on the one or more portions.”
However, in an analogous field of endeavor, Stopek teaches “identify a resolution of one or more 3-dimensional models for the one or more portions of the subject based on the indication that the procedure is to be performed on the one or more portions” (Stopek, [0082] discloses “In step 725, it is determined whether the three dimensional model and CT images have sufficient resolution to identify a target nerve proximate the identified portion of the lung. For example, if the identified portion of the lung for treatment is on a primary or secondary bronchial tree, then the three dimensional model and CT images may provide sufficient resolution to identify a target nerve. However, if the identified portion is on a tertiary or terminal bronchial tree, the three dimensional model and CT images may not provide sufficient resolution to do such.”)
It would have been obvious to one of ordinary skill in the art before the effective filing
date of the claimed invention to have modified the combination of Pfister and Dougherty to incorporate the teachings of Stopek by determining resolution of three dimensional model and CT images at a particular location (target nerve). One of ordinary skill in the art would be motivated to combine the Pfister, Dougherty, and Finley references in order to ensure images in the three dimensional model have sufficient resolution for the identification of structures: Stopek, [0082] discloses “For example, if the identified portion of the lung for treatment is on a primary or secondary bronchial tree, then the three dimensional model and CT images may provide sufficient resolution to identify a target nerve. However, if the identified portion is on a tertiary or terminal bronchial tree, the three dimensional model and CT images may not provide sufficient resolution to do such.” Accordingly, the combination of Pfister, Dougherty, and Stopek discloses the invention of Claim 3.
Claims 7-9 and 12-16 are rejected under 35 U.S.C. 103 as being unpatentable over Pfister et al. (US 2009/0274271 A1) in view of Dougherty et al. (US 2019/0318484 A1), further in view of Cohen-Gadol et al. (US 2023/0149091 A1).
Regarding Claim 7, the combination of Pfister and Dougherty does not explicitly teach the system of Claim 7.
However, in an analogous field of endeavor, Cohen-Gadol teaches “The system of claim 1, wherein the one or more processors are further configured to:
identify, upon execution of the simulation of the procedure, a plurality of candidate paths for the tool through the 3-dimensional model, wherein the plurality of candidate paths comprises the candidate path” (Cohen-Gadol, [0030] discloses “One example of actions the disclosed system may take to determine the optimum paths to the tumor are illustrated at 300 in FIG. 3. Paths are optionally calculated at 301, ranked or scored at 302, and sorted at 303.” Cohen-Gadol, [0106] also discloses “The method of any preceding example including preparing a three-dimensional volumetric model of the tumor according to the physical attributes of the tumor”; where optimum paths are a plurality of candidate paths);
“determine, based on the simulation, a first value for a performance metric for the candidate path of the plurality of candidate paths;
determine, based on the simulation, a second value for the performance metric for a second candidate path of the plurality of candidate paths” (Cohen-Gadol, [0054] discloses “The system may be configured to score or rank the surgical paths at 302 according to one or more scoring criteria”; see Fig. 7, which describes different ranking metrics including length, trespass, straightness, path alignment, and hazard zone; where scores of each of the optimum paths are first and second values for a performance metric for candidate paths);
“select the candidate path based on a comparison of the first value and the second value” (Cohen-Gadol, [0030] discloses “Paths are optionally calculated at 301, ranked or scored at 302, and sorted at 303.” Cohen-Gadol, [0061] also discloses “The system may be configured to rank the paths by sorting the scores from highest to lowest”; where sorting paths is comparing first and second values for performance metric); “and
provide, responsive to the selection, the indication for the candidate path for display via the graphical user interface” (Cohen-Gadol, [0061] discloses “In one example, the system may present the top ranked path, the top three ranked paths, or more, to a user as recommendations. These top-rated paths may be rendered graphically to a user interface using a display device”; where graphically rendering a top ranked path is providing an indication for the candidate path for display).
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Fig. 7 of Cohen-Gadol
It would have been obvious to one of ordinary skill in the art before the effective filing
date of the claimed invention to have modified the combination of Pfister and Dougherty to incorporate the teachings of Cohen-Gadol by ranking multiple possible paths to a tumor by various scores and displaying the top ranked path to the user by a display device. One of ordinary skill in the art would be motivated to combine the Pfister, Dougherty, and Cohen-Gadol references in order to reduce harm to tissue surrounding a tumor (Cohen-Gadol, [0003] discloses “The system is operable to rank and sort the different path options according to multiple criteria in order to determine the best available options for completing the operation while reducing or eliminating harm to surrounding portions of the brain.”) Accordingly, the combination of Pfister, Dougherty, Cohen-Gadol discloses the invention of Claim 7.
Regarding Claim 8, the combination of Pfister, Dougherty, and Cohen-Gadol teaches “The system of claim 1, wherein the one or more processors are further configured to:
identify, upon execution of the simulation of the procedure, a value of a performance metric related to the candidate path for the tool to perform” (Cohen-Gadol teaches “In another aspect, the system may be configured to determine the resulting cumulative hazard score for the path, as well as total path length and curvature, and provide parameters for a gradient descent algorithm that steers the path adjustment towards favorable conditions”; where a cumulative hazard score is a value of a performance metric);
“identify a threshold for the performance metric based on at least one of a type of procedure or a type of the anatomical structure” (Cohen-Gadol, [0053] discloses “An additional filtering process at 618 evaluates the path's hazard score against a maximum hazard threshold”; where a maximum hazard threshold is a threshold for the performance metric); “and
provide, responsive to the value of the performance metric satisfying the threshold, the candidate path for display via the graphical user interface” (Cohen-Gadol, [0053] discloses “After this process is completed for each approach volume and paths that overlap the tumor, a collection of fully constructed valid paths is available for evaluation and ranking.” Cohen-Gadol, [0061] also discloses “In one example, the system may present the top ranked path, the top three ranked paths, or more, to a user as recommendations. These top-rated paths may be rendered graphically to a user interface using a display device”; where graphically rendering a top ranked path is providing an indication for the candidate path for display). The proposed combination as well as the motivation for combining the Pfister, Dougherty, and Cohen-Gadol references presented in the rejection of Claim 7, apply to Claim 8 and are incorporated herein by reference. Thus, the apparatus recited in Claim 8 is met by Pfister, Dougherty, and Cohen-Gadol.
Regarding Claim 9, the combination of Pfister, Dougherty, and Cohen-Gadol teaches “The system of claims 8, wherein the one or more processors are further configured to: display, via the graphical user interface, one or more values of the performance metric in association with one or more candidate paths” (Cohen-Gadol, [0027] discloses “The disclosed system may be configured to display the top ranked resulting surgical paths in a user interface window that includes the name of the established approach, along with its rank.”) The proposed combination as well as the motivation for combining the Pfister, Dougherty, and Cohen-Gadol references presented in the rejection of Claim 7, apply to Claim 9 and are incorporated herein by reference. Thus, the apparatus recited in Claim 9 is met by Pfister, Dougherty, and Cohen-Gadol.
Regarding Claim 12, the combination of Pfister, Dougherty, and Cohen-Gadol teaches “The system of claim 11, wherein the one or more processors are further configured to:
receive, subsequent to the display of the candidate path, a command to reject the candidate path displayed via the graphical user interface” (Cohen-Gadol, [0066] discloses “For example, the user interface may set input enabling a path editing mode at 801. When enabled, user input selecting a path to edit is accepted via an input device at 802”; where selecting a path to edit necessarily requires not selecting, or rejecting remaining path options; where all other recommended paths include a candidate path);
“remove, responsive to the command, the display of the candidate path” (Cohen-Gadol, [0066] discloses “When enabled, user input selecting a path to edit is accepted via an input device at 802, and all other recommended paths are optionally hidden from view at 803”); “and
display, responsive to the command, a second candidate path identified during execution of the simulation” (Cohen-Gadol, [0066] discloses “The system may then display control points along the selected path to a display device, preferably in a way that allows the system to accept user input interacting with the control points”; where displaying path with user-adjusted control points is displaying a second candidate path). The proposed combination as well as the motivation for combining the Pfister, Dougherty, and Cohen-Gadol references presented in the rejection of Claim 7, apply to Claim 12 and are incorporated herein by reference. Thus, the apparatus recited in Claim 12 is met by Pfister, Dougherty, and Cohen-Gadol.
Regarding Claim 13, the combination of Pfister, Dougherty, and Cohen-Gadol teaches “The system of claim 1, wherein the one or more processors are further configured to:
receive, via one or more sensors, a data stream of the procedure performed via the robotic medical system on the subject in a medical environment” (Dougherty, [0117] discloses “Accordingly, a real-time image feed from bronchoscopic video camera 630 may be used to view the operation of the medical device”);
“determine a first value of a performance metric associated with the procedure performed via the robotic medical system on the subject in the medical environment”;
determine a second value of the performance metric related to the candidate path identified during execution of the simulation” (Cohen-Gadol, [0054] discloses “The system may be configured to score or rank the surgical paths at 302 according to one or more scoring criteria”; see Fig. 7, which describes different ranking metrics including length, trespass, straightness, path alignment, and hazard zone. Cohen-Gadol teaches “In another aspect, the system may be configured to determine the resulting cumulative hazard score for the path, as well as total path length and curvature, and provide parameters for a gradient descent algorithm that steers the path adjustment towards favorable conditions”; where cumulative hazard scores for each path are first and second values of a performance metric); “and
provide a notification via the graphical user interface based on a comparison of the first value and the second value” (Cohen-Gadol, [0061] discloses “In one example, the system may present the top ranked path, the top three ranked paths, or more, to a user as recommendations. These top-rated paths may be rendered graphically to a user interface using a display device”; where displaying a top ranked path is providing a notification based on a comparison of the first and second values. Cohen-Gadol, [0027] also discloses “The disclosed system may be configured to display the top ranked resulting surgical paths in a user interface window that includes the name of the established approach, along with its rank.”) The proposed combination as well as the motivation for combining the Pfister, Dougherty, and Cohen-Gadol references presented in the rejection of Claim 7, apply to Claim 13 and are incorporated herein by reference. Thus, the apparatus recited in Claim 13 is met by Pfister, Dougherty, and Cohen-Gadol.
Regarding Claim 14, the combination of Pfister, Dougherty, and Cohen-Gadol teaches “The system of claim 13, wherein the one or more processors are further configured to:
generate a value of a second performance metric based at least in part on the comparison of the first value and the second value” (Cohen-Gadol, [0061] discloses “After scoring of each path is complete, the system is optionally configured to determine a final ranking at 707. This final ranking may, for example, be determined by summing together the scores of the individual rankings 701-706 for each path under consideration”; where a final ranking is a value of a second performance metric); “and
display, via the graphical user interface, the value of the second performance metric” (Cohen-Gadol, [0027] discloses “The disclosed system may be configured to display the top ranked resulting surgical paths in a user interface window that includes the name of the established approach, along with its rank.”) The proposed combination as well as the motivation for combining the Pfister, Dougherty, and Cohen-Gadol references presented in the rejection of Claim 7, apply to Claim 14 and are incorporated herein by reference. Thus, the apparatus recited in Claim 14 is met by Pfister, Dougherty, and Cohen-Gadol.
Regarding Claim 15, the combination of Pfister, Dougherty, and Cohen-Gadol teaches “The system of claim 13, wherein the one or more processors are further configured to:
display a location of the tool during the procedure performed via the robotic medical system on the subject in the medical environment” (Dougherty, [0121] discloses “Additionally, as shown in panel 700, an indicia 718 (shown as a crosshair) of the location of steerable catheter 600 is displayed”; where a steerable catheter is a tool); “and
display the location of the tool on the graphical user interface comprising the indication of the candidate path for the tool to perform the procedure via the robotic medical system” (Dougherty, [0123] discloses “Navigation system 70 may also be able to display a navigation pathway 416 in the virtual volumetric scene”; see Fig. 13). The proposed combination as well as the motivation for combining the Pfister, Dougherty, and Cohen-Gadol references presented in the rejection of Claim 7, apply to Claim 15 and are incorporated herein by reference. Thus, the apparatus recited in Claim 15 is met by Pfister, Dougherty, and Cohen-Gadol.
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Fig. 13 of Dougherty
Regarding Claim 16, the combination of Pfister, Dougherty, and Cohen-Gadol teaches “The system of claim 15, wherein the one or more processors are further configured to: determine a distance between the location of the tool and the candidate path for the tool” (Pfister, [0084] discloses “Other user-feedback techniques may also be used, such as displaying on the display 26 offsets (in degree or distance) between the planned instrument trajectory and the optical axis of the system” Pfister, [0041] discloses “d. Laser guidance can be used if the planned instrument trajectory can be targeted in such a manner that the optical axis of the x-ray source on the C-arm coincides with the planned trajectory”); “and provide a second notification responsive to the distance being greater than a threshold” (Pfister, [0084] discloses “Alternatively, a lamp may be provided, the color of which changes as the two are more closely aligned. Acoustic signals and haptic force feedback are other examples of acceptable feedback techniques”; where displaying an offset, changing a lamp color, and haptic feedback are a second notification responsive to a distance being greater than a threshold.)
Allowable Subject Matter
Claims 4 and 17 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Regarding Claim 4, none of the previously cited prior art references explicitly teach the system of Claim 4.
Pfister teaches aligning 3D images using specific points (Pfister, [0064] discloses “At step 1830 (FIG. 18A), the 3D patient data set is co-registered to the x-ray image acquired using the imaging system. In one embodiment (see FIG. 18C), at step 1832 the co-registering step comprises applying a transform to the 3D patient image data set such that points in a resulting overlay image align with counterpart points in the x-ray image”; where points in an x-ray image are predetermined coupling points in a digital environment). However, Pfister does not explicitly teach using coupling points comprising a first and second vein. That is, although the prior art teaches aligning 3D and x-ray images of an organ, the cited prior art does not explicitly teach the alignment based on the alignment of two veins of the organ.
Thus, none of the previously cited prior art teach, alone or in combination, the ordered combination of “The system of claim 1, wherein the anatomical structure comprises an organ, the predetermined coupling points comprise a first vein and a second vein, and the one or more processors are further configured to:
align a first point on the 3-dimensional model of the organ with the first vein in the digital environment; and
align a second point on the 3-dimensional model of the organ with the second vein in the digital environment.”
Regarding Claim 17, none of the previously cited prior art references explicitly teach the system of Claim 17.
Although Pfister discloses a method that may be used for multiply types of “percutaneous puncture procedures, such as needle biopsies,” (Pfister, [0003]), and as recited above, Pfister teaches generating a notification by display, light, or haptics when the path and optical axis are not aligned, Pfister does not explicitly teach changing a threshold distance between a tool location and a path based on the type of surgery.
Thus, none of the previously cited prior art references explicitly teach, alone or in combination, the ordered combination of “The system of claim 16, wherein the threshold is selected based at least in part on a type of the procedure or the type of the anatomical structure.”
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Fahim et al. (US 10413363 B2) discloses an augmented reality device to display candidate puncture locations in a three-dimensional model to a surgeon.
Pinzi et al. (The Adaptive Hermite Fractal Tree (AHFT): a novel surgical 3D path planning approach with curvature and heading constraints, published 2019.
Hu et al. (Path Planning for Semi-automated Simulated Robotic Neurosurgery, published 2015)
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/CAROLINE TABANCAY DUFFY/Examiner, Art Unit 2662
/AMANDEEP SAINI/Supervisory Patent Examiner, Art Unit 2662
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