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 .
Priority
This application claims benefit of provisional application 63/650,803 filed 05/22/2024.
Information Disclosure Statement
The information disclosure statement (IDS) submitted was filed on 05/22/2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 4 is objected to because of the following informalities:
“determining a control command” should be corrected to:
“determining a second control command” because claim 3 which claim 4 depends upon already recites a “first” control command
Claim 6 is objected to because of the following informalities:
“wherein at least one of the 3D image and 2D images…” corrected to:
“wherein at least one of the 3D image or 2D images…”
Claim 8 is objected to because of the following informalities:
“2D image plane” should be corrected to:
“2D imaging plane”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 20-23 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 20 recites the limitation "the articulable portion". There is insufficient antecedent basis for this limitation in the claim.
Claim 21 recites the limitation “the second position captured in the 3D image”. There is insufficient antecedent basis for this limitation in the claim. Moreover, it is unclear whether the second position is referring to a second position captured in the original 3D image or a second position captured in the additional 3D image.
Claims 22-23 are rejected by virtue of dependency on rejected claim 21.
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.
Claims 1-2, 5-10, 12-13, 15-16, and 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Gerboni (US20240024047) in view of Homan (US20100172541) and Zhao (US20200242767).
Regarding claim 1, Gerboni teaches a medical system (1100) (Fig. 11, [0099-0105]) comprising:
a manipulator assembly (1102) configured to drive a flexible elongate device (1104; 1202) (Figs. 11 & 12A, [0101], “the medical instrument 1104 may include, deliver, couple to, and/or control any of the flexible instruments described herein”, [0107], “The medical instrument system 1200 includes an elongate flexible device 1202, such as a flexible catheter”); and
a control system (1112) coupled to the manipulator assembly (Fig. 11, [0102], [0105-0106], [0111]), the control system (1112) configured to:
receive a three-dimensional (3D) image of a distal portion of the flexible elongate device and a target structure (Fig. 9, [0106], “The virtual visualization system processes images of the surgical site imaged using imaging technology such as computerized tomography (CT)”, [0092], “an image 902 displaying a target site 904, an elongate flexible device 906…The image 902 can be a… CBCT image”, [0148], “receiving image data of an anatomic region including the target and the distal portion of the elongate flexible device”);
determine a two-dimensional (2D) plane (502) for movement of the distal portion of the flexible elongate device from a first position captured in the 3D image to a second position that points toward the target structure (Fig. 5, [0078], “During retraction and/or adjustment, the distal portion 506 can be constrained to move only along directions within and/or overlapping the movement plane 502”, [0067], “the distal portion can be continuously adjusted during retraction so the distal portion remains oriented toward the target site”, [0069]);
receive 2D images captured over time ([0046], “the pose can also be determined based on image data from an external imaging device (e.g., a fluoroscopic imaging system)”, [0051], “live fluoroscopy”, [0066], [0069], [0090], “the image 802 can be a real-time fluoroscopic image or video allowing the operator to continuously track the location and pose of the elongate flexible device 806”, [0092]); and
control the manipulator assembly to move the distal portion of the flexible elongate device from the first position to the second position based on the 2D images (Abstract, “retracting… and adjusting, via the control system, the pose of the distal portion of the elongate flexible device so the distal portion remains oriented toward the target”, [0046], “In a further example, the pose can also be determined based on image data from an external imaging device (e.g., a fluoroscopic imaging system)”, [0064], “…The pose data can be used to…calculate an adjusted pose that would realign the distal portion with the target site”, [0106]).
However, Gerboni fails to teach wherein the 2D plane is a 2D imaging plane for viewing movement and is determined based on the 3D image.
In an analogous image guided procedure field of endeavor, Homan teaches such a feature. Homan teaches scanning a volume (300) with a CT-apparatus (Fig. 3a, [0058]). Homan teaches selecting a slice (301) from the volume which include an entry point and a target point and determining a planned path (304) from the selected slice (301) (Figs. 3a-3b, Abstract, [0058-0059]). Homan further teaches recording a fluoroscopy image (Figs. 3e & 4c) whose plane is parallel to the planned path or selected slice (Figs. 3e & 4c, [0062-0063]). Homan therefore teaches wherein a movement plane for a planned path may be used as a 2D imaging plane and wherein the plane may be determined based on a 3D image (volume 300).
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 invention of Gerboni to have the movement plane be a 2D imaging plane for viewing movement and be determined based on the 3D image (Figs. 3a-3b, 3e, & 4c, Abstract, [0058-0059], [0062-0063]). A path to a target may be planned from an acquired 3D scan as recognized by Homan (Abstract, [0058-0059]), and the using the plane as an imaging plane for viewing movement may predictably allow for continuous monitoring of the elongate device for navigation.
However, the modified combination noted above fails to teach wherein the 2D images are in the 2D imaging plane.
In an analogous image guided procedure field of endeavor, Zhao teaches such a feature. Zhao teaches a manipulator assembly (102) (Fig. 1, [0031]) and an elongated flexible device comprising a catheter (202) (Fig. 2A, [0047]). Zhao teaches a fluoroscopic imaging system (370) configured to obtain fluoroscopic images of a patient while the catheter (360) is extended within the patient (Fig. 5, [0065]). Zhao teaches the preferred fluoroscopic plane of viewing may be generally parallel to the trajectory between a distal tip of an instrument to a target tissue area (Fig. 15, [0091]). Moreover, Zhao teaches obtaining fluoroscopic images in a desired fluoroscopic imaging planed (Fig. 16, [0092]). Zhao therefore teaches wherein the received 2D images may be from a desired or preferred fluoroscopic plane which is parallel to the trajectory between the distal tip of the instrument and target.
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 invention of Gerboni to have the preferred fluoroscopic plane of view be parallel to the trajectory or movement of the instrument as taught by Zhao (Figs. 15-16, [0091-0092]). By having the 2D images be captured in a plane parallel to the trajectory, most accurate information may be provided to a clinician about whether an instrument such as a needle has intercepted a target tissue area or has avoided an area that would cause injury to a patient as recognized by Zhao ([0091]).
Regarding claim 2, Gerboni in view of Homan and Zhao teaches the invention as claimed above in claim 1.
Gerboni further teaches wherein the control system controls the manipulator assembly to move the distal portion of the flexible elongate device from the first position to the second position using a feedback control based on the 2D images (Fig. 1, [0068], “iterative retraction”, [0069], “At step 160, the method 100 optionally includes checking the positioning of the medical instrument with respect to the target site. This verification can be performed by imaging the medical instrument and patient anatomy (e.g., using fluoroscopy…Subsequently the image data can be analyzed to determine whether the medical instrument is still positioned properly with respect to the target site…If the positioning is not satisfactory, the medical instrument can be repositioned by repeating some or all of the previous steps of the method 100. For example, some or all of steps 130, 135, 140, and/or 150 can be repeated to adjust the elongate flexible device, if proper positioning can be achieved with relatively small corrections”).
Regarding claim 5, Gerboni in view of Homan and Zhao teaches the invention as claimed above in claim 1.
Gerboni further teaches wherein the 3D image is generated using one selected from the group consisting of: cone beam computed tomography (CBCT), and tomosynthesis ([0039], “the image data can be generated by…an intraoperative computed tomography (CT) imaging system”, [0106], “The virtual visualization system processes images of the surgical site imaged using imaging technology such as computerized tomography (CT)”, [0069], “This verification can be performed by imaging the medical instrument and patient anatomy (e.g., using fluoroscopy or a cone beam CT (CBCT) imaging system or other imaging device)”, [0092], “an image 902 displaying a target site 904, an elongate flexible device 906…The image 902 can be a… CBCT image”).
Regarding claim 6, Gerboni in view of Homan and Zhao teaches the invention as claimed above in claim 1.
Gerboni further teaches wherein at least one of the 3D image and 2D images are generated using ultrasound ([0039], [0066], [0106], wherein a disjunctive interpretation of the claim is used, i.e. wherein the 3D image or 2D images are generated using ultrasound).
Regarding claim 7, Gerboni in view of Homan and Zhao teaches the invention as claimed above in claim 1.
Gerboni further teaches wherein the 2D images are generated using fluoroscopy ([0046], “the pose can also be determined based on image data from an external imaging device (e.g., a fluoroscopic imaging system)”, [0051], “live fluoroscopy”, [0066], [0069], [0090], “the image 802 can be a real-time fluoroscopic image or video allowing the operator to continuously track the location and pose of the elongate flexible device 806”, [0092]).
Regarding claim 8, Gerboni in view of Homan and Zhao teaches the invention as claimed above in claim 1.
Gerboni further teaches wherein the 2D image plane is further determined such that the 2D images include the target structure ([0078], “The movement plane 502 can be aligned with a target site 504”).
Regarding claim 9, Gerboni in view of Homan and Zhao teaches the invention as claimed above in claim 1.
Gerboni further teaches wherein the control system is further configured to: augment the 2D images with a graphical representation (810) of the target structure ([0087], [0091]).
Regarding claim 10, Gerboni in view of Homan and Zhao teaches the invention as claimed above in claim 1.
However, Gerboni fails to teach wherein the control system is further configured to: generate an indication of the 2D imaging plane, and provide the indication to a user interface.
In an analogous image guided procedure field of endeavor, Homan teaches such a feature. Homan teaches scanning a volume (300) with a CT-apparatus (Fig. 3a, [0058]). Homan teaches selecting a slice (301) from the volume which include an entry point and a target point and determining a planned path (304) from the selected slice (301) (Figs. 3a-3b, Abstract, [0058-0059]). Homan further teaches recording a fluoroscopy image (Figs. 3e & 4c) whose plane is parallel to the planned path or selected slice (Figs. 3e & 4c, [0062-0063]). Homan further teaches volume data within the slice can be projected onto a fluoroscopic image, allowing for structures around the planned path and target to be made visible ([0017]). Homan therefore teaches displaying to a user a fluoroscopic image including content of the slice, thus generating an indication of the 2D imaging plane and providing said indication to a user interface.
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 invention of Gerboni to display the slice to a user as taught by Homan (Figs. 3e & 4c, [0062-0063], [0017]). Structures around the planned path and target may be made visible to users as recognized by Homan ([0017]).
Regarding claim 12, Gerboni in view of Homan and Zhao teaches the invention as claimed above in claim 1.
However, Gerboni fails to teach wherein the control system is further configured to: provide instructions for reconfiguring an imaging device to enable capturing of the 2D images in the 2D imaging plane, wherein the instructions are provided to one selected from the group consisting of a user interface and the imaging device.
In an analogous image guided procedure field of endeavor, Zhao teaches such a feature. Zhao teaches a manipulator assembly (102) (Fig. 1, [0031]) and an elongated flexible device comprising a catheter (202) (Fig. 2A, [0047]). Zhao teaches a fluoroscopic imaging system (370) configured to obtain fluoroscopic images of a patient while the catheter (360) is extended within the patient (Fig. 5, [0065]). Zhao teaches the preferred fluoroscopic plane of viewing may be generally parallel to the trajectory between a distal tip of an instrument to a target tissue area (Fig. 15, [0091]). Moreover, Zhao teaches obtaining fluoroscopic images in a desired fluoroscopic imaging planed (Fig. 16, [0092]). Zhao further teaches the system or user may receive a set of joint configurations for a fluoroscopy system to achieve a system configuration for obtaining fluoroscopic images in the desired imaging plane ([0092]). Zhao therefore teaches providing instructions (joint configurations) for reconfiguring via a user interface (joint configurations provided to user) and/or imaging device (joint configurations provided to system) to enable capturing of the 2D images in the 2D imaging plane.
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 invention of Gerboni to have the system provide joint configurations to itself or a user as recognized by Zhao ([0092]). The set of joint configurations may predictably allow for the user or system to reconfigure the fluoroscopic imaging device to obtain fluoroscopic images in a desired imaging plane as recognized by Zhao ([0092]).
Regarding claim 13, Gerboni in view of Homan and Zhao teaches the invention as claimed above in claim 1.
Gerboni further teaches wherein controlling the manipulator assembly to move the distal portion of the flexible elongate device from the first position to the second position comprises: constraining the movement of the distal portion based on a user control input ([0077], [0081-0082]).
Regarding claim 15, Gerboni in view of Homan and Zhao teaches the invention as claimed above in claim 1.
Gerboni further teaches wherein controlling the manipulator assembly to move the distal portion of the flexible elongate device from the first position to the second position comprises at least one selected from the group consisting of applying an amplitude limit, applying a torque limit, and applying a speed limit to the movement of the distal portion ([0052] “a retraction velocity threshold”, wherein a velocity threshold comprises a speed limit).
Regarding claim 16, Gerboni in view of Homan and Zhao teaches the invention as claimed above in claim 1.
Gerboni further teaches wherein the control system is further configured to: determine a first operation context, and based on the first operation context, allow the control of the manipulator assembly to move the distal portion of the flexible elongate device from the first position to the second position based on the 2D images ([0044], “The presence and/or type of the elongate flexible device and/or medical instrument may affect the operational mode of the elongate flexible device… if a diagnostic flexible device is detected or an imaging medical instrument is present, the elongate flexible device can remain in the first retraction mode (e.g., the normal retraction mode). In some embodiments, the first retraction mode is the default or normal operational mode for the elongate flexible device”, [0028], “During and/or after retraction, the system can adjust the pose of the distal portion of the elongate flexible device so the distal portion remains oriented toward the target site”, [0046], [0064], wherein images provide pose data for adjusting pose of the flexible device to realign with the target).
Regarding claim 20, Gerboni in view of Homan and Zhao teaches the invention as claimed above in claim 1.
Gerboni further teaches wherein the movement of the distal portion of the flexible elongate device from the first position to the second position comprises at least one selected from the group consisting of: an articulation of the articulable portion and an articulation of the articulable portion in combination with a retraction movement of the flexible elongate device (Figs. 1, 5 & 6, [0028], wherein adjusting (articulating) is combined with retraction, [0049], [0056], “Accordingly, step 150 can include adjusting (e.g., articulating) the distal portion of the elongate flexible device to reorient it”, [0059], “the adjustment includes articulating the distal portion 302”, [0078-0079]).
Regarding claim 21, Gerboni in view of Homan and Zhao teaches the invention as claimed above in claim 1.
Gerboni further teaches wherein the control system is configured to: receive an additional 3D image (Fig. 1, [0039], wherein in step 110 a first 3D image (CT image) may be obtained by an intraoperative computed tomography (CT) imaging system, [0069], wherein in step 160 an additional 3D (CBCT) image may be obtained to check the position of the medical instrument after retraction/adjustment).
However, Gerboni fails to teach determine, based on the additional 3D image, an updated 2D imaging plane for viewing movement of the distal portion of the flexible elongate device from the second position captured in the 3D image to a third position that points toward the target structure.
In an analogous image guided procedure field of endeavor, Homan teaches such a feature. Homan teaches scanning a volume (300) with a CT-apparatus (Fig. 3a, [0058]). Homan teaches during a procedure, a number of 3D reconstructions may be obtained ([0038]). Homan therefore teaches receiving additional 3D images. Homan teaches CT acquisitions (plural) may be made to check if the planned path of a needle must be corrected ([0038]). Homan teaches selecting a slice (301) from the volume which include an entry point and a target point and determining a planned path (304) from the selected slice (301) (Figs. 3a-3b, Abstract, [0058-0059]). Homan further teaches recording a fluoroscopy image (Figs. 3e & 4c) whose plane is parallel to the planned path or selected slice (Figs. 3e & 4c, [0062-0063]). Because Homan teaches repeatedly reacquiring the 3D volume/reconstruction throughout the procedure to check needle positioning, a PHOSITA would recognized the plane (slice) determination is similarly repeated with the updated or additional 3D volume and based on the updated 3D volume (image).
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 invention of Gerboni to reacquire a number of 3D reconstructions throughout the procedure and subsequently determine a 2D imaging plane from the 3D reconstruction volume as recognized by Homan ([0038], [0058-0059], [0062-0063]). The repeated reacquiring of a 3D volume and updating the 2D imaging plane may predictably allow for more accurate tracking and monitoring of an insertion procedure step by step.
Claims 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Gerboni (US20240024047) in view of Homan (US20100172541) and Zhao (US20200242767) as applied to claim 2 above, and further in view of Stoianovici (US20030120283).
Regarding claim 3, Gerboni in view of Homan and Zhao teaches the invention as claimed above in claim 2.
However, Gerboni fails to teach wherein using the feedback control based on the 2D images comprises: in a first 2D image of the 2D images, determining a first spatial error between the distal portion of the flexible elongate device and the target structure, and determining a control command that reduces the first spatial error when controlling the manipulator assembly to move the distal portion.
In an analogous image guided procedure field of endeavor, Stoianovici teaches such a feature. Stoianovici teaches automated alignment and insertion of a needle controlled by fluoroscopic feedback ([0021]); Stoianovici teaches fluoro-servoing using x-ray fluoroscopic feedback ([0037]). Stoianovici teaches wherein a robot (102) controls positioning of a needle (Claim 1, [0031], [0053]). Stoianovici teaches moving the needle in incremental steps proportional to orientation error which is measured in an x-ray projection at step S3-4 (Figs. 2-3, [0044]). Stoianovici teaches wherein the algorithm converges to a needle position in which the needle points towards the target ([0044]). Stoianovici therefore teaches determining a spatial error and controlling the needle such that the spatial error is reduced by using x-ray projection 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 invention of Gerboni to measure orientation error from the fluoroscopic images and to control the orientation of the instrument to correct the error as taught by Stoianovici (Figs. 2-3, [0044]). By measuring and reducing orientation error measured in an image, an instrument such as a needle may be pointed towards a target accurately as recognized by Stoianovici ([0044]).
Regarding claim 4, Gerboni in view of Homan, Zhao, and Stoianovici teaches the invention as claimed above in claim 3.
However, Gerboni fails to teach wherein using the feedback control based on the 2D images further comprises: in a second 2D image of the 2D images, determining a second spatial error between the distal portion of the flexible elongate device and the target structure, and determining a control command that reduces the second spatial error when controlling the manipulator assembly to move the distal portion.
In an analogous image guided procedure field of endeavor, Stoianovici teaches such a feature. Stoianovici teaches automated alignment and insertion of a needle controlled by fluoroscopic feedback ([0021]); Stoianovici teaches fluoro-servoing using x-ray fluoroscopic feedback ([0037]). Stoianovici teaches wherein a robot (102) controls positioning of a needle (Claim 1, [0031], [0053]). Stoianovici teaches moving the needle in incremental steps proportional to orientation error which is measured in an x-ray projection at step S3-4 (Figs. 2-3, [0044]). Stoianovici teaches wherein the algorithm converges to a needle position in which the needle points towards the target ([0044]). Stoianovici therefore teaches wherein orienting the needle to point towards a target is an iterative process and therefore uses multiple images to check orientation error after each re-orienting. Stoianovici further teaches a second step of aligning the needle orientation towards the target using the same angle-error feedback described previously, thereby allowing for the needle to the aligned in two different Fluoro views (Figs. 2a & 2b, Fig. 3, [0051]). Stoianovici therefore teaches wherein error is measured using at least two images (iteratively or in a 2nd view).
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 invention of Gerboni to check orientation error iteratively to correct alignment or to use two views for alignment as taught by Stoianovici (Figs. 2a & 2b, Fig. 3, [0044], [0051]). Using multiple images to check orientation error predictably allows for an iterative process of re-orienting an instrument such that an algorithm converges a needle orientation to point towards a target as recognized by Stoianovici ([0044]). Moreover by using multiple images or views, the needle or instrument may be more accurately aligned, e.g. aligned in multiple perspectives as further recognized by Stoianovici (Figs. 2a & 2b, [0051]).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Gerboni (US20240024047) in view of Homan (US20100172541) and Zhao (US20200242767) as applied to claim 10 above, and further in view of Birenbaum (US20220022840).
Regarding claim 11, Gerboni in view of Homan and Zhao teaches the invention as claimed above in claim 10.
However, Gerboni fails to teach wherein the control system is further configured to confirm a configuration of a 2D imaging device for capturing the 2D images by verifying the 2D imaging plane using a validation of at least one of the 2D images against the 3D image.
In an analogous image guided procedure field of endeavor, Birenbaum teaches such a feature. Birenbaum teaches determining an optimal angle of placement of the fluoroscopic imaging device (124) and positioning the fluoroscopic imaging device (124) in an optimal position for clearly depicting both a catheter and a target by determining a slice in which both the target and the catheter are most visible ([0089-0090]). Birenbaum therefore teaches confirming/determining a configuration of a 2D imaging device for capturing 2D images. Birenbaum further teaches comparing live 2D fluoroscopic images to slices of a fluoroscopic 3D reconstruction to determine a best match ([0070]). Birenbaum therefore further teaches validating of at least one of the 2D images against the 3D image via determining a best match. By combining these teachings, Birenbaum teaches confirming a configuration of a 2D imaging device for capturing the 2D images and verifying the 2D imaging plane using a validation of at least one of the 2D images against the 3D image.
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 invention of Gerboni to determine the pose of the fluoroscopic imaging device for imaging the target and catheter and comparing the live 2D images to the 3D image as taught by Birenbaum ([0070], [0089-0090]). An optimal viewing angle may predictably be achieved by determining a pose of the fluoroscopic imaging device for imaging as recognized by Birenbaum ([0089-0090]). Moreover by comparing live images to slices of the 3D reconstruction, a best match may predictably be found as recognized by Birenbaum ([0070]), thereby allowing for an operator to know the imaging device is in a correct pose.
Claims 14 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Gerboni (US20240024047) in view of Homan (US20100172541) and Zhao (US20200242767) as applied to claims 1 and 16 above, and further in view of Ahmadi (US20250331937).
Regarding claim 14, Gerboni in view of Homan and Zhao teaches the invention as claimed above in claim 1.
Gerboni further teaches wherein controlling the manipulator assembly to move the distal portion of the flexible elongate device from the first position to the second position comprises: constraining the movement of the distal portion to a plane, regardless of user control input (Fig. 5, [0078]).
However, Gerboni fails to teach wherein the movement is constrained to a direction from the first position to the second position.
In an analogous manipulation of instruments field of endeavor, Ahmadi teaches such a feature. Ahmadi teaches a surgical system including a robotic arm and controller for aligning an end effector with a target trajectory (Abstract). Ahmadi teaches constraining an end effector (20) of the robot to a selected target trajectory such that the end effector (20), and an instrument it’s holding (guide tube 101), may only move along the direction of the selected trajectory (Fig. 6C, [0126]). Ahmadi therefore teaches constraining movement to a direction from a first position to a second position.
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 invention of Gerboni to constrain the movement to a direction from the first position to the second position as taught by Ahmadi (Fig. 6C, [0126]). Doing such may help prevent misalignment of an instrument, i.e. flexible elongate device, with a target trajectory as recognized by Ahmadi ([0126]).
Regarding claim 18, Gerboni in view of Homan and Zhao teaches the invention as claimed above in claim 16.
However, Gerboni fails to teach wherein the control system is further configured to: determine a second operation context, and based on the second operation context, block a control of the manipulator assembly to move the distal portion of the flexible elongate device from the second position to a third position based on the 2D images.
In an analogous manipulation of instruments field of endeavor, Ahmadi teaches such a feature. Ahmadi teaches a surgical system including a robotic arm and controller for aligning an end effector with a target trajectory (Abstract). Ahmadi teaches determining that an instrument is affixed to the guide tube and responsive to the guide tube being aligned with the target trajectory, constraining an end effector (20) of the robot to a selected target trajectory such that the end effector (20), and an instrument it’s holding (guide tube 101), may only move along the direction of the selected trajectory (Fig. 6C, [0031], [0126]). The guide tube being aligned with the target trajectory comprises a second operation context determined by the system. Moreover, a “third position” comprises any position not on the trajectory. Ahmadi therefore teaches determining a second operation context (alignment with target trajectory) and blocking control of the manipulator assembly to move the distal portion of an instrument from the second position to a third position via locking or constraining movement to the target trajectory. Gerboni above teaches wherein pose (orientation/alignment) of the flexible elongate member may be based on 2D imaging data.
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 invention of Gerboni to determine alignment with the target trajectory then lock movement to only inside the target trajectory as taught by Ahmadi (Fig. 6C, [0031], [0126]). By locking movement to only inside the target trajectory, i.e. blocking movement outside the trajectory, misalignment with the target trajectory may predictably be prevented as recognized by Ahmadi ([0126]).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Gerboni (US20240024047) in view of Homan (US20100172541) and Zhao (US20200242767) as applied to claim 16 above, and further in view of Barbagli (US20200078096).
Regarding claim 17, Gerboni in view of Homan and Zhao teaches the invention as claimed above in claim 16.
However, Gerboni fails to teach wherein the first operation context comprises a non-extended biopsy needle.
In an analogous medical system field of endeavor, Barbagli teaches such a feature. Barbagli teaches a manipulator assembly (102) and a flexible elongate device (202) (Figs. 1-2, [0024], [0041]). Barbagli teaches wherein a biopsy needle (608) may be inserted into the flexible elongate device ([0061]). Barbagli similarly teaches wherein the system may determine an operational state or mode of the flexible robotic system ([0061]). Barbagli teaches an operational state indicating that a medical instrument, i.e. biopsy needle, is not protruding out from the lumen (non-extended) ([0011], [0045], [0061]). Barbagli teaches an insertion sensor to determine how far the needle (608) protrudes ([0061]). Barbagli teaches when the needle (608) is retracted, the flexible body of the flexible elongate device, i.e. catheter, may become compliant (flexible) ([0011], [0069-0070]), therefore allowing movement of the flexible elongate device.
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 invention of Gerboni to include a non-extended biopsy needle as an operation context as taught by Barbagli ([0011], [0045], [0061], [0069-0070]). By ensuring that the needle is sheathed or retracted, safety may be provided to the patient when controlling the flexible elongate device to move within the body; allowing for the flexible elongate device to move unrestrained while the needle is protruding may cause damage to surrounding tissue of the patient.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Gerboni (US20240024047) in view of Homan (US20100172541), Zhao (US20200242767), and Ahmadi (US20250331937) as applied to claim 18 above, and further in view of Chow (US8118803).
Regarding claim 19, Gerboni in view of Homan, Zhao, and Ahmadi teaches the invention as claimed above in claim 18.
Gerboni further teaches wherein an instrument deployed via the flexible elongate device may comprise a biopsy needle ([0040]).
However, Gerboni fails to teach wherein the second operation context comprises one selected from the group consisting of: an extended biopsy needle and an insertion movement of the flexible elongate device required by the movement of the distal portion of the flexible elongate device from the second position to the third position.
In an analogous flexible elongate device field of endeavor, Chow teaches such a feature. Chow teaches a needle catheter (180) configured to accommodate a needle (Fig. 1, Col. 2 line 55 – Col. 3 line 3). Chow teaches when the needle (182) is extended forward, a needle stop (192) may cause the needle to stop extending past a pre-determined distance, thereby limiting penetration of the needle (Fig. 4e, Col. 9 lines 4-22). Chow therefore teaches wherein the second operation context may comprise an extended needle and blocking movement from a second position to a third position via limiting penetration distance along a trajectory.
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 invention of Gerboni to have the second operation context comprise an extended biopsy needle and to block movement past a pre-determined distance as taught by Chow (Fig. 4e, Col. 9 lines 4-22). By doing the above, patient safety may be improved as the needle is prevented from penetrating unintended tissue.
Claims 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Gerboni (US20240024047) in view of Homan (US20100172541) and Zhao (US20200242767) as applied to claim 21 above, and further in view of Dickhans (US20170156685).
Regarding claim 22, Gerboni in view of Homan and Zhao teaches the invention as claimed above in claim 21.
However, Gerboni fails to teach wherein the control system is further configured to: determine an operation context, and wherein the receiving of the additional 3D image is performed based on the operation context.
In an analogous image guided procedure field of endeavor, Dickhans teaches such a feature. Dickhans teaches providing visual guidance for navigating inside a patient’s chest (Abstract). Dickhans teaches receiving CBCT image data of the patient’s chest (Fig. 1, Abstract, [0035], [0048]). Dickhans teaches determining whether a patient moved during a CBCT imaging process ([0069]). Dickhans teaches if the amount of patient movement exceeds a predetermined threshold, to reinitiate the CBCT imaging processing and thus reacquire an additional CBCT image ([0069]). Dickhans therefore teaches determining an operation context (patient movement) and receiving an additional 3D image based on the operation context (patient movement).
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 invention of Gerboni to determine patient motion and based on patient motion, reacquire the 3D CBCT image as taught by Dickhans (Fig. 1, Abstract, [0035], [0048], [0069]). Patient motion during a CBCT scanning procedure may predictably cause the image data to be unusable as recognized by Dickhans ([0069]), therefore requiring another 3D CBCT image.
Regarding claim 23, Gerboni in view of Homan, Zhao, and Dickhans teaches the invention as claimed above in claim 22.
However, Gerboni fails to teach wherein the operation context comprises at least one selected from the group consisting of: a difference in a configuration of the flexible elongate device after execution of the movement of the distal portion of the flexible elongate device from the first position to the second position, and wherein the difference exceeds a threshold value, a patient motion, a mismatch between a representation of the flexible elongate device in at least one of the 2D images and a sensed configuration of the flexible elongate device, and a mismatch between an articulation of an articulable body portion in a representation of the flexible elongate device in at least one of the 2D images and a commanded articulation.
In an analogous image guided procedure field of endeavor, Dickhans teaches such a feature. Dickhans teaches providing visual guidance for navigating inside a patient’s chest (Abstract). Dickhans teaches receiving CBCT image data of the patient’s chest (Fig. 1, Abstract, [0035], [0048]). Dickhans teaches determining whether a patient moved during a CBCT imaging process ([0069]). Dickhans teaches if the amount of patient movement exceeds a predetermined threshold, to reinitiate the CBCT imaging processing and thus reacquire an additional CBCT image ([0069]). Dickhans therefore teaches receiving an additional 3D image based on an operation context and wherein the operation context comprises patient movement.
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 invention of Gerboni to have the operation context comprise patient motion for acquiring an additional 3D CBCT image as taught by Dickhans (Fig. 1, Abstract, [0035], [0048], [0069]). Patient motion during a CBCT scanning procedure may predictably cause the image data to be unusable as recognized by Dickhans ([0069]), therefore requiring another 3D CBCT image.
Conclusion
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/TOMMY T LY/ Examiner, Art Unit 3797
/SERKAN AKAR/ Primary Examiner, Art Unit 3797
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