DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/22/2025 has been entered.
Response to Amendment
The amendment filed on 12/22/2025 has been entered. Claims 22-38 and 40 remain pending the application.
Response to Arguments
Applicant's arguments filed on 12/22/2025 have been fully considered but they are moot.
Applicant argues on pages 5-6 that the previous rejection does not address the newly added limitations to the claims related to updating a sensed location. This argument is moot in view of the new grounds of rejection necessitated by amendment which relies on newly cited portions of Langan and Kang to disclose these limitations in the claims. Accordingly, this argument is moot.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 22-25, 30, and 40 are 35 U.S.C. 103 as being unpatentable over Langan et al. (US20160166329, hereafter Langan) and Kang et al. (US20130096574, hereafter Kang).
Regarding claims 22 and 40, Langan discloses in Figures 1-4 a system and method, comprising:
a catheter (Langan, Para 59; “It will also be appreciated that the devices/needles as discussed herein may be […] intravascular navigated devices (e.g., catheters”);
a display (display 64);
a processor; and a memory (system controller 48) having stored thereon instructions, which, when executed by the processor (Langan, Para 25; “In practice, the system controller 48 may incorporate one or more processing devices that include or communicate with tangible, non-transitory, machine readable media collectively storing instructions executable by the one or more processors to perform the operations described herein.”), cause the processor to:
display, on the display, a three-dimensional (3D) model of a luminal network from pre-procedural images, the 3D model including a target (target 132) (Langan, Para 44; “an initial planning acquisition (e.g., a CBCT or CT image acquisition) may be performed (block 124) to generate a three-dimensional (3D) volume 126 of the anatomical area of the patient where the procedure is to be performed”) (Langan, Para 17; “pre-procedure 3D imaging, generally CT or CBCT imaged volumes, may be employed”) (Langan, Para 45; “For example, the 3D volume 126 may be used to identify (block 130) the target structure or region 132 and to plan the procedure (block 134), such as by determining an entry point 140, a path 144, and identification of critical structures 148 to avoid, and so forth. The procedure plan (e.g., target 132, entry point 140, path 144, and structures to avoid 148) may be used to determine (block 154) operating parameters under which the primary C-arm to be moved during navigation of the tool will operate during the procedure”) and a pathway to navigate the catheter to the target (Langan, Para 29; "the operator workstation may enable the operator to perform one or more of marking the target region in 3D (e.g., by tracing an outline of a tumor), (partially) planning the trajectory of a device (e.g., by tracing the intended path of a needle), choosing a center view around which the tomosynthesis acquisition will be centered, or setting up other acquisition parameters, and so forth") (Langan, Para 45; "For example, the 3D volume 126 may be used to identify (block 130) the target structure or region 132 and to plan the procedure (block 134), such as by determining an entry point 140, a path 144, and identification of critical structures 148 to avoid, and so forth.");
receive cone-beam computed tomography (CBCT) images (Langan, Para 16; “access to the patient is significantly improved relative to computed tomography (CT) imaging system or conventional Cone Beam Computed Tomography (CBCT) with a C-arm imaging system. The present approach also offers improved imaging and 3D resolution relative to conventional radiological approaches as well as a temporal image sampling rate or update rate that is sufficient for real-time (or near real-time) tracking in navigational procedures and superior to what is typically obtained in CBCT imaging.”) of a luminal network (Langan, Para 52; “When the clinician believes the needle has reached its target (decision block 280), CBCT or tomosynthesis with lateral views may be performed, if desired, to achieve higher image quality to verify (block 282) needle position 250.”);
detect a distal portion of the catheter and the target in the CBCT images (Langan, Para 52; “When the clinician believes the needle has reached its target (decision block 280), CBCT or tomosynthesis with lateral views may be performed, if desired, to achieve higher image quality to verify (block 282) needle position 250.”) (Langan, Para 55; “The location of the target region within the volume may be updated, either by registration, or by the operator. In the final stages of the procedure, a further acquisition in “evaluation mode” may be performed to verify placement of the needle tip relative to the target region.”) (Langan, Para 55; “With this in mind, as part of an “evaluation mode” of the process 190 during which the emphasis is on reconstruction of needle and its current position relative to the target region, as well as anatomical context and detail, and allows for evaluation of the progress of the procedure. In one implementation, at regular intervals, or as requested by the operator, X-ray data is acquired at a high frame rate. During this time (i.e., the “evaluation mode”), the gantry moves through a tomosynthesis trajectory with a larger angle (i.e., a larger or wider orbit). In one embodiment, the full field of view is imaged during the evaluation mode (i.e., the X-ray beam is not collimated down to a small area). The reconstructed volume may contain added special emphasis on the current needle position (e.g., in-painted), as well as the target region (e.g., as overlayed contour, or marker).”);
update a sensed location of a distal portion of the catheter with a detected location of the distal portion of the catheter from the CBCT images (Langan, Para 55; “The location of the target region within the volume may be updated, either by registration, or by the operator. In the final stages of the procedure, a further acquisition in “evaluation mode” may be performed to verify placement of the needle tip relative to the target region.”) (Langan, Para 52; “When the clinician believes the needle has reached its target (decision block 280), CBCT or tomosynthesis with lateral views may be performed, if desired, to achieve higher image quality to verify (block 282) needle position 250.”) (Langan, Para 54; “While the needle or tool position may be updated near continuously or with great frequency as X-ray acquisitions 240 occur over time, in certain embodiments the target position 210 is updated (block 270) at a lower rate, such as at a rate consistent with procedural need.”); and
display, on the display, the updated location of the distal portion of the catheter in the 3D model (Langan, Para 55; “The location of the target region within the volume may be updated, either by registration, or by the operator. In the final stages of the procedure, a further acquisition in “evaluation mode” may be performed to verify placement of the needle tip relative to the target region.”) (Langan, Para 52; “When the clinician believes the needle has reached its target (decision block 280), CBCT or tomosynthesis with lateral views may be performed, if desired, to achieve higher image quality to verify (block 282) needle position 250.”).
Langan does not clearly and explicitly disclose displaying an updated pathway from the updated location of the distal portion of the catheter to the target in the 3D model based.
In an analogous surgical navigation system field of endeavor Kang discloses displaying an updated pathway from an updated location of a distal portion of a medical tool to a target in a 3D model based on imaging (Kang, Para 45; "In another embodiment, toolpath optimization in real or near-real time may be utilized to assist an operator in cutting out a targeted volume of tissue.") (Kang, Para 46; "Referring to FIG. 6C, a bounding volume (304) such as a sphere for a substantially spherical bone cutting burr (with cutting tool centerpoint labeled as element 306), may be analyzed automatically in real or near-real time as intersecting with the voxel mesh (302); the values of the voxels in this effected intersecting volume may be numerically analyzed and summed in view of the potential field function (300), and the output from this summation may be used as an input in the controls scheme to alter the tool path […] the tool path optimization may continue to evolve, and to help the operator to remove all of the bone or other tissue, as per the preoperative plan.").
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Langan to include displaying an updated pathway from the updated location of the distal portion of the catheter to the target in the 3D model based in order to optimize the path as needed to complete the procedure based on newly acquired information or changes in the spatial relationship between the tool and the tissue structure as taught by Kang (Kang, Para 45-46 and 4) which improves precision and safety.
Regarding claim 23, Langan as modified by Kang above discloses all of the limitations of claim 22 as discussed above.
Langan further discloses wherein the instructions further cause the processor to detect a location of the catheter within the luminal network, and display, on the display, a distal portion of the catheter in the 3D model (Langan, Para 50; “3D position 250 may be determined (block 252) from the acquired projections in substantially real-time and used to update (block 256) the initial volume 196 to depict the current position 250 of the needle in an updated or displayed volume 254. In one embodiment, the update of the volume may consist of in-painting the estimated location of the tool/needle. In certain embodiments, the needle and surrounding tissue may be visualized in three-dimensions (i.e., as a volumetric representation) to convey the position, orientation, and curvature of the needle (or other tool) in the context of the surrounding tissue”) (Langan, Para 49; “acquisitions 242 may be prompted in response to or taking in to account target position 210 and/or needle position 250 over the course of the procedure. For example, based on the current target or needle position and/or orientation, or on changes to the target or needle position, additional acquisitions 242 may be prompted. Likewise, acquisitions may be prompted based on an elapsed time since a previous acquisition, or an elapsed time since a needle or target position update”) (Langan, Para 59; “It will also be appreciated that the devices/needles as discussed herein may be […] intravascular navigated devices (e.g., catheters”).
Regarding claim 24, Langan as modified by Kang above discloses all of the limitations of claim 23 as discussed above.
Langan further discloses wherein the instructions further cause the processor to display the location of the distal portion of the catheter in the luminal network as the catheter is navigated through the luminal network towards the target (Langan, Para 50; “3D position 250 may be determined (block 252) from the acquired projections in substantially real-time and used to update (block 256) the initial volume 196 to depict the current position 250 of the needle in an updated or displayed volume 254. In one embodiment, the update of the volume may consist of in-painting the estimated location of the tool/needle. In certain embodiments, the needle and surrounding tissue may be visualized in three-dimensions (i.e., as a volumetric representation) to convey the position, orientation, and curvature of the needle (or other tool) in the context of the surrounding tissue”) (Langan, Para 49; “acquisitions 242 may be prompted in response to or taking in to account target position 210 and/or needle position 250 over the course of the procedure. For example, based on the current target or needle position and/or orientation, or on changes to the target or needle position, additional acquisitions 242 may be prompted. Likewise, acquisitions may be prompted based on an elapsed time since a previous acquisition, or an elapsed time since a needle or target position update”) (Langan, Para 59; “It will also be appreciated that the devices/needles as discussed herein may be […] intravascular navigated devices (e.g., catheters”).
Regarding claim 25, Langan as modified by Kang above discloses all of the limitations of claim 24 as discussed above.
Langan further discloses wherein the instructions further cause the processor to detect changes in a location of the catheter, and display, on the display, an updated location of the distal portion of the catheter in the 3D model (Langan, Para 50; “3D position 250 may be determined (block 252) from the acquired projections in substantially real-time and used to update (block 256) the initial volume 196 to depict the current position 250 of the needle in an updated or displayed volume 254. In one embodiment, the update of the volume may consist of in-painting the estimated location of the tool/needle. In certain embodiments, the needle and surrounding tissue may be visualized in three-dimensions (i.e., as a volumetric representation) to convey the position, orientation, and curvature of the needle (or other tool) in the context of the surrounding tissue”) (Langan, Para 49; “acquisitions 242 may be prompted in response to or taking in to account target position 210 and/or needle position 250 over the course of the procedure. For example, based on the current target or needle position and/or orientation, or on changes to the target or needle position, additional acquisitions 242 may be prompted. Likewise, acquisitions may be prompted based on an elapsed time since a previous acquisition, or an elapsed time since a needle or target position update”) (Langan, Para 59; “It will also be appreciated that the devices/needles as discussed herein may be […] intravascular navigated devices (e.g., catheters”).
Regarding claim 30, Langan as modified by Kang above discloses all of the limitations of claim 22 as discussed above.
Langan further discloses a biopsy tool or ablation tool configured to be inserted through the catheter to the target (Langan, Para 59; “It will also be appreciated that the devices/needles as discussed herein may be navigated/inserted percutaneously (e.g., a biopsy needle), as well as intravascular navigated devices (e.g., catheters for ablations, embolizations, etc.)”).
Claims 26-28 are rejected under 35 U.S.C. 103 as being unpatentable over Langan and Kang as applied to claim 25 above, and in further view of Walker et al. (US20140275985, hereafter Walker).
Regarding claim 26, Langan discloses all of the limitations of claim 25 as discussed above.
Langan does not clearly and explicitly disclose wherein the catheter includes a sensor, and the location of the catheter is determined based on data from the sensor.
In an analogous surgical navigation of a catheter field of endeavor Walker discloses wherein a catheter (Walker, Para 45; “Various localization systems and methods for tracking, performing localization of, and/or controlling an elongate instrument, e.g., a robotically controlled elongate instrument, in real time, in a clinical or other environment, are described herein. Various elongate instruments are contemplated for use in the various systems described herein, e.g., a catheter or vascular catheter”) includes a sensor, and the location of the catheter is determined based on data from the sensor (Walker, Para 45; “The various methods and systems may include integrating or registering a localization system or a localization sensor coupled to an elongate instrument, with an image. A Traxtal electromagnetic tracking or localization system is one example of a system that allows for the tracking of a location, position and/or orientation of a localization sensor placed in a pulsating electromagnetic or magnetic field”) in addition to imaging the location of the catheter (Walker, Para 138; “elongate instrument tracking may be performed using an active contour (“snake”) that tracks at least a portion of the elongate instrument, e.g., the shaft or articulation section, in an image, e.g., a fluoroscopy image”) (Walker, Para 159; “In certain variations, elongate instrument tracking may also include performing an image-based search, e.g., a template matching search or focused template matching search, along the active contour to track features of the elongate instrument, e.g., to enhance or confirm accuracy of the active contour or to locate a specific feature of the elongate instrument”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Langan wherein the catheter includes a sensor, and the location of the catheter is additionally determined based on data from the sensor in order to improve the precision and accuracy of the tracked location of the catheter as taught by Walker (Walker, Para 183).
Regarding claim 27, Langan as modified by Kang and Walker above discloses all of the limitations of claim 26 as discussed above.
Langan does not clearly and explicitly disclose wherein the sensor is an electromagnetic (EM) sensor.
However, Walker further discloses wherein the sensor is an electromagnetic (EM) sensor (Walker, Para 45; “The various methods and systems may include integrating or registering a localization system or a localization sensor coupled to an elongate instrument, with an image. A Traxtal electromagnetic tracking or localization system is one example of a system that allows for the tracking of a location, position and/or orientation of a localization sensor placed in a pulsating electromagnetic or magnetic field”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Langan wherein the sensor is an electromagnetic (EM) sensor in order to improve the precision and accuracy of the tracked location of the catheter as taught by Walker (Walker, Para 183).
Regarding claim 28, Langan as modified by Kang and Walker above discloses all of the limitations of claim 27 as discussed above.
Langan does not clearly and explicitly disclose an EM field generator configured to generate an EM field around the luminal network of the patient.
However, Walker further discloses an EM field generator configured to generate an EM field around the luminal network of the patient (Walker, Para 5; “a system for tracking or localizing a robotically controlled elongate instrument may include: an image of an anatomy of a patient; an electromagnetic localization sensor coupled to an elongate instrument; and/or an electromagnetic field generator. The generator may be configured to produce an electromagnetic field in which the electromagnetic localization sensor is detected. The localization sensor may provide localization data for at least a portion of the elongate instrument, where the localization data may be registered to the image to provide a continuously updated location of at least a portion of the elongate instrument in the image. This may facilitate robotic navigation of the elongate instrument through the anatomy”) (Walker, Para 45; “Various localization systems and methods for tracking, performing localization of, and/or controlling an elongate instrument, e.g., a robotically controlled elongate instrument, in real time, in a clinical or other environment, are described herein. Various elongate instruments are contemplated for use in the various systems described herein, e.g., a catheter or vascular catheter”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Langan to include an EM field generator configured to generate an EM field around the luminal network of the patient in order to improve the precision and accuracy of the tracked location of the catheter as taught by Walker (Walker, Para 183).
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Langan and Kang as applied to claim 25 above, and in further view of Schneider et al. (US20130131503, hereafter Schneider).
Regarding claim 29, Langan as modified by Kang above discloses all of the limitations of claim 25 as discussed above.
Langan does not clearly and explicitly disclose wherein the instructions further cause the processor to determine that the catheter is at the target.
In an analogous surgical navigation of a catheter field of endeavor Schneider discloses wherein the instructions further cause a processor to determine that a catheter is at a target (Schneider, Para 7; “The method includes determining, at the computer system, if a tip of a catheter has been positioned at the determined location of the tip of the guidewire, and providing, by the computer system to a user interface, an indication that the tip of the catheter has been positioned at the determined location of the tip of the guidewire. The predetermined location corresponds to a location of a target device. The target device is internal to the patient. The indication that the tip of the catheter has been positioned at the determined location comprises at least one of visual and audible confirmation”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Langan wherein the instructions further cause the processor to determine that the catheter is at the target as taught by Langan in order to make the device easier to use by providing useful notifications to the user.
Claims 31 and 34-36 are rejected under 35 U.S.C. 103 as being unpatentable over Langan and Kang as applied to claim 30 above, and in further view of Whitman et al. (US20030050654, hereafter Whitman) and Seeley et al. (US20030130576, hereafter Seeley).
Regarding claim 31, Langan as modified by Kang above discloses all of the limitations of claim 30 as discussed above.
Langan does not clearly and explicitly disclose wherein the instructions further cause the processor to detect that the inserted tool is a biopsy tool, and display, on the display, a representation of the biopsy tool in relation to the target.
In an analogous surgical navigation field of endeavor Whiteman discloses a processor detecting that an inserted tool is a biopsy tool (Whitman, Para 21; “he electromechanical surgical device includes a first memory unit configured to store a plurality of operating programs or algorithms, each corresponding to a respective type of surgical instrument. The control system is configured to detect the type of surgical instrument attached to the electromechanical surgical device and to select or read the operating program or algorithm corresponding to the attached surgical instrument”) (Whitman, Para 5; “an electronic biopsy instrument with wiperless position sensors”) (Whitman, Para 39; “The surgical instrument or attachment may be, for example, a surgical stapler, a surgical cutter, a surgical stapler-cutter, a linear surgical stapler, a linear surgical stapler-cutter, a circular surgical stapler, a circular surgical stapler-cutter, a surgical clip applier, a surgical clip ligator, a surgical clamping device, a vessel expanding device, a lumen expanding device, a scalpel, a fluid delivery device or any other type of surgical instrument”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Langan wherein the instructions further cause the processor to detect that the inserted tool is a biopsy tool in order to select the operating program or algorithm corresponding to the biopsy tool and therefore operate the tool correctly as taught by Whitman (Whitman, Para 21 and 53).
In an analogous surgical navigation field of endeavor Seeley discloses displaying on the display, a representation of the biopsy tool in relation to a target (Seeley, Para 4; “In tool navigation systems of this type, the display visible to the surgeon may show an image of the surgical tool, biopsy instrument, pedicle screw, probe or the like projected onto a fluoroscopic image, so that the surgeon may visualize the orientation of the surgical instrument in relation to the imaged patient anatomy, while an appropriate reconstructed CT or MRI image, which may correspond to the tracked coordinates of the probe tip, is also displayed”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Langan wherein the instructions further cause the processor to display, on the display, a representation of the biopsy tool in relation to the target in order to allow a surgeon to visualize the orientation of the surgical instrument relative to the patient as taught by Seeley (Seeley, Para 4-5).
Regarding claim 34, Langan as modified by Kang above discloses all of the limitations of claim 30 as discussed above.
Langan further discloses wherein the inserted tool is an ablation tool (Langan, Para 59; “It will also be appreciated that the devices/needles as discussed herein may be navigated/inserted percutaneously (e.g., a biopsy needle), as well as intravascular navigated devices (e.g., catheters for ablations, embolizations, etc.)”).
Langan does not clearly and explicitly disclose wherein the instructions further cause the processor to detect that the inserted tool is an ablation tool, and display, on the display, a representation of the ablation tool in relation to the target.
In an analogous surgical navigation field of endeavor Whiteman discloses a processor detecting the type of a connected tool (Whitman, Para 21; “he electromechanical surgical device includes a first memory unit configured to store a plurality of operating programs or algorithms, each corresponding to a respective type of surgical instrument. The control system is configured to detect the type of surgical instrument attached to the electromechanical surgical device and to select or read the operating program or algorithm corresponding to the attached surgical instrument”) (Whitman, Para 5; “an electronic biopsy instrument with wiperless position sensors”) (Whitman, Para 39; “The surgical instrument or attachment may be, for example, a surgical stapler, a surgical cutter, a surgical stapler-cutter, a linear surgical stapler, a linear surgical stapler-cutter, a circular surgical stapler, a circular surgical stapler-cutter, a surgical clip applier, a surgical clip ligator, a surgical clamping device, a vessel expanding device, a lumen expanding device, a scalpel, a fluid delivery device or any other type of surgical instrument”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Langan wherein the instructions further cause the processor to detect that the inserted tool is an ablation tool in order to select the operating program or algorithm corresponding to the biopsy tool and therefore operate the tool correctly as taught by Whitman (Whitman, Para 21 and 53).
In an analogous surgical navigation field of endeavor Seeley discloses displaying on the display, a representation of a tool in relation to a target (Seeley, Para 4; “In tool navigation systems of this type, the display visible to the surgeon may show an image of the surgical tool, biopsy instrument, pedicle screw, probe or the like projected onto a fluoroscopic image, so that the surgeon may visualize the orientation of the surgical instrument in relation to the imaged patient anatomy, while an appropriate reconstructed CT or MRI image, which may correspond to the tracked coordinates of the probe tip, is also displayed”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Langan wherein the instructions further cause the processor to display, on the display, a representation of the ablation tool in relation to the target in order to allow a surgeon to visualize the orientation of the surgical instrument relative to the patient as taught by Seeley (Seeley, Para 4-5).
Regarding claim 35, Langan as modified by Kang, Whitman, and Seeley above discloses all of the limitations of claim 34 as discussed above.
Langan further discloses wherein the instructions further cause the processor to acquire additional imaging of the luminal network to confirm placement of the ablation tool in a tumor at the target (Langan, Para 17; “such as tissue (including the navigational target region, e.g., a tumor)”) (Langan, Para 29; “one embodiment the operator workstation may enable the operator to perform one or more of marking the target region in 3D (e.g., by tracing an outline of a tumor)”) (Langan, Para 2; “For example, […] RF ablation of liver tumors […] may involve the insertion and navigation of a needle or needle associated tool through the body of a patient”) (Langan, Para 52; “When the clinician believes the needle has reached its target (decision block 280), CBCT or tomosynthesis with lateral views may be performed, if desired, to achieve higher image quality to verify (block 282) needle position 250.”) (Langan, Para 55; “The location of the target region within the volume may be updated, either by registration, or by the operator. In the final stages of the procedure, a further acquisition in “evaluation mode” may be performed to verify placement of the needle tip relative to the target region.”).
Regarding claim 36, Langan as modified by Kang, Whitman, and Seeley above discloses all of the limitations of claim 35 as discussed above.
Langan further discloses wherein the additional imaging is fluoroscopic imaging or CBCT imaging (Langan, Para 52; “When the clinician believes the needle has reached its target (decision block 280), CBCT or tomosynthesis with lateral views may be performed, if desired, to achieve higher image quality to verify (block 282) needle position 250.”) (Langan, Para 55; “The location of the target region within the volume may be updated, either by registration, or by the operator. In the final stages of the procedure, a further acquisition in “evaluation mode” may be performed to verify placement of the needle tip relative to the target region.”).
Claims 32-33 are rejected under 35 U.S.C. 103 as being unpatentable over Langan and Kang as applied to claim 30 above, and in further view of Macaulay et al. (US20060184011, hereafter Macaulay).
Regarding claim 32, Langan as modified by Kang above discloses all of the limitations of claim 30 as discussed above.
Langan further discloses wherein the instructions further cause the processor to identify a pathway to the target (Langan, Para 45; “For example, the 3D volume 126 may be used to identify (block 130) the target structure or region 132 and to plan the procedure (block 134), such as by determining an entry point 140, a path 144, and identification of critical structures 148 to avoid, and so forth. The procedure plan (e.g., target 132, entry point 140, path 144, and structures to avoid 148)”).
Langan does not clearly and explicitly disclose wherein the instructions further cause the processor to identify an exit point from the luminal network to arrive at the target.
In analogous surgical navigation field of endeavor Macaulay identifying an exit point from a luminal network to arrive at a target (Macaulay, Para 14; “FIGS. 2A through 2C show steps in a method for using the MRI guidable tissue penetrating catheter device of FIG. 1 to form a penetration tract from a location within the lumen of one blood vessel to a target location”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Langan wherein the instructions further cause the processor to identify an exit point from the luminal network to arrive at the target in order to properly guide penetrating catheters when needed for treatment as taught by Macaulay (Macaulay, Para 2-6).
Regarding claim 33, Langan as modified by Kang above discloses all of the limitations of claim 30 as discussed above.
Langan further discloses wherein the instructions further cause the processor to identify a pathway to the target (Langan, Para 45; “For example, the 3D volume 126 may be used to identify (block 130) the target structure or region 132 and to plan the procedure (block 134), such as by determining an entry point 140, a path 144, and identification of critical structures 148 to avoid, and so forth. The procedure plan (e.g., target 132, entry point 140, path 144, and structures to avoid 148)”).
Langan does not clearly and explicitly disclose wherein the instructions further cause the processor to identify an exit point in a wall of the luminal network to access the target.
In analogous surgical navigation field of endeavor Macaulay identifying an exit point from a wall of a luminal network to arrive at a target (Macaulay, Para 14; “FIGS. 2A through 2C show steps in a method for using the MRI guidable tissue penetrating catheter device of FIG. 1 to form a penetration tract from a location within the lumen of one blood vessel to a target location”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Langan wherein the instructions further cause the processor to identify an exit point in a wall of the luminal network to access the target in order to properly guide penetrating catheters when needed for treatment as taught by Macaulay (Macaulay, Para 2-6).
Claims 37-38 are rejected under 35 U.S.C. 103 as being unpatentable over Langan, Kang, Whitman, and Seeley as applied to claim 35 above, and further in view of Anand et al. (US20160242838, hereafter Anand).
Regarding claim 37, Langan as modified by Kang, Whitman, and Seeley above discloses all of the limitations of claim 35 as discussed above.
Langan does not clearly and explicitly disclose wherein the instructions further cause the processor to display, on the display, a projected ablation zone around a radiating portion of the ablation tool.
In an analogous surgical navigation field of endeavor Anand discloses displaying, on a display, a projected ablation zone around a radiating portion of an ablation tool (Anand, Para 48; “the boundary of the ablation zone 16 or the three-dimensional size of the ablation zone 16 has to be determined precisely within the tissue 10 to remove e.g. all tumor cells and to reduce the risk of cancer recurrence. Hence, the boundary of the ablation zone 16 is determined”) (Anand, Para 55; “updated during the ablation procedure include thermal constants such as thermal diffusivity and perfusion rate, electrical properties such as electrical conductivity and average flow rate in the blood vessels visualized in the computer tomography or ultrasound images. By means of this flexibility of the thermal model, e.g. for local heterogeneities, the temperature map and the ablation zone 16 can be precisely determined so that the boundary of the ablation zone 16 as the region of interest can be precisely measured non-invasively in order to optimize the thermal treatment”)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Langan wherein the instructions further cause the processor to display, on the display, a projected ablation zone around a radiating portion of the ablation tool in order to eliminate all the cancer cells to reduce recurrence as taught by Anand (Anand, Para 48).
Regarding claim 38, Langan as modified by Kang, Whitman, Seeley, and Ananda above discloses all of the limitations of claim 37 as discussed above.
Langan does not clearly and explicitly disclose wherein the instructions further cause the processor to display, on the display, the projected ablation zone on the 3D model or on the acquired additional imaging.
In an analogous surgical navigation field of endeavor Anand discloses displaying, on a display, a projected ablation zone on a 3D model (Anand, Para 48; “the boundary of the ablation zone 16 or the three-dimensional size of the ablation zone 16 has to be determined precisely within the tissue 10 to remove e.g. all tumor cells and to reduce the risk of cancer recurrence. Hence, the boundary of the ablation zone 16 is determined”) (Anand, Para 55; “updated during the ablation procedure include thermal constants such as thermal diffusivity and perfusion rate, electrical properties such as electrical conductivity and average flow rate in the blood vessels visualized in the computer tomography or ultrasound images. By means of this flexibility of the thermal model, e.g. for local heterogeneities, the temperature map and the ablation zone 16 can be precisely determined so that the boundary of the ablation zone 16 as the region of interest can be precisely measured non-invasively in order to optimize the thermal treatment”)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Langan wherein the instructions further cause the processor to display, on the display, the projected ablation zone on the 3D model or on the acquired additional imaging in order to eliminate all the cancer cells to reduce recurrence as taught by Anand (Anand, Para 48).
Conclusion
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/JOHN D LI/Primary Examiner, Art Unit 3798
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