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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/15/2025, 01/14/2026, 05/05/2026, and 06/05/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3-11 and 13-20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Moller et al. (Pub. No.: US 2024/0390076).
Consider claim 1, Moller discloses a method of navigating an instrument within an anatomy (paragraph [0073], navigation of a medical instrument to a target location in the anatomy), comprising:
generating a graphical user interface (GUI) that includes a first navigation feature depicting a spatial relationship between the instrument and a target within the anatomy (paragraph [0073], Fig. 4, graphical user interface 400 can operate in a navigation mode that is used to monitor the navigation of a medical instrument to a target location in the anatomy);
receiving first image data captured by a first imaging system external to the anatomy while the instrument is disposed within the anatomy (paragraph [0065], with patient CT scan, create a 3D model of anatomy, wherein the 3D model may be registered to the actual patient anatomy and/or the catheter within the patient anatomy. Consequently, the real-time position and orientation of the catheter may be projected onto the 3D model, see paragraph [0066]);
receiving first sensor data via a sensor disposed on the instrument (paragraph [0074], Fig. 5, live camera view 502 can be captured by an imaging device (e.g., a camera, an endoscope) located at the distal end of the elongate device);
determining a mapping between a first coordinate space associated with the first imaging system and a second coordinate space associated with the sensor based at least in part on the first image data and the first sensor data (paragraph [0098], Fig. 8A, operator O could command control system 112 to map live camera view 802 and/or the current pose of the elongate device to virtual view 804 (i.e., a rendering of the 3D model of the anatomy of patient P (e.g., from the perspective of the distal end of instrument 104), see paragraph [0073]));
determining an updated spatial relationship between the instrument and the target based at least in part on the mapping between the first coordinate space and the second coordinate space (paragraph [0098], control system 112 could update the registration based on that mapping);
receiving user input associated with the GUI (paragraph [0104], Figs. 8, 9, Graphical user interface 900 also includes up/down arrow button 904 for inputting a manual incremental adjustment of virtual view 804); and
displaying, on the GUI, the first navigation feature or a second navigation feature depicting the updated spatial relationship between the instrument and the target based on the received user input (paragraph [0098], operator O could command control system 112 to map live camera view 802 and/or the current pose of the elongate device to virtual view 804 as manually adjusted, and control system 112 could update the registration based on that mapping).
Consider claim 11, Moller discloses a controller for a medical system (paragraph [0045], Fig. 1, Teleoperated medical system 100 may also include control system 112), comprising:
a processing system (paragraph [0045], control system 112 includes at least one memory and at least one computer processor (not shown);
a memory storing instructions that, when executed by the processing system (paragraph [0045], Control system 112 also includes programmed instructions (e.g., a non-transitory machine-readable medium storing the instructions)), cause the controller to:
generate a graphical user interface (GUI) that includes a first navigation feature depicting a spatial relationship between an instrument and a target within an anatomy (paragraph [0073], Fig. 4, graphical user interface 400 can operate in a navigation mode that is used to monitor the navigation of a medical instrument to a target location in the anatomy);
receive first image data captured by a first imaging system external to the anatomy while the instrument is disposed within the anatomy (paragraph [0065], with patient CT scan, create a 3D model of anatomy, wherein the 3D model may be registered to the actual patient anatomy and/or the catheter within the patient anatomy. Consequently, the real-time position and orientation of the catheter may be projected onto the 3D model, see paragraph [0066]);
receive first sensor data via a sensor disposed on the instrument (paragraph [0074], Fig. 5, live camera view 502 can be captured by an imaging device (e.g., a camera, an endoscope) located at the distal end of the elongate device);
determine a mapping between a first coordinate space associated with the first imaging system and a second coordinate space associated with the sensor based at least in part on the first image data and the first sensor data (paragraph [0098], Fig. 8A, operator O could command control system 112 to map live camera view 802 and/or the current pose of the elongate device to virtual view 804 (i.e., a rendering of the 3D model of the anatomy of patient P (e.g., from the perspective of the distal end of instrument 104), see paragraph [0073]));
determine an updated spatial relationship between the instrument and the target based at least in part on the mapping between the first coordinate space and the second coordinate space (paragraph [0098], control system 112 could update the registration based on that mapping);
receive user input associated with the GUI (paragraph [0104], Figs. 8, 9, Graphical user interface 900 also includes up/down arrow button 904 for inputting a manual incremental adjustment of virtual view 804); and
display, on the GUI, the first navigation feature or a second navigation feature depicting the updated spatial relationship between the instrument and the target based on the received user input (paragraph [0098], operator O could command control system 112 to map live camera view 802 and/or the current pose of the elongate device to virtual view 804 as manually adjusted, and control system 112 could update the registration based on that mapping).
Consider claims 3, 13, Moller discloses wherein the displaying of the second navigation feature comprises: determining a correction associated with the updated spatial relationship (paragraph [0095], Figs. 8A-8C, registration between a 3D model and the patient anatomy is inaccurate); and applying the correction to the spatial relationship depicted by the first navigation feature (paragraph [0095], Figs. 8A-8C, adjust virtual view 804 as the elongate device moves in the patient anatomy so that virtual view 804 roughly corresponds to live camera view 802).
Consider claims 4, 14, Moller discloses wherein the displaying of the first navigation feature or the second navigation feature comprises: displaying a toggle feature indicating which of the first or second navigation features is displayed on the GUI (paragraph [0104], Fig. 9, graphical user interface 900 includes a linking status toggle button 902 to toggle the status of a linking mode with respect to the elongate device and virtual view 804); and
toggling between the first navigation feature and the second navigation feature for display on the GUI responsive to the user input (paragraph [0116], input toggling a linking mode between movement of the elongate device and the one or more visual representations).
Consider claims 5, 15, 7, 17, Moller discloses wherein the generating of the GUI comprises: receiving second image data captured by a second imaging system external to the anatomy while the instrument is not disposed within the anatomy (paragraph [0065], pre-operative planning steps may include segmentation of a patient CT scan to create a three-dimensional (3D) representation (e.g., a 3D model) of anatomy);
receiving second sensor data via the sensor disposed on the instrument (paragraph [0074], Fig. 5, live camera view 502 can be captured by an imaging device (e.g., a camera, an endoscope) located at the distal end of the elongate device);
determining a mapping between the second coordinate space and a third coordinate space associated with the second imaging system based at least in part on the second image data and the second sensor data (paragraph [0098], Fig. 8A, operator O could command control system 112 to map live camera view 802 and/or the current pose of the elongate device to virtual view 804 (i.e., a rendering of the 3D model of the anatomy of patient P (e.g., from the perspective of the distal end of instrument 104), see paragraph [0073])); and
determining the spatial relationship between the instrument and the target based at least in part on the mapping between the second coordinate space and the third coordinate space (paragraph [0098], control system 112 could update the registration based on that mapping).
Consider claims 6, 16, Moller discloses wherein the second imaging system is a computed tomography (CT) system (paragraph [0065], pre-operative planning steps may include segmentation of a patient CT scan).
Consider claims 8, 18, Moller discloses wherein the first navigation feature includes an anatomical model having positions of the instrument and the target overlaid thereon based on their spatial relationship (paragraph [0065], with patient CT scan, create a 3D model of anatomy, wherein the 3D model may be registered to the actual patient anatomy and/or the catheter within the patient anatomy. Consequently, the real-time position and orientation of the catheter may be projected onto the 3D model, see paragraph [0066]).
Consider claims 9, 19, Moller discloses wherein the second navigation feature includes the anatomical model having positions of the instrument and the target overlaid thereon based on their updated spatial relationship (paragraph [0065], with patient CT scan, create a 3D model of anatomy, wherein the 3D model may be registered to the actual patient anatomy and/or the catheter within the patient anatomy. Consequently, the real-time position and orientation of the catheter may be projected onto the 3D model, see paragraph [0066]).
Consider claims 10, 20, Moller discloses wherein the displaying of the first navigation feature or the second navigation feature comprises: displaying the first navigation feature and the second navigation feature concurrently in the GUI (paragraph [0073], local view 430 includes a live camera view of images captured by instrument 104 inside patient P and local view 430 in navigation mode can also include a virtual view).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 2 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Moller in view of Duindam et al. (Pub. No.: US 2019/0320878).
Consider claims 2, 12, Moller discloses presenting images of a surgical site recorded pre-operatively or intra-operatively using image data from imaging technology such as, computed tomography (CT) (paragraph [0042]).
Moller does not specifically disclose wherein the first imaging system is a cone beam computed tomography (CBCT) system.
Duindam discloses wherein the first imaging system is a cone beam computed tomography (CBCT) system (paragraph [0117], an image or images from a cone-beam CT scanner (i.e., first imaging system) that are obtained while a medical instrument is in place while additionally, images such as preoperative images (i.e., second imaging system), may also be registered into the common reference frame for use in image-guided medical procedures).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to replace the first imaging system as disclosed by Moller with the imaging system as taught by Duindam to obtain shape data from that medical instrument at or around the time the image or images are captured and to bring the image into a common reference frame with the medical instrument (Duindam, paragraph [0117].
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 2, 5 and 11, 12 and 15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-3 and 14-16 of copending Application No. 19/034,431 in view of Moller et al. (Pub. No.: US 2024/0390076). The highlighted portions of the Examined Application are limitations not claimed by the copending application.
Examined Application
Copending Application No. 19/034,431
1.A method of navigating an instrument within an anatomy, comprising: generating a graphical user interface (GUI) that includes a first navigation feature depicting a spatial relationship between the instrument and a target within the anatomy; receiving first image data captured by a first imaging system external to the anatomy while the instrument is disposed within the anatomy; receiving first sensor data via a sensor disposed on the instrument; determining a mapping between a first coordinate space associated with the first imaging system and a second coordinate space associated with the sensor based at least in part on the first image data and the first sensor data; determining an updated spatial relationship between the instrument and the target based at least in part on the mapping between the first coordinate space and the second coordinate space; receiving user input associated with the GUI; and displaying, on the GUI, the first navigation feature or a second navigation feature depicting the updated spatial relationship between the instrument and the target based on the received user input.
1. A method of navigating an instrument within an anatomy, comprising: generating a graphical interface depicting a spatial relationship between the instrument and a target within the anatomy; receiving first image data captured by a first imaging system external to the anatomy while the instrument is disposed within the anatomy; receiving first sensor data via one or more sensors associated with a sensor system, the one or more sensors including at least a first sensor disposed on the instrument; determining a mapping between a first coordinate space associated with the first imaging system and a second coordinate space associated with the sensor system based at least in part on the first image data and the first sensor data; and updating the graphical interface to depict an updated spatial relationship between the instrument and the target based at least in part on the mapping between the first coordinate space and the second coordinate space.
2.The method of claim 1, wherein the first imaging system is a cone beam computed tomography (CBCT) system.
2. The method of claim 1, wherein the first imaging system is a cone beam computed tomography (CBCT) system.
5.The method of claim 1, wherein the generating of the GUI comprises: receiving second image data captured by a second imaging system external to the anatomy while the instrument is not disposed within the anatomy; receiving second sensor data via the sensor disposed on the instrument; determining a mapping between the second coordinate space and a third coordinate space associated with the second imaging system based at least in part on the second image data and the second sensor data; and determining the spatial relationship between the instrument and the target based at least in part on the mapping between the second coordinate space and the third coordinate space.
3. The method of claim 1, wherein the generating of the graphical interface comprises: receiving second image data via a second imaging system external to the anatomy; receiving second sensor data via the first sensor disposed on the instrument; determining a mapping between the second coordinate space and a third coordinate space associated with the second imaging system based at least in part on the second image data and the second sensor data; and determining the spatial relationship between the instrument and the target based at least in part on the mapping between the second coordinate space and the third coordinate space.
11.A controller for a medical system, comprising: a processing system; a memory storing instructions that, when executed by the processing system, cause the controller to: generate a graphical user interface (GUI) that includes a first navigation feature depicting a spatial relationship between an instrument and a target within an anatomy; receive first image data captured by a first imaging system external to the anatomy while the instrument is disposed within the anatomy; receive first sensor data via a sensor disposed on the instrument; determine a mapping between a first coordinate space associated with the first imaging system and a second coordinate space associated with the sensor based at least in part on the first image data and the first sensor data; determine an updated spatial relationship between the instrument and the target based at least in part on the mapping between the first coordinate space and the second coordinate space; receive user input associated with the GUI; and display, on the GUI, the first navigation feature or a second navigation feature depicting the updated spatial relationship between the instrument and the target based on the received user input.
14. A controller for a medical system, comprising: a processing system; and a memory storing instructions that, when executed by the processing system, cause the controller to: generate a graphical interface depicting a spatial relationship between the instrument and a target within the anatomy; receive first image data captured by a first imaging system external to the anatomy while the instrument is disposed within the anatomy; receive first sensor data via one or more sensors associated with a sensor system, the one or more sensors including at least a first sensor disposed on the instrument; determine a mapping between a first coordinate space associated with the first imaging system and a second coordinate space associated with the sensor system based at least in part on the first image data and the first sensor data; and update the graphical interface to depict an updated spatial relationship between the instrument and the target based at least in part on the mapping between the first coordinate space and the second coordinate space.
12.The controller of claim 11, wherein the first imaging system is a cone beam computed tomography (CBCT) system.
15. The controller of claim 14, wherein the first imaging system is a cone beam computed tomography (CBCT) system.
15.The controller of claim 11, wherein the generating of the GUI comprises: receiving second image data captured by a second imaging system external to the anatomy while the instrument is not disposed within the anatomy; receiving second sensor data via the sensor disposed on the instrument; determining a mapping between the second coordinate space and a third coordinate space associated with the second imaging system based at least in part on the second image data and the second sensor data; and determining the spatial relationship between the instrument and the target based at least in part on the mapping between the second coordinate space and the third coordinate space.
16. The controller of claim 14, wherein the generating of the graphical interface comprises: receiving second image data via a second imaging system external to the anatomy; receiving second sensor data via the first sensor disposed on the instrument; determining a mapping between the second coordinate space and a third coordinate space associated with the second imaging system based at least in part on the second image data and the second sensor data; and determining the spatial relationship between the instrument and the target based at least in part on the mapping between the second coordinate space and the third coordinate space.
The copending application fails to disclose receiving user input associated with the GUI; and displaying, on the GUI, the first navigation feature or a second navigation feature depicting the updated spatial relationship between the instrument and the target based on the received user input.
Moller discloses receiving user input associated with the GUI (paragraph [0104], Figs. 8, 9, Graphical user interface 900 also includes up/down arrow button 904 for inputting a manual incremental adjustment of virtual view 804); and
displaying, on the GUI, the first navigation feature or a second navigation feature depicting the updated spatial relationship between the instrument and the target based on the received user input (paragraph [0098], operator O could command control system 112 to map live camera view 802 and/or the current pose of the elongate device to virtual view 804 as manually adjusted, and control system 112 could update the registration based on that mapping).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to replace the graphical user interface as disclosed by copending application with the graphical user interface as taught by Moller to manually adjust virtual view to account for the deviations, so that virtual view can substantially match live camera view (Moller, paragraph [0098]).
Claims 1, 11, and 12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 2, and 12 of copending Application No. 19/090,297 in view of Moller et al. (Pub. No.: US 2024/0390076). The highlighted portions of the Examined Application are limitations not claimed by the copending application.
Examined Application
Copending Application No. 19/090,297
1.A method of navigating an instrument within an anatomy, comprising: generating a graphical user interface (GUI) that includes a first navigation feature depicting a spatial relationship between the instrument and a target within the anatomy; receiving first image data captured by a first imaging system external to the anatomy while the instrument is disposed within the anatomy; receiving first sensor data via a sensor disposed on the instrument; determining a mapping between a first coordinate space associated with the first imaging system and a second coordinate space associated with the sensor based at least in part on the first image data and the first sensor data; determining an updated spatial relationship between the instrument and the target based at least in part on the mapping between the first coordinate space and the second coordinate space; receiving user input associated with the GUI; and displaying, on the GUI, the first navigation feature or a second navigation feature depicting the updated spatial relationship between the instrument and the target based on the received user input.
12. A method performed by a controller for a medical system, comprising: generating a graphical interface depicting a first spatial relationship between an instrument and a target within an anatomy; receiving first image data depicting the anatomy having the instrument disposed therein, the first image data captured by a first imaging system positioned external to the anatomy; determining a second spatial relationship between the instrument and the target within the anatomy based at least in part on the first image data; and updating the graphical interface to depict the second spatial relationship between the instrument and the target.
11.A controller for a medical system, comprising: a processing system; a memory storing instructions that, when executed by the processing system, cause the controller to: generate a graphical user interface (GUI) that includes a first navigation feature depicting a spatial relationship between an instrument and a target within an anatomy; receive first image data captured by a first imaging system external to the anatomy while the instrument is disposed within the anatomy; receive first sensor data via a sensor disposed on the instrument; determine a mapping between a first coordinate space associated with the first imaging system and a second coordinate space associated with the sensor based at least in part on the first image data and the first sensor data; determine an updated spatial relationship between the instrument and the target based at least in part on the mapping between the first coordinate space and the second coordinate space; receive user input associated with the GUI; and display, on the GUI, the first navigation feature or a second navigation feature depicting the updated spatial relationship between the instrument and the target based on the received user input.
1. A medical system comprising: a first imaging system; and control circuitry configured to: generate a graphical interface depicting a first spatial relationship between an instrument and a target within the anatomy; receive first image data depicting the anatomy having the instrument disposed therein, the first image data captured by the first imaging system while positioned external to the anatomy; determine a second spatial relationship between the instrument and the target within the anatomy based at least in part on the first image data; and update the graphical interface to depict the second spatial relationship between the instrument and the target.
12.The controller of claim 11, wherein the first imaging system is a cone beam computed tomography (CBCT) system.
2. The medical system of claim 1, wherein the first imaging system is a cone beam computed tomography (CBCT) imaging system.
The copending application fails to disclose receiving user input associated with the GUI; and displaying, on the GUI, the first navigation feature or a second navigation feature depicting the updated spatial relationship between the instrument and the target based on the received user input.
Moller discloses receiving user input associated with the GUI (paragraph [0104], Figs. 8, 9, Graphical user interface 900 also includes up/down arrow button 904 for inputting a manual incremental adjustment of virtual view 804); and
displaying, on the GUI, the first navigation feature or a second navigation feature depicting the updated spatial relationship between the instrument and the target based on the received user input (paragraph [0098], operator O could command control system 112 to map live camera view 802 and/or the current pose of the elongate device to virtual view 804 as manually adjusted, and control system 112 could update the registration based on that mapping).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to replace the graphical user interface as disclosed by copending application with the graphical user interface as taught by Moller to manually adjust virtual view to account for the deviations, so that virtual view can substantially match live camera view (Moller, paragraph [0098]).
These are provisional nonstatutory double patenting rejections.
Conclusion
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/Gerald Johnson/
Primary Examiner, Art Unit 3797
Prosecution Insights