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 .
Response to Arguments
Applicant's arguments filed 04/02/2026 have been fully considered but they are not persuasive.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, applicant argues on page 9 of the remarks that “Torjesen's system already displays medical imaging data on conventional 2D screens in the imaging coordinate system. The system uses fluoroscopy, ultrasound, and other imaging modalities to capture internal anatomy and displays these images on workstations.” However, Powell also discloses a workstation 224 which includes a secondary display 226 that can display a mirrored image of the display on the display device 104 (i.e., head-mounted display device) worn by the user (see paragraph [0045], Fig. 2A). Therefore, it would have been obvious to replace (or modify) the display system as disclosed by Torjesen with (or to include) the display system as taught by Powell to allow the surgeon to visualize aspects of a surgical site that may be obscured in the physical scene (Powel, paragraph [0047]) and to provide a mirrored image of the display on head-mounted display device worn by the user (Powell, paragraph [0045]).
Further, given that Powell’s head-mounted display device only mirror’s the display image of the workstation without changing its own system’s operational principle as applicant argues on page 10 of the remarks, it would have been obvious to one having ordinary skill in the art to implement the system in a similar manner and/or provide a simple substitution of one display for another contrary to applicant’s argument on page 10 of the remarks.
Accordingly, the rejection is maintained.
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 1-3, 5, 6, 8, 10, 12-15, 18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Torjesen et al. (Pub. No.: WO 2024/141395) in view of Powell et al. (Pub, No.: WO 2023/287862).
Consider claims 1, 18, Torjesen discloses a system for image-guided intervention of a patient (page 4, lines 27-29, optical (shape) sensing based interventional procedure on a patient), comprising:
an endoluminal probe (page 15, lines 9-17, endoluminal probe 151 (e.g. ultrasound probe) or TEE probe (e.g. transesophageal echocardiography probe)) configured to acquire a real-time image of an internal site within the patient (page 15, lines 9-17, rendering in the probe image volume in real-time as the probe is manipulated to view the anatomy);
a tracking system configured to track a position and an orientation of the endoluminal probe (page 15, lines 9-17, endoluminal probe 151 (e.g. ultrasound probe) is tracked wherein a position and/or an orientation of an interventional device is tracked, see page 4, lines 30-33);
a display system configured to display the real-time image acquired by the endoluminal probe (page 7, line 3-6, facilitating a display of a manual navigation of an interventional device along a planned surgical path in real-time, see page 12, lines 4-9); and
a registration system configured to register the real-time image from the endoluminal probe with a preoperative image of the internal site (page 13, line 36 – page 14, line 9, register the endoluminal image with the preoperative 3D model),
wherein the display system overlays the registered real-time image from the endoluminal probe with the preoperative image to assist in navigation and intervention at the internal site (page 13, line 36 – page 14, line 9, rendering the position of an endoluminal device on a preoperative 3D model).
Torjesen does not specifically disclose wherein the display system includes an extended reality headset configured to provide stereoscopic three-dimensional visualization of the overlaid registered real-time image and preoperative image.
Powell discloses wherein the display system includes an extended reality headset (paragraph [0047], head-mounted display) configured to provide stereoscopic three-dimensional visualization of the overlaid registered real-time image and preoperative image (paragraph [0047], image data, such as CT scans, can be registered to and overlaid over the image of the scene 108 (e.g., a patient undergoing surgery including a surgical instrument or tool) via a head-mounted display, wherein image processing device 103 can render 3D representations of the instrument 301 on the user interface 330 in the 3D view 332, see paragraph [0048], Fig. 3).
Therefore, it would have been obvious having ordinary skill in the art before the effective filing date of the claimed invention to replace (or modify) the display system as disclosed by Torjesen with (or to include) the display system as taught by Powell to allow the surgeon to visualize aspects of a surgical site that may be obscured in the physical scene (Powel, paragraph [0047]) and to provide a mirrored image of the display onto a head-mounted display device worn by the user (Powell, paragraph [0045]).
Consider claim 2, the combination of Torjesen and Powell discloses wherein the endoluminal probe includes an ultrasound transducer located at a distal end configured to ultrasonically image the internal site (page 15, lines 9-17, endoluminal probe 151 (e.g. ultrasound probe or TEE probe (e.g. transesophageal echocardiography probe) known in art to include an ultrasound transducer at the tip to produce ultrasound images (per Wikipedia)).
Consider claim 3, the combination of Torjesen and Powell discloses wherein the tracking system includes at least one of:
an inertial measurement unit (IMU);
an electromagnetic sensor; and
a fiber optic shape sensor (page 1, lines 23-29, optical (shape) sensor provided by a Fiber Optical RealShape (FORS) fiber),
integrated with the endoluminal probe to track the position and the orientation of the endoluminal probe (page 8, lines 21-26, cap with a known shape template is retrofitted to the TEE probe and the (FORS) guidewire is integrated into a shape template in the cap).
Consider claims 5, 6, Torjesen does not specifically disclose wherein the tracking system includes advanced model targeting of the endoluminal probe to determine the position and the orientation.
Powell discloses wherein the tracking system includes advanced model targeting of the endoluminal probe to determine the position and the orientation (paragraph [0033], Fig. 1, optical markers (e.g., fiducial markers, marker balls) in the scene 108, such as markers 111 coupled to the instrument 101).
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 tracking system as disclosed by Torjesen with the tracking system as taught by Powell to capture images of the scene from a different perspective compared to other ones of the trackers (Powell, paragraph [0033]).
Consider claim 8, the combination of Torjesen and Powell discloses wherein the preoperative image is obtained from one of computed tomography (CT), magnetic resonance imaging (MRI), and positron emission tomography (PET) of the patient (paragraph [0023], preoperative image data can be computerized tomography (CT) scan data) (page 15, lines 9-17, CT imaging).
Consider claim 10, the combination of Torjesen and Powell discloses a catheter configured to be inserted within the patient (page 5, lines 9-14, catheter 32 provides a surgical function, a therapeutic function and/or a diagnostic function for anatomical objects within a patient), wherein the tracking system is further configured to track a position and an orientation of the catheter (page 12, lines 21-32, tracking the position and orientation of a catheter).
Consider claim 12, the combination of Torjesen and Powell discloses wherein the endoluminal probe includes an ultrasound transducer located at a distal end configured to ultrasonically image the internal site in three dimensions (page 15, lines 9-17, endoluminal probe 151 (e.g. ultrasound probe) or TEE probe (e.g. transesophageal echocardiography probe) is known the art to include an ultrasound transducer located at a distal end (per Wikipedia) wherein the position and orientation of the probe to be tracked in six (6) degrees of freedom, see page 8, lines 21-26).
Consider claim 13, the combination of Torjesen and Powell discloses a catheter configured to be inserted in an anatomy passageway of the patient (page 5, lines 9-14, catheter 32 provides a surgical function, a therapeutic function and/or a diagnostic function for anatomical objects within a patient), the catheter including a fiber optic shape sensors to track a position and a shape of the catheter (page 8, lines 18-20, 3D Hub (Unicath) is attached to a catheter and a (FORS) guidewire is inserted through the 3D hub and the catheter).
Consider claim 14, the combination of Torjesen and Powell discloses wherein the display system is configured to render a computer model of the catheter derived from the fiber optic shape sensing and register the computer model with the real-time endoluminal probe image and the preoperative image (page 13, line 36 – page 14, line 9, registration between preoperative 3D imaging data and intraoperative imaging containing a FORS device (e.g., an intraoperative 3D scan), the FORS device may be affixed or integrated to the endoluminal imaging device with endoluminal space via ultrasound or optical catheter, see page 15, lines 9-17).
Consider claim 15, the combination of Torjesen and Powell discloses wherein the endoluminal probe includes an intravascular ultrasound (IVUS) catheter configured to image a hepatic vasculature of the patient (page 4, lines 17-26, endoscopic hepatectomy procedures utilizing an optical (shape) sensor wherein a 3D Hub (Unicath) is attached to a catheter or an IVUS probe and a (FORS) guidewire is inserted through the 3D hub and the catheter or the IVUS probe, see page 8, lines 18-20).
Consider claim 20, the combination of Torjesen and Powell discloses tracking an imaging position and orientation of a C-arm fluoroscopy system (page 8, line 33 – page 9, line 2, a (FORS) guidewire is registered to x-ray c-arm images, wherein FORS are tracked, see page 8, lines 21-26); and
registering real-time fluoroscopy images from the C-arm system with the endoluminal probe real-time image (page 9, lines 3-11, the (ultrasound) probe is registered to the fluoroscopy imaging space) and preoperative image (page 13, line 36 – page 14, line 9, registration between preoperative 3D imaging data and intraoperative imaging containing a FORS device).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable the combination of Torjesen and Powell in view of Lampert et al. (Pub. No.: US 2016/0003610).
Consider claim 4, the combination of Torjesen and Powell does not specifically disclose wherein the tracking system includes a wireless inertial sensor and wireless electromagnetic sensor attached to the endoluminal probe.
Lampert discloses wherein the tracking system includes a wireless inertial sensor and wireless electromagnetic sensor attached to the endoluminal probe (paragraph [0046], endoscope 46 can include one or more motion tracking elements 47 including an electromagnetic sensor in combination with an inertial measurement unit such as an inertial sensor, see paragraph [0064]).
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 tracking system as disclosed by the combination of Torjesen and Powell with the tracking system as taught by Lampert to track changes in spatial disposition of the endoscope in six degrees of freedom (Lampert, paragraph [0046]).
Claims 9 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Torjesen and Powell in view of Csavoy et al. (Pat. No.: US 8,010,177, Applicant’s IDS filed 03/10/2025).
Consider claims 9, 19, the combination of Torjesen and Powell does not specifically disclose wherein the registration system is configured to dynamically update registration between the real-time image and the preoperative image to account for patient motion.
Csavoy discloses wherein the registration system is configured to dynamically update registration between the real-time image and the preoperative image to account for patient motion (col. 9, lines 18-33, relative motion is forwarded to the coil array controller 52, which updates registration correlation (e.g., correlate the acquired intraoperative image data with preoperative image data, see col. 12, lines 5-27)).
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 registration system as disclosed by the combination of Torjesen and Powell with the registration system as taught by Csavoy to order to maintain accurate navigation (Csavoy, col. 9, lines 18-33).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Torjesen and Powell in view of Panescu et al. (Pub. No. 2021/0007796).
Consider claim 11, the combination of Torjesen and Powell discloses wherein the display system is further configured to display a representation of the interventional tool registered with the real-time image from the endoluminal probe overlaid on the preoperative image (page 12, line 33 – page 13, line 3, endobronchial ultrasound (EBUS) probe deploying an interventional tool from a working channel that is registered to the EBUS image wherein rendering the position of an endoluminal device on a preoperative 3D model, see page 13, line 36 – page 14, line 9).
The combination of Torjesen and Powell does not specifically disclose the interventional tool including a catheter.
Panescu discloses the interventional tool including a catheter (paragraph [0265], catheter may be advanced though an endobronchial ultrasound delivery sheath).
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 interventional tool as disclosed by the combination of Torjesen and Powell with the catheter as taught by Panescu in order to provide a method for treating a lung tumor of a patient (Panescu, paragraph [0265]).
Claims 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Torjesen and Powell in view of Glossop et al. (Pub. No.: US 2010/0217117).
Consider claim 16, the combination of Torjesen and Powell does not specifically disclose wherein the tracking system is configured to track a position and orientation of a puncture needle configured to place a shunt between a hepatic vein and a portal vein of a hepatic vasculature of the patient under image guidance.
Glossop discloses wherein the tracking system is configured to track a position and orientation of a puncture needle (paragraph [0051], puncture needle 203 having a position indicating element 301, that provides position and orientation of the tip portion of puncture needle 203 in concert with a tracking device 121) configured to place a shunt between a hepatic vein and a portal vein of a hepatic vasculature of the patient under image guidance (paragraph [0053], puncture needle is used to perform a TIPS (transjugular intrahepatic portosystemic shunt) procedure and thereby bridge the portal vein and the hepatic vein, wherein the procedure is image-guided, see paragraph [0040]).
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 tracking system as disclosed by the combination of Torjesen and Powell with the tracking device as taught by Glossop in order to confirm a successful traversal of the portal vein (Glossop, paragraph [0053]).
Consider claim 17, the combination of Torjesen and Powell does not specifically disclose wherein the display system is configured to display a projected trajectory of the puncture needle registered with a real-time IVUS images from the hepatic vasculature.
Glossop discloses wherein the display system is configured to display a projected trajectory of the puncture needle registered with a real-time IVUS images from the hepatic vasculature (paragraph [0067], trajectory of puncture needle 203 are generated, projected, and/or displayed on a computer display (e.g., display device 115) onto which the registered images of the portal vein have been loaded, wherein the image space information of the images are then registered to the position sensor (of the punctured needle 203, see para. [0061]) space information, see paragraph [0062]).
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 display as disclosed by the combination of Torjesen and Powell with the display as taught by Glossop in order to indicate to the physician performing the procedure if trajectory of puncture needle will result in a "hit" at a point on the portal vein prior to extending puncture needle and testing for blood return (Glossop, paragraph [0067]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GERALD JOHNSON whose telephone number is (571)270-7685. The examiner can normally be reached Monday-Friday 8am-5pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Carey Michael can be reached at (571)270-7235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Gerald Johnson/
Primary Examiner, Art Unit 3797
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