DETAILED ACTION
Response to Amendment
This Office Action is responsive to the amendment filed on 01/05/2026. As indicated by the amendment: claims 21-23 and 30 have been amended. In response to the amendments of claims 21 and 30, their rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, have been withdrawn Claims 21-40 are presently pending in the application.
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.
Claim(s) 21-23, 25, 27, 30, 31, 33, 35 and 38-39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fan et al. (US 2014/0051985) in view of Hasegawa et al. (US 9460536 B2) in view of Williams et al. (US 8527033 B1) in view of Duncan et al. (US 2013/0079812 A1) in view of Saglam et al. (US 2014/0243849 A1)
Regarding claim 21, Fan discloses a robotic system comprising: an endoscope (ureteroscope; par. [0030]-[0031]) configured to be navigated through an anatomy; one or more processors (within 170/180; par. [0029]) configured to: receive first data from a first sensor (orientation sensor; par. [0034]), the first data indicating an orientation of the endoscope; determine a target for percutaneous access based on the position of the endoscope (par. [0034]-[0035]; the position of the ureteroscope allows the target to be “painted” and allows visualization of the target via images captured, processed and displayed); receive second data from a second sensor (par. [0029] and [0045]) disposed on the needle (142; par. [0029] and [0045]), the second data indicating a position of the needle (par. [0029] and [0045]); and determine that a percutaneous port is created in the anatomy based at least in part on the position of the needle relative to the target (par. [0029] and [0035]; insertion of the needle creates an opening in the anatomy, interpreted as a percutaneous port).
Fan discloses that various systems exist to detect and track instruments used in a medical procedure, which employ electromagnetic transmission coils to calculate the location and orientation of the coils, which is used to generate a 3D rendering of the endoscope displayed on a screen (par. [(0003]-[0004]). Fan does not specifically disclose one or more processors configured to: receive first data indicating a position of the endoscope. Hasegawa teaches one such system disclosed by Fan, wherein the sensor is a position and orientation sensor used to determine the position and orientation of the endoscope (12; col. 5, Il. 13-20). Hasegawa teaches a processor (21) receives the data from the position and orientation sensor to display the position and direction of the distal end portion of the endoscope in a coordinate system so that the operator can easily grasp the location of the endoscope and the target (col. 12, ll. 18-23, col. 13, ll. 49-51 and col. 15, ll. 6-13). It would have been obvious to modify the one or more processor and the first alignment sensor of Fan, with that taught by Hasegawa, in order to determine the position and orientation of the sensor, and display it in a coordinate system to the operator, thereby improving the operation of the endoscope device by the operator as contemplated by Fan (par. [0003] and [0004)).
Fan does not specifically disclose the one or more processors configured to: display, on an interface, a first graphical element representing the target for percutaneous access in a coordinate system; and display, on the interface, a second graphical element representing the position of the needle relative to the target in the coordinate system. Williams teaches an analogous percutaneous access system wherein one or more processors (114/110; Fig. 1A) are configured to display, on an interface (150; Figs. 1A and 4), a first graphical element (102) representing the target (102) for percutaneous access (Fig. 4; col. 16, l. 54 – col. 17, l. 19); and display, on the interface (150; Fig. 4), a second graphical element (431; Fig. 4; col. 16, l. 54 – col. 17, l. 19) representing the position of the needle (130; col. 6, ll. 58-64) relative to the target (Fig. 4). Williams teaches using real-time images of the target site captured by an imaging system superimposed with information about the needle and trajectory to the target (col. 16, l. 54 – col. 17, l. 19). It would have been obvious to one having ordinary skill in the art to utilize the real-time imaging system of the ureteroscope of Fan and superimpose information about the position of the needle and its trajectory of the target on it in order to display a visual representation of the needle, trajectory and target within the object being imaged, as taught by Williams, thereby improving the internal positioning of instruments.
Fan discloses that its system is used for percutaneous nephrolithotomy (PCNL) procedure, and that a needle is inserted into the anatomy of a patient (par. [0032] and [0035]). However, Fan does not specifically disclose a medical instrument that is inserted through the percutaneous port toward the target. Duncan teaches that during a percutaneous nephrolithotomy (PCNL) procedure insertion of a needle creates a tract that allows insertion of a nephroscope that is used to remove the targeted kidney stones (par. [0003]). It would have been obvious to one having ordinary skill in the art to insert a medical instrument, such as a nephroscope, through the percutaneous port created by the needle in order to treat or remove the kidney stones, as taught by Duncan, and as well-known in the art.
However, Fan does not specifically disclose the system comprising a first robotic arm configured to manipulate the endoscope and navigate the endoscope through an anatomy, and a second robotic arm configured to manipulate the medical instrument. Saglam teaches an analogous robotic system wherein a robotic arm (38/35/49; Figs. 3, 5 and 8) is configured to manipulate an endoscope (33) through a natural orifice of a patient to a cavity (Fig. 11). Saglam teaches that advancing the endoscope using a robotic arm has several advantages including enabling the surgeon to perform treatments having longer duration and reducing the time of operation by keeping the endoscope in stable position and having a lower probability of missing the target in the organ because of reduction in surgeon’s concentration, or changing hands for different procedures (par. [0193]). It would have been obvious to incorporate a robotic arm of Saglam into the system of modified Fan, for use with the endoscope, as well as a second robotic arm for use with the medical instrument (i.e., nephroscope taught by Duncan), in order to provide the advantages of enabling the surgeon to perform treatments having longer duration and reducing the time of operation by keeping the endoscope in a stable position and having a lower probability of missing the target, or changing hands for different procedures, as taught by Saglam.
Regarding claim 22, Fan in view of Hasegawa in view of Williams in view of Duncan in view of Saglam disclose the robotic system of claim 21, wherein the concurrently manipulates the medical instrument (capable of this intended use as there are two separate robotic arms on carts that have medical instruments entering the body at different locations).
Regarding claim 23, Fan in view of Hasegawa in view of Williams in view of Duncan in view of Saglam disclose the robotic system of claim [[22]] 21, wherein the first robotic arm (Saglam: 38/35/49; Figs. 3, 5 and 8) includes a plurality of arm segments (Saglam: 35 and 38) that are coupled together via one or more joints (Saglam: 55/56; par. [0170]), the first robotic arm being configured to provide multiple degrees of freedom (Saglam: par. [0145] and [0170]).
Regarding claim 25, Fan in view of Hasegawa in view of Williams in view of Duncan in view of Saglam disclose the robotic system of claim 21, wherein the second graphical element (Williams: 431; Fig. 4) indicates an alignment of the needle to the target (Williams:102; Fig. 4).
Regarding claim 27, Fan in view of Hasegawa in view of Williams in view of Duncan in view of Saglam disclose the robotic system of claim 21, wherein the one or more processors (170/180) are further configured to: provide a notification that the needle has arrived at the target (par. [0039] – audio and/or visual feedback from the needle sensor signals on the user interface 180).
Regarding claim 30, Fan discloses a method comprising: receiving first data from a first sensor (orientation sensor; par. [0034]) disposed on a distal end of the endoscope within an anatomy (par. [0034]), the first data indicating an orientation of an endoscope; determining a target for percutaneous access based on the position of the endoscope (par. [0034]-[0035]; the position of the ureteroscope allows the target to be “painted” and allows visualization of the target via images captured, processed and displayed); receiving second data from a second sensor (par. [0029] and [0045]) disposed on the needle (142; par. [0029] and [0045]), the second data indicating a position of the needle (par. [0029] and [0045]); and determining that a percutaneous port is created in the anatomy based at least in part on the position of the needle relative to the target (par. [0029] and [0035]; insertion of the needle creates an opening in the anatomy, interpreted as a percutaneous port) a second robotic arm configured to control a medical instrument that is configured to be inserted into an anatomy.
Fan discloses that various systems exist to detect and track instruments used in a medical procedure, which employ electromagnetic transmission coils to calculate the location and orientation of the coils, which is used to generate a 3D rendering of the endoscope displayed on a screen (par. [(0003]-[0004]). Fan does not specifically disclose one or more processors configured to: receive first data indicating a position of the endoscope. Hasegawa teaches one such system disclosed by Fan, wherein the sensor is a position and orientation sensor used to determine the position and orientation of the endoscope (12; col. 5, Il. 13-20). Hasegawa teaches a processor (21) receives the data from the position and orientation sensor to display the position and direction of the distal end portion of the endoscope in a coordinate system so that the operator can easily grasp the location of the endoscope and the target (col. 12, ll. 18-23, col. 13, ll. 49-51 and col. 15, ll. 6-13). It would have been obvious to modify the one or more processor and the first alignment sensor of Fan, with that taught by Hasegawa, in order to determine the position and orientation of the sensor, and display it in a coordinate system to the operator, thereby improving the operation of the endoscope device by the operator as contemplated by Fan (par. [0003] and [0004)).
Fan does not specifically disclose displaying, on an interface, a first graphical element representing the target for percutaneous access in a coordinate system; displaying, on the interface, a second graphical element representing the position of the needle relative to the target in the coordinate system. Williams teaches an analogous percutaneous access system wherein one or more processors (114/110; Fig. 1A) are configured to display, on an interface (150; Figs. 1A and 4), a first graphical element (102) representing the target (102) for percutaneous access (Fig. 4; col. 16, l. 54 – col. 17, l. 19); and display, on the interface (150; Fig. 4), a second graphical element (431; Fig. 4; col. 16, l. 54 – col. 17, l. 19) representing the position of the needle (130; col. 6, ll. 58-64) relative to the target (Fig. 4). Williams teaches using real-time images of the target site captured by an imaging system superimposed with information about the needle and trajectory to the target (col. 16, l. 54 – col. 17, l. 19). It would have been obvious to one having ordinary skill in the art to utilize the real-time imaging system of the ureteroscope of Fan and superimpose information about the position of the needle and its trajectory of the target on it in order to display a visual representation of the needle, trajectory and target within the object being imaged, as taught by Williams, thereby improving the internal positioning of instruments.
Fan discloses that its system is used for percutaneous nephrolithotomy (PCNL) procedure, and that a needle is inserted into the anatomy of a patient (par. [0032] and [0035]). However, Fan does not specifically disclose inserting a medical instrument through the percutaneous port toward the target. Duncan teaches that during a percutaneous nephrolithotomy (PCNL) procedure insertion of a needle creates a tract that allows insertion of a nephroscope that is used to remove the targeted kidney stones (par. [0003]). It would have been obvious to one having ordinary skill in the art to insert a medical instrument, such as a nephroscope, through the percutaneous port created by the needle in order to treat or remove the kidney stones, as taught by Duncan, and as well-known in the art.
However, Fan does not specifically disclose movement of the endoscope controlled by a first robotic arm and manipulating the medical instrument using a second robotic arm. Saglam teaches an analogous robotic system wherein a robotic arm (38/35/49; Figs. 3, 5 and 8) is configured to manipulate an endoscope (33) through a natural orifice of a patient to a cavity (Fig. 11). Saglam teaches that advancing the endoscope using a robotic arm has several advantages including enabling the surgeon to perform treatments having longer duration and reducing the time of operation by keeping the endoscope in stable position and having a lower probability of missing the target in the organ because of reduction in surgeon’s concentration, or changing hands for different procedures (par. [0193]). It would have been obvious to incorporate a robotic arm of Saglam into the system of modified Fan, for use with the endoscope, as well as a second robotic arm for use with the medical instrument (i.e., nephroscope taught by Duncan), in order to provide the advantages of enabling the surgeon to perform treatments having longer duration and reducing the time of operation by keeping the endoscope in a stable position and having a lower probability of missing the target, or changing hands for different procedures, as taught by Saglam.
Regarding claim 31, Fan in view of Hasegawa in view of Williams in view of Duncan in view of Saglam disclose the method of claim 30, wherein the first robotic arm (Saglam: 38/35/49; Figs. 3, 5 and 8) includes a plurality of arm segments (Saglam: 35 and 38) that are coupled together via one or more joints (Saglam: 55/56; par. [0170]).
Regarding claim 33, Fan in view of Hasegawa in view of Williams in view of Duncan in view of Saglam disclose the method of claim 30, wherein the first graphical element (Williams: 102; Fig. 4; col. 16, l. 54 – col. 17, l. 19) and the second graphical element (Williams: 431; Fig. 4; col. 16, l. 54 – col. 17, l. 19) indicate an orientation of the needle to the distal end of the endoscope based on the first data (par. [0029]; Hasegawa: col. 12, ll. 18-23, col. 13, ll. 49-51 and col. 15, ll. 6-13).
Regarding claim 35, Fan in view of Hasegawa in view of Williams in view of Duncan in view of Saglam disclose the method of claim 30, further comprising: providing a notification that the needle has arrived at the target (par. [0039] – audio and/or visual feedback from the needle sensor signals on the user interface 180).
Regarding claim 38, Fan in view of Hasegawa in view of Williams in view of Duncan in view of Saglam disclose the method of claim 30, but does not specifically disclose it further comprising: determining that the endoscope is in an updated position (Williams: movement of the imaging system); and responsive to determining that the endoscope is in the updated position, centering the target (Williams: 102) on the interface or changing a view angle of the target on the interface to facilitate alignment of the needle (142) with the target (Williams: Fig. 4; col. 16, l. 54 – col. 17, l. 19).
Regarding claim 39, Fan in view of Hasegawa in view of Williams in view of Duncan in view of Saglam disclose the method of claim 30, wherein the endoscope is a ureteroscope (par. [0030]-[0031]) that includes a working channel (par. [0031]).
Claim(s) 24 and 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fan in view of Hasegawa in view of Williams in view of Duncan in view of Saglam applied to claims 21 and 30, respectively, above, and further in view of Blumenkranz et al. (US 2016/0101263 A1).
Regarding claim 24, Fan in view of Hasegawa in view of Williams in view of Duncan in view of Saglam disclose the robotic system of claim 21, but does not specifically disclose wherein the first sensor is an electromagnetic (EM) sensor configured to receive EM fields emitted by one or more EM field generators placed around the anatomy. Blumenkranz teaches an analogous robotic system wherein an analogous orientation sensor (150) is part of an electromagnetic (EM) sensor system to track the shape, orientation and position of the endoscope (par. [0040]). It would have been obvious to one having ordinary skill in the art to include the EM sensor system of Blumenkranz in the system of Fan in order to accurately track the shape, position and orientation of the endoscope in three-dimensional space, as contemplated by Fan, and taught by Blumenkranz.
Regarding claim 32, Fan in view of Hasegawa in view of Williams in view of Duncan in view of Saglam disclose the method of claim 30, but does not specifically disclose wherein the first sensor is an electromagnetic (EM) sensor configured to receive EM fields emitted by one or more EM field generators placed around the anatomy. Blumenkranz teaches an analogous robotic system wherein an analogous orientation sensor (150) is part of an electromagnetic (EM) sensor system to track the shape, orientation and position of the endoscope (par. [0040]). It would have been obvious to one having ordinary skill in the art to include the EM sensor system of Blumenkranz in the system of Fan in order to accurately track the shape, position and orientation of the endoscope in three-dimensional space, as contemplated by Fan, and taught by Blumenkranz.
Claim(s) 26 and 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fan in view of Hasegawa in view of Williams in view of Duncan in view of Saglam as applied to claims 21 and 30, respectively, and further in view of Liu et al. (US 2012/00269167 A1).
Regarding claim 26, Fan in view of Hasegawa in view of Williams in view of Duncan in view of Saglam disclose the robotic system of claim 21, but does not specifically disclose wherein the one or more processors are further configured to: obtain a three-dimensional (3D) representation of an internal structure of the patient anatomy; and register the first data to the 3D representation. Liu teaches a tracking registration and calibration system for EM-tracked endoscopes wherein a three dimensional representation of an internal structure of the anatomy is obtained (par. [0003] and [0010]; Fig. 4) and data received from a first alignment sensor is registered to the 3D representation to determine a frame of reference for the data that aligns with a position and orientation of the anatomy if free space (par. [0042]-[0043]). It would have been obvious to one having ordinary skill in the art to incorporate a registration system into that of modified Fan in order to utilize the patient's anatomy as a roadmap while the procedure is performed thereby improving the image guided endoscopy and procedure.
Regarding claim 34, Fan in view of Hasegawa in view of Williams in view of Duncan in view of Saglam disclose the method of claim 30, but does not specifically disclose further comprising: identifying a three-dimensional (3D) representation of an internal structure of the patient anatomy; and registering the first data to the 3D representation. Liu teaches a tracking registration and calibration system for EM-tracked endoscopes wherein a three dimensional representation of an internal structure of the anatomy is obtained (par. [0003] and [0010]; Fig. 4) and data received from a first alignment sensor is registered to the 3D representation to determine a frame of reference for the data that aligns with a position and orientation of the anatomy if free space (par. [0042]-[0043]). It would have been obvious to one having ordinary skill in the art to incorporate a registration system into that of modified Fan in order to utilize the patient's anatomy as a roadmap while the procedure is performed thereby improving the image guided endoscopy and procedure.
Claim(s) 28 and 36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fan in view of Hasegawa in view of Williams in view of Duncan in view of Saglam as applied to claims 21 and 30, respectively, and further in view of Selover et al. (US 2014/0275981 A1).
Regarding claim 28, Fan in view of Hasegawa in view of Williams in view of Duncan in view of Saglam disclose the robotic system of claim 21, but does not specifically disclose wherein the one or more processors are further configured to provide a notification indicating that the needle is positioned outside a target course for the needle to arrive at the target. Selover teaches a system wherein a notification module provides a notification to a user of a surgical instrument when it is not positioned along the trajectory to a target site (par. [0008]-[0009]). It would have been obvious to one having ordinary skill in the art to notify the operator when the surgical instrument is not positioned along the trajectory to a target site, as taught by Selover, thereby ensuring that the needle is in alignment with the target.
Regarding claim 36, Fan in view of Hasegawa in view of Williams in view of Duncan in view of Saglam disclose the method of claim 30, but does not specifically disclose further comprising: providing a notification indicating that the needle is positioned outside a target course for the needle to arrive at the target. Selover teaches a system wherein a notification module provides a notification to a user of a surgical instrument when it is not positioned along the trajectory to a target site (par. [0008]-[0009]). It would have been obvious to one having ordinary skill in the art to notify the operator when the surgical instrument is not positioned along the trajectory to a target site, as taught by Selover, thereby ensuring that the needle is in alignment with the target.
Claim(s) 29 and 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fan in view of Hasegawa in view of Williams in view of Duncan in view of Saglam as applied to claims 21 and 30, respectively, and further in view of Hulvershorn et al. (US 2011/0060229 A1).
Regarding claim 29, Fan in view of Hasegawa in view of Williams in view of Duncan in view of Saglam disclose the robotic system of claim 21, but does not specifically disclose wherein the one or more processors are further configured to provide a notification indicating that the needle is positioned within the anatomy. Hulvershorn teaches a system wherein a notification is provided when the needle (24) is positioned within a target anatomical site (par. [0082] and [0127]) in order to verify proper placement (par. [0002]). It would have been obvious to one having ordinary skill in the art to alert the operator that the needle has entered the anatomical site in order to verify proper placement, as taught by Hulvershorn.
Regarding claim 37, Fan in view of Hasegawa in view of Williams in view of Duncan in view of Saglam disclose the method of claim 30, but does not specifically disclose further comprising: providing a notification indicating that the needle is positioned within an organ of the patient anatomy. Hulvershorn teaches a system wherein a notification is provided when the needle (24) is positioned within a target anatomical site (par. [0082] and [0127]) in order to verify proper placement (par. [0002]). It would have been obvious to one having ordinary skill in the art to alert the operator that the needle has entered the anatomical site in order to verify proper placement, as taught by Hulvershorn.
Claim(s) 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fan in view of Hasegawa in view of Williams in view of Duncan in view of Saglam as applied to claim 30 above, and further in view of Hyde et al. (US 2013/0072783 A1).
Regarding claim 40, Fan in view of Hasegawa in view of Williams in view of Duncan in view of Saglam disclose the robotic system of claim 30, but does not specifically disclose further comprising: analyzing image data of the patient anatomy to identify one or more landmarks of anatomy; and identifying a location of the endoscope based on the one or more landmarks of anatomy and the first data. Hyde teaches a system wherein a feature matching circuit is configured to determine a substantial correspondence between an objective landmark feature on a reference image and a landmark feature on a present-location image captured by and endoscope (par. [0014]-[0015]). The system also includes a proximity indicator circuit that determines the proximity of the distal end of an endoscope to the region of interest if a substantial correspondence exists between the landmarks in the reference and captured images (par. [0015]). Hyde teaches that feature matching allows the operator to know whether or not the distal end of the endoscope is close to the region of interest (par. [0015]). It would have been obvious to one having ordinary skill in the art to include the feature matching and proximity indicator circuits of Hyde in the system of Fan in order to allow the operator to know whether or not the distal end of the endoscope is close to the region of interest, as taught by Hyde.
Response to Arguments
Applicant's arguments filed 01/05/2026 have been fully considered but they are not persuasive. Applicant first contends that the Examiner interprets Saglam’s robotic manipulator 31 as both a first robotic arm and a second robotic arm (see Remarks at page 8). The Examiner respectfully disagrees. Contrary to that contended by Applicant, the Examiner has not suggested that a robotic cart of Saglam includes two robotic arms (see Remarks at page 9). As is clear from the discussion above, the Examiner states that it would have been obvious to incorporate a robotic arm of Saglam into the system of modified Fan, for use with the endoscope, as well as a second robotic arm for use with the medical instrument (nephroscope taught by Duncan to remove the targeted kidney stones), in order to provide the advantages of enabling the surgeon to perform treatments having longer duration and reducing the time of operation by keeping the endoscope in a stable position and having a lower probability of missing the target, or changing hands for different procedures, as taught by Saglam.
Next, Applicant contends that Fan teaches away from using multiple robotic carts (see Remarks at page 9). The Examiner respectfully disagrees and asserts that the cited paragraphs of Fan relied upon by Applicant (par. [0028] and [0037]) are directed to the ETF 162 which is an entirely hand-held system. The Examiner has not suggested attaching the ETF to a robotic cart. Rather, and as discussed above, the Examiner suggests using a robotic arm for the endoscope and as well as a second robotic arm for the medical instrument. Fan does not teach away from robotic arms for an endoscope or nephroscope. Accordingly, the rejection is maintained.
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.
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/RYNAE E BOLER/Examiner, Art Unit 3795
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
01/30/2026