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, see page 8, filed 24 November 2025, with respect to double patenting rejection have been fully considered and are persuasive in view of terminal disclaimer filed on 24 November 2025. The double patenting rejection of 22 August 2025 has been withdrawn.
Applicant’s arguments, see pages 8-10, filed 24 November 2025, with respect to 112 rejections have been fully considered and are persuasive in view of amendment. The 112 rejections of 22 August 2025 has been withdrawn.
Applicant's arguments filed 24 November 2025 have been fully considered but they are not persuasive.
With respect to 103 rejections, applicant argues that Heuscher in view of Zhao do not disclose claim 1, as Zhao’s disclosure with tracking system, is for tracking tool based on video images, rather than images that traverse a region of the patient anatomy, and does not provide sufficient information as to the position of robotic instruments in case field of view is outside or occluded, and Zhao relies on kinematics information for prediction of the robotic instruments (page 12). Thus, applicant argues that Heuscher and Zhao fail to teach an imaging system external to the patient anatomy, source transversing the anatomy, detector detecting the traversed beam
Applicant further argues that Zhao is directed to combining kinematic information with video images, and X-ray imaging of Heuscher is different from the video imaging system of Zhao, thus, combination of prior arts would result in use of kinematic information with video images not for images based on beams traversing first and second regions of the patient anatomy (page 13).
However, the examiner respectfully disagrees.
First, the examiner submits that Heuscher already discloses X-ray imaging system, and modification of X-ray imaging system with kinematic information of robotic instrument disclosed by Zhao do not result in incorporating video images and kinematic information. Heuscher already discloses all the limitations including beam transversing the anatomy since it teaches CT and controlling CT imaging system, except the following limitations.
the robot to move from a first region to a second region that is different from the first region and configured to provide movement parameters that define movement of the interventional instrument within the patient anatomy
receive the movement parameters from the robot
control the imaging system based on the position of the interventional instrument and the movement parameters received from the robot.
Thus, adding a position sensor to existing Heuscher’s robotic instrument, to provide kinematic information (claimed movement parameter) of the robot would not result in changing X-ray imaging system of Heuscher with Zhao’s video images.
Moreover, the examiner submits that Zhao does not exclude use of X-ray imaging system. Rather, paragraphs [0052] and [0191] explicitly and clearly discloses that tool tracking in image guided surgery of X-ray or CT modalities, would enhance a surgeon’s experience. Thus, combining Heuscher with Zhao would not result in replacing X-ray imaging system with Zhao’s video images, rather, having extra kinematic information would enhance image guided surgery experience for physician.
Therefore, absent any evidence to the contrary, the examiner maintains that the combination of reference teaches and/or makes obvious the claimed limitations.
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) 1-3, 5, 7-12, 14-17, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over “Heuscher,” US 2010/0274120 (hereinafter Heuscher) and “Zhao et al.,” US 2012/0020547 (hereinafter Zhao).
Regarding to claim 1, Heuscher teaches an interventional system comprising:
a robot configured to move an interventional instrument within a patient anatomy (interventional procedures performed by robotic arm [0020]),
an imaging system, external to the patient anatomy (CT scanner [0019]), comprising:
an imaging source configured to emit a beam for traversing the patient anatomy (radiation source [0050], [0020] Figure 1), and
an imaging detector configured to detect the beam after having traversed the patient anatomy (detector [0020] Fig. 1);
a controller (collimator controller [0027]) configured to:
obtain a position of the interventional instrument within the patient anatomy at the second region (when the tip is moving slowly through the subject [0030]), and
control the imaging system based on the position of the interventional instrument, so that the imaging system emits the beam to traverse the second region of the patient anatomy that includes the interventional instrument (cooperate with CT controller and collimator controller to monitor movement of instrument tip and move the X-ray source and detector to maintain beam in position to scan the location of instrument tip [0027], If the tip is moving slowly through the subject, the X-ray beam may be gated on/off to generate image more slowly [0030]-[0031])
Heuscher does not explicitly disclose following limitations:
the robot to move from a first region to a second region that is different from the first region and configured to provide movement parameters that define movement of the interventional instrument within the patient anatomy
receive the movement parameters from the robot
control the imaging system based on the position of the interventional instrument and the movement parameters received from the robot.
However, in the analogous field of endeavor in tracking robotic medical tools, Zhao teaches following limitations:
the robot to move from a first region to a second region that is different from the first region and configured to provide movement parameters that define a position that the robot moved the interventional instrument within patient anatomy (the robotic surgical arms include positional sensors to provide kinematic information [0037], assist in tracking of robotic instruments [0042], kinematic information may be result of movement of the robotic surgical arm, instrument [0065]);
receive the movement parameters from the robot (the robotic surgical arms include positional sensors to provide kinematic information [0037])
control the imaging system based on the position of the interventional instrument in the tracking image and the movement parameters received from the robot (robotic instruments are tracked so that the endoscopic camera is centered in the field of view of the surgical site [0054], integrates kinematics information and visual information to for robust and accurate tool tracking performance [0055])
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify tracking system as taught by Heuscher to incorporate teaching of Zhao, as Heuscher already discloses tracking via images, and a robotic arm to manipulate the instrument, and since using both kinematics and visual information for tracking a tool was well known in the art as taught by Zhao. One of ordinary skill in the art could have combined the elements as claimed by Heuscher with no change in their respective functions, adding a sensor to its robotic arm for providing kinematic information, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to robust and accurate tool tracking performance ([0055]), and there was reasonable expectation of success.
Regarding to claim 11, Heuscher teaches a controller comprising:
A memory (data memory [0024]); and
a processor coupled to memory ([0024]) and configured to:
obtain a position of the interventional instrument with the patient anatomy at the second region (tracking the position of a catheter [0019]; detected position of the medical instrument tip [0031])
control imaging parameters of an imaging system external to the patient anatomy based on the position of the interventional instrument, so that the imaging system emits a beam that traverses the second region of the object including the interventional instrument (cooperate with CT controller and collimator controller to monitor movement of instrument tip and move the X-ray source and detector to maintain beam in position to scan the location of instrument tip [0027], If the tip is moving slowly through the subject, the X-ray beam may be gated on/off to generate image more slowly, x-ray source are moved in coordination with a detected position of the medical instrument tip [0030]-[0031]).
Heuscher does not explicitly disclose following limitations:
Receive movement parameters that define movement of an interventional instrument by a robot within a patient anatomy from a first region to a second region that is different from the first region,
control the imaging system based on the position of the interventional instrument and the movement parameters received from the robot.
However, in the analogous field of endeavor in tracking robotic medical tools, Zhao teaches following limitations:
Receive movement parameters that define movement of an interventional instrument by a robot within a patient anatomy from a first region to a second region that is different from the first region (the robotic surgical arms include positional sensors to provide kinematic information [0037], assist in tracking of robotic instruments [0042], kinematic information may be result of movement of the robotic surgical arm, instrument [0065]);
control the imaging system based on the position of the interventional instrument in the tracking image and the movement parameters received from the robot (robotic instruments are tracked so that the endoscopic camera is centered in the field of view of the surgical site [0054], integrates kinematics information and visual information to for robust and accurate tool tracking performance [0055])
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify tracking system as taught by Heuscher to incorporate teaching of Zhao, as Heuscher already discloses tracking via images, and a robotic arm to manipulate the instrument, and since using both kinematics and visual information for tracking a tool was well known in the art as taught by Zhao. One of ordinary skill in the art could have combined the elements as claimed by Heuscher with no change in their respective functions, adding a sensor to its robotic arm for providing kinematic information, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to robust and accurate tool tracking performance ([0055]), and there was reasonable expectation of success.
Regarding to claim 16, Heuscher teaches a method comprising:
Obtaining a position of the interventional instrument within the patient anatomy (image with tip is located [0028]; detected position of the medical instrument tip [0031])
controlling the imaging parameters of an imaging system external to the patient anatomy based on the position of the interventional instrument, so that that imaging system emits a beam that traverses the second region of the patient anatomy (cooperate with CT controller and collimator controller to monitor movement of instrument tip and move the X-ray source and detector to maintain beam in position to scan the location of instrument tip [0027], If the tip is moving slowly through the subject, the X-ray beam may be gated on/off to generate image more slowly, x-ray source are moved in coordination with a detected position of the medical instrument tip [0030]-[0031]).
Heuscher does not explicitly disclose following limitations:
Receiving movement parameters that define movement of an interventional instrument by a robot within a patient anatomy.
controlling imaging parameters of an imaging system based on the position of the interventional instrument and the movement parameters received from the robot.
However, in the analogous field of endeavor in tracking robotic medical tools, Zhao teaches following limitations:
Receiving movement parameters that define movement of an interventional instrument by a robot within a patient anatomy from a first region to a second region that is different from the first region (the robotic surgical arms include positional sensors to provide kinematic information [0037], assist in tracking of robotic instruments [0042], kinematic information may be result of movement of the robotic surgical arm, instrument [0065]);
controlling the imaging system based on the position of the interventional instrument in the tracking image and the movement parameters received from the robot (robotic instruments are tracked so that the endoscopic camera is centered in the field of view of the surgical site [0054], integrates kinematics information and visual information to for robust and accurate tool tracking performance [0055])
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify tracking system as taught by Heuscher to incorporate teaching of Zhao, as Heuscher already discloses tracking via images, and a robotic arm to manipulate the instrument, and since using both kinematics and visual information for tracking a tool was well known in the art as taught by Zhao. One of ordinary skill in the art could have combined the elements as claimed by Heuscher with no change in their respective functions, adding a sensor to its robotic arm for providing kinematic information, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to robust and accurate tool tracking performance ([0055]), and there was reasonable expectation of success.
Regarding to claims 2, 7-8, 12, and 17, Heuscher and Zhao together teach all limitations of claim 1 as discussed above.
Heuscher further discloses following limitations:
Of claim 2, wherein the controller is further configured to obtain the position of the interventional instrument by at least one of:
Identifying the position of the interventional instrument in tracking images of the interventional instrument within the patient anatomy generated by the imaging system (image to track the tip of the instrument [0028])
Of claim 7, wherein the controller is further configured to control a direction of the beam emitted by the imaging system based on the position of the interventional instrument (width or beam angle [0031] and [0033]) and to control a width of the beam emitted by the imaging system on a position that the robot moved the interventional instrument (width or beam angle [0031] and [0033]).
Of clam 8, further comprising a position determination processor configured to:
provide an object image showing the patient anatomy (diagnostic image, high resolution image [0029]-[0031] and [0035]), and
display the object image and a representation of the interventional instrument at obtained position of the interventional instrument in the object image (superimposing images of the sub-region in which the tip is located on the diagnostic image, display superimposed images [0028], [0030], [0037]).
Of claim 12, wherein the processor is further configured to obtain the position of the interventional instrument by at least one of:
Identifying the position of the interventional instrument in tracking images of the interventional instrument within the patient anatomy generated by the imaging system (image to track the tip of the instrument [0028])
Of claim 17, wherein obtaining the position of the interventional instrument comprises at least one of:
Identifying the position of the interventional instrument in tracking images of the interventional instrument within the patient anatomy generated by the imaging system (image to track the tip of the instrument [0028])
Regarding to claims 3, 9-10, 14-15, and 19-20, Heuscher and Zhao together teach all limitations of claims 1, 11, and 16 as discussed above.
Zhao further discloses following limitations:
Of claim 3, wherein the controller is further configured to obtain the position of the interventional instrument based on the movement parameters (kinematic position and orientation [0065]).
Of claim 9, wherein the movement parameters include information about one or more of: a shape, an orientation, a direction of movement, and a speed of the interventional instrument at a position that the robot moved the interventional instrument (orientation [0031], orientation sensor [0042])
Of claim 10, wherein the robot defines a robot reference frame and is further configured to provide the movement parameters in the robot reference frame (position of a chosen reference point [0113]); the imaging system defines an image reference frame (endoscopic camera frame of reference [0065] and [0204]); and the controller is further configured to: transform a position that the robot moved the interventional instrument from the robot reference frame to the image reference frame on the transformed position that the robot moved the interventional instrument (kinematic transformation applied to pose correction [0031], transformation of the local coordinate of the 3D point on the tool to the camera coordinate of the tool [0113]), and control the imaging parameters based on the transformed position that the robot moved the interventional instrument (control the motion of the imaging system [0054]), pose correction [0070])
Of claim 14, wherein the movement parameters include information about one or more of: a shape, an orientation, a direction of movement, and a speed of the interventional instrument at a position that the robot moved the interventional instrument (orientation [0031], orientation sensor [0042])
Of claim 15, the robot defines a robot reference frame and is further configured to provide the movement parameters in the robot reference frame (position of a chosen reference point [0113]); the imaging system defines an image reference frame (endoscopic camera frame of reference [0065] and [0204]); and the processor is further configured to: transform the position that the robot moved the interventional instrument from the robot reference frame to the image reference frame (kinematic transformation applied to pose correction [0031], transformation of the local coordinate of the 3D point on the tool to the camera coordinate of the tool [0113]), and control the imaging parameters based on the transformed position that the robot moved the interventional instrument (control the motion of the imaging system [0054]), pose correction [0070])
Of claim 19, wherein the movement parameters include information about one or more of: a shape, an orientation, a direction of movement, and a speed of the interventional instrument at a position that the robot moved the interventional instrument(orientation [0031], orientation sensor [0042])
Of claim 20, wherein: the robot defines a robot reference frame and is further configured to provide the movement parameters in the robot reference frame (position of a chosen reference point [0113]); the imaging system defines an image reference frame (endoscopic camera frame of reference [0065] and [0204]); and the method further comprises: transforming the position that the robot moved the interventional instrument from the robot reference frame to the image reference frame (kinematic transformation applied to pose correction [0031], transformation of the local coordinate of the 3D point on the tool to the camera coordinate of the tool [0113]), and controlling the imaging parameters based on the transformed position that the robot moved the interventional instrument (control the motion of the imaging system [0054]), pose correction [0070]).
Regarding to claim 5, Heuscher and Zhao together teach all limitations of claim 1 as discussed above.
Heuscher teaches wherein the imaging system further comprises a collimator (collimator [0027] and [0030]-[0031]), and the controller is configured to control the collimator to collimate the beam based on the position of the interventional instrument, so that the beam traverses the region of the object including the interventional instrument ([0027]-[0031]).
Heuscher does not disclose based on based on the movement parameters received from the robot.
However, in the analogous field of endeavor in tracking robotic medical tools, Zhao teaches robotic instruments are tracked and along with image information so that the endoscopic camera is centered in the field of view of the surgical site ([0054], integrates kinematics information and visual information to for robust and accurate tool tracking performance [0055]).
Claim(s) 4, 6, 13, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Heuscher and Zhao as applied to claims 1, 11 and 16 above, and further in view of “Lloyd,” US 2008/0119725 (hereinafter Lloyd).
Regarding to claims 4, 13, and 18, Heuscher and Zhao together teach all limitations of claims 1, 11, and 16 as discussed above.
Heuscher further teaches wherein the controller is further configured to determine an accuracy of the determination of the position of the interventional instrument; and control the imaging system based on the accuracy ([0027]), but does not explicitly disclose an accuracy value.
However, in the analogous field of endeavor in tracking instrument in medical procedures, Llyod teaches determining a position of a tracked instrument is within the accuracy region ([0028]-[0029], [0060], and [0069]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify tracking system as taught by Heuscher to incorporate teaching of Lloyd, as Heuscher already discloses tracking via images and controlling the imaging system based on the accuracy, and since using accuracy value was well known in the art as taught by Llyod. One of ordinary skill in the art could have combined the elements as claimed by Heuscher with no change in their respective functions, scoring and thresholding the accuracy value, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to provide user the level of accuracy in tracked position and alerts the use when needed ([0072]), and there was reasonable expectation of success.
Regarding to claim 6, Heuscher and Zhao together teach all limitations of claim 5 as discussed above.
Heuscher further teaches wherein the controller is further configured to control the collimator to have a narrower opening when an accuracy value indicating accuracy of the determination of the position of the interventional instrument indicates a higher accuracy, and to have a wider opening when the accuracy value indicates a lower accuracy (narrow cone when registering tip position and in the event of tracking component does not register the instrument tip, the collimator component can widen the collimator aperture [0027]).
Heuscher does not explicitly disclose an accuracy value.
However, in the analogous field of endeavor in tracking instruments during medical procedures, Llyod teaches determining a position of a tracked instrument is within the accuracy region ([0028]-[0029], [0060], and [0069]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify tracking system as taught by Heuscher to incorporate teaching of Lloyd, as Heuscher already discloses tracking via images and controlling the imaging system based on the accuracy, and since using accuracy value was well known in the art as taught by Llyod. One of ordinary skill in the art could have combined the elements as claimed by Heuscher with no change in their respective functions, scoring and thresholding the accuracy value, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to provide user the level of accuracy in tracked position and alerts the use when needed ([0072]), and there was reasonable expectation of success.
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 PATRICIA J PARK whose telephone number is (571)270-1788. The examiner can normally be reached Monday-Thursday 8 am - 3 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Pascal M Bui-Pho can be reached on 408-918-9701. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PATRICIA J PARK/Primary Examiner, Art Unit 3793