DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 09 June 2026 has been entered.
Response to Arguments
Applicant's arguments filed 11 May 2026 have been fully considered but they are not persuasive.
With respect to 103 rejections in view of amendment, applicant argues that Heuscher make passing reference of a robotic arm procedure, but does not disclose that the robot provides movement parameters to a controller, rather concerns a CT based tracking system to maintain a FOV of beam on medical instrument, thus, control is based on tracking the instrument tip using tracking arrangement, not on “movement parameters received from a robot as claimed (pages 9-10). Applicant further argues that Zhao does not cure the deficiency, because Zhao discloses displacement transducers, positional sensor that kinematic information generated by transducers and sensors are reported back to robotic system and a tool tracking in image guided surgery, but does not teach controlling imaging parameters of source and detector as recited in claim 1, as Zhaos’ image is in context of providing image guided surgery information, not controlling an external x-ray source and detector based on robot movement parameters, as in [0052] and [0191] of Zhao and the applicant concludes that claims are patentable.
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.
Heuscher does not just pass reference on robot, but rather makes it clear teaching that x-ray source and detector are moved using an external control, either automatically in coordination with a detected position of the medical instrument tip or manually and if an interventional robotic arm is being used, the controls for the arms and the movement of the source/detector can be combined ([0031]). Thus, Heuscher does indicate that coordinated movement of robotic arm with source/detector movement.
Heuscher does not teach receiving movement parameters from robot, the movement parameters associated with the robot moving the interventional instrument from a first region to a second region, thus, Zhao provides 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 and instrument [0065]. Thu, contrary to applicant’ argument that movement parameters are transducers reporting back to the robot, Zhao clearly teaches using the positional sensors for kinematic information which provide movement of the robotic surgical arm and the instrument.
Heuscher already teaches controlling external imaging system, including source, detector and collimators based on movement parameters. And Zhao also discloses that robotic instruments are tracked so that the endoscopic camera is centered in the field of view of the surgical site ([0054]), thus is concerned with controlling imaging parameters of the imaging system based on the tracked instrument position for image guidance procedures. Both Heuscher and Zhao are directed to use positional information of robotic arm controlling interventional instrument and controlling the imaging system based on the tracked positions.
Thus, adding a position sensor to existing Heuscher’s robotic instrument, to provide kinematic information (claimed movement parameter) of the robot, since, Zhao explicitly and clearly discloses that tool tracking in image guided surgery of X-ray or CT modalities, would enhance a surgeon’s experience ([0052] and [0191]). Thus, combining Heuscher with Zhao would result in extra kinematic information that 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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 11-15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 11 recites “a patient anatomy” twice and it is not clear whether region of a patient anatomy is from a single patient or two mor more patients.
Claims 12-15 are rejected as they inherit rejection of claim 11 as set forth above.
Allowable Subject Matter
Claim 2 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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, 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 traversing the patient anatomy (detector [0020] Fig. 1);
a controller (collimator controller [0027]) configured to:
receive, movement parameters associated with the robot moving the interventional instrument from a first region of the patient anatomy to a position within a second region in the patient anatomy (when the tip is moving slowly through the subject [0030], the examiner notes that moving the instrument from a first region to second region can be accomplished by any movement of the instrument (such as “slowly moving tip”), interventional procedures performed by robotic arm [0020]), and
control first imaging parameters of the imaging source according to received movement parameter, so that the imaging system emits the beam to traverse only 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 [0030]-[0031])
control second imaging parameters of the imaging detector according to received movement parameters in order to detect the beam traversing only 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]; traversing regions including 232 and 234 before modifying collimator, and with collimator, Figures 3A-3E show second region being traversed excluding other regions)
Heuscher does not explicitly disclose following limitations:
A robot configured to provide movement parameters associated with the robot moving the interventional instrument
Receive from the robot, movement parameters associated with the robot moving the interventional instrument from a first region of the patient’s anatomy to a position within a second region in the patient anatomy.
control the imaging parameters according to the received movement parameters
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 from the robot, the movement parameters associated with the robot moving the interventional instrument (the robotic surgical arms include positional sensors to provide kinematic information [0037]) from a first region of the patient anatomy to a position within a second region in the patient anatomy ( kinematic information may be a result of movement of the robotic arm, robotic 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 11, Heuscher teaches a controller comprising:
A memory (data memory [0024]); and
a processor coupled to memory ([0024]) and configured to:
receive movement parameters moving an 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 first imaging parameters of the imaging source according to received movement parameter, so that the imaging system emits the beam to traverse only 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 [0030]-[0031])
control second imaging parameters of the imaging detector according to received movement parameters in order to detect the beam traversing only 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]; traversing regions including 232 and 234 before modifying collimator, and with collimator, Figures 3A-3E show second region being traversed excluding other regions)
Heuscher does not explicitly disclose following limitations:
Receive movement parameters associated with a robot moving an interventional instrument from a first region of a patient anatomy to a second region in a patient anatomy
Determine from the received movement parameters a position of the interventional instrument within the patient anatomy at the second region
control the imaging parameters according to the received movement parameters
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]);
Determine from the received movement parameters a position of the interventional instrument within the patient anatomy at the second region (current position based on robot kinematics [0059], kinematic information from movement of robotic surgical arm and the instrument [0065])
control the imaging parameters 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:
Receiving movement moving the interventional instrument within the patient anatomy (image with tip is located [0028]; detected position of the medical instrument tip [0031], )
control first imaging parameters of the imaging source according to received movement parameter, so that the imaging system emits the beam to traverse only 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 [0030]-[0031])
control second imaging parameters of the imaging detector according to received movement parameters in order to detect the beam traversing only 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]; traversing regions including 232 and 234 before modifying collimator, and with collimator, Figures 3A-3E show second region being traversed excluding other regions)
Heuscher does not explicitly disclose following limitations:
Receiving movement associated with the robot moving the interventional instrument from a first region of a patient anatomy to a second region in a patient anatomy.
Determine from the received movement parameters a position of the interventional instrument within the 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]);
Determining from the received movement parameters a position of the interventional instrument within the patient anatomy at the second region (current position based on robot kinematics [0059], kinematic information from movement of robotic surgical arm and the instrument [0065])
controlling the imaging parameters 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 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 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 that 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]).
Claims 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
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.
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, 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/PATRICIA J PARK/Primary Examiner, Art Unit 3793
