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 Amendment
Applicant’s Amendments filed on November 5, 2025, has been entered and made of record.
Currently pending Claims(s) 1-3 and 5-8
Independent Claim(s) 1
Amended Claim(s) 1-2 and 5-6
Canceled Claim(s) 4
Response to Arguments
This office action is responsive to Applicant’s Arguments/Remarks Made in an Amendment received on November 5, 2025.
In view of amendments filed on November 5, 2025, the objection to claim 4 no longer applies, since the claim has been canceled. Additionally, the Applicant has amended claim 1 to include the subject matter from the canceled claim 4. Claim 1 now discloses the limitation of positioning a sterile drape onto the robotic manipulator, and the target pattern is now on the sterile drape. The Examiner believes that this claim in its newly amended state does not overcome the prior art of record; thus, the rejections under 35 USC 103 have been updated in the body of rejection below to address the amendments.
In the Non-Final Rejection on May 5, 2025, the Examiner showed that the base reference, Ali, teaches hand-eye calibration using a camera mounted to a robotic arm which views a stationary calibration pattern on a planar board, and the Examiner made a prima facia case of obviousness for the additional limitations of the present invention which Ali fails to disclose:
The present invention discloses that the calibration target pattern is located on the robotic manipulator [Claim 1]. The target pattern is on the stationary base of the robot and is not located on the moving arm [Claim 7, Fig. 1].
The present invention discloses the use of a sterile drape positioned onto the robotic manipulator [Claim 1] for maintaining sterility of the surgical environment. Some embodiments include positioning a planar calibration board or display onto the drape [Claims 2-3], and other embodiments include printing or forming the calibration pattern onto the drape itself [Claim 5].
Rui renders obvious the positioning of the calibration target pattern on the stationary portion of the robotic manipulator, since Rui teaches positioning a target pattern on the base of a manipulator and provides a rationale for keeping the target pattern parallel to the camera lens for the calibration method. Philippe renders obvious the use of a sterile drape with a calibration target, since Philippe teaches the use of a sterile drape for medical robot calibration and provides the rationale for maintaining sterility of the surgical environment. However, the Applicant has presented arguments against the Examiner’s rejections and prima facia cases, and the Examiner’s responses are presented in the following paragraphs.
In view of Applicant Arguments/Remarks filed November 5, 2025, with respect to the claims, the Applicant argued that a combination of the prior art of record—Ali (doi:10.3390/s19122837), Rui (CN 112428264 A), and Philippe (WO 2017/144115 A1)—fail to render the present invention obvious.
First, the Applicant pointed out that Ali does not contemplate the use of a sterile drape as a calibration surface, and similarly, Rui does not suggest or motivate the use of a flexible, sterile drape as a calibration surface or address the constrains of maintaining sterility of the surgical environment [Remarks Page 1, Paragraphs 2-3]. The Examiner agrees and acknowledges here that neither Ali or Rui teaches or suggests the use of a sterile drape. Both teach calibration with a planar calibration pattern, and only Rui suggests use in medical applications.
Second, the Applicant argues that, although Philippe does disclose the use of sterile surgical drapes with printed or adhered markers for tracking and identification purposes, Philippe does not teach using these markers for camera calibration, and the markers are instead used to inform the system that a drape has been added over the refence array so accommodations can be made when positioning the surgical instruments [Remarks Page 1, Paragraph 4]. The Examiner agrees that the markers are detected by the camera(s) of the tracking system for the purpose of calibrating the position of the medical instruments rather than the intrinsic or extrinsic parameters of the camera(s) itself. Additionally, the Examiner agrees that Philippe, when taken alone, does not disclose both the camera calibration method of the present invention and the use of a sterile drape as a calibration target. Rather, the Examiner argues that Ali effectively teaches the camera calibration method, and that Philippe renders obvious the use of a drape as a calibration target in place of (or in combination with) the planar calibration target taught by Ali. Specifically, the Examiner had argued that draping the robotic manipulator would be obvious since it would maintain sterility of the surgical area [Philippe Page 1, Paragraph 2], and draping surgical instruments and machines is well known in the art for maintaining sterility and would be reasonably expected in many surgical applications.
Finally, the Applicant argued that Philippe does not teach or suggest using drapes specifically for camera calibration or disclose the integration of such drapes into a robotic manipulator [Remarks Page 2, Paragraph 1]; thus, the Examiner’s argument for maintaining sterility of the surgical environment does not effectively explain why a target pattern is positioned or engraved onto a sterile drape for camera calibration purposes [Remarks Page 2, Paragraph 2]. Thus, the Examiner updates the argument to fully explain the rationale here. As stated above, draping the robotic manipulator would be obvious since it would maintain sterility of the surgical area [Philippe Page 1, Paragraph 2]. Regarding the calibration target itself, Philippe teaches that calibration targets are positioned and/or engraved on top of the surgical drape because the drape is covering existing calibration targets ([Philippe Page 4, Paragraph 2] “On the surface of the cover portion, calibration recesses or reference points, for example recessed, engraved or printed recesses or points, can be formed at positions which mirror or correspond to the position of respective recesses or points on the tracking reference array, in order to provide separate calibration or reference locations associated to the respective drape.” [Philippe Page 5, Paragraph 2] “If the presence is known, certain deviations and differences, such as new positions, can be compensated by the navigation system. In another alternative, new reference points (printed, engraved, laser labeled etc.) could be added onto/into the cover for microscope verification/user calibration.”). Thus, positioning a calibration pattern onto the sterile drape would be obvious so that the pattern is visible to tracking cameras.
In summary, Philippe provides motivation for positioning or engraving a target pattern on a sterile drape in the calibration of surgical tracking systems, because:
Using a drape maintains sterility of the environment and are commonly used in medical applications.
Target patterns are printed and/or positioned on the drape since the drape is covering a surface that may have previously been used as a calibration pattern.
Thus, the Examiner argues that it would have been obvious to one of ordinary skill in the art to combine the teachings of Ali and Philipe.
For the reasons stated above, the Examiner maintains the rejections to the newly amended claims using the prior art of record. The rejections have been updated in the body of this office action below to address the new amendments and the Applicant’s arguments.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-2 and 5-8 are rejected under 35 U.S.C. 103 as being unpatentable over Ali et al. (E.R. Methods for Simultaneous Robot-World-Hand–Eye Calibration: A Comparative Study. Sensors 2019, 19, 2837; doi:10.3390/s19122837), hereafter Ali, and further in view of Rui et al. (CN 112428264 A), hereafter Rui, and Philippe et al. (WO 2017/144115 A1), hereafter Philippe.
Regarding claim 1, Ali teaches a method of calibrating a camera used for robotic surgery ([Section 1, Paragraph 1] “Hand-eye calibration is an essential component of vision-based robot control also known as visual servoing. Visual servoing effectively uses visual information from the camera as feedback to plan and control action and motion for various applications such as robotic grasping and medical procedures.”), comprising the steps of:
(b) positioning a camera of the robotic manipulator (Fig. 1 shows a camera positioned at the end of a robot arm. [Section 1, Paragraph 2] “Hand–eye calibration requires accurate estimation of the homogenous transformation between the robot hand/end-effector and the optical frame of the camera affixed to the end effector.”);
(c) causing the robotic manipulator to move the camera to a plurality of positions and orientations (Fig. 1a shows moving the robot arm to different positions of viewing the calibration; [Section 1, Paragraph 2] “Hand–eye calibration requires accurate estimation of the homogenous transformation between the robot hand/end-effector and the optical frame of the camera affixed to the end effector. The problem can be formulated as AX = XB, where A and B are the robotic arm and camera poses between two successive time frames, respectively, and X is the unknown transform between the robot hand (end effector) and the camera.” At least two different positions and orientations A and B are required for performing hand-eye calibration.);
(d) capturing images of the target pattern using the camera in the plurality of positions and orientations (Fig 1a shows moving the robot arm to different positions to capture images. Fig. 3 shows captured images of calibration targets from various poses using the camera on the robot arm. [Section 3.1, Paragraph 1] “the collection provides three real datasets with varying robot poses and calibration patterns as shown in Figure 3.”); and
(e) analyzing the captured images to determine calibration parameters for the camera ([Section 2, Paragraph 4] “In this study, we utilize industrial-grade calibration boards in order to estimate the camera intrinsic parameters and camera extrinsics for the robot-world-hand–eye calibration problem.” Using calibration boards to estimate intrinsic parameters involves performing calculations utilizing images of the boards from different camera orientations and positions. Sections 2, 2.1, and 2.2 teach methods and equations of using the captured image data to obtain calibration parameters.).
Ali fails to teach that the calibration target pattern is on the robot. However, Rui teaches that the target pattern is on a robot manipulator (Fig. 1 shows a calibration pattern 15 mounted to the base of the robotic manipulator.).
Ali and Rui are analogous in the art to the claimed invention, because both teach methods of calibrating a camera mounted to a robot arm. 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 Ali’s methods by mounting the calibration target pattern on the base of the robot manipulator. This modification allows for the camera lens to be parallel to the calibration target pattern when viewing the pattern for the calibration process (Rui Fig. 1; Rui [0031] “to calibrate the linear array camera lens to be parallel to the calibration plate.”).
Additionally, Ali fails to teach positioning a sterile drape on a robotic manipulator, the sterile drape having a target pattern thereon.
However, Phillipe teaches (a) positioning a sterile drape on a robotic manipulator ([Page 1, Paragraph 2] “Sterile surgical drapes are used to cover patients or medical instruments in operating rooms in order to keep the environment of the operation site sterile.”),
the sterile drape having a target pattern thereon (Phillipe teaches using calibration markers on the sterile drape covering for calibration of robotic manipulators and surgical instruments. [Page 4, Paragraph 2] “On the surface of the cover portion, calibration recesses or reference points, for example recessed, engraved or printed recesses or points, can be formed at positions which mirror or correspond to the position of respective recesses or points on the tracking reference array, in order to provide separate calibration or reference locations associated to the respective drape.” [Page 4, Paragraph 4 – Page 5, Paragraph 1] “One embodiment envisages marking or designating, on the surface of the cover portion, one or more additional functional areas, such as
- retro-reflective tracking markers, for example flat markers,
- device identification labels, for example UDI (Unique Device Identification) labels,
- remote control areas, for example on defined areas of the cover portion, or labels such as symbols, text markers or color codes, recognizable for a medical navigation system and creating commands when interacting with a navigated instrument.
Such a marking or designating of functional areas may have multiple purposes and advantages… new reference points (printed, engraved, laser labeled etc.) could be added onto/into the cover for microscope verification/user calibration.”).
Ali and Philippe are analogous in the art to the claimed invention, because both teach methods of calibrating a robotic system for performing surgery. Therefore, it would be obvious to one of ordinary skill in the effective filing date of the claimed invention to position a sterile drape on the robotic manipulator and any other equipment which could be used for medical applications. This modification would allow for the medical equipment to remain sterile when used for surgery (Phillipe [Page 1, Paragraph 2] “Sterile surgical drapes are used to cover patients or medical instruments in operating rooms in order to keep the environment of the operation site sterile. EP 1 810 636 A1 describes a sterile drape including a flat film portion for covering C-arm attachments.”). Additionally, it would have been obvious to one of ordinary skill to position or engrave a target pattern onto the sterile drape. This modification would allow for a target pattern to be visible and not covered by the drape, and the pattern on the drape can be used alternatively to existing calibration patterns that are covered (Philippe [Page 4, Paragraph 2] “On the surface of the cover portion, calibration recesses or reference points, for example recessed, engraved or printed recesses or points, can be formed at positions which mirror or correspond to the position of respective recesses or points on the tracking reference array, in order to provide separate calibration or reference locations associated to the respective drape.”).
Regarding claim 2, Ali teaches wherein the target pattern is a planar member with the target pattern shown thereon (See Figs. 1-3. [Section 3.1, Paragraph 2] “In addition, the calibration board used in the third dataset is a ChArUco pattern with square size of 60 mm, shown in Figure 3c.”).
Regarding claim 5, Ali fails to teach wherein the target pattern is printed or formed on the sterile drape.
However, Philippe teaches wherein the target pattern is printed or formed on the sterile drape ([Abstract] “This invention relates to a sterile surgical drape comprising a cover portion.” [Page 4, Paragraph 2] “On the surface of the cover portion, calibration recesses or reference points, for example recessed, engraved or printed recesses or points, can be formed at positions which mirror or correspond to the position of respective recesses or points on the tracking reference array, in order to provide separate calibration or reference locations associated to the respective drape.” Fig. 2 shows a resulting pattern formed on the sterile drape from the printed recesses or points.).
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 Ali’s invention by forming the target pattern on a sterile drape rather than using a calibration board. This modification would allow for the robot manipulator to be draped, which allows for the manipulator to be sterile in surgical applications (Philippe [Page 1, Paragraph 2] “Sterile surgical drapes are used to cover patients or medical instruments in operating rooms in order to keep the environment of the operation site sterile. EP 1 810 636 A1 describes a sterile drape including a flat film portion for covering C-arm attachments.”). Additionally, this modification would allow for a target pattern to be visible and not covered by the drape, and the pattern on the drape can be used alternatively to existing calibration patterns that are covered (Philippe [Page 4, Paragraph 2] “On the surface of the cover portion, calibration recesses or reference points, for example recessed, engraved or printed recesses or points, can be formed at positions which mirror or correspond to the position of respective recesses or points on the tracking reference array, in order to provide separate calibration or reference locations associated to the respective drape.”).
Regarding claim 6, Ali fails to teach wherein the target pattern is adhered to the sterile drape.
However, Philippe teaches wherein the target pattern is adhered to the sterile drape ([Abstract] “This invention relates to a sterile surgical drape comprising a cover portion.” [Page 4, Paragraph 4] “One embodiment envisages marking or designating, on the surface of the cover portion, one or more additional functional areas, such as:
- retro-reflective tracking markers, for example flat markers,
- device identification labels, for example UDI (Unique Device Identification) labels,
- remote control areas, for example on defined areas of the cover portion, or labels such as symbols, text markers or color codes, recognizable for a medical navigation system and creating commands when interacting with a navigated instrument.”
These features can be used in the verification and calibration processes.).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify the methods of Ali and Rui by placing the target pattern on a sterile drape rather than on a rigid, planar member. This modification would allow for the robot manipulator to be draped, which allows for the manipulator to be sterile in surgical applications (Philippe [Page 1, Paragraph 2] “Sterile surgical drapes are used to cover patients or medical instruments in operating rooms in order to keep the environment of the operation site sterile. EP 1 810 636 A1 describes a sterile drape including a flat film portion for covering C-arm attachments.”). Additionally, this modification would allow for a target pattern to be visible and not covered by the drape, and the pattern on the drape can be used alternatively to existing calibration patterns that are covered (Philippe [Page 4, Paragraph 2] “On the surface of the cover portion, calibration recesses or reference points, for example recessed, engraved or printed recesses or points, can be formed at positions which mirror or correspond to the position of respective recesses or points on the tracking reference array, in order to provide separate calibration or reference locations associated to the respective drape.”).
Regarding claim 7, Ali teaches wherein the robotic manipulator includes a first portion that remains stationary during movement of the camera by the robotic manipulator (Fig. 1a shows that the robot arm has a base that remains stationary.), and
a second portions that moves during movement of the camera by the robotic manipulator (Fig. 1a shows movement of the arm while the base remains stationary.),
Ali fails to teach that the target pattern is attached to the first portion of the robot manipulator. However, Rui teaches wherein the step of positioning the target pattern comprises attaching the target pattern to the first portion of the robotic manipulator (Fig. 1 shows the calibration board 15 mounted on the base 11. The base 11 is stationary and the arm 12 holding the camera moves.).
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 Ali’s teachings by attaching a planar member with a calibration target pattern to the first portion of the robotic manipulator. This modification allows for the camera lens to be parallel to the calibration target pattern when viewing the pattern for the calibration process (Rui Fig. 1; Rui [0031] “to calibrate the linear array camera lens to be parallel to the calibration plate.”).
Regarding claim 8, Ali teaches wherein the step of causing the robotic manipulator to move the camera to a plurality of positions and orientations includes moving the robotic manipulator in a closed loop to maintain the pattern within the image plane of the camera ([Section 3.1, Paragraph 1] “The primary aim in recording these datasets was to collect real data for various robot-world-hand–eye calibration tests. With this aim, the collection provides three real datasets with varying robot poses and calibration patterns as shown in Figure 3.” A robot arm with a camera on the end effector was moved around to different poses, and images of the calibration board were captured at each pose. Fig. 2 shows the robot arm, and Fig. 3 shows resulting pictures where the calibration board is in the image plane.).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Ali et al. (E.R. Methods for Simultaneous Robot-World-Hand–Eye Calibration: A Comparative Study. Sensors 2019, 19, 2837; doi:10.3390/s19122837), in view of Rui (CN 112428264 A) and Philippe et al. (WO 2017/144115 A1), and further in view Grossmann et al. (US 8,743,214 B2), hereafter Grossmann.
Regarding claim 3, Ali fails to teach that the calibration target pattern is displayed on a screen; however, Grossman teaches wherein the planar member is a screen displaying the pattern (Fig. 12; Col. 4, line 65 “Displaying a sequence of one or more patterns on the monitors containing calibration features is disclosed that enable accurate camera calibration from as few as one viewing position of the camera with respect to the monitors.”).
Ali and Grossman are analogous in the art to the claimed invention, because both teach methods of camera calibration method using target patterns. 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 Ali’s methods by using a screen to display a calibration pattern rather than using a rigid calibration board. This modification can allow for a lower cost of manufacturing and use for calibration patterns (Grossman [Col. 1, line 28] “3D calibration targets typically require great manufacturing accuracy to place the target fiducials at precise locations, resulting in a high cost.”).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Alamdar et al. (Investigation of a Hybrid Kinematic Calibration Method for the “Sina” Surgical Robot. IEEE ROBOTICS AND AUTOMATION LETTERS, VOL. 5, NO. 4.) teaches calibrating the inverse kinematics of complex surgical robots involving a robotic arm. As seen in Fig. 2, the method involves using calibration markers which are located on the base of a robotic arm.
Bogojevic (EP 1810636 A1) teaches a sterile cover for tracking attachments of C-arm X-ray devices. It includes transparent film and reinforced film sections and can be pulled tightly on a surface for visibility through the cover.
Marchese (US 12,178,543 B2) teaches a sterile drape used for covering a robotic manipulator so that it remains sterile and does not contaminate the surgical instrument that it uses during surgery. Additionally, the sterile drape provides EMI shielding to protect against electrostatic discharge or electromagnetic interference.
THIS ACTION IS MADE FINAL. 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 ERIC JAMES SHOEMAKER whose telephone number is (571)272-6605. The examiner can normally be reached Monday through Friday from 8am to 5pm ET.
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/Eric Shoemaker/
Patent Examiner
/XIAO LIU/Primary Examiner, Art Unit 2664