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 .
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 1-20 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.
Claims 1 and 16, and all dependents thereof, recite the limitation “…a sensor disposed on a second instrument external to the anatomy.” It is unclear what is meant to be “external to the anatomy” (i.e. it is unclear if the sensor is external to the anatomy or if the second instrument is external to the anatomy) and whether the external element must remain external throughout the entire execution of the method steps. For example, the percutaneous access needle is external to the anatomy prior to insertion, but is then internal. The disclosure uses essentially the same language as the claim (“a sensor disposed on a second instrument external to the anatomy”) and provides no clarity as to what, specifically, must be/remain “external to the anatomy.” For the purposes of further examination, this limitation will be interpreted to mean that the second instrument, which has a sensor, is external to the anatomy for at least a part of the time of the procedure or that a portion of the second instrument remains external to the anatomy after the start of the procedure.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-5, 8, 16, and 17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ayvali et al. (US 2021/0298590 A1, Sep. 30, 2021) (hereinafter “Ayvali”).
Regarding claims 1 and 16: Ayvali discloses a method and control system comprising: a processing system; and a memory storing instructions that, when executed by the processing system ([0065]), cause the control system to: receive first sensor data via a sensor disposed on a first instrument within an anatomy, the first sensor data indicating a pose of the first instrument ([0047], [0086]-[0087]); receive an image depicting a portion of the anatomy in a field-of-view (FOV) of a camera disposed on or proximate to a distal end of the first instrument ([0074], [0100]-[0101]); and generate a graphical interface that includes the image and an instrument alignment feature indicating an alignment of the second instrument with the FOV of the camera based at least in part on the first sensor data and the second sensor data ([0093], figs. 11-12B, [0160]-[0161]).
Regarding claim 2: Ayvali discloses the method of claim 1, wherein the instrument alignment feature includes a three- dimensional (3D) model of the second instrument ([0017], [0177], [0192], fig. 14-2).
Regarding claim 3: Ayvali discloses the method of claim 2, wherein the 3D model comprises a cone having an orientation indicating a coaxiality of the first instrument with the second instrument ([0188]-[0190] - cone icon representing needle, needle icon "indicates" the alignment, orientation, and position of the needle relative to the scope which would include coaxiality).
Regarding claim 4: Ayvali discloses the method of claim 2, wherein the 3D model comprises a rectangular plane intersecting a circle at an orientation indicating a coaxiality of the first instrument with the second instrument ([0188]-[0190] - icon 1480 is shown as a "rectangular plane intersecting a circle" in at least figs. 14-1 and 14-2, needle icon "indicates" the alignment, orientation, and position of the needle relative to the scope which would include coaxiality).
Regarding claims 5 and 17: Ayvali discloses the method of claim 2 and the system of claim 16, wherein the instrument alignment feature includes a three-dimensional (3D) model of the second instrument ([0017], [0177], [0192], fig. 14-2), the generating of the graphical interface comprising: mapping the 3D model to a first coordinate space associated with the first and second sensor data based on the pose of the second instrument ([0087] - position data of the needle and scope are registered to the patient coordinate frame, [0089] - coordinate system calibration); converting the 3D model from the first coordinate space to a second coordinate space associated with the camera based at least in part on the pose of the first instrument ([0123] - positional offset/translation to register needle and scope with target position, where the registered position of the needle relative to the target is used for the projection - [0177], [0192], [0181] - and where the camera is calibrated "to determine a transform/relationship between the visual image space of the camera and the position in the electromagnetic field associated with images/features depicted and/or otherwise appearing in the image field of the camera"); and transforming the 3D model in the second coordinate space to a two-dimensional (2D) projection on the image based on one or more intrinsic parameters of the camera ([0177], [0181], [0192] - camera calibration is "based on one or more intrinsic parameters of the camera" and the camera coordinate system is used to project the needle representation onto the 2D image).
Regarding claim 8: Ayvali discloses the method of claim 1, wherein the instrument alignment feature depicts an orientation of each of the first instrument and the second instrument in relation to an AP plane, a CC plane, or a combination thereof ([0091] - trajectory is determined and represented relative to anatomical planes).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 6-7, 9, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ayvali et al. (US 2021/0298590 A1, Sep. 30, 2021) (hereinafter “Ayvali”) in view of Ayvali et al. (US 2023/0225802 A1, Jul. 20, 2023) (hereinafter “Ayvali ‘802”).
Regarding claims 6 and 18: While Ayvali discloses displays which would show whether the first and second instrument are coaxial ([0188]-[0190]), Ayvali is silent on displaying, on the graphical interface, a coaxiality feature indicating whether the second instrument is coaxial with the first instrument based on the first sensor data and the second sensor data.
Ayvali ‘802, in the same field of endeavor, discloses tracking the positions of a first and second instrument using first and second sensor data ([0032], [0036]) and displaying, on a graphical interface, a coaxiality feature indicating whether the second instrument is coaxial with the first instrument based on the first sensor data and the second sensor data ([0074]-[0075], [0103]-[0104], [0149], [0154], fig. 10, guidance 1010). Ayvali ‘802 further teaches that such features can provide guidance for placing the instruments in a way that is correlated with success of the procedure ([0149], [0154]).
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method and control system of Ayvali to include the coaxiality feature of Ayvali ‘802 on the graphical interface in order to provide guidance for improving the success of the procedure in view of the further teachings of Ayvali ‘802.
Regarding claim 7: Ayvali and Ayvali ‘802 disclose the method of claim 6, wherein the coaxiality feature indicates whether the second instrument is coaxial with the first instrument in an anterior and posterior (AP) plane, a cranial and caudal (CC) plane, or a combination thereof (Ayvali ‘802 - [0154], fig. 10, guidance 1010 and 1020).
Regarding claim 9: Ayvali discloses the method of claim 8 but is silent on wherein the instrument alignment feature further indicates a range of suitable orientations for the second instrument based on the orientation of the first instrument, the range of suitable orientations being associated with a threshold degree of coaxiality between the first and the second instruments.
Ayvali ‘802, in the same field of endeavor, discloses providing guidance for a first and second instrument including an alignment feature which indicates a range of suitable orientations for the second instrument based on the orientation of the first instrument, the range of suitable orientations being associated with a threshold degree of coaxiality between the first and the second instruments ([0149]-[0150] - "and the angle between needle and scope should be less than a determinable angle"; [0154], fig. 10, guidance 1020). Ayvali ‘802 further teaches that such features can provide guidance for placing the instruments in a way that is correlated with success of the procedure ([0149], [0154]).
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide an indication of a range of suitable orientations as taught by Ayvali ‘802 in order to provide guidance for improving the success of the procedure in view of the further teachings of Ayvali ‘802.
Claim(s) 10-12 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ayvali et al. (US 2021/0298590 A1, Sep. 30, 2021) (hereinafter “Ayvali”) in view of Tognaccini et al. (US 2015/0366625 A1, Dec. 24, 2015) (hereinafter “Tognaccini”).
Regarding claims 10 and 19: Ayvali discloses the method of claim 1 and the control system of claim 16, where the first and second instruments may be controlled by a robotic arm ([0062]-[0063], [0151]) but is silent on determining a pose of a robotic arm configured to manipulate the first instrument or the second instrument; determining a range of movement achievable by the robotic arm based on the pose of the robotic arm; and displaying, on the graphical interface, a first visual guide depicting the range of movement achievable by the robotic arm.
Tognaccini, in the same problem-solving area of surgical robots, discloses providing an auxiliary view to an operator to assist in performing a medical procedure on a patient using a medical robotic system ([0010]) where providing the auxiliary view includes: determining a pose of a robotic arm configured to manipulate a first instrument or a second instrument (figs. 9-11, [0073], step 902 state information, [0109]); determining a range of movement achievable by the robotic arm based on the pose of the robotic arm (determining a range of movement achievable by the robotic arm based on the pose of the robotic arm (figs. 19-29, [0093]-[0094], [0109]); and displaying, on the graphical interface, a first visual guide depicting the range of movement achievable by the robotic arm (figs. 20-29, [0089], [0109]). Tognaccini further teaches that it can be difficult to properly position an entry guide supported by a robotic arm using only the camera of the robotic system ([0009]) and that the auxiliary view can assist with proper placement ([0010]).
It would have been prima facie for one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method and system of Ayvali by providing the auxiliary view as taught by Tognaccini in order to assist the user with proper placement of the robotic arm and associated instruments.
Regarding claim 11: Ayvali and Tognaccini disclose the method of claim 10. Tognaccini further discloses detecting a change in the pose of the robotic arm ([0090], [0107] - the guide is repositioned and the entire calculation is performed again, including obtaining the state information for the new position and updating the display); and updating the first visual guide to depict a new range of movement achievable by the robotic arm based on the change in pose of the robotic arm ([0090], [0107] - the guide is repositioned and the entire calculation is performed again, including obtaining the state information for the new position and updating the display).
Regarding claim 12: Ayvali and Tognaccini disclose the method of claim 10. Tognaccini further discloses determining a range of rotation achievable by a sterile adapter coupled to the robotic arm based on the pose of the robotic arm ([0055], [0067]; figs. 9-11, [0073], step 902 state information, [0109]; the state information includes rotation and the motion boundaries include rotation); and displaying, on the graphical interface, a second visual guide depicting the range of rotation achievable by the sterile adapter ([0092], figs. 20-29 - the plurality of range of motion boundary guides include rotation, include at least a "second" guide, and are applicable to any sterile adapter attached to a tool/manipulator).
Claim(s) 13-15 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ayvali et al. (US 2021/0298590 A1, Sep. 30, 2021) (hereinafter “Ayvali”) in view of Graetzel et al. (US 2021/0393338 A1, Dec. 23, 2021) (hereinafter “Graetzel”) and How to set profiles for your DualSense Edge wireless controller on PS5 consoles (www.playstation.com/en-us/support/hardware/set-up-edge-controller/; Mar. 26, 2023) (hereinafter “PS5”).
Regarding claims 13 and 20: Ayvali discloses the method of claim 1 and the control system of claim 16, where the instruments are operated via a video game controller ([0078]). Ayvali is silent on any details of the controller including determining whether the first instrument or the second instrument is being controlled by a user; and displaying, on the graphical interface, a first control scheme or a second control scheme based on whether the first instrument or the second instrument is being controlled by the user, the first control scheme indicating a mapping of user inputs to controls for the first instrument and the second control scheme indicating a mapping of user inputs to controls for the second instrument.
Graetzel, in the same field of endeavor, discloses operating a first and second instrument of a surgical system using a video game controller ([0249]), where operating the instruments comprises determining whether the first instrument or the second instrument is being controlled by a user ([0139] - the user can selected the desired instrument for control from a plurality of instruments, where the selection is "determining" which instrument is controlled by the user, [0211] - button to switch between controlling different instruments, [0251] - button to switch instrument control); and performing the operations based on control schemes which map the controller inputs to various actions to be performed by the instruments ([0083]-[0084]). Graetzel further teaches that providing control schemes (controller input mapping) allows a user to operate the instrument(s) in different modes which may more intuitively correspond user inputs, thereby improving the performance of the procedure ([0086]-[0087]).
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method and control system of Ayvali by providing control schemes for operating the instruments as taught by Graetzel in order to improve performance of the procedure by allowing more intuitive control in view of the further teachings of Graetzel.
Further regarding claims 13 and 20: Ayvali and Graetzel are silent on displaying the controls schemes corresponding to the first and second instruments.
PS5, in the same problem solving area of video game controllers, discloses a game controller set-up function which allows the user to set up a plurality of "control schemes" or profiles having different control mappings and causes display of the control schemes for the user to view and edit (see whole document).
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method and system of Ayvali and Graetzel by providing display of the control schemes as taught by PS5 in order to allow the user to view and edit the control mapping.
Regarding claim 14: Ayvali, Graetzel, and PS5 disclose the method of claim 13, further comprising: determining whether the user is holding an assigned button of an input device (it is noted that this is a standard function of game controllers such as those used by Ayvali and Graetzel, and that the controller would not function if there was no determination of whether the user was pressing/holding a button; Graetzel also discloses that buttons provide control input - [0249]); and displaying, on the graphical interface, a third control scheme responsive to determining that the user is holding the assigned button, the third control scheme indicating a mapping of user inputs to controls for a third instrument (Graetzel - fig. 7, [0139] - at least three instruments are supported; PS5 - any of the plurality of control schemes, including a third control scheme, may be accessed by pressing a specific button - see How to use profile shortcuts and How to customize your controller's button assignments).
Regarding claim 15: Ayvali, Graetzel, and PS5 disclose the method of claim 14, wherein the third instrument comprises a laser and the third control scheme is displayed only while the user is holding the assigned button (Ayvali - [0122] one of the instruments may be a laser; Graetzel - [0139] - one of the plurality of tools may be a laser; PS5 - press and hold to display control scheme, see How to use profile shortcuts and How to customize your controller's button assignments).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Wong et al. (US 2024/0324870 A1, Oct. 3, 2024) - discloses every limitation of at least claims 1 and 16
Graetzel et al. (US 2021/0393344 A1, Dec. 23, 2021) - discloses calibration of control schemes
Plewe et al. (US 2021/0196312 A1, Jul. 1, 2021) - discloses displays for aligning percutaneous access instruments
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAROLYN A PEHLKE whose telephone number is (571)270-3484. The examiner can normally be reached 9:00am - 5:00pm (Central Time), Monday - Friday.
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, Chris Koharski can be reached at (571) 272-7230. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CAROLYN A PEHLKE/Primary Examiner, Art Unit 3799
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