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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/04/2024 and 12/03/2024 were filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The disclosure is objected to because of the following informalities: Paragraph 9 of applicant’s disclosure recites “Figs.1A-1D illustrate a graphical user interface…” However, applicant’s drawings do not contain Figs 1A-1D. Applicant’s drawings only contain Fig.1. Appropriate correction and/or clarification is required.
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.
Claims 1-16, 18 and 20-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Itkowitz (US 2020/0163731 A1).
Regarding claim 1, Itokowitz teaches a medical system comprising: a display system [(see at least Fig.3-320, paragraph 45) “Physician's console 106 also includes a stereoscopic image display system 320. ”]; an input system including a first control device; and a control system, wherein the control system includes a processing unit including one or more processors, and wherein the processing unit is configured to [(see at least paragraph 44) “The console 106 may include additional input devices, including one or more foot pedals, like the exemplary foot pedals 306A and 306B. The foot pedals may include left and right foot pedals and may vary in number in different embodiments. As depicted, the console 106 includes six foot pedals 306.”]: display, on the display system, an image of a field of view of a surgical environment [(see at least Figs 6A-6B)], wherein the image is generated by an imaging component, determine a first keypoint on a first tool in the surgical environment [(see at least Fig.6A-604 and 602A-C)], determine a selection region associated with the first keypoint of the first tool [(see at least Fig.6B-614)], determine a position of a cursor relative to the field of view, the position of the cursor corresponding to a position of the first control device [(see at least Fig.6A, paragraph 58) “FIG. 6A includes an assignment indicator 604, showing that the instrument 602B is assigned to one of the master controllers 302, and a selection indicator 606, shown as a grasping hand. The selection indicator 606 may be shown by a visual representation of the master controller or by another user interface element, in other embodiments. The proxy position of the master controller may be used to determine the position of the selection indicator 606, which is shown as grasping at the center of the assignment indicator 604, and may indicate that instrument 602B is assigned to the master controller 302B. In other words, FIG. 6A shows the proxy position of the master controller 302B as coinciding with the proxy position of the instrument 602B. As depicted, the selection indicator 606 is a right hand indicator, communicating to the physician that the right hand master controller (master controller 302B) is assigned to the control of instrument 602B. FIG. 7A shows the position of the physician's left hand (LH) and right hand (RH) in the workspace reference frame, which are engaged in the master controllers 302A and 302B, respectively, to control the instruments 602A and 602B, respectively.”], determine if the position of the cursor overlaps the selection region [(see at least Fig.6B)], provide a directional cue if the position of the cursor overlaps the selection region to direct the cursor toward the first keypoint, and engage the first control device to manipulate the first tool when the cursor reaches the first keypoint. [(see at least Figs.6B,7B, paragraph 62) “As shown in FIGS. 6B and 7B, the control system 108 may receive a motion based input from the master controller 302B, as the physician moves the master controller 302B to a location associated with the unassigned instruments 602C. This may be done by moving the master controller 302B, such that a proxy position thereof moves or aligns to a proxy position of instrument 602C. This motion based input may include the first input component and the second input component. As the physician moves the master controller 302B along a path 712, the selection indicator 606 (associated with the proxy position of the master controller 302B) moves along a corresponding path 612, providing the physician with visual feedback of the movement of the master controller 302B relative to the instruments 602. The selection indicator 606 changes position and orientation in the view 600 as the master controller 302B is moved. In order to effect a reassignment, the physician may move the master controller 302B so that the selection indicator 606 becomes aligned with the candidate indicator 608. In doing so, the physician may move the selection indicator 606 outside of a boundary 614 that is associated with the instrument 602B. This may be the first input component, which entails a disassociation of the master controller from the previously assigned instrument 602B. As depicted in FIG. 6B, the boundary 614 may be a spherical boundary in some embodiments, and generally circular in other embodiments. The boundary 614 may or may not be shown to the physician in the view 600. When the selection indicator 606 moves outside of the boundary 614, the assignment indicator 604 may change to a candidate indicator 608, like that associated with the instrument 602C. The control system 108 may thereafter treat the instrument 602B as an unassigned instrument.”]
Regarding claim 2, Itkowitz teaches wherein providing the directional cue includes providing a haptic force to the first control device. [(see at least paragraph 66) “For example, when the selection indicator 606 enters the boundary 616 as shown in FIG. 6C, the control system 108 may cause the master controller 302B to drift or move towards the proper alignment associated with the instrument 602C. When such haptic feedback is provided, the change in the control assignment of the selected instrument, at operation 508, may be performed before additional instrument reassignment input is received from the foot pedals 306, the elbow pads 308, or the buttons 418 on the master controllers 302. However, actual control of the instrument 602C may not begin until the master controller 302 completes its drift or movement toward the proper alignment. By providing the haptic feedback only when the master controller 302 is near a final position for reassignment, such as within the threshold or boundary 616, the control system 108 may avoid surprise and or discomfort to the physician if the final position of the master controller 302 results in a non-ergonomic pose of the operator's hand.”]
Regarding claim 3, Itkowitz teaches wherein providing the directional cue includes displaying a zipline graphic that extends between the cursor and the first keypoint. [(see at least Figs.6A-6B, paragraph 43) “When an instrument control mode is selected, each master controller 302 is coupled to control a corresponding robotic arm 210 of the patient-side assembly 102. For example, the left master controller 302A may be coupled to control robotic arm 210A and/or its associated instrument 220A, and the right master controller 302B may be coupled to control arm 210D and its corresponding instrument 220D. In some instances, control of the arm 210 may be performed in an arm control mode, while control of the instrument 220 may be performed in a distinct instrument control mode. If the robotic arm 210B is used during a medical procedure and is positioned on the left side, then the physician may desire to reassign the left master controller 302A from controlling arm 210A and instrument 220A to controlling arm 210B and instrument 220B, instead. Likewise, if the robotic arm 210E is to be used during a medical procedure and is positioned on the right side, then right master controller 302B can be switched between controlling arm 210D and instrument 220D to controlling arm 210E and instrument 220E. In alternative embodiments, any of the instrument arms may be controlled by either the left or right master controller to accommodate the physician's preference, the view available to the physician, or the requirements of a particular procedure”]
Regarding claim 4, Itkowitz teaches wherein the cursor includes an identification symbol representing the first control device. [(see at least Figs.6A-6B, paragraph 44) “The console 106 may include additional input devices, including one or more foot pedals, like the exemplary foot pedals 306A and 306B. The foot pedals may include left and right foot pedals and may vary in number in different embodiments. As depicted, the console 106 includes six foot pedals 306. However, other embodiments may include only one or two foot pedals. The console 106 may further include elbow switches or pads 308A and 308B. The elbow pads 308 may permit the physician to activate a feature, by pushing against a pad 308 with either the corresponding elbow. Some embodiments include pads disposed for activation by the physician's knees. For example, the console 106 may include a left kneepad and right kneepad, which may operate as buttons or switches when activated by the physician.”]
Regarding claim 5, Itkowitz teaches wherein the first control device is manipulatable in more than two translational degrees of freedom. [(see at least paragraph 42) “The depicted master controllers 302A and 302B may include kinematic chains that are used to control the medical tools (which include the endoscope and various cannulas). The master controllers 302 may be referred to simply as “manipulators,” and their associated arms 210 and medical instruments 220 may be referred to simply as “slave.” In the depicted embodiment, the physician grasps a pincher assembly 304A or 304B on each master controller 302, typically with the thumb and forefinger, and can move the pincher assembly 304 to various positions and orientations. Each master controller 302 generally allows for movement within the master workspace with a plurality of degrees of freedom, typically with six degrees of freedom, three rotational degrees of freedom and three translational degrees of freedom.”]
Regarding claim 6, Itkowitz teaches further comprising: a second control device manipulatable in more than two translational degrees of freedom. [(see at least paragraphs 42,48) As in 42 “The depicted master controllers 302A and 302B may include kinematic chains that are used to control the medical tools (which include the endoscope and various cannulas). The master controllers 302 may be referred to simply as “manipulators,” and their associated arms 210 and medical instruments 220 may be referred to simply as “slave.” In the depicted embodiment, the physician grasps a pincher assembly 304A or 304B on each master controller 302, typically with the thumb and forefinger, and can move the pincher assembly 304 to various positions and orientations. Each master controller 302 generally allows for movement within the master workspace with a plurality of degrees of freedom, typically with six degrees of freedom, three rotational degrees of freedom and three translational degrees of freedom.”]
Regarding claim 7, Itkowitz teaches wherein the processing unit is further configured to: receive an initiation signal to enter a swap mode; responsive to movement of the first control device, move the cursor from the first keypoint toward a second tool in the image of the field of view; and engage the first control device to manipulate the second tool when the cursor reaches a second keypoint of the second tool. [(see at least paragraphs 48, ) As in 48 “The depicted master controller 302 includes first, second, and third gimbal members 402, 404, and 406. The touch sensitive handle provided by finger assembly 304 includes a tubular support structure 412, a first grip 414A, and a second grip 414B. The first grip 414A and the second grip 414B are supported at one end by the structure 412. In some embodiments, the grips 414 may include loops of material that help secure the physician's fingers in place relative to the structure of the grips. Additionally, some embodiments may include more than two grips connected to the support structure 412 or two grips 414 and another control mechanism, like a button, switch, track pad, or scroll-wheel. For example, the master controller 302 may include a button 418 that may be activated by the physician to switch control modes or perform a particular action” As in 64 “] Returning to FIG. 5, the processing device may assign control of the selected instrument 602C to the master controller 302B based on the association brought about by the received input, at operation 508. When the activation of the instrument reassignment input is detected at operation 502, this may be detected by identifying an interaction with the elbow pad 308B or other activation input of FIG. 3. The user may release the elbow pad 308B or activate the elbow pad 308B again in order to affect the change. Thereafter, the instrument reassignment state may be terminated by the control system 108 and a standard operational state may be entered, such that subsequent manipulation of the master controller 302B causes movement of the instrument 602C along a path 614 as shown in FIG. 6D, the movement caused by the movement along the path 714 of the master controller 302B as shown in FIG. 7D, at operation 510.”]
Regarding claim 8, Itkowitz teaches wherein a second selection region is associated with the second keypoint of the second tool and wherein the processing unit is further configured to provide a second directional cue when the position of the cursor overlaps the second selection region. [(see at least paragraph 58) “FIG. 7A shows the position of the physician's left hand (LH) and right hand (RH) in the workspace reference frame, which are engaged in the master controllers 302A and 302B, respectively, to control the instruments 602A and 602B, respectively. FIG. 6B also includes a reassignment candidate indicator 608, which identifies a candidate that is not currently assigned to either of the master controllers 302. In some embodiments, when a particular master controller 302 has been selected for reassignment, all of the instruments that are unassigned can be highlighted with a candidate indicator, like the candidate indicator 608.”]
Regarding claim 9, Itkowitz teaches wherein the initiation signal is generated based on receipt of a user input at the first control device. [(see at least paragraph 48) “Additionally, some embodiments may include more than two grips connected to the support structure 412 or two grips 414 and another control mechanism, like a button, switch, track pad, or scroll-wheel. For example, the master controller 302 may include a button 418 that may be activated by the physician to switch control modes or perform a particular action.”]
Regarding claim 10, Itkowitz teaches wherein the initiation signal is a double input at a finger switch of the first control device while the first control device is otherwise stationary. [(see at least paragraph 48) “Additionally, some embodiments may include more than two grips connected to the support structure 412 or two grips 414 and another control mechanism, like a button, switch, track pad, or scroll-wheel. For example, the master controller 302 may include a button 418 that may be activated by the physician to switch control modes or perform a particular action. As shown, the button 418 is mounted at a proximal end of the support structure 412, disposed between the grips 414, such that it can be actuated when a hand grips the support structure 412. The button 418 may include a redundant button or a similar but non-redundant button disposed on the opposite side of the support structure 412. However, one or more similar buttons may be positioned elsewhere in other embodiments. The finger assembly 304 can be rotated about axis A, illustrated in FIG. 4. The grips 414A and 414B can be squeezed or pinched together about the tubular structure 412.”]
Regarding claim 11, Itkowitz teaches wherein the processing unit is further configured to receive a grip indication before the first control device is engaged to manipulate the second tool. [(see at least paragraph 48) “The finger assembly 304 can be rotated about axis A, illustrated in FIG. 4. The grips 414A and 414B can be squeezed or pinched together about the tubular structure 412. The “pinching” or grasping degree of freedom in the grips is indicated by arrows Ha and Hb. These or other movements of the grips 414 relative to the support structure 412 may provide commands to manipulate the end effectors 230 of instruments 220.”]
Regarding claim 12, Itkowitz teaches wherein a dimension of the selection region is changeable based on a proximity of the first tool to the second tool. [(see at least paragraphs 59-60) As in 59 “FIG. 6A may also include an off-screen instrument indicator 610 to alert the physician to the presence of an instrument (e.g., an instrument 602D) that is present at the interventional site but that is outside of the view 600 as provided by the endoscope 222. The off-screen instrument indicator 610 may include a directional component that points to the location of the instrument 602D and indicates the orientation of the instrument 602D. A proxy position of the out-of-view instrument 602D may be computed and translated into the endoscopic reference frame and represented in the view 600 by the off-screen instrument indicator 610. In general, the positions of the indicators 606, 608, and/or 610 may be determined by the control system 108 and rendered in a three-dimensional space defined by the view 600 of the interventional site to allow to physician to interact with the tools represented by the indicators.”]
Regarding claim 13, Itkowitz teaches wherein a location of the second keypoint of the second tool is adjustable based on a proximity of the first tool to the second tool. [(see at least paragraphs 59-60) As in 60 “In some embodiments, the instrument 602D may be selected for reassignment by interaction between the selection indicator 606 and the off-screen instrument indicator 610, in a manner like that describe herein with respect to FIG. 602C. In some embodiments, when an off-screen instrument, like instrument 602D is selected by selecting the indicator 610, the instrument 602D may be subsequently operated in a limited instrument control mode. For example, the instrument 602D may be moved along an insertion axis only. Commands from the master controller 302 to manipulate the wrist or the end effector of the instrument 602D may be ignored or suppressed by the control system. In some embodiments, the control system 108 may impose limits on the amount of movement permissible to the instrument 602D or haptic feedback (such as a resistive force that provides viscous drag) can be provided to communicate the need for caution when manipulating an off-screen instrument. Additional control or full control may be provided after the instrument 602D becomes visible in the view 600.”]
Regarding claim 14, Itkowitz teaches wherein if the first keypoint is within a threshold distance from the second keypoint, evaluate a three-dimensional motion of the first control device and engage the first control device to manipulate the second tool based on the three- dimensional motion of the first control device. [(see at least paragraph 63) “In some implementations, the assignment indicator 606 may be displayed when the physician positions the selection indicator 606 within a boundary 616 that surrounds center of the candidate indicator 608 or, in other words, when the proxy position of the master controller 302B is within a threshold of the proxy position of the instrument 602C. This threshold may be defined in terms of two-dimensional distance, three-dimensional distance, orientation, and/or combinations of these terms. The assignment indicator 604 may be shown in connection with the instrument 602C before the control system 108 actually has reengaged control by the master controller 302B, such that subsequent movement of the master controller 302B may prevent the assignment of control of the instrument 602C.”]
Regarding claim 15, Itkowitz teaches wherein the first tool is outside the field of view and the selection region is at least partially within the field of view. [(see at least paragraph 59) “FIG. 6A may also include an off-screen instrument indicator 610 to alert the physician to the presence of an instrument (e.g., an instrument 602D) that is present at the interventional site but that is outside of the view 600 as provided by the endoscope 222. The off-screen instrument indicator 610 may include a directional component that points to the location of the instrument 602D and indicates the orientation of the instrument 602D. A proxy position of the out-of-view instrument 602D may be computed and translated into the endoscopic reference frame and represented in the view 600 by the off-screen instrument indicator 610. In general, the positions of the indicators 606, 608, and/or 610 may be determined by the control system 108 and rendered in a three-dimensional space defined by the view 600 of the interventional site to allow to physician to interact with the tools represented by the indicators.”]
Regarding claim 16, Itkowitz teaches wherein the first tool is a medical instrument or is a menu displayed on the display system. [(see at least paragraph 40) “During operation of the teleoperational medical system 100, one or more of the medical instruments 220 may be replaced by other medical instruments 220 or the medical instruments 220 may be moved among the manipulator arms 208.”]
Regarding claim 18, Itkowitz teaches wherein the selection region is centered on the first keypoint. [(see at least paragraph 58) “FIG. 6A includes an assignment indicator 604, showing that the instrument 602B is assigned to one of the master controllers 302, and a selection indicator 606, shown as a grasping hand. The selection indicator 606 may be shown by a visual representation of the master controller or by another user interface element, in other embodiments. The proxy position of the master controller may be used to determine the position of the selection indicator 606, which is shown as grasping at the center of the assignment indicator 604, and may indicate that instrument 602B is assigned to the master controller 302B.”]
Regarding claim 20, Itkowitz teaches wherein the processing unit is further configured to: determine an axial direction of the first tool relative to an imaging position of the imaging component; and engage the first control device to manipulate the first tool when an orientation of the first control device matches an orientation of an end effector of the first tool within an angular tolerance. [(see at least paragraphs 36-37) As in 36 “Each of the coupling arms 206 may be connected to an orienting platform 214. The orienting platform 214 may be capable of 360 degrees of rotation. The assembly 102 may also include a telescoping horizontal cantilever 216 for moving the orienting platform 214, and thereby the coupling arms 206, in a horizontal direction.” As in 37 “In the present example, each of the coupling arms 206 connects to a manipulator arm 208, such that FIG. 2 depicts manipulator arms 208A, 208B, 208C, and 208D (collectively or generically referred to as manipulator arm(s) 208). The manipulator arms 208 may connect directly to a medical instrument 220. The manipulator arms 208 may be teleoperational and may include multiple joints to allow for the positioning and repositioning of the arms 208 and attached instruments by the physician O. In some examples, the coupling arms 206 connecting to the orienting platform 214 are not teleoperational. Rather, such coupling arms 206 are positioned as desired before the physician O begins operation with the teleoperative components”]
Regarding claim 21, Itokowitz teaches wherein determining the position of the cursor relative to the field of view includes mapping the cursor to a normalized device coordinate space of a single eyepiece of a stereoscopic imaging system, wherein determining a selection region includes mapping the selection region to the normalized device coordinate space of the single eyepiece of a stereoscopic imaging system, and wherein determining if the position of the cursor overlaps the selection region is determined independent of depth. [(see at least Fig.6A, paragraph 59) “FIG. 6A may also include an off-screen instrument indicator 610 to alert the physician to the presence of an instrument (e.g., an instrument 602D) that is present at the interventional site but that is outside of the view 600 as provided by the endoscope 222. The off-screen instrument indicator 610 may include a directional component that points to the location of the instrument 602D and indicates the orientation of the instrument 602D. A proxy position of the out-of-view instrument 602D may be computed and translated into the endoscopic reference frame and represented in the view 600 by the off-screen instrument indicator 610. In general, the positions of the indicators 606, 608, and/or 610 may be determined by the control system 108 and rendered in a three-dimensional space defined by the view 600 of the interventional site to allow to physician to interact with the tools represented by the indicators.”]
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.
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.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Itkowitz in view of Frielinghaus (US 2020/0261161 A1).
Regarding claim 19, Itkowitz has all of the elements of claim 1 as discussed above.
Itkowitz does not explicitly teach wherein determining the position of the cursor includes determining an affine transformation of the first control device to affect motion scaling and a position offset of an initial cursor position.
However, Frielinghaus teaches wherein determining the position of the cursor includes determining an affine transformation of the first control device to affect motion scaling and a position offset of an initial cursor position. [(see at least paragraph 58) “these two relative movements can be expressed by an affine transformation in 3D space I and R, where I denotes the relative movement of the medical instrument base relative to its mount and R denotes the relative movement of the robotic system at the instrument mount base. The transformation R*I.sup.−1 is representative of the orientation of the medical instrument base at the TCP.”]
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Itkowitz to incorporate the teachings of Frielinghaus of wherein determining the position of the cursor includes determining an affine transformation of the first control device to affect motion scaling and a position offset of an initial cursor position in order to accurately measure the respective movement of the medical instrument. [(Frielinghaus 59)]
The Examiner has cited particular paragraphs or columns and line numbers in the references applied to the claims above for the convenience of the Applicant. Although the specified citations are representative of the teachings of the art and are applied to specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested of the Applicant in preparing responses, to fully consider the references in their entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the Examiner. See MPEP 2141.02 [R-07.2015] VI. A prior art reference must be considered in its entirety, i.e., as a whole, including portions that would lead away from the claimed Invention. W.L. Gore & Associates, Inc. v. Garlock, Inc., 721 F.2d 1540, 220 USPQ 303 (Fed. Cir. 1983), cert, denied, 469 U.S. 851 (1984). See also MPEP §2123.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
(US 2022/0125517 A1) Zimmermann - ULTRASOUND BASED MULTIPLE BONE REGISTRATION SURGICAL SYSTEMS AND METHODS OF USE IN COMPUTER-ASSISTED SURGERY
(US 2022/0287676 A1) Steines - AUGMENTED REALITY GUIDANCE FOR IMAGING SYSTEMS
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOHAMMED YOUSEF ABUELHAWA whose telephone number is (571)272-3219. The examiner can normally be reached Monday-Friday 8:30-5:00 with flex.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Wade Miles can be reached at 571-270-7777. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MOHAMMED YOUSEF ABUELHAWA/Examiner, Art Unit 3656
/WADE MILES/Supervisory Patent Examiner, Art Unit 3656
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