DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant’s arguments have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
i. Claims 1, 2, 5 – 14, 16, 18 – 20 are rejected under 35 U.S.C. 103 as being unpatentable over Itkowitz (2014/0018960), Shelton IV et al. (2019/0201122; hereinafter Shelton) and Chu (2006/0253109) in view of Navkar et al. (2019/0223964; hereinafter Navkar; this combination of references hereinafter referred to as ISCN).
Regarding claim 1, Itkowitz discloses a system [0002] for a hand-centric controller ([0009]: Master interface) for visualization [0007], the system comprising:
a camera (Comprising 112 of Figure 1A, 1B; see also Figure 3A) showing a surgical site (Comprising 303);
an actuated control system (Comprising 190), wherein the actuated control system controls the camera's field of view (Control system processes, updates information representative of light [0086] forming each channel of endoscope’s field of view [0085]); and
a hand-centric controller (Comprising 170) comprising a plurality of control elements (Comprising 242 of Figure 2B; [0020]; [0039]: Comprising at least additional tool manipulator on console of other surgeon) and a fastening member (Comprising 225), wherein
the hand-centric controller (Comprising 170) provides a user control of the actuated control system ([0122]: Master tool grip motion transferred to servo control system) via at least one control element of the plurality of control elements (Comprising 220) while manipulating the surgical tool (Controlling at least end effector grasp [0077] and position, orientation [0079]), wherein
activation of the at least one control element (Comprising 220) causes, via communication, execution of a predefined function (e.g. End effector positioning [0046], change in which one among instruments is currently manipulated, display toggling [0060]), wherein
the hand-centric controller (Comprising 170 of Figures 1A, 1B) is located remotely ([0152]: With each of 101, 195) from the camera (Comprising 112), wherein
the hand-centric controller (Comprising 170) is configured for use within a sterile field [0045], wherein
a second control element of the plurality of control elements of the hand-centric controller is a physical button or switch that is configured to enable the user to selectively engage/disengage, by actuation of the physical button or switch, with a head tracking device comprising 3D glasses configured to be worn by the user (Head-mounted display comprising presence sensor [0109] inhibiting use [0091] and implemented in at least one example as a pressure switch disposed on the master tool grip [0059]), the head tracking device configured to detect head movements of the user [0102] and register user input for control of the actuated control system based on the detected head movements (Head-in sensor determination of presence [0102] measurement failure inhibits [0091] surgical instrument operation [0092]).
Itkowitz does not explicitly disclose the controller wherein the camera is configured to record images.
In the same field of endeavor, Shelton’s implementation of a surgical robot [0217] comprises an imaging device [0219] recording snapshot(s) of the surgical site [0227] engaged by an end effector joined at the end of a handheld unit ([0373]; Figure 20) enhancing surgical operation [0290], with adaptability to the current tasks [0332].
It would be obvious to one having ordinary skill in the art before the filing date of the claimed invention for the controller of Itkowitz to be modified wherein the camera is configured to record images, in view of the teaching of Shelton, to enhance surgical operations’ adaptability.
Itkowitz in view of Shelton does not explicitly disclose the controller wherein connection of the surgical tool is enabled by the fastener.
In the same field of endeavor, Chu’s implementation of a robot for minimally invasive procedures [0002] leverages fastening by way of grasping members (Comprising 12 of Figure 1) opening and closing around surgical instruments [0017] to facilitate more easily disassembling and sterilizing the assembly [0006].
It would be obvious to one having ordinary skill in the art before the filing date of the claimed invention for the controller of Itkowitz to be modified wherein connection of the surgical tool is enabled by the fastener, in view of the teaching of Chu, to facilitate more easily disassembling and sterilizing the assembly.
Itkowitz and Shelton in view of Chu does not explicitly disclose the controller wherein when the physical button or switch causes disengage of the head tracking device, any detected head movements by the head tracking device are prevented from controlling the actuated control system.
In the same field of endeavor, Navkar discloses camera control of a laparoscope [0001] wherein when the physical button or switch causes disengage of the head tracking device, any detected head movements by the head tracking device are prevented from controlling the actuated control system ([0072]: State of a deactivated clutch switch sends command – among others – to deactivate the head tracking system). This is among measures implemented to reduce complications and operating time, as well as abrupt movement of the operating field [0002].
It would be obvious to one having ordinary skill in the art before the filing date of the claimed invention for the controller of Itkowitz to be modified wherein when the physical button or switch causes disengage of the head tracking device, any detected head movements by the head tracking device are prevented from controlling the actuated control system, in view of the teaching of Navkar, to reduce complications and operating time, as well as abrupt movement of the operating field.
Regarding claim 2, ISCN discloses the system of claim 1. Itkowitz discloses the system wherein the hand-centric controller (220 corresponding to 170 of Figures 1A, 1B; [0020]) is attachable, via the fastening member (Comprising 225).
Itkowitz does not expressly state the system being provided wherein a surgical tool is attachable via the fasting member.
In the same field of endeavor, Chu’s implementation of a robot for minimally invasive procedures [0002] leverages fastening by way of grasping members (Comprising 12 of Figure 1) opening and closing around surgical instruments [0017] to facilitate more easily disassembling and sterilizing the assembly [0006].
It would be obvious to one having ordinary skill in the art before the filing date of the claimed invention for the controller of Itkowitz to be modified wherein a surgical tool is attachable via the fasting member, in view of the teaching of Chu, to facilitate more easily disassembling and sterilizing the assembly.
Regarding claim 5, ISCN discloses the system of claim 2. Itkowitz discloses the system wherein the fastening member comprises a front flap (Figure 2A: e.g. Comprising 231A) and a rear flap (Comprising e.g. 231B), wherein the user attaches the surgical tool or a tubing of the surgical tool (Other end of 241 coupling to 190 [0064] for connection to / control of at least one respective instrument [0058]) to the hand-centric controller (Comprising 170 of Figures 1A, 1B) by gripping the front flap and the rear flap ([0063]: “…grasp the pair of levers…”) around the surgical tool or around the tubing of the surgical tool (Comprising 241).
Regarding claim 6, ISCN discloses the system of claim 2.
Itkowitz does not expressly disclose the system wherein the fastening member comprises a sleeve, wherein hand-centric controller is attachable to the surgical tool or a tubing of the surgical tool via the sleeve enveloping the surgical tool or the tubing of the surgical tool.
In the same field of endeavor, Chu implements a surgical robot for minimally invasive procedures [0002] wherein the fastening member comprises a sleeve (Comprising 50 of Figures 1, 3), wherein hand-centric controller ([0036]: Corresponding to any one among “…hand operated lever or switch…” or “…chord or remote control…”) is attachable to the surgical tool or a tubing of the surgical tool (Comprising 56) via the sleeve (Comprising 50) enveloping the surgical tool or the tubing of the surgical tool (Comprising 56). This structure is among measures by which a surgical helping hand system may be implemented that is easily disassembled and sterilized [0006].
It would be obvious to one having ordinary skill in the art before the filing date of the claimed invention for the system of Itkowitz to be modified wherein hand-centric controller is attachable to the surgical tool or a tubing of the surgical tool via the sleeve enveloping the surgical tool or the tubing of the surgical tool, in view of the teaching of Chu, to facilitate a surgical helping hand system that is easily disassembled and sterilized.
Regarding claim 7, ISCN discloses the system of claim 2.
Itkowitz does not explicitly disclose the system wherein the fastening member comprises a clip, wherein the hand-centric controller is attachable to the surgical tool or a tubing of the surgical tool via the clip hooking on to the surgical tool or the tubing of the surgical tool.
In the same field of endeavor, Chu implements a surgical robot for minimally invasive procedures [0002] wherein the fastening member comprises a clip ([0008]: Clamp), wherein the hand-centric controller ([0036]: Corresponding to any one among “…hand operated lever or switch…” or “…chord or remote control…”) is attachable to the surgical tool or a tubing of the surgical tool (Comprising 56 of Figure 1) via the clip hooking on to the surgical tool or the tubing of the surgical tool (“…closed position…” [0042] illustrated in Figure 4C). This structure is among measures by which a surgical helping hand system may be implemented that is easily disassembled and sterilized [0006].
It would be obvious to one having ordinary skill in the art before the filing date of the claimed invention for the system of Itkowitz to be modified wherein the fastening member comprises a clip, wherein the hand-centric controller is attachable to the surgical tool or a tubing of the surgical tool via the clip hooking on to the surgical tool or the tubing of the surgical tool, in view of the teaching of Chu, to facilitate a surgical helping hand system that is easily disassembled and sterilized.
Regarding claim 8, ISCN discloses the system of claim 2. Itkowitz discloses the system where the fastening member comprises one or more of: an adjustable ring (Comprising 227 of Figure 2B; [0072]: Sizeable) or a palm of the user [0071], or an elastomeric strap.
Regarding claim 9, ISCN discloses the system of claim 1. Itkowitz discloses the system wherein the predefined function comprises one or more of: a movement along any of the six degrees of freedom of x, y, z, roll, pitch, or yaw ([0141], [0142]); a movement on a hemisphere around the focal point; an increase or a decrease in lighting associated with the camera; a zoom function [0060]; a focus function [0060]; a use of fluorescence; a use of color lighting; a recording function; a hyperspectral function; an image capture function; an unlock button for actuated motion; or a selection of an image mode.
Regarding claim 10, ISCN discloses the system of claim 1.
Itkowitz does not expressly state the system wherein the at least one control element comprises one or more of: a joystick, a thumbstick, a directional button, or a track pad.
In the same field of endeavor, Shelton discloses a surgical robot [0217] comprising input devices selected from a list of alternatives including a joystick [0277]. This is among measures by which the performance of surgical operations may be improved [0290].
It would be obvious to one having ordinary skill in the art before the filing date of the claimed invention for the system of Itkowitz to be modified wherein the at least one control element comprises one or more of: a joystick, a thumbstick, a directional button, or a track pad, in view of the teaching of Shelton, to improve the performance of surgical procedures.
Regarding claim 11, ISCN discloses the system of claim 1. Itkowitz discloses the system wherein the at least one control element (Figure 2A: Comprising 170A, 170B) is arranged symmetrically so the hand-centric controller can be used identically by either hand [0062].
Regarding claim 12, ISCN discloses the system of claim 1.
Itkowitz does not expressly state the system wherein the system further comprises a programmable feedback module, wherein the programmable feedback module causes, via the hand-centric controller and in response to feedback from the camera, one or more of: a vibration, an acoustic feedback, a tactile feedback, a haptic feedback, or an indicator light.
In the same field of endeavor, Shelton discloses a surgical robot [0217] using an indicator light to warn a user that laser light based measurements discern surgical devices approaching collision [0377]. This is among measure by which implementation of situational awareness may benefit varying measures of accuracy during the procedure [0307].
It would be obvious to one having ordinary skill in the art before the filing date of the claimed invention for the system of Itkowitz to be modified wherein the system further comprises a programmable feedback module, wherein the programmable feedback module causes, via the hand-centric controller and in response to feedback from the camera, one or more of: a vibration, an acoustic feedback, a tactile feedback, a haptic feedback, or an indicator light, in view of the teaching of Shelton, to improve the accuracy of varying aspects of a surgical procedure.
Regarding claim 13, ISCN discloses the system of claim 1.
Itkowitz does not expressly state the system further comprising: a pairing module, wherein the pairing module pairs the hand-centric controller to the camera, wherein the pairing causes only one camera to be controlled by only one hand-centric controller.
In the same field of endeavor, Shelton discloses a surgical robot [0217] further comprising: a pairing module ([0399], [0412]: Pairing performed by control circuit), wherein the pairing module pairs the hand-centric controller to the camera, wherein the pairing causes only one camera to be controlled by only one hand-centric controller (Device pairing regulated by inferences regarding the surgical procedure [0304] in at least one example determining the procedure type and utilizing a single one among multiple imaging devices [0328]). This is among measure by which implementation of situational awareness may benefit varying measures of accuracy during the procedure [0307].
It would be obvious to one having ordinary skill in the art before the filing date of the claimed invention for the system of Itkowitz to be modified as further comprising: a pairing module, wherein the pairing module pairs the hand-centric controller to the camera, wherein the pairing causes only one camera to be controlled by only one hand-centric controller, in view of the teaching of Shelton, to improve the accuracy of varying aspects of a surgical procedure.
Regarding claim 14, ISCN discloses the system of claim 1. Itkowitz discloses the system wherein the plurality of control elements enables the user to engage/disengage [0091].
Itkowitz does not expressly state the system being provided wherein a third control element of the plurality of control elements is a voice control device.
However, Shelton’s surgical robot [0217] receives commands by microphone [0277]. This is among measure by which implementation of situational awareness may benefit varying measures of accuracy during the procedure [0307].
It would be obvious to one having ordinary skill in the art before the filing date of the claimed invention for the system of Itkowitz to be modified wherein a third control element of the plurality of control elements is a voice control device, in view of the teaching of Shelton, to improve accuracy of varying aspects of a surgical procedure.
Regarding claim 16, ISCN discloses the system of claim 1. Itkowitz discloses the system wherein the at least one control element generates a machine vision analysis of the images recorded by the camera, and wherein the machine vision analysis tracks a location of a tip of the surgical tool in the images recorded by the camera (Vision processing discerning instrument position and orientation in real time [0153] in one example visualizing surgeons’ {Comprising 101, 195 of Figure 1B} respective control of actual and ghost instruments during proctoring exercise [0154], [0155]; Figure 8).
Regarding claim 18, ISCN discloses the system of claim 1. Itkowitz discloses the system wherein the hand-centric controller reusable (“…handed-off the master tool grip to another surgeon…” [0059], as a teaching of engagement by more than one user, teaches the grip being “…reusable…”).
Regarding claim 19, ISCN discloses the system of claim 1. Itkowitz discloses the system wherein the hand-centric controller is sterile [0044].
Regarding claim 20, ISCN discloses the system of claim 1. Itkowitz discloses the system wherein the hand-centric controller is draped [0044].
ii. Claims 3, 4 are rejected under 35 U.S.C. 103 as being unpatentable over ISCN, as applied to claim 2 above, and further in view of Galili et al. (2019/0223977; hereinafter Galili).
Regarding claims 3, 4, ISCN discloses the system of claim 2. Itkowitz discloses the system wherein position and orientation of the master tool grip are carried by cables [0064].
ISCN does not explicitly disclose the system wherein the fastening member comprises a zip tie, wherein the hand-centric controller is attached by tightening the zip tie wherein the fastening member comprises a zip tie base, wherein the hand-centric controller is easily attached and removed from the zip tie base.
In the same field of endeavor, Galili discloses implementing a holder for various medical instruments ([0124]; e.g. Comprising 805 of Figure 13B) using a zip tie (Comprising 822, 824; see also Figure 13A) which may at a later time release and allow access to said medical instrument [0129]. This is among measures by which secure coupling of medical tools may be achieved [0001].
It would be obvious to one having ordinary skill in the art before the filing date of the claimed invention for the system of Itkowitz to be modified wherein the fastening member comprises a zip tie, wherein the hand-centric controller is attached by tightening the zip tie wherein the fastening member comprises a zip tie base, wherein the hand-centric controller is easily attached and removed from the zip tie base, in view of the teaching of Galili, to achieve secure coupling of medical tools.
iii. Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over ISCN, as applied to claim 1 above, and further in view of Orban, III (2008/0140088; hereinafter Orban).
Regarding claim 17, ISCN discloses the system of claim 1.
ISCN does not explicitly disclose the system wherein the hand-centric controller is disposable.
In the same field of endeavor, Orban discloses the implementation of surgical robot [0057] comprising an instrument sterile adapter (“…ISA…”; 300 of Figure 9A) which in at least one example, is disposable [0126]. This is among measures by which cost is reduced while preserving greater robustness [0011].
It would be obvious to one having ordinary skill in the art before the filing date of the claimed invention for the system of Itkowitz to be modified wherein the hand-centric controller is disposable, in view of the teaching of Orban, to lower the cost of a robust surgical robot system.
Inquiries
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/AARON MIDKIFF/
Examiner, Art Unit 2621
/AMR A AWAD/Supervisory Patent Examiner, Art Unit 2621
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