DETAILED ACTION
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 § 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(s) 21, 22, 24-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ishihara et al (JP2020006231A); hereinafter Ishihara, Cone et al (US20200022761A1); hereinafter Cone (both cited previously), and Zhang et al (CN 113648066 A); hereinafter Zhang.
Regarding claim 21, Ishihara teaches a minimally invasive robotic surgery (MIS) robot system (a remote control device for remotely operating a patient side system) , at least comprising:
a master manipulator handle (operating handle(s) 1), for driving at least one slave manipulator coupled thereto (surgical manipulator 201);
a display-and-control portion (display 3, control device 6, [0086]-[0089] "the control device 6 can be constituted by a single control device that performs centralized control, or by a plurality of control devices that perform decentralized control in cooperation with each other", the control device that performs the centralized control is integrated with the display section, so that the centralized control of the apparatus is more intuitively and clearly performed by the display section, which is conventional technical means in the art), for controlling the master manipulator handle and the at least one slave manipulator coupled to the master manipulator handle (controls both instrument art 201a and the operating handles 1);
and a foot-operated clutch portion (operating pedal portion 2 includes a clutch pedal 24), for breaking signal communication between the master manipulator and the at least one slave manipulator (temporarily severing connection between surgical manipulator 201 to operating handle 1);
wherein when a human operator uses the display-and-control portion to establish signal communication between the master manipulator handle and any of said at least one slave manipulator (further, in the first to third embodiments, the example of the configuration in which the attached display unit 3 is connected to the remote operation device by a wired cable so as to be able to perform information communication has been described),
the display-and-control portion is at least capable of according to types of instruments on two said slave manipulators that are currently in communicative connection to master manipulator handles ( the operation handle 1 constitutes an operation unit on the master side in a master-slave type system, and the instrument arm 201A and the camera arm 201B which hold a medical instrument constitute an operation unit on the slave side) that are different from each other, (first manipulator supporting a first medical device and a camera arm supporting an endoscope - the slave manipulators are different from each other) respectively, defining a moving space of any said slave manipulator in a corresponding surgical area by means of calling movement schemes corresponding to the types of the instruments (operation mode executed by instrument 201 is a series of positions and postures);
Ishihara fails to teach switching between an intrinsic braking portion and a security braking portion. Cone teaches the foot-operated clutch portion comprises an intrinsic safety braking portion for performing braking operations on intrinsic safety operations ([0053] pedal assembly that controls non-energy devices) and a security braking portion for performing braking operations on dangerous operations including performing laser operations or triggering an emergency stop of the MIS robot system ([0052] pedal assembly for specialized devices such as energy devices),
wherein the display-and-control portion, in response to that at least one said master manipulator handle is switched from a first operation not related to laser operations to a second operation related to laser operations ([0004] pedals may be used to switch instruments), performs at least one of the following operations:
switching the corresponding intrinsic safety braking portion of the foot-operated clutch portion to the neutral position in a first activated state of the intrinsic safety braking portion, where the intrinsic safety braking portion is in a to-be-activated state ([0042] detect the user's foot hovering a distance over surface 216, but not yet contacting surface 216. In this aspect, it is particularly important that sensor 220 be mounted at a specific, and known, location on foot pedal 202 so that the foot presence can be immediately detected – hovering is a to be activated state), and
switching the corresponding security braking portion of the foot-operated clutch portion to the neutral position in a second activated state of the security braking portion, where the security braking portion is in an activated-standby state.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Ishihara with Cone because there is some teaching, suggestion, or motivation to do so. Cone teaches that there should be a method for controlling the more specialized devices such as energy devices (e.g., assemblies 200B and 200D) [different than] those that control non-energy devices such as scalpels” ([0053]) implying that energy emitting devices require more specialization than non-energy emitting ones.
The combination of Ishihara and Cone fail to teach the braking system in the neutral position being different from the on and off position. Zhang teaches the intrinsic safety braking portion and the security braking portion are configured to each have at least one neutral position in addition to an on position and an off position, wherein the security braking portion is to be switched among the on position, the off position, and the at least one neutral position based on corresponding states determined by the display-and-control portion (warning mode),
so that the security braking portion at the at least one neutral position is capable of performing the braking operations different from the braking operations on the dangerous operations related to the off position (locking the current pose of the surgical instrument 13, and/or controlling the warning device to warn according to a second warning mode (action)), the at least one neutral position comprising engagement of at least one of a mechanical connection or an electrical connection so that when the security braking portion is engaged, component damage to the MIS robot system is prevented (locking the current pose constitutes a mechanical connection, anti-collision implies preventing component damage);
and the intrinsic safety braking portion is to be switched from at least one of the on position and the off position to the at least one neutral position by an external-force operation (when the distance is greater than a second preset value and less than a third preset value) different from an operation that switches it to the off position (when the distance is greater than a second preset value and less than a third preset value, and the second preset value is greater than or equal to zero, controlling the warning device to warn according to a first warning mode, when the distance is smaller than or equal to a first preset value and the first preset value is larger than or equal to zero, locking the current pose of the surgical instrument, and/or controlling a warning device to warn according to a second warning mode), so that the intrinsic safety braking portion at the at least one neutral position is capable of performing the braking operations different from the braking operations on the intrinsic safety operations related to the off position. It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Ishihara and Cone with Zhang because there is some teaching, suggestion, or motivation to do so. Zhang teaches that having different braking systems based on distance helps prevent collision.
Regarding claim 22, Ishihara teaches the MIS system of claim 21, wherein when the human operator uses the display-and-control portion to control any two slave manipulators of said at least one slave manipulator that are in communicative connection to master manipulator handles that are different from each other, respectively, to move (a control program corresponding to the type of the instrument 201a is stored in the storage unit 62, and the control unit 61 reads out these control programs according to the type of the attached instrument 201a). Ishihara fails to teach the corresponding moving space. Zhang teaches the corresponding moving space (calibration space) of the two slave manipulators allowable by the system are kept within moving intervals and/or moving spacing provided by the movement schemes corresponding to the types of the instruments (possibility of collision can be quantitatively judged according to distance, step s2 generating a distance between the distal ends of the surgical instruments requires identifying the instruments). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify the combination of Ishihara, Cone, and Min with Zhang because there is some teaching, suggestion, or motivation to do so. Zhang teaches that by defining the particular moving space and preventing collision “the use difficulty of the master-slave surgical robot is reduced, the experience requirement on doctors is reduced, the safety can be improved, and the problem that people are eagerly solved but cannot successfully detect the collision of the surgical instruments all the time is solved”.
Regarding claim 24, the combination of Ishihara, Cone, and Zhang teaches the MIS system of claim 21. Ishihara teaches the system further comprising: arm supports (armrest 5), which are movably coupled to the master manipulator handles (pair of connecting portions 52 and the operating portion 53, the operation handle 1 can be moved within a predetermined three-dimensional operation area A (see FIGS. 7 and 8) ), and are used to receive and perform posture adjustment of arms of the human operator; a multi-axis robotic arm, which is capable of adjusting its own spatial location when driven by the display-and-control portion (the operation handle 1 is configured to be movable in the up-down direction (Z direction), the left-right direction (X direction), and the front-back direction (Y direction) with respect to the support portion 91); and a display screen (display unit 3), which is coupled to the multi-axis robotic arm and is used to display images in a surgical area in a mouth cavity of a patient in a real-time manner (The display unit 3 can display an image captured by the endoscope 201b).
Regarding claim 25, the combination of Ishihara, Cone, and Zhang teaches the MIS system of claim 24, wherein Ishihara further teaches the master manipulator handle comprises a first operating handle and a second operating handle (operating handle 1) provided on a top of a control console (figure 1 part 1) such that the first operating handle and/or the second operating handle is configured to have its central axis angled with respect to an edge of the top at a predetermined angle (figure 2 part 1).
Regarding claim 26, the combination of Ishihara, Cone, and Zhang teaches the MIS system of claim 24, wherein Ishihara further teaches the arm supports are coupled to the master manipulator handle and a top of a control console (The arm support 51 is arranged on the near side (Y1 direction side) of the operation handle 1) such that the arm supports are rotatable about the master manipulator handles (rotating the left and right operation handles 1 about the middle point between the left and right operation handles 1), wherein the arm support comprises a support pole (pillar 44) and an arm bracket (support mechanism 9) that are coupled to each other, wherein the support pole has a support pole end distant from the arm bracket coupled to the top of the control console, and the arm bracket has an arm bracket end distant from the support pole coupled to the master manipulator handle (fig 2).
Regarding claim 27, the combination of Ishihara, Cone, and Zhang teaches the MIS system of claim 21, wherein Ishihara further the display-and-control portion is arranged on a top of a control console (control device 6), and comprises: a first support post and a second support post that are movable and are coupled to each other; and a touch screen that provides functions about process control and display (display portion 3 includes a display portion 31b that displays a 3D image); wherein the first support post is coupled to the top of the control console, and the touch screen is deposited at an end of the second support post (post 44 is fixed to the support 91 of the support mechanism 9 and the mounting 33 of the display 3 is fixed to the mounting 41 of the display support arm 4).
Regarding claim 28, the combination of Ishihara, Cone, and Zhang teaches the MIS system of claim 24, wherein Ishihara further teaches the multi-axis robotic arm (display supporting arm 4 comprises a plurality of supporting members with turning axes in the plumb direction) is provided on a top of a control console (display portion 3 mounted on the mounted portion 41 can be moved in a horizontal direction), and includes a plurality of mechanical shafts that are coupled to each other and are to be driven independently (display supporting arm 4 is to be supported by mount 41 so as to be able to rotate centered on the axis of rotation A1,A2, and A3 in the plumb direction), so that the multi-axis robotic arm is capable of moving with at least three degrees of freedom in response to a driving instruction given by the display-and- control portion (mounted part 41 is supported by the supporting member having the turning axis in the plumb direction so as to be angularly adjustable by 3 degrees of freedom).
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Ishihara, Cone, and Zhang, further in view of Yates (cited previously). The combination of Ishihara, Cone, and Zhang teaches the MIS system of claim 22. Ishihara further teaches when the human operator uses the display-and-control portion to control the any two said slave manipulators that are in communicative connection to master manipulator handles that are different from each other, respectively (a control program corresponding to the type of the instrument 201a is stored in the storage unit 62, and the control unit 61 reads out these control programs according to the type of the attached instrument 201a). Ishihara and Cone fail to teach a travel speed. Zhang teaches a travel speed of any one of the two said slave manipulators allowable by the system is associated with spacing between the one of the two said slave manipulators and the other of the two slave manipulators (movement speed is high due to mistaken touch of the main hand 21 can be avoided, the abnormality of the surgical instrument 13 can be found in time, and the current pose of the surgical instrument 13 can be locked, and the collision detection method is high in reliability and strong in practicability). Ishihara, Zhang, and Cone fail to teach manipulating the travel speed. Yates teaches the travel speed changes gradually in a linear/non-linear manner with change in a spatial distance between the any two of said at least one slave manipulator ([0053] Such changes in the maximum allowable velocity of movement (e.g., increase or decrease) can thus be related to the footprint area defined by the end effector and such relationship can be linear or nonlinear). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Ishihara and Zhang with Yates because there is some teaching, suggestion, or motivation to do so. Yates teaches that due to the potential damage that can be made within the window area 2100 and the footprint area, the control system sets the velocity of movement of the associated robotic arm such that as either the window area 2100 or the rotational speed of the end effector (i.e., a factor of the footprint area) increase, the velocity or maximum allowable velocity is decreased. This can at least reduce the extent of damage created by the end effector if the end effector is moved in an undesired area ([0053]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Dhrasti SNEHAL Dalal whose telephone number is (571)272-0780. The examiner can normally be reached Monday - Thursday 8:30 am - 6:00 pm, Alternate Friday off, 8:30 am - 5:00 pm.
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/D.S.D./Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796