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 § 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.
Claim(s) 1-8,11-16, 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Steinle et al (US 20190046278, hereinafter Steinle) in view of Holmberg et al (US 9870002, hereinafter Holmberg).
Regarding Claim 1, Steinle teaches:
a surgical system (see at least robotic system in Fig. 2 and par. 0084 ) comprising:
a tool (see at least surgical tool in par. 0087 and Fig. 2 ) ;
a robot configured to move the tool (see at least "The holding arm 2 (for example, attached to the patient couch 5) comprises a plurality of joints and a locking mechanism (for example, a brake) associated with each joint. In a first status of the robotic system 1 (for example, an unlocked status of the holding arm 2) a manual movement of the holding arm 2 is allowed (for example, for a coarse-adjustment of the robotic system 1). In a second status of the robotic system 1 (for example, a locked status of the holding arm 2) a manual movement of the holding arm 2 is inhibited (for example, for a fine-adjustment of the robotic system 1 by the fine-adjustment unit 3)." in par. 0085) ;
a controller (see at least "The computer 4 is operatively associated with the at least one actuator" in par. 0087) programmed to:
generate a plan for the robot to move, in a planned amount of time, the tool from a starting pose to a target pose (see at least “In a (for example second) exemplary step, planned position data which describes (for example, defines) at least one planned position (for example, location and/or orientation) of the tool relative to the anatomical structure of the patient is determined. Determining the planned position data is based on the image data. In one example, the planned position is associated with (for example, defined by) a trajectory (also referred to as a target trajectory) comprising an entry point and a target point of the tool relative to the anatomical structure of the patient.” In par. 0012 and "In one example, the control data is associated with information describing a maximum time for moving the tool (for example, in the second status of the robotic system). In particular, the movement of the tool may be stopped, if a specific time constraint (for example, a predetermined time period describing a maximum time) has expired. After stopping the movement new (for example, updated) control data may be determined (for example, comprising selection of another target trajectory)." in par. 0032);
control the robot to provide automated movement of the tool based on the plan such that the robot moves the tool toward the target pose without requiring user assistance (see at least "The disclosed method provides, in a first aspect, a medical data processing method for determining control data for an automated movement of a robotic system to move a tool operatively associated with the robotic system." in par. 0010 and “In particular, in the first status a coarse-adjustment of at least one part of the robotic system is allowed. The manual movement (for example, adjustment) may be executed by a user (for example, a surgeon). In the second status a manual movement of the at least one part of the robotic system is inhibited. The first status of the robotic system may be associated with a coarse-adjustment mode of the robotic system. The second status of the robotic system may be associated with a fine-adjustment mode of the robotic system.” In par. 0013) ; and
stop the automated movement if the target pose is not reached after the automated movement for a maximum time. (see at least "In one example, the control data is associated with information describing a maximum time for moving the tool (for example, in the second status of the robotic system). In particular, the movement of the tool may be stopped, if a specific time constraint (for example, a predetermined time period describing a maximum time) has expired. After stopping the movement new (for example, updated) control data may be determined (for example, comprising selection of another target trajectory)." in par. 0032)
Steinle does not appear to explicitly teach all of the following, but Holmberg does teach:
Controlling a trajectory to approach a target position according to the planned amount of time (see at least "The commanded velocity profile may be discrete or continuous. When the commanded velocity profile is continuous, it may be discretized into a plurality of velocity points corresponding to a plurality of time points. " in col. 6 lines 49-53 and “Specifically, the control system may determine the target position that is predicted to cause the motor controller to drive the motor with the target velocity 524 at time point t=1 by determining an intersection point 710 between a first line 700 and a second line 702. The first line 700 may be defined as a line through a point corresponding to the starting velocity 708 and the starting time point t=0 and having a slope corresponding to the first maximum acceleration. The second line 702 may be defined as a line through a point corresponding to the target velocity 524 and the target time point t=1 and having a slope corresponding to the second maximum acceleration.” In col. 24 lines 32-43 )
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system taught by Steinle to incorporate the teachings of Holmberg wherein velocity of the robot is planned and executed over a motion trajectory so that it travels to and stops at a target position, in order to arrive at the maximum time taught by Steinle to correspond to a planned time for reaching the final target position. The motivation to incorporate the teachings of Holmberg would be to avoid overshooting the target position (see col. 5 lines 54-60), which improves accuracy.
Regarding Claim 2, Steinle as modified by Holmberg teaches:
the surgical system of Claim 1, wherein:
Steinle further teaches: the controller is programed to generate the target pose based on a position of a patient (see at least " Determining the planned position data is based on the image data. In one example, the planned position is associated with (for example, defined by) a trajectory (also referred to as a target trajectory) comprising an entry point and a target point of the tool relative to the anatomical structure of the patient. The entry point and the target point may be selected manually by a surgeon, for example by selecting (for example, marking) the respective points on the image. The target point may be associated with a position of a region of interest (for example, a tumor). The entry point may be selected such that the target trajectory does not intersect with a specific part of the anatomical structure (for example, a critical structure). In one example, the entry point and the target point may be determined (for example, calculated) automatically." in par. 0012) ; and
the starting pose and the target pose are spaced apart from the patient. (see at least " In one embodiment, the movement of the tool may me restricted by at least one constraint (for example a threshold value, in particular associated with a distance or time). In particular, the control data is associated with information describing a minimum distance between the tool and a part (for example a surface) of the anatomical structure of the patient. In particular, a plurality of points (for example, points arranged equidistantly) may be selected on the target trajectory. For each of these points a minimum distance to the part of the anatomical structure of the patient may be determined. If the movement of the tool cannot comply with the minimum distance, new (for example, updated) control data may be determined. This way an unwanted collision of the tool with the anatomical structure of the patient may be avoided." in par. 0031)
Regarding Claim 3, Steinle as modified by Holmberg teaches:
the surgical system of Claim 1,
Steinle further teaches: wherein the planned amount of time is a preset duration, and wherein the controller is programmed to generate the plan by generating a path for the automated movement subject to a constraint requiring the automated movement to be expected to take the preset duration. (see at least "In one example, the control data is associated with information describing a maximum time for moving the tool (for example, in the second status of the robotic system). In particular, the movement of the tool may be stopped, if a specific time constraint (for example, a predetermined time period describing a maximum time) has expired. After stopping the movement new (for example, updated) control data may be determined (for example, comprising selection of another target trajectory)." in par. 0032)
Regarding Claim 4, Steinle as modified by Holmberg teaches:
the surgical system of Claim 3,
Steinle does not appear to explicitly teach all of the following, but Holmberg does teach:
wherein the controller is further programed to generate the plan by planning a rate of movement of the tool along the path. (see at least " In one example, a method is provided that includes determining a target velocity for a motor, where a position-controlled motor controller is configured to drive the motor to a commanded position with a characteristic acceleration profile. The method also includes determining a target position that, when commanded to the motor controller, is predicted to cause the motor controller to drive the motor with the target velocity at a target time point by driving the motor with the characteristic acceleration profile. The method additionally includes providing an instruction for execution by the position-controlled motor controller, the instruction configured to cause the position-controlled motor controller to drive the motor to the target position." in col. 1 lines 37-49)
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system taught by Steinle to incorporate the teachings of Holmberg wherein velocity of the robot is planned and executed over a motion trajectory so that it travels to and stops at a target position. The motivation to incorporate the teachings of Holmberg would be to avoid overshooting the target position (see col. 5 lines 54-60), which improves accuracy.
Regarding Claim 5, Steinle as modified by Holmberg teaches:
the surgical system of Claim 4,
Steinle does not appear to explicitly teach all of the following, but Holmberg does teach:
wherein the controller is programmed to slow the rate of movement of the tool along the path as the tool approaches the target pose. (see at least " Second, during a second time interval, as the motor approaches the target position, the position-controlled motor controller may drive the motor with a second maximum acceleration in a second direction opposite to the first direction (e.g., a negative acceleration). Driving the motor in the second direction may cause the motor to slow down as the motor approaches the target position so as not to overshoot the target position. Thus, the motor may reach the target position at zero velocity (i.e., the motor may be stopped at the target position). This fixed and predictable behavior of the position-controlled motor controller may be used to determine a target position that, when commanded to the position-controlled motor controller, is predicted to cause the motor controller to drive the motor with a target velocity at a known/predetermined future time (i.e., a target time point)." in col. 5 line 53 to col. 6 line 1 )
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system taught by Steinle to incorporate the teachings of Holmberg wherein velocity of the robot is planned and executed over a motion trajectory so that it travels to and stops at a target position. The motivation to incorporate the teachings of Holmberg would be to avoid overshooting the target position (see col. 5 lines 54-60), which improves accuracy.
Regarding Claim 6, Steinle as modified by Holmberg teaches:
the surgical system of Claim 1,
Steinle further teaches: wherein the controller is programmed to generate the plan by adjusting a predefined arc to obtain a planned path from the starting pose to the target pose. (see at least " In particular, the control data is associated with information describing a minimum distance between the tool and a part (for example a surface) of the anatomical structure of the patient. In particular, a plurality of points (for example, points arranged equidistantly) may be selected on the target trajectory. For each of these points a minimum distance to the part of the anatomical structure of the patient may be determined. If the movement of the tool cannot comply with the minimum distance, new (for example, updated) control data may be determined. This way an unwanted collision of the tool with the anatomical structure of the patient may be avoided." in par. 0031)
Regarding Claim 7, Steinle as modified by Holmberg teaches:
7. The surgical system of Claim 1,
Steinle further teaches: wherein the plan indicates translations and rotations of the tool by the robot. (see at least " In a (for example second) exemplary step, planned position data which describes (for example, defines) at least one planned position (for example, location and/or orientation) of the tool relative to the anatomical structure of the patient is determined “ in par. 0012)
Regarding Claim 8, Steinle as modified by Holmberg teaches:
the surgical system of Claim 1,
Steinle further teaches: wherein the plan indicates points in space where the tool is planned to be at different times during the planned amount of time. (see at least “In one example, determining the control data comprises evaluating whether the tool can arrive at a planned position (for example, a selected target trajectory) by movement of the actuator. This may be determined by applying the inverse kinematics of the actuator (for example, the actuator comprised in the robotic fine-adjustment unit). In case of a linear movement of the actuator, the linear translation of the actuator may be determined. For more complex movements of the actuator numerical optimization methods for non-linear systems, for example the Jacobian Inverse technique may be applied. If the tool can arrive at the planned position, the actuator may be instructed to move. If the tool cannot arrive at the planned position, new (for example, updated) control data may be determined (for example, comprising selection of another target trajectory).” In par. 0030 and " In particular, the control data is associated with information describing a minimum distance between the tool and a part (for example a surface) of the anatomical structure of the patient. In particular, a plurality of points (for example, points arranged equidistantly) may be selected on the target trajectory. For each of these points a minimum distance to the part of the anatomical structure of the patient may be determined. " in par. 0031)
Regarding Claim 11, Steinle as modified by Holmberg teaches:
11. The surgical system of Claim 10, wherein:
Steinle further teaches: the robot is a robotic arm comprising joints; the internal data of the robot is data from the joints of the robotic arm (see at least " In one example, the actual position of the element of the robotic system is acquired by determining the position of one or more joints of the robotic system." in par. 0021 ) ; and
the starting pose and the target pose are spaced apart from a patient. (see at least " In one embodiment, the movement of the tool may be restricted by at least one constraint (for example a threshold value, in particular associated with a distance or time). In particular, the control data is associated with information describing a minimum distance between the tool and a part (for example a surface) of the anatomical structure of the patient. In particular, a plurality of points (for example, points arranged equidistantly) may be selected on the target trajectory. For each of these points a minimum distance to the part of the anatomical structure of the patient may be determined. If the movement of the tool cannot comply with the minimum distance, new (for example, updated) control data may be determined. This way an unwanted collision of the tool with the anatomical structure of the patient may be avoided." in par. 0031).
Regarding Claim 12, Steinle as modified by Holmberg also teaches:
A method for implementing the system of Claim 1 (see Claim 1 analysis for rejection of the system).
Regarding Claim 13, Steinle as modified by Holmberg also teaches:
A method for implementing the system of Claim 2 (see Claim 2 analysis for rejection of the system).
Regarding Claim 14, Steinle as modified by Holmberg also teaches:
A method for implementing the system of Claim 3 (see Claim 3 analysis for rejection of the system).
Regarding Claim 15, Steinle as modified by Holmberg also teaches:
A method for implementing the system of Claim 4 (see Claim 4 analysis for rejection of the system).
Regarding Claim 16, Steinle as modified by Holmberg also teaches:
A method for implementing the system of Claim 6 (see Claim 6 analysis for rejection of the system).
Regarding Claim 18, Steinle as modified by Holmberg also teaches:
A method for implementing the system of Claim 8 (see Claim 8 analysis for rejection of the system).
Regarding Claim 19, Steinle as modified by Holmberg teaches:
the method of Claim 18, comprising
Steinle further teaches: forcing, by the surgical robot, the tool toward the points in space as the different times occur during the planned amount of time. (see at least "In one example, determining the control data comprises selecting a planned position of the tool out of a plurality of planned position (described by the planned position data) based on a proximity to an actual position of the element (for example, the tool) of the robotic system (described by the actual position data). In particular, determining the control data comprises calculating a distance between the actual position of the element of the robotic system and the at least one planned position of the tool. In one example, determining the control data comprises calculating a distance between the actual position of the element of the robotic system and each planned position of the tool out of a plurality of planned positions of the tool (described by the planned position data)." in par. 0026)
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Steinle et al (US 20190046278, hereinafter Steinle) in view of Holmberg et al (US 9870002, hereinafter Holmberg) and Fuerst et al (US 20200268453, hereinafter Fuerst).
Regarding Claim 9, Steinle as modified by Holmberg teaches:
9. The surgical system of Claim 8,
Steinle and Holmberg do not appear to explicitly teach all of the following, but Fuerst does teach:
wherein the controller is programmed to control the robot to exert a spring force on the tool driving the tool to the points in space at corresponding times of the different times during the planned amount of time. (see at least " In one variation, according to the algorithm, manual guidance of the robotic arm 19/tool drive 23 toward the trocar 36 by a user can be influenced by a virtual spring modeled by the processor that simulates a spring constant from which a force that is proportional to an offset from a planned trajectory toward the trocar 63 is generated, for example, via the robotic arm actuators 17, to cause the robotic arm 19/docking interface 27 to return toward the planned trajectory and toward an alignment with attachment portion 69 of the trocar 63." in par. 0068)
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system taught by Steinle as modified by Holmberg to incorporate the teachings of Fuerst wherein a virtual spring force model is used to bring the robot arm and attached surgical tool back to the planned trajectory when deviation from the trajectory is detected, in order arrive at the same corrective control during the automated motion process taught by Steinle. The motivation to incorporate the teachings of Fuerst would be to maintain alignment with the planned trajectory (see par. 0068).
Claim(s) 10, 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Steinle et al (US 20190046278, hereinafter Steinle) in view of Holmberg et al (US 9870002, hereinafter Holmberg) and Lynch et al (US 20190008599, hereinafter Lynch).
Regarding Claim 10, Steinle as modified by Holmberg teaches:
the surgical system of Claim 8,
Steinle further teaches: wherein the controller is further programmed to:
detect, based on internal data of the robot and during the automated movement, a spatial deviation of the tool from a first point of the points in space where the tool is planned to be at a current time of the different times during the planned amount of time (see at least " In one embodiment, the control data is associated with information describing an accuracy of movement of the robotic system. The information describing an accuracy of movement may comprise information regarding a predetermined maximal distance between the actual position of the element of the robotic system (for example, the actual position trajectory) and a point associated with the target trajectory (for example, the target point or the entry point) after performing a movement of the tool in the second status of the robotic system. In particular, determining the control data may comprise determining the distance between the actual position of the element of the robotic system (for example, the actual position trajectory) and a point associated with the target trajectory (for example, the target point or the entry point) after performing a movement of the tool in the second status of the robotic system. In particular the predetermined maximal distance is compared with the determined distance. If the determined distance is larger than the predetermined maximal distance, new (for example, updated) control data may be determined. " in par. 0033) ; and
Steinle and Holmberg do not appear to explicitly teach all of the following, but Fuerst does teach:
stop the automated movement if the spatial deviation is by more than a threshold amount. (see at least " According to some embodiments, processes 310-340 are concurrently applied to each of the repositionable arms and/or end effectors of the computer-assisted medical device so that a deviation in the motion of any of the repositionable arms and/or end effectors that is above a threshold trigger the halting and recovery of processes 350 and 360." in par. 0050)
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system taught by Steinle as modified by Holmberg to incorporate the teachings of Lynch wherein the robot arm movement is halted when spatial deviation above a threshold from desired motion is detected. The motivation to incorporate the teachings of Lynch would be to “reduce the likelihood of injury to a patient, injury to medical personnel, damage to the computer-assisted medical device, damage to other equipment, and/or the like.” (see par. 0049).
Regarding Claim 20, Steinle as modified by Holmberg and Lynch also teaches:
A method for implementing the system of Claim 10 (see Claim 10 analysis for rejection of the system).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Steinle et al (US 20190046278, hereinafter Steinle) in view of Holmberg et al (US 9870002, hereinafter Holmberg) and Kim et al (US 20220265373, hereinafter Kim)
Regarding Claim 17, Steinle as modified by Holmberg teaches:
The method of Claim 12, comprising
Steinle and Holmberg do not appear to explicitly teach all of the following, but Kim does teach:
initiating the automated movement in response to a user input and stopping the automated movement in response to removal of the user input. (see at least " In this particular embodiment, the surgeon may depress and hold an input device, e.g., foot pedal to allow positioning of the robotic arm over patient 2401. Such positioning can be automatically performed by the robotic arm 2211 or via hand-guiding by a user. At this step, the GUI 100, which is part of the digital processing device 2001, or the “Pulse” system, may not provide any user prompts. Alternatively, user prompt can indicate the status of the robotic arm 2211, e.g., place the robotic arm over the patient, or instructive information for the user, e.g., hand-guide to move the robotic arm to be over the patient. After the robotic arm is positioned over the patient 2401, if the user depresses and holds an input device, e.g., clutch, of the robotic arm 2211, the use can hand-guide the robotic arm with six degree of freedom 2402 to a ready position for connecting to a retractor 2403. Alternatively, the robotic arm may automatically move to the position for connecting to a retractor. …If a red button is pressed after position hold or smart guide state, the robotic arm may get ready to depart the surgical site 2406. The GUI may not display any information to indicate the departure of the robotic arm. Alternatively, the GUI may display information to indicate the departure. When the user provides an input such as pressing the clutch, the robotic arm can depart automatically from the surgical site and reach a predetermined location when it stops 2407 or when the user releases the clutch 2408." in par. 0084)
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system taught by Steinle as modified by Holmberg to incorporate the teachings of Kim wherein automated movement of the robot is activated by the surgeon pressing a clutch and stops if the clutch is released. The motivation to incorporate the teachings of Kim would be to improve the responsiveness and interaction between the surgeon and the automated movement of the robot arm (see par. 0004)
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DYLAN M KATZ whose telephone number is (571)272-2776. The examiner can normally be reached Mon-Thurs. 8:00-6:00.
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, Abby Lin can be reached on (571) 270-3976. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DYLAN M KATZ/Primary Examiner, Art Unit 3657
Prosecution Insights