DETAILED ACTION
Status of Claims
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-4, 6-8, 11-16, 18-21, 23, 25-27, 29-32 are pending.
Claims 5, 9-10, 17, 22, 24, 28 are cancelled.
Information Disclosure Statement
Applicant should note that the large number of references in the attached IDS (2/2/2024) have been considered by the examiner in the same manner as other documents in Office search files are considered by the examiner while conducting a search of the prior art in a proper field of search. See MPEP 609.05(b). Applicant is requested to point out any particular references in the IDS which they believe may be of particular relevance to the instant claimed invention in response to this office action.
Claim Rejections - 35 USC § 102
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 1-3, 13, 15, 21, and 27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhou et al. (US 20200054403 A1, 2020-02-20) (hereinafter “Zhou”).
Regarding claims 1-3, 13, 15, 21, and 27, Zhou teaches a method for calibrating a surgical instrument of a teleoperated robotic surgery system (Fig. 4A-C, 5A-C),wherein the surgical instrument comprises a plurality of transmission elements446; Fig. 3), and an articulated end-effector device, which is mechanically connectable through respective tendons to the transmission elements, to determine a univocal correlation between a set of movements of the transmission elements and a respective movement or pose of the articulated end-effector device (e.g., 246, Fig. 3; [0039]-[0044]), wherein the teleoperated robotic surgery system further comprises, in addition to said surgical instrument, a plurality of motorized actuators and a controller, the motorized actuators being operatively connectable to respective transmission elements to impart a movement to the transmission elements controlled by the controller (e.g., 230, 210, Fig. 3; [0037]-[0042]); wherein the method comprises the steps of: arranging and locking the articulated end-effector device in a known predetermined position (e.g., [0082] “As another example, movement of the end effector may be subject to a physical constraint, such as a maximum range of motion of a joint, a hard stop (e.g., as imposed by a cannula wall), an opposing motion of another drive disk, as well as other physical constraints.”), considered as the reference position of the articulated end-effector device, wherein said reference position of the articulated end-effector device is univocally associated with a respective resulting position of each of the transmission elements (e.g., [0049] (disclosing physical constraints)); actuating the motorized actuators so that each of the motorized actuators contacts with a respective transmission element (e.g., Figs. 4A-C; [0048]-[0058]); storing the position of all the motorized actuators when each motorized actuator comes into contact with a respective transmission element, and considering the set of stored positions of the motorized actuators as the reference position of the motorized actuators univocally associated with the reference position of the end device (e.g., [0064], [0083]), defining a kinematic zero condition, by associating said stored reference position of the motorized actuators with a virtual zero point with respect to which movements imparted by the controller to the motorized actuators are to be referred (e.g., [0064], [0083]); wherein said actuating step comprises controlling the motorized actuators so that the motorized actuators apply a force greater than zero and less than or equal to a threshold force on the respective transmission element of the surgical instrument (e.g., [0058], [0071], [0082]) (as recited claim 1); wherein said threshold force is predetermined in a preliminary step of determining a threshold force, to impart a preload to the tendons operatively connected to both the transmission elements and the articulated end-effector device, under conditions in which the end-effector device is held still and locked, and wherein said actuating step comprises controlling the motorized actuators so that the motorized actuators apply a force equal to said threshold force on the respective transmission element of the surgical instrument, within a tolerance (e.g., [0053] “While monitoring the one or more motor operating parameters of a particular actuator, when one or more of these parameters satisfies (e.g., meets or reaches) a predetermined, condition or threshold, the detection of such a situation can be interpreted by control unit 210 as a mechanical engagement event.”) (as recited claim 2); wherein the teleoperated robotic surgery system comprises force sensors (e.g., [0053]), each force sensor being operatively connected to a respective transmission element, and/or wherein the motorized actuators are configured to apply the force to respective transmission elements and detect the force actually applied to each transmission element, and wherein said step of applying a force greater than zero and less than a threshold force on each transmission element comprises applying a force to the transmission element by a feedback control loop, wherein a feedback signal is representative of the force applied to the transmission element as actually detected by the respective force sensor operatively connected to the transmission element or to the respective motorized actuator (e.g., [0053] “In some embodiments, the motor operating parameters monitored by the control unit 210 (via sensors 236) are interpreted to mean successful mechanical engagement of a tool disk with a drive disk. These can include measurements of torque applied by the actuator 238-j as measured by a torque or force sensor, measurements of current supplied to a motor of the actuator 238-j when attempting to drive the actuator to move at a certain velocity (e.g., where the sensor 236-j may include a current sensing resistor in series with a motor input drive terminal), measurements of electrical impedance as seen into the input drive terminals of the motor of the actuator when attempting to drive the motor to move at a certain velocity (e.g., where the sensor 236-j may also include a voltage sensing circuit to measure voltage of the motor input drive terminal), speed of the actuator 238-j (e.g., where the sensor 236-j may include a position encoder (sensor) on an output shaft of the actuator 238-j or on a drive shaft of the motor), as well as other parameters referred to here as motor operating parameters [construed as feedback signals]. While monitoring the one or more motor operating parameters of a particular actuator, when one or more of these parameters satisfies (e.g., meets or reaches) a predetermined, condition or threshold, the detection of such a situation can be interpreted by control unit 210 as a mechanical engagement event. Note that satisfying the predetermined condition may for example mean that the monitored operating parameter exhibits certain changes, as per the threshold, relative to an operating parameter of another motor that is part of the same actuator 238-j or that is part of another actuator 238-i which his being controlled by the control unit 210 simultaneously during the engagement detection process.”) (emphases added) (as recited claim 3); wherein said actuating step comprises controlling the motorized actuators so that, in a first contact step between motorized actuators and respective transmission elements, a first speed is imparted to the motorized actuators and a first force is applied on the respective transmission elements (e.g., [0050]) (as recited claim 13); wherein said actuating step comprises, in addition to said first contact step: a retraction step, in which the motorized actuators retract by a shift, a second advancement and second contact step, in which the motorized actuators advance at a second speed and stop when a contact force equal to a second force is detected (e.g., [0074]) (as recited claim 15); wherein the controller moves the articulated end-effector device, when the articulated end-effector device is in the condition to move without being locked by external constraints, applying a maximum operating force, wherein said maximum operating force is less than or equal to said threshold force (e.g., [0053]-[0054]), or wherein the motorized actuators comprise pistons and/or rotary discs (e.g., [0006], [0097]) (as recited claim 21); and, as discussed and cited directly above, a teleoperated robotic surgery system comprising a surgical instrument, a plurality of motorized actuators and a controller, wherein the surgical instrument comprises a plurality of transmission elements associated with a respective plurality of tendons, and a articulated end-effector device, which is mechanically connectable through respective tendons to the transmission elements, to determine a unique correlation between a set of movements of the transmission elements and a respective movement or pose of the articulated end-effector device, wherein said articulated end-effector device is adapted to be arranged and locked in a known predetermined position, considered as a reference position of the articulated end-effector device, wherein said reference position of the articulated end- effector device is univocally associated with a respective resulting position of each of the transmission elements; wherein the motorized actuators are operatively connectable to respective transmission elements to impart movement to the transmission elements under the control of the controller; wherein the controller, when the articulated end-effector device is arranged and locked in said known predetermined position, considered as the reference position, is configured to: actuate the motorized actuators so that each of the motorized actuators comes into contact with a respective transmission element, controlling the motorized actuators so that the motorized actuators apply a force greater than zero and less than or equal to a threshold force on the respective transmission element of the surgical instrument; store the position of all the motorized actuators when each motorized actuator comes into contact with a respective transmission element, and consider the set of stored positions of the motorized actuators as the reference position of the motorized actuators univocally associated with the reference position of the end-effector device; define a kinematic zero condition by associating said stored reference position of the motorized actuators with a virtual zero point with respect to which the movements imparted by the control means to the motorized actuators are to be referred (as recited claim 27).
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.
Claims 4, 6-8, 11, 14, 16, 18, 23, and 29-32 are rejected under 35 U.S.C. 103 as being unpatentable over Zhou.
Regarding claims 4, 6-8, 11, 14, 16, 18, 23, and 29-32, Zhou teaches a method for calibrating a surgical instrument of a teleoperated robotic surgery system, as discussed above. Zhou also teaches physical constraint from opposing actuators (e.g., [0061]), adjusting speed of the engagement process based on feedback control (e.g., [0050]-[0053]). However, Zhou does not teach that the opposing actuators are operated to center the position of an end effector. Zhou also does not teach the specific operating parameter values recited in the claims at issue.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Zhou such that the invention further comprises
wherein said articulated end effector device comprises joints (e.g., [0059], [0066]), and wherein said predetermined known position of the articulated end-effector device is: a position corresponding to the condition in which each joint of the articulated end-effector device is in a centered position of the joint workspace thereof, or a position corresponding to the condition in which the articulated end-effector device is aligned with the axis of a shaft of the surgical instrument (as recited claim 4); wherein the reference position of the articulated end-effector device is held constrained by a tip cap (as recited claim 6); wherein said threshold force, at which the motors of the motorized stop in contact with the respective transmission elements is in a range of 0.01 N to 5.0 N (as recited claim 7); wherein a control of an offset between the reference position of the motorized actuators, and of each of the motorized actuators, independently of the others, and a predetermined nominal zero position is carried out, and if the offset is greater than a maximum allowable absolute offset, the calibration procedure is considered invalid, or wherein a control of the relative offset between the positions reached by each motorized actuator when in contact with the corresponding transmission element is carried out, and if the relative offset is greater than a maximum allowable relative offset, the calibration procedure is considered invalid (as recited claim 8); wherein one or more pairs of antagonistic transmission elements are provided, being operatively connectable to respective one or more pairs of antagonistic tendons (i.e., opposing actuators, as discussed above), each pair of antagonistic tendons being adapted to move a single-piece link of the articulated end-effector device in opposite movement directions (as recited claim 11); wherein said actuating step comprises controlling the motorized actuators so that said first speed is in a range of 0.1 to 30 mm/s, and/or to stop the movement of said motorized actuators when said first force is detected to be in a range of 0.01 to 2 N (as recited claim 14); wherein the second force is equal to said threshold force, or wherein said second speed is lower than said first speed; and/or wherein said second force is greater than said first force (as recited claim 16); wherein, in said retraction step, the movement of the motorized actuators is controlled so that the force applied by the motorized actuators reaches a third force value, wherein said third force value is in a range of 0.1 to 5 N (as recited claim 18); wherein the antagonistic tendons are operatively connected to both respective transmission elements and respective links of the articulated end-effector device to actuate, with opposite movements, at least one degree of freedom among said at least one degree of freedom of the articulated end-effector device, wherein, after the step of contact or engagement between motorized actuators and transmission elements, the defining step is carried out simultaneously on the antagonistic tendons of a pair of agonistic-antagonistic tendons for each degree of freedom of the end device, and, said defining step is applied in sequence to the pairs of antagonistic tendons, or is carried out for one pair at a time; or wherein the antagonistic tendons are operatively connected to both respective transmission elements and respective links of the articulated end-effector device to actuate, with opposite movements, at least one degree of freedom of said at least one degree of freedom of the articulated end-effector device, wherein, after the step of contact or engagement between motorized actuators and transmission elements, the defining step comprises, for each of the controlled degrees of freedom of the end-effector device: bringing each of the degrees of freedom of the end-effector device to an end-of- stroke abutment, applying a high force to the respective transmission element, thus stressing the respective tendon; storing, for each of the degrees of freedom, the corresponding position of the transmission element which is thus obtained; defining and/or recalculating the kinematic zero position based on the stored positions of the transmission element for each of the degrees of freedom; wherein, said bringing, applying, storing, and defining and/or recalculating steps are carried out for all the transmission elements, for the transmission elements and the mutually antagonistic tendons, so that for each degree of freedom, the two positions of the two transmission elements associated with the antagonistic tendons of said degree of freedom are stored (as recited claim 23); wherein said threshold force, at which the motors of the motorized actuators stop in contact with the respective transmission elements is in a range of 0.05 N to 2.0 N (as recited claim 29); wherein said actuating step comprises controlling the motorized actuators so that said first speed is between 1 and 10 mm/s, and/or to stop the movement of said motorized actuators when said first force is detected to be in a range of 0.05 N to 0.5 N (as recited claim 30); wherein the second force is equal to said threshold force, or wherein said second speed is lower than said first speed, and in a range of 0.1 to 5 mm/s; and/or wherein said second force is greater than said first force, and in a range of 0.1 to 5N (as recited claim 31); wherein the second force is equal to said threshold force, or wherein said second speed is lower than said first speed, and in a range 0.5 to 3 mm/s; and/or wherein said second force is greater than said first force, and in a range of 0.5 to 2N (as recited claim 32) in order to improve the maneuverability of different sorts of end effectors while ensure effective calibration and engagement.
Claims 12 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Zhou, as applied to claim 1, and further in view of Simi et al. (US 20210137618 A1, 2021-05-13) (hereinafter “Simi”).
Regarding claims 12 and 26, Simi teaches a method for calibrating a surgical instrument of a teleoperated robotic surgery system, as discussed above, except comprising elastic elements for preloading transmission elements. Simi teaches elastic elements for preloading transmission elements. See, e.g., Fig. 10 and associated text. Simi also teaches polymeric tendons. See, e.g., [0226].
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the teachings of Simi with the invention taught by Zhou such that the invention further comprises wherein elastic elements are provided, which act on respective transmission elements to keep a constant minimum preload level adapted to space apart the transmission elements from the respective motorized actuators (as recited in claim 12); wherein said tendons are polymer tendons, made of intertwined polymer fibers (as recited in claim 26) in order to ensure the accuracy of the calibration.
Allowable Subject Matter
Claims 19 and 25 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The prior art of record does not teach or suggest the claimed invention of a method according to claim 13, wherein said actuating step comprises controlling the motorized actuators so that the motorized actuators advance at a speed equal to a third speed, greater than said first speed and second speed, when the position of the motorized actuators is in a predetermined range in which the controller knows that a free stroke regime is occurring, prior to the first contact with the transmission elements, along a space corresponding to a stroke (as recited claim 19); wherein a flexible and elastic sterile drape is interposed between said motorized actuators and said surgical instrument, and wherein the force generated by the resistance of said sterile drape is a known off-set or bias force, and wherein the controller is configured to take into account, or to remove or not consider, said known off-set or bias force from the force checks carried out, and/or from comparison with the threshold force (as recited claim 20); and method according to claim 1, wherein an angular distance between the kinematic zero position of a degree of freedom and an end-of-stroke thereof is known, and wherein the defining step comprises: bringing one degree of freedom of the end-effector device to the stroke end abutment, bringing the force acting on a tendon of a pair of antagonistic tendons to a high force value; storing the position of the transmission element corresponding to said tendon; keeping the high force applied to said tendon, while the step of applying an antagonistic force to the other tendon of the pair of antagonistic tendons is carried out, wherein said high force is greater than said antagonistic force; storing the position of the transmission element corresponding to said antagonistic tendon; calculating the kinematic zero position of the antagonistic transmission elements of said pair of antagonistic transmission elements based on the stored values of the respective positions; moving said transmission elements to the calculated kinematic zero position (as recited claim 25).
For these reasons the claims are believed to be allowable over the art of record.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SCOTT T LUAN whose telephone number is (571)270-1860. The examiner can normally be reached on 9am-5pm, M-F (generally).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gary Jackson, can be reached on 571-272-4697. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Scott Luan, Ph.D.
/SCOTT LUAN/Primary Examiner, Art Unit 3792