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 Amendment
This office action is in response to the amendments filed February 26, 2026. Claims 1, 6-8, 12, 13, and 17 are amended. Claim 5 is cancelled. Claims 1-4, 6-20, and 24-26 are pending and addressed below.
Response to Arguments
Applicant’s amendments to claims 1 and 17 have overcome the rejection under 35 USC 112(b). The rejection under 35 USC 112(b) of claims 1-20 and 24-26 is withdrawn.
Applicant’s amendments to claims 7 and 8 have overcome the rejection under 35 USC 112(b). The rejection under 35 USC 112(b) of claims 7 and 8 is withdrawn.
Applicant’s amendments to claim 12 have overcome the rejection under 35 USC 112(b). The rejection under 35 USC 112(b) of claim 12 is withdrawn.
Applicant’s amendments to claim 13 have overcome the rejection under 35 USC 112(b). The rejection under 35 USC 112(b) of claim 13 is withdrawn.
Applicant’s arguments regarding the rejection of the claims under 35 USC 103 have been fully considered but are not persuasive.
Applicant argues that the combination of Smaby in view of Flory would not have been obvious due to Flory being primarily directed towards fiber rope deepwater mooring lines. However, examiner notes that the applicant’s disclosure identifies that tendons comprise “a plurality of wound/braided polymeric fibers” (specification, page 11) similar to Smaby (Smaby, [0053], “The cables may be manufactured from a variety of metal (e.g., tungsten or stainless steel) or polymer (e.g., high molecular weight polyethylene) materials.”) and Flory (Flory, page 2, “Synthetic fiber ropes are made of polymer fibers which are viscoelastic materials. Thus the change-in-length characteristics of these ropes are similarly viscoelastic, meaning that deformation is a function of both the applied load and the rate of application”). Furthermore, Flory provides a variety of graphs of tension versus deformation (stretch) of loading and unloading (see at least Fig. 4 of Flory). The abstract of Flory summarizes that the paper aims identify stretching and stiffening of material properties of these polymer ropes and proceeds to perform plenty of loading/unloading experiments between tension and stretch levels. An observation Flory aimed to record is the effects of permanent stretch due to applied loading (see at least Figs. 2 and 7 of Flory), where loading beyond an elastic region causes plastic deformation that affects the amount of loading required to achieve a certain level of deformation from there on which one of ordinary skill in the art would find obvious. As Flory pertains to conditioning polymer fibers and the cables disclosed in Smaby also deal with tensioning said cables, one would recognize that Flory is pertinent to Smaby.
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.
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 1-4, 6-9, 10-14, 16-18, and 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over US20180228563A1 (Smaby et al.) from the IDS and further in view of “Defining, Measuring, and Calculating the Properties of Fiber Rope Deepwater Mooring Lines” (Flory et al.) from the IDS.
Regarding claim 1, Smaby et al. disclose a method for conditioning a surgical instrument of a robotic surgery system, wherein the surgical instrument comprises:
an articulatable in at least one degree of freedom;
See Fig. 10 of Smaby et al. [0086] of Smaby et al. disclose, “The tensioning element 302a, when driven, moves the end effector in a first direction in the degree of freedom, and the tensioning element 302b, when driven, moves the end effector in a second direction in the degree of freedom.”
at least one tendon, which is operatively connectable to a respective at least one motorized actuator of the robotic surgery system,
See Fig. 10 of Smaby et al. [0090] of Smaby et al. disclose, “The assembly apparatus 400 includes a first drive mechanism 402 and a second drive mechanism 404. The first drive mechanism 402 is powered by a first motor 406, and the second drive mechanism 404 is powered by a second motor 408. The first drive shaft 304 is carried by the first drive mechanism 402, and the second draft shaft 306 is carried by the second drive mechanism 404. As discussed with respect to the assembly process 500, the two drive mechanisms 402, 404 can be used to pre-tension the tensioning elements 302a, 302b. The first motor 406 and the second motor 408, when driven, cause rotation of the first drive mechanism 402 and the second drive mechanism 404, respectively. In this regard, the first and second motors 406, 408 are activated to drive the tensioning elements 302a, 302b to apply the preloads to the tensioning elements 302a, 302b.”
said at least one tendon being mounted to said surgical instrument to be operatively connectable to a respective motorized actuator, among said at least one motorized actuator, and operatively associated with at least one degree of freedom among said at least one degree of freedom of the end-effector,
See rationale of “at least one tendon, …” above. The tendon(s) are shown as tensioning elements 302a and 302b, where both elements are connected to their motors (406 and 408, respectively) to control motion of the end effector in at least one degree of freedom.
wherein said at least one degree of freedom which is operatively associated with the at least one tendon is adapted to be mechanically activated by an action of said at least one respective motorized actuator by said at least one tendon which is operatively connectable thereto;
[0086] of Smaby et al., “The tensioning elements 302a, 302b, when driven, cause motion in a degree of freedom for an end effector to which the tensioning elements 302a, 302b are coupled. The tensioning element 302a, when driven, moves the end effector in a first direction in the degree of freedom, and the tensioning element 302b, when driven, moves the end effector in a second direction in the degree of freedom.”
wherein the method comprises:
(i) locking at least one degree of freedom of said at least one degree of freedom of the end-effector;
[0121] of Smaby et al., “In some examples, the static frictional force on the tensioning element 302 a is estimated independently from the static frictional force on the tensioning element 302 b. To estimate the frictional force on the tensioning element 302 a, the first motor 406 drives the first drive shaft 304 while the second motor 408 is fixed. The torque sensor 418 coupled to the first motor 406 generates a signal indicative of the minimum required torque to drive the first drive shaft 304, and the value for this minimum required torque is indicative of the frictional force on the tensioning element 302 a. To estimate the frictional force on the tensioning elements 302 b, the second motor 408 drives the second drive shaft 306 while the first motor 410 is fixed. The torque sensor 420 coupled to the second motor 408 generates a signal indicative of the minimum required torque to drive the second drive shaft 306, and the value for this minimum required torque is indicative of the frictional force on the tensioning element 302 b.”
(ii) tensile-stressing the respective at least one tendon, operatively associated with said at least one locked degree of freedom, by applying a conditioning force, according to at least one time cycle, to the respective at least one tendon to be stressed under tensile load;
[0110] of Smaby et al., “In some implementations, the constructional stretch is removed from each of the first and second tensioning elements 302a, 302b by, for example, cyclically applying tension to each of the first and second tensioning elements 302a, 302b. During a cycle of applied tension, a tension force is applied to the tensioning element and then released. The cyclic application of tensions can enable removal of constructional stretch at lower overall loads.” Here, the conditioning force is the tension force cyclically applied and released.
wherein said at least one time cycle comprises:
at least one low-load period, in which a low conditioning force is applied to said respective tendon, which results in a respective low tensile load on the respective tendon;
Smaby et al. discloses the use of a cycle of applied tension ([0110], “During a cycle of applied tension, a tension force is applied to the tensioning element and then released.”) where the tension would increase and decrease between a low and high load level. Specifically, Smaby et al. disclose from the same paragraph that “cyclic application of tensions can enable removal of constructional stretch at lower overall loads”, where the constructional stretch removal would be completed by the cycling conditional forces.
at least one high-load period, in which a high conditioning force is applied to said respective tendon, which results in a respective high tensile load on the respective tendon.
In light of the above rationale regarding “low-load periods”, a high-load period (the application of a tension force) applies a high conditioning force (the tension force).
a plurality of time cycles, wherein, in at least two adjacent time cycles, the respective value of the high conditioning force increases.
Smaby et al. disclose the cycling of loads from low to high (see claim 1) and increasing the number of cycles ([0111], “In some examples, the number of cycles of tension is between for example, 3 and 20, e.g., 3 to 10, 5 to 15, 10 to 20, etc.”) and varying the tension force ([0111], “The tension forces applied to remove the constructional stretches is, for example, 100% to 200% of the maximum allowed tension in.”), but Smaby et al. does not explicitly disclose the increasing the high conditioning force with adjacent time cycles of a plurality of time cycles.
From a similar field of endeavor, Flory et al. disclose a rope model that outlines the advantages of stretching rope. In the section “Rope Constructional Stretch”, Flory et al. disclose that “When the rope is first tensioned, the various yarns and strands compact and realign, and the lay length of the yarns and strands in the laid or braided rope increases. These actions cause the rope length to increase.” (page 2, column 2, lines 4-9). Furthermore, on lines 20-31 of the same column, “This constructional stretch ratcheting effect depends on the applied tension. A given amount of ratcheting occurs when a given tension is first applied, and more might occur during several more cycles to that same tension. No more ratcheting occurs while the rope is held at that tension or is cycled again to that tension. But if a higher tension is then applied, additional ratcheting can take place. Once this ratcheting constructional stretch occurs, it remains, even after tension is reduced or removed. Thus it is similar to the permanent stretch discussed later. But unlike permanent stretch, under constant tension constructional stretch does not increase with time.”
One of ordinary skill in the art would find it obvious, prior to the applicant’s effective filing date, to increase the high conditioning force during adjacent time cycles as higher constructional stretch are required during operation of surgical machines as not properly conditioning the tendons could cause errors and inaccuracies due to a changing stiffness, further creating a new point of error that could lead to mishandling the device during an operation on an individual.
Regarding claim 2, with all of the limitations of claim 1, the method further comprises: tensile-stressing at least one pair of antagonistic tendons;
[0086] of Smaby et al., “The tensioning elements 302 a, 302 b, when driven, cause motion in a degree of freedom for an end effector to which the tensioning elements 302 a, 302 b are coupled. The tensioning element 302 a, when driven, moves the end effector in a first direction in the degree of freedom, and the tensioning element 302 b, when driven, moves the end effector in a second direction in the degree of freedom.” Here, the first and second directions of the same degree of freedom indicate that they are antagonistic tendons.
maintaining said tendons in a tensile-stressed state by applying a holding force to the tendons which is adapted to determine a load state on the tendons.
See Fig. 13 of Smaby et al. and [0117]. The process described by Fig. 13 contains step 516 which discloses the drive of both tensioning elements ([0117], tensioning elements 302a and 302b) to a desired torque. Step 520 shows that a determination of a load state being acceptable is made, indicating that a load state on tendons can be made.
Regarding claim 3, with all of the limitations of claim 1, the method further comprises:
wherein the locking step comprises:
fitting a constraining element abutting on the articulated end-effector, wherein the constraining element is configured to lock one or more of said at least one degree of freedom of the articulated end-effector in a predetermined configuration/pose, and
See Fig. 10 of Smaby et al. End effector of the device abuts the nest 430, where the nest 430 “inhibits motion of the distal end component 428 such that the tensions can be applied to the tension elements 302 a, 302 b without causing motion of the first drive shaft 304 and the second drive shaft 306.” [0117].
wherein the unlocking step comprises:
releasing the articulated end-effector from the condition in which the articulated end-effector abuts said constraining element.
[0117] of Smaby et al., “The assembly apparatus 400 controls the motors 406, 408 to apply equal predetermined levels of torque while the position of the distal end component 428 is maintained. In this regard, when the distal end component 428 is removed from the nest 430, the distal end component 428 remains at the central position within the range of motion.” When the end effector (distal end component 428) is released from the nest 430, it is unlocked.
Regarding claim 4, with all of the limitations of claim 1, the method further comprises:
wherein the surgical instrument comprises:
at least one pair of antagonistic tendons comprising said at least one tendon, wherein said pair of antagonistic tendons acts on only one degree of freedom associated therewith, thus determining antagonistic effects; and
See rationale of claim 2 regarding the actuation within the same degree of freedom in different directions.
wherein the robotic surgery system comprises:
at least one pair of antagonistic motorized actuators among said motorized actuators, wherein each element of said pair of antagonistic motorized actuators is associated with a respective tendon of said pair of antagonistic tendons; and wherein:
See rationale of claim 2 regarding the antagonistic tension components 302a and 302b with their own respective motors 304 and 306 respectively.
the step of locking a degree of freedom comprises simultaneously activating both of the antagonistic motorized actuators connected to the pair of antagonistic tendons associated with the degree of freedom to be locked, to pull the respective tendons with a same pulling speed;
While Smaby et al. disclose antagonistic tendons (see rationale of claim 2) and actively opposing antagonistic tendon tensions against each other with various loads ([0112], “In some implementations, steps 510 and 512 are performed simultaneously. If the constructional stretch is removed from both the first tensioning element 302 a and the second tensioning element 302 b at the same time, the first and second tensioning elements 302 a, 302 b may experience a greater amount of tension. In some implementations, to reduce the amount of tension experienced by each of the first and second tensioning elements 302 a, 302 b during the removal of the constructional stretches, steps 510 and 512 are performed sequentially, with the constructional stretch of the first tensioning element 302 a being removed before the constructional stretch of the second tensioning element 302 b being removed.”), Smaby et al. do not explicitly disclose locking a degree of freedom by activating the pair of antagonistic tendons with the same pulling speed.
Given that Smaby et al. disclose antagonistic tendons applying load in different directions for a stronger tensioning effect, one of ordinary skill in the art would find it obvious, prior to the applicant’s effective filing date, that pulling at equal speed would result in optimizing tension in both tendons as Smaby et al. disclose that a greater amount of tension may be experienced by opposite tensions at the same time. Unequal pulling would result in a change of position within the degree of freedom.
the step of unlocking the locked degree of freedom comprises deactivating at least one of the antagonistic motorized actuators connected to the pair of antagonistic tendons associated with the degree of freedom to be unlocked.
One of ordinary skill in the art would find it obvious, prior to the applicant’s effective filing date, that releasing one of the antagonistic tendons of equal loads through deactivating one of the actuators would unlock the locked end effector.
Regarding claim 6, with all of the limitations of claim 1, the method further comprises:
wherein, in at least two adjacent time cycles of the plurality of time cycles, a respective value of the high conditioning force remains constant.
Similar to the rationale of claim 1 regarding a plurality of said time cycles, one of ordinary skill in the art would find it obvious, that continuously cycling at the same load can help to achieve a steady state level of the rope’s length.
Regarding claim 7, with all of the limitations of claim 1, the method further comprises:
wherein the surgical instrument comprises a plurality of tendons, and
See Fig. 10 of Smaby et al. where the figure discloses at least two tendons.
wherein a respective stress pattern is applied to each tendon,
[0110] of Smaby et al., “In some implementations, the constructional stretch is removed from each of the first and second tensioning elements 302 a, 302 b by, for example, cyclically applying tension to each of the first and second tensioning elements 302 a, 302 b. During a cycle of applied tension, a tension force is applied to the tensioning element and then released. The cyclic application of tensions can enable removal of constructional stretch at lower overall loads.”
periods of the high and low conditioning forces,
See the above rationale of claim 1 regarding “low-load periods”, where a cycle of conditioning forces includes a low conditioning force and a high conditioning force.
wherein one or more conditions occur from the group consisting of:
wherein the values of said conditioning forces are different on at least one tendon or different tendons or different pairs of antagonistic tendons,
[0112] of Smaby et al., “In some implementations, to reduce the amount of tension experienced by each of the first and second tensioning elements 302 a, 302 b during the removal of the constructional stretches, steps 510 and 512 are performed sequentially, with the constructional stretch of the first tensioning element 302 a being removed before the constructional stretch of the second tensioning element 302 b being removed.” Here, the application of conditioning forces is not simultaneously applied and therefore the values of the conditioning forces are different on at least one tendon or different tendons.
wherein, the values of the high conditioning force and/or the low conditioning force applied to the tendons which are involved in the actuation of the degree of freedom of opening/closure are higher with respect to the other tendons, and/or
wherein, the excursion between high conditioning force and low conditioning force is greater for the tendons which are involved in the actuation of the degree of freedom of opening/closure.
Smaby et al. disclose the use of a high or low conditioning force ([0111], “The tension forces applied to remove the constructional stretches is, for example, 100% to 200% of the maximum allowed tension in.”) and moving along the degree of freedom regarding opening and closing ([0067], “If the end effector 128 is a forceps, the tensioning elements 143 a and 143 b, when driven, open and close the jaws of the forceps”).
Regarding claim 8, with all of the limitations of claim 1, the method further comprises:
cycles of the application periods of the high and low conditioning forces,
See the above rationale of claim 7.
wherein one or more conditions occur from the group consisting of:
the values of said conditioning forces are the same on all the tendons.
In light of the rationale of claim 7 showing the considerations needed for the length of the cable, one of ordinary skill in the art would find it obvious, prior to the applicant’s effective filing date, to apply the same level of conditioning to all tendons to reduce tracking of which rope may or may not be nearing its tension or deformation limits, allowing for more reliable use and minimal potential issues during use.
Regarding claim 9, with all of the limitations of claim 1, the method further comprises:
wherein a plurality of N time cycles is provided, so as to determine an alternation between successive low-load periods and high-load periods,
[0111] of Smaby et al., “In some examples, the number of cycles of tension is between, for example, 3 and 20, e.g., 3 to 10, 5 to 15, 10 to 20, etc.
wherein during the low-load periods of the n-th cycle a respective low conditioning force is applied, and
[0110] of Smaby et al., “In some implementations, the constructional stretch is removed from each of the first and second tensioning elements 302 a, 302 b by, for example, cyclically applying tension to each of the first and second tensioning elements 302 a, 302 b. During a cycle of applied tension, a tension force is applied to the tensioning element and then released. The cyclic application of tensions can enable removal of constructional stretch at lower overall loads.”
wherein during the high-load periods of the n-th cycle a respective high conditioning force is applied.
. [0110] of Smaby et al., “In some implementations, the constructional stretch is removed from each of the first and second tensioning elements 302 a, 302 b by, for example, cyclically applying tension to each of the first and second tensioning elements 302 a, 302 b. During a cycle of applied tension, a tension force is applied to the tensioning element and then released. The cyclic application of tensions can enable removal of constructional stretch at lower overall loads.”
Regarding claim 10, with all of the limitations of claim 9, the method further comprises:
wherein said low conditioning forces of the different time cycles correspond to a same predetermined low conditioning force value, and wherein said high conditioning forces correspond to gradually increasing high conditioning force values, until reaching a maximum high force value.
In light of the rationale of claim 5 regarding the ratcheting effect, one of ordinary skill in the art would find it obvious, prior to the applicant’s effective filing date, that the low conditioning force of different time cycles would remove constructional stretch if a minimum load were high enough, otherwise, it would have no effect. Furthermore, one of ordinary skill in the art would find it obvious to increase the high conditioning force gradually to apply additional ratcheting, applying more stretch as needed at higher values of force while also cyclically stretching the rope during more iterations of the stretch.
Regarding claim 11, with all of the limitations of claim 10, the method further comprises:
wherein the high conditioning force value of the n-th time cycle is calculated according to the following formula:
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where n is the current cycle, N is the total number of cycles and Nc is the number of cycles at constant Fhigh and Fhigh_max is a settable value.
In light of the rationale of claim 5, where gradually increasing the force would be obvious to one of ordinary skill in the art, one of ordinary skill in the art would find it further obvious, prior to the applicant’s effective filing date, to formulate a relationship based on the available variables disclosed (such as [0111] disclosing number of cycles and low and high tension forces being based on maximum allowed tension) as there exists evidence from the disclosure that relates them together as functional dependents or objective measures to optimize. This is further motivated given that the equation is equivalent to choosing how much extra force is provided at a fixed amount every cycle.
Regarding claim 12, with all of the limitations of claim 9, the method further comprises:
the at least one low-load period has a first time duration comprising, in addition to a first holding sub-step with first holding time duration, a first ramp sub-step having a first ramp time duration, such that a sum of said first holding time duration and first ramp time duration corresponds to said first time duration;
Smaby et al. discloses the use of a cycle of applied tension ([0110]) where a tension force is applied to the tensioning element (first ramp sub-step and a first ramp time duration) and released. However, Smaby et al. does not disclose holding the applied tension over a holding time duration.
From a similar field of endeavor, see Fig. 2 of Flory et al. While not shown, the process aims to permanently stretch the rope by ramping tension to an upper bound and holding the tension for a duration (where the horizontal red arrows to the right show a tension load was maintained to induce permanent stretch). From column 1 of page 3, “Permanent stretch of a fiber rope usually follows a pattern such that the amount of stretch which takes place in one minute is doubled in 10 minutes, is tripled in 100 minutes, etc.” Clearly, this shows the effects of holding tension about a time duration. The graph continues to show the relief of tension and permanent stretch resulting.
One of ordinary skill in the art would find it obvious, prior to the applicant’s effective filing date, to combine the process of Flory et al. to the system of Smaby et al. as there exists extra stretching effects from holding tension for a duration (see subsection“Permanent Stretch” of section “Part 1: Fiber Rope Stretch and Stiffness Characteristics”).
the at least one low-load period has a second time duration comprising, in addition to the second holding sub-step with second holding time duration, a second ramp sub-step having a second ramp time duration, such that a sum of said second holding time duration and second ramp time duration corresponds to said second time duration,
As Smaby et al. discloses a plurality of cycles [0111] and in light of the rationale directly above, one of ordinary skill in the art would find it obvious, prior to the applicant’s effective filing date, to apply the same ramping and holding tensions over multiple cycles.
wherein said first holding time duration is greater than said first ramp time duration and said second holding time duration is greater than said second ramp time duration,
and
As Smaby et al. in view of Flory et al. disclose the complete time duration consisting of ramping and holding durations, one of ordinary skill in the art would find it obvious to try, prior to the applicant’s effective filing date, each of the cases here (greater than, equal to, or less than) as there are a finite number of possibilities to try.
wherein said first time duration is in the range of 0.2 seconds to 30.0 seconds, and said second time duration is in the range of 0.2 seconds to 5.0 seconds.
While Smaby et al. do not explicitly disclose the explicit times of the duration, Flory et al. provide a relationship of stretch and time (column 2, lines 6-11, “Permanent stretch can usually be plotted as a straight line against time on a semi-log graph. This permanent stretch can then be represented by an equation of the form S = Ln (t / A) where S is stretch, t is time at applied tension, and A is the slope of the permanent stretch line on a semi-log graph.”)
In light of Smaby et al. teaching the cycle of applied high and low tensions in view of the time-dependent relationship disclosed of Flory et al., one of ordinary skill in the art would find it obvious, prior to the applicants’ effective filing date, that the time durations chosen would be modified based off the tension applied, amounting the specific duration to nothing more than routine optimization.
Regarding claim 13, with all of the limitations of claim 12, the method further comprises:
wherein said first time duration is in the range of 1.0 seconds to 3.0 seconds, and wherein said second time duration is in the range of 1.0 seconds to 3.0 seconds, or
In light of the rationale regarding the last limitation of claim 12, one of ordinary skill in the art would find it obvious that the duration of time used for a first and second cycle would be a result of routine optimization as detailed in the mentioned rationale.
Regarding claim 14, with all of the limitations of claim 1, the method further comprises:
wherein said low conditioning force has a positive value greater than a friction value given by a sum of static sliding friction of the tendon on surfaces of the surgical instrument and of internal frictions of actuation and transmission of the surgical instrument, so as to determine in any case a tensile stress on the tendon.
[0119] of Smaby et al., “Rather than corresponding to target preloads, the target tensions correspond to the sum of target preloads and additional tensions to overcome the external loads. Portions of the first and second tensions, for example, overcome frictional loads along the drivetrain. The frictional loads include, for example, frictional loads on the first and second tensioning elements 302 a, 302 b, frictional loads on the first drive mechanism 402, frictional loads at the joint about which the distal end component 428 rotates, etc. The frictional loads include static frictional loads and/or dynamic frictional loads. The remainder of the first and second tensions corresponds to the preloads on the tensioning elements 302 a, 302 b. Based on this friction compensation, the target tensions on the tensioning elements 302 a, 302 b can be selected to achieve target preloads."
Regarding claim 16, with all of the limitations of claim 1, the method further comprises:
wherein said number N of time cycles is in the range of 1 to 30.
Smaby et al. disclose a plurality of time cycles ([0111], “In some examples, the number of cycles of tension is between, for example, 3 and 20, e.g., 3 to 10, 5 to 15, 10 to 20, etc. The tension forces applied to remove the constructional stretches is, for example, 100% to 200% of the maximum allowed tension in.”) that fall within the range of 1 to 30.
Regarding claim 17, Smaby et al. disclose a robotic surgery system comprising a surgical instrument, at least one motorized actuator and a control unit, wherein the surgical instrument comprises:
an articulated end-effector having at least one degree of freedom;
See Fig. 10 of Smaby et al. [0086] of Smaby et al. disclose, “The tensioning element 302a, when driven, moves the end effector in a first direction in the degree of freedom, and the tensioning element 302b, when driven, moves the end effector in a second direction in the degree of freedom.”
at least one tendon, which is operatively connectable to a respective at least one motorized actuator of the robotic surgery system,
See Fig. 10 of Smaby et al. [0090] of Smaby et al. disclose, “The assembly apparatus 400 includes a first drive mechanism 402 and a second drive mechanism 404. The first drive mechanism 402 is powered by a first motor 406, and the second drive mechanism 404 is powered by a second motor 408. The first drive shaft 304 is carried by the first drive mechanism 402, and the second draft shaft 306 is carried by the second drive mechanism 404. As discussed with respect to the assembly process 500, the two drive mechanisms 402, 404 can be used to pre-tension the tensioning elements 302a, 302b. The first motor 406 and the second motor 408, when driven, cause rotation of the first drive mechanism 402 and the second drive mechanism 404, respectively. In this regard, the first and second motors 406, 408 are activated to drive the tensioning elements 302a, 302b to apply the preloads to the tensioning elements 302a, 302b.”
said at least one tendon being mounted to said surgical instrument to be operatively connectable to both a respective motorized actuator, among said at least one motorized actuator, and operatively associated with degree of freedom among said at least one degree of freedom of the end-effector,
See rationale of “at least one tendon, …” above. The tendon(s) are shown as tensioning elements 302a and 302b, where both elements are connected to their motors (406 and 408, respectively) to control motion of the end effector in at least one degree of freedom.
wherein said at least one degree of freedom which is operatively associated with the at least one tendon is adapted to be mechanically activated by an action of said at least one respective motorized actuator by said at least one tendon which is operatively connectable thereto;
[0086] of Smaby et al., “The tensioning elements 302a, 302b, when driven, cause motion in a degree of freedom for an end effector to which the tensioning elements 302a, 302b are coupled. The tensioning element 302a, when driven, moves the end effector in a first direction in the degree of freedom, and the tensioning element 302b, when driven, moves the end effector in a second direction in the degree of freedom.”
wherein said control unit of the robotic surgery system is configured to control the performance of the following actions:
(i) locking at least one degree of freedom of said at least one degree of freedom of the end-effector;
[0121] of Smaby et al., “In some examples, the static frictional force on the tensioning element 302 a is estimated independently from the static frictional force on the tensioning element 302 b. To estimate the frictional force on the tensioning element 302 a, the first motor 406 drives the first drive shaft 304 while the second motor 408 is fixed. The torque sensor 418 coupled to the first motor 406 generates a signal indicative of the minimum required torque to drive the first drive shaft 304, and the value for this minimum required torque is indicative of the frictional force on the tensioning element 302 a. To estimate the frictional force on the tensioning elements 302 b, the second motor 408 drives the second drive shaft 306 while the first motor 410 is fixed. The torque sensor 420 coupled to the second motor 408 generates a signal indicative of the minimum required torque to drive the second drive shaft 306, and the value for this minimum required torque is indicative of the frictional force on the tensioning element 302 b.”
One of ordinary skill in the art would find it obvious, prior to the applicant’s effective filing date, that the fixing of the motor pairs (406 and 408 in the first case and 408 and 410 in the second case) of a degree of freedom would lock the degree of freedom of said at least one degree of freedom.
(ii) tensile-stressing the respective at least one tendon, operatively connected to said at least one locked degree of freedom, by applying a conditioning force, according to at least one time cycle, to the respective at least one tendon to be stressed under tensile load;
[0110] of Smaby et al., “In some implementations, the constructional stretch is removed from each of the first and second tensioning elements 302a, 302b by, for example, cyclically applying tension to each of the first and second tensioning elements 302a, 302b. During a cycle of applied tension, a tension force is applied to the tensioning element and then released. The cyclic application of tensions can enable removal of constructional stretch at lower overall loads.” Here, the conditioning force is the tension force cyclically applied and released.
wherein said at least one time cycle comprises:
at least one low-load period, in which a low conditioning force is applied to said respective tendon, which results in a respective low tensile load on the respective tendon;
Smaby et al. discloses the use of a cycle of applied tension ([0110], “During a cycle of applied tension, a tension force is applied to the tensioning element and then released.”) where the tension would increase and decrease between a low and high load level. Specifically, Smaby et al. disclose from the same paragraph that “cyclic application of tensions can enable removal of constructional stretch at lower overall loads”, where the constructional stretch removal would be completed by the cycling conditional forces.
at least one high-load period, in which a high conditioning force is applied to said respective tendon, which results in a respective high tensile load on the respective tendon.
In light of the above rationale regarding “low-load periods”, one of ordinary skill in the art would find it further obvious, prior to the applicant’s effective filing date, a cycle of conditioning forces that includes a low conditioning force would also comprise a high conditioning force.
a plurality of time cycles, wherein, in at least two adjacent time cycles, the respective value of the high conditioning force increases.
Smaby et al. disclose the cycling of loads from low to high (see claim 1) and increasing the number of cycles ([0111], “In some examples, the number of cycles of tension is between for example, 3 and 20, e.g., 3 to 10, 5 to 15, 10 to 20, etc.”) and varying the tension force ([0111], “The tension forces applied to remove the constructional stretches is, for example, 100% to 200% of the maximum allowed tension in.”), but Smaby et al. does not explicitly disclose the increasing the high conditioning force with adjacent time cycles of a plurality of time cycles.
From a similar field of endeavor, Flory et al. disclose a rope model that outlines the advantages of stretching rope. In the section “Rope Constructional Stretch”, Flory et al. disclose that “When the rope is first tensioned, the various yarns and strands compact and realign, and the lay length of the yarns and strands in the laid or braided rope increases. These actions cause the rope length to increase.” (page 2, column 2, lines 4-9). Furthermore, on lines 20-31 of the same column, “This constructional stretch ratcheting effect depends on the applied tension. A given amount of ratcheting occurs when a given tension is first applied, and more might occur during several more cycles to that same tension. No more ratcheting occurs while the rope is held at that tension or is cycled again to that tension. But if a higher tension is then applied, additional ratcheting can take place. Once this ratcheting constructional stretch occurs, it remains, even after tension is reduced or removed. Thus it is similar to the permanent stretch discussed later. But unlike permanent stretch, under constant tension constructional stretch does not increase with time.”
One of ordinary skill in the art would find it obvious, prior to the applicant’s effective filing date, to increase the high conditioning force during adjacent time cycles as higher constructional stretch are required during operation of surgical machines as not properly conditioning the tendons could cause errors and inaccuracies due to a changing stiffness, further creating a new point of error that could lead to mishandling the device during an operation on an individual.
Regarding claim 18, with all of the limitations of claim 17, the system further comprises:
wherein said surgical instrument further comprises at least one transmission element operatively connected to a respective at least one tendon among said tendons and operatively connectable to a respective motorized actuator, wherein said at least one transmission element is a rigid element and said at least one tendon is deformable under tensile load.
See Fig. 10 of Smaby et al. From the figure, a transmission element (first drive shaft 304) is operatively connected to a respective at least one tendon (tensioning element 302a) among said tendons (tensioning elements 302a and 302b) and operatively connectable to a respective motorized actuator (first and second motors 406 and 048), wherein at least one transmission element is a rigid element and said at least one tendon is deformable under tensile load ([0053], “The cables may be manufactured from a variety of metal (e.g., tungsten or stainless steel) or polymer (e.g., high molecular weight polyethylene) materials.”, where each material can be deformed under tensile load).
While the transmission element (first drive shaft 304) is not explicitly disclosed to be rigid, one of ordinary skill in the art would find it obvious, prior to the applicant’s effective filing date, that the drive shafts are rigid as a flexible drive shaft would have power generated by a motor cause it to twist and not properly actuate the end effector of the system.
Regarding claim 25, with all of the limitations of claim 1, the method further comprises:
wherein said number N of time cycles is less than 10.
[0111] of Smaby et al., “In some examples, the number of cycles of tension is between for example, 3 and 20, e.g., 3 to 10, 5 to 15, 10 to 20, etc.” Here, Smaby et al. disclose the use of 3 to 10 cycles of tension.
Regarding claim 26, with all of the limitations of claim 1, the method further comprises:
wherein said number N of time cycles is in the range of 3 to 8.
In light of the rationale of claim 25, one of ordinary skill in the art would find it obvious, prior to the applicants’ effective filing date, that, as Smaby et al. discloses achieving a certain level of stretch through cycles (see Fig. 13 of Smaby et al., step 510 and 512 “removing constructional stretch”) and has disclosed the use of 8 cycles (within the range of 3 to 10 cycles), changing the upper end of the number of cycles to 8 would amount to nothing more than routine optimization.
Claims 15 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over US20180228563A1 (Smaby et al.) from the IDS in view of “Defining, Measuring, and Calculating the Properties of Fiber Rope Deepwater Mooring Lines” (Flory et al.) from the IDS and further in view of US20190191967A1 (Yamamoto et al.) from the IDS.
Regarding claim 15, with all of the limitations of claim 1, the method further comprises:
said low conditioning force has a value in the range of 0.2 N to 3.0 N, and said high conditioning force has a value in the range of 8.0 N to 50.0 N.
While Smaby et al. disclose the use of conditioning forces ([0110] of Smaby et al., “During a cycle of applied tension, a tension force is applied to the tensioning element and then released. The cyclic application of tensions can enable removal of constructional stretch at lower overall loads.”), where a released tension force would be anywhere from the value of the released tension force to zero, Smaby et al. do not explicitly disclose a specific range of forces for acceptable low and high values.
From a similar field of endeavor, Yamamoto et al. disclose a robotic system comprising tendons under pretension for end effector control. From [0113] of Yamamoto et al., “Unlike earlier master-slave flexible robotic endoscopy systems, a system in accordance with an embodiment of the present disclosure need not establish and maintain precise tendon tensions from the time of actuation assembly manufacture onward. Rather, in various embodiments, an initial minimum acceptable tendon pretension level or range can be established as part of manufacturing an actuator assembly 400 (e.g., approximately 1.0-30.0 N, depending upon tendon length), and precise tendon pretensioning or retensioning can occur by way of adjustment of actuator/motor position and/or torque prior to the performance of an endoscopic procedure.”
As Smaby et al. disclose a low and high tension load and Yamamoto disclose an overall range of 1-30 N, one of ordinary skill in the art would find it obvious, prior to the applicant’s effective filing date, that a low load range would be close to the 1 N, such as the claimed 1-3 N range, and a high load range would be towards the higher end of the 1-30 range of Yamamoto, where the claimed 8-50 range shows significant overlap. Such adjustments toe the force values would amount to nothing more than routine optimization.
Regarding claim 24, with all of the limitations of claim 1, the method further comprises:
wherein said low conditioning force has a value in the range of 1.0 N to 3.0 N, and said high conditioning force has a value in the range of 10.0 N to 20.0 N.
In light of the rationale of claim 15, one of ordinary skill in the art would find it obvious, prior to the applicant’s effective filing date, that from a range of conditioning forces spanning 1.0 N to 30.0 N, it would be obvious to try a range from 1.0 N to 3.0 as a low force and 10.0 to 20.0 N as a high force.
Claims 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over US20180228563A1 (Smaby et al.) from the IDS in view of “Defining, Measuring, and Calculating the Properties of Fiber Rope Deepwater Mooring Lines” (Flory et al.) from the IDS and further in view of WO2017064301 (Simi et al.) from the IDS.
Regarding claim 19, with all of the limitations of claim 17, the system further comprises:
further comprising a sterile barrier interposed between said at least one transmission element and respective at least one motorized actuator.
While Smaby et al. do not explicitly disclose a sterile barrier between a transmission element and a motorized actuator, from a similar field of endeavor, Simi et al. disclose a robotic surgical assembly that contains a “tendon drive system 50 comprises at least one further pusher assembly 94, or opposite pusher assembly 194, opposed to said pusher assembly 94 and suitable to push on at least one portion of tendon deflectable portion 93 of said opposite tendon 190” [0417], where “pusher assembly 94 also comprises at least one sterile barrier 87, suitable to substantially impede mutual bacterial contamination of the two environments it separates.” [0399] and “According to an embodiment, said pusher assembly 94 comprises an electric motor, suitable to move said pushing element 95.” [0411]
One of ordinary skill in the art would find it obvious, prior to the applicant’s effective filing date, to utilize the sterile barrier disclosed by Simi et al. with the disclosure of Smaby et al. as mutual bacterial contamination of two environments, where one is a patient receiving a surgery, would take a step towards preventing possible infections from hostile elements within the outside environment in cases where sterility of the operating room may have been compromised.
Regarding claim 20, with all of the limitations of claim 17, the system further comprises:
wherein the operating connection between the at least one tendon of the surgical instrument and the respective at least one motorized actuator is determined by a detachable mono-lateral constraint coupling; or
While Smaby et al. do not disclose a mono-lateral constraint coupling to operatively connect at least one tendon to at least one motorized actuator, Simi et al. disclose in [0379] that “According to an embodiment, said pusher assembly 94 acts as a unilateral constraint for said tendon 90”. [0378] of Simi et al. discloses that, “When said pusher assembly pushes in said pushing direction, transversal to the tendon path T-T, it tends to lengthen locally, only locally, said tendon path. Such a localized path lengthening, which create a larger, local tendon loop is directly related to the amount of advancement of the pusher assembly. The creation of such a larger local tendon loop results at the opposite end of the tendon, in a proportional moving back of the distal endpoint of the tendon 92 which is fastened to the tendon termination feature 82 on the joint member and hence results in a movement of the joint member.
One of ordinary skill in the art would find it obvious, prior to the applicant’s effective filing date, that the disclosed movement system of Simi et al. can be integrated into the system of Smaby et al. as a direct substitute.
wherein the robotic surgery system further comprises a constraining element fitted on the articulated end-effector, wherein the constraining element is configured to lock one or more of said at least one degree of freedom of the articulated end-effector in a predetermined configuration/pose, or
See Fig. 10 of Smaby et al. From [0117] of Smaby et al., “The nest 430 inhibits motion of the distal end component 428 such that tensions can be applied to the tension elements 302 a, 302 b without causing motion of the first drive shaft 304 and the second drive shaft 306”, where the distal end component 428 can be the end effector ([0097]) of the surgical instrument. As shown in the figure, the distal end component 428 is locked within a certain pose in at least one degree of freedom of the device.
wherein said at least one tendon of the surgical instrument comprises a plurality of wound/braided polymeric fibers, or is a polymeric strand.
[0053] of Smaby et al., “The cables may be manufactured from a variety of metal (e.g., tungsten or stainless steel) or polymer (e.g., high molecular weight polyethylene) materials”)
Conclusion
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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/J.J./Examiner, Art Unit 3656
/WADE MILES/Supervisory Patent Examiner, Art Unit 3656
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