DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant’s arguments, see Remarks dated 09/08/2025, with respect to the rejection(s) of claims 1-20 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration as necessitated by the new limitations introduced by the amended claims, a new ground(s) of rejection is made over Evans et al (US 20190125465 A1) in view of Prisco et al (US 20100331820 A1).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 21 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 21 recites the limitation "the second drive cable capstan" in line 11. There is insufficient antecedent basis for this limitation in the claim.
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 1-5 and 7-21 are rejected under 35 U.S.C. 103 as being unpatentable over Evans et al (US 20190125465 A1) in view of Prisco et al (US 20100331820 A1).
Regarding claim 1, Evans teaches a surgical tool, comprising:
a drive housing (608) having opposing distal and proximal ends (see Fig. 6; housing 608 having a distal end nearer to the end effector and a proximal end nearer to the robotic manipulator);
first and second drive cable capstans (see Fig. 10; first drive cable capstan 1012a and second drive cable capstan 1012b) arranged within the drive housing and asymmetrically aligned between the distal and proximal ends (Fig. 10);
a first drive cable (808a) extending distally from the drive housing (see [0050]; drive cable 808a extends proximally from the end effector to the drive housing) and actuatable by operation of the first drive cable capstan (see [0063]; each drive cable capstan 1012a-d is operably coupled to a corresponding one of the drive cables 808a-d); and
a second drive cable (808b) extending distally from the drive housing (see 0050]; drive cable 808a extends proximally from the end effector to the drive housing) and actuatable by operation of the second drive cable capstan (see [0063]; each drive cable capstan 1012a-d is operably coupled to a corresponding one of the drive cables 808a-d),
wherein the first and second drive cables operate antagonistically (see [0053-0054]; the drive cables 808a-d may be characterized as antagonistic cables that cooperatively, yet antagonistically, operate to cause relative or tandem movement, i.e. when the first drive cable 808a is actuated, the second drive cable 808b naturally follows as coupled to the first drive cable 808a and vice versa).
Evans is silent regarding wherein a stiffness of the first and second drive cables is equalized by adjusting one or more characteristics of one or both of the first and second drive cables.
Prisco teaches a surgical tool (100) comprising a first and second drive cable (see Prisco Fig. 2A; tendons 230A and 230B) which are coupled to one another (see Prisco Fig. 2A, [0025-0026]; tendons 230A and 230B are both coupled to the same link 240) and may be actuatable by a first and second drive system (spring systems 210),
wherein a stiffness of the first and second drive cables is equalized by adjusting one or more characteristics of one or both of the first and second drive cables (see Prisco Fig. 2A, [0025-0026]; two tendons 230a and 230b are coupled to the same link so that a change in tension in one tendon causes a relative or tandem movement in the other tendon which unbalances the equilibrium of forces and causes the link to move until a new equilibrium is established, a new equilibrium may be established by increasing or relaxing tension in one tendon 230a/b by changing the tension applied to the tendons by spring systems 210 via stretching one of springs 216).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify Evans’ surgical tool having first and second drive cables which operate antagonistically with Prisco’s method of establishing equilibrium between coupled drive cables via spring systems which allow for constant force with variable position. One of ordinary skill in the art would have been motivated to make this modification in order to control tension (stiffness) in the tendons via asymmetric or constant force spring systems so that the surgical device can be compliant for positioning/shaping without damaging the tendons or connections to the tendons within the device or to a backend mechanism (Prisco [Abstract]).
Regarding claim 2, Evans in view of Prisco teaches the surgical tool of claim 1, further comprising:
a first input (906c) rotatably mounted to a bottom of the drive housing (see Evans Fig. 9, [0057]; each drive input comprises a rotatable disc),
the first drive cable capstan extending from the first input (see Evans Fig. 11, [0062-0065]; each drive input 906 has a corresponding input shaft 1010, wherein drive input 906c corresponds to the first input shaft 1010a, each input shaft 1010a-d has a corresponding drive cable capstan 1012a-d); and
a second input (906d) rotatably mounted to the bottom of the drive housing (see Evans Fig. 9, [0057]; each drive input comprises a rotatable disc),
the second drive cable capstan extends from the second input (see Evans Fig. 11, [0062-0065]; each drive input 906 has a corresponding input shaft 1010, wherein drive input 906d corresponds to the first input shaft 1010b, each input shaft 1010a-d has a corresponding drive cable capstan 1012a-d).
wherein the first and second inputs (906c and 906d) are asymmetrically aligned between the distal and proximal ends (Fig. 9).
Evans is silent regarding wherein equalizing the stiffness of the first and second drive cables creates an equivalent compliance between motors that drive the first and second inputs.
Prisco teaches wherein equalizing the stiffness of the first and second drive cables creates an equivalent compliance between motors that drive the first and second inputs (see Prisco Fig. 2A, [0026]; actuation of link 240 can be achieved by activating a motor 250 to turn a drive system 212 and change the tension in at least one of the tendons 230A/B, which causes the link to move until a new equilibrium is established by equalizing the tension in the tendons 230A/B via stretching one or both of springs 216).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify Evans’ surgical tool having first and second drive cables which operate antagonistically with Prisco’s method of establishing equilibrium between coupled drive cables via spring systems which allow for constant force with variable position. One of ordinary skill in the art would have been motivated to make this modification in order to control tension (stiffness) in the tendons via asymmetric or constant force spring systems so that the surgical device can be compliant for positioning/shaping without damaging the tendons or connections to the tendons within the device or to a backend mechanism (Prisco [Abstract]).
Regarding claim 3, Evans in view of Prisco teaches the surgical tool of claim 1, further comprising:
third and fourth cable capstans (1012c and 1012d) arranged within the drive housing and symmetrically aligned between the distal and proximal ends (Fig. 10);
a third drive cable (808c) extending distally from the drive housing (see Evans [0050]; drive cable 808c extends proximally from the end effector to the drive housing) and actuatable by operation of the third drive cable capstan (see Evans [0063]; each drive cable capstan 1012a-d is operably coupled to a corresponding one of the drive cables 808a-d); and
a fourth drive cable (808d) extending distally from the drive housing (see Evans [0050]; drive cable 808d extends proximally from the end effector to the drive housing) and actuatable by operation of the fourth drive cable capstan (see Evans [0063]; each drive cable capstan 1012a-d is operably coupled to a corresponding one of the drive cables 808a-d).
Evans is silent regarding wherein a stiffness of the third and fourth drive cables is equal.
Prisco teaches wherein a stiffness of the first and second drive cables is equalized by adjusting one or more characteristics of one or both of the first and second drive cables (see Prisco Fig. 2A, [0025-0026]; two tendons 230a and 230b are coupled to the same link so that a change in tension in one tendon causes a relative or tandem movement in the other tendon which unbalances the equilibrium of forces and causes the link to move until a new equilibrium is established, a new equilibrium may be established by increasing or relaxing tension in one tendon 230a/b by changing the tension applied to the tendons by spring systems 210 via stretching one of springs 216), and
wherein there may be a variable number of tendons attached to a link (see Prisco [0016]; each link 240 may have one or more tendons that terminate at link 240, with two tendons 230A/B pictured in Fig. 2A for ease of illustration, Fig. 3, [0028]; where three tendons are pictured coupled to the same link).
Therefore, extending the plurality of tendons coupled to the link to include a fourth tendon would have been an obvious modification of the prior art device with established precedent (Prisco [0016]), and would amount to only a duplication of existing parts. The addition of a third and fourth tendon would allow for control of two degrees of freedom for the link (Prisco [0028]).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify Evans’ surgical tool having third and fourth drive cables with Prisco’s method of establishing equilibrium between coupled drive cables via spring systems which allow for constant force with variable position. One of ordinary skill in the art would have been motivated to make this modification in order to control tension (stiffness) in the tendons while controlling multiple degrees of freedom of articulation (Prisco [0028]) via asymmetric or constant force spring systems so that the surgical device can be compliant for positioning/shaping without damaging the tendons or connections to the tendons within the device or to a backend mechanism (Prisco [Abstract]).
Regarding claim 4, Evans in view of Prisco teaches the surgical tool of claim 3. Evans is silent regarding wherein the stiffness of the first and second drive cables is equalized to the stiffness of the third and fourth drive cables by adjusting one or more characteristics of one or more of the first, second, third, and fourth drive cables.
Prisco teaches establishing an equilibrium of tension (stiffness) applied to multiple tendons coupled to a common link via a spring system attached to each tendon (Prisco [0027-0028]). The example as applied in Prisco Fig. 3 pictures three tendons, however it has been established that there may be a variable number of tendons attached to a link (see Prisco [0016]; each link 240 may have one or more tendons that terminate at link 240, with two tendons 230A/B pictured in Fig. 2A for ease of illustration, Fig. 3, [0028]; where three tendons are pictured coupled to the same link).
Therefore, extending the plurality of tendons coupled to the link to include a fourth tendon would have been an obvious modification of the prior art device with established precedent (Prisco [0016]), and would amount to only a duplication of existing parts. The addition of a third and fourth tendon would allow for control of two degrees of freedom for the link (Prisco [0028]) using a spring system corresponding to each tendon which can establish an equilibrium between the tendons (0026-0028]).
Regarding claim 5, Evans in view of Prisco teaches the surgical tool of claim 3, further comprising:
an elongate shaft (602) that extends from the drive housing (Evans Fig. 6); and
an end effector (604) operatively coupled to a distal end of the elongate shaft (Evans Fig. 6) and including opposing upper and lower jaws (jaws 610 and 612),
wherein the first and second drive cables extend within the shaft toward the end effector (see Evans [0050]; drive cables 808a-d extends proximally from the end effector to the drive housing) and are actuatable to open and close the upper jaw (see Evans [0053]; actuation of drive cable 808a acts on and pivots the first jaw 610 towards an open position, actuation of the second drive cable 808b acts on and pivots the first jaw 612 towards a closed position), and
wherein the third and fourth drive cables extend within the shaft toward the end effector (see Evans [0050]; drive cables 808a-d extends proximally from the end effector to the drive housing) and are actuatable to open and close the lower jaw (see [0053]; actuation of drive cable 808c acts on and pivots the second jaw 612 towards an open position, actuation of the fourth drive cable 808d acts on and pivots the second jaw 612 towards a closed position).
Evans is silent regarding wherein the first and second drive cables are actuatable to open the upper and lower jaws and wherein the third and fourth drive cables are actuatable to close the upper and lower jaws. The way that the drive cables of Evans are antagonistically coupled (first and second drive cables are a pair and third and fourth drive cables are a pair), each pair of cables is capable of pivoting the connected jaw in two opposite directions. For example, with respect to the orientation of the end effector in Fig. 8, the first and second drive cables can move the first jaw 610 about the pivot axis to the right in order for the jaw to be in an open position or to the left in order for the jaw to be in a closed position. The antagonistic operation of the cable pairing results in being able to articulate the jaw of the end effector in two opposite directions. This same principle applies to the third and fourth drive cables attached to the second jaw 612, although in the case of the second jaw, an actuation of the third cable causes the jaw to pivot about the axis to the left to open the jaw and an actuation of the fourth cable causes the jaw to pivot to the right to close the jaw.
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Therefore, it can be appreciated that without changing the antagonistic operation of the coupled drive cables, if the first drive cable remained connected to the first jaw 610 and the second drive cable were connected to the second jaw 612, an articulation of the first or second drive cables would result in the respective jaws pivoting in the same directions as caused by the current configuration; where the first drive cable causes a pivot to the right and the second drive cable causes a pivot to the left. This would effectively cause the first and second drive cables, which are antagonistically operable, to open both the first and second jaws using the same actuation principles as disclosed in Evans. The same scenario applies to the third and fourth drive cables actuating to close the first and second jaws.
Since this manner of connecting the drive cables would not change the antagonistic operation of the cables themselves, or the manner in which the jaws of the end effector were articulated, it may be regarded as a mere rearrangement of parts. The rearrangement of the drive cables to connect an antagonistic pair to opposite jaws of the end effector rather than the same jaw would not change the operation of the drive cables or end effector as disclosed by the prior art. See MPEP 2144.04(VI)(C).
Regarding claim 7, Evans in view of Prisco teaches the surgical tool of claim 1 wherein each drive cable comprises a flexible cable (see Evans [0049]; drive cables 808a-d). Evans is silent regarding wherein each drive cable comprises a flexible cable and a stiffness component coupled to the flexible cable.
Prisco teaches wherein wherein each drive cable includes a flexible cable (230) and a stiffness component (216) coupled to the flexible cable, and
wherein the one or more characteristics include:
a length of the stiffness component (see Prisco [0026]; equilibrium may be re-established by stretching one or more spring 216 corresponding to a tendon 230); or
a material of the stiffness component (see Prisco [0025-0026]; wherein the material of the stiffness component is a spring).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify Evans’ surgical device having drive cables with Prisco’s system for establishing equilibrium of tension (stiffness) between cables (tendons) using a spring as a stiffness component. One of ordinary skill in the art would have been motivated to make this modification in order to establish equilibrium between the tension experienced by the drive cables in various positions by using a spring system which results in constant force with variable position (Prisco [0025-0026]).
Regarding claim 8, Evans and Prisco teach the surgical tool of claim 7, wherein the flexible cable is made of a flexible material selected from the group consisting of a metal, a polymer, a synthetic fiber, an elastomer, and any combination thereof (see Evans [0049]; drive cables 808a-d can be made from a variety of materials including metal or a polymer; Prisco [0015]; tendons can be made of stranded or woven cables, monofilament lines, or tubes made of metal or a synthetic material that provides sufficient strength and flexibility for operation of the systems).
Regarding claim 9, Evans and Prisco teach the surgical tool of claim 7. They are silent wherein a ratio of stiffness between a stiffness of the stiffness component and a stiffness of the flexible cable is between 1:1 and 10:1.
However, it can be appreciated that the claimed range covers a broad range of relationships between the stiffness of the stiffness component and the stiffness of the flexible cable, and that the stiffness component, must, by nature be at least as stiff or stiffer than the flexible cable. So therefore, discovering the optimum or workable range of the ratio of stiffness between the stiffness component and the flexible cable would have been obvious to one of ordinary skill in the art.
MPEP 2144.05(II)(A) states that: "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 10, Evans in view of Prisco teaches the surgical tool of claim 1 wherein each drive cable includes a flexible cable having a distal section and a proximal section (see Evans [0050]; drive cables 808a-d extends proximally from the end effector to the drive housing
Evans is silent regarding wherein each drive cable also includes:
a stiffness component having opposing distal and proximal ends,
the distal section being coupled to the distal end of the stiffness component, and
the proximal section being coupled to the proximal end of the stiffness component, and
wherein the one or more characteristics include:
a length of the distal section;
a length of the proximal section;
a material of the distal and proximal sections;
a cross-sectional diameter of the distal and proximal sections;
whether one or both of the distal and proximal sections is braided;
a type of braiding construction of one or both of the distal and proximal sections;
a length of the stiffness component;
a material of the stiffness component;
a cross-section of the stiffness component; and
whether there is more than one stiffness component.
Prisco teaches wherein each drive cable includes:
a flexible cable having a distal section (230) and a proximal section (see Prisco [0018]; the proximal end of each spring 216 may be attached to a cable); and
a stiffness component (216) having opposing distal and proximal ends (see Prisco Fig. 2A; where the distal end of the spring 216 is closest to the link 240 and the opposing proximal end is closest to the motors 250),
the distal section being coupled to the distal end of the stiffness component (see Prisco Fig. 2A; distal section is defined as the tendon 230A which is coupled to a distal side of the spring 216 which acts as the stiffness component), and
the proximal section being coupled to the proximal end of the stiffness component (see Prisco [0018]; the proximal end of each spring 216 may be attached to a cable), and
wherein the one or more characteristics include:
a length of the stiffness component (see Prisco [0026]; equilibrium may be re-established by stretching one or more spring 216 corresponding to a tendon 230); or
a material of the stiffness component (see Prisco [0025-0026]; wherein the material of the stiffness component is a spring).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify Evans’ surgical device having drive cables with Prisco’s system for establishing equilibrium of tension (stiffness) between cables (tendons) using a spring as a stiffness component. One of ordinary skill in the art would have been motivated to make this modification in order to establish equilibrium between the tension experienced by the drive cables in various positions by using a spring system which results in constant force with variable position (Prisco [0025-0026]).
Regarding claim 11, Evans and Prisco teach the surgical tool of claim 10. They are silent wherein a ratio of stiffness between a stiffness of the stiffness component and a stiffness of the flexible cable is between 1:1 and 10:1.
However, it can be appreciated that the claimed range covers a broad range of relationships between the stiffness of the stiffness component and the stiffness of the flexible cable, and that the stiffness component, must, by nature be at least as stiff or stiffer than the flexible cable. So therefore, discovering the optimum or workable range of the ratio of stiffness between the stiffness component and the flexible cable would have been obvious to one of ordinary skill in the art.
MPEP 2144.05(II)(A) states that: "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 12, Evans in view of Prisco teaches the surgical tool of claim 1. Evans is silent regarding wherein equalizing the stiffness of the first and second drive cables includes adjusting the one or more characteristics of one or both of the first and second drive cables and thereby altering the stiffness between 0% and 25%, wherein altering the stiffness between 0% and 25% constitutes a delta (change) shift from an original stiffness of the first and second drive cables.
Prisco teaches a system for equalizing the stiffness of the first and second tendons by adjusting one or more characteristics of one or both of the first or second tendons as described above. Prisco is silent regarding wherein equalizing the stiffness of the first and second drive cables alters the stiffness between 0% and 25%, wherein altering the stiffness between 0% and 25% constitutes a delta (change) shift from an original stiffness of the first and second drive cables.
However, it can be appreciated that the prior art of Prisco discloses the general conditions of equalizing the stiffness (tension) of coupled drive cables by altering the stiffness of the first and/or second drive cables. MPEP 2144.05(II)(A) states that: "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
The relative delta between the original stiffness and the adjusted stiffness of the drive cables would merely involve discovering an optimum or workable range through routine experimentation to achieve the desired stiffness equilibrium.
Regarding claim 13, Evans in view of Prisco teaches the surgical tool of claim 1, further comprising:
first and second drive gears forming part of the first and second drive cable capstans, respectively (see Evans [00634]; each drive cable capstan 1012a-d has a driven gear 1016 couples thereto or forming part thereof);
first and second driven gears positioned within the drive housing to be driven by the first and second drive gears, respectively as the first and second drive cable capstans rotate (see Evans [0064]; rotation of the first input shaft 1010a will correspondingly rotate the associated drive gear 1014 and drive the associated driven gear 1016 to control movement of the first drive cable 808a); and
first and second cable pulleys coupled to the first and second driven gears, respectively (pulleys 1102 and/or 1206),
wherein the first drive cable is received by the first cable pulley, and the second drive cable is received by the second cable pulley (see Evans Figs. 11-12 [0069-0072]; the drive cables 808 wraps around one of pulley tracks 1102 or 1206 on its respective drive capstan/drive capstan gear based on the orientation of the capstan within the drive housing).
Examiner also notes Evans paragraph [0071] which states ‘the accompanying description of the third drive cable capstan 1012c is equally applicable to the first, second, and/or fourth drive cable capstans 1012a,b,d of FIG. 10.’
Regarding claim 14, Evans teaches a method of operating a surgical tool, comprising:
positioning the surgical tool adjacent a patient for operation (see Evans [0089 a method of operating a surgical tool that includes positioning the surgical tool adjacent a patient for operation), the surgical tool including:
a drive housing (608) having opposing distal and proximal ends (see Evans Fig. 6; housing 608 having a distal end nearer to the end effector and a proximal end nearer to the robotic manipulator);
first and second inputs (906c and 906d) rotatably mounted to a bottom of the drive housing (see Evans Fig. 9, [0057]; each drive input comprises a rotatable disc),
the first and second inputs (906c and 906d) being asymmetrically aligned between the distal and proximal ends (Fig. 9),
first and second drive cable capstans (Fig. 10; first drive cable capstan 1012a and second drive cable capstan 1012b) extending from the first and second inputs, respectively (see Evans Fig. 11, [0062-0065]; each drive input 906 has a corresponding input shaft 1010, wherein drive input 906c corresponds to the first input shaft 1010a, and wherein drive input 906d corresponds to the first input shaft 1010b, each input shaft 1010a-d has a corresponding drive cable capstan 1012a-d); and
a first drive cable (808a) extending distally from the drive housing (see [0050]; drive cable 808a extends proximally from the end effector to the drive housing) and actuatable by operation of the first drive cable capstan (see [0063]; each drive cable capstan 1012a-d is operably coupled to a corresponding one of the drive cables 808a-d); and
a second drive cable (808b) extending distally from the drive housing (see 0050]; drive cable 808a extends proximally from the end effector to the drive housing) and actuatable by operation of the second drive cable capstan (see [0063]; each drive cable capstan 1012a-d is operably coupled to a corresponding one of the drive cables 808a-d),
actuating first and second motors to drive the first and second inputs (see Evans [0057]; each drive input 906a-f comprises a rotatable disc configured to align with and couple to a corresponding actuator of a given tool driver), and thereby causing the first and second drive cables to move and operate antagonistically (see Evans [0053-0054]; the drive cables 808a-d may be characterized as antagonistic cables that cooperatively, yet antagonistically, operate to cause relative or tandem movement, i.e. when the first drive cable 808a is actuated, the second drive cable 808b naturally follows as coupled to the first drive cable 808a and vice versa).
Evans is silent regarding adjusting one or more characteristics of one or both of the first and second drive cables and thereby equalizing a stiffness of the first and second drive cables; and
wherein equalizing the stiffness of the first and second drive cables creates an equivalent compliance between the first and second motors.
Prisco teaches a surgical tool (100) comprising a first and second drive cable (see Prisco Fig. 2A; tendons 230A and 230B) which are coupled to one another (see Prisco Fig. 2A, [0025-0026]; tendons 230A and 230B are both coupled to the same link 240) and may be actuatable by a first and second drive system (spring systems 210),
wherein a stiffness of the first and second drive cables is equalized by adjusting one or more characteristics of one or both of the first and second drive cables (see Prisco Fig. 2A, [0025-0026]; two tendons 230a and 230b are coupled to the same link so that a change in tension in one tendon causes a relative or tandem movement in the other tendon which unbalances the equilibrium of forces and causes the link to move until a new equilibrium is established, a new equilibrium may be established by increasing or relaxing tension in one tendon 230a/b by changing the tension applied to the tendons by spring systems 210 via stretching one of springs 216); and
wherein equalizing the stiffness of the first and second drive cables creates an equivalent compliance between motors that drive the first and second inputs (see Prisco Fig. 2A, [0026]; actuation of link 240 can be achieved by activating a motor 250 to turn a drive system 212 and change the tension in at least one of the tendons 230A/B, which causes the link to move until a new equilibrium is established by equalizing the tension in the tendons 230A/B via stretching one or both of springs 216).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify Evans’ method of operating a surgical tool having first and second drive cables which operate antagonistically with Prisco’s method of establishing equilibrium between coupled drive cables via spring systems which allow for constant force with variable position. One of ordinary skill in the art would have been motivated to make this modification in order to control tension (stiffness) in the tendons via asymmetric or constant force spring systems so that the surgical device can be compliant for positioning/shaping without damaging the tendons or connections to the tendons within the device or to a backend mechanism (Prisco [Abstract]).
Regarding claim 15, Evans in view of Prisco teaches the method of claim 14. Evans is silent regarding wherein adjusting the one or more characteristics comprises adjusting the one or more characteristics of one or both of the first and second drive cables and thereby altering the stiffness between 0% and 25%, wherein altering the stiffness between 0% and 25% constitutes a delta (change) shift from an original stiffness of the first and second drive cables.
Prisco teaches a system for equalizing the stiffness of the first and second tendons by adjusting one or more characteristics of one or both of the first or second tendons as described above. Prisco is silent regarding wherein equalizing the stiffness of the first and second drive cables alters the stiffness between 0% and 25%, wherein altering the stiffness between 0% and 25% constitutes a delta (change) shift from an original stiffness of the first and second drive cables.
However, it can be appreciated that the prior art of Prisco discloses the general conditions of equalizing the stiffness (tension) of coupled drive cables by altering the stiffness of the first and/or second drive cables. MPEP 2144.05(II)(A) states that: "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
The relative delta between the original stiffness and the adjusted stiffness of the drive cables would merely involve discovering an optimum or workable range through routine experimentation to achieve the desired stiffness equilibrium.
Regarding claim 16, Evans in view of Prisco teaches the method of claim 14, further comprising:
third and fourth inputs (906e and 906f) rotatably mounted to the bottom of the drive housing and symmetrically aligned between the distal and proximal ends (see Evans Fig. 9, [0057]; each drive input comprises a rotatable disc);
third and fourth cable capstans (1012c and 1012d) extending from the third and fourth inputs, respectively (see Evans Fig. 11, [0062-0065]; each drive input 906 has a corresponding input shaft 1010, wherein drive input 906e corresponds to the third input shaft 1010c, and drive input 906f corresponds to the fourth input shaft 1010d, and each input shaft 1010a-d has a corresponding drive cable capstan 1012a-d);
a third drive cable (808c) extending distally from the drive housing (see Evans [0050]; drive cable 808c extends proximally from the end effector to the drive housing) and actuatable by operation of the third drive cable capstan (see Evans [0063]; each drive cable capstan 1012a-d is operably coupled to a corresponding one of the drive cables 808a-d); and
a fourth drive cable (808d) extending distally from the drive housing (see Evans [0050]; drive cable 808d extends proximally from the end effector to the drive housing) and actuatable by operation of the fourth drive cable capstan (see Evans [0063]; each drive cable capstan 1012a-d is operably coupled to a corresponding one of the drive cables 808a-d).
Evans is silent regarding wherein a stiffness of the third and fourth drive cables is equal.
Prisco teaches wherein a stiffness of the first and second drive cables is equalized by adjusting one or more characteristics of one or both of the first and second drive cables (see Prisco Fig. 2A, [0025-0026]; two tendons 230a and 230b are coupled to the same link so that a change in tension in one tendon causes a relative or tandem movement in the other tendon which unbalances the equilibrium of forces and causes the link to move until a new equilibrium is established, a new equilibrium may be established by increasing or relaxing tension in one tendon 230a/b by changing the tension applied to the tendons by spring systems 210 via stretching one of springs 216), and
wherein there may be a variable number of tendons attached to a link (see Prisco [0016]; each link 240 may have one or more tendons that terminate at link 240, with two tendons 230A/B pictured in Fig. 2A for ease of illustration, Fig. 3, [0028]; where three tendons are pictured coupled to the same link).
Therefore, extending the plurality of tendons coupled to the link to include a fourth tendon would have been an obvious modification of the prior art device with established precedent (Prisco [0016]), and would amount to only a duplication of existing parts. The addition of a third and fourth tendon would allow for control of two degrees of freedom for the link (Prisco [0028]).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify Evans’ method of operating a surgical tool having third and fourth drive cables with Prisco’s method of establishing equilibrium between coupled drive cables via spring systems which allow for constant force with variable position. One of ordinary skill in the art would have been motivated to make this modification in order to control tension (stiffness) in the tendons while controlling multiple degrees of freedom of articulation (Prisco [0028]) via asymmetric or constant force spring systems so that the surgical device can be compliant for positioning/shaping without damaging the tendons or connections to the tendons within the device or to a backend mechanism (Prisco [Abstract]).
Regarding claim 17, Evans in view of Prisco teaches the method of claim 14. Evans is silent regarding the method further comprising equalizing the stiffness of the first and second drive cables to the stiffness of the third and fourth drive cables by adjusting one or more characteristics of one or more of the first, second, third, and fourth drive cables.
Prisco teaches establishing an equilibrium of tension (stiffness) applied to multiple tendons coupled to a common link via a spring system attached to each tendon (Prisco [0027-0028]). The example as applied in Prisco Fig. 3 pictures three tendons, however it has been established that there may be a variable number of tendons attached to a link (see Prisco [0016]; each link 240 may have one or more tendons that terminate at link 240, with two tendons 230A/B pictured in Fig. 2A for ease of illustration, Fig. 3, [0028]; where three tendons are pictured coupled to the same link).
Therefore, extending the plurality of tendons coupled to the link to include a fourth tendon would have been an obvious modification of the prior art device with established precedent (Prisco [0016]), and would amount to only a duplication of existing parts. The addition of a third and fourth tendon would allow for control of two degrees of freedom for the link (Prisco [0028]) using a spring system corresponding to each tendon which can establish an equilibrium between the tendons (0026-0028]).
Regarding claim 18, Evans in view of Prisco teaches the method of claim 14,
Wherein the surgical tool further includes an elongate shaft (602) that extends from the drive housing (Evans Fig. 6); and
an end effector (604) operatively coupled to a distal end of the elongate shaft (Evans Fig. 6) and including opposing upper and lower jaws (jaws 610 and 612),
the method further comprising:
actuating the first and second motors to move the first and second drive cables (see Evans [0057]; each drive input comprises a rotatable disc configured to align with and couple to a corresponding actuator of a given tool driver, [0062-0065]; each drive input 906 has a corresponding input shaft 1010, and each input shaft 1010a-d has a corresponding drive cable capstan 1012a-d) and thereby open and close the upper jaw (see Evans [0053]; actuation of drive cable 808a acts on and pivots the first jaw 610 towards an open position, actuation of the second drive cable 808b acts on and pivots the first jaw 612 towards a closed position), and
actuating third and fourth motors to drive the third and fourth inputs (see Evans [0057]; each drive input comprises a rotatable disc configured to align with and couple to a corresponding actuator of a given tool driver, [0062-0065]; each drive input 906 has a corresponding input shaft 1010, and each input shaft 1010a-d has a corresponding drive cable capstan 1012a-d), and thereby causing the third and fourth drive cables to move and to open and close the lower jaw (see [0053]; actuation of drive cable 808c acts on and pivots the second jaw 612 towards an open position, actuation of the fourth drive cable 808d acts on and pivots the second jaw 612 towards a closed position).
Evans is silent regarding wherein the first and second drive cables open the upper and lower jaws and wherein the third and fourth drive cables close the upper and lower jaws. The way that the drive cables of Evans are antagonistically coupled (first and second drive cables are a pair and third and fourth drive cables are a pair), each pair of cables is capable of pivoting the connected jaw in two opposite directions. For example, with respect to the orientation of the end effector in Fig. 8, the first and second drive cables can move the first jaw 610 about the pivot axis to the right in order for the jaw to be in an open position or to the left in order for the jaw to be in a closed position. The antagonistic operation of the cable pairing results in being able to articulate the jaw of the end effector in two opposite directions. This same principle applies to the third and fourth drive cables attached to the second jaw 612, although in the case of the second jaw, an actuation of the third cable causes the jaw to pivot about the axis to the left to open the jaw and an actuation of the fourth cable causes the jaw to pivot to the right to close the jaw.
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Therefore, it can be appreciated that without changing the antagonistic operation of the coupled drive cables, if the first drive cable remained connected to the first jaw 610 and the second drive cable were connected to the second jaw 612, an articulation of the first or second drive cables would result in the respective jaws pivoting in the same directions as caused by the current configuration; where the first drive cable causes a pivot to the right and the second drive cable causes a pivot to the left. This would effectively cause the first and second drive cables, which are antagonistically operable, to open both the first and second jaws using the same actuation principles as disclosed in Evans. The same scenario applies to the third and fourth drive cables actuating to close the first and second jaws.
Since this manner of connecting the drive cables would not change the antagonistic operation of the cables themselves, or the manner in which the jaws of the end effector were articulated, it may be regarded as a mere rearrangement of parts. The rearrangement of the drive cables to connect an antagonistic pair to opposite jaws of the end effector rather than the same jaw would not change the operation of the drive cables or end effector as disclosed by the prior art. See MPEP 2144.04(VI)(C).
Regarding claims 19 and 20, Evans in view of Prisco teaches the method of claim 14, wherein each drive cable comprises a flexible cable (see Evans [0049]; drive cables 808a-d). Evans is silent regarding wherein each drive cable comprises a flexible cable and a stiffness component coupled to the flexible cable.
Prisco teaches wherein wherein each drive cable includes a flexible cable (230) and a stiffness component (216) coupled to the flexible cable, and
wherein adjusting the one or more characteristics of one or both of the first and second drive cables includes at least one of the following:
a length of the stiffness component (see Prisco [0026]; equilibrium may be re-established by stretching one or more spring 216 corresponding to a tendon 230); or
a material of the stiffness component (see Prisco [0025-0026]; wherein the material of the stiffness component is a spring).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify Evans’ method of operating a surgical device having drive cables with Prisco’s system for establishing equilibrium of tension (stiffness) between cables (tendons) using a spring as a stiffness component. One of ordinary skill in the art would have been motivated to make this modification in order to establish equilibrium between the tension experienced by the drive cables in various positions by using a spring system which results in constant force with variable position (Prisco [0025-0026]).
Regarding claim 21, Evans teaches a method of preparing a surgical tool wherein, the surgical tool comprises:
a drive housing (608) having a distal end (see Evans Fig. 6; housing 608 having a distal end nearer to the end effector and a proximal end nearer to the robotic manipulator);
a first drive cable capstan (1012a) rotatably mounted within the drive housing a first distance from the distal end (see Evans Fig. 10 [0063]; each drive cable capstan 1012a-d is rotatable mounted within the drive housing);
a second input (906d) rotatably mounted within the drive housing (see Evans [0057]; each drive input comprises a rotatable disc) a second distance different than first distance from the distal end (Evans Fig. 9);
a first drive cable (808a) extending distally from the drive housing (see [0050]; drive cable 808a extends proximally from the end effector to the drive housing) and actuatable by operation of the first drive cable capstan (see [0063]; each drive cable capstan 1012a-d is operably coupled to a corresponding one of the drive cables 808a-d); and
a second drive cable (808b) extending distally from the drive housing (see 0050]; drive cable 808b extends proximally from the end effector to the drive housing) and actuatable by operation of a second drive cable capstan (1012b, see [0063]; each drive cable capstan 1012a-d is operably coupled to a corresponding one of the drive cables 808a-d),
wherein the first and second drive cables operate antagonistically (see Evans [0053-0054]; the drive cables 808a-d may be characterized as antagonistic cables that cooperatively, yet antagonistically, operate to cause relative or tandem movement, i.e. when the first drive cable 808a is actuated, the second drive cable 808b naturally follows as coupled to the first drive cable 808a and vice versa).
Evans is silent regarding wherein the method comprises adjusting one or more characteristics of one or both of the first and second drive cables to equalize a stiffness of the first and second drive cables.
Prisco teaches a surgical tool (100) comprising a first and second drive cable (see Prisco Fig. 2A; tendons 230A and 230B) which are coupled to one another (see Prisco Fig. 2A, [0025-0026]; tendons 230A and 230B are both coupled to the same link 240) and may be actuatable by a first and second drive system (spring systems 210),
wherein a stiffness of the first and second drive cables is equalized by adjusting one or more characteristics of one or both of the first and second drive cables (see Prisco Fig. 2A, [0025-0026]; two tendons 230a and 230b are coupled to the same link so that a change in tension in one tendon causes a relative or tandem movement in the other tendon which unbalances the equilibrium of forces and causes the link to move until a new equilibrium is established, a new equilibrium may be established by increasing or relaxing tension in one tendon 230a/b by changing the tension applied to the tendons by spring systems 210 via stretching one of springs 216).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify Evans’ surgical tool having first and second drive cables which operate antagonistically with Prisco’s method of establishing equilibrium between coupled drive cables via spring systems which allow for constant force with variable position. One of ordinary skill in the art would have been motivated to make this modification in order to control tension (stiffness) in the tendons via asymmetric or constant force spring systems so that the surgical device can be compliant for positioning/shaping without damaging the tendons or connections to the tendons within the device or to a backend mechanism (Prisco [Abstract]).
Conclusion
The following prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Adams et al (US 20190125466 A1) which teaches cable driven motion systems for robotic surgical tools.
Burbank (US 20100011901 A1) which teaches a four-cable wrist with solid surface cable channels.
Evans (US 20190125467 A1) which teaches a constant force spring assembly system for robotic surgical tools.
Reid et al (US 20230172680 A1) which teaches a medical instrument a having single input for driving multiple cables.
Rogers (US 9198729 B2) which teaches an actuation cable having multiple friction characteristics.
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALISHA J SIRCAR whose telephone number is (571)272-0450. The examiner can normally be reached Monday - Thursday 9-6:30, Friday 9-5:30 CT.
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/A.J.S./Examiner, Art Unit 3792
/ALLEN PORTER/Primary Examiner, Art Unit 3796