DETAILED ACTION
This action is responsive to the “AMENDMENT UNDER 37 C.F.R. § 1.111” filed 19 August 2026. The Examiner acknowledges the amendments to claims 1, 13, 15, and 20. Claims 1-20 are pending.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Interpretation
Examiner Notes: currently, NO limitation invokes interpretation under § 112(f).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 8, 11, and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chrisman (US-20140324026-A1, previously presented) in view of Kokish (US-20150297864-A1, previously presented).
Regarding claim 1, Chrisman teaches
A torquer for an elongated medical device:
a body having a cavity defining a pathway [housing 14 (Chrisman Fig. 2)];
a first jaw movable within the cavity [a first finger of the clamping fingers 22 of collet unit 20 (Chrisman Figs. 2-4)];
a biasing member separate from the first jaw biasing the first jaw relative to the body [Return spring 26 applies a force in the distal axial direction against collet unit 20, which separates collet fingers 22 from guidewire 12 (Chrisman ¶0020)]; and
an actuator movable relative to the body, the movement of the actuator relative to the body moving the first jaw to perform at least one of pinching or unpinching the elongated medical device with the first jaw within the pathway [Actuator 16 transfers motion to collet unit 20 via linkage 18. Compression of actuator 16 thereby results in a movement of collet unit 20 in a proximal axial direction, resulting in the compression of collet fingers 22 by tapered sleeve 24 against guidewire 12 (Chrisman ¶0020)].
However, Chrisman fails to explicitly disclose the first jaw including a first pad having a compliant property; wherein the elongated medical device is pinched or unpinched with the first pad.
Kokish discloses a torquer for an elongated medical device, wherein Kokish discloses jaws including respective pads having a compliant property to pinch the elongated medical device [The dynamic gripper 404 may comprise a pair of opposing pads 406, 408. Similarly, the first static gripper 402a may comprise a pair of opposing pads 410a, 412a, and the second static gripper 402b may also comprise a pair of opposing pads 410b,412b. Accordingly, the grippers 404, 402a, and 402b may each selectively grip an elongate member between their respective opposing pads 406/408, 410a/412a, and 410b/412b. The pads 406/408, 410a/412a, and 410b/412b may each be relatively soft with respect to the particular elongate member being employed, in order to more securely grip the elongate member and minimize potential damage to the elongate member, for example by spreading grip load across an increased surface area of the elongate member (Kokish ¶0072); pad sections 422c (e.g., softer durometer) will slightly deform around elongate member 424 thereby increasing grip (Kokish ¶0082); For example, pads 406/408 may be made of a single durometer material including surface features (e.g., patterns, treads, or grooves) to optimize grip for elongate members 424 of all sizes. Further, pads 406/408 may include micro fibers or any other material with a high coefficient of friction, an ability to wick liquids, or an elasticity or lack of deformation under pressure (Kokish ¶0084)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the torquer of Chrisman to employ the first jaw including a first pad having a compliant property; wherein the elongated medical device is pinched or unpinched with the first pad, so as to allow for a secure grip of the elongate medical device, while preventing damage to the elongate medical device, and as this modification would amount to mere application of a known technique to a known device (method, or product) ready for improvement to yield predictable results [allow for gripping of an elongated medical device] [MPEP § 2143(I)(D)].
Regarding claim 8, Chrisman in view of Kokish teaches
The torquer of claim 1, wherein the pads are elastomeric pads [Kokish ¶¶0082, 0084] and wherein pressure between the elastomeric pads and the elongated medical device is substantially equalized along an entire length that the elastomeric pads contact the elongated medical device in a fully pinched position [Kokish ¶0072].
Regarding claim 11, Chrisman in view of Kokish teaches
The torquer of claim 1, wherein the biasing member includes one or more helical compression springs having a longitudinal axis being parallel or co-linear with a longitudinal axis of the body [Chrisman ¶0020, Figs. 2-3].
Regarding claim 13, Chrisman in view of Kokish teaches
The torquer of claim 1.
However, Chrisman is not particular regarding the diameter of the elongated medical device [The center of the housing 14 may be slotted in order to pass a wire 12 of various diameters through the torque device 10 (Chrisman ¶0023)], such that Chrisman in view of Kokish fails to explicitly disclose wherein the pathway can accommodate an elongated medical device having a diameter of 0.014 inches through and including 0.038 inches.
Kokish discloses accommodated elongated medical devices having a diameter of 0.014 inches through and including 0.038 inches [The multi-durometer pad sections may manipulate elongate members including a diameter between 0.250 inches and 0.010 inches or any subrange therebetween, For example, an elongate member diameter may include 0.150 inches, 0.035 inches, 0.025 inches, 0.020 inches, 0.018 inches, 0.014 inches, less than 0.014 inches, or any diameter suitable to the application (Kokish ¶0079)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the torquer of Chrisman in view of Kokish to employ wherein the pathway can accommodate elongated medical device having a diameter of 0.014 inches through and including 0.038 inches, as this modification would amount to mere application of a known technique to a known device (method, or product) ready for improvement to yield predictable results [MPEP § 2143(I)(D)].
Claim(s) 2, 5-7, 10, 12, and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chrisman in view of Kokish, as applied to claim 1 above, in further view of Godlewski (US-5350101-A, previously presented).
Regarding claim 2, Chrisman in view of Kokish teaches
The torquer of claim 1, wherein the first pad is formed from an elastomeric material [See § 103 modification of claim 1 above; Kokish ¶¶0072, 0082, 0084] and further including at least a second jaw movable relative to the body toward the first jaw [a second finger of the clamping fingers 22 of collet unit 20 (Chrisman Figs. 2-4)], the second jaw having a second pad formed from an elastomeric material [wherein a similar modification as applied in claim 1 above to employ a pad for the first jaw is considered to be applicable to the second jaw mutatis mutandis].
However, Chrisman is silent as to a material for the first and second jaws, such that Chrisman in view of Kokish fails to explicitly disclose wherein each jaw includes a pad base having a first elastic modulus that is greater than a second elastic modulus of the first and second pads.
Godlewski discloses a torquer for an elongated device, wherein Godlewski discloses a first and second jaw formed of a metal or plastic [The material used for collet 28 and chuck 36 can be plastic, metal or any other similar material (Godlewski Col 4:22-23); With regard to the above-disclosed structure, it is to be understood that the materials of tube feeder device 10 are preferably composed of a strong, yet lightweight, material such as hard plastic although some metals may also be usable (Godlewski Col 4:64-5:1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the torquer to Chrisman in view of Kokish to employ wherein the collet and clamping fingers are formed of a metal or plastic, such that each jaw includes a pad base having a first elastic modulus, as this modification would amount to mere simple substitution of one known element for another with similar expected results [material for forming a collet and clamping fingers for gripping an elongated medical device] [MPEP § 2143(I)(B)]. Based on the modification of Chrisman in view of Kokish and Godlewski, the first modulus is greater than a second modulus of the first and second pads [wherein the pad bases comprising metal (Godlewski Col 4:22-23, 4:64-5:1) and the pads comprising an elastomeric material (Kokish ¶¶0082, 0084) to prevent damage to the elongated medical device is considered to read on the first modulus of the pad bases being greater than the second modulus of the pads].
Regarding claim 5, Chrisman in view of Kokish and Godlewski teaches
The torquer of claim 2, wherein the body includes a cam surface contacting a nonlinear follower surface on each pad base [tapered sleeve 24 (Chrisman Figs. 2-3); Chrisman ¶0020, Figs. 2-3].
Regarding claim 6, Chrisman in view of Kokish and Godlewski teaches
The torquer of claim 5, wherein the follower surface is arcuate along a longitudinal axis of the torquer [Chrisman Figs. 2-3].
Regarding claim 7, Chrisman in view of Kokish and Godlewski teaches
The torquer of claim 6, wherein the cam surface is linear [Chrisman Figs. 2-3, wherein at least a portion of the tapered sleeve 24 is depicted as linear].
Regarding claim 10, Chrisman in view of Kokish and Godlewski teaches
The torquer of claim 2, wherein the biasing member biases the pads away from one another [Chrisman ¶0020, wherein Chrisman Figs. 2-3 depicts an “uncoupled configuration” wherein the spring 26 biases the jaws away from each other].
Regarding claim 12, Chrisman in view of Kokish and Godlewski teaches
The torquer of claim 2, wherein each jaw has a distal end and a proximal end, wherein one of the distal ends and proximal ends of the jaws move away from one another prior to the other of the distal ends and proximal ends of the jaws [Chrisman Figs. 2-3].
Regarding claim 14, Chrisman in view of Kokish and Godlewski teaches
The torquer of claim 2.
However, Chrisman in view of Kokish and Godlewski fails to explicitly disclose wherein a magnitude of a force applied to the elongated medical device from the pads is between 200 to 400 N, and a magnitude of an elastic modulus of the pads is between 200 to 400 MPa, and a length of the pads is less than 50 mm, and a durometer value of the pads is between 45D to 75D, and where a magnitude of an elastic modulus of each pad base is greater than 3.5 GPa.
There is no evidence of record that establishes that changes to the pads and pad bases taught by the combination of Chrisman in view of Kokish and Godlewski regarding each of a magnitude of a force applied to the elongated medical device from the pads, a magnitude of a modulus of the pads, a length of the pads, a durometer value of the pads, and a magnitude of a modulus of each pad base would result in a difference in function of the torquer as taught by the combination of Chrisman in view of Kokish and Godlewski. Further, a person having ordinary skill in the art being faced with modifying the pads and pad bases of Chrisman in view of Kokish and Godlewski would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed moduli, length, and durometer values of the pads and pad bases, respectively. Lastly, the Applicant has not disclosed that the claimed ranges of each of the magnitude of a force applied to the elongated medical device from the pads, magnitude of a modulus of the pads, length of the pads, durometer value of the pads, and magnitude of a modulus of each pad base solves any stated problem, indicating that each value may be within the respectively claimed ranges as exemplary embodiments [Applicant’s Specification ¶0115] and therefore there appears to be no criticality placed on the ranges as claimed such that they produce unexpected results.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Chrisman in view of Kokish and Godlewski to employ wherein a magnitude of a force applied to the elongated medical device from the pads is between 200 to 400 N, and a magnitude of a modulus of the pads is between 200 to 400 MPa, and a length of the pads is less than 50 mm, and a durometer value of the pads is between 45D to 75D, and where a magnitude of a modulus of each pad base is greater than 3.5 GPa, as an obvious matter of design choice within the skill of the art.
Claim(s) 3-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chrisman in view of Kokish and Godlewski, as applied to claim 2 above, in further view of Wienhold (US-6260857-B1, previously presented).
Regarding claim 3, Chrisman in view of Kokish and Godlewski teaches
The torquer of claim 2, wherein each jaw is free to pivot about a cam surface on the body independent of one another [tapered sleeve 24 (Chrisman Figs. 2-3); Apparatus 10 comprises a clamping mechanism, in this case a collet unit 20 (consisting of clamping fingers 22) and tapered sleeve 24. Actuator 16 transfers motion to collet unit 20 via linkage 18. Compression of actuator 16 thereby results in a movement of collet unit 20 in a proximal axial direction, resulting in the compression of collet fingers 22 by tapered sleeve 24 against guidewire 12 (Chrisman ¶0020, Figs. 2-3)].
However, Chrisman in view of Kokish and Godlewski fails to explicitly disclose wherein the jaws are not connected to one another.
Wienhold discloses similarly functional systems to Chrisman, Kokish, and Godlewski for pinching an elongate device using jaws movable within a body, wherein Wienhold discloses the use of non-connected jaws to pinch an elongated device [Although the chuck 10 is depicted in FIGS. 1-4 as utilizing two jaws 16 spaced at 180.degree. from each other, this has been done for illustrative purposes only. The preferred embodiment uses three jaws 16A spaced at 120.degree. intervals around the longitudinal axis 13 of the chuck 10. FIG. 5 shows an end view of the inventive chuck 10 using the preferred jaw 16A configuration as viewed from the forward face 30. This configuration is also the preferred configuration for the alternate embodiments shown in FIGS. 6, 7, 7B, 8 and 8A (Wienhold Col 7:56-65)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the torquer of Chrisman in view of Kokish and Godlewski to employ wherein the jaws are not connected to one another, as this modification would amount to mere simple substitution of one known element [jaws of Chrisman as connected via collet unit 20] for another [non-connection between jaws of Wienhold] with similar expected results [MPEP § 2143(I)(B)].
Regarding claim 4, Chrisman in view of Kokish, Godlewski, and Wienhold teaches
The torquer of claim 3, wherein a distal end and a proximal end of the elastomeric pad move radially away from a torquer longitudinal axis as the jaw pivots about the cam surface [Chrisman Figs. 2-3, wherein at least a distal-most tip of clamping fingers 22 and a portion proximal to the distal-most tip of clamping fingers 22 are depicted as moving radially away from a torquer longitudinal axis, such that based on the § 103 modification above in view of Kokish, the elastomeric pads similarly move away from the longitudinal axis].
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chrisman in view of Kokish and Godlewski, as applied to claim 2 above, in further view of Rollins (US-9050438-B2).
Regarding claim 9, Chrisman in view of Kokish and Godlewski teaches
The torquer of claim 2.
However, Chrisman in view of Kokish and Godlewski fails to explicitly disclose wherein the biasing member biases the pads toward one another.
Rollins discloses a torquer for an elongated medical device, wherein Rollins further discloses alternative embodiments in which a biasing member separate from jaws of the torquer may be employed to bias the jaws toward one another [The device 220 further includes a locking mechanism assembly that locks the lateral position of the guidewire 102. As seen in FIG. 21, when the user releases the trigger 232, the device remains in a locked position, allowing the user to rotate the guidewire 102. As seen in FIG. 22, when the user depresses the trigger 232, the device remains in an unlocked position, allowing the user to slide the device 220 along the guidewire 102 and preventing guidewire rotation. In the locked position, the trigger 232 maintains an outer tube 222 in a proximal position, proximally biased by a spring 226. The outer tube includes an inner passage that generally decreases in diameter in a distal direction. The inner surface of the outer tube 222 presses against a wedge portion 224A of a wedge tube 224, causing the wedge tube 224 to press against and lock onto the guidewire 102 (Rollins Col 7:8-22, Figs. 21-22)], or may be employed to bias the jaws away from one another [The device 190 locks on to the guidewire 102 when the user releases trigger 196 (see FIG. 19) and unlocks the guidewire 102 when the user depresses trigger 196. The trigger 196 moves an outer tubing 198 which is biased in a distal direction by a spring 204… When the trigger 196 is released, as in FIG. 19, the outer tubing 198 is moved distally by the spring 204, causing the smaller diameter region of the inner passage of the outer tubing 198 to press against the wedge 200A of wedge tube 200. The wedge 200 then compresses around the guidewire 102, locking the guidewire 102 in place relative to the device 190 (Rollins Col 6:42-61, Figs. 19-20)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the torquer of Chrisman in view of Kokish and Godlewski to employ wherein the biasing member biases the pads toward one another, as this modification would amount to mere application of a known technique to a known device (method, or product) ready for improvement to yield predictable results [use of a biasing member to bias elements relative to one another] [MPEP § 2143(I)(D)].
Claim(s) 15-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chrisman (US-20140324026-A1, previously presented) in view of Kokish (US-20150297864-A1, previously presented) and Wienhold (US-6260857-B1, previously presented).
Regarding claim 15, Chrisman teaches
A torquer releasably pinching an elongated medical device, comprising:
a body having a cavity defining a pathway [housing 14 (Chrisman Fig. 2)];
at least two jaws movable within the cavity, each jaw having a pad base [clamping fingers 22 of collet unit 20 (Chrisman Figs. 2-4), wherein a surface of the fingers 22 that contact the guidewire 12 is considered to define a pad base];
a biasing member separate from the jaws biasing the jaws relative to the body [Return spring 26 applies a force in the distal axial direction against collet unit 20, which separates collet fingers 22 from guidewire 12 (Chrisman ¶0020)]; and
a knob movable relative to the body, the movement of the knob relative to the body moving the jaws relative to one another pinching or unpinching the elongated medical device with the pad bases within the pathway [Actuator 16 transfers motion to collet unit 20 via linkage 18. Compression of actuator 16 thereby results in a movement of collet unit 20 in a proximal axial direction, resulting in the compression of collet fingers 22 by tapered sleeve 24 against guidewire 12 (Chrisman ¶0020); wherein the actuator 16 being rounded and configured to be gripped as depicted in at least Chrisman Figs. 1-3 is considered to read on the broadest reasonable interpretation of a knob, defined as a small rounded ornament or handle (https://www.merriam-webster.com/dictionary/knob)].
However, Chrisman fails to explicitly disclose a pad secured to each pad base, wherein the jaws are not connected to one another; and wherein the elongated medical device is pinched or unpinched with the pads.
Kokish discloses a torquer for an elongated medical device, wherein Kokish discloses jaws including respective pads having a compliant property to pinch the elongated medical device [The dynamic gripper 404 may comprise a pair of opposing pads 406, 408. Similarly, the first static gripper 402a may comprise a pair of opposing pads 410a, 412a, and the second static gripper 402b may also comprise a pair of opposing pads 410b,412b. Accordingly, the grippers 404, 402a, and 402b may each selectively grip an elongate member between their respective opposing pads 406/408, 410a/412a, and 410b/412b. The pads 406/408, 410a/412a, and 410b/412b may each be relatively soft with respect to the particular elongate member being employed, in order to more securely grip the elongate member and minimize potential damage to the elongate member, for example by spreading grip load across an increased surface area of the elongate member (Kokish ¶0072); pad sections 422c (e.g., softer durometer) will slightly deform around elongate member 424 thereby increasing grip (Kokish ¶0082); For example, pads 406/408 may be made of a single durometer material including surface features (e.g., patterns, treads, or grooves) to optimize grip for elongate members 424 of all sizes. Further, pads 406/408 may include micro fibers or any other material with a high coefficient of friction, an ability to wick liquids, or an elasticity or lack of deformation under pressure (Kokish ¶0084)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the torquer of Chrisman to employ a pad secured to each pad base; wherein the elongated medical device is pinched or unpinched with the pads, so as to allow for a secure grip of the elongate medical device, while preventing damage to the elongate medical device, and as this modification would amount to mere application of a known technique to a known device (method, or product) ready for improvement to yield predictable results [allow for gripping of an elongated medical device] [MPEP § 2143(I)(D)].
However, Chrisman in view of Kokish fails to explicitly disclose wherein the jaws are not connected to one another.
Wienhold discloses similarly functional systems to Chrisman and Kokish for pinching an elongate device using jaws movable within a body, wherein Wienhold discloses the use of non-connected jaws to pinch an elongated device [Although the chuck 10 is depicted in FIGS. 1-4 as utilizing two jaws 16 spaced at 180.degree. from each other, this has been done for illustrative purposes only. The preferred embodiment uses three jaws 16A spaced at 120.degree. intervals around the longitudinal axis 13 of the chuck 10. FIG. 5 shows an end view of the inventive chuck 10 using the preferred jaw 16A configuration as viewed from the forward face 30. This configuration is also the preferred configuration for the alternate embodiments shown in FIGS. 6, 7, 7B, 8 and 8A (Wienhold Col 7:56-65)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the torquer of Chrisman in view of Kokish to employ wherein the jaws are not connected to one another, as this modification would amount to mere simple substitution of one known element [jaws of Chrisman as connected via collet unit 20] for another [non-connection between jaws of Wienhold] with similar expected results [MPEP § 2143(I)(B)].
Regarding claim 16, Chrisman in view of Kokish and Wienhold teaches
The torquer of claim 15, wherein the body includes a cam surface contacting a nonlinear follower surface on each pad base [tapered sleeve 24 (Chrisman ¶0020, Figs. 2-3)].
Regarding claim 17, Chrisman in view of Kokish and Wienhold teaches
The torquer of claim 16, wherein each jaw is free to pivot about the cam surface independent of one another [tapered sleeve 24 (Chrisman ¶0020, Figs. 2-3)].
Regarding claim 18, Chrisman in view of Kokish and Wienhold teaches
The torquer of claim 17, wherein pressure between the pads [Kokish ¶¶0082, 0084] and the elongated medical device is substantially equalized along an entire length of the pads [Kokish ¶0072].
Regarding claim 19, Chrisman in view of Kokish and Wienhold teaches
The torquer of claim 15.
However, Chrisman in view of Kokish and Wienhold fails to explicitly disclose wherein a magnitude of a force applied to the elongated medical device from the pads is between 200 to 400 N, and a magnitude of an elastic modulus of the pads is between 200 to 400 MPa, and a length of the pads is less than 50 mm, and a durometer value of the pads is between 45D to 75D, and where a magnitude of an elastic modulus of the pad base is greater than 3.5 GPa.
There is no evidence of record that establishes that changes to the pads and pad bases taught by the combination of Chrisman in view of Kokish and Wienhold regarding each of a magnitude of a force applied to the elongated medical device from the pads, a magnitude of a modulus of the pads, a length of the pads, a durometer value of the pads, and a magnitude of a modulus of each pad base would result in a difference in function of the torquer as taught by the combination of Chrisman in view of Kokish and Wienhold. Further, a person having ordinary skill in the art being faced with modifying the pads and pad bases of Chrisman in view of Kokish and Wienhold would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed moduli, length, and durometer values of the pads and pad bases, respectively. Lastly, the Applicant has not disclosed that the claimed ranges of each of the magnitude of a force applied to the elongated medical device from the pads, magnitude of a modulus of the pads, length of the pads, durometer value of the pads, and magnitude of a modulus of each pad base solves any stated problem, indicating that each value may be within the respectively claimed ranges as exemplary embodiments [Applicant’s Specification ¶0115] and therefore there appears to be no criticality placed on the ranges as claimed such that they produce unexpected results.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Chrisman in view of Kokish and Wienhold to employ wherein a magnitude of a force applied to the elongated medical device from the pads is between 200 to 400 N, and a magnitude of an elastic modulus of the pads is between 200 to 400 MPa, and a length of the pads is less than 50 mm, and a durometer value of the pads is between 45D to 75D, and where a magnitude of an elastic modulus of the pad base is greater than 3.5 GPa, as an obvious matter of design choice within the skill of the art.
Regarding claim 20, Chrisman teaches
A torquer releasably engaging an elongated medical device, comprising:
a body having a cavity defining a pathway [housing 14 (Chrisman Fig. 2)];
at least two jaws movable within the cavity [clamping fingers 22 of collet unit 20 (Chrisman Figs. 2-4), wherein a surface of the fingers 22 that contact the guidewire 12 is considered to define a pad base];
a biasing member separate from the jaws biasing the jaws relative to the body [Return spring 26 applies a force in the distal axial direction against collet unit 20, which separates collet fingers 22 from guidewire 12 (Chrisman ¶0020)]; and
a knob movable relative to the body the movement of the knob relative to the body moving the jaws relative to one another pinching or unpinching the elongated medical device with the jaws within the pathway [Actuator 16 transfers motion to collet unit 20 via linkage 18. Compression of actuator 16 thereby results in a movement of collet unit 20 in a proximal axial direction, resulting in the compression of collet fingers 22 by tapered sleeve 24 against guidewire 12 (Chrisman ¶0020); wherein the actuator 16 being rounded and configured to be gripped as depicted in at least Chrisman Figs. 1-3 is considered to read on the broadest reasonable interpretation of a knob, defined as a small rounded ornament or handle (https://www.merriam-webster.com/dictionary/knob)].
However, Chrisman fails to explicitly disclose each jaw having an elastomeric pad, wherein the jaws are not connected to one another; wherein the elongated medical device is pinched or unpinched with the pads, and wherein pressure between the elastomeric pads and the elongated medical device is substantially equalized along an entire length of the elastomeric pads in a fully pinched position.
Kokish discloses a torquer for an elongated medical device, wherein Kokish discloses jaws including respective pads having a compliant property to pinch the elongated medical device, wherein pressure between the elastomeric pads and the elongated medical device is substantially equalized along an entire length of the elastomeric pads in a fully pinched position [The dynamic gripper 404 may comprise a pair of opposing pads 406, 408. Similarly, the first static gripper 402a may comprise a pair of opposing pads 410a, 412a, and the second static gripper 402b may also comprise a pair of opposing pads 410b,412b. Accordingly, the grippers 404, 402a, and 402b may each selectively grip an elongate member between their respective opposing pads 406/408, 410a/412a, and 410b/412b. The pads 406/408, 410a/412a, and 410b/412b may each be relatively soft with respect to the particular elongate member being employed, in order to more securely grip the elongate member and minimize potential damage to the elongate member, for example by spreading grip load across an increased surface area of the elongate member (Kokish ¶0072); pad sections 422c (e.g., softer durometer) will slightly deform around elongate member 424 thereby increasing grip (Kokish ¶0082); For example, pads 406/408 may be made of a single durometer material including surface features (e.g., patterns, treads, or grooves) to optimize grip for elongate members 424 of all sizes. Further, pads 406/408 may include micro fibers or any other material with a high coefficient of friction, an ability to wick liquids, or an elasticity or lack of deformation under pressure (Kokish ¶0084)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the torquer of Chrisman to employ each jaw having an elastomeric pad, wherein the elongated medical device is pinched or unpinched with the pads, and wherein pressure between the elastomeric pads and the elongated medical device is substantially equalized along an entire length of the elastomeric pads in a fully pinched position, so as to allow for a secure grip of the elongate medical device, while preventing damage to the elongate medical device, and as this modification would amount to mere application of a known technique to a known device (method, or product) ready for improvement to yield predictable results [allow for gripping of an elongated medical device] [MPEP § 2143(I)(D)].
However, Chrisman in view of Kokish fails to explicitly disclose wherein the jaws are not connected to one another.
Wienhold discloses similarly functional systems to Chrisman and Kokish for pinching an elongate device using jaws movable within a body, wherein Wienhold discloses the use of non-connected jaws to pinch an elongated device [Although the chuck 10 is depicted in FIGS. 1-4 as utilizing two jaws 16 spaced at 180.degree. from each other, this has been done for illustrative purposes only. The preferred embodiment uses three jaws 16A spaced at 120.degree. intervals around the longitudinal axis 13 of the chuck 10. FIG. 5 shows an end view of the inventive chuck 10 using the preferred jaw 16A configuration as viewed from the forward face 30. This configuration is also the preferred configuration for the alternate embodiments shown in FIGS. 6, 7, 7B, 8 and 8A (Wienhold Col 7:56-65)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the torquer of Chrisman in view of Kokish to employ wherein the jaws are not connected to one another, as this modification would amount to mere simple substitution of one known element [jaws of Chrisman as connected via collet unit 20] for another [non-connection between jaws of Wienhold] with similar expected results [MPEP § 2143(I)(B)].
Response to Arguments
Applicant’s arguments, see Applicant’s Remarks p. 7-10, filed 19 August 2026, with respect to the rejection(s) of claim(s) 1, 15, 20, and those dependent therefrom under § 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Chrisman (US-20140324026-A1, previously presented) in view of Kokish (US-20150297864-A1, previously presented) with respect to claim 1, and Chrisman in view of Kokish and Wienhold (US-6260857-B1, previously presented) with respect to claims 15 and 20.
The Applicant asserts that Godlewski fails to disclose or fairly suggest the actuator movable relative to the body, “the movement relative to the body” moving the first jaw to perform at least one of pinching or unpinching the EMD, as the Applicant notes that Godlewski discloses that the clamping motion is caused “as chuck 36 [body] slides along collet 28 [jaw]” when “further proximal motion of actuator 58 [actuator] will not move advancer 20” because the advancer 20 contacts housing 16 [Godlewski Col 5:15-34] and that the releasing is caused when “further distal motion of actuator 58 will cause chuck 36 to slide relative to now-stationary collect 28” because the further distal movement of the collect is limited by spacer 66, such that Godlewski discloses that the motion of the chuck with respect to the collet, when the collet and advancer are rendered stationary from contact with the housing 16 or the spacer 66 causes the clamping and releasing. However, the Examiner notes that Applicant’s arguments with respect to claim(s) 1, 15, and 20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Chrisman in view of Kokish is applied to teach the subject matter of claim 1 [and Chrisman in view of Kokish and Wienhold is applied to teach the similar subject matter of claims 15 and 20], wherein Chrisman is considered to teach the argued limitation [Chrisman ¶0020].
The Applicant disagrees with the previously applied motivation to combine Godlewski in view of Kokish with Wienhold [Non-Final Rejection dated 26 May 2026, p. 5], as Wienhold discloses a spring “between the foot 46 of each of the adjustable jaws 16 and the internal side 72 of the shroud 17” [Wienhold Col 4:29-39], which the Applicant notes defines a spring biasing features relative to one another by contacting both features, wherein the Applicant notes that as Godlewski discloses that the actuator 58 functions to clamp and release the collet based on moving the actuator and chuck with respect to the collet, when the collet is immobilized from contact with the housing 16 and the spacer 66, the inclusion of a biasing member to bias the chuck with respect to the collet would change the principle of operation of Godlewski from releasing the collet grip based on moving the chuck relative to the collet at the distal end of the actuator’s range of motion. However, the Examiner notes that Applicant’s arguments with respect to claim(s) 1, 15, and 20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Regarding claim 10, the Applicant asserts that based on the above-given reasons presented by the Applicant as to why a valid prima facie case of obviousness over Godlewski in view of Kokish and Wienhold cannot be established with respect to claim 1, a valid prima facie case of obviousness over Godlewski in view of Kokish and Wienhold cannot be established with respect to claim 10. The Applicant further asserts that the Office Action fails to establish that Chrisman remedies the deficiencies of Godlewski in view of Kokish. However, the Examiner notes that Applicant’s arguments with respect to claim(s) 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Chrisman in view of Kokish is applied to teach the subject matter of claim 1, wherein the Examiner notes that while Godlewski is applied in the rejection of claim 2 [from which claim 10 depends from], the argued subject matter of Godlewski is not specifically applied in the rejection of claims 2 or 10.
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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/SEVERO ANTONIO P LOPEZ/Examiner, Art Unit 3791
