DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Interpretation
Examiner Notes: currently, NO limitation invokes interpretation under § 112(f).
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(s) 2, 14, 19, and those dependent therefrom is/are 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 2 recites the term “modulus” [lines 4, 5], which is considered indefinite, as the Examiner notes that there is no language in claim 2 to explicitly define which or what “modulus” is being referred to. For examination purposes, the Examiner has interpreted the “modulus” to refer to an elastic modulus. The Examiner notes that claims 14 and 19 recite similarly indefinite subject matter that is interpreted similar to claim 2 mutatis mutandis.
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) 1-9 and 11-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Godlewski (US-5350101-A, cited by Applicant) in view of Kokish (US-20150297864-A1, cited by Applicant) and Wienhold (US-6260857-B1, cited by Applicant).
Regarding claim 1, Godlewski teaches
A torquer for an elongated medical device:
a body having a cavity defining a pathway [rigid chuck 36 (Godlewski Figs. 2-3), wherein as depicted in Figs. 2-3, the rigid chuck 36 has a cavity and pathway therethrough];
a first jaw movable within the cavity [tapered portion 34a (Godlewski Figs. 2-4); a substantially rigid chuck 36 which surrounds collet 28 and which is axially movable relative to advancer 20. As shown in FIG. 2, each tapered portion 34a, b can be formed with steps 35 to provide an audible indication of chuck 36 sliding relative to collet 28 to indicate that chuck 36 has gripped collet 28 (Godlewski Col 4:11-17, Figs. 2-4)];
an actuator movable relative to the body moving the first jaw pinching and/or unpinching the elongated medical device within the pathway [further proximal motion of actuator 58 will not move advancer 20 but will instead cause chuck 36 to slide along the tapered portions 34 of collet segments 30 to thereby clamp collet 28 around tube 12 (Godlewski Col 5:15-18, Figs. 2-3)].
However, Godlewski fails to explicitly disclose the first jaw including a first pad having a compliant property, wherein the elongated medical device is pinched 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 Godlewski to employ the first jaw including a first pad having a compliant property, wherein the elongated medical device is pinched 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.
However, while Godlewski discloses wherein the first jaw may be biased relative to the body [Once unconstrained by chuck 36, collet segments 30a, b resiliently retract from tube 12 to their normal, biased position shown in FIG. 3 to release the grip of collet 28 on tube 12], the combination of Godlewski in view of Kokish fails to explicitly disclose a biasing member separate from the first jaw biasing the first jaw relative to the body.
Wienhold discloses similarly functional systems to Godlewski and Kokish for pinching an elongate device using jaws movable within a body, wherein Wienhold discloses a biasing member separate from a first jaw biasing the first jaw relative to the body [A compression spring 80 is axially disposed in the cavity 70 created by the shroud 17. The spring 80 is mounted between the foot 46 of each of the adjustable jaws 16 and the internal side 72 of the shroud 17… Spring 80 urges the jaws 16 axially toward the hub end 22 of the spindle 12 and into the tool bore 32, and also forces the sleeve 14 towards the hub end 22 (the clamping position) of the spindle 12 (Wienhold Col 4:29-39)].
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 Godlewski in view of Kokish to employ a biasing member separate from the first jaw biasing the first jaw relative to the body, so as to prevent accidental unpinching of the elongated medical device by the first jaw.
Regarding claim 2, Godlewski in view of Kokish and Wienhold teaches
The torquer of claim 1, wherein the first pad is formed from an elastomeric material [Kokish ¶0084] and further including at least a second jaw movable relative to the body toward the first jaw [tapered portion 34b (Godlewski Col 4:11-17, Figs. 2-4)], the second jaw having a second pad formed from an elastomeric material [Kokish ¶0072; wherein the § 103 modification to the first jaw to include a first pad having a compliant property would be similarly applicable to the second jaw to employ a second pad formed from an elastomeric material mutatis mutandis], wherein each jaw includes a pad base [wherein the tapered portions 34a,b are considered to define the pad base (see Godlewski Figs. 2-4)] having a first modulus that is greater than a second modulus of the first and second pads [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); wherein the pad bases comprising metal/hard plastic (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 3, Godlewski in view of Kokish and Wienhold teaches
The torquer of claim 2, wherein each jaw is free to pivot about a cam surface on the body independent of one another [As shown in FIG. 2, each tapered portion 34a, b can be formed with steps 35 to provide an audible indication of chuck 36 sliding relative to collet 28 to indicate that chuck 36 has gripped collet 28 (Godlewski Col 4:13-17), wherein as depicted in Figs. 203, each jaw pivots in the depicted plane of the figures as each jaw slides along the cam surface of the body (see Annotated Fig. 1), wherein based off of the modification in view of Wienhold wherein the jaws are not connected, the movement of one jaw is not considered to specifically result in movement of the other jaw].
PNG
media_image1.png
362
650
media_image1.png
Greyscale
Annotated Fig. 1. Figure 2 of Godlewski has been annotated to indicate the cam surface of the body.
However, Godlewski in view of Kokish and Wienhold fails to explicitly disclose wherein the jaws are not connected to one another.
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 Godlewski in view of Kokish and Wienhold 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 Godlewski as connected in Figs. 2-4] for another [non-connection between jaws of Wienhold] with similar expected results [MPEP § 2143(I)(B)].
Regarding claim 4, Godlewski in view of Kokish 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 [Godlewski Figs. 2-3; wherein based on the § 103 modification above, the pads of each jaw move radially away from the claimed axis as the jaw pivots about the cam surface (see Annotated Fig. 1)].
Regarding claim 5, Godlewski in view of Kokish and Wienhold teaches
The torquer of claim 2, wherein the body includes a cam surface contacting a nonlinear follower surface on each pad base [see Annotated Fig. 1, wherein the steps 35 (Godlewski Col 4:13-17) are considered to define a non-linear follower surface of each pad base].
Regarding claim 6, Godlewski in view of Kokish and Wienhold teaches
The torquer of claim 5, wherein the follower surface is arcuate [wherein as depicted in Godlewski Fig. 4, at least portions of the collet 28 that are configured to interact with the cam surface (see Annotated Fig. 1) are considered to be arcuate as the collet is round].
Regarding claim 7, Godlewski in view of Kokish and Wienhold teaches
The torquer of claim 6, wherein the cam surface is linear [see Annotated Fig. 1].
Regarding claim 8, Godlewski in view of Kokish and Wienhold 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 [Further, due to the flexibility of each segments 30 collet 28 is capable of gripping various sizes of stock with substantially equal force (Godlewski Col 4:2-5); Kokish ¶0072].
Regarding claim 9, Godlewski in view of Kokish and Wienhold teaches
The torquer of claim 2, wherein the biasing member biases the pads toward one another [Wienhold Col 4:29-39].
Regarding claim 11, Godlewski in view of Kokish and Wienhold 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 [Wienhold Col 4:29-39].
Regarding claim 12, Godlewski in view of Kokish and Wienhold 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 [Godlewski Figs. 2-3].
Regarding claim 13, Godlewski in view of Kokish and Wienhold teaches
The torquer of claim 1.
However, while Godlewski discloses wherein the pathway can accommodate elongated medical devices of a wide range of diameters [a stock feeder device which can grip and advance stock which has a wide range of diameters (Godlewski Col 1:64-66)], Godlewski in view of Kokish and Wienhold as presently modified fails to explicitly disclose wherein the pathway can an accommodate 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 Godlewski in view of Kokish and Wienhold to employ wherein the pathway can an 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)].
Regarding claim 14, Godlewski in view of Kokish and Wienhold teaches
The torquer of claim 2.
However, Godlewski in view of Kokish and Wienhold do not 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 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.
There is no evidence of record that establishes that changes to the pads and pad bases taught by the combination of Godlewski 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 Godlewski 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 Godlewski 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 Godlewski 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 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.
Regarding claim 15, Godlewski teaches
A torquer releasably pinching an elongated medical device, comprising:
a body having a cavity defining a pathway [rigid chuck 36 (Godlewski Figs. 2-3), wherein as depicted in Figs. 2-3, the rigid chuck 36 has a cavity and pathway therethrough];
at least two jaws movable within the cavity, each jaw having a pad base [tapered portions 34a, b (Godlewski Figs. 2-4); a substantially rigid chuck 36 which surrounds collet 28 and which is axially movable relative to advancer 20. As shown in FIG. 2, each tapered portion 34a, b can be formed with steps 35 to provide an audible indication of chuck 36 sliding relative to collet 28 to indicate that chuck 36 has gripped collet 28 (Godlewski Col 4:11-17, Figs. 2-4), wherein the tapered portions 34a,b are considered to define the pad bases themselves];
a knob movable relative to the body moving the jaws relative to one another pinching or unpinching the elongated medical device within the pathway [further proximal motion of actuator 58 will not move advancer 20 but will instead cause chuck 36 to slide along the tapered portions 34 of collet segments 30 to thereby clamp collet 28 around tube 12 (Godlewski Col 5:15-18, Figs. 2-3), wherein the actuator 58 being rounded as depicted in Godlewski Fig. 1 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, Godlewski fails to explicitly disclose each jaw having a pad secured to the pad base, wherein the elongated medical device is pinched or unpinched by 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 Godlewski to employ the first jaw including a first pad having a compliant property, wherein the elongated medical device is pinched 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.
However, while Godlewski discloses wherein the first jaw may be biased relative to the body [Once unconstrained by chuck 36, collet segments 30a, b resiliently retract from tube 12 to their normal, biased position shown in FIG. 3 to release the grip of collet 28 on tube 12], the combination of Godlewski in view of Kokish fails to explicitly disclose fails to explicitly disclose a biasing member separate from the jaws biasing the jaws relative to the body; and wherein the jaws are not connected to one another.
Wienhold discloses similarly functional systems to Godlewski and Kokish for pinching an elongate device using jaws movable within a body, wherein Wienhold discloses a biasing member separate from a first jaw biasing the first jaw relative to the body [A compression spring 80 is axially disposed in the cavity 70 created by the shroud 17. The spring 80 is mounted between the foot 46 of each of the adjustable jaws 16 and the internal side 72 of the shroud 17… Spring 80 urges the jaws 16 axially toward the hub end 22 of the spindle 12 and into the tool bore 32, and also forces the sleeve 14 towards the hub end 22 (the clamping position) of the spindle 12 (Wienhold Col 4:29-39)]. Wienhold further 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 Godlewski in view of Kokish to employ a biasing member separate from the jaws biasing the jaws relative to the body, so as to prevent accidental unpinching of the elongated medical device by the first jaw. It also 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 Godlewski 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 Godlewski as connected in Figs. 2-4] for another [non-connection between jaws of Wienhold] with similar expected results [MPEP § 2143(I)(B)].
Regarding claim 16, Godlewski 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 [see Annotated Fig. 1, wherein the steps 35 (Godlewski Col 4:13-17) are considered to define a non-linear follower surface of each pad base].
Regarding claim 17, Godlewski 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 [As shown in FIG. 2, each tapered portion 34a, b can be formed with steps 35 to provide an audible indication of chuck 36 sliding relative to collet 28 to indicate that chuck 36 has gripped collet 28 (Godlewski Col 4:13-17), wherein as depicted in Figs. 203, each jaw pivots in the depicted plane of the figures as each jaw slides along the cam surface of the body (see Annotated Fig. 1), wherein based off of the modification in view of Wienhold wherein the jaws are not connected, the movement of one jaw is not considered to specifically result in movement of the other jaw].
Regarding claim 18, Godlewski in view of Kokish and Wienhold teaches
The torquer of claim 17, wherein pressure between the pads and the elongated medical device is substantially equalized along an entire length of the 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 [Further, due to the flexibility of each segments 30 collet 28 is capable of gripping various sizes of stock with substantially equal force (Godlewski Col 4:2-5); Kokish ¶0072].
Regarding claim 19, Godlewski in view of Kokish and Wienhold teaches
The torquer of claim 15.
However, Godlewski in view of Kokish and Wienhold do not 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 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.
There is no evidence of record that establishes that changes to the pads and pad bases taught by the combination of Godlewski 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 Godlewski 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 Godlewski 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 Godlewski 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 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.
Regarding claim 20, Godlewski teaches
A torquer releasably engaging an elongated medical device, comprising:
a body having a cavity defining a pathway [rigid chuck 36 (Godlewski Figs. 2-3), wherein as depicted in Figs. 2-3, the rigid chuck 36 has a cavity and pathway therethrough];
at least two jaws movable within the cavity [tapered portions 34a, b (Godlewski Figs. 2-4); a substantially rigid chuck 36 which surrounds collet 28 and which is axially movable relative to advancer 20. As shown in FIG. 2, each tapered portion 34a, b can be formed with steps 35 to provide an audible indication of chuck 36 sliding relative to collet 28 to indicate that chuck 36 has gripped collet 28 (Godlewski Col 4:11-17, Figs. 2-4), wherein the tapered portions 34a,b are considered to define the pad bases themselves];
a knob movable relative to the body moving the jaws relative to one another pinching or unpinching the elongated medical device within the pathway [further proximal motion of actuator 58 will not move advancer 20 but will instead cause chuck 36 to slide along the tapered portions 34 of collet segments 30 to thereby clamp collet 28 around tube 12 (Godlewski Col 5:15-18, Figs. 2-3), wherein the actuator 58 being rounded as depicted in Godlewski Fig. 1 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, Godlewski fails to explicitly disclose each jaw having a pad secured to the pad base, wherein the elongated medical device is pinched or unpinched by the pads; 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 Godlewski to employ each jaw having a pad secured to the pad base, wherein the elongated medical device is pinched or unpinched by the pads; 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.
However, while Godlewski discloses wherein the first jaw may be biased relative to the body [Once unconstrained by chuck 36, collet segments 30a, b resiliently retract from tube 12 to their normal, biased position shown in FIG. 3 to release the grip of collet 28 on tube 12], the combination of Godlewski in view of Kokish fails to explicitly disclose fails to explicitly disclose a biasing member separate from the jaws biasing the jaws relative to the body; and wherein the jaws are not connected to one another.
Wienhold discloses similarly functional systems to Godlewski and Kokish for pinching an elongate device using jaws movable within a body, wherein Wienhold discloses a biasing member separate from a first jaw biasing the first jaw relative to the body [A compression spring 80 is axially disposed in the cavity 70 created by the shroud 17. The spring 80 is mounted between the foot 46 of each of the adjustable jaws 16 and the internal side 72 of the shroud 17… Spring 80 urges the jaws 16 axially toward the hub end 22 of the spindle 12 and into the tool bore 32, and also forces the sleeve 14 towards the hub end 22 (the clamping position) of the spindle 12 (Wienhold Col 4:29-39)]. Wienhold further 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 Godlewski in view of Kokish to employ a biasing member separate from the jaws biasing the jaws relative to the body, so as to prevent accidental unpinching of the elongated medical device by the first jaw. It also 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 Godlewski 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 Godlewski as connected in Figs. 2-4] for another [non-connection between jaws of Wienhold] with similar expected results [MPEP § 2143(I)(B)].
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gill (US-20200398031-A1, cited by Applicant) in view of Kokish (US-20150297864-A1, cited by Applicant).
Regarding claim 10 [written in long-hand format to incorporate the subject matter of claims 1-2 therein], Gill teaches
A torquer for an elongated medical device:
a body having a cavity defining a pathway [cap 16 (Gill Figs. 3, 8), wherein as depicted in Figs. 3 and 8, the cap 16 has a cavity and a pathway for guidewire 12];
a first jaw movable within the cavity [a finger of fingers 24 (Gill Figs. 3-4, 7A-B); The collet 22 has a plurality of longitudinally extending fingers 24 that are spring biased towards an open position 26. When the fingers are in a compressed and closed position 28, the fingers will grip the guidewire 12 and securely retain it for manipulation and advancing into the vascular system… As the collet 22 continues to move distally, the second tapered face 50 engages and slides along the tapered surface 56 of the cap 16 which in turn compresses the plurality of fingers 24 onto the guidewire, thereby gripping the guidewire 12 so that the torque device can move the guidewire without sliding along the longitudinal surface of the guidewire (Gill ¶0042)];
a biasing member separate from the first jaw biasing the first jaw relative to the body [The collet 22 has a plurality of longitudinally extending fingers 24 that are spring biased towards an open position 26 (Gill ¶0042), wherein the fingers 24 being movable distally and proximally relative to the body between a closed and open position is considered to read the spring biasing the first jaw relative to the body]; and
an actuator movable relative to the body moving the first jaw pinching and/or unpinching the elongated medical device within the pathway [When the control lever 30 is moved to the closed position 34, a cam 38 on the distal end 40 of the control lever moves into engagement with a proximal end 42 of the tubular sleeve 36 thereby moving the tubular sleeve distally toward the cap 16… As the tubular sleeve 36 moves distally, a distal end 46 of the tubular sleeve 36 engages the collet 22… thereby forcing the collet to move distally… As the collet 22 continues to move distally, the second tapered face 50 engages and slides along the tapered surface 56 of the cap 16 which in turn compresses the plurality of fingers 24 onto the guidewire, thereby gripping the guidewire 12 so that the torque device can move the guidewire without sliding along the longitudinal surface of the guidewire (Gill ¶0042)];
further including at least a second jaw movable relative to the body toward the first jaw [a different finger of fingers 24 from the finger identified as the first jaw (Gill Figs. 3-4, 7A-B)], wherein each jaw includes a pad base [wherein each finger of fingers 24 itself is considered to define a pad base];
wherein the biasing member biases the pads away from one another [Gill ¶0042].
However, while it is understood that the fingers 24 of Gill are considered to be made of a material, Gill fails to explicitly disclose within the same embodiment that the fingers 24 are made of a certain material, such that the pad base of each jaw has a first modulus.
Gill discloses in separate embodiments that a collet for use in a torquer to grip a guide wire [wherein a collet is understood to comprise fingers] may comprise a metal or polymer [The first collet 122 and the second collet 126 are formed from any metal or polymer that will not damage the guidewire, and preferably are made from brass (Gill ¶0045)].
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 Gill to employ wherein the pad bases comprise metal, such that the pad base of each jaw has a first modulus, as this modification would amount to mere simple substitution of one known element for another [material to comprise a collet to grip an elongated medical device] with similar expected results [MPEP § 2143(I)(B)].
However, Gill fails to explicitly disclose the first jaw including a first pad having a compliant property, wherein the first jaw pinches and/or unpinches the elongated medical device with the first pad; wherein the first pad is formed from an elastomeric material, and the second jaw having a second pad formed from an elastomeric material; and wherein the first modulus is greater than a second modulus of the first and second 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 Gill to employ the first jaw including a first pad having a compliant property, wherein the elongated medical device is pinched with the first pad; wherein the first pad is formed from an elastomeric material, and the second jaw having a second pad formed from an elastomeric material, so as to allow for a secure grip of the elongate medical device, while preventing damage to the elongate medical device. Based on the modification of Gill by subject matter as taught by Kokish, the first modulus is greater than a second modulus of the first and second pads [wherein the pad bases comprising metal 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].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEVERO ANTONIO P LOPEZ whose telephone number is (571)272-7378. The examiner can normally be reached M-F 9-6 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Marmor II can be reached at (571) 272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SEVERO ANTONIO P LOPEZ/Examiner, Art Unit 3791
Prosecution Insights