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
The Applicant filed Amendments to the Claims and Remarks on January 20, 2026 in response to the Examiner’s Final Office Action, mailed October 28, 2025.
Amendments to the Claims
At this time, claims 1-20 are pending. Claims 1, 17, and 18 have been amended. Claims 19 and 20 have been withdrawn. The Applicant has added no new claims. The Applicant asserts that no new matter is added. (Remarks, pg. 8)
However, the Examiner disagrees to assertions that no new matter is added and, further, that such amendments to claims 1, 17, and 18 can be supported by paras. [0064]-[0066] of the Specification and Fig. 2 of the Drawings. This has been discussed further in a section below.
Claim Rejections - 35 U.S.C. § 102 and 103
Applicant’s arguments, see Remarks, pg. 8-19, filed January 20, 2026, with respect to the rejections of claims 1-18 under 35 U.S.C. § 102 and 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 Therefore, the rejection has been withdrawn.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 Yu, Kokish, and Bian (cited below).
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on January 20, 2026 has been entered.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 1, the claim limitations as amended include terms such as “relay delivery”, “first delivery phase, and “second delivery phase”. The Applicant claims that these amendments “can be supported by paragraphs [0064]-[0066] of the originally filed specification and FIG. 2 of the originally filed drawings.” (Remarks, pg. 8) The Examiner disagrees that such terms are supported by the mentioned paragraphs of the specification, nor any additional paragraphs. Figure 2 of the Drawings does not convincingly support these amendments either. Dependent claims 2-16 inherit the same deficiencies.
Regarding claims 17 and 18, each independent claim as amended includes the limitation of “the front clamper is arranged outside the body”. The Examiner disagrees that such terms are supported by the mentioned paragraphs of the specification, nor any additional paragraphs. Figure 2 of the Drawings does not convincingly support these amendments either.
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.
Claims 1-4 and 6-18 are rejected under 35 U.S.C. 103 as being unpatentable over Yu (US 2014/0276391) in view of Kokish et al. (US 9408669 B2, hereinafter referred to as Kokish).
Regarding amended, independent claim 1, Yu discloses a catheter insertion system. Yu further discloses a slave-end apparatus for an interventional robot (robotic instrument driver or catheter insertion system 102 in Figs. 2 and 3; [0015]: “System 100 includes a robotic instrument driver or catheter insertion system 102…”), comprising:
a body (base 108 in Fig. 1 and 2), a first drive mechanism (first carriage 312 in Fig. 3), a second drive mechanism (carriage 104 and associated active drive mechanism 320 in Fig. 3) proximal to the first drive mechanism that are successively mounted on the body;
wherein the first drive mechanism is configured to clamp and rotate (clamping via manipulation mechanism of sheath carriage 104 and leader carriage 106; rotating on yaw angle 304, 310 about axes 128, 308 in Fig. 3; [0022]) a first catheter ([0022]: “Elongate member 122 extends between carriages 104, 106 and passes through carriage 104 within sheath 130. More generally, catheter or elongate member(s) 302 extend from sheath carriage 104 and catheter 302 may include, as an example, an outer sheath or catheter, an inner catheter, and a guidewire.”) and a second catheter ([0026]: “The second carriage 104 is configured for inserting, retracting or rolling a second elongate member such as an inner catheter”), and the second drive mechanism is configured to clamp and rotate (clamping via manipulation mechanism of sheath carriage 104 and leader carriage 106; rotating on yaw angle 304, 310 about axes 128, 308 in Fig. 3; [0022]) a first guide wire and a second guide wire ([0019]: “An elongate member 122 that may include an inner catheter and/or guidewire extends between sheath carriage 104 and leader carriage 106, and generally along a length direction 124 for bed 110.”; [0026]: “That is, assembly 102 may be a robotic instrument driver 102 for driving one or more elongate members… third carriage 106 is configured in another example to insert, retract or roll a third elongate member that may be, for instance, a guidewire.”); and
during a first delivery phase, the first guidewire is inserted into the first catheter, the first drive mechanism and the second drive mechanism are configured to respectively clamp and cooperatively advance the first catheter and the first guidewire to a target position along an axial direction of the body (see axis 300 in Fig. 3; [0019]: “Carriages 104, 106 are also each moveable along rail 120 and along direction 124, which in one embodiment is defined also as an advancement axis for elongate elements of the catheter.”; [0022]: “Each carriage 104, 106 is moveable 300 axially with respect to the other, as well as with respect to rail 120.”); and
during a second delivery phase, the first drive mechanism is configured to clamp and advance the second catheter to guide the second catheter into the first catheter ([0022]: “…catheter 302 may include, as an example, an outer sheath or catheter, an inner catheter, and a guidewire.”), and the second drive mechanism is configured to clamp and advance the second guidewire to guide the second guidewire into the second catheter ([0022]).
Yu is silent to a front clamper proximal to the first drive mechanism that are successively mounted on the body; and
the front clamper [is] configured to perform relay delivery of the first catheter, the second catheter, the first guide wire, and the second guide wire, wherein:
subsequently, during a handover phase, the first drive mechanism and the second drive mechanism are configured to release the first catheter and the first guidewire respectively, while the front clamper is configured to clamp the first catheter; and
during a second delivery phase, the front clamper is configured to clamp the first catheter to prevent the first catheter from moving along the axial direction.
However, Kokish teaches a robotically controlled surgical system. Kokish further teaches a front clamper (dynamic gripper 440 in Fig. 4-9) proximal to the first drive mechanism that are successively mounted on the body; and
…the front clamper [is] configured to perform relay delivery of the first catheter, the second catheter, the first guide wire, and the second guide wire ([col. 5, li. 12-18]), wherein:
subsequently, during a handover phase, the first drive mechanism and the second drive mechanism are configured to release the first catheter and the first guidewire respectively ([col. 5, li. 35-42]: “Accordingly, upon reaching a limit to the range of motion, i.e., at an axially furthest position in one direction, the dynamic grippers 440 generally release the elongate member, move back in an opposite direction, and re-grip the elongated member for continued axial movement. While the dynamic grippers 440 are not gripping the elongated member, the static grippers 442 may hold the elongated member in place to prevent movement or loss of position.”; note that the static grippers 442 work in conjunction with dynamic grippers 440 to prevent such a movement in an axial direction.), while the front clamper is configured to clamp the first catheter ([col. 5, li. 26-28]: “The grippers 440, 432 may generally work in sequence such that at least one of the grippers 440, 432 is gripping the elongate member at any given time.”); and
during a second delivery phase, the front clamper is configured to clamp the first catheter to prevent the first catheter from moving along the axial direction ([col. 5, li. 39-42]: “While the dynamic grippers 440 are not gripping the elongated member, the static grippers 442 may hold the elongated member in place to prevent movement or loss of position.”; note that the static grippers 442 work in conjunction with dynamic grippers 440 to prevent such a movement in an axial direction.).
Kokish is of a similar field of pursuit to Yu and the instant application in being a system for controlling catheter insertion. It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the invention of Yu to include a front clamper in order to assist in performing the delivery phases of the amended claim 1 and to more effectively manipulate the guidewires and catheters to ensure proper placement within the patient.
Regarding claim 2, in view of the Yu/Kokish combination, Yu is silent to a plurality of front clampers;
wherein a plurality of first catheters one-by-one pushed by the first drive mechanism to desired positions are respectively clamped by the plurality of front clampers.
However, Kokish teaches a plurality of front clampers (clamps 445, 447 in Figs. 4-9); wherein a plurality of first catheters ([col. 4, li. 39-40]: “…may each selectively clamp an elongate member, e.g., a guidewire or catheter…”) one-by-one pushed by the first drive mechanism to desired positions are respectively clamped by the plurality of front clampers ([col. 4, li. 36-41]: “Each of the grippers 440, 442 may comprise a clamp 445, 447 having a pair of opposing pads 444 a, 444 b and 446 a, 446 b, respectively. Accordingly, the grippers 440, 442 may each selectively clamp an elongate member, e.g., a guidewire or catheter, between their respective opposing pads 444 a, 444 b and 446 a, 446 b.”).
Kokish is of a similar field of pursuit to Yu and the instant application in being a system for controlling catheter insertion. It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the invention of Yu to include a plurality of front clampers in order to more effectively manipulate the guidewires and catheters to ensure proper placement within the patient.
Regarding claim 3, in view of the Yu/Kokish combination, Yu discloses that the second drive mechanism is configured to clamp and rotate (clamping via manipulation mechanism of sheath carriage 104 and leader carriage 106; rotating on yaw angle 304, 310 about axes 128, 308 in Fig. 3; [0022]), together with the first drive mechanism, the first catheter and the second catheter ([0026]: “The second carriage 104 is configured for inserting, retracting or rolling a second elongate member such as an inner catheter”).
Regarding claim 4, in view of the Yu/Kokish combination, Yu discloses that the second drive mechanism (carriage 104 and associated active drive mechanism 320 in Fig. 3) comprises:
a first assembly configured to clamp and rotate (clamping via manipulation mechanism of sheath carriage 104 and leader carriage 106; rotating on yaw angle 304, 310 about axes 128, 308 in Fig. 3; [0022]) the first catheter and the second catheter ([0023]: “The sheath carriage 104 and leader carriage 106 (or pods) may contain an articulation mechanism for steering the pullwires of a catheter (not shown) and a manipulation mechanism for inserting, retracting and rolling an elongate member.”), and a second assembly configured to clamp and rotate (clamping via manipulation mechanism of sheath carriage 104 and leader carriage 106; rotating on yaw angle 304, 310 about axes 128, 308 in Fig. 3; [0022]) the first guide wire and the second guide wire ([0019]: “An elongate member 122 that may include an inner catheter and/or guidewire extends between sheath carriage 104 and leader carriage 106, and generally along a length direction 124 for bed 110.”; [0026]: “That is, assembly 102 may be a robotic instrument driver 102 for driving one or more elongate members… third carriage 106 is configured in another example to insert, retract or roll a third elongate member that may be, for instance, a guidewire.”).
Regarding claim 6, in view of the Yu/Kokish combination, Yu is silent to that the second assembly is a slave-end guide wire and catheter twisting apparatus for the interventional robot.
However, Kokish teaches that the second assembly is a slave-end guide wire and catheter twisting apparatus for the interventional robot ([col. 4, li. 19-22]: “Additionally, the instruments 109 may generally insert and rotate the associated elongate member, i.e., the guidewire and catheter sheath, independently, as described above regarding the instruments 104, 106.”).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the system of Yu to include a slave-end guide wire and catheter twisting apparatus as defined by Kokish clampers in order to more effectively manipulate the guidewires and catheters to ensure proper placement within the patient.
Regarding claim 7, in view of the Yu/Kokish combination, Yu is silent to a rear clamper; wherein in a case that the second drive mechanism moves to a boundary position within a predefined degrees of freedom, and is to be restored to release the second guide wire, the rear clamper is configured to clamp the second guide wire to prevent movement thereof.
However, Kokish teaches a rear clamper (grippers 432 in Figs. 6 and 8); wherein in a case that the second drive mechanism moves to a boundary position within a predefined degrees of freedom, and is to be restored to release the second guide wire, the rear clamper (grippers 432 in Figs. 6 and 8) is configured to clamp the second guide wire to prevent movement thereof ([col. 5, li. 27-28]: “…at least one of the grippers 440, 432 is gripping the elongate member at any given time.”; [col. 5, li. 32-42]: “A range of axial motion associated with the dynamic grippers 440 may be …be limited to a predetermined axial distance D… upon reaching a limit to the range of motion… the dynamic grippers 440 generally release the elongate member, move back in an opposite direction, and re-grip the elongated member for continued axial movement. While the dynamic grippers 440 are not gripping the elongated member, the static grippers 442 may hold the elongated member in place to prevent movement or loss of position.”).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the Yu/Kokish combination to include a rear clamper to provide more control over the manipulation of the guide wires associated. Additionally, it would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the Yu/Kokish combination to include this control mechanism to prevent danger to the patient from the system exceeding thresholds.
Regarding claim 8, in view of the Yu/Kokish combination, Yu is silent to that the front clamper and the rear clamper are respectively positioned at a front portion and a rear portion of the body;
wherein the front clamper and the rear clamper are both mounted on the body and movable relative to the body; or
one of the front clamper and the rear clamper is mounted on the body and movable relative to the body, and the other of the front clamper and the rear clamper is mounted separately from the body; or
the front clamper and the rear clamper are both mounted separately from the body.
However, Kokish teaches that the front clamper and the rear clamper (grippers 432 in Figs. 6 and 8) are respectively positioned at a front portion and a rear portion of the body (see Fig. 8);
wherein the front clamper and the rear clamper (grippers 432 in Figs. 6 and 8) are both mounted on the body and movable relative to the body; or
one of the front clamper and the rear clamper (grippers 432 in Figs. 6 and 8) is mounted on the body and movable relative to the body, and the other of the front clamper and the rear clamper is mounted separately from the body ([col. 4, li. 30-32]: “…moveable component 440. In the illustrated example, the moveable component 440 is a dynamic gripper 440.”); or
the front clamper and the rear clamper (grippers 432 in Figs. 6 and 8) are both mounted separately from the body.
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the invention of Yu to include the front and rear clampers of Kokish in one of the configurations defined above to provide more control over the manipulation of the catheters and guide wires associated.
Regarding claim 9, in view of the Yu/Kokish combination, Yu discloses a third drive mechanism ([0026]: “…a third carriage, such as carriage 106…”) mounted on the body (base 108 in Fig. 1 and 2); wherein the third drive mechanism is configured to clamp and rotate (clamping via manipulation mechanism of sheath carriage 104 and leader carriage 106; rotating on yaw angle 304, 310 about axes 128, 308 in Fig. 3; [0022]), together with the first drive mechanism, the first catheter and the second catheter ([0026]: “Further, third carriage 106 is configured in another example to insert, retract or roll a third elongate member that may be, for instance, a guidewire.”).
Regarding claim 10, in view of the Yu/Kokish combination, Yu discloses the first drive mechanism (active drive member 312 in Fig. 3), the first catheter (elongate member 122 in Fig. 3) and the second catheter ([0026]: “…a second elongate member such as an inner catheter”), and the third drive mechanism (carriage 106 and associated active drive mechanism 314 in Fig. 3).
However, Yu is silent to in a case that the first drive mechanism moves to a boundary position within a predefined degrees of freedom and is to be restored to release the first catheter and the second catheter, the third drive mechanism is configured to clamp the first catheter and the second catheter to prevent movement thereof.
Kokish teaches in a case that the first drive mechanism moves to a boundary position within a predefined degrees of freedom and is to be restored to release the first catheter and the second catheter, the third drive mechanism is configured to clamp the first catheter and the second catheter to prevent movement thereof ([col. 5, li. 32-42]: “A range of axial motion associated with the dynamic grippers 440 may be …be limited to a predetermined axial distance D… upon reaching a limit to the range of motion… the dynamic grippers 440 generally release the elongate member, move back in an opposite direction, and re-grip the elongated member for continued axial movement. While the dynamic grippers 440 are not gripping the elongated member, the static grippers 442 may hold the elongated member in place to prevent movement or loss of position.”; the grippers 440, 442 are components of the overall drive mechanism invention of Kokish.).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the Yu/Kokish combination to include this control mechanism to prevent danger to the patient from the system exceeding thresholds.
Regarding claim 11, in view of the Yu/Kokish combination, Yu discloses that the third drive mechanism ([0026]: “…a third carriage, such as carriage 106…”) move along the same axial direction as the first drive mechanism and the second drive mechanism (see axis 300 in Fig. 3; [0019]: “Carriages 104, 106 are also each moveable along rail 120 and along direction 124, which in one embodiment is defined also as an advancement axis for elongate elements of the catheter.”; [0022]: “Each carriage 104, 106 is moveable 300 axially with respect to the other, as well as with respect to rail 120.”).
Regarding claim 12, in view of the Yu/Kokish combination, Yu discloses that the third drive mechanism is positioned between the first drive mechanism and the second drive mechanism.
Yu does not disclose the third drive mechanism is positioned between the first drive mechanism and the second drive mechanism.
However, Yu does teach a first drive mechanism (active drive mechanism 312 in Fig. 3), a second drive mechanism (carriage 104 and associated active drive mechanism 320 in Fig. 3), and a third drive mechanism (carriage 106 and associated active drive mechanism 314 in Fig. 3). It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention that the components of the Yu/Kokish combination could be rearranged to the orientation of Yu and still accomplish the similar goal of effectively manipulating the catheters and guidewires to aid in proper placement.
Regarding claim 13, in view of the Yu/Kokish combination, Yu discloses that the first drive mechanism, the second drive mechanism and the third drive mechanism are all active drive mechanisms ([0024]: “Thus, as shown in FIG. 3, robotic instrument driver 102 includes carriage 104 and its corresponding active drive mechanism 314, carriage 106 and its corresponding active drive mechanism 320 and active drive mechanism 312 that is directly coupled and stationary with respect to rail 120 via a support 322… Similarly, active drive mechanism 320, in one embodiment may be attached to carriage 106 to manipulate a guidewire that passes through the center of, and is part of, catheter 302.”).
Regarding claim 14, in view of the Yu/Kokish combination, Yu discloses that the first drive mechanism and the second drive mechanism are active drive mechanisms ([0024]: “Thus, as shown in FIG. 3, robotic instrument driver 102 includes carriage 104 and its corresponding active drive mechanism 314, carriage 106 and its corresponding active drive mechanism 320 and active drive mechanism 312 that is directly coupled and stationary with respect to rail 120 via a support 322.”), and the third drive mechanism is a passive drive mechanism ([0027]: “Referring to FIG. 4, a scissors-like mechanism may be placed onto catheter 302. The scissors-like mechanism may be a collapsible passive mechanism fabricated from, for instance, plastic or metal, and of such a mass that the catheter extends therethrough with a scissors-action. The mechanism may be positioned between sheath carriage 104 and the patient access site 132 as mechanism 400, and/or between carriages 104, 106 as mechanism 402.”).
Regarding claim 15, in view of the Yu/Kokish combination, Yu discloses an exchange mechanism; wherein the exchange mechanism is a rapid exchange mechanism or a coaxial exchange mechanism ([0022]: “More generally, catheter or elongate member(s) 302 extend from sheath carriage 104 and catheter 302 may include, as an example, an outer sheath or catheter, an inner catheter, and a guidewire.”; Note that the “outer sheath or catheter” and “inner catheter” of Yu function as a coaxial exchange mechanism.).
Regarding claim 16, in view of the Yu/Kokish combination, Yu discloses the exchange mechanism is detachably fixed to the second drive mechanism, or the exchange mechanism and the second drive mechanism are integrally designed ([0042]: “It will be appreciated that the aforementioned method and devices may be modified to have some components and steps removed, or may have additional components and steps added, all of which are deemed to be within the spirit of the present disclosure.”).
Regarding amended, independent claim 17, Yu discloses a slave-end apparatus for an interventional robot (robotic instrument driver or catheter insertion system 102 in Figs. 2 and 3; [0015]: “System 100 includes a robotic instrument driver or catheter insertion system 102…”), comprising:
a body (base 108 in Fig. 1 and 2), a first drive mechanism (first carriage 312 in Fig. 3), a second drive mechanism (carriage 104 and associated active drive mechanism 320 in Fig. 3) proximal to the first drive mechanism that are successively mounted on the body;
wherein the first drive mechanism is configured to clamp and rotate (clamping via manipulation mechanism of sheath carriage 104 and leader carriage 106; rotating on yaw angle 304, 310 about axes 128, 308 in Fig. 3; [0022]) a first catheter ([0022]: “Elongate member 122 extends between carriages 104, 106 and passes through carriage 104 within sheath 130. More generally, catheter or elongate member(s) 302 extend from sheath carriage 104 and catheter 302 may include, as an example, an outer sheath or catheter, an inner catheter, and a guidewire.”) and a second catheter ([0026]: “The second carriage 104 is configured for inserting, retracting or rolling a second elongate member such as an inner catheter”), and the second drive mechanism is configured to clamp and rotate (clamping via manipulation mechanism of sheath carriage 104 and leader carriage 106; rotating on yaw angle 304, 310 about axes 128, 308 in Fig. 3; [0022]) a first guide wire and a second guide wire ([0019]: “An elongate member 122 that may include an inner catheter and/or guidewire extends between sheath carriage 104 and leader carriage 106, and generally along a length direction 124 for bed 110.”; [0026]: “That is, assembly 102 may be a robotic instrument driver 102 for driving one or more elongate members… third carriage 106 is configured in another example to insert, retract or roll a third elongate member that may be, for instance, a guidewire.”); and
in a case that the first guide wire runs into the first catheter, and the first guide wire and the first catheter are respectively clamped by the second drive mechanism and the first drive mechanism and move along a same axial direction on the body to a desired position (see axis 300 in Fig. 3; [0019]: “Carriages 104, 106 are also each moveable along rail 120 and along direction 124, which in one embodiment is defined also as an advancement axis for elongate elements of the catheter.”; [0022]: “Each carriage 104, 106 is moveable 300 axially with respect to the other, as well as with respect to rail 120.”), the first catheter and the first guide wire are respectively taken off from the first drive mechanism and the second drive mechanism, the second catheter is caused to run into the first catheter ([0022]: “…catheter 302 may include, as an example, an outer sheath or catheter, an inner catheter, and a guidewire.”), the second guide wire is caused to run into the second catheter ([0022]), and the second catheter and the second guide wire are respectively clamped by the first drive mechanism and the second drive mechanism and move along the same axial direction on the body (see axis 300 in Fig. 3; [0019]: “Carriages 104, 106 are also each moveable along rail 120 and along direction 124, which in one embodiment is defined also as an advancement axis for elongate elements of the catheter.”; [0022]: “Each carriage 104, 106 is moveable 300 axially with respect to the other, as well as with respect to rail 120.”).
Yu is silent to a front clamper proximal to the first drive mechanism that are successively mounted on the body;
the first drive mechanism and move along a same axial direction on the body toward the front clamper … the front clamper takes over to clamp the first catheter … and the second catheter and the second guide wire move along the same axial direction on the body toward the front clamper;
wherein the front clamper is arranged outside the body.
However, Kokish teaches a front clamper proximal to the first drive mechanism that are successively mounted on the body (dynamic gripper 440 in Fig. 4-9);
the first drive mechanism and move along a same axial direction on the body toward the front clamper … the front clamper takes over to clamp the first catheter … and the second catheter and the second guide wire move along the same axial direction on the body toward the front clamper ([col. 5, li. 12-18]; [col. 5, li. 35-42];
wherein the front clamper is arranged outside the body (dynamic gripper 440 is shown is being more forward than the remainder of its support surface 401 in Figs. 4-9).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the invention of Yu to include the front clamper of Kokish to more effectively manipulate the guidewires and catheters to ensure proper placement within the patient.
Regarding amended, independent claim 18, Yu discloses a slave-end apparatus for an interventional robot (robotic instrument driver or catheter insertion system 102 in Figs. 2 and 3; [0015]: “System 100 includes a robotic instrument driver or catheter insertion system 102…”), comprising:
a body (base 108 in Fig. 1 and 2), a first drive mechanism (first carriage 312 in Fig. 3), a second drive mechanism (carriage 104 and associated active drive mechanism 320 in Fig. 3) proximal to the first drive mechanism that are successively mounted on the body;
wherein the first drive mechanism is configured to clamp and rotate (clamping via manipulation mechanism of sheath carriage 104 and leader carriage 106; rotating on yaw angle 304, 310 about axes 128, 308 in Fig. 3; [0022]) a first catheter ([0022]: “Elongate member 122 extends between carriages 104, 106 and passes through carriage 104 within sheath 130. More generally, catheter or elongate member(s) 302 extend from sheath carriage 104 and catheter 302 may include, as an example, an outer sheath or catheter, an inner catheter, and a guidewire.”) and a second catheter ([0026]: “The second carriage 104 is configured for inserting, retracting or rolling a second elongate member such as an inner catheter”), and the second drive mechanism is configured to clamp and rotate (clamping via manipulation mechanism of sheath carriage 104 and leader carriage 106; rotating on yaw angle 304, 310 about axes 128, 308 in Fig. 3; [0022]) a first guide wire and a second guide wire ([0019]: “An elongate member 122 that may include an inner catheter and/or guidewire extends between sheath carriage 104 and leader carriage 106, and generally along a length direction 124 for bed 110.”; [0026]: “That is, assembly 102 may be a robotic instrument driver 102 for driving one or more elongate members… third carriage 106 is configured in another example to insert, retract or roll a third elongate member that may be, for instance, a guidewire.”).
Yu is silent to a front clamper proximal to the first drive mechanism that are successively mounted on the body; and
the front clamper is arranged outside the body.
However, Kokish teaches a front clamper proximal to the first drive mechanism that are successively mounted on the body (dynamic gripper 440 in Fig. 4-9); and
the front clamper is arranged outside the body (dynamic gripper 440 is shown is being more forward than the remainder of its support surface 401 in Figs. 4-9).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the invention of Yu to include the front clamper of Kokish to more effectively manipulate the guidewires and catheters to ensure proper placement within the patient.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over the Yu/Kokish combination in view of Bian et al. (US 2016/0051794, hereinafter referred to as Bian).
Regarding claim 5, in view of the Yu/Kokish combination, the Yu/Kokish combination does not disclose that the first assembly of the second drive mechanism is configured to clamp an Y adapter connected to the first catheter and the second catheter to clamp the first catheter and the second catheter, and rotate a Luer connector of the Y adapter to drive the first catheter and the second catheter to rotate.
However, Bian teaches catheter or guide wire manipulating device for vascular intervention. Bian further teaches that the first assembly of the second drive mechanism is configured to clamp an Y adapter (Y adapter fixation 35 in Fig. 5) connected to the first catheter and the second catheter to clamp the first catheter and the second catheter, and rotate a Luer connector (entry support 37 in Fig. 5) of the Y adapter ([0029]: “FIG. 5 shows a structure of catheter/guide wire support component. …includes Y adapter fixation 35, an entry support 37… The Y adapter fixation 35 is configured to install a Y adapter quickly. The entry support is a hollow structure to support the catheter/guide wire when the catheter/guide wire is transmitted into the mechanism.”) to drive the first catheter and the second catheter to rotate ([0022]: “The catheter/guide wire support component 2 includes a Y adapter fixation and an entry support. The Y adapter fixation is used to install a Y adapter quickly, and the entry support can support and guide the catheter/guide wire effectively into the mechanism. The catheter or guide wire manipulating device drives the catheter/guide wire to move along two directions: advancement and rotation. An advancement mechanism of the catheter/guide wire is attached to the rotation mechanism. …clamping the catheter/guide wire”).
Bian is of a similar pursuit to the instant application in being a catheter or guidewire manipulation system. Though a Luer connector of the Y adapter is not specifically mentioned by name, the entry support (37 in Fig. 5) in combination with Y adapter fixation (37 in Fig. 5) allows a similar function of a luer connector. It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the Yu/Kokish combination to include the Y adapter, catheter/guide wire support component, and manipulation method of Bian to appropriately manipulate and control placement of the Yu/Kokish combination first and second catheters.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARY G SCHLUETER whose telephone number is (703)756-4601. The examiner can normally be reached M-F 9:00am-5:30pm EST.
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/M.G.S./Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796