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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 08/29/2025 has been entered.
Response to Arguments
Applicant’s arguments, see “Applicant Arguments/Remarks”, filed 08/29/2025, regarding the rejections under U.S.C. 112(b) have been fully considered and are persuasive. The rejections under U.S.C. 112(b) have been withdrawn.
Applicant’s arguments to Claims 1 and 22, that Weitzner does not teach the amended subject matter, is unpersuasive. The amendments to the claims are taught by Weitzner, as cited below in the U.S.C. 102, as Weitzner teaches a connector at a distal end of the tube (mating plate 508), wherein the connector is configured to detachably connect to an end effector (end effector 502), wherein a distal end of the handle actuation wire includes a connector element (mating plate 508) coupled at a distalmost end of the tube (Figs. 113a/113b) configured to detachably connect to a corresponding connector element of an end effector actuation wire of the end effector, a proximal portion of the end effector is received within the distal opening of the cavity (Para. 0418, “FIG. 113 illustrates a mating plate 508 positioned proximate to the interface of the catheter body 25 and end effector 502 of tool 40. As describe above with respect to plate 63, mating plate 508 can facilitated mating of control cables 510 with end effector 502”), wherein the connector includes a plurality of channels configured to receive at least one of the handle actuation wire and the handle articulation wire and the handle articulation wire (Fig. 113A/113B).
Applicant’s arguments with respect to the rejection(s) of Claims 24-25 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 Therefore, the rejection has been withdrawn.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 Weitzner, Shulze, and Baxter.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-4, 9-11, 13-15, and 21-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2008070556 awarded to Weitzner et al, hereinafter Weitzner.
Regarding Claim 1, Weitzner teaches a medical device (abstract), comprising: a handle having a proximal end and a distal end (frame 22, Fig. 1), and one or more actuators configured to move between the distal end and the proximal end (spool of spool mount 812, Para. 00447, “In one exemplary aspect, the proximal end of the inner body 802 can mate with a spool mount 812 on control member 24 which is articulated via the trigger on the handle 304 of the control member”)), wherein the one or more actuators are connected to a handle actuation wire (Para. 00447, “In one exemplary aspect, the proximal end of the inner body 802 can mate with a spool mount 812 on control member 24 which is articulated via the trigger on the handle 304 of the control member. It should be appreciated that the spool and/or thumb ring can be driven via movement of handle 304 or trigger 306”); a tube having a longitudinal axis and extending from the distal end of the handle (inner body 802), a connector at a distal end of the tube (mating plate 508), wherein the connector is configured to detachably connect to an end effector (end effector 502), wherein a distal end of the handle actuation wire includes a connector element (mating plate 508) coupled at a distalmost end of the tube (Figs. 113a/113b) configured to detachably connect to a corresponding connector element of an end effector actuation wire of the end effector (Para. 0418, “FIG. 113 illustrates a mating plate 508 positioned proximate to the interface of the catheter body 25 and end effector 502 of tool 40. As describe above with respect to plate 63, mating plate 508 can facilitated mating of control cables 510 with end effector 502”), wherein the connector includes a plurality of channels configured to receive at least one of the handle actuation wire and the handle articulation wire and the handle articulation wire (Fig. 113A/113B), wherein the at least one of the plurality of channels is angled relative to the longitudinal axis of the tube (Para. 0183, “In another embodiment, channel bodies 50a, 50b, 50c, and/or 50d can articulate independently of shaft 750 at the distal end of guide tube 26. For example, the channel bodies can be detached from shaft 750 and independently moved via, for example, control wires and/or pre-shaped materials. In addition, or alternatively, the guide tube can include various structures for causing the channels, instruments within the channels, and/or the instruments themselves to angle away from one another (e.g., diverge)”).
Regarding Claim 2, Weitzner teaches the medical device according to claim 1, further comprising the end effector and wherein the end effector includes a medical tool (end effector 502, Fig. 125a), and movement of the one or more actuators in at least one of a proximal direction and a distal direction is configured to cause the medical tool to be actuated (Para. 00449, “Control wire 776 can mate with an end effector control wire 778 when the inner and outer bodies are mated. When force is applied on control wire 776, the force can be transmitted to control wire 778 for actuating end effector 502”).
Regarding Claim 3, Weitzner teaches the medical device according to claim 1, wherein the one or more actuators includes a spool (spool of spool mount 812), and the handle includes a handle body on which the spool translates (spool mount 812).
Regarding Claim 4, Weitzner teaches the medical device according to claim 1, wherein the one or more actuators includes at least one articulation control device (articulation section 772), and wherein the at least one articulation control device is connected to the handle articulation wire (articulation wires 774, Para. 00447, “In another embodiment, a user can articulate the inner body via manipulation of outer body control member 24”).
Regarding Claim 9, Weitzner teaches the medical device according to claim 4, wherein the end effector includes an extender attached at a proximal end to an end effector connector and at a distal end to a medical tool (inner body 802), wherein movement of the at least one articulation control device bends the extender (Para. 00449-00450, “For example, pull wires 774 can extend to articulation section 772 for driving the inner body. When positioned within the outer body, articulation of the inner body drives the outer body. [00450] In one aspect, illustrated in FIG. 125A, the inner body can include a control wire 776 for driving the end effector of the outer body. Control wire 776 can mate with an end effector control wire 778 when the inner and outer bodies are mated. When force is applied on control wire 776, the force can be transmitted to control wire 778 for actuating end effector 502.”).
Regarding Claim 10, Weitzner teaches the medical device according to claim 1, wherein the connector includes a distal facing cavity (lumen 770), and wherein a proximal portion of the end effector is configured to be inserted at least partially into the cavity when the end effector is connected to the connector (Fig. 125a).
Regarding Claim 11, Weitzner teaches the medical device according to claim 9, wherein the end effector includes at least one end effector articulation wire disposed radially outward of the extender (articulation wire 774).
Regarding Claim 13, Weitzner teaches the medical device according to claim 1, wherein a proximal force applied to the handle is configured to disconnect the end effector from the connector, and wherein the proximal force is sufficient to deform at least one of the handle actuation wire and the end effector actuation wire to disconnect the end effector from the connector effector (Para. 00453 discusses the docking and undocking of 776 to 778”).
Regarding Claim 14, Weitzner teaches the medical device according to claim 13, wherein the connector is configured to be attached to another end effector after the end effector is disconnected from the connector (Para. 00453 discusses the docking and undocking of 776 to 778”, whereby another end effector could be docked after removal).
Regarding Claim 15, Weitzner teaches the medical device according to claim 1, further comprising a rotation control device connected to the handle and the tube, wherein rotation of the rotation control device is configured to rotate the end effector about the longitudinal axis of the tube (Para. 00458, “In one aspect, system 20 provides at least two degrees of freedom to the distal end of tool 40 which is controlled by moving control member 24 on rail 224. For example, a end effector can be rotated and moved longitudinally by manipulating control member 24”).
Regarding Claim 21, Weitzner teaches the medical device according to Claim 1, wherein at least one other channel of the plurality of channels is parallel to the longitudinal axis of the tube (Fig. 123c).
Regarding Claim 22, Weitzner teaches a medical device, comprising: a handle having a proximal end and a distal end (frame 22, Fig. 1), and an actuator configured to move between the distal end and the proximal end (spool of spool mount 812, Para. 00447, “In one exemplary aspect, the proximal end of the inner body 802 can mate with a spool mount 812 on control member 24 which is articulated via the trigger on the handle 304 of the control member”)); a tube having a longitudinal axis and extending from the distal end of the handle (inner body 802), a connector at a distal end of the tube (mating plate 508, Figs. 113A/113B), wherein the connector is configured to detachably connect to an end effector (end effector 502), the end effector including a base (Fig. 125B, shaft 782); wherein the end effector includes an extender attached at a proximal end to an end effector connector and at a distal end to a medical tool (inner body 802), wherein movement of the at least one articulation control device bends the extender (Para. 00449-00450, “For example, pull wires 774 can extend to articulation section 772 for driving the inner body. When positioned within the outer body, articulation of the inner body drives the outer body. [00450] In one aspect, illustrated in FIG. 125A, the inner body can include a control wire 776 for driving the end effector of the outer body. Control wire 776 can mate with an end effector control wire 778 when the inner and outer bodies are mated. When force is applied on control wire 776, the force can be transmitted to control wire 778 for actuating end effector 502.”) wherein, when the end effector is detachably connected to the connector, a proximal portion of the end effector is received within the distal opening of the cavity (Para. 0418, “FIG. 113 illustrates a mating plate 508 positioned proximate to the interface of the catheter body 25 and end effector 502 of tool 40. As describe above with respect to plate 63, mating plate 508 can facilitated mating of control cables 510 with end effector 502”, Para. 0160, “In addition, mating plate 63 can include one or more apertures for the passage of channels 42 and/or 44a, 44b. In one aspect, mating plate 63 is mated to the distal end of articulation body member 58 via welding, adhering, mechanical interlock, and/or frictional engagement”).
Regarding Claim 23, Weitzner teaches the medical device of claim 22, wherein the extender includes a coil (Para. 0371, “Control cable 368 can be a torquable, flexible filament, coil, cable, or wire that transmits torque to the distal end effector. In one aspect, control cable 368 can additionally drive actuation of the end effector as described herein. For example, where distal end effector actuation is desired, handle 304 can include a trigger or similar mechanism to actuate the distal end effector”).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 5-8 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2008070556 awarded to Weitzner et al, hereinafter Weitzner, in view of U.S. Patent Publication 20060206145 awarded to Griego et al, hereinafter Griego.
Regarding Claim 5, Weitzner teaches the medical device according to claim 4. Weitzner does not teach wherein the one or more actuators includes a first articulation control device and a second articulation control device, wherein the first articulation control device and the second articulation control device are each configured to move between a proximalmost end position and a distalmost end psotion, and wherein the proximalmost end position of the second articulation control device is distal of the distanlmost end position of the first articulation control device.
However, Griego teaches the usage of a two spool system, wherein one spool is used for actuation and one spool is used for articulation, both spools moving proximally and distally (Para. 0070, “For example, as shown in FIG. 10A, a deflection controller for the deflection control member 71 may be provided as an additional spool 667b integrally formed in a handle assembly 600 together with the spool 667a for controlling the operation of the end effector assembly. By this arrangement, the deflection of the control shaft may be independently operated by the additional spool 667b”), wherein the actuation spool is distal to the articulation spool (Fig. 10a).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Weitzner by Griego, i.e. by using the control system in Griego in the device of Weitzner, for the predictable purpose of simply substituting one known spool control system for another.
Regarding Claim 6, Weitzner modified by Griego makes obvious the medical device according to Claim 4. Weitzner further teaches wherein the end effector includes an end effector articulation wire (Fig. 125a shows multiple articulation wires 774), wherein the handle articulation wire is configured to engage the end effector articulation wire when the end effector is connected to the connector, and wherein movement of the at least one articulation control device is configured to move the end effector from a first position, wherein the end effector is aligned with the longitudinal axis, to a second position, wherein at least a portion of the end effector is angled relative to the longitudinal axis (Para. 00449-00450, “For example, pull wires 774 can extend to articulation section 772 for driving the inner body. When positioned within the outer body, articulation of the inner body drives the outer body. [00450] In one aspect, illustrated in FIG. 125A, the inner body can include a control wire 776 for driving the end effector of the outer body. Control wire 776 can mate with an end effector control wire 778 when the inner and outer bodies are mated. When force is applied on control wire 776, the force can be transmitted to control wire 778 for actuating end effector 502”).
Regarding Claims 7 and 8, Weitzner modified by Griego makes obvious the medical device according to Claim 6. Weitzner does not teach in the previously cited embodiment wherein the at least one articulation control device includes a plurality of articulation control devices, and wherein the plurality of articulation control devices are radially spaced about the handle, wherein each of the plurality of articulation control devices is attached to a corresponding handle articulation wire.
However, in a separate embodiment, Weitzner teaches the usage of multiple controls per articulation wire for the purposes of improving the degrees of freedom controlled by the articulation system (Para. 00219, “In one aspect, control mechanism 156 includes wheels 160a and 160b, where two strands (e.g., 60a, 60b) mate with one of wheels 160a, 160b to control left/right movement of the articulation portion 56 of guide tube 26 and the other two strands (e.g., 60c, 6Od) mate with other of wheels 160a, 160b to control up/down movement of the articulation section. Depending on the configuration of controls 30, more or fewer than four strands can mate with more or fewer wheels. For example, while the articulation section is described as providing two degrees of freedom, fewer strands and/or wheels can be used where only a single degree of freedom is necessary. Regardless of the configuration of the control mechanism, the strands can mate with wheels via welding, adhering, mechanically interlocking, and/or frictionally engaging”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify Weitzner modified by Griego, i.e. by using a separate spool for each of Weitzner’s radially spaced articulation wires, as Weitzner teaches controlling each wire separately for improving the control of the device as taught above.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over WO 2008070556 awarded to Weitzner et al, hereinafter Weitzner (cited on Applicant’s IDS), in view of U.S. Patent Publication 20020099368 awarded to Schulze, hereinafter Schulze.
Regarding Claim 12, Weitzner teaches the medical device according to claim 1. Weitzner does not teach wherein the distal end of the handle actuation wire includes a hook, wherein a proximal end of the end effector actuation wire includes a hook for connection to the hook of the handle actuation wire.
However, Schulze teaches the usage of two actuator components connected by hooks on both ends (Para. 0050).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Weitzner by Schulze, i.e. by using hooks to connect the actuating wires of Weitzner, as Weitzner teaches that multiple types of connection can be used (Para. 00454, “When the inner body is mated the snap fit can provide a user with tactile feedback and indicate proper docking of the inner and outer bodies. One skilled in the art will appreciate that a variety of additional or alternative mating mechanisms can permit docking of the inner and outer bodies”).
Claims 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2008070556 awarded to Weitzner et al, hereinafter Weitzner (cited on Applicant’s IDS), in view of U.S. Patent Publication 20020099368 awarded to Schulze, hereinafter Schulze, further in view of U.S. Patent Publication 20120074201 awarded to Baxter et al, hereinafter Baxter.
Regarding Claim 24, Weitzner teaches a medical device, comprising: a handle having a proximal end, a distal end, (frame 22, Fig. 1), and an actuator configured to move between the distal end and the proximal end (spool of spool mount 812, Para. 00447, “In one exemplary aspect, the proximal end of the inner body 802 can mate with a spool mount 812 on control member 24 which is articulated via the trigger on the handle 304 of the control member”)), wherein the actuator is connected to a handle actuation wire (Para. 00447, “In one exemplary aspect, the proximal end of the inner body 802 can mate with a spool mount 812 on control member 24 which is articulated via the trigger on the handle 304 of the control member. It should be appreciated that the spool and/or thumb ring can be driven via movement of handle 304 or trigger 306”); a tube having a longitudinal axis and extending from the distal end of the handle (inner body 802); the end effector includes an end effector articulation wire (Fig. 125a shows multiple articulation wires 777, Para. 00449-00450, “For example, pull wires 774 can extend to articulation section 772 for driving the inner body. When positioned within the outer body, articulation of the inner body drives the outer body. [00450] In one aspect, illustrated in FIG. 125A, the inner body can include a control wire 776 for driving the end effector of the outer body. Control wire 776 can mate with an end effector control wire 778 when the inner and outer bodies are mated. When force is applied on control wire 776, the force can be transmitted to control wire 778 for actuating end effector 502”); and a connector at a distal end of the tube (shaft 750), wherein the connector includes a cavity (Fig. 7f), wherein a hooked, proximal end of the end effector actuation wire is detachably connected to a hooked, distal end of the handle actuation wire within the cavity. Weitzner does not teach wherein the distal end of the handle actuation wire includes a hook, wherein a proximal end of the end effector actuation wire includes a hook for connection to the hook of the handle actuation wire, and wherein at least one of the hooked, proximal end of the end effector actuation wire or the hooked, distal end of the handle actuation wire are formed from a flexible material.
However, Schulze teaches the usage of two actuator components connected by hooks on both ends (Para. 0050).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Weitzner by Schulze, i.e. by using hooks to connect the actuating wires of Weitzner, as Weitzner teaches that multiple types of connection can be used (Para. 00454, “When the inner body is mated the snap fit can provide a user with tactile feedback and indicate proper docking of the inner and outer bodies. One skilled in the art will appreciate that a variety of additional or alternative mating mechanisms can permit docking of the inner and outer bodies”).
Further, Baxter teaches the usage of articulation wires ending in a hook make of flexible material (Para. 0120).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify Weitzner modified by Schulze by Baxter, i.e. by make the hooks of Weitzner/Schulze of a flexible material, since it is within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use (see MPEP 2144.07), and Baxter shows this is a known embodiment in the art.
Regarding Claim 25, Weitzner modified by Schulze makes obvious the medical device of claim 24, wherein the connector includes a proximal connector portion coupled to the tube. Weitzner further teaches wherein the connector includes a distal connector portion coupled to the end effector, wherein the distal connector portion is detachably coupled to the proximal connector portion (Para. 0180, “FIG. 7F illustrates a cross-section of guide tube 26 showing channel body 50a movably mated with shaft 750. In one aspect, channel body 50a includes a surface feature that mates with a surface feature of shaft 750. In the illustrated embodiment, channel body 50a includes a mating feature 752 having a curved or c-shaped outer surface corresponding to a mating feature 754 of shaft 750. In use, channel body 50a can slide along shaft 750 by slide mating feature 752 within mating feature 754. One skilled in the art will appreciate that a variety of movable mating features could be substituted for mating features 752, 754”), wherein, while coupled, a portion of the distal connector portion is received within the proximal connector portion (Weitzner Para. 0178, “Shaft 750 can also include an articulation section for steering the channels. For example, control wires can extend through or along shaft 750 to a distal articulation section. Tensioning the control wires can drive one or more degrees of freedom of shaft 750, including, for example, up/down and/or left/right movement”).
Conclusion
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/JLM/
Examiner, Art Unit 3792
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792