DETAILED ACTION
A complete action on the merits of claims 1-11 follows below.
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 .
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 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.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1 and 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Jeong (US Pub. No. 2018/0064485) in view of Huang et. al. (US Pub. No. 2012/0010616).
Regarding Claim 1, Jeong teaches an electrode apparatus for nerve denervation or modulation in vivo (abstract), comprising:
a main body 100 including a shaft 10 (Figs. 4-5 and 8); an electrode unit (Figs. 5-8) formed to be drawn out from one end of the shaft and configured to denervate or modulate at least part of nerves on a tube in a body ([0043]-[0049]);
an electrode guide 20 [including a plurality of joint units and a wire connecting the plurality of joint units to each other and configured to guide the electrode unit]; and
a driving unit located inside the main body and configured to control [the joint units and the wire] to increase a difference in displacement therebetween in order for the electrode guide to be in a wound state to enclose circumference of the tube in the body and control [the joint units and the wire] to decrease the difference in displacement therebetween in order for the electrode guide to be in a rectilinear state (“the operator may manipulate the loop control 90 to curl the loop 20 around the circumferential tissue 5 and perform denervation. Upon completing the denervation, the operator may release the loop control 90 to uncurl loop 20. In the second mode, the loop 20 may remain curled when the distal portion 11 is brought into proximity to the target tissue. Then, the operator may manipulate the loop control 90 to uncurl the loop 20, position the loop 20 around the target tissue, release the loop control 90 to curl the loop 20 around the renal artery and perform denervation” [0048], also see [0044]-[0046]);
however, the electrode guide is a flexible structure configured to curl around the tissue for denervation process with manipulation of loop control 90 and not including a plurality of joint units and a wire connecting the plurality of joint units to each other and configured to guide the electrode unit as claimed.
In the same field of articulation shafts Huang teaches the use of an articulation handle 905 comprising an articulation actuator 969 operatively coupled to the end effector by wires 901 and 902 coupled to a plurality of joint units (plurality of spine members 964) such that rotation of the articulator 969 in each direction would pull on each of the wires in order to articulate/guide the distal end in any direction (see Figs. 27-35, best seen in Figs. 33 and 35 and [0112]-[0113]).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to use a plurality of joint units and a wire connecting the plurality of joint units to each other and configured to guide the end effector by pulling on the wire with a articulation actuator on the handle for a better guide in navigation and better control in positioning the end effector/electrode around the target area.
Regarding Claim 9, Jeong in view of Huang teaches wherein the wire 901 is protruded from one end of the shaft with a smaller displacement than the joint units 964 and provides a force of pulling the joint units in a direction to be wound around the tube (Figs. 27-35 and [0112]-[0113]).
Regarding Claim 10, Jeong in view of Huang teaches wherein each joint unit includes: a hinge unit (the section of each spine member 964 including a central opening allowing the wire to pass through is here interpreted to be a hinge allowing the end effector to rotate and articulate around/about the section) formed on one or both sides of the joint unit (Fig. 35) in a longitudinal direction to be connected to an adjacent joint unit (Fig. 35); and a wire hole 907 formed to allow insertion of the wire 901 at a location spaced apart from a rotation center of the hinge unit (a rotation center being closer to the center of the spine where the articulation takes place, Figs. 27-35 and [0111]-[0112]).
Regarding Claim 11, Jeong teaches wherein the plurality of joint units 964 is made of an elastically deformable material (flexible material as seen in Fig. 35) and formed as one body, and a winding support groove of which at least a part of a space is deformed to be closed by a force of the wire is formed between adjacent joint units of the electrode guide (Fig. 33 vs. Fig. 35).
Allowable Subject Matter
Claims 2-8 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Regarding Claim 2, Jeong teaches the invention as applied above, but neither alone or in combination teaches the driving unit includes: a rod block of which one end is connected to the joint units and which is moved in forward and backward directions; a wire block configured to support the wire and moved in the forward and backward directions; and a variable connection unit configured to connect the rod block and the wire block to each other and vary a distance between the rod block and the wire block.
Regarding Claim 8, Jeong teaches the invention as applied above, but neither alone or in combination teaches wherein the driving unit includes: a motor unit; a rod block including a rod of which one end is connected to the joint units and which is moved in the forward and backward directions by means of the motor unit; and a wire block configured to support wire and move in the forward and backward directions in parallel to the rod block, and when the rod block is moved in the forward direction, a distance between the rod block and the wire block increases, and when the rod block is moved in the backward direction, the distance between the rod block and the wire block decreases.
Claims 3-7 objected due to dependency over claim 2.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KHADIJEH A VAHDAT whose telephone number is (571)270-7631. The examiner can normally be reached M-F 9-6 EST.
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/KHADIJEH A VAHDAT/Primary Examiner, Art Unit 3794