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 Amendment
The amendment filed 25 June 2026 has been entered. Claim 1 is currently amended. Claims 13-14 are canceled, and claim 15 is new. Claims 1-12 and 15 are pending in the application.
Claim Objections
Claim 1 is objected to because of the following informalities: in line 1, “in body” should read --in a body--. Appropriate correction is required.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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 1, 5, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Yang et al. (WO 2022/045530, effectively filed 28 August 2020; see attached machine translation), hereinafter Yang, in view of Sliwa, JR. et al. (US PGPub No. 2002/0042610), hereinafter Sliwa.
Regarding claim 1, Yang teaches an electrode apparatus for nerve denervation or modulation in a body (surgical device in Figs. 7 and 14; par. 0013: “high-frequency surgical device for nerve blocking”), comprising:
a main body including a shaft (Figs. 11 and 14: connecting part 1200);
an electrode unit 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 the body (Figs. 7 and 14: flexible PCB 1150 of electrode portion 1100; par. 0059: “The electrode (117) is intended to wrap around the outer wall of a tube, such as an artery or bronchus, and to selectively perform either impedance measurement or high-frequency energy transfer”);
and an electrode guide coupled to the electrode unit (Figs. 7 and 14: shape memory alloy 1120) and configured to be deformed into a wound state to bring the electrode unit into contact with the tube in the body (par. 0087: “the diameter of the flexible PCB can be implemented to be adjustable to fit arteries of various sizes, as shown in Fig. 7, taking this into consideration”);
wherein the electrode guide is arranged along an outer side of the electrode unit such that in the wound state, the electrode unit is positioned between the tube and the electrode guide (Fig. 7: flexible PCB positioned between artery and shape memory alloy),
wherein, as the electrode guide is deformed into the wound state, at least a portion of the electrode guide is spaced apart from the electrode unit such that the electrode unit is brought into contact with the tube (Figs. 7 and 14: space between flexible PCB 1150 and shape memory alloy 1120 in wound state).
Yang does not explicitly teach wherein the electrode guide includes a plurality of joint units that are configured to allow the electrode guide to surround a circumference of the tube. However, in an analogous art, Sliwa teaches an electrode apparatus with a plurality of joint units configured to surround a circumference of a tube in the body (Fig. 49: cells 304 with hinges 303; par. 0180: “the device 300 may be used to extend around a single vessel, such as the aorta, pulmonary vein, SVC or IVC”), and further teaches the interchangeability of articulated elements with pre-shaped elements (par. 0011: “Slidable, rotatable, articulated, pivotable, bendable, pre-shaped or steerable elements may be used”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to substitute one known element (articulated joint units shown in Sliwa) for another (pre-shaped nitinol loop shown in Yang), because one of ordinary skill in the art could have performed such a substitution by known means, and the results were predictable, namely, multiple articulated joint units in the electrode guide to provide finer motor control for wrapping around a tube in the body than a single pre-shaped loop.
Regarding claim 5, the combination teaches the device of claim 1 as described previously. Yang further teaches wherein the electrode guide further includes a tip coupled to the electrode unit (Figs. 7 and 14: flexible PCB 1150 and shape memory alloy 1120 coupled at the tip), which in the apparatus of the combined reference would be connected to the shaft by the plurality of joint units.
Regarding claim 15, the combination teaches the device of claim 1 as described previously. Yang further teaches wherein a spacing between the electrode unit and the electrode guide when the electrode unit and the electrode guide are in the shaft differs from a spacing between the electrode unit and the electrode guide when the electrode guide is in the wound state (Figs. 7 and 14: spacing between flexible PCB 1150 and shape memory alloy 1120 larger in curved wound state than spacing between flexible PCB and shape memory alloy within shaft 1200).
Claims 2-3 and 6-12 are rejected under 35 U.S.C. 103 as being unpatentable over Yang in view of Sliwa and further in view of Kim et al. (US PGPub No. 2020/0107898), hereinafter Kim.
Regarding claim 2, Yang in view of Sliwa teaches the device of claim 1 as described previously. Sliwa further teaches wherein each joint unit includes: a hinge unit formed on one or both sides of the joint unit in a longitudinal direction to be connected to an adjacent joint unit (Fig. 50: hinges 30 connecting adjacent cells 304), but the combination does not explicitly teach a winding support unit formed on one or both sides of the joint unit in the longitudinal direction to support the adjacent joint unit in the wound state. However, in an analogous art, Kim teaches a winding support unit formed on one or both sides of the joint unit in the longitudinal direction to support the adjacent joint unit in the wound state (Figs. 5A-5B: angled connection planes on bending segments 110), which improves fine control of the surgical instrument’s movement by reducing slack in bending actuation wires (Figs. 3A-5B and par. 0077: “with the improved bending segments 110 configured to reduce the length ΔL of the slack, the movement of the surgical apparatus 1 can be finely controlled”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to provide the joint units of the combined reference with the winding support units taught by Kim, in order to improve fine movement control by reducing slack in bending actuation wires, as taught by Kim.
Regarding claims 3 and 9, Yang in view of Sliwa teaches the devices of claims 1 and 5 as described previously. Kim further teaches wherein in the wound state, the electrode guide includes: a first joint group including a plurality of joint units each having a first length in a longitudinal direction to be connected to an adjacent joint unit and disposed to form a first radius of curvature closer to the tip joint (that is, the distal end); and a second joint group including a plurality of joint units each having a second length greater than the length of each joint unit of the first joint group in the longitudinal direction and disposed to form a second radius of curvature greater than the first radius of curvature (Fig. 21C and par. 0135: “the connecting parts 120 may be positioned such that the distance between the bending segments gets shorter toward the distal end and longer toward the proximal end”).
Kim teaches that these configurations provide better bending properties towards the proximal end (par. 0133: “Thus, the steerable member 100 bends more easily toward the proximal end thereof” and par. 0135: “the longer the distance between the bending segments, the easier the bending of the steerable member. This results in restriction of the bending near the distal end and improvement in the bending properties near the proximal end”). 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 the combined reference to form first and second joint groups having smaller and greater radii of curvature, as taught by Kim, in order to improve bending properties towards the proximal end, as taught by Kim.
Regarding claim 4, the combination teaches the device of claim 2 as described previously. Kim further teaches wherein in the wound state, the joint units include: a first joint group including a plurality of joint units in which surfaces of the winding support units have a first angle with respect to the longitudinal direction and which is disposed to form a first radius of curvature; and a second joint group including a plurality of joint units in which surfaces of the winding support units have a second angle greater than the first angle with respect to the longitudinal direction and which is disposed to form a second radius of curvature greater than the first radius of curvature (Fig. 21A and par. 0133: “as shown in FIG. 21A, the bending segments 110 have lumens formed at a distance from the center of a cross-section of the steerable member, and the closer to the proximal end of the steerable member, the more distant the lumens in the bending segments get from the center of the cross-section of the steerable member. In this case, the moment applied to the steerable member 100 is smaller at the distal end and increases towards the proximal end”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the angles of the winding support units in the combined reference in the manner taught by Kim, for the same reasons set forth previously in the rejection of claim 3.
Regarding claims 6-8, Yang in view of Sliwa teaches the devices of claims 1 and 5 as described previously, and Yang in view of Sliwa and Kim teaches the device of claim 2 as described previously. Kim further teaches wherein each joint unit further includes a through-hole formed in the longitudinal direction at a location spaced apart from a rotation center of the hinge unit (Figs. 5A-5B: lumens 112 formed in bending segments 110), and the electrode guide further includes a wire formed to sequentially penetrate the plurality of joint units, inserted into the through-hole, and coupled to the tip joint, and configured to guide the plurality of joint units to be in the wound state and provide a force of supporting the winding support units to each other between adjacent joint units (Fig. 5B: bending actuation wires 400; par. 0072: “when the bending actuation wires 400 are moved by the manipulating part 10, the plurality of bending segments 110 move hingedly, thus causing the steerable member 100 to bend”). Kim teaches that this configuration of actuation wires and lumens reduces length of slack (par. 0083: “when bending occurs, the wire 400b on the other side of the center of curvature has a greater contact area with the inner wall of the lumen 112, thereby reducing the length of the slack”) and improves fine movement control for the surgical instrument (par. 0077: “with the improved bending segments 110 configured to reduce the length ΔL of the slack, the movement of the surgical apparatus 1 can be finely controlled”). 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 the device of the combined reference by providing a through-hole and actuation wire, as taught by Kim, in order to reduce the length of slack and thereby improve fine movement control for the surgical instrument, as taught by Kim.
Regarding claim 10, Yang in view of Sliwa teaches the device of claim 1 as described previously. Kim teaches, in another embodiment, wherein the plurality of joint units is made of an elastically deformable material and formed as one body (Fig. 10 and par. 0100: “the steerable member of FIG. 10 can be bent using the elasticity of the connecting parts;” par. 0101: “a plurality of bending segments 110 formed integrally with one another and a plurality of connecting parts 120. For example, it may be manufactured by a molding method using a flexible plastic resin”), and a winding support groove, of which at least a part of a space is deformed to be closed in the wound state, is formed between adjacent joint units of the electrode guide (Fig. 10: grooves between bending segments 110 and connecting parts 120; examiner notes that at least part of these spaces would close in the wound state, as broadly as claimed). Kim teaches that this configuration is an explicit alternative to a mechanically hinged structure (par. 0100: “While the steerable member of FIGS. 5 to 9 can be bent using the mechanical hinge structure of the connecting parts, the steerable member of FIG. 10 can be bent using the elasticity of the connecting parts”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to provide the device of the combined reference with the continuous flexible structure as taught in the Fig. 10 embodiment of Kim, since Kim teaches that the continuous flexible structure and mechanically hinged structures are obvious alternatives of one another.
Regarding claim 11, the combination teaches the device of claim 10 as described previously. The combination does not explicitly teach wherein each winding support groove is recessed in a wedge shape. However, Kim teaches wedge-shaped support grooves (as seen in Figs. 3-5B), and it would have been an obvious matter of design choice to make the winding support grooves of the combined reference in whatever form or shape was desired or expedient. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
Regarding claim 12, the combination teaches the device of claim 10 as described previously. Kim further teaches the limitations of claim 12 for the same reasons set forth previously in the rejection for claim 6.
Response to Arguments
Applicant’s arguments, filed 25 June 2026, with respect to the rejection(s) of claim 1 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, in light of the amendments to the claim, the previous rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Yang. As described previously, Yang teaches wherein the electrode guide is arranged along an outer side of the electrode unit such that, in the wound state, the electrode unit is positioned between the tube and the electrode guide, and as the electrode guide is deformed into the wound state, at least a portion of the electrode guide is spaced apart from the electrode unit such that the electrode unit is brought into contact with the tube.
Applicant’s arguments with respect to the combination of Jeong and Sliwa have been considered but are moot because the new ground of rejection does not rely on the Jeong reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVINA E LEE whose telephone number is (571)272-5765. The examiner can normally be reached Monday through Friday between 8:00 AM and 5:30 PM (ET).
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/D.E.L./Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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