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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 27 January 2026 has been entered. Claim 1 is currently amended, and claims 13-14 are new. Claims 1-14 are pending in the application.
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.
Claims 1 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Jeong et al. (US PGPub No. 2019/0133681), hereinafter Jeong, in view of Sliwa, JR. et al. (US PGPub No. 2002/0042610), hereinafter Sliwa.
Regarding claim 1, Jeong teaches an electrode apparatus for nerve denervation or modulation in a body (Fig. 4: catheter apparatus 100), comprising:
a main body including a shaft (Figs. 4-5: shaft 10, distal portion 11);
an electrode unit (Figs. 6A-6B: electrodes 23; par. 0053: “the loop 20 includes a body 21 and one or more electrodes 23 disposed on the body 21”) 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 (Fig. 5: loop 20; par. 0052: “the loop 20 may be retracted into the shaft 10. As the loop control 90 is moved forward (or downward), the loop 20 may emerge from the distal portion 11 and become a straight segment or curl into a semi-circle. As the loop control 90 is moved backward (or upward), the loop 20 may curl around the target tissue or renal artery RA”);
and an electrode guide coupled to the electrode unit and deformed into a wound state to bring the electrode unit into contact with the tube in the body, wherein the electrode guide is configured to surround a circumference of the tube with the electrode unit interposed therebetween, and is spaced apart from both the tube in the body and the electrode unit in the wound state (Figs. 10: substrate 25; par. 0072: “a substrate 25 embedded in the body 21 and separated from the electrodes 23 by a certain distance” and par. 0080: “As the temperature of the substrate 25 reaches the critical temperature, the substrate 25 may curl more tightly around the target tissue as the shape-memory alloy of the substrate 25 may return to the pre-deformed state. The loop 20 including the substrate 25 may curl more tightly around the target tissue so that the electrodes 23 included to the loop may firmly contact the circumferential tissue, as depicted in FIG. 11B”).
Jeong 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 loop shown in Jeong), 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. Jeong further teaches wherein the electrode guide further includes a tip coupled to the electrode unit (Fig. 10: substrate 25 coupled to electrodes 23 via body 21, as broadly as claimed), which in the apparatus of the combined reference would be connected to the shaft by the plurality of joint units.
Claims 2-3 and 6-12 are rejected under 35 U.S.C. 103 as being unpatentable over Jeong in view of Sliwa and further in view of Kim et al. (US PGPub No. 2020/0107898), hereinafter Kim.
Regarding claim 2, Jeong 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, Jeong 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, Jeong in view of Sliwa teaches the devices of claims 1 and 5 as described previously, and Jeong 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, Jeong 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.
Election/Restrictions
Newly submitted claims 13-14 are directed to an invention that lacks unity with the invention originally claimed for the following reasons:
The newly submitted claims (Group II) and the originally claimed invention (Group I) do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Groups I and II lack unity of invention because even though the inventions of these groups require the technical feature of an electrode apparatus for nerve denervation or modulation in body, comprising: a main body including a shaft; an electrode unit that is configured to denervate or modulate at least part of nerves on a tube in the body; an electrode guide coupled to the electrode unit, the electrode guide including a plurality of joint units; wherein the joint units of the electrode guide are configured to allow the electrode guide to surround a circumference of the tube with the electrode unit interposed therebetween and spaced apart from both the tube in the body and the electrode unit;
this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Jeong and Sliwa, as described previously in the prior art rejection under 35 U.S.C. 103.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 13-14 are withdrawn from consideration as being directed to a nonelected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Response to Arguments
Applicant’s arguments, filed 27 January 2026, with respect to the rejection(s) of claim(s) 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 Sliwa. As previously described, Sliwa teaches a plurality of joint units for surrounding a circumference of a tube in the body, as well as the interchangeability of articulated elements with pre-shaped elements.
Applicant's arguments regarding the particular combination of Jeong and Kim have been fully considered but they are not persuasive.
In response to applicant's argument that the device of Jeong would be rendered unsatisfactory for its intended purpose if modified with the segments of Kim because Kim’s segments are not disclosed to surround a tube, and that the segments of Kim would not be able to bend if surrounded with the material surrounding the substrate of Jeong, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
In response to applicant's argument that Kim is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Kim is reasonably pertinent to the particular problem with which the inventor was concerned, i.e., providing fine motor control for a bendable portion of a catheter.
Conclusion
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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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/D.E.L./Examiner, Art Unit 3794