DETAILED ACTION
Applicant's amendments and remarks, filed 11/25/25, are fully acknowledged by the Examiner. Currently, claims 1-9 and 11 are pending with claim 10 canceled, and claims 1, 2, 4, 5, and 7-9 amended. The following is a complete response to the 11/25/25 communication.
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 (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.
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 1-9 and 11 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. Claim 1 recites, in part, “the electrode unit including a plurality of joint units” and “the plurality of joint units coupled to an end of the electrode unit.” The claim is not enabled because one of ordinary skill in the art would not know how to make or use the invention. It is unclear how an electrode unit including the joint units would have the same joint units coupled to the electrode unit, if the joint units are already part of the electrode unit. The breadth of the claims does not enable this feature. The nature of the invention does not address how a part of an electrode unit can be separately attached to the same electrode unit. The prior art does not teach a portion of an electrode unit being attached to itself. One of ordinary skill in the art would not know how to add a portion of an electrode unit to itself. This is not predicted in the art, nor is there direction provided by the inventor on how to attach joint units that are already included in the electrode unit to the electrode unit. Examiner has not found working examples of this feature, and no known amount of experimentation would result in the electrode unit and joint units as claimed. For at least these reasons, claim 1 and its dependent claims are rejected for being not enabled.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-9 and 11 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "the body" in two places. There is insufficient antecedent basis for this limitation in the claim. It is unclear to examiner if the body refers to “a main body” or a body of the subject, or some other body. Claims 2-9 and 11 are rejected for their dependency on rejected claim 1.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-3, 4, 7-9, and 11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by O'Keefe (US 2020/0170701).
Regarding claim 1, O'Keefe teaches an electrode apparatus for nerve denervation or modulation in vivo, comprising:
a main body including a shaft (15);
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 (end effector 30 as in par. [0194]);
an electrode guide configured to guide the electrode unit, the electrode unit including a plurality of joint units and a wire connecting the plurality of joint units to each other (electrode guide as flex spine 80 with wires 220 to articulate the joints of spine 80) and a tip joint (end effector mount 210) connected to an end of the plurality of joint units (210 connected to 80 as in Fig. 2), joint units of the plurality of joint units being connected sequentially to each other (joints of 80 connected to each other to flex), the plurality of joint units coupled to an end of the electrode unit and the wire (80 coupled to electrode unit and wire as in Fig. 2); and
a driving unit located inside the main body and configured to drive the joint units and the wire to protrude from the one end of the shaft (drive unit as thumbstick 385 outside of the main body), wherein the driving unit drives the joint units in conjunction with the wire to have different displacements (385 to adjust the position of the device using the articulation).O’Keefe further teaches wherein the tip joint and the plurality of joint units are configured to be drawn out from one end of the shaft to form a curved winding path (210 and the joints of 80 are drawn out to form a curved winding path as in at least Fig. 2 with 80 flexible to curve) such that the electrode unit, drawn out at one side of the electrode by the tip joint encloses the tube in the body (30 encloses nerves using jaws 216 and 217).
Regarding claim 2, O'Keefe teaches wherein 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 (290 as in Fig. 28 and par. [0247]);
a wire block configured to support the wire and moved in forward and backward directions (330 as in par. [0226]); 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 (variable connection unit 310).
Regarding claim 3, O'Keefe teaches wherein the variable connection unit includes:
a rod link rotatably connected to the rod block (block 290 with link 326);
a wire link rotatably connected to the wire block (330);
a hinge pin configured to rotatably connect the rod link and the wire link to each other (330 and 290 connected via cam 370 having a pin to rotate); and
a pin slot formed to slidably accommodate the hinge pin and extending in a tilted direction with respect to the forward and backward directions (par. [0247] cam 370 rotatably mounted in handle 10).
Regarding claim 5, O'Keefe teaches wherein the driving unit includes:
a frame including a guide slit (frame of handle 10 with slot to hold 370 to pivot);
a rod block including a rod that supports the plurality of joint units and a rod slider slidably inserted into the guide slit (290 as in Fig. 28 and par. [0247]); anda wire block including a wire slider slidably inserted into the guide slit and configured to support the wire (330 as in par. [0226]).
Regarding claim 7, O'Keefe teaches wherein the wire is protruded from one end of the shaft with a smaller displacement than the joint units and provides a force of pulling the joint units in a direction to be wound around the tube (cables 220 protrudes less than the flex spine 80 as in par. [0224]).
Regarding claim 8, O'Keefe 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 (cutouts in 140 form hinges as in Fig. 5); and
a wire hole formed to allow insertion of the wire at a location spaced apart from a rotation center of the hinge unit (holes 145).
Regarding claim 9, O'Keefe 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 (hinge as portions that are not cutout allowing for bending); and a winding support unit formed on one or both sides of the joint unit in the longitudinal direction to support the adjacent joint unit (winding support 35), and since adjacent joint units are supported by means of the winding support unit, a force of supporting the joint units is provided to the joint units in an opposite direction to a direction to be wound around the tube (joint units spaced apart from tube 270).
Regarding claim 11, O'Keefe teaches wherein the plurality of joint units is made of an elastically deformable material and formed as one body (80 as one body with cutouts), 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 (support groove between the coil spirals, as in Fig. 7 and par. [0091)).
Claim(s) 4 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over O'Keefe in view of Barrish (US 2016/0279388).
Regarding claim 4, O'Keefe teaches wherein the driving unit includes:
a rod block including a rod of which one end is connected to the plurality of joint units (block 290 with link 326); anda wire block configured to support wire and move in forward and backward directions in parallel to the rod block (330 as in par. [0226]), and
when the rod block is moved in the forward direction, a distance between the rod block and the wire block increases (cam pushes rod block and wire away from each other in a first position), and when the rod block is moved in the backward direction, the distance between the rod block and the wire block decreases (cam in a second position has rod block and wire block closer to each other, as in par. [0247]).
O'Keefe is silent wherein the driving unit includes a motor unit; the rod which is moved in forward and backward directions by means of the motor unit;
However, Barrish teaches a motor for actuating pull wires to articulate an end effector (par. [0222]).
It would have been obvious to one of ordinary skill in the art to modify O'Keefe with the motor controlling the articulation as in Barrish, to automate control of the device.
Regarding claim 6, O'Keefe teaches the rod block is moved in the forward and backward
directions in engagement with the rotation shaft (290 as in Fig. 28 and par. [0247]), and the wire block includes a sliding hole slidably accommodating the rotation shaft and moves in the forward and backward directions while the wire block and the rod block are connected to each other to have a variable distance therebetween (variable connection unit 310).
O'Keefe is silent regarding wherein the driving unit further includes a motor unit including a rotation shaft rotatably supported by the frame.
However, Barrish teaches a motor for actuating pull wires to articulate an end effector (par. [0222]).
It would have been obvious to one of ordinary skill in the art to modify O'Keefe with the motor controlling the articulation as in Barrish, to automate control of the device.
Response to Arguments
Applicant's arguments filed 11/25/25 have been fully considered but they are not persuasive. Applicant argues that 80 is a unitary body and not discrete joint units. However, not only is the joint units not claimed as discrete, the segments of 80 would be considered discrete joint units as the cutouts in 80 clearly delineate specific segments of 80 and control are able to articulate. Applicant’s remaining arguments are dependent on arguments addressed above and are not persuasive for the same reasoning.
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 BO OUYANG whose telephone number is (571)272-8831. The examiner can normally be reached M-F 8-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Rodden can be reached at 303-297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BO OUYANG/Examiner, Art Unit 3794
/MICHAEL F PEFFLEY/Primary Examiner, Art Unit 3794