DETAILED ACTION
Applicant's amendments and remarks, filed 4/3/26, are fully acknowledged by the Examiner. Currently, claims 1-12 are pending. The following is a complete response to the 4/3/26 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.
Information Disclosure Statement
The IDS filed 7/31/24 is considered.
The information disclosure statement filed 12/19/24 fails to comply with 37 CFR 1.98(a)(1), which requires the following: (1) a list of all patents, publications, applications, or other information submitted for consideration by the Office; (2) U.S. patents and U.S. patent application publications listed in a section separately from citations of other documents; (3) the application number of the application in which the information disclosure statement is being submitted on each page of the list; (4) a column that provides a blank space next to each document to be considered, for the examiner’s initials; and (5) a heading that clearly indicates that the list is an information disclosure statement. The information disclosure statement has been placed in the application file, but the information referred to therein has not been considered.
The IDS filed 12/19/24 does not include the Non Patent Literature filed 12/19/24.
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.
Claim(s) 1, 4-10, and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Salahieh (US 11,376,061), in view of O'Sullivan (US 2005/0015082), in view of Leeflang (US 2017/0056616).
Regarding claim 1, Salahieh teaches an electrode catheter comprising: a catheter shaft (902)
including a shaft main body enclosing a first lumen and a second lumen separated from each other (902 with lumens 910 and 928), and
a reinforcement layer embedded into the shaft main body (928);
an electrode and mounted to an outer peripheral portion of the shaft main body (218 on shaft 236);
wherein the reinforcement layer has conductivity and surrounds the second lumen without surrounding the first lumen (928 surrounds 924 without surrounding 819).
Salahieh is silent regarding the electrode having a ring shape, and a lead wire electrically conductive to the electrode and inserted into the first lumen. However, Salahieh does suggest wires can be used rather than a conductor coat (col. 19, lines 35-38).
However, O'Sullivan teaches a lead wire for ring electrodes (par. [0044] lead wire 50 in lead wire lumen 40).
It would have been obvious to one of ordinary skill in the art to modify Salahieh with the lead wire as in O'Sullivan, allowing for electrical connection of the electrode to a source for treatment.
Salahieh is further silent regarding the reinforcement layer, in a cross-sectional orthogonal to the axial direction of the catheter shaft, inside the electrode, the reinforcement layer surrounds the second lumen without surrounding the first lumen.
However, Leeflang teaches an end effector element with a reinforcement layer (142) and is inside the electrode radially (as in at least Figs. 5-6).
It would have been obvious to one of ordinary skill in the art to modify Salahieh such that the reinforcement layer and lumen extend such that they are inside the electrode, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70. Furthermore, it appears that the invention would perform equally well with the reinforcement layer and lumen inside the electrode as they would still allow for the conductivity to use the device.
Regarding claim 4, Salahieh teaches a braided material as part of a catheter device (col. 14, lines
30-44).
Salahieh is not explicit wherein the reinforcement layer is constituted by a braid obtained by braiding a plurality of element wires into a tubular shape, a cross-sectional shape of each of the plurality of element wires is a flat shape in a cross section orthogonal to a center line of the element wire.
It would have been obvious to one of ordinary skill in the art to modify Salahieh with the braid, such that the material is a flat shape in a cross section (given cross sections are 2d by definition), as a stiffening element (col. 14, lines 30-44).
Regarding claim 5, Salahieh teaches wherein the catheter shaft is formed with a side hole extending from an outer peripheral surface of the shaft main body to the first lumen at a mounting position of the electrode (717 at the portions of the electrode), and the side hole is provided about a center of the first lumen while avoiding a circumferential-direction range including the entire reinforcement layer (Fig. 7).
Regarding claim 6, Salahieh teaches comprising a handle attached to a proximal end side portion of the shaft main body (320), wherein the reinforcement layer is provided at least in an axial-direction range continuous from the handle to the electrode (928 along an axial-direction).
Regarding claim 7, Salahieh teaches wherein the second lumen communicates an external space outside a living body and an internal space inside the living body when a distal end side portion of the shaft main body is inserted into the living body (irrigation from fluid reservoir 326 in Fig. 6 outside the body to balloon inside the body as in at least col. 20, lines 28-46).
Regarding claim 8, Salahieh teaches wherein the electrode is used to output electricity supplied for treatment of a treated portion of a living body (col. 13, lines 1-26).
Regarding claim 9, Salahieh teaches wherein a cross-sectional area of the second lumen is larger than a cross-sectional area of the first lumen in a cross section orthogonal to an axial direction of the catheter shaft (Fig. 19b).
Regarding claim 10, Salahieh teaches wherein a material of the reinforcement layer is a metal (col. 16, lines 60-67).
Regarding claim 12, Salahieh teaches the side hole penetrates the main body and is covered by the electrode (apertures 717 through the main body, the apertures surrounded by the electrical conductor as in col. 8, lines 5-12).
Claim(s) 2, 3, and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Salahieh in view of O'Sullivan, in view of Leeflang, in further view of Lunn (US 2009/0240206).
Regarding claim 2, Salahieh teaches wherein the catheter shaft includes a lumen tube forming the second lumen (second lumen 924), but is silent regarding the shaft main body is formed of at least one resin layer, and the reinforcement layer is wound around the lumen tube and is embedded into the at least one resin layer covering the lumen tube.
However, Lunn teaches a shaft formed of resin as in par. [0049].
It would have been obvious to one of ordinary skill in the art to modify Salahieh such that the shaft main body is formed of a resin layer, as in Lunn, as a known shaft material for electrosurgical treatment. One of ordinary skill in the art would appreciate that the conductive layer of Salahieh would be embedded in the larger resin structure.
Regarding claim 3, Salahieh is silent, but Lunn teaches wherein the at least one resin layer covering the lumen tube is formed by extrusion-molding (par. [0049]).
Regarding claim 11, Salahieh is silent regarding a method of manufacturing the catheter shaft of claim 2 comprising:
extrusion-molding the at least one resin layer covering the lumen tube and thus embedding the reinforcement layer, in a state where the reinforcement layer is wound around an outer peripheral portion of the lumen tube.
However, Lunn teaches extrusion molding a resin layer, and a reinforcement layer around the lumen tube (par. [0046] and [0049]).
It would have been obvious to one of ordinary skill in the art to modify Salahieh with the method of manufacturing the catheter shaft of Lunn, as a known method of creating catheter shafts with multiple lumens and reinforcement layers.
Response to Arguments
Applicant's arguments filed 4/3/26 have been fully considered but they are not persuasive. Applicant argues that the 928 as a conductive layer is too thin to be considered a reinforcement layer. However, 928 as a layer as opposed to a thin lead would be a reinforcement of the conductive structure of the device to deliver power to an electrode, and would be considered a reinforcement layer.
Applicant further argues that there would be no desire to have a lead as the conductive paths of Salahieh are not leads. However, Salahieh does suggest wires can be used rather than a conductor coat (col. 19, lines 35-38). It would have been obvious to one of ordinary skill in the art to modify Salahieh with the lead wire as in O’Sullivan to electrically connect the electrode as an alternative element for conductivity.
Conclusion
THIS ACTION IS MADE FINAL. 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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/BO OUYANG/Examiner, Art Unit 3794
/MICHAEL F PEFFLEY/Primary Examiner, Art Unit 3794
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