DETAILED ACTION
This action is in response to amendments received on 6/4/2026. Claims 1-15 were previously pending. Claims 1-2, 4 and 7-14 have been amended and claims 3 and 5-6 have been canceled. A complete action on the merits of claims 1-2, 4 and 7-15 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.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/20/2026 was filed after the mailing date of the Non-Final rejection on 02/11/2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
Claims 1-2, 4, 7-12 and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zarins (US Pub. No. 2013/0296767).
Regarding Claim 1, Zarins teaches a catheter having a longitudinal direction (Fig. 5B), the catheter comprising:
a first tube 303; and
at least one electrode support portion 300 disposed inside the first tube (“the apparatus 300 is advanced to a treatment site within sheath or guide catheter 303” [0053]), the at least one electrode support portion comprising a first electrode support portion (one of branches/electrode elements 306” in Fig. 5B), a second electrode support portion (a second one of branches/electrode elements 306” in Fig. 5B), and a third electrode support portion (a third one of branches/electrode elements 306” in Fig. 5B) spaced apart from each other (Fig. 5B),
wherein a length of the first electrode support portion in the longitudinal direction is different from at least one of a length of the second electrode support portion in the longitudinal direction and a length of the third electrode support portion in the longitudinal direction such that an opening area of the at least one electrode support portion is configured to change according to an extent to which a predetermined area of the at least one electrode support portion is exposed by pulling the first tube proximally (“the electrodes may self-expand after removal of a sheath or a guide catheter 303 constraining the electrodes in a reduced delivery configuration” [0052], as seen in Fig. 5B a length of the first electrode support portion in the longitudinal direction is different from at least one of a length of the second electrode support portion in the longitudinal direction and a length of the third electrode support portion in the longitudinal direction and furthermore as sheath or a guide catheter 303 that had been constraining the electrodes 307 in a reduced delivery configuration is removed the apparatus 300 is self-expanded such that an opening area of the at least one electrode support portion is configured to change according to an extent to which a predetermined area of the at least one electrode support portion is exposed by pulling the first tube proximally).
Regarding Claim 2, Zarins teaches further comprising: at least one electrode portion disposed on the at least one electrode support portion (the area including electrodes 307 positioned on balloon 304, Fig. 5B).
Regarding Claim 4, Zarins teaches wherein the at least one electrode support portion includes: a first area; a second area in contact with a proximal end of the first area and extending proximally and inside the first tube; and a third area in contact with a proximal end of the second area and extending proximally (different areas of the balloon 304 that is interpreted to be the electrode support portion in Fig. 5B by drawing a line between each of the most distal area, the center area comprising electrodes 307 and the most proximal area dividing the balloon section into three areas in contact with one another in a longitudinal direction).
Regarding Claim 7, Zarins teaches further comprising: a plurality of electrodes 307, wherein the plurality of electrodes comprises:
a first electrode (first one of electrodes 307) disposed in a first area of the first electrode support portion (Fig. 5B); a second electrode (second one of electrodes 307) disposed in a first area of the second electrode support portion (Fig. 5B); and a third electrode (third one of electrodes 307) disposed in a first area of the third electrode support portion (Fig. 5B).
Regarding Claim 8, Zarins teaches wherein the first electrode, the second electrode, and the third electrode are spaced apart in a longitudinal direction (electrodes 307 are spaced apart in a longitudinal direction, Fig. 5B).
Regarding Claim 9, Zarins teaches wherein the first electrode, the second electrode, and the third electrode are offset from each other in a plane intersecting a longitudinal direction (Fig. 5B).
Regarding Claim 10, Zarins teaches wherein the first electrode support portion, the second electrode support portion, and the third electrode support portion are disposed to have the same angle with respect to a center of the first tube (Fig. 5B, they are positioned on the outer wall of balloon 304).
Regarding Claim 11, Zarins teaches further comprising: a second tube (positioning element/balloon 304) disposed inside the first tube 303 (Fig. 5B in view of “sheath or a guide catheter 303 constraining the electrodes in a reduced delivery configuration” [0052]).
Regarding Claim 12, Zarins teaches wherein the at least one electrode support portion is disposed between the first tube 303 and the second tube 304 (Fig. 5B).
Regarding Claim 15, Zarins teaches wherein the opening area changes in the first area or the second area (the opening area changes as the balloon self-expands as sheath 303 is removed as discussed in [0052] thus the opening area is interpreted to be changes in either of the first area or the second area or both).
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 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Zarins as applied above in view of Demarais (US Pub. No. 2007/0129760).
Regarding Claims 13 and 14, Zarins teaches the invention as applied above, but is silent in teaching further comprising: at least one marker disposed in the second area and wherein the at least one marker comprises a plurality of markers, and wherein the plurality of markers are disposed along predetermined intervals in the longitudinal direction.
In the same field of invention, Demarais teaches “optional radiopaque markers 308 positioned along the shaft of the catheter in the region of the positioning element 304” [0036] shown in Fig. 3A. In view of the interpretation of the areas given above, the radiopaque markers are positioned at the central region/area of the balloon 304 and thus positioned in the second area and spaced apart longitudinally.
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to add a plurality of markers longitudinally spaced at the area where the electrodes are provided on the balloon in order to better aid a user in the correct deployment and placement of the treatment instrument at the target area under visualization.
Response to Arguments
Applicant’s arguments with respect to claims 1-2, 4 and 7-15 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument as necessitate by amendments.
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 extension fee 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 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
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