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 December 5th, 2025 has been entered. Applicant’s amendments to the claims have overcome the 112(b) rejection previously set forth in the Non-Final Rejection mailed August 5th, 2025.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 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.
Claim Rejections - 35 USC § 112
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 1-4, 6 & 20-24 are 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.
Regarding claim 1, the claim recites “that flexes” and it is unclear if this limitation is to be interpreted as a functional limitation or as an active method step since the preamble recites “a catheter tip electrode”, referring to an apparatus claim. For examination purposes, the limitation will be interpreted as a functional limitation and as “that is configured to flex”.
Claims 2-4, 6 & 20-24 are also rejected by virtue of their dependency on claim 1.
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 1-4, 6 & 20-24 are rejected under 35 U.S.C. 103 as being unpatentable over de la Rama et al. (U.S. Pub. No. 20110313417), herein referred to as “de la Rama” in view of Zhu et al. (U.S. Pat. No. 6363286), herein referred to as “Zhu”.
Regarding claim 1, de la Rama discloses a catheter tip electrode (Abstract: A catheter apparatus … and a plurality of flexible electrode segments on a distal portion of the catheter body adjacent the distal end), comprising:
an electrode (flexible electrode segment 18) that flexes upon application of an external force ([0032]: a series of annular or ring-like surface channels, gaps, grooves, or through-thickness openings 26, 28, respectively, cut or otherwise formed into the sidewall. Elongated gaps define elongated areas of decreased wall thickness and decreased cross-sectional area of the sidewall, while elongated openings extend completely through the thickness of the sidewall. These elongated features including gaps and openings are referred to herein as elongated stiffness reductions);
a distal end portion (distal end 12) adjacent the electrode and defining a distal end ([0032]: a distal end 12 which is flat with a rounded corner; see Figs. 1-3 where distal end 12 is adjacent the flexible electrode 18); and
a wire electrode (band electrode 82; [0048]: band electrode 82 is typically about 0.25 to about 0.5 mm in length; see Fig. 3; wherein a thin electrode of that length is seen as a wire electrode),
while de la Rama discloses wherein the wire electrode extends circumferentially (band electrode 82; see Fig. 3),
but de la Rama fails to explicitly disclose a wire electrode that extends circumferentially from a location where the wire electrode exits an interior of the catheter tip electrode to a distal end of the wire electrode, the distal end of the wire electrode being spaced apart from a remainder of the wire electrode, including the location where the wire electrode exits the interior of the catheter tip electrode.
However, Zhu discloses a wire electrode (electrode 430) that extends circumferentially from a location where the wire electrode exits an interior of the catheter tip electrode to a distal end of the wire electrode, the distal end of the wire electrode being spaced apart from a remainder of the wire electrode, including the location where the wire electrode exits the interior of the catheter tip electrode (Col. 4, lines 56-63: the at least one electrode 430 comprises a wire filament 432 is disposed about the circumference of the lead body 415. In one embodiment, the wire filament 432 is partially disposed about the circumference of the lead body 415. The wire filament 432 is electrically coupled with the conductor 480. In one embodiment, the wire filament 432 is formed by extending the conductor 480 through the lead 415; wherein partially disposed about the circumference is seen as the distal end of the wire electrode being spaced apart from a remainder of the wire electrode, including the location where the wire electrode exits the interior of the catheter tip electrode; see Fig. 4).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the wire electrode of de la Rama to the wire electrode of Zhu, for the purpose of the electrode providing a high impedance which reduces current drain from the power source and the small size enables treatment of smaller areas of tissue with high current density, resulting in less energy consumption (Zhu: Col. 6, lines 25-31).
Regarding claim 2, de la Rama discloses wherein the wire electrode wraps around an outer circumference of the electrode (band electrode 82, see Figs. 3 & 4).
Regarding claim 3, de la Rama discloses wherein the wire electrode (band electrode 82) is disposed adjacent the distal end portion (see Fig. 3 where the band electrode 82 is adjacent distal end 12).
Regarding claim 4, de la Rama discloses wherein the wire electrode (band electrode 82) comprises a wire ([0048]: the band electrode 82 is typically about 0.25 to about 0.5 mm in length) and an insulation (nonconductive segment 20’).
Regarding claim 6, de la Rama discloses wherein the wire electrode is electrically insulated from the electrode ([0048]: Another band electrode 82 may be provided on the nonconductive segment 20'; wherein the flexible electrode 18 and band electrode 82 are separated by nonconductive segment 20’ such that they are insulated from each other).
Regarding claim 20, de la Rama in view of Zhu discloses wherein the wire electrode has a hemispherical cross-section or a circular cross-section (see Zhu Fig. 4 where the electrode 430 has a circular cross-section).
Regarding claim 21, de la Rama in view of Zhu discloses wherein the location where the wire exits the interior of the catheter tip electrode and the distal end of the wire electrode are located at a same axial position along a longitudinal axis of the catheter tip electrode (Col. 4, lines 56-63: the at least one electrode 430 comprises a wire filament 432 is disposed about the circumference of the lead body 415. In one embodiment, the wire filament 432 is partially disposed about the circumference of the lead body 415. The wire filament 432 is electrically coupled with the conductor 480. In one embodiment, the wire filament 432 is formed by extending the conductor 480 through the lead 415; wherein partially exposed about the circumference is seen as the location where the wire exits the interior of the catheter tip electrode and the distal end of the wire electrode are located at a same axial position along a longitudinal axis of the catheter tip electrode since a circumference defines a circle such that the ends would be on both the circle and the same axial position relative to the longitudinal axis).
Regarding claim 22, de la Rama in view of Zhu disclose wherein the distal end of the wire electrode is spaced apart from the location where the wire electrode exits the interior of the catheter tip electrode (Col. 4, lines 56-63: the at least one electrode 430 comprises a wire filament 432 is disposed about the circumference of the lead body 415. In one embodiment, the wire filament 432 is partially disposed about the circumference of the lead body 415. The wire filament 432 is electrically coupled with the conductor 480. In one embodiment, the wire filament 432 is formed by extending the conductor 480 through the lead 415).
Regarding claim 23, de la Rama in view of Zhu discloses a wire electrode conductor (Zhu: conductor 480) coupled to the wire electrode and extending into a wire electrode lumen defined within the catheter tip electrode (see Fig. 4 where the conductor 480 is within the lead body 415/the catheter tip electrode).
Regarding claim 24, de la Rama in view of Zhu discloses wherein the wire electrode conductor and the wire electrode form a single structure (Zhu: Col. 4, lines 61-63: the wire filament 432 is formed by extending the conductor 480 through the lead 415).
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 Abigail M Ziegler whose telephone number is (571) 272-1991. The examiner can normally be reached M-F 8:30 a.m. - 5 p.m. EST.
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/ABIGAIL M ZIEGLER/Examiner, Art Unit 3794
/THOMAS A GIULIANI/Primary Examiner, Art Unit 3794