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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/5/2025 has been entered.
Response to Amendment
Acknowledgment is made to the amendment received 12/5/2025.
Response to Arguments
Applicant’s arguments with respect to claims 1, 2, 14, and 19 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. Previously, claims 1, 14, and 19 were rejected under 35 U.S.C. 102(a)(1) as being anticipated by Eliason, while claim 2 was rejected under 35 U.S.C. 103 as being unpatentable over Eliason in view of Townley. Now, based on amendments to the claim language, claims 1, 14, and 19, are rejected under 35 U.S.C. 103 as being unpatentable over Eliason in view of Hill, while claim 2 is rejected 35 U.S.C. 103 as being unpatentable over Eliason in view of Hill and Ge.
Claim Rejections - 35 USC § 103
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 9-10, 13-14 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Eliason et al., US 20180325455, herein referred to as “Eliason”, in view of Hill et al. US 20130231659, herein referred to as “Hill”.
Regarding claim 1, Eliason discloses an electrode assembly for a catheter system (Figure 8), the electrode assembly comprising: an inner electrode basket (Figure 8: splines 76 and spherical envelope 80) comprising a first proximal end (Figure 8: end connected to catheter), a first distal end (Figure 8: distal end of splines 76), and a first plurality of struts extending between the first proximal end and the first distal end (Figure 8: splines 76); and an outer electrode basket (Figure 8: splines 78 and spherical envelope 82) comprising a second proximal end (Figure 8: end connected to catheter), a second distal end (Figure 8: distal end of splines 78), and a second plurality of struts extending between the second proximal end and the second distal end (Figure 8: splines 78), wherein the first proximal end is positioned within and is coaxial with the second proximal end (Figure 8) and the first distal end is positioned within and coaxial with the second distal end (Figure 8) such that the inner electrode basket is positioned within and coaxial with the outer electrode basket (Figure 8: spherical envelopes 80 and 82), wherein the inner electrode basket is angularly offset from the outer electrode basket such that the first plurality of struts and the second plurality of struts alternate about a circumference of the electrode assembly (Figure 8: splines 76 are offset from splines 78 and alternate), and wherein each strut of the first plurality of struts and each strut of the second plurality of struts comprises a respective electrode thereon (Figure 8: each spline 76 and 78 has an electrode and [0037]: “In the embodiment show in FIG. 8, splines 76, 78 both include electrodes.”). Eliason does not explicitly disclose an electrode assembly wherein the plurality of struts of the inner basket extend from the first proximal end to the first distal end and are co-planar with a longitudinal axis of the catheter shaft, the longitudinal axis extending through the inner electrode basket, and wherein the plurality of struts of the outer basket extend from the second proximal end to the second distal end and are co-planar with the longitudinal axis of the catheter shaft, the longitudinal axis extending through the outer electrode basket.
However, Hill teaches a device (Figure 7) wherein the plurality of struts of the inner basket extend from the first proximal end to the first distal end and are co-planar with a longitudinal axis of the catheter shaft (Figure 7: electrode struts 712), the longitudinal axis extending through the inner electrode basket (Figure 7), and wherein the plurality of struts of the outer basket extend from the second proximal end to the second distal end and are co-planar with the longitudinal axis of the catheter shaft (Figure 7: outer basket 708), the longitudinal axis extending through the outer electrode basket (Figure 7).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the electrode assembly of Eliason so that the plurality of struts of the inner basket extend from the first proximal end to the first distal end and are co-planar with a longitudinal axis of the catheter shaft, the longitudinal axis extending through the inner electrode basket, and the plurality of struts of the outer basket extend from the second proximal end to the second distal end and are co-planar with the longitudinal axis of the catheter shaft, the longitudinal axis extending through the outer electrode basket as taught by Hill to eliminate the possible problems associated with an electrode touching artery walls and causing injury there (Hill [0079]).
Regarding claim 6, Eliason in view of Hill discloses the electrode assembly of claim 1, and Hill further teaches an electrode assembly wherein the inner electrode basket and the outer electrode basket comprise an electrically conductive shape memory material ([0045]: “Self-expandable members may be formed of any material that is in a compressed state when force is applied and in an expanded state when force is released. Such members may be formed of steel or of shape memory alloys such as Nitinol or any other self-expandable material.”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the catheter system of Eliason so that the inner electrode basket and the outer electrode basket comprise an electrically conductive shape memory material as taught by Hill so that the baskets can change shape based on a force applied to them (Hill [0045]).
Regarding claim 7, Eliason in view of Hill discloses the electrode assembly of claim 1, and Hill further teaches an electrode assembly wherein each strut of the first plurality of struts is equidistant from an adjacent one of the second plurality of struts (Figure 3B: each multiple spacer struts 314 and each multiple electrode struts 316 are equidistant from the adjacent strut).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the catheter system of Eliason so that each strut of the first plurality of struts is equidistant from an adjacent one of the second plurality of struts as taught by Hill since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Regarding claim 9, Eliason in view of Hill discloses the electrode assembly of claim 1, and Eliason further discloses an electrode assembly wherein each strut of the first plurality of struts (Figure 8: splines 76) defines a first radial maximum at a first axial position between the first proximal end and the first distal end (Figure 8: spherical envelope 80), wherein the first radial maxima are circumferentially aligned with one another (Figure 8: splines 76 are circumferentially aligned at spherical envelope 80), and wherein each strut of the second plurality of struts (Figure 8: splines 78) defines a second radial maximum at a second axial position between the first proximal end and the first distal end (Figure 8: spherical envelope 82), wherein the second radial maxima are circumferentially aligned with one another (Figure 8: splines 78 are circumferentially aligned at spherical envelope 82).
Regarding claim 10, Eliason in view of Hill discloses the electrode assembly of claim 9, and Eliason further discloses an electrode assembly wherein the first axial position is the same as the second axial position (Figure 8: spherical envelopes 80 and 82 are at the same axial position).
Regarding claim 11, Eliason in view of Hill discloses the electrode assembly of claim 1, and Hill further discloses an electrode assembly (Figure 7) wherein the first proximal end comprises a first annular proximal collar (Figure 7: ring 722), the first distal end comprises a first annular distal collar (Figure 7: ring 720), the second proximal end comprises a second annular proximal collar (Figure 7: distal end of catheter 730 has an annular collar), and the second distal end comprises a second annular distal collar (Figure 7: distal stop 726).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the electrode assembly of Eliason so that the first proximal end comprises a first annular proximal collar, the first distal end comprises a first annular distal collar, the second proximal end comprises a second annular proximal collar, and the second distal end comprises a second annular distal collar as taught by Hill so that the baskets can be expanded and contracted by moving a pull wire (Hill [0068]).
Regarding claim 13, Eliason in view of Hill discloses the electrode assembly of claim 1, and Eliason further discloses an electrode assembly wherein the first plurality of struts, the first distal end, and the first proximal end are integrally formed (Figure 8: splines 76 are integrally formed), and wherein the second plurality of struts, the second distal end, and the second proximal end are integrally formed (Figure 8: splines 78 are integrally formed).
Regarding claim 14, Eliason discloses a method of forming an electrode assembly (Figure 8), the method comprising: forming an inner electrode basket (Figure 8: splines 76 and spherical envelope 80) including a first proximal end (Figure 8: end connected to catheter), a first distal end (Figure 8: distal end of splines 76), and a first plurality of struts extending between the first proximal end and the first distal end (Figure 8: splines 76); forming an outer electrode basket (Figure 8: splines 78 and spherical envelope 82) including a second proximal end (Figure 8: end connected to catheter), a second distal end (Figure 8: distal end of splines 78), and a second plurality of struts extending between the second proximal end and the second distal end (Figure 8: splines 78), wherein each strut of the first plurality of struts and each strut of the second plurality of struts comprises a respective electrode thereon (Figure 8: each spline 76 and 78 has an electrode and [0037]: “In the embodiment show in FIG. 8, splines 76, 78 both include electrodes.”); positioning the first proximal end within and coaxial with the second proximal end (Figure 8); positioning the first distal end within and coaxial with the second distal end (Figure 8); and orienting the inner electrode basket relative to the outer electrode basket such that the first plurality of struts and the second plurality of struts alternate about a circumference of the electrode assembly (Figure 8: splines 76 are offset from splines 78 and alternate). Eliason does not explicitly disclose a method of forming an electrode assembly comprising: the first plurality of struts being co-planar with a longitudinal axis of the inner electrode basket, the longitudinal axis extending through the inner electrode basket; and the second plurality of struts being co-planar with a longitudinal axis of the outer electrode basket, the longitudinal axis extending through the outer electrode basket.
However, Hill teaches a method of forming an electrode assembly (Figure 7) comprising: the first plurality of struts being co-planar with a longitudinal axis of the inner electrode basket (Figure 7: electrode struts 712), the longitudinal axis extending through the inner electrode basket (Figure 7); and the second plurality of struts being co-planar with a longitudinal axis of the outer electrode basket (Figure 7: outer basket 708), the longitudinal axis extending through the outer electrode basket (Figure 7).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method of Eliason so that the first plurality of struts are co-planar with a longitudinal axis of the inner electrode basket, the longitudinal axis extending through the inner electrode basket, and the second plurality of struts are co-planar with the longitudinal axis of the outer electrode basket, the longitudinal axis extending through the outer electrode basket as taught by Hill to eliminate the possible problems associated with an electrode touching artery walls and causing injury there (Hill [0079]).
Regarding claim 15, Eliason in view of Hill discloses the method of claim 14, and Hill further teaches a method wherein forming the inner electrode basket comprises forming the inner electrode basket from an electrically conductive shape memory material, and wherein forming the outer electrode basket comprises forming the outer electrode basket from the electrically conductive shape memory material ([0045]: “Self-expandable members may be formed of any material that is in a compressed state when force is applied and in an expanded state when force is released. Such members may be formed of steel or of shape memory alloys such as Nitinol or any other self-expandable material.”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method of Eliason so that the inner electrode basket and the outer electrode basket comprise an electrically conductive shape memory material as taught by Hill so that the baskets can change shape based on a force applied to them (Hill [0045]).
Regarding claim 16, Eliason in view of Hill discloses the method of claim 15, and Eliason further discloses a method further comprising electrically insulating the inner electrode basket from the outer electrode basket (Figure 8: the proximal and distal ends of splines 76 and 78 do not have electrodes and thus are insulated from each other).
Regarding claim 17, Eliason in view of Hill discloses the method of claim 16, and Eliason further discloses a method wherein electrically insulating the inner electrode basket from the outer electrode basket comprises depositing an electrically insulating material between the first proximal end and the second proximal end and between the first distal end and the second distal end (Figure 8: the proximal and distal ends of splines 76 and 78 do not have electrodes and thus are insulated from each other).
Regarding claim 19, Eliason discloses a catheter system (Figure 2) comprising: a flexible catheter shaft (Figure 2: shaft 24); a handle coupled to a proximal end of the catheter shaft (Figure 2: handle 22); and an electrode assembly sized for advancement through the catheter shaft to a distal end of the catheter shaft (Figure 2: basket electrode assembly 30 and Figure 8), the electrode assembly comprising: an inner electrode basket (Figure 8: splines 76 and spherical envelope 80) comprising a first proximal end (Figure 8: end connected to catheter), a first distal end (Figure 8: distal end of splines 76), and a first plurality of struts extending between the first proximal end and the first distal end (Figure 8: splines 76); and an outer electrode basket (Figure 8: splines 78 and spherical envelope 82) comprising a second proximal end (Figure 8: end connected to catheter), a second distal end (Figure 8: distal end of splines 78), and a second plurality of struts extending between the second proximal end and the second distal end (Figure 8: splines 78), wherein the first proximal end is positioned within and is coaxial with the second proximal end and the first distal end is positioned within and coaxial with the second distal end such that the inner electrode basket is positioned within and coaxial with the outer electrode basket (Figure 8), wherein the inner electrode basket is angularly offset from the outer electrode basket such that the first plurality of struts and the second plurality of struts alternate about a circumference of the electrode assembly (Figure 8), and wherein each strut of the first plurality of struts and each strut of the second plurality of struts comprises a respective electrode thereon (Figure 8: each spline 76 and 78 has an electrode and [0037]: “In the embodiment show in FIG. 8, splines 76, 78 both include electrodes.”). Eliason does not explicitly disclose a catheter system wherein the plurality of struts of the inner basket extend from the first proximal end to the first distal end and are co-planar with a longitudinal axis of the catheter shaft, the longitudinal axis extending through the inner electrode basket, and wherein the plurality of struts of the outer basket extend from the second proximal end to the second distal end and are co-planar with the longitudinal axis of the catheter shaft, the longitudinal axis extending through the outer electrode basket.
However, Hill teaches a catheter system (Figure 7) wherein the plurality of struts of the inner basket extend from the first proximal end to the first distal end and are co-planar with a longitudinal axis of the catheter shaft (Figure 7: electrode struts 712), the longitudinal axis extending through the inner electrode basket (Figure 7), and wherein the plurality of struts of the outer basket extend from the second proximal end to the second distal end and are co-planar with the longitudinal axis of the catheter shaft (Figure 7: outer basket 708), the longitudinal axis extending through the outer electrode basket (Figure 7).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the catheter system of Eliason so that the plurality of struts of the inner basket extend from the first proximal end to the first distal end and are co-planar with a longitudinal axis of the catheter shaft, the longitudinal axis extending through the inner electrode basket, and the plurality of struts of the outer basket extend from the second proximal end to the second distal end and are co-planar with the longitudinal axis of the catheter shaft, the longitudinal axis extending through the outer electrode basket as taught by Hill to eliminate the possible problems associated with an electrode touching artery walls and causing injury there (Hill [0079]).
Claims 2-5, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Eliason in view of Hill, further in view of Ge et al., US 20160317212, herein referred to as “Ge”.
Regarding claim 2, Eliason in view of Hill discloses the electrode assembly of claim 1, and Hill further teaches an electrode assembly wherein, when energized, the inner electrode basket is configured to act as one of a cathode or an anode (Figure 8: splines 76), and the outer electrode basket is configured to act as one of the cathode or the anode (Figures 8: splines 78). Eliason in view of Hill does not explicitly disclose an electrode assembly wherein, when energized, the inner electrode basket is configured to act as one of a cathode with a positive charge or an anode with a negative charge, and the outer electrode basket is configured to act as the other of the cathode or the anode.
However, Ge teaches an electrode assembly (Figure 2B and 2AA) wherein, when energized, the inner electrode basket (Figure 2AA: anode 2) is configured to act as one of a cathode with a positive charge or an anode with a negative charge ([0049]: “In FIG. 2AA, anode 2 includes individual struts 33 that form a closed cage, similar to cathode cage 1 illustrated in FIG. 2B. In such an embodiment, the volume defined by anode 2 may be smaller in diameter than that defined by cathode cage 1.”), and the outer electrode basket is configured to act as the other of the cathode or the anode (Figure 2B: cathode cage 1).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the electrode assembly of Eliason so that when energized, the inner electrode basket is configured to act as one of a cathode with a positive charge or an anode with a negative charge, and the outer electrode basket is configured to act as the other of the cathode or the anode as taught by Ge to cause an electrochemical reaction in the treatment volume, as defined by the volume enclosed by the outer basket (Ge [0056]).
Regarding claim 3, Eliason in view of Hill and Ge discloses the electrode assembly of claim 2, and Eliason further discloses an electrode assembly further comprising an electrically insulating material disposed between the first proximal end and the second proximal end and between the first distal end and the second distal end, such that the inner electrode basket is electrically insulated from the outer electrode basket (Figure 8: the proximal and distal ends of splines 76 and 78 are insulated, thus the electrode baskets are insulated from each other).
Regarding claim 4, Eliason in view of Hill and Ge discloses the electrode assembly of claim 2, and Eliason further discloses an electrode assembly wherein, when energized, the first plurality of struts has one of a positive charge or a negative charge (Figure 8: splines 76), and the second plurality of struts has the other of the positive charge or the negative charge (Figures 8: splines 78). Ge further discloses an electrode assembly wherein, when energized, the first strut has one of a positive charge or a negative charge (([0049]: “In FIG. 2AA, anode 2 includes individual struts 33 that form a closed cage, similar to cathode cage 1 illustrated in FIG. 2B. In such an embodiment, the volume defined by anode 2 may be smaller in diameter than that defined by cathode cage 1.”), and the second strut has the other of the positive charge or the negative charge, such that the electric charge of adjacent struts in the electrode assembly alternates between a positive charge and a negative charge about the circumference of the electrode assembly (Figure 2B: cathode cage 1). In combination with Eliason, splines 76 of Eliason are combined with anode 2 of Ge because this is the inner electrode basket, while splines 78 of Eliason are combined with cathode cage 1 of Ge because this is the outer electrode basket. Since the splines of Eliason alternate, the combination would result in the electrode assembly alternating between a positive charge and a negative charge about the circumference of the electrode assembly.
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the electrode assembly of Eliason so that when energized, the first plurality of struts has one of a positive charge or a negative charge, and the second plurality of struts has the other of the positive charge or the negative charge as taught by Ge to cause an electrochemical reaction in the treatment volume, as defined by the volume enclosed by the outer basket (Ge [0056]).
Regarding claim 5, Eliason in view of Hill and Ge discloses the electrode assembly of claim 2, and Eliason further discloses an electrode assembly further comprising an insulating material deposited on proximal ends of the first plurality of struts and proximal ends of the second plurality of struts (Figure 8: each of splines 76 and 78 has a space on the proximal end before there is an electrode that acts as an insulator).
Regarding claim 20, Eliason in view of Hill discloses the catheter system of claim 19, further comprising a generator electrically coupled to the electrode assembly and configured to energize the electrode (Figure 2: cable connector 20 and [0025]), wherein, when the electrode assembly is energized by the generator, the inner electrode basket is configured to act as one of a cathode with a positive charge or an anode with a negative charge (Figure 8: splines 76), and the outer electrode basket is configured to act as one of the cathode or the anode (Figure 8: splines 78). Eliason in view of Hill does not explicitly disclose a catheter system wherein, when the electrode assembly is energized by the generator, the inner electrode basket is configured to act as one of a cathode with a positive charge or an anode with a negative charge, and the outer electrode basket is configured to act as the other of the cathode or the anode.
However, Ge teaches a catheter system (Figures 2B and 2AA and 3) wherein, when the electrode assembly is energized by the generator (Figure 3: DC generator 46), the inner electrode basket (Figure 2AA: anode 2) is configured to act as one of a cathode with a positive charge or an anode with a negative charge ([0049]: “In FIG. 2AA, anode 2 includes individual struts 33 that form a closed cage, similar to cathode cage 1 illustrated in FIG. 2B. In such an embodiment, the volume defined by anode 2 may be smaller in diameter than that defined by cathode cage 1.”), and the outer electrode basket is configured to act as the other of the cathode or the anode (Figure 2B: cathode cage 1).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the catheter system of Eliason so that when energized, the inner electrode basket is configured to act as one of a cathode with a positive charge or an anode with a negative charge, and the outer electrode basket is configured to act as the other of the cathode or the anode as taught by Ge to cause an electrochemical reaction in the treatment volume, as defined by the volume enclosed by the outer basket (Ge [0056]).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Eliason in view of Hill, further in view of Vale et al., US 20200305900, herein referred to as “Vale”.
Regarding claim 18, Eliason in view of Hill discloses the method of claim 14, with Eliason disclosing a method wherein forming the inner electrode basket further comprises constructing the inner electrode basket to define a profile of each strut of the first plurality of struts (Figure 8: splines 76) having a first radial maximum (Figure 8: spherical envelope 80), wherein forming the outer electrode basket further comprises constructing the outer electrode basket to define a profile of each strut of the second plurality of struts (Figure 8: splines 78) having a second radial maximum (Figure 8: spherical envelope 82), and wherein orienting the inner electrode basket relative to the outer electrode basket comprises orienting the inner electrode basket relative to the outer electrode basket such that the first radial maximum of each strut of the first plurality of struts is equidistant from an adjacent second maximum of a corresponding one of the second plurality of struts (Figure 8: all struts have the same axial position for their radial maximum). Eliason in view of Hill does not explicitly disclose a method wherein the inner and outer electrode baskets are constructed by heat-setting.
However, Vale teaches a method wherein the inner and outer electrode baskets are constructed by heat-setting ([0185]).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method of Eliason so that the inner and outer electrode baskets are constructed by heat-setting as taught by Vale so that the framework can be any of a huge range of shapes and may be rendered visible under fluoroscopy through the addition of alloying elements or through a variety of other coatings or marker bands (Vale [0185]).
Conclusion
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/N.W.R./Examiner, Art Unit 3794 /SEAN W COLLINS/Primary Examiner, Art Unit 3794