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 .
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.
Response to Amendment
Acknowledgement is made to the amendment received 01/21/2026.
Acknowledgement is made to the amendment of claims 1, 3, 8-9, 13, and 17.
Acknowledgement is made to the cancellation of claims 2, 6-7.
Acknowledgement is made to the withdrawal of claims 13-20.
Acknowledgement is made to the newly added claims 21-23.
Any claims listed above as cancelled have sufficiently overcome any rejections set forth in any of the prior office actions.
Any claims listed above as withdrawn have been withdrawn from further consideration by the examiner, as these claims are drawn to a non-elected invention.
Claims 1, 3-5, 8-12 and 21-23 are pending as rejected below. A complete action on the merits appears below.
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, 3-4, 8-9, 11, and 21-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kordis (US 5725525 A).
Regarding claim 1, Kordis teaches an end effector (Fig. 1A; electrode support assembly 20) of a catheter (Fig. 1A; probe 10), the end effector comprising:
a plurality of spines (Fig. 1A; flexible spline elements 22) configured to expand away from a longitudinal axis of the end effector to form a basket shape (Col. 5, Lines 58-60);
a first frame loop (Fig. 3; two spline elements 22 are paired together in an integral body 42 and input into slot 56C) comprising a first pair of spines of the plurality of spines such that spines of the first pair of spines are disposed across from each other with respect to the longitudinal axis (Col. 6, Lines 35-40), the first frame loop comprising a distal portion (Fig. 3; detent 46) proximate a distal end of the end effector and traversing the longitudinal axis;
a second frame loop (Fig. 3; two spline elements 22 are paired together in an integral body 42 and input into slot 56B), distinct from the first frame loop, comprising a second pair of spines of the plurality of spines such that spines of the second pair of spines are disposed on a first side of the first frame loop (as broadly as is currently claimed, the spline elements of slot 56B are located on a side which is above that of 56C);
a third frame loop (Fig. 3; two spline elements 22 are paired together in an integral body 42 and input into slot 56D), distinct from the first frame loop and the second frame loop, comprising a third pair of spines of the plurality of spines such that spines of the third pair of spines are disposed on a second side of the first frame loop (as broadly as is currently claimed, the spline elements of slot 56D are located on a side which is below that of 56C), the second side being opposite the first side (the side which is above the spline integral body is opposite the side below the spline integral body as broadly as is currently claimed), each of the second frame loop and the third frame loop comprising an angled portion (the distal end of the frame loops teach this limitation as broadly as is currently claimed, as any portion which contains any angle, such as an angle of 180° teaches the language of “an angled portion” as broadly as is currently claimed) proximate the distal end of the end effector such that each angled portion overlaps a portion of the distal portion of the first frame loop (Fig. 22 shows the distal portions of the frame loops as overlapping as broadly as is currently claimed); and one or more electrodes (Fig. 38; electrode bands 96) coupled to the plurality of spines.
Regarding claim 3, Kordis teaches the end effector of claim 1, the angled portion of each of the second and third frame loop being coupled to the first frame loop (It should be understood within a broadest reasonable interpretation that all elements of an apparatus are “coupled to” all other elements, either directly, indirectly, electrically, etc. and therefore is taught as broadly as is currently claimed).
Regarding claim 4, Kordis teaches the end effector of claim 1, spines of the first pair of spines, the second pair of spines, and the third pair of spines being disposed symmetrically about the longitudinal axis (Col. 2, Lines 35-50 and Col. 6, Lines 60-67).
Regarding claim 8, Kordis teaches the end effector of claim 21, the second frame loop being disposed entirely on the first side of the first frame loop, and the third frame loop being disposed entirely on the second side of the first frame loop (Col. 7, Lines 35-45).
Regarding claim 9, Kordis teaches the end effector of claim 1, further comprising: a retainer (Fig. 9A; cap 48) coupling the first frame loop, the second frame loop, and the third frame loop proximate a distal end of the end effector.
Regarding claim 11, Kordis teaches the end effector of claim 1, wherein the basket shape is approximately spherical (Col. 2, Lines 35-50).
Regarding claim 21, Kordis teaches an end effector (Fig. 1A; electrode support assembly 20) of a catheter (Fig. 1A; probe 10), the end effector comprising:
a plurality of spines (Fig. 1A; flexible spline elements 22) configured to expand away from a longitudinal axis of the end effector to form a basket shape (Col. 5, Lines 58-60);
a first frame loop (Fig. 3; two spline elements 22 are paired together in an integral body 42 and input into slot 56C) comprising a first pair of spines of the plurality of spines such that spines of the first pair of spines are disposed across from each other with respect to the longitudinal axis (Col. 6, Lines 35-40), the first frame loop comprising a distal portion (Fig. 3; detent 46) proximate a distal end of the end effector and traversing the longitudinal axis;
a second frame loop (Fig. 3; two spline elements 22 are paired together in an integral body 42 and input into slot 56B), distinct from the first frame loop, comprising a second pair of spines of the plurality of spines such that spines of the second pair of spines are disposed on a first side of the first frame loop (as broadly as is currently claimed, the spline elements of slot 56B are located on a side which is above that of 56C);
a third frame loop (Fig. 3; two spline elements 22 are paired together in an integral body 42 and input into slot 56C), distinct from the first frame loop and the second frame loop, comprising a third pair of spines of the plurality of spines such that spines of the third pair of spines are disposed on a second side of the first frame loop (as broadly as is currently claimed, the spline elements of slot 56D are located on a side which is below that of 56C), the second side being opposite the first side (the side which is above the spline integral body is opposite the side below the spline integral body as broadly as is currently claimed), each of the second frame loop and the third frame loop comprising an angled portion (the distal end of the frame loops teach this limitation as broadly as is currently claimed, as any portion which contains any angle, such as an angle of 180° teaches the language of “an angled portion” as broadly as is currently claimed) proximate the distal end of the end effector such that each angled portion abuts the distal portion of the first frame loop (Cambridge dictionary defines the term abut as being that “it is next to it on one side” and therefore these frames teach this claim limitation as broadly as is currently claimed); and
one or more electrodes (Fig. 38; electrode bands 96) coupled to the plurality of spines.
Regarding claim 22, Kordis teaches the end effector of claim 21, further comprising:
a retainer (Fig. 9A; cap 48) coupling the first frame loop, the second frame loop, and the third frame loop proximate a distal end of the end effector.
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 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.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Kordis (US 5725525 A) in view of Uihlein (US 20110112547 A1).
Regarding claim 5, Kordis teaches the end effector of claim 1, the first pair of spines being disposed approximately 180° from each other with respect to an imaginary circle about the longitudinal axis (Col. 6, Lines 60-67).
However, Kordis fails to teach the second pair of spines being disposed approximately 60° from each other with respect to the imaginary circle, and the third pair of spines being disposed approximately 60° from each other with respect to the imaginary circle.
Kordis further teaches the electrode support structure including at least three generally flexible splines, the splines being provided with two spline elements (Col. 6, Lines 33-35), which are connected by a distal hub element (Col. 2, Lines 20-25).
Uihlein teaches a balloon-shaped wire basket composed of wire strands and a distal fixing disk element (Abstract).
Uihlein further teaches the wire strands as being able to be able to be fixed on the fixing disc element where they are intersecting and are crossing over other wires or where the wires are fixed without intersecting and the wires are looped through two adjacent openings in the fixing disc, such as those which are shown as being 60° from each other ([0050]).
Therefore, it would have been obvious to a person having ordinary skill before the effective filing date to have combined the spline elements which all overlap as is taught by Kordis with the known connection position of wires of a balloon-shaped wire basket as being through openings which are adjacent to one another as is taught by Uihlein as both intersecting and not intersecting are taught as perform the same function of fixing wires through a distal connection element containing openings as is taught by Uihlein and it has been held that combining parts of an invention which perform the same function involves only routine skill in the art. MPEP 2144.06(II).
Claims 10, 12, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Kordis (US 5725525 A) in view of Olson (US 20190282116 A1).
Regarding claim 10, Kordis teaches the end effector of claim 1.
However, Kordis fails to specifically teach each electrode of the one or more electrodes defining a lumen through the electrode so that each spine of the plurality of spines extends through the lumen of each of the one or more electrodes.
Olson teaches a basket end effector having a plurality of basket splines including a plurality of electrodes ([0053]- [0055]).
Olson further teaches the electrodes as being ring electrodes ([0044]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the electrodes as being ring electrodes, as is taught by Olson, into the electrodes on the splines as is taught by Kordis, to produce the predictable result of electrodes being located on splines, as is taught by Olson, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Regarding claim 12, in accordance with the above rejection of claim 10, Olson further teaches the end effector of claim 1, wherein the one or more electrodes are configured to deliver electrical pulses for irreversible electroporation, the electrical pulses including a peak voltage of at least 900 volts (V) ([0076] teaches the electrodes as being capable of use for a variety of purposes, such as ablation, and therefore any electrode which is configured to deliver energy is configured to deliver this energy in an irreversible electroporation ablation pattern as broadly as is currently claimed).
Regarding claim 23, in accordance with the above rejection of claim 10, Olson further teaches the end effector of claim 21, each electrode of the one or more electrodes defining a lumen through the electrode so that each spine of the plurality spines extends through the lumen of each of the one or more electrodes ([0044]).
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot because the amendments have necessitated new grounds of rejection.
Specifically, applicant’s arguments of the limitations that art not taught by the Olson reference are moot in view of the new rejection of Kordis.
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 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 date of this final action.
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/L.R.L./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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