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 07/16/2026.
Acknowledgement is made to the amendment of claims 1 and 11.
Acknowledgement is made to the cancellation of claims 2, 10, 12, and 17-20.
Acknowledgement is made to the newly added claim 28.
Any claims listed above as cancelled have sufficiently overcome any rejections set forth in any of the prior office actions.
Claims 1, 3, 5-6, 9, 11, 13, 15-16, 21-22, and 26-28 are pending as rejected below. A complete action on the merits appears below.
Election/Restrictions
In response to applicant’s election of claims 1, 3-9, 11, 13-16, and 21-27 which are noted as being drawn to the election of:
Group I: drawn to a catheter assembly
Species 1: Fig. 8A-9, the catheter assembly being a linear catheter
Sub-Species F: Fig. 5, the electrodes being circular electrodes arranged in a grid around a circumference and the tip having a circular shape
Claims 4, 7-8, 14, and 23-25 have been withdrawn from further consideration by the examiner, as these claims are drawn to a non-elected invention. Specifically, claims 4 and 14 appear to be drawn to Fig. 3D and Fig. 3E, claims 7-8 and claims 23-24 appear to be drawn to Fig. 10A-B, and claim 25 appears to be drawn to Fig. 12A-13.
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.
Claims 1, 3, 21 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Stewart (US 20180325586 A1) in view of Sutermeister (US 20190350649 A1).
Regarding claim 1, Stewart teaches a catheter assembly (Fig. 4; ablation catheter 350) comprising:
a tip electrode array comprising at least one tip electrode (Fig. 4; tip electrode 355 is located at the distal end 353 of the shaft 353), the tip electrode array located at a distal end of the catheter assembly ([0074]); and
a mini electrode array (Fig. 4; mini-electrode sets 357) comprising a plurality of mini electrodes (Fig. 4; mini electrodes 358), the mini electrode array positioned proximal of the tip electrode array ([0074]), wherein each of the at least one tip electrode and each of the plurality of mini electrodes are activated independent of one another for mapping applications ([0050], [0059]- [0060]).
However, Stewart fails to specifically teach multiple electrodes of the at least one tip electrode and the plurality of mini electrodes being activated in unison for ablation applications.
Stewart instead teaches using the mini electrode for mapping and the tip electrode for ablation ([0004]).
Sutermeister teaches a catheter for electrophysiological mapping and ablation using a plurality of electrodes (Abstract).
Sutermeister further teaches the plurality of electrodes as detecting electrophysiological characteristics of tissue and selectively ablate the tissue in various polar configurations ([0012]- [0013], [0024], [0035], [0043], [0052]) such as each electrode being paired with another adjacent electrode to facilitate bipolar mapping and tissue ablation ([0054]- [0055]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the ability for the electrodes to be used for both mapping and ablation, as is taught by Sutermeister, into the catheter assembly having a plurality of electrodes which are usable together or individually to map and ablate tissue as is taught by Stewart, to produce the predictable result of ablating and/or mapping tissue with any desirable electrodes based on the procedure, as is taught by Sutermeister, 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 3, Stewart teaches the catheter assembly of claim 1, wherein the plurality of mini electrodes comprise a plurality of circular electrodes ([0015], [0066]).
Regarding claim 21, Stewart teaches the catheter assembly of claim 1, wherein the plurality of mini electrodes are formed on a flex circuit substrate ([0076]).
Regarding claim 28, Stewart teaches the catheter assembly of claim 1, wherein the mini electrode array include a first group of mini electrodes and a second group of mini electrodes, each of the groups of mini electrodes comprising a plurality of circular electrodes arranged in a grid, and wherein each of the groups of mini electrodes is located at a different angular position around the circumference of the catheter assembly (Fig. 4; mini-electrodes 357 teach this claim limitation as broadly as is currently claimed, specifically in view of the breadth of the terms “group” and “grid” as broadly as is currently provided in the claim, limitation).
Claims 5 is rejected under 35 U.S.C. 103 as being unpatentable over Stewart (US 20180325586 A1) in view of Sutermeister (US 20190350649 A1) further in view of Goldin (US 6546270 B1).
Regarding claim 5, Stewart as modified teaches the catheter assembly of claim 1.
However, Stewart fails to teach the catheter assembly, wherein the at least one tip electrode comprises a plurality of tip electrodes, and wherein the tip electrode array assembly further comprises a plurality of non-conductive segments that separate the plurality of tip electrodes.
While Stewart does not explicitly teach the tip electrode as being a plurality of tip electrodes, there is no evidence that more than wire and opening makes a meaningful difference to the function of the device compared to the currently taught tip electrode and it has been held that a duplication of parts is an obvious modification, as the mere duplication of parts has no patentable significance unless a new and unexpected result is produced (MPEP 2144.04(VI)(B)).
Goldin teaches a multi-electrode catheter for signal sensing to determine signals relevant to mapping applications and delivering ablation energy having at least one electrode for delivering said ablation energy (Abstract).
Goldin further teaches the at least one electrode as being an electrode assembly comprising a plurality of electrodes (Col. 17, Lines 30-35). Each individual electrode being electrically insulated from the other individual electrodes by a non -conductor (Col. 17, Lines 10-30).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the non-conductor between each of the plurality of electrodes, as is taught by Golding, into the catheter assembly having a plurality of tip electrodes as is taught by Stewart as is currently modified, to produce the predictable result of electrically insulating each individual electrode from the other individual tip electrodes, as is taught by Goldin, 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).
Further, while Goldin does not explicitly teach the non-conductor as being a plurality of non-conductors, there is no evidence that more than wire and opening makes a meaningful difference to the function of the device compared to the currently taught non-conductor and it has been held that a duplication of parts is an obvious modification, as the mere duplication of parts has no patentable significance unless a new and unexpected result is produced (MPEP 2144.04(VI)(B)).
Claims 6 is rejected under 35 U.S.C. 103 as being unpatentable over Stewart (US 20180325586 A1) in view of Sutermeister (US 20190350649 A1) further in view of Jung (US 20190365451 A1).
Regarding claim 6, Stewart as modified teaches the catheter assembly of claim 1.
However, Stewart fails to teach the catheter assembly, wherein the mini electrode array comprises four mini electrodes arranged in a square grid pattern.
Jung teaches a catheter assembly having a plurality of electrode on a flex circuit formed at a point proximal to the distalmost point of the catheter (Abstract, [0061]).
Jung further teaches the electrodes as comprising four electrodes which are formed in a square configuration ([0061]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have provided the electrodes of the electrode sets as is taught by Stewart, to be in the form of any known suitable shape, such as a square as is taught by Jung as, it has been held that a change of shape is an obvious modification (MPEP 2144.04(V)(B)), specifically as there is no evidence that using a known suitable shape, such as a simple geometric shape, would produce a predictable result that would be unexpected by a person having ordinary skill in the art.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Stewart (US 20180325586 A1) in view of Sutermeister (US 20190350649 A1) further in view of Wang (US 20080071267 A1).
Regarding claim 9, Stewart teaches the catheter assembly of claim 1.
However, Stewart fails to teach the catheter assembly wherein the tip electrode array has a flat shape.
Wang teaches a catheter having a distal tip having an electrode (Abstract).
Wang further teaches the distal portion as being formed in any of a variety of shapes, such as a flat tip ([0015]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have provided the distal portion containing the tip electrode as is taught by Stewart, to be in the form of any known suitable shape, such as a flat shape as is taught by Wang, as it has been held that a change of shape is an obvious modification (MPEP 2144.04(V)(B)), specifically as there is no evidence that using a known suitable shape, such as a simple geometric shape, would produce a predictable result that would be unexpected by a person having ordinary skill in the art.
Claims 11, 13, 16, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Stewart (US 20180325586 A1) in view of Howard (US 20180214202 A1).
Regarding claim 11, Stewart teaches an electroporation system (Fig. 1; system 50) comprising:
a generator (Fig. 1; generator 154); and
a catheter (Fig. 1; catheter device 100) coupled to the generator, the catheter comprising:
a handle (Fig. 1; handle 206);
a shaft (Fig. 1; shaft 202) extending distally from the handle; and
a catheter assembly ([0074] teaches the ablation catheters distal end usable with the system) coupled to a distal end of the shaft, the catheter assembly comprising:
a tip electrode array comprising at least one tip electrode (Fig. 4; tip electrode 355 is located at the distal end 352 of the shaft 351), the tip electrode array located at a distal end of the catheter assembly ([0074]); and
a mini electrode array (Fig. 4; mini-electrode sets 357) comprising a plurality of mini electrodes (Fig. 4; mini electrode 358), the mini electrode array positioned proximal of the tip electrode array ([0074]), wherein each of the at least one tip electrode and each of the plurality of mini electrodes are configured to be activated independent of one another for mapping applications ([0050], [0059]- [0060]), and wherein at least some of the at least one tip electrode and the plurality of mini electrodes are configured to be activated in unison for ablation applications ([0078]).
However, Stewart fails to teach the generator being configured to simultaneously activate multiple electrodes of the at least one tip electrode and the plurality of mini electrodes for ablation applications.
Stewart instead teaches using the mini electrode for mapping and the tip electrode for ablation ([0004]).
Howard teaches a system for energy delivery and tissue mapping having a plurality of electrodes and a generator (Abstract).
Howard further teaches the generator as delivering mapping energy to each electrode individually to map tissue and to delivery energy to the electrodes in each pair together (Abstract, [0006], [0008]). This provides a device which performs mapping and ablation and the ablation allowing an effectively wider electrode spacing and effectively larger electrode area when delivering energy ([0010]- [0012])
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the ability to activate any of the plurality of electrodes together for mapping or ablation, as is taught by Howard, into the electrodes for mapping and ablation as is taught by Stewart, to produce the predictable result of providing electrodes which can both map and deliver a larger electrode area when delivering energy, as is taught by Howard., 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 13, Stewart teaches the system of claim 11, wherein the plurality of mini electrodes comprise a plurality of circular electrodes ([0015], [0066]).
Regarding claim 16, Stewart teaches the system of claim 11, wherein the catheter is a linear catheter (Fi. 1; shaft 202 extends along longitudinal axis 214; [0083] so as to produce a linear ablation along tissue).
Regarding claim 27, Stewart teaches the system of claim 11, wherein the plurality of mini electrodes are formed on a flex circuit substrate ([0076]).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Stewart (US 20180325586 A1) in view of Howard (US 20180214202 A1) and Goldin (US 6546270 B1).
Regarding claim 15, Stewart as modified teaches the system of claim 11.
However, Stewart fails to teach the system wherein the at least one tip electrode comprises a plurality of tip electrodes, and wherein the tip electrode array assembly further comprises a plurality of non-conductive segments that separate the plurality of tip electrodes.
While Stewart does not explicitly teach the tip electrode as being a plurality of tip electrodes, there is no evidence that more than wire and opening makes a meaningful difference to the function of the device compared to the currently taught tip electrode and it has been held that a duplication of parts is an obvious modification, as the mere duplication of parts has no patentable significance unless a new and unexpected result is produced (MPEP 2144.04(VI)(B)).
Goldin teaches a multi-electrode catheter for signal sensing to determine signals relevant to mapping applications and delivering ablation energy having at least one electrode for delivering said ablation energy (Abstract).
Goldin further teaches the at least one electrode as being an electrode assembly comprising a plurality of electrodes (Col. 17, Lines 30-35). Each individual electrode being electrically insulated from the other individual electrodes by a non -conductor (Col. 17, Lines 10-30).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the non-conductor between each of the plurality of electrodes, as is taught by Golding, into the catheter assembly having a plurality of tip electrodes as is taught by Stewart as is currently modified, to produce the predictable result of electrically insulating each individual electrode from the other individual tip electrodes, as is taught by Goldin, 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).
Further, while Goldin does not explicitly teach the non-conductor as being a plurality of non-conductors, there is no evidence that more than wire and opening makes a meaningful difference to the function of the device compared to the currently taught non-conductor and it has been held that a duplication of parts is an obvious modification, as the mere duplication of parts has no patentable significance unless a new and unexpected result is produced (MPEP 2144.04(VI)(B)).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Stewart (US 20180325586 A1) in view of Howard (US 20180214202 A1) and Jung (US 20190365451 A1).
Regarding claim 22, Stewart teaches the system of claim 11.
However, Stewart fails to teach the system wherein the mini electrode array comprises four mini electrodes arranged in a square grid pattern.
Jung teaches a catheter assembly having a plurality of electrode on a flex circuit formed at a point proximal to the distalmost point of the catheter (Abstract, [0061]).
Jung further teaches the electrodes as comprising four electrodes which are formed in a square configuration ([0061]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have provided the electrodes of the electrode sets as is taught by Stewart, to be in the form of any known suitable shape, such as a square as is taught by Jung as, it has been held that a change of shape is an obvious modification (MPEP 2144.04(V)(B)), specifically as there is no evidence that using a known suitable shape, such as a simple geometric shape, would produce a predictable result that would be unexpected by a person having ordinary skill in the art.
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Stewart (US 20180325586 A1) in view of Howard (US 20180214202 A1) and Wang (US 20080071267 A1).
Regarding claim 26, Stewart as modified teaches the system of claim 11.
However, Stewart fails to teach the system wherein the tip electrode array has a flat shape.
Wang teaches a catheter having a distal tip having an electrode (Abstract).
Wang further teaches the distal portion as being formed in any of a variety of shapes, such as a flat tip ([0015]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have provided the distal portion containing the tip electrode as is taught by Stewart, to be in the form of any known suitable shape, such as a flat shape as is taught by Wang as it has been held that a change of shape is an obvious modification (MPEP 2144.04(V)(B)), specifically as there is no evidence that using a known suitable shape, such as a simple geometric shape, would produce a predictable result that would be unexpected by a person having ordinary skill in the art.
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 Stewart reference are moot in view of the new rejections under the incorporations of Sutermeister and Howard.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LINDSAY REGAN LANCASTER whose telephone number is (571)272-7259. The examiner can normally be reached Monday-Thursday 8-4 EST.
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/L.R.L./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/ Supervisory Patent Examiner, Art Unit 3794
