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.
Status of the Claims
The current office action is made responsive to claims filed 12/29/2025.
Acknowledgement is made to the amendment of claims 5, 9, and 15.
Acknowledgement is made to the cancellation of claims 2, 10, 12, and 17-20.
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Any claims listed above as withdrawn have been withdrawn from further consideration by the examiner, as these claims are drawn to a non-elected invention.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, 5-6, 9, 11, 13, 15-16, 21-22, and 26-27 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Claims 4, 7-8, 14, and 23-25 have been withdrawn from further consideration by the examiner, as these claims are drawn to a non-elected invention.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 § 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, 11, 13, 16, 21, and 27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stewart (US 20180325586 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 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]).
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 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]).
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 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 27, Stewart teaches the system of claim 11, wherein the plurality of mini electrodes are formed on a flex circuit substrate ([0076]).
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 5 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Stewart (US 20180325586 A1) in view of Goldin (US 6546270 B1).
Regarding claim 5, Stewart 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)).
Regarding claim 15, Stewart 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)).
Claims 6 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Stewart (US 20180325586 A1) in view of Jung (US 20190365451 A1).
Regarding claim 6, Stewart 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.
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.
Claims 9 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Stewart (US 20180325586 A1) 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.
Regarding claim 26, Stewart 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 that any search sufficient to cover the scope of an independent claim necessarily requires a search of all species and sub-species is currently unpersuasive as a search is performed based on what is positively recited in the claim language, not every possible variation which could be relevant to what is being claimed, and therefore a search does not “cover every potential species thereof.” It should also be noted that the currently presented argument is an argument relevant to the election of species as a whole and is not relevant specifically to the species election which has been presented for this instant application. Further, Applicant had the opportunity, as provided in the restriction requirement, to provide an argument such as the sub-species being obvious variants of one another and has instead argued that all of these species are patentably distinct and each species therefore requires a different field of search which is defined in the restriction requirement to be “searching different classes and subclasses or employing different search queries” and the mutually exclusive characteristics of the patentably distinct species require by definition different searches.
Conclusion
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/L.R.L./Examiner, Art Unit 3794
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