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 05/22/2026.
Acknowledgement is made to the amendment of claims 1, 12, 16, and 18.
Acknowledgement is made to the cancellation of claims 7, 13-14, and 17.
Any claims listed above as cancelled have sufficiently overcome any rejections set forth in any of the prior office actions.
Claims 1-6, 8-12, 15-16 and 18-20 are pending. A complete action on the merits appears below.
Claim Objections
Claim 20 is objected to because of the following informalities: “the representation the catheter” is grammatically incorrect. Appropriate correction is required.
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 16 and 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Viswanathan (US 10842572 B1).
Regarding claim 16, Viswanathan teaches system for electroporation ablation, comprising:
a catheter (Fig. 1A-B; ablation device 110; Col. 1, Lines 45-50) having a plurality of electrodes (Col. 5, Lines 29-40); and
a controller (Fig. 1B; processor 142, Col. 6, Lines 45-50) configured to:
generate, a software widget including a representation of the location of at least one of the plurality of electrodes in a cross-sectional view of the catheter and an indication of one or more therapeutic sessions of electroporation ablation conducted by the catheter (Col. 14, Lines 60-67 teach the output device as displaying a visual representation of the map of the tissue surface and expected ablation zone as is shown in Fig. 4, where the ablation/catheter device 430, the tissue region 410, and the interface 442 of the distal tip of the ablation/catheter device 430 and the tissue 410); and
display, in a first portion of a graphical user interface, the software widget (Col. 14, Line 60-67)
wherein the software widget includes an indication identifying a therapeutic session of the one or more therapeutic sessions (Col. 15, Lines 10-20),
generate, based on a model of electric fields, a graphical representation of the electric fields of the plurality of electrodes (Fig. 4; pulsed electric field 441): and
display in a second portion of the graphical representation of the electric fields of the plurality of electrodes beside the software widget, wherein the first portion displaying the software widget and the second portion displaying the graphical representation of the electric fields are simultaneously displayed side-by-side in the graphical user interface (Fig. 4 displays the electric field and the widget portion as being next to each other and therefore teaches the limitations of these elements as being “beside” and “side-by-side” relative to each other as broadly as is currently claimed).
Regarding claim 18, Viswanathan teaches the system of claim 16 wherein the cross-sectional view of the catheter in the software widget includes a first representation of the catheter at a first therapeutic session and a second representation of the catheter at a second therapeutic session, wherein the first and second representations show a rotational difference between the catheter at the first and second therapeutic sessions (Col. 7, Lines 1-30 and 45-50, Col. 16, Lines 60-67, Col. 17, Lines 30-40 teaches the map of the target tissue surface as being updated and displayed in real-time).
Regarding claim 19, Viswanathan teaches the system of claim 16 wherein the software widget includes an alignment indicator representing axial relation between a catheter axis of the catheter and a target axis of a target ablation area of the electroporation ablation (Col. 15, Lines 1-30 and 45-50 discusses the representations shown as which include a representation of the catheter’s axis and the target tissue’s axis and the relationship between them as broadly as is claimed being displayed).
Regarding claim 20, Viswanathan teaches the system of claim 19 wherein the representation the catheter includes a first representation of the catheter at a first time and a second representation of the catheter of the second time (Col. 7, Lines 5-10 teaches the visual representation as displaying the position, orientation, and/or configuration of the tracked device as it moves through target anatomy).
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 1-6, 8-12, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Viswanathan (US 10842572 B1) in view of Rubinsky (US 8298222 B2).
Regarding claim 1, Viswanathan teaches a system for performing electroporation ablation of target tissue in or near the heart (Abstract), the system comprising:
a catheter (Fig. 1A-B; ablation device 110; Col. 1, Lines 45-50) including an electrode assembly (Col. 5, Lines 29-40) having a plurality of deployment states (Col. 8, Line 65- Col. 9, Line 18), including a first state having a first shape and a second state having a second shape, different from the first shape, the electrode assembly including a plurality of electrodes (Col. 5, Lines 29-40);
wherein the catheter is adapted to position the electrode assembly at a first location proximate the target tissue (Col. 15, Lines 12-30); and
a controller (Fig. 1B; processor 142, Col. 6, Lines 45-50) configured to:
generate a first graphical representation of a first predicted ablation zone by determining overlap between an anatomical map of the target tissue and a first model of electric fields generated by the plurality of electrodes when the electrode assembly is at a first position relative to the target tissue (Col. 8, Line 65- Col. 9, Line 18 and Col. 15, Lines 12-30 and 45-50 discuss the use of the processor to graphically display the electrodes located on the splines relative to the patient tissue throughout the procedure, wherein as the device is moved to provide treatment, both the current and previous projected ablation zones are displayed);
generate a second graphical representation of a second predicted ablation zone by determining overlap between the anatomical map of the target tissue and a second model of electric fields generated by the plurality of the electrodes when the electrode assembly is at a second position relative to the target tissue (Col. 8, Line 65- Col. 9, Line 18 and Col. 15, Lines 12-30 and 45-50 discuss the use of the processor to graphically display the electrodes located on the splines relative to the patient tissue throughout the procedure, wherein as the device is moved to provide treatment, both the current and previous projected ablation zones are displayed);
display, on a graphical display (Col. 13, Lines 15-30, Col. 14, Lines 60-70 and Col. 18, Lines 37-42), an overlay of the first graphical representation of the first predicted ablation zone and the second graphical representation of the second predicted ablation zone.
Further, Viswanathan teaches the representation of electroporation ablation by the delivery of electrical pulses from electrodes as first and second visual representations of electroporation on a graphic display (Abstract, Fig. 1A)
However, Viswanathan fails to teach the representation of the electroporation as including an inner field representation indicative of a field sufficient to perform irreversible electroporation and an outer field representation indicative of a field sufficient to perform reversible electroporation, wherein the inner field representation is spatially contained within the outer field representation, wherein the inner field representation and the outer field representation are simultaneously displayed as part of the graphical representation; and wherein the inner field representation is visually distinguished from the outer field representation using different indicia.
Rubinsky teaches utilizing at least two electrodes to apply reversible and irreversible electroporation to patient tissue within a target area (Col. 4, Lines 25-40).
Rubinsky further shows a representation of the first and second electrodes (Fig. 6; electrodes 1 and 2) providing electroporation to patient tissue where the electrodes are surrounded by two areas, an area which represents an irreversibly electroporated area and immediately surrounds the electrodes (Fig. 6; irreversibly electroporated area 3) and an area which represents a reversibly electroporated area and further surrounds the electrodes (Fig. 6; reversibly electroporated area 3’). Wherein the reversibly and irreversibly electroporated areas are shown by distinctive marks which are used so as distinguish the areas from one another (Fig. 6; the area 3 is shown as being separate from the area 3’ clearly by the use of separate lines and therefore teaches the limitation of the “indicia” being “different” as broadly as currently claimed).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the representation of the electroporation having two distinct areas, an inner area representing an irreversible electroporation field and an outer area representing a reversible electroporation field, as is taught by Rubinsky, into the representation of electroporation on a graphic display, as is taught by Viswanathan, to produce the predictable result of displaying portions of an electric field, wherein the electric field is known to contain said portions, such as an electric field for electroporation containing irreversible and reversible electroporation, as is taught by Rubinsky, 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 2, Viswanathan teaches the system of claim 1 wherein the first predicted ablation zone is further based on the electrode assembly being in the first state and the second predicted ablation zone is based on the electrode being in the second state (Col. 8, Line 65- Col. 9, Line 18 and Col. 15, Lines 12-30 and 45-50 discuss the use of the processor to graphically display the electrodes located on the splines relative to the patient tissue throughout the procedure, as the device is moved).
Regarding claim 3, Viswanathan teaches the system of claim 1 wherein the catheter is further adapted to rotate the electrode assembly from the first position to the second position (Col. 15, Lines 10-15 and 45-50 discuss the ablation zones as can be seen in Fig. 4-8, which teach this language as broadly as is currently claimed, wherein the catheter is rotated along an axis which allows the distal portion of the catheter to be moved from a position which is perpendicular to the tissue interface to a position which is parallel with the tissue interface).
Regarding claim 4, Viswanathan teaches the system of claim 1 wherein the catheter includes a catheter shaft defining a longitudinal axis, wherein the electrode assembly includes a plurality of splines, a proximal end and a distal end, wherein at least a part of the plurality of electrodes are disposed on the plurality of splines, wherein the proximal end of the electrode assembly extends from the catheter shaft (Col. 8, Lines 50-70).
Regarding claim 5, Viswanathan teaches the system of claim 4 wherein each spline of the plurality of splines is arranged in a curve around the longitudinal axis and between the distal end and the proximal end of the electrode assembly when the catheter is in the first state (Fig. 2A; the splines are shown as being rounded during use).
Regarding claim 6, Viswanathan teaches the system of claim 4, wherein the plurality of splines are arranged in petal-like curves when the catheter is in the second state (Col. 8, Line 65- Col. 9, Line 18 and Col. 15, Lines 12-30 and 45-50 as broadly as is currently claimed, the splines shown are shaped in “petal-like” curves, as the type of plant and stage of development, for example, have not been positively recited to further limit the breadth of the term “petal-like”).
Regarding claim 8, Viswanathan teaches the system of claim 1 wherein the first predicted ablation zone is based on areas where the electric fields have a field strength exceeding a predefined threshold in magnitude (Col. 14, Lines 50-55, additionally, as broadly as claimed, any applied electric field reads on this claim language, as the threshold, as broadly as is claimed, could be for example, zero or very small so that anything which exceeds that, such as a field strength strong enough to produce an ablation as is taught by Viswanathan, reads on this claim language).
Regarding claim 9, Viswanathan teaches the system of claim 8 wherein the second predicted ablation zone is based on areas where the electric fields have a field strength exceeding a predefined threshold in magnitude (Col. 14, Lines 50-55, additionally, as broadly as claimed, any applied electric field reads on this claim language, as the threshold, as broadly as is claimed, could be for example, zero or very small so that anything which exceeds that, such as a field strength strong enough to produce an ablation as is taught by Viswanathan, reads on this claim language).
Regarding claim 10, Viswanathan teaches the system of claim 9 wherein the graphical display further includes a first representation of the catheter (Col. 8, Line 65- Col. 9, Line 18 and Col. 15, Lines 12-30 and 45-50 discuss the use of the processor to graphically display the electrodes located on the splines relative to the patient tissue throughout the procedure, wherein as the device is moved to provide treatment, both the current and previous projected ablation zones are displayed).
Regarding claim 11, Viswanathan teaches the system of claim 1 wherein the controller is further configured to:
generate, a software widget including a representation of the catheter and an indication of one or more therapeutic sessions of electroporation ablation performed by the catheter (Col. 13, Lines 15-30, Col. 14, Lines 60-70 and Col. 18, Lines 37-42); and
display the software widget in the graphical user interface, wherein the software widget includes an indication identifying a therapeutic session of the one or more therapeutic sessions (Col. 8, Line 65- Col. 9, Line 18 and Col. 15, Lines 12-30 and 45-50).
Regarding claims 12 and 15, the recited methods are considered inherent as being taught by the use of the device currently rejected by Viswanathan as modified.
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 Viswanathan/Callas reference are moot in view of the new rejections under Viswanathan and Viswanathan/ Rubinsky.
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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