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 11/03/2025.
Acknowledgement is made to the amendment of claims 1, 12, and 16.
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 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, 15-16, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Viswanathan (US 10842572 B1) in view of Callas (US 20120095459 A1).
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);
generate an indication of a difference between the first and second predicted ablation zones (Col. 18, Lines 30-40 discusses the visual representation of the ablated zones and the expected zones and being provided with two different indicia further Col. 8, Line 65- Col. 9, Line 18 and Col. 15, Lines 12-30 and 45-50 as broadly as is currently claimed, the ablation zones are shown as distinct by the different lines indicating a difference between the two zones); and
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.
However, Viswanathan fails to specifically teach the first graphical representation including a first inner field representation indicative of a field sufficient to perform irreversible electroporation and a first outer field representation indicative of a field sufficient to perform reversible electroporation
Viswanathan does further teach visually differentiating zone types where the zones are distinguished based on the provided therapy (Col. 18, Line 65- Col. 19, Line 5).
Callas teaches a device for delivering therapeutic energy, such as an ablation device using irreversible electroporation using a pulse generator and one or more electrodes ([0005]).
Callas further teaches there being situations where it is advantageous to show multiple boundary zones as a result of a therapy, such as that of reversible electroporation and irreversible electroporation ([0061]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the teaching of showing multiple boundary zones based on a therapy, such as reversible electroporation and irreversible electroporation, as is taught by Callas, into the device which visually differentiates zone types based on the therapy, as is taught by Viswanathan, to produce the predictable result of providing the advantages of these boundary zones as is situationally relevant, as is taught by Callas, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable result is an obvious modification. MPEP 2141(III).
For more information regarding the known spatial relationship between reversible and irreversible electroporation (i.e. the irreversible electroporation field being located within the reversible electroporation field) see the provided conclusion references.
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 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 and an indication of one or more therapeutic sessions of electroporation ablation conducted by the catheter (Fig. 12; ablation device 1250 is shown at a point which provides estimated ablation zone 1230); and
display, in a first portion of a graphical user interface, the software widget (Col. 18, Lines 30-40),
wherein the software widget includes an indication identifying a therapeutic session of the one or more therapeutic sessions (Col. 5, Lines 13-25, Col, 9, Lines 40-50, Col. 12, Lines 5-12),
generate, based on a model of electric fields, a graphical representation of the electric fields of the plurality of electrodes (Fig. 12; ablation zones 1220, 1222, 1224 are depicted at a position separate from and beside the position of the estimated ablation zone 1230 and the ablation device 1250): and
display in a second portion of the graphical representation of the electric fields of the plurality of electrodes beside the software widget (Col. 18, Lines 30-40).
Regarding claim 18, Viswanathan teaches the system of claim 16 wherein the software widget includes a cross-sectional view of the catheter (Col. 7, Lines 1-30 and 45-50).
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).
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 reference are moot in view of the new rejections under Viswanathan and Callas.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure:
US 8298222 B2- Fig. 6 shows the electrodes as being surrounded by irreversibly electroporated area and further surrounded by reversibly electroporated area
US 20110106221 A1- [0014] discusses the comparison of the electroporation effects between irreversible electroporation and reversible electroporation based on the electric field distribution
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/L.R.L./Examiner, Art Unit 3794