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 11/25/2025.
Acknowledgement is made to the amendment of claims 1, 3, 5, and 11.
Acknowledgement is made to the cancellation of claims 2 and 12.
Any claims listed above as cancelled have sufficiently overcome any rejections set forth in any of the prior office actions.
Claims 1, 3-11, and 13-20 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, 3-8, 11, and 13-18 are rejected under 35 U.S.C. 103 as being unpatentable over Fish (US-20110118727-A1) in view of Ikemoto (US-20150181185-A1), Stewart (US-20190030328-A1), and Hawkins (US-20130281920-A1).
Regarding claim 1, Fish teaches a medical system (Fig. 1; system 10), comprising:
a plurality of electrodes (Fig. 1; electrodes 16, 52, 54) that includes at least one electrode configured to be positioned at a distal end of an ablation catheter and being positionable in proximity to a target region of tissue to be ablated ([0041]); and
a generator ([0040]) comprising processing circuitry configured to:
generate at least one pulse to be delivered to the at least one electrode of the plurality of electrodes, the at least one electrode being at a distal end of an ablation catheter and being positionable in proximity to a target region of tissue to be ablated ([0039], [0060]);
store measurements of parameters ([0090]); and
determine an index of completeness indicative of a completeness of ablation of the target region of tissue, the index of completeness determined based at least in part on a change in a measured parameter relative to an expected change in the measured parameter, the change in the measured parameter being caused at least in part on an extent of ablation of the target region, wherein the processing circuitry is configured to set a predetermined dimension of lesion formation ([0105], [0118]).
Fish fails to teach the index of completeness for the lesion as comprising a ratio of an achieved dimension versus the predetermined dimension of lesion formation.
Fish further teaches achieving lesion dimensions from the delivery of energy to the target tissue ([0105]- [0106]).
Ikemoto teaches a device for determining the information such as the state of a lesion or total information concerning diseases relative to the specific lesion, which is referred to as a lesion index (Abstract, [0011]).
Ikemoto further teaches the state of the lesion, which is referred to as the lesion index, as being a ratio of the portion which is indicated as being a lesion compared to the portion which is determined prior as being possible to be a lesion ([0094]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have substituted the teaching of utilizing this known manner of determining an index of a portion of tissue which has completed the process of becoming a lesion, as is known by Ikemoto, into the index for determining the completeness of a lesion as is taught by Fish, to produce the predictable result of determining a lesion index which is a value which provides an indication of the state of the lesion, as is taught by Ikemoto. MPEP 2141(III)
Fish further fails to teach the measured parameter being at least one from a group consisting of a temperature, an impedance, a voltage, a current, a power, and an electrogram (EGM) waveform of the target region.
Hawkins teaches a tissue ablation system which uses sensing methods to gauge the amount of ablation (Abstract, [0020]).
Hawkins further teaches a variety of known parameters as being utilized to determine an amount of ablation, including temperature, impedance, etc. ([0020]).
Therefore would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the use of a known parameter, such as temperature or impedance, for determining the degree of ablation, as is taught by Hawkins, into a device for assessing the effect produced during an ablation, as is taught by Fish, to produce the predictable result of determining the degree of ablation using a known parameter, as is taught by Hawkins 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. MPEP2141(III)
Fish further fails to teach the energy being generated by the generator and delivered by the ablation catheter as being at least one pulsed electric field (PEF) pulse.
Stewart teaches a medical system having a catheter, an energy generator, and one or more electrodes for providing the energy to treat tissue (Abstract, [0057]).
Stewart further teaches the generator as being capable of delivering a variety of energies, such as radiofrequency ablation, pulsed field ablation for electroporation, and the like ([0057]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have substituted the energy source for delivering ablative energy taught by Fish with the generator taught by Stewart as both generators teach delivering a form of electrosurgical energy to electrodes to ablate tissue and it has been held that substituting parts of an invention which perform the same function involves only routine skill in the art. MPEP 2144.06(II)(B)
Regarding claim 3, Fish as modified further teaches the system of Claim 1, wherein the processing circuitry is configured to be preprogrammed with a threshold for an acceptable ratio of completeness, and wherein the processing circuitry is configured terminate the generation of PEF energy based on achieving the threshold for the acceptable ratio of completeness ([0090], [0099]).
Regarding claim 4, Fish as modified further teaches the system of Claim 1, wherein the processing circuitry is configured to generate an alert based on the determined ratio of completeness exceeding a predetermined acceptable ratio of completeness threshold ([0098], [0122]).
Regarding claim 5, Fish as modified further teaches the system of Claim 1, further comprising a display in communication with the processing circuitry, and wherein the processing circuitry is configured to cause display of the index of completeness for at least a subset of the plurality of electrodes ([0015]).
Regarding claim 6, Fish as modified further teaches the system of Claim 5, wherein the processing circuitry is configured to cause display of an area about the plurality of electrodes treated with PEF energy ([0089]- [0092]).
Regarding claim 7, Fish as modified teaches the system of Claim 1, wherein the processing circuitry is configured to cause display of at least one of a color-coded indicator and a variable opacity based on the ratio of completeness for each of the plurality of electrodes ([0090]).
Regarding claim 8, Fish as modified teaches the system of Claim 1, wherein the processing circuitry is configured to measure impedance of at least one of each electrode, between adjacent electrodes, between one of the plurality of electrodes and a ground electrode ([0047]).
Regarding claims 11, 13-18, the method steps are the same as described as the steps the apparatus and system are configured to perform and therefore taught in the same way as seen in claims 1 and 3-8.
Claim 9-10 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Fish (US-20110118727-A1) in view of Ikemoto (US-20150181185-A1) Stewart (US-20190030328-A1) , and Hawkins (US-20130281920-A1) further in view of Mathur (US-20130138097-A1).
Regarding claim 9, Fish as modified teaches the system of claim 1.
However, Fish fails to specifically teach the system of claim 1, wherein determining the index of completeness comprises determining
C
=
k
×
(
T
f
-
T
i
)
∆
T
n
, where "k" is a constant, "Tf” is the final temperature, "Ti" is the initial temperature, and "ΔTn" is the expected change in temperature.
However, Fish further teaches utilizing temperature measurements changing over time to determine the completion of an ablation ([0041]).
Mathur teaches an ablation system including a generator, an ablation element, and a feedback system to determine when an ablation should be terminated (Abstract).
Mathur further teaches the feedback system as being programmed to calculate an expected feedback parameter and then compare a measured parameter to the expected parameter by dividing the measured parameter by the expected parameter to receive a percentage and then comparing that percentage to a preselected threshold ([0038]- [0039]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have substituted the teaching of the parameter which is compared to a threshold to determine completeness of an ablation as being determined by dividing the measured parameter by the expected parameter to determine a percentage, in the case of Fish, this parameter is temperature changing from an initial to a current, as is taught by Mathur, for the parameter which is compared to a threshold to determine completeness of an ablation as being a measured temperature over time, as is taught by Fish, as a simple substitution of one known use of determining a parameter which is compared to a threshold to determine when to terminate ablation energy for another as it has been held that substituting parts of an invention which perform the same function involves only routine skill in the art. MPEP 2144.06(II)(B).
Regarding claim 10, Stewart further teaches determining ablation completeness based on impedance measurements ([0006], [0009]).
In accordance with the above rejection of claim 9, Fish further teaches the parameter which is compared to a threshold to determine ablation completeness as being a change in a measured parameter ([0047]) and in the above incorporation of Mathur further teaches the threshold as being determined by dividing a measured parameter by that of an expected parameter to receive a percentage ([0038]- [0039]).
Regarding claims 19-20, the method steps are the same as described as the steps the apparatus and system are configured to perform and therefore taught in the same way as seen in claims 9 and 10.
Response to Arguments
In response to Applicant’s argument that Ikemoto does not teach an “achieved formation” as the lesion already exists, the Examiners agrees that the lesion of Ikemoto is not being created by an ablation procedure, as this limitation is being taught by Fish. Rather, Ikemoto is being incorporated to teach the known use of a ratio of a measured dimension as being determined to be a lesion in comparison to some predetermined value of a dimension, in this situation, the value which is determined prior to the processing of the dimensions that of being possible to be a lesion, such as the total area, as broadly as is currently claimed by the term “predetermined dimension of lesion formation”. Therefore, Ikemoto gives an index of a ratio of the dimension which has achieved the formation of the lesion in comparison to some predetermined dimension as broadly as is currently claimed. In view of the request for continued examination, the above provided rejection has been modified to clarify what portion of the claim features are taught by Fish in comparison to what is taught by Ikemoto.
In response to Applicant’s arguments that Mathur does not teach the formula for the index of completeness as provided in claim 9 as the index is defined as a ratio and Mathur presents the formula as a percentage is currently unpersuasive. This is unpersuasive as percentage which is multiplied by 100% to provide the percentage is a constant as broadly as is currently claimed as a constant is simply a fixed value or a value which does not change, and therefore, as broadly as is claimed 100% falls within this definition. Further, a ratio is defined by Merriam-Webster as “the relationship in quantity, amount, or size between two or more things” and therefore, as broadly as is claimed, the definition of a ratio, as broadly as is currently claimed is taught by Mathur.
Conclusion
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/L.R.L./Examiner, Art Unit 3794