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
Acknowledgement is made to the claims received 05/22/2026.
Acknowledgement is made to the cancellation of claims 2 and 12.
Acknowledgement is made to the newly added claims 21.
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Any claims listed above as withdrawn have been withdrawn from further consideration by the examiner, as these claims are drawn to a non-elected invention.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, 3-11, and 13-21 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.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Fish (US-20110118727-A1) in view of Ikemoto (US-20150181185-A1), and Stewart (US-20190030328-A1).
Regarding claim 21, 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 ([0039], [0060]);
store measurements of parameters ([0090]); and
determine an index of completeness, 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 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)
Response to Arguments
Applicant’s argument that Ikemoto does not teach the limitation of “wherein the index of completeness comprises a ratio of an achieved dimension from delivery of PEF energy to the target tissue versus the predetermined dimension of lesion formation” as the lesion already exists and therefore is not formed, and for this reason there is no achieved formation is currently unpersuasive. Attention is currently being brought to the rejection of this limitation as Ikemoto is not cited in isolation but rather as an incorporation into an obviousness rejection. In view of this, Ikemoto is not cited as teaching the achieved lesion dimensions by the delivery of energy as this limitation is taught by the base reference of Fish (Non-Final Rejection 02/26/2026, Para. 18, “Fish further teaches achieving lesion dimensions from the delivery of energy to the target tissue”). Rather, Ikemoto is cited for teaching the known use of a lesion index, which is an index for determining the state of a lesion, as being a ratio of a portion of the tissue which is indicated as being a lesion, i.e. an achieved dimension of lesion formation, as the lesion formation does not have to be “achieved” by the delivery of energy during a electrosurgical procedure, as this limitation has already been taught by Fish, instead it must simply have a dimension of a tissue which has “achieved” the status of being indicated as a lesion. Specifically, as the term “achieve” means “to attain,” where “attain” is defined as “to reach in the course of development or growth” (Dictionary.com online dictionary). Therefore, the dimension of any tissue which has reached the state of being lesion tissue would have an “achieved” dimension of lesion formation as broadly as is currently claimed in view of the incorporation of Ikemoto into Fish.
Further, it must be noted that arguing that Ikemoto does not teach the entirety of the limitation is an argument against the reference individually, and in response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Applicant’s argument that Mathur does not teach the limitation of the equations found in claims 9-10 and 19-20 as the cited portion of Mathur is a “value/value comparison” and does not teach a measured delta being divided by an expected delta, is currently unpersuasive. Specifically, as this argument is referring to the reference of Mathur in isolation. The reference of Mathur teaches dividing the measured parameter by the expected parameter, this is in view of the parameter which is taught by Fish as being the change in temperature over time (Non-Final Rejection 02/26/2026, Para. 40 “Fish further teaches utilizing temperature measurements changing over time”). Specifically, applicant’s argument states that Mathus “does not teach … a measured delta (Tf-Ti) and dividing by an expected delta (ΔTn)” which can also be written as
T
f
-
T
i
Δ
T
n
. However, as Mathur teaches dividing the measured parameter by the expected parameter when the parameter is a change in temperature, as is taught by Fish, would be the measured parameter, i.e. measured change in temperature over time, which can be written as
T
f
-
T
i
, divided by the expected parameter, i.e. measured change in temperature over time, which can be written as
Δ
T
n
, would provide the equation
T
f
-
T
i
Δ
T
n
. Therefore, Mathur as incorporated into Fish teaches this limitation as broadly as is currently claimed.
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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