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 04/06/2026.
Acknowledgement is made to the amendment of claims 1-2, 8, 13, and 20.
Acknowledgement is made to the cancellation of claims 14-19.
Acknowledgement is made to the newly added claims 21-26.
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Any claims listed above as withdrawn have been withdrawn from further consideration by the examiner, as these claims are drawn to a non-elected invention.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 1-16 and 20-26 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 1-2, 8, 13, and 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Nagy (US 5291894 A) in view of Garbagnati (US 20090306654 A1), Lui (US 20200030022 A1), and Lucci (US 20200245883 A1).
Regarding claim 13, Nagy teaches a high frequency device (Abstract), comprising:
a high frequency energy generator (Fig. 1; processing unit 4 is discussed in Col. 1, Lines 10-16 and Col. 2, Lines 50-69 as comprising a signal generator which can generate signals with any desired wave shape and frequency, wherein the frequency is a higher variable frequency of electromagnetic waves) configured for generating and outputting a high frequency power required for a high frequency treatment (Col. 2, Lines 35-45);
a treatment component (Fig. 1; treatment head 1) electrically connected to the high frequency energy generator (Col. 2, Lines 35-55), wherein the treatment component is configured for transmitting the high frequency power outputted by the high frequency energy generator to a treatment site of a heart to perform the high frequency treatment on the treatment site;
a signal acquisition device comprising an electrocardiogram (ECG) signal acquisition device (Fig. 1; electrocardiogram sensor 10), wherein the ECG signal acquisition device comprises an electrode, and the electrode is in contact with a body surface site of a patient to acquire a lead ECG signal represented by a cardiac electrophysiological activity acting on a body surface during a high frequency treatment process; and
a controller (Fig. 4; processing unit 4) electrically connected to the ECG signal acquisition device and the high frequency energy generator, wherein the controller is configured for receiving the lead ECG signals, and controlling the radio frequency power outputted by the radio frequency energy generator according to the lead ECG signal (Col. 3, Line 55- Col. 4, Line 5 and Col. 4, Line 30-50).
However, Nagy fails to teach this high frequency energy generator for treating a patient as being radio frequency for ablation.
Garbagnati teaches treating patient tissue by the application of high frequency electromagnetic energy, wherein the high frequency electromagnetic energy is radiofrequency energy for providing an ablation (Abstract).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the high frequency electromagnetic energy as being radio frequency energy to ablate patient tissue, as is taught by Garbagnati, into the high frequency electromagnetic energy for treating patient tissue as is taught by Nagy, to produce the predictable result of using a known high frequency electromagnetic energy to treat patient tissue, as is taught by Garbagnati, 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).
Nagy further fails to specifically teach the electrode being in contact with a body surface site to acquire a lead ECG signal as being a plurality of electrodes which therefore contact a plurality of different body surface sites and acquire multi-lead ECG signals.
However, while Nagy does not explicitly teach the “electrode” as being plural “electrodes”, there is no evidence that more than one electrode makes a meaningful difference to the function of the device compared to the currently taught wire and opening 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)). Therefore the use of a plurality of electrodes is not patentably distinct over the use of a single electrode.
Nagy further fails to teach the treatment site as being an interventricular septal hypertrophy or an inner wall of myocardium.
Liu teaches a system and method for treatment of hypertrophic cardiomyopathy using an RF ablation electrode system including an RF ablation generator and ECG monitoring ([0043]).
Liu further teaches the treatment site as being the intraventricular septum by being introduced via the myocardium (Abstract).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the treatment site as being the hypertrophic area of the interventricular septum, as is taught by Liu, into the device for treating tissue as is taught by Nagy as currently modified, to produce the predictable result of treating hypertrophic cardiomyopathy, as is taught by Liu, 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).
Nagy further fails to teach the ECG signals comprising a real-time ST-segment amplitude.
Nagy does however teach controlling the radio frequency energy generator based on analysis results of ECG/heart rate measurements (Col. 3, Line 55- Col. 4, Line 5 and Col. 4, Line 30-50).
Lucci teaches a variety of ECG metrics which are relevant to a patient ([0013], [0020], [0173]).
Lucci teaches these metrics as including heart rate, heart rate variability, PVE burden or counts, and changes in a size or shape of morphology of the ECG signal, such as that of the ST segment ([0013], [0020], [0173]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the use of an ST segment as a known ECG metric, as is taught by Lucci, into the ECG metrics as is taught by Nagy, to produce the predictable result of using a known measurement to determine the state of a patient, as is taught by Lucci, 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 claims 1-2, 8 and 21, the recited methods are considered inherent in the ordinary use of the device as described by Nagy as modified in claim 13.
Regarding claim 20, the recited computer-readable storage medium is taught by the current rejection of Nagy as modified in claim 13.
Claims 3-5 are rejected under 35 U.S.C. 103 as being unpatentable over Nagy (US 5291894 A) in view of Garbagnati (US 20090306654 A1) Lui (US 20200030022 A1), and Lucci (US 20200245883 A1) further in view of Ben-David (US 7904151 B2).
Regarding claim 3, Nagy as modified teaches the method of claim 2.
However, Nagy fails to teach the step of analyzing, by the controller, the real- time heart rate according to the multi-lead ECG signals to obtain the analysis result, and controlling the radio frequency power outputted by the radio frequency energy generator according to the analysis result further comprises: calculating, by the controller, the real-time heart rate according to the multi-lead ECG signals, and determining whether the real-time heart rate falls within a heart rate threshold range; and in response to the real-time heart rate not falling within the heart rate threshold range, controlling, by the controller, the radio frequency energy generator to stop outputting the radio frequency power.
Ben-David teaches an apparatus for placement at a site of the heart of a patient, wherein the apparatus comprises a sensor for sensing an electrical parameter, such as the heart rate of the patient, and controlling an electrical stimulation, in the form of a current applied by an electrode, in response to these received RCG and heart rate values (Abstract, Col. 57, Lines 50-35).
Ben-David further teaches a variety of known applications of the stimulation or lack thereof, in response to the received parameters relative to predetermined thresholds (Col. 52, Lines 18-32). For example, the energy generator is controlled not to provide stimulation when the heart rate of the subject is not within a heart rate threshold range (Col. 66, Lines 21-25), the stimulation is not applied when the change in heart rate relative to a prior heart rate is greater than a threshold (Col. 14, Lines 64-67), and that the control unit is adapted to provide current (Col. 46, Lines 40-45 and Col. 47, Lines 11-16).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the use of controlling the energy from the generator based on a variety of heart rate related measurements based on the relationship between the heart rate of the patient and the electrical stimulation, as is taught by Ben-David, into the device which controls energy applied to tissue based on heart related measured parameters as is taught by Nagy, to produce the predictable result of controlling physiological outcomes based on measured physiological parameters, as is taught by Ben-David, 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 4, Ben-David further teaches the method of claim 2, wherein the step of analyzing, by the controller, the real- time heart rate according to the multi-lead ECG signals to obtain the analysis result, and controlling the radio frequency power outputted by the radio frequency energy generator according to the analysis result (Col. 66, Lines 21-25) further comprises: calculating, by the controller, a change rate of heart rate according to the multi-lead ECG signals, and determining whether the change rate of heart rate is greater than a first change rate threshold of heart rate, wherein the change rate of heart rate is a change rate of the real-time heart rate relative to an initial heart rate (Col. 14, Lines 64-67),; and in response to the change rate of heart rate being greater than the first change rate threshold of heart rate, controlling, by the controller, the radio frequency energy generator to stop outputting the radio frequency power (Col. 14, Lines 64-67).
Regarding claim 5, Ben-David further teaches the method of claim 2, wherein the step of analyzing, by the controller, the real- time heart rate according to the multi-lead ECG signals to obtain the analysis result, and controlling the radio frequency power outputted by the radio frequency energy generator according to the analysis result further comprises: calculating, by the controller, a variation rate of heart rate according to the multi-lead ECG signals, and determining whether an absolute value of the variation rate of heart rate is less than a variation rate threshold of heart rate, wherein the variation rate of heart rate is a variation rate of the real-time heart rate relative to an initial heart rate (Col. 46, Lines 20-25); and in response to the absolute value of the variation rate of heart rate not being less than the variation rate threshold of heart rate, controlling, by the controller, the radio frequency energy generator to stop outputting the radio frequency power (Col. 14, Lines 64-67).
Claims 6-7 and 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Nagy (US 5291894 A) in view of Garbagnati (US 20090306654 A1) Lui (US 20200030022 A1), Lucci (US 20200245883 A1) and Ben-David (US 7904151 B2), further in view of Arnold (US 4573478 A).
Regarding claim 6, Nagy as modified teaches claim 4.
However, Nagy fails to teach wherein the radio frequency ablation device further comprises a first counter electrically connected to the controller, and the step of analyzing, by the controller, the real-time heart rate according to the multi-lead ECG signals to obtain the analysis result, and controlling the radio frequency power outputted by the radio frequency energy generator according to the analysis result further comprises: determining, by the controller, whether the change rate of heart rate is greater than a second change rate threshold of heart rate; in response to the change rate of heart rate being greater than the second change rate threshold of heart rate, controlling, by the controller, a count value of the first counter to add one, and determining whether the count value of the first counter is greater than a first count threshold, wherein the second change rate threshold of heart rate is less than the first change rate threshold of heart rate; and in response to the count value of the first counter being greater than the first count threshold, controlling, by the controller, the radio frequency energy generator to pause outputting the radio frequency power, and clearing the count value of the first counter to zero.
Ben-David further teaches the known use of a counter for counting the number of heart beats in a time period (Col. 29, Line 25-48) and the controller being configured for determining is a heart rate exceeds first and second thresholds wherein the first threshold is greater than the second and if the value exceeds the first threshold stopping the power and if the value is not greater than the first threshold, reduce the power (Col. 14., Line 54- Col. 15, Line 21).
However, Ben-David fails to teach the control from the controller being based on controlling count values in response to heart rate parameters.
Arnold teaches an apparatus for sensing a patient’s heart rate using a circuit (Abstract).
Arnold further teaches the use of counters which detect heart beats and use the heart beats as a trigger for the device (Abstract).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the known use of a heart rare counter to control a device, as is taught by Arnold, into the device which is controlled based on ECG parameters as is taught by Nagy as modified, to produce the predictable result of controlling the device based on an ECG heartbeat signal, as is taught by Arnold, 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 7, Ben-David teaches the method of claim 6, wherein the step of analyzing, by the controller, the real- time heart rate according to the multi-lead ECG signals to obtain the analysis result, and controlling the radio frequency power outputted by the radio frequency energy generator according to the analysis result further comprises: in response to the value not being greater than the threshold, controlling, by the controller, the radio frequency energy generator to reduce the outputted radio frequency power (Col. 14., Line 54- Col. 15, Line 21).
In accordance with the above rejection of claim 6, Arnold teaches the value as being the count value of the counter (Abstract).
Regarding claim 11, Nagy as modified teaches the method of claim 8.
However, Nagy fails to teach the method wherein the radio frequency ablation device further comprises a second counter electrically connected to the controller, and the step of analyzing, by the controller, the real-time ST-segment amplitude according to the multi-lead ECG signals to obtain the analysis result, and controlling the radio frequency power outputted by the radio frequency energy generator according to the analysis result further comprises:
obtaining, by the controller, a change rate of ST-segment amplitude according to the multi- lead ECG signals, and determining whether the change rate of ST-segment amplitude is greater than a change rate threshold of ST-segment amplitude, wherein the change rate of ST-segment amplitude is a change rate of the real-time ST-segment amplitude relative to an initial ST-segment amplitude;
in response to the change rate of ST-segment amplitude being greater than the change rate threshold of ST-segment amplitude, controlling, by the controller, a count value of the second counter to add one, and determining whether the count value of the second counter is greater than a second count threshold; and
in response to the count value of the second counter being greater than the second count threshold, controlling, by the controller, the radio frequency energy generator to pause outputting the radio frequency power, and clearing the count value of the second counter to zero.
In accordance with the above modification, Arnold teaches the device comprising a second counter for counting a parameter which is separate from the first parameter (Abstract).
In accordance with the above incorporation of Ben-David, Ben-David teaches controlling radio frequency generator energy to stop/reduce outputting the radio frequency power when a parameter relevant to the heart, such as the heart rate or the change in heart rate variability exceeds a threshold (Col. 66, Lines 21-25).
In accordance with above modification, Lucci teaches the parameter for controlling the device as being the ST-segment amplitude ([0013]).
Regarding claim 12, in accordance with the above provided rejection of claim 11, Ben-Davis teaches the method of claim 11, wherein the step of analyzing, by the controller, the real-time ST-segment amplitude according to the multi-lead ECG signals to obtain the analysis result, and controlling the radio frequency power outputted by the radio frequency energy generator according to the analysis result further comprises: in response to the count value of the second counter not being greater than the second count threshold, controlling, by the controller, the radio frequency energy generator to reduce the outputted radio frequency power (Col. 66, Lines 21-25).
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Nagy (US 5291894 A) in view of Garbagnati (US 20090306654 A1) further in view of Lui (US 20200030022 A1), Lucci (US 20200245883 A1), Ben-David (US 7904151 B2), and Ghosh (US 20190030331 A1).
Regarding claim 9, Nagy as modified teaches the method of claim 8.
However Nagy fails to teach the method wherein the step of analyzing, by the controller, the real- time ST-segment amplitude according to the multi-lead ECG signals to obtain the analysis result, and controlling the radio frequency power outputted by the radio frequency energy generator according to the analysis result further comprises: obtaining, by the controller, the real-time ST-segment amplitude according to the multi-lead ECG signals, and calculating an offset of ST-segment amplitude, wherein the offset of ST-segment amplitude is an offset of the real-time ST-segment amplitude relative to an initial ST-segment amplitude; determining, by the controller, whether the offset of ST-segment amplitude is less than an offset threshold of ST-segment amplitude; and in response to the offset of ST-segment amplitude not being less than the offset threshold of ST-segment amplitude, controlling, by the controller, the radio frequency energy generator to stop outputting the radio frequency power.
In accordance with the above incorporation of Ben-David, Ben-David teaches controlling radio frequency generator energy to stop outputting the radio frequency power when a parameter relevant to the heart, such as the heart rate or the change in heart rate variability exceeds a threshold (Col. 66, Lines 21-25).
However, Ben-David modified into Nagy fails to teach this relevant parameter as being an offset of an ECG feature.
Ghosh teaches signals being received from the body surface to determine specific ECG features as being use to evaluate cardiac health and/or therapy ([0007]).
Ghosh further teaches the ECG feature as being a segment offset ([0007]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the ECG features as including an offset, as is taught by Ghosh, into the ECG parameters, as is taught by the modified device of Nagy, to produce the predictable result of using a known ECG feature to evaluate cardiac health and/or therapy, as is taught by Ghosh, 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 10, in accordance with the above incorporation, Lucci teaches the method wherein the step of analyzing, by the controller, the real-time ST-segment amplitude according to the multi-lead ECG signals to obtain the analysis result, and controlling the radio frequency power outputted by the radio frequency energy generator according to the analysis result further comprises: calculating, by the controller, a variation rate of ST-segment amplitude according to the multi- lead ECG signals, and determining whether an absolute value of the variation rate of ST-segment amplitude is less than a variation rate threshold of ST-segment amplitude, wherein the variation rate of ST-segment amplitude is a variation rate of the real-time ST-segment amplitude relative to an initial ST-segment amplitude ([0013], [0020], [0173]).
In accordance with the above rejection, Ben-David further teaches the claim limitation wherein in response to the absolute value of the variation rate of ST-segment amplitude not being less than the variation rate threshold of ST-segment amplitude, controlling, by the controller, the radio frequency energy generator to stop outputting the radio frequency power, as Ben-David teaches controlling radio frequency generator energy to stop outputting the radio frequency power when a parameter relevant to the heart, such as the heart rate or the change in variability of a parameter related to heart rate exceeds a threshold (Col. 66, Lines 21-25).
Claims 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Nagy (US 5291894 A) in view of Garbagnati (US 20090306654 A1), Lui (US 20200030022 A1), and Lucci (US 20200245883 A1) further in view of Robinson (US 20210137384 A1).
Regarding claim 22, Nagy as modified teaches the method of claim 21.
However, Nagy fails to teach the step of controlling, by the controller, the radio frequency power outputted by the radio frequency energy generator according to the multi-lead ECG signals, comprises:
Determining, by the controller, whether the risk level of arrhythmia is high according to the multi-lead ECG signals; and
Controlling, by the controller, the radio frequency energy generator to stop outputting the radiofrequency power when the risk level of arrythmia is high.
Robinson teaches a method for controlling an ablation based on information relevant to arrhythmia risk (Abstract).
Robinson further teaches controlling the ablation so as to provide the ablation when the risk level of arrhythmia is not high ([0099], [0110])
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the known use of not providing ablation when a cardiac arrhythmia risk is high, as is taught by Robinson, into the method for controlling the ablation of patient tissue as is taught by Nagy as modified, to produce the predictable result of providing ablation without high risk of arrhythmias, as is taught by Robinson, 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 23, Nagy as modified teaches the method of claim 22.
In accordance with the above modification, Ben-David teaches not providing ablation when at least one of the following conditions is satisfied:
the real-time heart rate does not fall within a heart rate threshold range (Col. 66, Lines 21-25);
a change rate of heart rate is not less than a first change rate threshold of heart rate, wherein the change rate of heart rate is a change rate of the real-time heart rate relative to an initial heart rate;
an absolute value of the variation rate of heart rate is not less than a variation rate threshold of heart rate, wherein the variation rate of heart rate is a variation rate of the real-time heart rate relative to an initial heart rate;
an offset of ST segment amplitude is not less than an offset threshold of ST segment amplitude; or
an absolute value of the variation rate of ST segment amplitude is not less than a variation rate threshold of ST segment amplitude.
Further, in accordance with the above modification, Robinson teaches not providing ablation when the risk level of arrythmia is high ([0099], [0110]).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Nagy (US 5291894 A) in view of Garbagnati (US 20090306654 A1), Lui (US 20200030022 A1), Lucci (US 20200245883 A1) and Robinson (US 20210137384 A1) further in view of Govari ‘259 (US 20210113259 A1)
Regarding claim 24, Nagy as modified teaches the method of claim 22.
However, Nagy fails to teach the method further comprising:
determining, by the controller, whether a temperature is greater than a temperature upper limit; controlling, by the controller, the radio frequency energy generator to stop outputting the radio frequency power when the temperature is greater than a temperature upper limit.
Govari ‘259 teaches a method for ablating patient tissue (Abstract).
Govari ‘259 further teaches that if the monitored temperature exceeds a predefined maximal temperature, halting the ablation ([0008]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the feature of halting an ablation when a temperature exceeds a predefined maximal temperature, as is taught by Govari ‘259, into the method for providing ablation to tissue as is taught by Nagy as modified, to produce the predictable result of controlling the ablation based of predefined temperature limits, as is taught by Govari ‘259, 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).
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Nagy (US 5291894 A) in view of Garbagnati (US 20090306654 A1), Lui (US 20200030022 A1), Lucci (US 20200245883 A1) and Robinson (US 20210137384 A1) further in view of Govari ‘209 (US 20170209209 A1).
Regarding claim 25, Nagy as modified teaches the method of claim 24.
However, Nagy fails to teach the method further comprising:
determining, by the controller, whether an actual ablation time reaches a set ablation time;
controlling, by the controller, the radio frequency energy generator to stop outputting the radio frequency power when the actual ablation time reaches the set ablation time; or controlling, by the controller, to return to the step of determining, by the controller, whether the radio frequency power is manually adjusted when the actual ablation time does not reach the set ablation time.
Govari ‘209 teaches a method for providing radiofrequency power to patient tissue (Abstract).
Govari ‘209 further teaches that when an impedance measurement exceeds a preset value, halting ablation ([0021]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated halting the ablation of tissue when a measured impedance value exceeds a preset value, as is taught by Govari ‘209, into the method for ablating patient tissue as is taught by Nagy as modified, to produce the predictable result of controlling ablation based of predefined impedance values, as is taught by Govari ‘209, 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).
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Nagy (US 5291894 A) in view of Garbagnati (US 20090306654 A1), Lui (US 20200030022 A1), Lucci (US 20200245883 A1) and Robinson (US 20210137384 A1) further in view of Highsmith (US 20170105783 A1).
Regarding claim 26, Nagy as modified teaches the method of claim 25.
However, Nagy fails to teach the method further comprising:
determining, by the controller, whether an impedance meets a preset impedance condition; controlling, by the controller, the radio frequency energy generator to pause outputting the radio frequency power when the impedance meets the preset impedance condition; and controlling, by the controller, to execute the step of determining, by the controller, whether the actual ablation time reaches the set ablation time when the impedance does not meet the preset impedance condition.
Highsmith teaches providing patient tissue with ablation power and controlling said power based on measured ablation parameters (Abstract).
Highsmith further teaches stopping the power being supplied during the ablation session when a time exceeds a threshold ablation session time ([0016]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the known use of stopping the supply of ablation power when a time exceeds a threshold, as is taught by Highsmith, into the method for controlling an ablation as is taught by Nagy as modified, to produce the predictable result of controlling an ablation based on a predefined ablation session time, as is taught by Highsmith, 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).
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 Nagy/Garbagnati reference are moot in view of the new rejections under Nagy/Garbagnati/Lui and Lucci.
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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