DETAILED ACTION
This action is in response to amendments received on 1/12/2026. Claims 1 and 15-26 were previously rejected. Claims 1 and 15-24 have been amended. A complete action on the merits of claims 1 and 15-26 follows below.
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.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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, 15-26 are rejected under 35 U.S.C. 103 as being unpatentable over Francischelli (US Pub. No. 2010/0023004) in view of Long (US Pub. No. 2014/0052126), Sano (US Pub. No. 2017/0266438) and further in view of SHERMAN (US Pub. No. 2014/0066913).
Regarding Claim 1, Francischelli teaches an electronic apparatus (Fig. 1) for delivering Coherent Sine Burst Irreversible Electroporation energy to a biological tissue ([0027]-[0028]) to be treated, the electronic apparatus comprising:
at least one electrode of a plurality of electrodes that is positionable either on or near the biological tissue to be treated (“one or more electroporation electrodes 26” [0027] or “electrodes 102, 104” [0045], Fig. 1, [0041]-[0042]; Figs. 8A-D, [0045]-[0047]); and
a power generator (22) for supplying electric energy to the at least one electrode (26/ 102,104), said power generator (22) being configured to generate a respective electric signal (S) to energize the at least one electrode ([0028]),
wherein the electric signal (S) is formed by alternating over time a first electric signal (S1) with a second electric signal (S2), each first electric signal (S1) being the same (Figs. 3 & 5E);
said first electric signal (S1) is supplied to the at least one electrode of the plurality of electrodes (26/ 102,104) during a first time interval (T1) and said second electric signal (S2) is supplied to the at least one electrode of the plurality of electrodes (26/ 102,104) during a second time interval (T2) subsequent to the first time interval (T1) (Figs. 3 & 5E);
said first electric signal (S1) is a continuous bipolar signal comprising two or more basic sine waves (SB) in said first time interval (T1) and consisting of one positive half-wave and one negative half-wave, each half-wave having the same width, and the first electric signal (S1) (Fig. 5); and
said second electric signal (S2) has an amplitude equal to zero in said second time interval (T2) (Fig. 5), wherein said power generator comprises a single control unit 34 and a power unit (22) for generating said respective electric signals (S) ([0029]);
said power unit 22 being electrically connected to said plurality of electrodes whereby the plurality of electrodes provides one of a unipolar voltage, a bipolar voltage, or a combination of bipolar and unipolar voltage (Fig. 1 and [0027]-[0028]);
although Francischelli teaches “the pulse generator 22 can vary in one or more of the following manners: waveform shape, pulse polarity, amplitude, pulse duration, interval between pulses, number of pulses per second (frequency), total number of pulses, combination of waveforms, etc. One or more of these parameters can be altered or changed during the ablation procedure. In more general terms, the pulse generator 22 is adapted to generate a high density energy gradient in the range of 10-1,000 V/cm, pulsed at rates on the order of 1-1,000 microseconds. The voltage level, pulse rate, waveform, and other parameters can be varied as described below, with the pulse generator 22 including, in some embodiments, a controller that automatically dictates operational parameters as a function of one or more characteristics of the cardiac tissue target site (e.g., tissue type (such as fatty tissue, thickness, cell orientation, naturally-occurring electrical activity, etc.))” in [0028], does not specifically teach each basic sine wave having a peak-to-peak mean amplitude in the range 2,000 V to 20,000 V and having a frequency in the range 25 kHz to 75 kHz; and; wherein the power unit (201) is configured, in the presence of an electrical return path, to supply adjacent electrodes of the plurality of electrodes with individual electric signals (S) that are out of phase with one another in order to cause the plurality of electrodes to provide a combination of bipolar and unipolar voltage; wherein the power unit (201) is configured to vary the extent to which the individual electric signals (S) supplied to adjacent electrodes of the plurality of electrodes are out of phase with one another.
In the same field of irreversible electroporation treatment, Long teaches supplying a sin waveform 80 having a peak to peak voltage of 200-12000 V for optimum results. It would have been obvious to one having ordinary skill in the art at the time the invention was made to supply a peak to peak voltage of about 2000-12000 V (which lies in the range claimed) in the invention of Francischelli since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Moreover, in the same field of irreversible electroporation treatment Sano teaches “embodiments may employ administering electroporation based therapy using a pulse rate of about 1 Hz to 20 GHz, such as for example from about 10 Hz to 20 GHz, or about 50 Hz to 500 Hz, or 100 Hz to 1 kHz, or 10 kHz to 100 kHz, or from 250 kHz to 10 MHz, or 500 kHz to 1 MHz, such as from 900 kHz to 2 MHz, or from about 100 MHz to about 10 GHz, including from about 200 MHz to about 15 GHz and so on. In an exemplary embodiment, the pulse rate is between 100 kHz and 10 MHz” in [0170]. It would have been obvious to one having ordinary skill in the art at the time the invention was made to supply a frequency in the range 25 kHz to 75 kHz in the invention of Francischelli since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Furthermore, in the same field of irreversible electroporation treatment SHERMAN teaches “an energy generator in communication with the plurality of electrodes, the generator programmable to deliver alternating current energy between approximately 100 volts RMS and approximately 2000 volts RMS or greater. The generator is further programmable to deliver energy in unipolar mode, bipolar mode, and a combination thereof” in the abstract and further teaches the energy generator configured, in the presence of an electrical return path, to supply adjacent electrodes with individual electric signals that are out of phase with one another in order to cause the electrodes to provide a combination of bipolar and unipolar voltage; wherein the power unit is configured to vary the extent to which the individual electric signals (S) supplied to adjacent electrodes are out of phase with one another (“the generator programmable to deliver energy in at least one of bipolar mode and combination of unipolar mode and bipolar mode … energy delivered to each of the plurality of electrodes may be delivered at either an in-phase angle or out-of-phase angle relative to the energy delivered to adjacent electrodes” [0009] and “a plurality of electrodes 26, with each electrode being capable of operating out of phase from one or more adjacent electrodes. This allows for the device 14 to operate in unipolar mode, bipolar mode, or combination thereof” [0024]). It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to allow the power unit to be operable in one or more modes of operation, including for example: (i) bipolar energy delivery between at least two electrodes, (ii) monopolar or unipolar energy delivery to one or more of the electrodes or electrically-conductive portions on the medical device within a patient's body and through a patient return or ground electrode spaced apart from the electrodes of the medical device, such as on a patient's skin or on an auxiliary device positioned within the patient away from the medical device, for example, and (iii) a combination of the monopolar and bipolar modes as well as having individual electrodes of the plurality of electrodes held out of phase with one another such that bipolar energy is driven between the selected out of phase electrodes in view of the teachings of SHERMAN in order to get optimum results by creating deeper and stronger lesions in cardiac ablation using irreversible electroporation.
Regarding Claim 15, Francischelli in view of Long and Sano teaches wherein said first electric signal (S1) has the frequency in the range of 35 kHz to 65 kHz ([0170] of Sano).
Regarding Claim 16, Francischelli in view of Long and Sano teaches wherein said first electric signal (S1) has the frequency in the range of 40 kHz to 60 kHz ([0170] of Sano).
Regarding Claim 17, Francischelli in view of Long and Sano teaches wherein said first electric signal (S1) has the frequency in the range of 45 kHz to 55 kHz ([0170] of Sano).
Regarding Claim 18, Francischelli teaches wherein said first electric signal (S1) comprises from two to fifteen basic sine waves (SB) in said first time interval (T1) (Fig. 5E of Francischelli).
Regarding Claim 19, Francischelli teaches wherein the second time interval (T2) of the second electric signal (S2) has a duration from at least 1 millisecond to 1 second (Fig. 3 of Francischelli).
Regarding Claim 20, Francischelli in view of Long, Sano and SHERMAN teaches wherein the power unit is configured to vary the extent to which the individual electric signals (S) supplied to adjacent electrodes of the plurality of electrodes are out of phase with one another between 0° and 180° (“any phase angle between 0.degree. and 180.degree. could be used to create the desired combined voltage between electrodes” [0025] of SHERMAN).
Regarding Claim 21, Francischelli teaches a method for controlling at least one electrode (26) of a plurality of electrodes (“one or more electroporation electrodes 26” [0027] or “electrodes 102, 104” [0045]) in an electronic apparatus (Fig. 1) for delivering Coherent Sine Burst Irreversible Electroporation energy to a biological tissue ([0027]-[0031]) to be treated, the electronic apparatus comprising the plurality of electrodes (26/ 102,104) positionable either on or near the biological tissue (Fig. 1, [0041]-[0042]; Figs. 8A-D, [0045]-[0047]) to be treated, and a power generator (22) for supplying electric energy to the or each electrode (26/ 102,104), the power generator (22) being configured to generate a respective electric signal (S) to energize each of the plurality of electrodes (26/ 102,104), wherein said power generator (22) comprises a single control unit 34 and a power unit (22) ([0029]) for generating said respective electric signals (S), said power unit (201) being electrically connected to all electrodes of said plurality of electrodes;
the method comprising the steps of:
forming the electric signal (S) by alternating over time a first electric signal (S1) with a second electric signal (S2), each first electric signal (S1) being the same (Fig. 5);
supplying to the at least one electrode 26 of the plurality of electrodes the first electric signal (S1) during a first time interval (T1) and the second electric signal (S2) during a second time interval (T2), subsequent to the first time interval (T1) (Fig. 5),
said first electric signal (S1) being a continuous bipolar signal comprising two or more basic sine waves (SB) in the first time interval (T1) and consisting of one positive half-wave and one negative half-wave, each half-wave having the same width, and the first electric signal (S1) and said second electric signal (S2) having an amplitude equal to zero in a second time interval (T2) subsequent to the first time interval (T1) (Fig. 5),
although Francischelli teaches “the pulse generator 22 can vary in one or more of the following manners: waveform shape, pulse polarity, amplitude, pulse duration, interval between pulses, number of pulses per second (frequency), total number of pulses, combination of waveforms, etc. One or more of these parameters can be altered or changed during the ablation procedure. In more general terms, the pulse generator 22 is adapted to generate a high density energy gradient in the range of 10-1,000 V/cm, pulsed at rates on the order of 1-1,000 microseconds. The voltage level, pulse rate, waveform, and other parameters can be varied as described below, with the pulse generator 22 including, in some embodiments, a controller that automatically dictates operational parameters as a function of one or more characteristics of the cardiac tissue target site (e.g., tissue type (such as fatty tissue, thickness, cell orientation, naturally-occurring electrical activity, etc.))” in [0028], does not specifically teach each basic sine wave having a peak-to-peak mean amplitude in the range 2,000 V to 20,000 V having a frequency in the range 25 kHz to 75 kHz, whereby the plurality of electrodes provides one of a unipolar voltage, a bipolar voltage, or a combination of bipolar and unipolar voltage, wherein the method further comprises: in the presence of an electrical return path supplying, by said power unit (201), adjacent electrodes (3) with individual electric signals (S) that are out of phase with one another in order to cause the electrodes (3) to provide said combination of bipolar and unipolar voltage; wherein the power unit (201) is configured to vary the extent to which the individual electric signals (S) supplied to adjacent electrodes of the plurality of electrodes are out of phase with one another.
In the same field of irreversible electroporation treatment, Long teaches supplying a sin waveform 80 having a peak to peak voltage of 200-12000 V for optimum results. It would have been obvious to one having ordinary skill in the art at the time the invention was made to supply a peak to peak voltage of about 2000-12000 V (which lies in the range claimed) in the invention of Francischelli since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Moreover, in the same field of irreversible electroporation treatment Sano teaches “embodiments may employ administering electroporation based therapy using a pulse rate of about 1 Hz to 20 GHz, such as for example from about 10 Hz to 20 GHz, or about 50 Hz to 500 Hz, or 100 Hz to 1 kHz, or 10 kHz to 100 kHz, or from 250 kHz to 10 MHz, or 500 kHz to 1 MHz, such as from 900 kHz to 2 MHz, or from about 100 MHz to about 10 GHz, including from about 200 MHz to about 15 GHz and so on. In an exemplary embodiment, the pulse rate is between 100 kHz and 10 MHz” in [0170]. It would have been obvious to one having ordinary skill in the art at the time the invention was made to supply a frequency in the range 25 kHz to 75 kHz in the invention of Francischelli since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Furthermore, in the same field of irreversible electroporation treatment SHERMAN teaches “an energy generator in communication with the plurality of electrodes, the generator programmable to deliver alternating current energy between approximately 100 volts RMS and approximately 2000 volts RMS or greater. The generator is further programmable to deliver energy in unipolar mode, bipolar mode, and a combination thereof” in the abstract and further teaches the energy generator configured, in the presence of an electrical return path, to supply adjacent electrodes with individual electric signals that are out of phase with one another in order to cause the electrodes to provide a combination of bipolar and unipolar voltage; wherein the power unit is configured to vary the extent to which the individual electric signals (S) supplied to adjacent electrodes are out of phase with one another (“the generator programmable to deliver energy in at least one of bipolar mode and combination of unipolar mode and bipolar mode … energy delivered to each of the plurality of electrodes may be delivered at either an in-phase angle or out-of-phase angle relative to the energy delivered to adjacent electrodes” [0009] and “a plurality of electrodes 26, with each electrode being capable of operating out of phase from one or more adjacent electrodes. This allows for the device 14 to operate in unipolar mode, bipolar mode, or combination thereof” [0024]). It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to allow the power unit to be operable in one or more modes of operation, including for example: (i) bipolar energy delivery between at least two electrodes, (ii) monopolar or unipolar energy delivery to one or more of the electrodes or electrically-conductive portions on the medical device within a patient's body and through a patient return or ground electrode spaced apart from the electrodes of the medical device, such as on a patient's skin or on an auxiliary device positioned within the patient away from the medical device, for example, and (iii) a combination of the monopolar and bipolar modes as well as having individual electrodes held out of phase with one another such that bipolar energy is driven between the selected out of phase electrodes in view of the teachings of SHERMAN in order to get optimum results by creating deeper and stronger lesions in cardiac ablation using irreversible electroporation.
Regarding Claim 22, Francischelli in view of Long and Sano teaches wherein said first electric signal (S1) has a frequency in the range of 35 kHz to 65 kHz ([0170] of Sano).
Regarding Claim 23, Francischelli in view of Long and Sano teaches wherein said first electric signal (S1) has a frequency in the range of 40 kHz to 60 kHz ([0170] of Sano).
Regarding Claim 24, Francischelli in view of Long and Sano teaches wherein said first electric signal (S1) has a frequency in the range of 45 kHz to 55 kHz ([0170] of Sano).
Regarding Claim 25, Francischelli teaches wherein said first electric signal (S1) comprises from two to fifteen basic sine waves (SB) in said first time interval (T1) (Fig. 5E of Francischelli).
Regarding Claim 26, Francischelli teaches wherein the second time interval (T2) of the second electric signal (S2) has a duration from at least 1 millisecond to 1 second (Fig. 3 of Francischelli).
Response to Arguments
Applicant’s arguments with respect to claims 1 and 15-26 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument as necessitate by amendments.
Conclusion
THIS ACTION IS MADE FINAL. 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
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/KHADIJEH A VAHDAT/Primary Examiner, Art Unit 3794