DETAILED ACTION
A complete action on the merits of claims 1-20 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.
Information Disclosure Statement
Applicant should note that the large number of references in the attached IDS have been considered by the examiner in the same manner as other documents in Office search files are considered by the examiner while conducting a search of the prior art in a proper field of search. See MPEP 609.05(b). Applicant is requested to point out any particular references in the IDS which they believe may be of particular relevance to the instant claimed invention in response to this office action.
Claim Objections
Claims 8, 10 and 16 are objected to because of the following informalities:
“the heart” in claim 8 should be amended to recite --a heart--.
“the range” in line 2 of claim 10 should be amended to recite --a range--.
“the range” in line 2 of claim 16 should be amended to recite --a range--.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 13 and 15-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 13 recites the limitation “the pulse waveform includes delivering the voltage pulses to a plurality of electrode sets with voltage pulses delivered to a first electrode set being offset by a period of time from voltage pulses delivery to a second electrode set”. There is insufficient antecedent basis for this limitation in the claim. First, as no voltage pulses have been introduced prior to this recitation, it is unclear what voltage pulses are being referred to. Moreover, it is noted that claim 1 on which this claim depends on introduces “a plurality of ablation electrodes”. It is unclear if a plurality of electrode sets claimed here is the same, part of or different than the plurality of ablation electrodes of claim 1. Furthermore, it is unclear if only two sets of electrodes are present or more than two. It is unclear in what relationship the electrodes are to each other and/or to the plurality of ablation electrodes of claim 1. Clarification and appropriate correction is required.
Claim 15 recites the limitation “at least two electrode sets of the plurality of electrode sets”. There is insufficient antecedent basis for this limitation in the claim. It is noted that claim 14 on which this claim depends on introduces “a plurality of ablation electrodes”. It is unclear if the plurality of electrode sets are part of the plurality of ablation electrodes or in addition to those electrodes. It is further unclear how many sets there are and in what relationship they are to each other and to the plurality of ablation electrodes of claim 14. Clarification and appropriate correction is required.
Claim 17 recites the limitation “a first electrode set of the plurality of electrode sets offset by a period of time from delivering voltage pulses to a second electrode set of the plurality of electrode sets”. There is insufficient antecedent basis for this limitation in the claim. It is noted that claim 14 on which this claim depends on introduces “a plurality of ablation electrodes”. It is unclear if the plurality of electrode sets are part of the plurality of ablation electrodes or in addition to those electrodes. It is further unclear how many sets there are and in what relationship they are to each other and to the plurality of ablation electrodes of claim 14. Clarification and appropriate correction is required.
Claims 16 and 18-20 are rejected due to dependency over a rejected claim.
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 and 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Long (US pub. No. 2014/0052126) in view of Francischelli (US Pub. No. 2010/0023004).
Regarding Claim 1, Long teaches a method of ablating tissue by irreversible electroporation ([0034]), the method comprising:
positioning a portion of an ablation catheter in proximity to one or more pulmonary veins of a patient, the portion defining a loop-shape and including a plurality of ablation electrodes; and
delivering a pulse waveform to selected sets of the plurality of ablation electrodes, wherein: a first level of a hierarchy of the pulsed waveform 80 that includes a first set of pulses ([0057]-[0064] and Figs. 6-8), each pulse of the first set of pulses having a pulse time duration (T in Fig. 5);
a second level (Tw in Figs. 6-8) of the hierarchy that includes a plurality of first sets of pulses as a second set of pulses and second time delays (T1-Tw) separating successive first sets of pulses of the plurality of first sets of pulses, each second time delay being at least three times the duration of a first time delay ([0058]-[0064] and Figs. 6-7, more than three pulses 80 in each set are shown); and
a third level of the hierarchy (combination of T1+Tw or T2-(T1+Tw) as seen in Fig. 7) includes a plurality of second sets of pulses as a third set of pulses and third time delays separating successive second sets of pulses of the plurality of second sets of pulses (Tb in Fig. 7), each third time delay being at least thirty times the duration of a second time delay ([0057]-[0064] and Fig. 7); however, Long does not specifically teach the first level of the hierarchy include first time delays separating successive pulses of the first set of pulses.
In the same field of invention, Francischelli teaches “waveform of the pulsed, high voltage energy as generated by the pulse generator 22 can have a variety of formats. Several non-limiting examples of waveforms in accordance with the present disclosure are shown in FIGS. 5A-5E” in [0032] and shows both a sin wave as in Fig. 5E similar to waveform 80 of Long as well as a square waveform with time delays separating successive pulses of the first set of pulses such as in Fig. 5B.
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to supply a different first waveform such as that shown in Fig. 5B of Francischelli that includes delays between successive pulses as they are all known variations of pulsed high voltage IEP waveforms used to ablate tissue as Francischelli teaches in [0028].
Regarding Claim 10, Long teaches wherein each pulse of each first set of pulses includes biphasic pulses each with a voltage amplitude of at least 500 Volts, the pulse time duration of each biphasic pulse being in the range from about 0.5 nanosecond to about 20 microseconds ([0057]-[0061] of Long, also see [0028]-[0030], [0037] and [0060] of Francischelli).
Regarding Claim 11, Long ion view of Francischelli teaches wherein positioning the portion of the ablation catheter includes positioning the portion of the ablation catheter epicardially ([0038] teaches a number of tissue treatment regions that the system is configured to be positioned at and Francischelli teaches cardiac electroporation ablation, especially epicardial IEP in [0044] and [0077]).
Regarding Claim 12, Long in view of Francischelli teaches wherein the ablation catheter is an endocardial ablation catheter ([0044] of Francischelli).
Claims 14-16 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Long in view of Francischelli and further in view of in view of Mickelsen (US Pub. No. 2015/0182740).
Regarding Claim 14, Long teaches a method of ablating tissue by irreversible electroporation ([0034]), the method comprising:
positioning a portion of an ablation catheter in proximity to one or more pulmonary veins of a patient (“tissue treatment region may be located in the patient's brain, lung, breast, liver, gall bladder, pancreas, prostate gland, various internal body lumen defined by the esophagus, stomach, intestine, colon, arteries, veins, anus, vagina, cervix, fallopian tubes, and the peritoneal cavity” [0038]), the portion defining [a loop-shape] and including a plurality of ablation electrodes (“electrosurgical system may generally comprise two or more electrodes configured to be positioned into or proximal to undesirable tissue in a tissue treatment region (e.g., a target site, or a surgical site)” [0036]);
generating a first level of a hierarchy 80 of the pulsed waveform that includes a first set of pulses ([0057]-[0064] and Figs. 6-8), each pulse of the first set of pulses having a pulse time duration (T in Fig. 5); a second level of the hierarchy (Tw in Figs. 6-8) that includes a plurality of first sets of pulses as a second set of pulses and second time delays separating successive first sets of pulses of the plurality of first sets of pulses (T1-Tw), each second time delay being at least three times the duration of a first time delay ([0058]-[0064] and Figs. 6-7, more than three pulses 80 in each set are shown); and a third level of the hierarchy (combination of T1+Tw or T2-(T1+Tw) as seen in Fig. 7) includes a plurality of second sets of pulses as a third set of pulses and third time delays separating successive second sets of pulses of the plurality of second sets of pulses (Tb in Fig. 7), each third time delay being at least thirty times the duration of a second level time delay ([0057]-[0064] and Fig. 7); however, Long does not specifically teach the first level of the hierarchy include first time delays separating successive pulses of the first set of pulses.
In the same field of invention, Francischelli teaches “waveform of the pulsed, high voltage energy as generated by the pulse generator 22 can have a variety of formats. Several non-limiting examples of waveforms in accordance with the present disclosure are shown in FIGS. 5A-5E” in [0032] and shows both a sin wave as in Fig. 5E similar to waveform 80 of Long as well as a square waveform with time delays separating successive pulses of the first set of pulses such as in Fig. 5B.
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to supply a different first waveform such as that shown in Fig. 5B of Francischelli that includes delays between successive pulses as they are all known variations of pulsed high voltage IEP waveforms used to ablate tissue as Francischelli teaches in [0028].
Furthermore, neither Long nor Francischelli teach generating a set of pacing signals with a cardiac stimulator; delivering the set of pacing signals to a heart; generating voltage pulses in the form of a pulsed waveform and delivering the pulsed waveform to selected sets of the plurality of ablation electrodes in synchrony with the set of pacing signals.
In the same field of invention, Mickelsen teaches “electrodes 530 can be capable of monitoring and/or delivering RF energy, electroporation impulses, and programmed cardiac pacing and/or neuro-stimulus. Unlike other known ablation catheters, the electrodes 530 of the described ablation catheter 20 also can have the capability of delivering extended bipolar high voltage, ultra-short impulses” in [0115] and as seen in Fig. 32. Further Mickelsen teaches “independent electrodes 530 can be assigned polarity individually or in groups” in [0149].
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to use the same catheter and plurality of electrodes for both pacing signals to a heart as well as generating voltage pulses in the form of a pulsed waveform and delivering the pulsed waveform to selected sets of the plurality of ablation electrodes in synchrony with the set of pacing signals in order to allow “monitor the vital signals of the subject. For example, the electrodes 530 can receive the electronic signals produce by the subject's heart to which the electrode 530 is in contact. In an aspect, the electrode 530 can act like an EKG. In another aspect, the electrode 530 can monitor the atrial pacing (including the atria refractory period), the ventrical pacing (including the ventricular refractory period), the cycle length, the QT interval, and the QRS interval of the subject's heart” as Mickelsen teaches in [0117] and to allow the user to sink the ablation with the heart cycle of the patient for better results.
Regarding Claim 15, Long in view of Francischelli and Mickelsen teaches wherein delivering the pulsed waveform includes delivering the pulsed waveform such that each second set of pulses of the plurality of second sets of pulses is delivered during a refractory period associated with a distinct pacing signal of the set of pacing signals and the second sets of pulses delivered to at least two electrode sets of the plurality of electrode sets are delivered during a single refractory period ([0115]-[0117] and [0149] of Mickelsen).
Regarding Claim 16, Long in view of Francischelli teaches wherein each pulse of each first set of pulses includes biphasic pulses each with a voltage amplitude of at least 500 Volts, the pulse time duration of each biphasic pulse being in the range from about 0.5 nanosecond to about 20 microseconds ([0057]-[0061] of Long, also see [0028]-[0030], [0037] and [0060] of Francischelli).
Regarding Claim 19, Long in view of Francischelli and Mickelsen teaches wherein positioning the portion of the ablation catheter includes positioning the portion of the ablation catheter epicardially ([0038] teaches a number of tissue treatment regions that the system is configured to be positioned at and Francischelli teaches cardiac electroporation ablation, especially epicardial IEP in [0044] and [0077], also see [0138]-[0139] and Fig. 47 of Mickelsen).
Regarding Claim 20, Long in view of Francischelli and Mickelsen teaches wherein the ablation catheter is an endocardial ablation catheter ([0044] of Francischelli, also see [0138]-[0139] and Fig. 47 of Mickelsen).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No. 10,322,286. Although the claims at issue are not identical, they are not patentably distinct from each other because they both claim a method of ablating tissue by irreversible electroporation, the method comprising: positioning a portion of an ablation catheter in proximity to one or more pulmonary veins of a patient, the portion defining a loop-shape and including a plurality of ablation electrodes; and delivering a pulse waveform to selected sets of the plurality of ablation electrodes, wherein: a first level of a hierarchy of the pulsed waveform that includes a first set of pulses and first time delays separating successive pulses of the first set of pulses, each pulse of the first set of pulses having a pulse time duration; a second level of the hierarchy that includes a plurality of first sets of pulses as a second set of pulses and second time delays separating successive first sets of pulses of the plurality of first sets of pulses, each second time delay being at least three times the duration of a first time delay; and a third level of the hierarchy includes a plurality of second sets of pulses as a third set of pulses and third time delays separating successive second sets of pulses of the plurality of second sets of pulses, each third time delay being at least thirty times the duration of a second time delay and/or a method of ablating tissue by irreversible electroporation, the method comprising: positioning a portion of an ablation catheter in proximity to one or more pulmonary veins of a patient, the portion defining a loop-shape and including a plurality of ablation electrodes; generating a set of pacing signals with a cardiac stimulator; delivering the set of pacing signals to a heart; generating voltage pulses in the form of a pulsed waveform, wherein: a first level of a hierarchy of the pulsed waveform that includes a first set of pulses and first time delays separating successive pulses of the first set of pulses, each pulse of the first set of pulses having a pulse time duration; a second level of the hierarchy that includes a plurality of first sets of pulses as a second set of pulses and second time delays separating successive first sets of pulses of the plurality of first sets of pulses, each second time delay being at least three times the duration of a first time delay; and a third level of the hierarchy includes a plurality of second sets of pulses as a third set of pulses and third time delays separating successive second sets of pulses of the plurality of second sets of pulses, each third time delay being at least thirty times the duration of a second level time delay; delivering the pulsed waveform to selected sets of the plurality of ablation electrodes in synchrony with the set of pacing signals.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 10,709,891. Although the claims at issue are not identical, they are not patentably distinct from each other because they both claim a system and method of ablating tissue by irreversible electroporation, the method comprising: positioning a portion of an ablation catheter in proximity to one or more pulmonary veins of a patient, the portion defining a loop-shape and including a plurality of ablation electrodes; and delivering a pulse waveform to selected sets of the plurality of ablation electrodes, wherein: a first level of a hierarchy of the pulsed waveform that includes a first set of pulses and first time delays separating successive pulses of the first set of pulses, each pulse of the first set of pulses having a pulse time duration; a second level of the hierarchy that includes a plurality of first sets of pulses as a second set of pulses and second time delays separating successive first sets of pulses of the plurality of first sets of pulses, each second time delay being at least three times the duration of a first time delay; and a third level of the hierarchy includes a plurality of second sets of pulses as a third set of pulses and third time delays separating successive second sets of pulses of the plurality of second sets of pulses, each third time delay being at least thirty times the duration of a second time delay, wherein a fourth level of the hierarchy that includes a plurality of third sets of pulses as a fourth set of pulses and fourth time delays separating successive third sets of pulses of the plurality of third sets of pulses, each fourth time delay being at least ten times the duration of a third time delay and/or sets of electrodes, wherein delivering the pulse waveform includes delivering the voltage pulses to a plurality of electrode sets with voltage pulses delivered to a first electrode set being offset by a period of time from voltage pulses delivery to a second electrode set and/or delivering the pulsed waveform to selected sets of the plurality of ablation electrodes in synchrony with the set of pacing signals.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,144,541. Although the claims at issue are not identical, they are not patentably distinct from each other because they both claim a system and method of ablating tissue by irreversible electroporation, the method comprising: positioning a portion of an ablation catheter in proximity to one or more pulmonary veins of a patient, the portion defining a loop-shape and including a plurality of ablation electrodes; and delivering a pulse waveform to selected sets of the plurality of ablation electrodes, wherein: a first level of a hierarchy of the pulsed waveform that includes a first set of pulses and first time delays separating successive pulses of the first set of pulses, each pulse of the first set of pulses having a pulse time duration; a second level of the hierarchy that includes a plurality of first sets of pulses as a second set of pulses and second time delays separating successive first sets of pulses of the plurality of first sets of pulses, each second time delay being at least three times the duration of a first time delay; and a third level of the hierarchy includes a plurality of second sets of pulses as a third set of pulses and third time delays separating successive second sets of pulses of the plurality of second sets of pulses, each third time delay being at least thirty times the duration of a second time delay, wherein a fourth level of the hierarchy that includes a plurality of third sets of pulses as a fourth set of pulses and fourth time delays separating successive third sets of pulses of the plurality of third sets of pulses, each fourth time delay being at least ten times the duration of a third time delay.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 10,512,779. Although the claims at issue are not identical, they are not patentably distinct from each other because they both claim a system and method of ablating tissue by irreversible electroporation, the method comprising: positioning a portion of an ablation catheter in proximity to one or more pulmonary veins of a patient, the portion defining a loop-shape and including a plurality of ablation electrodes; and delivering a pulse waveform to selected sets of the plurality of ablation electrodes, wherein: a first level of a hierarchy of the pulsed waveform that includes a first set of pulses and first time delays separating successive pulses of the first set of pulses, each pulse of the first set of pulses having a pulse time duration; a second level of the hierarchy that includes a plurality of first sets of pulses as a second set of pulses and second time delays separating successive first sets of pulses of the plurality of first sets of pulses, each second time delay being at least three times the duration of a first time delay; and a third level of the hierarchy includes a plurality of second sets of pulses as a third set of pulses and third time delays separating successive second sets of pulses of the plurality of second sets of pulses, each third time delay being at least thirty times the duration of a second time delay, wherein a fourth level of the hierarchy that includes a plurality of third sets of pulses as a fourth set of pulses and fourth time delays separating successive third sets of pulses of the plurality of third sets of pulses, each fourth time delay being at least ten times the duration of a third time delay and/or a system and method of ablating tissue by irreversible electroporation, the method comprising: positioning a portion of an ablation catheter in proximity to one or more pulmonary veins of a patient, the portion defining a loop-shape and including a plurality of ablation electrodes; generating a set of pacing signals with a cardiac stimulator; delivering the set of pacing signals to a heart; generating voltage pulses in the form of a pulsed waveform, wherein: a first level of a hierarchy of the pulsed waveform that includes a first set of pulses and first time delays separating successive pulses of the first set of pulses, each pulse of the first set of pulses having a pulse time duration; a second level of the hierarchy that includes a plurality of first sets of pulses as a second set of pulses and second time delays separating successive first sets of pulses of the plurality of first sets of pulses, each second time delay being at least three times the duration of a first time delay; and a third level of the hierarchy includes a plurality of second sets of pulses as a third set of pulses and third time delays separating successive second sets of pulses of the plurality of second sets of pulses, each third time delay being at least thirty times the duration of a second level time delay; delivering the pulsed waveform to selected sets of the plurality of ablation electrodes in synchrony with the set of pacing signals.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 10,512,505. Although the claims at issue are not identical, they are not patentably distinct from each other because they both claim a system and method of ablating tissue by irreversible electroporation, the method comprising: positioning a portion of an ablation catheter in proximity to one or more pulmonary veins of a patient, the portion defining a loop-shape and including a plurality of ablation electrodes; and delivering a pulse waveform to selected sets of the plurality of ablation electrodes, wherein: a first level of a hierarchy of the pulsed waveform that includes a first set of pulses and first time delays separating successive pulses of the first set of pulses, each pulse of the first set of pulses having a pulse time duration; a second level of the hierarchy that includes a plurality of first sets of pulses as a second set of pulses and second time delays separating successive first sets of pulses of the plurality of first sets of pulses, each second time delay being at least three times the duration of a first time delay; and a third level of the hierarchy includes a plurality of second sets of pulses as a third set of pulses and third time delays separating successive second sets of pulses of the plurality of second sets of pulses, each third time delay being at least thirty times the duration of a second time delay and/or wherein a fourth level of the hierarchy that includes a plurality of third sets of pulses as a fourth set of pulses and fourth time delays separating successive third sets of pulses of the plurality of third sets of pulses, each fourth time delay being at least ten times the duration of a third time delay and/or generating a set of pacing signals with a cardiac stimulator; and delivering the set of pacing signals to a heart, the voltage pulses being delivered in synchrony with the set of pacing signals such that each second set of pulses of the plurality of second sets of pulses is delivered during a refractory period associated with a distinct pacing signal of the set of pacing signals and the second sets of pulses delivered to at least two electrode sets of the plurality of electrode sets are delivered during a single refractory period and/or wherein the voltage pulses are delivered to a first electrode set of the at least two electrode sets offset by a period of time from delivering the voltage pulses to a second electrode set of the at least two electrode sets.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 10,709,502. Although the claims at issue are not identical, they are not patentably distinct from each other because they both claim a system and method of ablating tissue by irreversible electroporation, the method comprising: positioning a portion of an ablation catheter in proximity to one or more pulmonary veins of a patient, the portion defining a loop-shape and including a plurality of ablation electrodes; and delivering a pulse waveform to selected sets of the plurality of ablation electrodes, wherein: a first level of a hierarchy of the pulsed waveform that includes a first set of pulses and first time delays separating successive pulses of the first set of pulses, each pulse of the first set of pulses having a pulse time duration; a second level of the hierarchy that includes a plurality of first sets of pulses as a second set of pulses and second time delays separating successive first sets of pulses of the plurality of first sets of pulses, each second time delay being at least three times the duration of a first time delay; and a third level of the hierarchy includes a plurality of second sets of pulses as a third set of pulses and third time delays separating successive second sets of pulses of the plurality of second sets of pulses, each third time delay being at least thirty times the duration of a second time delay and/or wherein a fourth level of the hierarchy that includes a plurality of third sets of pulses as a fourth set of pulses and fourth time delays separating successive third sets of pulses of the plurality of third sets of pulses, each fourth time delay being at least ten times the duration of a third time delay and/or generating a set of pacing signals with a cardiac stimulator; and delivering the set of pacing signals to a heart, the voltage pulses being delivered in synchrony with the set of pacing signals such that each second set of pulses of the plurality of second sets of pulses is delivered during a refractory period associated with a distinct pacing signal of the set of pacing signals and the second sets of pulses delivered to at least two electrode sets of the plurality of electrode sets are delivered during a single refractory period and/or wherein the voltage pulses are delivered to a first electrode set of the at least two electrode sets offset by a period of time from delivering the voltage pulses to a second electrode set of the at least two electrode sets.
Allowable Subject Matter
Claims 2-9, 13 and 17-18 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph and Double Patenting set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Regarding Claim 2, Long in view of Francischelli and Mickelsen teaches the invention as applied above, but neither alone or in combination teach wherein a fourth level of the hierarchy that includes a plurality of third sets of pulses as a fourth set of pulses and fourth time delays separating successive third sets of pulses of the plurality of third sets of pulses, each fourth time delay being at least ten times the duration of a third time delay.
Claims 3-9 depend on claim 2.
Regarding Claims 13 and 17, Long teaches “electrosurgical system may generally comprise two or more electrodes configured to be positioned into or proximal to undesirable tissue in a tissue treatment region (e.g., a target site, or a surgical site)” [0036], but not sets of electrodes, wherein delivering the pulse waveform includes delivering the voltage pulses to a plurality of electrode sets with voltage pulses delivered to a first electrode set being offset by a period of time from voltage pulses delivery to a second electrode set/ wherein delivering the pulsed waveform generator includes delivering voltage pulses to a first electrode set of the plurality of electrode sets offset by a period of time from delivering voltage pulses to a second electrode set of the plurality of electrode sets.
Claim 18 depends on claim 17.
Conclusion
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/KHADIJEH A VAHDAT/Primary Examiner, Art Unit 3794
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