DETAILED ACTION
The following is a Non-Final Office Action on the merits.
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
Acknowledgment is made to the amendment received 6/22/2026.
Applicant’s arguments with respect to the priority are persuasive. Accordingly, this action is set forth as a non-final office action.
Applicant’s amendments are sufficient to overcome the specification objection set forth in the previous office action.
Applicant’s amendments are sufficient to overcome the claim objections set forth in the previous office action except for those below.
Applicant’s amendments are sufficient to overcome the 35 USC 112(b)/second paragraph rejections set forth in the previous office action except for those below.
The Examiner notes that the 35 USC 112(b) rejection with respect to the unbounded range of claim 4 is withdrawn as the originally filed disclosure provides support for an electrode capable of delivery RF signals at any force applied between the electrode and the tissue since the originally filed disclosure only discusses applying the RF signals and HV pulses between the “tip electrode 15” and the body electrodes (no mention is made that the RF signals and HV pulses are applied to ring electrodes discussed in Par. [0047].
The Examiner notes that the 35 USC 112(b) rejection with respect to the unbounded range of claim 14 is withdrawn as the originally filed disclosure provides support for an upper bound of 40% in Par. [0065].
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 & 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 17/980515, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
Application No. 17/980515, fails to provide adequate support for claim 14 as there is no mention in Application no. 17/980515 that a “combined lesion is at least 20% greater than a lesion formed by the same radiofrequency signals lone or the same high voltage pulses alone”.
Accordingly, claims 1-2, 4 & 7-13 are given the priority benefit date of 12/3/2019.
Accordingly, claim 14 is given the priority benefit date of 9/11/2022.
Claim Objections
Claim 11 is objected to because of the following informalities: amend “adjacent pulse trains” to -adjacent pulse trains of the plurality of pulse trains- in ll. 3. Appropriate correction is required.
Claim Rejections - 35 USC § 112
Claims 4 & 12 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 4 recites the limitation "approximately 5 grams or more". It is unclear how this would further limit the claim from which it depends since it fails to recite further structure, either implicitly or explicitly.
Claim 12 recites the limitation "a plurality of pulse trains"; however, claim 10, upon which claim 12 depends, recites "a pulse train". It is unclear if the "plurality of pulse trains" include the single "pulse train" recited in claim 10. For purposes of examination, the claim will be interpreted as -The ablation system of claim 10, wherein the pulse train comprises a plurality of pulse trains that in turn provide a pulsed field (PF) burst.-
Claim Interpretation
With the amendment of 6/22/2026, the claims no longer recite the high voltage pulses are DC high voltage pulses. Claim 7 recites the “high voltage pulses include an amplitude of at least 800 V”. Under BRI, since neither claim 1 nor claim 7 limit the high voltage pulses to DC high voltage pulses, the RMS voltage amplitude of AC pulses is considered to read on the claim.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-2, 4, 7 & 14 is/are rejected under 35 U.S.C. 102(a)(1) or 102(a)(2) as being anticipated by Sherman (2014/0066913).
Concerning claim 1, as illustrated in at least Figs. 1-4, Sherman discloses an ablation system (system 10; [0023]) comprising:
an ablation energy generator configured to provide radiofrequency signals at high power and to provide high voltage pulses (energy generator 16 may be an RF energy generator capable of delivering energy in multiple modes, such as unipolar, bipolar, and combination thereof, such as 4:1, 2:1, and 1:1 (a duty cycle-controlled power delivery system and the generator 16 is capable of delivering pulsed alternating current (AC) RF energy of approximately 500 volts RMS to approximately 2000 volts RMS or more (for example, up to 3000 V); [0020]); and
a catheter having an end effector electrically coupled to the ablation energy generator, the end effector comprising at least one electrode (medical device 14 is a catheter having an end effector comprising electrodes 26 connected to generator 16; [0017]) configured to deliver the high voltage pulses from the at least one electrode to organ tissue inside a body of a patient to first and second return electrodes coupled to the body of the patient and deliver the radiofrequency signals between the at least one electrode to one of the first or second return electrodes (energy generator 16 may simultaneously or selectively deliver to the electrode(s) 26, RF energy in multiple modes, including unipolar, at a lower voltage (for example, approximately 100 to approximately 150 volts RMS) for ablating tissue using primarily heat energy and pulsed alternating current (AC) RF energy of approximately 500 volts RMS to approximately 2000 volts RMS or more (for example, up to 3000 V for electroporating tissue to greater deeper lesions without a substantial increase in heat energy, and thus unintended damage to non-target tissue or tissue charring may be avoided; [0020-0022]).
Concerning claim 2, Sherman discloses the radiofrequency signals and the high voltage pulses are configured to be applied either sequentially or simultaneously to the organ tissue ([0022]; Fig. 4).
Concerning claim 4, Sherman discloses the at least one electrode (26) is configured to deliver the radiofrequency signals when a contact force between the at least one electrode and the organ tissue is approximately 5 grams or more as the system may be adjusted manually and thus activated when the electrode applies the claimed force ([0018]).
Concerning claim 7, Sherman discloses the high voltage pulses to have an amplitude of at least 800 V ([0022]).
Concerning claim 14, Sherman discloses in which the at least one electrode (26) is configured to deliver the high voltage pulses and the radiofrequency signals to the organ tissue to form a combined lesion in the organ tissue such that the combined lesion is greater than a lesion formed by the same radiofrequency signals alone or the same high voltage pulses alone ([0006-0008], [0020]). Sherman fails to specifically disclose the combined lesion to be at least 20% greater. Sherman teaches delivering both RF energy and electroporation energy produces deeper lesions without the production of high heat, and particularly that deep lesions are sometimes required to effectively treat some cardiac conditions ([0006-0008]). It would have been obvious to one having ordinary skill in the art at the time the invention the invention was effectively filed to modify the invention of Sherman such that the combined lesion is at least 20% greater in view of the teachings of Sherman as Applicant appears to have placed no criticality on the claimed value (indicating only that the “combined depth can be about 20% to about 40% greater than either of the first depth and the second size” in Par. [0066]), since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-2, 4, 7, 9-10 & 12-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sherman (2014/0066913) in view of Viswanathan et al. (2018/0311497).
Concerning claim 1, as illustrated in at least Figs. 1-4, Sherman discloses an ablation system (system 10; [0023]) comprising:
an ablation energy generator configured to provide radiofrequency signals at high power and to provide high voltage pulses (energy generator 16 may be an RF energy generator capable of delivering energy in multiple modes, such as unipolar, bipolar, and combination thereof, such as 4:1, 2:1, and 1:1 (a duty cycle-controlled power delivery system and the generator 16 is capable of delivering pulsed alternating current (AC) RF energy of approximately 500 volts RMS to approximately 2000 volts RMS or more (for example, up to 3000 V); [0020]); and
a catheter having an end effector electrically coupled to the ablation energy generator, the end effector comprising at least one electrode (medical device 14 is a catheter having an end effector comprising electrodes 26 connected to generator 16; [0017]) configured to deliver the high voltage pulses from the at least one electrode to organ tissue inside a body of a patient to first and second return electrodes coupled to the body of the patient and deliver the radiofrequency signals between the at least one electrode to one of the first or second return electrodes (energy generator 16 may simultaneously or selectively deliver to the electrode(s) 26, RF energy in multiple modes, including unipolar, at a lower voltage (for example, approximately 100 to approximately 150 volts RMS) for ablating tissue using primarily heat energy and pulsed alternating current (AC) RF energy of approximately 500 volts RMS to approximately 2000 volts RMS or more (for example, up to 3000 V for electroporating tissue to greater deeper lesions without a substantial increase in heat energy, and thus unintended damage to non-target tissue or tissue charring may be avoided, the RF energy and HV pulses being delivered from the electrode(s) (26) through body tissue to a return electrode or multiple return electrodes when connected to the generator to complete the circuit; [0020-0022]).
Sherman fails to disclose the high voltage pulses to be DC high voltage pulses. However, Viswanathan et al. teach an ablation system comprising an ablation energy generator configured to provide high voltage pulses that are either DC or AC pulses to irreversibly electroporate tissue ([0040]). Thus, Viswanathan et al. teach the functional equivalence of DC and AC high voltage pulses to produce the predictable result of irreversible electroporation. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Sherman such that the high voltage pulses are DC high voltage pulses in view of the teachings of Sherman to provide the predictable result of irreversible electroporation.
Concerning claim 2, Sherman discloses the radiofrequency signals and the high voltage pulses are configured to be applied either sequentially or simultaneously to the organ tissue ([0022]; Fig. 4).
Concerning claim 4, Sherman discloses the at least one electrode (26) is configured to deliver the radiofrequency signals when a contact force between the at least one electrode and the organ tissue is approximately 5 grams or more as the system may be adjusted manually and thus activated when the electrode applies the claimed force ([0018]).
Concerning claim 7, Viswanathan et al. further disclose the high voltage pulses include an amplitude of at least 800 V (height of each pulse (1000) or the voltage amplitude of the pulse (1000) can be in the range from about 400 volts, about 1,000 volts, about 5,000 volts, about 10,000 volts, about 15,000 volts, including all values and sub ranges in between) ([0174]).
Concerning claim 9, Viswanathan et al. further disclose a duration of each of the HV pulses to be less than 20 microseconds (pulse width/duration can be about 0.5 microseconds, about 1 microsecond, about 5 microseconds, about 10 microseconds, about 25 microseconds, about 50 microseconds, about 100 microseconds, about 125 microseconds, about 140 microseconds, about 150 microseconds, including all values and sub-ranges in between) ([0045], [0174]).
Concerning claim 10, Viswanathan et al. further disclose a plurality of high voltage pulses of the high voltage pulses provides a pulse train (m1: 1110) of approximately 100 microseconds (total time duration of second set of pulses 1110 can be between about 20 microseconds and about 10 milliseconds, including all values and subranges in between) ([0178]; Fig. 10-11).
Concerning claim 12, Viswanathan et al. further disclose a plurality of pulse trains (m1: 1100, 1110) provides a pulsed field (PF) burst (m2: 1120) ([0175]; Fig. 11).
Concerning claim 13, Viswanathan et al. further disclose the PF burst (m2: 1120) to comprises at least 2 pulse trains (m1: 1110) with a duration of the PF burst comprising any value selected from zero to 500 milliseconds (In some embodiments, the total time duration of the third set of pulses can be between about 60 microseconds and about 200 milliseconds, including all values and sub ranges in between) ([0178]).
Concerning claim 14, Sherman discloses in which the at least one electrode (26) is configured to deliver the high voltage pulses and the radiofrequency signals to the organ tissue to form a combined lesion in the organ tissue such that the combined lesion is greater than a lesion formed by the same radiofrequency signals alone or the same high voltage pulses alone ([0006-0008], [0020]). Sherman fails to specifically disclose the combined lesion to be at least 20% greater. Sherman teaches delivering both RF energy and electroporation energy produces deeper lesions without the production of high heat, and particularly that deep lesions are sometimes required to effectively treat some cardiac conditions ([0006-0008]). It would have been obvious to one having ordinary skill in the art at the time the invention the invention was effectively filed to modify the invention of Sherman such that the combined lesion is at least 20% greater in view of the teachings of Sherman as Applicant appears to have placed no criticality on the claimed value (indicating only that the “the high voltage pulse can provide approximately 60 Joules or less” in Par. [0062]), since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sherman (2014/0066913), or in the alternative, Sherman (2014/0066913) in view of Viswanathan et al. (2018/0311497), as applied to claim 7, in further view of Grasse et al. (2013/0338467).
Concerning claim 8, Sherman or Sherman in view of Viswanathan et al. fail to disclose each of the high voltage pulses configured to deliver approximately 60 Joules or less. However, Grasse et al. disclose an ablation system comprising an ablation energy generator configured to delivery either AC or DC high voltage pulses, where each of the high voltage pulses is configured to deliver approximately 20-200 Joules pulse waveforms to produce the desired tissue affects and to avoid substantial heat energy transfer to adjacent healthy tissue by conduction or convection ([0042], [0109-0110]). It would have been obvious to one having ordinary skill in the art at the time the invention the invention was effectively filed to modify the invention of Sherman or Sherman in view of Viswanathan et al. such each of the high voltage pulses configured to deliver approximately 60 Joules or less in view of the teachings of Grasse et al. as Applicant appears to have placed no criticality on the claimed value (indicating only that the “combined depth can be about 20% to about 40% greater than either of the first depth and the second size” in Par. [0066]), since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sherman (2014/0066913) in view of Viswanathan et al. (2018/0311497), as applied to claim 7, in further view of Francischelli et al. (2010/0023004).
Concerning claim 11, Viswanathan et al. further disclose a plurality of high voltage pulses of the high voltage pulses provides a pulse train ([0178]; Fig. 10-11). Sherman in view of Viswanathan et al. fail to disclose the plurality of pulse trains have a time gap of any value selected from 0.3 to 1000 milliseconds between adjacent pulse trains. However, Francischelli et al. disclose an ablation system comprising an energy system generator configured to deliver high voltage pulses in a pulse train having a time gap of 250-1000 millisecond train intervals ([0031]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention Sherman in view of Viswanathan et al. such that the plurality of pulse trains have a time gap of any value selected from 0.3 to 1000 milliseconds as taught by Francischelli et al. as applicant appears to have placed no criticality on the claimed range (and merely states: “A time gap of any value selected from 0.3 to 1000 milliseconds can be provided between adjacent pulse trains. in Par. [0062]) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
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 1-2, 4 & 8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-42 of U.S. Patent No. 11,540,877. Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite an ablation system comprising an ablation energy generator configured to provide radiofrequency signals at high power and to provide high voltage pulses; and a catheter having an end effector coupled to the ablation energy generator comprising an electrode configured to deliver the HV pulses and the radiofrequency signals between the at least one electrode and one of the first and/or second return electrodes.
Claims 1-2, 4 & 8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 6 of U.S. Patent No. 12,102,374. Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite an ablation system comprising an ablation energy generator configured to provide radiofrequency signals at high power and to provide high voltage pulses; and a catheter having an end effector coupled to the ablation energy generator comprising an electrode configured to deliver the HV pulses and the radiofrequency signals between the at least one electrode and one of the first and/or second return electrodes.
Claims 1-2, 4, 7-9 & 11-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7-8, 11-15 of U.S. Patent No. 12,514,635. Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite an ablation system comprising an ablation energy generator configured to provide radiofrequency signals at high power and to provide high voltage pulses; and a catheter having an end effector coupled to the ablation energy generator comprising an electrode configured to deliver the HV pulses and the radiofrequency signals between the at least one electrode and one of the first and/or second return electrodes.
Claims 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 4 of copending Application No. 17/079700. Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite an ablation system comprising an ablation energy generator configured to provide radiofrequency signals at high power and to provide high voltage pulses; and a catheter having an end effector coupled to the ablation energy generator comprising an electrode configured to deliver the HV pulses and the radiofrequency signals between the at least one electrode and one of the first and/or second return electrodes.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments.
Applicant’s arguments with respect to the rejection(s) of the claims have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Sherman (2014/0066913).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Long et al. (2017/0215953) teaches high voltage pulses with either AC or DC energy ([0083]). Schweitzer et al. (2018/0289417) teach high voltage DC electroporation pulses that output 200 J of energy ([0033]). Davalos et al. (2007/0043345) teach electroporation protocols involve the generation of electrical fields in tissue and are affected by the Joule heating of the electrical pulses. When designing tissue electroporation protocols it is important to determine the appropriate electrical parameters that will maximize tissue permeabilization without inducing deleterious thermal effects ([0055]).
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/JAYMI E DELLA/Primary Examiner, Art Unit 3794
JAYMI E. DELLA
Primary Examiner
Art Unit 3794
Prosecution Insights