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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/11/2025 has been entered.
Response to Amendment
Acknowledgment is made to the amendment received 12/11/2025.
Applicant’s amendments are sufficient to overcome the provisional obviousness double patenting rejections to 17/980015.
Claim Objections
Claim 1 is objected to because of the following informalities: amend “of probe” to -of the probe- in ll. 4. Appropriate correction is required.
Claim 3 is objected to because of the following informalities: amend “the first and the second sequence” to -the first and second sequences- in ll. 2-3. Appropriate correction is required.
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) 1-3, 5-8 & 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stewart (2017/0035499, previously cited) in view of Deem et al. (2010/0049178) and Azure (2017/0258518).
Concerning claims 1 & 21, as illustrated in at least Figs. 1 & 4, Stewart discloses a medical apparatus (system 10; [0039]), comprising:
a probe having a distal end, a proximal end and a length configured for insertion into a body of a patient (medical device 12; [0039]) and comprising an array of electrodes disposed successively along the length of probe and configured to contact tissue within the body, the array having a proximal electrode at the proximal end of the probe and a distal electrode at the distal end of the probe and a plurality of intermediary electrodes between the proximal electrode and the distal electrode, wherein the array of electrodes is numbered sequentially (plurality of electrodes 24 can have a linear configuration and be numbered sequentially; [0040]); and
an electrical signal generator configured to apply during a first period of time while the probe contacts the tissue, between pairs of electrodes in the array, a first sequence of bipolar pulses applied to all pairs of electrodes during the first period of time, wherein each of the pairs are pairs of immediately adjacent electrodes of the array of electrodes, and to apply during a second period of time while the probe remains in contact with the tissue, between pairs of electrodes in the array, a second sequence of the bipolar pulses, wherein the second sequence is applied to all the pairs of electrodes during the second period of time, wherein each of the pairs are pairs of immediately adjacent electrodes in the array of electrodes (pulse field ablation generator 14 is configured to apply four pulse trains that each include 20-1000 pulses during first and second periods of time to immediately adjacent electrodes; [0039], [0046], [0051]).
Stewart et al. fail to disclose the first sequence of bipolar pulses applied to all odd-even numbered pairs of electrodes and the second sequence of bipolar pulses applied to all even-odd numbered pairs of electrodes, wherein the odd-even pairs are different than the even-odd pairs, wherein the odd-even numbered pairs are pairs between an odd numbered electrode and an immediately adjacent electrode of the array on a distal side of the odd numbered electrode and wherein the even-odd numbered pairs are pairs between an even numbered electrode and an immediately adjacent electrode of the array on a distal side of the even numbered electrode. However, Deem et al. disclose a medical apparatus configured to electroporate the tissue and comprising a linear array of electrodes (1236-1240) with respect to treating tissue, where a first and third sequence of pulses is applied to odd-even (1236-1237 & 1238-1239) numbered pairs of electrodes and a second and fourth sequence of pulses is applied to even-odd (1237-1238 & 1239-1240) numbered pairs of electrodes, wherein the odd-even pairs are different than the even-odd pairs, wherein the odd-even numbered pairs are pairs between an odd numbered electrode and an immediately adjacent electrode of the array on a distal side of the odd numbered electrode and wherein the even-odd numbered pairs are pairs between an even numbered electrode and an immediately adjacent electrode of the array on a distal side of the even numbered electrode. 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 Stewart et al. such that the first sequence of bipolar pulses applied to all odd-even numbered pairs of electrodes simultaneously and the second sequence of bipolar pulses applied to all even-odd numbered pairs of electrodes, wherein the odd-even pairs are different than the even-odd pairs and wherein the odd-even numbered pairs are pairs between an odd numbered electrode and an immediately adjacent electrode of the array on a distal side of the odd numbered electrode and wherein the even-odd numbered pairs are pairs between an even numbered electrode and an immediately adjacent electrode of the array on a distal side of the even numbered electrode in order to provide the benefit of achieving a treatment effect between specific electrodes as taught by Deem et al. ([0264]; Fig. 53)
Stewart et al. in view of Deem et al. fail to disclose all the odd-even pairs and even-odd pairs are activated simultaneously during the first and second sequences, respectively. However, Azure disclose a medical apparatus configured to electroporate the tissue where electrode pairs can be activated individually or sequentially such that only one electrode pair is activated at any one moment, or multiple pairs can be activated simultaneously. It would have been an obvious matter of design choice to one having ordinary skill in the art at the time the invention was effectively filed to modify the invention of Stewart et al. in view of Deem et al. such that all the odd-even pairs and even-odd pairs are activated simultaneously during the first and second sequences, since Applicant has not disclosed that activating simultaneously solves any stated problem or is for any particular purpose and Azure teaches activation of electrode pairs either individually, sequentially or simultaneously to be equivalents in the art for treating tissue by applying an electric field across the target tissue. ([0097-0068])
Concerning claim 2¸Stewart discloses the bipolar pulses have an amplitude sufficient to cause irreversible electrophoresis (IRE) in the tissue ([0050]).
Concerning claim 3¸Stewart discloses the amplitude of each of the bipolar pulses in the sequence is at least 200 V, and a duration of each of the bipolar pulses is less than 20 ms ([0046], [0050]).
Concerning claim 5¸ Stewart discloses the electrical signal generator (14) is configured to generate a plurality of pulse trains comprising the first and second sequences of the bipolar pulses, wherein the pulse trains are separated by intervals (pulse trains do not last into T-wave) in which the bipolar pulses are not applied ([0053]).
Concerning claim 6, Stewart discloses the probe (12) is configured to apply the first and second sequences of the bipolar pulses so as to ablate the tissue in the heart ([0039]; Fig. 1).
Concerning claims 7-8, Stewart discloses the electrical signal generator (14) configured to apply the first and second sequences asynchronously or synchronously with respect to a beating of the heart ([0025]).
Claim(s) 4 & 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stewart (2017/0035499, previously cited) in view of Deem et al. (2010/0049178) and Azure (2017/0258518), as applied to claims 1-2, in further view of Sherman (2014/0066913, previously cited).
Concerning claim 4¸Stewart in view of Deem et al. and Azure fail to disclose wherein the electrical signal generator is further configured to apply to the electrodes radio-frequency (RF) signals having a power sufficient to thermally ablate the tissue contacted by the array of electrodes. However, Sherman discloses a medical apparatus (10) comprising a probe having a plurality of electrodes (26) and an electrical signal generator (16) configured to apply both IRE and RF signals to the electrodes (26). 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 Stewart in view of Deem et al. and Azure such that the electrical signal generator is further configured to apply to the electrodes radio-frequency (RF) signals having a power sufficient to thermally ablate the tissue contacted by the array of electrodes in order to provide the benefit of a more effective and efficient ablation since electroporation may not result in immediate ablation of the treated tissue (that is, the treated cells may continue to function somewhat normally for a time after electroporation) and thus immediate current blockage as taught by Sherman ([0021-0022], [0026-0028]).
Concerning claim 9¸ Stewart in view of Deem et al. and Azure fail to disclose the probe comprises a plurality of temperature sensors adjacent to the array of electrodes, and wherein the electrical signal generator is configured to apply the bipolar pulses responsively to temperatures measured by the temperature sensors. However, Sherman discloses a medical apparatus for tissue ablation comprising a probe (14) having a plurality of temperature sensors (29) adjacent to the electrodes (26), and wherein the electrical signal generator is configured first and second sequences of bipolar pulses responsively to a temperature measured by the temperature sensors (29). 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 Stewart in view of Deem et al. and Azure such that the probe comprises a plurality of temperature sensors adjacent to the array of electrodes, and wherein the electrical signal generator is configured to apply the first and second sequences of bipolar pulses responsively to a temperature measured by the temperature sensors in order to provide the benefit of adjusting energy delivery to avoid unintended tissue damage as taught by Sherman. ([0018]; Fig. 1 & 4)
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stewart (2017/0035499, previously cited) in view of Deem et al. (2010/0049178) and Azure (2017/0258518), as applied to claim 1, in further view of Howard et al. (2018/0214202, previously cited).
Concerning claim 10¸ while Stewart discloses applying multiple pulse trains ([0046]), Stewart in view of Deem et al. and Azure fail to disclose the electrical signal generator is configured to apply a third sequence of the bipolar pulses between pairs of electrodes in the array of electrodes that are separated by at least one other electrode in the array. However, Howard et al. disclose an electrical signal generator configured to apply a third sequence of bipolar pulses between pairs of electrodes in an array of electrodes that are separated by at least one other electrode in the array. 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 Stewart in view of Deem et al. and Azure such that the electrical signal generator is configured to apply a third sequence of the bipolar pulses between pairs of electrodes in the array of electrodes that are separated by at least one other electrode in the array in order to provide the benefit of allowing for larger electrode separation distances between active electrodes thereby driving the electric field deeper into the underlying tissue and creating a deeper ablation lesion as taught by Howard et al. ([0097]).
Claim(s) 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stewart (2017/0035499, previously cited) in view of Deem et al. (2010/0049178) and Azure (2017/0258518), as applied to claim 1, in further view of Francischelli et al. (2010/0023004, previously cited).
Concerning claims 13-14, Stewart et al. disclose the electrical signal generator (14) configured to route the bipolar pulses to the array of electrodes through multiple output channels ([0042]). Stewart in view of Deem et al. and Azure fail to disclose the electrical signal generator comprises a network of switches configured to switch within 3 milliseconds between applying the first sequence and applying the second sequence of the bipolar pulses and comprises a pulse generation assembly, which generates the bipolar pulses, and a pulse routing and metrology assembly, which is configured to route the bipolar pulses to the electrodes through the multiple output channels. However, Francischelli et al. further disclose a controller (84) configured to transmit control signals to the electrical signal generator (22), and wherein the electrical signal generator (22) comprises a network of multiple, mutually connected fast switches (32) configured to switch within 3 milliseconds between applying the first sequence and applying the second sequence of the bipolar pulses and the electrical signal generator comprises a pulse generation assembly (22), which generates the bipolar pulses, and a pulse routing and metrology assembly (S/W circuit, sensor(s) 28), which is configured to route the bipolar pulses to the electrodes. 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 Stewart in view of Deem et al. and Azure such that the electrical signal generator comprises a network of switches configured to switch within 3 milliseconds between applying the first sequence and applying the second sequence of the bipolar pulses and the electrical signal generator comprises a pulse generation assembly, which generates the bipolar pulses, and a pulse routing and metrology assembly, which is configured to route the bipolar pulses to the electrodes through the multiple output channels in order to provide the benefit of delivering effective electroporation ablation energy to optimize electroporation resulting in narrow transmural lesions with minimal damage to surrounding tissue as taught by Francischelli et al. (Abstract; [0029], [0033- 0036], [0038-0040]; Fig. 1-2A).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stewart (2017/0035499, previously cited) in view of Deem et al. (2010/0049178), Azure (2017/0258518) and Francischelli et al. (2010/0023004, previously cited), as applied to claim 14, in further view of Wetzig et al. (6,350,263, previously cited).
Concerning claim 15, Stewart in view of Deem et al., Azure and Francischelli et al. fail to specifically disclose each of the output channels is coupled to a respective one of the electrodes, and the pulse routing and metrology assembly comprises multiple modules, including a respective module for each output channel, each module comprises one or more switches for switching the bipolar pulses among the output channels. However, Wetzig et al. disclose a medical apparatus comprising a probe (11) and a signal generator (1) comprising a signal generation assembly (15) and a signal routing and metrology assembly (9) where signals are routed to electrodes (11) via output channels each of the output channels is coupled to a respective one of the electrodes (11), and the signal routing and metrology assembly (9) comprises multiple modules (9.3, 9.6), including a respective module for each output channel, each module comprises one or more switches (S1-6) for switching the signals among the output channels. 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 art Stewart et al. in view of Deem et al., Azure and Francischelli et al. such that each of the output channels is coupled to a respective one of the electrodes, and the pulse routing and metrology assembly comprises multiple modules, including a respective module for each output channel, each module comprises one or more switches for switching the bipolar pulses among the output channels in order to provide the benefit of an automatic time-sequential actuation of the channels/electrodes according to a desired program for treatment as taught by Wetzig et al. (Col. 3, ll. 45-58, Col. 4, ll. 30-43; Fig. 1)
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stewart (2017/0035499, previously cited) in view of Deem et al. (2010/0049178), Azure (2017/0258518), Francischelli et al. (2010/0023004, previously cited) and Wetzig et al. (6,350,263, previously cited), as applied to claim 15, in further view of Sherman et al. (2008/0281322, previously cited).
Concerning claim 16, Stewart in view of Deem et al., Azure, Francischelli et al. and Wetzig et al. fail to disclose each of the modules comprises a transformer, which couples each of the multiple output modules to the pulse generation assembly. However, Sherman et al. disclose a medical apparatus and method where channel modules each comprise a transformer, which couple each module to the pulse generation assembly (34). 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 Stewart in view of Deem et al., Azure, Francischelli et al. and Wetzig et al. such that each of the modules comprises a transformer, which couples the module to the pulse generation assembly in order to provide the benefit of providing patient electrical isolation as taught by Sherman et al. ([0138]; Fig. 1-2)
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stewart (2017/0035499, previously cited) in view of Deem et al. (2010/0049178), Azure (2017/0258518), as applied to claim 15, in further view of Simpson et al. (6,752,804, previously cited).
Concerning claim 17, while Wetzig et al. further discloses each of the modules (9) comprises a metrology module (9.6) (Col. 4, ll. 7-15 & 30-44, Col. 5, ll. 1-6). Stewart in view of Deem et al., Azure, Francischelli et al. and Wetzig et al. fail to disclose each of the modules comprises a metrology module coupled to measure a voltage and a current applied to the output channel that is coupled to the respective module, and wherein the apparatus comprises a controller, which is coupled to control the pulse generation assembly responsively to the measured voltage and current. However, Simpson et al. disclose a medical apparatus and method comprising an electrical signal generator comprising (18) multiple modules including a metrology module (68) which is coupled to measure a voltage and a current applied to the output channel that is coupled to the respective module, and wherein the apparatus comprises a controller (42), which is coupled to control a signal generation assembly (54) responsive to the measured voltage and current. 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 Stewart in view of Deem et al., Azure, Francischelli et al. and Wetzig et al. such that each of the modules comprises a metrology module coupled to measure a voltage and a current applied to the output channel that is coupled to the respective module, and wherein the apparatus comprises a controller, which is coupled to control the pulse generation assembly responsively to the measured voltage and current in order to provide the benefit of feedback to the controller as taught by Simpson et al. (Col. 13, ll. 47-59; Fig. 1 & 3)
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-9, 13-15 & 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-42 of U.S. Patent No. 11,540,877 in view of Azure (2017/0258518). Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite a medical apparatus and method for tissue ablation comprising a probe and an electrical signal generator configured to apply first and second sequences of bipolar pulses between all odd-even pairs of electrodes and all even-odd pairs of electrodes of an array during first and second periods of time, where the odd-even pairs are different than the even-odd pairs. The patent fails to disclose the odd-even pairs and even-odd pairs are activated simultaneously during the first and second sequences, respectively. However, Azure disclose a medical apparatus configured to electroporate the tissue where electrode pairs can be activated individually or sequentially such that only one electrode pair is activated at any one moment, or multiple pairs can be activated simultaneously. It would have been an obvious matter of design choice to one having ordinary skill in the art at the time the invention was effectively filed to modify the invention of patent such that the odd-even pairs and even-odd pairs are activated simultaneously during the first and second sequences, since Applicant has not disclosed that activating simultaneously solves any stated problem or is for any particular purpose and Azure teaches activation of electrode pairs either individually, sequentially or simultaneously to be equivalents in the art for treating tissue by applying electric field across the target tissue. ([0067-0068])
Response to Arguments
Applicant’s arguments with respect to the claims 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.
Conclusion
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/JAYMI E DELLA/Primary Examiner, Art Unit 3794
JAYMI E. DELLA
Primary Examiner
Art Unit 3794