DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 October 23rd, 2025 has been entered.
Response to Amendment
The amendment filed October 23rd, 2025 has been entered. Applicant’s amendments to the Claims have overcome the claim objections and most of the 112(b) rejections previously set forth in the Final Office Action mailed August 27th, 2025.
Response to Arguments
Applicant’s arguments, see pages 7-12, filed October 23rd, 2025, with respect to the rejection(s) of claim(s) 1, 9 & 17 under 35 U.S.C. 103 have been fully considered and are persuasive in view of the amendment and the prior interpretation of the current prior art of record. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of a new interpretation of the current prior art of record.
In response to applicant's argument on pages 10-11 that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). In the instant case, Howard is relied upon to teach the successive delivery of multiple pulse trains to electrodes on a loop/ring shaped catheter in a predefined sequence, wherein each pulse train is seen as a time slot, and Byrd teaches the single electrode pair activation, selection of electrodes constituting the pair and an empty time slot. Additionally, Howard teaches that a single pair of electrodes may be activated ([0078]: electrodes termed as “neutral,” “inactive,” “disconnected,” “decoupled,” or “unpowered” are those electrodes that are not connected to either of the polarities of the source of electrical energy during such energy deliveries; [0136]: it will be understood that the treatment element shown in FIGS. 41 and 42 may instead be a portion of a treatment element such as that shown in FIG. 1; [0137]: Referring now to FIG. 41, a treatment element 32 (or portion of a treatment element) is shown that includes a first active electrode 38a, a second active electrode 38b, a first neutral electrode 38c, and a second neutral electrode 38d. Although not shown, the device may include additional active and/or neutral electrodes. The first 38a and second 38b active electrodes may have opposite polarities; wherein this describes a configuration where only a pair of electrodes may be activated, see also Figs. 41-44 & [0137]-[0140]), as detailed in the updated rejection below.
Therefore, these arguments are not persuasive and the Examiner maintains that the current prior art teaches the newly disclosed claim limitations.
Claim Objections
Claims 8, 14 & 16 objected to because of the following informalities:
Claim 8, line 4: “time slots of” should read --time slots--,
Claim 14, line 4: “after lapse” should read --after a lapse--,
Claim 16, line 4: “time slots of” should read --time slots--.
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 3, 8, 11, 16 & 19 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 3 recites the limitation “the respective time slot” in line 3. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 8, the claim recites “a third electrode” in line 4 and it is unclear if this is the same electrode as part of the plurality of electrodes recited in claim 1, from which claim 8 depends, or is a different electrode. For examination purposes, these are the same electrodes and the limitation will be interpreted as “a third electrode of the plurality of electrodes”.
Claim 11 recites the limitation “the respective time slot” in line 3. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 16, the claim recites “a third electrode” in line 4 and it is unclear if this is the same electrode as part of the plurality of electrodes recited in claim 9, from which claim 16 depends, or is a different electrode. For examination purposes, these are the same electrodes and the limitation will be interpreted as “a third electrode of the plurality of electrodes”.
Claim 19 recites the limitation “the respective time slot” in line 3. There is insufficient antecedent basis for this limitation in the 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.
Claims 1-3, 5, 7-11 & 13, 15-19 are rejected under 35 U.S.C. 103 as being unpatentable over Howard et al. (U.S. Pub. No. 20180214202, cited in IDS), herein referred to as “Howard” in view of Byrd et al. (U.S. Pub. No. 20210161582, previously cited), herein referred to as “Byrd”.
Regarding claim 1, Howard discloses a method, the method comprising:
receiving a predefined pattern ([0086]: the generator 14 may include processing circuitry including a processor 46 in communication with one or more controllers and/or memories containing software modules containing instructions or algorithms to provide for the automated operation and performance of the features, sequences, calculations, or procedures described herein and/or required for a given medical procedure; [0141]: As will be appreciated by one of skill in the art, certain concepts described herein may be embodied as a method, data processing system, and/or computer program product) comprising:
(1) a set of time slots ([0114]: the generator 14 may be programmed and configured to deliver ablation energy according to a predefined cycle, in which a first train of pulses (for example, 100 pulses) is delivered with focus on delivery through electrode E1 followed immediately (for example, within 20 ms) by a second train of pulses (for example, 100 pulses) delivered with focus on delivery through electrode E2; wherein a train of pulses is seen as a time slot), wherein each of the time slots defines (a) an electrode- pair (EP) from a plurality of electrodes ([0098]: After a train of biphasic pulses has been delivered using only the odd electrodes, the device electrode distribution system 16 may then switch to using only the even numbered electrodes (that is, electrodes E2, E4, E6, E8, E10, E12, E14, and E16) for a similar train of pulses. This second delivery pattern is shown in FIG. 8; see paragraphs [0137]-[0140] & Figs. 41-44, specifically [0137]: Referring now to FIG. 41, a treatment element 32 (or portion of a treatment element) is shown that includes a first active electrode 38a, a second active electrode 38b, a first neutral electrode 38c, and a second neutral electrode 38d; such that Howard discloses a single electrode pair) arranged along a ring-shaped distal end of an intrabody probe ([0081]: The medical device 12 may further include one or more treatment elements 32 at, coupled to, or on the elongate body distal portion 28 for energetic, therapeutic, and/or investigatory interaction between the medical device 12 and a treatment site or region … includes a carrier element 36 bearing a plurality of electrodes 38 … the carrier element 36 may form a loop in the expanded configuration), (b) a duration ([0114]: the generator 14 may be programmed and configured to deliver ablation energy according to a predefined cycle, in which a first train of pulses (for example, 100 pulses) is delivered with focus on delivery through electrode E1 followed immediately (for example, within 20 ms) by a second train of pulses (for example, 100 pulses) delivered with focus on delivery through electrode E2; wherein a first train is seen as a time slot), and (c) a waveform of one or more bipolar ablation pulses (BAPs) to be delivered by the single EP during the duration of the time slot ([0114]: the generator 14 may be programmed and configured to deliver ablation energy according to a predefined cycle, in which a first train of pulses (for example, 100 pulses) is delivered with focus on delivery through electrode E1), and wherein the predefined pattern is configured to generate electric fields that span the ring-shaped distal end of the intrabody probe with selected spatial overlaps in the electric fields generated (see Figs. 3-24 & 41-44 where the delivery patterns show the electric fields and that the electric fields overlap; see also [0117]: By sequentially delivering fields using different vector patterns, the electroporation effect may be enhanced to affect a greater percentage of the cells in the target tissue area); and
causing, in response to receiving the instructions to ablate at a target intrabody location, each waveforms to be generated based on the predefined pattern ([0086]: As such, the generator 14 may include processing circuitry including a processor 46 in communication with one or more controllers and/or memories containing software modules containing instructions or algorithms to provide for the automated operation and performance of the features, sequences, calculations, or procedures described herein and/or required for a given medical procedure … These preliminary pulses may also be applied to assess whether the electrodes in positioned properly relative to the target tissue. The preliminary pulses may be delivered with or without automated, immediate, subsequent delivery of one or more therapeutic pulse trains; [0114]: For example, the generator 14 may be programmed and configured to deliver ablation energy according to a predefined cycle, in which a first train of pulses (for example, 100 pulses) is delivered with focus on delivery through electrode E1 followed immediately (for example, within 20 ms) by a second train of pulses (for example, 100 pulses) delivered with focus on delivery through electrode E2. This cycle may be repeated or focused energy may be delivered through other electrodes); and
causing the waveforms to be delivered to the EPs as defined by the predefined pattern stored ([0086]: As such, the generator 14 may include processing circuitry including a processor 46 in communication with one or more controllers and/or memories containing software modules containing instructions or algorithms to provide for the automated operation and performance of the features, sequences, calculations, or procedures described herein and/or required for a given medical procedure; [0114]: For example, the generator 14 may be programmed and configured to deliver ablation energy according to a predefined cycle, in which a first train of pulses (for example, 100 pulses) is delivered with focus on delivery through electrode E1 followed immediately (for example, within 20 ms) by a second train of pulses (for example, 100 pulses) delivered with focus on delivery through electrode E2. This cycle may be repeated or focused energy may be delivered through other electrodes).
But Howard fails to explicitly disclose a single electrode- pair (EP) from a plurality of electrodes, wherein the single EPs in at least two of the time slots of the set of time slots include a common electrode of the plurality of electrodes and are separated by at least one time slot from the set of time slots, and (2) an empty time slot during which no BAP is applied to any single EP from the plurality of electrodes.
However, Byrd discloses a method ([0002]: the present disclosure relates to electroporation systems and methods of controlling electroporation systems), comprising: (1) a set of time slots ([0052]: In some embodiments, for example, a first pair of electrodes may be energized according to an electroporation energization strategy, and subsequently, a second pair of electrodes may be energized according to the electroporation energization strategy; wherein each energization of a pair is seen as a time slot), wherein each of the time slots defines: (a) a single electrode-pair (EP) from a plurality of electrodes ([0052]: the electrodes of electrode assembly 12 may be energized sequentially such that only some of electrodes are energized at a given time. That is, not all electrodes of electrode assembly 12 are energized simultaneously. In some embodiments, for example, a first pair of electrodes may be energized according to an electroporation energization strategy, and subsequently, a second pair of electrodes may be energized according to the electroporation energization strategy), the electrodes may be sequentially energized as pairs by energizing, in sequence, the first and second electrodes), wherein the single EPs in at least two of the time slots of the set of time slots include a common electrode of the plurality of electrodes and are separated by at least one time slot from the set of time slots ([0052]: the electrodes may be sequentially energized as pairs by energizing, in sequence, the first and third electrodes, the second and fourth electrodes, the third and fifth electrodes; wherein the first pair (first & third) and third pair (third & fifth) have the 3rd electrode as the common electrode and are separated by the second pair (second & fourth));
(2) an empty time slot during which no BAP is applied to any single EP from the plurality of electrodes (Fig. 9, portion of burst signal where no pulse signals 700 are applied, wherein the duration of the train of pulse signals 700 are the time slot, the portion without pulse signals 700 immediately after is the time gap; [0070]: burst period 902 is selected to allow a power supply (e.g., a capacitor) of electroporation generator 26 to recharge to a sufficient voltage to maintain the voltage amplitude of pulse signal 700 at or near the target voltage amplitude (e.g., at least 90% of a target voltage amplitude));.
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the method of Howard to comprise a single electrode pair to include the steps of Byrd, as taught by Byrd, for the purpose of the selective energizing may be based on contact between the electrodes and tissue enabling the power supply to recharge to a sufficient voltage to maintain the voltage amplitude of pulse signal 700 at or near the target voltage amplitude (e.g., at least 90% of a target voltage amplitude) (Byrd: [0033], [0070]).
Regarding claim 2, Howard discloses repeating delivery of the waveforms to the plurality of electrodes based on the predefined pattern ([0114]: These two delivery patterns shown in FIGS. 21 and 22 may be delivered sequentially such that focused energy is delivered first through electrode E1 and then through electrode E2, and this sequence may be repeated any number of times and/or combined with other delivery patterns).
Regarding claim 3, Howard discloses wherein the waveform of each time slot of the set of time slots is delivered successively to the single EPs associated with the respective time slot ([0114]: These two delivery patterns shown in FIGS. 21 and 22 may be delivered sequentially).
Regarding claim 5, Howard discloses wherein the waveform of two or more time slots of the set of time slots is delivered simultaneously to the single EPs associated with the two or more time slots ([0112]: FIGS. 17-25 show further examples of energy delivery patterns in a first plurality of electrodes 38a connected to a first polarity includes fewer electrodes than a second plurality of electrodes 38b connected to a second polarity … the first plurality of electrodes 38a includes two adjacent electrodes, the second plurality of electrodes 38b includes five adjacent electrodes; for example, see Fig. 17 where active electrodes 38a (E3 & E4) are paired with inactive electrodes 38b (E6-E9) such that any of the inactive electrodes form a bipolar pair with the active electrodes such that the waveform is delivered to two pairs of electrodes simultaneously).
Regarding claim 7, Howard discloses wherein the BAPs comprise irreversible electroporation (IRE) BAPs ([0087]: The generator 14 may provide electrical pulses to the medical device 12 to perform an electroporation procedure to cardiac tissue or other tissues within the patient's body).
Regarding claim 8, Howard in view of Byrd discloses wherein the predefined pattern includes a first time slot of the set of time slots including a first electrode of the plurality of electrodes and a second electrode of the plurality of electrodes and a second time slot of the set of time slots of including the first electrode and a third electrode (Byrd: [0052]: the electrodes may be sequentially energized as pairs by energizing, in sequence, the first and second electrodes, the second and third electrodes, the third and fourth electrodes, and so on).
Regarding claim 9, Howard discloses a system, comprising:
a processor ([0086]: the generator 14 may include processing circuitry including a processor 46 in communication with one or more controllers and/or memories containing software modules containing instructions or algorithms to provide for the automated operation and performance of the features, sequences, calculations, or procedures described herein and/or required for a given medical procedure); and
a non-transitory computer readable medium storing a plurality of instructions, which when executed ([0141]: Furthermore, the disclosure may take the form of a computer program product on a tangible computer usable storage medium having computer program code embodied in the medium that can be executed by a computer. Any suitable tangible computer readable medium may be utilized including hard disks, CD-ROMs, electronic storage devices, optical storage devices, or magnetic storage devices), cause the processor to:
receive a predefined pattern ([0086]: the generator 14 may include processing circuitry including a processor 46 in communication with one or more controllers and/or memories containing software modules containing instructions or algorithms to provide for the automated operation and performance of the features, sequences, calculations, or procedures described herein and/or required for a given medical procedure; [0141]: As will be appreciated by one of skill in the art, certain concepts described herein may be embodied as a method, data processing system, and/or computer program product) comprising:
a set of time slots ([0114]: the generator 14 may be programmed and configured to deliver ablation energy according to a predefined cycle, in which a first train of pulses (for example, 100 pulses) is delivered with focus on delivery through electrode E1 followed immediately (for example, within 20 ms) by a second train of pulses (for example, 100 pulses) delivered with focus on delivery through electrode E2; wherein a train of pulses is seen as a time slot), wherein each of the time slots defines (a) a electrode-pair (EP) from a plurality of electrodes ([0098]: After a train of biphasic pulses has been delivered using only the odd electrodes, the device electrode distribution system 16 may then switch to using only the even numbered electrodes (that is, electrodes E2, E4, E6, E8, E10, E12, E14, and E16) for a similar train of pulses. This second delivery pattern is shown in FIG. 8; see paragraphs [0137]-[0140] & Figs. 41-44, specifically [0137]: Referring now to FIG. 41, a treatment element 32 (or portion of a treatment element) is shown that includes a first active electrode 38a, a second active electrode 38b, a first neutral electrode 38c, and a second neutral electrode 38d.; such that Howard discloses a single electrode pair) arranged along a ring-shaped distal end of an intrabody probe ([0081]: The medical device 12 may further include one or more treatment elements 32 at, coupled to, or on the elongate body distal portion 28 for energetic, therapeutic, and/or investigatory interaction between the medical device 12 and a treatment site or region … includes a carrier element 36 bearing a plurality of electrodes 38 … the carrier element 36 may form a loop in the expanded configuration), (b) a duration ([0114]; the generator 14 may be programmed and configured to deliver ablation energy according to a predefined cycle, in which a first train of pulses (for example, 100 pulses) is delivered with focus on delivery through electrode E1 followed immediately (for example, within 20 ms) by a second train of pulses (for example, 100 pulses) delivered with focus on delivery through electrode E2; wherein a first train is seen as a time slot), and (c) a waveform of one or more bipolar ablation pulses (BAPs) to be delivered by the single EP during the duration of the time slot ([0086]: The generator 14 may be configured to deliver a sampling pulse prior to delivery of a full series or “pulse train” of pulsed electric field ablative therapy pulses; [0114]: the generator 14 may be programmed and configured to deliver ablation energy according to a predefined cycle, in which a first train of pulses (for example, 100 pulses) is delivered with focus on delivery through electrode E1), and wherein the predefined pattern is configured to generate electric fields that span the ring-shaped distal end of the intrabody probe with selected spatial overlaps in the electric fields generated (see Figs. 3-24 & 41-44 where the delivery patterns show the electric fields and that the electric fields overlap; see also [0117]: By sequentially delivering fields using different vector patterns, the electroporation effect may be enhanced to affect a greater percentage of the cells in the target tissue area), and
cause, in response to instructions to ablate at a target intrabody location, waveforms based on the predefined pattern ([0086]: As such, the generator 14 may include processing circuitry including a processor 46 in communication with one or more controllers and/or memories containing software modules containing instructions or algorithms to provide for the automated operation and performance of the features, sequences, calculations, or procedures described herein and/or required for a given medical procedure … These preliminary pulses may also be applied to assess whether the electrodes in positioned properly relative to the target tissue. The preliminary pulses may be delivered with or without automated, immediate, subsequent delivery of one or more therapeutic pulse trains; [0114]: For example, the generator 14 may be programmed and configured to deliver ablation energy according to a predefined cycle, in which a first train of pulses (for example, 100 pulses) is delivered with focus on delivery through electrode E1 followed immediately (for example, within 20 ms) by a second train of pulses (for example, 100 pulses) delivered with focus on delivery through electrode E2. This cycle may be repeated or focused energy may be delivered through other electrodes); and
cause the waveforms to be delivered the EPs as defined by the received predefined pattern ([0086]: As such, the generator 14 may include processing circuitry including a processor 46 in communication with one or more controllers and/or memories containing software modules containing instructions or algorithms to provide for the automated operation and performance of the features, sequences, calculations, or procedures described herein and/or required for a given medical procedure; [0114]: For example, the generator 14 may be programmed and configured to deliver ablation energy according to a predefined cycle, in which a first train of pulses (for example, 100 pulses) is delivered with focus on delivery through electrode E1 followed immediately (for example, within 20 ms) by a second train of pulses (for example, 100 pulses) delivered with focus on delivery through electrode E2. This cycle may be repeated or focused energy may be delivered through other electrodes).
But Howard fails to explicitly disclose a single electrode-pair (EP) from a plurality of electrodes, wherein the single EPs in at least two of the time slots of the set of time slots include a common electrode of the plurality of electrodes and are separated by at least one time slot from the set of time slots, and (2) an empty time slot during which no BAP is applied to any single EP from the plurality of electrodes.
However, Byrd discloses a system ([0002]: the present disclosure relates to electroporation systems and methods of controlling electroporation systems), comprising: a set of time slots ([0052]: In some embodiments, for example, a first pair of electrodes may be energized according to an electroporation energization strategy, and subsequently, a second pair of electrodes may be energized according to the electroporation energization strategy; wherein each energization of a pair is seen as a time slot), wherein each of the time slots defines (i) a single electrode-pair (EP) from a plurality of electrodes ([0052]: the electrodes of electrode assembly 12 may be energized sequentially such that only some of electrodes are energized at a given time. That is, not all electrodes of electrode assembly 12 are energized simultaneously. In some embodiments, for example, a first pair of electrodes may be energized according to an electroporation energization strategy, and subsequently, a second pair of electrodes may be energized according to the electroporation energization strategy) the electrodes may be sequentially energized as pairs by energizing, in sequence, the first and second electrodes), wherein at least two EPs in the pattern include a common electrode of the plurality of electrodes and are separated by at least one time slot from the set of time slots ([0052]: the electrodes may be sequentially energized as pairs by energizing, in sequence, the first and third electrodes, the second and fourth electrodes, the third and fifth electrodes; wherein the first pair (first & third) and third pair (third & fifth) have the 3rd electrode as the common electrode and are separated by the second pair (second & fourth)); and
(2) an empty time slot during which no BAP is applied to any single EP from the plurality of electrodes (Fig. 9, portion of burst signal where no pulse signals 700 are applied, wherein the duration of the train of pulse signals 700 are the time slot, the portion without pulse signals 700 immediately after is the time gap; [0070]: burst period 902 is selected to allow a power supply (e.g., a capacitor) of electroporation generator 26 to recharge to a sufficient voltage to maintain the voltage amplitude of pulse signal 700 at or near the target voltage amplitude (e.g., at least 90% of a target voltage amplitude)).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the system of Howard to comprise a single electrode pair, as taught by Byrd, and to include the processor of Byrd for the purpose of the selective energizing may be based on contact between the electrodes and tissue and enabling the power supply to recharge to a sufficient voltage to maintain the voltage amplitude of pulse signal 700 at or near the target voltage amplitude (e.g., at least 90% of a target voltage amplitude) (Byrd: [0033], [0070]).
Regarding claim 10, Howard discloses wherein the plurality of instructions further cause the processor to repeat delivery of the waveforms to the plurality of electrodes based on the predefined pattern ([0114]: These two delivery patterns shown in FIGS. 21 and 22 may be delivered sequentially such that focused energy is delivered first through electrode E1 and then through electrode E2, and this sequence may be repeated any number of times and/or combined with other delivery patterns).
Regarding claim 11, Howard discloses wherein the plurality of instructions further cause the processor to successively deliver the waveform of each time slot to the single EPs associated with the respective time slot ([0114]: These two delivery patterns shown in FIGS. 21 and 22 may be delivered sequentially).
Regarding claim 13, Howard discloses wherein the plurality of instructions further cause the processor simultaneously deliver the waveform of two or more time slots of the set of time slots to the single EPs associated with the two or more time slots ([0112]: FIGS. 17-25 show further examples of energy delivery patterns in a first plurality of electrodes 38a connected to a first polarity includes fewer electrodes than a second plurality of electrodes 38b connected to a second polarity … the first plurality of electrodes 38a includes two adjacent electrodes, the second plurality of electrodes 38b includes five adjacent electrodes; for example, see Fig. 17 where active electrodes 38a (E3 & E4) are paired with inactive electrodes 38b (E6-E9) such that any of the inactive electrodes form a bipolar pair with the active electrodes such that the waveform is delivered to two pairs of electrodes simultaneously).
Regarding claim 15, Howard discloses wherein the BAPs comprise irreversible electroporation (IRE) BAPs ([0087]: The generator 14 may provide electrical pulses to the medical device 12 to perform an electroporation procedure to cardiac tissue or other tissues within the patient's body).
Regarding claim 16, Howard in view of Byrd discloses wherein the predefined pattern includes a first time slot of the set of time slots including a first electrode of the plurality of electrodes and a second electrode of the plurality of electrodes and a second time slot of the set of time slots of including the first electrode and a third electrode (Byrd: [0052]: the electrodes may be sequentially energized as pairs by energizing, in sequence, the first and second electrodes, the second and third electrodes, the third and fourth electrodes, and so on).
Regarding claim 17, Howard discloses a computer program product, comprising a non-transitory computer-readable medium having computer-readable program code embodied therein to be executed by one or more processors ([0141]: As will be appreciated by one of skill in the art, certain concepts described herein may be embodied as a method, data processing system, and/or computer program product. Accordingly, these concepts described herein may take the form of an entirely hardware embodiment, an entirely software embodiment or an embodiment combining software and hardware aspects. Furthermore, the disclosure may take the form of a computer program product on a tangible computer usable storage medium having computer program code embodied in the medium that can be executed by a computer. Any suitable tangible computer readable medium may be utilized including hard disks, CD-ROMs, electronic storage devices, optical storage devices, or magnetic storage devices), the program code including instructions to:
receive a predefined pattern ([0086]: the generator 14 may include processing circuitry including a processor 46 in communication with one or more controllers and/or memories containing software modules containing instructions or algorithms to provide for the automated operation and performance of the features, sequences, calculations, or procedures described herein and/or required for a given medical procedure; [0141]: As will be appreciated by one of skill in the art, certain concepts described herein may be embodied as a method, data processing system, and/or computer program product)comprising:
(1) a set of time slots ([0114]: the generator 14 may be programmed and configured to deliver ablation energy according to a predefined cycle, in which a first train of pulses (for example, 100 pulses) is delivered with focus on delivery through electrode E1 followed immediately (for example, within 20 ms) by a second train of pulses (for example, 100 pulses) delivered with focus on delivery through electrode E2; wherein a train of pulses is seen as a time slot), wherein each of the time slots defines: (a) a electrode-pair (EP) from a plurality of electrodes ([0098]: After a train of biphasic pulses has been delivered using only the odd electrodes, the device electrode distribution system 16 may then switch to using only the even numbered electrodes (that is, electrodes E2, E4, E6, E8, E10, E12, E14, and E16) for a similar train of pulses. This second delivery pattern is shown in FIG. 8; see paragraphs [0137]-[0140] & Figs. 41-44, specifically [0137]: Referring now to FIG. 41, a treatment element 32 (or portion of a treatment element) is shown that includes a first active electrode 38a, a second active electrode 38b, a first neutral electrode 38c, and a second neutral electrode 38d.; such that Howard discloses a single electrode pair) arranged along a ring- shaped distal end of an intrabody probe ([0081]: The medical device 12 may further include one or more treatment elements 32 at, coupled to, or on the elongate body distal portion 28 for energetic, therapeutic, and/or investigatory interaction between the medical device 12 and a treatment site or region … includes a carrier element 36 bearing a plurality of electrodes 38 … the carrier element 36 may form a loop in the expanded configuration), (b) duration ([0114]; the generator 14 may be programmed and configured to deliver ablation energy according to a predefined cycle, in which a first train of pulses (for example, 100 pulses) is delivered with focus on delivery through electrode E1 followed immediately (for example, within 20 ms) by a second train of pulses (for example, 100 pulses) delivered with focus on delivery through electrode E2; wherein a first train is seen as a time slot), and (c) a waveform of one or more bipolar ablation pulses (BAPs) to be delivered by the EP during the duration of the time slot ([0114]: the generator 14 may be programmed and configured to deliver ablation energy according to a predefined cycle, in which a first train of pulses (for example, 100 pulses) is delivered with focus on delivery through electrode E1), and wherein the predefined pattern is configured to generate electric fields that span the ring-shaped distal end of the intrabody probe with selected spatial overlaps in the electric fields generated (see Figs. 3-24 & 41-44 where the delivery patterns show the electric fields and that the electric fields overlap; see also [0117]: By sequentially delivering fields using different vector patterns, the electroporation effect may be enhanced to affect a greater percentage of the cells in the target tissue area); and
cause waveforms to be generated based on the predefined pattern in response to instructions to ablate at a target intrabody location ([0086]: As such, the generator 14 may include processing circuitry including a processor 46 in communication with one or more controllers and/or memories containing software modules containing instructions or algorithms to provide for the automated operation and performance of the features, sequences, calculations, or procedures described herein and/or required for a given medical procedure … These preliminary pulses may also be applied to assess whether the electrodes in positioned properly relative to the target tissue. The preliminary pulses may be delivered with or without automated, immediate, subsequent delivery of one or more therapeutic pulse trains; [0114]: For example, the generator 14 may be programmed and configured to deliver ablation energy according to a predefined cycle, in which a first train of pulses (for example, 100 pulses) is delivered with focus on delivery through electrode E1 followed immediately (for example, within 20 ms) by a second train of pulses (for example, 100 pulses) delivered with focus on delivery through electrode E2. This cycle may be repeated or focused energy may be delivered through other electrodes); and
cause the waveforms to be delivered to the single EPs as defined by the predefined pattern ([0086]: As such, the generator 14 may include processing circuitry including a processor 46 in communication with one or more controllers and/or memories containing software modules containing instructions or algorithms to provide for the automated operation and performance of the features, sequences, calculations, or procedures described herein and/or required for a given medical procedure; [0114]: For example, the generator 14 may be programmed and configured to deliver ablation energy according to a predefined cycle, in which a first train of pulses (for example, 100 pulses) is delivered with focus on delivery through electrode E1 followed immediately (for example, within 20 ms) by a second train of pulses (for example, 100 pulses) delivered with focus on delivery through electrode E2. This cycle may be repeated or focused energy may be delivered through other electrodes).
But Howard fails to explicitly disclose a single electrode-pair (EP) from a plurality of electrodes, wherein the single EPs in at least two of the time slots of the set of time slots include a common electrode of the plurality of electrodes and are separated by at least one time slot from the set of time slots and (2) an empty time slot during which no BAP is applied to any single EP from the plurality of electrodes.
However, Byrd discloses a computer program product ([0029]: In some embodiments, electroporation generator 26 and/or computer system 32 may be programmed or otherwise configured to run an algorithm that identifies and/or selects which electrodes or electrode pairs of electrode assembly 12 to energize), comprising: a set of time slots ([0052]: In some embodiments, for example, a first pair of electrodes may be energized according to an electroporation energization strategy, and subsequently, a second pair of electrodes may be energized according to the electroporation energization strategy; wherein each energization of a pair is seen as a time slot), wherein each of the time slots defines: (i) a single electrode-pair (EP) from a plurality of electrodes ([0052]: the electrodes of electrode assembly 12 may be energized sequentially such that only some of electrodes are energized at a given time. That is, not all electrodes of electrode assembly 12 are energized simultaneously. In some embodiments, for example, a first pair of electrodes may be energized according to an electroporation energization strategy, and subsequently, a second pair of electrodes may be energized according to the electroporation energization strategy), wherein the single EPs in at least two of the time slots of the set of time slots include a common electrode of the plurality of electrodes and are separated by at least one time slot from the set of time slots ([0052]: the electrodes may be sequentially energized as pairs by energizing, in sequence, the first and third electrodes, the second and fourth electrodes, the third and fifth electrodes; wherein the first pair (first & third) and third pair (third & fifth) have the 3rd electrode as the common electrode and are separated by the second pair (second & fourth)) and
(2) an empty time slot during which no BAP is applied to any single EP from the plurality of electrodes (Fig. 9, portion of burst signal where no pulse signals 700 are applied, wherein the duration of the train of pulse signals 700 are the time slot, the portion without pulse signals 700 immediately after is the time gap; [0070]: burst period 902 is selected to allow a power supply (e.g., a capacitor) of electroporation generator 26 to recharge to a sufficient voltage to maintain the voltage amplitude of pulse signal 700 at or near the target voltage amplitude (e.g., at least 90% of a target voltage amplitude)).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the computer program product of Howard to comprise a single electrode pair, as taught by Byrd, to include the processor of Byrd for the purpose of the selective energizing may be based on contact between the electrodes and tissue and enabling the power supply to recharge to a sufficient voltage to maintain the voltage amplitude of pulse signal 700 at or near the target voltage amplitude (e.g., at least 90% of a target voltage amplitude) (Byrd: [0033], [0070]).
Regarding claim 18, Howard discloses wherein the program code including further instructions to repeat delivery of the waveforms to the plurality of electrodes based on the predefined pattern ([0114]: These two delivery patterns shown in FIGS. 21 and 22 may be delivered sequentially such that focused energy is delivered first through electrode E1 and then through electrode E2, and this sequence may be repeated any number of times and/or combined with other delivery patterns).
Regarding claim 19, Howard discloses wherein the waveform of each time slot of the set of time slots is delivered successively to the single EPs associated with the respective time slots ([0114]: These two delivery patterns shown in FIGS. 21 and 22 may be delivered sequentially; [0112]: FIGS. 17-25 show further examples of energy delivery patterns in a first plurality of electrodes 38a connected to a first polarity includes fewer electrodes than a second plurality of electrodes 38b connected to a second polarity … the first plurality of electrodes 38a includes two adjacent electrodes, the second plurality of electrodes 38b includes five adjacent electrodes; for example, see Fig. 17 where active electrodes 38a (E3 & E4) are paired with inactive electrodes 38b (E6-E9) such that any of the inactive electrodes form a bipolar pair with the active electrodes such that the waveform is delivered to two pairs of electrodes simultaneously).
Claims 4, 12 & 20 are rejected under 35 U.S.C. 103 as being unpatentable over Howard in view of Byrd as applied to claims 1, 10 & 17, above, and further in view of Viswanathan (U.S. Pub. No. 20190336207, cited in IDS).
Regarding claim 4, Howard in view of Byrd fails to disclose wherein the waveform of two or more time slots of the set of time slots delivered to the single EPs associated with the two or more time slots, respectively, with a defined temporal overlap.
However, Viswanathan discloses wherein the waveform of two or more time slots of the set of time slots delivered to the single EPs associated with the two or more time slots, respectively, with a defined temporal overlap ([0061]: A first electrode pairing set of a first clique may deliver a set of groups of pulses 1703, 1705, 1707 denoted by thin brackets in FIG. 17. Similarly, a second electrode pairing set of a first clique may deliver a set of groups of pulses 1723, 1725 denoted by thick brackets in FIG. 17). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the method of Howard in view of Byrd to include a defined temporal overlap, as taught by Viswanathan for the purpose of the interleaving or multiplexing processes described herein may increase the efficiency or speed with which an ablation energy sequence may be delivered in each heartbeat (Viswanathan: [0065]).
Regarding claim 12, Howard in view of Byrd fails to disclose wherein the plurality of instructions further cause the processor to deliver the waveform of two or more time slots of the set of time slots to the single EPs associated with the two or more time slots, respectively, with a defined temporal overlap.
However, Viswanathan discloses wherein the plurality of instructions further cause the processor ([0039]: In some embodiments, a system includes a pulse waveform generator and an ablation device coupled to the pulse waveform generator. The ablation device includes at least one electrode configured for ablation pulse delivery to tissue during use. The pulse waveform generator is configured to deliver voltage pulses to the ablation device in the form of a pulsed waveform) to deliver the waveform of two or more time slots of the set of time slots to the single EPs associated with the two or more time slots, respectively, with a defined temporal overlap ([0061]: A first electrode pairing set of a first clique may deliver a set of groups of pulses 1703, 1705, 1707 denoted by thin brackets in FIG. 17. Similarly, a second electrode pairing set of a first clique may deliver a set of groups of pulses 1723, 1725 denoted by thick brackets in FIG. 17). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the processor of Howard in view of Byrd to include a defined temporal overlap, as taught by Viswanathan for the purpose of the interleaving or multiplexing processes described herein may increase the efficiency or speed with which an ablation energy sequence may be delivered in each heartbeat (Viswanathan: [0065]).
Regarding claim 20, Howard fails to disclose wherein the waveforms of two or more time slots of the set of time slots are delivered to the single EPs associated with the two or more time slots, respectively, with one of: i) a defined temporal overlap; ii) or a time gap between repetitions of the predefined pattern such that the generation of each waveform[[s]] generated based on the predefined pattern are repeated after a lapse of the time gap.
However, Viswanathan discloses wherein the waveforms of two or more time slots of the set of time slots are delivered to the single EPs associated with the two or more time slots, respectively, with one of: i) a defined temporal overlap ([0039]: In some embodiments, a system includes a pulse waveform generator and an ablation device coupled to the pulse waveform generator. The ablation device includes at least one electrode configured for ablation pulse delivery to tissue during use. The pulse waveform generator is configured to deliver voltage pulses to the ablation device in the form of a pulsed waveform; [0061]: A first electrode pairing set of a first clique may deliver a set of groups of pulses 1703, 1705, 1707 denoted by thin brackets in FIG. 17. Similarly, a second electrode pairing set of a first clique may deliver a set of groups of pulses 1723, 1725 denoted by thick brackets in FIG. 17); ii) or a time gap between repetitions of the predefined pattern such that the generation of each waveform generated based on the predefined pattern are repeated after a lapse of the time gap.
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the computer program product of Howard to include a defined temporal overlap, as taught by Viswanathan for the purpose of the interleaving or multiplexing processes described herein may increase the efficiency or speed with which an ablation energy sequence may be delivered in each heartbeat (Viswanathan: [0065]).
Claims 6, 14 & 20 are rejected under 35 U.S.C. 103 as being unpatentable over Howard in view of Byrd as applied to claims 1, 10 & 17, above, and further in view of Castellvi et al. (U.S. Pub. No. 20230172650, earliest effective filing date), herein referred to as “Castellvi”.
Regarding claim 6, Howard in view of Byrd fails to disclose scheduling a time gap between repetitions of the predefined pattern and repeating generation of each of waveform generated based on the predefined pattern after a lapse of the time gap.
However, Castellvi discloses scheduling a time gap (inter bundle delay 26) between repetitions of the predefined pattern (bundles 24) and repeating generation of each of waveform generated based on the predefined pattern after a lapse of the time gap (see Fig. 5; [0261]: packets 20 are grouped into batches or bundles 24, such as illustrated in FIG. 5. Here, two bundles 24 are illustrated, each bundle 24 being comprised of three packets 20. The bundles 24 are separated by inter-bundle delays 26). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the method of Howard in view of Byrd to include the steps of Castellvi, for the purpose of the inter bundle delays/time gap occurring during sensitive portions of the heartbeat, thus, energy is applied outside of sensitive portions of the heartbeat so as to avoid inducing arrhythmias (Castellvi: [0261]).
Regarding claim 14, Howard in view of Byrd fails to disclose wherein the plurality of instructions further cause the processor to schedule a time gap between repetitions of the predefined pattern to provide instructions to repeat generation of each waveform generated based on the predefined pattern after lapse of the time gap.
However, Castellvi discloses wherein the plurality of instructions further cause the processor to ([0327]: As mentioned previously, one or more energy delivery algorithms 152 are programmable, or can be pre-programmed, into the generator 104 for delivery to the patient P) schedule a time gap (inter bundle delay 26) between repetitions of the predefined pattern (bundles 24) to provide instructions to repeat generation of each waveform generated based on the predefined pattern after lapse of the time gap (see Fig. 5; [0261]: packets 20 are grouped into batches or bundles 24, such as illustrated in FIG. 5. Here, two bundles 24 are illustrated, each bundle 24 being comprised of three packets 20. The bundles 24 are separated by inter-bundle delays 26). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the processor Howard in view of Byrd to include the processor of Castellvi for the purpose of the inter bundle delays/time gap occurring during sensitive portions of the heartbeat, thus, energy is applied outside of sensitive portions of the heartbeat so as to avoid inducing arrhythmias (Castellvi: [0261]).
Regarding claim 20, Howard in view of Byrd fails to disclose wherein the waveforms of two or more time slots of the set of time slots are delivered to the single EPs associated with the two or more time slots, respectively, with one of: i) a defined temporal overlap; ii) or a time gap between repetitions of the predefined pattern such that the generation of each waveforms generated based on the predefined pattern are repeated after a lapse of the time gap.
However, Castellvi discloses wherein the waveforms of two or more time slots of the set of time slots are delivered to the single EPs associated with the two or more time slots, respectively, with one of: i) a defined temporal overlap; ii) or a time gap (inter bundle delay 26) between repetitions of the predefined pattern (bundles 24) such that the generation of each waveform generated based on the predefined pattern are repeated after a lapse of the time gap (see Fig. 5; [0261]: packets 20 are grouped into batches or bundles 24, such as illustrated in FIG. 5. Here, two bundles 24 are illustrated, each bundle 24 being comprised of three packets 20. The bundles 24 are separated by inter-bundle delays 26). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the computer program product of Howard in view of Byrd to include a time gap, as taught by Castellvi, for the purpose of the inter bundle delays/time gap occurring during sensitive portions of the heartbeat, thus, energy is applied outside of sensitive portions of the heartbeat so as to avoid inducing arrhythmias (Castellvi: [0261]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Abigail M Ziegler whose telephone number is (571) 272-1991. The examiner can normally be reached M-F 8:30 a.m. - 5 p.m. EST.
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/ABIGAIL M ZIEGLER/Examiner, Art Unit 3794
/THOMAS A GIULIANI/Primary Examiner, Art Unit 3794