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 .
Claim Objections
Claims 1, 11, and 15 are objected to because of the following informalities:
In claim 1, line 9, “so as generate” should read --so as to generate--
In claim 1, line 17, “sequences” should read --sequence--
In claim 11, line 22, “first electrode pair” should read --the first electrode pair—
In claim 15, line 2, “and the wherein” should read –and wherein--
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 5-7, 9-10, and 15 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 5 recites the limitation "the plurality of electrical pulse sequences" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, this limitation will be interpreted as the electrical pulse sequence recited in claim 1. Claims 6-7 and 9-10 are necessarily rejected as depending upon a rejected base claim.
Claims 6-7 and 9-10 each recite the limitation “the DC pulses.” There is insufficient antecedent basis for this limitation in the claims. For examination purposes, this limitation will be interpreted as --the plurality of DC pulses-- as recited in claim 5.
Claim 7 recites the limitation “each pulse sequence” in line 2. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, this limitation will be interpreted as --each electrical pulse sequence of the plurality of electrical pulse sequences-- as recited in claim 5.
Claim 9 recites the limitations "the second electrical pulse sequence" in lines 3-4 and “the first electrical pulse sequence” in line 5. There is insufficient antecedent basis for these limitations in the claim.
Claim 10 recites the limitation "the electroporation ablation generator" in line 2. There is insufficient antecedent basis for this limitation in the claim, and it is unclear whether this limitation refers to the electroporation generator as recited in claim 1. For examination purposes, this limitation will be interpreted as the same electroporation generator recited in claim 1.
Claim 10 also recites the limitations "the first anode-cathode pair" in line 3 and “the second anode-cathode pair” in line 4. There is insufficient antecedent basis for these limitations in the claim. For examination purposes, these limitations will be interpreted as any first and second electrode pair.
Claim 15 recites the limitation "the electroporation ablation generator" in 3. There is insufficient antecedent basis for this limitation in the claim, and it is unclear whether this limitation refers to the electroporation generator as recited in claim 11. For examination purposes, this limitation will be interpreted as the same electroporation generator recited in claim 11.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-7, 9, 11-14, and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Azure (US PGPub No. 2009/0076500) in view of Maor (US PGPub No. 2016/0113709).
Regarding claims 1 and 11, Azure teaches an electroporation ablation system for treating target tissue (Fig. 1: device 10 and Fig. 16: system 200), the electroporation ablation system comprising:
an ablation catheter including: a handle (Fig. 1: proximal portion 18); a shaft having a distal end and defining a longitudinal axis of the ablation catheter (Fig. 1: delivery member 12 having distal portion 14);
and an electroporation electrode arrangement at the distal end of the shaft (Fig. 1: electrodes 22; par. 0032: “a non-insulated portion of the electrode provides an electric field delivery surface”);
and including a plurality of electrodes spatially arranged so as generate a plurality of electric fields when electrical energy is delivered to selected pairs of the electrodes, each electrode pair configured to generate an electric field when electrical energy is delivered thereto (Figs. 17A-17D: electrodes pairs 274, 276, 282, 284; par. 0067: “the electrode pairs define a circuit and an applied field extends between the two electrodes of the pair”),
the plurality of electric fields including a first electric field having a first orientation relative to the longitudinal axis when electrical energy is delivered to a first electrode pair,
and a second electric field having a second orientation relative to the longitudinal axis when electrical energy is delivered to a second electrode pair (Figs. 17B-17D: various electric field orientations between different electrode pairs),
and an electroporation generator operatively coupled to the electroporation electrode arrangement and configured to generate and deliver the electrical energy to each selected pair of electrodes (Fig. 16: power unit 210; par. 0060: “A power unit 210 can include any means of generating electrical power used for operating a device of the invention and applying electrical current to a target tissue as described herein. A power unit 210 can include, for example, one or more electrical generators;” par. 0067: “Electrode pairs can be activated individually or sequentially such that only one electrode pair is activated at any one moment”).
Azure does not explicitly teach wherein the electroporation generator is configured to generate and deliver a plurality of electrical pulse sequences to the electrode pairs. However, in an analogous art, Maor teaches an electroporation ablation system with a generator configured to generate and deliver electrical pulse sequences to electrode pairs, which increases electroporation effectiveness (par. 0112: “effectiveness of electroporation for volume reduction is increased by delivery of an increased number of pulses”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the system of Azure by configuring the generator to generate and deliver a plurality of electrical pulse sequences to the electrode pairs, as taught by Maor, in order to increases electroporation effectiveness, as taught by Maor.
Regarding claims 2-4 and 12-14, the combination teaches the system of claims 1 and 11 as described previously. Azure further teaches electric field orientations that are generally aligned with the longitudinal axis (Fig. 17D), circumferential about the longitudinal axis (Fig. 17B), and transverse to the longitudinal axis (Fig. 17C), and that a device can include any combination of these three orientations (par. 0067: “A device can include a plurality of electrode pairs configured as described, with different pairs of the plurality applying fields in different directions across the target tissue. Configuration and arrangement of electrodes in this manner can permit application of fields through the tumor and in a plurality of different directions”).
Regarding claims 5-6, the combination teaches the system of claim 1 as described previously. Maor further teaches wherein the electrical pulse sequence comprises a plurality of DC pulses, and wherein the DC pulses are monophasic pulses, biphasic pulses, or triphasic pulses (par. 0211: “Electroporation pulses are optionally modeled as discrete square DC pulses of length t1 with a pulse frequency f”).
Regarding claims 7 and 9, the combination teaches the system of claim 1 as described previously. Maor further teaches wherein the electroporation generator is configured to generate the DC pulses of each pulse sequence separated by an inter-pulse delay, and wherein at least some of the DC pulses of a first electrical pulse sequence are delivered during a respective inter-pulse delay of a second electrical pulse sequence, and vice versa (par. 0144: “pulses are delivered alternately to different pairs of electrodes”). Maor teaches that alternating pulse delivery between different pairs of electrodes reduces electroporation time and reduces thermal damage effects (par. 0144: “By switching among electrodes for delivery of electroporating pulses, in some embodiments, electroporation protocol times are reduced, while distributing heating effects over a wider area, and potentially reducing thermal damage effects; in particular, reducing focal thermal damage effects”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the system of the combined reference by configuring the generator to alternate pulse delivery between the first and second pairs of electrodes, as taught by Maor, in order to reduce electroporation time and reduce thermal damage effects, as taught by Maor.
Regarding claim 16, Azure teaches a method of generating and delivering a signal to electrodes in an electroporation ablation system, the method comprising: delivering electrical energy to a first electrode pair of an electroporation catheter having a longitudinal axis so as to generate a first electric field having a first orientation relative to the longitudinal axis; and delivering electrical energy to a second electrode pair of the electroporation catheter so as to generate a second electric field having a second orientation relative to the longitudinal axis (Figs. 17A-17C: various electric fields having various orientations relative to longitudinal axis; par. 0067: “Different electrode pairs can be activated to apply electric fields to different portions of the target tissue and/or fields having different directions/orientations”). Azure in view of Maor further teaches delivering first and second electrical pulse sequences to the first and second electrode pairs, respectively, for the same reasons set forth in the rejection of claims 1 and 11.
Regarding claim 17, the combination teaches the method of claim 16 as described previously. Maor further teaches alternatingly delivering over a time period, the first electrical pulse sequence to the first electrode pair and delivering the second electrical pulse sequence to the second electrode pair to produce a dynamically gyrating electric field that comprises a changing pattern over the time period, for the same reasons set forth in the rejection of claims 7 and 9.
Regarding claims 18-20, the combination teaches the method of claim 16 as described previously. Azure further teaches the limitations of 18-20 for the same reasons set forth previously in the rejection of claims 2-4 and 12-14.
Claims 8, 10, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Azure in view of Maor and further in view of Viswanathan et al. (US PGPub No. 2018/0043153), hereinafter Viswanathan.
Regarding claim 8, Azure in view of Maor teaches the system of claim 1 as described previously but does not explicitly teach wherein the electroporation generator is configured to generate a plurality of electrical pulse sequence sets having a pause therebetween, wherein each electrical pulse sequence set comprises a plurality of electrical pulse sequences.
However, in the same field of endeavor, Viswanathan teaches a hierarchical structure of waveforms comprising a plurality of electrical pulse sequence sets (Fig. 5: first packet 158, second packet 163), each comprising a plurality of electrical pulse sequences (Fig. 5: first and second set of pulses in first packet 158), all of which can be generated with a suitable pulse generator (par. 0047). Viswanathan also teaches that hierarchical waveforms as disclosed have the advantage of providing a good degree of control and selectivity for applications in different tissue types (par. 0047).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the system of the combined reference by configuring the generator to generate a hierarchical structure of waveforms comprising a plurality of electrical pulse sequence sets, as taught by Viswanathan, in order to provide a good degree of control and selectivity for applications in different tissue types, as taught by Viswanathan.
Regarding claims 10 and 15, Azure in view of Maor teaches the systems of claims 1 and 11 as described previously. Maor further teaches alternate delivery of electrical DC pulse sequences between the first and second electrode pairs, as described in the rejection of claims 7 and 9. The combination does not explicitly teach wherein the electrical pulse sequences comprise a plurality of biphasic pulses.
However, Viswanathan teaches biphasic pulses for electroporation (Fig. 5: biphasic pulse 151) as an explicit alternative to monophasic pulses (par. 0047: “It is understood that while the examples herein identify separate monophasic and biphasic waveforms for clarity, it should be noted that combination waveforms, where some portions of the waveform hierarchy are monophasic while other portions are biphasic, can also be generated/implemented” and par. 0051: “While inequality (1) was explicitly written for a monophasic hierarchical waveform, a similar inequality may be written for a biphasic waveform, or for a waveform that combines monophasic and biphasic elements”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to substitute the biphasic pulses of Viswanathan for the monophasic pulses of the combined reference, since Viswanathan teaches biphasic and monophasic electroporation pulses as obvious alternatives of one another, and the results would have been predictable, that is, electroporation of tissue would occur using either type of waveform.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Günther et al. (US PGPub No. 2021/0330371) teaches electrolytic electroporation ablation waveforms delivering electrolysis and electroporation sequentially and separately.
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/D.E.L./Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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