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
Claim 1 is objected to because of the following informalities:
Claim 1, line 5: “pluses” should read –pulses--.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 2-8 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Regarding claim 7, the claim states “7. The method of claim 7,”. A claim cannot depend on itself. Regarding claims 2-6 and 8, those claims also depend from claim 7. Dependent claims inherit the deficiencies from the claims from which they depend and are similarly rejected over 35 U.S.C. 112(d). It would appear that applicant meant for claims 2-8 to depend from claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Olson, WO 2018191149, herein referred to as "Olson", in view of Azure et al., US 20090076502, herein referred to as “Azure”.
Regarding claim 1, Olson discloses a method for irreversible electroporation (Figure 1: system 10 and Abstract), comprising: while multiple electrodes (Figure 1: catheter electrode assembly 12 and [0025]: “system 10 includes a catheter electrode assembly 12 including a constellation, or array, of catheter electrodes”) of an expandable distal end of a catheter (Figure 1: catheter electrode assembly 12 is at distal section 48 of shaft 44 which is at the distal end of catheter 14 and [0031]: “For example, where distal section 48 includes a balloon or basket catheter, handle 42 may be configured to transition distal section 48 from a collapsed state to an expanded state.”) is in contact with a tissue in an organ (Figure 1: catheter electrode assembly 12 and tissue 16), generating irreversible electroporation (IRE) pluses using an IRE pulse generator (Figure 1: electroporation generator and [0018]: “the present disclosure relates to electroporation systems and methods of energizing a catheter for delivering irreversible electroporation (IRE) using intracardiac catheters”); and selecting first and second pairs of the electrodes (Figure 6: 620 and 630 and [0020]: “Each electrode element, also referred to herein as a catheter electrode, is individually wired such that it can be selectively paired or combined with any other electrode element to act as a bipolar or a multi-polar electrode.”) that would apply the IRE pulses at the first and second orientations (Figure 1: localization and navigation system 30 and [0055]: “Localization and navigation system 30 is configured to select 630 electrodes 306 and to control electroporation generator 26 to energize 640 subset of electrodes 306.”); and applying the IRE pulses to the selected region of tissue (Figure 6: 640), by connecting the IRE pulse generator to the selected pairs of the electrodes (Figure 1: electroporation generator 26). Olson does not explicitly disclose a method comprising: receiving a first orientation and a second orientation along which electric fields in tissue are to be generated by the IRE pulses; and selecting first and second pairs of the electrodes that would apply the IRE pulses at the first and second orientations such that the electric fields generated in the second orientation crosses over electric fields generated in the first orientation in a selected region of tissue; and applying the IRE pulses to the selected region of tissue at both the first and second orientations, by connecting the IRE pulse generator to the selected pairs of the electrodes.
However, Azure teaches a method (Figure 1: device 10 and Abstract) comprising: receiving a first orientation and a second orientation along which electric fields in tissue are to be generated by the IRE pulses ([0054]: “As described above with reference to FIGS. 4 and 5, the present invention can include insertion and positioning of a plurality or array of individual electrodes, with the electrodes being controlled individually or in groups and activated to deliver current field to the target tissue in a plurality of different orientations and directions. Electrodes can be differentially activated in various different pairs or groups such that the desired electric field is delivered to the target tissue in a plurality of different directions.”); and selecting first and second pairs of the electrodes that would apply the IRE pulses at the first and second orientations ([0054]: “As described above with reference to FIGS. 4 and 5, the present invention can include insertion and positioning of a plurality or array of individual electrodes, with the electrodes being controlled individually or in groups and activated to deliver current field to the target tissue in a plurality of different orientations and directions. Electrodes can be differentially activated in various different pairs or groups such that the desired electric field is delivered to the target tissue in a plurality of different directions.”) such that the electric fields generated in the second orientation crosses over electric fields generated in the first orientation in a selected region of tissue (Figure 6B: arrows in the middle of the simple four electrode grouping 118); and applying the IRE pulses to the selected region of tissue at both the first and second orientations ([0057]: “As shown in FIG. 6B, a simple four electrode grouping 118 of an array can be differentially activated in pairs, with each different pair of electrodes 120 providing a different field delivery and orientation (possible field flow/orientations are illustrated by arrows).”), by connecting the IRE pulse generator to the selected pairs of the electrodes ([0042]: “An integrated CPU monitors overall system power consumption and availability and controls the output of the signal generator and amplifier based on the treatment parameters input by the operator.” And Figure 6B: simple four electrode grouping 118).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method disclosed by Olson so that it includes receiving a first orientation and a second orientation along which electric fields in tissue are to be generated by the IRE pulses; and selecting first and second pairs of the electrodes that would apply the IRE pulses at the first and second orientations such that the electric fields generated in the second orientation crosses over electric fields generated in the first orientation in a selected region of tissue; and applying the IRE pulses to the selected region of tissue at both the first and second orientations, by connecting the IRE pulse generator to the selected pairs of the electrodes, as taught by Azure, for more precise control of the current applied to the tissue, containment of the applied field to the desired location, as well control of heating or limited temperature increase in the target tissue (Azure [0054]).
Regarding claim 2, Olson in view of Azure discloses the method according to claim 7, and Olson further discloses a method wherein each of the electrodes (Figure 2: multiple electrodes 204) comprises a plurality of electrode segments (Figure 2: two of multiple electrodes 204 adjacent each other on a spline 202 are two electrode segments), and wherein selecting the pairs comprises individually including any of the electrode segments in the one or more pairs (Figure 2: multiple electrodes 204 and [0020]: “Each electrode element, also referred to herein as a catheter electrode, is individually wired such that it can be selectively paired or combined with any other electrode element to act as a bipolar or a multi-polar electrode.”).
Regarding claim 3, Olson in view of Azure discloses the method according to claim 7, and Olson further discloses a method wherein the electrodes (Figure 2: multiple electrodes 204) are disposed equiangularly about a longitudinal axis of the distal end (Figure 2: electrodes 204 are on splines 202 which are disposed equiangularly about a longitudinal axis of poles 206 and 208, which are at distal section 48 of shaft 44).
Regarding claim 4, Olson in view of Azure discloses the method according to claim 7, and Olson further discloses a method wherein selecting the pairs comprises selecting first and second pairs of the electrodes (Figure 2: multiple electrodes 204 and [0020]: “Each electrode element, also referred to herein as a catheter electrode, is individually wired such that it can be selectively paired or combined with any other electrode element to act as a bipolar or a multi-polar electrode.”) along mutually orthogonal orientations ([0038]-[0043]).
Regarding claim 5, Olson in view of Azure discloses the method according to claim 7, and Olson further discloses a method wherein applying the IRE pulses comprises applying bi-phasic IRE pulses ([0027]-[0028] and [0055]).
Regarding claim 6, Olson in view of Azure discloses the method according to claim 7, and Azure further discloses a method (Figure 1: device 10) wherein the electrodes (Figure 6B: electrodes 120) are arranged in a plurality of rows (Figure 6B: simple four electrode grouping 118 has two rows), and further comprising selecting one electrode for each of the first and second bipolar pairs of the electrode from one of the plurality of rows and another electrode for each of the first and second bipolar pairs from another one of the plurality of rows (Figure 6B: the diagonal arrows show that both of the pairs of electrodes contain one electrode from each row).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method disclosed by Olson so that the electrodes are arranged in a plurality of rows and the switching assembly so that it includes selecting one for each of the first and second bipolar pairs of the electrode from one of the plurality of rows and another electrode for each of the first and second bipolar pairs from another one of the plurality of rows, as taught by Azure, for more precise control of the current applied to the tissue, containment of the applied field to the desired location, as well control of heating or limited temperature increase in the target tissue (Azure [0054]).
Regarding claim 7, Olson in view of Azure discloses the method according to claim 7, and Olson further discloses a method wherein each of the first and second pairs of the electrodes are bipolar pairs (Figure 2: multiple electrodes 204 and [0020]: “Each electrode element, also referred to herein as a catheter electrode, is individually wired such that it can be selectively paired or combined with any other electrode element to act as a bipolar or a multi-polar electrode.”).
Claims 8 is rejected under 35 U.S.C. 103 as being unpatentable over Olson in view of Azure, further in view of Imran et al., US 20100268295, herein referred to as “Imran”.
Regarding claim 8, Olson in view of Azure discloses the method of claim 7, with Olson disclosing a method wherein the IRE pulse generator (Figure 1: electroporation generator and [0018]: “the present disclosure relates to electroporation systems and methods of energizing a catheter for delivering irreversible electroporation (IRE) using intracardiac catheters”) is configured to generate IRE pulses at a defined pulse voltage amplitude to affect IRE ablation in the region of tissue ([0047]), but Olson in view of Azure does not explicitly disclose a method further comprising adjusting the defined pulse voltage amplitude to be lower than otherwise applied to affect IRE ablation in the region with only one of the first and second pairs, wherein the lowering is configured to affect IRE ablation based on the applying of the IRE pulses to the selected region of tissue at both the first and second orientations.
However, Imran teaches a method (Figure 2 and [0001]) comprising adjusting the defined pulse voltage amplitude to be lower than otherwise applied to affect IRE ablation in the region with only one of the first and second pairs (Figure 3: electrode pairs 52/assemblies 50), wherein the lowering is configured to affect IRE ablation based on the applying of the IRE pulses to the selected region of tissue at both the first and second orientations ([0042]: “The voltage level for achieving cardioversion can be adjusted based on one or more of the following factors (the "conversion voltage adjustment factors"): … iv) the number of electrode pairs defining the area (the more electrodes the lower the voltage”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method disclosed by Olson so that the defined pulse voltage amplitude applied in both the first orientation and the second orientation is lower than otherwise applied to ablate the region with only one of the first and second bipolar pairs in only one orientation as taught by Imran to reduce pain experienced by the patient (Imran [0041]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nora W Rhodes whose telephone number is (571)272-8126. The examiner can normally be reached Monday-Friday 10am-6pm EST.
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/N.W.R./Examiner, Art Unit 3794
/SEAN W COLLINS/Primary Examiner, Art Unit 3794
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