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 .
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 (i.e., changing from AIA to pre-AIA ) 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.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/24/2024 was filed after the mailing date of the application on 10/24/2024. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment
In the Amendments filed 08/29/2025, claims 1-16 are amended. Claims 1-16 are under examination herein.
Claim Objections
Claim 1 is objected to for the use of the phrase “the ablation electrodes” in line 7 when referring to the “at least two ablation electrodes” in line 4. Appropriate correction is required.
Claim 2 is objected to for the use of the phrase “the ablation electrodes” when referring to the “at least two ablation electrodes” of claim 1. Appropriate correction is required.
Claim 4 is objected to for the use of the phrase “at least one of the ablation electrodes” when referring to the “at least two ablation electrodes” of claim 1. Appropriate correction is required.
Claims 14 and 15 are objected to for the use of commas (e.g., “0,2 mm and 2,5mm”) instead of periods (0.2mm and 2.5mm) when referring to the spacing between electrodes. 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 1, 5-7, 9, and 16 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.
Regarding claim 1, the claim recites the phrase “in particular” in line 4 and 11. The use of the phrase “in particular” renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP 2173.05(d).
Regarding claim 5, the claim recites the use of “two or more pairs of ablation electrodes”, whereas claim 1 recites “at least two ablation electrodes”. It is unclear to the Examiner if the pairs of claim 5 are the same two ablation electrodes of claim 1, or are instead additional electrodes. The Examiner suggests that the Applicant further defines the ablation electrodes using a different labeling convention (i.e., a first pair of ablation electrodes, a second pair of ablation electrodes) or uses a consistent recitation throughout the disclosure (i.e., at least two ablation electrodes instead of referring to “two or more pairs of ablation electrodes”).
Regarding claim 6, the claim recites the phrase “… apply a pulse of an electrical energy substantially simultaneously to the tissue and/or such that at least two of the pairs apply separate pulses”. The phrase “and/or” renders the claim indefinite, as the pulse cannot be simultaneous or separate at the same time.
The claim is further rendered indefinite for the phrase “substantially simultaneous”, as the Examiner cannot determine what would make the pulse “substantially simultaneously”. In other words, the Examiner cannot determine if a claim is “substantially simultaneous” if it is actually simultaneous, or instead has an acceptable delay or range of time before application of energy. Appropriate correction is required. The Examiner suggests clarifying the limitation to recite “… apply a pulse of an electrical energy substantially simultaneously or separately…” to define if the pulse can be simultaneous or separately applied.
The claim is further rendered indefinite for the phrase “at least two of the pairs”. There is insufficient antecedent basis for the limitation in the claim. Appropriate correction is required.
Regarding claim 7, the claim recites the use of “two or more pairs of ablation electrodes”, whereas claim 1 recites “at least two ablation electrodes”. It is unclear to the Examiner if the pairs of claim 7 are the same two ablation electrodes of claim 1, or are instead additional electrodes. The Examiner suggests that the Applicant further defines the ablation electrodes using a different labeling convention (i.e., a first pair of ablation electrodes, a second pair of ablation electrodes) or uses a consistent recitation throughout the disclosure (i.e., at least two ablation electrodes instead of referring to “two or more pairs of ablation electrodes”).
Regarding claim 9, the claim recites the limitation “an ablation electrode” and “a mapping electrode”. There is insufficient antecedent basis for the limitation in this claim. The Examiner cannot determine if the ablation electrode of claim 9 is an additional ablation electrode outside of the ablation electrodes of claim 1 and if the mapping electrode is an additional mapping electrode outside of the mapping electrode of claim 8. Appropriate correction is required.
Regarding claim 16, the claim recites the phrase “in particular” in line 3 and 4. The use of the phrase “in particular” renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP 2173.05(d).
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.
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 1-16 are rejected under 35 U.S.C. 103 as being unpatentable over Byrd (US 2021/0121228 A1).
Regarding claim 1, Byrd teaches
“A catheter for ablation a tissue using pulsed-field (PF) energy configured for connection to a high-voltage generator for generating PF energy (Fig. 1, p.[0018] "the present disclosure relates to the electroporation systems and catheters for electroporation..."),”
“Whereby the catheter comprises at least two ablation electrodes, in particular at least six ablation eletrodes (Fig. 5, showing at least six ablation electrodes 304 as described in p.[0043] "First type catheter electrodes 304 are used by system 10 during electroporation."), configured for applying PF energy to the tissue (Fig. 5, p.[0043] "... First type catheter electrodes 304 are used by system 10 during electroporation...", note that electroporation is a type of PF energy)”,
“wherein the catheter is configured such that, in an ablation position of the catheter, the ablation electrodes contact the tissue along a main axis of the catheter (Fig. 3-5 show electrodes were positioned along a main longitudinal axis, and therefore would contact tissue along a main longitudinal axis)”,
“wherein the catheter comprises at least two separate electrical conductors to connect to said electrodes to said high-voltage pulse generator for generating PF energy (Fig. 6, p.[0050] in particular, "… electrode wires 606 carry electrical current from a power source coupled to connector 208 to catheter electrodes 214... there are fifteen electrode wires. One electrode wire 606 is connected to all of first type catheter electrodes 304. The remaining fourteen electrodes 606 are connected to a different second type catheter electrode 306...")”, and
“wherein the ablation electrodes of said catheter are spaced apart such that the electric field inside cardiac tissue (p.[0003] teaches ablation of cardiac tissue being known in the art and contemplated as tissue to be treated) exceeds an intensity of 400 V/cm at a depth of 5mm when they are energized by said waveform (Fig. 1, p.[0025] "… generator 26 may be configured to produce an electric current that is delivered via electrode assembly 12 as a pulsed electric field in the form of short-duration D.C. pulses (e.g., a nanosecond to several milliseconds duration, 0.1 to 20 ms duration, or any duration suitable for electroporation) between closely spaced electrodes capable of delivering an electric field strength (i.e., at the tissue site) of about 0.1 to 1.0 kV/cm.")”.
Byrd does not explicitly teach that the electric field inside cardiac tissue exceeds an intensity of 400 V/cm at a depth of 5mm when energized, but does teach a system that is capable of achieving this range. It would have been obvious to one of ordinary skill of the art before the effective filing date of the art to use Byrd to arrive at the claimed invention, especially given that there is no criticality of the range expressed by the applicant. As stated in MPEP 2144.05, "In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)". Byrd teaches a system that can achieve the range and therefore teaches the claimed invention.
Regarding claim 2, the limitations of claim 1 are taught as described above. Byrd teaches “wherein the catheter is configured such that the tissue is ablated along a portion of the main axis, wherein the portion spans at least over a distance between the ablation electrodes” in Figures 3-5 the orientation of electrodes 214, 304, 306, and 506 is over a portion of the main axis and spans a distance between ablation electrodes. The tissue would be ablated across the portion of the electrodes on the main axis (as further taught in p.[0003]), and therefore teaching the claimed limitation.
Regarding claim 3, the limitations of claim 1 are taught as described above. Byrd teaches “wherein the catheter is configured such that an elongated profile is ablated into the tissue” in Figures 3-5 the orientation of electrodes 214, 304, 306, and 506 is over a portion of the main axis and spans an elongated distance between ablation electrodes. The tissue would be ablated across the portion of the elongated profile of the electrodes on the main axis, and therefore teaches the claimed limitation.
Regarding claim 4, the limitations of claim 1 are taught as described above. Byrd teaches “wherein at least one of the ablation electrodes is positioned at a sidewall of the catheter such that it is distanced to a tip of the catheter” in Figures 3-5 which show that the electrodes 214, 304, 306, and 506 are positioned on the side of the catheter at a distance from a tip of the catheter, therefore teaching the limitation as described.
Regarding claim 5, the limitations of claim 1 are taught as described above. Byrd teaches “wherein the catheter comprises two or more pairs of ablation electrodes positioned along the main axis” in Figure 5, specifically the use of electrode pairs 214/304/506 positioned along the main axis and therefore teaches the claimed limitation. Note that any electrodes can be defined as pair and be selected for use individually or as a pair, as described in p.[0019].
Regarding claim 6, the limitations of claim 5 are taught as described above. Byrd does not explicitly teach "wherein the catheter is configured such that at least two pairs apply a pulse of an electrical energy substantially simultaneously to the tissue and/or such that at least two of the pairs apply separate pulses of the electrical energy to the tissue in the ablation position", but does suggest that the system is capable of such a configuration in p.[0019], which states "The first type catheter electrodes are all electrically connected together to a single connection in the catheter." The first type catheter electrodes, 214/304/506 are connected to a single connection and therefore could deliver electrical energy substantially simultaneously, if desired (p.[0038, 0043]). Note that any electrodes can be defined as pair and be selected for use individually or as a pair, as described in p.[0019]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use Byrd to arrive at the claimed invention. As stated in Byrd, it is known in the art of electroporation to deliver pulses of energy and such energy delivery produces predictable results (p.[0004,0020,0025].
Regarding claim 7, the limitations of claim 5 are taught as described above. Byrd does not explicitly teach "wherein the two or more pairs of ablation electrodes are positioned along the main axis such that the application of the electrical energy in the ablation position causes a contiguous elongated profile without gaps ablated in the tissue", but does describe that the system is capable of achieving such a configuration. Byrd states in p.[0041-0044] that the first type electrodes "spacing may be developed to provide a targeted range of energy density to tissue, as well as provide sufficient electroporation coverage for different human anatomic geometries. In general, a sufficient number of electrodes 214 with appropriate lengths 310 and 312 are desired to provide substantially even and continuous coverage around the circumference of variable diameter loop 300". Note that any electrodes can be defined as pair and be selected for use individually or as a pair, as described in p.[0019]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use Byrd to arrive at the claimed invention. As stated in Byrd (p.[0044]), different spaces and geometries may be developed to provide a targeted range of energy density to tissue, as well as to provide sufficient electroporation coverage for different human anatomic geometries and such a modification produces predictable results.
Regarding claim 8, the limitations of claim 1 are taught as described above. Byrd teaches the use of mapping electrodes for sensing the tissue in p.[0027, 0043], which in part (p.[0043]) states "A selection interface (discussed in more detail below), allows second type catheter electrodes 306 to be selectively used for electroporation and navigation/mapping" and teaches the limitation as described.
Regarding claim 9, the limitations of claim 8 are taught as described above. Byrd teaches that the catheter has a selection interface that allows for second type electrode catheters to act as either a mapping electrode or an ablation electrode, depending on the desired procedure of the device in p.[0043], whereas Figure 7 and p.[0053-0056] further describes how the selection interface performs this function. The selection interface allows for second type electrodes to function as either mapping or ablation electrodes to allow for electroporation and navigation/mapping without increasing the size of the shaft (p.[0045]).
Regarding claim 10, the limitations of claim 9 are taught as described above. Byrd does not explicitly teach the spacing between electrodes (either mapping nor ablation, where either first or second type electrodes can be ablation or mapping electrodes as detailed in p.[0043]), but does suggest that the system could be modified to arrive at the claimed range. Note that any electrodes can be defined as pair and be selected for use individually or as a pair, as described in p.[0019]. Byrd teaches in p.[0044] that "Diameter 400 and catheter electrode 214 spacing may be developed to provide a targeted range of energy density to tissue, as well as to provide sufficient electroporation coverage for different human anatomic geometries. In general, a sufficient number of electrodes 214 with appropriate lengths 310 and 312 are desired to provide substantially even and continuous coverage around the circumference of variable diameter loop 300, while still allowing enough flexibility to allow variable diameter loop 300 to expand and contract to vary diameter 400 to the desired extremes." It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use Byrd to arrive at the claimed invention. As stated in Byrd, modifying the spacing of the electrodes allows for a targeted range of energy density to tissue, to provide sufficient electroporation coverage for different human anatomic geometries (p.[0043]), with Byrd further recognizing that varying the length of diameter of electrodes (and therefore their spacing) may "help prevent arcing during electroporation operations" and produces predictable results.
Regarding claim 11, the limitations of claim 10 are taught as described above. Byrd does not explicitly teach the spacing between electrodes (either mapping nor ablation, where either first or second type electrodes can be assigned as pairs of ablation or mapping electrodes as detailed in p.[0043]), but does suggest that the system could be modified to arrive at the claimed inter-pair distance. Note that any electrodes can be defined as pairs and be selected for use individually or as a pair, as described in p.[0019]. Byrd teaches in p.[0044] that "Diameter 400 and catheter electrode 214 spacing may be developed to provide a targeted range of energy density to tissue, as well as to provide sufficient electroporation coverage for different human anatomic geometries. In general, a sufficient number of electrodes 214 with appropriate lengths 310 and 312 are desired to provide substantially even and continuous coverage around the circumference of variable diameter loop 300, while still allowing enough flexibility to allow variable diameter loop 300 to expand and contract to vary diameter 400 to the desired extremes." It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use Byrd to arrive at the claimed invention. As stated in Byrd, modifying the spacing of the electrodes allows for a targeted range of energy density to tissue, to provide sufficient electroporation coverage for different human anatomic geometries (p.[0043]), with Byrd further recognizing that varying the length of diameter of electrodes (and therefore their spacing) may "help prevent arcing during electroporation operations" and produces predictable results.
Regarding claim 12, the limitations of claim 11 are taught as described above. Byrd does not explicitly teach "wherein six of pairs of mapping electrodes arranged on the catheter to function as three pairs of ablation electrodes", but does state that the second type electrodes 508 can become ablation electrodes (p.[0043,0045] and be selectively activated for ablation p.[0054-0057]. Note that any electrodes can be defined as pairs and be selected for use individually or as a pair, as described in p.[0019]. It is the Examiner's position that any six mapping electrodes arranged on the catheter could be selected to function as three pairs of ablation electrodes, given that there are a sufficient number of electrodes, and that the selection of specific electrodes does not provide any novelty or nonobvious results.
Regarding claim 13, the limitations of claim 8 are taught as described above. Byrd teaches “wherein the catheter comprises at least one pair of mapping electrodes and one pair of ablation electrodes”, “wherein the electrical conductors connected to the mapping electrodes are in a separate lumen of the catheter than the electrical conductors connected to the ablation electrodes”, and “wherein conductors connected to mapping and/or ablation electrodes of opposite polarity do not share a lumen” in Figure 5. Note that any electrodes can be defined as pairs and be selected for use individually or as a pair, as described in p.[0019]. Figure 5 shows at least a pair of mapping electrodes with second type electrodes 306 and at least a pair of ablation electrodes with first type electrodes 304, with each mapping electrode conductors and ablation electrode conductors having their own separate lumen within their own distinct wire, as taught in p.[0050] "Electrode wires 606 are isolated from one another and are not electrically connected to each other within catheter 200." The conductors do not share a lumen regardless of polarity as they are within their own distinct wire casings and therefore teaches the claimed limitation.
Regarding claim 14, the limitations of claim 8 are taught as described above. Byrd does not explicitly teach the spacing between electrodes (either mapping nor ablation, where either first or second type electrodes can be ablation or mapping electrodes as detailed in p.[0043]), but does suggest that the system could be modified to arrive at the claimed range. Note that any electrodes can be defined as pairs and be selected for use individually or as a pair, as described in p.[0019]. Byrd teaches in p.[0044] that "Diameter 400 and catheter electrode 214 spacing may be developed to provide a targeted range of energy density to tissue, as well as to provide sufficient electroporation coverage for different human anatomic geometries. In general, a sufficient number of electrodes 214 with appropriate lengths 310 and 312 are desired to provide substantially even and continuous coverage around the circumference of variable diameter loop 300, while still allowing enough flexibility to allow variable diameter loop 300 to expand and contract to vary diameter 400 to the desired extremes." It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use Byrd to arrive at the claimed invention. As stated in Byrd, modifying the spacing of the electrodes allows for a targeted range of energy density to tissue, to provide sufficient electroporation coverage for different human anatomic geometries (p.[0043]), with Byrd further recognizing that varying the length of diameter of electrodes (and therefore their spacing) may "help prevent arcing during electroporation operations" and produces predictable results.
Regarding claim 15, the limitations of claim 8 are taught as described above. Byrd does not explicitly teach the spacing between electrodes (either mapping nor ablation, where either first or second type electrodes can be ablation or mapping electrodes as detailed in p.[0043]), but does suggest that the system could be modified to arrive at the claimed range. Note that any electrodes can be defined as pairs and be selected for use individually or as a pair, as described in p.[0019]. Byrd teaches in p.[0044] that "Diameter 400 and catheter electrode 214 spacing may be developed to provide a targeted range of energy density to tissue, as well as to provide sufficient electroporation coverage for different human anatomic geometries. In general, a sufficient number of electrodes 214 with appropriate lengths 310 and 312 are desired to provide substantially even and continuous coverage around the circumference of variable diameter loop 300, while still allowing enough flexibility to allow variable diameter loop 300 to expand and contract to vary diameter 400 to the desired extremes." It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use Byrd to arrive at the claimed invention. As stated in Byrd, modifying the spacing of the electrodes allows for a targeted range of energy density to tissue, to provide sufficient electroporation coverage for different human anatomic geometries (p.[0043]), with Byrd further recognizing that varying the length of diameter of electrodes (and therefore their spacing) may "help prevent arcing during electroporation operations" and produces predictable results.
Regarding claim 16, the limitations of claim 1 are taught as described above. Byrd does not explicitly teach the spacing between electrodes (either mapping nor ablation, where either first or second type electrodes can be ablation or mapping electrodes as detailed in p.[0043]), but does suggest that the system could be modified to arrive at the claimed range. Note that any electrodes can be defined as pairs and be selected for use individually or as a pair, as described in p.[0019]. Byrd teaches in p.[0044] that "Diameter 400 and catheter electrode 214 spacing may be developed to provide a targeted range of energy density to tissue, as well as to provide sufficient electroporation coverage for different human anatomic geometries. In general, a sufficient number of electrodes 214 with appropriate lengths 310 and 312 are desired to provide substantially even and continuous coverage around the circumference of variable diameter loop 300, while still allowing enough flexibility to allow variable diameter loop 300 to expand and contract to vary diameter 400 to the desired extremes." It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use Byrd to arrive at the claimed invention. As stated in Byrd, it would have been obvious for one of ordinary skill in the art to try to modify the spacing of the electrodes to allow for a more targeted range of energy density to be applied to the tissue to provide sufficient electroporation coverage for different human anatomic geometries (p.[0043]), with Byrd further suggesting that varying the length of diameter of electrodes (and therefore their spacing) may "help prevent arcing during electroporation operations" and produces predictable results.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Abigail M Bock whose telephone number is (571)272-8856. The examiner can normally be reached M-F 7:30am - 5:00pm.
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/ABIGAIL BOCK/Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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