DETAILED ACTION
The following is a Final Office Action on the merits.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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.
Response to Amendment
Acknowledgment is made to the amendment received 9/18/2026.
Applicant’s amendments are sufficient to overcome the specification objection, claim objections and 35 USC 112(b)/second paragraph rejections set forth in the previous office action.
Support for claims 2-3 in combination with the amendments to claim 1 can be found in the originally filed disclosure stating: “Larger surface area electrodes may be used for mapping, tissue ablation, and/or localization.”
Claim Objections
Claim 1 is objected to because of the following informalities: amend “Ablation energy” to -the ablation energy- in ll. 8-9. Appropriate correction is required.
Claim 29 is objected to because of the following informalities: amend “strut. to -strut each of the first plurality of electrode, the second plurality of electrode, or the combination thereof is disposed upon- in ll. 3. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 27-28 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 27-28 recite the struts “are configured to be energized”. There is no support in the originally filed disclosure for the struts to be energized along with first and second pluralities of electrodes. For purposes of examination, the claim will be interpreted as the electrodes on the strut “are configured to be energized”.
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 24-25 & 31 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 24 recites the limitation "the electrode support member" in ll. 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 25 recites the limitation "the electrode support member" in ll. 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 31 recites “each of the plurality of struts carries at least one electrode of the first plurality of electrode and at least one electrode of the second plurality of electrodes”; however, claim 1, upon which claim 31 depends, recites the limitations of “a first plurality of electrodes disposed on each of the plurality of struts” and “a second plurality of electrodes disposed on each of the plurality of struts”. It is unclear how claim 31 further limits claim 1 form which it depends since claim 1 already recites each of the first and second electrode pluralities to be disposed on each strut.
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.
Claim 31 is 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.
Claim 31 recites “each of the plurality of struts carries at least one electrode of the first plurality of electrode and at least one electrode of the second plurality of electrodes”; however, claim 1, upon which claim 31 depends, recites the limitations of “a first plurality of electrodes disposed on each of the plurality of struts” and “a second plurality of electrodes disposed on each of the plurality of struts”. Since claim 1 already recites each of the first and second electrode pluralities to be disposed on each strut claim 31 fails to further limit claim 1 from which it depends.
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
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.
Claim(s) 1-2, 5-7, 9, 13, 24-33 & 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pappone et al. (2018/0042667, previously cited) in view of Govari et al. (2022/0071693).
Concerning claim 1, as illustrated in at least Fig. 7, Pappone et al. disclose a multi-electrode assembly of a mapping and ablation catheter (mapping and ablation catheter 206; [0080]), the assembly comprising:
a planar array including a plurality of struts extending in a common plane (planar array comprised of arms 210, 212, 214, 216, 218 & 220; [0080]);
a first plurality of electrodes disposed on each of the plurality of struts, the first plurality of electrodes being configured to detect electrophysiological characteristics of cardiac tissue in contact with the planar array or deliver ablation energy to the cardiac tissue (mapping electrodes 228 collect ECG data; [0082], [0085]); and
a second plurality of electrodes disposed on each of the plurality of struts, the second plurality of electrodes being configured to deliver ablation energy to the cardiac tissue (heating electrodes 230 and 232 can be in communication with an energy source (e.g., radiofrequency (RF) generator), which can be configured to deliver energy (e.g., RF energy) to tissue (e.g., cardiac tissue) via one or more of the electrodes 230, 232, which can cause the tissue to be heated; [0080-0081]).
Pappone et al. fail to disclose each of the second plurality of electrodes have a larger total surface area than each of the first plurality of electrodes. However, Govari et al. disclose a multi-electrode assembly of a mapping and ablation catheter comprising a first plurality of mapping electrodes (26) and a second plurality of ablation electrodes (38) disposed an electrically-insulative substrates (56) positioned on each of a plurality of struts (50), where each of the second plurality of ablation ring electrodes (38) have an exposed surface area (A2) that is greater than (by at least three times) the exposed surface area (A1) of the first plurality of mapping electrodes (26). At the time the invention was effectively filed, it would have been obvious one of ordinary skill in the art to modify the invention of Pappone et al. such that each of the second plurality of electrodes have a larger total surface area than each of the first plurality of electrodes in order to provide the benefit of a larger surface area needed to provide effective ablation as taught by Govari et al. ([0053], [0068], [0091]; Fig. 8).
Concerning claim 2, Pappone et al. disclose the first plurality of electrodes (228) is selected from the group consisting of ring electrodes, tip electrodes, tip-segment electrodes, split ring electrodes, and ring-segment electrodes ([0038]; Fig. 7).
Concerning claim 5, Govari et al. further disclose each of the second plurality of ablation electrodes (38) extend a greater length along a corresponding strut (50) than each of the first plurality of electrodes (26) (Fig. 1-3 & 11).
Concerning claim 6, while Pappone et al. disclose the plurality of struts can be formed form nitinol ([0041]), Pappone et al. fail to specifically disclose the plurality of struts includes an electrically-insulative substrate positioned on a surface of a respective strut. However, Govari et al. further disclose the plurality of struts (50) comprise a nitinol base and an electrically-insulative substrate (56) positioned on a surface of each strut (50). At the time the invention was effectively filed, it would have been obvious one of ordinary skill in the art to modify the invention of Pappone et al. such that the plurality of struts includes an electrically-insulative substrate positioned on a surface of a respective strut in order to provide the benefit of insulating and securing conductors from the power source to the electrodes as taught by Govari et al. ([0017], [0079], [0094]; Fig. 14)
Concerning claim 7, Govari et al. further disclose the first plurality of mapping electrodes (26) and a second plurality of ablation electrodes (38) disposed on the electrically insulative substrate (56) ([0094], [0114]; Fig. 14).
Concerning claim 9, Pappone et al. disclose at least one electrode of the first plurality (228) is positioned between two electrodes of the second plurality (228) (Fig. 7).
Concerning claim 13, Pappone et al. disclose the planar array includes at least four struts (210, 212, 214, 216, 218, 220), and each strut includes at least four electrodes (228) ([0080-0082]; Fig. 7).
Concerning claim 24, Pappone et al. disclose at least some electrodes in a group of electrodes including the first and second pluralities of electrodes (228, 230, 232) are configured to be activated independent from one another in an unganged configuration ([0090-0091]; Fig. 8)
Concerning claim 25, Pappone et al. disclose at least some electrodes in a group of electrodes including the first and second pluralities of electrodes (228, 230, 232) are configured to be activated in unison in a ganged configuration ([0090-0091]; Fig. 8)
Concerning claim 26, Pappone et al. disclose the at least four struts (210, 212, 214, 216, 218, 220) includes first and second outer struts (210, 220) and first and second inner struts (212, 214, 216, 218) ([0080-0082]; Fig. 7).
Concerning claim 27, Pappone et al. disclose the electrodes (228, 230, 232) on the first and second outer struts (210, 220) are configured to be energized together to form an outer loop, and the first and second inner struts (212, 214, 216, 218) are configured to be energized together to form an inner loop ([0090-0091]; Fig. 7).
Concerning claim 28, Pappone et al. disclose the inner loop and the outer loop are of opposite polarity ([0090-0091]; Fig. 7).
Concerning claim 29, Pappone et al. disclose each of the first plurality of electrodes (228), the second plurality of electrodes (230, 232), or a combination thereof extend around an entire circumference of a corresponding strut (Fig. 7).
Concerning claim 30, Pappone et al. disclose along at least one strut of the plurality of struts (210, 212, 214, 216, 218, 220), at least one electrode of the second plurality of electrodes (230, 232) is positioned between adjacent electrodes of the first plurality of electrodes (228) (Fig. 7).
Concerning claim 31, Pappone et al. disclose each of the plurality of struts (210, 212, 214, 216, 218, 220) carries at least one electrode of the first plurality of electrodes (228) and at least one electrode of the second plurality of electrodes (230, 232) (Fig. 7).
Concerning claim 32, Pappone et al. disclose a proximal connector (108/222); and a distal coupler (distal end not labeled in Fig. 7), wherein the plurality of struts (210, 212, 214, 216, 218, 220) extend between the proximal connector and the distal coupler ([0039]; Fig. 7).
Concerning claim 33, Pappone et al. disclose the first and second pluralities of electrodes (228, 230, 232) are distributed along a central region of the plurality of struts (210, 212, 214, 216, 218, 220) (Fig. 7).
Concerning claim 35, Pappone et al. disclose at least the first plurality of electrodes or the second plurality of electrodes are configured to function as a single large electrode. ([0090-0091]; Fig. 7).
Claim(s) 3 & 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pappone et al. (2018/0042667, previously cited) in view of Govari et al. (2022/0071693), as applied to claim 2, in further view of Sterrett et al. (2017/0112405).
Concerning claims 3 & 34, Pappone et al. in view of Govari et al. fail to disclose the second plurality of electrodes to be spot electrodes, printed electrodes, conductive traces, or a combination thereof that are electrically coupled to signal processing circuitry by conductive traces extending on or within one or more thin film layers carried by the plurality of struts. However, Govari et al. disclose the first plurality of electrodes (26) to comprise a plurality of spot electrodes, printed electrodes, conductive traces, or a combination thereof ([0068]; Fig. 1 & 11) and Sterrett et al. disclose a multi-electrode assembly of a mapping and ablation catheter comprising a plurality of electrodes used for diagnostic, therapeutic, and/or mapping procedures that are either ring (electrodes 146; [0100]) or printed strip electrodes/conductive traces (at least electrodes 502 in Fig. 19A-20; [0180]) that are electrically coupled to signal processing circuitry (inherent diagnostic and/or mapping system) by conductive traces extending on or within one or more thin film layers carried by the plurality of struts. At the time the invention was effectively filed, it would have been obvious one of ordinary skill in the art to modify the invention of Pappone et al. such that the second plurality of electrodes comprises a plurality of spot electrodes, printed electrodes, conductive traces, or a combination thereof as taught by Govari et al. that are electrically coupled to signal processing circuitry by conductive traces extending on or within one or more thin film layers carried by the plurality of struts as taught by Sterrett et al. since Sterrett et al. teach ring and printed/strip electrodes/conductive traces to be equivalents in the art for the purposes of both therapeutic and mapping procedures and in order to provide the benefit of maintaining good electrical contact with the tissue while mapping as compared to relatively rigid metallic ring electrodes as taught by Sterrett et al. ([0004-0005], [0081-0082], [0230])
Response to Arguments
Applicant’s arguments are moot in view of the new ground(s) of rejection.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAYMI E DELLA whose telephone number is (571)270-1429. The examiner can normally be reached on M-Th 6:00 am - 4:45 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Rodden can be reached on (303) 297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAYMI E DELLA/Primary Examiner, Art Unit 3794
JAYMI E. DELLA
Primary Examiner
Art Unit 3794
