DETAILED ACTION
The following is a First Action, Non-Final Office Action on the merits.
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 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.
Election/Restrictions
Applicant’s election without traverse of Species B (Figs. 1E, 1G, 2B, planar array) in the reply filed on 6/8/2026 is acknowledged.
Claims 14-23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/8/2026.
The Examiner further withdraws claim 4 as being drawn to Fig. 1B & 2A illustrating “tip electrode” 205 or 805.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) & 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application Nos. PCT/US2023/065038 & 63/324791 provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
Accordingly, the claims are given the priority date of 3/29/2022.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Specification
The amendment filed 9/9/2024 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: the incorporation by reference of the national stage entry application is regarded as new matter. An incorporation by reference statement added after an application’s filing date is not effective because no new matter can be added to an application after its filing date (see 35 U.S.C. 132(a) (See MPEP 608.01(p)). An international application designating the U.S. has two stages (international and national) with the filing date being the same in both stages. Often the date of entry into the national stage is confused with the filing date (See MPEP 1893.03(b)). In this case, the filing date of the application is 3/28/2023 and the incorporation by reference specification amendment was made on 9/9/2024.
Applicant is required to cancel the new matter in the reply to this Office Action.
Claim Objections
Claim 1 is objected to because of the following informalities: amend “ablation energy” to -ablation therapy- in ll. 5. Appropriate correction is required.
Claim 5 is objected to because of the following informalities: amend “the struts” to -the two or more struts- in ll. 2 & 4 (twice). Appropriate correction is required.
Claim 5 is objected to because of the following informalities: amend “electrophysiological characteristics” to -the electrophysiological characteristics- in ll. 4. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: amend “includes electrode” to -includes an electrode- in ll. 2. Appropriate correction is required.
Claim 8 is objected to because of the following informalities: amend “electrophysiological characteristics” to -the electrophysiological characteristics- in ll. 4. Appropriate correction is required.
Claim 11 is objected to because of the following informalities: amend “the struts” to -the two or more struts- in ll. 2. Appropriate correction is required.
Claim 12 is objected to because of the following informalities: amend “the struts” to -the two or more struts- in ll. 1. Appropriate correction is required.
Claim 12 is objected to because of the following informalities: amend “ablation energy” to -the ablation energy- in ll. 2. Appropriate correction is required.
Claim 13 is objected to because of the following informalities: amend “each strut” to -each of the at least four struts- in ll. 2. 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.
Claim 5-13 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 electrodes" in ll. 3. There is insufficient antecedent basis for this limitation in the claim.
Claims 6-13 depend from claim 5 and are thus also rejected.
Claim 13 recites the limitation “the planar array comprises at least four struts”; however, claim 5, upon which claim 13 depends, recites the limitation “a planar array including two or more struts”. It is unclear if the “at least four struts” is in addition to the two or more struts. For purposes of examination, the claim will be interpreted as -the two or more struts comprise at least four struts-.
Claim 13 recites the limitation “each strut includes at least four electrodes”; however, claim 1, upon which claim 13 depends, recites the limitations “a first plurality of electrodes” and claim 5, upon which claim 13 depends, recites the limitation “at least a portion of the plurality of electrodes are configured and arranged on the struts”. It is unclear if the “at least four electrodes” is in addition to the “first plurality of electrodes”. For purposes of examination, the claim will be interpreted as -each of the at least four struts includes at least four electrodes of the first plurality electrodes-.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-3, 5-13 & 24-25 is/are rejected under 35 U.S.C. 102(a)(1) or 102(a)(2) as being anticipated Pappone et al. (2018/0042667).
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 first plurality of electrodes (mapping electrodes 228; [0082]); and
an electrode support member (longitudinally extending arms 210, 212, 214, 216, 218, 220, which can form a flexible framework (e.g., planar array) and heating electrodes 230, 232; [0080]);
wherein a portion of the electrode support member is adapted to deliver ablation therapy (heating electrodes 230, 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]), and wherein at least a portion of the first plurality of electrodes are configured and arranged on the electrode support member to detect electrophysiological characteristics of a tissue in contact therewith (at least two mapping electrodes 228 are arranged on arms 210, 212, 214, 216, 218, 220 and collect ECG data; [0082], [0085]).
The Examiner notes that claim 1 fails to limit the electrode support member to a single structural element and the struts and heating electrodes of Pappone et al. in combination read on the claimed “electrode support member”.
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 3, Pappone et al. disclose the electrode support member (210, 212, 214, 216, 218, 220, 230, 232) further comprises a plurality of spot electrodes (230, 232), printed electrodes, conductive traces, or a combination thereof ([0080-0081]; Fig. 7).
Concerning claim 5, Pappone et al. disclose the electrode support member (210, 212, 214, 216, 218, 220 in conjunction with 230, 232) is configured as a planar array including two or more struts (210, 212, 214, 216, 218, 220, in conjunction with 230, 232) wherein at least a portion of the plurality of electrodes (228) are configured and arranged on the struts (210, 212, 214, 216, 218, 220, 230, 232) to detect electrophysiological characteristics of the tissue in contact with the planar array ([0082], [0085]; Fig. 7).
Concerning claim 6, Pappone et al. disclose at least one of the first plurality of electrodes (228) includes electrodes (228) formed on an electrically-insulative substrate (non-conductive material) positioned on a surface of the strut (210, 212, 214, 216, 218, 220, in conjunction with 230, 232) ([0062], Fig. 7).
Claim 7 is rejected upon the same rationale as applied to claim 2.
Concerning claim 8, Pappone et al. disclose a second plurality of electrodes (others of electrodes 228) selected from the group consisting of spot electrodes (ring electrode can also be considered spot electrodes), printed electrodes, and a combination thereof, wherein the second plurality are configured and arranged to detect electrophysiological characteristics of the tissue in contact therewith ([0082], [0085]; Fig. 7).
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 10, Pappone et al. disclose the first plurality of electrodes (228) is selected from the group consisting of spot electrodes (ring electrode can also be considered spot electrodes), printed electrodes, and a combination thereof (Fig. 7).
Concerning claim 11, Pappone et al. disclose the first plurality of electrodes (228) are uniformly spaced along the struts (Fig. 7).
Concerning claim 12, Pappone al. disclose a surface of the struts (210, 212, 214, 216, 218, 220, in conjunction with 230, 232) comprises exposed metal (230, 232), wherein the surface is capable of delivering ablation energy between the at least two struts (210, 212, 214, 216, 218, 220, in conjunction with 230, 232) ([0080-0081]; Fig. 7).
Concerning claim 13, Pappone et al. disclose the planar array includes at least four struts (210, 212, 214, 216, 218, 220, in conjunction with 230, 232), 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 plurality of electrodes (228) and the electrode support member (210, 212, 214, 216, 218, 220 in conjunction with 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 plurality of electrodes (228) and the electrode support member (210, 212, 214, 216, 218, 220 in conjunction with 230, 232) are configured to be activated in unison in a ganged configuration ([0090-0091]; Fig. 8)
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Govari et al. (2022/0071693) tech a first plurality of electrodes (38) mounted on a PCB electrode support member (24) having exposed conductive areas (26) (Fig. 2). Govari et al. (2022/0087734) teach a multi-electrode assembly comprising a plurality of electrodes (11/44) configured to detect EP characteristics and an electrode support member (12/36) configured to deliver therapy. de la Rama et al. (2018/0000541) teach a multi-electrode assembly comprising a plurality of electrodes (99) configured to detect EP characteristics and an electrode support member (56) configured to deliver therapy.
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/JAYMI E DELLA/Primary Examiner, Art Unit 3794
JAYMI E. DELLA
Primary Examiner
Art Unit 3794
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