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.
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. 365(c) & 119(e) 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/US2023/020187 & 63/336059 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 benefit date of 4/28/2022.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-12 & 15-20) in the reply filed on 7/24/2026 is acknowledged. The Examiner notes typographical errors in the claim listings for Group I & II in the previous office action, where claim 14 was erroneously included with Group I since it is dependent on claim 13.
Claims 13-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 4/28/2026.
Drawings
The drawings are objected to because Figs. 2-6 & 8-17 are shaded.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities: the preliminary amendment to the specification on 10/24/2024 is unclear if both the PCT and provisional application are incorporated by reference since the second sentence was not amended and reads as a singular “prior application”. Further, if the amendment is meant to incorporate the PCT, this is regarded as new matter. An incorporation by reference of the international patent application is/would be ineffective as it would have been/would be added on the date of entry into the national phase, which is after the filing date of the instant application. The filing date of this national stage application is the filing date of associated PCT, in this case 4/27/2023, see MPEP 1893.03(b). Therefore, a specification amendment after 4/27/2023 that includes the incorporation by reference is/would be new matter, per MPEP 608.01(p).
Appropriate correction is required.
Claim Objections
Claim 1 is objected to because of the following informalities: amend “the wires” to -the plurality of wires- in ll. 19. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: amend “the plurality of electrodes includes at least two electrodes attached to the third wire portion” to -the at least one electrode attached to the third wire portion comprises at least two electrodes of the plurality of electrodes attached to the third wire portion- in ll. 1-2. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: amend “at least one electrode” to -at least one electrode of the plurality of electrodes- in ll. 20 & 21 (twice). Appropriate correction is required.
Claim 4 is objected to because of the following informalities: amend “the wire framework” to -the self-expanding wire framework- in ll. 4. Appropriate correction is required.
Claim 7 is objected to because of the following informalities: amend “at least one electrode” to -at least one electrode of the plurality of electrodes- in ll. 2. Appropriate correction is required.
Claim 8 is objected to because of the following informalities: amend “at least one electrode” to -at least one electrode of the plurality of electrodes- in ll. 2. Appropriate correction is required.
Claim 15 is objected to because of the following informalities: amend “some tissue” to -some of the tissue- in ll. 7. Appropriate correction is required.
Claim 19 is objected to because of the following informalities: amend “RF” to -radiofrequency (RF)- in ll. 2. Appropriate correction is required.
Claim 19 is objected to because of the following informalities: amend “DC” to -direct current (DC)- in ll. 4. Appropriate correction is required.
Claim Interpretation
Claims 1 & 7-8 recite the limitation “at least one electrode attached” to a respective structural element (e.g., “second wire portion”, “third wire portion”, “outer catheter shaft”, and “nose cone”. All recitations are regarded as different electrodes of the plurality of electrodes.
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) 1-5, 10, 15 & 17-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maguire et al. (2005/0165391) in view of Holmes, Jr. et al. (2018/0360531).
Concerning claim 1, as illustrated in at least Fig. 1-2B & 6, Kunis et al. disclose a medical device system for ablating a tissue of a patient (systems are disclosed for the mapping of electrical signals and the ablation of tissue; Abstract), the system comprising:
an elongate outer catheter shaft defining a first lumen and a longitudinal axis (inner shaft 78; [0071]);
a self-expanding wire framework comprising a proximal end attached to a distal end portion of the outer catheter shaft and a distal end attached to a nose cone (carrier assembly 85 has a proximal end attached to distal end of inner shaft 78 and distal end attached to distal tip 94 and comprises carrier arms 88 made of shape memory material nitinol; [0060], [0070], [0111]); and
an elongate inner catheter slidably disposed in the first lumen and defining a second lumen, a distal end portion of the inner catheter being fixedly attached to the nose cone (control shaft 84 is slidably disposed within inner shaft 78 having a guidewire lumen and has a distal end portion fixed to distal tip 94; [0053], [0070-0071], [0110), wherein the wire framework further comprises:
a plurality of wires that each individually extend between the distal end portion of the outer catheter shaft and the nose cone, the plurality of wires being reconfigurable between a low-profile delivery configuration and a radially expanded configuration (carrier arms 88 individually extend between the distal end of inner catheter 78 and distal tip 94 and are reconfigurable between a low-profile delivery configuration and a radially expanded configuration; [0070-0071]), wherein, in the expanded configuration, each of the wires includes four wire portions serially arranged along a proximal-to- distal direction and comprising: (i) a first wire portion extending radially outward from the distal end portion of the outer catheter shaft, (ii) a second wire portion extending radially inward, (iii) a third wire portion extending generally parallel to the longitudinal axis, and (iv) a fourth wire portion extending radially inward to the nose cone (see annotated Fig. 1 below with four boxes equating to each of the four portions arranged along a proximal-to-distal direction);
a plurality of electrodes on the plurality of wires (ablation electrode elements 92 are mounted to carrier arms 88; [0058], [0070]),
wherein each of the wires includes at least one electrode attached to the second wire portion (ablation electrode elements 92 are mounted to carrier arms 88 at the second portion; [0058], [0070]).
Kunis et al. fail to disclose at least one electrode attached to the third wire portion. However, Holmes et al. disclose a medical device system for ablating tissue of a patient comprising an expandable framework (320) having four portions serially arranged along a proximal-to- distal direction and comprising: (i) a first portion extending radially outward from the distal end portion of the outer catheter shaft (proximal portion of proximal balloon portion 323), (ii) a second portion extending radially inward (distal portion of proximal balloon portion 323), (iii) a third portion extending generally parallel to the longitudinal axis (proximal and middle portions of cylindrical balloon portion 324), and (iv) a fourth portion extending radially inward to the nose cone (distal portion of cylindrical balloon portion 324), where the second portion includes at least one electrode (electrodes that function as return electrodes) attached thereto and the third portion includes at least one electrode (260) attached thereto. 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 Kunis et al. such that the second portion includes at least one electrode attached thereto and the third portion includes at least one electrode attached thereto in order to provide the benefit of limiting the bipolar field as taught by Holmes, Jr. et al. ([0102-0104]; Fig. 3A-B)
Concerning claim 2, Kunis et al. disclose a guidewire slidably disposable in the second lumen and distally extendable through and beyond the nose cone (94) ([0053]).
Concerning claim 3, Kunis et al. disclose a delivery sheath (76) defining a lumen configured for radial containment of the plurality of wires (88) in the low-profile delivery configuration ([0070]); Fig. 1).
Concerning claim 4-5 & 20, Kunis et al. fail to disclose a hood catheter with an expandable distal end portion that is conical when expanded and configured for contacting and conforming with a tissue wall around an ostium with which the wire framework is engageable, wherein the expandable distal end portion is sized to radially contain the plurality of wires when the plurality of wires are in the radially expanded configuration. However, Holmes, Jr. et al. further disclose a hood catheter (360) with an expandable distal end portion (362) that is conical when expanded and configured for contacting and conforming with a tissue wall around an ostium with which the expandable framework (370) is engageable, wherein the expandable distal end portion (362) is sized to radially contain the expandable framework (370) are in the radially expanded configuration, the hood catheter (360) configured to prevent blood flow from passing through a wall of the hood catheter (360) and capturing embolic material simultaneously while energizing electrodes to ablate. 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 Kunis et al. to further comprise a hood catheter with an expandable distal end portion that is conical when expanded and configured for contacting and conforming with a tissue wall around an ostium with which the wire framework is engageable, wherein the expandable distal end portion is sized to radially contain the plurality of wires when the plurality of wires are in the radially expanded configuration in order to provide the benefit of capturing and removing any particulate and/or coagula/thrombus formed in conjunction with the ablation process to prevent emboli from being in the patient’s vasculature as taught by Holmes, Jr. et al. ([0038], [0040-0041], [0108-0110]; Fig. 4A-B).
Concerning claim 10, Kunis et al. disclose the plurality of wires (88) can be reconfigured between the low-profile delivery configuration and the expanded configuration by longitudinally sliding the inner catheter relative to the outer catheter (78) ([0071]; Fig. 1-2B).
Concerning claim 15, Kunis et al. disclose advancing the system (50) into the patient to engage the wire framework (85) with a pulmonary vein (15) of the patient, wherein the first and second wire portions are in a left atrium of the patient and the third and fourth wire portions are in the pulmonary vein (see annotated Fig. 1 above); and energizing at least some of the plurality of electrodes (92), wherein the energizing provides an energy sufficient for ablation or electroporation of at least some tissue of the pulmonary vein or around the pulmonary vein (15 ([0048], [0071]; Fig. 1).
Concerning claim 17, Holmes, Jr. et al. further disclose the energizing comprising using the at least one electrode attached to each second portion as a anode; and using the at least one electrode attached to each third wire portion as an cathode ([0102-0104]; Fig. 3A-B), and thus, Kunis et al. in view of Holmes, Jr. et al. fail to specifically disclose using the at least one electrode attached to each second wire portion as a cathode; and using the at least one electrode attached to each third wire portion as an anode. It would have been an obvious matter of design choice to one having ordinary skill in the art at the time the invention was effectively filed to modify the invention of Kunis et al. in view of Holmes, Jr. et al. to further comprise using the at least one electrode attached to each second wire portion as a cathode; and using the at least one electrode attached to each third wire portion as an anode, since Applicant has not disclosed that orienting the electric field as claimed solves any stated problem or is for any particular purpose and it appears that the invention would perform equally as well with the electric field oriented in an opposite manner and since Applicant places no criticality on the claimed subject matter, merely stating in the originally filed disclosure: “Any of the electrodes can be a cathode. Any of the electrodes can be an anode.”
Concerning claim 18, Holmes, Jr. et al. further disclose the energizing comprising using the at least one electrode attached to each second portion as an anode; and using the at least one electrode attached to each third wire portion as a cathode ([0102-0104]; Fig. 3A-B).
Concerning claim 19, Kunis et al. disclose delivering RF energy from at least one electrode attached to each second wire portion, but fail to disclose delivering pulsed DC energy from the at least one electrode attached to each third wire portion as a cathode. Holmes, Jr. et al. further disclose delivering RF energy at or near a PV ostium in combination with delivering electroporation energy within the PVs to achieve a highly effective approach of direct PV ablation (electroporation within the PVs) and safe RF ablation outside of the veins for wide area circumferential ablation lines which provides two safeguards to prevent any re-connection ([0048]) and also disclose using at least one electrode attached to each third wire portion as a cathode ([0102-0104]; Fig. 3A-B). 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 Kunis et al. to further comprise delivering RF energy from at least one electrode attached to each second wire portion, and also delivering pulsed DC energy from the at least one electrode attached to each third wire portion as a cathode in order to provide the benefit of achieving a highly effective approach of direct PV ablation (electroporation within the PVs) and safe RF ablation outside of the veins for wide area circumferential ablation lines which provides two safeguards to prevent any re-connection as taught by Holmes, Jr. et al. ([0048])
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kunis et al. (2007/0083194) and Holmes, Jr. et al. (2018/0360531), as applied to claim 4, in further view of Kassab et al. (2012/0289951).
Concerning claim 6, Kunis et al. in view of Holmes, Jr. et al. fail to disclose the hood catheter is configured to allow blood flow through a wall of the hood catheter while not allowing embolic material to pass therethrough. However, Kassab et al. disclose a hood catheter (22) used in conjunction with an ablation element (50), the hood catheter (22) being configured to allow blood flow through a wall of the hood catheter while not allowing embolic material that is larger than openings in the mesh to pass therethrough. 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 Kunis et al. in view of Holmes, Jr. et al. such that the hood catheter is configured to allow blood flow through a wall of the hood catheter while not allowing embolic material to pass therethrough in order to provide the benefit of maintaining blood flow from the blood vessel to an atrial cavity during ablation as taught by Kassab et al. ([0009], [0034-0035],
Claim(s) 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kunis et al. (2007/0083194) in view of Holmes, Jr. et al. (2018/0360531), as applied to claim 1, in further view of Coulombe et al. (2016/0157913).
Concerning claims 7-8, Kunis et al. in view of Holmes, Jr. et al. fail to disclose at least one electrode attached to the outer catheter shaft and at least one electrode attached to the nose cone. However, Coulombe et al. disclose a medical system for ablating tissue comprising an expanding framework (26) and at least one electrode (24) attached to an outer catheter shaft (20) and at least one electrode (30) attached to a nose cone (40). 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 Kunis et al. in view of Holmes, Jr. et al. to further comprise at least one electrode attached to the outer catheter shaft and at least one electrode attached to the nose cone in order to provide the benefit of impedance sensing and/or 3D navigation of the treatment catheter within the atrial chamber and positioning the treatment catheter within, for example, a pulmonary vein as taught by Coulombe et al. ([0028], [0030]; Fig. 1).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kunis et al. (2007/0083194) in view of Holmes, Jr. et al. (2018/0360531), as applied to claim 1, in further view of Hazan et al. (WO2018/229768).
Concerning claim 9, Kunis et al. in view of Holmes, Jr. et al. fail to specifically disclose at least two electrodes on the third wire portion. However, Hazan et al. disclose a medical device system for ablation comprising an expandable framework (202, 204) having first and second portions (202) and third and fourth portions (204), and at least two electrodes (212, 210) along the same longitudinal portion of the third portion (204). 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 Kunis et al. in view of Holmes, Jr. et al. to further comprise at least two electrodes on the third wire portion in order to provide the benefit of both ablation and stimulation electrodes used to map electrical activity and/or propagation; and/or optionally used to verify ablation results as taught by Hazan et al. (Pg. 19, ll. 8-18, Pg. 22-23, ll. 9-12; Fig. 2-3)
Claim(s) 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kunis et al. (2007/0083194) in view of Holmes, Jr. et al. (2018/0360531), as applied to claim 1, in further view of Marass et al. (2023/0052114, with provisional 63/232353 providing support).
Concerning claim 11-12, Kunis et al. in view of Holmes et al. fail to disclose a balloon positioned within and shaped to conform to the wire framework. However, Marass et al. disclose a medical device system for ablation comprising a balloon (208) positioned within and shaped to conform to a wire framework (204). 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 Kunis et al. in view of Holmes et al. to further comprise a balloon positioned within and shaped to conform to the wire framework in order to provide the benefit of the balloon functioning as an insulator by selectively filling the spaces between the framework, and generally reduces energy losses, which may result in increased lesion size as taught by Marass et al. ([0050]; Fig. 3A).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kunis et al. (2007/0083194) in view of Holmes, Jr. et al. (2018/0360531), as applied to claim 15, in further view of Desimone et al. (2018/0296264).
Concerning claim 16, Kunis et al. in view of Holmes, Jr. et al. fail to disclose stretching, by the wire framework, the at least some tissue of the pulmonary vein or around the pulmonary vein, wherein the stretching occurs simultaneously with the energizing. However, DeSimone et al. disclose a method for ablating tissue comprising stretching the tissue to produce membrane poration and induced apoptosis by virtue of the stretch itself. 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 Kunis et al. in view of Holmes, Jr. et al. to further comprise stretching, by the wire framework, the at least some tissue of the pulmonary vein or around the pulmonary vein, wherein the stretching occurs simultaneously with the energizing in order to provide the benefit of producing membrane poration and inducing apoptosis by virtue of the stretch itself as taught by DeSimone et al. ([0101])
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Margolis (2015/0051595) disclose a plurality of electrodes axially offset from one another to ablate a helical shape to avoid stenosis.
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/JAYMI E DELLA/Primary Examiner, Art Unit 3794
JAYMI E. DELLA
Primary Examiner
Art Unit 3794
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