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.
Election/Restrictions
Claims 11-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.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 06/10/2026.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/04/2024, 03/24/2025, 09/05/2025, 02/12/2026, and 04/27/2026 was filed after the mailing date of the application on 09/04/2024. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Priority
The instant application is a CON of 17/371,008, now U.S. Patent No. 12,102,382, filed 07/08/2021. U.S. Patent No. 12,102,382 cites 63/076,614 as a provisional patent, filed 09/10/2020. U.S. Patent No. 12,102,382 was issued 10/01/2024. The instant application was filed 09/04/2024. Therefore, the instant application was copending with U.S. Patent No. 12,102,382 and the instant application is granted an effective filing date of the provisional patent of 09/10/2020.
Claim Interpretation
Claim 2 states that the “spines are arranged generally along a longitudinal axis”. The Examiner is interpreting the word “generally” to mean that the spines are approximately or otherwise close to aligned along a longitudinal axis, as there is no information in the specification that defines what “generally along” the longitudinal axis would be otherwise.
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.
Claims 1-4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gross (European Patent Publication EP 3181082 A1), herein after “Gross”.
Regarding claim 1, Gross teaches the limitations
“a medical probe, comprising a flexible insertion tube having proximal and distal ends (24)”, “a basket assembly (20) at the distal end of the flexible insertion tube, the basket assembly comprising a plurality of spines (34),”,
” each spine comprising an inner and outer side, and wherein each given electrode comprises a conductive material biased towards the outer side of its respective spine” in Figure 5, more electrode material towards outside than inside spline 154, Note that 154 is capable of conducting electrical currents as stated in p.[0039] "Because electrode 38 is typically a ring, it can conduct current from pad 52 around PCB 152 and scaffold 154 to a portion of the electrode that faces radially outward (and that is the tissue-contact portion of the electrode)." Note further in col. 12, line 59 through col. 13, line 1-6 "The apparatus according to any one of inventive concepts 64-65, wherein each one of the electrodes is shaped to define a ring surrounding a body of one of the elongate elements, the ring including: an electrically-conductive outward-facing partial-ring portion;”.
“and a plurality of electrodes (38), each electrode comprising conductive material (col. 12, line 59 through col. 13, lines 1-6) having a lumen therethrough fitting a given spine and each electrode being non-radially symmetric about each respective lumen such that more conductive material of each electrode is disposed on the outer side of the respective spine than the inner side of its respective spine” in Figures 1A (as shown annotated below) and Figure 5, section B-B particularly. Figure 5 (included with annotations below) shows that a lumen or tube is formed in between the electrode and a given spine. This is further illustrated in p.[0039], which states “In the electrode region of the electrode devices described hereinabove (and as shown in particular in the cross-section of Fig. 4), the PCB (and more specifically pad 52) is disposed radially outward from the scaffold (e.g., on a radially-outward-facing surface of the scaffold). In contrast, in the electrode region of electrode device 142, PCB 152 (and more specifically pad 52) is disposed radially inward from scaffold 154 (e.g., on a radially-inward-facing surface of the scaffold). The PCB (typically pad 52 thereof) is sandwiched between the scaffold and the portion of electrode 38 that faces radially inward (and that is not the tissue-contact portion of the electrode). Because electrode 38 is typically a ring, it can conduct current from pad 52 around PCB 152 and scaffold 154 to a portion of the electrode that faces radially outward (and that is the tissue-contact portion of the electrode). Such a configuration of electrode device 142 allows its PCB to be disposed radially inward from its scaffold, at least in electrode region 162. Typically, in proximal and distal regions (164 and 166, respectively) of electrode device 142, PCB 152 is disposed radially outward from scaffold 154. Therefore this configuration of electrode device 142 facilitates the placement of a single passthrough site 36 at each hinge region (160a and 160b) of the electrode device”.
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Figure 1A of Gross (EP 3181082 A1) Figure 5 of Gross (EP 3181082 A1)
Regarding claim 2, the limitations of claim 1 are taught as described above. Gross teaches ‘wherein the spines are arranged generally along a longitudinal axis of the flexible insertion tube, and the inner side of each spine faces towards the longitudinal axis and the outer side of each spine faces away from the longitudinal axis” in Figure 5, which shows that the spines are arranged generally around longitudinal axis ax1 of insertion tube 24, with the spines 154 having an inner face that face ax1 and an outer face facing away from the longitudinal axis, therefore teaching the claimed limitation as described.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Gross.
Regarding claim 3, the limitations of claim 1 are taught as described above. Gross does teach an electrode that extends in a length direction, width direction, and height direction with a first thickness on the first side of the lumen and a second thickness on the second side of the lumen in Figure 5. The electrodes have a length, width, and height as seen in Figure 5. The Examiner is citing electrode as elements 38 and 52 in the claimed limitation given that an electrode is “a conductor through which electricity enters or leaves an object, substance, or region” as defined by Meriam Webster dictionary and conductive pad 52 can conduct electricity (p.[0039]). Therefore, the electrode of Gross has a first thickness in the height direction (wherein the height direction is the radial outward direction of the electrode) to the outer portion of the lumen (the first side), a second thickness in the height direction to the inner portion of the lumen (the second side, including element 52) with the second thickness being larger than the first, teaching the limitation as described.
Regarding claim 4, the limitations of claim 1 are taught as described above. Gross teaches “wherein each spine is planar at its respective electrode, and a surface area of each electrode is greater on an outer side of each respective plane compared to an inner side of each respective plane” in Figure 5, which shows that the spine is planar (having a flat and level surface) when passing through the electrode, and having a greater surface area on the outward face of the spine than the inner face of the spine, where control rod 48 obscures and therefore minimizes the surface area of the inner face of the electrode, therefore teaching the claimed limitation as described.
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 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Gross in view of Webster (European Patent Publication EP 0879613 B1) herein after “Webster”.
Regarding claim 5, the limitations of claim 1 are taught as described above. Gross does not teach “wherein each respective electrode has a notch between the lumen and the inner side of its respective spine”; however, Webster does. Webster, in an analogous electrode catheter, teaches this limitation in Fig. 7, and col 6, lines 38- col 7, lines 12, "With reference to FIG. 7, there is shown yet another embodiment wherein the tip section 12 carries a tip electrode 23. The distal end of the puller wire 30 extends into a hole in the tip electrode 23 is attached thereto, e.g., by soldering. The hole in the tip electrode 23 may be axial as shown or off axis as desired.” It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a notch between the lumen and inner side of the spine, as taught in Webster, in Gross, because one of ordinary skill in the art would have been able to carry out such a substitution and the results are reasonably predictable of the notch allowing for passage of an inner wire passing through the lumen to electrify the electrodes of the spine.
Regarding claim 6, the limitations of claim 5 are taught as described above. Gross does not teach the limitation “wherein each given spine comprises a wire affixed to the inner side of the respective spine, and wherein the notch comprises solder material forming an electrical connection between the each given electrode and the wire” however Webster does teach this limitation in an analogous catheter device. Webster teaches this limitation in Fig. 7, col 6, lines 38- col 7, lines 12, which states "The electrode lead wire 34 likewise extends into a hole in the tip electrode 23 and is electrically bonded, e.g., by soldering thereto. It is to be understood that any suitable means for fixedly attaching the puller wire 30 and electrode lead wire 34 to the tip electrode 23 may be used as desired." It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use solder material to attach to the wire to the inner side of the spine, as taught in Webster, in Gross, because one of ordinary skill in the art would have been able to carry out such a substitution and the results are reasonably predictable of the notch allowing for passage of an inner wire passing through the lumen to electrify the electrodes of the spine.
Regarding claim 7, the limitations of claim 1 are taught as described above. Gross does not teach the limitation “and further comprising an adhesive material applied to an inner surface of each given electrode, and wherein the inner surface is defined by the lumen of the each given electrode” however Webster teaches the limitation in Fig. 7, col 6, lines 38- col 7, lines 12, "The electrode lead wire 34 likewise extends into a hole in the tip electrode 23 and is electrically bonded, e.g., by soldering thereto. It is to be understood that any suitable means for fixedly attaching the puller wire 30 and electrode lead wire 34 to the tip electrode 23 may be used as desired." It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use an adhesive to secure the inner electrode surface to the spine, as taught in Webster, in Gross. Webster states that any suitable means of connecting the electrode to the puller wire, and adhesive material is considered a suitable material under broadest reasonable interpretation. Using adhesive prevents the electrode from moving when in use and produces predictable results. Webster, Gross, and the claimed invention are considered analogous pieces of art given that they are in the same field of electrode catheters.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Gross in view of Rothman (WIPO Patent Publication, WO 2016/075544), herein after “Rothman”.
Regarding claim 8, the limitations of claim 1 are taught as described above. Gross does not explicitly teach the limitation “wherein each of the electrodes has one or more smoothed edges”, however, Rothman does in p.[00127] which states "The electrodes 2414 can be substantially coplanar with an outer surface of the insulating sections 2416 and/or the shaft 2406, or may project beyond the insulating sections 2416 by a distance. In various embodiments, for example, the electrodes 2414 can extend a radial distance from the adjacent insulating portions 2416 and include a smoothed edge (e.g., a beveled edge) to reduce denuding of the adjacent arterial wall." It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention smooth the edges of the electrodes, as taught in Rothman, in Gross. As stated in Rothman, smoothing the edges of the electrodes prevents unintentional cutting or abrasion of surrounding tissues while using the electrodes and produces predictable results of preventing of unwanted tissue damage during use. Gross, Rothman, and the claimed invention are considered analogous pieces of art given that they are in the same field of electrode catheters.
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Gross in view of Olson (WIPO Patent Publication WO 2019/177809), herein after “Olson”.
Regarding claim 9, the limitations of claim 1 are taught as described above. Gross does not explicitly teach the limitation “and further comprising a set of spray ports configured to deliver an irrigation fluid to the electrodes”, however Olson does in p.[0084] which states "Though not shown in Figs. 2A-B, various embodiments of the planar array catheter 201 may include one or more irrigation ports. For example, proximal irrigant port(s) may be located on/at the distal end of proximal bushing 208, the proximal irrigant port(s) positioned to deliver irrigant to or near the point where the electrode carrying struts 2l0i.sub.-5 exit from the distal end of the proximal bushing, that is mounted on the distal end of the catheter shaft 205 in this embodiment. In some more specific embodiments, a second, distal irrigation port(s) may be located near the distal intersection of the struts and on or near distal tip 215. In yet further embodiments, if desired, multiple irrigation ports could be present at various positions along the struts 210. Where more than one irrigant port is positioned at proximal and/or distal ends of the planar array 201, more uniform irrigant distribution at or near the proximal/distal apex of the struts 210 may be facilitated." It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use irrigation ports to deliver irrigation fluid to the electrodes, as taught in Olson, in Gross. As stated in Olson, irrigation ports can be oriented at various positions along the struts (or spines) in order to facilitate cooling of the electrodes and produces predictable results of cooling the electrodes. Olson, Gross, and the claimed invention are considered analogous inventions given that they are in the same field of electrode catheters.
Regarding claim 10, the limitations of claim 1 are taught as described above. Gross does not teach the limitation “and further comprising a set of spray ports configured to deliver an irrigation fluid between the spines” explicitly, however, Olson does. Olson teaches this limitation in p.[0084] which states "Though not shown in Figs. 2A-B, various embodiments of the planar array catheter 201 may include one or more irrigation ports. For example, proximal irrigant port(s) may be located on/at the distal end of proximal bushing 208, the proximal irrigant port(s) positioned to deliver irrigant to or near the point where the electrode carrying struts exit from the distal end of the proximal bushing, that is mounted on the distal end of the catheter shaft 205 in this embodiment. In some more specific embodiments, a second, distal irrigation port(s) may be located near the distal intersection of the struts 2l0i.sub.-5 and on or near distal tip 215. In yet further embodiments, if desired, multiple irrigation ports could be present at various positions along the struts 210. Where more than one irrigant port is positioned at proximal and/or distal ends of the planar array 201, more uniform irrigant distribution at or near the proximal/distal apex of the struts 210 may be facilitated." It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use irrigation ports to deliver irrigation fluid to between the spines, as taught in Olson, in Gross. As stated in Olson, irrigation ports can be oriented at various positions along the struts (or spines) in order to facilitate more uniform irrigant distribution and produces predictable results of cooling the electrodes/spines during use. Olson, Gross, and the claimed invention are considered analogous inventions given that they are in the same field of electrode catheters.
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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