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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after allowance or after an Office action under Ex Parte Quayle, 25 USPQ 74, 453 O.G. 213 (Comm'r Pat. 1935). Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant's submission filed on 07/01/2026 has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/01/2026 was filed after the mailing date of the Notice of Allowability on 04/09/2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 1-8, 10-14, and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Fuentes-Ortega (US Patent Publication 2021/0015551) in view of Beeckler (US Patent Publication 2022/0104873).
Regarding claim 1, Fuentes-Ortega teaches
“An end effector of a catheter (Figs 2A-3, p.[0024] "… an end effector (200) of a flexible catheter (120)…"), the end effector comprising,”
“a frame (Fig. 2A-4, p.[0038], "… leaflet (210) of end effector (200)…")”,
“comprising one or more struts extending along a longitudinal axis (Fig 2A-4, p.[0049] "… each leaflet (210) is flexible enough to compress within outer sheath as shown in Figure 2A; yet is resiliently biased toward the expanded configuration shown in Figure 2B... one or more resilient features (not shown) are added to body (220) to impart the resilient bias. By way of example only, one or more nitinol strips or other nitinol structures may be applied to body (220), such as along any one or more inner members (242), outer members (230, 232), or central spine member (240). Such nitinol strips may be applied using vapor deposition process or other manufacturing techniques noted above. In versions where (250, 260) are provided on inner surfaces (212) and on outer surfaces (214), the nitinol strips or other resilient members may be interposed between layers of the flexible material...", where the nitinol strips are the struts)”,
“a polymeric (p.[0038], "… body (220) may be formed of polyimide, poly ether ketone, or any suitable flex circuit substrate…", where body (220) is seen as comprising membranes (215), see below)), encapsulation surrounding a majority of the frame (p.[0035], "... a membrane (215) may be provided between adjacent connectors (213a, 213b)", wherein the parts of the substrate/membrane can also be defined as encapsulation as claimed)”,
“a first membrane Fig. 4, p.[0042] "As also shown in Figure 4, mapping electrodes (250) are positioned on outer surfaces (214) of leaflets (210) in this example. In addition, or in the alternative, mapping electrodes (250) may be positioned on inner surfaces (212) of leaflets (210).", wherein the surfaces are considered membranes covering the aforementioned nitinol strips. Figure 4 shows several leaf branches which therefore are disposed on/between adjacent struts), to define a generally planar first surface exposed to ambient environment (Fig. 4, p.[0038] "... body (220) of the present example is flexible and has a generally flat, planar configuration.")”,
“at least one first electrode disposed on the first membrane (Fig. 4, p.[0038], "… Leaflet (210) of this example includes a body (220) with a plurality of electrodes (250, 260) and sensors (270) secured thereto", wherein the several leaf branches comprise electrodes, and hence they are disposed on a membrane since the leaf body surfaces cover the nitinol strips and are between adjacent struts) such that a majority of the at least one first electrode is positioned between the one or more struts of the frame (Figure 4; Several electrodes are positioned on the branches or close to what is considered an "inner" strut, and therefore is considered that a majority of the electrodes are positioned between one or more "outer" struts of the frame.)”
Fuentes-Ortega does not teach “a first membrane disposed on the polymeric encapsulation”, but Beeckler does in an analogous catheter device. Beeckler teaches “a first membrane disposed on the polymeric encapsulation (p.[0030,0032,0034,0052,0054])”. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a first membrane disposed on the polymeric encapsulation, as taught in Beeckler, in Fuentes-Ortega in order to “conform to an anatomy’s variable shape surface” (p.[0030]) which produces predictable results of creating a flexible catheter.
Regarding claim 2, the limitations of claim 1 are taught as described above. Fuentes-Ortega teaches the limitations of claim 2 in Figures 3-4. Note that any other leaf structure or leaf branch can be defined as having a second membrane, and further, the back surface comprises electrodes and can be identified as a second membrane. Therefore, the claimed limitation is taught.
Regarding claim 3, the limitations of claim 2 are taught as described above. Fuentes-Ortega teaches the limitation “in which one of the pluralities of the first electrodes and second electrodes that are not in contact with tissue comprising a reference electrode” in Fig. 4, and p.[0040] "… each pair of mapping electrodes (250) is configured to provide bipolar sensing of electrocardiogram signals as the pair of electrodes (250) is placed in contact with cardiovascular tissue. Thus, a pair of electrodes (250) may be considered as collectively forming a single "sensor"...", where the electrodes not in contact can be considered as reference electrodes that measure the non-contact background signal.
Regarding claim 4, the limitations of claim 2 are taught as described above. Fuentes-Ortega teaches “wherein the polymeric encapsulation is positioned between the first membrane and the second membrane” in Figure 3, with membrane 215.
Regarding claim 5 and 6, the limitations of claim 1 are taught as described above. Fuentes-Ortega teaches “the one or more struts comprising a proximal strut and a pair of struts extending distally from the proximal strut” and “the one or more struts comprising a proximal strut and between two and twelve struts extending distally from the proximal strut” in Figures 3-4, which shows how the struts expand from one proximal portion near the center of the branch, then extends into several struts distally, and teaches the claimed limitation as described.
Regarding claim 7, the limitations of claim 1 are taught as described above. Fuentes-Ortega teaches the limitations of claim 7 in Figures 3-4, which shows how the struts have a "loop" like structure with how the leaves include multiple offshoots that approximate a perimeter of the end effector, and are connected with the strut having a first proximal end (as seen in Figure 4, above the dashed line "RA"), a second proximal end proximal of the first proximal end (Figure 4, below dashed line "RA"), and extend between one another via the main strut (Figure 4, the central strut before and after splitting).
Regarding claim 8, the limitations of claim 1 are taught as described above. Fuentes-Ortega teaches “at least a portion of the one or more struts comprising a flexibility gradient along a portion of a length of the respective strut” in Figures 2A-4, where the leaves implicitly have a flexibility gradient being more flexible where fewer materials and struts are connected, and therefore teaches the claimed limitation as described.
Regarding claim 10, the limitations of claim 1 are taught as described above. Fuentes-Ortega teaches “the at least one first electrode being positioned to contact tissue” in p.[0003] "The electrodes may be placed in contact with cardiac tissue or other vascular tissue and then activated with RF energy to thereby ablate the contacted tissue" which teaches the claimed limitation as described.
Regarding claim 11, the limitations of claim 1 are taught as described above. Fuentes-Ortega teaches “the at least one first electrode comprising a plurality of closely spaced coplanar electrode pairs” in Figure 4, with electrodes 250 and 260.
Regarding claim 12, the limitations of claim 1 are taught as described above. Fuentes-Ortega teaches the limitations of claim 12 in Figure 4, where the inner leaf struts are narrower than the outer leaf struts, with electrodes being centered on each of the respective struts and therefore teaches the limitation as described.
Regarding claim 13, the limitations of claim 1 are taught as described above. Fuentes-Ortega teaches “the at least one first electrode comprising a plurality of first electrodes distributed in a first electrode density zone and a plurality of second electrodes distributed in a second electrode density zone, and the plurality of second electrodes in the second electrode density zone being spaced further apart from each other than the plurality of first electrodes in the first electrode density zone” in Figure 4. Figure 4 shows regions of higher and lower electrode density zones, such as higher zones towards the distal end of the leaflet and lower zones towards the central axis of the leaflet.
Regarding claim 14, the limitations of claim 1 are taught as described above. Fuentes-Ortega teaches “further comprising: a navigation sensor positioned such that at least a portion of the navigation sensor is between the one or more struts” in Figures 3-4, and further in p.[0046] "… Leaflet (210) of the present example further includes a plurality of position sensors (270)." Note that it is the Examiner's position that position sensors constitute a form a navigation sensor (given that one must determine their initial position before they can navigate throughout the body) and teaches the limitation as described.
Regarding claims 16-17, the limitations of claim 1 are taught as described above. Fuentes-Ortega teaches “the end effector, in free space, comprising a curvature defining an arcuate path” and “the end effector, pressed to a planar surface, comprising a planar shape” in Figures 3-4. Note that the leaves of Figure 3-4 have arcuate ends/edges, and therefore, comprise a curvature defining an arcuate path to teach the claimed limitation as described. Further, when the leaves of Figures 3-4 are expanded (such as shown in Figure 2B-4), each leaflet is biased towards having a flat configuration (p.[0050], "…In addition to providing a resilient bias toward the expanded configuration shown in FIG. 2B, resilient members such as nitinol structures may also bias each leaflet (210) toward having a flat configuration..."). Therefore, it is the Examiner's position that if the end effector were to be pressed to a planar surface, it would create a planar (or relatively flat) shape, and teaches the claimed limitation as described.
Regarding claim 18, the limitations of claim 1 are taught as described above. Fuentes-Ortega teaches “wherein the at least one first electrode comprises a singular electrode having a surface area over a majority of the generally planar first surface” in Figure 4. The first surface is defined relative to the first membrane, hence can be arbitrarily defined, for example, on a single leaf branch. In Figure 4, there are long ablation electrodes 260, with several branch struts and leaf subsections can be defined, which shows that the single ablation electrode covers a majority of the surface, e.g., close to the leaf distal tip or on the thin strut at the proximal end.
Regarding claim 19, the limitations of claim 18 are taught as described above. Fuentes-Ortega teaches “wherein the at least one first electrode comprises a plurality of smaller electrodes disposed at predetermined locations on the generally planar first surface” in Figure 4. The first surface is defined relative to the first membrane, hence can be arbitrarily defined, for example, on a single leaf branch. In Figure 4, there are small electrodes 250 on the edge of the leaves, which constitute as the plurality of smaller electrodes, and teach the limitation as described.
Regarding claim 20, the limitations of claim 1 are taught as described above. Fuentes-Ortega teaches the limitations of claim 20 in Figures 2A-4, with the four-leaf structure, which shows at least one electrode (250, 260), membrane(s) (surfaces 214, 212), frames of leaves 210, and struts as described above. Further, the additional membrane structures are found on additional leaves of the four-leaf structure, which have multiple struts, membranes, and polymeric encapsulations, and therefore teaches the claimed limitation as described.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Fuentes-Ortega (US Patent Publication 2021/0015551) and Beeckler (US Patent Publication 2022/0104873) in view of Govari (US Patent Publication 2019/0365464).
Regarding claim 9, the limitations of claim 1 are taught as described above. Fuentes-Ortega teaches a flex circuit in p.[0048], "Other methods may be employed to provide electrodes (250, 260), position sensors (270), conductive traces, or other circuit components on body (220), including but not limited to sputter deposition, chemical vapor deposition (CVD), thermal deposition, etc. Regardless of the methods used, each leaflet (210) may ultimately constitute a flex circuit."
Fuentes-Ortega nor Beeckler does not teach that the flex circuit includes serpentine traces connected to at least one first or second electrode, but Govari does in an analogous expandable catheter device. Govari teaches serpentine traces in Figures 3-4 with serpentine flexible circuit tracks 52. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use serpentine tracks, as taught in Govari, in Fuentes-Ortega/Beeckler. As described in Govari, the use of these distinctly oriented and shaped traces allows for "orientation and directional guidance" through radiographic imaging (p.[0041]) and produces predictable results for improved orientation and directional guidance of the catheter.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Fuentes-Ortega (US Patent Publication 2021/0015551) and Beeckler (US Patent Publication 2022/0104873) in view of Roest (US Patent No. 8,203,912).
Regarding claim 15, the limitations of claim 1 are taught as described above. Fuentes-Ortega/Beeckler does not teach one or more piezoelectric transducers disposed under a respective electrode of the at least one of first electrode, but Roest does in an analogous electrode device. Roest teaches a transducer underneath an electrode in Figure 8, with piezoelectric transducer element 814 beneath electrode 810. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a piezoelectric transducer under the electrode of the device, as taught in Roest, in Fuentes-Ortega/Beeckler. As stated in Roest, the use of transducers can "in at least some instances, result in an improved transmission of power." and produces predictable results of improving power transmission (col. 1, lines 22-23).
Conclusion
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/ABIGAIL BOCK/Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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