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 .
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 final rejection. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on May 26th, 2026 has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted May 27th, 2026 has been considered by the Examiner.
Response to Arguments
Applicant’s arguments, see pages 7-8, filed May 26th, 2026, with respect to the rejection(s) of claim(s) 1 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of newly found prior art that teaches the newly disclosed claim limitations.
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.
Claims 1-8, 10 & 23-26 are rejected under 35 U.S.C. 103 as being unpatentable over Sallee et al. (U.S. Pub. No. 20170049349, previously cited), herein referred to as “Sallee” in view of Jin et al. (U.S. Pub. No. 20210370053 , earliest effective filing date), herein referred to as “Jin” and further in view of Papaioannou et al. (U.S. Pub. No. 20160184008, previously cited), herein referred to as “Papaioannou”.
Regarding claim 1, Sallee discloses a catheter for electrophysiological measurement (catheter 10; Abstract: An electrode for cardiac signal sensing; [0002]: The present invention relates to cardiac signal sensing devices. More specifically, the invention relates to flexible electrodes and methods for making flexible electrodes for use in a cardiac mapping catheter), the catheter comprising:
a catheter shaft (elongate lead body 14) including a proximal end (proximal end 20) and a distal end (distal 22);
a flexible circuit ([0062]: the flexible polymer substrate 34, the conductive layer 40, the intermediate metal layer 42, the electrical trace 50, and the electrical interconnect 52 already made in the form of a flexible printed circuit (FPC)) disposed on the catheter shaft ([0060]: As shown in FIG. 3, the spline 30 may further include an electrical trace 50, an electrical interconnect 52, and a backside insulating layer 54; wherein the spline 30 is disposed on the end of elongate lead body 14 & the FPC is seen as being indirectly disposed on the catheter shaft), the flexible circuit comprising:
a first dielectric layer (flexible polymer substrate 34);
an electrical conductor (conductive layer 40) attached to the catheter and configured to be communicatively coupled to an electronic control unit (ECU) ([0049]: electrode array 16 may project from the distal end 22 of the lead body 14 … electrical connection 18 may extend from the handle 12 to a mapping data recording and analysis system (not shown); [0055]: electrode 36 may include a conductive layer 40; see Fig. 3 where conductive layer 40 is on spline 30 which is attached to elongate lead body 14 in Fig. 2B & the electrical conductor is seen as being indirectly disposed on the catheter shaft);
a second dielectric layer (insulating polymer layer 48) disposed on the electrical conductor ([0055]: insulating polymer layer 48 may be formed on the second portion 64 of the intermediate metal layer 42, and the second portion 68 of the iridium-containing layer 44; see Fig. 3 where insulating polymer layer 48 is on conductive layer 40); and
an electrode (electrode 36) disposed on the electrical conductor (see Fig. 3 where electrode 36 is on conductor 40), wherein a contact surface area of the electrode includes an impedance reduction layer (iridium oxide layer 46 & iridium containing layer 44; see Fig. 3 where this is an outer layer/a contact surface area of electrode 36; [0069]: The activation may reduce the electrical impedance of the electrode 36 by as much as three orders of magnitude compare to the electrode 36 without the iridium oxide layer 46),
but Sallee fails to disclose wherein the impedance reduction layer includes a surface texture having a pattern comprising repeating uniform plume structures or repeating uniform dimple structures and a surface roughness, each in a range between 1 and 30 µm.
However, Jin discloses wherein the impedance reduction layer includes a surface texture having a pattern comprising repeating uniform plume structures or repeating uniform dimple structures and a surface roughness ([0078]: improved, taller nanopillar/nanostructure configuration for lowered impedance and higher signal sensing capability; [0096]: Illustrated at FIG. 4 … At reference letter (c) is a Pt-10% Ir alloy surface with RF processed nanowire array; [0100]: Turning now to FIG. 6, illustrated are nanopillar growth directions on neural stimulator electrodes … At reference letter (b), illustrated is a uniform nanopillar array, such that if a nanopatterning approach is utilized, a very uniform nanopillar array is obtained without the formation of such undesirable tilted nanopillars on unwanted locations), each in a range between 1 and 30 µm ([0095]: The desired nanopillar dimension is 50-300 nm average diameter and 0.5-30 μm tall). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the impedance reduction layer of Sallee to comprise a surface texture having a pattern, as taught by Jin, for the purpose of the length of the nanopillars plays an important role of dictating the degree of impedance reduction, the length of improved, taller nanopillar/nanostructure configuration for lowered impedance and higher signal sensing capability and the pattern preventing unwanted electrical signals sent to wrong directions or at wrong angles (Jin: [0130], [0078], [0100]).
But Sallee in view of Jin fail to disclose wherein the contact surface area of the impedance reduction layer is 1.0 mm2 or less
However, Papaioannou discloses wherein a contact surface area of the electrode includes an impedance reduction layer, wherein the impedance reduction layer includes a surface texture ([0057]: Disposed over the surface of the porous substrate are the one or more sensing microelectrodes 40 … may involve more than one layers, with the outer most layer comprising suitable electrode material (or alloys) known in the art, such as gold, platinum, platinum/iridium … the metal coating 40 is made of a platinum-iridium alloy, e.g. 90% Platinum/10% Iridium, applied to the surface of the porous substrate 38 by metallization treatment or process impregnating a thin layer of platinum-iridium alloy onto the porous substrate 38, as known in the art; wherein this is seen as an impedance reduction layer disposed on an electrode);
wherein the contact surface area of the impedance reduction layer is 1.0 mm2 or less ([0060]: Advantageously, the surface electrodes 40 are sized as micro-electrodes for obtaining highly localized electrograms and providing high density mapping of heart tissue. The surface area of each surface electrode ranges between about 0.2 mm2 and 2.0 mm2, preferably between about 0.5 mm2 and 1 mm2).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the contact surface area of Sallee in view of Jin to be the contact surface area of Papaioannou for the purpose of producing micro-electrodes for obtaining highly localized electrograms and providing high density mapping of heart tissue (Papaioannou: [0060]).
Regarding claim 2, Sallee discloses wherein the electrical conductor is a trace positioned along a flexible circuit ([0062]: FIGS. 4-12 are schematic views illustrating a method for fabricating the electrode 36 shown in FIG. 3 in accordance with embodiments of the present invention. The method may begin as shown in FIG. 4 with the flexible polymer substrate 34, the conductive layer 40, the intermediate metal layer 42, the electrical trace 50, and the electrical interconnect 52 already made in the form of a flexible printed circuit (FPC)).
Regarding claim 3, Sallee discloses wherein the impedance reduction layer is a platinum coating ([0058]: the iridium-containing layer 44 may be formed primarily of iridium and platinum may make up the balance).
Regarding claim 4, Sallee discloses wherein the platinum coating is a platinum iridium coating ([0058]: the iridium-containing layer 44 may be formed primarily of iridium and platinum may make up the balance).
Regarding claim 5, Sallee discloses a gold layer (intermediate layer 42; [0057]: intermediate metal layer 42 may be made of gold) disposed between a copper layer of the electrical conductor ([0056]: conductive layer 40 may be made of a non-biocompatible material, such as copper or a copper alloy) and the impedance reduction layer (see the layering of 46/44/42/40 in Fig. 3).
Regarding claim 6, Sallee discloses wherein the impedance reduction layer is configured to reduce impedance at the electrode by at least fifty percent as compared to a similarly sized electrode without the impedance reduction layer ([0069]: The activation may reduce the electrical impedance of the electrode 36 by as much as three orders of magnitude compare to the electrode 36 without the iridium oxide layer 46)).
Regarding claim 7, Sallee discloses wherein the impedance reduction layer has a thickness of 1 µm ([0065]: the iridium-containing layer 44 may have a thickness of as little as about 0.1 microns, about 0.2 microns, or about 0.4 microns, or as great as about 0.6 microns, about 0.8 microns, or about 1 micron) but fails to explicitly disclose wherein the impedance reduction layer has a thickness of between 1 µm and 30 µm.
However, Papaioannou discloses wherein the impedance reduction layer (metal coating 40) has a thickness of between 1 µm and 30 µm ([0058]: the metal coating may have a uniform thickness ranging from 0.2 µm to about 2.0 µm … coating forming one or more microelectrodes 40X, as shown in FIGS. 5A and 5B, has non-uniform thickness e.g. thicker towards the center and thinner towards the periphery. This allows for a protrusion configuration or a raised profile. The ratio of the central thickness H to the thickness at the periphery may range between about 2 and 20; such that the protruding thickness would extend the range to be in the range from 4 µm to 40 µm). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the thickness of Sallee in view of Jin to the thickness of Papaioannou for the purpose of the thickness allowing for improved contact with the heart tissue and consequently improved electrogram quality (Papaioannou: [0060]).
Regarding claim 8, Sallee discloses wherein the impedance reduction layer is configured to increase biocompatibility of the electrode ([0054]: the electrodes 36 are able to flex with deployment of the electrode array 16, while also maintaining low impedance and biocompatibility).
Regarding claim 10, Sallee in view of Jin and Papaioannou disclose wherein the contact surface area of the impedance reduction layer is 0.5 mm2 or less (Papaioannou: [0060]: The surface area of each surface electrode ranges between about 0.2 mm2 and 2.0 mm2).
Regarding claim 23, Sallee discloses wherein the second dielectric layer (insulating polymer layer 48) includes one or more apertures to expose the electrode to provide the contact surface area for placement against tissue within a body of a patient ([0055]: The insulating polymer layer 48 may not be formed on the iridium-oxide layer 46).
Regarding claim 24, Sallee discloses an intermediate layer (intermediate metal layer 42) disposed on the electrical conductor ([0055]: The intermediate metal layer 42 may be formed on at least a portion of the conductive layer 40) and configured to facilitate adhesion between the electrical conductor and the impedance reduction layer ([0073]: In the embodiments described above, each of the conductive layer 40, the intermediate metal layer 42, the iridium-containing layer 44, and the iridium oxide layer 46 is formed only on one other material which may lead to overall improved layer-to-layer adhesion by optimizing the deposition process for deposition on a single material).
Regarding claim 25, Sallee discloses wherein the catheter is a planar catheter, a basket catheter ([0052]: FIG. 2A shows the electrode array 16 undeployed in a radially retracted position. FIG. 2B shows the electrode array 16 deployed in a radially extended position), or a linear catheter.
Regarding claim 26, Sallee in view of Jin discloses wherein the pattern further comprises repeating line structures (Jin: [0100] Turning now to FIG. 6, illustrated are nanopillar growth directions on neural stimulator electrodes … At reference letter (b), illustrated is a uniform nanopillar array, such that if a nanopatterning approach is utilized, a very uniform nanopillar array is obtained).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Abigail M Ziegler whose telephone number is (571)272-1991. The examiner can normally be reached M-F 8:30 a.m. - 5 p.m. EST.
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/ABIGAIL M ZIEGLER/Examiner, Art Unit 3794
/BEVERLY M FLANAGAN/Primary Examiner, Art Unit 3794
