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 .
Response to Amendment
The amendment filed December 18th, 2025 has been entered. Applicant’s amendments to the claims have overcome the 112(b) rejection previously set forth in the Non-Final Office Action mailed November 5th, 2025.
Response to Arguments
Applicant's arguments filed December 18th, 2025 have been fully considered but they are not persuasive.
Regarding Applicant’s arguments on pages 6-7 that Peterson does not teach or suggest a pattern including plumes or dimples, the Examiner respectfully disagrees on the grounds that Applicant has not clearly specified in the claims what a plume means in the context of the instant Application’s disclosure. “Plume” as defined, “something resembling a feather: such as a. a plumose appendage of a plant, b. an elongated and usually open and mobile column or band…” (merriam-webster) or “any plumose part or formation; plumage; a vertically or longitudinally moving, rising, or expanding fluid body, as of smoke or water” (dictionary.com) describes something different from what is shown in the instant application’s Fig. 7, which as described in paragraph [0054] of the instant specification as having plumes. From the dictionary definitions and what is shown in the instant application’s disclosure, the Examiner is interpreting “plumes” as any projection from a surface, such that Peterson’s macrostructures are seen as plumes.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., Applicant describes Peterson’s macrostructures as complex & varying in contrast to the invention, however, language to further detail the pattern comprising plums or dimples shown in Fig. 7 such as language describing the pattern to be simple and repeating) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Therefore, these arguments are not persuasive and the Examiner maintains that the current prior art of record discloses the claims’ 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 & 23-25 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 Petersen et al. (U.S. Pub. No. 20140067031, previously cited), herein referred to as “Petersen” 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 including plumes or dimples and a surface roughness, each in a range between 1 and 30 µm.
However, Petersen discloses wherein the impedance reduction layer includes a surface texture having a pattern including plumes or dimples ([0045]: at least some of the macrostructures 62 may have a major dimension D1 that is in the range of about 5 micrometers to about 200 micrometers; wherein the macrostructures are seen as the pattern and Fig. 5 shows them as plumes) and a surface roughness, each in a range between 1 and 30 µm ([0045]: at least some of the macrostructures 62 may have a major dimension D1 that is in the range of about 5 micrometers to about 200 micrometers. In some embodiments, as shown in FIG. 6, nanostructures 66 may be formed on the macrostructures 64. In some embodiments, as shown in FIG. 6, nanostructures 66 may be formed on the macrostructures 64. It will be appreciated that the complex surface structure including macrostructures 62 and nanostructures 66 will provide a greatly increased surface area and hence improved current transfer; [0046]: FIG. 6 is a schematic illustration of a portion of the electrode 38 showing nanostructures 66. It will be appreciated that inclusion of the nanostructures 66 may substantially increase the surface area of the electrode 38, and thus substantially increase the ability of the electrode 38 to transfer current in either a sensing application or a shocking application … at least some of the nanostructures 66 may have a major dimension D2 that is in the range of about 100 nanometers to about 2 micrometers; wherein macrostructures 62 are the pattern and nanostructures 66 are the surface roughness and the ability to improve current transfer is seen as a functional equivalent to being able to reduce impedance). 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 have a pattern and surface roughness, as taught by Petersen, for the purpose of the complex surface structure including macrostructures and nanostructures will provide a greatly increased surface area and hence improved current transfer and nanostructures may substantially increase the surface area of the electrode, and thus substantially increase the ability of the electrode to transfer current in either a sensing application or a shocking application (Petersen: [0045], [0046]).
But Sallee in view of Petersen 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 Petersen 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 Petersen 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 Petersen 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.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Rodden can be reached at (303) 297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ABIGAIL M ZIEGLER/Examiner, Art Unit 3794
/THOMAS A GIULIANI/Primary Examiner, Art Unit 3794