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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 September 22nd, 2025 has been entered.
Response to Amendment
The amendment filed September 22nd, 2025 has been entered. Claims 1-8, 10-16 and 35-36 remain pending in the application. Claims 17-34 are withdrawn from consideration. Applicant’s amendments to the claims have overcome the objections and previously set forth in the Final Office Action mailed May 21st, 2025.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-8, 10-16 and 35-36 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The claim amendments changed the scope of the claimed invention. See new grounds for rejection below.
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 1-3, 6, 10-16, and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Tooker et al. (US Pat. 9,399,128) herein referred to as “Tooker” in view of Clements et al. (U.S. PGPub. No. 2020/0138313) herein referred to as “Clements” further in view of McDonald et al. (U.S. PGPub. No. 2014/0058487) herein referred to as “McDonald”.
Regarding claim 1, Tooker embodiment 1 discloses an implantable medical electrode for stimulation or sensing (the flexible neural interface with integrated stiffening shank described here is suitable for implantation in both humans and animals, Col. 4, lines 31-33) wherein the electrode comprises:
an electrically insulating substrate having a substrate surface (multilayer body 402, Col. 7, lines 65-66, Figures 4A and 4B),
wherein the substrate surface comprises at least one recess (top electrodes 408 are recessed from the top polymer layers, Col. 8, lines 1-2, Figures 4A and 4B)
wherein the at least one recess comprises: a bottom surface (bottom surface, see modified Figure 4B below) arranged at a first distance to the substrate surface (first distance, see modified Figure 4B below)
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and a first wall and a second wall opposed from each other and each connecting the bottom surface to the substrate surface (first wall and a second wall, see modified Figure 4B below)
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a layer of conductive polymer in contact with the first surface of the conducting element and contained within the first and second walls of the recess and not extending outside the recess (top electrode 408 contained within the walls of the recess, made of any conductive material (including conductive polymers), Figure 4B, Col. 7, lines 1-4, and Col. 7, lines 38-52),
and a connecting element (the electrodes are sandwiched between polymer layers and connected by traces 410 (seen as a connecting element), Col. 8, lines 2-4, Figures 4A and 4B),
wherein the layer of conductive polymer has a maximum thickness that is less than the first distance, thereby defining a void between the conductive polymer and the substrate surface (conductive polymer layer 408 is a thickness less than the first distance, defining a void between the conductive polymer and substrate surface, see modified Figure 4B below).
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Tooker embodiment 1 discloses the claimed invention except for wherein the first distance is in a range from 20um to 50um. It would have been an obvious matter of design choice to have modified the first distance to be from 20 um to 50um, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Tooker embodiment 1 further discloses wherein the neural interface can be used with multiple layers of interconnection trace metal for both the top and bottom electrodes (Col. 6, lines 40-44), however Tooker embodiment 1 does not explicitly disclose a conducting element having first and second surfaces opposite each other and arranged with the second surface in contact with the bottom surface and the conducting element contained within the first and second walls of the recess and not extending outside the walls of the recess, wherein the layer of conductive polymer is in contact with the first surface of the conducting element, thus forming an electrical connection with the conducting element when a current is applied and a connecting element coupled to the second surface of the conducting element.
Clements discloses an example electrode patch comprising a plurality of electrodes (Abstract). Clements further discloses a conducting element having first and second surfaces opposite each other and arranged with the second surface in contact with the bottom surface (electrode contacts 106A and traces are fabricated onto the flexible substrate within a recess, Paragraph [0056], Figures 3A-3C) and the conducting element contained within the first and second walls of the recess such that the conductive polymer does not extend laterally outside the walls of the recess (electrode contact 106A is contained within the recess and does not extend laterally outside the walls of the recess, Figures 3A-3C),
wherein the layer of conductive polymer is in contact with the first surface of the conducting element (the hydrogel 106B can be fixed or bonded to the electrode contact 106A, Paragraph [0056], the hydrogel that forms the electrodes 106 is conductive, for example, by ionic conductivity or by including conductive fillers (i.e., conductive polymers) in the hydrogel, Paragraph [055], Figures 3A-3C),
thus forming an electrical connection with the conducting element when a current is applied (the hydrogel 106B, which is attached to the relatively small electrode contact 106A, “sticks out” relative to the flexible substrate 102, the raised geometry facilitates the creation of an intimate, stable interface between the hydrogel and the skin surface, Paragraph [0057])
and a connecting element coupled to the second surface of the conducting element (each of the traces 118 extends between one of the electrode 106 and the peripheral region 120, the traces 118 can be fabricated onto the flexible substrate 102, Paragraph [0060], Figure 1).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified the implantable electrode structure as taught by Tooker embodiment 1 to incorporate wherein the conducting element is contained within the first and second walls of the recess such that the conductive polymer does not extend laterally outside the walls of the recess and an electrode contact layer between the conductive polymer layer and the connecting element as taught by Clements. In doing so the conducting element would be connected to the conductive polymer on its top surface and the connecting element on its bottom surface and the conducting element would be contained within the first and second walls of the recess. The motivation to do so being to form a conductive contact between the electrical trace and the electrode in order to be able to record signals from the patient (Clements, Paragraph [0060]).
Further, Took embodiment 1 does not explicitly discloses wherein said void is configured to promote tissue ingrowth for anchoring the electrode.
McDonald discloses an implantable lead for stimulating tissue including a lead body (Abstract) wherein the device comprises voids configured to promote tissue ingrowth for anchoring the electrode (it may be advantageous to arrange the apertures 512 along at least a portion of the lead 501 such that the size, shape, orientation, and arrangement of the apertures are configured and arranged to promote tissue ingrowth to facilitate anchoring of the lead 501 to the patient tissue, Paragraph [0077]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the implantable electrode structure as taught by Tooker embodiment 1 to incorporate wherein the void is of whatever size or shape necessary so that the void is configured to promote tissue ingrowth for anchoring the electrode as taught by McDonald. The motivation to do so being to promote tissue ingrowth to facilitate anchoring the electrode to the patient tissue (McDonald, Paragraph [0060]).
Regarding claim 2, Tooker embodiment 1 in view of Clements and McDonald discloses the implantable medical electrode of claim 1.
Tooker embodiment 1 further discloses wherein the layer of conductive polymer has a maximum thickness such that does not extend beyond the substrate surface (top electrode 408 does not extend beyond the substrate surface, Figure 4B).
Regarding claim 3, Tooker embodiment 1 in view of Clements and McDonald discloses the implantable medical electrode of claim 1.
Tooker embodiment 1 further discloses wherein the substrate is flexible (flexible neural interface, i.e., flexible substrate, Col. 7, lines 61-62, Figures 4A and 4B).
Regarding claim 6, Tooker embodiment 1 in view of Clements and McDonald discloses the implantable medical electrode of claim 1.
Tooker embodiment 1 further discloses a connecting element capable of connecting the conducting element to a current source (the electrodes are sandwiched between polymer layers and connected by traces 410, wherein the connector region of the device is not shown, but is capable of connecting the conducting element to a current source, Col. 8, lines 2-5, Figure 4A).
Regarding claim 10, Tooker embodiment 1 in view of Clements and McDonald discloses the implantable medical electrode of claim 1.
Tooker embodiment 1 further discloses wherein the at least one recess has a geometry selected from the group consisting of a cylinder, a cube, a cuboid, a trapezoid, a square, a circle, a rectangle, and a triangle (recess is a circle, Figure 4A).
Regarding claim 11, Tooker embodiment 1 in view of Clements and McDonald discloses the implantable medical electrode of claim 1.
Tooker embodiment 1 further discloses wherein the implantable medical electrode comprises a plurality of recesses arranged in a pattern throughout the electrode (plurality of circular recesses arranged in a line pattern throughout the electrode, Figure 4A).
Regarding claim 12, Tooker embodiment 1 in view of Clements and McDonald discloses the implantable medical electrode of claim 1.
Tooker embodiment 1 further discloses wherein the pattern is selected from the group consisting of a grid, axial lines, radial lines (plurality of circular recesses are arranged in an axial line, Figure 4A).
Regarding claim 13, Tooker embodiment 1 in view of Clements and McDonald discloses the implantable medical electrode of claim 1.
Tooker embodiment 1 further discloses wherein the substrate comprises a material selected from the group consisting of a polymer, a natural rubber, a natural fiber, and a ceramic (polymer-based neural probe with an integrated stiffening shank, Col. 3, lines 30-32, a top polymer layer 34 deposited on the top electrode metal 32, wherein openings are etched in the top polymer for the top electrodes and external connections, Col. 5, lines 27-32, Figures 4A and 4B).
Regarding claim 14, Tooker embodiment 1 in view of Clements and McDonald discloses the implantable medical electrode of claim 1.
Tooker embodiment 1 further discloses wherein the substrate comprises a polymer the polymer is selected from the group consisting of a polyester, a polyethylene foam, a cellulose rayon non-woven material, polyethylene vinyl acetate, polyurethane, and polyimide (the fabrication process is independent of the specific type of polymer used to create the neural interface, polyimides and parylenes are the two most commonly used due to their biocompatibility, Col. 6, lines 57-65).
Regarding claim 15, Tooker embodiment 1 in view of Clements and McDonald discloses the implantable medical electrode of claim 1.
However Tooker embodiment 1 does not explicitly disclose a conducting element wherein the conducting element comprises a metal selected from the group consisting of platinum, gold, nitinol, and alloys thereof.
Clements discloses a conducting element (electrode contact 106A, Figures 3A-3C) wherein the conducting element comprises a metal selected from the group consisting of platinum, gold, nitinol, and alloys thereof (electrodes may be composed of any substantially conductive material including but not limited to metals (such as gold, silver, platinum, and various alloys), Paragraph [0104])
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Tooker embodiment 1 in view of Clements and McDonald to incorporate the teachings of Clements by including wherein the conducting element comprises a metal selected from the group consisting of platinum, gold, nitinol, and alloys thereof. The motivation to do so being to compose the electrode of a conductive material for apply stimulation and/or record electrical activity from each electrode (Clements, Paragraphs [0104] and [0060]).
Regarding claim 16, Tooker embodiment 1 in view of Clements and McDonald discloses an implantable medical device comprising the implantable medical electrode of claim 1 (the flexible neural interface with integrated stiffening shank described here is suitable for implantation in both humans and animals, Col. 4, lines 31-33, comprising implantable medical electrodes 408, Figures 4A and 4B, (see claim 1 rejection)).
Claims 4, 8, and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Tooker embodiment 1 in view of Clements and McDonald further in view of Tooker embodiment 2.
Regarding claim 4, Tooker embodiment 1 in view of Clements and McDonald discloses the implantable medical electrode of claim 1.
Tooker embodiment 1 in view of Clements and McDonald does not explicitly disclose wherein the layer of conductive polymer protrudes above the substrate surface, however, Tooker embodiment 2 discloses wherein the layer of conductive polymer protrudes above the substrate surface (the top electrode 508 made of a conductive polymer is outside the polymer layers, Figure 5B, Col. 8, lines 18-30).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified the conductive polymer layer as taught by Tooker embodiment 1 in view of Clements and McDonald to incorporate the teachings of Tooker embodiment 2 by including a conductive polymer layer that protrudes above the substrate surface. The motivation to do so being to provide a conductive contact with the patient for accurate recording and stimulation (Tooker, Col. 6, lines 19-39).
Regarding claim 8, Tooker embodiment 1 in view of Clements and McDonald further in view of Tooker embodiment 2 discloses the implantable medical electrode of claim 4.
However Tooker embodiment 1 in view of Clements and McDonald does not explicitly disclose wherein the layer of conductive polymer protruding above the substrate surface comprises a pattern of lines.
Tooker embodiment 2 discloses wherein the layer of conductive polymer protruding above the substrate surface comprises a pattern of lines (conductive polymer 508 extending above the substrate surface comprises a pattern of lines, Figure 5A, electrodes can be arranged independently in a variety of ways (i.e. straight lines), Col. 8, lines 36-38).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified the conductive layer as disclosed by Tooker embodiment 1 to protrude above the substrate surface and comprise a pattern of lines as taught by Tooker embodiment 2. The motivation to do so being to effectively organize the electrodes onto a single neural interface for effective recording and stimulation (Tooker, Col. 8, lines 31-42).
Regarding claim 36, Tooker embodiment 1 in view of Clements and McDonald further in view of Tooker embodiment 2 discloses the implantable medical electrode of claim 4.
Tooker embodiment 1 in view of Clements and McDonald does not explicitly disclose wherein the layer of conductive polymer protruding above the substrate surface has a top view geometry of at least one selected from the group consisting of a circle, a square, a rectangle, a triangle, or a trapezoid, however, Tooker embodiment 2 further discloses wherein the layer of conductive polymer protruding above the substrate surface has a top view geometry of at least one selected from the group consisting of a circle, a square, a rectangle, a triangle, or a trapezoid (layer of conductive polymer protruding above the surface 508, has a top view geometry of a circle, Figure 5A).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Tooker embodiment 1 in view of Clements and McDonald to incorporate the teachings of Tooker embodiment 2 by including wherein the layer of conductive polymer protruding above the substrate surface has a top view geometry of at least one selected from the group consisting of a circle, a square, a rectangle, a triangle, or a trapezoid. The motivation to do so being to effectively organize the electrodes onto a single neural interface for effective recording and stimulation (Tooker, Col. 8, lines 31-42).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Tooker in view of Clements and McDonald further in view of Wilks et al. (Wilks, Seth J, et al. “Poly(3,4-Ethylene Dioxythiophene) (PEDOT) as a Micro-Neural Interface Material for Electrostimulation.” Frontiers, Frontiers, 13 May 2009) herein referred to as “Wilks”.
Regarding claim 5, Tooker embodiment 1 in view of Clements and McDonald discloses the implantable medical electrode of claim 1.
However, Tooker embodiment 1 in view of Clements and McDonald does not explicitly disclose wherein the layer of conductive polymer has a charge storage capacitance ranging from 1 to 400 mC/cm2.
Wilks discloses wherein the layer of conductive polymer has a charge storage capacitance ranging from 1 to 400 mC/cm2 (PEDOT exhibits enhanced charge storage capacity at 75.6 ± 5.4 mC/cm2 which falls within the range of 1 to 400 mC/cm2, Wilks, Page 1, Abstract, see attached).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Tooker embodiment 1 in view of Clements and McDonald to incorporate the teachings of Wilks by including a layer of conductive polymer that has a charge storage capacitance ranging from 1 to 400 mC/cm2. The motivation to do so being to provide a lower amplitude voltage and a more ohmic representation of the applied current (Wilks, Page 1, Abstract, see attached).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Tooker in view of Clements and McDonald further in view of Shippy, III et al. (US Pat. 8275455) herein referred to as “Shippy”.
Regarding claim 7, Tooker embodiment 1 in view of Clements and McDonald discloses the implantable medical electrode claim 1.
However Tooker embodiment 1 in view of Clements and McDonald does not explicitly disclose wherein the layer of conductive polymer comprises PEDOT.
Shippy discloses an implantable medical electrode wherein the layer of conductive polymer comprises PEDOT (a conductive polymer electrode may be formed using any suitable conductive polymer including poly(3,4-ethylenedioxythiophene) (PEDOT), Col. 5, lines 49-54).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Tooker embodiment 1 in view of Clements and McDonald to incorporate the teachings of Shippy by including a layer of PEDOT on the conducting element. The motivation to do so being to form a conductive polymer electrode utilizing known materials in the art as the rate of release of a therapeutic agent can change depending on the oxidation state of the conductive polymer (Shippy, Col. 3, lines 5-24).
Claim 35 is rejected under 35 U.S.C. 103 as being unpatentable over Tooker in view of Clements and McDonald further in view of Zeng et al. (US 2021/0102304) herein referred to as “Zeng”.
Regarding claim 35, Tooker embodiment 1 in view of Clements and McDonald further in view of Tooker embodiment 2 discloses the implantable medical electrode of claim 4.
However Tooker embodiment 1 in view of Clements and Tooker embodiment 2 does not explicitly disclose wherein the layer of conductive polymer protrudes above the substrate surface at a distance of from 0.1 to 2.0 um.
Zeng discloses wherein the layer of conductive polymer protrudes above the substrate surface at a distance of from 0.1 to 2.0 um (the electrically conductive layers have a thickness of 0.02 to 10um, claim 6, wherein the material for the electrically conductive layer comprises conductive polymers, Abstract and the examiner interprets the protrusion of the conductive polymer above the substrate as being a thickness of 0.1 to 2 um above the surface of the substrate).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Tooker embodiment 1 in view of Clements and McDonald and Tooker embodiment 2 to incorporate the teachings of Zeng by including a layer of conductive that protrudes above the substrate surface at a distance from 0.1 to 2 um. The motivation to do so being to provide a consistent thickness of the entire electrically conductive layer to eliminate the influence of the edge effect and make the electric field distribution of the electrically conductive layer more uniform (Zeng, Paragraph [0049]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Dana Stumpfoll whose telephone number is (703)756-4669. The examiner can normally be reached 9-5 pm (CT), M-F.
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/D.S./Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794