DETAILED ACTION
Status of Claims
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-17 are pending.
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 1-13 are rejected under 35 U.S.C. 103 as being unpatentable over Dearden et al. (US 20240058602 A1, 2024-02-22) (hereinafter “Dearden”) in view of Park et al. (Electrochemical Evaluations of Fractal Microelectrodes for Energy Efficient Neurostimulation. Sci Rep. 2018 Mar 12;8(1):4375) (hereinafter “Park”).
Regarding claims 1-13, Dearden teaches an electrode lead for transmitting electrical current to a nerve, the electrode lead comprising: an elongate lead body having a proximal end and a distal end; and an electrode including: a biocompatible, pliable, electrically insulative substrate at the distal end of the lead body, and at least one electrically conducive contact on the insulative substrate (e.g., [0006]-[0007], [0040]-[0059]). See also Figs. 2, 6, 10, 12 and associated text. [D1]
Dearden does not teach embossed tissue contact surface. Park teaches texturing (or embossing) the tissue contact surface with various geometric patterns to improve electrode efficiency. See, e.g., Table 1 (disclosing various perimeter-to-area ratios), Fig. 3 and associated text. [P1]
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the teachings of Park with the invention taught by Dearden such that the invention further comprises an embossed tissue contact surface (e.g., [D1], [P1]) (as recited in claim 1); wherein the insulative substrate comprises a nerve cuff with an inner surface configured to abut against the nerve; and the at least one electrically conductive contact is associated with the inner surface in such a manner that the embossed tissue contact surface abuts against the nerve when the inner surface abuts the nerve (e.g., [D1], [P1]) (as recited in claim 2); wherein the nerve cuff is configured to be circumferentially disposed around the nerve and has a pre-set furled state that defines an inner lumen and is movable to an unfurled state (e.g., [D1], [P1]) (as recited in claim 3); wherein the nerve cuff is configured to be helically disposed around the nerve and has a pre-set furled state that defines an inner lumen and is movable to an unfurled state (e.g., [D1], [P1]) (as recited in claim 4); wherein the insulative substrate comprises a cylindrical substrate configured to be placed adjacent to the spinal cord; and the at least one electrically conductive contact comprises a ring-shaped contact and the embossed tissue contact surface extends completely around the cylindrical substrate (e.g., [D1], [P1]) (as recited in claim 5); wherein the insulative substrate comprises a flat, rectangular substrate defining a front face; and the at least one electrically conductive contact is associated with the front face in such a manner that the embossed tissue contact surface will abut against the nerve when the inner front face abuts the nerve (e.g., [D1], [P1]) (as recited in claim 6); wherein the at least one electrically conductive contact comprises a plurality of electrically contacts (e.g., [D1], [P1]) (as recited in claim 7); wherein the at least one electrically conductive contact has a smooth surface area defined by the outer perimeter of the embossed tissue contact surface; and the embossed tissue contact surface defines an effective surface area that is bounded by the outer perimeter and that is at least twice the smooth surface area (e.g., [D1], [P1]) (as recited in claim 8); wherein the embossed tissue contact surface comprises a three-dimensional surface with a raised and/or depressed texture (e.g., [D1], [P1]) (as recited in claim 9); a method of forming an implantable neurostimulator electrode, the method comprising: combining a plurality of electrically conductive members that include respective rear surfaces and embossed tissue contact surfaces with a biocompatible, pliable, electrically insulative substrate that includes a plurality of windows in such a manner that exposed portions of the embossed tissue contact surfaces are within the windows (e.g., [D1], [P1]) (as recited in claim 10); wherein the substrate comprises a nerve cuff with an inner surface configured to abut against the nerve; and the windows are associated with the inner surface (e.g., [D1], [P1]) (as recited in claim 11); wherein the nerve cuff is configured to be circumferentially disposed around a nerve and has a pre-set furled state that defines an inner lumen and is movable to an unfurled state (e.g., [D1], [P1]) (as recited in claim 12); wherein the nerve cuff is configured to be helically disposed around a nerve and has a pre- set furled state that defines an inner lumen and is movable to an unfurled state (e.g., [D1], [P1]) (as recited in claim 13) in order to improve electrode efficiency.
Claims 14-17 are rejected under 35 U.S.C. 103 as being unpatentable over Dearden in view of Park and Wen et al. (CN 112402786 A, 2021-02-26) (hereinafter “Wen”).
Regarding claims 14-17, as discussed above, Dearden (in view of Park) teaches a method of forming an electrode for an implantable neurostimulator, comprising combining the electrically conductive contact with a biocompatible, pliable, electrically insulative substrate (e.g., [D1], [P1]).
Dearden (in view of Park) does not teach placing electrically conductive material in physical contact with a tooling surface having a surface pattern; embossing the surface pattern onto the electrically conductive material to form an electrically conductive contact with an embossed tissue contact surface.
Wen teaches placing electrically conductive material in physical contact with a tooling surface having a surface pattern; embossing the surface pattern onto the electrically conductive material to form an electrically conductive contact with an embossed tissue contact surface (e.g., English translation: “Further, the bump is formed by means of punching on the electrode contact. Further, the bump is more than one, a plurality of the bumps are uniformly distributed on the electrode contact.”). [W1]
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the teachings of Park with the invention taught by Dearden (in view of Park) such that the invention further comprises placing electrically conductive material in physical contact with a tooling surface having a surface pattern; embossing the surface pattern onto the electrically conductive material to form an electrically conductive contact with an embossed tissue contact surface (e.g., [D1], [P1], [W1]) (as recited in claim 14); wherein the electrically insulative substrate includes a window; and the electrically conductive contact is combined with the electrically insulative substrate in such a manner that at least a portion of the embossed tissue contact surface is within the window (e.g., [D1], [P1], [W1]) (as recited in claim 15); wherein the electrically insulative substrate comprises a cylindrical substrate configured to be placed adjacent to the spinal cord; the electrically conductive material is ring-shaped; the electrically conductive contact is ring-shaped; and the ring-shaped electrically conductive contact is combined with the cylindrical subtrate in such a manner that the embossed tissue contact surface extends completely around the cylindrical substrate (e.g., [D1], [P1], [W1]) (as recited in claim 16); wherein the electrically conductive material comprises a substantially cylindrical ring; embossing the surface pattern onto the electrically conductive material comprises causing the substantially cylindrical ring to roll upon the tooling surface, and the method further comprises flattening embossed substantially cylindrical ring such that the embossed tissue contact surfaces are substantially rectangular prior to combining the electrically conductive contact with the electrically insulative substrate (e.g., [D1], [P1], [W1]) (as recited in claim 17) in order to improve electrode efficiency.
Prior Art of Record
The prior art made of record and not relied upon is considered to be pertinent to applicant's disclosure.
Maschino et al. (US 6600956 B2, 2003-07-29) teaches a similar electrode structure. See, e.g., Figs. 3, 4A, 7A.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SCOTT T LUAN whose telephone number is (571)270-1860. The examiner can normally be reached on 9am-5pm, M-F (generally).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gary Jackson, can be reached on 571-272-4697. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Scott Luan
/SCOTT LUAN/Primary Examiner, Art Unit 3792
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