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 .
Election/Restrictions
Claims 10-13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II, there being no allowable generic or linking claim.
Election was made without traverse in the reply filed on 19 December 2025 of Group I, directed to Claims 1-9 and 14.
Claim Objections
Claim 4 is objected to because of the following informalities:
Claim 4 recites “wherein mechanical properties of the biocompatible solid electrolyte is controlled”. However, this should be “wherein mechanical properties of the biocompatible solid electrolyte are controlled” for grammatical clarity.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 7 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). The claim recites “the second interface functional group induces at least one of hydrogen and covalent bonds with nerve”. Therefore, the claim encompasses a nerve (i.e. a structure of a human organism). For purposes of examination, the Examiner is interpreting this limitation as “the second interface functional group induces at least one of hydrogen and is configured to covalently bond with a nerve”.
Claim 14 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). The claim recites “the nerve stimulator electrode according to claim 1 that is in contact with a nerve”. Therefore, the claim encompasses a nerve (i.e. a structure of a human organism). For purposes of examination, the Examiner is interpreting this limitation as “the nerve stimulator electrode according to claim 1 that is configured to be in contact with a nerve”.
Claim Rejections - 35 USC § 103
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.
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.
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 1-4, 6, 8-9, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Yadavalli et al. (US Publication No. 2018/0355194) in view of Ackermann et al. (US Publication No. 2018/0280691).
Regarding Claims 1 and 14, Yadavalli et al. discloses a biocompatible, biomedical electrode (Abstract, Paragraph 0003, 0006, 0064) comprising a biocompatible solid electrolyte (biocompatible gel electrolyte, Paragraph 0007, 0009, 0018, 0034); and an ion diffusion barrier (flex sheet/substrate, Figs. 1A-B; Paragraph 0033-0034, 0064, 0067) formed on the biocompatible solid electrolyte (gel electrolyte, Figs. 1A-B; Paragraph 0007, 0009, 0018, 0034), wherein the biocompatible solid electrolyte comprises an ionic liquid and a biocompatible polymer matrix (ionic liquids and polymer matrices, Paragraph 0034, 0019-0020).
However, Yadavalli et al. does not explicitly disclose wherein the electrode is a nerve stimulator electrode which is part of a nerve stimulator comprising a pulse generator for generating electrical nerve stimulation pulses; the nerve stimulator electrode is in contact with a nerve; and a wire connection for electrically connecting the pulse generator and the nerve stimulator electrode.
Ackermann et al. teaches a nerve stimulator (Abstract; Paragraph 0073) comprising a pulse generator (114, Fig. 1A; Paragraph 0138) for generating electrical nerve stimulation pulses (Paragraph 0072-0075, 0138; Claim 1); and a nerve stimulator electrode (EICCC electrode 100, Fig. 1A; Paragraph 0138) is in contact with a nerve (N, Fig. 1A; and a wire (lead 112, Fig. 1A Paragraph 0138) connection for electrically connecting the pulse generator and the nerve stimulator electrode (Paragraph 0138, 0072-0075, Claim 1), wherein the nerve stimulator electrode comprises an ion conductive polymer and an electrolyte with a selective barrier (Paragraph 0073).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to configure the biocompatible, biomedical electrode disclosed by Yadavalli et al. to specifically comprise a nerve stimulator electrode in contact with a nerve which is part of a nerve stimulator comprising a pulse generator for generating electrical nerve stimulation pulses and a wire connection for electrically connecting the pulse generator and the nerve stimulator electrode, as taught by Ackermann et al., in order to implement therapeutic effects on a nerve such as to cause nerve block to treat disorders such as pain, movement disorders, psychiatric disorders, cardiovascular health, as well as management of disease states such as diabetes (see Ackermann et al., Paragraph 0004; Abstract).
Regarding Claim 2, Yadavalli et al. discloses the electrode (Abstract, Paragraph 0003, 0006, 0064) further wherein the biocompatible solid electrolyte allows ion movement (ion transport, Paragraph 0034, 0064, 0067) and forms an electric double layer under an electric field (Paragraph 0062, 0064, 0075).
Regarding Claim 3, Yadavalli et al. discloses the electrode (Abstract, Paragraph 0003, 0006, 0064) further wherein at least one of mechanical modulus (range of Young’s modululs, Paragraph 0019, 0021; Claim 9) and tensile yield point (mechincal strength/flexibility, Paragraph 0018) of the biocompatible solid electrolyte (biocompatible gel electrolyte, Paragraph 0007, 0009, 0018, 0034) is controlled depending upon a content of the ionic liquid (ionic liquid material of electrolyte, Paragraph 0018, 0034).
Regarding Claim 4, Yadavalli et al. discloses the electrode (Abstract, Paragraph 0003, 0006, 0064) further wherein mechanical properties of the biocompatible solid electrolyte is controlled depending upon a crosslinking density of the biocompatible polymer (“moduli may be tuned by controlling the degree of crosslinking of the proteins”, Paragraph 0021; see also Paragraph 0049, 0065, 0067).
Regarding Claim 6, Yadavalli et al. discloses the electrode (Abstract, Paragraph 0003, 0006, 0064) further wherein the biocompatible polymer comprises at least one of chitosan, collagen, gelatin, alginate, hyaluronic acid, cellulose (Paragraph 0020, 0025) or polylactide (Paragraph 0025) or a copolymer thereof (Paragraph 0020, 0025).
Regarding Claim 8, Yadavalli et al. discloses the electrode (Abstract, Paragraph 0003, 0006, 0064) further wherein a nano-micro pattern is comprised on a surface of the ion diffusion barrier (creating nano-micro pattern, Paragraph 0018, 0025, 0030-0036, 0049, 0062, 0065).
Regarding Claim 9, Yadavalli et al. discloses the electrode (Abstract, Paragraph 0003, 0006, 0064) further wherein the ion diffusion barrier comprises at least one of graphene oxide or transition metal dichalcogenides (Paragraph 0018, 0028, 0048).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Yadavalli et al. (US Publication No. 2018/0355194) in view of Ackermann et al. (US Publication No. 2018/0280691), further in view of Noshadi et al. (US Publication No. 2021/0151263).
Regarding Claim 5, Yadavalli et al. discloses a biocompatible, biomedical electrode (Abstract, Paragraph 0003, 0006, 0064) wherein the biocompatible solid electrolyte comprises an ionic liquid and a biocompatible polymer matrix (ionic liquids and polymer matrices, Paragraph 0034, 0019-0020). However, neither Yadavalli et al. nor Ackermann et al. explicitly discloses wherein the ionic liquid comprises a choline cation and a carboxylic anion paired with the choline cation, wherein the choline cation comprises at least one of choline bicarbonate, choline hydroxide and choline chloride, and the carboxylic anion comprises at least one of acetate, propionate, glycolate, benzoate, tiglate, malate, succinate, tartrate, fumarate and maleate.
Noshadi et al. teaches an electrode device comprising an ionic liquid (Paragraph 0031) which comprises a choline cation and a carboxylic anion paired with the choline cation (choline cation and carboxylic anion biomolecules/biocompatible organic molecules, Paragraph 0031), wherein the choline cation comprises choline bicarbonate (Paragraph 0031), and the carboxylic anion comprises at least one of acetate, propionate, malate, succinate, and maleate (Paragraph 0031).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to configure the ionic liquid in the electrode disclosed by Yadavalli et al. and Ackermann et al. in combination to comprise a choline cation and a carboxylic anion paired with the choline cation, wherein the choline cation comprises at least one of choline bicarbonate, choline hydroxide and choline chloride, and the carboxylic anion comprises at least one of acetate, propionate, glycolate, benzoate, tiglate, malate, succinate, tartrate, fumarate and maleate, as taught by Noshadi et al., in order to implement biomolecule/biocompatible organic molecule for the ionic liquid, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Yadavalli et al. (US Publication No. 2018/0355194) in view of Ackermann et al. (US Publication No. 2018/0280691), further in view of O’Brien et al. (US Patent No. 7,879,942).
Regarding Claim 7, Yadavalli et al. discloses a biocompatible, biomedical electrode (Abstract, Paragraph 0003, 0006, 0064) wherein the ion diffusion barrier (flex sheet/substrate, Figs. 1A-B; Paragraph 0033-0034, 0064, 0067) with functionalized interfaces (Paragraph 0019, 0065, 0068) which form covalent bonds (Paragraph 0065). However, neither Yadavalli et al. nor Ackermann et al. explicitly discloses wherein the ion diffusion barrier comprises a first interface functional group and a second interface functional group on a surface thereof, wherein the first interface functional group induces at least one of hydrogen and covalent bonds with the solid electrolyte, and the second interface functional group induces at least one of hydrogen and covalent bonds with nerve.
O’Brien et al. teaches a biomedical device including electrodes (Abstract; Col. 1, Lines 15-30) comprising a first interface functional group and a second interface functional group on a surface thereof (functional groups, Col. 2, Line 52 – Col. 4, Line 40), wherein the first interface functional group induces at hydrogen (hydrogen/“branch-inducing”, Col. 2, Line 52 – Col. 4, Line 40), and the second interface functional group induces hydrogen (hydrogen/“branch-inducing”, Col. 2, Line 52 – Col. 4, Line 40).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to configure the ion diffusion barrier in the electrode disclosed by Yadavalli et al. and Ackermann et al. in combination to comprise a first interface functional group and a second interface functional group on a surface thereof, wherein the first interface functional group induces at least one of hydrogen and covalent bonds with the solid electrolyte, and the second interface functional group induces at least one of hydrogen and covalent bonds with nerve, as taught by O’Brien et al., in order to provide a suitable ion diffusion barrier, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).
Conclusion
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/PAMELA M. BAYS/Primary Examiner, Art Unit 3796