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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 07/06/2026 has been entered.
Response to Amendment
The Amendments filed July 06, 2026 have been entered. Applicant’s amendments have overcome the 112(a) and 112(b) rejections previously set-forth in the Final Rejection mailed on 04/10/2026. Currently, claim 1 has been amended, claims 4 and 13-14 have been cancelled, claims 15-18 have been newly added, and claims 1-3, 6-12, 15-18 are pending in the application.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-3, 6-12, and 15-18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation, “a silicone rubber material forming the elastic portion” in lines 14-15. It is unclear to Examiner whether this silicone rubber material forming the elastic portion is the same as the silicone rubber of the elastic pillar portion already recited earlier in the claim, or if it is a different silicone rubber material. For examination purposes, Examiner will treat both silicone rubber material of the elastic pillar portion and the silicone rubber material of the conductive resin as the same, but separate/individual materials of the biomedical electrode. Claims 2-3, 6-12, and 15-18 are also rejected because they are dependent on claim 1.
Claim 2 recites, “the silicone rubber” in line 2. The recitation renders the scope of the claim as indefinite because it is unclear to Examiner whether this silicone rubber is the silicone rubber that forms the conductive resin layer or if it is the silicone rubber that that forms the elastic pillar portion as recited in claim 1. For examination purposes, Examiner will treat the silicone rubber of claim 2 as the silicone rubber of the conductive resin layer.
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, 7-12, and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Chi (U.S. Patent No. 9314183 B2), in view of Miyaji (J.P. Application No. 2017183328 A), and further in view of Kato (U.S. Application No. 20170081515 A1).
Regarding independent claim 1, Chi discloses a biomedical electrode (40) comprising:
a plate-shaped support portion (42) (Figs. 7-9);
an elastic pillar portion (44a-44f) that is provided on a first surface of the plate-shaped support portion (Col. 4, lines 24-32);
a conductive layer (i.e., conductive material that makes up transducer (57); Col. 5, lines 57-63) that is formed to cover a distal end of the pillar portion (Col. 4, lines 36-42);
wherein the elastic pillar portion is flexible over its entire body (the elastic pillar portion can be made from nylon or any other elastomer plastics that are flexible and bendable), and does not include a conductive filler (Col. 5, lines 47-50), and when a distal end portion including the distal end covered with the conductive layer comes into contact with a measurement portion (i.e., the user’s scalp) through the conductive layer, the elastic pillar portion is deformable (i.e., joint 54 is deformed/bend) in a state where it follows a shape of the measurement portion (Col. 4, lines 39-45);
However, Chi does not disclose the conductive layer being a conductive resin layer, nor the conductive resin layer being formed of a conductive silicone rubber comprising a conductive filler, a silicone rubber material that is the same as a silicone rubber material forming the elastic pillar portion, and silica particles, wherein the conductive filler includes one or more selected from the group consisting of metal particles, silver or silver chloride particles, metal fiber, metal-coated fiber, carbon black, acetylene black, graphite, carbon fiber, carbon nanotube, conductive polymer, conductive polymer-coated fiber, and metal nanowire. Finally, Chi does not disclose wherein the thickness of the conductive resin layer positioned at the distal end of the elastic pillar portion is 5 um or more and 200 um or less.
Miyaji, in the same field of endeavor, teaches a worn electronic device (100) (page 2, lines 2-3 under “Description”) comprising a substrate (20) (analogous to the elastic pillar portion of Chi) with a first elastomer, and a wiring (10) (analogous to the conductive layer of Chi) with a third elastomer and a conductive filler (page 3, lines 4-5 & Fig. 1), wherein the first elastomer and the third elastomer are made with the same silicone rubber-based curable composition (page 4, lines 11 and 14) due to its excellent stretchability, heat resistance, chemical stability, and biocompatibility properties (page 4, lines 6-8). The wiring includes a conductive resin composition including a combination of the third elastomer, the conductive filler (e.g., silver powder; page 10, lines 1-5, under “Conductive filler”), and silica particles as necessary in order to improve the hardness and mechanical strength of a cured product formed from the conductive resin composition (page 9, lines 1-4, under “Silica Particles (B)”). Lastly, the thickness of the conductive resin composition (i.e., the wiring) positioned at the distal end of the substrate is 100 μm or more in order to obtain high electrical conductivity (page 3, lines 5-8, bottom-up).
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 substituted the flexible and bendable material that makes up the elastic pillar portion of Chi with the silicone rubber-based curable composition taught by Miyaji due to its excellent stretchability, heat resistance, chemical stability, and biocompatibility properties (Miyaji, page 4, lines 6-8).
Furthermore, 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 substituted the conductive material that makes up the conductive layer of Chi with the conductive resin composition taught by Miyaji, which includes the same silicone rubber-based curable composition of the elastic pillar portion, the conductive filler, the silica particles, and the specific thickness in order to improve the hardness and mechanical strength of the cured product formed from the conductive resin composition and to achieve the necessary electrical conductivity (Miyaji, page 3, lines 5-8, bottom-up; page 9, lines 1-4, under “Silica Particles (B)”).
However, Chi/Miyaji combination are not explicit regarding when measured at 370C according to JIS K 6253 (1997), a type A durometer hardness of a surface of the elastic pillar portion is 15 or higher and 35 or lower.
Kato, in the same field of endeavor, teaches an addition-curable liquid silicone rubber composition that produces a low-hardness silicone rubber having a durometer A hardness after curing of from 5 to 40 (pa. 0008).
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 durometer hardness of the elastic pillar portion of Chi to be at the specific range taught by Kato for the purpose of allowing the elastic pillar portion to exhibit high elasticity to be conformed to non-uniform surfaces.
Regarding claim 7, Chi/Miyaji/Kato combination discloses the distal end of the elastic pillar portion has a substantially circular surface (Chi, see profile of distal end of 57, as shown in Fig. 7, illustrating a substantially circular surface).
Regarding claim 8, Chi/Miyaji/Kato combination discloses a plurality of elastic pillar portions (144a-44f) protrude from the first surface of the plate-shaped support portion (Chi, Col. 4, lines 24-32).
Regarding claim 9, Chi/Miyaji/Kato combination discloses the plurality of elastic pillar portions are arranged to surround a center portion of the plate-shaped support portion (Chi, See Fig. 7).
Regarding claim 10, Chi/Miyaji/Kato combination discloses the biomedical electrode is used as an electroencephalographic electrode (Chi, Col. 6, lines 16-19).
Regarding claim 11, Chi/Miyaji/Kato combination discloses a biomedical sensor comprising the biomedical electrode (Chi, Col. 1, lines 24-27).
Regarding claim 12, Chi/Miyaji/Kato combination discloses a biomedical signal measurement system comprising the biomedical sensor (Chi, Col. 2, lines 15-22).
Regarding claim 15, Chi/Kato combination discloses the invention substantially as claimed in claim 1 and discussed above.
However, they do not teach wherein the elastic pillar portion comprises a cured product of an insulating silicone rubber-based curable composition, and wherein the conductive resin layer comprises a cured product of a conductive silicone rubber-based curable composition in which the conductive filler is added to the insulating silicone rubber-based curable composition.
Miyaji, in the same field of endeavor, teaches a worn electronic device (100) (page 2, lines 2-3 under “Description”) comprising a substrate (20) (analogous to the elastic pillar portion of Chi) with a first elastomer, and a wiring (10) (analogous to the conductive layer of Chi) with a third elastomer and a conductive filler (page 3, lines 4-5 & Fig. 1), wherein the first elastomer and the third elastomer are made with the same silicone rubber-based curable composition (page 4, lines 11 and 14) due to its excellent stretchability, heat resistance, chemical stability, and biocompatibility properties (page 4, lines 6-8). The wiring includes a conductive resin composition including a combination of the third elastomer and the conductive filler (e.g., silver powder; page 10, lines 1-5 under “Conductive filler”).
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 substituted the flexible and bendable material that makes up the elastic pillar portion of Chi with the silicone rubber-based curable composition taught by Miyaji due to its excellent stretchability, heat resistance, chemical stability, and biocompatibility properties (Miyaji, page 4, lines 6-8).
Furthermore, 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 substituted the conductive material that makes up the conductive layer of Chi with the conductive resin composition taught by Miyaji, which includes the same silicone rubber-based curable composition of the elastic pillar portion and the conductive filler due to its high conductivity properties.
Regarding claim 16, Chi/Kato combination discloses the invention substantially as claimed in claims 1 and 15 and discussed above.
However, they do not teach wherein the insulating silicone rubber-based curable composition comprises a vinyl group-containing organopolysiloxane (A), an organohydrogen polysiloxane (B), silica particles (C) and a silane coupling agent (D).
Miyaji, in the same field of endeavor, teaches the silicone rubber-based curable composition contains silicone rubber as the elastomer, wherein the silicone rubber is obtained by crosslinking a vinyl group-containing linear organopolysiloxane (A-1) with an organohydrogenpolysiloxane (A-2) (page 4, lines 1-4, under “Elastomer (A)”). The silicone rubber-based curable composition also contains silica particles (B) to improve the hardness and mechanical strength of the cured product formed from the silicone rubber-based curable composition (page 9, lines 1-4, under “Silica particles (B)”) and a silane coupling agent (C) in order to further improve the mechanical strength of the cured product (page 7, lines 1-9, under “Silane coupling agent (C)”).
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 substituted the flexible and bendable material that makes up the elastic pillar portion of Chi with the silicone rubber-based curable composition taught by Miyaji, including the vinyl group-containing organopolysiloxane, the organohydrogen polysiloxane, the silica particles, and the silane coupling agent due to its excellent stretchability, mechanical strength, chemical stability, and biocompatibility properties (Miyaji, page 4, lines 6-8).
Regarding claim 17, Chi/Kato combination discloses the invention substantially as claimed in claims 1 and 16 and discussed above.
However, they do not teach wherein the vinyl group-containing organopolysiloxane (A) comprises a first vinyl group-containing linear organopolysiloxane having a vinyl group content of 0.4 mol% or lower, and a second vinyl group-containing linear organopolysiloxane having a vinyl group content of 0.5 mol% to 15 mol%.
Miyaji, in the same field of endeavor, teaches the vinyl group-containing linear organopolysiloxane (A-1) as described above has two or more vinyl groups in the molecule, and the vinyl group content is 0.2 mol% or less. The first vinyl group-containing linear organopolysiloxane (A-1 (a)) preferably has a vinyl group content of 0.01 to 0.15 mol%, and the second vinyl group-containing linear organopolysiloxane (A-1 (b)) preferably has a vinyl group content of 0.28 to 12 mol% in order to produce a more effective crosslink density in the crosslinked network of silicone rubber which yields an increased tear strength and durability of the cured product of the silicone rubber-based curable composition (page 5, lines 3-13).
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 substituted the flexible and bendable material that makes up the elastic pillar portion of Chi with the silicone rubber-based curable composition taught by Miyaji, including the mol% of the first and second vinyl group-containing groups in order to produce a more effective crosslink density in the crosslinked network of silicone rubber which yields an increased tear strength and durability of the cured product of the silicone rubber-based curable composition (Miyaji, page 5, lines 3-13).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Chi, Miyaji, and Kato as applied to claim 1 above, and further in view of Kwon (U.S. Patent No. 10588569 B2).
Regarding claim 2, Chi/Kato combination discloses the invention substantially as claimed in claim 1 and discussed above.
Miyaji teaches the content of the elastomer (A) in the silicone rubber-based curable composition is preferably 95% by mass or less based on the entire solid content of the silicone rubber-based curable composition (page 7, lines 10-11).
However, they do not disclose the content of the conductive filler is 1 vol% or higher and 45 vol% or lower.
Kwon, in the same field of endeavor, teaches a conductive layer formed from a conductive filler (e.g., silver) (Col. 4, lines 17-31) that is 1 vol% or higher and 45 vol% or lower (Col. 6, lines 1-10) with respect to 100 vol% of a silicone rubber (Col. 7, lines 2-7). If the content of the conductive filler is too small, the electrical conductivity may be insufficient, and if the content of the conductive filler is too large, the stretchability of the conductive layer tends to decrease (Col. 6, lines 1-10).
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 volume percent of the conductive material to be the specific percentage volumes of the conductive filler and the silicone rubber taught by Kwon, for the purpose of providing increased conductivity, increased stability in high and low temperatures, and prevent cracks.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Chi, Miyaji, and Kato as applied to claim 1 above, and further in view of Pushpala (U.S. Application No. 20170128009 A1).
Regarding claim 3, Chi/Miyaji/Kato combination discloses the biomedical electrode containing conductive coating over varying parts of its structure (Chi, Col. 5, lines 50-63), and the invention substantially as claimed in claim 1 discussed above.
However, they do not disclose wherein the conductive layer is configured to cover a second surface of the plate-shaped support portion opposite to the first surface, and a thickness of the conductive resin layer positioned at the distal end of the elastic pillar portion is more than a thickness of the conductive resin layer positioned on the second surface of the plate-shaped support portion.
Pushpala, in the same field of endeavor, teaches a biomedical electrode (300) comprising a plate-shape portion (see planar portion seen in Fig. 2A), and a pillar portion (120) (pa. 0095 & Figs. 2A, 11A), wherein a conductive layer (140) is formed to cover a distal end of the pillar portion (pa. 0032), and is also configured to cover a second surface of the plate-shaped support portion opposite to the first surface (pa. 0033 & Fig. 2A), and a thickness of the conductive resin layer positioned at the distal end of the elastic pillar portion and a thickness of the conductive layer positioned on the second surface of the plate-shaped support portion are non-uniform manner, such that some regions of the conductive layer are thicker than others (pa. 0059 & Figs. 8A-8C).
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 thickness of the conductive resin layer for the purpose of further facilitating high quality signal sensing.
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 added a conductive resin layer to cover a second surface of the plate-shaped support portion opposite to the first surface for the purpose of increasing the conductive surface area that contact’s the user.
Furthermore, 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 thickness of the conductive resin layer so that the thickness of the conductive resin layer positioned at the distal end of the elastic pillar portion is more than the thickness of the conductive resin layer positioned on the second surface of the plate-shaped support portion given that thickness proportions can be modified in a finite number of ways and it would have been obvious to try modify the thickness of different portions of the conductive resin layer for the purpose of further facilitating high quality signal sensing.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Chi, Miyaji, and Kato, as applied to claim 1 above, and further in view of Nishiwaki (W.O. Application No. 2016136182 A1).
Regarding claim 6, Chi/Miyaji/Kato combination discloses wherein the elastic pillar portion may be configured to have different shapes (Chi, see the two embodiments of Figs. 7 and 10).
However, they do not explicitly disclose the elastic pillar portion has a substantially truncated conical shape of which a diameter decreases toward the distal end.
Nishiwaki, in the same field of endeavor, teaches a biomedical electrode comprising a plurality of barb members (4, analogous to the elastic pillar portions), wherein the barb members are configured so that the diameter is smaller (tapered) as more moving from the proximal end to the distal end (pa. 0020, 0021 & Fig. 3).
It would have been an obvious matter of design choice to one having ordinary skill in the art at before the effective filing date of the claimed invention to modified the distal end shape of the elastic pillar portions of Chi to be tapered, since it appears that the invention would perform equally as well with either configuration and they both yield the same predictable results of parting the user’s hair in order to properly contact the scalp.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Chi, Miyaji, and Kato, as applied to claim 1 above, and further in view of Okada (U.S. Patent No. 9562158 B2).
Regarding claim 18, Chi/Miyaji/Kato combination discloses the invention substantially as claimed in claims 1 and 16 and discussed above.
However, they do not teach wherein the silane coupling agent (D) comprises a silane coupling agent having a trimethylsilyl group and a silane coupling agent having a vinyl group-containing organosilyl group.
Okada, in the same field of endeavor, teaches a silicone rubber-based hardening composition includes a linear organopolysiloxane having a vinyl group (A), an organohydrogen polysiloxane (B), and a silica filler (C) of which surface is treated with a silane coupling agent having a trimethylsilyl group (abstract) and can be further treated with a silane coupling agent having an organosilyl group containing a vinyl group (Col. 17, lines 41-46).
It would have been an obvious matter of design choice to one having ordinary skill in the art at before the effective filing date of the claimed invention to modified the silane coupling agent to include a silane coupling agent having a trimethylsilyl group and a silane coupling agent having a vinyl group-containing organosilyl group, as taught by Okada, for the purpose of providing exceptional hydrophobicity, high thermal stability, and efficient polymer crosslinking capabilities.
Response to Arguments
Applicant’s arguments, see pages 7-12, filed 07/06/2026, with respect to the 103 rejection of claim 1 under Chi, Kwon, and Boock combination have been fully considered and are persuasive. Specifically, Applicant’s amendments to claim 1 to further require the biomedical electrode to comprise the specific structural and material relationship between the silicone rubber of the elastic pillar portion and the elastic rubber of the conductive resin layer is defined over Chi, Kwon, and Boock given that they do not contemplate this claimed structure. Therefore, the rejection has been withdrawn. However, upon further consideration, the following new grounds of rejection have been set forth in the action above:
Claims 1, 7-12, and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Chi (U.S. Patent No. 9314183 B2), in view of Miyaji (J.P. Application No. 2017183328 A), and further in view of Kato (U.S. Application No. 20170081515 A1).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Chi, Miyaji, and Kato as applied to claim 1 above, and further in view of Kwon (U.S. Patent No. 10588569 B2).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Chi, Miyaji, and Kato as applied to claim 1 above, and further in view of Pushpala (U.S. Application No. 20170128009 A1).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Chi, Miyaji, and Kato, as applied to claim 1 above, and further in view of Nishiwaki (W.O. Application No. 2016136182 A1).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Chi, Miyaji, and Kato, as applied to claim 1 above, and further in view of Okada (U.S. Patent No. 9562158 B2).
It is the Examiner’s position that the newly filed rejections based on the combination of references are tenable for at least the reasonings set forth in the action above.
Conclusion
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/A.V.G./Examiner, Art Unit 3794 /Ronald Hupczey, Jr./Primary Examiner, Art Unit 3794
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