DETAILED ACTION
This action is pursuant to claims filed on June 3, 2026. Claims 1, 3, 5-16 and 19-22 are pending. Claims 2, 4, and 17-18 is/are canceled. A final action on the merits of claims 1, 3, 5-16 and 19-22 is as follows.
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 . 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 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.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 19 is rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Hatakeyama (U.S. PGPub. No. 2019/0298891).
In regards to independent claim 19, Hatakeyama discloses an electrically conductive material (living body contact layer 2 in Figs. 1-2) formed from polymer particles (resin (B) containing silicone resin, [0032], [0102], [0143]), an electrical conductor (carbon material 5 comprising carbon black, carbon nanotube, [0036], [0038], [0143]), and an ionic conductor (ionic material (salt) A, [0143]). The examiner notes that the limitation “the electrically conductive material being impregnated within a foam or textile substrate” in claim 19 is directed to the electrically conductive material being used on an article such as a foam or textile substrate in its intended use. Hatakeyama discloses that the electrically conductive material is applied to a textile substrate ([0141]: the electro-conductive base material 2 may be a cloth with electro-conductive polymer kneaded; the cloth can be a mesh-form of woven metal wires) and cured ([0150]). In other words, the electrically conductive material is capable of partially impregnating through the surface of the mesh form of woven metal wires before curing.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claim 1, 3, 5-8, and 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Hatakeyama (U.S. PGPub. No. 2019/0298891, and further in view of Dong (CN 105233404).
In regards to independent claim 1, Hatakeyama discloses a composite material (bio-electrode 1 in Figs. 1-2), comprising:
a textile or foam substate that is not electrically conductive (an electro-conductive base material 2 in Fig. 1; [0141]: the electro-conductive base material may be a cloth with the surface being coated with electro-conductive paste, or a cloth into which electro-conductive polymer is kneaded; note that the cloth, which is a type of textile, is not electrically conductive prior to coating or kneading conductive paste or polymer); and
an electrically conductive material (living body contact layer 2 in Figs. 1-2) formed from polymer particles (resin (B) containing silicone resin, [0032], [0102], [0143]), an electrical conductor (carbon material 5 comprising carbon black, carbon nanotube, [0036], [0038], [0143]), and an ionic conductor (ionic material (salt) A, [0143]) being disposed on the textile or foam substrate (Fig. 1: electro-conductive base material 2 and the living body contact layer 3 is disposed over the electro-conductive base material 2, [0135]-[0136], [0138]-[0141]).
However, Hatakeyama does not disclose an adhesive layer disposed between the textile or foam substrate and the electrically conductive material.
Dong teaches the concept of providing a thin adhesive film (film 2 in Fig. 1) between a silver cloth (layer 1 in Fig. 1) and a composite material (layer 3) to enhance adhesion of the silver cloth and the composite layer. In addition, Dong discloses that the adhesive film aids in solidifying and reducing the loss of conductivity and wear and tear of the silver cloth due to multiple washings ([0030]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify an appropriate adhesive film between the textile or foam substrate and the electrically conductive material of Hatakeyama, so that the adhesive film protects the textile of Hatakeyama from loss of conductivity and wear and tear during use and multiple washings ([0030]).
The Examiner notes that the concept of connecting conductive elements such as one or more contact pads using conductive adhesive is also known in the art as evidenced by Rogers et al. (U.S. PGPub. No. 2011/0230747, [0025]: an adhesive layer provided between the electronic device and the bioresorbable substrate, barrier layer and/or the biocompatible layer. Useful adhesive layers for bonding comprise a polymer, an elastomer (e.g. PDMS), a prepolymer, a thin metal layer, a silk layer, etc.) and would have been obvious in light of Hatakeyama/Dong combination so that the thin adhesive layer operates as intended to provide electrical coupling between the textile or foam substrate and the electrically conductive material of Hatakeyama.
In regards to claim 3, Hatakeyama/Dong combination further discloses the electrically conductive layer comprises a border around a perimeter of a major surface of the electrically conductive layer (the bioelectrode 1 comprises the rectangular major shaped perimeter; note that the surface of the base layer 2 is around or faced in the opposite direction of the living body contact layer 2 in Figs. 1-2).
In regards to claim 5, Hatakeyama/Dong combination further discloses wherein the polymer particles comprises acrylonitrile butadiene rubber (NBR), natural rubber, silicone, silicone acrylic, polyurethane, polyvinylidene fluoride, polyvinylidene chloride, or a fluoropolymer (resin (B) is polyurethane silicone resin, [0032], [0102], [0143]).
In regards to claim 6, Hatakeyama further discloses wherein the electrical conductor comprises carbon nanotubes, graphene or graphite structures, metal nanowires, and combinations thereof (carbon material 5 comprising carbon black, carbon nanotube, [0036], [0038], [0143]).
In regards to claim 7, Hatakeyama further discloses wherein the ionic conductor comprises glycosaminoglycans, fluorosulfonic acids, sulfated polysaccharides, phosphonic polyvinylsulfonic acids, graphene oxide, modified graphene oxide, and combinations thereof ([0022]: component A comprises fluorosulfonic acid).
In regards to claim 8, Hatakeyama further discloses wherein a mass ratio of the ionic conductor to the electrical conductor is from 0.5 to 10 ([0093]-[0094]: component A (ionic conductor) is 0.5 to 300 parts by mass on a basis of 100 parts by mass of the component B (electrical conductor)).
In regards to claim 10, Hatakeyama further discloses wherein the electrically conductive material further comprises an adhesive or a dispersant ([0059]: urethane base adhesive).
In regards to claim 11, Hatakeyama further discloses wherein the textile or foam substrate comprises cheesecloth, cotton, a polymer, a woven fabric, or a non-woven fabric, or wherein the textile or foam substrate is an open-cell foam (a cloth is a type of either woven or non-woven fabric [0135]-[0136], [0138]-[0141]).
In regards to claim 12, Hatakeyama further discloses wherein the electrical conductors are aligned to obtain anisotropic conductivity (carbon material 5 comprising carbon black, carbon nanotube aligned along the plane of the electrode 1, [0036], [0038], [0143]; note that carbon nanotubes exhibit a strong anisotropic property in the direction of the CNTs compared to other directions).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Hatakeyama and Dong as applied to claim 1 above, and further in view of Hatakeyama et al. (hereinafter ‘Hatakeyama ‘569’, U.S. PGPub. No. 2022/0110569), and further in view of Green et al. (U.S. Pat. No. 6,919,076).
In regards to independent claim 9, Hatakeyama/Dong combination discloses the invention substantially as claimed in claim 1 and discussed above. Hatakeyama further discloses wherein the electrical conductor comprises carbon nanotubes (carbon material 5 comprising carbon black, carbon nanotube, [0036], [0038], [0143]).
However, Hatakeyama/Dong combination does not disclose wherein the ionic conductor comprises a moisturizing agent.
Hatakeyama ‘569 teaches a bio-electrode composition similar to that of Hatakeyama. Hatakeyma ‘569 further teaches providing additives to provide excellent moisture-holding property such as polyglycerine structure which has high hygroscopicity ([0018]) as doing so is capable of exhibiting more excellent moisture-holding property, and consequently more excellent sensitivity to ions released from skin ([0041]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to provide an additive to provide excellent moisture holding property ([0018]).
However, Hatakeyama/Hatakeyama ‘569 combination does not disclose wherein the the moisturizing agent is glycosaminoglycan.
Green teaches that humectant for moisturizing agents include polyglycerin or substitutes of polyglycerin including hydrolyzed glycosaminoglycans (col. 22, ln.62 – col. 23, ln. 47). Therefore, it would have been obvious to one having ordinary skill in the art at before the effective filing date of the invention to substitute polyglycerin with glycosaminoglycan since the equivalence of one humectant for moisturizing agent with another and the selection of any one of these known equivalents would be within the level of ordinary skill in the art.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Hatakeyama and Dong as applied to claim 1 above.
In regards to claim 13, Hatakeyama/Dong combination discloses substantially all the limitations of the claim(s) except wherein the composite material is in the form of a sleeve or wherein the composite material is in the form of a sheet having a length of at least 10 cm x 10 cm.
It would have been an obvious matter of design choice to one having ordinary skill in the art before the effective filing date of the invention to modify the design or size of the composite material of Hatakeyama for its purpose of positioning the electrode material against a living body, since applicant has not disclosed that the shape or size solves any stated problem or is for any particular purpose other than to accommodate the shape and size of the composite material for its intended use of placing it against a desired portion of the living body.
Claims 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over King et al. (hereinafter ‘King’, U.S. PGPub. No. 2020/0323491), in view of Hatakeyama, and further in view of Dong.
In regards to independent claim 14, King discloses a garment (a textile garment 100 in Fig. 1A-1B) comprising: a first textile layer (single textile layer 110 to be worn directly against the skin) having a plurality of electrodes attached thereto (a plurality of electrodes 130 disposed on the textile layer 110).
However, King does not disclose a composite material attached to the first textile layer, the composite material comprising: an electrically conductive material formed from polymer particles, an electrical conductor, and an ionic conductor, the electrically conductive material being disposed on the textile or foam substrate; wherein the composite material covers the electrodes of the plurality of electrodes.
Hatakeyama teaches providing an electrically conductive material (living body contact layer 2 in Figs. 1-2) formed from polymer particles (resin (B) containing silicone resin, [0032], [0102], [0143]), an electrical conductor (carbon material 5 comprising carbon black, carbon nanotube, [0036], [0038], [0143]), and an ionic conductor (ionic material (salt) A, [0143]). Hatakeyama discloses that the electrically conductive material is applied to a textile substrate that is not electrically conductive ([0141]: the electro-conductive base material may be a cloth with the surface being coated with electro-conductive paste, or a cloth into which electro-conductive polymer is kneaded; note that the cloth, which is a type of textile, is not electrically conductive prior to coating or kneading conductive paste or polymer) and cured ([0150]). Hatakeyama explains that the electrically conductive material covering the conductive cloth enhances adhesion with excellent electric conductivity, free from risk of causing allergies even when it is worn on skin for a long time ([0050]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the plurality of electrodes of King and incorporate the electrically conductive material on the electrodes as taught by Hatakeyama, as doing so provides excellent electric conductivity during wet or dried conditions, reduces allergic risks and effective adhesion to the skin of the wearer ([0050]).
However, Hatakeyama does not disclose an adhesive layer disposed between the textile or foam substrate and the electrically conductive material.
Dong teaches the concept of providing a thin adhesive film (film 2 in Fig. 1) between a silver cloth (layer 1 in Fig. 1) and a composite material (layer 3) to enhance adhesion of the silver cloth and the composite layer. In addition, Dong discloses that the adhesive film aids in solidifying and reducing the loss of conductivity and wear and tear of the silver cloth due to multiple washings ([0030]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify an appropriate adhesive film between the textile or foam substrate and the electrically conductive material of Hatakeyama, so that the adhesive film protects the textile of Hatakeyama from loss of conductivity and wear and tear during use and multiple washings ([0030]).
The Examiner notes that the concept of connecting conductive elements such as one or more contact pads using conductive adhesive is also known in the art as evidenced by Rogers et al. (U.S. PGPub. No. 2011/0230747, [0025]: an adhesive layer provided between the electronic device and the bioresorbable substrate, barrier layer and/or the biocompatible layer. Useful adhesive layers for bonding comprise a polymer, an elastomer (e.g. PDMS), a prepolymer, a thin metal layer, a silk layer, etc.) and would have been obvious in light of Hatakeyama/Dong combination so that the thin adhesive layer operates as intended to provide electrical coupling between the textile or foam substrate and the electrically conductive material of Hatakeyama.
In regards to claim 15, in view of the combination in claim 14 above, although King/Hatayama combination is silent as to the composite attached to the first textile layer is by an adhesive, or by sewing, or by a hook and loop fastener, it would have been obvious to one of ordinary skill in the art to attach the conductive material of Hatakeyama to the electrodes of King via any of the claimed methods as doing so is merely one of several possibilities from which one of ordinary skill in the art would select to generally attach two layers.
In regards to claim 16, King/Hakeyama combination further discloses the garment having a form factor of a sleeve, vest or a skullcap (Fig. 1A shows a sleeveless shirt which is considered a vest).
Claims 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over King et al. (hereinafter ‘King’, U.S. PGPub. No. 2020/0323491), in view of Hatakeyama.
In regards to independent claim 20, King discloses a garment (a textile garment 100 in Fig. 1A-1B) comprising: a first textile layer (single textile layer 110 to be worn directly against the skin) having a plurality of electrodes attached thereto (a plurality of electrodes 130 disposed on the textile layer 110).
However, King fails to disclose the electrically conductive material of claim 19 attached to the first textile layer; wherein the electrically conductive material covers the electrodes of the plurality of electrodes.
Hatakeyama teaches providing an electrically conductive material (living body contact layer 2 in Figs. 1-2) formed from polymer particles (resin (B) containing silicone resin, [0032], [0102], [0143]), an electrical conductor (carbon material 5 comprising carbon black, carbon nanotube, [0036], [0038], [0143]), and an ionic conductor (ionic material (salt) A, [0143]). Hatakeyama discloses that the electrically conductive material is applied to a textile substrate ([0141]: the electro-conductive base material may be a cloth with the surface being coated with electro-conductive paste, or a cloth into which electro-conductive polymer is kneaded; note that the cloth, which is a type of textile, is not electrically conductive prior to coating or kneading conductive paste or polymer) and cured ([0150]). In other words, the electrically conductive material being partially impregnating through the surface of the cloth before curing. Hatakeyama explains that the electrically conductive material covering the conductive cloth enhances adhesion with excellent electric conductivity, free from risk of causing allergies even when it is worn on skin for a long time ([0050]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the plurality of electrodes of King and incorporate the electrically conductive material on the electrodes as taught by Hatakeyama, as doing so provides excellent electric conductivity during wet or dried conditions, reduces allergic risks and effective adhesion to the skin of the wearer ([0050]).
In regards to claim 21, given that the claim does not necessarily recite how the thickness effectively avoids electrical conduction between neighboring electrodes through the composite material, it is the examiner’s position that since the composite material are spaced apart from each other, the spacing inherently avoids electrical conduction between neighboring electrodes.
In regards to claim 22, in view of the combination in claim 14, Hatakeyama’s conductive material (conductive base 2 and living body contact layer 2 in Figs. 1-2) is a second ply, and King’s garment comprising the first textile layer is the first ply (garment material 110 in Fig. 1A of King). Since the modified electrodes are disposed on the first ply and the conductive material is disposed on the electrodes, the electrodes are disposed between the first ply (garment material 110) and the second ply (the conductive material).
Response to Arguments
Applicant’s arguments filed on June 3, 2026 have been fully considered.
With respect to independent claims 1 and 14, Applicant argues that Hatakeyama fails to disclose, teach, or suggest, in part, “an adhesive layer disposed between the textile or foam substrate and the electrically conductive material” is persuasive. Therefore, the rejection of claims 1-8 and 10-12 has been withdrawn.
Upon an updated search, Dong (CN 105233404) teaches the concept of providing a thin adhesive film (film 2 in Fig. 1) between a silver cloth (layer 1 in Fig. 1) and a composite material (layer 3) to enhance adhesion of the silver cloth and the composite layer. In addition, Dong discloses that the adhesive film aids in solidifying and reducing the loss of conductivity and wear and tear of the silver cloth due to multiple washings ([0030]).
In addition, the concept of connecting conductive elements such as one or more contact pads using conductive adhesive is known in the art as evidenced by Rogers et al. (U.S. PGPub. No. 2011/0230747, [0025]). Taken together, it would have been obvious to provide an adhesive layer between the textile or foam substrate and the electrically conductive material to reduce the loss of conductivity and wear and tear of the textile during multiple washings while providing the electrical connection between the textile and the electrically conductive material.
With respect to independent claim 19, Applicant argues that Hatakeyama does not disclose, teach, or suggest, in part “the electrically conductive material being impregnated within a foam or textile substrate” since the electrically conductive material [conductive base material 2] is a woven metal. However, this argument is unpersuasive as a textile by definition is a woven material. In addition, Hatakeyama discloses that the electro-conductive base material can also be a cloth [a textile] into which electrode-conductive polymer is kneaded or the like ([0141]). Therefore, it is the Examiner’s position that Hatakeyama discloses a textile and the argument is unpersuasive.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 EUNHWA KIM whose telephone number is (571)270-1265. The examiner can normally be reached 9AM-5:30PM.
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/EUN HWA KIM/Primary Examiner, Art Unit 3794 7/1/2026