DETAILED ACTION
This action is pursuant to the claims filed on 12/23/2025. Claims 1-2 and 4-7 are pending. A first action on the merits of claims 1-2 and 4-7 is as follows.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/23/2025 has been entered.
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, 4, and 6-7 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 second sheet member that openably closes the opening as a check valve … and the second sheet member is configured to function as a check valve”. It is unclear if the second occurrence of “a check valve” is intended to claim antecedent basis to the first occurrence of the term. For examination purposes, this limitation will be interpreted as “the check valve”.
Claim 4 line 11 recites the limitation “a substrate is located between the exposed to on a side contacting the living body water-absorbent gel layer and the hydrophilic gel layer”. The limitation “between the exposed to on a side contacting the living body layer…” is indefinite. The metes and bounds of this claim are unclear. For examination purposes, this limitation will be interpreted as the substrate being located between the living body water-absorbent gel layer and the hydrophilic gel layer.
Claim 6 recites the limitation "the water release member main body" in line 14. There is insufficient antecedent basis for this limitation in the claim. For examination purposes this limitation will be interpreted as the waterproof member main body. Claim 7 inherits this deficiency.
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(s) 6-7 is/are rejected under 35 U.S.C. 102(a)(1) or (a)(2) as being anticipated by Ginestet (U.S. PGPub No. 2021/0259634).
Regarding claims 6-7, Ginestet teaches A bioelectrode comprising an electrode portion that acquires an electric signal of a living body or outputs an electric signal to the living body (see Figs 5-6), the bioelectrode comprising a first terminal portion including two or more pole terminals that input or output the electric signal in the electrode portion to an outside (Figs 6-7 [0113] connection to battery 320 and electrodes 340), the bioelectrode further comprising a waterproof member that waterproofs, in a state where the first terminal portion is connected to a second terminal portion of a biosignal processor (Fig 7 pogo pins 430 of circuit board 400 and corresponding terminals in cradle 325 shown in Fig 6 and 15), a connection portion at least between the first and second terminal portions (Fig 7 and [0113], bottom part 410, gasket 440, and top part 420 provides a water proof cover for circuit board 400, pogo pins 430 and corresponding connection to battery 320 and electrodes 340), wherein the waterproof member is formed from a waterproof member main body as a lower container and a lid member engaged with the water release member main body (Fig 7, bottom part 410 is waterproof member main body engaged with lid member 420), includes a housing space for the biosignal processor (Fig 7 cover houses circuit board 400; [0114] disclosing circuit board 400 includes processor and memory components), and the first and second terminal portions exist in the housing space (Fig 6-7 and 15, pogo pins 430 and corresponding second terminal portions exist within housing space defined by cradle 325 and housing 400); the waterproof member main body and the lid member are engaged in a state where a waterproof property is secured so that water does not enter a defined internal space (Fig 7, reusable component 220 is waterproofed when lid members 420/410 are engaged), and a groove that receives a protrusion formed on a side wall surface of the biosignal processor is formed around an inner surface of a side wall of the waterproof member main body (see modified Fig 7 below, lower part 410 has multiple grooves on an interior surface that receives various protrusions of circuit board 400; for example, the corners of circuit board 400 are protrusions received within grooves created by bottom and side surfaces of lower lid 410; grooves of bottom lid 410 receive pogo pins 410 and gasket 430, an outward protrusion on side wall of lower lid 410 forms a groove that holds protruding side wall of circuit board 400 in place); wherein the waterproof member waterproofs and defines a housing space that houses the biosignal processor (Fig 7, circuit board 400 is encased in housing).
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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.
Claim(s) 1 is/are rejected under 35 U.S.C. 103 as being unpatentable over Li (U.S. PGPub No. 2016/0317057) in view of Libbus (U.S. PGPub No. 2009/0076364).
Regarding claim 1, Li teaches A bioelectrode (see Figs 2-3) comprising an electrode portion that acquires an electric signal of a living body or outputs an electric signal to the living body (see Figs 2-3), wherein the electrode portion is provided with an electrolyte layer that is configured to be in close contact with the living body (Figs 2-3 and [0038], layer of conductive gel applied to lower electrode layer 232), the electrode portion is provided with a sheet-like cover member that covers at least a part or all of a surface of the electrolyte layer on a side configured to not be in close contact with the living body (Figs 2-3, electrode layer 220 covers a part or all of a surface of conductive gel layer), the cover member is formed from a first sheet member having a waterproof property (Fig 3, substrate 225 of cover member comprises silicone as disclosed in [0035] which is a known waterproof material), an opening that penetrates in a thickness direction is provided in a region of the cover member covering the electrolyte layer (Figs 2-3, opening 235); and a second sheet member that openably closes the opening as a check valve is provided and integrated with an adhesive or by welding on an outer surface of the cover member (Figs 2-3, adhesive layer 250 adheres the elastic layer 210 closes opening 235 and covers the electrode layer 220; [0037] discloses breathability of electrode layer 220 and elastic layer 210, such that the elastic layer 210 “openably closes” the openings 235 of electrode layer 220); and the second sheet member is configured to release a moisture from the electrolyte layer ([0037] “The elastic layer 210 and the shearable electrode layer 220 are also breathable to allow aspiration and moisture from the skin to be released to the environment”)
Li fails to teach wherein the sheet member is configured to function as a check valve for a moisture transfer to prevent a moisture entry into the electrolyte layer.
In related prior art, Libbus teaches a similar device comprising a similar sheet member configured to function as a check valve for a moisture transfer to prevent a moisture entry into the electrolyte layer and release a moisture from the electrolyte layer ([0088-0089] gel cover 180 is a functional check valve to allow moisture to exit while keeping external moisture out). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Li in view of Libbus to incorporate the gel cover of Libbus to arrive at claim 1. Doing so would advantageously enable the device to remain breathable to allow moisture to exit the device from the gel layer while simultaneously advantageously keeping the device water resistant from external moisture ([0088-0089]).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Li in view of Ylotalo (U.S. PGPub No. 2012/0209102), and in further view of Libbus.
Regarding claim 2, Li teaches A bioelectrode comprising an electrode portion that acquires an electric signal of a living body or outputs an electric signal to the living body (Fig 3 electrode 200 with electrode portion 220), wherein the electrode portion comprising a conductive material on a substrate (Fig 3, substrate 225 with conductive materials 231/232 attached thereon; Li is silent to how the conductive materials 231/232 are provided on the substrate 225) and an electrolyte layer that is configured to be in close contact with the living body ([0038] layer of conductive gel can be applied to electrode layer 232 on side of substrate 225 where layer 232 is applied), and the substrate is provided with an opening that penetrates in a thickness direction in a region of the substrate where the electrode layer and a conductive layer are not formed (Fig 3 opening 235); the electrode portion is provided with a sheet-like cover member that covers at least a part or all of a surface of the electrolyte layer on a side configured to not be in close contact with the living body (Figs 2-3, adhesive layer and elastic layer 250/210), an opening that penetrates in a thickness direction is provided in a region of the cover member covering the electrolyte layer (Fig 3 openings 255/215), the opening provided in the cover member is provided at a position not facing the opening formed in the substrate (See Figs 2-3, openings are in different positions).
Li fails to teach the conductive material of the electrode portions is laminated on to the substrate.
In related prior art, Ylotalo discloses a similar device wherein similar layers may be attached to a substrate sheet by adhesive, printing, or laminating as is known in the art ([0031]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the conductive materials of the electrode portion of Li in view of Ylotalo to incorporate the conductive materials as laminated on the substrate. Doing so would be obvious to one of ordinary skill in the art as laminating is a well-known method for attaching two distinct layers together to yield the predictable result of providing the two layers as a securely connected multi-layered product.
Li fails to teach a cloth is provided on the cover member on a side configured to contact the living body, located between the substrate and the cover member, and configured to suppress a leakage of an electrolyte and enable a moisture transfer between the opening of the cover member and the opening of the substrate.
In related prior art, Libbus teaches a similar device comprising a similar a cloth is provided on the cover member on a side configured to contact the living body, located between the substrate and the cover member, and configured to suppress a leakage of an electrolyte and enable a moisture transfer between the opening of the cover member and the opening of the substrate ([0037-0038] breathable tape 110T and gel cover 180 function to suppress leakage of the hydrogel; [0038] breathable tape is a tricot-knit polyester fabric; examiner notes a knit material is reasonably interpreted as a ‘cloth’ as claimed). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Li in view of Ylotalo and Libbus to incorporate a water resistant, breathable cloth material on a skin side between the elastic layer 210 and substrate 225 of Li to arrive at claim 2. Doing so would advantageously enable the device to remain breathable to allow moisture to exit the device from the gel layer while simultaneously advantageously keeping the device water resistant from external moisture and suppressing leakage of the internal hydrogel ([0088-0089]).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Li in view of Dunagan (U.S. PGPub No. 2011/0130640), Holzhacker (U.S. PGPub No. 2011/0288393), and in further view of Ylotalo.
Regarding claim 4, Li teaches A bioelectrode comprising an electrode portion that acquires an electric signal of a living body or outputs an electric signal to the living body (Fig 3 electrode 200 with electrode portion 220), wherein the electrode portion is provided with an electrolyte layer that is configured to be in close contact with the living body ([0038] layer of conductive gel can be applied to electrode layer 232); a water-absorbent gel layer formed of a gel having water absorbency ([0038] layer of conductive hydrogel is necessarily water absorbent)
Li fails to teach a substrate is located between two gel layers; and the gel layers are in close contact with each other in an opening provided in the substrate to maintain an integrity.
In related prior art, Holzhacker teaches a substrate is located between two gel layers; and the two gel layers are in close contact with each other in an opening provided in the substrate to maintain an integrity (Figs 5-6, gel layers 54a and 54b with mesh substrate 54c therebetween with an opening to maintain integrity). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the hydrogel of Li in view of Holzhacker to incorporate the two gel layers with a substrate therebetween having an opening provided in the substrate such that the gel layers are in close contact in said opening. Doing so would be a simple substitution of one well-known hydrogel layer configuration (Li, Fig 3 disclosing a single hydrogel layer applied at lower surface 232) for another well-known hydrogel layer configuration (Holzhacker, Fig 6, disclosing two hydrogel layers 54a-b with a substrate with an opening therebetween) to yield the predictable result of sensing and transmitting physiological signals from a subject.
Li/Holzhacker fails to teach wherein the first gel layer is a water-absorbent gel layer formed of a gel having water absorbency, and the second gel layer is a hydrophilic gel layer formed of a gel having hydrophilicity in a part or all of a region.
In related prior art, Dunagan teaches a similar device wherein at least the electrolyte layer is formed by a water-absorbent gel layer formed of a gel having water absorbency and a hydrophilic gel layer formed of a gel having hydrophilicity in a part or all of a region (Fig 1B, hydrogel 104 and hydrogel 108; [0040] disclosing hydrogel 104 comprising cloth or gauze material (i.e., water absorbent); [0046] disclosing at least a portion of contact layer 108 is a conductive, hydrophilic hydrogel 108c). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the upper layer of conductive material of Li in view of Holzhacker and Dunagan to incorporate the hydrophilic gel layer and water absorbent gel layer with a substrate with an opening therebetween. Doing so would be obvious to one of ordinary skill in the art as both water-absorbing gel layers and hydrophilic gel layers are well-known in the art to yield the predictable result of providing a conductive layer in a physiological sensing environment.
Li/Dunagan fails to teach the conductive material of the electrode portions is laminated on to the substrate.
In related prior art, Ylotalo discloses a similar device wherein similar layers may be attached to a substrate sheet by adhesive, printing, or laminating as is known in the art ([0031]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the conductive materials of the electrode portion of Li in view of Dunagan and Ylotalo to incorporate the hydrogels as laminated on the substrate. Doing so would be obvious to one of ordinary skill in the art as laminating is a well-known method for attaching two distinct layers together to yield the predictable result of providing the two layers as a securely connected multi-layered product.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Li in view of Ylotalo, Libbus, and in further view of Shibata (U.S. PGPub No. 2017/0333696).
Regarding claim 5, Li/Ylotalo/Libbus teaches the device of claim 2 as stated above.
Li fails to teach wherein the substrate is provided with a support member that supports a rim of the electrolyte layer in a state where at least a part of the electrolyte layer is exposed to on a side contacting the living body, and an opening having a size capable of supporting a rim portion of the electrolyte layer is provided in the support member.
In related prior art, Shibata teaches a similar device (see Figs 1-2) wherein the substrate is provided with a support member that supports a rim portion of a living body-contacting surface of the electrolyte layer in a state where at least a part of the electrolyte layer is exposed on a side configured to contact the living body (Figs 1-2, retaining member 20 is provided on an underlying substrate and functions to supports rim of electrolyte gel 11 exposed to a living body side); and an opening having a size capable of supporting the rim portion of the electrolyte layer is provided in the support member (Fig 2 opening of retainer member 20 has a size that supports the rim of electrolyte gel 11). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Li in view of Ylotalo, Libbus, and Shibata to incorporate the support member for supporting a rim of the electrolyte layer to arrive at the device of claim 5. Doing so would be obvious to one of ordinary skill in the art to advantageously provide a retaining member connected to the conductive material to support the electrolyte layer in place on the skin of a user.
Response to Arguments
Applicant’s arguments, see remarks, filed 12/23/2025, with respect to the rejection(s) of claim(s) 4 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the Holzhacker reference.
Applicant's arguments filed 12/23/2025 with respect to claims 1-2 and 5-7 have been fully considered but they are not persuasive.
Regarding claims 6-7, on pages 9-11 of the remarks, applicant alleges Ginestet fails to teach “a groove that receives a protrusion formed on a side wall surface of the biosignal processor is formed around an inner surface of a side wall of the waterproof member main body”. These arguments are unpersuasive. The lower part 410 of Ginestet has multiple grooves on an inner surface thereof that receives various protrusions of circuit board 400. For example, in reference to the modified Figure 7 above, the corners of circuit board 400 are protrusions formed by the sidewalls received within grooves created by bottom and side surfaces of lower lid 410; grooves of bottom lid 410 receive pogo pins 410 and gasket 430, an outward protrusion on side wall of lower lid 410 forms a groove that holds protruding side wall of circuit board 400 in place. The examiner maintains that there are multiple interpretations of the Ginestet reference that reads on the claim language.
Furthermore, on page 13 of the remarks, the applicant alleges that there are no protrusions formed on the side wall surface of circuit board 400. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., such specific limitation of “a side wall surface”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). In the instant case, “a side wall surface of the biosignal processor” is not limited sufficiently to provide such a narrow scope as alleged by the applicant. As presently recited, the broadest reasonable interpretation of “a side wall surface” is determined to be any surface of a wall of the device.
Regarding claim 1, on page 13-16 of the remarks, the applicant argues. Li does not disclose “a second sheet member that openably closes the opening as a check valve”. Applicant references their own Figure 3 to show a second sheet member (18) that openably closes the opening (15) as a check valve. Meanwhile, figures 2-3 of the Li reference discloses an elastic layer (210) that covers an opening (235) while simultaneously allowing for breathability through the opening as disclosed in [0037].
The applicant further argues, on page 18, against the Libbus reference stating that Libbus fails to disclose a check valve as recited in claim 1. Claim 1 recites “a check valve for a moisture transfer to prevent a moisture entry into the electrolyte layer and release a moisture from the electrolyte layer”. The applicant cites [0089] of Libbus, however, said citation of Libbus explicitly discloses a function in which the gel cover 180 prevents external moisture from penetrating into the hydrogel while simultaneously allowing moisture vapor from the gel to exit through the gel cover 180. These arguments are unpersuasive.
Regarding claim 2, on pages 19-23, applicant argues the combination of Li and Libbus would not have motivated one of ordinary skill in the art to provide the cloth between the substrate and cover member as claimed. Stating on page 22 that one of ordinary skill in the art would have placed the breathable tape 110T of Libbus between Li’s substrate and gel layer because that aligns with the position of Libbus’ breathable tape.
First, this proposed modification would require incorporating the breathable, non-conductive tape 110T either above or below the electrode layer 232 of Li. Such a modification would clearly interfere with the gel/electrode interface of Li.
Second, Figure 3 of Li teaches a gel layer placed on the skin-side surface of the device, an electrode layer 220, with a substrate 225 therein, located above the gel layer, and a breathable cover member 210 located above the electrode layer 220. Meanwhile, Figure 1J of Libbus teaches a gel layer 114A-D, an electrode layer 112A-D, a cloth 110T above the electrode layer 112, and a breathable cover member 162 above the cloth layer 110T. [0084] of Libbus states the cover member 162 as breathable. Since Libbus discloses the cloth layer 110T above the electrode layer 112 and below the analogous cover member 162, one of ordinary skill in the art would modify Li in view of Libbus to incorporate the cloth member 110T of Libbus above the electrode layer 120 and below the cover member 210 of Li to arrive at the device as claimed. As such these arguments are unpersuasive.
Arguments directed to claim 5 are unpersuasive for the reasons stated above regarding claim 2.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Adam Z Minchella whose telephone number is (571)272-8644. The examiner can normally be reached M-Fri 7-3 EST.
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/ADAM Z MINCHELLA/Primary Examiner, Art Unit 3794