DETAILED ACTION
This action is pursuant to claims filed on 2/18/2026. Claims 23-24, and 26-44 are pending, claims 25 and 45-56 have been cancelled by the applicant. A final action on the merits of claims 23-24, and 26-44 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 .
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.
Claim 27 is 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.
Claims 27 is rejecting for reciting “optionally” in the claim. Specifically reciting, “Y optionally forms a ring […].”The recitation of “optionally” is indefinite because the metes and bounds of the claim are not properly defined as it is unclear if the limitations that follow are actually required. The limitations in the claims that follow “optionally” will not be treated as required by the claim.
Claim Rejections - 35 USC § 102
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 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) 23, 26, 27, 28, 29, 32, 33, 34, 41, 42, and 44 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Hatakeyama et al. (hereinafter ‘Hatakeyama’, US 20190209740 A1).
Regarding independent claim 23, Hatakeyama discloses a bio-electrode (bioelectrode shown in Figs. 1 and 2) comprising:
a porous, stretchy base material (base material 2 in Figs. 1 and 2; [0051], [0096], [0132]: the bio-electrode is stretchable which means that the base has at least some degree of stretch; [0127]: the electro-conductive base can be a cloth or mesh which both inherently have some degree of porosity and stretchability);
an adhesive, conductive film containing silicon (living body contact layer 3 in Figs. 1 and 2; [0119]: the living body contact layer has tackiness, which is adhesive; [0129]: the living body contact layer can be selected based on a balance of flexibility, tackiness, and texture; [0128]: the living body contact layer includes a silicone chain, which contains silicon); and
a conducting path ([0169]: copper wiring 9 in Fig. 3b which is connected to the aluminum disc 8 which is an exemplary base; [0123]: the electro-conductive base material is electrically connected to a sensor device – the electrical connection from the base to the sensor device is the conductive path),
wherein the adhesive, conductive film is formed on one surface of the porous, stretchy base material (the conductive film is formed on the top of the base material as seen in Figs. 1 and 2),
the conducting path is connected to the adhesive, conductive film ([0123]: the electro-conductive base material connects the living body contact layer to the connection to the sensor device – thus the conductive film is connected to the conductive path as it is connected to the conductive base), and penetrates the porous, stretchy base material to be exposed on the opposite side (“conducting path” as recited in the claim does not have any structure, it is simply the conductive connection between the adhesive, conductive film and the sensor device – since the base material transfers the signal from the adhesive pad, to a connector, to a sensor device, the conductive path penetrates through the base as the conductive particles that make up the base are dispersed throughout), or is exposed on a side surface of the porous, stretchy base material (as seen in Figs. 2 and 3b, the connection to the sensor device comes off of the base material’s side; in Fig. 2 it is shown as coming off of the left side and in Fig. 3, the wiring 9 is shown coming off of the base material 8 and then extends to the side – thus the conductive path is exposed on a side of the base material)
wherein the adhesive, conductive film containing silicon contains an ionic material (A) selected from the group consisting of salts of ammonium, lithium, sodium, and potassium formed with any of fluorosulfonic acid, fluorosulfonimide, and N-carbonylfluorosulfonic amide ([0020]: the living body contact layer is formed from the bio-electrode composition; [0021]-[0023]: the bio-electrode composition comprises a resin and an electro-conductive material where in the electro-conductive material is a polymer compound having one or more repeating units from the group consisting of fluorosulfonic acid salts shown by the following formula (1)-1, fluorosulfonic acid salts shown by the following formula (1)-2, sulfonimide salts shown by the following formula (1)-3, and sulfonamide salts shown by the following formula (1)-4, wherein X+ represents a sodium ion, potassium ion, or a cation having an ammonium ion structure – the salt is a flurosulfonic acid and sodium, potassium, or ammonium ion).
Regarding claim 26, Hatakeyama discloses the bio-electrode according to claim 23, wherein the ionic material (A) has a partial structure shown by the following general formulae (1)-1 to (1)-4 (see structure from [0023]),
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wherein Rf1 and Rf2 each represent a hydrogen atom, a fluorine atom, an oxygen atom, a methyl group, or a trifluoromethyl group, provided that when Rf1 and Rf2 represent an oxygen atom, the single oxygen atom represented by Rf1 and Rf2 bonds to a single carbon atom to form a carbonyl group; Rf3 and Rf4 each represent a hydrogen atom, a fluorine atom, or a trifluoromethyl group, provided that at least one of Rf1 to Rf4 is a fluorine atom or a trifluoromethyl group; Rf5, Rf6, and Rf7 each represent a fluorine atom, a trifluoromethyl group, or a linear or branched alkyl group having 1 to 4 carbon atoms, and have at least one fluorine atom; M+ represents an ion selected from the group consisting of an ammonium ion, a sodium ion, and a potassium ion; and "m" represents an integer of 1 to 4 (see limitations disclosed in [0023]; because of the groupings claimed comprise “or”, the options disclosed in paragraph [0023] also satisfy the claim language).
Regarding claim 27, Hatakeyama discloses the bio-electrode according to claim 23, wherein the ionic material (A) comprises at least one ionic polymer selected from the group consisting of repeating units A1 to A7 shown by the following general formula (2) (see paragraph [0027] which discloses the groups below – while the Xs are replaced with Zs and the Rs are numbered differently, the structure is the same),
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wherein R1, R3, R5, R8, R10, R11, and R13 each independently represent a hydrogen atom or a methyl group; R2, R4, R6, R9, R12, and R14 each independently represent a single bond, or a linear, branched, or cyclic hydrocarbon group having 1 to 13 carbon atoms, the hydrocarbon group having no other group or having either or both of an ester group and an ether group; R7 represents a linear or branched alkylene group having 1 to 4 carbon atoms, and one or two hydrogen atoms in R7 are not substituted or substituted with a fluorine atom; X1, X2, X3, X4, X6 and X7 each independently represent any of a single bond, a phenylene group, a naphthylene group, an ether group, an ester group, and an amide group; X5 represents any of a single bond, an ether group, and an ester group; Y represents any of an oxygen atom and a -NR19- group; R19 represents any of a hydrogen atom, a linear, branched, or cyclic alkyl group having 2 to 12 carbon atoms, and a phenyl group, and have no other group or have one or more selected from the group consisting of an ether group, a carbonyl group, an ester group, and an amide group; Y optionally forms a ring together with R4; Rf1' and Rf5' each represent a fluorine atom, a trifluoromethyl group, or a linear or branched alkyl group having 1 to 4 carbon atoms, and have at least one fluorine atom; "m" represents an integer of 1 to 4; a1, a2, a3, a4, a5, a6, and a7 are 0≤al≤1.0, 0≤a2≤1.0, 0≤a3≤1.0, 0≤a4≤1.0, 0≤a5≤1.0, 0≤a6≤1.0, 0≤a7≤1.0, and 0<a1+a2+a3+a4+a5+a6+a7≤1.0; M+ represents an ion selected from the group consisting of an ammonium ion, a sodium ion, and a potassium ion (see limitations disclosed in [0028]; because of the groupings claimed comprise “or”, the options disclosed in paragraph [0028] also satisfy the claim language; R14 is a single bond as seen in the last equation).
Regarding claim 28, Hatakeyama discloses the bio-electrode according to claim 23, wherein the ionic material (A) comprises an ammonium ion shown by the following general formula (3) as an ammonium ion for forming the ammonium salts (see [0023] for ammonium ion structure),
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wherein R101d, R101e, R101f, and R101g each represent a hydrogen atom, a linear, branched, or cyclic alkyl group having 1 to 15 carbon atoms, a linear, branched, or cyclic alkenyl group or alkynyl group having 2 to 12 carbon atoms, or an aromatic group having 4 to 20 carbon atoms, and have no other group of have one or more selected from the group consisting of an ether group, a carbonyl group, an ester group, a hydroxy group, an amino group, a nitro group, a sulfonyl group, a sulfinyl group, a halogen atom, and a sulfur atom; and R101d and R101e, or R101d, R101e, and R101f, are not bonded to each other or are bonded together with a nitrogen atom bonded therewith to form a ring in which R101d and R101e, or R101d, R101e, and R101f, represent an alkylene group having 3 to 10 carbon atoms, or to form a heteroaromatic ring having the nitrogen atom in the general formula (3) within the ring (see [0023]; the specific ring requirements of R101d and R101e, or R101d, R101e, and R101f are not required because the claim recites this is “optional”).
Regarding claim 29, Hatakeyama discloses the bio-electrode according to claim 23, further comprising, in addition to the component (A), an adhesive resin as a component (B) that is different from the component (A), which is one or more selected from the group consisting of a silicone resin, a (meth) acrylate resin, and a urethane resin ([0064]-[0065]: the bioelectrode composition comprises a resin having a urethane bond and a silicone chain; [0096]: the resin having urethane bond and silicone chain).
Regarding claim 32, Hatakeyama discloses the bio-electrode according to claim 23, further comprising a component (C), which is one or more selected from the group consisting of a carbon powder, a metal powder, a silicon powder, and a lithium titanate powder ([0037], [0039]: the bio-electrode composition comprises a carbon material such as carbon black and carbon nanotube).
Regarding claim 33, Hatakeyama discloses the bio-electrode according to claim 32, wherein the carbon powder is one or both of carbon black and carbon nanotube ([0039]: the carbon material can be either or both of carbon black and carbon nanotube).
Regarding claim 34, Hatakeyama discloses the bio-electrode according to claim 23, wherein the conducting path comprises one or more selected from the group consisting of gold, silver, silver chloride, platinum, aluminum, magnesium, tin, tungsten, iron, copper, nickel, stainless steel, chromium, titanium, carbon, and a conductive polymer ([0169]: the conductive path is the copper wiring 9).
Regarding claim 41, Hatakeyama discloses a production method for the bio-electrode according to claim 23, the method comprising:
preparing a conducting path that penetrates a porous, stretchy base material, or preparing a conducting path ([0123]: the electro-conductive base material is electrically connected to a sensor device – the electrical connection from the base and the sensor device is the conductive path – thus a conductive path is prepared as the method follows from the structure) on the porous, stretchy base material (base material 2 in Figs. 1 and 2; [0051], [0096], [0132]: the bio-electrode is stretchable which means that the base has at least some degree of stretch; [0127]: the electro-conductive base can be a cloth or mesh which both inherently have some degree of porosity and stretchability) so that the conducting path is exposed on a side surface of the porous, stretchy base material (as seen in Figs. 2 and 3b, the connection to the sensor device comes off of the base material’s side; in Fig. 2 it is shown as coming off of the left side and in Fig. 3, the wiring 9 is shown coming off of the base material 8 and then extends to the side – thus the conductive path is exposed on a side of the base material) and forming an adhesive, conductive film comprising silicon (living body contact layer 3 in Figs. 1 and 2; [0119]: the living body contact layer has tackiness, which is adhesive; [0129]: the living body contact layer can be selected based on a balance of flexibility, tackiness, and texture; [0128]: the living body contact layer includes a silicone chain, which contains silicon – the adhesive, conductive film is formed as the method follows from the structure) so as to be connected to one side of the conducting path ([0123]: the electro-conductive base material connects the living body contact layer to the connection to the sensor device – thus the conductive film is connected to the conductive path), the one side being attached to a skin (the living body contact layer contacts the skin, thus the side of the conductive path that connects to the living body contact layer is attached to the skin).
Regarding claim 42, Hatakeyama discloses the production method for the bio-electrode according to claim 41, the method comprising:
forming the adhesive, conductive film containing silicon on one side of the conducting path that penetrates the porous, stretchy base material, or the conducting path that is on the porous, stretchy base material and exposed on a side surface of the porous, stretchy base material (the adhesive, conductive film 3 is formed on stretchy base material as seen in Figs 1 and 2 which is connected to the exposed conductive path on the side surface of the base as seen in Figs. 2 and 3b as the electro conductive base forms part of the conductive bath as explained in [0123]), the one side being attached to a skin (the “one side of the conducting path” is attached to the skin through the living body contact layer),
by transferring the formed, adhesive, conductive film comprising silicon onto a release linear or by directly printing the formed, adhesive, conductive film comprising silicon onto the conducting path ([0138]: the bio-electrode composition, which forms the living body contact layer, is printed onto the electro-conductive base – the electro conductive base forms an end of the conductive path as explained above and in [0123] since there is no distinct structure provided to the conducting path).
Regarding claim 44, Hatakeyama discloses a measurement method for a bio-signal comprising: attaching the bio-electrode according to claim 23 to a skin ([0118]: the bioelectric signals are measured from the skin – thus it is inherent that the bioelectrode is attached to the skin); and measuring the bio-signal after showering ([0118]: the electrode is worn for a long-time – this would inherently mean that the bio-electrode is worn after showering unless the person has never showered in their entire life since the claim does not dictate how long after showering the signal is measured), or during bathing or showering.
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 24 is rejected under 35 U.S.C. 103 as being unpatentable over Hatakeyama as applied to claims 23 and described above, in view of Komatsu et al. (hereinafter ‘Komatsu’, US 20200187803 A1).
Regarding claim 24, Hatakeyama discloses the bio-electrode according to claim 23, wherein the porous, stretchy base material is a fabric ([0127]: the electro-conductive base can be a cloth)
However, Hatakeyama is silent to whether the cloth that forms the conductive base is woven or non-woven.
Komatsu teaches an electrode member for measuring biological information comprising a flexible substrate, an electrode section on the flexible substrate, and wiring connecting to the electrode section ([Abstract]). Komatsu further teaches that the flexible base material can be a fabric material made of woven, knitted, or non-woven fabrics ([0119]). Additionally, Komatsu teaches that woven or non-woven fabric can contain conductive fibers or threads to form a conductive fabric ([0137]). Thus, Komatsu teaches that both woven and non-woven fabrics are both known in the art to be used as stretchable, conductive layers. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention substitute the cloth layer of Hatakeyama with the non-woven fabric of Komatsu since the substitution for the non-woven fabric taught by Komatsu would have yielded predictable results, namely, forming a stretchable, conductive layer that also would inherently have a degree of porosity, similar to Hatakeyama.
Claims 30 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Hatakeyama as applied to claims 29/23 and described above, in view of Hatakeyama et al. (hereinafter ‘Hatakeyama 023’, US 20180229023 A1).
Regarding claim 30, Hatakeyama discloses the bio-electrode according to claim 29.
However, Hatakeyama is silent to the component (B) comprising a diorganosiloxane having an alkenyl group and an organohydrogen polysiloxane having a SiH group.
Hatakeyama 023 teaches a bioelectrode composition including an ionic material such as a lithium salt, a sodium salt, a potassium salt, or an ammonium salt and a component B which is a resin other than the ionic material, which is an extremely similar composition to both Hatakeyama and the claimed invention ([Abstract]). The resin of Hatakeyama 023 is also similar to that of Hatakeyama as it is a urethane resin containing a silicon atom ([0113]). The resin of Hatakeyama 023 additionally includes a diorganosiloxane having an alkenyl group and an organohydrogen polysiloxane group having a plurality of SiH groups with modified siloxane having a group selected from an amino group, an oxirane group, an oxetane group, a polyether group, a hydroxy group, a carboxyl group, a mercapto group, a methacryl group, an acrylic group, a phenol group, a silanol group, a carboxylic acid an anhydride group, an aryl group, an aralkyl group, an amide group, an ester group, and a lactone ring added ([0114]). This composition to the silicone-based resin enhances the compatibility with the salt ([0114]). Therefore, 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 diorganosiloxane having an alkenyl group and an organohydrogen polysiloxane group having a pluraility of SiH groups with modified siloxane having a group selected from an amino group, an oxirane group, an oxetane group, a polyether group, a hydroxy group, a carboxyl group, a mercapto group, a methacryl group, an acrylic group, a phenol group, a silanol group, a carboxylic acid an anhydride group, an aryl group, an aralkyl group, an amide group, an ester group, and a lactone ring added in order to enhance the resins compatibility with the added salt.
Regarding claim 31, Hatakeyama discloses the bio-electrode according to claim 29 further comprising a silicone resin ([Abstract]: the resin comprises a silicone chain in the main chain).
However, Hatakeyama is silent to the component (B) further comprising a silicone resin having an SiO2 unit and an RXSiO(4-x)/2 unit, wherein R represents a substituted or unsubstituted monovalent hydrocarbon group having 1 to 10 carbon atoms, and "x" represents a number in a range of 2.5 to 3.5.
Hatakeyama 023 teaches a bioelectrode composition including an ionic material such as a lithium salt, a sodium salt, a potassium salt, or an ammonium salt and a component B which is a resin other than the ionic material, which is an extremely similar composition to both Hatakeyama and the claimed invention ([Abstract]). The resin of Hatakeyama 023 is also similar to that of Hatakeyama as it is a urethane resin containing a silicon atom ([0113]). The resin of Hatakeyama 023 additionally includes a silicone resin having an SiO2 unit and an RXSiO(4-x)/2 unit, wherein R represents a substituted or unsubstituted monovalent hydrocarbon group having 1 to 10 carbon atoms, and "x" represents a number in a range of 2.5 to 3.5 ([0024]). This composition of such a resin component aids in forming a living body contact layer that is particularly favorable in compatibility with the ionic material, provides better adhesion to the base and skin, and aids in water repellency ([0025]). Therefore, 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 SiO2 unit and an RXSiO(4-x)/2 unit, wherein R represents a substituted or unsubstituted monovalent hydrocarbon group having 1 to 10 carbon atoms, and "x" represents a number in a range of 2.5 to 3.5 to increase compatibility, adhesion, and water repellency.
Claim 35 is rejected under 35 U.S.C. 103 as being unpatentable over Hatakeyama as applied to claims 23 and described above, in view of Zhu et al. (hereinafter ‘Zhu’, US 20170172439 A1).
Regarding claim 35, Hatakeyama discloses the bio-electrode according to claim 23. Hatakeyama further discloses the wire 9 of the electrical connection being simply taped to the conductive base 8 as seen in Fig. 4 ([0169]).
However, Hatakeyama does not disclose the conducting path having a snap shape.
Zhu teaches various embodiments for bioelectrodes which can include snap connectors or direct connections as seen in Figs. 1A and 1B. Zhu further states that fabrication with a snap allows for use with conventional ECG machines already in existence ([0065]). Incorporating a snap onto the back of the electrode structure is of routine skill in the art and would simply provide Hatakeyama with a known connection method between the wire and the electrode. Furthermore, this would yield the predictable result of creating a removable connection between the wires and the electrode base, similar to the adhesive tape currently disclosed by Hatakeyama. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the conductive snap with the electrode of Hatakeyama such that a removable connection is formed between the wire and the electrode which would allow for connections with other conventional measurement machines.
Claims 36, 37, and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Hatakeyama as applied to claims 23 and described above.
Regarding claim 36, Hatakeyama discloses the bio-electrode according to claim 23 as described above. Hatakeyama further discloses an embodiment in which the electro-conductive base is aluminum and has a thickness of 0.2mm ([0169]).
However, Hatakeyama is silent to the cloth electro-conductive base being less than 1mm thick.
It would have been an obvious matter of design choice to modify the thickness of the cloth electro-conductive base to be 0.2mm thick, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955). Furthermore, Hatakeyama states that the embodiment is just an exemplification, and any examples that have substantially the same feature and demonstrate the same functions and effects as those in the technical concept described in claims of the present invention are included in the technical scope of the present invention ([0175]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to change the thickness of the cloth, stretchy electro-conductive base to be 0.2mm thick as doing so only requires a mere change in the size of a component to a size that has been disclosed by Hatakeyama.
Regarding claim 37, Hatakeyama discloses the bio-electrode according to claim 36. Hatakeyama further teaches the porous, stretchy, electro-conductive base has a thickness of 0.2mm which is equivalent to 200 micrometers, based on the combination above. Hatakeyama further discloses the living body contact layer preferably has a thickness of 2 micrometers or more and 3mm or less ([0129]). Thus, the entirety of the bioelectrode would be 500 micrometers or less when the living body contact layer is between 2 and 300 micrometers, which is within the disclosed range (200 micrometers for the base plus 300 micrometers for the living body contact layer). Furthermore, it would have been an obvious matter of design choice to modify the thickness of the cloth electro-conductive base with the living body contact layer to be 500 micrometers or less, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art and is within the scope of the invention as evidenced by Hatakeyama ([0175]). In re Rose, 105 USPQ 237 (CCPA 1955).
Regarding claim 38, Hatakeyama discloses the bio-electrode according to claim 23, wherein the metal base material includes an adhesive layer ([0196]: the copper wiring is connected to the aluminum disk 8, which forms the electro-conductive base, by adhesive tape – thus the adhesive tape forms the adhesive layer).
However, Hatakeyama is silent to the adhesive layer being present in other embodiments of the base.
Hatakeyama discloses that the electro-conductive base material is connected electrically to a sensor device ([0125]). The connection disclosed by Hatakeyama is a wired connection as seen in Figs. 3b and 4. Furthermore, Hatakeyama states that the embodiment is just an exemplification, and any examples that have substantially the same feature and demonstrate the same functions and effects as those in the technical concept described in claims of the present invention are included in the technical scope of the present invention ([0175]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to utilize the adhesive tape taught by the metal disc embodiment with the electro-conductive cloth base embodiment as doing so would yield the predictable result of connecting the base to the sensor device and is within the scope of the invention.
Claim 39 and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Hatakeyama as applied to claims 23 and described above, in view of Coggins (US 20130085368 A1).
Regarding claim 39, Hatakeyama discloses the bio-electrode according to claim 23 and described above.
However, Hatakeyama is silent to covering a top of the adhesive, conductive film with a release liner.
Coggins teaches an electrode including an conductive patient contact side with a backing layer as seen in Fig. 2, similar to the device disclosed in Hatakeyama ([Abstract]). Coggins further discloses that the conductive composition, which contacts the patient, may be temporarily adhered to a release liner ([0019]). This release liner is used to protect the patient contact surface of the electrode prior to application of the electrode to the patient ([0019]). Incorporating a release liner on the patient contacting portion of the electrode disclosed by Hatakeyama is of ordinary skill in the art and would yield the predictable result of protecting the electrode contact surface. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the release liner of Coggins with the electrode of Hatakeyama such that a release liner is included on the patient contact surface in order to protect the adhesive, conductive layer prior to application.
Regarding claim 40, the Hatakeyama/Coggins combination discloses the bio-electrode according to claim 39, wherein the release liner is selected from the group consisting of a fluorine resin, polyethylene, polypropylene, cyclic polyolefin, polyethylene terephthalate (Coggins [0019]: the release film can be polyethylene terephthalate), polybutylene terephthalate, polyethylene naphthalate, polybutylene naphthalate, polyvinyl chloride, polymethylmethacrylate, polyvinyl acetate, polystyrene, polymethylpentene, polyimide, polyphenylene sulfide, polysulfone, polyethersulfone, polyetherketone, polyamide-imide, polyetherimide, polyacetal, polycarbonate, polyphenylene ether, polyacrylonitrile, cellophane, and paper, to which, excluding the fluorine resin, a fluorine-based peeling agent or a silicone/fluorine-based peeling agent is applied (Coggins [0019]: the release film is coated in silicone; a “/” is a broad term that can be used to designate “and” or “or”, and because the claim does not define the exact peeling agent or directly state “and” or “or”, the “/” is interpreted as “or”).
Claim 43 is rejected under 35 U.S.C. 103 as being unpatentable over Hatakeyama as applied to claims 41/23 and described above, in view of Ishikubo et al. (hereinafter ‘Ishikubo’, US 20230355152 A1).
Regarding claim 43, Hatakeyama discloses the production method for the bio-electrode according to claim 41, further comprising an adhesive, conductive film material comprising silicon onto the conductive base ([0138]: the bio-electrode composition, which forms the adhesive, conducting layer, is printed onto the conductive base) and curing the adhesive, conductive film material ([0139]: the bioelectrode composition, which forms the adhesive, conducting layer, is cured).
However, Hatakeyama is silent to printing the adhesive, conductive film onto a release liner first.
Ishikubo teaches a bioelectrode and a method of producing a bioelectrode ([Abstract]). Ishikubo further teaches two methods for manufacturing the bioelectrode. The first method involves directly printing the conductive layer onto the base layer, similar to the process disclosed by Hatakeyama ([0062]). The second method involves printing the conductive substrate onto a release film, then bonding the conductive electrode layer to the base, and finally removing the release film, as the claimed method requires ([0063]-[0065]). The substitution of one known method (printing the conductive layer onto a release liner and transferring to the base as taught by Ishikubo) for another (printing the conductive layer directly onto the base as disclosed by Hatakeyama) would have been obvious to one of ordinary skill in the art at the time of the invention since the substitution of the method from Ishikubo would have yielded predictable results, namely, the lamination of a conductive layer onto a base. Furthermore, both Ishikubo and the instant application discuss directly printing the conductive film onto a base (Ishikubo ([0062]) or onto the conducting path (Instant application [0061]). Therefore, because both the prior art and the instant application contemplate both methods of manufacturing, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to substitute the method of printing onto a release liner for the direct printing method.
Response to Amendment
The amendments to claims 23, 28, 36, 38, 39, 41, and 42 overcome the 112b rejections of record. The 112b rejections of those claims and their dependents are withdrawn. The 112b rejection of claim 27 remains because there is still a recitation of “optionally.”
Response to Arguments
Applicant’s arguments with respect to claim 23 have been fully considered but are not persuasive. The applicant argues that Hatakeyama does not disclose the conducting path connected to the adhesive, conductive film. Further stating that the wiring is connected to the base material, not the conductive film. This argument is not persuasive. As broadly claimed, “conducting path” has no structure. It is not claimed as wiring or traces. It is simply a conducting path that connects to the adhesive, conducting film, and either penetrates or is exposed on a side surface of the base material. The claim does not state how it connects to the adhesive, conductive film or the structure of the path. The connection from the sensor device shown in Fig. 2 is connected to the adhesive, conductive film through the conductive base. Hatakeyama states that the electro-conductive base connects the living body contact layer to the sensor device ([0123]). The conductive path to the sensor device is connected to the adhesive, conductive layer through the electro-conductive base. The electrical signal travels from the living body, though the layer 3, through the layer 2, and then to the device thought the connection piece ([0123]). An electrical connection between the living body contact layer 3 and the conduction path is explicitly disclosed by Hatakeyama. Thus, the conductive path is electrically connected to the adhesive, conducting layer and mechanically connected, though indirectly, to the adhesive, conductive layer. The claim does not differentiate between mechanical vs. electrical connection or between direct vs. indirect connection. Therefore, because the claim does not state how the conducting path connects to the adhesive, conducting layer, the electrical connection through the electro-conductive base satisfies the claim language and the rejection is maintained.
The arguments directed to the benefits and effects of the instant application versus the prior art are not persuasive because these benefits and/or results are not claimed and Hatakeyama discloses the structure of claim 23 as described above.
The rejections to the dependent claims are maintained because the rejection of the independent claim is maintained.
Applicant does not challenge the application of Komatsu, Hatakeyama ‘023, Zhu, Coggins, Ishikubo, and Irie as applied. The applicant simply states that they do not remedy the stated differences of claim 23. Therefore, the rejections are maintained.
The rejections of claims 23-24, and 26-44 are maintained because Hatakeyama still discloses the claimed subject matter of claim 23 as described above and applicant does not provide specific arguments against the rejections to the dependent claims.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/W.M./Examiner, Art Unit 3794