DETAILED ACTION
This action is pursuant to claims filed on 5/8/2026. Claims 1, 3-7, 9-12, and 14 are pending. Claims 2, 8, and 13 have been cancelled by the applicant. A non-final action on the merits of claims 1, 3-7, 9-12, and 14 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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 5/8/2026 has been entered.
Priority
The foreign priority date of 11/17/2022 for foreign application number JP 2022-184475 is acknowledged. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Acknowledgment is made of applicant's claim for foreign priority based on an application JP 2023-82859 filed in Japan on 5/19/2023. It is noted, however, that applicant has not filed a certified copy of the foreign application as required by 37 CFR 1.55 and the retrieval attempt under the priority document exchange program on 4/17/2024 failed.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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, 3-7, 9-12, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Hatakeyama et al. (hereinafter ‘Hatakeyama’, US 20200317840 A1) in view of Hatakeyama et al. (hereinafter ‘Hatakeyama ‘665’, US 20210307665 A1) and in further view of Hatakeyama et al. (hereinafter ‘Hatakeyama ‘897’, EP 3067897 A1).
Regarding independent claim 1, Hatakeyama discloses a bio-electrode (bio-electrode of Fig. 1) comprising an electro-conductive base material (electro-conductive base material 2 in Fig. 1) and a living body contact layer (living body contact layer 3 in Fig. 1) formed on the electro-conductive base material ([0131]: the living body contact layer is formed on the electro-conductive base material), wherein
the living body contact layer comprises an electro-conductive polymer composite ([0013]-[0017]: the bioelectrode comprises a living body contact layer that is formed of a component A which is a polymer compound and a lithium titanate powder) and one or more additives ([0128]: electrical conductivity can be improved by adding a carbon material and to improve stretchability and adhesion to the skin by additives and so forth), wherein
the electro-conductive polymer composite including
a component B: a dopant polymer ([0016]-[0017]: the living body contact layer comprises a polymer compound with a repeating unit-a), and
the component B dopant polymer contains a repeating unit having any of fluorosulfonic acid, fluorosulfonimide, and N-carbonyl-fluorosulfonamide ([0016]: the polymer compound has a repeating unit-a selected from ammonium salt, a sodium salt, a potassium salt, and a silver salt of any of fluorosulfonic acid, fluorosulfonimide, and N-carbonyl-fluorosulfonamide) and has a weight-average molecular weight of 1,000 to 500,000 ([0088]: the molecular weight of the component is preferably 2000-500,000; because the range taught by the prior art is entirely within the claimed range, the range is anticipated; see MPEP 2131.03).
However, Hatakeyama is silent to the living body contact layer comprising one or more groups selected from an ionic additive and a silicone compound having a polyglycerin structure.
Hatakeyama ‘665 teaches a bioelectrode comprising a body contacting layer that includes a resin component and an ionic material formed of repeating units that are the same as both Hatakeyama and the present invention ([0045], [0111]-[0114]). Hatakeyama ‘665 further teaches that the layer can comprise an electric conductivity improver such as a metal powder, carbon material, silicon powder, or a lithium titanate powder ([0045]). Again, this is very similar to the electrode of Hatakeyama that includes carbon or lithium titanate to improve electrical conductivity. Hatakeyama ‘665 goes on to further state that the bio-electrode composition may contain an ionic additive such as sodium chloride, potassium chloride, calcium chloride, magnesium chloride, saccharin sodium salt, acesulfame potassium, and other salts ([0174]). Additionally, Hatakeyama ‘665 states that the bio-electrode composition may contain a silicone compound having a polyglycerin structure ([0175]). Utilizing these additives can help to increase the ionic conductivity of the bio-electrode composition ([0174]). Additionally, it would be of routine skill in the art to combine the ionic additives or the silicone compound of Hatakeyama ‘665 with the bioelectrode of Hatakeyama because doing so would maintain operability, since their base structures are nearly identical, and would lead to the expected outcome of increased ionic conductivity. 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 ionic additives and the silicone compound of Hatakeyama ‘665 with the bioelectrode of Hatakeyama in order to improve ionic conductivity.
However, the Hatakeyama/Hatakeyama ‘665 combination is silent to the polymer composite including a π-conjugated polymer.
Hatakeyama ‘897 teaches a conductive material comprising a π-conjugated polymer and a dopant polymer which contains one or more repeating units and has a weight-average molecular weight in the range of 1,000 to 500,000 ([Abstract]). Furthermore, the dopant polymer contains a fluorinated sulfonic acid, similar to the polymer compound of Hatakeyama, and contains one or more repeating units selected from a1 to a4 represented in formula 1 of Hatakeyama ‘897 ([0042]). The repeating units a1-a4 represented by the various formulas of Hatakeyama ‘897 ([0042]-[0046]) are identical to several of the selections for repeating unit-a of the polymer compound for Hatakeyama ([0068]-[0071]) and the instant application ([0164]-[0169]). Hatakeyama ‘897 further teaches that utilizing a conductive material formed of a composite between a dopant polymer and a π-conjugated polymer with a gold or silver nanowire forms a conductive material that has excellent conductivity, transparency, flatness, flexibility, durability, and low surface roughness ([0027]-[0030]). While not specifically directed towards a bioelectrode, all of the benefits of the conductive material of Hatakeyama ‘897 would positively impact the bioelectrode of the Hatakeyama/Hatakeyama ‘665 combination and because the repeating units that form the respective polymers have identical subunit options, the combination would not be rendered inoperable. 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 layer of the Hatakeyama/Hatakeyama ‘665 combination with the conductive layer of Hatakeyama ‘897 to form a layer with composed of a π-conjugated polymer and a dopant polymer that results in excellent conductivity, transparency, flatness, flexibility, and durability as well as low surface roughness.
Regarding claim 3, the Hatakeyama/Hatakeyama ‘665/Hatakeyama ‘897 combination discloses the bio-electrode according to claim 1, wherein the electro-conductive base material 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, and carbon (Hatakeyama [0135]: the electro-conductive base material may comprise one or more species selected from gold, silver, silver chloride, platinum, aluminum, magnesium, tin, tungsten, iron, copper, nickel, stainless steel, chromium, titanium, and carbon).
Regarding claim 4, the Hatakeyama/Hatakeyama ‘665/Hatakeyama ‘897 combination discloses the bio-electrode according to claim 1 as described above. The combination further teaches the component A π-conjugated polymer is a polymerized product of one or more precursor monomers selected from the group consisting of monocyclic aromatic compounds, polycyclic aromatic compounds, acetylenes, and derivatives thereof (Hatakeyama ‘897 [0034]: examples of the precursor monomer of the π-conjugated polymer include monocyclic aromatic compounds such as pyrroles, thiophenes, thiophene vinylenes, selenophenes, tellurophenes, phenylenes, phenylene vinylenes, and anilines; polycyclic aromatic compounds such as acenes; and acetylenes; and a homopolymer or a copolymer of these monomers).
Regarding claim 5, the Hatakeyama/Hatakeyama ‘665/Hatakeyama ‘897 combination discloses the bio-electrode according to claim 4/1 as described above. The combination further teaches the monocyclic aromatic compounds are pyrroles, thiophenes, thiophenevinylenes, selenophenes, tellurophenes, phenylenes, phenylenevinylenes, or anilines, and the polycyclic aromatic compounds are acenes (Hatakeyama ‘897 [0034]: examples of the precursor monomer of the π-conjugated polymer include monocyclic aromatic compounds such as pyrroles, thiophenes, thiophene vinylenes, selenophenes, tellurophenes, phenylenes, phenylene vinylenes, and anilines; polycyclic aromatic compounds such as acenes).
Regarding claim 6, the Hatakeyama/Hatakeyama ‘665/Hatakeyama ‘897 combination discloses the bio-electrode according to claim 1, wherein the component B dopant polymer has any of repeating units represented by the following general formulae (1)-1 to (1)-4 (Hatakeyama [0018]: the repeating unit a is preferably a repeating unit having at least one of the structures represented by the following formulae (1)-1 to (1)-4; the formulas match as shown),
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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, Rf1 and Rf2 being a single oxygen atom bonded to a single carbon atom to form a carbonyl group when Rf1 and Rf2 represent an oxygen atom, and Rf3 and Rf4 each represent a hydrogen atom, a fluorine atom, or a trifluoromethyl group, at least one of Rf1 to Rf4 being 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, having at least one fluorine atom; and “m” represents an integer of 1 to 4 (Hatakeyama [0018]: the language matches the limitations above).
Hatakeyama also discloses that the M+ represents ion selected from an ammonium ion, a sodium ion, and a potassium ion ([0018]).
However, the Hatakeyama does not disclose that the M+ represents a hydrogen ion.
Hatakeyama ‘897 further discloses that the SO3- can be bonded to a H+ ion as described in paragraphs [0017] and [0031]. The repeating units have nearly identical structures to both Hatakeyama and Hatakeyama ‘665, as well as the instant application. The dopant polymer may contain an acidic polymer which contains a fluorinated sulfonic acid containing a hydrogen ion bonded to the SO3- group ([0042]). Alternatively, the cation may be represented by a hydrogen ion, lithium ion, sodium ion, potassium ion, amine compound, or sulfonium compound ([0043], [0044], [0045], [0046]). By using such a component, the material can be improved in filterability, film-formability, affinity to an organic solvent and an organic substrate, and transmittance after film formation ([0047]). The monomer that constitutes the dopant polymer of the component (B) may use a sulfo group. Alternatively, a monomer having a lithium salt, sodium salt, potassium salt, ammonium salt, or a sulfonium salt of a sulfo group may be used ([0072]). This is just like Hatakeyama and Hatakeyama ‘665 which use sodium, potassium, and ammonium salts in the dopant polymer. Thus, it would be obvious to one of ordinary skill in the art to utilize a hydrogen ion in place of a sodium, potassium, or ammonium ion since Hatakeyama ‘897 clearly teaches that a hydrogen ion is a known alternative to the other salts. 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 a hydrogen ion for the M+ in order to improve filterability, film-formability, affinity to an organic solvent and an organic substrate, and transmittance after film of the layer.
Regarding claim 7, the Hatakeyama/Hatakeyama ‘665/Hatakeyama ‘897 combination discloses the bio-electrode according to claim 6/1 as described above, wherein the component B dopant polymer has one or more repeating units selected from repeating units-A1 to -A7 represented by the following general formulae (2) (Hatakeyama [0020]: the repeating unit a is preferably at least one repeating unit selected from repeating units a1-a7 as shown by the formula; the formulas match as shown),
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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, R14, and R15 each independently represent a single bond or a linear, branched, or cyclic hydrocarbon group having 1 to 13 carbon atoms, the hydrocarbon group is unsubstituted or substituted with one or more groups selected from an ester group, an ether group, an amide group, a carbamate group, a thiocarbamate group, and a urea group; R7 represents a linear or branched alkylene group having 1 to 4 carbon atoms, one or two hydrogen atoms in R7 being unsubstituted or substituted with a fluorine atom; X1, X2, X3, X4, X6, and X7 each independently represent a single bond, a phenylene group, a naphthylene group, an ether group, an ester group, or an amide group; X5 represents a single bond, an ether group, or an ester group; Y represents an oxygen atom or an -NR19- group; R19 represents a hydrogen atom, a linear, branched or cyclic alkyl group having 2 to 12 carbon atoms, or a phenyl group and is unsubstituted or substituted with one or more groups selected from an ether group, a carbonyl group, an ester group, and an amide group; wherein when Y is an NR19 group and R19 represents a linear, branched or cyclic alkyl group having 2 to 12 carbon atoms, or a phenyl group and R4 is a linear, branched, or cyclic hydrocarbon group having 1 to 13 carbon atoms a rind is formed, otherwise no ring is formed; Rf1’ and Rf5’ each represent a fluorine atom, a trifluoromethyl group, or a linear or branched alkyl group having 1 to 4 carbon atoms, having at least one fluorine atom; “m” represents an integer of 1 to 4; a1, a2, a3, a4, a5, a6, and a7 satisfy 0≤a1≤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 (Hatakeyama [0018] and [0020]: the language matches the limitations above; furthermore, while the placeholders of X-7, X5, R15, and R17 are different between the Hatakeyama and the instant application, the specific examples of a5 and a7 from [0069]-[0071] match the specific examples of a5 and a7 of the instant application thus disclosing that the chemical structures are the same).
Hatakeyama also discloses that the M+ represents ion selected from an ammonium ion, a sodium ion, and a potassium ion ([0018]).
However, the Hatakeyama does not disclose that the M+ represents a hydrogen ion.
Hatakeyama ‘897 further discloses that the SO3- can be bonded to a H+ ion as described in paragraphs [0017] and [0031]. The repeating units have nearly identical structures to both Hatakeyama and Hatakeyama ‘665, as well as the instant application. The dopant polymer may contain an acidic polymer which contains a fluorinated sulfonic acid containing a hydrogen ion bonded to the SO3- group ([0042]). Alternatively, the cation may be represented by a hydrogen ion, lithium ion, sodium ion, potassium ion, amine compound, or sulfonium compound ([0043], [0044], [0045], [0046]). By using such a component, the material can be improved in filterability, film-formability, affinity to an organic solvent and an organic substrate, and transmittance after film formation ([0047]). The monomer that constitutes the dopant polymer of the component (B) may use a sulfo group. Alternatively, a monomer having a lithium salt, sodium salt, potassium salt, ammonium salt, or a sulfonium salt of a sulfo group may be used ([0072]). This is just like Hatakeyama and Hatakeyama ‘665 which use sodium, potassium, and ammonium salts in the dopant polymer. Thus, it would be obvious to one of ordinary skill in the art to utilize a hydrogen ion in place of a sodium, potassium, or ammonium ion since Hatakeyama ‘897 clearly teaches that a hydrogen ion is a known alternative to the other salts. 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 a hydrogen ion for the M+ in order to improve filterability, film-formability, affinity to an organic solvent and an organic substrate, and transmittance after film of the layer.
Regarding claim 9, the Hatakeyama/Hatakeyama ‘665/Hatakeyama ‘897 combination discloses the bio-electrode according to claim 1, wherein the living body contact layer comprises a component C: a resin ([0091]: the living body layer can comprise a resin), wherein the component C resin is one or more kinds selected from a (meth)acrylate resin, a (meth)acrylamide resin, a urethane resin, polyvinyl alcohol, polyvinylpyrrolidone, polyoxazoline, polyglycerin, polyglycerin-modified silicone, cellulose, polyethylene glycol, and polypropylene glycol (Hatakeyama [0091]: the resin can be silicone type, an acrylic type, or a urethane type – urethane type resin is urethane resin).
Regarding claim 10, the Hatakeyama/Hatakeyama ‘665/Hatakeyama ‘897 combination discloses the bio-electrode according to claim 1, wherein the living body contact layer comprises a component D, wherein the component D is one or more selected from a carbon powder, a metal powder, a silicon powder, and a lithium titanate powder ([0013]-[0015]: the bioelectrode comprises a lithium titanate powder; [0033]: the bioelectrode further comprises a carbon material in addition to the lithium titanate powder).
Regarding claim 11, the Hatakeyama/Hatakeyama ‘665/Hatakeyama ‘897 combination discloses the bio-electrode according to claim 10, wherein the carbon powder is one or both of carbon black and carbon nanotube ([0035]: the carbon material is more preferably either or both of carbon black and carbon nanotube).
Regarding claim 12, the Hatakeyama/Hatakeyama ‘665/Hatakeyama ‘897 combination discloses the bio-electrode according to claim 10/1 as described above, wherein the metal powder is any of gold nanoparticles, silver nanoparticles, copper nanoparticles, and silver nanowire ([0118]: the inventive bio-electrode composition can also contain a metal powder selected from gold, silver, platinum, copper; [0120]: size of 100 μm or less which is interpreted as a nanoparticle since the size is not defined by the claim).
Furthermore, it would have been an obvious matter of design choice to modify the size of the powder to nanoparticles, 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).
Regarding claim 14, the Hatakeyama/Hatakeyama ‘665/Hatakeyama ‘897 combination discloses a method for manufacturing a bio-electrode according to claim 1 (Hatakeyama [0143], the method inherently follows from the composition of the combination of claim 1 as described above), the method comprising:
applying a bio-electrode composition containing the electro-conductive polymer composite onto the electro-conductive base material (Hatakeyama [0143]: applying the inventive bioelectrode composition onto the electro-conductive base material; the Hatakeyama/Hatakeyama ‘665/Hatakeyama ‘897 combination form the layer of claim 1 as described above); and
curing the bio-electrode composition to form the living body contact layer (Hatakeyama [0143]: curing the bio-electrode composition to form the living body contact layer).
Response to Arguments
Applicant’s arguments, filed 5/8/2026, on page 7, with respect to the 112b rejections of claims 7 have been fully considered and are persuasive in light of the amendments. The 112b rejection of claim 7 has been withdrawn.
Applicant’s arguments filed 5/8/2026 with respect to the 103 rejections of claim 1 have been fully considered but are not persuasive. Applicant initially argues that the Hatakeyama/Hatakeyama ‘665/Hatakeyama ‘897 combination does not disclose the dopant polymer of claim 1 because it is different than the ionic materials described in Hatakeyama and Hatakeyama ‘665 because the disclosures do not suggest using an “acid” as the ionic material or polymer compound. This is not persuasive. Claim 1 does not require the use of an acid as the ionic material. Claim 1 simply states that “the component B dopant polymer contains a repeating unit having any of flurosulfonic acid, flurosulfonimide, and N-carbonyl-fluorosulfonamide” and Hatakeyama states in paragraph [0016] that the polymer compound has a repeating unit-a selected from ammonium salt, a sodium salt, a potassium salt, and a silver salt of any of fluorosulfonic acid, fluorosulfonimide, and N-carbonyl-fluorosulfonamide. Thus, the polymer contains repeating units that have the required structures. The claim is not specific to the form of these structures.
Applicant’s arguments that Hatakeyama ‘897 does not disclose a bioelectrode containing a living body contact layer formed as a film of the electro-conductive polymer composite comprising the π-conjugated polymer and the dopant of claim 1 is not persuasive. Hatakeyama is not used to teach the entire film, only the inclusion of a π -conjugated polymer. As described above, Hatakeyama ‘897 teaches that utilizing a conductive material formed of a composite between a dopant polymer and a π-conjugated polymer with a gold or silver nanowire forms a conductive material that has excellent conductivity, transparency, flatness, flexibility, durability, and low surface roughness ([0027]-[0030]). While not specifically directed towards a bioelectrode, all of the benefits of the conductive material of Hatakeyama ‘897 would positively impact the bioelectrode of the Hatakeyama/Hatakeyama ‘665 combination and because the repeating units that form the respective polymers have identical subunit options, the combination would not be rendered inoperable. 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 layer of the Hatakeyama/Hatakeyama ‘665 combination with the conductive layer of Hatakeyama ‘897 to form a layer with composed of a π-conjugated polymer and a dopant polymer that results in excellent conductivity, transparency, flatness, flexibility, and durability as well as low surface roughness.
Applicant’s arguments that Hatakeyama and Hatakeyama ‘665 do not teach the material containing an acid while Hatakeyama ‘897 does not disclose using a material with a repeating unit containing a salt is not persuasive. Hatakeyama ‘897 clearly states that the monomer that constitutes the dopant polymer of the component (B) may use a sulfo group. Alternatively, a monomer having a lithium salt, sodium salt, potassium salt, ammonium salt, or a sulfonium salt of a sulfo group may be used ([0072]). This is just like Hatakeyama and Hatakeyama ‘665 which use sodium, potassium, and ammonium salts in the dopant polymer. Thus, it would be obvious to one of ordinary skill in the art to utilize a hydrogen ion in place of a sodium, potassium, or ammonium ion since Hatakeyama ‘897 clearly teaches that a hydrogen ion is a known alternative to the other salts. Therefore, the combination is proper.
Therefore, the combination of Hatakeyama, Hatakeyama ‘665, and Hatakeyama ‘897 is a proper combination that discloses all of the limitations of claim 1 and the dependent claims as described above.
The rejections of dependent claims remain because the rejection of the independent claim 1 is maintained.
Conclusion
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/W.M./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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