DETAILED ACTION
This action is pursuant to claims filed on 12/3/2025. Claims 1 and 4-7 are pending. A final action on the merits of claims 1 and 4-7 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 § 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 and 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over Ishikubo et al. (hereinafter ‘Ishikubo’, US 20230355152 A1) in view of Hatakeyama et al. (hereinafter ‘Hatakeyama’, US 20190209740 A1) and in further view of Fujishita (US 20190276629 A1).
Regarding claim 1, Ishikubo discloses a bioelectrode (bioelectrode 100 in Fig. 1A) comprising a layered structure (layered structure clear in Fig. 1A) of a fiber base layer ([0036]: the base layer may be made of fabric – fabric is inherently fibrous) composed of non-conductive fibers ([0059]: the fabric is made of twisted yarn by knitting or weaving; [0036] – [0037]: the base is made of leather, foam, fabric, rubber or any suitable material and forms the a steering wheel cover and I s a decorative member capable of presenting an external appearance surface of the steering wheel or vehicle interior component; [0038]: the base is coated with a conductive layer – therefore, the base layer fibers are inherently non-conductive because it must be coated with conductive particles in order to function as an electrode) and a conductive layer (conductive layer 121 in Fig. 1A and 1B), wherein the conductive layer is formed of a conductive material comprising carbon ([0041]: carbon can be used as the conductive filler 121a in conductive layer 121; [0054]: the carbon filler can form the layer in black), urethane resin ([0043]: the matrix 121b of the conductive layer can be made of the combination of polyurethane polyol and isocyanate which together form a urethane resin), and a solvent ([0043]: dispersibility, coatability, and viscosity can be adjusted by adding a solvent),
wherein the fiber base layer is in a form selected from the group consisting of woven fabric, knitted fabric, and non-woven fabric ([0059]: the fabric forming the base layer is made of twisted yarn by knitting or weaving),
wherein the bioelectrode further comprises a mixed layer (layer 130 in Fig. 1A) in which fibers and a conductive material are mixed ([0055]-[0056]: the underlayer 130 permeates into the base 110 and the conductive layer can merge with the underlayer 130 such that the boundary cannot be discerned; therefore, the layer 130 has both conductive material and fibers dispersed in the layer thus they are mixed because the claim does not state how or to what extent the fibers and conductive materials mix within the layer), the mixed layer located between the fiber base layer and the conductive layer (layer 130 is located between the base and conductive layer as seen in Fig. 1A),
wherein a thickness of the conductive layer is 1 to 200 micrometers ([0015]: the thickness of the first conductive layer is to 100 µm or less), and
wherein the bioelectrode has a static friction resistance (Fs) of 0.16 N/cm2 or more (the static friction resistance is not simply a property of the layer, but is dependent upon the friction coefficient of the surface of the electrode and the force applied to the electrode – thus, the static friction resistance is a functional result of use; [0049]: the surface layer of the electrode is made of a carbon in a silicone binder – silicone has a high coefficient of friction, approximately 1 as evidenced by Jehbco Silicones; therefore, since the claim limitation is based off of the use of the device, the static friction resistance of the electrode can be well over 0.16 N/cm2 when the silicone surface of the electrode is contacted with sufficient force).
However, Ishikubo is silent to the carbon filler being specifically carbon black.
Hatakeyama teaches a bioelectrode having a urethane-based coating doped with carbon material disposed on a base material 2 ([0123]). The base material of the device may further be a cloth coated with an electroconductive paste, extremely similar to the device of Ishikubo ([0127]). Hatakeyama further discloses that the carbon material which improves the electric conductivity preferably be carbon black, carbon nanotube, or a combination thereof ([0116]). The substitution of one known element (the carbon black of Hatakeyama) for another (the generic carbon of Ishikubo) would have been obvious to one of ordinary skill in the art at the time of the invention since the substitution of the carbon black shown in Hatakeyama would have yielded similar and predictable results to the carbon filler of Ishikubo, namely, providing a conductive means in a urethane resin for sensing purposes.
However, the Ishikubo/Hatakeyama combination is silent to the solvent being a water-based thickener.
Fujishita teaches a method of forming a porous body utilizing a urethane resin and a thickener ([Abstract]). Fujishita further teaches that the urethane resin can be modified with a thickener selected from the group consisting of carboxymethyl cellulose, a polyacrylic acid salt, and a polymerization product of (meth)acrylic acid and (a) an (meth)acrylic acid ester ([0094]). Utilizing a thickener in combination with the urethane resin allows for the flexibility, moisture permeability, and wear resistance to be improved ([0094]). While not particularly directed towards a bioelectrode, Fujishita is directed towards improving the performance capabilities of a urethane resin layer which can be used as a coating agent ([0002]). Because Ishikubo contemplates the use of a solvent in the urethane resin to modify the properties of the layer, such as viscosity, it would be of routine skill in the art to combine the thickening agent of Fujishita with the conductive layer of Ishikubo. 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 thickening agent of Fujishita with the urethane resin layer of Ishikubo such that the resulting conductive layer exhibits superior performance capabilities.
In Fig. 1A of Ishikubo, the thickness of the mixed layer 130 is less than 50% of the total thickness and is above 0.5% of the total thickness, if the drawings are drawn to scale. Ishikubo further states that the layer 130 is mixed with the conductive and base layers to ensure adhesion between the layers ([0055]-[0057]). Additionally, Ishikubo also states that the mixed layer 130 is made of the same polymer matrix as the conductive layer 121.
However, the Ishikubo/Hatakeyama/Fujishita does not explicitly state a percentage of the mixed layer, which is a value obtained by dividing a thickness value of the mixed layer by a total value of each thickness of the conductive layer, the mixed layer, and the fiber base layer provided in the bioelectrode and multiplying a resultant value by 100, is in a range between 0.5 to 50%.
The viscosity of the mixed layer 130 is also modified through the addition of the thickening agent as taught by Fujishita since it is formed of the same polymer matrix. Furthermore, the thickness of the mixed layer 130 depends on the coatability and viscosity of the mixed layer as that determines how far it would penetrate into the base fabric layer. Thus, adjusting the viscosity of the polymer matrix directly effects the thickness of the mixed layer. Furthermore, the instant application does not provide criticality to the thickness of the layer since the percentage of the mixed layer can be anywhere between 0.1% and 80% and does not state any unexpected effects for the layer to be the claimed thickness percentage ([0060]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to set the percentage of the mixed layer to be between 0.5 to 50%, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify the thickness of the polymer matrix such that the percentage of the mixed layer is set to be between 0.5 to 50% since it is merely a result of adjusting the viscosity of the layer and no criticality is provided in the instant application to that thickness percentage.
Regarding claim 4, the Ishikubo/Hatakeyama/Fujishita combination discloses the bioelectrode according to claim 1,wherein the water-based thickener is a polyacrylic acid-based compound (Fujishita [0094]: the thickener is a polyacrylic acid salt; [0075]: the polyacrylic acid salt is a polymerization product of at least one compound of acrylic acid).
Regarding claim 5, the Ishikubo/Hatakeyama/Fujishita combination discloses the bioelectrode according to claim 1 as described above.
Hatakeyama further teaches utilizing a urethane resin formed by the reaction of an isocyanate compound and polyether having hydroxy groups at the terminals. This creates a polyurethane resin in which a polyether group is introduced to impart excellent flexibility. This allows the bioelectrode to maintain better contact with the skin to facilitate signal acquisition ([0059]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify the urethane resin with a polyether in order to improve flexibility and signal acquisition.
Regarding claim 6, the Ishikubo/Hatakeyama/Fujishita combination discloses the bioelectrode according to claim 1, wherein a volume resistivity of the bioelectrode is 1 x 106 Ω*cm or less (this is an inherent property of the bioelectrode of the Ishikubo/Hatakeyama/Fujishita combination which discloses the claimed structure of the bioelectrode substantially as described above. Therefore, because the structure recited in the claim is substantially identical to the reference, the claimed properties are presumed to be inherent. See MPEP 2112.01).
Furthermore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to set the volume resistivity of the bioelectrode to 1 x 106 Ω*cm or less, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over the Ishikubo/Hatakeyama/Fujishita combination as applied to claim 1, in further view of Zukoshi (US 20230109551 A1).
Regarding claim 7, the Ishikubo/Hatakeyama/Fujishita combination discloses the bioelectrode according to claim 1. Ishikubo further discloses that the base fabric can form the cover of a steering wheel ([0037]).
However, the combination is silent to the specific type of fabric.
Zukoshi teaches a steering wheel cover that is easy to attach to a steering wheel ([Abstract]). The fabric steering wheel cover provides a secure grip comfort and safety after attaching the steering wheel cover ([0016]). The material of the fabric includes synthetic leather, leather, vinyl, polyester, cotton and the like ([0039]). While not particularly directed towards a bioelectrode, Zukoshi is directed towards improving the performance capabilities of a steering wheel cover, which is also a goal of Ishikubo (Ishikubo [0036]: material of base is selected for texture and tactile feel). Furthermore, the surface resistivity of polyester, also known as PET, is 1013 Ohm/sq as evidenced by Phoenix Technologies (Phoenix Technologies International LLC, “Polyethylene terephthalate Key Properties”). It is within routine skill in the art to choose any of the known materials for a steering wheel cover and choosing a particular material with the claimed surface resistance value to provide electrical insulation, involves routine skill in the art. 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 polyester steering wheel cover for the base material of the Ishikubo/Hatakeyama/Fujishita combination to improve comfort and grip to the user, resulting in a base material that has a surface resistance greater than 1010 Ohms.
Response to Arguments
Applicant's arguments filed 12/3/2025 have been fully considered but they are not persuasive.
Applicant initially argues that Ishikubo teaches away from the claimed invention because it teaches a contrary teaching of diluting a solvent. This argument is not persuasive. Ishikubo states that solvents can be utilizes a solvent to adjust the viscosity ([0043]). Adjusting the viscosity can be thickening or thinning the conductive paste, based on specific need. Coatability and dispersibility can be improved by thickening a solution if the solution is too thin prior to printing. Solvents can also be used as both thinning agents and thickening agents. Ishikubo makes no statement that a thicker paste would be detrimental to the device or render the manufacturing method inoperable. In fact, it is routine in the art to thicken pastes for printing if they are too thin to start. Therefore, because Ishikubo makes no statements regarding a thicker paste being detrimental or thinner paste being preferred, Ishikubo does not teach away from adding a thickening agent as taught by Fujishita and it would be obvious to use a thickening agent in the urethane resin of Ishikubo such that the resulting conductive layer exhibits superior performance capabilities as taught by Fujishita.
Applicant further argues that it would not be obvious to modify Ishikubo as taught by Hatakeyama because Hatakeyama does not teach a second conductive layer. This argument is not persuasive. Hatakeyama is not used to teach a base layer coated with a conductive layer, even though Hatakeyama discloses that exact structure (Hatakeyama [0127]: base can be cloth coated with a conductive paste). Hatakeyama is simply used to teach that carbon black is a known conductive filler alternative to simple carbon. Regardless of how the conductive paste is combined with the base material, the carbon black is one of several carbon types taught by Hatakeyama to provide conductivity in a urethane resin paste. The substitution of one known element (the carbon black of Hatakeyama) for another (the generic carbon of Ishikubo) would have been obvious to one of ordinary skill in the art at the time of the invention since the substitution of the carbon black shown in Hatakeyama would have yielded similar and predictable results to the carbon filler of Ishikubo, namely, providing a conductive means in a urethane resin for sensing purposes. Therefore, the rejection remains.
Applicants arguments regarding Ishikubo not teaching the claimed mixed layer are also not persuasive. Applicant argues that the layer 130 does not constitute a layer in which fibers and a conductive material are mixed. The clearly states “a mixed layer in which fibers and a conductive material are mixed, the mixed layer being located between the fiber base layer and the conductive layer.” This claim language indicates that the “mixed layer” is a distinct layer which contains fibers and conductive materials. Mixed is a very broad term and both fibers and conductive particles being present is a mixture. The claim does not state how the fibers and conductive particles are dispersed in the layer. Ishikubo explicitly states the underlayer 130 permeates into the base 110 and the conductive layer can merge with the underlayer 130 such that the boundary cannot be discerned ([0055]-[0056]). Applicant’s statement that this Ishikubo does not state this is incorrect. In paragraph [0055], Ishikubo states, “the underlayer 130 permeates into the inside of the base 110 as in the case of the base 110 being made of natural leather, synthetic leather, or fabric, the term “underlayer 130” indicates a layer including a permeated portion as well.” Further, in paragraph [0056], Ishikubo states, “by forming the underlayer 130 with use of the same matrix as that of the first conductive layer 121, the first conductive layer 121 and the underlayer 130 are integrated into an inseparable state, and adhesion between both the layers can be maintained even when they are extended […] there is a possibility that the first conductive layer 121 and the underlayer 130 merge with each other and a boundary between both the layers cannot be discerned.” Ishikubo is very clear that the layer 130 merges with both the base layer and the conductive layer. The layer 130 has both conductive material and fibers dispersed in the layer, thus the fibers and conductive materials are both mixed within the layer 130. The claim does not require that the conductive particles and fibers be mixed with each other. The fibers are mixed in the base of the mixed layer and the conductive particles are mixed at the top of the mixed layer. Both fibers and a conductive material are mixed inside of a mixed layer, they are just mixed in different areas. The claim requires that be a distinct layer between the base and the conductive layer in which both fibers are mixed and a conductive material is mixed. It is not claimed as a section in which the conductive material permeates into the base layer. Therefore, the rejection remains.
Applicant’s arguments regarding the mixed layer ration are not persuasive. Modifying the thickness of the polymer matrix such that the percentage of the mixed layer is set to be between 0.5 to 50% since it is merely a result of adjusting the viscosity of the layer. The claimed range is extremely broad, 0.5% up to 50%. The specification even states that the percentage of the mixed layer can be 0.1% to 80% (Instant Application [0011]). This is a very broad range. Indicating a lack of criticality. This mixed layer of Ishikubo is clearly less than 100% of the thickness of the device as seen in Fig. 1A and described in paragraphs [0055]-[0056] because while the layer 130 penetrates into the layers, it does not penetrate completely through both layers, thus it is under 100% of the thickness. Furthermore, while the applicant states that a mixed layer of 57% had a larger resistance value and inferior conductivity and a mixed layer of 0.4% had inferior peel strength, these are considered acceptable since the Applicant’s own disclosure states that the mixed layer can be 0.1% up to 80% of the thickness of the device. Thus, while 0.5% up to 50% is preferred, it is not critical. Additionally, in paragraphs [0055]-[0056], Ishikubo states that having the underlayer 130 being made of the same polymer matrix as the conductive layer and penetrating into the base layer improves adhesion between the layers. Additionally, Fig. 1A of Ishikubo clearly shows that the mixed layer is between the claimed 0.5% and 50% thickness percentage. Thus, it is expected that mixing the layers improves adhesion between the layers, so it is not persuasive that this percentage yields an unexpected adhesion force. It is also obvious that if the layers were to be mixed at 100%, the resistance would increase since the base is an insulator, which is also an expected result. Neither of these are unexpected results. It would have been obvious to one having ordinary skill in the art at the time the invention was made to set the percentage of the mixed layer to be between 0.5 to 50%, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify the thickness of the polymer matrix such that the percentage of the mixed layer is set to be between 0.5 to 50% since it is merely a result of adjusting the viscosity of the layer and no criticality is provided in the instant application to that thickness percentage as indicated by the very large range disclosed.
Applicant’s arguments regarding the claimed static friction resistance are not persuasive. Applicant argues that a skilled person in the art would not have recognized the benefits of achieving a static friction resistance of 0.16 N/cm2 or more. This is not persuasive. The static friction resistance is not simply a property of the layer, but is dependent upon the friction coefficient of the surface of the electrode and the force applied to the electrode. Thus, the static friction resistance is a functional result of use. Ishikubo, in paragraph [0049], discloses that the surface layer of the bioelectrode is made of a carbon in a silicone binder. Silicone has a high coefficient of friction, approximately 1 as evidenced by Jehbco Silicones. Even a applying a small force to this layer would yield a static friction resistance greater than the claimed range. Therefore, since the claim limitation is based off of the use of the device, the static friction resistance of the electrode can be well over 0.16 N/cm2 when the silicone surface of the electrode is contacted with sufficient force.
Therefore, the rejection of claim 1 remains and thus the rejections of the independent claims remain.
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