DETAILED ACTION
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
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.
Claims 1-4 and 8-12 are rejected under 35 U.S.C. 103 as being unpatentable over Hatakeyama et al. US 2018/0229023 A1 in view of Ramjit et al. US 2014/0303261 A1, and further in view of Futashima et al. US 2020/0275853 A1, with evidence from Surfactant Technology Platform Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone - Surfactant - SAAPedia - Surfactant Technology Platform, dated 2012-10-14. (Year: 2012).
Hatakeyama discloses a bioelectrode with incorporates adhesive and elastic polymers, used for medical wearable devices (para [0046])
Reference Ramjit teaches an adhesive composition used for a medical device (abstract), which include electrodes (para [0004]).
Reference Futashima describes a bioelectrode and wearables for health monitoring devices (para [0053])
Hatakeyama discloses (page 66, see reference claim 1) a bio-electrode composition comprising an ionic material (A) and a (B) resin other than the component (A). Where the component (A) has a repeating unit “a” which can be a sodium salt, a potassium salt or an ammonium salt of N-carbonyl sulfonamide having a structure represented by formula (1) -R1-C(=O)-N--SO2-Rf1M+.
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Regarding claims 1-3 and 8-9, Hatakeyama discloses (see reference claims 2 and 9) the polymer compound with the repeating units “a” represented by the general formula as depicted below:
Wherein, R2 represents either a hydrogen atom or a methyl group, Rf1 represents a linear or a branched alkyl group or a phenyl group having 1 to 4 carbon atoms, having one or more fluorine atoms or a trifluoromethyl group; M+ represents any of a sodium ion, a potassium ion or an ammonium ion; R1 represent a single bond, or a linear, a branched, or a cyclic divalent hydrocarbon group having 1 to 40 carbon atoms, etc.
Hatakeyama’s repeat unit “a” meets the requirement of polymer compound (A) which is a N-carbonyl fluorosulfonamide as required by instant claim 1, that of repeat unit (1)-4 as required by claim 2, and repeat units a7 as required by instant claim 3.
Hatakeyama further discloses (page 68, see reference claim 9) that component (B) of the bio-electrode composition comprises a silicone resin having a RxSiO(4-x)/2 unit, wherein R represents a substituted or an unsubstituted monovalent hydrocarbon group having 1 to 10 carbon atoms, and x represents a number of 2.5 to 3.5, and a SiO2 unit, diorganosiloxane having an alkenyl group, and organohydrogen polysiloxane having a SiH group, thus meeting the claimed requirements of resin component (D) as required by instant claims 8 and 9.
Hatakeyama creates an adhesive film from the polymer compositions for contact with skin (paras [0001] and [0182]). Hatekeyama is silent on the presence of filler particles and on the polyglycerin silicone compound, however notes that variations and modifications are within the scope of the invention (paras [0189]-[0190]), thus encouraging a skilled artisan to look to analogous art such as Ramjit to optimize the adhesive film composition. Like Hatakeyama, Ramjit teaches adhesive compositions applicable to skin (abstract), and teaches incorporation of silica particles (paras [0020] –[0023] and [0105]) in the adhesive, to improve skin friendliness and residue-free detachment after application (paras [0001] and [0106]).
Analogous art Futashima teaches a bioelectrode comprising a silver coating layer which contains a modified silicone such as a polyglycerin-modified silicone (paras [0007], [0008] and [0009]). Futashima discloses (Futashima, para [0073]) polyglycerin-modified silicone (KF-6106, manufactured by Shin-Etsu Chemical Co., Ltd) as the modified silicone. Shin-Etsu’s website further provides information and evidence that KF-6106 is a polyglyceryl -3 polydimethylsiloxyethyl dimethicone. The structure support is provided by Surfactant Technology Platform, which provides the schematic formula of polyglyceryl -3 polydimethylsiloxyethyl dimethicone to be as highlighted below:
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The structure as provided above is readily envisioned to meet the claimed requirement of structure (4) and (4)-1, where R1’ and R3’ are C1 carbon atoms, R4’ is either R1’ group (C1 carbon atom) or an oxygen atom, the R4’ moieties bond to each other. R2’ represents a group having a polygylcerin group structure shown by formula (4)-1; R5’ is alkylene group with 3 carbon atoms, c’ is 0 and d’ is 3.
Advantageously, Futashima provides the motivation (paras [0025]-[0028]) to utilize modified silicone such as polyglycerin-modified silicone as it acts as an electrical conductivity improving material, by providing a path for migration of the ions. The bioelectrode which is derived from a modified silicone has excellent flexibility (para [0062]). Thus, even when fitted for a long period, the bioeletrode causes no discomfort and can suitably conform to movements of a living body while maintaining satisfactory electrical conductivity.
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the invention to have incorporated in Hatekeyama’s composition the silica particles as fillers as taught by Ramjit and further have added polyglycerin-modified silicone (KF-6106) as taught by Futashima, to create a bioelectrode adhesive composition with improved skin friendliness and enhanced flexibility.
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Regarding claim 4, Hatekeyama teaches (see reference claim 5) a bio-electrode composition wherein the component (A) comprises an ammonium ion represented by the following general formula as the M+, structure presented below, which corresponds to the required formula (3).
Regarding claim 10, Hatakeyama discloses bio-electrode composition comprising an organic solvent, thus meeting the claimed requirement (page 68, reference claim 10).
Regarding claims 11 and 12, Hatakeyama discloses carbon black and/or carbon nanotube, thus meeting the claimed requirements (page 68, reference claim 12).
Response to Arguments
Applicant's declaration and arguments filed on 03/04/2026 have been fully considered but they are not persuasive.
Applicant discusses in the Remarks (page 11, 2nd and 3rd para) that the bioelectrode composition enables quick signal collection, causes no skin residue, and provides excellent moisture-holding property, which is attributed to the presence of filler particles and silicone compound having a polyglycerin structure.
Applicant’s arguments against the reference combination of Hatekeyama and Ishikawa (Remarks, page 12, first four paras) have been considered but are moot because the new ground of rejection does not rely on Ishikawa for any teaching or matter specifically challenged in the remarks.
As discussed in the main rejection, the new ground of rejection is now based on the combination of Hatekeyama, Ramjit and Futashima, where Hatekeyama teaches the bioelectrode composition with the required polymer compound (A), Ramjit teaches silica particles corresponding to applicant’s (B) and Futashima discloses the silicone compound (C) with the polyglycerin structure, where each secondary reference provides appropriate motivation to a person skilled in the art. Reference Ramjit advocates incorporation of silica particles to generate residue free detachment of an adhesive composition (Ramjit para [0001]) while Futashima recommends the use of silicone with polyglycerin structure for improved conductivity and flexibility (Futashima paras [0025]-[0028]). Futashima’s silicone compound would inherently possess the moisture retention due to the polyglycerin moieties, which are known to be hygroscopic. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
The new experimental data as provided in the declaration under 37 C.F.R. §1.132 is acknowledged, where the applicant has provided a complete data set of the bioelectrode composition where all the variables are kept constant, which include the ionic materials, filler particles, polyglycerin-silicone compounds, resins, organic solvents and additives, which are compositions 43-46 [Table 1]. Comparative bio-electrode composition just has the absence of inorganic particles and demonstrates no difference in the average time until ECG signal appears with respect to Examples 1-4, but shows the presence of residue on skin after the electrodes were peeled from the skin ([Table 2] and Figs 1 and 2).
In response to applicant’s arguments and the new data set provided in the declaration, as discussed above the combination of Hatekeyama, Ramjit and Futashima teach the inclusion of silica particles in the adhesive composition, where the role of silica particles is specifically to offer skin friendly use, so that the adhesive can be peeled without a skin residue (see Ramjit paras [0001], [0023] and [0106]). Thus, utilization of filler particles such as silica in the bioelectrode composition to achieve no skin residue would be an expected outcome. "Expected beneficial results are evidence of obviousness of a claimed invention, just as unexpected results are evidence of unobviousness thereof." In re Gershon, 372 F.2d 535, 538, 152 USPQ 602, 604 (CCPA 1967). The evidence presented is insufficient to rebut the prima facie case because the experiments do not support unexpected results and thus are not commensurate in scope with the claimed invention. See MPEP 716.02 (c) II. and 716.02(d). Applicant’s arguments and the new data set of the declaration, are therefore not convincing, and the absence of skin residue upon peeling the electrode, is found to be not novel.
The prior art combination of Hatekeyama, Ramjit and Futashima, teaches the required ionic polymer, filler and the polyglycerin silicone compound, corresponding to applicant’s (A), (B) and (C) where the final bioelectrode would attain similar property profile as the instant specification, and therefore the rejection is maintained.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/HEIDI R KELLEY/Supervisory Patent Examiner, Art Unit 1765
/S.M.D./
Examiner
Art Unit 1765
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