DETAILED ACTION
This action is pursuant to the claims filed on 11/05/2025. Claims 1-17 and 22 are pending. A final action on the merits of claims 1-17 and 22 is as follows.
Response to Amendment
Applicant’s amendment to the claims are acknowledged and entered accordingly.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-2, 8, 17, and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Naier (U.S. PGPub No. 2019/0048193) in view of Takaki (WO 01/48111).
Regarding claim 1, Naier teaches An electrode (Figs 1-3), comprising: (A) a conductive pressure sensitive adhesive layer (adhesive hydrogel 3; [0006] [0078] [0093] disclosing hydrogel as adhesive), which comprises components: (A1) at least one (meth)acrylic polymer, which is obtained by polymerizing (meth)acrylic monomers ([0032-0040] hydrogel comprises a methacrylic polymer formed from repeating units of methacrylic monomers which define the monomers), optionally with vinyl monomers, wherein at least 10 wt.-% of the (meth)acrylic monomers contain at least one –OH group, wt.-% being based on total weight of the (meth)acrylic polymer ([0038] discloses additional monomers including a monomer containing an -OH group; [0051] additional monomers are 15 to 35 wt% of total polymer); (A2) at least one ionic liquid ([0025] functionalized monomers are ionic liquids); (A3) optionally at least one ionic conductivity promoter different from (A2) and (A4); (A4) optionally at least one electrically conductive particle; (A5) optionally at least one polyol; and (A6) optionally at least one solvent; (B) a conductive layer, which is in contact with the conductive pressure sensitive adhesive layer (A) (electrical lead element 5); (C) optionally a substrate, which is in contact with the conductive layer (B); and (D) optionally a release liner, which is in contact with the conductive pressure sensitive adhesive layer (A). Examiner notes above limitations preceded with “optionally” need not be taught by the prior art to read upon the claim.
Naier is silent to the wt% of water within the electrode, thus failing to teach wherein the electrode contains no more than 2 wt% of water.
In related prior art, Takaki teaches a similar electrode wherein the water wt% of a conductive adhesive is between 2 to 50% (see Pg 9). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the adhesive hydrogel of Naier in view of Tanaki to incorporate the conductive adhesive with 2 wt% of water in the electrode to arrive at claim 1. Doing so would advantageously provide a conductive adhesive an increased cohesive force and adhesion property (Pg 12). Furthermore, applicant appears to have placed no criticality on the claimed range and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In reWertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In reWoodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). In the instant case, Tanaki discloses a range of water wt% between 2 and 50% with the known result effective variables of moisturizing performance, conductivity, adhesion, and cohesion.
Regarding claim 2, in view of the combination of claim 1 above, Naier teaches wherein the (meth)acrylic monomers polymerized to form the at least one (meth)acrylic polymer (A1) are selected from methyl (meth)acrylate, hydroxyethyl acrylate, hydroxypropyl acrylate, hydroxybutyl acrylate, butyl acrylate, ethylhexylacrylate, acrylic acid, C2-C18 alkyl (meth)acrylate, (meth)acrylamide ([0037]); cyclohexyl (meth)acrylate, glycidyl (meth)acrylate, benzyl (meth)acrylate and combinations thereof; and the (meth)acrylic monomers containing at least one –OH group are present in an amount of at least 15 wt.-% and at most 65 wt.-%, based on the total weight of the acrylic polymer ([0051]). Therefore it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Naier to use at least one methacrylamide monomer and have the monomers containing at least one -OH group present in an amount of at least 15 to 65 wt% to arrive at claim 2 as applicant appears to have placed no criticality on the claimed range and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In reWertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In reWoodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 8, in view of the combination of claim 1 above, Naier teaches wherein the at least one (meth)acrylic polymer (A1) is present in an amount of 10 to 99 wt.-% ([0050-0052] total weight of additional monomers and cross-linked repetitive units is within 10-99 wt%) and the ionic liquid (A2) is present in an amount of 0.5 to 50 wt.-%, based on total weight of the conductive pressure sensitive adhesive layer (A) ([0050] functionalized monomers are in hydrogel at 1 to 10 wt%).
Naier fails to explicitly teach an exact weight % of the polymer in the conductive PSA layer.
Therefore it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Naier to use a wt % of 10 to 99% of the methacrylic polymer as applicant appears to have placed no criticality on the claimed range and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In reWertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In reWoodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 17, Naier teaches wherein the electrode does not contain more than 0.5 wt.-% of a hydrogel, based on total weight of the electrode; and does not contain more than 0.5 wt.-% of an aqueous electrolyte paste, based on the total weight of the electrode (Figs 1-3, electrode does not contain additional hydrogel, thus the electrode does not contain more than 0.5 wt% of a hydrogel or aqueous electrolyte paste; Examiner notes, while Naier denotes reference character 3 as a “conductive hydrogel”, this structure is mapped to and reads on the “pressure sensitive adhesive” of claim 1, and thus cannot be mapped to a distinct “hydrogel” or “aqueous electrolyte paste” as recited in claim 17).
Regarding claim 22, Naier/Takaki teach A method of monitoring biosignals comprising steps of: obtaining the electrode according to claim 1 (see rejection of claim 1 above); after removal of the release liner, if present, from the electrode ([0086] removing masking film 2), applying the conductive pressure sensitive adhesive layer of the electrode to skin such that the electrode is removably adhered to the skin ([0093]); and monitoring biosignals from the skin via the electrode (see Fig 4a [0076]).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Naier in view of Takaki, and in further view of Kawamura (U.S. PGPub No. 2008/0131488).
Regarding claim 3, Naier/Takaki teaches the device of claim 1 as stated above.
Naier fails to teach wherein the (meth)acrylic monomers polymerized to form the at least one (meth)acrylic polymer (A1) comprise hydroxyethyl acrylate and at least one of methyl (meth)acrylate, butyl acrylate, and ethylhexylacrylate; wherein the vinyl monomers, if present are selected from vinyl acetate, N-vinyl caprolactam, acrylonitrile, vinyl ether and combinations thereof.
In related prior art, Kawamura teaches a similar device wherein preferred copolymers for a pressure sensitive adhesive include hydroxyethyl acrylate ([0022]) and at least one of methyl (meth)acrylate, butyl acrylate, and ethylhexylacrylate ([0022] copolymer comprises hydroxyethyl acrylate and butyl acrylate). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the monomers of Naier in view of Kawamura to incorporate the hydroxyethyl acrylate and butyl acrylate to arrive at claim 3. Doing so would be obvious to one of ordinary skill in the art as hydroxyethyl acrylate and butyl acrylate are well-known monomers in the art to form a copolymer for pressure sensitive adhesives ([0022]).
Claim(s) 4, 10, and 12-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Naier in view of Takaki, and Hatakeyama (U.S. PGPub No. 2018/0229023).
Regarding claims 4, Naier/Takaki teaches the device of claim 1 as stated above.
Naier fails to teach the ionic liquid as claimed in claim 4.
In related prior art, Hatakeyama teaches a similar device wherein an ionic liquid comprises at least one of an imidazolium salt, a choline salt, a pyridinium salt, a pyrrolidinium salt, a phosphonium salt, a sulfonium salt and optionally an ammonium salt ([0054]); based on total weight of the conductive pressure sensitive adhesive layer (wt % of salt is necessarily based on a total weight of the PSA). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Naier in view of Takaki and Hatakeyama to incorporate a ammonium salt to arrive at claim 4. Doing so would advantageously incorporate a salt that provides high ion conductivity and lower reactivity to the skin ([0054]).
Regarding claim 15, Naier/Takaki/Hatakeyama teaches the device of claim 4 as stated above. Naier further teaches wherein the conductive layer (B) is the only conductive layer contained in the electrode in addition to the conductive pressure sensitive adhesive layer (Fig 1, lead element 5 is only other conductive layer besides hydrogel 3 when the device is standalone and not connected to external connector button 4).
Naier fails to teach wherein the conductive layer comprises Ag/AgCl
Hatakeyama teaches the similar device comprising a similar conductive layer (B) comprises Ag/AgCl (Fig 2 conductive substrate 2; [0139] comprising silver, silver chloride) and is the only conductive layer contained in the electrode in addition to the conductive pressure sensitive adhesive layer (Fig 2, substrate 2 is only other layer outside of hydrogel 3). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the conductive layer of Naier in view of Hatakeyama to incorporate the Ag/AgCl material. Doing so would have been obvious to one of ordinary skill in the art as Ag/AgCl is one of many well-known conductive materials for yielding predictable results therein ([0139]).
Regarding claims 10, Naier/Takaki teaches the device of claim 1 as stated above.
Naier fails to teach the electrically conductive particle of claim 10.
Hatakeyama teaches a similar device wherein the at least one electrically conductive particle (A4) is present in an amount of 0.1 to 35% by weight of total weight of the composition and is selected from the group consisting of metal (nano)particles, graphite (nano)particles, carbon (nano)particles, carbon nanowires, conductive polymer (nano)particles, and mixtures thereof ([0130] carbon nanotube disclosed as being 1 to 50 parts by mass relative to 100 parts by mass of a polymer). Therefore it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Naier in view of Hatakeyama to incorporate a carbon nanotube between 0.1 to 35 % by weight as applicant appears to have placed no criticality on the claimed range and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In reWertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In reWoodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Furthermore, providing the carbon nanotube would advantageously improve conductivity of the device ([0130]).
Regarding claims 12, Naier/Takaki teaches the device of claim 1 as stated above.
Naier fails to teach the solvent as claimed.
Hatakeyama teaches wherein the solvent is present in an amount of 0.001 to 5 wt.-%, based on the total weight of the conductive pressure sensitive adhesive layer (A) ([0128-0129] solvent is added 10 to 50,000 parts by mass relative to 100 parts by mass of a polymer). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Naier in view of Hatakeyama to incorporate a solvent. Doing so would be obvious to one of ordinary skill in the art as the use of solvents is well-known in the art to yield predictable results therein. Furthermore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use the solvent in an amount of 0.001 to 5 wt% as applicant appears to have placed no criticality on the claimed range and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In reWertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In reWoodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claims 13, Naier/Takaki teaches the device of claim 1 as stated above.
Naier fails to teach wherein the conductive pressure sensitive adhesive layer (A) has: (i) a thickness of 1 to 200 µm; and (ii) an impedance value of 101 to 107Ω at 10 Hz.
Hatakeyama teaches wherein the conductive pressure sensitive adhesive layer (A) has: (i) a thickness of 1 to 200 µm ([0143]) and (ii) an impedance value of 101 to 107Ω at 10 Hz ([0183] Table 3, impedance of each example is between 10 and 10^7 ohms). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Naier in view of Hatakeyama to incorporate a thickness of the PSA between 1 to 200 micrometers and an impedance value of 101 to 107Ω at 10 Hz to arrive at claim 13. Doing so would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention as applicant appears to have placed no criticality on the claimed range and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In reWertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In reWoodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 14, Naier/Takaki teaches the device of claim 1 as stated above.
Naier fails to teach wherein the conductive layer has a thickness of 0.1 to 500 µm; and is selected from a metal layer, a metal salt layer, a carbon layer and mixtures thereof.
Hatakeyama teaches the similar device comprising has a thickness of 0.1 to 500 µm; and is selected from a metal layer, a metal salt layer, a carbon layer and mixtures thereof (Fig 2 conductive substrate 2 [0139]; [0181] discloses aluminaum substrate 0.2 mm thick (equal to 200 micrometers)). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the conductive layer of Naier in view of Hatakeyama to incorporate 200 micrometer thick metal layer to arrive at claim 14. Doing so would have been obvious to one of ordinary skill in the art as aluminum is one of many well-known conductive materials for yielding predictable results therein ([0139] [0181]).
Claim(s) 5-7, 9, 11, and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Naier in view of Takaki, and Amano (U.S. PGPub No. 2006/0024494).
Regarding claims 5-7, Naier/Takaki teaches the device of claim 1 as stated above.
Naier fails to teach the ionic liquid as claimed in claims 5-7 respectively.
In related prior art, Amano teaches a similar device comprising a pressure sensitive adhesive having an ionic liquid comprising imidazolium acetates including 1-ethyl-3-methylimidazolium acetate ([0076-0077] ionic liquid includes 1-ethyl-3-methyl imidazolium acetate). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Naier in view of Amano to incorporate the imidazolium acetate salt to arrive at claims 5-7 respectively. Doing so would advantageously provide a well-known ionic liquid ([0076-0077] establishing the imidazolium acetate as well-known) to yield the predictable result of an ionic liquid within the pressure sensitive adhesive that provides increased stability and conductivity to the PSA ([0016-0019]).
Regarding claims 9, Naier/Takaki teaches the device of claim 1 as stated above.
Naier fails to teach the ionic conductivity promoter of claim 9.
Amano further teaches wherein the at least one ionic conductivity promoter (A3), different from (A2) and (A4), is present in an amount of 0.1 to 30 wt.-%, based on total weight of the conductive pressure sensitive adhesive layer ([0252] electrification preventing agent is 0.05 to 10 wt%); and is selected from choline chloride ([0238] choline chloride is cation-type electrification preventing agent in a methacrylic polymer), choline bitartrate, choline dihydrogen citrate, choline phosphate, choline gluconate, choline fumarate, choline carbonate, choline pyrophosphate and mixture thereof. Therefore it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Naier in view of Amano to incorporate the choline chloride at a wt % of 0.1 to 30%. Providing the choline chloride would advantageously provide a cation to prevent electrification ([0234] [0238]). Providing the choline chloride within the range would have bene obvious to one of ordinary skill in the art as applicant appears to have placed no criticality on the claimed range and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In reWertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In reWoodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claims 11, Naier/Takaki teaches the device of claim 1 as stated above.
Naier fails to teach the polyol of claim 11.
Amano teaches wherein the at least one polyol is present in an amount of 0.1 to 50 wt.-%, based on total weight of the conductive pressure sensitive adhesive layer; and is selected from polyether polyols and mixtures thereof ([0008] polyether polyol can be antistatic agent; [0335] antistatic agent is added 10% by weight to acryl based polymer). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Naier in view of Amano to incorporate the polyether polyol. Doing so would advantageously provide an antistatic agent to the PSA ([0008]). Furthermore, it would have been obvious to one having ordinary skill in the art at before the effective filing date of the claimed invention to have provided the polyol in an amount of 0.1 to 50 wt% based on the total weight of the PSA, 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, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). One would have done so to optimize the amount of the antistatic agent within the pressure sensitive adhesive to prove effective antistatic properties without diminishing other properties of the PSA, such as conductivity, peeling electrification voltage ([0375] [0474]).
Regarding claims 16, Naier/Takaki teaches the device of claim 1 as stated above.
Naier fails to teach the substrate of claim 16.
Amano teaches wherein the substrate (C) is present in a thickness of 10 to 500 µm ([0230-0232] substrate is between 5 to 50 micrometer) and is a flexible film selected from polyolefin films, polycarbonate films, thermoplastic polyurethane films, silicone films, woven films, non-woven films, and paper films ([0230] paper and non-woven fabric substrate; [0231] polyolefin film). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the substrate of Naier in view of Amano to incorporate a paper, non-woven fabric, or polyolefin film having a thickness of 10 to 500 micrometers to arrive at claim 16. Doing so would have been obvious to one of ordinary skill in the art as a simple selection of one well-known substrate material for a pressure sensitive adhesive sheet to yield predictable results therein ([0230-0232]). Providing the substrate between 10 to 500 micrometers thick would be obvious to one of ordinary skill in the art as Amano discloses a thickness of around 10 to 100 micrometers or 3 to 100 micrometers and applicant appears to have placed no criticality on the claimed range and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In reWertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In reWoodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Response to Arguments
Applicant’s arguments, see remarks, filed 11/05/2025, with respect to the rejection(s) of claim(s) 1 under 35 USC 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the Takaki reference.
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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/ADAM Z MINCHELLA/Primary Examiner, Art Unit 3794