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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-14 and 18-21) in the reply filed on 07/08/2024 is acknowledged.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). This patent application is a U.S. National Phase of PCT International Application No. PCT/NL2020/050147, filed March 6, 2020, which claims priority to European Application No. 19161223.3, filed March 7, 2019. The certified copy has been filed in parent Application No. 17/436,049, filed on 09/02/2021.
Response to Amendment
The Amendments under 37 CFR 1.132 filed 01/26/2026 is sufficient to overcome the rejection of claim 1 based upon being unpatentable over Isik in view of Bischof as set forth in the last Office action. However, claim 1 has been newly rejected as being unpatentable over Isik in view of Bischof, further in view of Reinhold (US 3911906 A).
Claims 1-6, 8-14, and 19-23 remain pending.
Response to Arguments
Applicant’s arguments, see Remarks, filed 01/26/2026, with respect to the rejection(s) of independent claim(s) 1 under 35 U.S.C. 103 as being unpatentable over Isik, et al. ("Cholinium-based ion gels as solid electrolytes for long-term cutaneous electrophysiology", MEHMET ISIK ET AL, JOURNAL OF MATERIALS CHEMISTRY C, VOL.3, NO. 34, 1 JANUARY 2015, PAGES 8942-8948) in view of Bischof (US 6121508 A) have been fully considered and are persuasive. However, upon further consideration, a new ground(s) of rejection is made in view of Reinhold (US 3911906 A).
Reinhold teaches wherein the ionically conductive pressure sensitive adhesive composition further comprises electrically conductive particles ([2] In accordance with the principles of the present invention it is essential that the composite body 12 provide a tacky skin-engaging surface 16 which is formed by a thin flexible layer 18 of pressure-sensitive adhesive material having fine electrically conductive particles dispersed throughout, including the tacky surface 16 in an amount sufficient to provide an electrical connection from the surface 16 through the layer 18 by particle to particle contact while permitting the surface 16 to remain tacky prior to skin engagement) in a range between 0.1 to 35% by weight of the ionically conductive pressure sensitive adhesive, and wherein the electrically conductive particles comprise at least one material taken from the group consisting of: metal containing particles and/or nanoparticles, carbon particles and/or nanoparticles, carbo nanowires, and conductive polymer particles and/or nanoparticles ([5] pressure sensitive adhesive material embodied in the surgical tape marketed by 3M Company under the trademark MICROPORE with fine powder carbon being utilized as the electrically conductive particles) ([5] A preferred amount of fine carbon powder to be included in the adhesive is 25%, although it will be understood that more or less can be used in accordance with the principles enunciated above). It would have been obvious to add the additional carbon particles taught by Reinhold to the ionically conductive pressure sensitive adhesive as taught by Isik to enhance the conductivity of the adhesive.
Applicant’s arguments, see Remarks, filed 01/26/2026, with respect to the rejection(s) of independent claim(s) 22 and 23 under 35 U.S.C. 103 are considered but not persuasive.
Hatakeyama (US 20170323698 A1) teaches wherein the resin of the ionically conductive pressure sensitive adhesive composition comprises a (meth)acrylate resin comprising 10-65% by weight of (meth)acrylate monomer having a hydroxy-group ([0102] It is also possible to esterify the carboxy group with hydroxyethyl (meth)acrylate, and to perform photoradical crosslinking of the (meth)acrylate moiety) ([0112] To perform photo-crosslinking, it is preferable to use a resin having (meth)acrylate terminals or adding a crosslinking agent having a terminal(s) of (meth)acrylate or a thiol group(s), together with adding a photoradical generator, which generates a radical by light) ([0113] Illustrative examples of the photoradical generator include…2-hydroxy-2-methylpropiophenone, 2-hydroxy-4′-(2-hydroxyethoxy)-2-methylpropiophenone…The loading amount of the photoradical generator is preferably in a range of 0.1 to 50 parts by mass on the basis of 100 parts by mass of the resin) ([0114] To the composition for forming the resin layer, an adhesion improving agent may be added in order to improve the adhesion property of the resin layer and the particles. Illustrative examples of such an adhesion improving agent include silane coupling agents having a thiol group, a hydroxy group, a carboxy group, an amide group, and a urethane group) where the photoradical generator is the "methacrylate monomer having a hydroxy-group" then the 0.1 to 50 parts by mass of the photoradical generator on the basis of 100 parts by mass of the resin would overlap with the claimed 10-65% range.
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) 1-4, 10, 11, 19, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Isik, et al. ("Cholinium-based ion gels as solid electrolytes for long-term cutaneous electrophysiology", MEHMET ISIK ET AL, JOURNAL OF MATERIALS CHEMISTRY C, VOL.3, NO. 34, 1 JANUARY 2015, PAGES 8942-8948) in view of Bischof (US 6121508 A), further in view of Reinhold (US 3911906 A).
Regarding claim 1, Isik et al. teaches a method of manufacturing a skin-compatible electrode (see page 8945, paragraph 2, page 8947, paragraph 2, Figure 5), the method comprising: printing a conductive ink (gold) onto a flexible substrate (polyimide) to form an electrically conductive layer in a circuit pattern comprising (see pages 8942-8948; using laser cut plastic polyimide (disclosing flexible substrates) (Kapton HN) electrodes with a thickness of 125 mm and an active area of 0.5 cm2. Evaporating 10 nm of chromium and 100 nm of gold on the Kapton electrode, the gold layer providing good electronic conductivity (forming a conductive layer is disclosed)): an electrode pad area (Fig 5) for transceiving electrical signals via skin, and a circuit lane electrically connected to the electrode pad area for guiding the electrical signals along the flexible substrate (see page 8945, paragraph 2, Fig. 5; bile ionogel was incorporated onto electrodes made of gold and PEDOT: PSS conducting polymers. The electrodes are fabricated on a thin layer of polyimide film, allowing stable and flexible contact with the skin. The choline-based ionogel is then used as an electrolytic interface between the skin and the electrode itself. This interface is an important element for successful transcutaneous signal transduction. Figure 5 shows a cross-section of an electrode. The polyimide layer makes the electrode easy to handle, its flexibility reduces mechanical stress in wearable conditions (exercise, long term contact...)) (this means that the electrically conductive gold layer acts as an electrode to transmit and receive electrical signals through the skin, and for passing an electrical signal, explained in connection with the following figure, where the region covered by the ionic gel layer projected downward as electrode pad region in the gold layer for detecting skin signals, the region covered by the insulating electrolyte projected downward as conductive path in the gold layer, and the conductive path leads the electrical signal along the polyimide film);
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and printing, coating or dispensing an adhesive composition (cholinium-based ion gel) onto the electrode pad area to form an adhesive interface layer in an adhesive pattern (see page 8945, paragraph 2, Figure 5), wherein the adhesive interface layer is conductive for, in use, maintaining an electrical connection for the electrical signals between the electrode pad area and skin (The cholinium-based ion gel is then used as the electrolytic interface between the skin and the electrode itself), wherein the adhesive interface layer is a dry film (see page 8943 section “Preparation of cholinium-based gels” lines 1-3: the ion gel does not comprise water) formed from the adhesive composition (see scheme 1 and p. 8943 section “Preparation of cholinium-based gels”) comprising an ionically conductive pressure sensitive adhesive composition comprising a resin (see page 8943 section “Preparation of cholinium-based gels” second paragraph “methacrylate”), and an ionic liquid (see page 8943 section “Preparation of cholinium-based gels” second paragraph “ionic liquids”), and wherein the ionic liquid is a salt which is liquid at temperatures of 100 C or below (Fig 2a; the ionic liquid is liquid at temp at or below 100 deg C) (Cholinium lactate properties) (see page 8945, paragraphs 2-3, p. 8947, paragraph 2, figure 5).
Isik et al. fails to specifically disclose the method comprising: printing a conductive ink onto a flexible substrate to form an electrically conductive layer in a circuit pattern, and wherein the ionically conductive pressure sensitive adhesive composition further comprises electrically conductive particles in a range between 0.1 to 35% by weight of the ionically conductive pressure sensitive adhesive, and wherein the electrically conductive particles comprise at least one material taken from the group consisting of: metal containing particles and/or nanoparticles, carbon particles and/or nanoparticles, carbo nanowires, and conductive polymer particles and/or nanoparticles.
However, Bischof teaches the method comprising: printing a conductive ink onto a flexible substrate to form an electrically conductive layer in a circuit pattern (Fig 1 and 2; [28] Means 16 for electrical communication includes a conductive layer 26 coated on at least the side 22 contacting field 14 of conductive medium) ([29] carbon ink layer 26). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the invention of Isik et al. to include the method comprising printing a conductive ink onto a flexible substrate to form an electrically conductive layer in a circuit pattern. Doing so prints a conductive ink on a substrate forming a patterned conductive layer as an electrode.
Further, Reinhold teaches wherein the pressure sensitive adhesive composition further comprises electrically conductive particles ([2] In accordance with the principles of the present invention it is essential that the composite body 12 provide a tacky skin-engaging surface 16 which is formed by a thin flexible layer 18 of pressure-sensitive adhesive material having fine electrically conductive particles dispersed throughout, including the tacky surface 16 in an amount sufficient to provide an electrical connection from the surface 16 through the layer 18 by particle to particle contact while permitting the surface 16 to remain tacky prior to skin engagement) in a range between 0.1 to 35% by weight of the pressure sensitive adhesive ([5] pressure sensitive adhesive material embodied in the surgical tape marketed by 3M Company under the trademark MICROPORE with fine powder carbon being utilized as the electrically conductive particles) ([5] A preferred amount of fine carbon powder to be included in the adhesive is 25%, although it will be understood that more or less can be used in accordance with the principles enunciated above), and wherein the electrically conductive particles comprise at least one material taken from the group consisting of: metal containing particles and/or nanoparticles, carbon particles and/or nanoparticles, carbo nanowires, and conductive polymer particles and/or nanoparticles ([5] pressure sensitive adhesive material embodied in the surgical tape marketed by 3M Company under the trademark MICROPORE with fine powder carbon being utilized as the electrically conductive particles) ([5] A preferred amount of fine carbon powder to be included in the adhesive is 25%, although it will be understood that more or less can be used in accordance with the principles enunciated above). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the ionically conductive adhesive of Isik et al. to include wherein the pressure sensitive adhesive composition further comprises electrically conductive particles in a range between 0.1 to 35% by weight of the pressure sensitive adhesive, and wherein the electrically conductive particles comprise at least one material taken from the group consisting of: metal containing particles and/or nanoparticles, carbon particles and/or nanoparticles, carbo nanowires, and conductive polymer particles and/or nanoparticles. Doing so further enhances the conductive properties of the adhesive. Further, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the invention of Isik et al. to include wherein the pressure sensitive adhesive composition further comprises electrically conductive particles in a range between 0.1 to 35% by weight of the ionically conductive pressure sensitive adhesive. 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.
Regarding claim 2, Isik et al. teaches the method according to claim 1, but fails to teach wherein a combined thickness of the flexible substrate, the electrically conductive layer at the electrode pad area, and the adhesive interface layer, and their respective material compositions, provides a combined stiffness at the electrode pad area in plane of the flexible substrate of less than two hundred thousand Newton per meter. However, Bischof teaches wherein a combined thickness of the flexible substrate, the electrically conductive layer at the electrode pad area, and the adhesive interface layer, and their respective material compositions, provides a combined stiffness at the electrode pad area in plane of the flexible substrate of less than two hundred thousand Newton per meter. ([48] An advantage to such materials is that webs formed from them can be made which exhibit good elasticity and stretch recovery. This means that the electrode can stretch well, in all directions, with movement of the subject, without loss of electrode integrity and/or failure of the seal provided by the skin adhesive. Material with a stretch recovery of at least about 85%, in all directions, after stretch of 50% is preferred). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the invention of Isik et al. to include wherein a combined thickness of the flexible substrate, the electrically conductive layer at the electrode pad area, and the adhesive interface layer, and their respective material compositions, provides a combined stiffness at the electrode pad area in plane of the flexible substrate of less than two hundred thousand Newton per meter. Doing so is necessary for flexibility, stretchability strength for the electrodes to perform well.
Regarding claim 3, Isik et al. teaches the method according to claim 1, wherein an electrically insulating composition is printed in a skin insulating pattern to form a skin insulating layer covering at least part of the circuit lane adjacent the electrode pad area for, in use, electrically insulating the circuit lane from the skin (Fig 5; dielectric, electrically insulating medium).
Regarding claim 4, Isik et al. teaches the method according to claim 1, wherein a dielectric adhesive composition is printed in an electrically insulating adhesive pattern to form an electrically insulating adhesive layer on the flexible substrate and/or the circuit lane at areas adjacent the adhesive pattern that, in use, improves adhesion of the electrode on the skin. (see page 8947, paragraph 6; The electrode active area was then coated by drop casting with 5 mL of a solution of poly(3,4-ethylenedioxythiophene) doped with poly(styrene sulfonate) (PEDOT:PSS) from (Clevios PH-1000 from Heraeus Holding GmbH). PEDOT:PSS was mixed with ethylene glycol (from Sigma-Aldrich), 4-dodecylbenzenesulfonic acid (Sigma Aldrich), and 3-methacryloxypropyltrimethoxysilane (Sigma Aldrich) with a ratio of 8/2/0.004/0.1 respectively to improve both conductivity, surface energy and surface adhesion).
Regarding claim 10, Isik et al. teaches the method according to claim 9, wherein the plurality of electrodes are arranged according to a predefined electrode pattern for transceiving a plurality of electrical signals at respective areas of skin ([abstract] electrodes arranged for recording ECG).
Regarding claim 11, Isik et al. teaches the method according to claim 9, wherein the electrode pattern comprises at least three electrodes for measuring electrocardiogram (ECG) signals via the skin ([abstract] electrodes arranged for recording ECG) (see page 8948, paragraph 1; ECG recordings were performed by placing one electrode on each wrist of a healthy volunteer to form a bipolar Limb Lead I derivation, one of the 12 ECG lead configurations used in clinics).
Regarding claim 19, Isik et al. teaches the method according to claim 1, but fails to teach wherein the electrically conductive particles are graphite based and/or carbon based. However, Reinhold teaches wherein the electrically conductive particles are graphite based and/or carbon based ([5] the carrier layer 20 is a thin flexible highly porous non-woven fabric and the adhesive material is a synthetic acrylic copolymer. A preferred amount of fine carbon powder to be included in the adhesive is 25%, although it will be understood that more or less can be used in accordance with the principles enunciated above). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the combined invention of Isik et al. and Bischof to include wherein the electrically conductive particles are graphite based and/or carbon based. Doing so adds conductivity to the adhesive without impacting the adhesion strength.
Regarding claim 20, Isik et al. teaches the method according to claim 1, wherein the ionically conductive pressure sensitive adhesive further comprises a polyether polyol in a range between 0.1 to 35% by weight of the ionically conductive pressure sensitive adhesive composition (page 8947, paragraph 2; Ethylene glycol is disclosed. As far as polyether polyols are used instead, this is only a routine improvement, and the content thereof can also be obtained according to routine experimentation). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the invention of Isik et al. to include wherein the ionically conductive pressure sensitive adhesive further comprises a polyether polyol in a range between 0.1 to 35% by weight of the ionically conductive pressure sensitive adhesive composition. Comprising a polyether polyol is obvious since these materials offer the benefits of cost-effectiveness, manufacturing feasibility, etc, as stated above. It has been held that “the selection of a known material based on its suitability for its intended use supports a pima facie obviousness determination”- MPEP 2144.07 In the instant case, one of ordinary skill in the art would recognize the benefits or suitability of the disclosed materials (e.g. cost-effectiveness, manufacturing feasibility, etc.).
Claim(s) 5 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Isik, et al. ("Cholinium-based ion gels as solid electrolytes for long-term cutaneous electrophysiology", MEHMET ISIK ET AL, JOURNAL OF MATERIALS CHEMISTRY C, VOL.3, NO. 34, 1 JANUARY 2015, PAGES 8942-8948) in view of Bischof (US 6121508 A), in view of Reinhold (US 3911906 A), further in view of Morita (US 20180055399 A1).
Regarding claim 5, Isik et al. teaches the method according to claim 1, but fails to teach wherein the conductive ink is printed in an exterior shielding pattern to form an exterior shielding layer on the flexible substrate, before printing the electrically conductive layer for, in use, shielding the electrically conductive layer from exterior electromagnetic interference. However, Morita teaches wherein the conductive ink is printed in an exterior shielding pattern to form an exterior shielding layer on the flexible substrate, before printing the electrically conductive layer for, in use, shielding the electrically conductive layer from exterior electromagnetic interference ([0046] the shield layer 40 provided around the electrode portion 10 and the entire length of the top and bottom of the electric wire 21 shields external noise, whereby detection accuracy is improved). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the combined invention of Isik et al. and Bischof to include wherein the conductive ink is printed in an exterior shielding pattern to form an exterior shielding layer on the flexible substrate, before printing the electrically conductive layer for, in use, shielding the electrically conductive layer from exterior electromagnetic interference. Doing so would aid in solving problems during manufacture such as avoiding electrode gel dehydration.
Regarding claim 6, Isik et al. teaches the method according to claim 5, but fails to teach wherein the conductive ink is printed in a skin shielding pattern to form a skin shielding layer for, in use, shielding the electrically conductive layer from electromagnetic interference, wherein a skin insulating layer is arranged between the skin shielding layer and the circuit lane for electrically insulating the skin shielding layer from the electrically conductive layer, and wherein the skin shielding layer is electrically connected to the exterior shielding layer. However, Morita teaches wherein the conductive ink is printed in a skin shielding pattern to form a skin shielding layer for, in use, shielding the electrically conductive layer from electromagnetic interference, wherein a skin insulating layer is arranged between the skin shielding layer and the circuit lane for electrically insulating the skin shielding layer from the electrically conductive layer, and wherein the skin shielding layer is electrically connected to the exterior shielding layer (Figs 5-9; shielding layers 40, insulation layers 30a and 30b, insulation layer 42). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the combined invention of Isik et al. and Bischof to include wherein the conductive ink is printed in a skin shielding pattern to form a skin shielding layer for, in use, shielding the electrically conductive layer from electromagnetic interference, wherein a skin insulating layer is arranged between the skin shielding layer and the circuit lane for electrically insulating the skin shielding layer from the electrically conductive layer, and wherein the skin shielding layer is electrically connected to the exterior shielding layer. Doing so would aid in solving problems during manufacture such as avoiding electrode gel dehydration.
Claim(s) 8, 9, 12-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Isik, et al. ("Cholinium-based ion gels as solid electrolytes for long-term cutaneous electrophysiology", MEHMET ISIK ET AL, JOURNAL OF MATERIALS CHEMISTRY C, VOL.3, NO. 34, 1 JANUARY 2015, PAGES 8942-8948) in view of Bischof (US 6121508 A), in view of Reinhold (US 3911906 A), further in view of McAdams (US 20060270942 A1).
Regarding claim 8, Isik et al. teaches the method according to claim 1, but fails to teach wherein the flexible substrate is cut according to a substrate cut pattern, wherein the circuit pattern forms a subset area of the substrate cut pattern. However, McAdams teaches wherein the flexible substrate is cut according to a substrate cut pattern, wherein the circuit pattern forms a subset area of the substrate cut pattern (Figs 7-8; [58-71] printing a plurality of electrodes on a flexible insulating substrate; screen printing enables precise patterning and positioning of electrodes and their associated leads; an array of test electrodes is disposed on a flexible backing of insulating material; a single piece of hydrogel 32 may be used to cover all test and reference electrodes 10, 22 and their leads, as shown in Figure 8, or a separate hydrogel "pad" may be placed on each test and reference electrode) (Fig 7; the electrode pattern forming a two-dimensional array of spaced apart electrode pad areas and the respective electrical paths). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the combined invention of Isik et al. and Bischof to include wherein the flexible substrate is cut according to a substrate cut pattern, wherein the circuit pattern forms a subset area of the substrate cut pattern. Doing so matches the pattern on top of the substrate to ensure proper fit on the electrical pads.
Regarding claim 9, Isik et al. teaches the method according to claim 1, but fails to teach comprising manufacturing a plurality of the electrodes on a common flexible substrate. However, McAdams teaches comprising manufacturing a plurality of the electrodes on a common flexible substrate (Fig 7; the electrode pattern forming a two-dimensional array of spaced apart electrode pad areas and the respective electrical paths). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the combined invention of Isik et al. and Bischof to include manufacturing a plurality of the electrodes on a common flexible substrate. Doing so allows for multiple electrodes on a single pad for ease of measurements.
Regarding claim 12, Isik et al. teaches the method according to claim 9, but fails to teach wherein areas of the skin-compatible patch between the electrode pad areas are covered by the electrically insulating adhesive layer. However, McAdams teaches wherein areas of the skin-compatible patch between the electrode pad areas are covered by the electrically insulating adhesive layer ([0061] A backing of suitable material (e.g. 1.6 mm adhesive foam, 8104/800C from Medifix, Luton, England) can be used, if necessary, to hold the `finger-like` peninsulas together and ease application). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the combined invention of Isik et al. and Bischof to include wherein areas of the skin-compatible patch between the electrode pad areas are covered by the electrically insulating adhesive layer. Doing so creates an insulating layer between electrode pad and adhesive layer, so there is no interference between them.
Regarding claim 13, Isik et al. teaches the method according to claim 9, but fails to teach wherein respective ones of the circuit lanes of the electrodes converge at a common external connection area. However, McAdams teaches wherein respective ones of the circuit lanes of the electrodes converge at a common external connection area (Fig 7; the respective electrical paths of the plurality of electrodes converge at a common external connection area). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the combined invention of Isik et al. and Bischof to include wherein respective ones of the circuit lanes of the electrodes converge at a common external connection area. Doing so creates a common external connection are for the electrodes to attach to and aids in simplicity of the pad.
Regarding claim 14, Isik et al. teaches the method according to claim 9, but fails to teach wherein the electrode pattern forms a two-dimensional array of spaced apart electrode pad areas with respective circuit lanes. However, McAdams teaches wherein the electrode pattern forms a two-dimensional array of spaced apart electrode pad areas with respective circuit lanes (Fig 7; the electrode pattern forming a twodimensional array of spaced apart electrode pad areas and the respective electrical paths). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the combined invention of Isik et al. and Bischof to include wherein the electrode pattern forms a two-dimensional array of spaced apart electrode pad areas with respective circuit lanes. Doing so creates a pattern of electrodes that will not interact with each other.
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Isik, et al. ("Cholinium-based ion gels as solid electrolytes for long-term cutaneous electrophysiology", MEHMET ISIK ET AL, JOURNAL OF MATERIALS CHEMISTRY C, VOL.3, NO. 34, 1 JANUARY 2015, PAGES 8942-8948) in view of Bischof (US 6121508 A), in view of Reinhold (US 3911906 A), further in view of Michot (US 20020009650 A1).
Regarding claim 21, Isik et al. teaches the method according to claim 1, but fails to teach wherein the adhesive composition is printed, coated, or dispensed as a layer of liquid material comprising the resin, the ionic liquid, in a solvent, and wherein the dry film of the adhesive interface layer is formed by evaporation of the solvent from said layer. However, Michot teaches wherein the adhesive composition is printed, coated, or dispensed as a layer of liquid material comprising the resin, the ionic liquid, in a solvent, and wherein the dry film of the adhesive interface layer is formed by evaporation of the solvent from said layer ([0217] evaporation of the solvent and drying under vacuum). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the combined invention of Isik et al. and Bischof to include wherein the adhesive composition is printed, coated, or dispensed as a layer of liquid material comprising the resin, the ionic liquid, in a solvent, and wherein the dry film of the adhesive interface layer is formed by evaporation of the solvent from said layer. Doing so does not rely on a specific temperature, is a cost-effective curing process, and creates a dry film layer.
Claim(s) 22 and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Isik, et al. ("Cholinium-based ion gels as solid electrolytes for long-term cutaneous electrophysiology", MEHMET ISIK ET AL, JOURNAL OF MATERIALS CHEMISTRY C, VOL.3, NO. 34, 1 JANUARY 2015, PAGES 8942-8948) in view of Bischof (US 6121508 A), in view of Reinhold (US 3911906 A), further in view of Hatakeyama (US 20170323698 A1).
Regarding claim 22, Isik et al. teaches the method according to claim 1, but fails to teach wherein the resin of the ironically conductive pressure sensitive adhesive composition comprises a (meth)acrylate resin comprising 10-65% by weight of (meth)acrylate monomer having a hydroxy-group.
However, Hatakeyama teaches wherein the resin of the ironically conductive pressure sensitive adhesive composition comprises a (meth)acrylate resin ([0102] It is also possible to esterify the carboxy group with hydroxyethyl (meth)acrylate, and to perform photoradical crosslinking of the (meth)acrylate moiety) ([0112] It is preferable to use a resin having (meth)acrylate terminals or adding a crosslinking agent having a terminal(s) of (meth)acrylate or a thiol group(s), together with adding a photoradical generator, which generates a radical by light) comprising 10-65% by weight of (meth)acrylate monomer having a hydroxy-group ([0113] Illustrative examples of the photoradical generator include…2-hydroxy-2-methylpropiophenone, 2-hydroxy-4′-(2-hydroxyethoxy)-2-methylpropiophenoe. The loading amount of the photoradical generator is preferably in a range of 0.1 to 50 parts by mass on the basis of 100 parts by mass of the resin) ([0114] To the composition for forming the resin layer, an adhesion improving agent may be added in order to improve the adhesion property of the resin layer and the particles. Illustrative examples of such an adhesion improving agent include silane coupling agents having a thiol group, a hydroxy group, a carboxy group, an amide group, and a urethane group). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the combined invention of Isik et al. and Bischof to include wherein the resin of the ironically conductive pressure sensitive adhesive composition comprises a (meth)acrylate resin comprising 10-65% by weight of (meth)acrylate monomer having a hydroxy-group. Doing so provides favorable mechanical strength and adhesion properties to the electro-conductive base material and particles ([0111] Such a non-silicon-containing resin makes the resin layer have particularly favorable mechanical strength and adhesion properties to the electro-conductive base material and particles). Further, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the invention of Isik et al. to include wherein the resin of the ironically conductive pressure sensitive adhesive composition comprises a (meth)acrylate resin comprising 10-65% by weight of (meth)acrylate monomer having a hydroxy-group. 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.
Regarding claim 23, Isik et al. teaches a method of manufacturing a skin-compatible electrode (see page 8945, paragraph 2, page 8947, paragraph 2, Figure 5), the method comprising: printing a conductive ink (gold) onto a flexible substrate (polyimide) to form an electrically conductive layer in a circuit pattern comprising (see pages 8942-8948; using laser cut plastic polyimide (disclosing flexible substrates) (Kapton HN) electrodes with a thickness of 125 mm and an active area of 0.5 cm2. Evaporating 10 nm of chromium and 100 nm of gold on the Kapton electrode, the gold layer providing good electronic conductivity (forming a conductive layer is disclosed)): an electrode pad area (Fig 5) for transceiving electrical signals via skin, and a circuit lane electrically connected to the electrode pad area for guiding the electrical signals along the flexible substrate (see page 8945, paragraph 2, Fig. 5; bile ionogel was incorporated onto electrodes made of gold and PEDOT: PSS conducting polymers. The electrodes are fabricated on a thin layer of polyimide film, allowing stable and flexible contact with the skin. The choline-based ionogel is then used as an electrolytic interface between the skin and the electrode itself. This interface is an important element for successful transcutaneous signal transduction. Figure 5 shows a cross-section of an electrode. The polyimide layer makes the electrode easy to handle, its flexibility reduces mechanical stress in wearable conditions (exercise, long term contact...)) (this means that the electrically conductive gold layer acts as an electrode to transmit and receive electrical signals through the skin, and for passing an electrical signal, explained in connection with the following figure, where the region covered by the ionic gel layer projected downward as electrode pad region in the gold layer for detecting skin signals, the region covered by the insulating electrolyte projected downward as conductive path in the gold layer, and the conductive path leads the electrical signal along the polyimide film); and printing, coating or dispensing an adhesive composition (cholinium-based ion gel) onto the electrode pad area to form an adhesive interface layer in an adhesive pattern (see page 8945, paragraph 2, Figure 5), wherein the adhesive interface layer is conductive for, in use, maintaining an electrical connection for the electrical signals between the electrode pad area and skin (The cholinium-based ion gel is then used as the electrolytic interface between the skin and the electrode itself), wherein the adhesive interface layer is a dry film (see page 8943 section “Preparation of cholinium-based gels” lines 1-3: the ion gel does not comprise water) formed from the adhesive composition (see scheme 1 and p. 8943 section “Preparation of cholinium-based gels”) comprising an ionically conductive pressure sensitive adhesive composition comprising a resin (see page 8943 section “Preparation of cholinium-based gels” second paragraph “methacrylate”), and an ionic liquid (see page 8943 section “Preparation of cholinium-based gels” second paragraph “ionic liquids”), and wherein the ionic liquid is a salt which is liquid at temperatures of 100 C or below (Fig 2a; the ionic liquid is liquid at temp at or below 100 deg C) (Cholinium lactate properties) (see page 8945, paragraphs 2-3, p. 8947, paragraph 2, figure 5).
Isik et al. fails to specifically disclose the method comprising: printing a conductive ink onto a flexible substrate to form an electrically conductive layer in a circuit pattern; and wherein the ionically conductive pressure sensitive adhesive composition further comprises electrically conductive particles in a range between 0.1 to 35% by weight of the ionically conductive pressure sensitive adhesive; wherein the resin of the ironically conductive pressure sensitive adhesive composition comprises a (meth)acrylate resin comprising 10-65% by weight of (meth)acrylate monomer having a hydroxy-group.
However, Bischof teaches the method comprising: printing a conductive ink onto a flexible substrate to form an electrically conductive layer in a circuit pattern (Fig 1 and 2; [28] Means 16 for electrical communication includes a conductive layer 26 coated on at least the side 22 contacting field 14 of conductive medium) ([29] carbon ink layer 26). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the invention of Isik et al. to include the method comprising printing a conductive ink onto a flexible substrate to form an electrically conductive layer in a circuit pattern. Doing so prints a conductive ink on a substrate forming a patterned conductive layer as an electrode.
Further, Reinhold teaches wherein the pressure sensitive adhesive composition further comprises electrically conductive particles ([2] In accordance with the principles of the present invention it is essential that the composite body 12 provide a tacky skin-engaging surface 16 which is formed by a thin flexible layer 18 of pressure-sensitive adhesive material having fine electrically conductive particles dispersed throughout, including the tacky surface 16 in an amount sufficient to provide an electrical connection from the surface 16 through the layer 18 by particle to particle contact while permitting the surface 16 to remain tacky prior to skin engagement) in a range between 0.1 to 35% by weight of the pressure sensitive adhesive ([5] pressure sensitive adhesive material embodied in the surgical tape marketed by 3M Company under the trademark MICROPORE with fine powder carbon being utilized as the electrically conductive particles) ([5] A preferred amount of fine carbon powder to be included in the adhesive is 25%, although it will be understood that more or less can be used in accordance with the principles enunciated above). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the ionically conductive adhesive of Isik et al. to include wherein the pressure sensitive adhesive composition further comprises electrically conductive particles in a range between 0.1 to 35% by weight of the pressure sensitive adhesive. Doing so further enhances the conductive properties of the adhesive. Further, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the invention of Isik et al. to include wherein the pressure sensitive adhesive composition further comprises electrically conductive particles in a range between 0.1 to 35% by weight of the ionically conductive pressure sensitive adhesive. 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.
Further, Hatakeyama teaches wherein the resin of the ironically conductive pressure sensitive adhesive composition comprises a (meth)acrylate resin ([0112] It is preferable to use a resin having (meth)acrylate terminals or adding a crosslinking agent having a terminal(s) of (meth)acrylate or a thiol group(s), together with adding a photoradical generator, which generates a radical by light) comprising 10-65% by weight of (meth)acrylate monomer having a hydroxy-group ([0113] Illustrative examples of the photoradical generator include…2-hydroxy-2-methylpropiophenone, 2-hydroxy-4′-(2-hydroxyethoxy)-2-methylpropiophenoe. The loading amount of the photoradical generator is preferably in a range of 0.1 to 50 parts by mass on the basis of 100 parts by mass of the resin) ([0114] To the composition for forming the resin layer, an adhesion improving agent may be added in order to improve the adhesion property of the resin layer and the particles. Illustrative examples of such an adhesion improving agent include silane coupling agents having a thiol group, a hydroxy group, a carboxy group, an amide group, and a urethane group). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the combined invention of Isik et al. and Bischof to include wherein the resin of the ironically conductive pressure sensitive adhesive composition comprises a (meth)acrylate resin comprising 10-65% by weight of (meth)acrylate monomer having a hydroxy-group. Doing so provides favorable mechanical strength and adhesion properties to the electro-conductive base material and particles ([0111] Such a non-silicon-containing resin makes the resin layer have particularly favorable mechanical strength and adhesion properties to the electro-conductive base material and particles). Further, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the invention of Isik et al. to include wherein the resin of the ironically conductive pressure sensitive adhesive composition comprises a (meth)acrylate resin comprising 10-65% by weight of (meth)acrylate monomer having a hydroxy-group. 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.
Conclusion
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/ASHLEIGH LAUREN KERN/Examiner, Art Unit 3794
/ADAM Z MINCHELLA/Primary Examiner, Art Unit 3794