DETAILED ACTION
This action is pursuant to RCE filed on 7/2/2026. Claims 23-24, and 26-44 are pending. A non-final action on the merits of claims 23-24, and 26-44 is as follows.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 6/9/2026 has been entered.
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) 23, 26, 27, 28, 29, 32, 33, 34, 35, 36, 37, 39, 40, 41, 42, and 44 are rejected under 35 U.S.C. 103 as being unpatentable over Hatakeyama et al. (hereinafter ‘Hatakeyama’, US 20190209740 A1) in view of Coggins (US 20130085368 A1).
Regarding independent claim 23, Hatakeyama discloses a bio-electrode (bioelectrode shown in Figs. 1 and 2) comprising:
a porous, stretchy base material (base material 2 in Figs. 1 and 2; [0051], [0096], [0132]: the bio-electrode is stretchable which means that the base has at least some degree of stretch; [0127]: the electro-conductive base can be a cloth or mesh which both inherently have some degree of porosity and stretchability);
an adhesive, conductive film containing silicon (living body contact layer 3 in Figs. 1 and 2; [0119]: the living body contact layer has tackiness, which is adhesive; [0129]: the living body contact layer can be selected based on a balance of flexibility, tackiness, and texture; [0128]: the living body contact layer includes a silicone chain, which contains silicon); and
a conducting path ([0169]: copper wiring 9 in Fig. 3b which is connected to the aluminum disc 8 which is an exemplary base; [0123]: the electro-conductive base material is electrically connected to a sensor device – the electrical connection from the base to the sensor device is the conductive path),
wherein the adhesive, conductive film is formed on one surface of the porous, stretchy base material (the conductive film is formed on the top of the base material as seen in Figs. 1 and 2),
wherein the adhesive, conductive film containing silicon contains an ionic material (A) selected from the group consisting of salts of ammonium, lithium, sodium, and potassium formed with any of fluorosulfonic acid, fluorosulfonimide, and N-carbonylfluorosulfonic amide ([0020]: the living body contact layer is formed from the bio-electrode composition; [0021]-[0023]: the bio-electrode composition comprises a resin and an electro-conductive material where in the electro-conductive material is a polymer compound having one or more repeating units from the group consisting of fluorosulfonic acid salts shown by the following formula (1)-1, fluorosulfonic acid salts shown by the following formula (1)-2, sulfonimide salts shown by the following formula (1)-3, and sulfonamide salts shown by the following formula (1)-4, wherein X+ represents a sodium ion, potassium ion, or a cation having an ammonium ion structure – the salt is a flurosulfonic acid and sodium, potassium, or ammonium ion).
In Fig. 4 of Hatakeyama, the wiring conductive path forms a lead-out electrode which is connected to alligator clips ([0169]).
However, while Hatakeyama discloses an electrical connection between a wire lead and the adhesive, conductive film, Hatakeyama is silent to the conducting path penetrating the porous, stretchy base material and directly connecting to the adhesive, conductive film.
Coggins teaches an electrode patch having a patient contact side and a connector side wherein the patient contact side includes a conductive layer and the connector side includes a press stud ([Abstract]). The patch of Coggins is analogous to the patch configuration shown in Fig. 4 of Hatakeyama. Coggins teaches a conductive path, formed by stud 124, eyelet 126, and conductive coating 140 as seen in Fig. 3 ([0021], [0026]). The layers of Coggins include an adhesive, conductive layer 116a and a backing layer 120 as seen in Fig. 3. The conductive path directly connects to the adhesive, conductive layer 112a, penetrates through the backing layer 120, and is exposed on the opposite side as seen in Fig. 3. Utilizing the eyelet and stud configuration allows for appropriate ECG lead wire connectors to snap onto the stud to achieve mechanical and electrical coupling of the electrode and lead wire, and allows the clinician to uncouple the ECG lead wire by simply pulling or unsnapping the connector from the electrode ([0003]). Modifying the wire lead of Hatakeyama for a stud configuration as taught by Coggins would be of routine skill in the art because it is merely substituting one form of connection for another. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Hatakeyama to have a stud conductive path which penetrates the base to directly connect to the adhesive, conductive layer as taught by Coggins since it is merely a substitution of one known element for another which would have yielded predictable results, namely, providing a removable connection to standard ECG measurement devices.
Regarding claim 26, the Hatakeyama/Coggins combination discloses the bio-electrode according to claim 23, wherein the ionic material (A) has a partial structure shown by the following general formulae (1)-1 to (1)-4 (see structure from [0023]),
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wherein Rf1 and Rf2 each represent a hydrogen atom, a fluorine atom, an oxygen atom, a methyl group, or a trifluoromethyl group, provided that when Rf1 and Rf2 represent an oxygen atom, the single oxygen atom represented by Rf1 and Rf2 bonds to a single carbon atom to form a carbonyl group; Rf3 and Rf4 each represent a hydrogen atom, a fluorine atom, or a trifluoromethyl group, provided that at least one of Rf1 to Rf4 is a fluorine atom or a trifluoromethyl group; Rf5, Rf6, and Rf7 each represent a fluorine atom, a trifluoromethyl group, or a linear or branched alkyl group having 1 to 4 carbon atoms, and have at least one fluorine atom; M+ represents an ion selected from the group consisting of an ammonium ion, a sodium ion, and a potassium ion; and "m" represents an integer of 1 to 4 (see limitations disclosed in [0023]; because of the groupings claimed comprise “or”, the options disclosed in paragraph [0023] also satisfy the claim language).
Regarding claim 27, the Hatakeyama/Coggins combination discloses the bio-electrode according to claim 23, wherein the ionic material (A) comprises at least one ionic polymer selected from the group consisting of repeating units A1 to A7 shown by the following general formula (2) (see paragraph [0027] which discloses the groups below – while the Xs are replaced with Zs and the Rs are numbered differently, the structure is the same),
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544
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wherein R1, R3, R5, R8, R10, R11, and R13 each independently represent a hydrogen atom or a methyl group; R2, R4, R6, R9, R12, and R14 each independently represent a single bond, or a linear, branched, or cyclic hydrocarbon group having 1 to 13 carbon atoms, the hydrocarbon group having no other group or having either or both of an ester group and an ether group; R7 represents a linear or branched alkylene group having 1 to 4 carbon atoms, and one or two hydrogen atoms in R7 are not substituted or substituted with a fluorine atom; X1, X2, X3, X4, X6 and X7 each independently represent any of a single bond, a phenylene group, a naphthylene group, an ether group, an ester group, and an amide group; X5 represents any of a single bond, an ether group, and an ester group; Y represents any of an oxygen atom and a -NR19- group; R19 represents any of a hydrogen atom, a linear, branched, or cyclic alkyl group having 2 to 12 carbon atoms, and a phenyl group, and have no other group or have one or more selected from the group consisting of an ether group, a carbonyl group, an ester group, and an amide group; Y forms a ring together with R4 wherein when Y is an NR19 group and R19 represents a linear, branched or cyclic alkyl group having 2 to 12 carbon atoms, or a phenyl group and R4 is a linear, branched, or cyclic hydrocarbon group having 1 to 13 carbon atoms a ring is formed, otherwise no ring is formed; Rf1' and Rf5' each represent a fluorine atom, a trifluoromethyl group, or a linear or branched alkyl group having 1 to 4 carbon atoms, and have at least one fluorine atom; "m" represents an integer of 1 to 4; a1, a2, a3, a4, a5, a6, and a7 are 0≤al≤1.0, 0≤a2≤1.0, 0≤a3≤1.0, 0≤a4≤1.0, 0≤a5≤1.0, 0≤a6≤1.0, 0≤a7≤1.0, and 0<a1+a2+a3+a4+a5+a6+a7≤1.0; M+ represents an ion selected from the group consisting of an ammonium ion, a sodium ion, and a potassium ion (see limitations disclosed in [0028]; because of the groupings claimed comprise “or”, the options disclosed in paragraph [0028] also satisfy the claim language; R14 is a single bond as seen in the last equation).
Regarding claim 28, the Hatakeyama/Coggins combination discloses the bio-electrode according to claim 23, wherein the ionic material (A) comprises an ammonium ion shown by the following general formula (3) as an ammonium ion for forming the ammonium salts (see [0023] for ammonium ion structure),
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wherein R101d, R101e, R101f, and R101g each represent a hydrogen atom, a linear, branched, or cyclic alkyl group having 1 to 15 carbon atoms, a linear, branched, or cyclic alkenyl group or alkynyl group having 2 to 12 carbon atoms, or an aromatic group having 4 to 20 carbon atoms, and have no other group of have one or more selected from the group consisting of an ether group, a carbonyl group, an ester group, a hydroxy group, an amino group, a nitro group, a sulfonyl group, a sulfinyl group, a halogen atom, and a sulfur atom; and R101d and R101e, or R101d, R101e, and R101f, are not bonded to each other or are bonded together with a nitrogen atom bonded therewith to form a ring in which R101d and R101e, or R101d, R101e, and R101f, represent an alkylene group having 3 to 10 carbon atoms, or to form a heteroaromatic ring having the nitrogen atom in the general formula (3) within the ring (see [0023]; the specific ring requirements of R101d and R101e, or R101d, R101e, and R101f are not required because the claim recites this is “optional”).
Regarding claim 29, the Hatakeyama/Coggins combination discloses the bio-electrode according to claim 23, further comprising, in addition to the component (A), an adhesive resin as a component (B) that is different from the component (A), which is one or more selected from the group consisting of a silicone resin, a (meth) acrylate resin, and a urethane resin ([0064]-[0065]: the bioelectrode composition comprises a resin having a urethane bond and a silicone chain; [0096]: the resin having urethane bond and silicone chain).
Regarding claim 32, the Hatakeyama/Coggins combination discloses the bio-electrode according to claim 23, further comprising a component (C), which is one or more selected from the group consisting of a carbon powder, a metal powder, a silicon powder, and a lithium titanate powder ([0037], [0039]: the bio-electrode composition comprises a carbon material such as carbon black and carbon nanotube).
Regarding claim 33, the Hatakeyama/Coggins combination discloses the bio-electrode according to claim 32, wherein the carbon powder is one or both of carbon black and carbon nanotube ([0039]: the carbon material can be either or both of carbon black and carbon nanotube).
Regarding claim 34, the Hatakeyama/Coggins combination discloses the bio-electrode according to claim 23, wherein the conducting path comprises one or more selected from the group consisting of gold, silver, silver chloride, platinum, aluminum, magnesium, tin, tungsten, iron, copper, nickel, stainless steel, chromium, titanium, carbon, and a conductive polymer ([0169]: the conductive path is the copper wiring 9).
Regarding claim 35, the Hatakeyama/Coggins combination discloses the bio-electrode according to claim 23, wherein the conducting path has a snap shape (snap shape shown in Fig. 3 of Coggins).
Regarding claim 36, the Hatakeyama/Coggins combination discloses the bio-electrode according to claim 23 as described above. The Hatakeyama/Coggins combination further discloses an embodiment in which the electro-conductive base is aluminum and has a thickness of 0.2mm ([0169]).
However, the Hatakeyama/Coggins combination is silent to the cloth electro-conductive base being less than 1mm thick.
It would have been an obvious matter of design choice to modify the thickness of the cloth electro-conductive base to be 0.2mm thick, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955). Furthermore, Hatakeyama states that the embodiment is just an exemplification, and any examples that have substantially the same feature and demonstrate the same functions and effects as those in the technical concept described in claims of the present invention are included in the technical scope of the present invention ([0175]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to change the thickness of the cloth, stretchy electro-conductive base to be 0.2mm thick as doing so only requires a mere change in the size of a component to a size that has been disclosed by Hatakeyama.
Regarding claim 37, the Hatakeyama/Coggins combination discloses the bio-electrode according to claim 36. Hatakeyama further teaches the porous, stretchy, electro-conductive base has a thickness of 0.2mm which is equivalent to 200 micrometers, based on the combination above. Hatakeyama further discloses the living body contact layer preferably has a thickness of 2 micrometers or more and 3mm or less ([0129]). Thus, the entirety of the bioelectrode would be 500 micrometers or less when the living body contact layer is between 2 and 300 micrometers, which is within the disclosed range (200 micrometers for the base plus 300 micrometers for the living body contact layer). Furthermore, it would have been an obvious matter of design choice to modify the thickness of the cloth electro-conductive base with the living body contact layer to be 500 micrometers or less, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art and is within the scope of the invention as evidenced by Hatakeyama ([0175]). In re Rose, 105 USPQ 237 (CCPA 1955).
Regarding claim 39, the Hatakeyama/Coggins combination discloses the bio-electrode according to claim 23 and described above.
However, the Hatakeyama/Coggins combination is silent to covering a top of the adhesive, conductive film with a release liner.
Coggins further discloses that the conductive composition, which contacts the patient, may be temporarily adhered to a release liner ([0019]). This release liner is used to protect the patient contact surface of the electrode prior to application of the electrode to the patient ([0019]). Incorporating a release liner on the patient contacting portion of the electrode disclosed by The Hatakeyama/Coggins combination is of ordinary skill in the art and would yield the predictable result of protecting the electrode contact surface. 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 release liner of Coggins with the electrode of The Hatakeyama/Coggins combination such that a release liner is included on the patient contact surface in order to protect the adhesive, conductive layer prior to application.
Regarding claim 40, the Hatakeyama/Coggins combination discloses the bio-electrode according to claim 39, wherein the release liner is selected from the group consisting of a fluorine resin, polyethylene, polypropylene, cyclic polyolefin, polyethylene terephthalate (Coggins [0019]: the release film can be polyethylene terephthalate), polybutylene terephthalate, polyethylene naphthalate, polybutylene naphthalate, polyvinyl chloride, polymethylmethacrylate, polyvinyl acetate, polystyrene, polymethylpentene, polyimide, polyphenylene sulfide, polysulfone, polyethersulfone, polyetherketone, polyamide-imide, polyetherimide, polyacetal, polycarbonate, polyphenylene ether, polyacrylonitrile, cellophane, and paper, to which, excluding the fluorine resin, a fluorine-based peeling agent or a silicone/fluorine-based peeling agent is applied (Coggins [0019]: the release film is coated in silicone; a “/” is a broad term that can be used to designate “and” or “or”, and because the claim does not define the exact peeling agent or directly state “and” or “or”, the “/” is interpreted as “or”).
Regarding claim 41, the Hatakeyama/Coggins combination discloses a production method for the bio-electrode according to claim 23, the method comprising:
preparing a conducting path that penetrates a porous, stretchy base material, or preparing a conducting path on the porous, stretchy base material so that the conducting path is exposed on a side surface of the porous, stretchy base material (Coggins [0008]: a method of providing an eyelet to contact the conductive layer and the proximal end to contact the press stud; as seen in Fig. 3, the conductive path is formed which is exposed on one surface of the base, penetrates the base, and connects to the adhesive, conductive layer) and forming an adhesive, conductive film comprising silicon (Hatakeyama: living body contact layer 3 in Figs. 1 and 2; [0119]: the living body contact layer has tackiness, which is adhesive; [0129]: the living body contact layer can be selected based on a balance of flexibility, tackiness, and texture; [0128]: the living body contact layer includes a silicone chain, which contains silicon – the adhesive, conductive film is formed as the method follows from the structure) so as to be connected to one side of the conducting path (Coggins Fig. 3 shows the adhesive, conductive layer connected to the conducting path), the one side being attached to a skin (Hatakeyama: the living body contact layer contacts the skin, thus the side of the conductive path that connects to the living body contact layer is attached to the skin).
Regarding claim 42, the Hatakeyama/Coggins combination discloses the production method for the bio-electrode according to claim 41, the method comprising:
forming the adhesive, conductive film containing silicon on one side of the conducting path that penetrates the porous, stretchy base material, or the conducting path that is on the porous, stretchy base material and exposed on a side surface of the porous, stretchy base material (Coggins Fig. 3 shows the adhesive, conductive film on the bottom side of the conductive path and is exposed on the surface of the base material), the one side being attached to a skin (the “one side of the conducting path” is attached to the skin through the living body contact layer),
by transferring the formed, adhesive, conductive film comprising silicon onto a release linear or by directly printing the formed, adhesive, conductive film comprising silicon onto the conducting path ([0138]: the bio-electrode composition, which forms the living body contact layer, is printed onto the electro-conductive base; as seen in Coggins, Fig. 3, the adhesive conductive layer 116a is formed directly on the conductive surface of the conducting path).
Regarding claim 44, the Hatakeyama/Coggins combination discloses a measurement method for a bio-signal comprising: attaching the bio-electrode according to claim 23 to a skin ([0118]: the bioelectric signals are measured from the skin – thus it is inherent that the bioelectrode is attached to the skin); and measuring the bio-signal after showering ([0118]: the electrode is worn for a long-time – this would inherently mean that the bio-electrode is worn after showering unless the person has never showered in their entire life since the claim does not dictate how long after showering the signal is measured), or during bathing or showering.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over the Hatakeyama/Coggins combination as applied to claims 23 and described above, in view of Komatsu et al. (hereinafter ‘Komatsu’, US 20200187803 A1).
Regarding claim 24, the Hatakeyama/Coggins combination discloses the bio-electrode according to claim 23, wherein the porous, stretchy base material is a fabric ([0127]: the electro-conductive base can be a cloth)
However, the Hatakeyama/Coggins combination is silent to whether the cloth that forms the conductive base is woven or non-woven.
Komatsu teaches an electrode member for measuring biological information comprising a flexible substrate, an electrode section on the flexible substrate, and wiring connecting to the electrode section ([Abstract]). Komatsu further teaches that the flexible base material can be a fabric material made of woven, knitted, or non-woven fabrics ([0119]). Additionally, Komatsu teaches that woven or non-woven fabric can contain conductive fibers or threads to form a conductive fabric ([0137]). Thus, Komatsu teaches that both woven and non-woven fabrics are both known in the art to be used as stretchable, conductive layers. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention substitute the cloth layer of the Hatakeyama/Coggins combination with the non-woven fabric of Komatsu since the substitution for the non-woven fabric taught by Komatsu would have yielded predictable results, namely, forming a stretchable, conductive layer that also would inherently have a degree of porosity, similar to Hatakeyama.
Claims 30 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over the Hatakeyama/Coggins combination as applied to claims 29/23 and described above, in view of Hatakeyama et al. (hereinafter ‘Hatakeyama 023’, US 20180229023 A1).
Regarding claim 30, the Hatakeyama/Coggins combination discloses the bio-electrode according to claim 29.
However, the Hatakeyama/Coggins combination is silent to the component (B) comprising a diorganosiloxane having an alkenyl group and an organohydrogen polysiloxane having a SiH group.
Hatakeyama 023 teaches a bioelectrode composition including an ionic material such as a lithium salt, a sodium salt, a potassium salt, or an ammonium salt and a component B which is a resin other than the ionic material, which is an extremely similar composition to both Hatakeyama and the claimed invention ([Abstract]). The resin of Hatakeyama 023 is also similar to that of Hatakeyama as it is a urethane resin containing a silicon atom ([0113]). The resin of Hatakeyama 023 additionally includes a diorganosiloxane having an alkenyl group and an organohydrogen polysiloxane group having a plurality of SiH groups with modified siloxane having a group selected from an amino group, an oxirane group, an oxetane group, a polyether group, a hydroxy group, a carboxyl group, a mercapto group, a methacryl group, an acrylic group, a phenol group, a silanol group, a carboxylic acid an anhydride group, an aryl group, an aralkyl group, an amide group, an ester group, and a lactone ring added ([0114]). This composition to the silicone-based resin enhances the compatibility with the salt ([0114]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the diorganosiloxane having an alkenyl group and an organohydrogen polysiloxane group having a pluraility of SiH groups with modified siloxane having a group selected from an amino group, an oxirane group, an oxetane group, a polyether group, a hydroxy group, a carboxyl group, a mercapto group, a methacryl group, an acrylic group, a phenol group, a silanol group, a carboxylic acid an anhydride group, an aryl group, an aralkyl group, an amide group, an ester group, and a lactone ring added in order to enhance the resins compatibility with the added salt.
Regarding claim 31, the Hatakeyama/Coggins combination discloses the bio-electrode according to claim 29 further comprising a silicone resin ([Abstract]: the resin comprises a silicone chain in the main chain).
However, the Hatakeyama/Coggins combination is silent to the component (B) further comprising a silicone resin having an SiO2 unit and an RXSiO(4-x)/2 unit, wherein R represents a substituted or unsubstituted monovalent hydrocarbon group having 1 to 10 carbon atoms, and "x" represents a number in a range of 2.5 to 3.5.
Hatakeyama 023 teaches a bioelectrode composition including an ionic material such as a lithium salt, a sodium salt, a potassium salt, or an ammonium salt and a component B which is a resin other than the ionic material, which is an extremely similar composition to both Hatakeyama and the claimed invention ([Abstract]). The resin of Hatakeyama 023 is also similar to that of Hatakeyama as it is a urethane resin containing a silicon atom ([0113]). The resin of Hatakeyama 023 additionally includes a silicone resin having an SiO2 unit and an RXSiO(4-x)/2 unit, wherein R represents a substituted or unsubstituted monovalent hydrocarbon group having 1 to 10 carbon atoms, and "x" represents a number in a range of 2.5 to 3.5 ([0024]). This composition of such a resin component aids in forming a living body contact layer that is particularly favorable in compatibility with the ionic material, provides better adhesion to the base and skin, and aids in water repellency ([0025]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the SiO2 unit and an RXSiO(4-x)/2 unit, wherein R represents a substituted or unsubstituted monovalent hydrocarbon group having 1 to 10 carbon atoms, and "x" represents a number in a range of 2.5 to 3.5 to increase compatibility, adhesion, and water repellency.
Claim 38 is rejected under 35 U.S.C. 103 as being unpatentable over the Hatakeyama/Coggins combination as applied to claims 23 and described above, in further view of McDonald (US 20220096820 A1).
Regarding claim 38, the Hatakeyama/Coggins combination discloses the bio-electrode according to claim 23 as described above. Hatakeyama further discloses an embodiment in which the copper wiring utilizes an adhesive tape in its connection ([0196]).
However, the Hatakeyama/Coggins combination is silent to the adhesive layer being present in the base.
McDonald teaches an electrode assembly with a plurality of medical electrodes ([Abstract]). As seen in Fig. 4E, the device comprises a hydrogel layer 460, a substrate 410, and a stud 470 and 450 penetrating through. The substrate comprises an adhesive flexible seal 480 on the top as seen in Fig. 4E. The adhesive flexible seal 480 has an adhesive layer that aids in attaching the electrode assembly 100 to a medical device ([0066]). The adhesive flexible seal further creates a waterproof barrier and aids with movement impact on signals ([0065]). It aids in reducing signal noise and artefacts present in the signals collected by the electrode assembly ([0065]). The waterproof connection along with the noise reduction is particularly advantageous where the patient must move or be submerged in water ([0065]). Incorporating an adhesive seal into the backing of the Hatakeyama/Coggins combination would be of routine skill in the art since Hatakeyama already contemplates utilizing an adhesive to connect to the medical device. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include an adhesive seal around the stud connection of the Hatakeyama/Coggins combination as taught by McDonald to provide for a more secure and waterproof connection to the ECG lead which aids in reducing signal noise and artefacts.
Claim 43 is rejected under 35 U.S.C. 103 as being unpatentable over The Hatakeyama/Coggins combination as applied to claims 41/23 and described above, in view of Ishikubo et al. (hereinafter ‘Ishikubo’, US 20230355152 A1).
Regarding claim 43, the Hatakeyama/Coggins combination discloses the production method for the bio-electrode according to claim 41, further comprising an adhesive, conductive film material comprising silicon onto the conductive base ([0138]: the bio-electrode composition, which forms the adhesive, conducting layer, is printed onto the conductive base) and curing the adhesive, conductive film material ([0139]: the bioelectrode composition, which forms the adhesive, conducting layer, is cured).
However, the Hatakeyama/Coggins combination is silent to printing the adhesive, conductive film onto a release liner first.
Ishikubo teaches a bioelectrode and a method of producing a bioelectrode ([Abstract]). Ishikubo further teaches two methods for manufacturing the bioelectrode. The first method involves directly printing the conductive layer onto the base layer, similar to the process disclosed by Hatakeyama ([0062]). The second method involves printing the conductive substrate onto a release film, then bonding the conductive electrode layer to the base, and finally removing the release film, as the claimed method requires ([0063]-[0065]). The substitution of one known method (printing the conductive layer onto a release liner and transferring to the base as taught by Ishikubo) for another (printing the conductive layer directly onto the base as disclosed by Hatakeyama) would have been obvious to one of ordinary skill in the art at the time of the invention since the substitution of the method from Ishikubo would have yielded predictable results, namely, the lamination of a conductive layer onto a base. Furthermore, both Ishikubo and the instant application discuss directly printing the conductive film onto a base (Ishikubo ([0062]) or onto the conducting path (Instant application [0061]). Therefore, because both the prior art and the instant application contemplate both methods of manufacturing, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to substitute the method of printing onto a release liner for the direct printing method.
Response to Amendment
The amendments to claim 27 overcome the 112b rejections of record. The 112b rejections of claim 27 has been withdrawn.
Response to Arguments
Applicant’s arguments with respect to claim 23 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Specifically, Hatakeyama is not used to teach the newly amended “direct” connection between the adhesive, conducting layer and the conducting path. Coggins is now used to teach the added limitation.
The arguments directed to the benefits and effects of the instant application versus the prior art are not persuasive because these benefits and/or results are not claimed, and the Hatakeyama/Coggins combination discloses the structure of claim 23 as described above. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Therefore, the rejection of independent claim 23 remains.
The rejections to the dependent claims remain because the rejection of the independent claim remains.
Applicant does not directly challenge the application of prior art to the dependent claims. The applicant simply states that the prior art does not remedy the stated differences of claim 23. Therefore, the rejections remain.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM E MOSSBROOK whose telephone number is (703)756-1936. The examiner can normally be reached M-F 8-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Stoklosa can be reached at (571) 272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/W.M./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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