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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/07/2026 has been entered.
Response to Arguments
Applicant’s arguments, see Remarks pg. 7, filed 01/06/2026, with respect to the rejection(s) of claim(s) 1 under 35 USC 103 have been fully considered and are persuasive in view of the argument that Dupelle does not disclose “a first conductive layer centrally located on the base layer configured to provide a defibrillation current to a patient; a second conductive layer extending at least partially around the first conductive layer on the base layer configured to obtain an ECG trace from the patient”. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Hayashi et al. (US 2014/0100466). See rejection below.
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, 3-5, 7, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Dupelle et al. (US 2006/0074452) (hereinafter Dupelle) in view of Hayashi et al. (US 2014/0100466) (hereinafter Hayashi) in view of DeSeve, III (US 2018/0250159) (hereinafter DeSeve), further in view of Ginestet et al. (WO 2019/241753) (hereinafter Ginestet).
Regarding claims 1 and 5, Dupelle discloses an electrode pad (Fig. 1-2, electrode 10), comprising: a base layer comprising a first side (foam substrate 12); a first conductive layer centrally located on the base layer (conductive element 14); a second conductive layer extending at least partially around the first conductive layer on the base layer (conductive element 18); and a hydrogel layer covering the first and second conductive layers on the first side of the base layer (electrolyte layer 16 covers conductive layers 14, 18, as best seen in Fig. 2; para. 7: ““There may be a substrate supporting the first and second electrically conductive elements and the electrically conductive material. The electrically conductive material may comprise a conductive gel. The conductive gel may be a solid gel. The solid gel may be a water-based hydrogel”);
Dupelle does not disclose the first conductive layer centrally located on the base layer configured to provide defibrillation current to a patient; the second conductive layer extending at least partially around the first conductive layer on the base layer configured to obtain an ECG trace from the patient; wherein the first conductive layer and second conductive layer are composed of conductive ink; wherein the conductive ink of the first conductive layer is composed of a first chemical compound and the conductive ink of the second conductive layer is composed of a second chemical compound, the first chemical compound being different than the second chemical compound, and the conductive ink of the first conductive layer is more conductive than the conductive ink of the second conductive layer; wherein the conductive ink is printed on the base layer.
Hayashi, however, teaches an ECG electrode set (Abstract) wherein in the alternative, as in modifications 1 and 2 which have been described with reference to FIGS. 5A and 5B, the electrocardiogram measurement electrodes may be placed so as to surround the defibrillation pads (para. 69).
It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to modify Dupelle to include the first conductive layer centrally located on the base layer configured to provide defibrillation current to a patient; the second conductive layer extending at least partially around the first conductive layer on the base layer configured to obtain an ECG trace from the patient. Making this modification would amount to a simple substitution of one known element (Dupelle’s electrode configuration) for another (Hayashi’s electrode configuration) to obtain predictable results (monitoring ECG and providing defibrillation concurrently).
Furthermore, DeSeve teaches a personal monitoring device (Abstract; Fig. 1) and that stretchable conductive ink traces will stretch along the body while conforming to it, as opposed to typical wires, which will limit range of movement during stretching and can flex away from the body because of their rigidity (Para. 81).
It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to modify Dupelle such that the first conductive layer and second conductive layer are composed of conductive ink of DeSeve. Making this modification would be useful for providing conductive layers which will stretch along the body while conforming to it, as taught by DeSeve. The Examiner notes that making this modification would result in the conductive ink being printed on the base layer, since the conductive layers of Dupelle are already disposed on the base layer, as evidenced above in the rejection of claim 1.
Furthermore, Ginestet teaches a re-wearable physiological monitoring device (Abstract), wherein contacts are printed using two layers of conductive ink with different physical and electrical properties such that the first layer of ink may have increased conductivity relative to the second layer of ink. The first layer of ink is a metal ink, while the second layer of ink is a carbon ink. The increased conductivity of the first layer ensures that there is adequate conductivity for a reliable electrical connection (Para. 136).
It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to modify modified Dupelle such that the conductive ink of the first conductive layer is composed of a first chemical compound and the conductive ink of the second conductive layer is composed of a second chemical compound, the first chemical compound being different than the second chemical compound, and the conductive ink of the first conductive layer is more conductive than the conductive ink of the second conductive layer. Making this modification would be useful for providing adequate conductive for a reliable electrical connection, as taught by Ginestat.
Regarding claim 3, Dupelle discloses the first conductive layer comprises a first circuit and the second conductive layer comprises a separate second circuit (Fig. 1-2, conductive elements 14, 18 are separate from each other; Fig. 3 depicts conductive element 14 with ECG circuit, conductive element 18 with pacing/defibrillation circuit).
Regarding claim 4, Dupelle discloses the first side of the base layer comprises a surface area which is larger than a surface area of each of the first and second conductive layers (Fig. 1, surface area of foam substrate 12 is larger than surface areas of both conductive layers 14, 18).
Regarding claim 7, Dupelle discloses the base layer is composed of foam material (Fig. 1-2, foam substrate 12).
Regarding claim 9, Dupelle discloses one of the first conductive layer and the second conductive layer is printed directly on to the base layer (Fig. 2, both layers 14 and 18 are printed directly onto base layer 12).
Claim(s) 2, 8, and 10-13 are rejected under 35 U.S.C. 103 as being unpatentable over modified Dupelle in view of Macur (US 2019/0046065).
Regarding claims 2 and 8, modified Dupelle does not disclose the second conductive layer comprises an ionizing surface for accelerating defibrillation recovery of the hydrogel layer after defibrillation, wherein at least one of the first conductive layer and second conductive layer is composed of silver chloride.
Macur, however, teaches a medical electrode (Abstract) comprising a surface of a conductive layer supporting at least two coatings of silver chloride coated silver, as well as a hydrogel layer contacting the surface of the conductive layer so as to provide an operative electrode surface, whereby improved uniformity of current density across the operative electrode surface, improved recovery time after delivering a defibrillation charge and improved ability to deliver pacing charges over extended periods are provided (Claim 1). As disclosed by Applicant, a chloride surface is considered an ionizing surface (see publication US 2021/0196181, para. 19, last sentence).
It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to modify modified Dupelle such that the second conductive layer comprises an ionizing surface for accelerating defibrillation recovery of the hydrogel layer after defibrillation, wherein at least one of the first conductive layer and second conductive layer is composed of silver chloride. Making this modification would be useful for providing improved uniformity of current density across the operative electrode surface, improved recovery time after delivering a defibrillation charge and improved ability to deliver pacing charges over extended periods, as taught by Macur.
Regarding claim 10, modified Dupelle teaches an electrode pad, comprising: a foam base layer comprising a first side; a first conductive layer comprising a first circuit centrally located on the base layer; wherein the first conductive layer is configured to provide a defibrillation current; a second conductive layer comprising a separate second circuit extending at least partially around the first conductive layer on the first side of the base layer; wherein the second conductive layer is configured to receive an electrical signal; a hydrogel layer covering the first and second conductive layers on the first side of the base layer (see rejection of claim 1 above); wherein the second conductive layer comprises an ionizing surface configured to accelerate defibrillation recovery of the hydrogel layer after defibrillation (see rejection of claim 2 above); wherein the first conductive layer and second conductive layer are composed of conductive ink; and wherein the conductive ink of the first conductive layer is composed of a first chemical compound and the conductive ink of the second conductive layer is composed of a second chemical compound, the first chemical compound being different than the second chemical compound, and the conductive ink of the first conductive layer is more conductive than the conductive ink of the second conductive layer (see rejection of claim 1 & 2 above).
Regarding claim 11, in regards to the limitation of “when a first voltage is provided to the first conductive layer, the first voltage is configured to be separate from a voltage provided to the second conductive layer,” the Examiner submits that modified Dupelle would be capable of providing these limitations. (See MPEP 2114(II): “‘[A]pparatus claims cover what a device is, not what a device does.’ Hewlett-Packard Co.v.Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a ‘recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus’ if the prior art apparatus teaches all the structural limitations of the claim”). Seeing that modified Dupelle discloses all the required structural limitations of claim 10, the Examiner submits that the disclosed electrode would be capable of performing the functions set forth above.
Regarding claim 12, modified Dupelle teaches an electrode pad, comprising: a foam base layer comprising a first side; a first conductive layer comprising a first circuit centrally located on the base layer; a second conductive layer comprising a separate second circuit extending at least partially around the first conductive layer on the first side of the base layer; a hydrogel layer covering the first and second conductive layers on the first side of the base layer (see rejection of claim 1 above); and an electrical connector attached to the first and second conductive layers configured for providing a voltage to the first and second conductive layers (Fig. 1-2, wires 22, 24; para. 16: “Wire 24 allows controlled electrical currents to be delivered to the depolarizing element 18 by electrical circuitry that delivers short-term, controlled amounts of energy, sufficient to depolarize the electrically conductive element 14 after it has been polarized by a prior pacing pulse”, i.e., wire 24 is electrically connected to both conductive elements 14, 18); wherein the second conductive layer comprises an ionizing surface configured to accelerate defibrillation recovery of the hydrogel layer after defibrillation (see rejection of claim 2 above); wherein the first conductive layer and second conductive layer are composed of conductive ink; and wherein the conductive ink of the first conductive layer is composed of a first chemical compound and the conductive ink of the second conductive layer is composed of a second chemical compound, the first chemical compound being different than the second chemical compound, and the conductive ink of the first conductive layer is more conductive than the conductive ink of the second conductive layer (see rejection of claims 1 & 2 above).
Regarding claim 13, modified Dupelle teaches the electrical connector comprises an end connected to the first and second conductive layers and a free end configured to connect to a voltage source (Fig. 3, wire 24 is electrically connected to both conductive elements 14, 18 at one end, other end connected to voltage source 34).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over modified Dupelle in view of Thomsen et al. (US 2013/0060098) (hereinafter Thomsen).
Regarding claim 6, modified Dupelle does not disclose that a first portion of the hydrogel layer extending over the first conductive layer has a first set of properties and a second portion of the hydrogel layer extending over the second conductive layer has a second set of properties which is different from the first set.
Thomsen, however, teaches a monitoring device (Abstract), wherein different forms or formulations of the hydrogel with different properties may be used within the same system or device, such as a formulation with conductive properties at one place on the base and a formulation with non-conductive properties at another place on the base. The hydrogel may form a transmission passage for the physiological signal from the individual to the detecting component (Para. 102). Thomsen also teaches that the hydrogel can amend a physiological signal, such as by filtering an electrical signal (Para. 104).
It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to modify modified Dupelle such that a first portion of the hydrogel layer extending over the first conductive layer has a first set of properties and a second portion of the hydrogel layer extending over the second conductive layer has a second set of properties which is different from the first set. Making this modification would amount to a simple substitution of one known element (hydrogel of Dupelle) for another (hydrogel of Thomsen) to obtain predictable results (forming a transmission passage for the physiological signal from the individual to the detecting component; filtering an electric signal, as taught by Thomsen).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Ichida et al. (US 2015/0173639) discloses a multi-layer bioelectrode (Abstract).
Takata (US 4787390) discloses an electrode sensor coated with an electrically conductive substance such as silver-silver chloride (Abstract; Col. 3, ll. 19-29).
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/A.A.G./Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792