DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3-5, 12, 20 and 27-30 are rejected under 35 U.S.C. 102(a)(1) and (2) as being anticipated by Hong et al. (US 2021/0290944, hereinafter “Hong”).
In regards to claims 1 and 20, Hong discloses a composition comprising: a semi-solid conductive gel for application to a patient's skin and for placement between the patient's skin and at least one insulated electrode (Figs. 4 and 5, element 110 is separated from electrode 210 by insulation 400; par. 0126, “hydrogel”); and at least one bulk electron transport agent disposed upon at least a portion of a surface of the semi-solid conductive gel and/or disposed within at least a portion of the semi-solid conductive gel (par. 0123), wherein the bulk electron transport agent is selected from the group consisting of an ionic compound, a metal, a non-metal, and combinations thereof (par. 0121, “carbon black”); and at least one insulated electrode that generates an alternating electric field upon application to a patient's skin in combination with the composition (Figs. 4 and 5, element 110 is separated from electrode 210 by insulation 400; par. 0126, “hydrogel”).
In regards to claim 3, the bulk electron transport agent is disposed upon at least a portion of the surface of the semi-solid conductive gel (par. 0123).
In regards to claims 4 and 5, the bulk electron transport agent comprises an amorphous carbon and/or a crystalline carbon comprising carbon black, graphene, or graphite (par. 0121; “activated carbon, graphite, carbon black, crumpled graphene particles, and rumpled reduced graphene oxide (RGO)”).
In regards to claim 12, the semi-solid conductive gel is a hydrogel (par. 0126).
In regards to claim 27, the at least one bulk electron transport agent is in the form of one or more layers (par. 0123, conductive film or conductive plate bound to surface).
In regards to claim 28, the at least one bulk electron transport agent is in the form of one or more films (par. 0123, conductive film bound to surface).
In regards to claim 29, the at least one bulk electron transport agent is in the form of one or more coatings (par. 0123, conductive film bound to surface).
In regards to claim 30, the at least one bulk electron transport agent includes a first bulk electron transport agent and a second bulk electron transport agent, and wherein the first bulk electron transport agent and the second bulk electron transport agent are different bulk electron transport agents (par. 0065; par. 0113; par. 0118, “conductive materials of the same kind or different kinds”; par. 0121, “mixed particles thereof”).
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.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Hong in view of Perrault et al. (US 6,347,246, hereinafter “Perrault”). Hong discloses the essential features of the claimed invention, including the bulk electron transport agent being disposed within the semi-solid conductive gel (par. 0123, “bound to both the surface and the inside”), but does not expressly disclose that the semi-solid conductive gel is cured. However, Perrault in the same field of endeavor of hydrogel electrodes teaches providing additives, such as conductivity enhancers, before curing the hydrogel to improve similar devices in the same way (col. 8, lines 38-55). One of ordinary skill could have applied Perrault’s teaching to Hong’s device by providing the agent before curing to yield no more than predictable results. 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 Hong by providing the conductivity enhancer before curing the hydrogel as this is the use of a known technique to improve similar devices in the same way.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Hong in view of Hyatt et al. (US 2014/0073896, hereinafter “Hyatt”). Hong discloses the essential features of the claimed invention, including providing carbon black particles as a bulk electron transport agent, but does not expressly disclose providing a carbon black film upon at least a portion of the surface of the gel. However, Hyatt in the same field of endeavor of medical electrodes teaches providing a carbon black film upon at least a portion of the surface of the gel (par. 0031) to provide the predictable results of improving the charge distribution over the surface of the electrode (par. 0008). 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 Hong by providing a carbon black film upon at least a portion of the surface of the gel to provide the predictable results of improving the charge distribution over the surface of the electrode.
Claims 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Hong in view of Buckley et al. (US 5,286,415, hereinafter “Buckley”). Hong discloses the essential features of the claimed invention, including suggesting a composition including carbon black and metal particles (par. 0121), but does not expressly disclose that this is an amalgamation of carbon black and copper. However, Buckley in the same field of endeavor of medical electrodes (col. 1, lines 11-12) teaches providing an electron transport agent comprising carbon black and copper in combination (col. 2, lines 30-35) to provide the predictable results of a highly conductive film-forming composition that imparts a smooth and easily spreadable coating (col. 1, lines 27-30). 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 Hong by providing an electron transport agent comprising carbon black and copper in combination to provide the predictable results of a highly conductive film-forming composition that imparts a smooth and easily spreadable coating.
Claims 9 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Hong in view of Haak et al. (US 6,317,629, hereinafter “Haak”). Hong discloses the essential features of the claimed invention including using a conductive carbon black powder (par. 0121), but does not expressly disclose that the carbon black is Ketjenblack or at a concentration of 1% to 50%. However, Haak in the same field of endeavor of body-applied medical electrodes teaches providing an electrode with a conductive filler comprising Ketjenblack with a concentration of 1% to 50% (col. 7, lines 1-10) to provide the predictable results of a commercially-available off-the-shelf material that provides for sufficient conductivity while still retaining sufficient tack for the electrode (col. 7, lines 1-10). 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 Hong by providing an electrode with a conductive filler comprising Ketjenblack with a concentration of 1% to 50% to provide the predictable results of a commercially-available off-the-shelf material that provides for sufficient conductivity while still retaining sufficient tack for the electrode.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Hong in view of Al-Lamee et al. (US 2003/0153964, hereinafter “Lamee”). Hong discloses the essential features of the claimed invention, but does not expressly disclose that the gel comprises at least one of: a polymer chain length in a range of from about 1 nm to about 200 nm; a pH in a range of from about 6 to about 8; a volume resistivity of less than about 100 Ohm-in; a skin adhesion rate of at least about 100 g/inch; a free salt present at a concentration in a range of from about 0.1 mM to about 1 M; and a thickness in a range of from about 10 mil to about 50 mil. However, Al-Lamee in the same field of endeavor of conductive gels for electrodes teaches providing the gel with a pH of 6-8 (par. 0062) to provide the predictable results of an adhesive gel that has low toxicity to skin. 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 Hong by providing the gel with a pH of 6-8 to provide the predictable results of an adhesive gel that has low toxicity to skin.
Claims 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Hong in view of Axelgaard et al. (US 6,038,464, hereinafter “Axelgaard”). Hong discloses the essential features of the claimed invention, including wherein the bulk electron transport agent is disposed in a gel skin layer, but does not expressly disclose that the composition is further defined as being a multi-layer structure that comprises: a scrim having a first and a second side; a gel tie layer attached to the first side of the scrim, wherein the gel tie layer is designed for contact with the at least one insulated electrode; and a gel skin layer attached to the second side of the scrim, wherein the gel skin layer is designed for contact with the patient's skin and wherein the scrim is structured such that the gel tie layer and the gel skin layer become embedded in the scrim in order to facilitate conductivity across the scrim between the gel tie layer and the gel skin layer; wherein the bulk electron transport agent is disposed between the scrim and the gel tie layer; or wherein the bulk electron transport agent is disposed between the scrim and the gel skin layer. However, Axelgaard in the same field of endeavor of compositions for body surface electrodes teaches providing a multi-layer structure (Fig. 5) that comprises: a scrim having a first and a second side (element 29); a gel tie layer attached to the first side of the scrim, wherein the gel tie layer is designed for contact with the at least one electrode (element 19); and a gel skin layer attached to the second side of the scrim, wherein the gel skin layer is designed for contact with the patient's skin (element 17) and wherein the scrim is structured such that the gel tie layer and the gel skin layer become embedded in the scrim in order to facilitate conductivity across the scrim between the gel tie layer and the gel skin layer (col. 6, line 56 to col. 7, line 24); and wherein the bulk electron transport agent is disposed between the scrim and the gel tie layer (element 30, col. 11, lines 28-36) to provide the predictable results of allowing for lower peel strength for the skin and higher peel strength for the electrode (col. 3, lines 25-30) while providing a reinforced bond between the two (col. 4, lines 5-10). Further, while Axelgaard discloses providing the bulk electron transport agent (element 29) in contact with the scrim layer (element 30) and that the layer 29 is effective with or without the scrim layer (col. 11, lines 29-31), Axelgarrd does not expressly disclose that the bulk electron transport agent is disposed between the scrim and the gel skin layer. However, it has been held that mere reversal of parts is a design choice that that is an obvious expedient if it fails to render no more than predictable results. See In re Gazda, 219 F.2d 449, 104 USPQ 400 (CCPA 1955). As is the case here, nothing on the record indicates that this design choice of reversing the parts would render anything more than predictable results. 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 Hong as set forth above to provide the predictable results of allowing for lower peel strength for the skin and higher peel strength for the electrode while providing a reinforced bond between the two.
Response to Arguments
Applicant's arguments filed 8/7/2025 have been fully considered but they are not persuasive. In regards to the rejection under section 102 in view of Hong, Applicant argued that Hong fails to disclose the claimed subject matter because Hong notes that the conductive composition includes a non-conductive matrix/scaffolding element including such substances as “collagen, fibrin, hyaluronic acid, polyacrylic acid-based, or polyvinyl alcohol; and one or two or more conductive unit bodies selected from fibrous, particulate, tubular, and plate shapes which are dispersed and bound to the hydrogel substrate to form a network” (par. 0126). Applicant concludes that, because the gel layer includes a component that is not conductive, the gel layer as a whole is not conductive, and thus fails to read on the claim language. Referring to Applicant’s disclosure at paragraphs 0113 and 0114, the composition of the instant claims may be formed of a polymer (including several of those disclosed in paragraph 0126 of Hong) in combination with a free salt (par. 0114). It is unclear how a distinction is made that the fibrin, collagen, or PVA polymer matrix of Hong is “non-conductive,” while the fibrin, collagen, or PVA polymer matrix of the instant application is “conductive,” but the rejection relies on the idea that Hong’s skin-contacting layer/composition as assembled reads on the claim language because it is a semi-solid conductive gel (by virtue of inclusion of the various conductive components described by Hong). The fact that this composition may include an element that is not conductive (and apparently the same non-conductive component(s) described by Applicant as being present in the inventive composition) does not render the composition as a whole non-conductive, and Hong describes throughout the disclosure that the skin-contacting gel layer is conductive (see, e.g., par. 0121). Hong further discloses that combinations of conductive components can be used (e.g., pars. 0120, 0121, 0122, 0123), and thus satisfying the “bulk electron transport agent” limitation(s).
In regards to claim 2, Applicant argued that Perrault’s teaching is not applicable to Hong because Hong is a high viscosity gel and Perrault is a low viscosity gel. Without conceding to the relative viscosities of Hong and Perrault that do not appear in the record, the examiner respectfully maintains the basis of rejection that Hong discloses the bulk electron transport agent dispersed within the gel matrix and Perrault teaches that it is known in the art to disperse such agent in a gel before curing.
Applicant further argued that Hyatt and Haak are not combinable with Hong because Hyatt and Haak have various differences in the electrical systems to which the electrodes are attached. All teachings relied upon are drawn to the electrode/body interface and compositions to provide this conductive path. The claims are drawn merely to a composition (claim 1) and a composition in combination with an electrode (claim 20) for any application whatsoever. The examiner respectfully maintains that an artisan of ordinary skill would reasonably look to the teachings of coupling electrodes to the body among Hong, Hyatt, and Haak as no specific physiological treatment or application is recited in the claims, and all of them are pertinent to the problem of coupling electrodes to the body. Types of power sources of the various disclosures or physiological treatments intended do not render the teachings of electrode/body coupling inoperable or unsatisfactory to the purpose of electrode/body coupling compositions.
Applicant further argued that the combination of Hong and Al-Lamee is improper because Al-Lamee uses a “concentrated sodium hydroxide” to the composition, which allegedly would destroy the structural integrity of Hong’s gel. Although establishment of this principle does not appear in the record, the examiner respectfully maintains that Al-Lamee discloses a desired pH for a gel electrode within the range recited in the claim, an artisan of ordinary skill could readily produce this pH using any number of substances, and provides a reason to do so for the motivation of low toxicity to skin cells. Applicant further argued that Al-Lamee fails to disclose all of the options recited in claim 14. However, these various features are recited in the alternative (“at least one of”).
Applicant further argued that the combination of Hong and Axelgaard is improper because Hong discloses that the two electrodes are not in contact with each other (par. 0103). It is that examiner’s understanding that the spaced “conductive part” and “stimulating part” discussed in paragraph 0103 refer to the two different electrodes (see “abstract”), and is not speaking to any proposed layer structure of the individual electrodes. Accordingly, the examiner respectfully maintains the combination and basis for applying the teaching of Axelgaard to Hong as set forth in the previous rejection and modified, necessitated by amendment, above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL W KAHELIN whose telephone number is (571)272-8688. The examiner can normally be reached M-F, 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at (571)270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL W KAHELIN/Primary Examiner, Art Unit 3792