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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 3/30/2026 has been entered.
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, 12, 20 and 31 are rejected under 35 U.S.C. 102(a)(1) and (2) as being anticipated by Palti (US 2006/0167499, hereinafter “Palti”).
In regards to claims 1 and 20, Palti discloses a system/kit, comprising:
a generator configured to generate an electrical signal having an alternating current waveform at a frequency in a range from 50 kHz to 576 kHz (par. 0027, “The electronic apparatus includes a generator that generates an alternating voltage waveform at frequencies in the range from about 50 KHz to about 500 KHz”);
a first conductive lead electrically coupled to the generator, the first conductive lead configured to carry the electrical signal (par. 0089, ”[t]he apparatus 200 includes a generator 210 and a pair of conductive leads 220 that are attached at one end thereof to the generator 210”); and
a pad electrically coupled to the first conductive lead (Fig. 11, elements 230), the pad comprising:
at least one insulated electrode electrically coupled to the first conductive lead and configured to emit a Tumor Treating Field (TTField) in the frequency range from 50 kHz to 576 kHz (par. 0089, “[t]he opposite ends of the leads 220 are connected to insulated conductors 230 that are activated by the electric signals (e.g., waveforms)”);
a semi-solid conductive gel for application to a patient's skin and for placement between the patient's skin and the at least one insulated electrode (par. 0100, “the isolects 230 can be shaped so as to conform with the body structure and/or (2) an intervening filler 270 (as illustrated in FIG. 10C), such as a gel, that has high conductance and a high effective dielectric constant”; the property of being “semi-solid” is definitional of a “gel” -- please see attached Merriam-Webster definition of gel); 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, 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. 0100, “[t]he gel can be made of hydrogels, gelatins, agar, etc., and can have salts dissolved in it to increase its conductivity” -- please see attached Wikipedia definition of “salt” as being an “ionic compound”).
In regards to claim 12, the semi-solid conductive gel is a hydrogel (par. 0100).
In regards to claim 31, the pad is a first pad, the system further comprising a second pad and a second conductive lead electrically coupled to the generator, the second conductive lead configured to carry the electrical signal to the second pad, wherein the first pad and the second pad are configured to be activated by the electrical signal from the generator to cause an electrical current to flow between the first pad and the second pad to generate the Tumor Treating Field (TTField) (Fig. 11, abstract).
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.
Claims 3-5 and 27-30 are rejected under 35 U.S.C. 103 as being unpatentable over Palti in view of Hong et al. (US 2021/0290944, hereinafter “Hong”).
Palti discloses the essential features of the claimed invention except for:
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;
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;
in regards to claim 27, the at least one bulk electron transport agent is in the form of one or more layers;
in regards to claim 28, the at least one bulk electron transport agent is in the form of one or more films;
in regards to claim 29, the at least one bulk electron transport agent is in the form of one or more coatings; or
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.
However, Hong in the same field of endeavor of body surface electrodes and same problem-solving area of optimizing contact of electrodes with the skin surface discloses:
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 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); and
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”)
to provide the predictable results of improving energy efficiency and propagating energy substantially without a loss by a high moisture content that is more effective for the subject (par. 0057).
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 Palti by providing the modifications set forth above to provide the predictable results set forth above.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Palti and Hong, further in view of Perrault et al. (US 6,347,246, hereinafter “Perrault”). Palti’s modified invention discloses the essential features of the claimed invention, including the bulk electron transport agent being disposed within the semi-solid conductive gel (Hong at 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 Palti’s modified 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 further modify Palti 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 Palti and Hong, further in view of Hyatt et al. (US 2014/0073896, hereinafter “Hyatt”). Palti’s modified invention discloses the essential features of the claimed invention, including providing carbon black particles as a bulk electron transport agent (see above), 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 Palti 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 Palti and Hong, further in view of Buckley et al. (US 5,286,415, hereinafter “Buckley”). Palti’s modified invention discloses the essential features of the claimed invention, including suggesting a composition including carbon black and metal particles (Hong at 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 further modify Palti 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 Palti and Hong, further in view of Haak et al. (US 6,317,629, hereinafter “Haak”). Palti’s modified invention discloses the essential features of the claimed invention including using a conductive carbon black powder (Hong at 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 further modify Palti 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 Palti and Hong, further in view of Al-Lamee et al. (US 2003/0153964, hereinafter “Lamee”). Palti’s modified invention 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 further modify Palti 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 Palti and Hong in view of Axelgaard et al. (US 6,038,464, hereinafter “Axelgaard”). Palti’s modified invention 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 further modify Palti 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 with respect to claims 1-9, 11, 12, 14, 16-20 and 27-31 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Kosierkiewicz (US 11,806,521) is another example of providing a conductive carbon bulk electron transport agent to an electrode.
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
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