DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of Group I pertaining to claims 1-9 and 21-32 in the reply filed on 15 May 2026 is acknowledged.
Claims 10-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II, there being no allowable generic or linking claim. Election was made without traverse.
Claim Objections
Claim 21 is objected to because of the following informalities: line 1 recites “…conductive material is or comprises hydrogel”. Appropriate correction is required.
Claim 223 is objected to because of the following informalities: line 1 recites conductive material is or comprises a conductive adhesive or a hydrogel”. Appropriate correction is required.
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(s) 1, 5-9, 21-24, 27, and 29-32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Van De Beek et al. (US Publication no. 2013/0066412) in view of Eiger (US Publication no. 2018/0264275).
In regard to claim 1, Van der Beek et al. disclose an electrode for supplying electrical stimulation to a subject’s body comprising (figure 12):
a sheet 36 of graphitized cloth or mesh material having a front face and a rear face (para 30 and 45-46),
PNG
media_image1.png
407
500
media_image1.png
Greyscale
at least one layer of conductive material 34 disposed on the front face of the sheet 36 (para 30, 47, and 49), wherein the at least one layer of conductive material 34 has a biocompatible front surface (para 47, gel layer 34 facilitates adherence of electrode to subject’s skin); and a first electrode 72 element positioned behind the sheet 36, the first electrode element 72 having a first front face disposed in electrical contact with the rear face of the sheet 36.
Sheet or layer 36 is described as a conductive layer comprises of either metallic foils, conductive polymers, graphitized or metallized cloth or wire mesh and is configured to distribute electric signals and is arranged on a manner such that electrical signals supplied through the electrode element 72 are distributed through the current spreader 36 and conductive gel 34, However, Van der Beek et al. do no teach that the spreader material comprises a sheet of anisotropic material having a front face and a rear face, the sheet having a first thermal conductivity in a direction that is perpendicular to the front face, wherein thermal conductivity of the sheet in directions that are parallel to the front face is more than two times higher than the first thermal conductivity.
Eiger a system and method for controlling heat dispersion in a medical device. Eiger describes use of a sheet of anisotropic material (TPG, thermally conductive material) such as thermally conductive pyrolytic graphite (HOPG) having an in plane of thermal conductivity greater than 10 W/m-K, and an out of plane thermal conductivity of less than 10 W/m-K (para 32 and 36). The “in plane” thermal conductivity comprising the plane parallel to a front face (i.e., in the x-y plane), wherein the “out of plane” thermal conductive is the plane perpendicular to the front face (i.e., in the z-plane or c direction, which is shown in axis of figure 12 of Van der Beek et al.) (para 34-35). The x-y plane’s thermal conductivity is high, whereas the z-plane thermal conductivity is low. Based on the thermal conductivity ranges provided by Eiger, the in plane of parallel plane thermal conductivity is at least 2x and even as much as 10x the thermal conductivity of the out of plane or perpendicular plane. Paragraph 32 illustrates another example that the thermal conductivity in the c direction (perpendicular) is only 3.5 W/m-K, and the a-b plane (parallel) is 400-1700 W/m-K, wherein even with the lowest in plane value, the thermal conductivity of the parallel plane is about 114 times higher than the perpendicular plane. The TPG/HOPG sheet enables heat to be evenly spread over the sheet’s x-y surface before being transferred along the z-plane.
It would have been obvious to one of ordinary skill in the art to substitute the pyrolytic graphite sheet taught by Eiger for the conductive current spreader of Van der Beek et al., since Van der Beek et al. teach that graphitized material as suitable for distributing electrical current across an electrode assembly, while Eiger teaches that pyrolytic graphite sheets exhibit exceptionally high in plane thermal conductivity. Such substitution would comprise the substitution of a known alternative graphite material in an existing current spreading structure with the benefit of another graphite material to provide the benefit of enhancing lateral heat distribution and reducing localized heating at the subject contacting interface to enhance subject comfort while maintaining the current spreading function.
The recitation that the apparatus is “for applying an alternating electric field to a subject’s body” is considered a recitation of the intended use that does not imply any further structure to the structurally distinguish the apparatus. The electrode of Van der Beek et al. is configured to conduct electrical signals from an electrode to a subject’s body and is therefore considered reasonably capable of operating under the recited intended use.
In regard to claim 5, Van der Beek et al. show in figure 12 the first electrode element 72 comprises a piece of metal having a front face (para 45, element 71 is a metal plate), and wherein the front face of the piece of metal is the first front face of the first electrode element (as shown in the annotated figure above).
In regard to claim 6, Van der Beek et al. in view of Eiger teach a sheet 36 comprising a sheet of graphite (Van der Beek et al., para 30, graphitized cloth or mesh), and when modified in view of Eiger would be substituted with the anisotropic sheet of pyrolytic graphite (Eiger, para 31, 33, and 36).
In regard to claim 7, Van der Beek et al. in view of Eiger teach that the sheet of anisotropic material is a sheet of pyrolytic graphite, graphite foil made from compressed high purity exfoliated mineral graphite, or graphitized polymer film (Van der Beek et al., para 30, graphitized cloth or mesh, substituted with Eiger’s pyrolytic graphite sheet, para 31, 33, and 36).
In regard to claim 8, Van der Beek et al. in view of Eiger teach that the thermal conductivity of the sheet in directions that are parallel to the front face is more than ten times higher than the first thermal conductivity (when sheet 36 is substituted for the sheet of pyrolytic graphite sheet, Eiger expressly teaches that the sheet has a in-plane (i.e. parallel) thermal conductivity of at least 10 x the out of plane conductivity (i.e., perpendicular) TPG, thermally conductive material such as thermally conductive pyrolytic graphite (HOPG) having an in plane of thermal conductivity greater than 10 W/m-K, and an out of plane thermal conductivity of less than 10 W/m-K (para 32 and 36), the other example at para 32 teaches the thermal conductivity in the c direction (perpendicular) is only 3.5 W/m-K, and the a-b plane (parallel) is 400-1700 W/m-K, wherein even with the lowest in plane value, the thermal conductivity of the parallel plane is about 114 times higher than the perpendicular plane).
In regard to claim 9, Van der Beek et al. in figure 12 teaches at least one layer of conductive material 34 comprises an adhesive (para 47, the gel layer 34 may be used to adhere the electrode 14 to the subject's skin, alternatively the embodiment of figure 3 teaches gel layer 34 may include an adhesive material to facilitate the connection between the electrode and the subject's skin). Modification of the gel layer to include the adhesive is considered to have been obvious in view of express suggestion in Van der Beek et al.
In regard to claim 21, Van der Beek et al. expressly teaches that the conductive material layer 34 comprises hydrogel (para 47).
In regard to claim 22, Van der Beek et al. teaches in figure 12 (relied on above) comprising a first rear layer of conductive material 74 positioned between the first front face of the first electrode element 72 and the rear face of the sheet 36, and wherein the first rear layer of conductive material 74 facilitates the electrical contact between the first front face of the first electrode element 72 and the rear face of the sheet 36 (para 45, second conductive layer 74 may be configured to conduct electric signals between the current spreader 36 and the metal plate 72).
In regard to claim 23, Van der Beek et al. teach that the first rear layer of conductive material 74 is or comprises a conductive adhesive or a hydrogel (para 45, second conductive layer 74 may also include adhesive material that enables the second conductive layer 74 to be adhered to other portions of the electrode).
In regard to claim 24, Van der Beek et al. teach that the conductive adhesive or hydrogel of conductive layer 74 is a conductive composite (para 45, may be made of carbon or other conductive materials). Selection of material on the basis of its suitability for the intended use has been held as obvious to one of ordinary skill in the art.
In regard to claim 27, Van der Beek et al. does not include a dielectric in the electrode construction.
In regard to claim 29, Van der Beek et al. in figure 12 teaches at least one layer of conductive material 34 comprises an adhesive (para 47, the gel layer 34 may be used to adhere the electrode 14 to the subject's skin, alternatively the embodiment of figure 3 teaches gel layer 34 may include an adhesive material to facilitate the connection between the electrode and the subject's skin). Modification of the gel layer to include the adhesive is considered to have been obvious in view of express suggestion in Van der Beek et al.
In regard to claim 30, Van der Beek et al. in view of Eiger teach that the sheet of anisotropic material is a sheet of pyrolytic graphite, graphite foil made from compressed high purity exfoliated mineral graphite, or graphitized polymer film (Van der Beek et al., para 30, graphitized cloth or mesh, substituted with Eiger’s pyrolytic graphite sheet, para 31, 33, and 36).
In regard to claim 31, Van der Beek et al. expressly teaches that the conductive material layer 34 comprises hydrogel (para 47).
In regard to claim 32, Van der Beek et al. in view of Eiger teach that the sheet of anisotropic material is a sheet of pyrolytic graphite, graphite foil made from compressed high purity exfoliated mineral graphite, or graphitized polymer film (Van der Beek et al., para 30, graphitized cloth or mesh, substituted with Eiger’s pyrolytic graphite sheet, para 31, 33, and 36).
Claim(s) 2-4 and 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Van De Beek et al. (US Publication no. 2013/0066412) in view of Eiger (US Publication no. 2018/0264275), further in view of Deslauriers (US Publication no. 2021/0346693).
In regard to claim 2, Van der Beek et al. in view of Eiger substantially suggest the invention as claimed, wherein Van der Beek et al. further teach in figure 12 (relied on above) comprising a first rear layer of conductive material 74 positioned between the first front face of the first electrode element 72 and the rear face of the sheet 36, and wherein the first rear layer of conductive material 74 facilitates the electrical contact between the first front face of the first electrode element 72 and the rear face of the sheet 36 (para 45, second conductive layer 74 may be configured to conduct electric signals between the current spreader 36 and the metal plate 72).
However, neither teach that the first electrode element comprises (i) a first layer of dielectric material having a front face and a rear face and (ii) a first layer of metal disposed on the rear face of the first layer of dielectric material, wherein the front face of the first layer of dielectric material is the first front face of the first electrode element.
Deslauriers describe a conductive electrode pad to applying tumor treating field. In one embodiment of the pad, Deslauriers teaches pad construction comprising: A pad, comprising: an electrode element connected to the topcoat layer, and configured to receive an electrical signal from a generator producing an electric signal as a TTField; a flexible polymer layer connected to the electrode element, the flexible polymer layer being constructed of a dielectric material; and a conductive gel element connected to the flexible polymer layer to electrically isolate the electrode element from the conductive gel element, the conductive gel element configured to be in contact with a patient's skin (para 568-572). In this manner, the pad of Deslauriers includes an electrode element with a first layer of dielectric, wherein the dielectric layer is disposed on the front face of the electrode, such that the rear face of the dielectric interfaces with the front face of the electrode, and the front face of the dielectric interfaces with the rear face of a gel layer, wherein the gel layer is the front face of the pad and configured to adhere to the skin of the subject.
It is considered to have been obvious to one of ordinary skill in the art to modify the electrode layer 72 of Van der Beek et al. by replacing it with the metal-backed dielectric electrode construction taught by Deslauriers in order to facilitate capacitive coupling of alternating electric fields while reducing undesirable electrochemical reactions and maintaining uniform electrical energy distribution across the patient contacting surface.
In regard to claim 3, Van der Beek et al. in view of Eiger and Deslauriers substantially suggest the invention as claimed, wherein Van der Beek et al. further teach in figure 12 (relied on above) comprising a first rear layer of conductive material 74 positioned between the first front face of the first electrode element 72 and the rear face of the sheet 36, and wherein the first rear layer of conductive material 74 facilitates the electrical contact between the first front face of the first electrode element 72 and the rear face of the sheet 36 (para 45, second conductive layer 74 may be configured to conduct electric signals between the current spreader 36 and the metal plate 72). However, none of the references teach a second electrode element positioned behind the sheet, the second electrode element having a second front face disposed in electrical contact with the rear face of the sheet, wherein the second electrode element comprises (i) a second layer of dielectric material having a front face and a rear face and (ii) a second layer of metal disposed on the rear face of the second layer of dielectric material. The Examiner considers this to comprise a duplication of the structure relied on Deslauriers for the metal backed dielectric electrodes. The Examiner further submits that supplying providing multiple metal backed dielectric electrodes elements was known and is evidenced by figure 1b of the present disclosure which shows this arrangement as prior art (para 4 of the present specification; constitutes Applicant admitted prior art, MPEP 2129). In view of this, it would have been obvious to one of ordinary skill in the art to provide the metal backed dielectric, as illustrates in Applicant’s admitted prior art of figure 1B, in the assembly described by Van der Beek et al. in view of Eiger and Deslauriers to distribute the applied alternative electric field over a larger treatment area while maintaining capacitive coupling between the electrode elements and the subject.
Additionally, in regard to claim 3, it would have been obvious to one of ordinary skill in the art to provide a common conductive rear layer extending beneath the plurality of metal backed dielectric electrodes, such as by enlarging the shape and size of layer 74 of Van der Beek et al., to simplify electrode assembly and provide a shared electrical interface with the sheet 36 to facilitate distribution of the applied alternative electric field. Moreover, Van der Beek et al. expressly suggest the size and shape of the element 74 may be altered upon choice (para 45).
In regard to claim 4, Van der Beek et al. in view of Eiger and Deslauriers substantially suggest the invention as claimed, wherein Van der Beek et al. further teach in figure 12 (relied on above) comprising a first rear layer of conductive material 74 positioned between the first front face of the first electrode element 72 and the rear face of the sheet 36, and wherein the first rear layer of conductive material 74 facilitates the electrical contact between the first front face of the first electrode element 72 and the rear face of the sheet 36 (para 45, second conductive layer 74 may be configured to conduct electric signals between the current spreader 36 and the metal plate 72). However, none of the references teach a second electrode element positioned behind the sheet, the second electrode element having a second front face disposed in electrical contact with the rear face of the sheet, wherein the second electrode element comprises (i) a second layer of dielectric material having a front face and a rear face and (ii) a second layer of metal disposed on the rear face of the second layer of dielectric material. The Examiner considers this to comprise a duplication of the structure relied on Deslauriers for the metal backed dielectric electrodes. The Examiner further submits that supplying providing multiple metal backed dielectric electrodes elements was known and is evidenced by figure 1b of the present disclosure which shows this arrangement as prior art (para 4 of the present specification; constitutes Applicant admitted prior art, MPEP 2129). In view of this, it would have been obvious to one of ordinary skill in the art to provide the metal backed dielectric, as illustrates in Applicant’s admitted prior art of figure 1B, in the assembly described by Van der Beek et al. in view of Eiger and Deslauriers to distribute the applied alternative electric field over a larger treatment area while maintaining capacitive coupling between the electrode elements and the subject.
Additionally in regard to claim 4, it would have been obvious to one of ordinary skill in the art to provide individual conductive rear layers corresponding to the respective metal backed dielectric electrodes, such as by duplicating layer 74 of Van der Beek et al., to facilitate electrical contact between each electrode element and sheet 36 while accommodating variations in electrode positioning and surface contact. Moreover, Van der Beek et al. expressly suggest the size and shape of the element 74 may be altered upon choice (para 45).
In regard to claim 28, Van der Beek et al. in view of Eiger substantially suggest the invention as claimed, however do not teach a capacitor in series with and behind the piece of metal. Deslauriers uses two blocking capacitors 82a and 82b electrically connected in series with electrode element 124 and are positioned on the non-patient side of the electrode 124 (para 97-98, the blocking capacitors 82a/82b may be components of leads 58a/58b (figure 2). It would have been obvious to one of ordinary skill in the art to incorporate capacitors behind the metal electrode to prevent undesirable DC current while permitting transmission of alternating electric fields, thereby reducing electrolysis and excessive heating.
Claim(s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Van De Beek et al. (US Publication no. 2013/0066412) in view of Eiger (US Publication no. 2018/0264275), further in view of Heintz et al. (US Publication no. 2020/0238073).
In regard to claim 25, Van der Beek et al. in view of Eiger substantially suggest the invention as claimed, however do not teach that the adhesive of hydrogel further comprises carbon particles, powder, fibers, flakes, or nanotubes. Heintz et al. teach that coating electrodes with hydrogels blended with conductive components such as carbon nanotubes may provide desired electrical characteristics with reduced stiffness (para 4). It would have been obvious to one of ordinary skill int eh art to incorporate carbon nanotubes into the conductive hydrogel to improve electrical conductivity and provide additional conductive pathways, thereby facilitating electrical coupling between the electrode assembly and subject’s skin.
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Van De Beek et al. (US Publication no. 2013/0066412) in view of Eiger (US Publication no. 2018/0264275) and Deslauriers (US Publication no. 2021/0346693), further in view of Palti et al. (US Publication no. 2011/0137229).
In regard to claim 26, Van der Beek et al. in view of Eiger and Deslauriers substantially suggest the invention as claimed, however none teach the dielectric constant of the dielectric material being at least 10. Palti et al. teaches dielectric materials used to apply alternating electric fields, including materials having dielectric constants of approximately 20-50 (107, 111, 112). It would have been obvious to one of ordinary skill in the art to utilize a dielectric material having a dielectric constant greater than 10, since Palti et al. teach that high dielectric constants increase electrode capacitance and reduce capacitive impedance, thereby increasing the proportion of applied alternating voltage delivered to the subject’s tissue and improving treatment efficiency.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Hardesty (US Patent no. 9,064,852) describes thermal properties of anisotropic pyrolytic carbon materials having thermal conductivity in a parallel plane greater than the thermal conductivity in the perpendicular plane.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN T GEDEON whose telephone number is (571)272-3447. The examiner can normally be reached M-F 8:00 am to 5:30 PM ET.
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, David E. Hamaoui can be reached at 571-270-5625. 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.
/BRIAN T GEDEON/Primary Examiner, Art Unit 3796 9 October 2026
Prosecution Insights