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
Claims 16-20 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected grouping of the method of making an electrode, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/06/2025. Below is the complete first examination of the elected claims 1-15 drawn to the product of an electrode.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/27/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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)(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.
Claim(s) 1, 3-10, 12-14 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Stewart (US Patent No 20170340232).
Regarding claim 1, Stewart teaches an electrode comprising: a backing (flange element 18 which shapes the electrode is equated to the backing, [0023]) having a first backing side and a second backing side (wherein the top and bottom of the element 18 are the respective first and second backing side, [0023], see also fig 3A), the backing has a planar surface (see the planar surface of element 18 in fig 3A) and a portion of the backing forms a raised section on the first backing side (see in which the backing forms a raised section relative to the release plate 22A of the electrode, fig 3A) and an indented section on the second backing side opposite the raised section, the indented section forms a cavity therein (see the receptacle or cavity 12 which forms from the indented section of the backing element 18, [0023]) the backing is not electrically conductive (wherein the backing and receptacle may be non-conductive, [0024]); an electrically conductive gel disposed at least partially within the cavity (see the hydrogel conductive pallet 20 found partially in the receptacle 12, [0023]); an eyelet penetrating the backing and electrically coupled with the electrically conductive gel (the snap connector 16 may be formed with an eyelet 16A which is found in contact with the conductive surface 14 of the electrode, [0025]); and a stud adapted to detachably couple the electrode to a lead wire and configured to attach to the eyelet (stud 16B is used to provide a conductive surface to additional components such as wires and control units, [0025]).
Regarding claim 3, Stewart teaches the electrode of claim 1, further comprising a scrim disposed on a portion of the electrically conductive gel, proximate the eyelet (see in which Stewarts backing element 18 has flange wings 18A and 18B formed of a textile material and are located proximate the electrically conductive gel 20, [0030], and therefore are considered to be a scrim).
Regarding claim 4, Stewart teaches the electrode of claim 3, wherein the scrim is a reinforcing textile material (see in which Stewarts backing element 18 has flange wings 18A and 18B formed of a textile material, [0030]) that physically reinforces the electrically conductive gel and facilitates adhesion of the electrically conductive gel to the backing (see from [0030], in which the flange wings 18A and 18B or the scrim is used to help support and form the electrically conductive gel during adhesion and placement).
Regarding claim 5, Stewart teaches the electrode of claim 4, wherein the scrim is formed from two sections (wherein the backing 18 is formed of two flanges 18A and 18B, [0030], thereby forming two sections).
Regarding claim 6, Stewart teaches the electrode of claim 4, wherein the scrim has a donut shape having an inner diameter to an outer diameter ratio of 1:2 (see in which the backing 18, part of the scrim and the receptacle 12 form a circular donut shape of the electrode, in which the larger diameter may range from 10-20mm and the smaller diameter ranges from 8-18mm. This leads to a ratio range between 1:1.1 and 1:2.5, thereby encompassing the claimed diameter ratio).
Regarding claim 7, Stewart teaches the electrode of claim 1, wherein the backing is a non- woven layer (wherein the electrode applicator or backing is composed typically of a non-woven fabric, [0004]).
Regarding claim 8, Stewart teaches the electrode of claim 1, wherein the backing is a woven layer (wherein the backing element 18 is often spun with polyethylene fibers, [0032], thereby teaching woven material).
Regarding claim 9, Stewart teaches the electrode of claim 1, wherein the electrically conductive gel is at least partially disposed on the second backing side surrounding the indented section (see in which the conductive hydrogel 20 is at least partially covering the conductive area 14 found on the second side of the backing 18, [0023]).
Regarding claim 10, Stewart teaches the electrode of claim 1, wherein the backing is a polymeric film (wherein the backing element 18 is often spun with polyethylene fibers, [0032], a type of polymeric film).
Regarding claim 12, Stewart teaches the electrode of claim 1, wherein the raised section is dome-shaped (see from the figure 2B in which the raised section of the backing 18 is a dome shape).
Regarding claim 13, Stewart teaches the electrode of claim 12, wherein the raised section has a radius of curvature of 20 mm (see from [0035] in which the radius of the backing 18 and receptacle 12 may range from 10 to 20mm, thereby encompassing the claimed radius of curvature).
Regarding claim 14, Stewart teaches the electrode of claim 1, wherein the indented section has a depth of no greater than 100 thousandths of an inch as measured from a plane formed by the second backing side of the backing (see from [0035], in which the total depth of the receptacle or indented section 12 is approximately 1.5mm which equates to approximately 60 thousandths of an inch, thereby teaching no greater than 100 thousandths).
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) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stewart (US Patent No 20170340232) in view of Cadarelli (Francois Cardarelli, Materials Handbook, from Springer International Publishing, 2018, presented through the Matmake website).
Regarding claim 2, Stewart teaches the electrode of claim 1.
Stewart does not explicitly state wherein the backing has a modulus of elasticity of less than 0.9 GPa.
However, Stewart does teach that the backing layer 18 of the electrode is made with polyethylene fibers, [0032]. Furthermore, it is known to those in the art that the material polyethylene has a modulus of elasticity ranging from 0.1-1.2 GPa at normal room temperature which is seen as taught by Cardarelli through the Matmake website.
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date, to use the polyethylene backing disclosed by Stewart, to teach a modulus of elasticity of the backing to be approximately between 0.1-1.2 GPa as disclosed by Cardarelli. Thereby, the polyethylene backing of Stewart would contain overlapping ranges with the claimed disclosure of less than 0.9 GPa and therefore the combination teaches the limitation of claim 2 of the present application.
Claim(s) 11, 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stewart (US Patent No 20170340232) in view of Strand (US Patent No 5454739).
Regarding claim 11, Stewart teaches the electrode of claim 10.
Stewart does not explicitly teach wherein the polymeric film comprises at least 80 percent low density polyethylene and no greater than 20 percent high density polyethylene.
However, the analogous conductive electrode patch taught by Strand does teach a backing layer 12 for an electrode component in which the material is made fully of a low-density polyethylene (col. 6, line 5). Therefore, if the backing is made fully of the low-density polyethylene it is 100% low density and 0% high density and by definition falls within the claimed limitations of at least 80% low density and less than 20% high density polyethylene.
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the electrode system taught by Stewart, with that of the specific electrode backing composition taught by Strand, as it is another electrode material known in the art to create a firm, yet flexible electrode patch as disclosed by the prior art of Strand.
Regarding claim 15, the combination teaches the electrode of claim 1, wherein a thickness of the backing is between 6 and 12 thousandths of an inch (see from Strand, col. 6., lines 5-10, in which the backing layer 12 for the electrode component may be extruded to a film thickness of 0.002 to 0.007 inches, thereby overlapping the claimed range of between 0.006 to 0.012 inches).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE M BROWN whose telephone number is (703)756-4534. The examiner can normally be reached 8:00-5:00pm EST, Mon-Fri, alternating Fridays off.
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, Linda Dvorak can be reached at 571-272-4764. 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.
/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/KYLE M. BROWN/Examiner, Art Unit 3794