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 .
Information Disclosure Statement
The information disclosure statement(s) filed 05/28/2024 has/have been considered by the Examiner.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. EP21212321.0, filed on 12/03/2021.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 recites, “…a carrier element (14) …” which includes the label parenthesis (14); however, the parenthesis labels are canceled in the other claims. It is not clear if this is deliberate, or if this was mistakenly left in the preliminary amendment. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-2, 6-9 and 15 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Cross (US 20130060313 A1 – hereinafter Cross).
Re. claim 1 and 15, Cross teaches a medical electrode device/method of forming a medica electrode device for implantation into a patient (abstract – “The present invention provides for an improved apparatus and method for electrical stimulation. A paddle having a thickness up to 0.030 inches is implanted adjacent the spinal cord dura mater…”), comprising:
a carrier element (figure 2, first and second paddle portions 22 and 24, respectively) being formed from an electrically insulating material (paragraph 0033 – “…the polyurethane material of first paddle portion 22 and second paddle portion 24”),
at least one contact element arranged on the carrier element (figure 2, electrodes 20) and comprising a contact portion for coupling to tissue in an implanted state of the medical electrode device (paragraph 0036 – “Top surface 104 provides electrical contact with the tissue to be stimulated and preferably extends slightly beyond second paddle portion 24 as discussed above”),
PNG
media_image1.png
400
544
media_image1.png
Greyscale
and at least one electrical supply line connected to the at least one contact element (figure 3, conductor 18 connected to electrode 20),
PNG
media_image2.png
384
540
media_image2.png
Greyscale
wherein the at least one contact element comprises a first fastening section and a second fastening section (figure 4, base 108 comprises arches 110 and 112), the first fastening section and the second fastening section being arranged at a distance with respect to each other along a length direction (figure 4 shows the arches 110 and 112 are longitudinally spaced from one another) and the at least one electrical supply line being connected to the at least one contact element at the first fastening section and the second fastening section (figure 4 shows the conductor 18 connected to the arches 110 and 112 and electrode 20) such that the at least one electrical supply line is arranged at a distance with respect to the contact portion along a height direction oriented perpendicularly to the length direction (figure 4 shows the perpendicular separation of the conductor 18 and the contact portion of the electrode 20),
PNG
media_image3.png
360
504
media_image3.png
Greyscale
wherein a portion of the carrier element (figure 4, crimp sleeve 98) extends through a space in between the contact portion and the at least one electrical supply line (figure 4 shows the crimp sleeve 98 has a top portion which extend through the space between the electrode 20 and the conductor 18).
PNG
media_image4.png
238
508
media_image4.png
Greyscale
Re. claim 2, Cross further teaches wherein the contact portion faces outside in a first direction along the height direction (figure 3, electrode 120 faces outward), wherein the at least one contact element comprises an edge contour facing in a second direction opposite the first direction (figure 4, 108 includes widened edges),
PNG
media_image5.png
360
504
media_image5.png
Greyscale
the first fastening section and the second fastening section being formed on the edge contour (figure 4, arches 112 and 110 are formed on the edges of the base 108).
Re. claim 6, Cross further teaches wherein at least one of the first fastening section and the second fastening section comprises a fastening opening in which the at least one electrical supply line is arranged (figure 4 shows the arches 110, 112 through which the conductor 18 goes through).
PNG
media_image3.png
360
504
media_image3.png
Greyscale
Re. claim 7, Cross further teaches wherein the fastening opening is circumferentially closed OR is circumferentially opened (figure 4, arches 110, 112 are shown to be circumferentially opened).
Re. claim 8, Cross further teaches wherein a connection element (figure 4, crimp sleeve 98) configured to connect the at least one electrical supply line to the first fastening section and the second fastening section, the connection element being fastened on the first fastening section and the second fastening section (figure 4 shows the crimp sleeve 98 fastened on the arches 110, 112).
PNG
media_image6.png
360
504
media_image6.png
Greyscale
Re. claim 9, Cross further teaches wherein the connection element comprises a conduit in which the at least one electrical supply line is received (figure, crimp sleeve 98).
PNG
media_image7.png
238
307
media_image7.png
Greyscale
Claim Rejections - 35 USC § 103
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) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cross (US 20130060313 A1 – hereinafter Cross).
Re. claim 3, Cross teaches the first and second fastening sections as stated above in claim 1 (figure 4, arches 112 and 110), but does not explicitly teach wherein at least one of the first fastening section and the second fastening section protrudes from the edge contour along the second direction.
However, it is held by the courts that the configuration of the fastening sections (arches 112 and 110) is considered a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration is significant. In the instant case, the arches 110 and 112 are shown to connect to the electric supply line (figure 4, conductor 18), and therefore modifying the shape to protrude outwards from the base 108 would not change operation of the device in securing the electric supply line, as well as delivering stimulation as a whole.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to try modifying shape of the arches 110, 112 of Cross, to a protruded configuration since such modification would still predictably result in in securing the electric supply line, as well as delivering stimulation as a whole.
Claim(s) 4-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cross (US 20130060313 A1 – hereinafter Cross) in view of Skubitz (US 9561363 B2 – hereinafter Skubitz).
Re. claim 4, Cross teaches the contact element (figure 4, electrodes 20) and the edge contour (figure 4, 108 includes widened edges) as stated above in claim 2, but does not explicitly teach wherein the at least one contact element comprises at least one engagement element protruding from the edge contour and engaging with the electrically insulating material of the carrier element.
Skubitz teaches a similar electrode assembly (abstract – “An insulative body of a medical electrical lead electrode assembly…”) which includes an insulative carrier (figure 3A, insulative carrier 200) comprising an outward contact surface 43 (figure 3A) comprising at least one engagement element protruding from the edge contour and engaging with the electrically insulating material of the carrier element (figure 3A shows the projections 420, 440 which extend beyond the edge of the carrier 200 and engages with the insulative carrier 200).
PNG
media_image8.png
190
350
media_image8.png
Greyscale
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Cross, specifically the contact element of Cross, to incorporate the protruding engagement element, or projections 420, 440 as taught by Skubitz, since such modification would predictably result in securing the contact element in place.
Re. claim 5, the combined invention of Cross and Skubitz (hereinafter the combined invention) further teaches wherein the first fastening section and the second fastening section are formed on a first portion and a second portion of the edge contour arranged at a distance with respect to each other along the length direction (figure 4 shows arches 110 and 112 are arranged on a first and second portion of the base 108 and along the length direction).
PNG
media_image9.png
360
504
media_image9.png
Greyscale
The combined invention further teaches the engagement element as stated above in claim 4 (figure 3A shows the projections 420, 440 which extend beyond the edge of the carrier 200 and engages with the insulative carrier 200), but does not explicitly teach wherein the at least one engagement element is arranged on a third portion of the edge contour extending in between the first portion and the second portion along the length direction.
The differences in the layout and arrangement of the essential working elements are not considered to comprise a critical advantage to the layout of elements disclosed by the combined invention, and thus is not considered to constitute a patentable difference. Since the combined invention demonstrates the capability of housing each of the working elements (i.e. projections 420, 440 of Skubitz) to fit within the base 108 of Cross, then the architecture in which the elements are arranged is not deemed critical. This difference, wherein the only difference being the arrangement and location of essential working elements, has been held by the reviewing courts as being obvious to one of ordinary skill in the art since it is motivated by choice in design and routine skill (In re Japikse, 86 USPQ 70). The location of each element is motivated by choice in design dictated by the limited available space.
PNG
media_image10.png
376
936
media_image10.png
Greyscale
Claim(s) 10-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cross (US 20130060313 A1 – hereinafter Cross) in view of Avery (US 3724467 A – hereinafter Avery).
Re. claim 10, Cross teaches the connection element as stated above in claim 8 (figure 4, crimp sleeve 98), but does not explicitly teach wherein the connection element comprises a plate body configured to fasten the at least one electrical supply line.
Avery teaches a similar medical electrode device (abstract – “An improved implantable device for electrically stimulating a selected portion of the spinal cord is provided”),
PNG
media_image11.png
258
296
media_image11.png
Greyscale
and includes an electrode pad (figure 1, neuro-stimulating implant 10) comprising electrodes 14 and a lead 16 (figure 2), and a connection element comprising a plate (figure 2, layers 18 and 20) which fastens the electrical supply line (lead 16) to the electrodes 14, shown in figure 2.
PNG
media_image12.png
138
238
media_image12.png
Greyscale
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the connection element of Cross, to incorporate the connection element layer plate as taught by Avery as stated above, since such modification would predictably result in fixing the electrical supply line to the contact portion of the electrode.
Re. claim 11, the combined invention of Cross and Avery further teaches wherein the at least one electrical supply line is arranged on a side of the plate body facing away from the contact portion (Avery figure 2 shows the lead 16 on the layer 20 facing away from the electrode 14).
PNG
media_image13.png
138
238
media_image13.png
Greyscale
Re. claim 12, the combined invention of Cross and Avery teaches the plate body, electrical supply line and the contact portion as stated above in claim 10, but does not explicitly teach wherein the at least one electrical supply line is arranged on a side of the plate body facing towards the contact portion.
The differences in the layout and arrangement of the essential working elements are not considered to comprise a critical advantage to the layout of elements disclosed by the combined invention, and thus is not considered to constitute a patentable difference. Since the combined invention demonstrates the capability of housing each of the working elements (i.e. electrical supply line) to fit within the plate body, then the architecture in which the elements are arranged is not deemed critical. This difference, wherein the only difference being the arrangement and location of essential working elements, has been held by the reviewing courts as being obvious to one of ordinary skill in the art since it is motivated by choice in design and routine skill (In re Japikse, 86 USPQ 70). The location of each element is motivated by choice in design dictated by the limited available space.
Claim(s) 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cross (US 20130060313 A1 – hereinafter Cross) in view of McLaughlin (US 11116964 B2 – hereinafter McLaughlin).
Re. claim 13, Cross teaches the carrier element as stated above in claim 1 (paragraph 0033 – “…the polyurethane material of first paddle portion 22 and second paddle portion 24”), but does not explicitly teach wherein said portion of the carrier element is a reinforcement layer embedded in the electrically insulating material of the carrier element.
McLaughlin teaches a similar medical electrode device (abstract – “An electrode array system includes a unitary body forming a plurality of apertures…”) comprising a carrier element (figure 3, electrode substrate 26), and a portion of the electrode substrate includes a reinforcement layer (figure 3, reinforcing material 36) embedded in the electrically insulating material of the carrier element (column 6, lines 47-55: “In accordance with illustrative embodiments and as noted below, a reinforcing material 36 (FIGS. 6A and 6B, discussed below) embedded within a base and/or cover elastomer layer mechanically strengthens the electrode array substrate assembly 26 without increasing rigidity or appreciable thickness. Among other things, this reinforcing material 36includes open areas, pores, strips, or apertures to allow elastomers to continuously encapsulate (e.g., micro-fiber, woven mesh, honeycomb, carbon fiber)”).
PNG
media_image14.png
570
398
media_image14.png
Greyscale
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify carrier element of Cross, to incorporate the reinforcing layer as taught by McLaughlin, since such modification would predictably result in mechanically strengthening the carrier element (column 6, lines 47-55).
Re. claim 14, the combined invention of Cross and McLaughlin further teaches wherein said reinforcement layer comprises a woven fabric (McLaughlin (column 6, lines 47-55: “In accordance with illustrative embodiments and as noted below, a reinforcing material 36 (FIGS. 6A and 6B, discussed below) embedded within a base and/or cover elastomer layer mechanically strengthens the electrode array substrate assembly 26 without increasing rigidity or appreciable thickness. Among other things, this reinforcing material 36includes open areas, pores, strips, or apertures to allow elastomers to continuously encapsulate (e.g., micro-fiber, woven mesh, honeycomb, carbon fiber)”).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anh-Khoa N. Dinh whose telephone number is (571)272-7041. The examiner can normally be reached Mon-Fri 7:00am-4:00pm EST.
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, CARL LAYNO can be reached at 571-272-4949. 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.
/ANH-KHOA N DINH/Examiner, Art Unit 3796