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 .
Response to Amendment
The amendment filed 04/21/2026 has been entered. Claims 1, 3-9, 12-14, 16-18 remain pending in the application. Applicant’s amendments to the claims have overcome the objections and rejections previously set forth in the Non-Final Office Action mailed 02/26/2026.
Response to Arguments
Applicant's arguments with respect to claims 1, 3-9, 12-14 & 16-18 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. The claim amendments changed the scope of the claimed invention. See new grounds for rejection below.
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 1, 3-4, 6-7, 12, 14 & 16-18 are rejected under 35 U.S.C 103 as being unpatentable over Liu et al. (US 20170246452) herein referred to as Liu in view of DAR et al. (US 20170296121) herein referred to as Dar.
Regarding Claim 1, Liu discloses A medical electrode device for implantation into a patient (Paragraph [0006]; wherein electrode ray is implanted into spinal cord), comprising: a carrier element being formed from an electrically insulating material and defining a surface generally extending along a plane of extension (Figure 11B, panel D, Polymer substrate & Second Polymer layer); and at least one electrode element arranged on the carrier element for at least one of emitting an electrical signal and receiving an electrical signal (Figure 11B, panel D, Electrode contact); wherein the at least one electrode has a width L2 (See annotated Figure 11B, panel D below); wherein the at least one electrode element comprises a first wall section and a second wall section (See annotated Figure 11B, panel D below), wherein said first wall section, in a cross-section along a cross-sectional plane perpendicular to said plane of extension (Figure 11B, panel D), extends straight along a perpendicular direction with respect to said plane of extension or at an oblique angle with respect to said perpendicular direction (Figure 11B, panel D), the first wall section being in contact with the electrically insulating material of the carrier element (Figure 11B, panel D), wherein said second wall section, in said cross-section along said cross-sectional plane perpendicular to said plane of extension, adjoins said first wall section and is curved (Figure 11B, panel D), the second wall section not being in contact with the electrically insulating material of the carrier element (Figure 11B, panel D), wherein the at least one electrode element comprises a third wall section adjoining the second wall section (See annotated Figure 11B, Panel D below), wherein said third wall section, in said cross-section along said cross-sectional plane perpendicular to said plane of extension, extends straight in a direction parallel to said plane of extension (See annotated Figure 11B, Panel D below; wherein third wall extends straight out therefore when a cross-section is taken perpendicular to the plane of extension, the wall is parallel to the plane of extension since it’s a flat straight line)- wherein the carrier element comprises a body portion and an overlapping portion (Figure 11B, Panel D; wherein the body portion is the polymer substrate and the overlapping portion is the second polymer layer), wherein the body portion contacts said first wall section of the at least one electrode element (Figure 11B, Panel D; wherein the body portion contacts the first wall section at its lower half) and the overlapping portion overlaps with said second wall section of the at least one electrode element along said perpendicular direction without contacting the second wall section (See annotated Figure 11B, Panel C below). However, Liu does not explicitly disclose Liu does not explicitly disclose wherein the third wall extends straight in a direction parallel to said plane of extension for a majority of L2; wherein the overlapping portion, within a volume of space between the first wall section and the third wall section and with respect to said cross-section along said cross-sectional plane perpendicular to said plane of extension, extends away at an angle with respect to the perpendicular direction and with respect to the second wall section, wherein the overlapping portion between the first wall section and the third wall section is straight or curved, wherein by means of the angled overlapping portion, which does not contact the second wall section, the at least one electrode element having curved edges formed by the second wall section and a flat surface formed by the third wall section is exposed towards an outside to come into contact with surrounding tissue.
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Dar discloses a medical electrode (Figure 8A & 8B) wherein the third wall extends straight in a direction parallel to said plane of extension for a majority of L2 (See annotated Figure 8A below); wherein the overlapping portion, within a volume of space between the first wall section and the third wall section and with respect to said cross-section along said cross-sectional plane perpendicular to said plane of extension, extends away at an angle with respect to the perpendicular direction and with respect to the second wall section (See annotated Figure 8A below), wherein the overlapping portion between the first wall section and the third wall section is straight or curved (Figure 8A; wherein 150 contains both curved and straight portions), wherein by means of the angled overlapping portion, which does not contact the second wall section, the at least one electrode element having curved edges formed by the second wall section (See annotated Figure 8B below) and a flat surface formed by the third wall section is exposed towards an outside to come into contact with surrounding tissue (Figure 8B, 56a). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the medical electrode taught by Liu to include the teachings on Dar. The motivation being to urge toward the skin surface and may create electrical contact with the skin surface in order to transfer electrical current to the skin surface (Dar, Paragraph [0138]).
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Regarding claim 3, Liu in view of Dar discloses the medical electrode device according to claim 1. Liu also discloses wherein the at least one electrode element protrudes along said perpendicular direction from the carrier element beyond said surface (Figure 11B, Panel D; wherein the electrode contact protrudes higher in the perpendicular direction of the carrier element)
Regarding claim 4, Liu in view of Dar discloses the medical electrode device according to claim 1. Liu also discloses wherein the second wall section in said cross-section along said cross-sectional plane perpendicular to said plane of extension comprises a curved portion having an angular width and a radius of curvature across said angular width (Figure 11B, Panel D; wherein second wall section is a curved wall therefore a curve has an angular width and a radius of curvature across the angular width)
Regarding claim 6, Liu in view of Dar discloses the medical electrode device according to claim 1. Liu also discloses wherein the second wall section in said cross-section along said cross-sectional plane perpendicular to said plane of extension comprises a first curved portion and a second curved portion having a different curvature than the first curved portion (See annotated Figure 11B, Panel D below), the second curved portion adjoining with said first wall section (See annotated Figure 11B, Panel D below).
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Regarding claim 7, Liu in view of Dar discloses the medical electrode device according to claim 6. Liu also discloses the first curved portion comprises a first angular width and a first radius of curvature across said first angular width (Figure 11B, Panel D; wherein first curved portion is a curved wall therefore a curve has an angular width and a radius of curvature across the angular width) and the second curved portion comprises a second angular width and a second radius of curvature across said second angular width (Figure 11B, Panel D; wherein second curved portion is a curved wall therefore a curve has an angular width and a radius of curvature across the angular width)
Regarding claim 12, Liu in view of Dar discloses the medical electrode device according to claim 1. Liu also discloses wherein the at least one electrode element, in a cross-section parallel to said plane of extension, comprises a generally rectangular shape (Figure 11B, Panel D; wherein electrode is a rectangle with a curve on one side therefore is a generally rectangular shape).
Regarding claim 14, Liu in view of Dar discloses the medical electrode device according claim 1. Liu also discloses wherein the carrier element is made from a silicone material (Paragraph [0206]; wherein the polymer substrate of the carrier element can be made of silicone).
Regarding claim 16, Liu in view of Dar discloses the medical electrode device according to claim 1. Liu discloses wherein the at least one electrode has length L1 (Figure 11A; wherein electrodes are a circle therefore L1 will be the same as L2) ;the third wall section extends straight in a direction parallel to said plane of extension for a majority of L1 (Figure 11A; as taught in claim 1 by Lorach, the third wall section extends straight in a direction parallel to said plane of extension for a majority of L2, therefore by the electrode and carrier being a circular shape, the third wall section extends straight in a direction parallel to said plane of extension for a majority of L1).
Regarding claim 17, Liu discloses A medical electrode device for implantation into a patient (Paragraph [0006]; wherein electrode ray is implanted into spinal cord), comprising: a carrier element being formed from an electrically insulating material and defining a surface generally extending along a plane of extension (Figure 11B, panel D, Polymer substrate & Second Polymer layer); and at least one electrode element arranged on the carrier element for at least one of emitting an electrical signal and receiving an electrical signal (Figure 11B, panel D, Electrode contact); wherein the at least one electrode element comprises a first wall section and a second wall section (See annotated Figure 11B, panel D below), wherein said first wall section, in a cross-section along a cross-sectional plane perpendicular to said plane of extension (Figure 11B, panel D), extends straight along a perpendicular direction with respect to said plane of extension or at an oblique angle with respect to said perpendicular direction (Figure 11B, panel D), the first wall section being in contact with the electrically insulating material of the carrier element (Figure 11B, panel D), wherein said second wall section, in said cross-section along said cross-sectional plane perpendicular to said plane of extension, adjoins said first wall section and is curved (Figure 11B, panel D), the second wall section not being in contact with the electrically insulating material of the carrier element (Figure 11B, panel D), wherein the body portion contacts the first wall section at its lower half) and the overlapping portion overlaps with said second wall section of the at least one electrode element along said perpendicular direction without contacting the second wall section (See annotated Figure 11B, Panel C below) wherein the second wall section in said cross-section along said cross-sectional plane perpendicular to said plane of extension comprises a first curved portion and a second curved portion having a different curvature than the first curved portion (See annotated Figure 11B, Panel D below), the second curved portion adjoining with said first wall section (See annotated Figure 11B, Panel D below); wherein the carrier element comprises a body portion and an overlapping portion (Figure 11B, Panel D; wherein the body portion is the polymer substrate and the overlapping portion is the second polymer layer), wherein the body portion contacts said first wall section of the at least one electrode element (Figure 11B, Panel D; However, Liu does not explicitly disclose wherein the third wall extends straight in a direction parallel to said plane of extension for a majority of L2; wherein a surface of the overlapping portion, with respect to said cross-section along said cross-sectional plane perpendicular to said plane of extension, extends away at an angle with respect to the perpendicular direction and with respect to the second wall section, wherein by means of the angled overlapping portion, which does not contact the second wall section, ,the at least one electrode element having curved edges formed by the second wall section and a flat surface formed by the third wall section is exposed towards an outside to come into contact with surrounding tissue.
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Dar discloses a medical electrode (Figure 8A & 8B) wherein the third wall extends straight in a direction parallel to said plane of extension for a majority of L2 (See annotated Figure 8A below); wherein a surface of the overlapping portion, with respect to said cross-section along said cross-sectional plane perpendicular to said plane of extension, extends away at an angle with respect to the perpendicular direction and with respect to the second wall section (See annotated Figure 8A below), wherein the overlapping portion between the first wall section and the third wall section is straight or curved (Figure 8A; wherein 150 contains both curved and straight portions), wherein by means of the angled overlapping portion, which does not contact the second wall section, the at least one electrode element having curved edges formed by the second wall section (See annotated Figure 8B below) and a flat surface formed by the third wall section is exposed towards an outside to come into contact with surrounding tissue (Figure 8B, 56a). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the medical electrode taught by Liu to include the teachings on Dar. The motivation being to urge toward the skin surface and may create electrical contact with the skin surface in order to transfer electrical current to the skin surface (Dar, Paragraph [0138]).
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Regarding claim 18, Liu discloses A medical electrode device for implantation into a patient (Paragraph [0006]; wherein electrode ray is implanted into spinal cord), comprising: a carrier element being formed from an electrically insulating material and defining a surface generally extending along a plane of extension (Figure 11B, panel D, Polymer substrate & Second Polymer layer); and at least one electrode element arranged on the carrier element for at least one of emitting an electrical signal and receiving an electrical signal (Figure 11B, panel D, Electrode contact); wherein the at least one electrode element comprises a first wall section and a second wall section (See annotated Figure 11B, panel D below), wherein said first wall section, in a cross-section along a cross-sectional plane perpendicular to said plane of extension (Figure 11B, panel D), extends straight along a perpendicular direction with respect to said plane of extension or at an oblique angle with respect to said perpendicular direction (Figure 11B, panel D), the first wall section being in contact with the electrically insulating material of the carrier element (Figure 11B, panel D), wherein said second wall section, in said cross-section along said cross-sectional plane perpendicular to said plane of extension, adjoins said first wall section and is curved (Figure 11B, panel D), the second wall section not being in contact with the electrically insulating material of the carrier element (Figure 11B, panel D), wherein the body portion contacts the first wall section at its lower half) and the overlapping portion overlaps with said second wall section of the at least one electrode element along said perpendicular direction without contacting the second wall section (See annotated Figure 11B, Panel C below) wherein the second wall section in said cross-section along said cross-sectional plane perpendicular to said plane of extension comprises a first curved portion and a second curved portion having a different curvature than the first curved portion (See annotated Figure 11B, Panel D below), the second curved portion adjoining with said first wall section (See annotated Figure 11B, Panel D below); wherein the carrier element comprises a body portion and an overlapping portion (Figure 11B, Panel D; wherein the body portion is the polymer substrate and the overlapping portion is the second polymer layer), wherein the body portion contacts said first wall section of the at least one electrode element (Figure 11B, Panel D; However, Liu does not explicitly disclose wherein the third wall extends straight in a direction parallel to said plane of extension for a majority of L2; wherein a surface the overlapping portion, with respect to said cross-section along said cross-sectional plane perpendicular to said plane of extension, extends away at an angle with respect to the perpendicular direction and with respect to the second wall section, wherein the angled overlapping portion is not in contact with the first wall section of the at least one electrode element, wherein by means of the angled overlapping portion, which does not contact the second wall section, the at least one electrode element having curved edges formed by the second wall section and a flat surface formed by a third wall section is exposed towards an outside to come into contact with surrounding tissue..
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Dar discloses a medical electrode (Figure 8A & 8B) wherein the third wall extends straight in a direction parallel to said plane of extension for a majority of L2 (See annotated Figure 8A below); wherein a surface of the overlapping portion, with respect to said cross-section along said cross-sectional plane perpendicular to said plane of extension, extends away at an angle with respect to the perpendicular direction and with respect to the second wall section (See annotated Figure 8A below), wherein the overlapping portion between the first wall section and the third wall section is straight or curved (Figure 8A; wherein 150 contains both curved and straight portions), wherein by means of the angled overlapping portion, which does not contact the second wall section, the at least one electrode element having curved edges formed by the second wall section (See annotated Figure 8B below) and a flat surface formed by the third wall section is exposed towards an outside to come into contact with surrounding tissue (Figure 8B, 56a). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the medical electrode taught by Liu to include the teachings on Dar. The motivation being to urge toward the skin surface and may create electrical contact with the skin surface in order to transfer electrical current to the skin surface (Dar, Paragraph [0138]).
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Claims 5, 8 & 9 are rejected under 35 U.S.C 103 as being unpatentable over Liu and Dar in further view of Lisy et al. (US 10376168) herein referred to as Lisy.
Regarding Claim 5, Liu in view of Dar discloses the medical electrode device according to claim 4. However, Liu in view of Dar does not explicitly disclose wherein radius of curvature is equal to or larger than 0.5 mm.
Lisy discloses a medical electrode device (Figure 1C) wherein radius of curvature is equal to or larger than 0.5 mm (Claim 16; wherein the radius of curvature is between 0.5-2 cm which is equivalent to 5-20mm and therefore is larger than 0.5mm). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the radius of curvature taught by Liu in view of Dar to be the dimensions taught by Lisy. The motivation being it would be obvious to try different radius’ of curvature to see which one allowed for the best overall electrode contact (MPEP 2143 (E)).
Regarding Claim 8, Liu in view of Dar discloses the medical electrode device according to claim 7. However, Liu in view of Dar does not explicitly disclose wherein the first radius of curvature is larger than the second radius of curvature.
Lisy discloses a medical electrode device (Figure 1C) wherein the first radius of curvature is larger than the second radius of curvature (Claim 16; wherein the first radius of curvature can have a size between 0.5-2.5cm and the second radius of curvature can have a size between 0.5-2.0cm wherein at their largest size, 2.5cm is greater than 2.0). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the radius of curvature taught by Liu in view of Dar to be the dimensions taught by Lisy. The motivation being it would be obvious to try different radius’ of curvature to see which one allowed for the best overall electrode contact (MPEP 2143 (E)).
Regarding Claim 9, Liu in view of Dar discloses the medical electrode device according to claim 7. However, Liu in view of Dar does not explicitly disclose wherein the first radius of curvature is equal to or larger than 0.5 mm, and the second radius of curvature is equal to or larger than 0.1 mm.
Lisy discloses a medical electrode device (Figure 1C) wherein the first radius of curvature is equal to or larger than 0.5 mm (Claim 16; wherein the first radius of curvature can have a size between 0.5-2.5cm which is equivalent to 5-25mm and therefore is larger than 0.5mm), and the second radius of curvature is equal to or larger than 0.1 mm (and the second radius of curvature can have a size between 0.5-2.0cm which is equivalent to 5-20mm and therefore is larger than 0.1mm). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the radius of curvature taught by Liu in view of Dar to be the dimensions taught by Lisy. The motivation being it would be obvious to try different radius’ of curvature to see which one allowed for the best overall electrode contact (MPEP 2143 (E)).
Claim 13 is rejected under 35 U.S.C 103 as being unpatentable over Liu and Dar in view of Stork et al. (US 10376168) herein referred to as Stork.
Regarding claim 13, Liu in view of Dar discloses the medical electrode device according to claim 1 wherein the electrode is formed from a metal material (Liu, Paragraph [0207]; wherein the electrodes are fabricated from one or more metals). However, Liu in view of Dar does not explicitly disclose wherein the at least one electrode element is formed from a metal material in a deep-drawing process.
Stork discloses a medical electrode device (Figure 1) wherein the at least one electrode element is formed from a metal material in a deep-drawing process (Paragraph [0076]; wherein component 11 of the electrode is made from a thin sheet of metal and formed by deep-drawing). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the electrode taught by Liu in view of Dar to be made by deep-drawing as taught by Stork. The motivation being it would be obvious to try different manufacturing methods to see what produces the best quality product (MPEP 2143 (E)).
Conclusion
THIS ACTION IS MADE FINAL. 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 ALYSSA M PAPE whose telephone number is (703)756-5947. The examiner can normally be reached M-F 7:30-5:00.
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ALYSSA M. PAPE
Examiner
Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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