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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/19/2025 has been entered.
Response to Amendment
The amendment filed 11/19/2025 has been entered. Claims 1,3-9, 12-14 & 17-18 remain pending in the application. Applicant’s amendments to the claims have overcome the objections and rejections previously set forth in the Final Office Action mailed 08/20/2025.
Response to Arguments
Applicant's arguments with respect to claims 1,3-9, 12-14 & 17-18 have been considered but are not seen as persuasive, see reasonings below.
Regarding claims 1, 17 & 18, Applicant argues that Liu and Lorach does not disclose the amended claim limitations. Examiner disagrees since Liu in view of Lorach does disclose the amended claim limitations, see rejection below.
Regarding claim 3-9, 12-14 & 16, Examiner sees claim 1 dependents as being unpatentable over Liu in view of Lorach as taught 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 Lorach et al. (US 20130096660) herein referred to as Lorach.
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, in said cross-section along said cross-sectional plane perpendicular to said plane of extension, extends at an angle with respect to the perpendicular direction, 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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Lorach discloses a medical electrode device (Figure 1) wherein wherein the third wall extends straight in a direction parallel to said plane of extension for a majority of L2(Figure 4, p1), wherein the overlapping portion, in said cross-section along said cross-sectional plane perpendicular to said plane of extension, extends at an angle z with respect to the perpendicular direction (Figure 3, 5), 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 (Figure 4; wherein angled overlap portion 5 does not contact second wall 8 wherein second wall 8 has curved edges and the third wall which is see as the top of 3 is a flat surface; Paragraph [0018]; wherein the cavity still allows for the electrodes to come into connect with surrounding tissue). 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 Lorach. The motivation being to allow for good electrical stimulation on the target tissue (Lorach, Paragraph [0018]).
Regarding claim 3, Liu in view of Lorach 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 Lorach 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 Lorach 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 Lorach 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 Lorach 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 Lorach 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 Lorachdiscloses 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 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, in said cross-section along said cross-sectional plane perpendicular to said plane of extension, extends at an angle with respect to the perpendicular direction, 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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Lorach discloses a medical electrode device (Figure 1) wherein the overlapping portion, in said cross-section along said cross-sectional plane perpendicular to said plane of extension, extends at an angle z with respect to the perpendicular direction (Figure 3, 5), 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 (Figure 4; wherein angled overlap portion 5 does not contact second wall 8 wherein second wall 8 has curved edges and the third wall which is see as the top of 3 is a flat surface; Paragraph [0018]; wherein the cavity still allows for the electrodes to come into connect with surrounding tissue). 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 Lorach. The motivation being to allow for good electrical stimulation on the target tissue (Lorach, Paragraph [0018]).
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 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, in said cross-section along said cross-sectional plane perpendicular to said plane of extension, extends at an angle with respect to the perpendicular direction, 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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Lorach discloses a medical electrode device (Figure 1) wherein the overlapping portion, in said cross-section along said cross-sectional plane perpendicular to said plane of extension, extends at an angle z with respect to the perpendicular direction (Figure 3, 5), wherein the angled overlapping portion is not in contact with the first wall section of the at least one electrode element (Figure 3; Figure 4; Paragraph [0055]; wherein combining the embodiments in Figure 3 and Figure 4 to allow for the electrode 3 seen in figure 4 to be spaced from the overlap portion 5 as seen in figure 3 would allow for none of the walls to come in contact with the overlap portion ), wherein by means of the angled overlapping portion, which does not contact the second wall section (Figure 3; Figure 4; Paragraph [0055]; wherein combining the embodiments in Figure 3 and Figure 4 to allow for the electrode 3 seen in figure 4 to be spaced from the overlap portion 5 as seen in figure 3 would allow for none of the walls to come in contact with the overlap portion ), 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 (Figure 4; wherein angled overlap portion 5 does not contact second wall 8 wherein second wall 8 has curved edges and the third wall which is see as the top of 3 is a flat surface; Paragraph [0018]; wherein the cavity still allows for the electrodes to come into connect with surrounding tissue). 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 Lorach. The motivation being to allow for good electrical stimulation on the target tissue (Lorach, Paragraph [0018]).
Claims 5, 8 & 9 are rejected under 35 U.S.C 103 as being unpatentable over Liu and Lorach in further view of Lisy et al. (US 10376168) herein referred to as Lisy.
Regarding Claim 5, Liu in view of Lorach discloses the medical electrode device according to claim 4. However, Liu in view of Lorach 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 Lorach 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 Lorach discloses the medical electrode device according to claim 7. However, Liu in view of Lorach 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 Lorach 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 Lorach discloses the medical electrode device according to claim 7. However, Liu in view of Lorach 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 Lorach 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 Lorach in view of Stork et al. (US 10376168) herein referred to as Stork.
Regarding claim 13, Liu in view of Lorach 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 Lorach 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 Lorach 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
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