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
This Action is in response to the Amendment filed June 10, 2026.
In view of the Amendment, the objection to the specification, as set forth in the Office Action dated 03/19/2026, is withdrawn.
Claim 8 is amended.
Claims 16-17 are added.
Claims 1-17 are pending.
Priority
Claims 1-17 are deemed to have an effective filing date of 02/17/2022 (Filing date of EP 22157183.9).
Response to Arguments
Applicant's arguments filed 06/10/2026 have been fully considered but they are not persuasive.
In response to Applicant’s argument that the Office Action dated 03/19/2026 (the Office Action) maps Robinson’s support member 602 to Applicant’s resilient member, the Examiner disagrees. To the contrary, the Office Action maps wings 612, 614 to the paddle wings with its recitation: “a first paddle wing and a second paddle wing (e.g., paragraph [0076]: paddle electrode assembly 600 comprises a supporting member 602 and paddle wings 612, 614)” on page 3, lines 15-17 of the Office Action. Supporting member 602 is not mapped to a specific claimed structure. The Office Action maps the resilient element to a knitted structure shown in Figs. 11c-e of Robinson on page 4, last three lines with the cite to paragraphs [0099]-[0101]: three-dimensional knitted structure of Figs. 11c-d corresponds to the device shown in Fig. 7 has one resilient element that runs exclusively along the longitudinal extension of the paddle structure at the tubular body 1142). The Examiner notes that paragraph [0112] of Robinson states that the electrode assembly may include one or more memory metal filaments knitted into the assembly and that Fig. 11e, described in paragraph [0101] of Robinson clearly shows a knitted resilient element across the longitudinal extension of the support element, where a wall of the knitted material with the wall of another part of the paddle structure surrounds a hollow space as shown in Fig. 11d.
In response to Applicant’s argument that “Robinson consistently discusses its wings as being resilient”, claims 1-17 do not preclude the wings being resilient.
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.
Claims 1-2, 4-7, 13, and 15-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2014/0288577 to Robinson et al. (hereinafter referred to as “Robinson”).
Regarding claim 1, Robinson discloses a paddle lead for implantation in the epidural space through an insertion tool (e.g., abstract and paragraph [0037]: implantation site may be the epidural space with the introducer entering …), the paddle lead comprising: a lead body comprising a plurality of conductors extending from a proximal portion of the lead body to a distal portion of the lead body (e.g., abstract: a support member carrying wires for electrically connected a control unit to electrodes of the electrode assembly; and paragraph [0100]: Fig. 11d, support member 1142); a paddle structure electrically coupled to the distal portion of the lead body and arranged distally of the lead body (e.g., abstract and Fig. 11d: paddle structure (1152, 1154)) is arranged distally of and coupled to the distal portion of the lead body/support member 1142), wherein the paddle structure has a longitudinal extension direction and comprises: a first paddle wing and a second paddle wing (e.g., paragraph [0076]: paddle electrode assembly 600 comprises a supporting member 602 and paddle wings 612, 614), wherein the first paddle wing and the second paddle wing are movable with respect to each other and can be present in an expanded state and in a collapsed state (e.g. paragraph [0076]: paddle wings are unfurled in Fig. 6a and are furled as shown in Fig. 6b); a plurality of first electrode poles arranged on the first paddle wing (e.g., paragraphs [0077]-[0078]: paddle wing electrode assembly has paddle wings 712, 714 where electrodes are formed on each wing and may include 4-8 rows of electrodes and 204 columns of electrodes), wherein each of the first electrode poles is electrically coupled to at least one of the plurality of conductors (e.g., abstract: a support member carrying wires for electrically connected a control unit to electrodes of the electrode assembly; and paragraphs [0077]-[0078]: Fig. 7a-c, support member 702, paddle wings 712, 714 with electrodes (not shown)); a plurality of second electrode poles arranged on the second paddle wing (e.g., paragraphs [0077]-[0078]: paddle wing electrode assembly has paddle wings 712, 714 where electrodes are formed on each wing and may include 4-8 rows of electrodes and 204 columns of electrodes), wherein each of the second electrode poles is electrically coupled to at least one of the plurality of conductors (e.g., abstract: a support member carrying wires for electrically connected a control unit to electrodes of the electrode assembly; and paragraphs [0077]-[0078]: Fig. 7a-c, support member 702, paddle wings 712, 714 with electrodes (not shown)); at least one resilient element connected with at least one of the first paddle wing and the second paddle wing (e.g., paragraph [0112]: an electrode assembly may include one or more memory metal filaments such as Nitinol), wherein the at least one resilient member biases at least one of the first paddle wing and the second paddle wing to the expanded state (e.g., paragraph [0112]: memory metal filaments are preformed to hold the electrode assembly in a first shape prior to implantation in a patient, and are configured to cause the electrode assembly to assume a second shape following implantation); wherein the at least one resilient element has a longitudinal extension direction that runs exclusively along the longitudinal extension direction of the paddle structure (e.g.., paragraphs [0099]-[0101]: three-dimension al knitted structure of Figs. 11c-d corresponds to the device shown in Fig. 7 has one resilient element that runs exclusively along the longitudinal extension of the paddle structure at the tubular body 1142) and in that the at least one resilient element has a wall that surrounds alone or with another part of the paddle structure a hollow space, wherein the hollow space also extends exclusively along the longitudinal extension direction of the paddle structure (e.g., paragraph [0036]: a polyethylene tube is inserted into the central section of the structure (region 1102 in Fig. 11b) will create the supporting member described above where a tube has a wall that surrounds a hollow space; or, the resilient element with the paddle structure has a wall that surrounds a hollow space – unnumbered hollow space of supporting member 1142 in Fig. 11d and Figs. 7a-b, 702).
With respect to claim 2, Robinson discloses the paddle lead according to claim 1, wherein the at least one resilient element is made from a different material than the first paddle wing and the second paddle wing (e.g., paragraph [0112]: resilient element is comprised of memory metal filaments and paragraph [0036]: polymers with different durometer rating can be used in different parts of the structure – thus each structure (support member, wings, resilient element) can be made from a different material).
As to claim 4, Robinson discloses the paddle lead according to claim 1, wherein the at least one resilient element has a circular or elliptic cross section (e.g., paragraph [0036]: when flat structure of the wings and support member knitting pattern has a tube with a diameter inserted to create the support member of Figs. 7 and 11d, the resilient element of Robinson has a circular cross-section).
With respect to claim 5, Robinson discloses the paddle lead according to claim 1, wherein the at least one resilient element has a cross section of a segment of a circle or of a segment of an ellipse (e.g., Fig. 11e - a portion of the resilient element has a rounded cross section).
With respect to claim 6, Robinson discloses the paddle lead according to claim 1, wherein the first paddle wing and the second paddle wing are connected with each other in a proximal portion of the first paddle wing and the second paddle wing, but unconnected in a distal portion of the first paddle wing and the second paddle wing (e.g., paragraphs [0077]-[0078]: paddle wings 712, 714 reside in a common nominal plane which passes tangentially to a cross-sectional circumference of the supporting member 802 – connected with each other at the proximal portion of each wing; Fig. 7c, paddle 726).
As to claim 7, Robinson discloses the paddle lead according to claim 1, wherein the at least one resilient element is connected with the first paddle wing and the second paddle wing (e.g., paragraphs [0100]-[0101] and Figs. 11d-e where the resilient element/knitted electrode assembly of yarn filaments is connected with the first paddle wing and the second paddle wing).
With respect to claim 13, Robinson discloses a paddle lead according to claim 1, wherein the at least one resilient element extends along a whole length of the paddle structure (e.g., paragraphs [0100]-[0101] and Figs. 11d-e).
Referring to claim 15, Robinson discloses a Method for manufacturing a paddle lead according to claim 1 (e.g., paragraph [0019]: method of constructing an electrode assembly …), the method comprising the following steps: providing a lead body comprising a plurality of conductors extending from a proximal portion of the lead body to a distal portion of the lead body (e.g., paragraph [0020]); arranging a paddle structure distally of the lead body and electrically coupling it to the distal portion of the lead body (e.g., paragraph [0021] as shown in Fig. 11d), wherein the paddle structure has a longitudinal extension direction and comprises: a first paddle wing and a second paddle wing (e.g., paragraph [0076]: paddle electrode assembly 600 comprises a supporting member 602 and paddle wings 612, 614), wherein the first paddle wing and the second paddle wing are movable with respect to each other and can be present in an expanded state and in a collapsed state (e.g. paragraph [0076]: paddle wings are unfurled in Fig. 6a and are furled as shown in Fig. 6b); a plurality of first electrode poles arranged on the first paddle wing (e.g., paragraphs [0077]-[0078]: paddle wing electrode assembly has paddle wings 712, 714 where electrodes are formed on each wing and may include 4-8 rows of electrodes and 204 columns of electrodes), wherein each of the first electrode poles is electrically coupled to at least one of the plurality of conductors (e.g., abstract: a support member carrying wires for electrically connected a control unit to electrodes of the electrode assembly; and paragraphs [0077]-[0078]: Fig. 7a-c, support member 702, paddle wings 712, 714 with electrodes (not shown)); a plurality of second electrode poles arranged on the second paddle wing (e.g., paragraphs [0077]-[0078]: paddle wing electrode assembly has paddle wings 712, 714 where electrodes are formed on each wing and may include 4-8 rows of electrodes and 204 columns of electrodes), wherein each of the second electrode poles is electrically coupled to at least one of the plurality of conductors (e.g., abstract: a support member carrying wires for electrically connected a control unit to electrodes of the electrode assembly; and paragraphs [0077]-[0078]: Fig. 7a-c, support member 702, paddle wings 712, 714 with electrodes (not shown)); at least one resilient element connected with at least one of the first paddle wing and the second paddle wing (e.g., paragraph [0112]: an electrode assembly may include one or more memory metal filaments such as Nitinol), wherein the at least one resilient member biases at least one of the first paddle wing and the second paddle wing to the expanded state (e.g., paragraph [0112]: memory metal filaments are preformed to hold the electrode assembly in a first shape prior to implantation in a patient, and are configured to cause the electrode assembly to assume a second shape following implantation); wherein the at least one resilient element has a longitudinal extension direction that runs exclusively along the longitudinal extension direction of the paddle structure (e.g.., paragraphs [0099]-[0101]: three-dimension al knitted structure of Figs. 11c-d corresponds to the device shown in Fig. 7 has one resilient element that runs exclusively along the longitudinal extension of the paddle structure at the tubular body 1142) and in that the at least one resilient element has a wall that surrounds alone or with another part of the paddle structure a hollow space, wherein the hollow space also extends exclusively along the longitudinal extension direction of the paddle structure (e.g., paragraph [0036]: a polyethylene tube is inserted into the central section of the structure (region 1102 in Fig. 11b) will create the supporting member described above where a tube has a wall that surrounds a hollow space; or, the resilient element with the paddle structure has a wall that surrounds a hollow space – unnumbered hollow space of supporting member 1142 in Fig. 11d and Figs. 7a-b, 702).
With respect to newly added claim 16, Robinson discloses a paddle lead according to claim 1, wherein the at least one resilient element does not comprise shape memory material (e.g., paragraphs [0036]: the electrode assembly is formed of a knitted fabric, the knitting parameters are preferably selected in order to provide the paddle wings with the desired amount of resilience to permit the wings to be furled with the introducer and to unfurl when released during implantation … knitting parameters include the filament resilience, filament diameter, stich selection, yarn tension during knitting … knitting structure would be produced with a mono-filament yarn made from a biocompatible polymer; [0090]: a variety of different types and shapes of conductive filaments may be used to knit an electrode assembly, … the conductive filament is a fiber manufactured from carbon nanotubes … platinum or other biocompatible conductive wire; and [0102]: as an alternative to knitting, a fabric paddle electrode, a fabric paddle electrode can be made – thus, Robinson discloses resilient element materials other than shape memory material can be used).
As to newly added claim 17, Robinson discloses the paddle lead according to claim 1, wherein the at least one first paddle wing and the at least one second paddle wing comprise a rigid material (e.g., paragraph [0038]: the electrode assembly has a longitudinal rigidity sufficient for implantation via an introducer – thus, the electrode assembly that spans first and second wings comprises a rigid material).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Robinson in view of US Patent Application Publication No. 2020/0316371 to Antonini et al. (hereinafter referred to as “Antonini”).
With respect to claim 3, Robinson discloses the paddle lead according to claim 1, but does not disclose that the at least one resilient element is made from an elastic plastic material. However, Antonini, in a related art: lead with a paddle body, teaches that shape memory materials, can include shape memory alloys, such as nitinol and shape-memory linked polymers (e.g. paragraph [0009] of Antonini). Accordingly, one of ordinary skill in the art would have recognized the benefits of a resilient element being made from an elastic plastic material in view of teachings of Antonini. Consequently, one of ordinary skill in the art would have modified the paddle lead of Robinson so that its at least one resilient element is made from an elastic plastic material in view of Antonini’s teachings that shape memory materials can be made from a polymer/plastic, and because the combination would have yielded a predictable result.
Claims 8-11 are rejected under 35 U.S.C. 103 as being obvious over Robinson in view of US Patent Application Publication No. 2001/0053885 to Gielen et al. (hereinafter referred to as “Gielen”).
With respect to claim 8, Robinson discloses the paddle lead according to claim 1, but does not expressly disclose that the paddle structure additionally comprises a ligament extending along the longitudinal extension direction of the paddle structure, wherein the ligament is arranged between the first paddle wing and the second paddle wing, wherein the at least one resilient element is also connected to the ligament. However, Gielen, in a related art: positioning therapy delivery electrodes within a spinal cord, teaches that a ligament (levers 330) may be used to adjust the position of the electrodes against the spine where the levers are between the two spans or wings 324 and are connected to the lead body (e.g., paragraphs [0077]-[0078] of Gielen). Accordingly, one of ordinary skill in the art would have recognized the benefits of using a ligament located between the paddle wings in view of the teachings of Gielen. Consequently, one of ordinary skill in the art would have modified the paddle lead of Robinson to employ levers to span out the electrodes in a predetermined angle so that the electrodes are positioned accurately within the spine in view of the teachings of Gielen that such was a known engineering expedient in the spinal art, and because the combination would have yielded a predictable result.
As to claim 9, Robinson in view of Gielen teaches the paddle lead according to claim 8, wherein the ligament is connected to the first paddle wing and the second paddle wing (e.g., Fig. 25 of Gielen – each of the levers of the ligament are attached to one of the paddle wings). Accordingly, one of ordinary skill in the art would have recognized the benefits of using a ligament connected to the paddle wings in view of the teachings of Gielen. Consequently, one of ordinary skill in the art would have modified the paddle lead of Robinson to employ levers to span out the electrodes on the wings/spans in a predetermined angle so that the electrodes are positioned accurately within the spine in view of the teachings of Gielen that such was a known engineering expedient in the spinal art, and because the combination would have yielded a predictable result.
With respect to claim 10, Robinson in view of Gielen teaches the paddle lead according to claim 8, but does not expressly teach that the paddle structure comprises two resilient elements, wherein a first of the two resilient elements is connected to the ligament and the first paddle wing, and wherein a second of the two resilient elements is connected to the ligament and the second paddle wing. However, it would have been obvious to one of ordinary skill in the art at the time the invention was made to use two resilient elements, one for each paddle wing, since it has been held that mere duplication of essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Accordingly, one of ordinary skill in the art would have recognized the benefits of using a resilient element connected to the ligament and the paddle wings in view of the teachings of Gielen. Consequently, one of ordinary skill in the art would have modified the paddle lead of Robinson to employ two resilient elements so that the electrodes on each wing are positioned accurately within the spine in view of the teachings of Gielen that such was a known engineering expedient in the spinal art, and because the combination would have yielded a predictable result.
As to claim 11, Robinson in view of Gielen teaches the paddle lead according to claim 10, wherein the first of the two resilient elements and the second of the two resilient elements are identical in construction (in view of case law that a duplication of a known resilient element only involves routine skill).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Robinson in view of US Patent Application Publication No. 2012/0083866 to King et al. (hereinafter referred to as “King”).
Robinson discloses the paddle lead according to claim 1, but does not expressly teach that the paddle structure comprises at least two resilient elements, wherein each of the at least two resilient elements extends only along a longitudinal section of the paddle structure, and wherein the at least two resilient elements are arranged longitudinally one behind the other. However, King, in a related art: implantable lead with paddle spans, teaches that it was known to employ two electrodes 510 with paddle wings/spans carrying electrodes where the electrodes 510 are arranged longitudinally one behind the other (e.g., paragraph [0069] and Figs. 10A, 10B of King). Since each electrode 510 of King would have a resilient element, one of ordinary skill in the art would have recognized the benefits of two resilient elements arranged longitudinally one behind the other. Consequently, one of ordinary skill in the art would have modified the paddle lead of Robinson to have two resilient elements arranged longitudinally one behind the other in view of the teachings of King that it was known to have two paddle leads one behind the other, and because the combination would have yielded a predictable result.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Robinson in view of US Patent Application Publication No. 2011/0264177 to Lindgren et al. (hereinafter referred to as “Lindgren”).
Robinson discloses the paddle lead according to claim 1, but does not expressly disclose that the hollow space is accessible only via a first end of the at least one resilient element and/or a second end of the at least one resilient element, the second end lying opposite the first end along the longitudinal extension direction of the at least one resilient element. The hollow space of Robinson is part of the lead body/supporting member. Lindgren, in a related art: implantable medical lead, teaches that an implantable lead 100 may have a closed channel 150 (hollow space) running the length of the lead (e.g., paragraph [0041] and Fig. 4). Accordingly, one of ordinary skill in the art would have recognized the benefits of a closed end medical lead in view of the teachings of Lindgren. Consequently, one of ordinary skill in the art would have modified the paddle lead of Robinson so that only one end of the support member and the resilient element that extends from the lead body is closed in view of the teachings of Lindgren that such was a known engineering expedient in the medical arts, and because the combination would have yielded a predictable result.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 CATHERINE M VOORHEES whose telephone number is (571)270-3846. The examiner can normally be reached Monday-Friday 8:30 AM to 4:30 PM.
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/CATHERINE M VOORHEES/Primary Examiner, Art Unit 3792
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