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 Arguments
Applicant's amendments and arguments filed 7/27/2026 have been fully considered and merit new grounds for rejection under 35 U.S.C. § 102 in view of Wicklund, previously cited. New portions are cited to correspond with the new claim interpretation under BRI, and therefore the rejection may be considered new grounds.
Wicklund teaches a carrier element (Fig. 8A-B, main trunk body, see Fig. 5 element 28) and an arrangement of contact elements arranged on the carrier element for contacting tissue (Fig. 8A-B, elements 26 array element are for contacting tissue and located on the electrode end, see ¶[0050] and ¶[0088]); and wherein the folded position includes a configuration in which a contact element makes physical contact with another contact element or a portion of the carrier that it otherwise does not do so when in the unfolded position (Fig. 8A-B, when folded, the contact elements 26 contact the body of the carrier element via contours 37).
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Clarified by annotations to Fig. 8A-B of Wicklund, above, the contact elements of Wicklund contact a portion of the carrier element, in a folded position, that they do not contact in an unfolded position.
Applicant’s arguments on pp. 9-11 are directed to whether Wicklund or Staunton teach amended subject matter, including the above arrangement of contact elements, carrier element, and contact between them in a folded or unfolded configuration. Based on the updated rejection, these remarks are unpersuasive in light of the teachings of Wicklund.
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) 1-7, 9, and 12-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wicklund (U.S. Patent Application Publication No. 2014/0081362) hereinafter referred to as Wicklund.
Regarding claim 1, Wicklund teaches a medical electrode device for implantation into a patient (Abstract), comprising:
a lead body (Fig. 3A-B, ¶[0053]) extending along a longitudinal axis and having a proximal end, a distal end and an inner lumen (Fig. 11A-B inner lumen element 19 “coaxial lumen”, proximal and distal ends are relative ends of the device) for receiving a mandrel (Fig. 11A-B, mandrel element 46 “stylet”); and
an electrode end (Fig. 3A-B, elements 13/14 “stimulator electrode contacts” and “electrode array”, and elements 24 “array element”) arranged at the distal end of the lead body (¶[0053] “distal segment of lead 23”) and comprising a carrier element (Fig. 8A-B, main trunk body, see Fig. 5 element 28) and an arrangement of contact elements arranged on the carrier element for contacting tissue (Fig. 8A-B, elements 26 array element are for contacting tissue and located on the electrode end, see ¶[0050] and ¶[0088]);
wherein a retaining device (Fig. 4A-D, elements 27a-d “keeper”) arranged on the electrode end (Fig. 8-10 and 12, ¶[0066]) and configured to interact with the mandrel (Fig. 12, stylet inside lumen, ¶[0066], ¶[0079]), wherein the electrode end is adjustable between a folded position and an unfolded position (Fig. 8A-B folded and unfolded), the retaining device being configured to retain the electrode end in the folded position and being actuatable for causing the electrode end to transfer from the folded position to the unfolded position (¶[0075], ¶¶[0085-0086]).
wherein the folded position includes a configuration in which a contact element makes physical contact with another contact element or a portion of the carrier that it otherwise does not do so when in the unfolded position (Fig. 8A-B, when folded, the contact elements 26 contact the body of the carrier element via contours 37).
Regarding claim 2, Wicklund teaches the medical electrode device according to claim 1.
Wicklund further teaches wherein the electrode end, in the folded position, comprises a first radial extension with respect to the longitudinal axis and, in the unfolded position, comprises a second radial extension with respect to the longitudinal axis larger than the first radial extension (Fig. 8A-B, folded and unfolded comprise different radial dimensions, and the unfolded configuration radial dimension is larger than the folded configuration radial dimension).
Regarding claim 3, Wicklund teaches the medical electrode device according to claim 1.
Wicklund further teaches wherein the electrode end comprises a first half on a first side of the longitudinal axis and a second half on a second side of the longitudinal axis opposite the first side, wherein the first half and the second half are approached towards one another in the folded position of the electrode end and substantially extend along a common plane in the unfolded position of the electrode end (Fig. 8A-B).
Regarding claim 4, Wicklund teaches the medical electrode device according to claim 1.
Wicklund further teaches wherein the retaining device is formed by at least one fixation element arranged on the carrier element (Fig. 4A-D, elements 27a-d “keeper”) and configured to interact with the mandrel in the folded position of the electrode end (Fig. 12, stylet inside lumen, ¶[0066], ¶[0079]).
Regarding claim 5, Wicklund teaches the medical electrode device according to claim 4.
Wicklund further teaches wherein the fixation element forms a loop for interacting with the mandrel (Fig. 4A-D, elements 27a-d “keeper” is a circle shape, forming a loop).
Regarding claim 6, Wicklund teaches the medical electrode device according to claim 4.
Wicklund further teaches wherein the fixation element is formed as a rigid element or is flexibly deformable (Fig. 4A-D, elements 27a-d “keeper”, ¶[0055]).
Regarding claim 7, Wicklund teaches the medical electrode device according to claim 4.
Wicklund further teaches wherein halves of the electrode end on different sides of the longitudinal axis each comprise an arrangement of fixation elements configured to interact with the mandrel for retaining the halves in the folded position of the electrode end (¶[0059] each is in arrangement with appropriate keeper structure as required).
Regarding claim 9, Wicklund teaches the medical electrode device according to claim 7.
Wicklund further teaches wherein each half comprises an arrangement of recesses for receiving the fixation elements of the respective other half therein in the folded position of the electrode end (Fig. 7A-B, element 37 “contours”).
Regarding claim 12, Wicklund teaches the medical electrode device according to claim 1.
Wicklund further teaches wherein the carrier element comprises a protruding web extending along the longitudinal axis (Fig. 12, core of 26 including shape denoted by contours 37, 42, 39, etc.) and forming an opening for guiding the mandrel (Fig. 12 element 38, 39), the protruding web having at least one gap opening in which the retaining device is received in the folded position of the electrode end for interacting with the mandrel (Fig. 12A-C).
Regarding claim 13, Wicklund teaches a system for implantation into a patient, comprising: a medical electrode device according to claim 1.
Wicklund further teaches a mandrel received in the inner lumen of the lead body (Fig. 12, ¶[0075], ¶¶[0085-0086]).
Regarding claim 14, Wicklund teaches the system according to claim 13.
Wicklund further teaches wherein the mandrel is movable with respect to the lead body of the medical electrode device to actuate the retaining device for causing the electrode end to transfer from the folded position to the unfolded position (Fig. 12, ¶[0075], ¶¶[0085-0086]).
Regarding claim 15, the claim is directed to a method comprising substantially the same subject matter as claim 1 and is rejected under substantially the same sections of Wicklund.
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(s) 8 and 10-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wicklund as applied to claim 1 above, and further in view of Staunton et al. (U.S. Patent Application Publication No. 2012/0022551) hereinafter referred to as Staunton.
Regarding claim 8, Wicklund teaches the medical electrode device according to claim 7.
Wicklund does not teach wherein the fixation elements of the halves alternate along the longitudinal axis in that a fixation element of one half is followed, when viewed along the longitudinal axis, by a fixation element of the other half.
Attention is drawn to the Staunton reference, which teaches wherein the fixation elements of the halves alternate along the longitudinal axis in that a fixation element of one half is followed, when viewed along the longitudinal axis, by a fixation element of the other half (Fig. 40, ¶[0173] these are alternating when viewed longitudinally, this Fig. is a cross-section of the view; one pull cable element 316 at the top, and one at the bottom).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the electrode and mandrel of Staunton to include pull wires, as taught by Staunton, because it allows for larger and more useful electrode arrays to be deployed and steered using a minimally invasive style surgery (Staunton ¶[0017]).
Regarding claims 10-11, Wicklund teaches the medical electrode device according to claim 1.
Wicklund does not explicitly teach a pull wire.
Attention is brought to the Staunton reference, which teaches a retaining device formed by a pull wire configured to interact with the mandrel for exerting a pulling force on the carrier element in the folded position of the electrode end (¶¶[0128-0129]); and
wherein the pull wire comprises at least one section extending in between edges of the electrode end spaced apart along a transverse direction with respect to the longitudinal axis to introduce a pulling force transverse to the longitudinal axis in the folded position of the electrode end (¶¶[0176-0177]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the electrode and mandrel of Staunton to include pull wires, as taught by Staunton, because it allows for larger and more useful electrode arrays to be deployed and steered using a minimally invasive style surgery (Staunton ¶[0017]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
U.S. Patent Application Publication No. 2011/0077660 to Janik et al. teaches a foldable implantable electrode assembly.
U.S. Patent Application Publication No. 2011/0257714 to Swanson teaches a folding paddle lead including contact portions, Fig. 4A-D
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 AMANDA L STEINBERG whose telephone number is (303)297-4783. The examiner can normally be reached Mon-Fri 8-4.
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/AMANDA L STEINBERG/ Examiner, Art Unit 3792
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