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 .
The amendment filed on June 30, 2026 has been received and considered. By this amendment, claims 1, 3, 4, 6, 7, 10, 11, and 13-17 are amended and claims 1-20 now pending in the application, with claims 17-20 withdrawn from further consideration as being drawn to a non-elected invention.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 6/12/2026, 7/29/2026, 8/5/2026, and 9/3/2026 has/have been acknowledged and is/are being considered by the Examiner.
Drawings
The Applicant is reminded to carefully review the drawing figures and the accompanying specification to ensure that all reference numerals present in the drawing figures are defined within the specification.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 1-6, 8-13, 15, and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Feler (U.S. 2013/0238077, previously cited). Regarding claim 1, Feler discloses a spinal cord stimulation device (Abstract) comprising:(a) an elongate thin film lead body 244 (see Figure 4); and(b) a thin film electrode body 230 disposed at one end of the elongate thin film lead body (see Figure 4), the thin film electrode body comprising: (i) a distal end, a proximal end, and first and second sides extending from the distal end to the proximal end (see Figure 4); (ii) at least one first pair of notches 412 defined in an outer edge of the first side and at least one second pair of notches 412 defined in an outer edge of the second side, whereby the electrode body has increased lateral and longitudinal flexibility (score lines 412 satisfy the broadest reasonable interpretation for notches, as a notch is understood to be an incision or slit in an object or edge); and (iii) at least two contacts 222 disposed on the electrode body (see annotated Figure 4 below).
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Regarding claim 2, Feler discloses that the at least two contacts comprises at least twelve contacts (see Figure 4, which shows 25 contacts).
Regarding claim 3, Feler discloses that opposing notches of the at least one first pair of notches and the at least one second pair of notches are disposed across from each other (see annotated Figure 4 above).
Regarding claim 4, Feler discloses that each notch of the at least one first pair of notches and the at least one second pair of notches extends inward toward a center of the electrode body and is transverse to a longitudinal axis of the electrode body (see annotated Figure 4 above).
Regarding claim 5, Feler discloses that the thin film electrode body comprises a distal flap disposed at a distal end of the thin film electrode body (the broadest reasonable interpretation for a “flap” is a broad or flat structure, usually thin and flexible that hangs loose or projects freely, which is satisfied by the distalmost portion of the thin film electrode body shown in Figure 4 and reproduced below).
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Regarding claim 6, Feler discloses that the at least one first pair of notches comprises two pairs of notches and the at least one second pair of notches comprises two pairs of notches (see annotated Figure 4 above).
Regarding claim 8, Feler discloses that the flap is moveable between a flat configuration and a pocket configuration (it is respectfully submitted that the flap is capable of being moved and manipulated into a pocket configuration based on the score lines and flexibility).
Regarding claim 9, Feler discloses that the flap is moveable between a flat configuration and a collar configuration (it is respectfully submitted that the flap is capable of being moved and manipulated into a collar configuration based on the score lines and flexibility).
Regarding claim 10, Feler discloses a spinal cord stimulation device (Abstract) comprising:(a) an elongate thin film lead body 244 (see Figure 4); and (b) a thin film electrode body 230 disposed at one end of the elongate thin film lead body (see Figure 4), the thin film electrode body comprising: (i) at least one pair of notches defined in first and second outer edges of the thin film electrode body, wherein a first notch of the at least one pair of notches is define in the first outer edge and a second notch of the at least one pair of notches is defined in the second outer edge, wherein the first and second outer edges are parallel with a longitudinal axis of the thin film electrode body (see annotated Figure 4 above); and (ii) at least two contacts disposed on the electrode body (see Figure 4), wherein first and second ends of the thin film electrode body are moveable in relation to each other via the at least one pair of notches such that the electrode body has increased longitudinal flexibility (“Score lines 410 and 412 extend intermediate each of the electrodes 222 to permit flexing of paddle portion 230”, paragraph [0031]).
Regarding claim 11, Feler discloses that the first and second notches are disposed across from each other (see annotated Figure 4 above).
Regarding claim 12, Feler discloses that the first and second outer edges are rotatable around a longitudinal axis of the electrode body (“The score lines of paddle portion facilitate the bending or shaping of paddle portion 230 to match the posterior shape of the epidural space.”, paragraph [0042], which is respectfully submitted to be a disclosure that the first and second outer edges are capable of rotation around a longitudinal axis of the electrode body).
Regarding claim 13, Feler discloses that the first and second notches extend inward toward a center of the electrode body and is transverse to the longitudinal axis of the electrode body (see annotated Figure 4 above).
Regarding claim 15, Feler discloses a spinal cord stimulation device (Abstract) comprising:(a) an elongate thin film lead body 244 (see Figure 4); and (b) a thin film electrode body 230 disposed at one end of the elongate thin film lead body (see Figure 4), the thin film electrode body comprising: (i) first and second edges parallel with a longitudinal axis of the thin film electrode body (see annotated Figure 4 above); (ii) at least two contacts 222 disposed on the electrode body; and (iii) at least two pairs of notches 412 defined in the first and second outer edges, wherein a first notch of the at least two pairs of notches is defined in the first outer edge and a second notch of the at least two pairs of notches is defined in the second outer edge, wherein each of the first and second notches extends inward toward a center of the electrode body and is transverse to a longitudinal axis of the electrode body (see annotated Figure 4 above); wherein the first and second outer edges are moveable in relation to each other such that the electrode body is laterally conformable to a shape of a target spinal cord (“the front surface or face 231 of paddle structure 230 includes lengthwise or longitudinal score lines 410 that extend between ends 250 and 252 from edge to edge”, paragraph [0031] and “The score lines increase the flexibility of the paddle in both the length and width directions which facilitate the implantation of the paddle within the epidural space of the spinal cord, and further permits the paddle to conform more uniformly to the target area of implantation to minimize the gap between the electrodes and targeted fibers.”, Abstract); and wherein first and second ends of the thin film electrode body are moveable in relation to each other via the at least one pair of notches such that the electrode body has increased longitudinal flexibility (“the front surface or face 231 of paddle structure 230 includes lengthwise or longitudinal score lines 410 that extend between ends 250 and 252 from edge to edge”, paragraph [0031] and “The score lines increase the flexibility of the paddle in both the length and width directions which facilitate the implantation of the paddle within the epidural space of the spinal cord, and further permits the paddle to conform more uniformly to the target area of implantation to minimize the gap between the electrodes and targeted fibers.”, Abstract).
Regarding claim 16, Feler discloses that the first and second notches are disposed across from each other on the electrode body (see annotated Figure 4 above).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 7, 14, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Feler (U.S. 2013/0238077, cited above) in view of Imran et al. (U.S. Patent No. 9,314,618). Feler discloses the invention substantially as claimed, but fails to disclose that each notch of the first pair of notches and the second pair of notches has curved sides such that a width of the notch decreases as a depth of the notch increases. Imran teaches flexible electrode arrays 100 having electrodes 106 and notches 120, wherein each notch of a first pair of notches and a second pair of notches has curved sides such that a width of the notch decreases as a depth of the notch increases (see Figures 9, 13A, and 13B, “a plurality of serrations or notches 120 cut into the film structure 107. The notches 120 may have any suitable shape, dimension or spacing. Likewise, the notches 120 may be symmetrical, non-symmetrical, present along one edge 111 of the film structure 107 or along more than one edge.”, col. 9, ln. 49-54). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Feler to include notches that have curved sides such that a width of the notch decreases as a depth of the notch increases, as taught by Imran, in order to provide anchoring and/or increased flexibility, and as it has been held that combining prior art elements according to known methods to yield predictable results requires only routine skill in the art. KSR Int'l Co. v. Teleflex Inc., 127 S.Ct. 1727, 1742, 82 USPQ2d 1385, 1396 (2007).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 10, and 15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/455,258 in view of Feler (U.S. 2013/0238077, cited above). Claim 1 of the copending application provides the invention claimed in claims 1, 10, and 15 of the present application except for the claimed notches. Feler teaches a spinal cord stimulation device including notches 412 (see Figure 4) that serve the purpose of allowing greater flexibility to the spinal cord stimulation device and “permits the paddle to conform more uniformly to the target area of implantation to minimize the gap between the electrodes and targeted fibers” (Abstract). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify claim 1 of the copending application to include notches, as taught by Feler, in order to allow greater flexibility to the spinal cord stimulation device and permit the paddle to conform more uniformly to the target area of implantation to minimize the gap between the electrodes and targeted fibers.
This is a provisional nonstatutory double patenting rejection.
Claims 1, 10, and 15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/796,426 in view of Feler (U.S. 2013/0238077, cited above). Claim 1 of the copending application provides the invention claimed in claims 1, 10, and 15 of the present application except for the claimed notches. Feler teaches a spinal cord stimulation device including notches 412 (see Figure 4) that serve the purpose of allowing greater flexibility to the spinal cord stimulation device and “permits the paddle to conform more uniformly to the target area of implantation to minimize the gap between the electrodes and targeted fibers” (Abstract). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify claim 1 of the copending application to include notches, as taught by Feler, in order to allow greater flexibility to the spinal cord stimulation device and permit the paddle to conform more uniformly to the target area of implantation to minimize the gap between the electrodes and targeted fibers.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed June 30, 2026 have been fully considered but they are not persuasive. Regarding the previous rejections of the claims as being anticipated by Feler, the Applicant argues that Feler fails to disclose the notches as presently claimed. As set forth in the rejection above, score lines 412 are considered to satisfy the broadest reasonable interpretation for the claimed notches, as a notch is understood to be an incision or slit in an object or edge. As such, and for at least the reasons given above, the rejections stand.
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 TAMMIE K MARLEN whose telephone number is (571)272-1986. The examiner can normally be reached Monday through Friday from 8 am until 4 pm.
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, Benjamin Klein can be reached at 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TAMMIE K MARLEN/Primary Examiner, Art Unit 3796
