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 .
Election/Restrictions
Applicant's election with traverse of Invention I, claims 1-17, in the reply filed on December 29, 2025 is acknowledged. The traversal is on the ground(s) that no search and/or examination burden exists and the method of claims 18-20 cannot be practiced by another and materially different apparatus than that described in claims 1-17. This is not found persuasive because as set forth in the restriction requirement, inventions I and II are classified in different areas and would require distinct searches in order to find each individual invention. Furthermore, as set forth in the restriction requirement, the process as claimed can be practiced by another and materially different apparatus, such as one including a pusher device.
The requirement is still deemed proper and is therefore made FINAL.
Claims 18-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on December 29, 2025.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 9/18/2023, 12/11/2023, 4/15/2024, 12/26/2024, 5/19/2025, and 1/29/2026 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 and 8-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Feler (U.S. 2013/0238077). 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) at least one deformation section 410 disposed longitudinally through the electrode body such that the at least one deformation section is parallel with a longitudinal axis of the lead body (“ 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(ii) at least two contacts 222 disposed on the electrode body (see Figure 4).
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 the at least one deformation section comprises at least two deformation sections (see Figure 4, which shows 4 longitudinal score lines).
Regarding claim 4, Feler discloses that the at least one deformation section comprises three deformation sections (see Figure 4, which shows 4 longitudinal score lines).
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 at least one distal deformation section comprising a first end disposed at a distal end of the at least one deformation section and a second end disposed at a side of the electrode body (see annotated Figure 4 below, where it is respectfully submitted that the claimed “deformation section” is merely a section that can deform and, thus, the section of the score line 410 illustrated in bold below and showing the distal end).
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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 two deformation sections 410 disposed longitudinally through the electrode body (see Figure 4);(ii) at least one first contact 222 disposed between a first outer edge of the electrode body and a first of the at least two deformation sections (see Figure 4); (iii) at least one second contact 222 disposed between the first and a second of the at least two deformation sections (see Figure 4); and (iv) at least one third contact disposed between the second of the at least two deformation sections and a second outer edge of the electrode body, wherein the first and second outer edges are moveable in relation to each other via the at least two deformation sections 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).
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Regarding claim 11, Feler discloses at least one pair of notches defined in the first and second sides of the electrode body, whereby the electrode body has increased lateral and longitudinal flexibility (score lines 410 and 412 shown in Figure 4 are notches defined in the first and second sides of the electrode body and give increased lateral and longitudinal flexibility).
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 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 annotated Figure 4 above).
Regarding claim 14, Feler discloses that the flap is moveable between a flat configuration and a pocket configuration or a collar configuration (it is respectfully submitted that the flap is capable of being moved and manipulated into a pocket or collar configuration based on the score lines and flexibility).
Regarding claim 15, Feler discloses a spinal cord stimulation device (Abstract) comprising:(a) an elongate thin film lead body 244 (see Figure 4); (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 three deformation sections 410 disposed longitudinally through the electrode body such that each of the at least three deformation sections is parallel with a longitudinal axis of the lead body (see annotated Figure 4 below); (ii) at least two contacts 222 disposed on the electrode body; and (iii) first and second outer edges moveable in relation to each other via the at least three deformation sections 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(c) 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 annotated Figure 4 below), wherein the flap is movable between a flat configuration and a pocket configuration or a collar configuration body (it is respectfully submitted that the flap is capable of being moved and manipulated into a pocket or collar configuration based on the score lines and flexibility).
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Regarding claim 16, Feler discloses at least one distal deformation section comprising a first end disposed at a distal end of one of the at least three deformation sections and a second end disposed at one of the first and second outer edges (see annotated Figure 4 below).
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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 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Feler (U.S. 2013/0238077, cited above). Feler discloses the invention substantially as claimed, but fails to disclose that the second end of the at least one distal deformation section is disposed between the distal flap and the distal end of the thin film electrode body. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to dispose the second end of the at least one distal deformation section between the distal flap and the distal end of the thin film electrode body, since it has been held that rearranging parts of an invention involves only routine skill in the art. MPEP 2144.04
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 at least one (claim 1), at least two (claim 10), and at least three (claim 15) deformation sections. Feler teaches a spinal cord stimulation device including at least three deformation sections 410 (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 at least one, at least two, and at least three deformation sections, 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 at least one (claim 1), at least two (claim 10), and at least three (claim 15) deformation sections. Feler teaches a spinal cord stimulation device including at least three deformation sections 410 (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 at least one, at least two, and at least three deformation sections, 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.
Conclusion
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.
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/TAMMIE K MARLEN/Primary Examiner, Art Unit 3796