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 arguments filed 2/10/2026 have been fully considered but they are not persuasive. The arguments under discussion can be found on page 9 of applicants response.
Claim 1 had been a mended to include language from claim 5. This language reads:
wherein the plurality of projections comprises:
a plurality of first projections extending radially away from the outer surface by a first distance; and
a plurality of second projections extending radially away from the outer surface by a second distance, the second distance being less than the first distance
Applicant argues that the plurality of first and second projections do not extend radially from the outer surface. It appears as though applicant is intending to limit the scope of the claims without limiting the claim language. The claim language requires that the projections extend radially away from the outer surface. As is seen in figure 7C of Wechter each lumen extends radially, which is interpreted to mean that the lumens have extension across the cross-section which travel in a radial direction. When looking at lumen 744, as an example, this is clearly radial extension it is not a single direction radial extension however it is broadly interpreted to include all types of radial extension away from the outer surface which is clear in figure 7C. The radius is defined
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as a point from the center to the furthest point, each red in the drawing below is a radius, there are multiple possible radii. Each lumen extends radially from at least one point along a radius to a second point along the radius as shown.
Applicant further argues that different points along the radius are chosen to demonstrate different distances. The claim language states a first distance and a second distance which is less than the first distance. There is no claim language limiting where this distance is measured from, the lumens each have numerous points at which distance can be measured and the claim language is broad enough that this could be any distance taken from any point along the lumen to the external surface. The language is broad and therefore cannot be interpreted as narrowly as applicant’s arguments are interpreting the claim language.
The prior art rejections are not withdrawn.
Claim Objections
Claim 6 depends from claim 5 which has been cancelled, it is assumed that claim 6 should depend from claim 1.
Appropriate correction is required.
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.
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.
Claims 1-9 are rejected under 35 U.S.C. 103 as being unpatentable over Shoberg et al. US 2017/0312500 previously recited in view of Wechter et al. US 2015/0088237 previously recited.
Regarding claim 1: Shoberg discloses a lead assembly 200 (figure 2A) comprising;
conductors extending from a conductor first end to a conductor second end along a longitudinal axis (B1-B4, figure 7B);
a spline body (“core member” 60 figure 7A) which extends along the longitudinal axis (figure 7B) and
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a plurality of projections disposed around an outer parameter of the spline body which extending radially away from an outer surface of the spline body, wherein the projections extend along the longitudinal axis and each projection comprises projection segments separated by longitudinal gaps (figures 7A-7B);
the projections define conductor channels which contain the conductors (each conductor B1-B4 is housed within its respective channel in figures 7A-7B) around an outer parameter of the spline body,
a plurality of electrical contacts E1/E6/E7/E8 (“electrodes”, figures 7A/7B) electrically coupled to the conductors at a conductor first end (paragraphs 0039-40 each electrode E1/E6/E7/E8 is connected to its respective conductor B1/B6/B7/B8); and
an outer lead body disposed radially outwards from at least a portion of the spline body and at least a portion of each conductor (the outer lead body in Shoberg is shown in figure 2A and is formed of electrodes E1-E8 spaced apart from spacers 1-8, this outer lead body is therefore formed from the electrodes and the insulative spacers, this is broadly considered to be disposed radially outward in that the electrodes inner surface is attached to the spline and the outer surface forms part of the lead body) .
Shoberg, therefore, discloses the claimed invention however Shoberg does not disclose a set of first projections that extend a first distance and second projections that extend a shorter distance from the spline body with the projections separated from one another. Wechter however teaches of a segmented electrode lead 300 (figures 3E-3G) which includes a conductor carrying element 702 (figures 7A-7C) which has multiple conductor lumens 774 which include conductors 740. Figures 7A and 7B show a similar design in which the projections for the lumens are equal distance from the body, however figure 7C demonstrates lumens 774 which extend differently from the body of the conductor carrying element. It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Shoberg to include projections which create lumens that extend different lengths to the base of the conductor carrying element (which is considered to be the spline) as taught by Wechter in order to receive two conductors in each lumen to accommodate a lead with segmented electrodes.
Regarding claim 2: Shoberg discloses that the projections electrically isolate the conductors from circumferentially adjacent conductors (paragraphs 0007, 0042 and claim 14. In this design the core member is insulative, the wires are housed in the channels and are thus electrically isolated from one another).
Regarding claim 3: Shoberg discloses that the projections define the conductor channels as helical extending along a longitudinal length of the spline body around the outer parameter of the spline body (paragraph 0041 “FIGS. 7A-B further illustrate electrical junctions 70 initially ‘clocked’ around central lumen 62 so that each conductor B1, B3-B8 extends in a relatively straight path. According to some methods, to provide some strain relief for conductors B1, B3-B8, each of electrodes B2-B8 may be rotated to a different degree about central lumen 62, so that the conductors extend along the helical path described above in conjunction with FIG. 3, prior to forming insulative spacers 2-8 (FIG. 2A)).
Regarding claim 4: Shoberg discloses the spline body comprises a plurality of separate spline segments (each electrode E1/E6/E7/E8 contains a spine segment) comprising; a portion of the spline body and respective projection segments with two or more projections, each spline segment is separated from a longitudinally adjacent spline segment by a longitudinal gap and each separate spline segment overlaps with an electrical contact (figures 7A-7B).
Regarding claim 6: Shoberg/Wechter discloses the claimed invention, Wechter further disclose that the second projections are separated from one another around a perimeter of the spline body from the first projections (figure 7C demonstrates that each lumen/projection is separated from all of the other lumens).
Regarding claim 7: Shoberg discloses that the channels which house the conductors and are formed from the spline body are lined with a slippery polymer J (figure 2B), this slippery polymer is considered to be a slip-tube in that once the polymer lines the lumen it will form a hollow tube, this polymer is within each channel.
Regarding claim 8: Shoberg discloses electrical contacts E1/E6/E7/E8 (figures 7A-7B) which include an annular body which defines an outer surface and an inner contact surface, the contact lumen is the inner surface of the electrode, the outer surface contacts tissue as is known in the art, the spline body is disposed inside the contact lumen of the electrode assembly and as is seen in figure 7A element 512 connects the spline projection to the electrode (figures 7A-7B).
Regarding claim 9: Shoberg discloses the projections B1-B8 are distributed evenly about the parameter of the spline body (figures 7A-7B).
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 PAULA J. STICE whose telephone number is (303)297-4352. The examiner can normally be reached Monday - Friday 7:30am -4pm MST.
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PAULA J. STICE
Primary Examiner
Art Unit 3796
/PAULA J STICE/Primary Examiner, Art Unit 3796
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