DETAILED ACTION
The following Office Action is in response to the Amendment filed on December 22, 2025. Claims 105-122 and 124 are currently pending.
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
Concerning the “III. Section 103 Rejections” section on pages 1-5 of the Applicant’s Response filed on December 22, 2025, the applicant’s arguments have been fully considered, but they are moot in view of the new ground(s) of rejection.
Claim Objections
Claim 112 is objected to because of the following informalities: Line 2 of the claim recites the phrase “extending readily inwards”, wherein the word “readily” appears to be a misspelling of the word “radially”. Appropriate correction is required.
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.
Claim(s) 111-116 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ranucci et al. (US 2015/0133972, hereinafter Ranucci).
Concerning claim 111, the Ranucci et al. prior art reference teaches a helical implant (Figures 1-15; 4), capable of being used to treat a fistula, comprising: a helical coil portion (See OA Figure 1 below) including a proximal most end and a distal most end (See OA Figure 1 below) having a driver interface portion (Figure 10; 24) configured to provide a push point of the helical implant and transfer force to drive the helical implant into tissue (Figure 10; walls defining cavity 24 provide push point transferring force to push central post 22 to drive implant into tissue), at least one feature disposed on the helical coil portion distal to the driver interface portion and proximal the distal most end of the helical coil portion (Figure 1; outer surface of coil winding may be interpreted as a feature | See OA Figure 1 below), wherein the driver interface portion is provided at a location distal the proximal most end of the helical coil portion and proximal the at least one feature (Figure 10; 24), wherein, in a delivery configuration, a distal end of an implant driver is configured to engage the driver interface portion of the helical implant to urge the helical implant into the tissue (Figure 15; implant driver 100 engages driver interface portion via wings 14).
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OA Figure 1
Concerning claim 112, the Ranucci reference teaches the helical implant of claim 111, wherein the driver implant portion includes a first portion extending radially inwards from the helical coil portion (Figure 10; lateral portion of cavity 24 extends radially inward from the helical coil portion) and a second portion extending radially outwards from the helical coil portion (Figure 10; distal radial wing 14 may be interpreted as being part of the driver interface portion, and extends radially outward from the helical coil portion).
Concerning claim 113, the Ranucci reference teaches the helical implant of claim 112, wherein the driver interface portion extends across a thickness of the helical implant (Figure 10; diameter of lateral portion of cavity 24 extends across the diameter of the thickness of the coil).
Concerning claim 114, the Ranucci reference teaches the helical implant of claim 111, wherein the helical coil portion includes a trough disposed along a length of the helical coil portion (inner surface of coil winding defines trough | See OA Figure 1 above) and a taper portion defined by a radially interior surface of the helical implant ([¶ 0030)].
Concerning claim 115, the Ranucci reference teaches the helical implant of claim 114, wherein the taper portion tapers toward the proximal end of the helical implant, and the taper portion is located distal of the driver interface portion (Figure 1; 4 | [¶ 0030]).
Concerning claim 116, the Ranucci reference teaches the helical implant of claim 111, wherein the helical implant is bioabsorbable ([¶ 0039]), and wherein the at least one feature is configured to inhibit the helical implant from moving in a direction away from the tissue during the delivery configuration (outer surface of coil winding will frictionally engage tissue as it is delivered, therein inhibiting the helical implant from moving in a direction away from the tissue during the delivery configuration).
Allowable Subject Matter
Claims 105-110, 117-122, and 124 are allowed.
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.
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/MARTIN T TON/Examiner, Art Unit 3771 3/5/2026