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 .
Allowable Subject Matter
The indicated allowability of claim 21 is withdrawn in view of the newly discovered reference(s) to Fanton et al. (US 2008/0275469) and Cerundolo (US 2006/0241619). Rejections based on the newly cited reference(s) follow.
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.
Claim(s) 1-7, 9, 13 and 21-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fanton et al. (US 2008/0275469, hereinafter “Fanton”) in view of Cerundolo (US 2006/0241619, hereinafter “Cerundolo”) and further in view of Cauldwell et al. (US 2009/0287246, hereinafter “Cauldwell”) as evidentiary reference.
Referring to claim 1, Fanton discloses a locking ferrule (FIG. 12, which is reproduced below, paras. [0243]-[0249]) for performing a tensionable knotless surgical procedure, comprising:
a cap portion 245;
a barrel portion 242;
a cannulation formed through the cap portion and the barrel portion;
a plurality of locking barbs 254 arranged within the cannulation and configured to establish a one-way locking mechanism for locking a suture 32a, 32b that is shuttled through the cannulation.
Fanton fails to disclose a slot that is connected to the cannulation.
However, in the same field of endeavor, which is a suture, Cerundolo discloses a slot 49 is formed in the cap portion 4 and the slot is communicated with suture pathways 44 (“One or more pathways 44 may be formed through the suture fixation device 4, such as by a hole or holes formed through the flange 43 (see also FIG. 15)...A recess 49 may be provided in the flange portion 43 to receive one or more knots, if formed with the suture(s) in the pathway 44.” (para. [0068])). Apparently, the slot prevent the knot from “stand proud” from the cap, thereby, avoiding tissue irritation and improve healing (extrinsic evidence, Cauldwell discloses “In some cases, knots and other bulky attachment means can irritate tissue over time. These knots may also "stand proud" above the tissue and interfere with movement and healing.”). In view of Cerundolo’s teaching, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the application, to substitute the cap of Fanton with the cap of Cerundolo for receiving one or more knots to avoid tissue irritation and improve healing.
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Referring to claim 2, Fanton/Cerundolo disclose the locking ferrule as recited in claim 1, wherein the cap portion includes a top surface, a bottom surface, and a side wall that extends between the top surface and the bottom surface (see FIG. 12 of Cerundolo reference).
Referring to claim 3, Fanton/Cerundolo disclose the locking ferrule as recited in claim 2, wherein the barrel portion protrudes from the bottom surface of the cap portion.
Referring to claim 4, Fanton/Cerundolo disclose the locking ferrule as recited in claim 1, wherein the barrel portion 242 (FIG. 12) includes an interior wall and an outer diameter wall.
Referring to claim 5, Fanton/Cerundolo disclose the locking ferrule as recited in claim 4, wherein at least a portion of the plurality of locking barbs 254 protrudes inwardly from the interior wall (FIG. 12).
Referring to claim 6, Fanton/Cerundolo disclose the locking ferrule as recited in claim 1, wherein each of the plurality of locking barbs 254 is angled in a direction toward the cap portion (FIG. 12).
Referring to claim 7, Fanton/Cerundolo disclose the locking ferrule as recited in claim 1, wherein the plurality of locking barbs are arranged in at least a first row and a second row within the cannulation (FIG. 12 shows cleat members 254 are positioned on both sides).
Referring to claim 9, Fanton/Cerundolo disclose the locking ferrule as recited in claim 1, wherein each of the plurality of locking barbs includes a pointed tip (FIG. 12 of Fanton reference shows the plurality of locking barbs 254 includes a pointed tip).
Referring to claim 13, Fanton/Cerundolo disclose the locking ferrule as recited in claim 1, wherein the suture 32 is arranged within the cannulation in a manner that forms a loop (FIG. 12).
Referring to claim 21, Fanton/Cerundolo disclose the locking ferrule as recited in claim 1, wherein the cap portion and the barrel portion are integrally formed as a unitary structure, and the cap portion has a larger outer diameter than the barrel portion such that the locking ferrule exhibits a profile resembling a top hat (the cross-section lines as shown in FIG. 12 shows the cap portion, which is similar to the cap portion of Cerundolo, and the barrel portion are single-unitary-component).
Referring to claim 22, Fanton/Cerundolo disclose the locking ferrule as recited in claim 1, wherein the plurality of locking barbs 254 are integrally formed with an interior wall that circumscribes the cannulation and protrude inwardly therefrom, and each locking barb of the plurality of locking barbs is angled in a common direction to passively engage the suture and establish the one-way locking mechanism (FIG. 12).
Referring to claim 23, Fanton/Cerundolo disclose the locking ferrule as recited in claim 1, wherein the slot opens into the cannulation (FIG. 15 of Cerundolo reference shows the slot 49 opens into the suture openings 44, thus, the cap of Fanton, which is similar to the cap of Cerundolo would have slot 49 opens into suture cannulations).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fanton et al. in view of Cerundolo as applied to claim 7 above and further in view of Coughlin (US 2007/0123988, hereinafter “Coughlin”).
Referring to claim 8, Fanton/Cerundolo discloses the locking ferrule as recited in claim 7 but fails to disclose wherein a first portion of the plurality of locking barbs of the first row are staggered relative to a second portion of the plurality of locking barbs of the second row. However, in the same field of endeavor, Coughlin discloses plurality of locking barbs 16 of top row are staggered relative to a plurality of locking barbs of bottom row (FIG. 2, which is reproduced below, para. [0040]). Coughlin discloses the advantage of the staggered arrangement is to provide a tightly gripped without damage that might otherwise occur if the row of teeth were in opposing alignment with each other (para. [0043]: “The staggered arrangement of the teeth 16 assure that the tendon 20 will be tightly gripped without damage that might otherwise occur if the row of teeth 16 in each leaf 14A and 14B were in opposing alignment with each other.”)
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Referring again to claim 8, in view of Coughlin’s teaching it would have been obvious to one of ordinary skill in the art, before the effective filing date of the application, to have arranged the barbs 254 of Fanton according to Coughlin’s suggestion so that it too would have the same advantage.
Claim(s) 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fanton et al. in view of Cerundolo as applied to claim 1 above and further in view of Hunter (US 8,915,943, which is cited in the most recent Office action, hereinafter “Hunter”).
Referring to claims 14-15, Fanton/Cerundolo discloses the invention substantially as claimed except for disclosing the suture includes a varying thickness, or wherein the suture includes at least one tapered region where the suture transitions between a thickened section and a thinned section. However, Hunter teaches a suture 200 that varies in thickness or includes at least one tapered region where the suture transitions between a thickened section and a thinned section (FIG. 2B, col. 13, lines 21-47).
Referring again to claims 14-15, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, in view of Hunter, to modify the suture of Fanton, so that it varies in thickness or includes at least one tapered region where the suture transitions between a thickened section and a thinned section. Such a modification would provide a suture with a desired and/or sufficient strength and flexibility for tensioning across a wound or incision.
Allowable Subject Matter
Claims 10-12 and 24 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 25 is allowable.
Referring to claims 10, 24 and 25, there is no art of record alone or in combination that teaches a suture anchor that includes the limitation of a slot that is formed in the cap portion and is arranged to open into the cannulation and the slot provides a cleat for locking a position of a free end portion of the continuous suture strand relative to the locking ferrule.
Conclusion
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/TUAN V NGUYEN/Primary Examiner, Art Unit 3771
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