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 with respect to claim(s) 1, 2, 4-6, 21-35 have been considered but are moot because the new ground of rejection over Martins et al. US 5306290 in view of Bonutti US 6592609 in view of Fanton et al. US 2008/0275469, as discussed below.
Martins et al. discloses a bone anchor system comprising a bone anchor and locking ferrule for stabilization.
Bonutti teaches an anchor or button for securing tissue comprising a suture system which may be used within a bone bore (button anchor 100 within bone 108) or adjacent soft tissue (similar anchor button 188 adjacent soft tissue 182) as alternative procedures of attachment, the anchor for each procedure each having the same construction (column 13, lines 52-53, column 16, lines 1-3). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Martins et al. with a surgical anchor being a surgical button for placement within bone or adjacent tissue, as taught by Bonutti, as a known substitute for the suture anchor for tensioning a suture or positioning within bone or adjacent tissue as required for a particular procedure or location.
Fanton et al. teaches an alternative to providing a knot for securing sutures in securing tissue to bone, the suture may be locked in place without tying a knot (paragraph 0012), comprising a locking ferrule comprising cleated passages (figure 2C, 12) comprising a one way locking mechanism (paragraph 0179, 0245).
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.
Claim(s) 1, 2, 4-6, 21-24, 27, 30, 31 and 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Martins et al. US 5306290 in view of Bonutti US 6592609, in view of Fanton et al. US 2008/0275469.
Regarding claims 1, 2, 24, 27, 30, and 35, Martins et al. discloses a suture locking system, comprising: a surgical anchor 135; a locking ferrule including a tubular body 5 with a cannulation that is surrounded by an inner diameter wall (figures 2- 5; cannulation within side holes 55 or 60, inner diameter walls surrounding openings of holes 55, 60); a flexible coupling 147 that extends between the surgical anchor 135 and the locking ferrule 5; and a suture 177 received through a cannulation (hole 55 or 60) and locked relative to the locking ferrule (tensioned and locked by knot 190 within locking ferrule 5, column 5, lines 39-47), wherein the cannulation extends along an axis that Is about parallel to a top surface of the surgical button (for example, cannulation 60 is parallel with top surface 15, figure 2).
Martins et al. discloses where the suture system may be used with bone and bone or with soft tissue as alternative procedures of attachment with a suture anchor or other devices as necessary (column 6, lines 43-46), but fails to disclose wherein the surgical anchor is a surgical button, or the cannulation that is surrounded by an inner diameter wall comprising a plurality of locking barbs that protrude from the inner diameter wall, the plurality of locking barbs oriented to establish a one-way locking mechanism within the cannulation to lock the suture relative to the locking ferrule by the one way-locking mechanism, the one way locking mechanism permits a suture to be tensioned in a first direction through the cannulation and prevents movement of the suture in a second, opposite direction, wherein the plurality of locking barbs are provided along an entire length of the cannulation.
Bonutti teaches an apparatus or button for securing tissue comprising a suture system which may be used within a bone bore (for example, button anchors 20 or 100 within bone 108, figures 4, 5) or adjacent soft tissue (similar anchor 158 adjacent soft tissue 182) as alternative procedures of attachment, the anchor for each procedure each having the same construction (column 13, lines 52-53, column 16, lines 1-3).
Fanton et al. teaches an alternative to providing a knot for securing sutures in securing tissue to bone, the suture may be locked in place without tying a knot (paragraph 0012), comprising a locking ferrule comprising cleated passages (figure 2C, 12) comprising a one way locking mechanism (paragraph 0179, 0245), configured to allow the suture to be tensioned in a first direction and prevent the suture from moving in a second direction (paragraph 0179, 0245; one-way movement inhibiting distal advancement), established by a plurality of locking barbs provided within a cannulation of the locking ferrule to lock the suture by the one-way locking mechanism (for example, figure 2C or figure 12, barbs or cleated 74 passages 60, 70, paragraph 0179), the plurality of locking barbs are provided along an entire length of the cannulation (figure 2C, along entire length of passages 60, 70), each locking barb is angled toward a common end of the locking ferrule (figures 2C or 12).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Martins et al. with a surgical anchor being a surgical button for placement within bone or adjacent tissue, as known in the art and taught by Bonutti, as a known substitute for the suture anchor for tensioning a suture for positioning between bone or tissue as required and positioned for a particular procedure, and to modify the cannulation to including a one-way locking mechanism, configured to allow the suture to be tensioned in a first direction and prevent the suture from moving in a second direction, established by a plurality of locking barbs provided within a cannulation of the locking ferrule to lock the suture by the one-way locking mechanism, the plurality of locking barbs are provided along an entire length of the cannulation, each locking barb is angled toward a common end of the locking ferrule, as taught by Fanton, et al. to allow for a locking mechanism comprising barbs to engage with and lock the suture without the use of a knot, as knots can be hard to maneuver in restricted space.
Regarding claim 4, Martins et al. discloses wherein the flexible coupling 147 is adjustable to reduce a distance between the surgical button and the locking ferrule (column 5, lines 15-29; the flexible coupling is drawn taught and secured with knot 155 to secure the distance between the button and locking ferrule and the positioning of the tissue or bone being connected).
Regarding claim 5, Martins et al. discloses wherein the flexible coupling is a second suture that is separate and distinct from the suture (figure 5, sutures 177 and 140).
Regarding claim 6, Martins et al. discloses wherein the flexible coupling is an adjustable suture loop (figure 5, free ends140 and 145 forming a loop at knot 155).
Regarding claim 21, Martins et al. discloses wherein the locking ferrule includes a tubular body 5 having the cannulation (figures 2-5).
Regarding claim 22, Martins et al. discloses the tubular body including the inner diameter wall (figures 2-5; inner diameter walls surrounding holes 55, 60 within tubular body 5), and an outer diameter wall that provides a smooth surface (figures 2-4; outer surface of member 5 can be considered smooth as it forms a flat surface texture sloped and free of additional threads or barbs).
Regarding claim 23, Martins et al. discloses wherein the flexible coupling is connected to the locking ferrule without passing through the cannulation (figures 2, 5; flexible coupling 147 passes through openings 35, 40 not cannulation 55 or 60).
Regarding claim 31, Martins et al. discloses a suture locking system, but fails to explicitly disclose a second surgical button; a second locking ferrule that includes a second one way locking mechanism; and a second flexible coupling that extends between the second surgical button and the second locking ferrule. However, It would have been obvious to one having ordinary skill in the art at the time the invention was made to provide a second surgical button, locking ferrule, and coupling to provide an additional system for use in tissue at a second location, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Claim(s) 25 and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable in view of Martins et al. US 5306290 in view of Bonutti US 6592609, in view of Fanton et al. US 2008/0275469, as discussed above, and further in view of To et al. US 2008/0294177.
Regarding claim 25 and 26, Martins et al in combination discloses the suture locking system essentially as claimed as discussed above, but fails to disclose the plurality of locking barbs are arranged in at least a first row and a second row, and further wherein the locking barbs of the first row are staggered relative to the locking barbs of the second row, each locking barb of the plurality of locking barbs includes a sharp tip that is configured to interdigitate with the suture.
To et al. teaches locking barbs within a locking sleeve, the barbs may be a plurality of locking barbs are arranged in at least a first row and a second row (figures 24A, 25), and further wherein the locking barbs of the first row are staggered relative to the locking barbs of the second row (figures 24A, 25), each locking barb of the plurality of locking barbs includes a sharp tip that is configured to interdigitate with the suture (for example, figure 2C or figure 12, barbs or cleated 74 passages 60, 70, paragraph 0179, interdigitate to hold the suture), each locking barb of the plurality of locking barbs includes a sharp tip that is configured to interdigitate with the suture (paragraph 0140, features 931 can be sharp enough to interlock with tether 534) as a known configuration for locking barbs to provide a one-way locking mechanism for a tether or suture having staggered first and second rows sufficient to engage and interdigit the tether or suture to lock and tension in a first direction.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Martins et al. in combination with a first and second row of barbs, the first and second row being staggered, as taught by To et al. as known in the art to provide an effective locking mechanism for engaging a suture or tether and secure without the use of a knot according to known methods to yield predictable results.
Claim(s) 28 and 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Martins et al. US 5306290 in view of Bonutti US 6592609, in view of Fanton et al. US 2008/0275469, as discussed above and further in view of Cook et al. US 2008/0195148.
Regarding claims 28 and 29, Martins et al. in combination discloses the suture locking system essentially as claimed as discussed above, but fails to disclose wherein the suture includes a varying thickness, the suture includes a thickened section and a thinned section, and the thickened section is about twice as thick as the thinned section.
However, Cook et al. teaches a suture for use with a surgical button stabilization system (paragraph 0012), the suture includes a varying thickness (figure 5, portions 22a being a thinned section, and portion 22 being a thicker section) to be pulled through surgical buttons (paragraph 0062), the preferred suture tape 22 includes dimensions (paragraph 0060, 0.54 mm to 0.859 mm, total thickness 2.25 mm to 4.0 mm, which tapers down to a #2 size suture) tapering to a thinner section on the ends allow a suture to be easily passed through openings during surgical procedures.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to provide a suture wherein the thickened section is about twice as thick as the thinned section, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Martins et al. with a suture of varying thickness, the suture includes a thickened section and a thinned section, and the thickened section is about twice as thick as the thinned section, as taught by Cook et al. to provide an appropriate suture that can be easily threaded through an opening during a surgical procedure while still being secured within a surgical button or fixation device.
Claim(s) 32-34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Martins et al. US 5306290 in view of Bonutti US 6592609, in view of Fanton et al. US 2008/0275469, as discussed above and further in view of Burkhart US 2009/0318960.
Regarding claims 32-34, Martins et al. in combination discloses the locking system essentially as claimed as discussed above, where the suture system may be used with bone and bone or with soft tissue as alternative procedures of attachment (column 6, lines 43-46), the suture is received through the locking ferrule and is locked relative to the locking ferrule by the one-way locking mechanism as discussed above, but fails to disclose a second suture that is received through the locking ferrule and the second locking ferrule, wherein the suture and the second suture are arranged in a crisscross pattern.
However, Burkhard teaches multiple anchor locking system may be used to attach bone to soft tissue for a desired procedure (for example, figures 1-4), comprising a first and second fixation devices each receiving a suture or suture chain extending in a criss-cross pattern over the soft tissue so that the structure is secured in place by the anchors or first and second fixation devices and to properly place tissue and bone together without redundant tissue at the margin, or other patterns as necessary to bridge the tissue with a smooth transition and compress the tear margin at more equal intervals (paragraphs 0010, 0014), the number of fixation devices may vary depending on the application (paragraph 0015, rows may have nay number and various number of anchors for a particular procedure as necessary). Examiner further notes the prior art of Martins et al. discloses the structures as claimed, and the locking ferrule would be configured to receive the second suture through the cannulated opening to connect a second locking ferrule, if required for the procedure to provide multiple fixation device along a target location.
Therefore, it would have been obvious to one having ordinary skill in the art to modify Martins et al. with a suture or second suture to be received through the locking ferrule and the second locking ferrule, the suture arranged in a criss-cross pattern, as taught by Burkhard, to provide multiple locking systems as necessary to attach tissue or bone and provide a smooth transition and compress the tear margin at more equal intervals.
Conclusion
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/CHRISTINA C LAUER/ Examiner, Art Unit 3771
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