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 the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Objections
Claim 1 is objected to because of the following informalities: for consistency, “the second anchor” (bridging lines 11-12 and again in line 12) and “the first anchor” (line 13) should read “the second soft anchor” and “the first soft anchor”. 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) 1, 2, and 8 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Stone et al. (US 2014/0163613; “Stone ‘613”). Regarding claim 1, Stone ‘613 discloses a surgical construct (fig. 11) consisting of a flexible coupler (182) knotlessly connected to a first soft anchor (184) and to a second soft anchor (186), wherein the flexible coupler comprises a first terminal end (from midpoint to 190) and a second terminal end (from midpoint to 188) and wherein the flexible coupler extends through a whole length of each of the first and second soft anchors (fig. 11) so that the first terminal end (end that includes 190) enters a first open end of the first soft anchor and exits a second open end of the first soft anchor and then enters a first open end of the second soft anchor and exits a second open end of the second soft anchor, and the second terminal end enters the second open end of the second anchor, exits the first open end of the second anchor and then enters the second open end of the first anchor (as shown by suture path in fig. 11 of Stone).
Regarding claim 2, the flexible coupler of Stone ‘613 passes at least once through a first tubular sheath of the first soft anchor and at least once through a second tubular sheath of the second soft anchor to form at least one closed, continuous, flexible loop with an adjustable perimeter (fig. 11).
Regarding claim 8, the construct (fig. 11: 168, 184, 186) consists essentially of suture (elongated, flexible braided sleeves forming anchors 184 and 186 are considered suture material, noting par. [0044] of the instant application defines “suture” as “a cable, filament, thread, wire, fabric, or any other flexible member suitable for tissue fixation in the body”).
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) 5, 6, 10, and 12-16 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Stone ‘613 in view of Stone (US 2011/0224799; “Stone ‘799”).
Regarding claims 5 and 6, Stone ‘613 discloses the invention substantially as stated above (see fig. 11 of Stone ‘613) except for wherein the flexible coupler is spliced through itself at one or more locations.
Regarding claim 10, Stone ‘613 discloses a surgical assembly (fig. 11) for tissue repairs comprising a first fixation device (184) and a second fixation device (186), each consisting essentially of suture (elongated, flexible braided sleeve, which is considered suture material, noting par. [0044] of the instant application defines “suture” as “a cable, filament, thread, wire, fabric, or any other flexible member suitable for tissue fixation in the body”), and a flexible coupler (182) passed through the first fixation device and through the second fixation device, the flexible coupler forming in a knotless manner at least one continuous adjustable tensioning loop (fig. 11) extending between the first fixation device (184) and the second fixation device (186), wherein each of the first fixation device (184) and the second fixation device (186) includes a tubular sheath with two open ends, and wherein the flexible coupler passes through each of the two open ends of each of the first fixation device and the second fixation device (fig. 11). Stone ‘613 fails to disclose at least one splice as claimed.
Stone ‘799 discloses a similar suture construct (fig. 4A or 4B) consisting of a flexible coupler (114) knotlessly connected to a first soft anchor (160) and a second soft anchor (other 160), the flexible coupler forming at least one closed, continuous flexible loop with an adjustable perimeter. Stone ‘799 teaches that the flexible coupler may be spliced through itself at one or more locations (at 130: see fig. 4a, 4b; at 224,232: see fig. 6) in order to allow the loop to self-lock in a reduced size or diameter configuration when tension is maintained without the use of a knot ([0033], [0036]). It would have been obvious to one of ordinary skill in the art to have modified the prior art of Stone ‘613 to include at least one splice as taught by Stone ‘799 in order to allow the loops of the suture construct to self-lock when tension is maintained without the use of a knot.
Regarding claims 6 and 12, ‘799 teaches that the flexible coupler may be spliced through itself at two separate locations (see passage portions 224, 232 in fig. 6; note also that passage 130 of figs. 4a, 4b may comprise additional passage portions as per [0029], such that the coupler is spliced through itself at two separate locations). It would have been obvious to one of ordinary skill in the art to have included splices at two separate locations on the construct of Stone ‘613 in view of Stone ‘799 in order to enhance knotless locking of the loops in a tensioned configuration by providing two areas of static friction between the interior surface of the passage of a splice and the exterior surface of the coupler passing through the passage ([0033]). Further regarding claim 12, the flexible coupler of Stone ‘613 forms two continuous adjustable, tensionable loops (fig. 11) extending between the first and second fixation devices.
Regarding claim 13, when ends of the flexible coupler are pulled, a perimeter and a length of each of the two continuous, adjustable, tensionable loops decreases and tensions the surgical assembly as understood in view of fig. 11 of Stone ‘613.
Regarding claim 14, the flexible coupler is suture or suture tape (182 of Stone ‘613 is considered a suture since it is a long filament used to fix tissue).
Regarding claim 15, the tissue repair is rotator cuff repair, AC joint repair, syndesmosis repair, Achilles tendon repair, patellar tendon repair, ACL/PCL reconstruction, hip and shoulder reconstruction, AC joint reconstruction, syndesmosis reconstruction, quad/patellar tendon rupture repair, or hallux- valgus repair. It is noted that the claims are drawn to the apparatus, not its method of use and thus the prior art must only be capable of being used in any one of the listed repairs in order to meet this limitation. Nonetheless, Stone ‘613 explicitly discloses using the surgical assembly during rotator cuff repair ([0019] of Stone ‘613).
Regarding claim 16, the tissue repair is osteochondral repair. It is noted that the claims are drawn to the apparatus, not its method of use and thus the prior art must only be capable of being used in any one of the listed repairs in order to meet this limitation. Since the surgical assembly of Stone ‘613 is capable of being used in osteochondral repair (i.e., bone and cartilage damage repair), it meets this recitation of intended use.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stone ‘613 in view of Lund (US 2018/0221133). Stone ‘613 discloses the invention substantially as stated above including that each of the first and second soft anchors (184,186) is an all-suture anchor (noting par. [0044] of the instant application defines “suture” as “a cable, filament, thread, wire, fabric, or any other flexible member suitable for tissue fixation in the body”), and the flexible coupler is suture, but does not expressly disclose that the suture is round, noting that the cross-section of the suture (182) is not explicitly disclosed.
Lund discloses a suture construct (fig. 3) comprising a flexible coupler (10) knotlessly connected to first and second anchors (70). Lund discloses that the suture may be round or flat, thus disclosing round as a suitable cross-section for suture used in a suture construct similar to that of Stone ‘613 (see [0041]). It would have been obvious to one of ordinary skill in the art to have modified the prior art of Stone ‘613 to construct the flexible coupler from round suture in view of Lund’s teaching that a round suture is a suitable material for a flexible coupler used to connect two anchors in a surgical construct and it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice (In re Leshin, 125 USPQ 416).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stone ‘613 in view of Stone et al. (US 2010/0292792; “Stone ‘792”). Stone ‘613 discloses the invention substantially as stated above except for the flexible coupler (suture 182) consisting essentially of an elastic material.
Stone ‘792 discloses a suture construct (12’, 12’’; see figs. 2c, 2d) and discloses that collagen is a known and satisfactory material for the flexible coupler (suture) ([0044]). It would have been obvious to one of ordinary skill in the art to have modified the prior art of Stone ‘613 to construct the flexible coupler such that it consists essentially of elastic material (collagen) in view of the Stone’s (‘792) teaching that collagen is a known and suitable material for the construction of suture in a self-locking construct and it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice (In re Leshin, 125 USPQ 416).
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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KSH 4/16/2026
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771
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