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 Amendment
The amendment filed 07/21/2026 has been entered. Claims 1 and 3-11 remain pending in the application, claims 2 and 12-20 are cancelled, and claims 21-30 have been added. Applicant’s amendments to the claims have overcome the interpretation of the prior art rejection previously set forth in the Non-Final Office Action mailed 04/09/2026, and a new rejection is applied as outlined below.
Response to Arguments
Applicant’s arguments with respect to claims have been considered but are moot because the new ground of rejection does not rely on the previous interpretation of the reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Arguments directed to the claims as amended are addressed in the body of the rejection below.
Claim Rejections - 35 USC § 102
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 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.
Claims 1, 3-11, 21-25, 27-28, and 30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chalekson (US PGPub 2018/0132843).
With regards to claim 1, Chalekson discloses (Figures 11A-11B) a locking ferrule 53 for performing a tensionable knotless surgical procedure (functional limitation – Chalekson’s locking ferrule comprises of the elements claimed below and thus is capable of performing a tensionable knotless surgical procedure), comprising:
a body 53 having an interior wall and an outer wall, the interior wall defining a cannulation formed through the body 53 (figure 11A – cannulation is where the suture 56/57 extends through);
a first side opening (top 58) formed through both the interior wall and the outer wall of the body 53 and connected to the cannulation, wherein the first side opening 58 extends laterally from an outer surface of the outer wall into the cannulation and is structurally distinct from the cannulation (figures 11A-11B); and
a first plurality of locking barbs 55 arranged within the first side opening 58 and configured to establish a first one-way locking mechanism for locking a suture 56/57 that is received through the first side opening 58 (paragraph 146).
With regards to claim 3, Chalekson discloses wherein the first side opening (top 58) opens through the interior wall into the cannulation (figure 11A).
With regards to claim 4, Chalekson discloses wherein each of the first plurality of locking barbs 55 includes a pointed tip (paragraph 146 – “a suture lock or cinching fixture 54 having a flexible, toothed (or otherwise gripping) claw portions 50 that feature a toothed, barbed or otherwise gripping internal surface, which portions govern lateral channels 58” – the toothed, barbed internal surface is interpreted to have a pointed tip).
With regards to claim 5, Chalekson discloses comprising a second side opening (bottom 58) formed through the body 53 and connected to the cannulation (figure 11A).
With regards to claim 6, Chalekson discloses wherein a first free end 56 of the suture passes through the first side opening (top 58), and a second free end 57 of the suture passes through the second side opening (bottom 58) (figure 11A; paragraph 146; paragraph 129 discloses similar suture materials 2/3 that “may be combined as a single suture forming a V-shape with two sub-lengths equivalent to the lengths of suture materials 2 and 3 and joined at an intersection on the non-barbed side of the suture lock or cinching fixture 6 (i.e., by joining opposite ends 2b and 3b), and this variant may be created from any of the dual-length suture material embodiments described herein” and therefore 56/57 is interpreted as a single suture).
With regards to claim 7, Chalekson discloses comprising a second plurality of locking barbs 55 arranged within the second side opening (bottom 58) and configured to establish a second one-way locking mechanism for locking the suture 56/57 (paragraph 146).
With regards to claim 8, Chalekson discloses wherein a free end 56 of the suture passes through the first side opening 58 (paragraph 146; figure 11A).
With regards to claim 9, Chalekson discloses comprising a second plurality of locking barbs 55 arranged within the cannulation and configured to establish a second one-way locking mechanism for locking the suture (figure 11A; paragraph 146; paragraph 129 discloses similar suture materials 2/3 that “may be combined as a single suture forming a V-shape with two sub-lengths equivalent to the lengths of suture materials 2 and 3 and joined at an intersection on the non-barbed side of the suture lock or cinching fixture 6 (i.e., by joining opposite ends 2b and 3b), and this variant may be created from any of the dual-length suture material embodiments described herein” and therefore 56/57 is interpreted as a single suture).
With regards to claim 10, the locking ferrule of Chalekson is capable for use wherein the suture 56/57 includes a plurality of partitions that interface with the first plurality of locking barbs 55 to create a rip-stop effect as a free end of the suture is being tensioned (since the suture is functionally recited in claim 1 and the structure of the suture is not required to be disclosed, and since the locking ferrule of Chalekson is capable of locking the suture, the locking ferrule would also be capable of locking the suture with a plurality of partitions that interface with the first plurality of locking barbs 55 to create a rip-stop effect as a free end of the suture is being tensioned).
With regards to claim 11, the locking ferrule of Chalekson is capable for use wherein the suture includes a varying thickness (the suture is functionally recited in claim 1 and the structure of the suture is not required to be disclosed, and since the locking ferrule of Chalekson is capable of locking the suture, the locking ferrule would also be capable of locking the suture with a varying thickness).
With regards to claim 21, Chalekson discloses wherein the second side opening (bottom 58) is formed through both the interior wall and the outer wall of the body 53 (figure 11A).
With regards to claim 22, Chalekson discloses wherein the second side opening (bottom 58) extends laterally from the outer surface of the outer wall into the cannulation and is structurally distinct from the cannulation (figure 11A).
With regards to claim 23, Chalekson discloses wherein the second side opening (bottom 58) is diametrically opposed to the first side opening (top 58) (figure 11A).
With regards to claim 24, the locking ferrule of Chalekson is capable for use wherein the suture 56/57 includes a plurality of partitions that interface with the first plurality of locking barbs 55 and the second plurality of locking barbs 55 to create a rip-stop effect as a free end of the suture 56/57 is being tensioned (since the suture is functionally recited in claim 1 and the structure of the suture is not required to be disclosed, and since the locking ferrule of Chalekson is capable of locking the suture, the locking ferrule would also be capable of locking the suture with a plurality of partitions that interface with the first plurality of locking barbs 55 to create a rip-stop effect as a free end of the suture is being tensioned).
With regards to claim 25, Chalekson discloses wherein the first one-way locking mechanism (paragraph 146) is configured to permit the suture 56/57 to pass through the first side opening (top 58) in a first direction away from the interior wall while preventing the suture 56/57 from being tensioned or otherwise moved in a second direction toward the interior wall (paragraph 146).
With regards to claim 27, Chalekson discloses wherein the first side opening (top 58) extends along an axis that is transverse to a longitudinal axis of the cannulation (figure 11A).
With regards to claim 28, Chalekson discloses wherein the cannulation extends along a first axis and opens through each opposing end of the body 53 (paragraph 146 – “This allows suture material strands 56 and 57 to be drawn though the suture lock”), and the first side opening (top 58) extends along a second axis that is transverse to the first axis without passing through either opposing end of the body 53 (figure 11A).
With regards to claim 30, Chalekson discloses (Figures 11A-11B) a suture locking system (figure 11A) for performing a tensionable knotless surgical procedure (functional limitation – Chalekson’s locking ferrule comprises of the elements claimed below and thus is capable of performing a tensionable knotless surgical procedure), comprising:
a suture 56/57 including a first free end 56 and a second free end 57 (figure 11A; paragraph 146; paragraph 129 discloses similar suture materials 2/3 that “may be combined as a single suture forming a V-shape with two sub-lengths equivalent to the lengths of suture materials 2 and 3 and joined at an intersection on the non-barbed side of the suture lock or cinching fixture 6 (i.e., by joining opposite ends 2b and 3b), and this variant may be created from any of the dual-length suture material embodiments described herein” and therefore 56/57 is interpreted as a single suture); and
a locking ferrule 53 including a body 53 having an interior wall, an outer wall, and a cannulation extending longitudinally through the body 53 (figure 11A),
a first side opening (top 58) formed through both the interior wall and the outer wall of the body 53 and connected to the cannulation, wherein the first side opening (top 58) extends laterally from an outer surface of the outer wall into the cannulation and is structurally distinct from the cannulation (figure 11A),
a second side opening (bottom 58) formed through both the interior wall and the outer wall of the body 53 and connected to the cannulation at a location spaced from the first side opening (top 58), wherein the second side opening (bottom 58) extends laterally from the outer surface of the outer wall into the cannulation and is structurally distinct from the cannulation (figure 11A),
a first plurality of locking barbs 55 arranged within the first side opening (top 58) and configured to establish a first one-way locking mechanism for locking the first free end 56 of the suture that is received through the first side opening (top 58) (paragraph 146; figure 11A), and
a second plurality of locking barbs 55 arranged within the second side opening (bottom 58) and configured to establish a second one-way locking mechanism for locking the second free end 57 of the suture that is received through the second side opening (bottom 58) (paragraph 146; figure 11A);
wherein the cannulation is configured to receive the first free end 56 and the second free end 57 of the suture, and the first side opening (top 58) and the second side opening (bottom 58) are each configured to receive a respective one of the first free end 56 and the second free end 57 of the suture from the cannulation (figure 11A).
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.
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Chalekson in view of Vaughan (US Patent 9,474,592)
With regards to claim 26, Chalekson discloses the locking ferrule as claimed in claim 1. Chalekson is silent wherein the outer wall includes threads or barbs for facilitating bone fixation.
However, in a similar field of endeavor of barbed sleeves, Vaughan teaches (Figures 1-2) wherein the outer wall 29 includes barbs 70 for facilitating bone fixation (Col 10 lines 9-67).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the locking ferrule of Chalekson to include wherein the outer wall includes threads or barbs for facilitating bone fixation as taught by for the purpose of fixing the sleeve to the bone (Col 10 lines 9-11 of Vaughan).
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Chalekson in view of Ruff et al. (US PGPub 2005/0267531), hereinafter known as “Ruff.”
With regards to claim 29, Chalekson discloses (Figures 11A-11B) a suture locking system (figure 11A) for performing a tensionable knotless surgical procedure (functional limitation – Chalekson’s locking ferrule comprises of the elements claimed below and thus is capable of performing a tensionable knotless surgical procedure), comprising:
a suture 56/57 including a free end; and
a locking ferrule 53 including a body 53 having an interior wall, an outer wall, and a cannulation extending longitudinally through the body 53 (figure 11A),
a side opening 58 formed through both the interior wall and the outer wall of the body and connected to the cannulation, wherein the side opening 58 extends laterally from an outer surface of the outer wall into the cannulation (figure 11A; paragraph 146), and
a plurality of locking barbs 55 arranged within the side opening 58 and configured to establish a one-way locking mechanism for locking the suture 56/57 that is received through the side opening 58 (paragraph 146; figure 11A).
Chalekson is silent wherein the suture includes a plurality of partitions spaced along a length of the suture, wherein the plurality of partitions of the suture are configured to interface with the plurality of locking barbs to create a rip-stop effect as a free end of the suture is being tensioned through the side opening.
However, in a similar field of endeavor of suture devices, Ruff teaches (Figure 1) wherein the suture 90 includes a plurality of partitions 94 spaced along a length of the suture 90 (paragraph 41).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the suture of Chalekson to include a plurality of partitions as taught by Ruff for the purpose of promoting tactile feedback and easy insertion of the suture into the tissue, or in the case of Chalekson, the locking ferrule.
The combination of Chalekson in view of Ruff results in the plurality of partitions 94 of Ruff that interface with the first plurality of locking barbs 55 of Chalekson to create a rip-stop effect as a free end of the suture is being tensioned (as disclosed in paragraph 146 of Chalekson).
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 MOHAMMED S ADAM whose telephone number is (571)272-8981. The examiner can normally be reached 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at 571-272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MOHAMMED S ADAM/Examiner, Art Unit 3771 08/05/2026
/KATHERINE H SCHWIKER/Primary Examiner, Art Unit 3771
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