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 .
DETAILED ACTION
Status of Claims
This office action is responsive to the amendment filed on 08/10/2026. As directed by the amendment: claims 14, 16, 18-19, 21-24 and 26-27 are withdrawn and new claim 31 has been added. Thus, claims 1-5, 7-10 and 30-31 are presently pending in this application.
Response to Arguments
Applicant's arguments with respect to claims 1-2 rejected under 35 U.S.C. 102(a)(1) and 102 (a)(2) as being anticipated by Beach (5810854); claim 3 rejected under 35 U.S.C. 103 as being unpatentable over Beach (5810854) in view of Mansmann (2013/0190815); claims 4, 5 and 30 rejected under 35 U.S.C. 103 as being unpatentable over Beach (5810854) in view of Yost et al. (2023/0107886) “Yost” and claims 7-10 rejected under 35 U.S.C. 103 as being unpatentable over Beach (5810854) in view of Phan et al. (2024/0206920) “Phan” have been considered but are moot in view of the new ground(s) of rejection.
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.
Claims 1-2 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Beach (5810854) in view of Wenzel et al. (2020/0360065) “Wenzel”.
Regarding claims 1 and 30-31, Beach discloses a system for repairing a tendon (abstract), the system comprising: a self-locking strap 10 (Fig. 1B; col. 4, lin. 54-61 discloses a ratchet locking mechanism) comprising: one or more leaders 14 adapted to attach the self-locking strap to a tendon (col. 4, lin. 61-63), a strap portion connected to a proximal portion of the one or more leaders 14 (strap 10 having teeth/grooves 16 are connected to leading end 14); a bone anchor 110 (Fig. 6A) configured for implantation into bone of a patient, the bone anchor comprising a ratchet 28 (Figs. 1C and 6A) configured to allow passage of the strap portion in a first direction and to prevent passage of the strap portion in a second direction opposite the first direction (col. 4, lin. 54-61 and col. 6, lin. 19-27 disclose the ratchet mechanism allowing the strap 10 to slide in only one direction and the bone anchor 110 receiving the strap 10). Beach is silent regarding one or more leaders adapted to attach the self-locking strap to a tendon when the one or more leaders are stitched to the tendon; comprising one or more needles at a distal end of each of the one or more leaders; and wherein the one or more leaders comprise a suture, monofilament, or a mesh material.
However, Wenzel teaches a similar self-locking strap 8 (Figs. 2A-2B; par. 0030) comprising one or more leaders (suture 7 and needle 11; par. 0030; Fig. 2B) adapted to attach the self-locking strap to a tendon when the one or more leaders are stitched to the tendon (the structure of the needle and the suture are fully capable of performing the intended use of attaching to a tendon when the leaders are stitched to the tendon); comprising one or more needles 11 at a distal end of each of the one or more leaders 7 (Fig. 2B and par. 0030) and wherein the one or more leaders comprise a suture, monofilament, or a mesh material (suture 7; par. 0030; Fig. 2B). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the self-locking strap adapted to attach to a tendon to include one or more leaders adapted to attach the self-locking strap to a tendon when the one or more leaders are stitched to the tendon; comprising one or more needles at a distal end of each of the one or more leaders; and wherein the one or more leaders comprise a suture, monofilament, or a mesh material, as taught and suggested by Wenzel, for allowing rapid fixation of the strap at the implantation site via a needle and suture which can be removed (pars. 0004-0005).
Regarding claim 2, Beach discloses wherein the strap portion 10 comprises a plurality of teeth 16 (Fig. 1B), wherein the ratchet is configured to engage the plurality of teeth (col. 4, lin. 54-61).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Beach (5810854) in view of Wenzel et al. (2020/0360065) “Wenzel” further in view of Mansmann (2013/0190815).
Beach in view of Wenzel discloses the claimed invention of claim 1; except for wherein the bone anchor comprises a threaded portion, wherein the ratchet is configured to rotate with respect to the threaded portion. However, Mansmann teaches a similar system comprising a bone anchor 200 (Fig. 5) comprises a threaded portion (par. 0135 discloses end 212 can be threaded), and a ratchet 220 is configured to rotate with respect to the threaded portion (rotatable gear 240; Fig. 5). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system in Beach in view of Wenzel to include wherein the bone anchor comprises a threaded portion, wherein the ratchet is configured to rotate with respect to the threaded portion, as taught and suggested by Mansmann, to provide a one-way rotational system.
Claims 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Beach (5810854) in view of Wenzel et al. (2020/0360065) “Wenzel” further in view of Yost et al. (2023/0107886) “Yost”.
Beach in view of Wenzel discloses the claimed invention of claim 1; except for wherein the self-locking strap comprises a plurality of leaders, each of the plurality of leaders is connected to the strap at the proximal portion of the strap and wherein the self-locking strap comprises two leaders. However, Wenzel teaches a similar self-locking strap comprising a leader connected to the strap at the proximal portion of the strap (Fig. 2B disclose the leader/suture 7 is attached to the strap 8 at a proximal portion of the strap comprising hole 10). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the self-locking strap in Beach to include a leader connected to the strap at the proximal portion of the strap, as taught and suggested by Wenzel, to provide ease of implantation of the strap at the implantation site.
Furthermore, Yost teaches a similar system capable for repairing a tendon (abstract and Figs. 27-29) comprising a self-locking strap 404 (par. 0115 discloses ratchet mechanism 408 which locks strap 404) comprises a plurality of leaders 452 (Fig. 29), wherein the self-locking strap comprises two leaders (as shown in Fig. 29). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system in Beach in view of Wenzel to include wherein the self-locking strap comprises a plurality of leaders, wherein the self-locking strap comprises two leaders, as taught and suggested by Yost, the use of two needles and leaders allows for a secured attachment and stable connection at the implantation site (par. 0012).
Claims 7-10 are rejected under 35 U.S.C. 103 as being unpatentable over Beach (5810854) in view of Wenzel et al. (2020/0360065) “Wenzel” further in view of Phan et al. (2024/0206920) “Phan”.
Beach in view of Wenzel discloses the claimed invention of claim 1; except for comprising an anchor insertion device configured to secure the bone anchor to bone of the patient; wherein the bone anchor comprises a plurality of cavities configured to mate with a plurality of pins of the anchor insertion device; wherein the anchor insertion device comprises a handle and a beam configured to be inserted into a central opening of the bone anchor and wherein the anchor insertion device comprises a sleeve configured to hold the bone anchor to the anchor insertion device prior to securing the bone anchor to the patient's bone. However, Phan teaches a similar anchor insertion device 65 (Fig. 3A-2) configured to secure a bone anchor 5 (Fig. 3D) to bone of the patient; wherein the bone anchor 5 comprises a plurality of cavities 60 configured to mate with a plurality of pins 115 of the anchor insertion device (par. 0054 and Fig. 3D); wherein the anchor insertion device comprises a handle (portion 70 is capable of being held like a handle; Fig. 3A-2) and a beam 55 (Fig. 3B-2) configured to be inserted into a central opening 12 (similar to anchor shown in Fig. 1C) of the bone anchor and wherein the anchor insertion device comprises a sleeve (tube 95; Fig. 3B-1) configured to hold the bone anchor to the anchor insertion device prior to securing the bone anchor to the patient's bone (tube 95 connects the anchor insertion device 65 to bone anchor 5; Fig. 3B-1; par. 0052). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system in Beach in view of Wenzel to include comprising an anchor insertion device configured to secure the bone anchor to bone of the patient; wherein the bone anchor comprises a plurality of cavities configured to mate with a plurality of pins of the anchor insertion device; wherein the anchor insertion device comprises a handle and a beam configured to be inserted into a central opening of the bone anchor and wherein the anchor insertion device comprises a sleeve configured to hold the bone anchor to the anchor insertion device prior to securing the bone anchor to the patient's bone, as taught and suggested by Phan, for facilitating the insertion of a bone anchor at the implantation site by securely attaching the bone anchor to the insertion device.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YASHITA SHARMA whose telephone number is (571)270-5417. The examiner can normally be reached on 8am-5pm M-Th; 8am-4pm Fri. If attempts to reach the examiner by telephone are unsuccessful, the examiner' s supervisor, Jerrah Edwards, can be reached at 408-918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/YASHITA SHARMA/
Primary Examiner, Art Unit 3774
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