Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions. Claims 11-29 are pending and examined below.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “…a first location that is adjacent to a first attachment point of a shoulder ligament” and “…a second location that is adjacent to a second attachment point of the shoulder ligament” of claim 21 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Applicant is advised that should claims 17-19 be found allowable, claims 27-29 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 11-17, & 27 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Fridman et al. (Augmented Brӧstrom Repair Using Biological Collagen Implant: Report on 9 Consecutive Patients, The Foot & Ankle Journal 1 (7):4, July 2008) hereinafter, Fridman, in view of Bonutti (US 20060089646 A1).
Regarding claim 11, Fridman teaches
a method of surgical repair (Figs. 1-8, Fridman), comprising:
inserting a first fixation device at a first location that is adjacent to a first attachment point of an ankle ligament (one end of strip is sutured to the distal end of the ATFL, Figs. 6-7, page 3, Fridman);
shuttling a suture construct (implant strip, Fig. 4, Fridman) that is connected to the first fixation device from the first location to a second location that is adjacent to a second attachment point of the ankle ligament (sutures to the proximal end of the ATFL, Figs. 6-7, page 3, Fridman), wherein
shuttling the suture construct (implant strip, Fig. 4, Fridman) includes passing the suture construct between the ankle ligament and a tissue overlying the ankle ligament (Figs. 6-7, Fridman);
connecting the suture construct to a second fixation device (second suture at proximal end, page 3, Fridman); and
after inserting the first fixation device and the second fixation device (sutures at distal and proximal ends, page 3, Fridman), the suture construct (implant strip, Fig. 4, Fridman) extends over the ankle ligament to reinforce the ankle ligament (Figs. 6-7, Fridman).
Fridman does not teach inserting a first fixation device into a first bone. However, Bonutti teaches repair, reconstruction, augmentation, and securing of tissue or implants during a surgical procedure (¶0013, Bonutti) wherein
inserting a first fixation device (30, Fig. 11B, Bonutti) into a first bone (262, Fig. 11B, Bonutti) at a first location (see annotated Fig. 11B below, Bonutti);
inserting the second fixation device (another 30, see annotated Fig. 11B below, Bonutti) into a second bone (264, Fig. 11B, Bonutti) at the second location (see annotated Fig. 11B below, Bonutti).
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 teachings of Fridman by incorporating the teaching above as taught by Bonutti in order to secure body tissue and/or an implant (¶0064, Bonutti).
Regarding claim 12, Fridman teaches
comprising establishing a tunnel that extends from the first location to the second location prior to shuttling the suture construct (cable is fed and drawn through, therefore there is a tunnel, Figs. 6-7, Fridman).
Regarding claim 13, Fridman teaches
wherein the tunnel is a soft tissue tunnel (hemostat placed under ATFL to facilitate weaving of the implant, Fig. 6, Fridman).
Regarding claim 14, Fridman teaches
wherein the tissue includes skin, muscle, and fascia (ATFL, Fig. 6, Fridman).
Regarding claim 15, Fridman teaches
wherein the ankle ligament is an anterior talofibular ligament (ATFL) (ATFL, Fig. 6, Fridman).
Regarding claim 16, Fridman teaches
comprising repairing or replacing the anterior talofibular ligament (ATFL) prior to inserting the first fixation device (ligament is repaired, Fig. 3, page 2, Fridman).
Regarding claims 17 & 27, Fridman teaches
wherein the suture construct includes a suture tape (Fig. 4, Fridman).
Claims 18-19 & 28-29 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Fridman in view of Bonutti and further in view of Van Kamp (US 4759765 A) hereinafter, Van.
Regarding claims 18 & 28, Fridman does not teach wherein the first fixation device and the second fixation device are knotless fixation devices. However, Van teaches a tissue augmentation device (abstract, Van)
wherein the first fixation device (14, Fig. 2, Van) and the second fixation device (32, Fig. 4, Van) are knotless fixation devices (14 and 32 are friction fit, therefore knotless, Figs. 2 & 4, Van).
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 teachings of Fridman and Bonutti by incorporating the teaching above as taught by Van in order to securely affix augmentation device to the bones (col. 3 lines 61-63, Van).
Regarding claims 19 & 29, Fridman does not teach wherein the first fixation device and the second fixation device are interference screws. However, Van teaches
wherein the first fixation device and the second fixation device are interference screws (14 and 32 are friction fit, therefore interference screws, Figs. 2 & 4, Van).
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 teachings of Fridman and Bonutti by incorporating the teaching above as taught by Van in order to securely affix augmentation device to the bones (col. 3 lines 61-63, Van).
Claim 20 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Fridman in view of Van.
Regarding claim 20, Fridman teaches
a surgical reconstruction system (Figs. 1-8, Fridman), comprising:
a ligament graft (ligament is repaired, Fig. 3, page 2, Fridman);
a suture tape (Fig. 4, Fridman); and
a curved suture passer (hemostats, Figs. 6-7, Fridman).
Fridman does not teach knotless suture anchors. However, Van teaches
at least two knotless suture anchors (14 and 32 are friction fit, therefore knotless, Figs. 2 & 4, Van).
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 teachings of Fridman by incorporating the teaching above as taught by Van in order to securely affix augmentation device to the bones (col. 3 lines 61-63, Van).
Claims 21-22, & 24-26 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Chudik (US 20070270804 A1) in view of Bonutti.
Regarding claim 21, Chudik teaches
a method of surgical repair (¶0058, Chudik), comprising:
inserting a first fixation device into a first bone at a first location that is adjacent to a first attachment point of a shoulder ligament (interference fixation device, Figs. 12-16, ¶0058, Chudik);
shuttling a suture construct (70, Fig. 12, Chudik) that is connected to the first fixation device from the first location to a second location that is adjacent to a second attachment point of the shoulder ligament (interference fixation device, Figs. 12-16, ¶0058, Chudik), wherein
shuttling the suture construct (70, Fig. 12, Chudik) includes passing the suture construct between the shoulder ligament (7, Figs. 12-16, Chudik) and a tissue overlying the shoulder ligament (Figs. 14-15, Chudik);
connecting the suture construct (70, Fig. 12, Chudik) to a second fixation device (interference fixation device, Figs. 12-16, ¶0058, Chudik); and
inserting the second fixation device into a bone at the second location (interference fixation device, Figs. 12-16, ¶0058, Chudik), wherein,
after inserting the first fixation device and the second fixation device, the suture construct (70, Fig. 12, Chudik) extends over the shoulder ligament (7, Figs. 12-16, Chudik) to reinforce the shoulder ligament (interference fixation device, Figs. 12-16, ¶0058, Chudik).
Chudik does not teach the fixation devices on two different bones. However, Bonutti teaches
inserting a first fixation device (30, Fig. 11B, Bonutti) into a first bone (262, Fig. 11B, Bonutti) and
inserting the second fixation device (another 30, see annotated Fig. 11B below, Bonutti) into a second bone (264, Fig. 11B, Bonutti).
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 teachings of Chudik by incorporating the teaching above as taught by Bonutti in order to secure body tissue and/or an implant (¶0064, Bonutti).
Regarding claim 22, Chudik teaches
comprising establishing a tunnel (62, Fig. 12, Chudik) that extends from the first location to the second location (61, Fig. 12, Chudik) prior to shuttling the suture construct (70, Fig. 12, Chudik).
Regarding claim 24, Chudik teaches
wherein the tissue includes skin, muscle, and fascia (skin and soft-tissue, ¶0043, Chudik).
Regarding claim 25, Chudik teaches
wherein the shoulder ligament is an acromioclavicular joint ligament (7, Figs. 12-16, Chudik).
Regarding claim 26, Chudik teaches
comprising repairing or replacing the acromioclavicular joint ligament (7, Figs. 12-16, Chudik) prior to inserting the first fixation device (interference fixation device, Figs. 12-16, ¶0058, Chudik).
Claim 23 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Chudik in view of Bonutti and further in view of Fridman.
Regarding claim 23, Chudik does not teach wherein the tunnel is a soft tissue tunnel. However, Fridman teaches a biologic scaffold that provides support for augmentation (page 1, Fridman)
wherein the tunnel is a soft tissue tunnel (hemostat placed under ATFL to facilitate weaving of the implant, Fig. 6, Fridman).
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 teachings of Chudik and Bonutti by incorporating the teaching above as taught by Fridman in order to feed and draw the implant through (page. 3, Fridman).
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Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KIA XIONG WHITE whose telephone number is (703)756-4773. The examiner can normally be reached 0830-1630 EST.
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/K.X.W./Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774
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