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 .
Election/Restrictions
Claims 16-26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/14/2025.
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 first and second fixation devices configured to couple to the same bone (claim 1), and the implant suture and a distinct graft suture (claim 1) 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 Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 states “an implant sized and shaped for placement in a repair site of a torn tissue, the implant being compressible and expandable and configured to absorb a repair material.” This limitation is indefinite as it is unclear whether or not the repair material is a positively recited claim element, or whether the implant must merely be capable of absorbing a repair material. Claim 14 further requires “wherein the repair device further comprises a repair material,” which is indefinite as it is unclear whether the repair material is the same as or different from the claim 1 repair material.
Claim 1 states “a second fixation device configured to couple the at least one graft suture to the first bone.” Claim 10 states, “wherein the second fixation device is configured for placement against a second bone.” These two limitations appear to contradict one another, as it is unclear how a single fixation device can both couple the graft suture to the first bone and be placed against the second bone.
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 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Murray (Pub. No.: US 2020/0171203) in view of Turk (Pub. No.: US 2023/0218386).
Murray discloses a tissue repair system, comprising:
a repair device (e.g., fig. 6) including:
an implant 42 sized and shaped for placement in a repair site of a torn tissue, the implant being compressible and expandable (e.g., para. 47) and configured to absorb a repair material (e.g., para. 47), and
a graft configured to be coupled to the implant (not disclosed);
at least one implant suture 22 (e.g., para. 33) configured to position the implant along or adjacent to a ruptured end of the torn tissue (e.g., para. 14);
a first fixation device 24 configured to couple the at least one implant suture to a first bone;
at least one graft suture 22 (e.g., fig. 3) configured to position the graft along or adjacent to the implant or the ruptured end of the torn ligament (e.g., para. 33); and
a second fixation device 24 configured to couple the at least one graft suture to the first bone (e.g., para. 37, fixation device is fully capable of being coupled to the first bone).
As provided in italicized text above, Murray lacks a graft configured to be coupled to the implant. Turk teaches a graft incorporated and fixated to native tissue for the purpose of strengthening the native ligament (abstract, fig. 2A-D). It would have been obvious to one of ordinary skill in the art to have provided the Turk graft with the Murray ligament repair for the purpose of reinforcing and strengthening the ligament-implant repair site. This modification would have occurred using known methods and would have yielded predictable results.
For claim 2, Murray discloses the tissue repair system according to claim 1, wherein the torn tissue is a ligament (abstract).
For claim 3, Murray discloses the tissue repair system of claim 2, wherein the ligament is an ACL (e.g., para. 11).
For claim 4, Murray discloses the tissue repair system according to claim 1, wherein the torn tissue is a tendon (e.g., para. 11).
For claim 5, Murray discloses the tissue repair system according to claim 1, wherein the torn tissue is cartilage (e.g., para. 11).
For claim 6, Murray discloses the tissue repair system according to claim 1, wherein the implant is a collagen scaffold configured to allow cell ingrowth (e.g., para. 39).
For claim 7, Turk teaches wrapping the graft along the native tendon (e.g., fig 2A-D). It would have been obvious to one of ordinary skill in the art to have provided the graft adjacent the implant along a length of the implant when combined with Murray as an obvious expedient to provide structural reinforcement to the implantation site. This modification would have occurred using known methods and would have yielded predictable results.
For claim 8, Turk teaches the tissue repair system according to claim 1, wherein the graft is configured to wrap around the scaffold (Turk, fig. 2A-C).
For claim 9, Murray discloses the tissue repair system according to claim 1, wherein the first fixation device is configured for placement against the first bone (e.g., fig. 5).
For claim 10, Murray discloses the tissue repair system according to claim 1, wherein the second fixation device is configured for placement against a second bone (e.g., fig. 5).
For claim 11, Turk teaches the tissue repair system according to claim 1, wherein the graft is selected from the group consisting of an autologous tendon graft, an allograft, and a synthetic tendon graft (e.g., para. 22).
For claim 12, Murray discloses the tissue repair system according to claim 1, wherein the repair device and the at least one first suture is preloaded and insertable through an arthroscopic cannula (e.g., fig. 3, para. 66).
For claim 13, Murray discloses the tissue repair system of claim 1, wherein the first fixation device and the second fixation device are selected from the group consisting of a screw, a barb, a helical fixation device, a staple, a clip, a snap, and a rivet (para. 51).
For claim 14, Murray discloses the tissue repair system of claim 1, wherein the repair device further comprises a repair material (e.g., para. 36).
For claim 15, Murray discloses the tissue repair system of claim 14, wherein the repair material is a platelet or plasma (e.g., para. 36).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUBA GANESAN whose telephone number is (571)272-3243. The examiner can normally be reached Monday-Friday, 8-5 MT.
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/SUBA GANESAN/Primary Examiner, Art Unit 3774