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
Applicant’s election without traverse of Group I, Claims 1-14 in the reply filed on 12/22/2025 is acknowledged.
Claims 15-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 12/22/2025.
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.
Claim(s) 1, 4-6, 8, and 10-11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2008/0140093 A1 to Stone et al. (hereinafter “Stone”) (cited in an IDS dated 09/23/2024).
Regarding claim 1, Stone discloses (see abstract; Figs. 1-10A; and [0038]-[0051]) a system (as shown in the Figures) for treating a bone or soft tissue of a patient (see [0038]), the system comprising: a graft ([0038]); an anchor assembly that includes a first anchor (150a), a second anchor (150b), and a suture (350) in operative association with the first anchor and the second anchor (see Fig. 4); and a deployment device (102 + 250 + 200) configured to deliver the anchor assembly to the bone or soft tissue of the patient (see [0049]).
Stone further discloses (claim 4) wherein the anchor assembly comprises a third anchor and a fourth anchor, and wherein the suture is in operative association with the third anchor and the fourth anchor (see [0039], one or more flexible anchors 150 with two being illustrative only, thus including four anchors); (claim 5) wherein at least one anchor of the anchor assembly does not pass through the graft (see [0041]); (claim 6) wherein at least one anchor of the anchor assembly is an expandable anchor (see [0040]); (claim 8) wherein at least one anchor of the anchor assembly is an all-suture anchor (see [0040]); (claim 10) wherein the deployment device comprises a spring loaded cartridge (see [0046]); (claim 11) wherein the deployment device comprises an awl (108) (see Figs. 1-4).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-3, 9, and 12-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jordan in view of US 2012/0179163 A1 to Housman et al. (hereinafter “Hausman”).
Regarding claim 1, Jordan discloses (see abstract; Figs. 1-7; and [0024]-[0034]) a system (as shown in the Figures) for treating a bone or soft tissue of a patient (see [0024]), the system comprising: a graft; an anchor assembly (pins 20, see Fig. 4) that includes a first anchor ("left" 20, Figs. 1/4), a second anchor ("right" 20, Figs. 1/4), and a suture (80) in operative association with the first anchor and the second anchor (see Figs. 1/4); and a deployment device (40, as shown in Fig. 4) configured to deliver the anchor assembly to the bone or soft tissue of the patient (see [0024]/[0030]).
Jordan further discloses (claim 2) wherein the deployment device is configured to store the anchor assembly prior to delivering the anchor assembly to the bone or soft tissue of the patient (see Fig. 4 and [0030]); (claim 3) wherein the deployment device comprises a sheath (42) that is configured to remain in an incision of the patient until each anchor of the anchor assembly is placed in the bone or soft tissue of the patient (see [0030]); (claim 9) wherein the deployment device comprises a strike surface (52) configured for malleting (see [0030]); (claim 12) wherein each anchor of the anchor assembly is self-awling (see Fig. 1 and [0024]); (claim 13) wherein each anchor of the anchor assembly is configured to be stored in a revolving barrel (before the pins are loaded in the device, they are fully capable of being stored in a revolving barrel if one desired to do so - note that the limitations of claim 13 are merely functional limitations and do not affect the structure of the claimed invention - a claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987) - see also MPEP 2114(II), which states that the manner of operating a device does not differentiate apparatus claims from the prior art); and (claim 14) wherein the deployment device comprises a first insertion shaft ("left" 43, Figs. 4-5) and a second insertion shaft ("right" 43, Figs. 4-5) that is parallel with the first insertion shaft (see Figs. 4-5 and [0024]), and wherein the first anchor is configured to releasably engage with the first insertion shaft and the second anchor is configured to releasably engage with the second insertion shaft (see Figs. 4-5 and [0024]/[0030]).
Jordan fails to specifically disclose, with respect to claim 1, a graft. Jordan is directed to attaching a ligament to the lower femur of a knee joint (see [0033] and Fig. 8A). Housman discloses, in the same field of endeavor of ligament repair and suture anchors, the known use of a graft ligament to repair a ligament injury at the knee joint such as an ACL rupture (see [0007]) for the purpose of using a graft ligament to repair the ruptured native ligament so that it extends between the bones of the knee in substantially the same way, and with substantially the same function, as the original ACL so as to restore normal function to the knee (see [0007]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have included a graft in Jordan's system in order to replace a ruptured native ligament so that it extends between the bones of the knee in substantially the same way, and with substantially the same function, as the original ACL so as to restore normal function to the knee.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jordan in view of Housman, as applied to claim 1 above, and further in view of US 2015/0127048 A1 to Curtis et al. (hereinafter “Curtis”).
Regarding claim 7, the combination of Jordan and Housman fails to specifically disclose wherein at least one anchor of the anchor assembly comprises polyether ether ketone. Jordan discloses that the anchor is made of a biocompatible product such as nitinol, stainless steel, titanium, or a non-deformable polymer (see [0034]). Curtis discloses, in the same field of endeavor of suture anchors, the known manufacture of suture anchors by making them out of materials such as nitinol, stainless stell, titanium, or non-deformable polymers, and further discloses where the anchor may be made of polyether ether ketone (PEEK) (see [0041]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination's system by making Jordan's anchor out of PEEK, since 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
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHAUN L DAVID whose telephone number is (571)270-5263. The examiner can normally be reached M-F 10AM-6:30PM.
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/SHAUN L DAVID/Primary Examiner, Art Unit 3771