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
In light of Applicant’s amendment, claim(s) 1, 8, 11-12 and 14 is/are amended and claim(s) 3-5, 7, and 13 is/are canceled. Claims 21-25 are added. Claims 1-2, 6, 8-12, and 14-25 are now pending examination.
The interpretation under U.S.C. 112(f) is withdrawn in light of Applicant’s amendment.
Election/Restrictions
Applicant’s election without traverse of species K and 2 in the reply filed on 10/27/2025 is acknowledged.
Claims 11-12 and 14-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/27/2025. As of the amendment made on 3/4/2026, claim 11 was amended to recite the limitation “an opening having a first portion that includes a plurality of locking barbs and a second portion that excludes any locking barbs, wherein the first portion is a first circumferential half of the opening and the second portion is a second circumferential half of the opening”. However, the elected embodiment of Figures 25-26 does not have any feature that would read on “wherein the first portion is a first circumferential half of the opening and the second portion is a second circumferential half of the opening”. However, the embodiment of Figure 27 does show this feature, and since the embodiment was not elected, the claims are withdrawn as being directed to a non-elected embodiment.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Specifically, the amendment to claim 1 requiring “a shuttle suture received through the first opening and the second opening and a suture connected to the shuttle suture” overcome the rejection as previously written. However, a new grounds of rejection is provided under Fleischman in view of Leung.
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) 1-2, 21-23, and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fleischman (US 20190117210 A1) (previously of record) in view of Leung et al. (US 20080234731 A1).
Regarding claim 1, Fleischman discloses a suture locking device (75A) (Figure 19; Paragraph 0139), comprising:
a surgical button (75A) including a first opening (one of a hole 103 featuring 95) compromising a plurality of locking barbs (100) and a second opening (78) that excludes any locking barbs (Figure 18-19; Paragraph 0139);
a suture (40) (Figure 17; Paragraph 0017; 0139); and
the plurality of locking barbs being angled in a common direction relative to the surgical button to allow the suture to advance in a first direction and resist movement in a second, opposite direction (Figure 17-19; Paragraph 0121; 0139).
Fleischman fails to specifically disclose a shuttle suture received through the first opening and the second opening and a suture connected to the shuttle suture and to lock the suture after the shuttle suture draws the suture through the second opening and into the first opening.
However, Leung is directed to a suture anchor system (30) and teaches a shuttle suture (50) received through the first opening (one half of 40) and the second opening (second half of 40) and a suture (34) connected to the shuttle suture (Figure 2; Paragraph 0022; 0031; 0033; 0038). As a result of the modification, the plurality of locking barbs would be angled in a common direction relative to the surgical button and fully capable to allow the suture to advance in a first direction and resist movement in a second, opposite direction to lock the suture after the shuttle suture draws the suture through the second opening and into the first opening.
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Fleischman such that a shuttle suture received through the first opening and the second opening and a suture connected to the shuttle suture, as taught by Leung, as both references and the claimed invention are directed to suture anchors. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fleischman with the teachings of Leung by incorporating a shuttle suture received through the first opening and the second opening and a suture connected to the shuttle suture in order to stiffen the suture to ensure smooth insertion while preventing deformation and limpness of the suture (Leung Paragraph 0032).
Regarding claim 2, Fleischman further discloses wherein the plurality of locking barbs are integrally formed features of a body of the surgical button (Figure 19; Paragraph 0139).
Regarding claim 21, the combination of Fleishman and Leung teaches the suture locking device as recited in claim 1, and Leung further discloses wherein the suture is connected to an eyelet (opening of 50 allowing for suture body 46) of the shuttle suture (Figure 2; Paragraph 0025).
Regarding claim 22, Fleischman further discloses wherein the plurality of locking barbs are arranged in at least a first row and a second row (Paragraph 0127).
Regarding claim 23, Fleischman further discloses wherein a first portion of the plurality of locking barbs of the first row are staggered relative to a second portion of the plurality of locking barbs of the second row (“suture-securing mechanisms 95 may comprise two “rows” and four “columns” (i.e., relative to the longitudinal axis of the suture-securing mechanism 95) of suture-holding elements (barbs or teeth) 100 that are offset from one another in order to prevent compressing sling 40 between the “points” of opposing barbs or teeth 100”, thus are staggered) (Paragraph 0127).
Regarding claim 25, Fleishman discloses a suture locking device (Figure 17-19; Paragraph 0139), comprising:
a surgical button (75) including a locking opening (one of 103) and a barbless shuttling opening (one of 103 that does not include barbs) that are separated by a bridge (area of the body of 75 between the holes) (paragraph 0139 states “at least one of the holes 103 including suture-holding elements (barbs or teeth) 100…. others of holes 103 may omit barbs or teeth 100”, thus it is disclosed that at least one of holes 103 would be barbless) (Figure 17-19; Paragraph 0139);
a suture (40) (Figure 17; Paragraph 0139); and
a locking ferrule (102) sized for insertion into the locking opening (103) (Paragraph 0125), the locking ferrule including a plurality of locking barbs (95) that are angled in a common direction relative to the surgical button to allow the suture to advance in a first direction and resist movement in a second, opposite direction to lock the suture through the shuttling opening and into the locking ferrule (Figure 17-19; Paragraph 0121; 0139).
Fleischman fails to specifically disclose a shuttle suture received through the locking opening and the barbless shuttling opening and a suture connected to the shuttle suture and to lock the suture after the shuttle suture draws the suture through the shuttling opening and into the locking ferrule.
However, Leung is directed to a suture anchor system (30) and teaches a shuttle suture (50) received through the first opening (one half of 40) and the second opening (second half of 40) and a suture (34) connected to the shuttle suture (Figure 2; Paragraph 0022; 0031; 0033; 0038). As a result of the modification, the plurality of locking barbs would be angled in a common direction relative to the surgical button and fully capable to allow the suture to advance in a first direction and resist movement in a second, opposite direction to lock the suture after the shuttle suture draws the suture through the shuttling opening and into the locking ferrule.
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Fleischman such that a shuttle suture received through the first opening and the second opening and a suture connected to the shuttle suture, as taught by Leung, as both references and the claimed invention are directed to suture anchors. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fleischman with the teachings of Leung by incorporating a shuttle suture received through the first opening and the second opening and a suture connected to the shuttle suture in order to stiffen the suture to ensure smooth insertion while preventing deformation and limpness of the suture (Leung Paragraph 0032).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fleischman in view Leung and further in view of an alternative embodiment of Fleischman.
Regarding claim 6, Fleischman as modified by Leung discloses the suture locking device as recited in claim 1 but fails to explicitly disclose wherein the plurality of locking barbs are provided within a locking ferrule that is insertable into the first opening of the surgical button.
However, an alternative embodiment of Fleischman teaches wherein the plurality of locking barbs are provided within a locking ferrule (95) that is insertable into the first opening of the surgical button (the suture securing mechanisms 95 comprise tubes 102 that are secured in the holes 103, thus are insertable into the first opening of the surgical button.) (Figure 19; Paragraph 0122-124).
It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fleischman’s integral barbs with the teachings of an alternative embodiment of Fleischman by incorporating wherein the plurality of locking barbs are provided within a locking ferrule that is insertable into the first opening of the surgical button in order to be able to selectively choose whether or not to apply one-way locking on the suture.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fleischman in view of Leung as modified by an alternative embodiment of Fleischman as applied to claim 6 above, and further in view of Liu (US 20190076141 A1) (previously of record).
Regarding claim 8, Fleischman as modified by Leung and an alternative embodiment of Fleischman teaches the suture locking device as recited in claim 6, but fails to explicitly disclose a shuttle device configured to shuttle the suture through the second opening and the locking ferrule.
However, Liu is directed to a suture locking device and teaches a shuttle device (305) configured to shuttle the suture (405) through a second opening (distal end of 200) and a locking ferrule (200) (Figure 5; Paragraph 0032-33). (As indicated above, the limitation “shuttle device” invokes 112(f). The corresponding structure in Liu is a wire which is equivalent to a passing wire, as disclosed in the present disclosure, thus would be fully capable of shuttling the suture through the second opening and locking ferrule of Fleischman.)
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Fleischman as modified by Leung such that a shuttle device configured to shuttle the suture through the first opening and the second opening, as taught by Liu, as both references and the claimed invention are directed to suture locking devices. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fleischman as modified by Leung with the teachings of Liu by incorporating a shuttle device configured to shuttle the suture through the first opening and the second opening in order to assure smooth passage of the suture (Liu Paragraph 0033).
Claim(s) 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fleischman in view of Leung and further in view of Armstrong et al. (US 20070031508 A1) (previously of record).
Regarding claim 9-10, Fleischman as modified by Leung discloses the suture locking device as recited in claim 1, but fails to explicitly disclose wherein the suture includes a varying thickness; wherein the suture includes at least one tapered region where the suture transitions between a thickened section and a thinned section.
However, Armstrong is directed to a tissue closure system and teaches a graft (20) wherein the graft includes a varying thickness (Figure 4-5; Paragraph 0019; 0050); wherein the graft includes at least one tapered region (113) where the graft transitions between a thickened section (114) and a thinned section (115) (Figure 4-5; Paragraph 0019; 0050). The graft of Armstrong is used similarly to sling 40 of Fleischman, thus is equivalent to the suture of the present invention.
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Fleischman as modified by Leung such that the suture includes a varying thickness; wherein the suture includes at least one tapered region where the suture transitions between a thickened section and a thinned section, as taught by Armstrong, as both references and the claimed invention are directed to tissue closure systems. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fleischman as modified by Leung with the teachings of Armstrong by incorporating the suture includes a varying thickness; wherein the suture includes at least one tapered region where the suture transitions between a thickened section and a thinned section in order to provide a snug fit near the implantation site (Armstrong Paragraph 0051).
Regarding claim 24, Fleischman as modified by Leung and Armstrong teaches the suture locking device as recited in claim 10, nut fails to explicitly disclose wherein the thickened section is about twice as thick as the thinned section of the suture.
However, Armstrong teaches a variety of diameters of thickened section and the thinned section, and provides values that would allow for the thickened section to be about twice as thick as the thinned section of the suture (Paragraph 0053).
There are a number of choices available to a person of ordinary skill in the art for the ratio between two thicknesses. Therefore, “When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under 103” KSR Int’l Co. v. Teleflex, Inc., 550 U.S. __, 82 USPQ2d 1385 (2007).
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 ZEHRA JAFFRI whose telephone number is (571)272-7738. The examiner can normally be reached 8 AM-5:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, DARWIN EREZO can be reached at (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Z.J./Examiner, Art Unit 3771
/KATHERINE H SCHWIKER/Primary Examiner, Art Unit 3771
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