DETAILED ACTION
This Office Action is a Response to Applicant’s Arguments and Amendment submitted 01/09/2026.
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 .
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 26-30 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Regarding claim 26, the claim recites “a surgical locking button including a disk portion…and a barrel portion protruding from the disk portion and extending into a bone tunnel formed in the bone”, which positively recites the bone tunnel as part of the claimed graft fixation system, therefore contravening 101 and AIA section 33(a) because the bone tunnel is considered as encompassing a human organism. It is suggested to amend the limitation to read as “a surgical locking button including a disk portion…and a barrel portion protruding from the disk portion and configured to extend[[ing]] into a bone tunnel formed in the bone”, or the like, in order to functionally recite the bone tunnel and resolve the issue. Claims 27-30 are dependent from claim 26 and inherit the deficiency by virtue of their dependency.
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) 1-3, 5-9, and 21-30 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2019/0117210 A1 to Fleischman et al. (hereinafter “Fleischman”) (cited in an IDS filed 01/13/2026).
Regarding claim 1, Fleischman discloses (see abstract; Figs. 4-16; Examiner' Diagram of Fig. 8 below; and [0096]-[0137]) a surgical locking button (75) comprising: a disk portion including a top surface and a bottom surface; a barrel portion protruding from the disk portion; a cannulation ("right" hole 103, see Fig. 10) extending through the disk portion and the barrel portion (see Figs. 4-16); a pair of apertures ("left" hole 103, Fig. 10; and hole 78, Figs. 7/10) extending through the disk portion and fully capable of securing a graft relative to a bone (these holes are fully capable of securing a graft relative to a bone via at least a suture inserted therein if one desired to do so as this is a functional intended use limitation - 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); wherein each aperture of the pair of apertures opens through both the top surface and the bottom surface of the disk portion (see Figs. 4-16, "left" hole 103 must open through the bottom surface of the disc portion in order to form a continuous hole through the barrel portion); and a locking barb (100, see Fig. 10) and extending into the cannulation and configured for locking a reinforcement suture (85) relative to the bone (see [0121]-[0127]).
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Fleischman further discloses (claim 2) wherein the disk portion and the barrel portion establish a unitary body of the surgical locking button (see [0114]-[0116]); (claim 3) wherein the locking barb is an integral feature of the unitary body (see [0121]-[0127]); (claim 5) wherein the locking barb includes a pointed tip that is configured to engage the reinforcement suture (see Fig. 11 and [0121]-[0127]); (claim 6) wherein the disk portion includes the top surface, the bottom surface, and a side wall extending between the top surface and the bottom surface (see Figs. 4-16); (claim 7) wherein the locking barb is angled in a direction toward the top surface (see Figs. 13-16, mechanism 95 could be inserted in either direction into hole 103 such that the locking barbs would be angled towards either the top surface or the bottom surface); (claim 8) wherein the barrel portion protrudes from the bottom surface (see Figs. 4-16); (claim 9) wherein each aperture of the pair of apertures is a round hole (see claims 4-16); (claim 21) wherein the barrel portion is cylindrical and includes a smooth, uninterrupted outer circumferential surface (see Fig. 13; barrel portion forms a cylindrical shaped protrusion along the outer surface thereof which defines a smooth uninterrupted outer circumferential surface - note that merely saying cylindrical or a smooth uninterrupted outer circumferential surface does not require or specify that these structures require a full 360 degree outer circumferential surface to define the protrusion as cylindrical); (claim 22) wherein the barrel portion is offset from a center of the disk portion (see Fig. 13); (claim 23) wherein the cannulation includes a uniform diameter (see Figs. 10-11); and (claim 24) wherein a plurality of locking barbs extend into the cannulation along an entire length of the cannulation and are arranged in at least a first row and a second row, and further wherein the locking barbs of the first row are staggered relative to the locking barbs of the second row (see Figs. 10-16 and [0121]-[0127]).
Regarding claim 25, Fleischman discloses (see abstract; Figs. 4-16; Examiner' Diagram of Fig. 8 above; and [0096]-[0137]) a surgical locking button (75), comprising: a disk portion fully capable of seating against a cortical surface of a bone (the washer is fully capable of seating against a bone cortical surface if one desired to do so as this is a functional intended use limitation - 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);a barrel portion extending from the disk portion and sized for insertion into a bone tunnel (as per above, the barrel portion is of a size where it is fully capable of being inserted into a bone tunnel as this is also an intended use recitation), wherein the barrel portion is offset from a center of the disk portion (see Figs. 7/13) and includes a smooth, uninterrupted outer circumferential surface (see Fig. 13; barrel portion forms a cylindrical shaped protrusion along the outer surface thereof which defines a smooth uninterrupted outer circumferential surface - note that merely saying cylindrical or a smooth uninterrupted outer circumferential surface does not require or specify that these structures require a full 360 degree outer circumferential surface to define the protrusion as cylindrical); a cannulation ("right" hole 103, see Fig. 10)extending through both the disk portion and the barrel portion (see Figs. 4-16) ;a plurality of locking barbs (100, see Fig. 10) arranged in staggered rows along an entire length of the cannulation (see Figs. 10-16 and [0121]-[0127]), each locking barb of the plurality of locking barbs projecting inwardly to engage and restrict movement of a reinforcement suture (85) in a single direction (see Figs. 10-16 and [0121]-[0127]); and at least one aperture (78) extending through the disk portion fully capable of receiving a graft connecting suture that is separate and distinct from any portion of the reinforcement suture (as per above, this is an intended use recitation and the hole 78 is fully capable of receiving a separate/distinct graft connecting suture inserted therein).
Regarding claim 26, Fleischman discloses (see abstract; Figs. 4-16; Examiner' Diagram of Fig. 8 above; and [0096]-[0137]) a surgical locking button (75), comprising: a disk portion fully capable of seating against a cortical surface of a bone (the washer is fully capable of seating against a bone cortical surface if one desired to do so as this is a functional intended use limitation - 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);a barrel portion extending from the disk portion and sized for insertion into a bone tunnel (as per above, the barrel portion is of a size where it is fully capable of being inserted into a bone tunnel as this is also an intended use recitation given the 101/AIA 33a rejection above), a cannulation ("right" hole 103, see Fig. 10)extending through both the disk portion and the barrel portion (see Figs. 4-16); a plurality of locking barbs (100, see Fig. 10) extending into the cannulation (see Fig. 10); an aperture ("left" hole 103, see Fig. 10) extending through the disk portion; a graft connecting suture (80, Fig. 11) received through the aperture fully capable of connecting a graft to the surgical locking button; and a reinforcement suture (85, Fig. 11) received through the cannulation and locked from movement in a specified direction relative to the surgical locking button by the plurality of locking barbs (see Figs. 10-16 and [0121]-[0127])
Fleischman further discloses (claim 27) wherein the plurality of locking barbs interdigitate with a thickened portion of the reinforcement suture to lock the reinforcement suture from the movement (see [0121]-[0127]); (claim 28) wherein the reinforcement suture is separate from and unattached to the graft connecting suture (see [0119] and [0111]); (claim 29) wherein the graft connecting suture is an adjustable loop or a whipstitched suture (see [0111]-[0119]); and (claim 30) wherein the plurality of locking barbs are arranged in at least a first row and a second row along a length of the cannulation, and further wherein the locking barbs of the first row are staggered relative to the locking barbs of the second row (see Figs. 10-16 and [0121]-[0127]).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-3, 5-9, and 21-30 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.
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 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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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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/SHAUN L DAVID/Primary Examiner, Art Unit 3771
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