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
Claims filed on January 9th, 2026 have been entered. Claims 1-3 and 21- 37 are pending in the application.
Claim Objections
Claims 26, 28, and 35 are objected to because of the following informalities:
Claim 26, Line 2 states “elongated slop”, it is suggested to change this to “elongated slot”.
Claim 27 is objected to for being dependent from objected claim 26.
Claim 35, Line 2 states “that bisect the disk”, it is suggested to change this to “that bisects the disk”.
Appropriate correction is required.
Applicant is advised that should claim 3 be found allowable, claim 23 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 § 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.
Claim 28 is 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 28 recites the limitation “wherein the reinforcement suture is clamped between a tip of the screw and the bridge”, it is unclear whether applicant intends to establish that the surgical locking button further comprises the reinforcement suture, or if applicant intends to further establish the function of the surgical locking button in regards to the reinforcement suture, as the reinforcement suture is not positively recited in preceding claim 1 and is only recited within a functional limitation within claim 1. For purposes of examination, this limitation is herein interpreted as functional language in regards to the surgical locking button and the reinforcement suture.
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.
Examiner’s Note: The limitation “wherein the reinforcement suture is clamped between a tip of the screw and the bridge” set forth in claim 28 is herein interpreted as functional language, as discussed above.
Claim(s) 1-3, 23, and 28 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kaiser et al. (US 2004/0260298).
Regarding claim 1, Kaiser teaches a surgical locking button (fixation device 100)(Figs. 1- 7) comprising: a disk portion including an elongated slot (central opening 120); a collar portion protruding from the disk portion (see annotated Fig. 5 below); a proximal surface of the collar portion establishing a bridge for securing a graft relative to a bone (see annotated Fig. 1 below)(Paragraphs 0047 and 0053); a threaded opening (see annotated Fig. 4, Paragraph 0049) formed in the elongated slot and extending from a top surface of the disk portion to the bridge (see annotated Figs. 4 and 5 below) and a screw (fastener 106) received within the threaded opening (Paragraph 0049).
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Regarding the screw configured for locking a reinforcement suture that is separate from the graft by clamping the reinforcement suture against the bridge, since this language is functional, the structure only needs to have the ability to complete the function, therefore as the disk portion has an opening for receiving the screw (Paragraph 0047) and as Kaiser teaches that a suture can be used within the device (Paragraph 0043), when a reinforcement suture is inserted into the opening and the fastener is then inserted into the opening, the suture would be secured separate from the graft and clamped against the bridge similar to what is shown in Fig. 1 (see Fig. 1)(Paragraph 0053).
Regarding claim 2, Kaiser teaches the surgical locking button as discussed above.
Kaiser further teaches wherein the disk portion and the collar portion establish a unitary body (first member 102) of the surgical locking button (Paragraph 0047)(see annotated Fig. 5 below).
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Regarding claims 3 and 23, Kaiser teaches the surgical locking button as discussed above.
Kaiser further teaches wherein the elongated slot (central opening 120) bisects the disk portion (see annotated Fig. 4 below).
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Regarding claim 24, Kaiser teaches the surgical locking button as discussed above.
Kaiser further teaches wherein the elongated slot includes a mid-section located between a pair of longitudinal ends that each include a reduced width compared to the mid-section (see annotated Fig. 4 below).
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Regarding claim 25, Kaiser makes obvious the surgical locking button as discussed above.
Kaiser further teaches wherein each longitudinal end of the pair of longitudinal ends opens into a scallop formed in a side wall of the disk portion (see annotated Fig. 4 below)(Paragraph 0047).
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Regarding claims 26 and 27, Kaiser makes obvious the surgical locking button as discussed above.
Kaiser further teaches wherein the mid-section of the elongated slot extends from the top surface of the disk portion to the proximal surface of the collar portion and wherein the threaded opening is formed at a center of the mid-section of the elongated slot (see annotated Fig. 5 below).
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Regarding claim 28, Kaiser teaches the surgical locking button as discussed above.
Regarding wherein the reinforcement suture is clamped between a tip of the screw and the bridge, since this language is functional, the structure only needs to have the ability to complete the function, therefore as the disk portion has an opening for receiving the screw (Paragraph 0049) and as Kaiser teaches that a suture can be used within the device (Paragraph 0043), when a reinforcement suture is inserted into the opening and the fastener is then inserted into the opening to where the tip of the screw is just at the bridge of the device, then the reinforcement suture would be clamped between a tip of the screw and the bridge.
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 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) 21, 22, and 29- 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kaiser et al. (US 2004/0260298).
Regarding claim 21, Kaiser teaches the surgical locking button as discussed above.
Kaiser further teaches wherein the disk portion includes the top surface, a bottom surface, and a circumferential side wall that extends between the top surface and the bottom surface (see annotated Fig. 5 below).
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Kaiser does not teach in the current embodiment wherein the disk portion includes a flat bottom surface.
However, it would have been obvious to try to one of ordinary skill in the art before the effective filing date to modify the bottom surface of the disk portion as taught by Kaiser to be a flat bottom surface as Kaiser discloses that the bottom surface can have protuberances or have a flat side profile and therefore be flat (Paragraph 0050). Thus, a flat bottom surface would have been obvious because “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 that product was 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, 550 U.S. at 421, 82 USPQ2d at 1397. See MPEP 2143.
Regarding claim 22, Kaiser makes obvious the surgical locking button as discussed above.
Kaiser further teaches wherein the disk portion includes at least one scallop formed in the circumferential side wall (recesses or opening 122)(see Fig. 4)(Paragraph 0047).
Regarding claims 29 and 32, Kaiser (Kaiser et al.) teaches a surgical locking button (fixation device 100)(Figs. 1- 7) comprising: a single piece, unitary button- shaped body (first member 102) including a disk portion and a collar portion protruding from the disk portion (see annotated Fig. 5 below); an elongated slot (central opening 120) bisecting the disk portion (see annotated Fig. 4 below); a proximal surface of the collar portion establishing a bridge for securing a graft relative to a bone (see annotated Fig. 1 below)(Paragraphs 0047 and 0053); a threaded opening (Paragraph 0049) formed at a center of the elongated slot and extending from a top surface of the disk portion to the bridge (see annotated Figs. 4 and 5 below) and a screw (fastener 106) received within the threaded opening (Paragraph 0049).
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Kaiser does not teach in the current embodiment wherein the screw is received within the threaded opening to clamp a suture against the bridge in claim 29 and wherein the suture is clamped between a tip of the screw and the bridge in claim 32.
Kaiser teaches in a different embodiment, a surgical system (fixation device 400)(Figs. 21)(Paragraph 0063) comprising a button (402) with an opening (420) that can receive a suture and a graft (flexible members 51)(Paragraph 0061) to secure them between a plug (406) and the wall of the opening (see Fig. 28A)(Paragraphs 0061 and 0063).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the surgical locking button as taught by the first embodiment of Kaiser to have the screw clamp a suture against the bridge as taught by the second embodiment as taught by the second embodiment of Kaiser, as Kaiser teaches that both embodiments are used to secure grafts and sutures (Paragraphs 0043 and 0069) and that the first embodiment is capable of retaining a suture or a graft (Paragraph 0043).
Regarding wherein the reinforcement suture is clamped between a tip of the screw and the bridge, as the disk portion has an opening for receiving the screw (Paragraph 0049) and as Kaiser teaches that a suture can be used within the device (Paragraph 0043), when a reinforcement suture is inserted into the opening and the fastener is then inserted into the opening to where the tip of the screw is just at the bridge of the device, then the reinforcement suture would be clamped between a tip of the screw and the bridge.
Regarding claim 30, Kaiser makes obvious the surgical locking button as discussed above.
Kaiser further teaches wherein the elongated slot includes a mid-section located between a pair of longitudinal ends that include a reduced width compared to the mid-section (see annotated Fig. 4 below).
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Regarding claim 31, Kaiser makes obvious the surgical locking button as discussed above.
Kaiser further teaches wherein each longitudinal end of the pair of longitudinal ends opens into a scallop formed in a side wall of the disk portion (see annotated Fig. 4 below)(Paragraph 0047).
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Claim(s) 33-37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kaiser et al. (US 2004/0260298) in view of Zenz-Olson et al. (US 2022/0323198).
Regarding claim 33, Kaiser (Kaiser et al.) teaches a graft fixation system (fixation device 100)(Figs. 1- 7) comprising: a surgical locking button (first member 102) including a disk portion and a collar portion monolithically protruding from the disk portion (see annotated Fig. 5 below); a proximal surface of the collar portion establishing a bridge for securing a graft relative to a bone (see annotated Fig. 1 below)(Paragraphs 0047 and 0053); a threaded opening formed in the disk portion (see annotated Fig. 4 below, Paragraph 0049) and a screw (fastener 106) secured within the threaded opening (Paragraph 0051).
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Regarding the disk portion configured to seat against a cortical surface of a bone, as this language is functional, the structure of the system only needs to be able to accomplish the function, therefore since Kaiser teaches that the fixation device is used with bone, and the disk portion is capable of being seated within it (Paragraph 0058), then the disk portion is capable of seating against a cortical surface of a bone.
Regarding the collar portion extending into a bone tunnel, as Kaiser teaches in Paragraph 0058 that the fixation device 100, which comprises the disk portion and the collar portion, can be implanted in the tunnel of the bone, then the collar portion extends into a bone tunnel.
Kaiser does not teach an adjustable loop and a reinforcement suture each connectable to the surgical locking button wherein the reinforcement suture is a separate structure from any portion of the adjustable loop or wherein the screw is secured within the threaded opening for clamping the reinforcement suture against the bridge.
Zenz-Olson (Zenz- Olson et al.) teaches a similar graft fixation system (abstract)(Figs. 2K- 2L) comprising: a surgical locking device (locking member 250, toggle body 251) including a disk portion and a collar portion (see annotated Fig. 2L below), a proximal surface of the collar portion establishing a bridge (see annotated Fig. 2L below), an opening (252, 253, 254) formed in the disk portion (Paragraph 0110), an adjustable loop (261) and a reinforcement suture (260) each connectable to the surgical locking button (see Fig. 2K), wherein the reinforcement suture is a separate structure from any portion of the adjustable loop (Paragraphs 0111 and 0112), wherein a locking portion (250) is secured within an opening (263)(Paragraph 0112).
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It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system as taught by Kaiser to comprise an adjustable loop and a reinforcement suture as taught by Zenz-Olson, as Kaiser teaches that a suture can be used with the system (Kaiser, Paragraphs 0002- 0005 and 0043) and Zenz- Olson teaches that the suture is used with a similar system for securing a tendon or other tissue (Zenz-Olson, Paragraphs 0008 and 0009).
Regarding wherein the screw is secured within the threaded opening for clamping the reinforcement suture against the bridge, as Kaiser teaches that a suture can be secured within the threaded opening (Paragraph 0043), and the combination has a suture and a graft, then the screw of the combination when secured within the threaded opening clamps the suture against the bridge.
Regarding claim 34, Kaiser makes obvious the surgical locking button as discussed above.
As discussed above, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system as taught by Kaiser to comprise an adjustable loop and a reinforcement suture as taught by Zenz-Olson, as Kaiser teaches that a suture can be used with the system (Kaiser, Paragraphs 0002- 0005) and Zenz- Olson teaches that the suture is used with a similar system for securing a tendon or other tissue (Zenz-Olson, Paragraphs 0008 and 0009).
The combination further teaches wherein the reinforcement suture (260) includes a first free end and a second free end that are crisscrossed over one another over the bridge (see annotated Figs. 2L and 3A below)(Zenz-Olson teaches that the suture is capable of crisscrossing over each other over the bridge as shown in this figure.).
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Regarding claim 35, Kaiser makes obvious the surgical locking button as discussed above.
Kaiser further teaches wherein the disk portion includes an elongated slot (central opening 120) that bisects the disk portion (see annotated Fig. 4 below).
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Regarding claim 36, Kaiser makes obvious the surgical locking button as discussed above.
Kaiser further teaches wherein the threaded opening is formed at a center of the elongated slot and extends from a top surface of the disk portion to the bridge (see annotated Fig. 5 below).
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Regarding claim 37, Kaiser makes obvious the surgical locking button as discussed above.
Kaiser further teaches wherein the elongated slot includes a mid-section located between a pair of longitudinal ends that include a reduced width compared to the mid-section (see annotated Fig. 4 below).
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Response to Arguments
Applicant's arguments filed January 9th, 2026 have been fully considered but they are not persuasive.
Applicant’s arguments, see Pages 6-7, regarding that Kaiser does not teach a disk portion having an elongated slot, a threaded opening formed in the elongated slot and a screw that clamps the reinforcement suture against a bridge of the collar portion, have been fully considered but are not persuasive, as discussed above, Kaiser teaches a surgical locking button (fixation device 100)(Figs. 1- 7) comprising: a disk portion including an elongated slot (central opening 120); a collar portion protruding from the disk portion (see annotated Fig. 5 below); a proximal surface of the collar portion establishing a bridge for securing a graft relative to a bone (see annotated Fig. 1 below)(Paragraphs 0047 and 0053); a threaded opening (see annotated Fig. 4, Paragraph 0049) formed in the elongated slot and extending from a top surface of the disk portion to the bridge (see annotated Figs. 4 and 5 below) and a screw (fastener 106) received within the threaded opening (Paragraph 0049).
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Regarding the screw configured for locking a reinforcement suture that is separate from the graft by clamping the reinforcement suture against the bridge, since this language is functional, the structure only needs to have the ability to complete the function, therefore as the disk portion has an opening for receiving the screw (Paragraph 0047) and as Kaiser teaches that a suture can be used within the device (Paragraph 0043), when a reinforcement suture is inserted into the opening and the fastener is then inserted into the opening, the suture would be secured separate from the graft and clamped against the bridge similar to what is shown in Fig. 1 (see Fig. 1)(Paragraph 0053).
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 LINDSEY R. RIVERS whose telephone number is (571)272-0251. The examiner can normally be reached Monday- Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at (571) 272- 4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/L.R.R./Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771
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